The American College of Rheumatology has the following list of symptoms and other measures that doctors can use as a guide to decide if a patient with symptoms has lupus.
If your doctor suspects you have lupus based on your symptoms, a series of blood tests will be done in order to confirm the diagnosis. The most important blood screening test is ANA. If ANA is negative, you don’t have lupus. However, if ANA is positive, you might have lupus and will need more specific tests. These blood tests include antibodies to anti-dsDNA and anti-Sm, which are specific to the diagnosis of lupus.
Source: Rheumatology.org
The clinical study is ongoing (that is, participants are receiving an intervention or being examined), but potential participants are not currently being recruited or enrolled.
Source: ClinicalTrials.gov
Acute cutaneous LE typically presents in the third decade of life and is frequently associated with active SLE. There are localized and generalized forms of ACLE. The localized form is the frequently described malar, or “butterfly” rash, which refers to erythema that occurs over both cheeks, extends over the nasal bridge, and spares the nasolabial folds. These lesions are classically transient, sun-induced, and non-scarring, although dyspigmentation can occur. Patients may initially mistake this rash for a sunburn, and only seek medical attention when it persists for several days. A fine surface scale and/or edema may be associated with the erythema. Malar rashes have been reported to be present in up to 52% of SLE patients at the time of diagnosis, with clinical activity of the rash paralleling that of the systemic disease. This rash can be confused with acne rosacea and seborrheic dermatitis, however the former is associated with the formation of papules and pustules, and the latter occurs within the nasolabial folds.
Source: NIH.gov
Any of the plasma proteins whose concentration increases or decreases by at least 25% during inflammation. Acute-phase proteins include C-reactive protein, several complement and coagulation factors, transport proteins, amyloid, and antiprotease enzymes. They help mediate both positive and negative effects of acute and chronic inflammation, including chemotaxis, phagocytosis, protection against oxygen radicals, and tissue repair. In clinical medicine the erythrocyte sedimentation rate or serum C-reactive protein level sometimes is used as a marker of increased amounts of acute-phase proteins.
The AIDS Drug Assistance Program (ADAP) provides free medications for the treatment of HIV/AIDS and opportunistic infections. The drugs provided through ADAP can help people with HIV/AIDS to live longer and treat the symptoms of HIV infection. ADAP can help people with partial insurance or who have a Medicaid spenddown requirement.
Source: Health.NY.gov
An intracellular molecule that undergoes structural and functional changes in response to binding of cell membrane receptors by ligands. Adapter proteins participate in the immune response by acting as a bridge for enzymes in the signaling pathway needed to activate lymphocytes and initiate a response to an antigen.
Adhesions are bands of scar-like tissue that form between two surfaces inside the body and cause them to stick together. As the body moves, tissues or organs inside are normally able to shift around each other. This is because these tissues have slippery surfaces.
Source: NIH.gov
The adrenal glands are small glands located on top of each kidney. They produce hormones that you can’t live without, including sex hormones and cortisol. Cortisol helps you respond to stress and has many other important functions.
Source: NIH.gov
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study is over. This may or may not be caused by the intervention being studied.
Source: ClinicalTrials.gov
Aggrecan is a type of protein known as a proteoglycan, which means it has several sugar molecules attached to it. It is the most abundant proteoglycan in cartilage, a tough, flexible tissue that makes up much of the skeleton during early development. Most cartilage is later converted to bone (a process called ossification), except for the cartilage that continues to cover and protect the ends of bones and is present in the nose, airways, and external ears. Aggrecan attaches to the other components of cartilage, organizing the network of molecules that gives cartilage its strength. These interactions occur at a specific region of the aggrecan protein called the C-type lectin domain (CLD). Because of the attached sugars, aggrecan attracts water molecules and gives cartilage its gel-like structure. This feature enables the cartilage to resist compression, protecting bones and joints. Although its role is unclear, aggrecan affects bone development.
Source: NIH.gov
Albumin is the main protein in blood plasma. Low levels occur in conditions associated with malnutrition, inflammation and liver and kidney diseases.
Source: Cancer.gov
A clinical trial design strategy used to assign participants to an arm of a study. Types of Allocation include Randomized, and Nonrandomized.
Source: ClinicalTrials.gov
Partial or complete loss of hair is called alopecia. It can be hereditary, stress-induced, or caused by autoimmune conditions, such as lupus. Other causes of hair loss, especially if it is in an unusual pattern, include:
Source: NIH.gov
The Accelerating Medicines Partnership (AMP) is a bold new venture between the NIH, 10 biopharmaceutical companies and several non-profit organizations to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets of disease. The ultimate goal is to increase the number of new diagnostics and therapies for patients and reduce the time and cost of developing them.
AMP will begin with three to five year pilot projects in three disease areas:
Source: NIH.gov
Analgesics, or pain relievers, are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.
