Glossary extracted starting with automatic seeds, with BOW for the domain hel and language EN
qol | Quality Of Life |
css | Plasma concentration at steady state |
diagnose | To find the cause of health problems. |
ultrasound | An imaging technique used to obtain pictures by bouncing sound waves off an object. |
pivotal study | A study, usually Phase III, which presents the data used by regulatory agencies to decide whether to approve a drug. |
preinvasive cancer | a cluster of malignant cells that has not yet invaded the deeper epithelial tissue or spread to other parts of the body |
myelinated fiber | A nerve fiber wrapped by a series of Schwann cells, resulting in greater conduction velocity. |
therapeutic window | This term is applied to the difference between the minimum and maximum doses that may be given subjects to obtain an adequate clinical response and avoid intolerable toxic effects |
stereotaxic coordinates | A Cartesian system in which points in the brain are referenced by coordinates in horizontal, sagittal, and frontal planes. |
miniature end-plate potential | A tiny, spontaneous postsynaptic potential recorded near the end-plate in muscle fibers, abbr |
risk | A measure of (1) the probability of occurrence of harm to human health or (2) the severity of harm that may occur |
trachea | The windpipe. |
therapy | Treatment intended and expected to alleviate a disease or disorder. |
follicular dendritic cells | Cells found in the germinal centers of lymphoid organs |
experimental treatment group | The group that receives the investigational treatment in a trial; the group to which the control group results are compared. |
carlavirus | (Siglum of carnation latent virus.) Member of a group of plant viruses with slightly flexuous, rod-shaped particles containing a single molecule of linear RNA, most of which are transmitted by aphids in a noncirculative manner. |
adjuvant therapy | Therapy provided to enhance the effect of a primary therapy; auxiliary therapy. |
transformation | the transfer of genetic materials from one organism to another by humans (genetic engineering); a means of genetic variation in bacteria by absorption and incorporation of DNA from another bacterial cell |
human pharmacology | The study of uses, actions and undesirable side effects of drugs in humans, which typically follows pharmacological studies on animals. |
mucociliary clearance | In the airways of the lungs, this system works to move mucus and particles breathed in to upper airways so they can be coughed out of the lungs. |
controlled trial | A prospective clinical trial comparing two or more treatments, or placebo and treatment(s) in similar groups of patients or within patients |
preclinincal study | See Preliminary Study. |
conference report | Go to NIAID's Funding Opportunity Planning and the Budget Cycle. |
orthopedist | Medical doctor specializing in problems of the musculoskeletal system, including the spine |
grant application | PIs oversee the scientific and technical aspects of a grant and the day-to-day management of the research |
perinatal | Events that occur at or around the time of birth. |
sterility | (1) The absence of viable contaminating microorganisms; aseptic state. |
placebo | An inactive substance against which investigational treatments are compared for efficacy |
dysphoria | Anxiety, depression or unease |
study endpoint | A pre-defined measure used to determine the outcome of a study |
medicare | A federal program of reimbursement to hospitals and physicians for healthcare provided to people 65 years of age and older, people eligible for Social Security disability payments for at least two years, and selected workers who need kidney transplantation or dialysis services. |
continuing review | is the periodic review of a research study by an IRB to evaluate whether the study continues to meet organizational and regulatory requirements |
side effect | Side effect |
biliary fibrosis | A disease of the gallbladder, bile ducts, and bile characterized by the replacement of normal tissue with fibrous tissue and loss of functional cells. |
feedforward inhibition | A situation in which the output of a neuron (or set of neurons) is used to inhibit neurons subsequent to it in a particular pathway. |
colitis | Inflammation of the colon. |
scotoma | An area of depressed or absent vision within the visual field, surrounded by an area of normal vision. |
control group | The group of individuals in a clinical study who do not receive the new treatment or drug, but instead are administered no treatment, an existing treatment or placebo |
focus: | small area of diseased plants within a population |
bacteria | Bacteria |
manufactured or fabricated data | Data or information created without performing the tasks required to get the data |
agency | The Food and Drug Administration |
preclinical investigations | Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its applications to humans. |
uniform anatomical gift act | Legislation adopted by all 50 States and the District of Columbia that indicates procedures for donation of all or part of a decedent's body for such activities as medical education, scientific research, and organ transplantation. |
phytosterols | Plant compounds that form the membranes of cells and help reduce blood cholesterol levels |
rhizotomy | Interruption of a spinal root within the spinal canal. |
cholinergic synapse | A junction between two cells that employs as its transmitter substance acetylcholine. |
complication | An additional problem that arises following an illness, treatment or procedure |
translational research | Studies that provide the bridge between basic research and patient care. |
responsible party | The sponsor, sponsor-investigator, or sponsor-designated principal investigator who is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information |
unblinding | Determination of the study treatment administered |
addiction | Strong chronic physiological and psychological dependence on a substance |
computed tomography scan | Diagnostic technique using x-ray to provide a computerized cross section image of soft tissue and bone |
clearance | The rate at which a substance is removed from the blood through normal processes. |
adverse event | Any change in health that occurs in a person after he or she enrolls in a clinical trial |
record | See STUDY RECORD. |
cd | Abbreviation for "cluster of differentiation," referring to cell surface molecules that are used to identify stages of maturity of immune cells, for example, CD4+ T cells. |
major histocompatibility complex | A group of genes that control aspects of the immune response |
plasma cells | Large antibody-producing cells that develop from B cells |
investigational product | A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a market authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. |
application package | See Grant Application Package. |
audition | The act of hearing or ability to hear. |
risk-benefit ratio | Risk to individual subject vs |
data monitoring committee | A group of independent scientists who monitor the safety and scientific integrity of a clinical trial |
investigator | A researcher responsible for conducting a clinical trial at a trial site. |
ade | Adverse Drug Experience |
phospholipid | A class of compounds in which phosphorus is part of a fatty substance. |
control group | In many clinical trials, one group of patients receives the experimental drug or treatment, while the control group receives either a standard treatment or placebo (see PLACEBO and STANDARD TREATMENT). |
epidemiology | The branch of medical science that deals with the study of incidence, distribution, and control of a disease in a population. |
package insert | Document that lists the most common adverse effects for an approved drug. |
nematode | More or less elongate, spindle-shaped, worm-like animals ranging in size from less than a millimeter to several meters in length, living as saprophytes in soil or water or as parasites of plants or animals. |
multicellular | composed of many cells (see unicellular) |
hiv/aids | HIV/AIDS |
tissue | A group of cells of similar structure which performs a special function. |
certified clinical research coordinator | CCRC with greater than two years experience and with certification earned by passing required program and exam. |
steam deodorization | Using boiling water to remove small odor causing molecules. |
recombinant | An organism whose genome contains integrated genetic material from a different organism |
petit mal attacks | epileptic seizures characterized by fixed stare, unconsciousness, unresponsiveness, and lack of activity. |
resistance | The opposition by a conductor to the passage of an electric current. |
principal investigator | The scientist or scholar with primary responsibility for the design and conduct of a research project |
rootstock | portion of the stem (trunk) and the associated root system into which a bud or scion is inserted in grafting |
genotype | genetic constitution of an individual or group; class or group of individuals sharing a specific genetic makeup (see phenotype ) |
research | Systematic investigation designed to develop or contribute to generalizable knowledge |
disease cycle | Of a disease caused by a biotic agent: the cyclical sequence of host and parasite development and interaction that result in disease, in reproduction or replication of the pathogen, and in the readying of a new generation of the parasite for infection. |
chemotherapy | The treatment, mostly of cancer, by the use of a series of cytotoxic drugs that attack cancerous cells |
neuropsychological | Involved with the brain and nervous system and behaviour. |
cldtot | Total distribution clearance |
coercion | In human subjects research, coercion occurs when an overt or implicit threat of harm (such as loss of services or access to programs to which the potential participant is otherwise entitled) is intentionally presented by one person to another in order to obtain compliance or research participation |
national select agents registry | For select agent-related information, see select agent |
monoclonal antibodies | Antibodies produced by a hybridoma or antibody-producing cell source for a specific antigen |
investigator | In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3] |
allegation of non-compliance | as an unproven assertion of non-compliance. |
hormone replacement therapy | the administration of estrogen and progestin to women to relieve the symptoms of menopause, prevent osteoporosis, and reduce the risk of heart disease. |
dl | deciliter |
cohort | A group of individuals with some characteristics in common. |
spermatheca | In nematodes: An enlarged portion of the female gonad between the oviduct and the uterus functioning in the storage of the sperm. |
biofeedback | Complementary medicine technique that trains you to control your body’s unconscious processes like breathing and heart rate, which can help to alleviate pain. |
pg/ml | Picograms (one millionth of a gram) per mililiter. |
clinical trial agreement | A letter outlining the terms of the contract between the sponsor and the University |
exclusion criteria | Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol. |
systemic | Of a chemical or a pathogen: Spreading internally throughout the plant body. |
hyperplasia | Abnormal increase in the elements composing a part (as tissue cells). |
repolarization phase | The return of the membrane potential from the peak overshoot of the spike back to the resting potential, syn |
consensual light reflex | Constriction of the pupil of the eye opposite that into which a light is shown. |
creatinine | A protein found in muscles and blood, and excreted by the kidneys in the urine |
partially hydrogenated | Treatment of an unsaturated fat with hydrogen to make it more solid. |
lobectomy | Excision of a lobe. |
hybrid | offspring of two individuals of different genotypes |
immune system | System that protects body from foreign substances and infections |
bridge award | See R56-Bridge award. |
social worker | Professional who may assist people to obtain tangible services, help communities or groups provide or improve social and health services, provide counseling and psychotherapy with individuals, families, and groups |
pm | Project Management, the discipline of planning, organizing, securing and managing resources to bring about the successful completion of specific project goals and objectives. |
noninfectious disease | a disease that is caused by an abiotic agent that cannot be transmitted from one plant to another |
nociceptive pain | Nociceptive pain is a result of injury to body tissues |
spermatocyte | In nematodes: A cell giving rise to spermatozoa or spermatozooids. |
xylem | A plant tissue consisting of tracheids, vessels, parenchyma cells, and fibers; functions in conduction of water and minerals and in structural support of the plant. |
fpr | See final proposal revision. |
glycoprotein | A conjugated protein in which the nonprotein group is a carbohydrate (i.e., a sugar molecule); also called glucoprotein. |
federal acquisition regulation | Go to HHSAR. |
short-term memory | Recall of learned responses or material having a duration of minutes to hours, syn |
follicle | A small anatomical cavity or deep narrow-mouthed depression; a small lymph node. |
releasing hormone | 1) a chemical that controls the production and release of other hormones |
translocation | movement of water, nutrients, chemicals, or food materials within a plant |
assurance | In a clinical trial, a formal written, binding commitment that is submitted to a federal agency by an institution in which the institution agrees to comply with regulations governing research with human subjects |
adme | An acronym in pharmacology and pharmacokinetics for Absorption, Distribution, Metabolism, Excretion. |
spasticity | Resistance of a limb to passive stretch due to increased tone in either flexors or extensors (usually extensors), but not both. |
mva | Modified Vaccinia Ankara (MVA) was developed to be a safe smallpox vaccine by further attenuating the standard smallpox vaccine during serial passage in chicken embryos |
crf | see Case Report Form |
central nervous system | The brain and the spinal cord. |
sporulation | The process of producing spores. |
accommodation | In the eye: adjustment of the eye for near vision by contraction of ciliary muscle; in membranes: elevation of critical firing level with prolonged small hypopolarization. |
host range | the range of plants on which an organism, particularly a parasite, feeds |
acuity | Clarity of vision measured as the minimum distance between two distinguishable points at a standard distance. |
neural | Related to or affecting the nervous system. |
pneumonia | Inflammation of soft lung tissue caused by bacterial, viral, or fungal pathogens that results in the formation of an exudate within alveoli |
hipaa | Health Insurance Portability and Accountability Act of 1996 |
dynamic index | The difference in rate of discharge of a spindle receptor during active stretching and maintained stretch. |
good manufacturing practice | Good manufacturing practice (GMP) |
primary infection | The first infection of a plant by a pathogen emerging from a dormant stage in its life cycle (overwintering or oversummering). |
informed consent | The patient’s confirmation of his or her willingness to participate in a clinical trial, along with written, signed and dated documentation |
bone marrow | Soft tissue located in the cavities of the bones where blood cells such as erythrocytes, leukocytes and platelets are formed |
thin filament | The smaller diameter myofilament of the myofibrils of striated muscle. |
antitoxins | Antibodies that recognize and inactivate toxins produced by certain bacteria, plants or animals |
subjects | See: human subjects |
lymphocyte | A type of white blood cell produced in the lymphoid organs that is primarily responsible for immune responses |
clinical efficacy | Clinical efficacy |
recombinant dna | See Biotechnology; Genetic Engineering. |
suspension of irb approval | An action initiated by the IRB or other officials of the organization to stop temporarily some or all research procedures pending future action by the IRB or by the Investigator or his/her study personnel. |
competition in contracting act | Public law increasing the number of government procurements awarded competitively |
medullary thyroid cancer | Thyroid cancer arising from the parafollicular cells |
necrosis | Necrosis |
infectious | pertaining to disease, capable of spreading from plant to plant |
anti-hat | Humanized Anti-Tac |
gravid | containing an egg or eggs; capable of depositing eggs |
a fiber | A myelinated nerve fiber with conduction velocity in the range from 1 to 120 m/sec; a class of fibers divisible into alpha, beta, gamma and delta subgroups. |
phs 398 grant application | Grantees use a PHS 2590 to continue a grant |
reconstituted vaccine | Reconstituted vaccine |
screening studies | Refers to studies that test how to identify diseases or conditions. |
complementary and alternative therapy | Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote wellbeing or treat health conditions |
collateral inhibition | Inhibition produced in a group of neurons by activity in some neurons of the group that excite inhibitory interneurons by way of collaterals of their axons; sometimes inaccurately used as syn |
antigen | A protein on the surface of a virus, bacteria or cell that can stimulate the immune system to produce antibodies as a defense mechanism. |
hisi | See highly influential scientific information. |
pnbc | Periods with New Bone Complications |
exclusion criteria | Characteristics or traits that exclude an otherwise eligible person from a study. |
510k device | A 510(k) is a pre-market submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device [21 CFR 807.92(a)(3)] |
dt | Diphtheria/Tetanus |
spirulina | An edible microorganism which has been used for nutrition in humans, poultry, and in aquaculture |
hepatitis b vaccine | Hepatitis B vaccine (HepB) |
sub-investigator | An individual member of the clinical study team who performs essential trial procedures and/or makes important trial-related decisions. |
nuremberg code | As a result of the medical experimentation conducted by Nazis during World War II, the U.S |
diphtheritic neuritis | A neuritis occurring in the period after an infection by diphtheria bacteria. |
ade | AIDS- Defining Event |
leukotomy | The operation of cutting the white matter in the oval center of the frontal lobe of the brain, syn |
sponsor | An individual, company, institution, or organization that initiates a clinical investigation |
contract research organization | A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s study-related duties and functions. |
pharmacokinetics | Studies that determine the action of a drug in the body over a period of time, including the processes of absorption, distribution, localization in tissues and excretion. |
psychologist | A professional who is licensed to provide therapeutic services, research and testing. There are clinical psychologists who provide counseling and psychotherapy. |
axoaxonic synapse | The synaptic junction between two axons thought to mediate presynaptic hypopolarization or presynaptic inhibition. |
prospective study | Research that follows a particular group over time |
postmenopausal | Occurring after menopause (change of life). |
assurance | A renewable permit granted by the federal government to an institution or research center to conduct clinical trials. |
topical analgesics | Analgesics designed for or involving application to or action on the surface of a part of the body |
gp120 | Glycoprotein 120, a protein that protrudes from the surface of HIV and binds to CD4+ T cells |
intent to treat | A type of analysis use for evaluating clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the experimental treatment. |
clinical assessment | An evaluation of the symptoms and progression of a disease. |
university medical center | A healthcare institution that is part of a university that teaches medical students and conducts basic research (preclinical research) and clinical trials |
flagellum | A whip-like appendage responsible for motility in the majority of motile bacteria and other protists, fungi, algae, etc |
epidermis: | surface layer of cells of leaves and other plant parts |
oxidizing agent | A compound that readily oxidizes other materials |
ich | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration with the purpose to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. |
aphagia | Abstention from eating. |
protanope | A person who lacks responses to red light; "red color-blind." |
amplification | Production of multiple copies of a DNA sequence, either in vivo or in vitro, starting with one or a few copies. |
dual peer review | Go to these resources: |
pathogenesis | stages in disease development |
cartilage | The connective, rubbery tissue that cushions bones at the joint. |
sympathetic nervous system | The sympathetic nervous system and the parasympathetic nervous system make up the autonomic nervous system |
formulation | The combination of biological substances and/or chemicals used to make dosage forms such as tablets, capsules and solutions. |
biotroph | An organism that derives nutrients from the living tissues of another organism (its host). |
conduction deafness | Hearing loss due to impairment of movement of the |
influenza | Influenza |
cthrough | Through plasma concentration |
telephone report | Notification via telephone to the FDA of unexpected fatal or life threatening advent associated with a clinical study. |
institutional review boards | Once clinical evaluation is completed, a new drug application must be submitted to FDA to obtain approval to market the drug |
cyclopentenoperhydrophenanthrene nucleus | a backbone structure common to cholesterol and its derivatives (e.g., steroid hormones) |
iatrogenic | Unexpected result of a medical treatment caused by the treatment itself |
suppressor t cells | (T8, CD8) |
drug discovery | Identification of new drug targets and leads for treatments or preventions either by identifying molecules with desired biological effects or by screening agents using an indicator system to show efficacy. |
pharmacotherapy | Medication based therapy |
parallel group study | A study in which two or more treatments are compared by randomly assigning participants to one of two treatment groups, which will receive the allocated medication throughout the duration of the study. |
direct operations | Funds for salary and other administrative costs |
hypothyroidism | decreased production of thyroid hormone, leading to symptoms of thyroid insufficiency. |
sham treatment | An inactive device or device/procedure that mimics the actual device and can be used as a placebo in a clinical trial. |
diabetes | Diabetes |
vein banding | A symptom of virus-infected leaves in which tissues along the veins are darker green than other laminar tissue. |
narcotic | Medication that produces pain relief by depressing the central nervous system. |
alveolar | Pertaining to the alveoli sac, the site of gas exchange in the lungs. |
intradermal | Introduced into the skin. |
cirrhosis | A chronic disease of the liver characterized by the replacement of normal tissue with fibrous tissue and the loss of functional liver cells. |
lod score | An expression of the probability that a gene and a marker are linked. |
submodality | Any division of one of the modalities, example: touch is a submodality of somesthesia. |
synergy | The interaction of two or more agents or forces so that their combined effect is greater than the sum of their individual effects |
polymers | Compounds formed from smaller units linked together. |
adr | Adverse Drug Reaction |
hypalgesia | Diminished pain sensation. |
autonomic nervous system | The portion of the nervous system concerned with regulation of the activity of cardiac muscle, smooth muscle and glands. |
jofoc | See justification for other than full and open competition. |
clinicaltrials.gov | Searchable database which provides patients, family members and the public with information about current ongoing clinical research studies |
subspecies | An infraspecific population defined on the basis of one or more characters (morphologic for most organisms) that distinguish its members from typical representatives of the species. |
control group | The group of patients who receive the standard treatment (no treatment or placebo) and who are compared to the group of patients receiving the investigational treatment. |
performance site | A site where research is performed. |
phycomycete | archaic term for a member of a group of fungi without cross walls (septa) in their mycelium |
dimorphism | Existence of two morphologically different forms in one organism. |
peer review | Review of a clinical trial by experts |
toxicity | The extent, quality or degree of being poisonous or harmful to the body. |
susceptibility | Being prone to, sensitive to, or lacking the ability to resist something. |
holotype | The single specimen designated or indicated as "the type" by the original author at the time of publication of the original description. |
heterothallic | The condition of being self-sterile, requiring a partner for sexual reproduction. |
muscle | Tissue of the body which primarily functions as a source of power. |
deviation | An incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the resultant data |
myopia | A pathological condition of refraction in which the eyeball is too long for the refractive power of the lens and images focus in front of the retina, syn |
efferent | Pathways leading from; in the case of peripheral nerves, those conducting away from the central nervous system. |
predisposition | an increase in susceptibility resulting from the influence of wounds or the environment |
agar | Mixture of polysaccharides derived from red algae that forms a gel at temperatures below about 40C |
chromatic aberration | Colored rings resulting from different amounts of refraction by a lens of light of different wavelengths. |
sporophyte | the diploid stage of a plant (see gametophyte) |
interferon | A general term used to describe a family of 20-25 proteins that cause a cell to become resistant to a wide variety of viruses |
blinded or blinding | A method used in a clinical trial to prevent participants and/or researchers from knowing whether the patient is receiving the experimental or control treatment in a trial |
sterilization | the total destruction of living organisms by various means, including heat, chemicals or irradiation |
t lymphocyte proliferation assay | Measures the strength of response of T memory cells (a subgroup of T lymphocytes) to HIV |
retrosplenial cortex | An outer brain component involved in the recall of episodes and can cause amnesia if damaged. |
mcg | microgram |
thyroid-binding proteins | Proteins to which thyroid hormones attach themselves and thus circulate in the bloodstream. |
diaschisis | A loss of function due to depression of activity at some distance from a lesion. |
mummy | a dried shriveled fruit; plant part or organ partially or completely replaced with fungal structures |
root hair | threadlike, single-celled outgrowths from a root epidermal cell |
race | A subspecies group of pathogens that infect a given set of plant varieties. |
endpoint | Overall outcome that the protocol is designed to evaluate. |
atrophy | A wasting away; a diminution in the size of a cell, tissue, or organ. |
intermediate zone | The part of a dermatome or receptive field outside the autonomous zone. |
facultative anaerobe | Refers to an organism that normally grows |
trenching | physical separation of soil in a vertical plane to sever grafted roots between trees |
complex cells | Neurons in visual cortex that are sensitive to bars of light moving in particular directions across the retina. |
interveinal | between (leaf) veins |
sieve tube | A series of phloem cells forming a long cellular tube through which food materials are transported. |
risk | the probability of harm or injury (physical, psychological, social, legal, or economic) occurring as a result of participation in a research study |
metastatic disease | Cancer that has spread from its original site to other parts of the body. |
norepinephrine | A substance secreted as a transmitter substance by sympathetic postganglionic nerve terminals and as a hormone by the adrenal medulla. |
clinical | Pertaining to or founded on observation and treatment of patients, as distinguished from theoretical or basic science. |
lactation | The period of time during which a woman is providing her breast milk to an infant or child. |
septate | with cross walls; having septa |
placebo | A placebo is an inactive pill, liquid, or powder that has no treatment value |
peer review | Formerly called competing supplement; the former term revision is now resubmission |
rising phase | The earliest positive-going portion of the nerve or muscle action potential, syn |
placebo | An inactive substance or treatment, such as a sugar pill, injection of sterile water, or sham medical device, that is given under the guise of treatment to separate the effects of the actual treatment being evaluated from psychological or other effects. |
inclusion criteria | The factors (or reasons) that allow a person to participate in a clinical study. |
mosaic vaccine | Mosaic HIV vaccines include inserts made from strings of amino acids (the building blocks of proteins) |
reticuloendothelial cells | A system of interstitial cells that includes all the phagocytic cells, which trap and consume foreign agents, except the leukocytes circulating in the bloodstream |
complex dosage requirements | When clinical trial participants are required to take an experimental drug or treatment several times a day or to take a combination of drugs and treatments. |
unanticipated | An event is "unanticipated" when it was unforeseeable at the time of its occurrence. |
dsptp | Division of Special Pathogen and Transplant Products, Office of Antimicrobial Resistance |
sponsor | Organization or individual that takes responsibility for initiation, management and/or financing of a clinical trial. |
alpha motoneuron | A motoneuron whose axon is an A fiber, syn |
hardiness | ability to withstand stress; often used to refer to cold hardiness |
second opportunity | Second opportunity |
facet block | An injection of local anesthetic near the problematic facet joint in the spine to help diagnose the cause and location of back pain and also to provide pain relief. |
titration | Determination of a given component in solution by addition of a liquid reagent of known strength until a given endpoint is reached |
dose-ranging study | A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful |
infammatory bowel disease | Infammatory bowel disease |
surround inhibition | The inhibition of a cell's discharge that results from stimulation of an annular area around the excitatory receptive field. |
secretion | A product of a gland, like sweat or saliva (see GLAND). |
autologous | Pertaining to the same organism or one of its parts; originating within an organism itself. |
lymph | A transparent, slightly yellow fluid that carries lymphocytes |
epitope | A unique shape or marker carried on an antigen's surface that triggers a corresponding antibody response |
metabolism | The use of calories and oxygen to produce energy. |
voluntary | Free of coercion, duress, or undue inducement |
range study | A clinical trial in which two or more doses of a substance are used to determine which one is most effective and least harmful. Read more. |
dendrite | Any of the usual branching protoplasmic processes that conduct impulses toward the body of a nerve cell |
sponsor | The organization or person (see Sponsor-Investigator) who oversees the clinical study and is responsible for analyzing the study data |
h�thle cell cancer | A form of follicular thyroid cancer |
risk-benefit analysis | Risk-benefit analysis |
sudden infant death syndrome | Sudden Infant Death Syndrome (SIDS) (also known as "crib" or "cot" death) |
live-vector vaccine | A vaccine that uses a non-disease-causing organism (virus or bacterium) to transport HIV or other foreign genes into the body, thereby stimulating an effective immune response to the foreign products |
enrollment | The number of participants in a clinical study |
critique | Also see reader and scientific review officer. |
cogwheel rigidity | The form of rigidity of Parkinsonism, in which the muscle lengthens in a series of little jerks when it is stretched. |
melanoma | any of several malignant neoplasms (usually of the skin) consisting of melanocytes |
subclinical | Conditions that are not detectable by standard clinical tests. |
g | gram |
bid | bis in die (twice daily) |
complement cascade | A precise sequence of events, usually triggered by an antigen-antibody complex, in which each component of the complement system is activated in turn |
pathogenesis | The origin and development of a disease. |
platelet aggregation | Clumping together of the platelets, possibly restricting blood flow. |
research | A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [ |
commons signing official | See signing official. |
off-label use | A drug prescribed for conditions other than those approved by the FDA. |
serology | Branch of science dealing with properties and reactions of sera, particularly the use of antibodies in the sera to examine the properties of antigens. |
lobectomy | Surgical removal of all or part of one lobe of the thyroid |
disinfestant | An agent that kills or inactivates pathogens in the environment or on the surface of a plant or plant organ before infection takes place. |
flagellum | A whip-like appendage responsible for motility in the majority of motile bacteria and other protists, fungi, algae, etc. |
sensitive | Responsive to a stimulus |
standard treatment | An effective treatment or drug approved by the FDA for a specific disease or condition. |
informed consent | The process of learning about a clinical study or trial before deciding whether to join |
tail | In nematodes: The portion of the body between the anus and the posterior terminus. |
cosmid | A plasmid into which has been inserted the cos site of bacteriophage. |
phytochemicals | Active chemicals in a plant that account for its medicinal properties. |
nerve deafness | Hearing loss due to damage to auditory receptors or auditory pathways of the central nervous system. |
auto-disable syringes | Auto-disable (AD) syringes |
hybridoma | A hybrid cell produced by the fusion of an antibody-producing lymphocyte with a tumor cell |
deterioration | The process of becoming worse |
in vitro | Testing or action outside an organism (i.e |
peer review | The process by which new scientific or medical findings, announced by one researcher, are reviewed by other scientists or physicians before these findings are published. |
cl/f | Apparent clearance |
host | A plant or animal harboring another organism. |
unknown | A clinical study in ClinicalTrials.gov with a status of Recruiting; Not yet recruiting; or Active, not recruiting and whose status has not been confirmed within the past 2 years |
single-blind study | See Blinding. |
parkinsonism | Basal ganglion disease characterized by hypokinesia, tremor at rest, and muscular rigidity. |
bradykinesia | Slowness of movement. |
antagonism | An ecological association between organisms in which one or more of the participants is harmed or has its activities limited. |
transcription | The process of synthesizing RNA from a DNA template |
ctx | C-telopeptide |
inclusion criteria | Characteristics or traits of people who are eligible for a study. |
palliative | A treatment that provides symptomatic relief, but not a cure. |
severe vaccine reaction | Severe vaccine reaction |
non-steroidal | Not containing steroids Steroids are hormones made from cholesterol and include testosterone and estrogen. |
virescence | Greening of tissue that is normally devoid of chlorophyll; the abnormal development of flowers in which all organs are green and partly or wholly transformed into structures like small leaves. |
levothyroxine sodium | Thyroid hormone supplements. |
in vivo | Testing or action inside an organism, such as a human subject or patient. |
genome | the complete genetic information of an organism or virus |
apv | Amprenavir |
reactive oxygen species | Extremely reactive oxygen products. Dig Deeper |
phase iv study | Phase IV studies are post-marketing studies conducted to gain additional information about a drug’s safety and efficacy and to compare the drug to competitors in the market – after the drug has been approved by the FDA. |
guardian | An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(3)]. |
institutional products | The Institutional Products industry is comprised primarily of institutional cleaning products, including some of the following product segments: sanitation and janitorial cleaners, industrial and technical cleaners, kitchen and catering cleaning agents, food and dairy processing cleaners, laundry agents and others. |
federalwide assurance | See institutional official for human subjects and risk. |
follicles | Microscopic spherical units that make up the thyroid gland. |
investigational product release | Regulatory compliance personnel’s authorization to ship investigational product. |
study endpoint | Results from a clinical trial used to judge the effectiveness of a drug treatment (see OUTCOME). |
endocrinology | The study of diseases and disorders of the endocrine system (like thyroid diseases and diabetes) |
perennial | something that occurs year after year; plant that survives for several to many years (see annual, biennial) |
protein | A large organized molecule composed of one or more amino acids chains |
biofeedback | A technique in which an individual learns to consciously control involuntary physical responses, including heart rate, brain waves, and muscle contractions |
double-blind | The design of a study in which neither the investigator or the subject knows which medication (or placebo) the subject is receiving. |
wind-up pain | Pain caused as a result of the release of chemicals from nerve cells in the spinal cord that intensify pain and the signal to the brain |
local | Local (or localized) |
minimal risk review | The term commonly used by the UW research community to refer to the expedited review process, as in "Minimal Risk review". |
legal guardian | See: guardian |
fsgs | Focal Segmental Glomerulosclerosis |
palliative care | Medical care provided by an interdisciplinary team that promotes quality of life and relieves suffering |
hyperpolarization | From the resting potential, a change in the transmembrane potential of a cell away from the isoelectric point (i.e., zero voltage). |
astigmatism | Unequal curvature of the refractive surfaces of the eye as a result of which a beam of light is not sharply focused on the retina. |
human subject | A patient or healthy individual participating in a research study |
research coordinator | A staff person chosen by the principal investigator to assist him/her in conducting the clinical trial (see PRINCIPAL INVESTIGATOR). |
dysplasia | Any abnormal development of tissues or organs |
indirect costs | Formerly used term—see facilities and administrative costs. |
dcc | See direct CAN citation. |
local anesthesia | The injection or application of an anesthetic drug that targets a specific area of the body. |
monoclonal antibody | antibody produced from clones of a single antibody-producing cell (see polyclonal antibody) |
umbilicate | Of the pileus: Having a central navel-like depression, sunken in the center, somewhat funnel-shaped. |
peripheral nervous system | All the nerves of the body except the brain and spinal cord. |
gill | A hymenium-covered, plate-like appendage that hangs from the under surface of the |
tracheitis | Inflammation of the trachea |
biofilm | A substance that sticks to wet surfaces |
impracticable | Refers to practical barriers (not just inconvenience) to conducting aspects of the research |
host | A plant that supports the growth and development of the parasite that has infected it. |
source data | All information contained in original records and certified copies (source documentation) of findings, observations or other activities in a clinical trial mandated for the reconstruction and evaluation of the study. |
joint | The area where two bones are attached for the result of motion of body parts. |
sooty mold | A fungus of the family Capnodiaceae and of certain other families of the order Dothideales |
otc | see Over-the-Counter |
technology transfer | Go to these resources: |
expedited review | Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB |
source data | All information contained in original records and certified copies of results, observations or other facets required for the reconstruction and evaluation of the study that is contained in source documents. |
syncytiotrophoblast | intracytoplasmic sperm insertion (ICSI) An in vitro fertilization technique for overcoming infertility due to oligospermia or azoospermia involving sperm microinjection (SMI), in which one or more sperm are injected through the zona pellucida, across the perivitelline space, through the vitelline membrane (the egg cell’s membrane), and into the substance (or cytoplasm) of the egg itself |
atopognosis | Loss of ability to correctly locate a sensation. |
hypoxia | Reduction of oxygen supply to tissue. |
intramuscular | In the muscle |
molecule | The smallest particle of a compound that has all the chemical properties of that compound |
thyrotropin receptor | The matching site on a thyroid cell that selectively captures thyroid stimulating hormone (TSH) to stimulate the production of thyroid hormones by the thyroid gland. |
assent | An agreement to participate in clinical research |
retrograde axoplasmic transport | The active movement of substances up the axon of a cell (toward the soma) in the retrograde direction at up to 100 mm/day. |
living donor | A living person who donates a body part for transplantation into another person |
modality | One of the basic senses: somesthesia, vision, audition, gustation and olfaction. |
guidelines | Written principles and practices pertaining to applying the regulations |
sequence | The order of nucleotides in RNA or DNA or of amino acids in a polypeptide. |
masculinization | the transformation of a structure (or behavior) to that typical of the male of the species. |
r- | Cytomegalovirus-seronegative |
fumigant: | a gas or volatile substance used to kill or inhibit the growth of microorganisms or other pests |
investigator | A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed |
hyperplasia | The enlargement of an organ or tissue owing to an increase in the number of cells. |
tropomyosin | A filamentous protein that is part of the thin filament of striated muscle. |
heterosis | increased vigor of hybrid offspring when compared to either parent |
statistical significance | A determination of the probability of obtaining the particular distribution of the data on the assumption that the null hypothesis is true |
russet | Brownish, roughened areas on the skin of fruit as a result of cork formation. |
aidstrials | An online database service administered by the National Library of Medicine, with information about clinical trials of agents under evaluation against HIV infection, AIDS and related opportunistic infections. |
yellow fever | Yellow fever |
related | An event is "related" if in the opinion of the investigator it is likely to have resulted from participation in the research study." |
data forms | Forms used to record patient data from original source documents |
null hypothesis | The proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention |
cirrhosis | A serious liver condition characterized by irreversible scarring of the liver that can lead to liver failure and death |
assist | See Application Submission System and Interface for Submission Tracking (ASSIST). |
osteopenia | Bone size that is below normal. |
in vivo | Literally, "in the living body;" processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro). |
diagnostic trials | Trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition |
ohrp | see Office for Human Research Protection |
vegetative | the somatic or asexual parts of a plant, which are not involved in sexual reproduction |
rapidly adapting | A rapid decline to zero of a response of a sensory neuron to a maintained stimulus. |
gcp | See: Good Clinical Practice |
neuropathy | Abnormal degenerative state of the nervous system. |
electrical synapse | The junction between two nerve cells at which communication is by direct transfer of charge not by release of a transmitter substance, syn |
endocrinologists | Doctors who specialise in the care of patients with disorders of the endocrine glands. |
review | The concurrent oversight of research on a periodic basis by an IRB |
mask-like face | Refers to the lack of spontaneous facial expressions in the patient with basal ganglion disease, particularly parkinsonism. |
rhizomycelium | Branching, anucleate or sparsely nucleate, rhizoidal filaments of variable width forming part of the thallus in some fungi |
oncology | The medical, surgical, and radiation treatment of tumors (cancerous, especially) |
in vitro | Literally, "in glass" or "test tube;" used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo. |
resorb | A process that creates a change in the body such as bone resorption in which the bone is broken down into its components. |
double-blind | The design of a study in which neither the investigator nor the subject knows which medication (or placebo) the subject is receiving. |
monosynaptic reflex | Reflex involving only one synapse within the central nervous system. |
