Clinical – Page 3

Phase I trial

Phase I study is the first stage of testing drugs in human subjects. They are designed to test the safety, side effects, best dose, and formulation method for the drug. Phase I trials are not randomized, and the drug is given to small group of 20-100 healthy volunteers.

Passive immunity

Protection against disease through antibodies produced by another human being or animal. Passive immunity is effective, but protection is generally limited and diminishes over time (usually a few weeks or months). For example, maternal antibodies are passed to the infant prior to birth and protect the baby for the first 4–6 months of life.

Mortality

The state of being human and not living forever.

Nucleoside Triphosphate (NTP)

A nucleoside containing a nitrogenous base bound to a 5-carbon sugar (either ribose or deoxyribose), with three phosphate groups bound to the sugar. They are the molecular precursors of both DNA and RNA, which are chains of nucleotides made through the processes of DNA replication and transcription.

Mortality rate

The number of deaths (in general, or due to a specific cause) in a particular population, scaled to the size of that population, per unit of time. Mortality rate is typically expressed in units of deaths per 1,000 individuals per year.

Nuisance parameter

A parameter that must be estimated, even though it is of no immediate interest. The most familiar example occurs in the construction of a confidence interval for an estimate of a population mean. The sample mean is the obvious estimate, but the population variance is a nuisance parameter that must also be estimated in order to determine the size of the interval.

mRNA Vaccine

A vaccine that uses mRNA to teach our cells how to make a protein—or even just a piece of a protein—that produces an immune response to a disease.

Nuremberg Code

A set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War.

Mucosa

The moist soft tissue that covers the inside surface of parts of the body such as the nose, mouth, lungs, and stomach and produces mucus to protect them.

Off Label

Use not listed on the label of FDA-approved medications.

Mucosal membranes

The soft, wet tissue that lines body openings, specifically the mouth, nose, rectum, and vagina.

Multiple Sclerosis (MS)

A disease of the central nervous system characterized by the destruction of the myelin sheath surrounding neurons, resulting in the formation of “plaques.” MS is a progressive and usually fluctuating disease with exacerbations (patients feeling worse) and remissions (patients feeling better) over many decades. In most patients, remissions eventually do not reach baseline levels and permanent disability and sometimes death occurs. The cause of MS is unknown. The most widely held hypothesis is that MS occurs in patients with a genetic susceptibility and that some environmental factors “trigger” exacerbations. MS is three times more common in women than men, with diagnosis usually made as young adults. See demyelinating disorders.

Multivalent vaccine

Vaccine designed to immunize against multiple antigens or microorganisms. When vaccine immunize against more than one antigen, we call them bivalent (two antigens), trivalent (three antigens), quadrivalent (four antigens) vaccine.

Mumps

Acute contagious viral illness caused by mumps virus, marked by swelling, especially of the parotid glands.

Myalgia

Medical term for muscle pain.

Necropsy

The examination of the body of an animal after its death.

Naïve polysaccharide

The polysaccharide that comprises the cell that is in its native or natural state and unaltered by denaturing agent, such as heat, chemical, enzyme action, or the exigencies of extraction.

Neuritis

Inflammation of the nerves.

Naïve protein

The protein inside the cell that is in its native or natural state and unaltered by denaturing agent, such as heat, chemical, enzyme action, or the exigencies of extraction.

Nomenclature

A system of naming organisms.

Monoclonal antibody

An antibody produced from a single cell lineage made by cloning a unique white blood cell.

Neutralization

The reduction in viral infectivity by binding the antibody to the surface of viral particles (virion), blocking the viral replication cycle.

Monoclonal Antibody Drug

Monoclonal antibody that has therapeutic effect by rending its target ineffective, inducing a specific cell signal, causing the immune system to attack specific cells, or bringing a drug to a specific cell type.

Neutralizing antibody

Antibodies that bind to cell-free virus and prevent it from infecting cells.

Monovalent vaccine

Vaccine designed to immunize against a single antigen or single microorganism. When vaccine immunize against more than one antigen, we call them bivalent (two antigens), trivalent (three antigens), quadrivalent (four antigens) vaccine.

Neutrophil

A type of white blood cell. It is the most abundant type of granulocytes and make up 40% to 70% of all white blood cells in humans. that plays an important role in acute inflammation. It migrates toward sites of infection or inflammation, through process called ‘chemotaxis’, and activate other immune cells by releasing cytokines. It is also capable of phagocytosis and degranulation of antimicrobial granules, playing key role as a part of innate immunity.

Morbidity

The condition of suffering from a disease or medical condition.