Source: NIH.gov
Anemia is a condition in which the body does not have enough healthy red blood cells. Red blood cells provide oxygen to body tissues. Possible causes of anemia include:
Source: NIH.gov
Angiogenesis is the growth of blood vessels from the existing vasculature. It occurs throughout life in both health and disease, beginning in utero and continuing on through old age. No metabolically active tissue in the body is more than a few hundred micrometers from a blood capillary, which is formed by the process of angiogenesis. Capillaries are needed in all tissues for diffusion exchange of nutrients and metabolites. Changes in metabolic activity lead to proportional changes in angiogenesis and, hence, proportional changes in capillarity. Oxygen plays a pivotal role in this regulation. Hemodynamic factors are critical for survival of vascular networks and for structural adaptations of vessel walls.
Source: NIH.gov
The study of anatomy, physiology, or pathology in laboratory animals in order to apply the results to human function and disease.
Inflammation of one or more vertebrae.
Autoantibodies directed against various nuclear antigens including DAutoantibodies directed against various nuclear antigens including DNA, RNA, histones, acidic nuclear proteins, or complexes of these molecular elements. Antinuclear antibodies are found in systemic autoimmune diseases including systemic lupus erythematosus, Sjogren’s syndrome, scleroderma, polymyositis, and mixed connective tissue disease. Autoantibodies directed against various nuclear antigens including DNA, RNA, histones, acidic nuclear proteins, or complexes of these molecular elements. Antinuclear antibodies are found in systemic autoimmune diseases including systemic lupus erythematosus, Sjogren’s syndrome, scleroderma, polymyositis, and mixed connective tissue disease.
Source: NIH.gov
Antinuclear antibodies that seem to be specific to Sjögren’s Syndrome. Their presence is associated with long disease duration, earlier disease onset, parotid gland enlargement, systemic manifestations and also with hypergammaglobulinemia, rheumatoid factors and monoclonal type II cryoglobulins.
Source: PubMed.gov
A protein produced by the immune system in response to a foreign substance such as a virus or bacterium.
Source: NIH.gov
An autoantibody against the cell membrane lipid, diphosphatidyl glycerol. It produces abnormal and sometimes life-threatening blood clotting. The antibody is found in a variety of autoimmune and infectious diseases, including in patients with the antiphospholipid antibody syndrome and syphilis.
A foreign substance that triggers the production of antibodies when it is introduced into the body.
Source: NIH.gov
The mechanism by which foreign antigens are taken into antigen-presenting cells (APCs) and broken up. Part of the antigen is then displayed (presented) on the surface of the APC next to a histocompatibility or self-antigen, activating T lymphocytes and cell-mediated immunity. T lymphocytes are unable to recognize or respond to most antigens without APC assistance.
The mechanism by which foreign antigens are taken into antigen-presenting cells (APCs) and broken up. Part of the antigen is then displayed (presented) on the surface of the APC next to a histocompatibility or self-antigen, activating T lymphocytes and cell-mediated immunity. T lymphocytes are unable to recognize or respond to most antigens without APC assistance.
Antimalarials are another type of drug commonly used to treat lupus. These drugs prevent and treat malaria, but doctors have found that they also are useful for lupus. A common antimalarial used to treat lupus is hydroxychloroquine. It may be used alone or in combination with other drugs and generally is used to treat fatigue, joint pain, skin rashes, and inflammation of the lungs. Clinical studies have found that continuous treatment with antimalarials may prevent flares from recurring.
Source: NIAMS.NIH.gov
Any of a group of autoantibodies that react against normal components of the cell nucleus. They are present in several immunologic diseases, including systemic lupus erythematosus, progressive systemic sclerosis, Sjögren syndrome, scleroderma, polymyositis, and dermatomyositis, and in some patients taking hydralazine, procainamide, or isoniazid. In addition, ANA is present in some normal people. Tests for ANAs are used in the diagnosis and management of autoimmune diseases.
Antioxidant defenses are compounds that inhibit oxidation—oxidation that can trigger the production of free radicals. Free radical activity can cause irreparable damage to the cells of organisms.
Antioxidants are intimately involved in the prevention of cellular damage — the common pathway for cancer, aging, and a variety of diseases like lupus.
Any of a group of immunoglobulin autoantibodies that react with phospholipids, which are one of the primary components of the cell membrane (the other components are glycolipids and steroids). These antibodies are found in patients with a variety of connective tissue and infectious disorders, including systemic lupus erythematosus, the antiphospholipid antibody syndrome, syphilis, and malaria. They cause abnormal blood clotting, thrombocytopenia; and in women of childbearing age, repeated miscarriages. The anticardiolipin antibodies are one type of antiphospholipid antibody.
Antiphospholipid syndrome (APS) is an autoimmune disease in which the body makes abnormal proteins in the blood called antiphospholipid autoantibodies that attack phospholipids (or fat) found in the outer wall of cells. This causes the damaged cells to stick to each other and become clots that can block critical blood flow in blood vessels.
Source: NIH.gov
Programmed cell death, a normal process in which cells die in a controlled and predictable way.
Source: NIH.gov
A group or subgroup of participants in a clinical trial who receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.
Source: ClinicalTrials.gov
Pain in the joint.