meaningful pain relief | The time point at which the patient feels that they have had a significant amount of pain relief post dose. |
muriform | Having bricklike cells in a wall with both longitudinal and transverse septa. |
immunization anxiety-related reaction | Immunization anxiety-related reaction |
clinical trial | A carefully designed and executed investigation of the effects of a drug (or vaccine) administered to human subjects |
investigator site file | File that is prepared for or by the investigator prior to study initiation and contains copies of documents relating to the clinical study |
time to onset | Time to onset |
inhale | To breathe in. |
neurobiology | A branch of biology that deals with the nervous system. |
ecg/ekg | Electrocardiogram |
culture | Sputum or throat swab is put on a medium for germs to grow in the laboratory, so the germ can be identified. |
healthy patient studies | Most Healthy Patient Studies are Phase I studies which are primarily concerned with assessing a drug's safety |
energy intake | Energy helps cells perform all of their functions, including building proteins and other substances the body may require |
metabolism | The sum of the processes by which a particular substance is handled (as by assimilation and incorporation, or by detoxification and excretion) in the living body. |
thyroid nodules | Small lumps or growths that can be felt in the neck |
ibc | See: Institutional Biosafety Committee |
motor cortex | That area of cerebral cortex, the stimulation of which leads to movements, syn |
herbicide | a chemical used for killing plants or inhibiting plant growth, e.g |
federal wide assurance | means a document that fulfills the requirements of 45 CFR Part 46 and is approved by the Secretary of Health and Human services |
booster injection | Booster injection |
conjugation | In general, any of various sexual processes in microorganisms in which gene transfer follows the establishment of direct contact between two (or more) cells which typically show little or no morphological differentiation from vegetative cells |
application integrity policy | Application Integrity Policy (AIP) is FDA’s policy for the integrity of data or information submitted in an application |
bias | A point of view that impairs fair judgment |
quarantine | Legal restriction of the movement of plant pests (or the products that may be harboring them) into areas where they do not occur. |
psoriasis | A chronic, non-contagious disease with inflamed lesions with silvery-white scabs of dead skin. |
excitatory postsynaptic potential | A hypopolarizing change in the transmembrane potential of a neuron due to synaptic activity that tends to increase the probability of discharge of the neuron, abbr |
administrative closure | Closure of a study that does not have IRB approval, due to: (1) a lapsed approval, or (2) a failure to respond to conditions of approval) |
dag | See Director's Advisory Group. |
audiogram | A plot of a patient's hearing ability, either an audibility curve or a hearing loss curve. |
data and safety monitoring | A plan to oversee the implementation of a study protocol for compliance monitoring. |
ventral | Front, or lower surface. |
antibiotic | Substance used to inhibit the growth of micro-organisms, including bacteria and fungi. |
recombinant vaccine | Vaccine that uses genetic material from a disease-causing organism to produce an immune response |
efficacy | The ability of a drug or treatment to produce a beneficial result. |
nerve | A bundle of fibers that uses electrical and chemical signals to transmit sensory and motor information from one body part to another. |
neuropathy | The name given to a group of disorders involving nerves |
infectious disease | A disease that can be transmitted from person to person or from organism to organism, and is caused by a microbial agent (e.g., common cold). |
iec | See independent ethics committee. |
assent | is the agreement by a child, or an adult who lacks full decision-making capacity to participate in a research or clinical investigation |
double-blinded study | A study in which neither the investigator nor the participant knows whether the participant is receiving a vaccine or a control |
lymphatic vessels | A bodywide network of channels, similar to the blood vessels, that transport lymph to the immune organs and into the bloodstream |
exclusion | The principle of plant disease prevention in which the pathogen is prevented from entering a given region. |
buffers | Buffers |
non-opiod | Medication that does not contain an opiod and may be available over-the-counter |
computer tomography | An imaging method in which the data is taken from multiple x-ray images to put together pictures of structures within the body. |
study endpoint | Outcome used to judge the effectiveness of a treatment, like a cure or lack of cure. |
double-blind study | A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy) |
select agents | Go to these resources: |
opisthotonos | A form of spasm in which the head and the heels are bent backward and the body bowed forward. |
plaque | A small disk-shaped formation or growth; a patch |
neurodevelopmental disorders | Neurodevelopmental disorders |
retina | Light-sensitive tissue at the back of the eye that transmits visual impulses via the optic nerve to the brain. |
federal policy | The federal policy that provides regulations for the involvement of human subjects in research |
beta-blockers | Drugs that can inhibit the sympathetic nervous system involving physical responses and reduce certain symptoms |
athermesthesia | Loss of temperature sensation. |
nih | National Institutes of Health: a federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers |
recruitment period | Time allowed to enroll all subjects for a study. |
in vivo testing | Testing conducted in living animal and human systems. |
clinical practice guidelines | Standards for physicians to adhere to in prescribing care for a given condition or illness. |
biologic | A product derived from a living organism that is used in the diagnosis or treatment of disease |
metaplasia | Changed condition of a structure or organ; hyperplastic class of symptoms characterized by overdevelopment other than that due to |
phosphatidylserine | A fatty compound combined with phosphorus found in the walls of cells and used to reduce dementia. |
magnetic resonance imaging | This diagnostic procedure, using magnetic fields, radio waves, and a computer, may be used to determine the source of pain. |
standardised | Using different techniques or preparations in order to conform to a reference or standard. |
dose-limiting toxicity | An adverse event or reaction during treatment on a clinical trial that prevents the dose of the study drug from being increased or to prevent continuation of treatment at any dosage level. |
fitness | The ability of an organism to survive and reproduce; the ability of an organism to pass its genes to the next generation. |
goitre | An enlargement of the thyroid gland for any reason |
cel | See commercial evaluation license. |
behavioral therapy | Psychotherapy that is concerned with the treatment of observable behaviors rather than underlying psychological processes |
bone graft | A piece of existing bone used to take the place of a missing bone in the patient's own body. |
nuremberg code | As a result of the medical experimentation conducted by Nazis during the Second World War, the U.S |
visualization | Creating a mental image of a desired outcome, and repeatedly playing that image in the mind for purpose of pain relief |
exhalation | Breath out air. |
standard operating procedure | Official, detailed, written instructions for the management of clinical trials |
antiemetic | Medication that prevents or alleviates nausea and vomiting |
children | Requirements differ depending on risk, complexity, and the probability of finding intervention differences |
translation | the assembling of amino acids into a protein using messenger RNA, ribosomes and transfer RNA |
individual case safety report | Individual case safety report (ICSR) |
skeletomotor neuron | A motoneuron whose axon is an A fiber; contacts extrafusal muscle fibers, syn |
surveillance | Surveillance |
polarized | Imbued with poles; experiencing a separation of charge; refers to difference in potential across a cell membrane. |
sham controlled study | Related Terms: Controlled Study |
qow | every other week |
aminoglycosides | A group of antibiotics used to treat bacterial infections |
organelle | A component of a cell with a specific function. |
parasympathetic nervous system | The division of the autonomic nervous system made up of ocular, bulbar, and sacral segments. |
scanning speech | Speaking characterized by irregular volumes and speech rhythms; a symptom of cerebellar disease. |
eir | See Employee Invention Report. |
ultrasound | High frequency sound waves used to obtain images inside the body |
national immunization programme | National immunization programme (NIP) |
phyllotaxy | arrangement of leaves on a stem in relation to one another |
permission | means the agreement of parent(s) or guardian to the participation of their child or ward in research. |
prevention trials | Refers to trials to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning |
upper respiratory infection | Generalized infection of the nasal cavity, pharynx, and larynx |
standard treatment | The treatment that is currently thought to be effective in medical practice. |
assignment | See receipt, referral, and assignment of grant applications. |
cryptomenorrhea | implantation The process by which the embryo’s trophoblast attaches to the mother’s endometrium and penetrates it, establishing contact between the trophoblast’s developing chorionic villi and the maternal blood |
models | Represents a living system and used in research. |
sterility | (2) The inability to procreate; the inability to conceive or induce conception. |
peptide | a natural or synthetic compound containing two or more amino acids linked together by peptide bonds. |
510 premarket notification | A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. |
endpoint | Overall outcome that the protocol is designed to evaluate |
equine-derived | Equine-derived |
exopathogen | Nonparasitic organism whose extracellular toxic metabolites cause disease in plants. |
lc/ms/ms methods | Liquid Chromatography mass spectrometery |
electroporation | A method by which nucleic acids or virus particles can be introduced into protoplasts or cells by creating transient pores in the plasma membrane using an electric pulse. |
ara | American Rheumatism Association |
paresthesea | A sense of picking, tingling, or creeping of the skin without cause, except for possible nerve injury. |
hypospadias | displacement of urethral opening from the tip to the ventral side of the phallus. |
saltatory conduction | Conduction of the nerve spike where the spike jumps from node to node. |
infection | The results of the presence of harmful microorganisms in the body |
stroke | Blockage or rupture of an artery to the brain |
alpha blocking | Disappearance of alpha rhythms from the EEG, syn |
privacy certificate | This is the equivalent of a federal Certificate of Confidentiality, but it is provided (and required by) the federal Department of Justice (DOJ) for any research involving DOJ |
review ethics board | An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation |
natural molecules | Molecules found as components of living systems |
case control study | Case control study |
private information | Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public |
sc | subcutaneous |
experimental drug | A drug that is not licensed by the FDA for use in humans or as a treatment for any disease or condition. |
dna | Deoxyribonucleic acid |
dose-response relationship | The relationship between the dose of some agent (such as a drug), or the extent of exposure, and a physiological response |
carpal tunnel syndrome | Nerve damage as a result of compression of the median nerve in the wrist |
environmental protection agency | Agency within the US Federal government which is responsible for protecting the environment and human health by both writing and enforcing regulations based on laws passed by Congress. |
causality assessment | Causality assessment (or causality association) |
epinasty | Downward curling of a leaf blade resulting from more rapid cell growth on the upper side of a petiole than on the lower side; often a |
conidiophore | A hypha, often specialized in structure, that bears one or more conidia. |
anomalous trichromacy | Color vision involving three pigments but one is abnormal, producing a weakness in response to that primary color. |
ide | See: Investigational Device Exemption |
pneumothorax | Abnormal presence of air or gas within the pleural cavity |
malaria | Malaria |
neutralizing antibody | An antibody that keeps a virus from infecting a cell, usually by blocking receptors on the cell or the virus |
cta | Clinical Trial Application |
haustorium | specialized branch of a parasite formed inside host cells to absorb nutrients (PDF); |
thyroxine | The primary hormone produced by the thyroid gland |
genotype | The genetic constitution of an organism. |
lumen | central cavity of a cell or other structure |
protocol | The specific set(s) of goals and procedures that define what will happen in a clinical trial |
tiller | a lateral shoot, culm, or stalk arising from a crown bud; common in grasses |
suspended | Recruiting or enrolling participants has halted prematurely but potentially will resume |
local research context | Knowledge of the institution and community environment in which human research will be conducted. |
employee invention report | Go to these resources: |
approved drugs | In the United States, the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed and administered |
striated muscle | Any muscle whose fibers are divided by transverse bands into striations. |
hot nodule | A lump in the thyroid gland that takes up more radioactive iodine on a scan than the normal surrounding thyroid tissue does |
synaptic vesicles | Small membrane-bound sacs in the presynaptic terminals that contain the transmitter substance. |
k award | See career development awards. |
malignant neoplastic disease | any malignant growth or tumor caused by abnormal and uncontrolled cell division; it may spread to other parts of the body through the lymphatic system or the blood stream |
eligibility criteria | Reasons for selection of participants to be excluded from a clinical trial (see INCLUSION/EXCLUSION CRITERIA). |
crossed-extension reflex | Contraction of contralateral extensor muscles concomitant with initiation of a withdrawal reflex. |
in situ | in its original place or environment |
peptides | Combinations of amino acids from the partial digestion of protein. |
pivotal study | Usually a phase III study that presents the data a governing body (e.g |
seroprevalence | As related to HIV infection: The proportion of persons who have serologic (i.e., pertaining to serum) evidence of HIV infection at any given time |
hypertrophy | abnormal increase in the size of cells in a tissue or organ, often resulting in the formation of galls or tumors |
mean | The arithmetic average, or the sum of all the values divided by the number of values. |
deletion | Elimination of a gene (i.e., from a chromosome) either in nature or in the laboratory |
protected group | See: vulnerable populations |
rheumatologist | Physician who specializes in medicine concerned with joints, muscles and bones and their roles in health and disease |
irb approval | The determination of the IRB that the research study has been reviewed and may be conducted at an institution with the constraints set forth by the IRB and by other institutional and Federal requirements. |
glandular carcinoma | malignant tumor originating in glandular epithelium |
randomization | The process by which trial participants are assigned to treatment or control groups in an unsystematic manner and by method of chance to reduce the likelihood of bias. |
institutional official | See: Authorized Institutional Official |
emulsion | Emulsion |
protocol | A detailed plan of a scientific experiment or medical treatment |
dead fetus | Special regulatory procedures apply for research with an expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached) [45 CFR 46.203(f)]. |
fovea | The central region of the retina specialized for detail vision, i.e., for acuity. |
hydathode | A specialized leaf structure with one or more openings through which water is discharged from the interior of the leaf to its surface. |
intrafusal muscle fiber | The contractile tissue of the muscle spindle; it lies inside the spindle. |
protoplast | A plant cell from which the cell wall has been removed. |
clinical investigator | A medical researcher in charge of carrying out a clinical trial’s protocol. |
irb approval | means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. |
initial review group | Formerly used term—see integrated review group and the related term study section. |
niaaa | National Institute on Alcohol Abuse and Alcoholism; an institute in NIH. |
clinical trial | Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent's safety and efficacy. |
hxv | Viruses that cause hepatitis are lettered A through G. |
combination or combined vaccine | Combination or combined vaccine |
preclinical study | A laboratory or animal study of a drug, device, or procedure to find out if the new treatment shows enough promise to be studied in humans. |
endemic | Pertaining to diseases associated with particular locales or population groups. |
theta rhythms | EEG records characterized by high voltage waves occurring at 4-8 per second. |
ryan white care act | The Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990 represents the largest dollar investment made by Congress to date specifically for the provision of services for people with HIV infection |
c fiber | Unmyelinated primary afferent neurons. |
rem sleep | The stage of sleep in which dreaming is associated with mild muscle jerks and rapid eye movements (REM), also characterized by a desynchronized EEG, thus the syn |
radiopaque contrast agents | Materials that stop or attenuate radiation that is passed through the body, creating an outline on film of the organ(s) being examined |
mri | Uses a large circular magnet and radio waves to generate signals from atoms in the body to produce pictures and organs inside the body. |
phase ii trials | The second phase of drug trials |
investigational | Experimental, unproven. |
f award | See fellowship award. |
prevention trials | A type of trial to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning |
nag | N-acetyl-β-D-glucosaminidase |
estrogen | 1) a class of steroid hormones, secreted primarily from the ovaries, that is responsible for initiation of estrus and for the development of secondary sexual characteristics in the female (e.g., 17ß-estradiol) |
inactive | Having no effect. |
mg | milligram |
research | R21s are not intended for new investigators, and there is no evidence that they provide a path to an independent research career |
malignant hepatoma | carcinoma of the liver |
encephalitis | A general term denoting inflammation of the brain. |
thrombocytopenia | A decreased number of blood platelets (cells important for blood clotting) |
unanticipated problems | In general, includes any incident, experience, or outcome that meets all of the following criteria: |
somatovisceral reflexes | Reflexes involving somatic stimuli and visceral responses. |
beta rhythms | EEG records characterized by low-voltage waves occurring at 14 to 50 per sec. |
off label | The unauthorized use of a drug for a purpose other than that approved of by the FDA. |
heterotroph | An organism that obtains its food from other organisms, living or dead. |
baseline | Baseline information is gathered at the beginning of a study from which variations found in the study are measured |
nuremberg code | A code of ethics developed from the Nuremberg Military Tribunal’s decision in the case of the US versus Karl Brandt, et al |
thalamotomy | The production of a circumscribed lesion in the thalamus. |
preservatives | Preservatives |
personally identifiable information | Go to these resources: |
center | See research center grant. |
immunization | The process of inducing immunity by administering an antigen (vaccine) to allow the immune system to prevent infection or illness when it subsequently encounters the infectious agent. |
dhhs | See Department of Health and Human Services. |
clinical trial | A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions. |
parallel track | A system of distributing experimental drugs to patients who are unable to participate in ongoing clinical efficacy trials and have no other treatment options |
measles | Measles |
general accounting office | See Government Accountability Office. |
ci | Confidence Interval |
transfusion | The introduction of whole blood or components of blood (such as plasma, platelets) from one person to another. |
immunodeficiency | A deficiency of immune response or a disorder characterized by deficient immune response; classified as antibody (B cell), cellular (T cell), combined deficiency or phagocytic dysfunction disorders. |
mesothelioma | a form of carcinoma of the mesothelium lining lungs or abdomen or heart; usually associated with exposure to asbestos dust |
otolith | Literally: stone in the ear; a calcium carbonate crystal found in the otolith organs of vertebrates, syn |
irb application | See: human subjects application |
qa | See: Quality Assurance |
peroxidase | These are compounds which neutralize harmful peroxides. |
investigator's brochure | A comprehensive document summarizing the body of information about an investigational drug |
life cycle | the cyclical stages in the growth and development of an organism |
daiop | Division of Anti-Infective and Ophthalmology Drug Products, Office of Antimicrobial Resistance |
dysgraphia | Inability to write properly. |
macrolides | A group of antibiotics used to treat lung infections, including azithromycin and erythromycin. |
integrase | An HIV enzyme used by the virus to integrate its genetic material into the host cell's DNA |
pcbs | Compounds from chlorination of biphenyl |
pesticide | a chemical used to control pests |
crustaformeria | In nematodes: Glandular region of the distal part of uterus that may play a role in the formation of the egg envelope; sometimes called the quadricolumella. |
adverse drug reaction | Any unintended reaction to a new treatment or drug when taken at doses typically used for diagnosis, therapy of disease, prophylaxis or for modification of physiological function, which may occur suddenly or develop over time. |
spatial summation | Algebraic addition of generator potentials elicited by stimuli at two different points. |
pharmacokinetics | The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. |
sub-investigator | An individual member of a clinical trial team to whom trial-related activities or procedures have been delegated by the investigator |
rem | Acronym for Roentgen Equivalent in Man; the unit of measurement for a dose of an ionizing radiation that produces the same biological effect as a unit of absorbed does (1 rad) of ordinary X-rays |
regulatory genes | As related to HIV: Three regulatory HIV genes-tat, rev and nef-and three so-called auxiliary genes-vif, vpr and vpu-contain information for the production of proteins that control (i.e., regulate) the virus's ability to infect a cell, produce new copies of the virus or cause disease |
iodine | A non-metallic element found in food |
isolate | An individual (as a spore or a single organism), viable part of an organism (as a cell) or a strain that has been isolated (as from diseased tissue, contaminated water or the air) |
bias | Basically, the vertical offset of a stimulus-response curve. |
retrovirus | Retrovirus |
frontal eye fields | Premotor areas of the cerebral cortex from which contraversive eye movements are evocable by electrical stimulation. |
third party subjects | An informal name for living individuals about whom researchers obtain individually identifiable private information from someone else but who themselves have no interaction with the researcher |
fasciculations | A small, local contraction of muscles visible through the skin; represents spontaneous discharge in one or more muscle fibers innervated by a motoneuron. |
organosulfur | Organic (carbon based) compounds that contain sulfur. |
allopathic | Traditional medicine |
isi | See influential scientific information. |
prisoner | means any individual involuntarily confined or detained in a penal institution |
soil invader | an organism whose population in soil diminishes in several months to years |
hormone | traditionally, a chemical substance produced by one part of the body that has an effect on another part of the body. |
cftr | see CYSTIC FIBROSIS CONDUCTANCE TRANSMEMBRANE REGULATOR |
aids | Acquired Immunodeficiency Deficiency Syndrome |
monitoring | Overseeing the progress of a clinical trial to ensure that it is conducted, recorded, and reported according to the protocol, standard operating procedures, good clinical practice guidelines, and applicable regulations. |
osteopath | A Doctor of Osteoepathy diagnoses and treats illness through hands on manual medicine and the body's musculoskeletal system |
photosynthate | product of photosynthesis |
justice | An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly. |
spiroplasma | A member of a group of pleomorphic, wall-less prokaryotes occurring as epiphytes or as intracellular or extracellular parasites or pathogens in a range of invertebrates and plants. |
deception | Intentionally misleading or withholding information about nature of experiment. |
hemoglobin | The component of red blood cells that carries oxygen. |
broadcast application | Application by spreading or scattering on the soil surface. |
unicellular | one-celled organism |
feeder root | fine root that absorbs water and dissolved nutrients |
peripheral nervous system | This system includes the nerves all over the body that relay messages like pain to the CNS. |
phytoestrogen | A plant material with estrogen (female hormone) activity. |
case report form | A record of pertinent information collected on each subject during a clinical trial, as outlined in the study protocol. |
contract research organization | A company with whom a drug or device manufacturer or sponsor contracts to perform clinical trial related activities |
baseline | A person's health status before he or she begins treatment in a clinical trial |
vegetative reproduction | Asexual reproduction. |
micropyle | In nematodes: A minute opening in the membrane of an egg through which the spermatozoa enter. |
bacteria | Tiny one-celled creatures that are often the cause of infections |
strain | Strain |
cidal | A property of a drug that means it acts by killing the target organism (e.g., bacteriocidal) |
failure to thrive | Not gaining weight or growing at a normal rate. |
ophthalmology | Field concerning the eye and eye diseases |
inclusion criteria | Refers to the characteristics that must be met by a subject in order to participate in a clinical trial, as outlined in the study protocol. |
resistin | A cysteine-rich protein that increases with increasing obesity. |
eligibility criteria | Summary criteria for participant selection |
passive surveillance | Passive surveillance (also known as spontaneous reporting) |
reflexology | Form of massage where a practitioner applies pressure to certain parts of the feet and hands to help promote relaxation and healing at specified points in the body |
efficacy | A product’s ability to produce beneficial effects on the duration or course of a disease |
thyrotropin | Another name for thyroid-stimulating hormone (TSH). |
megavitamins | Large quantities of vitamins taken on a regular basis. |
lidocaine | An anesthetic that produces pain relief by blocking the signals at the nerve endings in the skin |
private information | includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record) |
trichogyne | In some algae, lichens, and fungi, a projection from the female sex organ that receives the male gamete or nuclei before fertilization (karyogamy). |
systemic | Systemic |
ascending reticular activating system | A group of interconnected nuclei of the brain stem responsible for producing desynchronization of the EEG. |
phenolic compounds | Benzene family antioxidants with OH functional groups. |
fellowships | Go to these resources: |
abscission | Of plants: The shedding of leaves or other parts as the result of physical weakness in a specialized layer of cells (abscission layer) that develops at the base. |
protocol | The plan for a course of medical treatment or for a scientific experiment. |
good clinical practice | An international standard of guidelines and regulations used to ensure protection of subjects’ rights, confidentiality and integrity and the accuracy and credibility of data in clinical studies. |
saw palmetto | A plant from Florida and Mexico with berries used for prostate problems. |
gamma spasticity | A tonic contraction of one muscle or a group of synergistic muscles at a joint, caused by excitation of the gamma motoneurons innervating the muscles. |
ffr | See Federal Financial Report (FFR). |
analog | In chemistry, a compound with a structure similar to that of another compound, but differing from it in respect to certain components or structural makeup; it may have a similar or opposite action metabolically. |
biomedical research | Research that is conducted to contribute to an increased understanding of disease processes, new treatments and interventions, and the prevention and control of infectious and chronic diseases in clinical medicine and public health; and research involving human biological specimens (i.e |
heartwood | central cylinder of nonfunctional xylem in a woody stem (see sapwood) |
gmp | Good Manufacturing Practices, also referred to as Quality System under 21 CFR 820 |
channel | A passage in the membrane through which ions can flow, syn |
pdco | Paediatric Committee of EMA, responsible for the assessment of paediatric investigation plans |
ng | nanogram |
recurrent inhibition | Inhibition of an element produced by its own output through excitation of an inhibitory interneuron, cf., Collateral inhibition. |
gene | basic unit of heredity |
haploid | having a single complete set of chromosomes |
permission | The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)]. |
fttp | Full-time training position. |
sponsor-investigator | An individual who both initiates and conducts a clinical trial, and who directs the use, administration, and distribution of the investigational product |
masked study designs | Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects |
institutional review board | A board, committee, or other group that reviews and approves clinical studies at an investigative site |
central nervous system | Composed of the brain, spinal cord and its coverings (meninges). |
legally authorized representative | A person authorized either by statute or by court appointment to make decisions on behalf of another person |
somatosomatic reflexes | Reflexes involving somatic stimuli and somatic responses. |
tsh test | A test to measure the amount of thyroid-stimulating hormone (TSH) in the bloodstream. |
electrochemical equilibrium | A balance between chemical and electrical driving forces such that there is no net movement of ions across the cell membrane. |
phase iv trials | Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. |
radioactive drug | Any substance defined as a drug in |
eortc | European Organization for Research and Treatment of Cancer |
phase iii trials | Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained |
myelosuppression | Impairment of the blood cell-producing function of the bone marrow. |
pivotal study | Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug |
aerobe | An organism that requires free oxygen for respiration. |
apothecium | An ascus-bearing structure ( |
spiroplasma | spiral-shaped plant pathogenic mollicute (prokaryote without cell wall) |
placebo | A placebo (sometimes called a sham treatment), is a treatment that has no therapeutic value |
pre-clinical testing | Before a drug may be tested on humans, pre-clinical studies must be conducted either in vitro but usually in vivo on animals to determine that the drug is safe. |
psyllium | Members of the genus Plantago used for its dietary fiber properties as a laxative. |
haq | Health Assessment Questionaire |
smo | Site Management Organization |
central nervous system | Body system comprised of the brain and spinal cord |
ozone | a highly reactive form of oxygen (O3) that may injure plants |
aphis | See Animal and Plant Health Inspection Service. |
neuralgia | Pain along the length of a nerve. |
saccharomyces boulardii | A form of yeast from lychee and mangosteen fruit. |
withdraw | The point at which a clinical trial participant, for any reason, stops participating in the trial. |
pilot study | An early, small-to-moderate sized study, also known as a Phase 2 study |
gamete/germ cell | cell produced by gonad that contains half of genes necessary for production of offspring (e.g., oocyte in female, spermatozoan in male). |
dna | Deoxyribonucleic acid. |
obligate anaerobe | An organism that can grow only under anaerobic conditions. |
thyroid bed | The area of the thyroid that remains after surgical removal of the thyroid gland. |
cephalids | In nematodes: Two structures (posterior and anterior) situated in the cephalic region and extending in a complete circle around the body; possibly part of the nervous system |
generic | Chemical name of a drug as opposed to its brand name |
exogenous | Arising on the outside of the generating structure. |
fast muscle | Relative term, referring to the speed of twitch contraction and relaxation and to the relatively high rates of stimulation at which tetanic fusion occurs. |
study end point | A primary or secondary result used to evaluate the efficacy of a treatment. |
over the counter | Drugs available for purchase without a physician's prescription. |
crossed-innervation | Refers to the transplanting of one nerve onto a foreign muscle and the transplanting of the nerve from that muscle onto the muscle of the first nerve. |
cfr | See Code of Federal Regulations. |
disease triangle | refers to the three components necessary for disease to occur: susceptible plant, pathogen and favorable environment |
negative feedback | regulatory process that reduces the output of a system, such as the action of heat on a thermostat to limit the output of a furnace. |
squamous | Covered with or consisting of scales. |
dmc | See DATA MONITORING COMMITTEE (DMC). |
whooping cough | An acute infectious disease that causes inflammation of the larynx, trachea, and bronchi with spasmodic coughing that produces a distinct noise; also known as pertussis |
near-sightedness | A pathological condition of refraction in which the eyeball is too long for the refractive power of the lens and images come to a focus in front of the retina, syn |
endophyte | plant developing inside another organism; also used for endoparasitic fungi found in grass species |
crcl | Creatinine Clearance |
federal register | Publication of the federal government to establish new regulations or to change existing regulations. |
respect for persons | An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected. |
asthma | Asthma |
mentally disabled | See: Cognitively Impaired. |
budget authorization | See authorization. |
hypocotyl | portion of the stem below the cotyledons and above the root (see epicotyl) |
polypharmacy | The administration of many drugs together or the administration of excessive medication |
microbiology | The branch of biology that deals with microorganisms and their effects on other living organisms |
homokaryon | A hyphal cell, mycelium, organism, or spore in which all the nuclei are genetically identical. |
obligatory synapse | A synaptic junction at which a single presynaptic action potential initiates a postsynaptic action potential. |
placebo | A chemically inert substance given in the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug. |
referee | A participant in the peer review of an article; normally experienced in the same field. |
white muscle | A paler colored muscle consisting of fibers lacking high myoglobin concentrations; fast muscle fibers. |
root graft | the fusion of roots of two adjacent plants so that their water and food conducting (vascular) systems become joined |
technology transfer | Go to 15 USC 63 Sec |
rna | Ribonucleic Acid |
placebo | A substance that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied. |
whole body scan | A scan of the whole body used to view areas of radioactive iodine uptake after its oral administration. |
in vivo | A Latin term meaning "in body." After a candidate drug passes in vitro testing, it is then tested in living bodies |
effective dose | The dose of an investigational agent that produces the outcome considered "effective," as defined in the study protocol |
socially and economically disadvantaged | Go to HHS's Poverty Guidelines, Research, and Measurement. |
identifiable data | Data which are either (a) directly connected to name/other identifiers, or (b) indirectly connected via a study number or other coding scheme |
in vitro | An artificial environment created outside a living organism (e.g., in a test tube or culture plate) used in experimental research to study a disease or biologic process. |
flux | Movement of ions due to concentration forces, syn |
transposon | A discrete piece of DNA that can insert itself into other DNA sequences within the cell |
gmp | Good manufacturing practice. |
threshold of hearing curve | A graph of a person's threshold for detection of various pitches in the range of human hearing, syn |
pancreas | A long organ with glands found behind the stomach |
prodelphic | In nematodes: Having uteri parallel and anteriorly directed at the origin. |
antidromic | In the direction opposite that normally taken by action potentials in the nervous system. |
epileptogenic | Producing or capable of producing seizures. |
medical device amendments | Amendments to the Federal Food, Drug and Cosmetic Act passed in 1976 to regulate the distribution of medical devices and diagnostic products. |
risk | Risk |
messenger rna | A chain of specific ribonucleotides that codes for a specific protein; template for the assembly of amino acids into protein; in cells mRNA is transcribed from DNA, but some RNA viruses function directly as mRNA. |
imb | Internal monitoring board. |
imagery | Using mental images from memory or imagination to relieve pain |
dmard | Disease-Modifying Anti-Rheumatic Drug |
myofilament | Any of the small filaments that comprise a myofibril; either a thick or myosin filament, or a thin or actin filament. |
pharmacoeconomics | The study of cost-benefit ratios of drugs with other therapies or with similar drugs |
surrogate marker | A substitute; a person or thing that replaces another |
viscerosomatic reflexes | Reflexes involving visceral stimuli and somatic responses. |
human subjects exemption categories | See exemption categories, human subjects. |
antagonistic symbiosis | Parasitism; one organism of an association beefits at the expense of the other. |
dendritic cells | Patrolling immune system cells that may begin the HIV disease process by carrying the virus from the site of the infection to the lymph nodes, where other immune cells become infected |
randomization | Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group |
limen | The psychological term for threshold. |
alterations and renovations | Grant budget category for work to change the physical characteristics of an existing facility or installed equipment. |
tt | Tetanus Toxoid |
herpes zoster | An acute viral inflammation of nerves caused by reactivation of the herpes virus that causes chicken pox |
incidence | The number of new cases occurring in a given population over a certain period of time. |
spine | Column of bone, the vertebral column, that surrounds and protects the spinal cord |
transmitter substance | A compound released at a synapse from the presynaptic element that effects a change in potential of the postsynaptic cell. |
fungus | A eukaryotic, heterotrophic organism whose usually walled, threadlike cells absorb nutrients. |
immunoglobulin | A general term for antibodies, which bind to invading organisms, leading to their destruction |
secretary | means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated. |
epidemiology | The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population. |
withdraw | In a trial, to end a patient's participation before he or she reaches the designated end point. |
autopsy | Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts. |
dichromatism | Color vision involving only two pigments. |
off-label use | A drug prescribed for conditions other than those approved by the FDA. |
inclusion criteria | The criteria which all subjects must meet in order to be eligible to participate in a clinical study. |
iontophoresis | The introduction by means of an electrical current of ions of soluble salts into the tissues of the body. |
progress report for grants | Go to Program Officer Checklist SOP. |
weber-fechner function | The magnitude of the sensation evoked by a stimulus is proportional to the logarithm of the stimulus strength. |
minor | See: child; See also: assent |
generic drug | A medicinal product with the same active ingredient, but not necessarily the same inactive ingredients as a brand-name drug |
last verified date | The last verified date is the most recent date that all of a clinical study's information on ClinicalTrials.gov was confirmed as accurate and up to date |
retrospective studies | Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys |
alveoli | A tiny, thin-walled, capillary rich sac in the lungs where exchange of oxygen and carbon dioxide takes place |
prostaglandins | Hormone like substance that sensitizes pain receptors to mechanical and chemical stimulation and cause blood vessels to dilate |
sepsis | Sepsis (also known as "blood stream infection") |
killer t cells | Killer cells infected with HIV or other viruses or transformed by cancer |
inspection | The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO) facilities, or at other establishments deemed appropriate by the regulatory authority(ies. |
antigen | A substance that, when introduced into the body, is capable of inducing the production of a specific antibody |
titer | concentration of a virus; usually in infected cell |
off-label drug | A drug prescribed for conditions other than those approved by the MHRA |
microorganisms | A form of life that can be seen under a microscope |
assay | A way to measure how many parts of a certain ingredient are in a larger system, object or mixture. |
off-label use | When a drug is prescribed for conditions other than those approved by the FDA. |
bone plate | A thin metal implant affixed with screws used to immobilize bone segments by aligning the bone to aid the healing process. |
herd effect | Herd effect |
effectiveness | The degree to which a diagnostic test or treatment produces a desired result in patients in the daily practice of medicine. |
epiphytotic | an epidemic in a plant population |
prolepsis | A hyperplastic symptom of disease in which organs appear before the natural time |
vestibular-ocular reflex | Refers to the automatic movement of the eyes in the direction opposite to that in which the head is rotated. |
beta adrenergic effect | A constellation of effects produced by circulating epinephrine, or isoproterenol released from postganglionic sympathetic nerve terminals (if they exist) |
screening | Identifying a potential clinical trial participant by finding out if the person meets the eligibility criteria (see ELIGIBILITY CRITERIA). |
national regulatory authority | National regulatory authority (NRA) |
interventions | Primary interventions being studied |
phase 1 trials | First step in drug development to test a drug’s safety and to find out how the human body reacts to the drug |
therapy | Principle of plant disease control marked by the cure of disease, as with heat or systemic chemicals. |
hue | A quality of light correlated with its wavelength |
anova | Analysis of variances |
biological control | The deliberate use by humans of one species of organism to eliminate or control another. |
iom | Institute of Medicine |
terminated | Recruiting or enrolling participants has halted prematurely and will not resume |
epar | European Public Assessment Report - once a medicine has been granted a Community marketing authorisation by the EC, EMA publishes a full scientific assessment report. |
haart | Highly Active Antiretroviral Therapy |
synaptic delay | The time required for release of a chemical transmitter substance, its diffusion across the synaptic cleft, its interaction with the postsynaptic receptor, and the initiation of a change in postsynaptic membrane potential. |
clinical research | The study of drugs or treatments in human subjects that can be separated into therapeutic (where personal benefit is expected by the subject) and nontherapeutic (where the research is conducted to advance knowledge without the expectation of providing any benefit to the subject). |
bronchitis | Inflammation of the bronchi |
side effects | Results occurring in addition to the intended one. |
hyperglycemia | Higher than normal blood glucose or blood sugar in the bloodstream. |
gastroesophageal reflux disease | a condition in which food or liquid travels backwards from the stomach to the esophagus (the tube from the mouth to the stomach) |