Newcastle Disease Virus (NDV)

A virus that causes Newcastle Disease, a viral avian disease affecting many domestic and wild bird species. Though it can infect humans, most cases are non-symptomatic and rarely it can cause a mild fever and influenza-like symptoms and/or conjunctivitis in humans. Strains of Newcastle disease virus have been used to create viral vector vaccine candidates against Ebola and Covid-19.

Morbidity rate

The proportion of a particular population found to be affected by a medical condition (typically a disease) at a specific time.

Nucleoside

Glycosylamines that can be thought of as nucleotides without a phosphate group. A nucleoside consists simply of a nucleobase and a five-carbon sugar.

Locus

A specific, fixed position on a chromosome where a particular gene or genetic marker is located.

Mass spectrometry

A method used by scientists to measure and compare the mass and the electrical charge of ions, thereby determining the elemental or isotopic signature of a sample, the masses of particles and of molecules, and elucidating the chemical identity or structure of molecules and other chemical compounds.

Lyophilization

A low temperature dehydration process, also known as freeze drying, that involves freezing the product and lowering pressure, thereby removing the ice by sublimation.

Mast cell

A type of white blood cell, that is high similar both in appearance and function to basophil. It is best known for their role in allergy and anaphylaxis, but is also plays an important protective role as in defense against pathogens.

Measles

A highly contagious, vaccine-preventable infectious disease caused by measles virus. Symptoms typically include fever, cough, runny nose, and inflamed eyes. A red, flat rash which usually starts on the face and then spreads to the rest of the body typically begins three to five days after the start of symptoms.

Mechanism of Action (MoA)

A pharmacological term commonly used when discussing medications or drugs.

Median tissue culture infectious dose (TCID50)

The dilution of a virus required to infect 50% of a given cell culture.

Memory cell

A group of cells that help the body defend itself against disease by remembering prior exposure to specific organisms such as viruses and bacteria. Consequently, these cells are able to respond quickly when these organisms repeatedly threaten the body.

Memory

The ability of the immune system to quickly and specifically recognize an antigen that the body has previously encountered and initiate a corresponding immune response.

Meningitis

Inflammation of the membrane covering the brain and spinal cord.

Meningococcus

A bacterium involved in some forms of meningitis and cerebrospinal infection.

Meningoencephalitis

Inflammation of the brain and meninges.

Metabolism

The chemical changes that take place in a cell or an organism. These changes make energy and the materials cells and organisms need to grow, reproduce, and stay healthy. Metabolism also helps get rid of toxic substances.

Messenger RNA (mRNA)

An RNA produced by transcription that carries the code for a particular protein from the nuclear DNA to a ribosome in the cytoplasm and acts as a template for the formation of that protein.

Microbes

Tiny organisms (including viruses and bacteria) that can be seen only with a microscope.

Microbiome

The microorganisms in a particular environment (including the body or a part of the body).

Microenvironments

(Biology) the cells, molecules, and structures (such as blood vessels) that surround and support other cells and tissues.

Microorganism

An organism of microscopic size, which may exist in its single-celled form or as a colony of cells.

Minimally Clinically Important Difference (MCID)

Smallest change in a treatment outcome that an individual patient would identify as important and which would indicate a change in the patient’s management.

MMR vaccine

A vaccine against measles, mumps, and rubella.

Live attenuated vaccine

A vaccine created by reducing the virulence of a pathogen, but still keeping it viable. Attenuation takes an infectious agent and alters it so that it becomes harmless or less virulent.

Lymphocytes

Small white blood cells that help the body defend itself against infection.

Macrophage

A large white cell that is highly specialized in removal of dying or dead cells and cellular debris via phagocytosis. It is also one of antigen presenting cells, meaning they can present peptides from phagocytosed antigens on their cell surface for activation of T helper cells.

Macule

Non-raised skin lesions, normally red-colored.

Malaria

A mosquito-borne infectious disease caused by single-celled microorganisms of the Plasmodium group. Symptoms typically include fever, fatigue, vomiting, and headaches. In severe cases, it can cause jaundice, seizures, coma, or death.

Investigational Device

Device that is subject of a clinical study designed to evaluate the effectiveness and/or safety of the device.

Investigational Product

Preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic, or palliative used in a clinical trial.

Isotype switching

A biological mechanism that changes a B cell’s production of immunoglobulin from one type to another, such as from the isotype IgM to the isotype IgG.

Kinetics

The rate of change in a biochemical (or other) reaction.

Knock-out

A widely used genetic engineering technique that involves the targeted removal or inactivation of a specific gene within an organism’s genome.

Large biologics

Large-sized biologics, such as antibodies that are typically composed of 5000 to 50,000 atoms.