Source: NIH.gov
Arthritis is inflammation of one or more joints and it involves the breakdown of cartilage. Cartilage normally protects a joint, allowing it to move smoothly. Cartilage also absorbs shock when pressure is placed on the joint, such as when you walk. Without the normal amount of cartilage, the bones rub together, causing pain, swelling (inflammation), and stiffness. Usually the joint inflammation goes away after the cause goes away or is treated. Sometimes it does not. When this happens, you have chronic arthritis. Arthritis may occur in men or women. Osteoarthritis is the most common type.
Source: NIH.gov
Surgery to reshape, reconstruct, or replace a diseased or damaged joint. This may be done to alleviate pain, to permit normal function, or to correct a developmental, accidental, or hereditary joint defect.
Articular cartilage is the highly specialized connective tissue of diarthrodial joints. Its principal function is to provide a smooth, lubricated surface for articulation and to facilitate the transmission of loads with a low frictional coefficient. Articular cartilage is devoid of blood vessels, lymphatics, and nerves and is subject to a harsh biomechanical environment. Most important, articular cartilage has a limited capacity for intrinsic healing and repair. In this regard, the preservation and health of articular cartilage are paramount to joint health.
Source: NIH.gov
Aseptic meningitis is a disease caused by the inflammation of the protective membranes covering the brain and spinal cord known as the meninges. Unlike other forms of meningitis, aseptic meningitis is not caused by infection and cannot be spread person-to-person. Instead it can be caused by lupus, cancers, certain drugs, head injury, and brain surgery, among others. Meningitis is characterized by a sudden onset of fever, headache, and stiff neck. It is often accompanied by other symptoms, such as nausea, vomiting, photophobia (sensitivity to light), and altered mental status (confusion).
Source: CDC.gov
A procedure in which blood is collected, part of the blood such as platelets or white blood cells is taken out, and the rest of the blood is returned to the donor.
Source: Cancer.gov
Atherosclerosis is when fats and cholesterol (plaque) builds up along the inside wall lining your arteries. Arteries are blood vessels that carry oxygen-rich blood to your heart and other parts of your body.
Plaque is made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, plaque hardens and narrows your arteries. This limits the flow of oxygen-rich blood to your organs and other parts of your body.
Atherosclerosis can lead to serious problems, including heart attack, stroke, or even death.
Source: NIH.gov
An antibody, produced by B cells in response to an altered autoantigen on one type of the body’s own cells, that attacks and destroys these cells. Autoantibodies are the basis for autoimmune diseases such as rheumatoid arthritis and diabetes mellitus. Several theories exist about why autoantibodies are formed. The most common theory proposes that AAbs develop as the result of a combination of hereditary and environmental risk factors that cause an autoantigen to be falsely recognized as alien by B cells; as a result, antibodies are produced for its destruction.
Disease that results when the immune system mistakenly attacks the body’s own tissues. Examples include multiple sclerosis, type 1 diabetes, rheumatoid arthritis, and systemic lupus erythematosus. Autoimmune diseases can affect almost any part of the body, including the heart, brain, nerves, muscles, skin, eyes, joints, lungs, kidneys, glands, the digestive tract, and blood vessels. The classic sign of an autoimmune disease is inflammation, which can cause redness, heat, pain, and swelling.
How an autoimmune disease affects you depends on what part of the body is targeted. If the disease affects the joints, as in rheumatoid arthritis, you might have joint pain, stiffness, and loss of function. If it affects the thyroid, as in Graves’ disease and thyroiditis, it might cause tiredness, weight gain, and muscle aches. If it attacks the skin, as it does in scleroderma/systemic sclerosis, vitiligo, and systemic lupus erythematosus (SLE), it can cause rashes, blisters, and color changes.
Many autoimmune diseases don’t restrict themselves to one part of the body. For example, SLE can affect the skin, joints, kidneys, heart, nerves, blood vessels, and more. Type 1 diabetes can affect your glands, eyes, kidneys, muscles, and more.
Source: NIH.gov
The body’s tolerance of the antigens present on its own cells, i.e., autoantigens or self-antigens. It is theorized that autoreactive T lymphocytes are destroyed in the thymus by negative selection or in peripheral blood. Autoreactive T cells that escape destruction in the thymus may become tolerant because they are exposed to thousands of autoantigens as they circulate in the blood.
The loss of self-tolerance is believed to be due to many hereditary and environmental factors and occurs when autoantigens are damaged, when they link with a foreign antigen, when the structure of a autoantigen is very similar to that of a foreign antigen (molecular mimicry), or when autoreactive T cells are not adequately controlled or are activated by nonspecific antigens. The changes in the appearance of the autoantigen or activation of autoreactive T-cells result in autoantigens being perceived as foreign. Inflammation and destruction of the tissues bearing the antigen occur because of the production of autoantibodies by B cells or the cytotoxicity of autoreactive T cells, which attack the autoantigens.
B cells are essential for the development and pathogenesis of both systemic and organ-specific autoimmune diseases. Autoreactive B cells are typically thought of as sources of autoantibody, but their most important pathogenetic roles may be to present autoantigens to T cells and to secrete proinflammatory cytokines. A rate-limiting step in the genesis of autoimmunity then is the activation of autoreactive B cells. Here, mechanisms are discussed that normally prevent such activation and how they break down during disease. Integrating classic work with recent insights, emphasis is placed on efforts to pinpoint the precursor cells for autoantibody-secreting cells and the unique stimuli and pathways by which they are activated.