federal register | The CFR is divided into 50 volumes known as titles |
environmental signaling | 1) intracellular effects of exogenous chemical stimuli that mimic or antagonize effects of endogenous hormones |
tetanic contraction | Sustained contraction of a muscle without intervals of relaxation. |
antimicrobial | Can stop the growth of disease-causing germs. |
place theory | A theory that says pitch is encoded in terms of the place on the basilar membrane that gives maximum vibration in response to a given frequency of sound. |
lysis | Rupture and destruction of a cell. |
pharmacokinetics | The processes (in a living organism) of absorption, distribution, metabolism and excretion of a drug or vaccine. |
olivocochlear bundle | A bundle of efferent nerve fibers originating in the superior olive and ending on hair cells in the basilar membrane |
side effects | The action or effect of a drug (or vaccine) other than that desired |
triptans | Mediation often used to treat migraine symptoms as it constricts blood vessels in the brain to relieve swelling |
ascus | A cell that is the site of meiosis and in which endogenous spores (usually |
adverse events | Unanticipated problem involving risk that may be harmful |
wilting | Of plant disease: A symptom characterized by loss of turgor, which results in drooping of leaves, stems, and flowers. |
institution | Location of research |
phase iii trials | The third phase of drug trials |
p value | See Statistical Significance. |
human subjects | Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project |
precursor cells | Cells from which other cells are formed by natural processes. |
exonuclease | A nuclease that sequentially removes nucleotides from one end of a strand of nucleic acid. |
irb committee member | An individual appointed by the Senior Vice President for Research or designee to serve on the IRB. |
power function or relation | The relationship between two variables such that the equal percentage changes in one result in equal percentage changes in the other; an equation of the form y = xa. |
hyper-reflexia | Exaggerated reflexes. |
gavi | Global Alliance for Vaccines and Immunization |
symptoms | Any perceptible, subjective change in the body or its functions that indicates disease or phases of disease, as reported by the patient. |
spearman's rho | A mathematical computation of how far off a line drawn thru the main results, and what the actual results were. A value of 1.0 means that all points are perfectly on line and a value of zero means that the results were totally random and that no line could be drawn thru the results. |
thyroid hormones | T4 and T3, two hormones that tell the body how fast to work and how to use energy |
investigational treatment | An unapproved treatment, or a treatment used for a new purpose in clinical research |
placebo comparator arm | A group of participants that receives a placebo during a clinical study |
glucose | A sugar. |
results database | A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to summary results and registration information for completed or terminated clinical studies |
monogenic | Of nematodes: Producing offspring of only one sex. |
vaccination | The deliberate induction of protective immunity to a pathogen by administration of non-pathogenic forms of the pathogen or its antigens to induce a memory immune response.vaccine: An antigenic preparation used to produce active immunity to a disease in order to prevent or ameliorate the effects of infection by any natural or 'wild' strain of the organism.vaccinia virus: Closely related to the virus that causes cowpox, it is a member of the pox family of viruses which also includes smallpox |
budget period | In the Federal Financial Report for a final budget period, unliquidated obligations must be zero. |
phyllody | A change of floral petals (leaves) to foliage leaves. |
controlled clinical trials | Studies in which results observed in patients receiving a drug are compared to the results in patients who did not receive the drug. |
mpa | Mycophenolic Acid |
refractive index | A measure of the amount of bending of light on entering a medium; the speed of light in a vacuum/speed of light in the medium. |
ellipsoid | Having every plane section an ellipse or a circle. |
signs | Those characteristics that a physician can objectively detect or measure |
monitoring | Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, GCP and by regulatory requirements. |
phytoplasma | A prokaryotic, plant parasitic microorganism resembling a |
rotavirus | Rotavirus |
polyploid | having three or more complete sets of chromosomes (see haploid, diploid ) |
terminal | A swelling of an axon near its termination; the presynaptic structure in most synapses, syn |
placebo | An inactive substance given to a control group |
minor | See: child |
well-differentiated thyroid cancers | Papillary or follicular thyroid cancers showing well-differentiated cell structures. |
capillitium | A mass of sterile fibers interspersed among spores within a |
mortality rate | Death rate. |
tissue | A collection of similar cells acting together to perform a particular function |
homodimer | structure in which 2 identical subunits are associated. |
trifurcate | Bearing three branches or forks. |
quorum | A majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area. |
in-patient | Hospitalized patient |
relapse | A sudden worsening of preexisting symptoms, or the development of new neurologic symptoms, which lasts at least 24 hours |
adenohypophysis | anterior lobe of the pituitary gland |
post-market surveillance | The processes whereby manufacturers, regulators, health professionals, the public at large, and others monitor the performance and experience related to a given product's life-cycle in the open market. |
hypothalamic-pituitary-thyroid axis | A negative feedback mechanism through which hormone secretion is regulated |
trichromatism | Color vision involving three pigments. |
transmit: | to spread or transfer, as in spreading an infectious pathogen from plant to plant or from one plant generation to another |
epiphyte | organism growing on a plant surface, but not as a parasite |
rotation | growth of different kinds of crops in succession in the same field |
minimal risk | A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(i)] |
conflict of interest | In a clinical trial, a situation in which the interests of the researcher or institution are at odds with their professional obligation to the patient. |
nuclear bag fiber | An intrafusal muscle fiber with nuclei accumulated in an equatorial swelling. |
ib | The Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product and thus is a document of critical importance throughout the drug development process |
synergism/synergistic | An interaction between two or more agents (drugs) that produces or enhances an effect that is greater than the sum of the effects produced by the individual agents. |
electrotonic synapse | The junction between two nerve cells at which communication is by direct transfer of charge not by release of a transmitter substance, syn |
masking | A clinical trial design strategy in which one or more parties involved with the trial, such as the investigator or participant, do not know which participants have been assigned which interventions |
integrative synapse | A synaptic junction at which the critical firing level is reached only by the summation of EPSPs from many sources; a point of integration. |
viroid | Any of numerous kinds of small particles (250-400 nucleotides) of circular, single-stranded RNA that is unencapsidated and encodes no known proteins. |
glp | Good laboratory practice. |
callus | A mass of thin-walled, undifferentiated plant cells, developed as the result of wounding or culture on nutrient media. |
antibiotic | A drug that kills bacteria or slows bacterial growth |
pfts | See PULMONARY FUNCTION TESTS. |
pancreas | A gland situated near the stomach that secretes a digestive fluid into the intestine through one or more ducts and also secretes the hormone insulin. |
institutional official | An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and social/behavioral research. |
protocol | A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial |
dynamic response | The response of a primary spindle ending that signals rate of change of muscle length during stretch. |
standard treatment | A standard treatment is a treatment for a given disorder that is typically widely used and well understood in terms of its safety and effectiveness. |
hbv | Hepatitis B Virus. |
competition | A more or less active demand on the part of two organisms for some commodity (space, food, etc.) that is inadequate to provide for all organisms present. |
enrolling by invitation | A clinical study that selects its participants from a population, or group of people, decided on in advance by the researchers |
subject/study subject | See Human Subject. |
mri | Magnetic resonance imaging; an imaging procedure that produces a clear three-dimensional picture. |
count | A unit of measurement (used to gauge levels of radioactivity). |
compassionate use | When experimental drugs are provided to people before final FDA approval |
electrogenic pump | An energy-requiring process in which there is a net transfer of charge across the membrane resulting in a membrane voltage. |
headache | Head pain above the eyes or the ears, behind the head, or in the back of the upper neck |
bioequivalence study | A study which tests the same drug manufactured by two different companies to show that the two drugs are bioequivalent (the two drugs do not significantly differ in similar studies under similar conditions with the same dosage). |
protocol amendment | Changes or clarifications made in writing to the original protocol. |
injection | A method of administering drugs or nutrients into the body using a needle. |
ic | See institutes and centers. |
stanol | A fully saturated steroid alcohol such as cholesterol. |
sd | Standard Deviation |
abortion | inevitable miscarriage (IMC) Traditionally any bleeding from the vagina during early pregnancy with, on vaginal examination, opening of the cervix |
epidemiology | The branch of medical science that deals with the study of incidence and distribution and control of a disease among a specific group. |
mucoid | Resembling mucus; forming large moist sticky colonies of bacteria. |
hybrid | An offspring produced from mating plants or animals from different species, varieties or genotypes. |
existing data set | Data that existed prior to the initiation of a research project. |
quasi-experimental study | A study that is similar to a true experimental study except that it lacks random assignments of subjects to treatment groups |
focus | The location of a group of cells in the cerebral cortex whose abnormal discharge initiates seizures. |
contract modification | Written change order in the contract terms |
tolerance | Decreased responsiveness to a drug, due to a long period of exposure. |
withdrawn | Study halted prematurely, prior to enrollment of first participant |
drug product | The finished dosage form (i.e |
clinical investigator | A professional medical researcher involved in the carrying out a clinical trial protocol. |
quality of life trials | Also called Supportive Care trials |
phloem | food-conducting, food-storing tissue in the vascular system of roots, stems, and leaves |
clinically stable | When symptoms are not changing or progressing and, for the time being, are not expected to. |
phosphate | The usual form that phosphorus is found (PO4) and is linked to metals or hydrogen. |
ovary | Female sexual gland in which the ova, or eggs, are formed. |
gamma interferon | A T cell-derived stimulating substance that suppresses virus reproduction, stimulates other T cells and activates macrophage cells |
parathyroid glands | Four glands located on the back of the thyroid that produce parathyroid hormone. |
informed consent | Informed consent |
rhizomycelium | Branching, anucleate or sparsely nucleate, rhizoidal filaments of variable width forming part of the thallus in some fungi. |
neuroendocrine | involving both the nervous and endocrine systems. |
conjugate eye movements | Refers to rotation of the eyes in the same direction at the same time. |
dementia | Chronic intellectual impairment (i.e., loss of mental capacity) with organic origins that affects a person's ability to function in a social or occupational setting |
serm | Selective Estrogen Receptor Modulator, such as tamoxifen, which exhibits tissue-selective effects. |
facet joints | Joints located between two adjacent vertebrae at every spinal level |
paradoxical sleep | A stage of deep sleep characterized by desynchronized EEG patterns, REM, and dreaming, syn |
insulin | Insulin |
continuous dysesthesia | Continuous neuropathic pain that manifests as burning, electrical or other abnormal sensation |
condensate | Something that has turned into liquid, such as a liquid reduced from a gas or vapor, like water from steam. |
gate theory of pain | A theory that says the perception of pain depends not only upon activity in nociceptors, but also upon the balance between activity in nociceptors and large myelinated cutaneous afferent fibers. |
transpiration | The loss of water vapor from the surface of leaves and other aboveground parts of plants. |
recessive | a phenotypic trait that is expressed in diploid organisms only if both parents contribute the trait to the progeny |
lobes | The two halves of the thyroid gland that give it its butterfly-like shape |
clinical development | Term used to describe the cross-functional and cross-departmental activities that are required to bring an investigational product from Phase I through Phase IV. |
double-masked design | A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects |
prisoner | An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)] |
po | per os (oral) |
nervous system | The neurons and associated cells of the body. |
side effect | Undesired effect of a treatment |
picogram | One millionth of a gram. |
capsule | In bacteria: A layer of material external to but contiguous with the cell wall. |
suberized | Of cell walls: Hardened by their conversion to cork (suberin). |
anti-tnf | Anti-Tumor Necrosis Factor |
olfaction | The sense of smell. |
sputum density | A measurement of mucus or phlegm coughed up from lungs. |
migratory | migrating from place to place on a plant or from plant to plant when feeding (see sedentary) |
ich-international conference of harmonization | ICH is focused on the harmonization of technical requirements for the registration of pharmaceutical products in the U.S., Japan and European Union. |
phase i trials | The first phase of a drug trial |
bell-magendie law | The notion that sensory fibers enter the spinal cord through dorsal roots, motor fibers exit the spinal cord through ventral roots. |
recruitment | Identifying and enrolling participants for a study. See Recruitment Status. |
tracheosteneosis | Narrowing of the trachea due to inflammation |
adverse event | A negative experience encountered by an individual during the course of a clinical trial, that is associated with the drug |
protocol | The detailed plan for a clinical trial that states the trial's rationale, purpose, vaccine dosages, routes of administration, length of study, eligibility criteria and other aspects of trial design. |
assistance | Award of money, property, or services to accomplish a public purpose |
fwa | See: Federalwide Assurance |
epidemic | A change in the amount of disease in a population in time and space. |
sticker | Added to fungicide or bactericide preparations to improve the adhesion of the spray to the sprayed surface. |
radioactive isotopes | Unstable chemical elements that are used in diagnostic testing for thyroid disorders including thyroid cancer. |
green card | See Alien Registration Receipt Card. |
assent | A child's affirmative agreement to participate in a clinical investigation |
positive feedback | regulatory process that increases the output of a system. |
ggt | Gamma-Glutamyl Transferase |
placebo effect | A physical or emotional change occurring after a substance is taken or administered that is not the result of any special property of the substance |
intramuscular | Injected into the muscle. |
president's commission | President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research |
thymosin | A polypeptide hormone of the thymus that influences the maturation of T cells destined for an active role in cell-mediated immunity |
description | Go to these resources: |
slow muscle | Relative term, referring to the speed of twitch contraction and relaxation and to the relatively low rates of stimulation at which tetanic fusion occurs. |
randomization | A method by which study participants are assigned to a treatment group by chance (i.e |
demographic data | Refers to the characteristics of study participants, including sex, age, family medical history, and other characteristics relevant to the study in which they are enrolled. |
grant | Financial support provided for research study designed and proposed by the principal investigator(s) |
pilot study | See Preliminary Study. |
diagnostic interventional clinical trial | A diagnostic interventional trial assigns a group of human subjects to intervention based on the results of diagnostic tests and in most cases a comparison group to follow standard procedures |
intervention | Any measure whose purpose is to improve health or to alter the course of a disease |
eradicant | Any chemical agent that eliminates particular pathogen(s) from diseased plants treated with that agent. |
relapsing-remitting ms | Form of MS characterized by clearly defined disease relapses (flare-ups) with full recovery or with sequelae (resulting conditions) and residual deficit upon recovery |
sham rage | An outburst of behavior in an animal with a lesion somewhere above the tectum, resembling anger, but lacking direction. |
energy medicine | Based on the concept that human beings conduct a subtle form of energy and that illness results from disturbances of these subtle energies |
papillary cancer | A well-differentiated thyroid cancer composed of thyroid follicular cells |
magnetic resonance imaging | Medical imaging that uses radiofrequency radiation as its source |
budget period | See grant budget period. |
epidemic | an increase of disease in a population; a general and serious outbreak of disease (epiphytotic) |
gonadotropin | 1) hormone (released from pituitary gland) that stimulates the gonads |
hyaline | transparent or nearly so; translucent; often used in the sense of colorless |
sf-36 | Short-Form 36 |
phytohemagglutinin | A plant chemical used to stimulate the multiplication of white blood cells. |
bayh-dole act | Go to these resources: |
longitudinal study | A study conducted over a long period of time. |
empirical | Based on experimental data, not on a theory. |
rubella | Rubella (German measles) |
photophobia | Abnormal or painful visual intolerance of light |
spot | a symptom of disease characterized by a limited necrotic area, as on leaves, flowers, and stems |
cat scan | Abbreviation for Computerized Axial Tomography, an X-ray technique for producing images of internal bodily structures through the assistance of a computer. |
rhizoid | A root-like structure forming part of the thallus in certain algae and fungi; it may anchor the organism to the substratum and/or act as an absorptive organ. |
ionotropic transmission | Synaptic transmission in which the transmitter substance produces a change in ionic conductance of the postsynaptic membrane directly by interaction with a postsynaptic receptor. |
fte | Full-time equivalent. |
non-viable fetus | An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)] (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.203) |
esophagus | In nematodes: The portion of the alimentary canal between the |
postcoital test | incomplete miscarriage (IMC) Any miscarriage before all miscarriage tissue has been expelled |
documentation | All records, in any form, that describe or document methods, conduct and results of a study. |
phlegm | Mucus made from glands in the airways of the lung. |
half-life of a drug | The amount of time taken for the concentration of a drug in the body to decline by half. |
surveys | Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures. |
meiosis | The process in which a eukaryotic nucleus divides into nuclei whose ploidy is lower than that of the parent nucleus (typically, haploid nuclei being formed from diploid nuclei) and in which recombination usually occurs. |
macula lutea | An irregular yellowish depression in the retina surrounding the fovea. |
scientific review group | Scientific review officers act as intermediaries between principal investigators and reviewers and prepare summary statements for applications that are reviewed |
phase 2b trial | Controlled clinical study, also known as a "proof-of-concept" trial, provides valuable information on the safety and potential efficacy of the vaccine |
chromosome | The thread-like material that carriers genes, the units of heredity |
toxicity testing | Performing controlled testing in the laboratory to determine the toxicity of a compound or drug to an organism at various concentrations |
aura | Visual disturbance such as flashes of light, zigzagging patterns or blind spots that can signal the onset of pain |
reassortant vaccine | Reassortant vaccine |
passive reporting | Passive reporting |
polymodal nociceptor | A receptor that responds to more than one type of noxious stimulus, e.g., noxious heat and noxious mechanical stimuli. |
side effect | Any actions or effects of a drug or treatment that are different from the intended effects |
approved drug | Drug products approved by the FDA |
neutralization | The process by which an antibody binds to specific antigens, thereby "neutralizing" the microorganism |
hbv | A DNA virus in the family Hepadnaviridae |
lung cancer | carcinoma of the lungs; one of the commonest forms of cancer |
preventive medicine | Science to prevent disease rather than cure it or treat its smptoms. |
mrsa | Methicillin-Resistant Staphylococcus aureus |
irmer | Ionising Radiation (Medical Exposure) Regulations (2000). |
mutant | Of an organism, population, gene, chromosome, etc.: Differing from the corresponding |
herd immunity | Herd immunity |
viruliferous | an organism that is virus-laden, usually applied to insects or nematodes that serve as a vector for a given virus |
topical microbicide | Products classified by FDA which act to prevent vaginal transmission of sexually acquired diseases. |
d+ | Cytomegalovirus-seropositive donor |
declaration of helsinki | A series of guidelines adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964 |
ectotrophic | fungal development outside the root surface |
cra | see Clinical Research Associate |
closterovirus | (from Greek kloster, "thread") Member of a group of plant viruses with very long, flexuous, rod-shaped particles containing a single molecule of linear RNA, some members of which are transmitted by whiteflies. |
static | In biology, a property of a drug that means it acts by inhibiting the growth or spread of an organism such as bacteria (e.g., bacteriostatic) |
parent program announcement | Generally institutes do not set aside money to pay for the grants (unless a PAS), and applications are considered to be investigator-initiated |
single-blind study | A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking |
monocyte | A large, white blood cell in the blood that ingests microbes or other cells and foreign particles |
catheter | A flexible tube that is inserted into a cavity of the body to withdraw or introduce fluid, such as pain relievers or steroids. |
administrative standard | See OMB circulars. |
stevens-johnson syndrome | A severe and sometimes fatal form of erythema multiforme that is characterized by conjunctivitis (eye inflammation) and often results in blindness, Vincent's angina (trench mouth) and ulceration of the genitals and anus |
ethics | Conforming to an accepted standard of human behavior. |
biologic | Any substance (serum, toxin, vaccine, etc.) used to treat, prevent or cure diseases in man. |
hypertrophy | Increase in cell size causing an increase in the size of an organ or tissue. |
indemnification | Process to relieve the investigator, subinvestigators, IRB/IEC, and/or research institution of responsibility against hurt, loss, or damage to subjects resulting from participation in a clinical trial. |
open-label trial | A clinical trial in which the research staff and participants know which treatment (active or inactive) is being administered to the participant. |
clasp-knife reflex | Sudden release of tension of a spastic muscle that occurs near the maximum length as the muscle is gradually lengthened, syn |
incident rate | The rate of occurrence of new cases of a disease, adverse reaction, or other event in a given population at risk (e.g., the incidence of disease X is Y subjects per year per 100,000 population). |
protocol | A detailed plan for a clinical trial |
generic drug | A drug with the same molecular structure and active ingredient, but not necessarily the same inactive ingredients, as a brand-name drug |
mucus | A fluid made by membranes and glands |
neuropathic pain | Chronic pain due to an injury to the nervous system or a disease such as multiple sclerosis or stroke |
presynaptic element | The component of a synapse that releases the transmitter substance and/or conducts impulses in the afferent direction with respect to the synapse. |
h band | The lighter region in the center of the anisotropic or A band, from which the thin filaments are absent. |
sham comparator arm | A group of participants that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components |
facultative saprophyte | A mainly parasitic organism with the ability to survive for a part of its life cycle as a saprophyte and be cultured on artificial media. |
protocol | A document that identifies the plan or set of rules for conducting a specific clinical trial, and states the objectives, design, methodology, statistical considerations, and organization of a trial. |
plague | Plague |
herniated disc | Rupture of tissue that separates vertebrae of the spinal column |
confidentiality agreement | See: UW Confidentiality Agreement |
radioactive iodine uptake | A test measuring the amount of orally administered radioactive iodine taken up by the thyroid gland. |
hypothesis | Theory or assumption used as a guide in clinical research. |
assessment | An evaluation or appraisal of a condition, as in pain assessment |
oxidizes | To combine with oxygen. |
lobotomy | Incision into a lobe, cutting all the fibers in the white matter, syn |
documentation | All forms of records that describe or document study methods, conduct and results, including any adverse events and actions taken. |
alcoholic cerebellar degeneration | Degeneration of the cerebellum due to chronic over-consumption of alcohol. |
teratogenicity | The production of physical defects in offspring in utero (i.e., causing birth defects). |
areflexia | Absence of reflexes. |
palm kernel oil | An unsaturated oil from the kernel of the palm tree normally partially hydrogenated to make it more solid. This creates trans fatty acids which are harmful. |
guttation | Exudation of water from plants, particularly along the leaf margin. |
informed consent | The process of learning the key facts about a clinical trial before deciding whether or not to participate |
natural history | A collection of facts about the development of a natural process or condition, without a change in the conditions until an endpoint is reached- often applied to disease prevention. |
steroid | 1) molecule synthesized from cholesterol |
common rule | 1991 agreement to cover all federal-sponsored research by a common set of regulations. |
steroid | A lipid found in plants and animals that share a common underlying chemical structure |
restricted experiment | Go to the NIH Guidelines for Research Involving Recombinant DNA Molecules. |
denervation hypersensitivity | Elevated response of a nerve or muscle membrane receptor to a transmitter substance following resection or removal of its afferent nerve supply. |
expanded access | A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial |
electrical equivalent circuit | A collection of electrical components assembled in a particular configuration that behaves like the cell membrane. |
informed consent document | A document that describes the rights of clinical research participants and details about the study or trial |
rectal | Relates to the rectum; the place where feces are eliminated from the body. |
normal volunteers | Volunteer subjects used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with subjects who do have the condition |
cdc national aids clearinghouse | The CDC's comprehensive reference, referral and publication distribution service for HIV and AIDS information |
status epilepticus | Seizures that occur in series without intervening recovery periods. |
vegetative | A cell or structure that is not producing reproductive structures, usually in the assimilative state. |
minor change | Minor changes to IRB-approved research may be approved by the expedited review process (see Minimal Risk review) |
transmission | The transfer of a pathogen from one plant to another, or from one plant organ to another. |
spreader | A substance added to fungicide or bactericide preparations to improve contact between the spray and the sprayed surface; a surfactant. |
photophobia | Abnormal visual intolerance of light. |
risk-benefit ratio | The known risk of participating in a clinical trial weighed against the potential benefits. |
enzyme | A protein that accelerates a specific chemical reaction without altering itself (i.e., a catalyst). |
transpiration | water loss by evaporation from leaf surfaces and through stomata |
niaid | Roughly the top half of applications reviewed are recommended for funding, although a much smaller proportion is actually funded, largely due to budget contraints |
blinding | The process through which one or more parties to a clinical trial are unaware of the treatment assignments |
thallus | Any simple vegetative plant body that lacks roots, stems and leaves |
helsinki declaration | Guidelines, adopted in 1964 by the 18th World Medical Assembly (WMA) (Helsinki, Finland) and revised in 2000 by the 52nd WMA General Assembly, for physicians conducting biomedical research |
phase iii study | Phase III studies are large, multicenter studies of afflicted patients which test the new drug in comparison with a placebo or the standard therapy most commonly used to treat the condition or disease |
bias | When a point of view prevents impartial judgment on issues relating to the subject of that point of view |
efficacy | A drug or treatment's maximum ability to produce beneficial results regardless of dosage on the course or duration of a disease or condition. |
isometric contraction | A contraction during which the muscle does not change length. |
clinicaltrials.gov identifier | A unique identification code given to each clinical study registered on ClinicalTrials.gov |
haustorium | A specialized branch of a hypha formed inside a host cell by certain plant-parasitic fungi (especially obligate parasites) in order to obtain nutrients |
healing touch | A non-invasive technique that utilizes the hands to clear, energize, and balance energy fields |
sensitivity | Sensitivity |
static response | The response of spindle endings that signals maintained length of a muscle. |
osteoporosis | Low bone density which causes an increased risk of bone farctures. |
unexpected adverse drug reaction | An adverse reaction, the nature or severity of which is not consistent with the applicable product information in the investigators’ brochure for an unapproved investigational product, or on the package insert/summary of product characteristics for an approved product. |
tractotomy | Section of a tract. |
physical therapy | Branch of rehabilitative health that uses specially designed exercises and equipment to help patients regain or improve their physical abilities |
phase i trials | Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, to observe the side effects associated with increasing doses, and to gain early evidence of effectiveness |
pome | simple, fleshy, indehiscent fruit derived from several carpels, e.g |
broca's area | Areas 44 and 45 of the frontal cerebral cortex that plays a fundamental role in production of speech. |
statistical significance | The probability that an event or difference occurred by chance alone |
color opponent cells | Visual neurons in which one part of the receptive field (e.g., the center) is sensitive to light in one part of the visible spectrum (e.g., red light), while another part of the field (e.g., the surround) is sensitive to another part of the spectrum (e.g., green light). |
procedure | Something done to fix a health problem or learn more about it |
department or agency head | means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated. |
anemia | A lower than normal number of red blood cells. |
institutionalized | Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home). |
protocol | The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support |
laryngotracheotomy | Surgical incision into the larynx and trachea |
sebum | A fatty lubricant secreted by skin glands that coats and softens the skin and hair. |
current dollars | Go to these resources: |
cloning | An in vitro procedure in which a particular sequence of DNA (e.g., a gene) is reproduced in large amounts by inserting ("splicing") it into a suitable |
autonomy | An individual's right to consider alternatives, make choices, and act without undue influence or interference of others |
hand-washing facilities | A facility providing an adequate supply of running potable water, soap, and single-use towels or hot air drying machines. |
registry | A list of names and contact information of people who are willing to be contacted about research related to a specific topic |
spirometer | A device that measures air flow and lung volumes (see PULMONARY FUNCTION TESTS). |
run-in period of study | The period of time used to take patients off their existing medications in order to prepare them to be treated with a new drug |
clinical trials | Carefully controlled studies that are conducted in humans who volunteer to test the effectiveness and safety of new drugs, medical products or techniques |
efficacy | The ability of a drug to control or cure an illness. |
consent forms | A document that outlines all the potential risks, benefits and relevant information about a clinical study to the volunteer or participant |
collagen | The principal protein of the skin, tendons, cartilage, bone, and gives connective tissue its strength and flexibility. |
employee or agent | Refers to someone who: acts on behalf of an organization; exercises institutional authority or responsibility; or performs institutionally-designated activities. |
lyophilisation | Freeze drying. |
parenchyma | A tissue composed of living, thin-walled cells that can continue to divide even when mature; parenchyma cells usually leave intercellular spaces between them. |
outcome | The ultimate result of a medical test or treatment given to patient |
epidural injection | An injection of a substance into the epidural space within the spinal canal to produce anesthesia or pain relief. |
reverse transcriptase | This enzyme of the HIV virus (and other retroviruses) converts the single-stranded viral RNA into DNA, the form in which the cell carries its genes |
government-furnished property | Items the government possesses or acquires and provides a contractor |
hyperalgesia | Increased sensitivity to pain. |
toxin | poisonous substance of biological origin |
dhhs | A federal agency: U.S |
uterus | A hollow muscular organ located in the pelvic cavity of female mammals in which the fertilized egg implants and develops |
electronic grant file | File containing all official documentation for a grant. |
glycosylation | the process of adding sugar groups to a molecule. |
ra | Rheumatoid arthritis |
specificity | The ability of a test to detect the proportion of true negative results for the disease that the test is intended to reveal |
rogue | to remove and destroy individual plants that are diseased, infested by insects, or otherwise undesirable |
neuropsychologist | Psychologist who has specialized training and experience in understanding brain-behavior relationships |
contracting officer | For a legal description, see FAR 16.301-1. |
effectiveness | Effectiveness |
n-3 | Refers to fatty acids with the first double bond at the number three carbon; at the end opposite from the acid end. |
phase i unit | The facility which has been specifically designed and custom-built for conducting studies with normal, healthy participants/volunteers. |
nucleic acid | genetic material of all living organisms, including DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) |
study-directed inspections | Inspections conducted periodically to determine compliance with FDA regulations |
hypothesis | A tentative statement or supposition that may then be tested through research. |
mutation | A change in a gene (see AUTOSOMAL RECESSIVE, CARRIER, CHROMOSOME, GENE, GENETIC, HEREDITARY and INHERITED). |
areolation | A condition in which the transverse body annulation of a nematode traverses the lateral field. |
mtx | Methotrexate |
hiv | Human Immunodeficiency Virus |
standard case definition | Standard case definition |
biotechnology | Any technique that uses living organisms, or substances from organisms, biological systems, or processes to make or modify a product or process, to change plants or animals, or to develop micro-organisms for specific uses. |
aidsrrc | See AIDS Research Review Committee. |
children | Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)]. |
bar to award | Go to NIAID's Research Animals Involvement Codes on the Animals in Research portal. |
new drug application | An application submitted to the FDA requesting approval to market a new drug for human use |
abiotic | Non-living; of non-biological origin. |
cerebral | Pertaining to the cerebrum, the main portion of the brain. |
nerve block | A procedure in which an anesthetic agent is injected directly near a nerve to numb the area and help alleviate pain |
internode | the portion of a stem between two successive nodes |
long-term memory | Recall of learned responses or material having a duration of minutes to years. |
reciprocal inhibition | Interconnections of neurons arranged so that pathways that excite one group of motoneurons inhibit the antagonist motoneurons. |
secondary-progressive ms | Form of MS characterized by initial RR disease course followed by progression with or without occasional relapses, minor remissions (some recovery), and plateaus (leveling of condition). |
washout period | A time during a clinical trial when participants receive no drugs for the study so the effects of previous study drugs are removed. |
hr | hour |
baculovirus | A virus of insects used in the production of some HIV vaccines |
deuteromycotina | (Also Fungi Imperfecti.) A non-phylogenetic category originally created for fungi with no known sexual stage; the category still includes fungi with no known sexual stage, but it also includes the asexual stages of various fungi now known to have a sexual stage in the |
expired study | When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. |
rinne's test | A hearing test in which a tuning fork is placed on the mastoid process to distinguish conduction deafness from nerve deafness. |
era commons | Go to eRA. |
phase iia study | Pilot clinical trials to evaluate efficacy (and safety) in selected populations of subjects with the disease or condition to be treated, diagnosed, or prevented |
physical medicine and rehabilitation | Medical specialty concerned with diagnosing, evaluating and treating patients with physical disabilities |
full-board review | Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas |
cohort | A group of subjects initially identified as having one or more characteristics in common who are followed over time |
multiple project assurance | Permit given to institution for multiple federally funded research grants for a specified period of time |
organ | A part of the body that performs a specific function or group of functions |
physiatrist | A physician whose primary goal is to achieve maximal restoration of physical, psychological, social and vocational function through comprehensive rehabilitation |
adverse event following immunization | Adverse event following immunization (AEFI) |
ethnic and racial subgroup | See racial and ethnic categories and subpopulations. |
acupuncture | Ancient Chinese healing technique uses the insertion of strategically placed fine needles just beneath the skin’s surface that may help to prevent or treat diseases and illnesses |
cytokines | Proteins used for communication by cells of the immune system |
spirometer | Device used to improve lung expansion after an operation or during a hospital stay |
post-transfusion hepatitis | Liver inflammation, or hepatitis, that occurs when the body reacts unfavorably to a blood transfusion |
cytotoxic t cells | A lymphocyte that is able to kill foreign cells marked for destruction by the cellular immune system |
human leukocyte anitgens | Markers that identify cells as "self" and prevent the immune system from attacking them. |
crossover study | A study in which each participant receives both treatments, the new treatment and the control, in a randomized order so that treatment comparisons can be made within each participant. |
mmr vaccine | MMR vaccine |
gametogenesis | The development of gametes. |
hypothalamus | An endocrine gland in the brain that releases thyrotropin-releasing hormone (TRH). |
daids | See Division of AIDS. |
mature minor | Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care) |
application | See grant application. |
scab | roughened, crustlike diseased area on the surface of a plant organ |
fcoi | Financial Conflict of Interest See: conflict of interest |
control group | The control group is the measure to gauge the effectiveness of the experimental treatment |
quality assurance | The planned and systematic actions that are established to ensure that a trial is conducted and data are collected and recorded according to the protocol, standards of good clinical practice, and applicable regulations. |
cofunding | Funding arrangement through which two or more institutes or centers pay for a grant. |
results submission | The process of submitting and updating summary information about the results of a clinical study to a structured, public Web-based results database, such as the ClinicalTrials.gov results database. |
heterotrophic | Requiring organic substrates for growth and development; being incapable of synthesizing required organic materials from inorganic sources. |
inhibitory postsynaptic potential | An hyperpolarizing change in the membrane potential of a neuron due to synaptic activity that tends to decrease the probability of discharge in the neuron, abbr |
immunocompromised | A condition in which the immune system is weakened as the result of disease, drugs or malnutrition. |
crp | C-reactive protein |
asmf | The Active Substance Master File is a document containing complete information on an Active Pharmaceutical Ingredient. |
septum | A cross wall in a hypha or spore |
electromyogram | A recording of the electrical activity of muscle during contraction, abbr |
psychiatrist | Medical doctor specializing in the prevention, diagnosis and treatment of mental, addictive and emotional disorders |
placebo effect | A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance |
referred pain | Pain due to damage to an internal organ that is referred to a structure on the surface of the body. |
noninvasive | Not penetrating the body, as by incision |
guard cells | paired, specialized, epidermal cells that contain chloroplasts and surround a stoma |
upper motoneuron syndrome | A group of symptoms resulting from removal of supraspinal influences on spinal mechanisms. |
hypersensitivity | Hypersensitivity |
serum | The clear, thin and sticky fluid portion of the blood that remains after coagulation |
spinal fusion | Surgical fusion of two or more vertebrae for remedial immobilization of the spine |
drug substance | An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient. |
stimulatory hormone | a chemical released from the pituitary gland that elicits a response in a target organ. |
arachnoiditis | Painful inflammation and thickening of the arachnoid membrane around nerve roots |
fast axoplasmic transport | The active movement of substances down the axon of a neuron in the orthograde direction at up to 410 mm/day. |
diffusion | The process of becoming widely distributed that occurs because of molecular concentration differences only. |
endogenous | Arising from within the generating structure. |
vaccine efficacy | Vaccine efficacy |
toxicity | The extent, quality, or degree of harm to the body. |
intracellular | through or within cells |
null cell | A lymphocyte that develops in the bone marrow and lacks the characteristic surface markers of the B and T lymphocytes |
seizure | Seizure |
justice | An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly |
infection cushion | organized mass of hyphae formed on the surface of a plant from which numerous infective hyphae develop |
protanomaly | Color vision involving three pigments, but the red one is abnormal leading to reduced red sensitivity. |
occlusion | In neurophysiology, the inability of two action potentials to occupy the same region of membrane at the same time; thus an antidromic impulse blocks a concomitant orthodromic impulse in the same fiber by occlusion. |
