Clinical Glossary

A band of scar-like tissue that forms between two surfaces inside the body, connecting tissues or organs which are not normally connected.

Glands that sit on top of each kidney and secrete stress hormones.

A condition in which your liver is scarred and permanently damaged. Scar tissue replaces healthy liver tissue and prevents your liver from working normally.

The use of more than one method and especially more than one drug to treat a disease.

The use of artificial methods or other techniques to prevent pregnancy as a result of sexual intercourse. The major forms of artificial contraception are barrier methods, of which the most common is the condom; the contraceptive pill, which contains synthetic sex hormones that prevent ovulation in the female; intrauterine devices, such as the coil, which prevent the fertilized ovum from implanting in the uterus; and male or female sterilization.

A group of people in a medical study who receive either no treatment or the standard treatment, which is compared against a group who receive the treatment being studied.

An anti-CD40L* antibody fragment with the Fc moiety substituted by polyethylene glycol.

*A protein that is primarily expressed on the surface of activated T cells and belongs to a member of the tumor necrosis factor superfamily. Lack of CD40L results in an inability to undergo immunoglobulin class switch and only class IgM antibodies can be generated.

Atopic dermatitis, also known as eczema, is a non-contagious inflammatory skin condition. It is a chronic disease characterized by dry, itchy skin that can weep clear fluid when scratched. People with eczema also may be particularly susceptible to bacterial, viral, and fungal skin infections.

A branch of medicine dealing with the skin, its structure, functions, and diseases.

A method of administering medication to avoid unnecessary exposure of patients to subtherapeutic doses of an agent (ie, to treat as many patients as possible within the therapeutic dose range) while preserving safety and maintaining rapid accrual.

Also known as the FDA approved Dupixent (dupilumab) injection for the treatment of adults with prurigo nodularis (PN). This is the first FDA-approved treatment for PN. Dupixent is FDA-approved for multiple indications, including treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. Dupixent comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen and is given as an injection under the skin.

Sold under the brand name Orilissa, is a gonadotropin-releasing hormone antagonist (GnRH antagonist) medication which is used in the treatment of pain associated with endometriosis in women.

The presence and growth of functioning endometrial* tissue in places other than the uterus that often results in severe pain and infertility.

*The mucous membrane lining the uterus.

A quantitative sensory testing tool designed to quantify vibratory and thermal sensation in the vagina and clitoris in a reproducible manner.

The use of a machine to remove wastes and impurities from the blood when the kidneys are not working properly.

Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted:

• 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. Immunogenicity is a central aspect of vaccine development.
• Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug-antibodies (ADAs), inactivating the therapeutic effects of the treatment and potentially inducing adverse effects.

Lower respiratory tract infection (LRTI) is a term often used as a synonym for pneumonia but can also be applied to other types of infection including lung abscess and acute bronchitis.

Those responsible with measuring, recording, and assessing changes in research participants do not know which of the participants have received treatment and which have received a placebo. Knowing which group the subject belongs to could bias the researcher’s observations.

A parallel study is a type of clinical study where two groups of treatments, A and B, are given so that one group receives only A while another group receives only B.

Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.

The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.

The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.

After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.

Phlebotomy is the process of making a puncture in a vein, usually in the arm, with a cannula for the purpose of drawing blood. The procedure itself is known as a venipuncture, which is also used for intravenous therapy. A person who performs a phlebotomy is called a phlebotomist, although most doctors, nurses, and other technicians can also carry out a phlebotomy.

Abbreviation for Principal Investigator. The PI is an individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project.

A false or inactive medication or treatment that may still offer relief despite being ineffective. In clinical trials, the effectiveness of a new drug is often tested against a placebo.

A way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a “placebo” treatment which is specifically designed to have no real effect.

An inherited disorder characterized by the formation of abnormal cysts in enlarged ovaries; a leading cause of female infertility and a common cause of hirsutism.

A feature of many clinical trials in which participants are randomly assigned to either a group to be tested or a control group.

Sold under the brand names Orgovyx and Relumina among others, is a gonadotropin-releasing hormone antagonist (GnRH receptor antagonist) medication which is used in the treatment of prostate cancer in men and uterine fibroids in women.

Respiratory syncytial (sin-SISH-uhl) virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious. Infants and older adults are more likely to develop severe RSV and need hospitalization.

A clinical study sponsor refers to an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study or trial. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.

An orally bioavailable, selective nonsteroidal antagonist of the corticotropin-releasing factor type-1 (CRF1; CRF-1) receptor, that can potentially be used to prevent excess androgen production in congenital adrenal hyperplasia (CAH).

An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. Unadjuvanted vaccines, therefore, have the lack of an ingredient that help create stronger immune response. In other words, adjuvants help vaccines work better. Some vaccines that are made from weakened or killed germs contain naturally occurring adjuvants and help the body produce a strong protective immune response. However, most vaccines developed today include just small components of germs, such as their proteins, rather than the entire virus or bacteria. Adjuvants help the body to produce an immune response strong enough to protect the person from the disease he or she is being vaccinated against. Adjuvanted vaccines can cause more local reactions (such as redness, swelling, and pain at the injection site) and more systemic reactions (such as fever, chills and body aches) than non-adjuvanted vaccines.

Vaginal photoplethysmography (VPG, VPP) is a technique using light to measure the amount of blood in the walls of the vagina. The device that is used is called a vaginal photometer.

Commonly known as the chickenpox vaccine. Chickenpox is a very contagious disease caused by the varicella-zoster virus (VZV). It causes a blister-like rash, itching, tiredness, and fever.