Source: NIH.gov
A type of white blood cell that makes antibodies. B lymphocytes are part of the immune system and develop from stem cells in the bone marrow.
Source: NIH.gov
A one-celled organism without a true nucleus or cell organelles, belonging to the kingdom Procaryotae (Monera). The cytoplasm is surrounded by a rigid cell wall composed of carbohydrates and other chemicals that provide the basis for the Gram stain. Some bacteria produce a polysaccharide or polypeptide capsule, which inhibits phagocytosis by white blood cells. Bacteria synthesize DNA, RNA, and proteins, and they can reproduce independently but may need a host to provide food and a favorable environment. Millions of nonpathogenic bacteria live on human skin and mucous membranes; these are called normal flora. Bacteria that cause disease are called pathogens.
Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and gender, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
Source: ClinicalTrials.gov
In 2011, the FDA approved belimumab (Benlysta®), a B-lymphocyte stimulator (BLyS) protein inhibitor, for adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapies. Given by IV infusion, belimumab may reduce the number of abnormal B cells thought to be a problem in lupus.
In July 2017, belimumab (Benlysta®), was approved by U.S. Food and Drug Administration as a self-injectable (subcutaneous) formulation for people with systemic lupus erythematosus being treated with standard therapy. The new formulation allows patients to administer the drug to themselves as a once-weekly injection.
Source: FDA.gov
A biological pathway is a series of actions among molecules in a cell that leads to a certain product or a change in a cell. Such a pathway can trigger the assembly of new molecules, such as a fat or protein. Pathways can also turn genes on and off, or spur a cell to move.
Source: NIH.gov
A biopsy is a procedure that removes a small piece of living tissue from your body. The tissue is examined with a microscope for signs of damage or disease. Biopsies can be done on all parts of the body. A biopsy is the only test that can tell for sure if a suspicious area is cancer. But biopsies are performed for many other reasons too. There are different ways to do a biopsy. A needle biopsy removes tissue with a needle passed through your skin to the site of the problem. Other kinds of biopsies require surgery.
Source: NIH.gov
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.
Source: ClinicalTrials.gov
Blood tests help doctors check for certain diseases and conditions. They also help check the function of your organs and show how well treatments are working.
Source: NIH.gov
Nitrogen in the blood in the form of urea, the metabolic product of the breakdown of amino acids used for energy production. The normal concentration is about 8 to 18 mg/dL. The level of urea in the blood provides a rough estimate of kidney function. Blood urea nitrogen levels may be increased in the presence of dehydration, decreased renal function, upper gastrointestinal bleeding, or treatment with drugs such as steroids or tetracyclines.
Belimumab, a type of agent referred to as a B-lymphocyte stimulator (BLyS) protein inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in March 2011 for patients with lupus who are receiving other standard therapies, including those listed above. Given by IV infusion, belimumab may reduce the number of abnormal B cells thought to be a problem in lupus.
In studies conducted so far, African American patients and patients of African heritage did not appear to respond significantly to belimumab. An additional study of this patient population is planned to evaluate belimumab further in this subgroup of lupus patients. However, this difference in response to a treatment may be another indicator of the various ways that the disease affects different patients.
Because some treatments may cause harmful side effects, it is important to report any new symptoms to the doctor promptly. It is also important not to stop or change treatments without talking to the doctor first. In addition to medications for lupus itself, in many cases it may be necessary to take additional medications to treat problems related to lupus such as high cholesterol, high blood pressure, or infection.
Source: NIAMS.NIH.gov
Bullous systemic lupus erythematosus (BSLE) is an autoantibody-mediated disease with subepidermal blisters. It is a rare form of presentation of SLE that occurs in less than 5% of cases of lupus.
Source: NIH.gov
A bursa is a small, fluid-filled sac that acts as a cushion between a bone and other moving body parts such as muscles, tendons, or skin. Bursae are found throughout the body. Bursitis occurs when a bursa becomes swollen.
Source: NIAMS.NIH.gov
Butterfly rash is a red flat facial rash involving the malar region bilaterally and the bridge of the nose. The presence of a butterfly rash is generally a sign of lupus erythematosus (LE), but it can also include a plethora of conditions.
Source: NIH.gov
Cardiac tamponade is pressure on the heart that occurs when blood or fluid builds up in the space between the heart muscle (myocardium) and the outer covering sac of the heart (pericardium). This prevents the heart ventricles from expanding fully. The excess pressure from the fluid prevents the heart from working properly. As a result, the body does not get enough blood.
Cardiac tamponade is an emergency condition that needs to be treated in the hospital; the fluid around the heart must be drained as quickly as possible.
Source: MedlinePlus.gov
A physician specializing in treatment of heart disease.
The term cardiovascular refers to the heart (cardio) and the blood vessels (vascular). The cardiovascular system includes:
Source: MedlinePlus.gov
Inflammation of the layers of the heart. It usually involves two of the following: pericardium, myocardium, or endocardium.