neurohormone | a hormone produced by the brain. |
pathogen | an entity, usually a microorganism, that can incite disease . |
soil drench | application of a solution or suspension of a chemical to the soil, especially pesticides to control soilborne pathogens |
serum | The watery part of an animal fluid, normally the blood. |
well-being | Subject's physical and mental soundness. |
fetal material | The placenta, amniotic fluid, fetal membranes, and umbilical cord. |
debriefing | In the context of informed consent, the process of providing information to participants at the conclusion of study procedures |
spore | A discrete sexual or asexual reproductive unit, usually enclosed by a rigid wall, capable of being disseminated. |
isr | Injection Site Reaction |
biological specimen | A physical sample used for analysis, for example: urine, hair saliva, blood, or other tissues. |
osp | (UW) Office of Sponsored Programs See: http://www.washington.edu/research/?page=osp |
arthrospore | A spore resulting from the fragmentation of a hypha, as in the conidial stage of many |
gonad | an organ that produces cells (oocytes, spermatozoa) and hormones (estrogen, progesterone, testosterone) necessary for reproduction ( e.g., ovary [female] or testis [male]). |
chicken embryo fibroblast | MVA is propagated on primary chicken embryo fibroblast cells prepared from embryonated eggs |
virus | A microorganism composed of a piece of genetic material, RNA or DNA, surrounded by a protein coat |
treatment trials | Refers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. |
oxidative damage | The damage caused by free radicals and oxidizing agents. |
continuing non-compliance | A pattern of repeated actions or omissions taken by an Investigator that indicates a deficiency in the ability or willingness of an Investigator to comply with Federal regulations, Tulane University IRB Policy, or determinations or requirements of the Tulane University IRB. |
lobectomy | Surgical removal of a single lobe of a lung |
teratogen | a chemical that causes malformations in the fetus |
yellow fever vaccine | Yellow fever vaccine |
orphan drugs | An FDA category of medications used to treat rare diseases and conditions which affect fewer than 200,000 people |
retrovirus | HIV and other viruses that carry their genetic material in the form of RNA rather than DNA and have the enzyme reverse transcriptase that can transcribe it into DNA |
triiodothyronine | The secondary hormone produced by the thyroid gland |
intent to treat | Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized (See also Randomization) even if they never received the treatment. |
domestic | Located in the 50 states or the following: District of Columbia, U.S |
monitor | An individual selected by a sponsor to oversee the progress of a clinical investigation |
bioavailability study | A study which measures the rate and degree to which a drug is absorbed or available to the treatment site in the body. |
masking | An increase in the threshold for perception of a given stimulus caused by the presence of another stimulus. |
granulocyte | A cell type of the immune system filled with granules of toxic chemicals that enable them to digest microorganisms |
best frequency | The frequency of an auditory stimulus that gives the response of highest rate in an auditory neuron. |
humanitarian device exemption | A premarket approval application submitted under 21 CFR 814 Subpart H seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the FD&C Act as authorized by section 520(m)(2) of the Act. |
septum | A cross wall in a hypha or spore. |
dendrosomatic synapse | The synaptic junction between a dendrite and a cell soma in which the dendrite is presumed to be the presynaptic element. |
gland | A group of cells that make substances so that other parts of the body can work |
registry | A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies. |
standard treatment | The treatment that is normally provided to people with a given condition |
over-the-counter | Drugs available for purchase without a physician's prescription. |
myoclonus | Clonus. |
ct scan | Computerised axial tomographic scan; an imaging procedure |
monitoring | The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections. |
interleukin 10 | IMB See intermenstrual bleeding. |
lipid | Any of a group of fats and fat-like compounds, including sterols, fatty acids and many other substances. |
activation | In EEG: reduction in amplitude and increase in frequency of the EEG accompanying alerting, syn |
carrier | An organism that bears an infectious agent internally but shows no marked symptoms of the disease caused by that agent. |
guide | See initiative, institute-specific program announcement, and parent program announcement. |
action potential | The all-or-none, conducted voltage response of a nerve or muscle membrane that is used to communicate information from one cell to another, syn |
intent to treat | Analysis of clinical trial results that includes all data from patients in the groups to which they were randomized (i.e., assigned through random distribution) even if they never received the treatment |
subject identifier | Information that identifies the subject |
sop | Standard Operating Procedure |
nda | New Drug Application, a complete application (typically thousands of pages long) to the FDA (Food and Drug Administration) to begin marketing of a drug product in the US. |
critical firing level | The value of the trans-membrane voltage to which a nerve or muscle cell must be hypopolarized in order for an action potential to be evoked. |
aro | Academic Research Organization |
subthreshold stimulus | A stimulus whose strength is too low to initiate a response. |
cber | Center for Biologics Evaluation and Research; CBER is the department within FDA that regulates biological products for human use. |
static fusimotor neuron | Ag motoneuron whose activity increases the static responses of both primary and secondary spindle endings. |
last updated date | The last updated date is the most recent date that changes to study information were submitted to ClinicalTrials.gov |
x-ray | A diagnostic test that images bones by shooting a high-energy radiation through the body |
research | Go to these resources: |
rabies | Rabies |
vaccine-associated risk | Vaccine-associated risk |
novel technique | A newly used skill or procedure. |
micron | one millionth of a meter |
eligibility criteria | Rules for selecting subjects to participate in a clinical trial |
ind | Investigational New Drug application (also synonymous with "Notice of Claimed Investigational Exemption for a New Drug") |
post prandial | After a meal. |
retina | A delicate, multi-layered, light-sensitive membrane lining the inner eyeball and connected by the optic nerve to the brain. |
parasite | A plant or animal that lives and feeds on or within another living organism; does not necessarily cause disease. |
endonuclease | A nuclease which cleaves phosphodiester bonds within a nucleic acid strand. |
primary-progressive ms | Form of MS characterized by disease progression from onset, with occasional plateaus (leveling of condition) and temporary minor improvements possible. |
primary completion date | The date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected |
corticosteroids | Steroids used as an anti-inflammatory agent for pain. |
certified research coordinator | A research coordinator with two or more years of experience and who has passed the required program and exam to earn their certification. |
investigator | An individual who conducts a clinical study and directs the use, administration, and distribution of the investigational agent to a subject |
vector | An living agent that transmits a pathogen from an infected plant to an uninfected one. |
amino acids | Any of a class of organic compounds having a carboxyl group (COOH) and an amino group (NH2) |
transneuronal degeneration | Refers to the wasting of a nerve cell when the fibers that innervate it are severed. |
orphan drug | An FDA category which refers to drugs and treatments for rare diseases and conditions, or those which affect less than 200,000 people in the U.S |
efficacy | The ability of an intervention to produce the desired beneficial effect |
pharmacokinetics | The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. |
exclusion criteria | Factors used to determine whether an individual is ineligible for a trial. |
aefi surveillance | AEFI surveillance (also known as vaccine safety surveillance) |
case report form | A printed, optical, or electronic document used to record protocol-required information for each subject in the study. |
dtwp vaccine | DTwP vaccine |
suprathreshold stimulus | A stimulus that is of sufficient strength to give a response. |
wilt | drooping of leaves and stems due to lack of water (inadequate water supply or excessive transpiration); a vascular disease that interrupts normal water uptake |
mentally competent | Having the capacity to understand information, make decisions, and act reasonably. |
deception | In the context of informed consent, the omission of relevant information and/or presentation of misleading information about a study. |
basal metabolic rate | The rate of metabolism, or how fast the body uses calories and oxygen to produce energy. |
intramuscular injection | Intramuscular (IM) injection |
cervical vertebra | One of 7 upper vertebrae in the spinal column. |
trichromatic theory | Theory of color vision that says there are three fundamental color sensations and three different color receptors; color sensation is the result of activity in this ensemble, syn |
analysis | Main requirements for ensuring a valid analysis are as follows: |
categorical budget | See detailed budget. |
postsynaptic element | The component of a synapse that receives the transmitter substance and/or conducts impulses in the efferent direction with respect to the synapse. |
helper t cells | See CD4 (T4) or CD4+ Cells. |
eligibility criteria | A set of criteria for participant selection; includes Inclusion and Exclusion criteria. |
natural history study | Study of the natural development of something (such as an organism or a disease) over a period of time. |
ich | lnternational Conference on Harmonization |
percutaneous | Passage or absorption of substances into the body through unbroken skin. |
isometric | usually used for virus particles to describe those that are icosahedral in structure and appear approximately round |
ooze | mass of bacterial cells mixed with host fluids |
pulsatile release | a periodic (non-continuous) release of hormone |
cadaver | The body of a deceased person. |
protectant | Any chemical agent that interacts with a pathogen on the plant surface to inhibit infection before it takes place |
coincidental event | Coincidental event |
office of acquisitions | Go to these resources: |
spasm | Brief, automatic jerking movement that may be caused by stress, medication, excessive exercise, etc. |
rem sleep | A normal sleep stage with rapid and random eye movement. |
antibiotic | A chemical substance produced by a microorganism that has the capacity to kill or inhibit the growth of other microorganisms (e.g., penicillin, tetracycline, vancomycin, or methicillin). |
genetic | Hereditary or inherited |
resting membrane potential | The membrane potential of a cell that is not active, i.e., not generating spikes; the average membrane potential. |
epiglottitis | Inflammation of the epiglottis |
antidepressant | Medication typically used to treat symptoms of depression, but also commonly prescribed to help manage chronic pain and some of its symptoms, such as insomnia. |
hypothesis | A supposition or assumption used as a basis of reasoning and experimentation. |
q12h | every 12 hours |
genders eligible for study | The physical gender of persons who may participate in the clinical study (female, male, or both) |
legally acceptable representative | An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. |
funding opportunity announcement | Applications are considered to be investigator-initiated |
morphology | the study of the form of organisms; form and structure of organisms |
formulation | The mixture of chemicals and/or biological substances and excipients used to prepare dosage forms. |
lupus | Any of several diseases, which first affect the skin and joints, but often involve other parts of the body. |
audibility curve | A graph of a person's threshold for detection of various pitches in the range of human hearing, syn |
mycorrhiza | A specialized root structure resulting from a symbiotic relationship between a fungus and a higher plant. |
monitor | See Clinical Research Associate. |
archive date | Grants.gov term for the date a funding opportunity announcement expires and moves to the Grants.gov archive |
pathology | The study of diseases. |
td vaccine | Td vaccine |
strain | a distinct form of an organism or virus within a species, differing from other forms of the species biologically, physically, or chemically |
digestion | The process of breaking down the food we eat and absorbing its nutrients into the body for energy (see ABSORPTION). |
volva | A cup-like structure at the base of a |
enrolling | The act of signing up participants into a study |
depot effect | Depot effect |
children | Individuals who are under the legal age to give consent for participation in a clinical research study |
antihistamine | A therapeutic drug that inhibits the effects of histamines |
split-brain patient | A patient who has had her or his corpus callosum sectioned. |
flexor reflex afferent fibers | Nerve fibers stimulation of which evokes a flexion reflex, A and C-fibers and groups II, III and IV of muscle. |
ploidy | the number of (complete) sets of chromosomes in a cell, e.g |
memorandum of understanding | A formal agreement between Tulane University and another institution that identifies the Tulane University Institutional Review Board as the IRB of record for that institution and defines the responsibilities for both he Tulane IRB and the other institution. |
breathing | To inhale or exhale air through the lungs |
safety reports | In the event of any serious and/or unexpected adverse experience, the FDA requires a report. |
acupuncture | Complementary medicine technique using tiny needles inserted in the skin at certain points along the body to help manage pain. |
biomarkers | A biochemical or a substance in the body that can be used to measure disease activity or effects of treatment. |
serious adverse event | Go to definition in 21 CFR 812.3 and full 21 CFR 812 and the NIAID Human Subjects Resources portal. |
pharmacognosy | Study of natural substances (plants, animals, microorganisms) used for drugs. |
fungus | A eukaryotic, heterotrophic organism whose usually walled, threadlike cells absorb nutrients |
simple cells | Neurons in visual cortex that are sensitive to narrow bars of light oriented in a particular direction across the retina, but not sensitive to movement of the bar. |
living systems | Human, animal, or cell environments used for experimental purposes in clinical trials (see IN VITRO and IN VIVO). |
migraine | Periodic attacks of vascular headache, commonly associated with irritability, nausea, vomiting, constipation or diarrhea, and often photophobic. |
pertussis | Acute infectious disease that causes inflammation of the larynx, trachea, and bronchi with spasmodic coughing; commonly known as whooping cough because of the noise produced |
pharmacoeconomics | The study that compares the value of drugs with other therapies or with similar drugs in terms of their financial and quality of life cost and effects |
binasal hemianopsia | Hemianopsia or loss of vision involving the nasal visual fields of both eyes. |
dream sleep | A stage of sleep characterized by desychronized EEG patterns, REM, and dreaming, syn |
tricyclic antidepressants | Medications used to treat depression as well as some forms of anxiety, fibromyalgia, and chronic pain |
serologic test | Any of a number of tests that are performed on the clear portion of blood (serum) |
herbaceous | describing primary, soft, nonwoody tissue, as a plant or plant part; having the characteristics of an herb |
off label | The use of a drug for a purpose other than that approved of by Health Canada. |
polymerase | Any of several enzymes that catalyze the formation of DNA or RNA from precursor substances in the presence of preexisting DNA or RNA acting as templates (i.e., patterns) |
z line | The boundary of the sarcomere and point of attachment of thin filaments of adjacent sarcomeres. |
slow axoplasmic transport | The movement of substances down the axon of a neuron in the orthograde direction at up to 12 mm/day. |
delayed rectification | During a spike, the change in potassium conductance due to membrane hypopolarization that occurs after the change in sodium conductance. |
study completion date | The date that the final data for a clinical study were collected because the last study participant has made the final visit to the study location (that is, "last subject, last visit") |
study record | An entry in ClinicalTrials.gov that contains summary protocol information about a clinical study, such as recruitment status, eligibility criteria, contact information, and in some cases summary results |
sot | Solid Organ Transplant |
e-business point of contact | Person who manages an organization's grant activities and gives other staff privileges to submit grant applications through Grants.gov |
sympathetic nervous system | The division of the autonomic nervous system made up of thoracic and lumbar segments. |
nucleotides | The basic building blocks of nucleic acids (DNA and RNA) |
preamendments devices | Medical devices marketed before enactment of the 1976 Medical Device Amendments. |
demographic data | Characteristics of subjects including sex, age, family medical history and other characteristics pertinent to the study in which they are participating. |
confidentiality agreement | A letter sent to the investigator/institution to document their agreement to treat all information regarding the investigational product and the clinical trial in a confidential manner. |
rubella vaccine | Rubella vaccine |
control group | A comparison group of study subjects who are not treated with the investigational agent |
co-investigator | Researcher who works alongside the Principal Investigator or Lead Researcher |
monitor | Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol |
hymenophore | Spore-bearing structure; the part of a |
central sensitization | An increase in the excitability of neurons within the central nervous system, resulting in abnormal responses |
plasmogamy | the fusion of two sex cells |
site management organization | An organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site |
somatotopic organization | Pertaining to the orderly mapping of parts of the body onto the cerebral cortex and other parts of the nervous system. |
rotavirus vaccine | Rotavirus vaccine |
efficacy | The degree to which a diagnostic test or treatment produces a desired result in patients under the idealized circumstances of a clinical trial. |
informed consent | This is when participants learn the key facts about a clinical trial before they decide whether or not to take part |
topical anesthesia | A type of anesthesia that is applied on the skin, and they are available as creams, sprays, lotions and jellies. |
catheter | A tubular medical device for insertion into canals, vessels, passageways or body cavities, usually to permit injection (e.g., through an intravenous catheter into a vein) or withdrawal of fluids, or to keep a passage open. |
submission date | For paper applications, date due to the NIH Center for Scientific Review; differs from submission date. |
otolith organ | A vestibular organ containing otoliths, the utricle, or saccule. |
repository | A collection of data, samples or both made available to researchers for analyses intended to answer various research questions. |
era commons signing official | See signing official. |
reviews | Summaries of research in a particular area |
hipaa authorization | The formal documentation of consent for release of protected health information, given by either the patient or a legally authorized representative |
bronchogenic carcinoma | Aggressive form of cancer in cells of the bronchi |
germplasm | bearer of heredity material, often loosely applied to cultivars and breeding lines |
approved drug | In the United States, only drugs approved by the Food and Drug Administration (FDA) can be sold |
intervention | includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes |
mycelium | A mass of hyphae, often used to denote all hyphae comprising a thallus. |
comparator | An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. |
application guide | See SF 424 Application Guide. |
dark adaptation | An increase in the sensitivity of visual receptors as a function of time in the dark. |
efv | Efavirenz |
open design | An experimental design in which both the investigator(s) and the subjects know the treatment group(s) to which subjects are assigned. |
oropharyngeal | Relating to that division of the pharynx between the soft palate and the epiglottis |
institution | means any public or private entity or agency (including federal, state, and other agencies). |
antibody | Any immunoglobulin molecule produced in direct response to an antigen and which can combine specifically, non-covalently, and reversibly with the antigen which elicited its formation. |
plasmodium | naked multinucleate mass of protoplasm moving and feeding in amoeboid fashion |
unexpected adverse event | An adverse event that is unexpected for the investigational product and has not been reported in the investigator’s brochure or package insert or is an event that is being reported in greater severity or frequency than the same event previously reported. |
finger agnosia | Inability to recognize or indicate on command the fingers on one's own hand or the hands of others. |
nerve growth factor | A substance isolated from submaxillary glands that has the property of stimulating growth of sympathetic ganglion cells and, under certain circumstances, dorsal root ganglion cells. |
regulatory affairs | In clinical trials, the department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies |
rhizosphere | An environment regarded, variously, as (a) that region of the soil modified as a result of the uptake and deposition of substances by a growing root, (b) the root itself, together with that volume of soil which it influences, (c) the root surface together with that region of the surrounding soil in which the microbial population is affected by the presence of a root. |
biologic | Biologics are derived from living sources (such as humans, animals, micro-organisms) in contrast to most drugs which are chemically synthesized and have a known structure |
coding | Process by which features of a stimulus or information about an event are expressed in terms of nerve impulses or, in some cases, graded electrotonic potentials. |
royal jelly | A nutritious secretion from worker bees to nourish the larvae and queen bees. |
saprobe | organism that obtains nourishment from non-living organic matter |
microsclerotium | microscopic, dense aggregate of darkly pigmented, thick-walled hyphal cells |
domain | A region of a gene or gene product |
screening | The process clinicians use to see if a volunteer is eligible to participate in a clinical trial |
grand mal attacks | Epileptic seizures characterized by myoclonus, progressive myoclonus, loss of erect posture, and unconsciousness. |
f&a costs | See facilities and administrative costs. |
sign | indication of disease from direct observation of a pathogen or its parts present on diseased tissue |
endoscopy | Viewing the inside of a body cavity (e.g., colon) with an endoscope, a device using flexible fiber optics. |
standard operating procedure | Detailed, written descriptions for the management of clinical trials that must be adhered to during a study |
oscillometry | Measurement of changes, used in studying cardiovascular and respiratory functions. |
rheumatoid arthritis | Chronic autoimmune disease characterized by pain, stiffness, inflammation, swelling and often joint destruction |
dose-response | Dose-response |
anesthetic | A substance that causes lack of feeling (or awareness) and dulls pain. |
nuremberg code | A code of medical ethics set forth in 1947 for conducting human medical research in clinical trials |
intervention | Could include: a) physical procedures; b) social, psychological, or emotional manipulations, by which data are gathered; or c) manipulations of the subject or subject's environment performed for research purposes |
dir | See Division of Intramural Research. |
rheumatoid arthritis | Pain, swelling, stiffness, inflammation, and sometimes destruction of joints. |
cost-saving | Cost-saving |
beneficence | An ethical principle discussed in the Belmont Report that entails an obligation to promote good (or benefits). |
clinical research | Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy |
new drug application | An application submitted by the manufacturer of a drug to the FDA—after clinical trials have been completed—for a license to market the drug for a specified indication. |
burkholderia cepacia complex | Bacteria that can live in the lungs of people with CF and cause infection |
alpha-gamma coactivation | The tendency for alpha- and gamma-motoneurons to be activated together. |
cost estimate | Proposed expenditures necessary to accomplish the government's requirements. |
recruitment | Act of enrolling subjects with the proper inclusion criteria. |
blind study designs | See: Masked Study Designs; Double-Masked Design; and Single-Masked Design. |
neurohypophysis | 1) posterior lobe of the pituitary |
scoliosis | A condition involving an abnormal sideways curve in the spine. |
hearing loss curve | A plot of the threshold of hearing for a patient as deviations from normal for different frequencies of sound. |
resistance | The ability of an organism to exclude or overcome, completely or in some degree, the effect of a pathogen or other damaging factor. |
control group | In a clinical trial, the patient group(s) that does not receive the experimental treatment |
children | are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. |
preclinical | Testing of experimental drugs in the test tube or in animals |
budget appropriation | See appropriation. |
peer-reviewed publications | Professional journals that only publish articles subjected to a rigorous process which may require proof of findings in addition to peer review. |
program officer | Program class codes allow staff and NIAID's main advisory Council members to see where grant applications and grants reside administratively. |
crisp | Formerly used term |
warm fibers | Cutaneous thermoreceptors that increase their discharge rate with increasing skin temperature. |
muscarinic effect | The subset of actions normally produced by acetylcholine that can also be produced by muscarine. |
promoter | A region of DNA, usually upstream of a coding sequence, that binds RNA polymerase and directs the enzyme to the correct transcriptional start site. |
antibiotic | An antimicrobial agent, derived from cultures of a microorganism or produced semisynthetically, used to treat infections. |
translation | The synthesis of a protein directed by mRNA (messenger RNA) |
licensed healthcare professional | A person whose legally permitted scope of practice allows him or her to independently perform the activities required. |
primary muscle spindle receptor | The termination of a group Ia afferent fiber in the equatorial region of a muscle spindle, syn |
consent form | See Informed Consent. |
rai ablation | Administration of a radioactive form of iodine (131I) to try to destroy any remnant (normal or cancerous) thyroid tissue left after surgery in the thyroid bed or neck. |
assurance | A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [45 CFR 46.103]. |
cmp | See Office of Acquisitions. |
nerve cell | A cell specialized for excitability and conductivity, syn |
demyelination | Destruction, removal or loss of the myelin sheath of a nerve or nerves |
phytoalexin | A low molecular weight, antimicrobial compound synthesized by and accumulating in higher plants exposed to certain microorganisms (pathogenic and nonpathogenic). |
gastroenterology | The field of medicine that focuses on the function and disorders of the GI system, which includes the esophagus, stomach, pancreas, intestines, and liver. |
exempt research | Research that meets the definition of "human subjects research" but that is determined by HSD to be exempt from the federal human subjects regulations because it involves no more than minimal risk to subjects and all of the proposed research activities fit within one or more of certain methodological categories |
quality assurance | Systems and procedures designed to ensure that a study is being performed in compliance with Good Clinical Practice (GCP) guidelines and that the data being generated is accurate. |
emea | see European Medicines Agency |
cardiology/vascular diseases | Diseases having to do with the structure and function of the heart and blood vessels |
objective | The reason for performing a trial in terms of the scientific questions to be answered by the data collected during the trial |
orphan drugs | An FDA category that refers to medications used to treat diseases and conditions that occur rarely |
legally authorized representative | means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. |
cell-mediated immunity | The branch of the immune system in which the reaction to foreign material is performed by specific defense cells (i.e., killer cells, macrophage and other white blood cells) rather than antibodies. |
miosis | Constriction of the pupil of the eye. |
operculum | A flap or lid-like covering over the opening of an ascus or sporangium |
soleus | A broad flat muscle in the calf of the leg. |
cold fibers | Cutaneous primary afferent fibers that have cooling as an adequate stimulus and respond to cooling the skin with an increase in frequency of discharge. |
intravenous | Injected into the vein. |
protocols | IRBs can be domestic or foreign and must follow federal regulations and local institutional policy |
postsynaptic inhibition | Decrease in the probability of firing of a neuron because of the IPSPs generated in it. |
color blindness | In vision, inability to detect or weakness in response to one or more of the three primary colors. |
brand name drug | A brand name drug is a drug marketed under a proprietary, trademark-protected name. |
therapeutic | Refers to a substance that has a healing effect on a specific condition. |
acromegaly | A chronic disease caused by hypersecretion of the pituitary growth hormones |
airways | Tubes that bring outside air into the lungs |
cliv | Clearance after iv administration |
microscope | an instrument used to see small objects clearly by using light and lenses to magnify an object |
randomization | Commonly used to assign clinical trial participants to a treatment arm, based on chance (see ARM). |
spot | A symptom of disease characterized by a limited necrotic area, as on leaves, flowers, and stems. |
in vitro | experiment conducted in an artificial environment (etiology: "in glass"). |
compliance | Adherence to protocol requirements, standards of good clinical practice, and applicable regulations. |
sympathetic tone | Refers to the ongoing discharge in sympathetic nerve fibers that leads to a resting contraction of vascular smooth muscle. |
spleen | An organ located in the left upper abdomen that removes old red blood cell and other blood cells from circulation |
hypoxia | Abnormally low levels of oxygen throughout the body |
clamp connection | A recurving outgrowth of a cell that, at cell division, acts as a bridge to allow passage of one of the products of nuclear division into the penultimate cell, thereby assuring maintenance of the dikaryotic condition (of members of the |
over-enrollment | The number of subjects who completed their participation in a study is greater than was approved in the initial IRB application or in a subsequent modification |
medical records | REVISIT Records, either hardcopy or electronic, that contain medical information about a person |
squamule | A small scale or lobe. |
assurance | Regulatory term |
light adaptation | A reduction in sensitivity of visual receptors as a function of time in the light. |
recruitment | The process of identifying and enrolling suitable participants in a clinical trial. |
ipsilateral | On the same side. |
macrophage | A large immune system cell in the tissues that devours invading pathogens and other intruders |
epidural anesthesia | Anesthesia produced by injection of a local anesthetic into the peridural space of the spinal cord |
i2 | See IMPAC. |
withdrawal | You (or your legal representative, on your behalf) are free to withdraw from the study at any time without penalty or prejudice |
tritanope | A person who lacks response to blue light. |
karyotype | The chromosomal constitution of a eukaryotic cell in terms of the number, size amd morphology of the chromosomes at metaphase. |
pleuropneumonia | Inflammation of the pleural membranes (pleuritis) and the lungs |
ballism | Basal ganglion disease characterized by violent, flinging movements of the limbs due to contraction of proximal limb muscles. |
ec | Ethics Committee; required in EU for approval of clinical trials |
permission | Agreement of parents or guardians of a child or ward to participate in clinical research. |
obstructed | To block, make difficult to pass. |
doll's eye maneuver | A test of the vestibulo-ocular reflex in which the opposite direction is observed. |
interventions | Approach to treating a disease or condition |
crozier | A recurved hook at the tip of an ascogenous hypha, the penultimate cell of which will become the ascus. |
anc | Absolute Neutrophil Count |
postganglionic fiber | Nerve fibers originating in and running peripheral to an autonomic ganglion. |
optical density | A ratio between the light falling on a substance and the amount transmitted thru it. |
expanded access | The mechanism by which FDA makes it possible for doctors to use investigational new products for gravely ill patients outside the context of a clinical trial and before a product has received marketing approval. |
cadaveric | Having to do with a dead body (a cadaver). |
immobilization | The process of holding a joint or bone in place to prevent an injured area from moving while it heals using a splint, cast, or brace. |
sputum | Mucus or phlegm coughed up from lungs (see MUCUS and PHLEGM). |
antibiotic | Antibiotic |
complainant | An individual who reports sensitive information to Tulane University's IRB regarding potential non-compliance issues or research activities that have potentially placed participants or others at increased risk in relationship to the conduct of the research. |
phase iv study | After a drug has been approved by Health Canada, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events. |
sem | Standard Error of the Mean |
egg mass | group of eggs held together by a gelatinous matrix; common in root-knot and other nematodes |
nuremberg code | Code of human research ethics devised in 1947 after World War II |
in vitro | in glass, on artificial media, or in an artificial environment; outside the host |
etiolation | elongation of stems caused by reduced light intensities |
hormone | Secretion from glands |
fdaaa 801 | Section 801 of the Food and Drug Administration Amendments Act of 2007 (U.S |
systemic | Affecting the body as a whole. |
sputum culture | A test to see what germs may be growing in the sputum (see SPUTUM). |
key message | Key message |
program announcements | For electronic applications, applicants use the SF 424 Application Guide instructions and forms in the Grant Application Package. |
htsh | Human thyroid-stimulating hormone. |
kyphosis | An outward curve in the spine causing a humped back. |
cystic fibrosis-related diabetes | The body’s inability to move sugar from the blood into the cells for energy |
autotrophic | Capable of growth independent of outside sources of nutrients or growth factors. |
pre-clinical testing | Animal studies conducted to acquire information about safety and tolerance of drugs before conducting human testing in clinical trials. |
pituitary gland | A small gland the size of a peanut that is located behind the eyes at the base of the brain |
snellen eye test | This is the use of the standard eye chart to test ability to see letters of various sizes. |
has results | Indicates that summary information about the results for a clinical study registered on ClinicalTrials.gov |
heterozygous | Having different pairs of genes for any hereditary characteristic |
pre-hypertension | Slightly elevated blood pressure: a systolic pressure from 120 to 139 millimeters of mercury (mm Hg) or a diastolic pressure from 80 to 89 mm Hg. |
antagonist muscle | A muscle that acts in opposition to another at a joint. |
dysmetria | A condition in which there is improper measuring of distance in movement, disturbance of the power to control the range of movement, a symptom of cerebellar disease. |
academic records | Documentation of a student's achievement in school, college or university |
auc0∞ | Area Under the Curve time 0-time infinity |
case report form | A document used to record all pertinent information required by the clinical study protocol on each subject in a trial to be reported to the sponsor. |
tissue | group of cells, usually of similar structure, that perform the same or related functions |
compensation | See: payment |
pseudomonas aeruginosa | A type of bacteria that often lives in the lungs of people with CF and causes lung infections (see ANTIBIOTIC, BACTERIA and STAPHYLOCOCCUS AUREUS). |
informed consent | The process of learning the key facts, risks and benefits about a clinical trial in order to decide whether or not to participate |
clinical trial planning award | See Investigator-Initiated Clinical Trial Planning and Implementation Award (R34 or U01). |
transcription factors | Specific proteins which allow DNA recognition by RNA polymerases in eukaryotes. |
immunity | Natural or acquired resistance provided by the immune system to a specific disease |
gall | An abnormal plant structure formed in response to parasitic attack by certain microorganisms (bacteria, fungi, viruses) or insects |
consumer products | Consumer Products cover a broad range of products including consumer durables, non-durables and soft goods |
nematicide | agent, usually a chemical, that kills nematodes |
orthopedics | Relates to treatment of the spine and related structures. |
homozygous | having the same form (allele) of a gene on homologous chromosomes (see heterozygous) |
thyrotropin-releasing hormone | A hormone released by the hypothalamus that stimulates the pituitary gland to secrete thyroid-stimulating hormone (TSH) |
auscultation | Procedure that listens to sounds within the body, often with the aid of a stethoscope |
in vivo | Latin for “in living (body).” Usually refers to research done in living animals and humans. |
randomized | 1) not ordered |
fusion | A surgical procedure that immobilizes two or more vertebrae by uniting them together. |
broad spectrum | An antibiotic that is effective against a wide range of organisms. |
amyloid | Of spore walls, spore ornamentation, hyphal walls, ascus tips, etc.: Staining blue or grayish to blackish-violet in Melzer's reagent, presumably because of the presence of starch or a starch-like compound. |
pallesthesia | The sensation of vibration. |
dysesthesia | A persistent, painful sensation, produced by gentle stimulation, that often occurs after destruction of CNS pathways. |
30 day pma supplement | A supplemental application to an approved PMA in accordance with 21 CFR 814.39(e). |
antagonist | An agent or substance that counteracts the action of another. |
anesthesiologist | Physician who provides pain relief and maintains a stable condition during and following an operation or diagnostic procedure |
humanitarian use device | A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. |
nerve | A bundle of fibers that uses chemical and electrical signals to transmit sensory and motor information from one body part to another. |
nanogram | One billionth of a gram. |
authorized institutional official | An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research. |
open-label study | A study in which the treatment assignment is not blinded to the subjects or study personnel. |
visceral afferent fibers | Fibers carrying sensory information from visceral organs to the central nervous system. |
killed vaccine | Killed vaccine |
dmf | Drug Master File |
spinal shock | A condition following functional disconnection of the spinal cord from higher centers, which is characterized by areflexia, anesthesia, and lack of movements. |
acr 20 | American College of Rheumatology 20% responder rate |
vaccine | A biologic product generally made from an infectious agent or its components |
investigational product | An active ingredient or placebo in pharmaceutical form being tested in a clinical trial, which includes a marketed product used in a dissimilar manner than the approved form, when used for an unapproved indication or when used to acquire more information about an approved use. |
mycorrhiza | A specialized root structure resulting from a symbiotic relationship between a fungus and a higher plant |
drug-drug interaction | Changes in the effect of a drug when taken with another drug |
postoperative | Relating to, occurring in, or being the period following a surgical operation |
institutional review board certification | For research animals, see institutional animal care and use committee certification. |
arv | Antiretroviral |
pharmacodynamics | The study of the effects of drugs on the body and/or living structures and the relationship between drug absorption and effect. |
presbyopia | Hyperopia due to loss of elasticity of the lens at about age 40. |
tension headache | Mild or moderate pain of variable duration affecting both sides of the head and often accompanied by contraction of neck and scalp muscles |
expedited review | "A review procedure that does not require review by the convened IRB that is applicable to studies determined by the IRB to meet the expedited criteria as defined by the Federal Regulations." |
experimental drug | A drug that is not licensed by the FDA for use in humans or as a treatment for any disease or condition |
fetal material | The placenta, amniotic fluid, fetal membranes, and umbilical cord |
parent | means a child's biological or adoptive parent. |
genitourinary tract | The system of organs comprising the organs concerned with the production and excretion of urine and those concerned with reproduction |
sorus | A cluster or mass of spores or sporangia. |
phase iiia | Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug/product Application (NDA) or other dossier |
disease | abnormal functioning of an organism caused by the continuous irritation by a primary causal agent that results in production of symptoms |
data | This term is legally defined according to the institution |
immunotoxin | A plant or animal toxin (i.e., poison) that is attached to a monoclonal antibody and used to destroy a specific target cell |
colon cancer | a malignant tumor of the colon; early symptom is bloody stools |
full board review | Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas |
installation qualification | Documented evidence that installation instructions were followed for computer system hardware and/or software. |
thick filament | The larger diameter myofilament of the myofibrils of striated muscle. |
facet joint | Small joints located between and behind adjacent vertebrae |
parahippocampal gyrus | A brain component composed of gray matter and involved in memory. |
reactive hypertrophy | Excessive enlargement of a body part due to stress. |
giardiasis | A common protozoal infection of the small intestine spread via contaminated food and water and direct person-to-person contact. |
randomization | Assigning subjects or objects to a group on a random basis |
presbycusis | Decrease or loss of sensitivity to high frequencies of sound with advancing age. |
homozygous | Having the same pairs of genes for any hereditary characteristic. |
rosette | An abnormal condition in which the leaves form a radial cluster on the stem. |
cluster | Cluster |
teleomorph | The stage characterized by the production of asci/ascospores, basidia/basidiospores, teliospores, or other basidium-bearing organs. |
compound action potential | The response of a peripheral nerve to an electrical stimulus; represents the sum of the action potentials of all active fibers in the nerve. |
antibodies | Molecules in the blood or secretory fluids that tag, destroy or neutralize bacteria, viruses or other harmful toxins |
nernst equation | A mathematical formula stating the voltage across a cell membrane that results from a difference in ion concentration inside and outside the cell. |
ecb | See Electronic Council Book. |
stretch reflex | An automatic contraction of a muscle elicited by stretching it, syn |
anhidrosis | An abnormal deficiency of sweat. |
d | day |
euthyroidism | Having the proper amount of thyroid hormone in the body. |
necrosis | Localized death of cells or tissues. |
apoptosis | Cellular suicide, also known as programmed cell death |
clinical study materials | Study supplies (i.e., study test article, laboratory supplies, case report forms) provided by the study sponsor to the investigator. |
benzodiazepines | Drugs that work as tranquilizers |
in vitro testing | Non-clinical testing conducted in an artificial environment such as a test tube or culture medium. |