Lesion

An abnormal change in the structure of an organ due to injury or disease.

Lethal Dose 50 (LD50)

Dose of a medication that kills 50% of the population that has been administered that dose.

Linearization

A mathematical process of finding the linear approximation to a function at a given point.

Lipid Nanoparticles

Nanoparticles composed of lipids. They are a novel pharmaceutical drug delivery system, and a novel pharmaceutical formulation.

Liposome

A minute spherical sac of phospholipid molecules enclosing a water droplet, especially as formed artificially to carry drugs or other substances into the tissues.

Interaction (Qualitative & Quantitative)

Situations where the difference in treatment effects is influenced by factors other than the drug under study. For example, it describes situations where the difference in treatment effects between the treatment group and the control group varies depending on each center.

Internal pilot study

A phase in a trial after which progress is assessed against pre-specified targets. It gives an opportunity to stop trials which are not likely to reach their targets by estimating nuisance parameters.

Jaundice

Yellowing of the skin and eyes. This condition is often a symptom of hepatitis infection and hemolysis.

Intramuscular injection (IM)

A technique used to deliver a medication deep into the muscles.

Laminar flow

The property of fluid particles in fluid dynamics to follow smooth paths in layers, with each layer moving smoothly past the adjacent layers with little or no mixing.

Intussusception

A type of bowel blockage that happens when one portion of the bowel slides into the adjacent one, much like the pieces of a telescope; it is treated in a hospital and may require surgery.

Immunity

Protection against a disease. There are two types of immunity, passive and active. Immunity is indicated by the presence of antibodies or other components in the blood and can usually be determined with a laboratory test. See active and passive immunity.

Included Terms

The lowest-level term used to code various different terms researchers use to describe drug side effects.

Immunization

The process of being made immune or resistant to an infectious disease, typically by the administration of a vaccine. It implies that a vaccine will trigger an immune response.

Incubation period

The time from contact with an infectious agent to onset of disease.

Immunogenicity

Ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. Wanted immunogenicity typically relates to vaccines, where the injection of an antigen (the vaccine) provokes an immune response against the pathogen, protecting the organism from future exposure.

Indication

A condition which makes a particular treatment or procedure advisable.

Immunoglobulin

Substances made by the immune system that attack foreign substances. Also known as antibodies.

Indirect protection / Herd protection

A form of indirect protection which occurs when a sufficient percentage of a population has become immune to an infection, whether through previous infections or vaccination, thereby reducing the likelihood of infection for individuals who lack immunity.

Immunosenescence

Gradual deterioration of the immune system, brought on by natural age advancement.

Infectious

Capable of spreading from one person to another or from one living being to another, communicable.

Immunostaining

The process of identifying proteins in tissue sections by incubating the sample with antibodies specific to the protein of interest, then visualizing the bound antibody using a chromogen (immunohistochemistry or IHC) or fluorescence (immunofluorescence or IF).

Infectious titer

The number of virus particles capable to invade a host cell.

Immunosuppression

A condition in which the immune system is unable to protect the body from disease. This condition can be caused by diseases such as HIV infection or cancer or by certain drugs, such as steroids or those used in chemotherapy. Individuals whose immune systems are compromised should not receive live, attenuated vaccines.

Inflammation

Living organism response, including redness, swelling, heat, and pain, resulting from injury, usually infectious, to tissue.

Immunotoxicity

Adverse effects on the functioning of the immune system that result from exposure to chemical substances.

Inflammatory Bowel Disease (IBD)

A general term for a constellation of symptoms associated with inflammation of the bowel. Examples include ulcerative colitis and Crohn’s disease. Symptoms include abdominal pain, diarrhea, fever, loss of appetite, and weight loss.

Impartial Witness

A person who is independent of the trial and cannot be unduly influenced by the people involved with the trial and who attends the informed consent process if the participant or the participant’s LAR cannot read and who reads the ICF and any other written information supplied to the participant.

Influenza

A contagious with epidemic potential viral disease caused by Influenza virus, characterized by fever, prostration, muscular aches and pains, and inflammation of the respiratory tract.

In Vitro

Outside the body.

Injection

The act of putting a liquid, especially a drug, into a person’s body using a needle and a syringe.

In Vitro Diagnostic Product

A reagent used to detect or measure substances in a sample derived from the human body in order to determine the presence of disease or infection.

Innate immunity

A type of immunity that is present at birth and lasts a person’s entire life. It enables the body’s rapid, nonspecific response to bacteria or virus. Anatomical barriers such as skin, acute inflammatory reaction initiated by macrophages and mast cells, complement system comprises the innate immunity in human.

Terminology Category: Clinical