Carotid artery disease is a disease in which a waxy substance called plaque builds up inside the carotid arteries. (Plaque: In medicine, a small, abnormal patch of tissue on a body part or an organ. Plaques may also be a build-up of substances from a fluid, such as cholesterol in the blood vessels.)
Source: NIH.gov
A specialized type of dense connective tissue consisting of cells embedded in a ground substance or matrix. The matrix is firm and compact; its proteoglycans can store considerably more sodium than plasma can, which in turn allows cartilage to store water, which in turn helps cartilage withstand pressure or impact. Cartilage is bluish-white or gray and is semiopaque; it has no nerve or blood supply of its own. The cells lie in cavities called lacunae. They may be single or in groups of two, three, or four. Cartilage forms parts of joints in the adult skeleton, such as between vertebral bodies and on the articular surfaces of bones. It also occurs in the costal cartilages of the ribs, in the nasal septum, in the external ear and lining of the eustachian tube, in the wall of the larynx, and in the trachea and bronchi. It forms the major portion of the embryonic skeleton, providing a model in which most bones develop.
Cells are the basic building blocks of all living things. The human body is composed of trillions of cells. They provide structure for the body, take in nutrients from food, convert those nutrients into energy, and carry out specialized functions. Cells also contain the body’s hereditary material and can make copies of themselves. When someone has lupus, the immune system can’t tell the difference between the body’s healthy cells and bacteria and viruses, so the antibodies attack the body’s healthy cells.
Source: NIH.gov
The sum of all chemical changes that take place in a cell through which energy and basic components are provided for essential processes, including the synthesis of new molecules and the breakdown and removal of others.
Source: PubMed.gov
The central nervous system is made up of the brain and spinal cord. The brain functions to receive nerve impulses from the spinal cord and cranial nerves. The spinal cord contains the nerves that carry messages between the brain and the body.
In some patients, lupus affects the brain or central nervous system. This can cause headaches, dizziness, depression, memory disturbances, vision problems, seizures, stroke, or changes in behavior.
Source: NIAMS.NIH.gov, MedlinePlus.gov
Cerebritis, or inflammation of the brain, can be caused by infection or inflammation from disease.
Lupus Cerebritis is a serious neurological complication encountered in a good percentage of SLE cases.
Source: NIH.gov
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. (This does not apply if the PI is an employee of the sponsor.)
Source: ClinicalTrials.gov
Chemokines are low-molecular-weight proteins that stimulate recruitment of leukocytes. They are secondary pro-inflammatory mediators that are induced by primary pro-inflammatory mediators such as interleukin-1 (IL-1) or tumor necrosis factor (TNF). The physiologic importance of this family of mediators is derived from their specificity. Unlike the classic leukocyte chemo-attractants, which have little specificity, members of the chemokine family induce recruitment of well-defined leukocyte subsets. Thus, chemokine expression can account for the presence of different types of leukocytes observed in various normal or pathologic states.
Source: NIH.gov
A mild injury caused by cold and marked by localized redness, burning, and swelling on exposed body parts, esp. in cool, damp climates. The affected skin sometimes blisters or ulcerates. Insufficient blood flow into small blood vessels in the skin may contribute to the formation of chilblains.
Chondrocalcinosis is a condition characterized by deposits of calcium pyrophosphate dihydrate (CPPD) crystals in one or more joints that eventually results in damage to the affected joints. It most often affects the knee, wrist and pubic symphysis, the joint between the pubic bones in the front of the pelvis.
Source: MayoClinic.org
Chromosomes are thread-like structures located inside the nucleus of animal and plant cells. Each chromosome is made of protein and a single molecule of deoxyribonucleic acid (DNA). Passed from parents to offspring, DNA contains the specific instructions that make each type of living creature unique.
Source: Genome.gov
Chronic cutaneous lupus erythematosus (CCLE) is a form of cutaneous lupus erythematosus (CLE) that includes five different forms: discoid lupus erythematosus (DLE), chilblain lupus, hypertrophic or verrucous lupus erythematosus, lupus erythematosus tumidus, and lupus erythematosus panniculitis.
Source: NIH.gov
Chronic diseases are noncommunicable illnesses that are prolonged in duration, do not resolve spontaneously, and are rarely cured completely. Although chronic diseases are more common among older adults, they affect people of all ages and are now recognized as a leading health concern of the nation. Growing evidence indicates that a comprehensive approach to prevention can save tremendous costs and needless suffering.