longitudinal study | A study designed to follow subjects forward through time. |
ind | Investigational New Drug application, a proposal to the US Food and Drug Administration (FDA) to begin testing of a candidate drug in humans in order to assess its safety and effectiveness (efficacy). |
in vivo | experiment conducted using a whole organism. |
non-significant risk device study | A study of a device that does not meet the definition for a significant risk device |
clinical study materials | A complete set of study supplies such as study test article, laboratory supplies, case report forms, etc |
in vitro fertilization | in vitro fertilization IVF, or fertilization of the egg (the secondary oocyte) by a sperm (a spermatozoon) in vitro, i.e |
quality of life trials | Trials that explore ways to improve comfort and quality of life for individuals with a chronic illness. |
alpha spasticity | A tonic contraction of one muscle or a group of synergistic muscles at a joint, caused by excitation of alpha motoneurons innervating the muscles. |
microbes | Microscopic living organisms, including bacteria, protozoa and fungi. |
transduction | The virus-mediated transfer of host DNA (chromosomal or plasmid) from one host cell (the donor) to another (the recipient) |
carrier protein | Carrier protein |
evidence-based medicine | An approach to practicing medicine that involves consideration of results of clinical trials that are relevant to the disease or condition being treated when making decisions about how to treat patients. |
dendrite | Process of a neuron specialized to act as a receptor; the afferent process of a neuron. |
sexual dimorphism | A pronounced difference in the morphologies of the two sexes within a species. |
enzymes | Naturally occurring chemical substances in the human body that help a chemical reaction take place. |
transcription | the production of a complementary strand of RNA from a segment of DNA |
ibc | See institutional biosafety committee. |
aspiration | A procedure that removes fluid, air, or foreign bodies with suction |
dependence | Physical or psychological substance dependence |
stratification | A layered configuration. |
source documentation | Location where information is first recorded including original documents, data and records. |
bla | Biologics Licence Application An application to approve biologics in the US. |
music therapy | The use of music interventions to accomplish any range of goals, including improvement of motor skills, social/interpersonal development, cognitive development, self-awareness and spiritual enhancement. |
dynamic fusimotor neuron | A motoneuron whose activity increases predominantly the dynamic response of primary spindle endings to muscle stretch. |
phase i-iv studies | Complete description of the definitions of Phase I-IV. |
cutin | An insoluble polymer that, embedded in waxes, forms the cuticle covering the epidermal cell walls in the aerial parts of higher plants. |
iv | Intravenous |
canker | An imprecise term usually used for a plant disease characterized (in woody plants) by the death of cambium tissue and resulting loss and/or malformation of bark, or (in non-woody plants) by the formation of sharply delineated, dry, necrotic, localized lesions on the stem |
safety reports | FDA report required by investigator for any serious and unexpected adverse experience. |
kel | Elimination constant |
yield | the desired product resulting from growth or cultivation of a plant |
phase i study | The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans |
blood brain barrier | The barrier between brain blood vessels and brain tissues whose effect is to restrict what may pass from the blood into the brain. |
phase i study | Phase I studies are conducted on healthy volunteers to establish the effects of a new drug in humans |
toxoid vaccine | Toxoid vaccine |
sulfation | Combining with a sulfate group. |
cytoplasm | The living matter within a cell. |
gc-ms | Gas Chromatograph Mass Spectrometer |
cloning | An in vitro procedure in which a particular sequence of DNA (e.g., a gene) is reproduced in large amounts by inserting ("splicing") it into a suitable replicon, introducing the resultant recombinant (hybrid) molecule into a cell in which it can replicate, and finally growing the cells in culture. |
efficacy | Efficacy |
anovulation | The absence of ovulation, or egg production, in a woman’s reproductive cycle. |
minimal risk | is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. |
reconstitution | The process of adding liquid to a dry powder to make a new solution |
ftta | See Federal Technology Transfer Act. |
facultative parasite | organism that is normally saprophytic but is capable of being parasitic |
pacemaker cell | A cell that is rhythmically, spontaneously active, initiating activity in other cells in the same rhythm. |
efficacy | Evidence that the treatment provides benefit for the disorder under study |
historical controls | Control subjects (followed at some time in the past or for whom data are available through records) who are used for comparison with subjects being treated concurrently |
deficiency | A lack of something necessary to good health |
viscerovisceral reflexes | Reflexes involving visceral stimuli and visceral responses. |
hemianopsia | Loss of vision in either the nasal or temporal half of the visual field. |
clinical research associate | Person employed by the study sponsor or CRO to monitor a clinical study at all participating sites |
crude touch | Touch sensations of higher threshold and poor localizability. |
research | The UW IRB applies the following definition: A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge |
autoimmunization | The induction in an individual of an immune response to its own cells (tissue) |
causalgia | A persistent burning sensation of the skin, usually caused by damage to peripheral nerves |
valent | Valent |
io | Institutional Official See: Authorized Institutional Official |
vestigial | Pertaining to structures or organs that were well developed in an organism's ancestors but have become rudimentary during the course of evolution. |
washout period | The period of time in a clinical trial when patients are given a placebo or no drug at all to eliminate the effects of the first treatment before starting the second active treatment. |
endospore | resistant, thick-walled asexual spore formed within a bacterial or fungal cell |
neonatal tetanus | Neonatal tetanus |
peripheral | Situated away from the center, as opposed to being centrally located |
nuclear cataract | A cloudiness in the center of the lens of the eye. |
inclusion/exclusion criteria | The factors determining whether a person may or may not be allowed to enter a clinical trial |
bone marrow | The soft, fatty tissue that fills the cavities of bones and contains white and red blood cells. |
placebo | A placebo is an inactive pill, liquid or powder, that has no treatment value |
duloxetine | Serotonin inhibitor and norepinephrine reuptake used for pain management |
custom device | A device that is not generally available and that is not be used to determine its safety and effectiveness |
yeast | A unicellular member of the Endomycetales; sometimes used for a non-motile unicellular stage (e.g., of dimorphic animal parasites). |
cell | The basic unit of living organisms. |
dichotomous | Dividing into two equal branches. |
neurotransmitters | A chemical messenger released from a nerve cell that transmits an impulse from a nerve cell to another nerve, organ, muscle, or other tissue. |
assistant role | See assistant role for eRA Commons. |
dea | See Division of Extramural Activities. |
ataxia | Awkwardness and lack of fluidity in motor behavior associated with loss of control mechanisms of the cerebellum. |
mycoplasma | A wall-less prokaryotic microorganism of the class Mollicutes. |
antithyroid agents | Drugs that block the production of thyroid hormones by the thyroid gland. |
intranasal influenza | Intranasal influenza |
fiscal year | NIAID uses interim paylines before receiving its annual appropriation and immediately afterwards while our budget office is crunching the numbers to create actual paylines |
decerebrate rigidity | A spasticity resulting from functional disruption of brain stem activities at the midcollicular level. |
protein | A substance made of a string of amino acids |
information statement | UW Human Subjects term for a document used to provide information to research participants when the requirement for written consent has been waived. |
itn | See Immune Tolerance Network. |
potency | Potency |
cfr | See: Code of Federal Regulations |
oomycetes | A class of aquatic and terrestrial fungi (subdivision Mastigomycotina) that typically produce oogonia and zoosporangia in which form zoospores having one anteriorly-directed tinsel flagellum and one posteriorly-directed whiplash flagellum. |
scintigraphy | A diagnostic procedure using a radioactive agent with affinity for the tissue of interest followed by a whole body scan. |
bilateral agreement | General science agreement between the U.S |
competing continuation | See renewal |
anesthetic | Drug that causes numbness. |
treatment ind | A program to provide experimental treatments to a class of patients who lack satisfactory alternative treatment |
muscle spindle | A fusiform mechanoreceptor found mixed with extrafusal muscle fibers and in parallel with them. |
registration | The process of submitting and updating summary information about a clinical study protocol from its beginning to end, to a structured, Web-based registry that is accessible to the public, such as ClinicalTrials.gov. |
immediate-release medication | Medication that takes effect over a short period of time |
muscle nerve | A nerve most fibers of which innervate a muscle. |
t3 | The secondary hormone produced by the thyroid gland. |
pleomorphic | able to assume various shapes (and perhaps sizes); occurrence of more than one distinct form in the life cycle of an organism |
other ids | See OTHER STUDY ID NUMBERS. |
type | the example on which the description of a scientific name is based (the type genus of a family, or the type species of a genus) |
intrauterine insemination | IVF See in vitro fertilization. |
dosage | The prescribed amount of a drug that must be taken to get the benefit or intended result. |
transformant | A cell or organism that has undergone genetic transformation. |
dosage regimen | The schedule of doses, including the number of doses given in a time period; the elapsed time between each administered dose, or the time at which the doses are given; and the amount of medicine administered at each dosing time. |
balanced study | When a particular type of participant (for instance, females, people with certain lung function levels, African Americans, etc.) is equally represented in each study group. |
single-masked design | Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment |
dehydrated | Remove moisture. |
area grant | See Academic Research Enhancement Award. |
ablative surgery | Type of surgery performed on parts of the central or peripheral nervous system to help permanently alleviate pain by affecting the pathways of nerves. |
double-blind study | A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or another therapy. |
alpha rhythms | EEG records characterized by high-voltage waves occurring at 8-14 per sec. |
center for scientific review | Errors reflect inaccuracies, inconsistencies, omissions, or incorrect formatting |
soma | Cell body. |
placebo | A pharmaceutical preparation that contains no active substance (a sugar pill), and looks like the drug that is being tested. |
thoracic | The section of the spine that includes twelve rib-bearing vertebrae |
secretary | A U.S |
gcp | Good Clinical Practice |
expedited review | IRB review that is conducted by the IRB chair, or a designated voting member or group of voting members, rather than by the entire IRB |
vaccine | A substance that contains antigenic components from an infectious organism |
hyperstimulation analgesia | A reduction or elimination of pain sensation brought about as a result of strong stimulation outside a damaged area. |
gamma bias | Refers to the ongoing discharge of fusimotor neurons, syn |
dieback | Progressive death of shoots, branches and roots generally starting at the tip. |
fission | Cell division by cleavage (splitting) of the cell into two parts. |
abaxial | Directed away from the stem of a plant; pertaining to the lower surface of a leaf. |
eligibility criteria | Summary criteria for participation selection; includes inclusion and exclusion criteria. |
bell's palsy | Bell's palsy |
codon | A particular sequence of three nucleotides in |
ultrastructure | submicroscopic structure of a macromolecule, cell, or tissue |
wernicke's area | Area 22 of the temporal cerebral cortex that plays a fundamental role in reception and comprehension of speech. |
pre-eclampsia | Hypertension during pregnancy. |
placebo controlled study | A method of investigating drugs that utilizes a placebo |
off label | The unauthorized use of a drug for a purpose other than that approved of by a regulatory body such as the FDA. |
genotype | A pattern of genetic information that is unique to an individual or group |
subject | An individual who participates in clinical research, either as a recipient of the test article or of the control |
autogenic inhibition | Depression of the excitability of an motoneuron by the groups Ia and Ib afferent fibers that innervate the same muscle as the motoneuron. |
pap smear | A method for the early detection of cancer and other abnormalities of the female genital tract, especially of the cervix and uterus, employing exfoliated cells (cells that have been shed into vaginal fluid) and a special staining technique for microscopic examination that differentiates diseased tissue |
premarket approval | Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices. |
ethnographic research | Ethnography is the study of people and their culture |
preclinical | Testing of a vaccine or drug in cells or animals before testing in humans. |
trauma/emergency medicine | The medical specialties involving physical wounds or injuries |
tessellate | In nematodes: Checkered; a type of cuticular pattern in which the longitudinal ridges are broken by transverse striations into rows of squares. |
esr | Erythrocyte Sedimentation Rate |
drug-drug interaction | A modification of the effect of a drug when administered with another drug |
phase iv study | After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events. |
intramuscular | Injected directly into a muscle. |
purity | The relative absence of extraneous matter in a drug or vaccine that may or may not be harmful to the recipient or deleterious to the product. |
pilot study | A pilot trial is used to obtain information, and work out the logistics and management, deemed necessary for further clinical trials |
ectoparasite | A parasite that remains external to the host's cells or tissues. |
edison | See iEdison. |
institutionalized cognitively impaired | Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded). |
grants | Go to these resources: |
decomposition of movement | Lack of fluidity in movement characterized by the breaking down of composite movements into their component parts, a symptom of cerebellar disease. |
voltage clamp | A device for fixing the transmembrane voltage of a cell at a constant value. |
gamma tone | Refers to the ongoing discharge of fusimotor neurons, syn |
tabes dorsalis | A syphilitic infection of the dorsal root ganglion. |
bacterial carriage | Bacterial carriage |
depolarization | A change in the transmembrane potential of a cell to the isoelectric point (e.g., zero voltage). |
integration | The process by which the different parts of an organism are made a functional and structural whole, especially through the activity of the nervous system and of hormones |
pharmaceutical model | The pharmaceutical philosophy |
osteoarthritis | A non-inflammatory degenerative joint disease characterized by degeneration of cartilage and increase in bone size |
mucous membrane | A moist layer of tissue that lines body cavities or passages that have an opening to the external world (e.g., the lining of the mouth, nostrils or vagina). |
hiv | Human Immunodeficiency Virus, the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). |
preliminary study | Tests done with few subjects-often animal or cell studies. Read more. |
phase 3 trials | Usually the last type of clinical trial before a drug is approved by the FDA |
phytonutrients | See Phytochemicals. |
nonviable fetus | An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)] |
plasmapheresis | The selective removal of certain proteins or antibodies from the blood (followed by reinjection of the blood) |
anesthetic | Medication that causes loss of sensation-numbness |
larynx | The upper part of the trachea that contains the vocal cords, sometimes called the voice box. |
prevention trials or studies | Research to find better ways to prevent disease in people who have never had the disease or prevent disease from returning. |
standard operating procedure | Detailed written instructions that provide a structure to ensure that activities are performed in a consistent manner. |
vertebra | One of the 33 bony components that make up the spine. |
agency | U.S |
whole cell pertussis vaccine | Whole cell pertussis (wP) vaccine |
bronchoscopy | Visual examination of the bronchial passages of the lungs through a tube of an endoscope inserted into the upper lungs or extraction of material from the lungs by means of a bronchoscope |
placebo effect | An effect from the patient’s expectations rather than the treatment itself. |
nonelectrogenic pump | An ion pump whose operation does not result in a net transfer of charge into or out of the cell. |
biotechnology | The use of living organisms and their substances and other biological systems to create or change a drug or other product, to change plants or animals or to develop microorganisms. |
equilibrium potential | The value of the transmembrane voltage at which the net driving force for an ion or a membrane event (e.g., an EPSP or IPSP) is zero. |
inclusion enrollment report | Go to these NIH resources: |
clpo | Oral clearance |
inoculum density | a measure of the number of propagules of a pathogenic organism per unit area or volume |
oxidative stress | Increased oxidants in animal cells causing free radicals and damage. |
spine | 33 individual vertebrae that interlock to form a column from the skull to the small of the back |
autonomous zone | The part of the receptive field or dermatome of a nerve or root not shared with other nerves or roots. |
compensation | Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research |
on-response | The discharge of a neuron initiated when a stimulus is turned on. |
parenchyma | The tissue of an organ (as distinguished from supporting or connective tissue). |
aids | Acquired Immunodeficiency Syndrome (AIDS) occurs in individuals who have suffered long term infections with the human immunodeficiency virus (HIV) and have compromised immune systems |
receptor | A molecule that recognizes and binds with specific molecules |
grants management specialist | Grants awarded under expanded authorities may carry over unobligated funds from one budget period to another within an approved project period without prior approval, as stated in the Notice of Award. |
sinus headache | A headache caused by pressure within the sinus cavities of the head, usually in connection with infection of the sinuses |
drug | A substance (other than food) used in the diagnosis, treatment, cure or prevention of disease; used to enhance mental or physical well-being; or used to affect the function or structure of the body in humans or animals. |
vein clearing | A symptom of virus-infected leaves in which veinal tissue is lighter green than that of healthy plants. |
cd4+ t cells | White blood cells that orchestrate the immune response, signaling other cells in the immune system to perform their special functions |
axosomatic synapse | A synaptic junction in which an axon's bouton is the presynaptic element and a soma is the postsynaptic element. |
exclusion criteria | The factors (or reasons) that prevent a person from participating in a clinical study. |
site visit | A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research. |
bronchogram | X-ray image of the bronchi |
autonomy | Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others. |
national select agents registry | U.S |
irg | See integrated review group. |
anda | Abbreviated New Drug Application, the application procedure to approve a generic drug in the US. |
sexual dimorphism | having two distinct forms (e.g., differences in shape, size, coloring) of individuals within the same species, based on the gender of the individual. |
cold chain | Cold chain |
peer review | Careful review of a clinical trial by experts who consider its scientific merit, participant safety and ethics. |
dt vaccine | DT vaccine |
vulnerable subjects | Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners) |
research misconduct | Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. |
finding of non-compliance | as a proven assertion of non-compliance." |
spasm | A brief, automatic jerking movement |
investigational medical device | Go to these resources: |
metastasis | Transfer of a disease-producing agent (e.g., cancer cells or bacteria) from an original site of disease to another part of the body with development of a similar lesion in the new location (e.g., spread of cancer from an original site to other sites in the body). |
polyubiquitinated | Bonding together to the same target protein to destroy it. |
nicotinic effect | The subset of actions normally produced by acetylcholine that can also be produced by nicotine. |
lot | Lot (or lot-release) |
confidentiality | Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. |
clinical trial/study | A systematic study used to evaluate a drug, treatment or device in one or more human subjects in the treatment, prevention or diagnosis of a disease or condition |
endoparasite | parasitic organism that lives and feeds from inside its host (compare ectoparasite) |
sponsor | The organization that develops the treatment, drug or test, designs the study, and pays for costs associated with the clinical trial. |
neuromuscular junction | The synaptic contact between an motoneuron and the muscle fiber it innervates. |
aerio | See agency extramural research integrity officer. |
anaplastic thyroid cancer | Undifferentiated, fast-growing thyroid cancer. |
kg | kilogram |
single blind study | A study in which one of the parties (investigator or participant) is unaware of what medication subjects are receiving. |
co-hort | Group of subjects in a clinical trial with some characteristics in common who are followed up at standard, preset intervals. |
loudness | The "perceived intensity" of a sound related to both the amplitude of the sound wave and its frequency. |
lobar | A well-defined part of an organ or gland |
sponsor | Individual, company, institution or organization responsible for initiation, management and financing of a study. |
phenotype | The observable characteristics of an organism, either in total or with respect to one or more particular named characteristics. |
sponsor | An individual, company, institution, or organization that initiates, manages, and/or finances a clinical trial. |
occlusion | block or plug that stops flow of liquids (as in vessels) |
nda | NEW Drug Application |
cytopenia | Deficiency in the cellular elements of the blood. |
triplet codon | a set of three nucleotide bases in DNA or RNA that code for an amino acid |
bioassay | Any quantitative procedure in which a given organism is used for assay purposes. |
device | See: Medical Device. |
witches' broom | An abnormal form of plant growth, most common in woody plants, in which there is a profuse outgrowth of lateral buds to give a "witches' broom" appearance |
mosaic | A common symptom induced in leaves by many plant virus infections in which there is a pattern of dark green, light green and sometimes chlorotic areas |
institutes | It also receives all NIH grant applications and assigns them to institutes in some cases for peer review and for administration after award |
supramaximal stimulus | A stimulus whose intensity is greater than that which just gives a maximal response. |
hypersensitivity | The expression of extreme reactivity by a plant in response to a potential parasite or pathogen, the plant's response commonly serving to limit or prevent parasitization/disease. |
data management | The process of handling the data gathered during a clinical trial |
neuron | A cell specialized for excitability and conductivity, syn |
autism | Autism |
scientific merit | Generally conducted by an institute's advisory council, second-level review makes funding recommendations in the context of program priorities and balance |
afferent | Pathways leading to; in the case of peripheral nerves, those conducting to the central nervous system. |
drug | Drug (or medicine) |
aspergillosis | A fungal infection (resulting from the fungus Aspergillus) of the lungs that can spread through the blood to other organs |
results first received date | The date that summary information about the results of a clinical study was first submitted to the ClinicalTrials.gov results database. |
human subjects | Go to these resources: |
immunization safety | Immunization safety |
hde | See: humanitarian device exemption |
competing applications | CSR referral officers assign each application to an NIH institute and refer it to an integrated review group using NIH referral criteria |
approved drugs | In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed |
quality of life | A concept that considers a person’s physical, mental, and emotional health, level of independence, social relationships, personal beliefs and relationship to their environment. |
gmp | See Grants Management Program. |
annulospiral ending | The termination of a group Ia afferent fiber in the equatorial region of a muscle spindle, syn |
psychological approaches | Ways of helping patient cope with pain and related emotions that can increase pain |
somatic | Relating to the body as opposed to the mind |
virion | A virus particle existing freely outside a host cell |
cfda | See Catalog of Federal Domestic Assistance. |
lung clearance index | The result (a number) obtained from a multiple breath washout test |
nested case controlled studies | Matches specific groups and conditions |
parameters | A measure that determines whether an issue will be limited or accomplished. |
options analysis | Options analysis |
anomaloscope | A color-matching device used to detect anomalous trichromacy. |
synapse | The site at which neurons make functional contact. |
argyll robertson pupil | Pupil shows miosis of accommodation, but no light reflex. |
unmyelinated fiber | A nerve fiber without myelin surrounding it. |
defeminization | loss of female secondary sex characteristics. |
acupressure | Technique that uses pressure on certain points along the body to help control pain |
offsite adverse event | Regulatory term See: http://www.washington.edu/research/hsd/topics/Adverse+Events+and+Unanticipated+Problems |
overall impact score | These are roughly in the bottom half of applications being reviewed, though the percentage varies by study section and grant type |
mn | A strain of HIV used in vaccine development. |
probiotic | A substance which increases the amount of beneficial microorganisms. |
inflammation | An internal chemical reaction that produces redness, warmth, swelling, and pain due to infection, irritation or injury. |
binary fission | Fission in which two cells, usually of similar size and shape, are formed by the growth and division of one cell. |
oxidative | Chemically active oxygen like substances. |
nanomoles | This is the molecular weight of a substance in grams. |
perimenopause | The time period at the start of the menopause symptoms. |
extensor thrust reflex | An automatic increase in the contraction of physiological extensor muscles of the leg when the plantar surface of the foot contacts some non-noxious object. |
rosette | disease symptom characterized by short, bunchy growth habit due to shortened internodes and no comparable reduction in leaf size |
gcp | see Good Clinical Practice |
nomenclature | the scheme by which names are attached to objects, including organisms |
symptom | Any change in the body or its functions, as perceived by the patient, which could indicate the presence of disease. |
rt | Restricted Treated |
anomalous rectification | A decrease in the ionic conductance of the cell membrane with hypopolarization of the membrane. |
patient-controlled analgesia | A method by which the patient controls the amount of analgesia they receive |
clinical trial | Systematic study conducted in human subjects. |
prognostic indicators | Factors that can help predict a likely outcome (as in how, on average, thyroid cancer will progress). |
pivotal study | Usually a phase III study which presents the data that Health Canada uses to decide whether or not to approve a drug |
fieldwork | Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings) |
coded private information | Go to these resources: |
cox-2 inhibitor | Drugs that may relieve pain and inflammation that block COX-2 enzymes and active only at site of inflammation |
diffuse goitre | An enlargement of the entire thyroid gland. |
vaccine safety surveillance | Vaccine safety surveillance |
beneficence | An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm |
omega 3 fatty acids | Polyunsaturated oils in fish and a few vegetables oils. There is evidence their use reduces heart risk. |
toxic shock syndrome | Toxic shock syndrome |
biosketch | See Biographical Sketch. |
spinal stenosis | A condition in which the spinal canal narrows in one or more areas, and the spinal cord and/or nerves are compressed or choked. |
aneuploid | Chromosome constitution differing from the usual diploid constitution by loss or duplication of chromosomes or chromosomal segments. |
conductivity | The capacity of living matter to conduct action potentials. |
chronic | A disease or condition that lasts and is continuous |
effective dose | A product's ability to produce beneficial effects on the duration or course of a disease |
electrically excitable motor cortex | That area of the cerebral cortex, the stimulation of which leads to movements, syn |
client liaison | A client liaison is assigned to every client |
verification date | See LAST VERIFIED DATE. |
kupffer cells | Specialized macrophages in the liver |
interstitial segment | IUD Abbreviation either for intrauterine death (death of a fetus, prefacing a stillbirth) or for intrauterine (contraceptive) device, which, to resolve this ambiguity, is sometimes (though not in this book) abbreviated “IUCD’. |
arterial blood gases | Clinical test to identify levels of oxygen and carbon dioxide in arterial blood |
phytotherapy | Treatment of ailments with plant material. |
otc medications | Over-the-Counter (OTC) Medications are sold directly to consumers without the need for a prescription from a healthcare professional. |
toxin | A compound produced by a microorganism and being toxic to a plant or animal. |
decibel | A unit used to express the ratio of two sound pressures in hearing, equal to 1/10 the common log of the ratio of pressures. |
administrative hold | An action placing specific research activities on hold temporarily to allow for additional information to be obtained |
intrathecal anesthesia | Anesthesia placed in the space under the arachnoid membrane which covers the brain and spinal cord |
soil inhabitant | an organism that maintains its population in soil over a period of time |
hhs | See Department of Health and Human Services. |
ovoviviparous | Producing eggs that hatch within the body. |
qi | See: Quality Improvement |
statistical significance | A term based on statistical tests that is used to denote the probability that the observed association could have occurred by chance alone |
endotoxin | A toxin present inside a bacterial cell. |
embryo | Early stages of a developing organism, broadly referring to the time from implantation through the eighth week after conception |
pulsatility index | Related to the amount of blood flow in a blood vessel. |
nocifensive reflex | Automatic contraction of the flexor muscles of a limb so as to remove the limb from a noxious stimulus, syn |
belmont report | Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
oocyte | egg or sperm |
labeled lines | The notion that particular modalities and submodalities have their own special pathways to the brain and activity induced anywhere along one of these pathways is interpreted as a stimulus of the appropriate modality or submodality. |
aura | Sensations or feelings preceding an epileptic seizure. |
investigative site | The location where a study is being conducted |
epidemiology | A scientific discipline that studies the factors determining the causes, frequency, and distribution of diseases in a community or given population. |
dyskinesia | Impairment of the ability to move, resulting in fragmentary or incomplete movements. |
new drug application | An application made to FDA that requests a license to market a new pharmaceutical in the United States |
protocol | The detailed plan for a clinical trial that states the trial's rationale, purpose, drug or vaccine dosages, length of study, routes of administration, who may participate and other aspects of trial design |
radiopharmaceuticals | Drugs (compounds or materials) that may be labeled or tagged with a radioisotope |
magnetic resonance imaging | Diagnostic technology using magnetic fields to produce a computerized image (no x-ray involved) |
variegation | pattern of two or more colors in a plant part, as in a green and white leaf |
heterokaryon | A cell that contains genetically different nuclei or a thallus made up of such cells. |
spinal cord | Major column of nerve tissue that is connected to the brain and lies within the vertebral canal and from which the spinal nerves emerge |
helper t cell | Lymphocyte bearing the CD4 marker |
heterotopy | Hyperplastic symptom in which an organ develops in a position other than its normal one. |
nsaids | Non Steroidal Anti-Inflammatory Drugs, such as ibuprofen and aspirin (see ANTI-INFLAMMATORY AGENT). |
dale's principle | The concept that a neuron can synthesize only one chemical transmitter substance. |
ablate | To destroy the function of an organ or tissue |
antiserum | The serum from a vertebrate that has been exposed to an antigen and which contains antibodies that react specifically with the antigen. |
relative refractory period | The period after a spike when greater than normal stimuli are required to excite a nerve or muscle cell. |
adrenergic | pertaining or relating to catecholamines (i.e., epinephrine, norepinephrine, or dopamine). |
orthodromic | Conduction in the direction normally taken by action potentials. |
clinical research | Studies performed in humans that are intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population. |
nuremberg code | Go to the Belmont Report. |
preclinical | Refers to the testing of experimental drugs in the test tube or in animals—the testing that occurs before trials in humans may be carried out. |
tendon jerk reflex | An automatic contraction of a muscle elicited by stretching it, syn |
technical evaluation criteria | Go to NIAID's Contracts SOPs and Contracts portal. |
actin | A protein of the thin myofilament, localized to the I band of the sarcomere. |
immunization error | Immunization error |
brightness | A quantitative measure of the intensity of light, the amplitude of its waves or the number of photons. |
motor unit | An alpha motoneuron and the muscle fibers it innervates. |
pts-yrs | Patient-years |
picomoles/liter | One trillionth of the molecular weight of a substance in grams per liter. |
mycelium | A mass of hyphae, often used to denote all hyphae comprising a thallus |
anorexia | Lack or loss of the appetite for food. |
mmol | millimole |
marketing studies | Studies (most commonly Phase IV studies and some Phase III studies) which are executed to deliver clinical trial data to promote the product in the marketplace after the drug has been granted a license. |
human in vitro fertilization | Any fertilization involving human sperm and ova that occurs outside the human body. |
study coordinator | The person at a medical center or research facility who manages the daily activities of the study, including coordinating the treatment or testing of participants and reporting events of the study. |
trichogyne | In some algae, lichens, and fungi, a projection from the female sex organ that receives the male gamete or nuclei before fertilization ( |
voluntary | In the research context refers to a subject's decision to participate, or to continue to participate, in a research activity free of coercion, duress, or undue inducement. |
blind | A clinical trial is "blind" if participants are unaware of whether they are in the experimental or control arm (group) of the study; also called masked. |
multiple sclerosis | A disease in which there are multiple patches of demyelination in the white matter of the central nervous system |
addiction | The continued use of a mood-altering substance, despite adverse consequences |
dimorphic | Producing two morphologically different forms. |
curriculum vitae | A summary of an investigator’s education, training, and experience; similar to a resume. |
adr surveillance | ADR surveillance |
secondary outcome measure | A planned outcome measure in the protocol that is not as important as the primary outcome measure, but is still of interest in evaluating the effect of an intervention |
sae | Serious Adverse Event |
pyridoxal phosphate | Vitamin B6 combined with phosphate; the most common form of phosphorus. |
inclusion criteria | A list of criteria that must be met by all study subjects. |
tolerability | Ability to tolerate, put up with, or endure. |
diagnostic trials | Refers to trials that are are conducted to find better tests or procedures for diagnosing a particular disease or condition |
excretory pore | In nematodes: The exterior opening of the excretory system, generally located on the ventral side of the body near the basal region of the esophagus; also known as the orifice of the cervical gland. |
source document verification | Process of comparing data recorded on patient case report forms with the data originally recorded on source documents. |
valid | Of taxonomic names and epithets: Published in accordance with several articles of the Code of Nomenclature; such names may be |
inclusion criteria | Rules of eligibility that an individual must meet in order to participate in a clinical study |
assembly and budding | Names for a portion of the processes by which new HIV virus is formed in infected host cells |
hepatitis b | Hepatitis B |
facilitation | The addition of EPSPs in which the resultant is more than the algebraic sum of the individual EPSPs, cf., temporal summation. |
statistics | The study of probabilities |
thymus | A mass of glandular tissue located in the neck or chest of most vertebrates |
predicate devices | Currently legally marketed devices to which new devices may be found substantially equivalent under the 510(k) process. |
amnesic syndrome | Inability to remember past events; defect in formation of new long-term memories. |
beneficence | An ethical principle discussed in the Belmont Report |
scientific review group | Go to CSR Study Section Roster Index at CSR |
myelogram | An x-ray using contrast dye to identify nerve compression caused by a herniated disc or fracture of the spine. |
contract | Go to these resources: |
hev | Genelabs scientists discovered the Hepatitis E virus |
placebo | An inactive substance administered to some study participants while others receive the agent under evaluation, to provide a basis for comparison of effects. |
peripheral arterial disease | A disease with arteries outside the heart providing inadequate blood flow. |
pharmacokinetic study | The study of the processes of bodily absorption, distribution, metabolism and elimination of a drug or medicine. |
trigger | Set off disease in those who are genetically predisposed to developing a disease, or that causes a certain symptom to occur |
control system | A mechanism that regulates the output of a device. |
lymphoid tissue | Tonsils, adenoid, lymph nodes, spleen and other tissues that act as the body's filtering system, trapping invading microorganisms and presenting them to squadrons of immune cells that congregate there. |
symptom | indication of disease by reaction of the host, e.g |
protected health information | Individually identifiable health information including demographic data that relates to: |
heterozygous | having alternate forms (allele) of a gene on homologous chromosomes (see homozygous) |
rhizoplane | The root surface. |
expanded availability | Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them |
locf | Last Observation Carried Forward |
outcome | Overall results of a study or trial offered up for evaluation |
m | meter |
placebo controlled | Placebo controlled |
diploid | having two complete sets of chromosomes (2N) |
completed | The study has concluded normally |
gametangium | cell containing gametes or nuclei that act as gametes |
desynchronization | Reduction in amplitude and increase in frequency of the EEG accompanying alerting, syn |
single-unit smooth muscle | Smooth muscle containing many tight junctions that contracts as a unit and responds to stretch. |
neutrons | Particles without an electrical charge found in nucleus of various elements. |
gene | unit within an organism controlling heritable characteristics; genes are organized on chromosomes |
placebo | A pharmaceutical substance that contains no active ingredient and is designed to look just like the drug being tested |
bronchoscope | A modified endoscope that is a flexible fiberoptic tube with a small lens and eyepiece for viewing the bronchi on a computer monitor |
quartile | Twenty five percent or one fourth of the test group. |
fy | See fiscal year. |
bsc | See Board of Scientific Counselors. |
light reflex | Constriction of the pupils when a bright light is shown into an eye. |
range | Of a plant pathogen: The geographical region or regions in which it is known to occur. |
prophylactic | Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder. |
rppr | See Research Performance Progress Report (RPPR). |
pwfu | Patients who Withdrew From study prematurely |
ibrp | Introduction to Biomedical Research Program. |
experimental arm | A group of participants that receives the intervention that is the focus of the study |
completed study site | Term used when a clinical trial has been completed at the study site, in accordance with the protocol, and the study close-out visit has been performed and fully documented. |
sensitivity | The ability of a test to detect the proportion of true positive results for the disease that the test is intended to reveal |
wild poliovirus | Wild poliovirus |
alternative host | A plant other than the main host that a parasite can colonize; alternative hosts are not required for completion of the developmental cycle of the parasite. |
after-hyperpolarization | A membrane potential more negative than the resting membrane potential that occurs following termination of the spike, syn |
orbital | Relating to the bony cavity in the front of the skull around the eyes. |
topical microbicide working group | A cross-disciplinary working group within the FDA whose purpose is to develop and coordinate FDA regulatory and scientific policy regarding products to prevent vaginal transmission of sexually acquired diseases. |
pulmonary | Relating to the lungs. |
hormones | Chemicals produced by an endocrine gland and released into the blood |
principal investigator | Person responsible for the conduct of the clinical trial at a research site. |
adverse event | Any untoward or undesirable experience associated with participation in the research activity. |
feedback | The return of some of the output of a system as an input so as to exert some control over the process performed by the system. |
embryo | Early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy) |
immunostimulant | Any agent or substance that triggers or enhances the body's defense; also called immunopotentiators. |
gene | The main unit of heredity |
debriefing | Giving subjects previously undisclosed information about the research project following completion of their participation in research |
disease | An abnormal condition of a plant in which its physiology, morphology, and/or development is altered under the continuous influence of a pathogen. |
deuteranomaly | Color vision involving three pigments but the green one is abnormal, leading to reduced green sensitivity. |
symptoms | Those problems that a patient notices or feels |
amendment | See Protocol Amendment. |
gummosis | pathologic condition characterized by excessive formation of gums; the products of cell degeneration |
gamete | A haploid cell or nucleus involved in sexual reproduction, during which two gametes fuse to form a zygote. |
hiv | Human Immunodeficiency Virus, the causative agent in Acquired Immune Deficiency Syndrome (AIDS). |
nuremberg code | A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects. |
excitability | The ability to generate action potentials. |
safetynotes | Electronic data collection tool used to document interactions with callers |
wasting syndrome | The HIV wasting syndrome involves involuntary weight loss of 10 percent of baseline body weight plus either chronic diarrhea (two loose stools per day for more than 30 days) or chronic weakness and documented fever (for 30 days or more, intermittent or constant) in the absence of a concurrent illness or condition other than HIV infection that would explain the findings. |
septate | Having cross walls. |
placebo | A treatment that does not do anything and will not cause harm |
leydig cells | interstitial pregnancy An ectopic pregnancy located in the interstitial segment of the fallopian tube |
chemically gated channel | A normally closed ionic channel that is opened by action of a chemical transmitter substance. |
institution | (1) Any public or private entity or agency (including federal, state, and local agencies) [45 CFR 46.102(b)]. |
hyperalgesia | Term to describe excessive pain sensitivity. |
aids-related cancers | Several cancers are more common or more aggressive in people infected with HIV, the virus that causes AIDS |
microflora | the combination of all microorganisms in a particular environment |
primary outcome measure | The planned outcome measure in the protocol that is the most important for evaluating the effect of an intervention |
indication | Something that points to or suggests the proper treatment of a disease, as required by the cause or symptoms |
stomatitis | Any of numerous inflammatory diseases of the mouth having various causes, such as mechanical trauma, irritants, allergy, vitamin deficiency or infection. |
probe | A specific sequence of DNA or RNA used to detect complementary sequences by hybridization. |
random allocation | The assignment of subjects to treatment or control groups in an unsystematic manner. |
nerve | A collection of axons or nerve fibers. |
gene expression | The transcription of mRNA from the DNA sequence of a gene and the subsequent translation of that mRNA to give the protein gene product |
benign | A word to describe a non-malignant growth or mild illness. |
dtp vaccine | DTP vaccine |
polynicotinate | A combined form of niacin. |
tic | A repeated movement that the person who has it cannot control |
remuneration | Payment for participation in research |
long-acting/sustained-release medication | Medication that is released over a long period of time and is taken on a regular basis. |
randomization | A method based on chance by which study participants are assigned to a treatment group |
phase 4 trials | Research conducted after FDA approval to get additional information about the drug’s long-term risks, benefits, and best possible use. |
safetysearch | A secured, password protected, web-based search tool which allows clients 24/7 access to encrypted electronic case data via the Internet. SafetyCall clients are able to use SafetySearch to download case data into a comma delimited file (.csv) |
risk | The possibility of harm or discomfort for subjects participating in a clinical trial. |
medical devices | The Medical Device industry is very broad |
subliminal fringe | A group of neurons that is excited during a reflex, but which does not reach critical firing level and does not discharge a spike. |
investigational product labels | Labels attached to inner and outer containers of investigational products containing all information sufficient to identify the product and meet local regulations for such products. |
vessel | A xylem element or series of such elements whose function is to conduct water and mineral nutrients. |
direct costs | Also known as categorical budget. |
test article | Go to the definitions in 21 CFR 58.3 and full 21 CFR 58. |
experimental drug | A drug not licensed by the FDA for use in humans (see OFF-LABEL USE). |
quorum | Quorum refers to the minimum number of IRB members who must participate in an IRB meeting in order for the meeting to occur |
microorganisms | Microorganisms |
side effects | Any undesired actions or effects of a drug or treatment |
kyphoplasty | A surgical procedure that expands and stabilizes compression fractures of the spine. |
endpoint | Overall outcomes that the protocol is designed to evaluate |
who ps | World Health Organization Performance Status |
yr | year |
dmid | See Division of Microbiology and Infectious Diseases. |
first received date | The first received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry |
chorea | Basal ganglion disease characterized by rapid, complex, jerky movements that are involuntary. |
flexion reflex | Automatic contraction of the flexor muscles of a limb so as to remove the limb from a noxious stimulus, syn |
fermentation | Oxidation of certain organic substances in the absence of molecular oxygen. |
cross-bridge | The connection of the head of the myosin molecule with the thin filament in the A band of the sarcomere; according to the cross-bridge theory, the force generating apparatus of the muscle. |
mutant | Of an organism, population, gene, chromosome, etc.: Differing from the corresponding wild type by changes in one or more loci. |
serious non-compliance | Non-compliance which could significantly have (1) increased risks to, or jeopardize the safety, welfare, and/or rights of subject(s) or others, or (2) decreased potential benefits (including the scientific integrity of the research). |
spacer device | A hollow chamber that fits on the mouthpiece of a metered dose inhaler |
vesicle | A bladder-like sac or an evanescent bubble within which zoospores mature; any bubble-like cell or bubble-like membranous structure within a cell. |
integrate | To combine signals from a number of sources. |
fedbizopps.gov | See targeted research and the converse investigator-initiated. |
serious adverse event | See: adverse event/effect |
tuning curve | A plot for auditory neurons of the threshold stimulus strength against the frequency of the auditory stimulus. |
peptide | A short compound formed by linking two or more amino acids |
withdrawal scan | A radioactive iodine (131I) whole body scan performed when the patient has been withdrawn from thyroid hormone suppression therapy long enough for thyroid-stimulating hormone (TSH) levels to rise. |
cell cycle | The period from one cell division to the next. |
myogenic | Of muscle origin. |
mold | A downy fungal growth on a substratum, usually consisting of mycelium of a Hyphomycete or a Zygomycete. |
solicitation | Go to FAR 15.602 and the official definition in FAR 2.101. |
fhcrc | See: Fred Hutchinson Cancer Research Center |
polyphenols | Antioxidants found in most plants |
slowly adapting | A slow decline without complete cessation of a response of a sensory neuron to a maintained stimulus. |
dysdiadochokinesia | Impairment of ability to perform rapid alternating movements, a symptom of cerebellar disease. |
strain | A sub-species group of organisms distinguishable from the rest of the species by a heritable characteristic that the individuals in the group have in common. |
dendroaxonic synapse | The synaptic junction between a dendrite and an axon in which the dendrite is thought to be the presynaptic element. |
roguing | The removal of diseased plants from a crop in order to prevent the spread of the disease. |
ozone layer | a protective layer of ozone in the upper atmosphere that reduces ultraviolet radiation |
quintile | A subgroup that is 20%” or one fifth of the test group. |
adjuvant | Material added to improve some chemical or physical property (e.g., of a plant protectant) or a biological property (e.g., to improve antibody response to an antigen). |
ara form | See Awaiting Receipt of Application (ARA) form |
latency | The period when an organism (i.e., a virus or a bacterium) is in the body and not producing any ill effects |
ca | see Competent Authority |
accepts healthy volunteers | Indicates whether a clinical study allows people who do not have the condition or related conditions or symptoms being studied to participate in that study |
depth of field | The range of distances from an observer over which images are in focus for a given strength of lens. |
immediate recall | Memory of learned material or responses having a duration of minutes to perhaps hours, syn |
scotopic | Pertaining to vision in the dark. |
prevalence | A measure of the proportion of people in a population affected with a particular disease at a given time. |
peripheral nervous system | Includes nerves throughout the body that relay message such as pain to the CNS (Central Nervous System) |
symptom | Any condition that a person considers to show the presence of a disease or abnormality |
irb | A committee of physicians, statisticians, community advocates and others that reviews clinical trial protocols before they can be initiated |
basophil | A type of white blood cell, also called a granular leukocyte, filled with granules of toxic chemicals that can digest microorganisms |
sporangium | saclike fungal structure in which the entire contents are converted into an indefinite number of asexual spores |
experimental drug | A drug that is not FDA licensed for use in humans or as a treatment for a particular condition |
cooperative agreement | When two institutions are frequently engaged in research projects that would require IRB review by both institutions, standing agreements can be developed to govern which institution will provide sole review for a given study |
referred pain | Pain felt in one area of the body that does not accurately represent where the problem is, because the pain is referred there from another area, i.e |
inclusion criteria | The factors used to judge a participant's eligibility for inclusion in a trial |
second messenger | A substance, activated by interaction of a synaptic transmitter substance with the postsynaptic receptor, that causes either a change in membrane ionic permeability or activation of an electrogenic pump, leading to a change in postsynaptic membrane potential. |
f | Bioavailability |
immunogencity | The ability of an antigen or vaccine to stimulate immune responses. |
scientific review officer | Institutes review grant applications with their own review requirements |
temporal lobe epilepsy | Seizures characterized by stereotyped behavior, often with emotional outbursts and partial responsiveness, syn |
blinded study | A clinical trial design in which neither the participants nor the research staff knows which participants are receiving the experimental treatment and which are receiving a placebo (inactive treatment) |
institute | There are two levels: an informal NIH procedure and a formal HHS procedure |
api | Active Pharmaceutical Ingredient |
spectroscopy | The analysis of light type emissions to determine properties of their source. |
licensed drug | In the UK and Europe a drug needs to be approved by the MHRA/ EMEA before it can be marketed |
double blind | The design of a study in which neither the investigator or the subject knows which medication (or placebo) the subject is receiving. |
lobar pneumonia | An acute inflammatory disease that involves the bronchioles and alveoli; also known as bronchopneumonia |
asthenia | Weakness. |
mutation | A stable, heritable change in the nucleotide sequence of a genetic nucleic acid (DNA, or RNA in viruses, viroids, etc) typically resulting in the generation of a new |
sarcomere | The serially repeating unit of muscle that gives it its striated appearance. |
samhsa | Substance Abuse and Mental Health Services Administration; includes the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center on Mental Health Services |
amplification | A circumstance in which the output signal is greater than the input signal. |
antibody-dependent cell-mediated cytotoxicity | An immune response in which antibodies bind to target cells, identifying them for attack by the immune system |
phase ii trials | Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. |
monitoring | The act of supervising a clinical study, ensuring all aspects of the trial are conducted as stated in the clinical protocol, standard operating procedures, good clinical practice and by regulatory requirements. |
juvenile | The life stage of a nematode between the embryo and the adult; an immature nematode. |
award | Go to 37 CFR 401.2 and full 37 CFR 401. |
ctd/ectd | Common Technical Document (electronic CTD) is a set of harmonised structure and format specifications for application dossiers for the registration of medicines and designed to be used across Europe, Japan and the US. |
cephalosporins | A group of antibiotics used to treat bacterial infections (see ANTIBIOTIC and BACTERIA). |
parameter | Used to measure the quantity or function of something |
world health organization | World Health Organization (WHO) |
individual investigator agreement | This is a formal binding agreement signed by individuals who are collaborating on research conducted by an institution, but who themselves are not acting as employees or agents of an institution that has a FWA or that regularly conducts human subjects research |
water sprout | a small, rapidly growing shoot or branch on a large stem, developed from adventitious tissues; often develops as a result of stress or a change in environment such as the opening up of the canopy to greatly increased light levels |
glp | Good Laboratory Practice |
animal welfare assurance | Go to these resources: |
rtv | Ritonavir |
polydipsia | Excessive drinking persisting for long periods of time as in diabetes mellitus. |
clonus | The alternating contraction and relaxation of a rapidly extended muscle in spasticity, syn |
genotype | The genetic constitution of an individual. |
steatohepatitis | Includes fatty deposits and inflammation in the liver. |
physiology | The study of body functions and processes. |
hypopolarizing after-potential | A membrane potential more positive than the resting membrane potential that occurs following termination of the spike, syn |
preclinical | A laboratory or animal study that's done to determine if a new treatment is safe and effective enough to be studied in humans. |
human subjects review board | A group of people who review, approve, and monitor the clinical study protocol |
simple message | Simple message |
middle lamella | the layer, consisting largely of pectic substances, between the walls of adjacent plant cells |
enation | abnormal outgrowth from the surface of a stem or leaf |
risk-benefit ratio | The risk to individual participants compared to the potential benefits. |
phyllody | change of floral organs to leaflike structures |
clinical trial | A prospectively planned scientific study of the effects of a diagnostic test or treatment on selected patients, usually with respect to safety, efficacy, and/or quality of life. |
metabolite | Any substance produced by metabolism or by a metabolic process |
patient | Individual seeking medical care. |
qi gong | A component of traditional Chinese medicine that combines movement, meditation, and regulation of breathing to enhance the flow of qi (an term given to what is believed to be vital energy) in the body, improve blood circulation, and enhance immune function. |
dermatome | The area of skin innervated by a dorsal root. |
pneumoconiosis | Inflammation of the lungs caused by chronic inhalation of dust and other fine particles |
quality assurance reviews | Quality Assurance reviews are performed by the TUOHRP Director and office staff to verify that the electronic database is consistent with the IRB paper files and the paper files are collated in accordance with IRB policy and procedure. |
gibberellins | plant hormones (growth regulators) that affect stem elongation |
anti-androgen | chemical that acts as an antagonist at the androgen receptor or otherwise interferes with the effects of endogenous androgens. |
ein | See Employer Identification Number. |
carrier | A person having a single gene for a genetic trait or disorder like CF |
electroneuromyography | Testing and recording neuromuscular activity by electrical stimulation of the nerves |
sterile | unable to reproduce sexually; to be free of living microorganisms |
hcv | Hepatitis C virus is also referred to as nonA-nonB hepatitis and is the most common form of blood transfusion-acquired hepatitis. |
inflammation | The swelling of body tissues due to irritation or injury |
retrovirus | HIV and other viruses that carry their genetic material in the form of RNA and that have the enzyme reverse transcriptase |
vaccine-derived poliovirus | Vaccine-derived poliovirus (VDPV) |
risk | In a clinical trial, the probability of discomfort or harm to participants in a clinical trial. |
magnetic resonance imaging | An imaging procedure that produces a clear three-dimensional picture. |
dna polymerase | An enzyme that synthesizes a daughter strand(s) of DNA (under direction from a DNA template) |
helsinki declaration | See: Declaration of Helsinki. |
transdermal | Medication that is put on the skin and is absorbed through the skin into the bloodstream |
hyperopia | A pathological condition of refraction in which the eyeball is too short for the refractive power of the lens and images focus behind the retina, syn |
ganglion | A mass of nervous tissue, composed principally of nerve-cell bodies, usually lying outside the central nervous system. |
ob | Optimized Background |
grant application package | Go to these resources: |
antigen | Any substance that stimulates the immune system to produce antibodies |
cones | Visual receptors in the retina specialized for photopic and color vision. |
interventional pain management | Blocking of the body's production and/or transmission of pain signals to the brain by use of a neurological procedure, nerve block spinal cord stimulation, implantation of a drug delivery system or injection of an anesthetic. |
myofibril | A muscle fibril; one of the slender threads in a muscle composed of numerous myofilaments. |
emancipated minor | A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation |
vertigo | A sensation as if the world were revolving around the person or the person is revolving in space. |
promoter region | A location on DNA to which RNA polymerase will bind and initiate transcription of the associated gene(s). |
false negative | When a test wrongly shows an effect or condition to be absent (e.g., that a woman is not pregnant when, in fact, she is). |
amino acid sequence | The unique order of the "building blocks" (amino acids) that make up each protein. |
dmc | Data Monitoring Committee See: Data Safety Monitoring Board |
safety profile | A summary of clinical data that explains the possible side effects of a certain drug or treatment. |
pest | any organism that damages plants or plant products |
who | World Health Organization |
organism | A form of life, such as a plant, animal, bacterium (single bacteria) or fungus. |
postamendments devices | Medical devices marketed after enactment of the 1976 Medical Device Amendments. |
feedback inhibition | A situation in which the output of a neuron (or set of neurons) is used to inhibit (perhaps through an interneuron) further inputs to the neuron (or set of neurons). |
cbpr | See: community-based participatory research |
polyunsaturated fatty acids | Fatty acids with more than one double bond |
phase iib study | Well-controlled trials to evaluate efficacy (and safety) in subjects with the disease or condition to be treated, diagnosed, or prevented |
multicenter trial | See Multicenter Study |
aromatase | enzyme (e.g., CYP19) that converts testosterone to estradiol. |
germination | In bacteria or fungi, the process by which a spore gives rise to a vegetative cell or hypha. |
infection focus | initial site of infection, generally with reference to a population of plants |
facultative anaerobe | Refers to an organism that normally grows aerobically but can grow anaerobically. |
etiolation | A phenomenon exhibited by plants grown in the dark: etiolated plants are pale yellow and have long internodes and small leaves. |
recombinant dna | Genetic material that has been altered and recombined in the laboratory by cutting up DNA molecules and splicing together specific DNA fragments |
free t4 | The amount of T4 in the bloodstream that is not bound to carrier proteins. |
rehabilitation | Treatment plan, often exercise based, used to help you regain function or relieve pain caused by an illness or injury. |
habitat | a place with a particular kind of environment suitable for the growth of an organism |
immunoassay | a detection method based on antibodies specifically selected to react with the substance to be detected (the antigen) |
risk-potential benefit profile | An evaluation of the risks and potential benefits that have occurred during the course of the study. |
phi | See: Protected Health Information |
internist | A medical doctor who focuses on the prevention and treatment of adult diseases |
deferral | The decision (vote) by an IRB that the IRB is unable to approve the research because it cannot make the determinations required for approval |
anesthesia | The lack of tactile sensation. |
serotype | A subdivision of virus strains distinguished by protein or a protein component that determines its antigenic specificity. |
diagnosis | The determination of the presence of a specific disease or infection, usually accomplished by evaluating clinical symptoms and laboratory tests. |
thymine | (= 2, 6-di-hydroxy, 5-methylpyrimidine; 5-methyluracil) |
compartmentalization | In trees: the processes that result in isolation of wounded or diseased xylem from normal xylem by the formation of chemically and anatomically specialized tissue around the damaged zone. |
horner's syndrome | Sinking in of the eyeball, ptosis of the upper eyelid, constriction of the pupil, anhidrosis and flushing of the affected side of the face caused by paralysis of the cervical sympathetic nerves. |
institutional review board | A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research [45 CFR 46.102(g); 45 CFR 46.108; 45 CFR 46.109]. |
haustorium | A specialized branch of a hypha formed inside a host cell by certain plant-parasitic fungi (especially obligate parasites) in order to obtain nutrients. |
placebo | An inactive agent given to a study subject instead of an active drug |
conditional approval | IRB determination that the applicable criteria for IRB approval of an item have been met based on the assumption that specific conditions will be met by the researcher and subsequently verified. |
foia | See Freedom of Information Act. |
epithelioma | a malignant tumor of the epithelial tissue |
polyneuritis | Inflammation of many nerves at once. |
yoga | A philosophy and discipline applied to the development of mind, body and spirit |
plasmolysis | The shrinking and separation of the cytoplasm from the cell wall due to exosmosis of water from the protoplast. |
incompetence | Technically, a legal term meaning inability to manage one's own affairs |
vein banding | symptom of virus disease in which regions along veins are darker green than tissue between veins |
sacrum | The bottom portion of the spine that lies between the lumbar segment and the coccyx (tailbone). |
risk-benefit ratio | The risk to individual participants versus the potential benefits |
burden of disease | Burden of disease |
controlled study | A study in which a new drug or treatment is tested against a treatment with known effects |
randomized controlled trial | An experimental design in which individuals are assigned randomly to a treatment group or a control group and the outcomes are compared. |
adipsia | Absence of drinking or abnormal avoidance of drinking. |
myelin | A substance that sheathes nerve cells, acting as an electric insulator that facilitates the conduction of nerve impulses. |
formulation | A prescribed recipe for making a drug. |
basidium | A cell in which karyogamy and meiosis take place and which bears exogenous spores of sexual origin. |
v1 | Central (vascular) compartment |
contract research organization | A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor's study-related duties and functions. |
grant application | For electronic applications, the Facilities and Other Resources attachment is on the Research and Related Budget Other Project Information form |
multi-center | More than one medical or research institution, such as a multi-center clinical study. |
aromatization | process by which a compound forms aromatic ring (e.g., T to E2). |
hypoventilation | Reduced breathing rhythm that fails to meet the body's gas exchange demands |
plasma | The fluid part of a liquid (normally blood). |
audiometry | The testing of the sense of hearing. |
efficacy | Of a drug or treatment |
protozoa | A group of one-celled animals |
certified research coordinator | CRC with greater than two years experience and with certification earned by passing required program and exam. |
markers | A substance in the body that, when present in large or abnormal amounts, suggests the presence of disease |
termination of irb approval | An action initiated by the IRB or other officials of the organization to stop permanently some or all research procedures. |
minimal risk | The UW applies the definition of minimal risk provided in federal regulations (45 CFR 46.102): The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. |
recruitment period | Time frame allowed to recruit for a clinical trial. |
stabilizers | Stabilizers |
unfused tetanic contraction | A tetanic contraction in which individual twitch contributions can still be seen. |
dmf | Drug Master File is a document containing complete information on an Active Pharmaceutical Ingredient or finished drug dosage form |
controlled trial | A type of clinical trial in which observations made during the trial are compared to a standard (called the control) |
research | For paper grant applications use the Planned Enrollment Report |
research team | Investigator, subinvestigator and clinical research coordinator involved with study. |
obligate | Restricted to a particular set of environmental conditions, without which an organism cannot survive |
genus | A taxonomic rank above species and below family; the generic name of an organism is the first of the binomial |
seroconversion | The development of antibodies to a particular antigen |
equipoise | The state resulting from the presumed equality of the study treatments |
emancipated minor | An emancipated minor is a child who is legally considered an adult |
hypopolarization | A change in the membrane potential, usually away from the resting potential, toward the isoelectric point (i.e., zero voltage). |
stem cells | Cells from which all blood cells derive |
erythrocytes | Red blood cells whose major function is to carry oxygen to cells. |
parallel track trial | A system of making experimental drugs available to individuals who are unable to participate in clinical trials. |
hypothalamus | a part of the brain that regulates many basic body functions (e.g., temperature, appetite, reproduction). |
assent | Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. |
shot hole | A symptom in which small, diseased fragments of leaves fall off, leaving small holes in their place. |
weber fraction | The ratio of the just-noticeable-difference in stimulus strength to the standard stimulus strength. |
parasite | An organism living in or on another living organism (host) from which it extracts nutrients. |
open-label study | A study in which no blind is used, and all parties are aware of the drug and dose being administered and received |
disseminated bcg infection | Disseminated BCG infection |
weber's test | A hearing test using a tuning fork employed to distinguish conduction deafness from nerve deafness. |
proteinuria | Excess protein in the urine. |
inactivation | Closure of the voltage-gated ionic channels. |
principal investigator | In it, the principal investigator describes how the scientific environment will contribute to the success of the project |
field block injection | Used to relax tender muscles, reduce muscle pain and inflammation |
new drug application | An application submitted by the manufacturer of a drug to the FDA for a license to market the drug for a specific indication |
receptor | A molecule on the surface of a cell that serves as a recognition or binding site for antigens, antibodies or other cellular or immunological components |
endometrial cavity | interstitial trophoblast See extravillous trophoblast. |
rectum | In nematodes: Posterior gut of the female |
phialide | end cell of a conidiophore with one or more open ends through which a basipetal succession of conidia develops |
peer review | Review of a clinical trial by experts chosen by the study sponsor |
intestine | Tube in the digestive system that connects the stomach to the anus |
certificate of confidentiality | See: federal certificate of confidentiality |
subtype | Also called a clade |
control group | The standard against which an experimental treatment is evaluated |
variable | An element or factor that the research is designed to study, either as an experimental intervention or a possible outcome (or factor affecting the outcome) of that intervention. |
ethics advisory board | An interdisciplinary group that advises the Secretary, HHS, on general policy matters and on research proposals (or classes of proposals) that pose ethical problems. |
regulate | The act of controlling or directing the rate, time, levels, in a body process. |
enzymes | Proteins that help make and increase certain chemical processes in the body, like the breaking down of foods in digestion |
descriptive study | Any study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies). |
incomplete miscarriage | imminent miscarriage An alternative term for inevitable miscarriage. |
new drug application | A request from the manufacturer of a drug to the FDA for a license to market a new drug in the U.S |
evoked potential | An electrical response of a group of neurons produced by a stimulus to a sensory receptor or neural pathway. |
evidence-based | Evidence-based |
single-blind study | A study in which one party, whether the investigator or participant, is unaware of what treatment is applied to the participant (also called single-masked study). |
doctor of medicine | An academic degree for medical doctors and is the most common degree held by physicians and surgeons |
neutralizing domain | A section of HIV (most commonly on the envelope protein gp120) that elicits antibodies with neutralizing activity. |
radiation safety committee | At the University of Washington, the Radiation Safety Office is the operational arm of the University Radiation Safety Committee and is responsible for developing and carrying out a radiation safety program that ensures the safe use of ionizing radiation, and compliance with regulations |
ddi | Dideoxyinosine (didanosine, Videx), a nucleoside analog drug that inhibits the replication of HIV |
mucosal | A fluid made by mucous membranes and glands |
tg test | A test that measures the level of thyroglobulin (Tg) in the blood |
trophectoderm | Insler score See cervical score and monitoring. |
reiki | Practice of transmitting healing energy through the hands, based on ancient techniques |
axodendritic synapse | A synaptic junction in which an axon's bouton is the presynaptic element and a dendrite is the postsynaptic element. |
x-ray | A type of high energy photon that provides a picture of bone to rule out bone damage and/or fracture |
faca | See Federal Advisory Committee Act. |
p value | Statistical data, such as data from human tests of a candidate drug, are often accompanied by a P value, which is the mathematical probability that the data are the result of random chance |
chiropractic | Treatment based on the effect of spinal anatomy on the functioning of the body |
placebo | 1) a substance that has no chemically relevant effect on a test subject |
idea program | See Institutional Development Award Program. |
liver function tests | Refers to a group of blood tests used to evaluate the function of the liver |
mpag | Mycophenolic Acid Glucuronide |
cost-effective | Cost-effective |
toxicity | capacity of a substance to interfere with the vital processes of an organism |
expanded authorities | Go to the definition in 45 CFR Part 74 and these NIAID resources on the Grant Award and Management portal: |
gene therapy | The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germline (reproductive) cells. |
cleared device | In the U |
de-identified data | Information is de-identified if there is no reasonable basis to believe that the data can be linked to specific individuals |
nomenclature | A system of names, or naming, as applied to the subjects or study in any art or science, especially in botany and zoology. |
follicular cancer | A type of cancerous growth composed of thyroid follicular cells; also called follicular carcinoma |
expiration | When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically and all research activities must stop until the protocol is renewed. |
neurogenic | Of nerve origin. |
fda form 1572 | A list of commitments and requirements by the FDA for each investigator performing drug/biologics studies |
selenium | A sulfur family member essential in nutrition and found in whole grains and meats. |
contract | Go to NIAID's Independent Government Cost Estimate SOP. |
alt | Al anine aminotransferse |
tid | thrice daily |
laboratory | A workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. |
baseline | The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment being tested |
multicenter trial/study | A clinical trial conducted according to a single Protocol but at more than one site, and, therefore, carried out by more than one investigator. |
artery | A vessel carrying blood high in oxygen content away from the heart and to the farthest reaches of the body. |
concept clearance | Only some concepts approved by the Council are published as initiatives, depending on their priority and the availability of funds. |
ornithine | Reduces fatigue from heavy exercise. |
taxon | A taxonomic group of any rank. |
nih guide | Compare with broad agency announcement (BAA). |
enzyme | Protein that increases chemical reaction in a living organism |
pathogen | Pathogen |
end bulb | A swelling of an axon near its termination; the presynaptic structure in most synapses, syn |
recusal | An IRB member's absence from the IRB meeting due to a conflict of interest with respect to the item under consideration |
ascus | A cell that is the site of meiosis and in which endogenous spores (usually meiospores but sometimes also ascoconidia) are formed |
taproot | primary root that grows vertically downward and from which smaller lateral roots branch |
epinasty | abnormal, downward curling of a leaf, leaf part, or stem |
receptor potential | The nonpropagated change in membrane potential of a receptor that does not lead to action potentials in the receptor, but does generate them synaptically in another cell, cf., Generator potential. |
host factors | The body's potent mechanisms for containing HIV, including immune system cells called CD8+ T cells, which may prove more effective than any antiretro-viral drug in controlling HIV infection |
herniated disc | A disruption of the tissue that separates the vertebral bones of the spinal column. |
impedance matching device | A mechanism that compensates for differences in sound transmission through different media; in the ear, through air and perilymph. |
recombinant dna technology | The technique of isolating genes from one organism and purifying and reproducing them in another organism; sometimes called genetic engineering. |
clinical trial | A carefully planned study that evaluates the benefits and risks of treatments and screening tests on humans |
langerhans cells | Dendritic cells in the skin that pick up an antigen and transport it to the lymph nodes |
autograft | Tissue or organ transferred from one part of the body to another within the same individual. |
peronosporales | Specialized forms of the Oomycetes, including aquatic and terrestrial species; many species in this order are plant pathogens (damping-off fungi, downy mildews, and white rusts); unlike the true fungi, they lack chitin in their cell walls. |
cmax | Maximum plasma concentration |
recruitment | Act of enrolling people in a clinical trial. |
emergency use | the use of an FDA-regulated test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. |
countersigned | Signing of a grant-related document by more than one official, e.g., a grantee or training grant director and an institutional business official. |
diagnostic | Tests used to identify a disorder or disease in a living person. |
hla | See Human Leukocyte Antigens. |
control | A standard against which experimental observations may be evaluated |
protectant | agent, usually a chemical, applied to a plant surface in advance of a pathogen to prevent infection |
cd8+ t cells | White blood cells that kill cells infected with HIV or other viruses, or transformed by cancer |
tumor: | abnormal swelling or localized outgrowth, often roughly spherical, produced by a plant as a result of attack by a fungus, bacterium, nematode, insect or other organism |
act | Federal Food, Drug, and Cosmetic Act (sections 201 |
far | See Federal Acquisition Regulation. |
phytopathogenic | Of microorganisms: Capable of initiating disease in plants. |
hypesthesia | Reduced cutaneous sensation. |
sedimentation | The setting out of solids mixed into a liquid. |
dominant hemisphere | The cerebral hemisphere that contains the speech centers. |
brdpi | See Biomedical Research and Development Price Index. |
nectary | a nectar-secreting gland in a flower |
synaptic knob | A swelling of an axon near its termination; the presynaptic structure in most synapses, syn |
homonymous hemianopsia | Hemianopsia involving either the left or right halves of the visual fields of both eyes. |
clinical trial | A clinical trial is a research study that answers specific questions about a treatment |
multicenter trial | A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. |
absorb/absorption | The passage of substances into or across tissues, such as the passage of food and water from the intestines into the bloodstream |
subject/study subject | Participant in a study |
off label | The unapproved use or prescription of a drug for a purpose or condition other than that approved of by the FDA. |
masked symptoms | Virus-induced plant symptoms that are absent under some environmental conditions but appear when the host is exposed to certain conditions of light and temperature. |
end-plate potential | The hypopolarizing postsynaptic potential in the striated muscle that leads to the muscle spike. |
impaired glucose tolerance | A fasting blood sugar of 100 to 125 mg/dL and /or a blood sugar of 140 to 199 mg/dL 2 hours after an oral glucose load during an oral glucose tolerance test (OGTT). |
computed tomography scan | Diagnostic procedure, using X-ray technology and a computer, that may be used to help diagnose the source of your pain. |
inherited | Traits or conditions, like eye color or CF, that are genetically passed from parents to their children (see GENE and GENETIC). |
paraphysis | Sterile, elongated cell that may occur in the hymenium, intermixed with asci or basidia, elongating apically and having a free apex |
respect for persons | As discussed in the Belmont Report the principle that individual autonomy be respected and that persons with diminished autonomy be protected |
flower-spray endings | The termination of group II afferent fibers on the nuclear chain fibers of muscle spindles, syn |
agglutination | The formation of insoluble aggregates following the combination of antibodies with cells or other particulate antigens or with soluble antigens bound to cells or other particles or following the combination of soluble (or particulate) antigens with cell-bound or particle-bound antibodies. |
pharmacology | The medical science that deals with the discovery, composition, identification, biological/physiological effects, uses and manufacture of drugs. |
heterothallism | The phenomenon in which sexual reproduction requires the involvement of two different thalli. |
tmax | Time to maximum plasma concentration |
thyroid remnant | Some part of the original thyroid gland remaining after thyroidectomy surgery. |
tracheostomy | Surgical creation of an opening into the trachea, usually for insertion of a breathing tube |
cortical bone | The dense outer surface of bone that forms a protective layer around the marrow cavity. |
cep | Certificate of Suitability of the Monograph of the European Pharmacopoeia, a certification procedure with the purpose of providing proof that the quality of the substances used in human and veterinary medicines are suitably controlled by the relevant monographs of the European Pharmacopoeia. |
subjects | See: Human Subjects. |
pancytopenia | Deficiency of all cell elements of the blood. |
membrane potential | The electrical potential that exists across the cell membrane as a result of inhomogeneous ion distributions. |
serious adverse event | A serious adverse event includes the following medical outcomes after a product's use: death, life-threatening, requires inpatient or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly/birth defect or requires intervention to prevent permanent impairment or damage. |
controlled trials | Clinical trials that incorporate a control group |
non-compliance | "Failure to follow the regulations or the requirements and determinations of the IRB." |
disinfectant | A physical or chemical agent that frees a plant, organ, or tissue from infection. |
virus | a submicroscopic, intracellular, obligate parasite consisting of a core of infectious nucleic acid (either RNA or DNA) usually surrounded by a protein coat |
prostate | A male gland surrounding the bladder neck and urethra; it contributes to the semen. |
pd | Pharmacodynamics |
phagocytosis | The process of ingesting and destroying a virus or other foreign matter by phagocyte |
active treatment | In a clinical trial, treatment that is intended to reduce or eliminate the disease in a patient. |
postrotatory nystagmus | Nystagmus in the direction opposite to that of and due to a previous rotation, e.g., in a Barany chair. |
gmp | Good Manufacturing Practice |
multi-site trial | Research study conducted in more than one institution |
viviparous | Bearing living young. |
minimal medium | A type of culture medium lacking specific growth factors; it does not support the growth of some or all auxotrophic strains of a given organism but permits the growth of prototrophic strains. |
mumps | Mumps |
cardiac muscle | Striated muscle found in the heart. |
pneumonitis | Inflammatory condition of the lungs that is independent of a particular cause |
hypha | Filamentous part of a fungus, usually septate and consisting of several cells in linear succession |
sympathectomy | The transection, resection or other interruption of transmission in some portion of the peripheral sympathetic pathways. |
relaxation | State of deep rest in which the metabolism slows, less oxygen is needed, heart and respiration rates drop, blood pressure drops, and brain waves slow |
aucinf | Area under the Curve time infinity |
ide | See investigational device exemption. |
itt | Intention To Treat |
tonotopic representation | A distribution of sensitivity in auditory structures such that the range of audible tones is represented in sequence across the structure. |
nyctalopia | Congenital night-blindness caused by a lack of rod functioning in the retina. |
southern blotting | Procedure for transferring denatured DNA from an agarose gel to a nitrocellulose filter where it can be hybridized with a complementary nucleic acid. |
status | See Recruitment Status. |
pivotal study | A controlled, randomized study conducted to good clinical practices and subjected to intense monitoring to ensure its validity in order to provide critical information to authorities about the efficacy and safety of a new drug. |
smooth muscle | Muscle of the linings of internal organs and blood vessels that lacks cross-striations and is caused to contract by autonomic discharges. |
unexpected adverse drug reaction | A reaction that is not consistent in nature or severity with study application. |
investigator’s brochure | A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects |
certain agreements | As required by Section 801 of the Food and Drug Administration Amendments Act, in general, a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or to publish the study results in a scientific or academic journal after the trial is completed |
rehabilitation | Treatment plan used to help regain function or relieve pain caused by illness or injury |
western blot | A laboratory test for the presence of specific antibodies, more accurate than the ELISA test |
placebo | An inactive pill, liquid, or powder that has no treatment value. |
non-compliance | A situation, event, or process in human subjects research that is inconsistent with (1) the ethical principles of human subjects research as described in the Belmont Report; (2) federal, state, and/or local regulations applying to the research; (3) UW policies and procedures governing human subjects research; or (4) the research activities as approved by the UW IRB |
ferpa | See: Family Educational Rights and Privacy Act |
codon | A particular sequence of three nucleotides in mRNA coding for an amino acid. |
dependent variables | The outcomes that are measured in an experiment |
experimental study | A true experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation |
ich | International Conference on the Harmonization of Technical Requirements for registration of Pharmaceuticals for Human Use |
pi | See: Principal Investigator |
contraindication | A specific situation that will cause the administration of a treatment to be harmful to a person. |
cross-projection | The head of the myosin molecule projecting at right angles past the thin filaments; according to the electrostatic theory, the site of charge separation resulting in an electric field. |
genetic | relating to heredity; referring to heritable characteristics |