Source: CDC.gov
Chronic fatigue syndrome (CFS) is a disorder that causes extreme fatigue. This fatigue is not the kind of tired feeling that goes away after you rest. Instead, it lasts a long time and limits your ability to do ordinary daily activities. The main symptom of CFS is severe fatigue that lasts for 6 months or more. You also have at least four of these other symptoms:
Source: NIH.gov
While acute pain is a normal sensation triggered in the nervous system to alert you to possible injury and the need to take care of yourself, chronic pain is different. Chronic pain persists. Pain signals keep firing in the nervous system for weeks, months, even years. There may have been an initial mishap — sprained back, serious infection, or there may be an ongoing cause of pain — arthritis, cancer, ear infection, but some people suffer chronic pain in the absence of any past injury or evidence of body damage. Many chronic pain conditions affect older adults. Common chronic pain complaints include headache, low back pain, cancer pain, arthritis pain, neurogenic pain (pain resulting from damage to the peripheral nerves or to the central nervous system itself), psychogenic pain (pain not due to past disease or injury or any visible sign of damage inside or outside the nervous system). A person may have two or more co-existing chronic pain conditions. Such conditions can include chronic fatigue syndrome, endometriosis, fibromyalgia, inflammatory bowel disease, interstitial cystitis, temporomandibular joint dysfunction, and vulvodynia. It is not known whether these disorders share a common cause.
Source: NIH.gov
The study of the components of the immune system and their function.
A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. Two types of clinical studies are interventional studies (or clinical trials) and observational studies.
Source: ClinicalTrials.gov
A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Source: NIH.gov
A part of the clinical research process that answers specific questions about whether treatments or other interventions that are being studied are safe and work. Phase I trials test the best way to give a new treatment and the best dose. Phase II trials test whether a new treatment has an effect on the disease. Phase III trials compare the results of people taking a new treatment with the results of people taking the standard treatment. Phase IV trials are done using many people after a treatment has been approved and marketed to check for side effects that weren’t seen in the Phase III trial.
Source: NCI
A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called trial sponsor.
Source: NCI
Clinical studies that are no longer recruiting participants because they have enough participants already, because they are completed, or because they have been stopped for some reason. This also describes studies with very specific eligibility criteria that recruit participants by invitation only. Recruitment statuses for closed studies appear in red text in ClinicalTrials.gov search results and study records.
Source: ClinicalTrials.gov
Thinking skills, including language use, calculation, perception, memory, awareness, reasoning, judgment, learning, intellect, social skills, and imagination.
Cognitive impairment is defined as any difficulty with normal thought functions or processes, such as thinking, learning, or remembering. Cognitive impairment can occur as a neurological symptom of lupus. However, cognitive impairment is a common occurrence that happens to everyone at some time, not just lupus patients, and it can affect one single thought process or many thought processes either temporarily or permanently.
Source: HSS.edu
A group of individuals who share a common trait, such as birth year. In medicine, a cohort is a group that is part of a clinical trial or study and is observed over a period of time.
Source: NIH.gov
A research study that compares a particular outcome in groups of individuals who are alike in many ways but differ by a certain characteristic.
Source: NCI
A collaborator is an organization other than the sponsor that provides support for a clinical study. This may include funding, design, implementation, data analysis, or reporting.
Source: ClinicalTrials.gov
Collagen is the major insoluble fibrous protein in the extracellular matrix and in connective tissue. In fact, it is the single most abundant protein in the animal kingdom. There are at least 16 types of collagen, but 80 – 90 percent of the collagen in the body consists of types I, II, and III. These collagen molecules pack together to form long thin fibrils of similar structure. Type IV, in contrast, forms a two-dimensional reticulum; several other types associate with fibril-type collagens, linking them to each other or to other matrix components. At one time it was thought that all collagens were secreted by fibroblasts in connective tissue, but we now know that numerous epithelial cells make certain types of collagens. The various collagens and the structures they form all serve the same purpose, to help tissues withstand stretching.
Source: NIH.gov
The term “comorbidity” describes two or more disorders or illnesses occurring in the same person. They can occur at the same time or one after the other. Comorbidity also implies interactions between the illnesses that can worsen the course of both.
Source: NIH.gov
The complement system is made up of about 25 proteins that work together to assist, or “complement,” the action of antibodies in destroying bacteria. Complement also helps to rid the body of antibody-coated antigens (antigen-antibody complexes).
Complement proteins, which cause blood vessels to become dilated and then leaky, contribute to the redness, warmth, swelling, pain, and loss of function that characterize an inflammatory response.
Source: NIH.gov
A laboratory evaluation of all the cells that circulate in the blood, including the number and the hemoglobin content of red blood cells, the white blood cells (and their subtypes), and platelets. The typical CBC provides assessments of size and shape of red blood cells and platelets as well.
The CBC is among the most common blood tests performed in the clinical laboratory and aids in the diagnosis of anemia and erythrocytosis; bleeding and the repletion of blood cells by transfusion, thrombocytopenia and thrombocytosis; and infections and leukemias. Blood is obtained for the test from venipuncture or aspiration from an indwelling vascular access or port. It is taken to the laboratory in a tube that contains the anticoagulant ethylenediaminetetraacetic acid (EDTA).
The clinical study has ended normally, and participants are no longer being examined or treated (that is, the “last subject, last visit” has occurred).
Source: ClinicalTrials.gov
Connective tissue is the material inside your body that supports many of its parts. It is the “cellular glue” that gives your tissues their shape and helps keep them strong. It also helps some of your tissues do their work. Cartilage and fat are examples of connective tissue.