letter of indemnification | A legal document indicating protection or exemption from liability |
asthma | Condition characterized by widespread narrowing of the bronchioles and formation of mucus plugs |
hyperplasia | abnormal increase in the number of cells, often resulting in the formation of galls or tumors |
microbicide | An agent (e.g., a chemical or antibiotic) that destroys microbes |
hhsar | Go to HHS Acquisition Regulations and FAR. |
placebo-controlled study | A trial in which controls receive a sham treatment with no real effect. |
sae | see Serious Adverse Event |
peronosporales | Specialized forms of the |
human subject | A healthy individual or patient who becomes a participant in a research study. |
epidermis | The superficial layer of cells occurring on all plant parts. |
saprobe | An organism that obtains its nutrients from non-living organic matter (commonly dead and decaying plant or animal matter) by absorbing soluble organic compounds |
stylet | stiff, slender, hollow feeding organ of plant-parasitic nematodes or sap-sucking insects, such as aphids or leafhoppers |
resistant: | ability of a plant to prevent or impede disease development (see susceptible) |
t cell | White blood cell critical to the immune response |
transcriptional activation | The process by which the two DNA strands separate in order to allow replication |
statoconium | Calcium carbonate crystal found in the otolith organs of vertebrates, syn |
hypophysectomy | Surgical removal or other destruction of the pituitary. |
gastrointestinal | Body system including stomach and large and small intestines |
institutional review board | An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation |
false positive | When a test wrongly shows an effect or condition to be present (e.g |
capsid | The protein shell that surrounds the virus nucleic acid. |
joint | Fibrous connective tissue or cartilage where two bones are attached |
stage of disease | The extent or severity of disease as designated by numerals or letters |
axon | The straight, relatively unbranched process of a nerve cell or the efferent process of a nerve cell, syn |
intent to treat | Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment. |
pituitary gland | 1) located at the base of the brain |
reiki | Complementary medicine technique that uses gentle pressure from the hands to encourage “healing energy,” and is often used to treat both acute and chronic pain. |
pharmacology | The science of drugs, including their composition, uses, and effects. |
statistical significance | Indicates if a result was probably not by chance |
organizational effect | permanent effect of hormone in developing organism that determines the cellular response to hormones after development (as opposed to activational effect). |
antiretroviral agents | Substances used against retroviruses such as HIV |
trichomonas sp. | Water-borne flagellated protozoa which can cause urinary tract infections and vaginitis. |
nasopharyngeal | The cavity including the nose and throat. |
vascular cylinder: | the cylinder of vascular tissue in stems or roots |
review | refers to the evaluation of a proposal by the Institutional Review Board consistent with the policies established by appropriate federal agencies and the Belmont Report |
pasteurization | to free a material, usually a liquid, of selected harmful microorganisms using heat |
opioid | Medication class often prescribed to manage pain; drugs include codeine, morphine, fentanyl, and methadone. |
greater than minimal risk | The probability and magnitude of harm or discomfort anticipated in the research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests |
genetic code | the system of triplet codons composed of nucleotides of DNA or RNA that determine the amino acid sequence of a protein |
monopolar | Having a single pole; with respect to electrophysiology: stimulating or recording through one active electrode and one indifferent (or reference) electrode, cf |
logarithmic function or relation | The relationship between two variables such that equal percentage changes in one result in equal changes in the other; an equation of the form y = a log x + b. |
initial peer review | Go to NIAID's Contracts portal and the Negotiation, Source Selection, and Award SOP. |
n-acetyl cysteine | Is able to break the disulfide bonds in mucous and useful in coughs and cystic fibrosis. Reduces symptoms of schizophrenia and bi-polar disorder. Is a precursor to glutathione. |
salivary | Related to the saliva or fluid in the mouth. |
germ theory | the theory that infectious or contagious diseases are caused by microorganisms (germs) |
case-control study | A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors |
new drug application | The compilation of all non-clinical, clinical, pharmacological, pharmacokinetic and stability information required about a drug by the FDA in order to approve the drug for marketing in the U.S. |
clinical | Pertaining to or founded on observation and treatment of human participants or patients, as distinguished from theoretical or basic science. |
generalizability of results | The extent to which clinical trial results apply to individuals being treated outside the trial |
smpr | Skeletal Morbidity Period Rate |
polymerase chain reaction | A laboratory technique for quickly fusing large amounts of DNA together from a single DNA segment. |
control group | The standard by which experimental observations are evaluated |
blind trial | A clinical trial in which participants are unaware whether they are taking the experimental drug, placebo or standard treatment |
lsm | Least Squares Mean |
open-label study | A study in which all parties, (patient, physician and study coordinator) are informed of the drug and dose being administered |
sexual differentiation | the process by which a developing individual assumes the characteristics of either a male or a female. |
contraindicated | Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure). |
fwa | See Federalwide Assurance. |
symbiotic | The relationship between plants or animals where dissimilar species live together with each assisting the other |
panax ginseng | An herb generally produced in Asia with stimulant activity |
nda | New Drug Application, the application to approve a drug in the US. |
clinical investigator | A medical researcher in charge of carrying out a clinical trial's protocol. |
pineal gland | A small gland with the main function of producing melatonin. |
person months | Also see scientific overlap, budgetary overlap, and commitment overlap. |
aphasia | Impairment of communication by language in any form; expressive aphasia - inability to speak or write; receptive aphasia - inability to understand spoken or written language. |
monocot | plant with one cotyledon, such as grasses, grain crops, corn (see dicot) |
preganglionic fiber | Nerve fiber originating in the central nervous system and running to an autonomic ganglion. |
hematocrit | A laboratory measurement that determines the percentage of packed red blood cells in a given volume of blood. |
electroencephalogram | Recording from the scalp of the changes in electrical potential in the brain, primarily in the cerebral cortex, abbr |
clinical | Related to the study and treatment of people in a medical setting or clinic. |
stereopsis | Depth perception. |
cytokinins | Phytohormones that stimulate metabolism and cell division. |
contralateral | On the opposite side. |
experimental drug | A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition. |
emmetropia | The normal condition of the eye with respect to refraction. |
in vitro | A Latin term meaning "in glass." Initial studies for drug effectiveness are first conducted in vitro or in a "test tube" environment. |
pituitary | Relates to the pituitary gland which develops hormones which control other endocrine type glands. |
ethics committee | An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants. |
akinesia | Absence of movement. |
rac | See rDNA Advisory Committee (RAC). |
controls/control subjects | Subjects who are not exposed to the research intervention, treatment or manipulation, or who are exposed but do not have the characteristics under investigation. |
acropetal | Describes the development of structures (such as spores) in succession from the base towards the apex. |
prophylactic | Protecting against an ailment or its spreading. |
side effects | Any undesired actions or effects of the treatment |
substrate | the substance on which an organism lives or from which it obtains nutrients; chemical substance acted upon, often by an enzyme |
enteroceptor | A receptor that senses some aspect of the condition of the environment inside the body. |
ethics committee | An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants |
dtap vaccine | DTaP vaccine |
statistical significance | The probability that an event or change did or did not occur by chance. |
cervical cancer | A neoplasm of the uterine cervix that can be detected in the early curable stage by the Papanicolaou (Pap) test |
caloric test | A test of vestibular function involving the induction of nystagmus by putting warm or cold water in the external auditory meatus. |
polymerase chain reaction | The selective amplification of DNA by repeated cycles of (a) heat denaturation of the DNA, (b) annealing of two oligonucleotide primers that flank the DNA segment to be amplified and (c) the extension of the annealed primers with the heat insensitive Tag DNA polymerase. |
background noise | Adverse effects which are unrelated to the use of the product are sometimes referred to as, "background noise," loosely defined as alternative causes, reasons, concomitant medical conditions/illnesses or other contributing factors unrelated to product use. |
principal investigator | The scientist in charge of a research team conducting clinical trials. |
proband | The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic. |
decay | The gradual decomposition of dead organic matter. |
single blind trial | A trial where either the investigator or participant is unaware of which treatment arm the participant is assigned to (see BLIND TRIAL, DOUBLE BLIND TRIAL and ARM). |
double blind trial | A clinical trial in which neither the participants nor the staff knows which patients are receiving the experimental drug and which are receiving a placebo or standard therapy |
inactivated polio vaccine | Inactivated polio vaccine (IPV) |
crossover | A study design that has each patient in two or more treatments in a specified order. |
pancreatic insufficiency | The failure to properly digest food due to a lack of digestive enzymes made by the pancreas. |
experimental | Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy |
multicenter trial | A clinical trial conducted at multiple sites using a common protocol. |
efficacy | (Of a drug or treatment) |
protons | A component of atoms with a positive charge equal to that of an electron. |
bias | Partial judgment on issues relating to the subject of that point of view |
hydathode | epidermal leaf structure specialized for secretion or exudation of water; leaf opening at terminus of vein |
study type | The primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing. |
equitable | Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed [45 CFR 46.111(a)(3)]. |
injury | damage caused by transitory interaction with an agent such as an insect, chemical, or unfavorable environmental condition |
presynaptic inhibition | Decrease in the probability of firing of a neuron due to decrease in transmission to it that results from hypopolarization of afferent terminals on it. |
neotype | A specimen selected as the type subsequent to the original description in cases in which the primary types are definitely known to have been destroyed. |
overwinter | to survive or persist through the winter period |
binding | The process through which one or more parties to a clinical trial are unaware of the treatment assignments |
off-label use | The clinical use of an FDA-approved drug, device or biologic for a purpose or population that has not been approved by the FDA, or in a route or dose that has not be approved by the FDA |
dysesthesia | Unpleasant spontaneous or evoked abnormal sensation in people with neuropathic pain; distinct from pain in the classical sense |
rhinitis | Inflammation of the mucous membrane of the nose. |
past-pointing | An error in pointing to a target in the direction of a previous rotation, e.g., in a Barany chair. |
administration | (Route of Administration) |
clinical | Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. |
nsaid | Non-steroid, anti-inflammatory drugs to treat inflammation. |
rna blotting | A technique for transferring RNA from an agarose gel to a nitrocellulose filter on which it can be hybridized to a complementary DNA. |
informed consent | see consent |
mri | Magnetic resonance imaging |
investigational device exemptions | Exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20]. |
left-right confusion | Confusion of laterality. |
amendment | Any change to an IRB-approved study protocol regardless of the level of review it receives initially. |
somesthesia | Consciousness of the body and bodily sensations resulting from activity in enteroceptors and exteroceptors. |
paresis | Weakness, partial paralysis; adjectival form: paretic. |
micronutrient | an essential element needed by plants for growth and required in very small amounts (see macronutrient) |
ancova | Analysis of covariance |
maximal response | The largest electrical response obtainable from a nerve, tract or nucleus. |
randomization | A process that reduces the likelihood of bias by assigning people to treatment groups by chance alone (randomly) |
analgesic | A substance that causes a decrease in pain. |
abstain | is when an IRB member does not vote on a protocol under review. |
replicon | Any DNA sequence or molecule that possesses a replication origin and is therefore potentially capable of being replicated in a suitable cell. |
sod | An enzyme composed of metal-containing proteins that converts superoxide radicals into less toxic agents. |
rigidity | Stiffness of a limb due to increased tone in both flexors and extensors, cf., spasticity. |
transgenic | possessing a gene from another species; used to describe the organisms that have been the subject of genetic engineering |
myxamoeba | A naked cell capable of amoeboid movement; characteristic of the vegetative phase of myxomycetes and such Plasmodiophoromycetes as Plasmodiophora brassicae. |
a band | Anisotropic or dark band in striated muscle; contains actin and myosin. |
depression | Treatable illness that affects the mind, body, mood thoughts and perceptions |
oxidant | A substance that oxidizes another substance. |
withdrawal application | Investigator/sponsor letter to FDA or other regulatory body requesting application withdrawal when no additional work is envisioned. |
detect | To discover the existence, presence, or fact of |
waiver of hipaa authorization | A request for permission to access, obtain, use or disclose a research subject's Protected Health Information (PHI) for research purposes without obtaining the subject's specific authorization for that access, use, or disclosure |
thyroiditis | Inflammation of the thyroid gland. |
exteroceptor | A receptor that senses some aspect of the condition of the environment outside the body. |
gel | A matrix of polyacrylamide, agarose or similar material in which the electrophoresis of molecules is carried out. |
rheumatoid | Medical problems in the joints and connective tissue. |
ddc | Dideoxycytidine (zalcitabine, HIVID), a nucleoside analog drug that inhibits the replication of HIV |
efficacy | The ability of a drug to produce a desired effect |
phytoestrogen | plant-made compound that mimics estrogen activity. |
etiology | The study or theory of the factors that cause disease. |
aitrc | See Allergy, Immunology, and Transplantation Research Committee. |
disease incidence | number or percentage of plants affected by a disease within a population |
gim 10 | Grants Information Memorandum (GIM 10) is the Significant Financial Interest Disclosure Policy at the University of Washington Office of Research, Office of Sponsored Programs |
privacy | Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. |
stridor | Stridor |
minimal risk | The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests |
nerve blocks | Injections of anesthetic (or numbing) substances into nerves in order to reduce pain. |
porcine | Of or derived from pigs. |
spc or smpc | Summary of Product Characteristics, a specific document required by EMA summarising the key characteristics of a drug for which a Community marketing authorisation has been granted. |
typhoid | Typhoid (typhoid fever) |
neurosurgeon | Surgeon who specializes in diseases and conditions of the central nervous system, and the nerves that branch out from the spine |
over-the-counter | Medicine that is available without a visit to a medical professional and/or without a prescription. |
mitt | Modified Intention To Treat |
relapsing-progressive ms | Former name for progressive-relapsing MS. |
investigational medical device | Go to 21 CFR 812.3 and full 21 CFR 812. |
basipetal | Successive from apex to base. |
fission | form of cell division in prokaryotes |
pharmacology | The study of how drugs interact with living organisms, such as the characteristics, effects and uses of the medications. |
all-or-nothing | Independence of action potential amplitude from stimulus strength; also refers to tendency of spikes to travel over the entire membrane of a cell, syn |
e-biz poc | See e-business point of contact. |
deception | Intentionally misleading or withholding information about the nature of an experiment. |
randomization | The process of assigning trial subjects to treatment and control groups using the element of chance; random treatment assignments are performed to reduce bias. |
protocol | A protocol is the study plan on which a clinical trial is based |
non-significant risk device | An NSR device investigation is one that does not meet the definition for a significant risk study |
oviparous | Producing eggs that hatch after expulsion from the body. |
phase iv trials | Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. |
clade | Also called subtype |
consent | See: Informed Consent. |
biologically based therapy | Therapy that includes natural and biologically based practices, interventions and products such as herbal supplements and special dietary guidelines |
pneumonia | An inflammation of the lungs often caused by a bacterial or viral infection |
anaerobic | Not requiring free, molecular oxygen for respiration. |
single-blind study | A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study. |
crf | Case Report Form |
iq/oq/pq | Installation Qualification, Operational Qualification, Performance Qualification, measurements required for the qualification of laboratory equipment. |
budding | See Assembly and Budding. |
pitch | The quality of a sound determined by the frequency of its waves. |
endotracheal intubation | Insertion of a non-collapsible breathing tube into the trachea by way of the nose or mouth |
aet | Cumulative urinary excretion from administration until time t |
dementia | Loss of intellectual function. |
spherical aberration | Formation of rings around images due to unequal refraction in the center and on the periphery of a lens. |
twitch contraction | The all-or-none response of a muscle or muscle cell to a single brief stimulus. |
arra | See American Recovery and Reinvestment Act. |
ind | Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines in the US (usually to clinical investigators), being in practice the permission required for clinical investigations in the US. |
heritability | a measure of the ability of a characteristic to be passed from one generation to the next |
lateral inhibition | Refers to the inhibition of the discharge evoked by stimulation within a cell's excitatory receptive field that occurs when an area outside that receptive field is stimulated; alternatively inhibition of an element in a sensory system caused by activity in an adjacent element of the same type. |
sme | Small & Medium Enterprises |
facultative parasite | An organism that normally lives as a |
children | Institutions must indicate IRB or IEC approval annually in a noncompeting grant application and when major changes in a protocol or other procedures occur |
surveillance system | Surveillance system |
bouton terminaux | A swelling of an axon near its termination; the presynaptic structure in most synapses, syn |
human subject | means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information |
elimination | Elimination |
slime mold | A member of a category of eukaryotic organisms that typically have some fungal-like attributes and some animal-like attributes. |
gene expression | The process by which a gene's coded information is converted into the structures present and operating in the cell |
suffering | informed consent An administrative and legal device by which approval to proceed based on known or predicted consequences is obtained and recorded from a patient or from a volunteer for medical research, and thus avoiding an accusation for what otherwise might be an assault |
principal investigator | The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study). |
parathyroid | A gland near the thyroid gland producing a hormone to regulate calcium and phosphorus metabolism. |
thyroid-stimulating hormone | A hormone secreted by the pituitary gland that stimulates the thyroid gland to produce the thyroid hormones T4 and T3 |
cat scan | Computerised axial tomographic scan; an imaging procedure |
toxicology | The study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people |
oral | Taken by mouth. |
confidentiality | Prevention of unauthorized disclosure of a sponsor’s proprietary information or of a subject’s identity and personal medical information. |
conflict of interest | "For the purposes of human research a situation where an individual's personal or financial interest competes with that individual's obligation to protect the rights and welfare of subjects." |
large linked databases | Large linked databases (LLDBs) |
metabasidium | The cell in which meiosis occurs in members of the |
biologicals | Biologicals |
asthenia | Weakness, lack of strength. |
prequalified vaccine | Prequalified vaccine |
saturated fats | Solid fats with no double bonds. High intakes are considered heart risks. |
applications | Depending on the funding opportunity announcement and use of a subaward, investigators may need to use the Research and Related Subaward Budget Attachment. |
contract | They include the amortized annual costs associated with capital, installation, operations, maintenance, and disposal, discounted over the lifetime of a product. |
rflp | Restriction fragment length polymorphism |
neurosteroid | steroid produced in the brain. |
investigational new drug | A drug, or biological product that is used in a clinical trial but has not been approved by the FDA (the drug is either not available for a doctor to prescribe or, is available, but not approved by the FDA for the use being studied). |
antifolate | An agent that inhibits intracellular (i.e., inside cells) production of folinic acid |
secondary muscle spindle receptor | The termination of group II afferent fibers on nuclear chain fibers of muscle spindles, syn |
pharyngitis | Inflammation of the pharynx |
dait | See Division of Allergy, Immunology, and Transplantation. |
deuteranope | A person who lacks response to green light, "green color-blind." |
hypha | Filamentous part of a fungus, usually septate and consisting of several cells in linear succession. |
mutation | A stable, heritable change in the nucleotide sequence of a genetic nucleic acid (DNA, or RNA in viruses, viroids, etc) typically resulting in the generation of a new allele and a new phenotype. |
adrenergic synapse | A junction between two cells that employs as its substance one of the catecholamines: epinephrine, norepinephrine, and perhaps isoproterenol. |
sponsor-imposed suspension | A determination from the sponsor of the study to place specific research activities on hold |
phase ii study | Phase II studies are controlled studies conducted to test the safety and efficacy of a drug on a larger population of patients who are afflicted with the condition or disease the drug is targeting. |
animals in research | IACUCs independently determine that an institution is meeting requirements and complying with regulations |
nonsignificant risk device | An investigational medical device that does not present significant risk to the patient |
tylosis | A balloon-like outgrowth from a xylem parenchyma cell that expands into and blocks the lumen of a xylem vessel or a tracheid |
ml | millilitre |
signal | Signal |
autosomal recessive | A genetic trait or disorder that appears only when a person inherits a pair of chromosomes, each of which has the gene for the trait |
confounding factor | Confounding factor |
prostatic adenocarcinoma | cancer of the prostate gland |
clr | Renal clearance |
irradiation | Spread of the flexion reflex to involve additional muscle groups and additional movements with stronger stimulation. |
asst | See assistant role for eRA Commons. |
nsaid | Nonsteroidal anti-inflammatory (i.e., counteracting inflammation) drug. |
research team | In clinical trials, the group of healthcare professionals who conduct the trial; it typically includes a principal investigator and a clinical research coordinator. |
placebo effect | A change that occurs after a person takes a placebo. |
response | The change produced in an organism by a stimulus. |
necrosis | Death of a body part, such as a tumor. |
vaccine safety | Vaccine safety |
assent | means a child's affirmative agreement to participate in research |
ide | See: Investigational Device Exemptions. |
sledai | Systemic Lupus Erythematosus Activity Index |
serotonin antagonists | Drugs that bind to but do not activate serotonin receptors, thereby blocking the actions of serotonin or serotonin agonists. |
placebo controlled | A drug is studied by giving an inactive substance (a placebo) to one group of participants, while the drug being tested is given to another. |
open-label trial | A clinical trial in which doctors and participants know which drug or vaccine is being administered. |
chmp | Committee for Medicinal Products for Human Use (formerly known as Committee for Proprietary Medicinal Products - CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use. |
non-viable fetus | An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)] (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.203 |
agent of inoculation | That which transports inoculum from its source to or into the infection court (e.g., wind, splashing rain, insects, humans). |
inclusion criteria | The standards as outlined in the protocol used to determine whether a person might be allowed to participate in a clinical trial |
apraxia | Inability to carry out motor acts on command in the absence of paralysis. |
interstitial segment | intrauterine adhesions Adhesions inside the endometrial cavity caused by prior infection (endometritis), especially if there has been a curettage during the period of infection, or if curettage is performed in conditions of low estrogen |
plasmid | An extrachromosomal ring of DNA, especially of bacterial origin, that replicates autonomously. |
drug | Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions. |
visibility curve | A plot of the threshold for vision against the wavelength of light in the stimulus. |
tissue | A group of cells of a similar type and function. |
saccharomyces cerevisiae | A strain of yeast found on the skin of many fruits and used in winemaking, brewing, and baking. |
sciatic nerve | The largest nerve that runs from the back of the hip down the thigh to the calf in each leg |
diopter | A measure of the strength of a lens, the reciprocal of the focal length of the lens expressed in meters. |
phosphorylated | Reacting to bond to a phosphate group. |
loa | Letter of Authorization, meaning a written statement by the holder or designated agent or representative permitting the FDA to refer to the information contained in a document (DMF, IND, etc.) in support of another person's document. |
substitution | Recovery of function due to use of alternate movements. |
randomized clinical trials | Randomized clinical trials |
cor | See contracting officer's representative. |
serious non-compliance | An action or omission taken by an Investigator that any other reasonable Investigator would have foreseen as compromising the rights and welfare of a participant. |
taxonomy: | the science dealing with naming and classifying organisms |
xylem | part of vascular tissue that conducts water and minerals up the plant and also serves as support tissue for the plant |
neurotrophic effect | Interactions between nerve cells or between nerve cells and other types of cells in which the nerve fibers initiate or control molecular and/or functional modification in the other cells. |
neuropathy | Any and all disease or malfunction of the nerves |
applicant | Any person or company who submits an application or abbreviated application or an amendment or supplement to them to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application. |
compassionate use | A method of providing experimental drugs to very sick patients who have no other treatment options |
sodium pump | Mechanism for extrusion of sodium and uptake of potassium by cells against the concentration gradients for these ions, syn |
cytotoxic | An agent or process that is toxic to cells (i.e., it causes suppression of function or cell death). |
interstitial | Relating to or situated in the small, narrow spaces between tissues or parts of an organ. |
adverse event | Any unfavorable change that may affect a subject during or after a clinical trial; the change is not necessarily caused by the investigational product |
chronic-progressive ms | Former "catch-all" term for progressive forms of MS, now categorized as two separate forms of disease |
risk benefit ratio | Risk to individual subject vs |
vicarious function | Recovery of function due to assumption of control by another neurological structure. |
reinnervation | Refers to the reattachment of a nerve fiber to a muscle or another nerve fiber after the original connection has been severed. |
eosinophil | A type of white blood cell, called granulocyte, that can digest microorganisms |
allowable costs | For a legal description, see FAR 16.303. |
virion | A mature infectious virus particle existing outside a cell. |
anaphylactic shock | A life-threatening allergic reaction characterized by a swelling of body tissues (including the throat) and a sudden decline in blood pressure. |
sf-2 | A strain of HIV used in vaccine development. |
translucent | so clear that light may pass through |
plasma | That 10 percent of the blood that contains nutrients, electrolytes (dissolved salts), gases, albumin, clotting factors, wastes and hormones. |
blind or blinded trial | A trial in which the participant is not informed as to what arm (experimental or control) of the clinical trial he or she is on. |
antibiosis | An association between two organisms that is detrimental to the vital activities of one of them. |
mycotoxin | poisonous compound produced by a fungus |
spatial configuration | The shape of molecules |
pathogen | An agent (biotic or abiotic) that causes plant disease. |
comorbid | Disease or process that occurs simultaneously with another disease or process. |
expanded programme on immunization | Expanded Programme on Immunization (EPI) |
safety reports | FDA or other regulatory body reports required by investigator for any serious and unexpected adverse experience. |
tbw | Total Body Weight |
maa | Marketing Authorisation Application |
protoplasm | living contents of a cell |
long-term non-progressors | Individuals who are HIV-infected for seven or more years, have stable CD4+ T cell counts of 600 or more cells per cubic millimeter of blood, no HIV-related diseases and no previous antiretroviral therapy |
orphan drug | In Europe, orphan drug status is granted when the occurrence of the disease doesn’t exceed 5 patients per 10,000 inhabitants. |
t1/2u | Urinary half-life |
aids | See Acquired Immunodeficiency Syndrome. |
auc | Area Under the Curve |
lymphocyte | A white blood cell |
commensalism | Symbiosis in which neither organism is injured; one or neither may be benefited. |
minor non-compliance | Non-compliance that is neither serious nor continuing. |
de-identified information | De-identified health information neither identifies nor provides a reasonable basis to identify an individual |
clinical research associate | A person who is employed by a sponsor or contract research organization to monitor the progress of the clinical study at all participating sites |
randomization | A method based on chance by which study participants are assigned to different treatment groups. |
radiculopathy | Disease caused by compression, inflammation, and/or injury to a spinal nerve root in the low back |
lumbar vertebrae | The five vertebrae that make up your lower back |
enroll | Joining a clinical trial, after meeting all necessary criteria and signing the Informed Consent Form (see INCLUSION/EXCLUSION CRITERIA and INFORMED CONSENT DOCUMENT). |
benefit | A valued or desired outcome; an advantage. |
quality of life | A person’s physical, mental, and social well-being |
single-blind study | A study where one party, either the investigator or participant, is unaware of what medication the participant is taking. |
polygenic | A character controlled by many genes. |
focal length | The distance from the center of a lens to the point of focus of light from a distant object. |
hepatocyte | A liver cell. |
gamma camera | Stationary instrument that produces images of the thyroid gland after oral administration of radioactive materials. |
propagule | any part of an organism capable of independent growth |
control group | A control is the standard by which experimental observations are evaluated |
cro | See: Clinical Research Organization |
maximal stimulus | The stimulus strength that just yields the maximal response. |
competence | Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice |
prospective studies | Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied |
placebo controlled study | A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group |
preprandial | Before a meal. |
transformation | A process in which exogenous DNA is taken up by a (recipient) cell or protoplast, in which it may be incorporated into the chromosome (or, e.g., into a plasmid) by homologous recombination or converted into an autonomous replicon |
contract | An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds |
phase 2 drug trial | Phase 2 trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug |
significant risk device | An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject. |
tylosis | A balloon-like outgrowth from a xylem parenchyma cell that expands into and blocks the lumen of a xylem vessel or a tracheid. |
phase 2 trials | Research that tests the effectiveness and safety of a new drug |
nucleus | The center of an element made up of neutrons and protons. |
heterokaryon | cell with genetically different nuclei |
new drug application | Request for FDA approval to market a new drug. |
tissue culture | in vitro method of propagating healthy cells from plant tissues |
psychomotor epilepsy | Seizures characterized by stereotyped behavior often with emotional outbursts and partial responsiveness, syn |
polar | at one end or pole of the cell |
era | See Electronic Research Administration. |
v2 | Peripheral (extra-vascular) compartment |
grant compliance review | Evaluation by a grants management specialist to assess an institution's business and financial management systems to ensure that grantees follow grant regulations and policies. |
safety | The condition or state of being safe |
screening trials | Refers to trials which test the best way to detect certain diseases or health conditions. |
smallpox | Smallpox |
vision | The act of seeing; sight; sensations induced through photoreceptors. |
pharynx | The opening between the mouth and the esophagus (tube to the stomach). |
multi-nodular goitre | A goitre in which the enlargement consists of multiple lumps. |
golgi tendon organ | A receptor located at the muscle-tendon junction that signals developed tension in the muscle. |
brighton collaboration | Brighton Collaboration |
metabolism | The manner in which a drug is acted upon (taken up, converted to other substances, and excreted) by various organs of the body. |
primary afferent fiber | The first order fibers of a sensory system; those entering the dorsal roots of the spinal cord. |
fomite | An inanimate object that can harbor pathogenic microorganisms and thus serve as an agent of transmission of an infection. |
peritrichous | Of bacterial flagella: Distributed more or less uniformly over the cell surface. |
visual axis | A line perpendicular to a tangent to the cornea through the centers of the lens and the fovea. |
alexia | Inability to read. |
sponsor--investigator | An individual who both initiates and actually conducts, alone or with others, a clinical investigation |
treatment group | The group of participants who receive an experimental treatment. |
pi | Protease Inhibitor |
p24 | A protein in HIV's inner core |
cartilage | Tissue that cushions bones at joints and other locations |
standard of care | Treatment or medical management based on state-of-the-art health care (see STANDARD TREATMENT). |
breakthrough pain | Pain that occurs suddenly or as a result of a particular activity. |
saturation | Homogeneity or purity of wavelength of light. |
hemophilia | An inherited disease that prevents the normal clotting of blood. |
tremor at rest | An involuntary trembling which is suppressed or reduced when a movement is attempted. |
peripheral sensitization | Reduction in threshold and an increase in responsiveness of the peripheral ends of nociceptors |
motor end-plate | The specialized terminal of a motoneuron that forms a synaptic contact with the muscle membrane. |
guttation | exudation of watery, sticky liquid from hydathodes, especially along leaf margins |
valid | Of taxonomic names and epithets: Published in accordance with several articles of the Code of Nomenclature; such names may be legitimate or illegitimate. |
antiviral | A substance or process that destroys a virus or suppresses its replication. |
peer review | Evaluation of a research study by professional colleagues |
recruitment status | Indicates the current stage of a trial, whether it is planned, ongoing, or completed |
basidium | A cell in which karyogamy and meiosis take place and which bears exogenous spores of sexual origin |
fda | Food and Drug Administration; an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services. |
gamete | sex cell |
far point | The remotest point at which an object is clearly seen when the eye is at rest. |
system | 1) orderly, interconnected parts |
duct | A tube or passageway for secretions |
after-hypopolarization | A membrane potential more positive than the resting membrane potential that occurs following termination of the spike, syn |
lead researcher | See: Principal Investigator |
lymphoid interstitial pneumonitis | A form of pneumonia that involves the lower lobes (of the lungs) with extensive alveolar infiltration by mature lymphocytes, plasma cells and histiocytes |
direct light reflex | Constriction of the pupil when light is shown into the same eye. |
dna fingerprinting | A laboratory technique in which the banding patterns of DNA fragments from two different individuals are compared. |
prototroph | A strain of microorganism whose nutritional requirements do not exceed those of the corresponding wild-type strain. |
database | An organized compilation of information, usually maintained in a computer system. |
platelets | Cells that are produced in the bone marrow |
crada | See cooperative research and development agreement. |
exudate | Material that has passed from within a plant structure to the outer surface or into the surrounding medium; as in leaf exudate, root exudate, etc. |
protein carbonyl | The detection of protein=O groups which indicates oxidation damage to protein. |
seed | ripened ovule consisting of an embryo and stored food enclosed by a seed coat |
hormone response element | stretch of DNA that responds to an activated receptor complex. |
cell-mediated immunity | Cell-mediated immunity |
estrogen receptor beta | estrogen receptor that is the product of a separate gene from ER-alpha and distributed throughout the body with highest expression in prostate and ovaries. |
exclusion criteria | Rules of eligibility that exclude an individual from participation in a study. |
spontaneous reporting | Spontaneous reporting |
recruitment period | Time allowed to recruit all subjects for a study. |
physiological extensor muscle | Antigravity muscle. |
quality improvement | Periodic examination of organizational activities, policies, procedures and performance to identify best practices and target areas in need of improvement; includes implementation of corrective actions or policy changes where needed. |
pycnogenol | A pine bark extract with strong antioxidant properties |
in vitro | Latin for “in glass.” Usually refers to research in a laboratory, outside the body. |
thyroidectomy | Surgical removal of the thyroid gland. |
amniocentesis | The surgical insertion of a hollow needle through the abdominal wall and into the uterus of a pregnant female to obtain amniotic fluid (i.e., the serous fluid in which the embryo is suspended) especially to examine the fetal chromosomes for an abnormality or for the determination of the sex of the embryo |
seasonal breeder | an animal that produces offspring only during particular times of year. |
activational effect | 1) acute effect of hormone |
lenticel | a natural opening in the surface of a stem or tuber, fruit or root for gas exchange |
summary statement | NIAID can also bar an award for unacceptable inclusion of children, women, or minorities |
mr vaccine | MR vaccine |
blinding | A procedure in which one or more parties in a clinical trial are unaware of the treatment assignments in order to decrease biases and avoid the placebo effect |
sulfa drug | Any of a class of synthetic chemical substances derived from sulfanilamide and used to treat bacterial infections |
blinding | See MASKING (or Blinding). |
clinical investigator | A medical researcher, most often a medical doctor, responsible for carrying out a clinical research protocol (see PROTOCOL and PRINCIPAL INVESTIGATOR). |
all-or-none | Independence of action potential amplitude from stimulus strength; also refers to tendency of spikes to travel over the entire membrane of a cell, syn |
on-off response | The discharge of a neuron initiated both when a stimulus is turned on and when it is turned off with silence in between. |
spike | The all-or-none, conducted voltage response of a nerve or muscle membrane that is used to communicate information, syn |
intention tremor | An involuntary trembling which is heightened when a movement is attempted. |
translation | As related to HIV: The process by which HIV messenger RNA is processed in a cell's nucleus and transported to the cytoplasm, the cellular material outside the nucleus |
syndrome | Set of signs and symptoms that tend to occur together and which reflect the presence of a disease or an increased chance of developing a disease |
near point | The nearest point at which the eye can distinctly perceive an object. |
hyperpolarizing after-potential | A membrane potential more negative than the resting membrane potential that occurs following termination of the spike, syn |
photopic | Pertaining to vision in the light. |
critical period | the limited time frame in which an important development or action must occur (e.g., sexual differentiation). |
gwas | See genome-wide association study. |
quality assurance | The procedures and control systems established to ensure a study adheres to good clinical practice (GCP) guidelines and to ensure the protection of the trial participants. |
hyperalgesia | Excessive sensitivity to pain or enhanced intensity of pain sensation |
consent | A patient's oral and written agreement to participate in a clinical trial |
acupressure | Complementary medicine technique that uses pressure on certain points along the body to help with pain management. |
structure-activity relationship | The analysis of the relationship between the chemical structure of a compound and its biological or pharmacological activity |
blq | Below Limit of Quantification |
phase ii study | After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed. |
mitosis | A sequence of cellular events that culminates in the division of a eukaryotic nucleus into two genetically similar or identical nuclei whose ploidy is the same as that of the parent nucleus |
fibromyalgia | Characterized by chronic pain, stiffness, and tenderness of muscles, tendons, and joints all over the body without detectable inflammation |
flaccidity | Weakness, laxness, softness. |
temporal summation | Algebraic addition of generator potentials elicited by two stimuli applied at the same point in rapid succession. |
adenine | (= 6-aminopurine) |
double-blind trial | A clinical trial where neither the participant nor the investigator know which treatment the participant is receiving |
convergent eye movements | Refers to rotation of the eyes toward each other. |
off-response | The discharge of a neuron initiated when a stimulus is turned off. |
oocyte | Female germ cell. |
cder | Center for Drug Evaluation and Research; CDER is the department within FDA that regulates over-the-counter and prescription drugs, including certain biological therapeutics and generic drugs for human use. |
anti-inflammatory agent | Medication to reduce inflammation or irritation of body tissue |
systematics | the study of the kinds of organisms and the relationships between them |
crozier formation | Process of ascus development from coiled tips of ascigerous hyphae. |
time constant | The time over which the transmembrane voltage passively falls to 1/e of its initial value, abbr |
compound optimization | The process whereby a promising candidate drug molecule is systematically changed to improve its properties |
gamma motoneuron | A motoneuron whose axon is an Ag fiber, syn |
red muscle | Dark-red colored muscle tissue, composed of fibers rich in myoglobin; slow muscle fibers. |
acetylcholine | An acetic acid ester of choline, a transmitter substance at many peripheral nervous system synapses and perhaps some central synapses. |
genome | The complete set of genes in the chromosomes of each cell of a particular organism |
iavi | International AIDS Vaccine Initiative's mission is to ensure the development of preventive AIDS vaccines that are not only safe and effective, but also accessible to all people. |
informational translation | Informational translations are used where the original document remains the reference document, but translations of all or part of it will assist other parties in the review of documents |
antibiotic resistance | The ability of a bacterium to resist or overcome the effects of an antibiotic. |
endocrine glands | Glands that secrete hormones into the bloodstream. |
dua | See: Data Use Agreements |
signal | Sending information by active material or electrical impulse between body parts. |
broncho-alveolar lavage | A diagnostic test where fluid is taken from the bronchioles and alveoli part of the lungs. |
tetanus | Tetanus |
validate | To confirm or make true |
drug product | A finished dosage form (e.g |
qlq-c30 | Quality of Life Questionnaire-core 30 |
necrolysis | Shedding of surface components of tissue, such as cells from internal body surfaces, due to death of a portion of tissue. |
epidemic | A change in the amount of disease in a population in time and space |
symbiosis | A mutually beneficial association of two or more different kinds of organisms. |
clinical pharmacology | The science of drugs and their clinical use in man. |
toxicity | Degree of being poisonous to a living organism or person; ability to cause grave harm or death. |
phospholipase | Enzymes which metabolize phospholipids such as lecithin. |
avoidance | Principle of plant disease control marked by deliberate actions to take advantage of environmental factors and time unfavorable for disease development. |
hyperthyroidism | An abnormality of the thyroid gland in which secretion of thyroid hormone is usually increased and no longer under normal control |
amphid | In nematodes: A chemosensory organ, occurring laterally in pairs, located in the anterior region |
proliferation | A rapid and repeated production of new cells, tissues, or organs; specifically, a hyperplastic symptom of plant disease in which organs continue to develop after they have reached the point beyond which they normally do not grow. |
hertz | Cycles per sec, abbr |
zygote | A diploid cell resulting from the union of two gametes; a diploid nucleus resulting from the union of two haploid nuclei. |
adaxial | Directed toward the stem of a plant; pertaining to the upper surface of a leaf. |
negative feedback loop | A circuit in which part of the output is used to reduce the input to the circuit. |
incapacity | Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice |
efficacy | A product's ability to produce beneficial effects on the duration or course of a disease |
somaclonal variation | Variability in clones generated from a single mother plant, leaf, etc |
rna | See Ribonucleic Acid. |
short form consent process | This is an alternative method of obtaining and documenting consent, when a researcher occasionally and unexpectedly encounters a non-English-speaking subject in a study for which no consent form in the subject's language has been prepared and there is insufficient time and opportunity to obtain an appropriate written translation of the IRB-approved English version consent form |
poms index | A measurement of mood state based on numerous adjectives. |
radioactive iodine | Radioactive isotopes of iodine (131I or 123I) used in the diagnosis and treatment of some thyroid disorders |
impd | Investigational Medicinal Product Dossier is the basic document or set of documents required for the approval of clinical trials by the competent authorities in the EU. |
device | An instrument, apparatus, machine, implement or similar article designed for use in the diagnosis, treatment, prevention or cure of a disease or condition. |
medulla | Central part of an organ. |
satellite virus | A defective virus requiring a helper virus to provide functions necessary for replication |
informed consent | Go to 45 CFR 46.116 general requirements for informed consent and 21 CFR 50.20. |
translocation | Transfer of nutrients or virus through the plant. |
adrenaline | Adrenaline |
pk | Pharmacokinetic |
pregnancy | The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered) |
ahcpr | See Agency for Health Care Policy and Research. |
clinical study | A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes |
hybrid | The offspring of two individuals differing in one or more heritable characteristics. |
spike and dome complex | An EEG phenomenon: consisting of a rapid (15-18 msec) deflection with a return to baseline, followed by a much slower wave; a characteristic pattern, repeated frequently in epileptic cortex. |
intercrop | to grow two or more crops simultaneously on the same area of land |
visual field | The total extent of the visual world seen by one eye at rest. |
naturopathy | Treatment that avoids drugs and surgery and uses natural agents. |
cost sharing | See matching or cost sharing. |
outcome measure | A planned measurement described in the protocol that is used to determine the effect of interventions on participants in a clinical trial |
consultant | An individual whose expertise is required by the Principal Investigator to perform the research (A consultant may be a paid or unpaid contributor). |
habitat | A place with a particular kind of environment suitable for the growth of an organism. |
withdrawal application | Investigator/sponsor letter to FDA requesting application withdrawal when no additional work is envisioned. |
paraphysis | Sterile, elongated cell that may occur in the |
protocol | A study plan on which all clinical trials are based |
plasmodium | A multinucleated, usually naked (i.e., bounded only by a plasma membrane) mass of protoplasm that is usually motile and variable in size and form |
dsmp | See: Data Safety Monitoring Plan |
homonymous muscle | The muscle of origin of the nerve fibers being considered. |
plasmodium | A multinucleated, usually naked (i.e., bounded only by a plasma membrane) mass of protoplasm that is usually motile and variable in size and form. |
pre-clinical trials | Animal studies that provide safety data and information about an investigational product’s activities and effects |
meditation | Mental calmness and physical relaxation by suspending the stream of thoughts that normally occupy the mind |
sweat test | A test to diagnose CF |
parasexual cycle | A sequence involving heterokaryon formation, diploidization, and haploidization, often resulting in the formation of recombinant nuclei |
cc | NIH Warren Grant Magnuson Clinical Center |
btsh | Bovine (cow) thyroid-stimulating hormone. |
bitemporal hemianopsia | Hemianopsia or loss of vision involving the temporal visual fields of both eyes. |
nodal synapse | The junction between any part of a nerve cell and a node of Ranvier of a nerve fiber. |
controlled study | Controlled study |
endodermis | layer of cells within the root that separates the vascular tissue and the cortex |
reflex | A relatively stereotyped movement or response elicited by a stimulus applied to the periphery, transmitted to the central nervous system and then transmitted back out to the periphery. |
cmin | Minimum plasma concentration |
progressive-relapsing ms | Form of MS characterized by progressive disease from onset, with acute relapses, with or without full recovery |
coercion | The act or practice of coercing |
heterodimer | a structure consisting of unlike subunits. |
myosin | The protein of the thick myofilament, localized to the A band of the sarcomere. |
rickettsiae | Microorganisms similar to bacteria in most respects but generally capable of multiplying only inside living host cells; parasitic or symbiotic. |
trigger | Something that sets off a disease in people who are genetically predisposed to developing the disease or causes a certain symptom to occur in a person who has a disease. |
anesthesia | Loss of feeling or awareness |
certification | means the official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. |
expectorant | A drug that breaks up mucus and promotes the coughing reflex in order to expel the mucus |
pi/pil | Package Insert or Patient Information Leaflets are documents containing specific information about medical conditions, doses, side effects that are packed with medicines to give the user information about the product |
pharmacology | The scientific discipline that studies the action of drugs on living systems (animals or human beings). |
subject identification code | A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data. |
form genus | A non-phylogenetic category, equivalent to genus, distinguished on the basis of one or more morphological features |
phase iii study | The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients |
follow-up length servo mechanism | A process by which movements can be initiated indirectly by inputs to motoneurons rather than motoneurons. |
hcv | Hepatitis C Virus |
dendritic cells | Immune system cells with long, tentacle-like branches |
head | in plants, a type of inflorescence in which numerous small flowers are densely crowded on a disk or around a central stalk |
nontherapeutic research | Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future. |
far-sightedness | A pathological condition of refraction in which the eyeball is too short for the refractive power of the lens and images come to a focus behind the retina, syn |
benefit | A valued, favorable, or desired outcome. |
head | In nematodes: That portion anterior to the base of the stoma or stylet. |
aspergillus sp. | A family of fungi found worldwide that can opportunistically cause a disease of the respiratory tract called aspergillosis |
fungicide: | chemical or physical agent that kills or inhibits the growth of fungi |
therapeutic intent | The research physician's intent to provide some benefit to improving a subject's condition (e.g., prolongation of life, shrinkage of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected.) This term is sometimes associated with Phase 1 drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient's condition as well as assessing the safety and pharmacology of a drug. |
general anesthesia | The induction of a state of unconsciousness during a medical procedure through the administration of anesthetic drugs. |
competitive segment | Period of grant support, usually up to five years, before an applicant must recompete for funds |
closeout | See contract closeout or grant closeout. |
multi-unit smooth muscle | Smooth muscle containing few tight junctions, but richly innervated; responds as individual motor units, not as a single unit. |
contracts | Often used interchangeably with activity code. |
declaration of helsinki | A statement of ethical principles developed by the 18th World Medical Assembly, Helsinki, Finland, June 1964, to provide guidance to physicians who practice biomedical research involving human subjects |
lamina | expanded part of a leaf (see petiole) |
limited data sets | Protected Health Information (PHI) that excludes specific individual identifiers as described in HIPAA regulations |
withdrawal symptoms | Abnormal physical or psychological symptoms that occur after sudden drug withdrawal |
trigeminal nerve | The largest cranial nerves |
risk | The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study |
monitor | Person employed by the sponsor or CRO who verifies that a clinical study is being conducted in accordance with the protocol by assisting with the planning and initiation of a study and reviewing reports to assess the conduct of studies, among other duties |
cmvr | Cytomegalovirus retinitis |
transduction | the transfer of genes from one organism to another by viruses, especially in bacteria |
vaccine effectiveness | Vaccine effectiveness |
open label | Describes a clinical trial in which masking is not used |
experimental | Investigational, unproven. |
declaration of helsinki | A code of ethics for clinical research first approved by the World Medical Association in 1964 |
efficacy | The ability of a drug, test or treatment to relieve symptoms, detect or eliminate the disease. |
thyroglobulin | A large protein that acts as a storage site for thyroid hormones within the thyroid gland |
phagocyte | A cell that is able to ingest and destroy foreign matter, including bacteria. |
fetus | The product of conception from the time of implantation until delivery |
platelet | An irregularly shaped cell-like particle that is an important part of blood clotting. |
liposomes | A spherical particle in an aqueous (watery) medium (e.g., inside a cell) formed by a lipid bilayer enclosing an aqueous compartment |
drug sponsor | Person or entity responsible for marketing a new drug |
delta rhythms | EEG records characterized by high voltage waves occurring at less than 4/sec. |
empirical | Based on observation or experience, not experimental data. |
immunization | Immunization |
bronchospasm | A narrowing of the airway caused by contraction of smooth muscles in the bronchioles |
thyroid gland | A two-lobed gland lying at the base of the throat that produces hormones essential for a variety of metabolic processes in the body |
phase iiib study | Clinical trials conducted after regulatory submission of an NDA or other dossier, but prior to the medicine's approval and launch |
hud | See: humanitarian use device |
investigational device exemption | Exemption from FD & C Act to study investigational medical devices. |
hydrating | Add moisture. |
peroxide | An unstable compound with two oxygen atoms linked together. |
placebo controlled study | A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of patients, while the drug being tested is given to another group |
t1/2p | Bioloogical half-life of parent compound |
coenocyte | A multinucleate cell; a protoplast in which the nuclear divisions have not been followed by cytoplasmic cleavage. |
cro | see Contract Research Organization |
hypercomplex cells | Neurons in visual cortex that are sensitive to bars of light moving in particular directions across the retina and that require the bar to be less than a certain maximum length. |
root cap | a group of cells on a root that protects the growing tip |
troponin | A globular protein that is part of the thin filament of striated muscle. |
monoxenic culture | a culture containing one species of organism growing in the presence of one other species of organism |
dar | see Drug or Device Accountability Records |
lar | See: legally authorized representative |
post-licensure surveillance | Post-licensure surveillance (also known as post-marketing surveillance) |
nutrient | A substance providing nutrition and benefiting body processes. |
stilbene | 1) an aromatic hydrocarbon (C14 H12), produced by plants, often used as a phosphor and in making dyes |
giardia sp. | Flagellated protozoa that cause gastroenteritis in man (Giardia lamblia). |
nuclear chain fiber | an intrafusal muscle fiber with nuclei arranged in a line throughout its relatively uniform-diameter central region. |
isthmus | A small piece of thyroid tissue that connects the right and left lobes of the thyroid gland. |
full board review | When proposed research does not meet criteria to be reviewed by either exempt or expedited procedures, proposed research is reviewed at a convened meeting of the Institutional Review Board |
protein | a nitrogen-containing organic compound composed of units called amino acids |
standard treatment | The currently accepted treatment or intervention considered to be effective in the treatment of a specific disease or condition. |
gao | See Government Accountability Office. |
undifferentiated thyroid cancer | A form of thyroid cancer in which the cancer cells do not resemble thyroid cells |
dendrodendritic synapses | The synaptic junction between two dendrites. |
phytotoxic | harmful to plants (usually used to describe chemicals) |
shingles | An acute viral inflammation caused by reactivation of the herpes virus causing chicken pox |
multicenter study | A clinical trial involving patients at more than one site open-label study—a study in which all patients receive the experimental treatment. |
study endpoint | A primary or secondary outcome used to judge the effectiveness of a treatment. |
quiescence | That period of the prepenetration stage during which a pathogen may be inactive because environmental conditions are unfavorable for its growth. |
ethical approval | Research projects have to be reviewed for ethical approval in a number of areas: Is the trial worthwhile? Is it will organised? Is it safe for people taking part? Is it justified by the potential benefit? The approval decision is made by a committee of experts and non-experts who are not connected to the project |
investigator meeting | Meeting to provide training to investigators and other trial site staff on all aspects of a clinical study. |
inductance plethysmography | A machine to measure lung volume and lung health in people ages 6 years of age and older |
expression system | In HIV vaccine production, cells into which an HIV gene has been inserted to produce desired HIV proteins. |
incidence | Incidence |
laryngitis | Inflammation of the larynx |
patient-controlled analgesia | A way of giving pain medication that allows the patient to control when and how much medication they get depending on their need |
metaplasia | Changed condition of a structure or organ; hyperplastic class of symptoms characterized by overdevelopment other than that due to hypertrophy or hyperplasia |
recurrent miscarriage | integrity A systematic ethical goal that preserves the values of truth, accountability, equity and consistency. |
contraindicated | Used to describe when certain medicines or treatments should not be used. |
hyperalgesia | Extreme sensitivity to pain. |
mm | millimetre |
european medicines agency | A decentralised body of the European Union with headquarters in London |
pertussis vaccine | Pertussis vaccine |
abs | Abacavir |
idiq | See indefinite delivery indefinite quantity contract. |
fungicide | A chemical or physical agent that kills or inhibits the growth of fungi |
nucleoside analog | Nucleosides are related to nucleotides, the subunits of nucleic acids; however, they do not carry the phosphate groups of the nucleotides |
independent ethics committee | A specially constituted review body whose responsibility is to ensure the protection of the rights, welfare and safety of research participants |
broncho-alveolar fluid | Fluid found in the bronchiole and alveoli part of the lungs. |
rectification | In synapses: the property of allowing transmission through a pathway in only one direction; in membranes: a change in ionic conductance with a change in membrane potential. |
antibody | molecule in the body that combines with a foreign bacteria or virus to stop its activity or signal other molecules in the body to become active in fighting the foreign germ. |
alpha adrenergic effects | A constellation of effects produced by circulating norepinephrine or norepinephrine released from postganglionic sympathetic nerve terminals |
patient | An individual seeking medical care or who is under physician care for a condition or disease. |
assurance | is an agreement between an Organization and a federal agency that stipulates that the Organization will comply with the agency's regulatory requirements |
single project assurance | Permit given to institution for single grant in compliance with government standards |
sodium-potassium pump | Mechanism for extrusion of sodium and uptake of potassium by cells against the concentration gradients for these ions, syn |
latency | The time between application of a stimulus and appearance of a response. |
coccyx | The small tail-like bone at the bottom of the spinal column. |
recruitment status | The status of a trial, planned, ongoing, or completed |
sop | see Standard Operating Procedure |
treatment trials | Refers to trials that test new drugs, new combinations of drugs, or new approaches to standard medical treatments. |
athetosis | Basal ganglion disease characterized by slow, sinuous movements. |
baseline | The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested |
gametangium | A structure that contains gametes. |
nutraceutical | A food supplement with health benefits in addition to its nutritive value. |
congenital | A condition that is present at birth, whether or not it is inherited. |
synthetic vaccine | Synthetic vaccine |
sarcopenia | A decrease in muscle size and strength that occurs with aging, but exercise helps prevent it. |
standard treatment | A treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition. |
reciprocal innervation | Interconnections of neurons arranged so that pathways that excite one group of motoneurons inhibit the antagonist motoneurons and those that inhibit a group of motoneurons excite the antagonist motoneurons. |
agraphesthesia | Inability to recognize letters traced on the skin. |
necrosis | death of cells or tissue, usually accompanied by black or brown darkening |
receptor | In sensory system: a structure specialized to be sensitive to certain forms of energy; in synaptic transmission: the site of binding of a transmitter substances with postsynaptic membranes. |
phloem | Food-conducting tissue, consisting of sieve tubes, companion cells, phloem parenchyma, and fibers. |
periodontal | Relating to tissues and structures surrounding and supporting the teeth. |
hodgkin cycle | The regenerative sequence in which hypopolarization leads to increased conductance, leading to sodium ion influx and further hypopolarization. |
difference threshold | The smallest change in the magnitude or quality of a stimulus that can be detected by an observer. |
slam | Systemic Lupus Activity Measure |
herpes zoster | An acute inflammatory disease of the dorsal root ganglion caused by the virus of chickenpox and characterized by small vesicles occurring on the skin supplied by the affected nerve. |
controlled trials | Control is a standard against which experimental observations might be evaluated |
nucleoprotein | A compound of nucleic acid and protein. |
neutrophil | A white blood cell that destroys foreign bacteria in the body. |
para aminobenzoic acid | A B-Complex vitamin used to reduce free radicals. |
csr | See Center for Scientific Review. |
clinical trial | A type of research—also called interventional research—that follows certain government guidelines for testing the effect of drugs on people |
ide | Investigational Device Exemption |
deep tissues | Tissues including bone, muscle, tendons, joint capsules and fasciae |
toxic multinodular goitre | A thyroid gland that has multiple nodules functioning independently of the usual control mechanisms |
institution | The location of clinical research. |
validity | Validity |
new drug application | An application for a new drug submitted to the FDA to review and approve an experimental drug |
social experimentation | Systematic manipulation of, or experimentation in, social or economic systems; used in planning public policy. |
national pharmacovigilance centre | National pharmacovigilance centre |
application | Each opportunity has its own package, which includes forms called SF 424 R&R and PHS 398, and uses the instructions in an SF 424 Application Guide. |
nociceptor | A receptor whose adequate stimulus is strong enough to produce damage. |
vacuole | generally spherical organelle within a plant cell bound by a membrane and containing dissolved materials such as metabolic precursors, storage materials, or waste products |
polysynaptic reflex | A reflex involving more than one synapse in the central nervous system. |
bile | A bitter fluid produced by the liver and stored in the gallbladder |
safety profile | Safety profile |
hyperphagia | Ingestion of a greater than optimal quantity of food. |
laryngospasm | Closure of the glottis due to muscular contractions of the throat |
iia | See Individual Investigator Agreement. |
falling phase | The return of the membrane potential from the peak overshoot of the spike back to the resting potential, syn |
consent form | Document describing the risks, benefits, and study procedures so that potential subjects can make an informed decision whether or not to participate in the research. |
ema | European Medicines Agency |
capacitance | The ability of the nerve membrane to separate and store charge. |
nerve fiber | The straight, relatively unbranched process of a nerve cell, syn |
epidemic | A disease that spreads rapidly through a demographic segment of the human population, such as everyone in a given geographic area, a military base, or similar population unit, or everyone of a certain age or sex, such as the children or women of a region |
dual review | This refers to research that requires the review of more than one IRB, because the research engages more than one institution or organization |
antigen | Molecule of carbohydrate or protein which stimulates the production of an antibody, with which it reacts specifically. |
genome | The genetic information for an organism, consisting (in the case of viruses) of one or more species of either RNA or DNA, but not both. |
sponsor | Individual, company, institution or organization taking responsibility for initiation, management and financing of study. |
informed consent | means the knowing, legally effective consent of any individual or the individual's legally authorized representative |
mechanical inoculation | Of plant viruses, a method of experimentally transmitting the pathogen from plant to plant; juice from diseased plants is rubbed on test-plant leaves that usually have been dusted with carborundum or some other abrasive material. |
linear function or relation | The relationship between two variables such that the equal changes in one result in equal changes in the other; an equation of the form y = ax + b. |
central nervous system | Body system that includes the brain and spinal cord; your doctor may mention your CNS when talking about how pain occurs or the cause of your chronic pain. |
assent | NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects requires that children be included in clinical research barring a compelling rationale not to do so. |
tnm | A tumour staging system for classifying patients with thyroid cancer into groups based on tumour size (T), presence of lymph node metastases (N), and the presence of distant metastases (M) |
miscarriage | intermediate trophoblast See extravillous trophoblast. |
hypopolarization phase | The earliest positive-going portion of the nerve or muscle spike, syn |
nda | see New Drug Application |
fused tetanic contraction | A tetanic muscle contraction in which there is no trace of the individual twitches that have been summed. |
hav | Hepatitis A Virus. |
non- invasive procedure | A treatment that does not require an incision into the body or the removal of tissue. |
polyps | Swollen projecting masses of tissue-often tumorous. |
absolute refractory period | Time after an action potential during which the membrane cannot initiate another spike no matter how strong the stimulus. |
vss | volume of distribution at steady state |
susceptibility | The inability of a plant to resist the effect of a pathogen or other damaging factor. |
oral polio vaccine | Oral polio vaccine (OPV) |
axial | Belonging to, around, in the direction of, or along an axis. |
paternalism | Making decisions for others against or apart from their wishes with the intent of doing them good. |
cystic fibrosis | Hereditary disease characterized by excess mucus production in the respiratory and digestive tracts, and elsewhere in the body |
correlation coefficient | A statistical index of the degree of relationship between two variables |
postural fixation | Assumption of unusual body positions as in basal ganglion disease. |
protein | Proteins are a basic part of all living cells |
generator potential | A non-propagated change in the membrane potential of a receptor that leads to the generation of action potentials within the receptor itself, cf., receptor potential. |
human subjects research | Go to these resources: |
receptive field | The area of the periphery whose stimulation influence firing of a neuron. |
epidemic | Epidemic |
inflammation | Non specific immune response within tissues as result of injury or abnormal stimulation |
transcription | The process of constructing a messenger RNA molecule using a DNA molecule as a template with the resulting transfer of genetic information to the messenger RNA |
pathogen | Any disease-producing microorganism or material. |
advisory council | DAG also serves as an NIAID advisory board on research training issues. |
selective medium | a culture medium containing substances that specifically inhibit or prevent the growth of some species of microorganisms |
iacuc | See institutional animal care and use committee. |
hereditary | Traits or conditions, like eye color or CF, that are genetically passed from parents to their children (see GENE and GENETIC). |
pseudocoel | In nematodes: Body cavity containing a fluid in which the various internal organs are suspended. |
efficacy | A drug or treatment’s maximum ability to produce beneficial results regardless of dosage on the course or duration of a disease or condition. |
genome | The complete set of genetic information of an organism including DNA and RNA. |
symptom | A visible abnormality in a plant that results from disease. |
superantigen | Investigators have proposed that a molecule known as a superantigen, either made by HIV or an unrelated agent, may stimulate massive quantities of CD4+ T cells at once, rendering them highly susceptible to HIV infection and subsequent cell death |
phasmid | In nematodes: A pore-like structure located in the lateral field of the posterior region of nematodes belonging to the class Secernentea |
aidsdrugs | An online database service administered by the National Library of Medicine, with references to drugs undergoing testing against AIDS, AIDS-related complex and related opportunistic infections. |
thyroid scan | A picture of the thyroid gland obtained with a rectilinear scanner and radioactive materials. |
federal register | A weekly publication that identifies proposed and approved regulations. |
antiserum | The serum from a vertebrate that has been exposed to an antigen and which contains antibodies that react specifically with the antigen |
uppsala monitoring centre | Uppsala Monitoring Centre (UMC) |
intravenous | Putting a medicine right into a blood vessel, usually a vein, using a thin needle and a tube. |
renshaw inhibition | A form of collateral inhibition of motoneurons involving a special inhibitory interneuron, the Renshaw cell. |
cytoplasm | All of the substance of a cell other than the nucleus. |
sub-investigator | Helps design and conduct investigation at a study site. |
outcome measure | Measurement unit used to assess the effectiveness of a program or intervention, such as measures of disease activity, progression, or changes in MRI scans |
audit trail | Documentation of events that allows auditors to identify the original source of the data and track the path of changes made to the original documentation. |
electrophoresis | A procedure by means of which the members of a heterogenous population of charged particles can be separated by virtue of their dissimilar migration characteristics in an electric field. |
intervention difference | See analysis. |
resistance | The ability of an organism to defend itself, either from disease or from being harmed |
computed tomography | A three-dimensional image or picture of the body showing three measurements, such as height, width and depth |
inflationary factor | See escalation factor. |
sputum | Expectorated matter that is coughed out from the lungs |
cro | Contract Research Organization |
crozier | A recurved hook at the tip of an ascogenous hypha, the penultimate cell of which will become the |
emergence | growth of a seedling shoot through the soil surface |
complementary medicine | Treatment that falls outside the standard medical approaches |
hypertonia | A condition of excessive muscle tone; increased resistance to passive stretch. |
clamp connection | A recurving outgrowth of a cell that, at cell division, acts as a bridge to allow passage of one of the products of nuclear division into the penultimate cell, thereby assuring maintenance of the dikaryotic condition (of members of the Basidiomycotina). |
endocrine disruption | process by which an exogenous substance causes adverse health effects consequent to changes in endocrine function. |
vulnerable populations | Individuals who lack the capacity to provide informed consent or whose willingness to participate research may be subject to undue influence or coercion |
quadrantanopsia | Blindness in one quarter of the visual field. |
monoclonal antibody | Custom-made, identical antibody that recognizes only one epitope. |
placebo effect | A physical or emotional change, occurring after a treatment is administered that is not the result of the treatment |
advisory council | Investigators cannot apply for selective pay funding; rather, they are nominated by NIAID program officers |
ribosome | A cytoplasmic organelle composed of ribonucleic acid and protein that functions in the synthesis of protein |
investigational device exemption | Exemption from certain regulatory requirements that apply to commercially distributed medical devices in order to allow manufacturers to distribute devices that are intended solely for investigational use on human subjects |
human subjects research | See human subjects and research using human specimens or data. |
enzyme | A protein produced by cells to accelerate a specific chemical reaction without itself being altered |
award type | See activity code. |
assurance | A legally binding written document that requires a public or private institution to comply with applicable federal minimum standards for the protection of human subjects in research. |
pharmacology/toxicology | The science of drugs and poisonous materials (respectively) and their effects on the body |
contract proposal | See proposal. |
homologous | Similar in appearance or structure, but not necessarily function. |
hyporeflexia | Weakening of the reflexes. |
meta-analysis | the compilation and subsequent analysis of a large collection of individual studies for the purpose of integrating the findings |
iavi | International AIDS Vaccine Initiative |
randomization | Any of the many methods used to assign subjects to an experimental group or control group so that assignment is not influenced in any way by those making the assignments or by the researchers conducting the trial |
intervention | A vaccine (or drug or behavioral therapy) used in a clinical trial to improve health or alter the course of disease. |
toxoid | Toxoid |
dose-ranging study | A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful. |
hering-breuer reflex | The nervous mechanism that tends to limit inspiratory excursions, mediated by stretch receptors in the intercostal muscles whose activity leads to inhibition of inspiratory neurons in the brain stem. |
prevalence | The number of people in a given population affected with a particular disease or condition at a given time |
competence | A legal term denoting capacity to act on one's own behalf; the ability to understand information presented, to understand the consequences of acting (or not acting) on that information, and to make a choice |
private information | As defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). |
virus | An organism, smaller than bacteria, that causes infections like influenza, viral pneumonia, colds, and hepatitis (see BACTERIA and PNEUMONIA). |
ploidy | The number of (complete) sets of chromosomes in a cell. |
clinical trial | Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent’s safety and efficacy. |
affected community | This includes HIV-positive people, persons living with AIDS and other individuals, including their families, friends and advocates, directly impacted by HIV infection and its physical, psychological and sociological ramifications. |
pancreatic | Relating to the pancreas, a gland behind the stomach that secretes digestive enzymes. |
pharmacotherapy | Medication-based therapy. |
protocol amendment | A written description of changes to, or the formal clarification of, a protocol. |
hepatitis | Refers to “inflammation of the liver”, which can be caused by many things such as viruses, bacterial infections, trauma, adverse drug reactions, or alcoholism |
half-life | The time required for half the amount of a drug to be eliminated from the body. |
recent research | The NHRI normally uses research done in the last three years |
clinical study report | A Clinical Study Report (CSR) is a formal report that provides a comprehensive description of the design, methods and results of a clinical trial |
consent form | A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial |
esophagus | The tube that leads from the throat (pharynx) to the stomach. |
hypothesis | A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation. |
serum | The fluid fraction of coagulated (clotted) blood. |
i band | The isotropic or light band of striated muscle; contains only actin filaments. |
meniere's disease | Deafness, tinnitus, and vertigo resulting from accumulation of endolymph in the labyrinth. |
primary evoked potential | The change in potential recorded in a primary sensory cortical area following stimulation of the receptors associated with that area. |
oprr | See: Office for Protection from Research Risks. |
rank | Indicates the order in which studies appear in the Search Results list |
ethical | When a trial is in accordance with the rules/standards for right conduct or practice. |
synaptic cleft | Space between pre- and postsynaptic cells at a chemical synapse across which the transmitter substance must diffuse. |
nasopharyngitis | Inflammation of the nasal membrane and pharynx |
lignification | hardening of tissue through the deposition of lignin in the cell wall |
hgv | Genelabs scientists discovered the Hepatitis G virus |
saccade | An abrupt, rapid, small eye movement; usually occur in a series during scanning; also occurs as a part of nystagmus. |
hipaa | See: Health Insurance Portability & Accountability Act of 1996 |
competent authority | A national agency responsible under its national law for the control or regulation of a particular area, in this case pertaining to the control and regulation of clinical trials. |
mos | Medical Outcomes Study |
control | Economic reduction of crop losses caused by plant diseases. |
iec | see Independent Ethics Committee |
sorus | A cluster or mass of spores or sporangia |
spinal canal | The hollow passage through which the spinal cord runs. |
parthenogenesis | reproduction by the development of an unfertilized egg |
lupus | A Latin word that literally means "wolf." Lupus is also used to refer to a disease called Systemic Lupus Erythematosus (SLE), a serious, chronic autoimmune disease that often induces a facial rash that causes its sufferers to have a wolf-like appearance |
fdp | See Federal Demonstration Partnership. |
agnosia | Loss of the power to recognize the import of sensory stimuli. |
gene | A section of DNA that encodes a specific functional product (protein) |
threshold | Minimal stimulus required for a response or sensation. |
exotoxin | A toxic substance, made by bacteria, that is released outside the bacterial cell. |
chemotherapy | The use of chemical(s) (e.g., antibiotics or fungicides) for the treatment of a disease. |
oxidized | Reacted with an unstable oxygen containing compound. |
oap | Office of Antimicrobial Products, Center for Drug Evaluation and Research (CDER) |
cfr | Code of Federal Regulations |
advocacy and support groups | Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools. |
nda | See: New Drug Application. |
conventional | Following what is traditional or customary |
t4 | The primary hormone produced by the thyroid gland. |
fixed-price contracts | Go to FAR 49. |
placebo | An inactive substance designed to resemble the drug being tested |
confidentiality | The FDA and medical ethics require that the identities and medical information of all clinical trial participants be kept confidential |
monitoring | Activities to check patients' health status during a trial |
surfactant | A chemical that can reduce the surface tension of a liquid in which it is dissolved so that it spreads out more easily. |
autonomic nervous system | The part of the nervous system that controls the working of the heart muscle, the muscles of the digestive tract, the lungs and the glands. |
alkaline phosphatase | An enzyme that is normally present in certain cells within the liver, bone, kidney, intestine and placenta |
exclusion criteria | The standards as outlined in the protocol, used to determine whether a person may or may not be allowed to participate in a clinical trial |
cold nodule | A lump in the thyroid gland that does not take up iodine on a scan as well as the surrounding thyroid tissue does. |
lengthening reaction | Sudden release of tension of a spastic muscle that occurs near the maximum length as the muscle is gradually lengthened, syn |
stippling | series of small dots or speckles in which chlorophyll is absent |
orac | A method of measuring antioxidant capacities |
510 device | A medical device that is considered substantially equivalent to a device that was or is being legally marketed |
monocyte | A large white blood cell that ingests microbes or other cells and foreign particles |
auxotroph | A strain of microorganism lacking the ability to synthesize one or more essential growth factors. |
reproducible | To make a counterpart, image, or copy |
space constant | Distance along the membrane at which an imposed transmembrane voltage falls to l/e of its initial value, abbr |
surface assymetry index | A measurement of how round the surface of the eye is. |
pharmaceuticals | The Pharmaceutical Industry develops, produces, and markets drugs or pharmaceuticals licensed for use as medications |
sf 424 application guide | Applicants must NOT submit current and pending support with the application (using the attachment on the Research and Related Senior/Key Person Profile form from Grants.gov). |
bmi | A measurement comparing fat to muscle in the human body |
anti-tnfα | Anti-Tumor Necrosis Factor-alpha |
template | A gauge, pattern or mold used as a guide to the form of the piece being made |
esnap | Formerly used term |
microclimate | weather conditions on a small scale, e.g |
vaccine-preventable diseases | Vaccine-preventable diseases |
rna | A single-stranded molecule composed of chemical building blocks, similar to DNA |
convulsion | Convulsion |
tinnitus | A sensation of ringing, buzzing, roaring, clicking in the ears, not of external origin, in some cases audible to people other than the patient. |
sanitation | Principle of plant disease control involving removal and burning of infected plant parts and decontamination of tools, equipment, hands, etc. |
fasciation | malformation in shoots or floral organs manifested as enlargements and flattening as if several parts were fused |
pi | Principal Investigator |
dyscalculia | Impairment of ability to solve mathematical problems. |
davp | Division of Antiviral Drug Products, Office of Antimicrobial Products |
pcr | A highly sophisticated scientific method of detecting the presence of hepatitis B virus DNA or hepatitis C virus RNA in the blood |
measles vaccine | Measles vaccine |
karnofsky score | A subjective score between 0-100, assigned by a physician to describe a patient's ability to perform common tasks. |
transformation | A process in which exogenous DNA is taken up by a (recipient) cell or |
experimental drug | A drug that is not approved by the FDA for use in humans, or approved as a treatment for a particular indication. |
benefit | In the research context, something of positive value derived from research procedures |
post nasal drip | Flow of mucous from the back of the nasal passage, normally due to an infection or allergy. |
metabotropic transmission | Synaptic transmission in which the transmitter substance causes activation of a second messenger that causes the change in postsynaptic membrane potential. |
gout | Characterized by elevated levels of uric acid in the blood and produces lumps in and around joints |
adverse reaction | Unwanted side effect resulting from a drug or mixture of drugs |
phytomedicines | Medicines derived from plants. |
genetic screening | Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders. |
stroma | A compact mass of vegetative tissue, sometimes intermixed with host tissue, often bearing |
embryo | Organism in the early stages of development, the first six weeks in humans. |
astereognosis | Inability to recognize objects by feeling them. |
antiviral agent | A substance that has the capacity to stimulate cellular defenses against viruses |