There are over 200 disorders that impact connective tissue. Some, like cellulitis, are the result of an infection. Injuries can cause connective tissue disorders, such as scars. Others, such as Ehlers-Danlos syndrome, Marfan syndrome, and osteogenesis imperfecta, are genetic. Still others, like scleroderma, have no known cause. Each disorder has its own symptoms and needs different treatment.
Source: NIH.gov
A process in which patients are given important information such as possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help the patient decide if they want to be treated, tested, or take part in the trial. Patients are also given any new information that might affect their decision to continue. This is also called informed consent.
Source: NCI
A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a “historical control”).
Source: ClinicalTrials.gov
CAD happens when the arteries that supply blood to heart muscle become hardened and narrowed. This is due to the buildup of cholesterol and other material, called plaque, on their inner walls. This buildup is called atherosclerosis. As it grows, less blood can flow through the arteries. As a result, the heart muscle can’t get the blood or oxygen it needs. This can lead to chest pain (angina) or a heart attack. Most heart attacks happen when a blood clot suddenly cuts off the hearts’ blood supply, causing permanent heart damage.
Over time, CAD can also weaken the heart muscle and contribute to heart failure and arrhythmias. Heart failure means the heart can’t pump blood well to the rest of the body. Arrhythmias are changes in the normal beating rhythm of the heart.
People with lupus have a higher risk of CAD. This is partly because people with lupus have more CAD risk factors, which may include high blood pressure, high cholesterol, and type 2 diabetes. The inflammation that accompanies lupus also increases the risk of developing CAD. People with lupus are often less active because of fatigue, joint problems, and/or muscle pain, and this also puts them at risk.
Heart disease is the number one killer of all women, but women with lupus are 50 times more likely to have chest pain or a heart attack than other women of the same age.
Source: NIH.gov
According to the World Health Organization, coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
Corticosteroids, such as prednisone, hydrocortisone, methylprednisolone, and dexamethasone, are related to cortisol, which is a natural anti-inflammatory hormone. They work by rapidly suppressing inflammation. Corticosteroids can be given by mouth, in creams applied to the skin, by injection, or by intravenous (IV) infusion (dripping the drug into the vein through a small tube). Because they are potent drugs, the doctor will seek the lowest dose required to achieve the desired benefit.
In an effort to minimize side effects associated with corticosteroids, researchers are working to develop ways to limit or offset the use of corticosteroids. For example, corticosteroids may be used in combination with other, less potent drugs, or the doctor may try to slowly decrease the dose once the disease is under control.
Source: NIAMS.NIH.gov
According to the World Health Organization, Coronavirus disease (COVID-19) is a new strain of coronaviruses that was discovered in 2019 and has not been previously identified in humans.
Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and trouble breathing.
Creatinine is a chemical waste product of creatine. Creatine is a chemical made by the body and is used to supply energy mainly to muscles.
A blood test that measures the level of creatinine in the blood is used to test kidney function. Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in your blood. This is because less creatinine is released through your urine.
Source: MedlinePlus.gov
The symptoms involved in CREST syndrome are associated with the generalized form of the disease Systemic sclerosis (scleroderma). CREST is an acronym for the clinical features that are seen in a patient with this disease. The “C” stands for calcinosis, where calcium deposits form under the skin on the fingers or other areas of the body. The “R”, stands for Raynaud’s phenomenon, spasm of blood vessels in the fingers or toes in response to cold or stress. The “E” represents esophageal dysmotility, which can cause difficulty in swallowing. The “S” is for sclerodactyly, tightening of the skin causing the fingers to bend. Finally, the letter “T” is for telangiectasia, dilated vessels on the skin of the fingers, face, or inside of the mouth.
Source: MedlinePlus.gov
Cutaneous lupus causes a rash or lesion on the skin, usually when exposed to sunlight. One of the common types of skin lupus is called discoid lupus erythematosus (DLE). It is identified by a rash that appears on the face, neck, or scalp, and by hair loss.
A data monitoring committee (DMC) is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials.
Source: NIH.gov
Decorin is a protein coded for by the DCN gene. This protein is a component of the extracellular matrix, which is the intricate lattice of proteins and other molecules that forms in the spaces between cells. Decorin is found in the extracellular matrix of a variety of connective tissues, including skin, tendon, bone, and cartilage. Connective tissues support the body’s joints and organs. Decorin is involved in the organization of proteins called collagens. Collagens strengthen and support connective tissues throughout the body. Collagens also play an important role in the cornea, which is the clear outer covering of the eye. Bundles of collagen called fibrils must be strictly organized for the cornea to be transparent. Decorin ensures that these collagen fibrils are uniformly sized and regularly spaced.
Source: NIH.gov
An antigen-presenting cell that helps T cells respond to foreign antigens. Dendritic cells circulate in the blood and are also found in epithelial tissues, the Langerhans cells of the skin, and the interdigitating cells in lymph nodes.
Everyone occasionally feels blue or sad. But these feelings are usually short-lived and pass within a couple of days. When you have depression, it interferes with daily life and causes pain for both you and those who care about you. Depression is a common but serious illness.
Major depression—severe symptoms that interfere with your ability to work, sleep, study, eat, and enjoy life. An episode can occur only once in a person’s lifetime, but more often, a person has several episodes.
Persistent depressive disorder—depressed mood that lasts for at least 2 years. A person diagnosed with persistent depressive disorder may have episodes of major depression along with periods of less severe symptoms, but symptoms must last for 2 years.
People with a chronic illness such as lupus are at higher risk of depression. Studies show that as many as 60% of people with a chronic illness will have depression at some point in their lives.
Source: NIH.gov
A doctor who has special training to diagnose and treat skin problems.
Source: NIH.gov
A rare acute, subacute, or chronic disease of connective tissue, of unknown cause, marked by edema, rash, weakness, pain, and inflammation of the muscles.
Discoid lupus erythematosus—causes a skin rash that doesn’t go away
Source: NIH.gov
Cutaneous lesion that develops as a dry, scaly, red patch that evolves to an indurated and hyperpigmented plaque with adherent scale. Scarring may result in central white patches (loss of pigmentation) and skin atrophy.
Source: NIH.gov
A type of drug that causes the kidneys to make more urine. Diuretics help the body get rid of extra fluid and salt. They are used to treat high blood pressure, edema (extra fluid in the tissues), and other conditions. They are sometimes called water pills.
Source: NIH.gov
A type of clinical trial in which neither the researcher doing the study nor the patients know the specific type of treatment each patient receives until after the clinical trial is over. This type of study is done to make sure the study results are not biased.
Source: NCI
Drug-induced lupus erythematosus (DILE) is a lupus-like syndrome temporally related to continuous drug exposure which resolves upon drug discontinuation.
Source: NIH.gov
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies)
Source: ClinicalTrials.gov
Edema means swelling caused by excess fluid in the body’s tissues. It usually occurs in the feet, ankles and legs, but it can involve the entire body. Edema can be a symptom of lupus nephritis.
Source: MedlinePlus.gov, NIH.gov
An electrocardiogram, also called an EKG or ECG, is a simple, painless test that records the heart’s electrical activity.
An EKG shows:
Source: NIH.gov
Electrolytes are minerals in your body that have an electric charge. They are in your blood, urine and body fluids. Maintaining the right balance of electrolytes helps your body’s blood chemistry, muscle action and other processes. Sodium, calcium, potassium, chlorine, phosphate and magnesium are all electrolytes. You get them from the foods you eat and the fluids you drink.
Levels of electrolytes in your body can become too low or too high. That can happen when the amount of water in your body changes, causing dehydration or overhydration. Causes include some medicines, vomiting, diarrhea, sweating or kidney problems, such as lupus nephritis. Problems most often occur with levels of sodium, potassium or calcium.
Source: NIH.gov
A record of the electrical responses of the light-sensitive portions of the eye to stimulation. It can be used to identify congenital and acquired forms of blindness.
The key standards that people who want to participate in a clinical study must meet or the characteristics that they must have. These include inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.
Source: ClinicalTrials.gov
In clinical trials, an event or outcome that can be objectively measured to determine whether the intervention being studied is beneficial. The endpoints are usually included in the study objectives.
Source: NCI
A clinical study that selects its participants from a population, or group of people, decided on in advance by the researchers. These studies are not open to everyone who meets the eligibility criteria, but only to people in that particular population, who are specifically invited to participate.
Source: ClinicalTrials.gov
The number of participants in a clinical study. The “estimated enrollment” is the number of participants that the researchers need for the study.
Source: ClinicalTrials.gov
Eosinophils are specialized white blood cells that participate in inflammatory processes such as allergic diseases. They also are involved in tissue repair and remodeling.
In healthy people, eosinophils comprise approximately 1 to 6 percent of white blood cells. The body may produce more of these cells in response to parasitic and fungal infections. Certain allergic diseases, skin conditions, autoimmune disorders, cancers, and bone marrow diseases also may result in elevated eosinophil counts. Many people with eosinophilic disorders have high numbers of eosinophils in their blood or tissues over a long period of time. Sometimes, the presence of excess eosinophils in tissue, called “eosinophilic inflammation,” can result in tissue damage.
Source: NIH.gov
The study of the patterns, causes, and control of disease in groups of people.
Source: NIH.gov
Reddening of the skin. Erythema is a common but nonspecific sign of skin irritation, injury, or inflammation. It is caused by dilation of superficial blood vessels in the skin.
A nonspecific laboratory test used as a marker of inflammation. In this test, the speed at which erythrocytes settle out of unclotted blood is measured. Blood to which an anticoagulant has been added is placed in a long, narrow tube, and the distance the red cells fall in 1 hr is the erythrocyte sedimentation rate (ESR). Normally it is less than 10 mm/hr in men and slightly higher in women. The speed at which the cells settle depends on how many red blood cells clump together. Clumping is increased by the presence of acute-phase proteins released during inflammation.
Outside of the living body. Refers to a medical procedure in which an organ, cells, or tissue are taken from a living body for a treatment or procedure, and then returned to the living body.
Source: Cancer.gov
The factors (or reasons) that prevent a person from participating in a clinical study.
Source: ClinicalTrials.gov
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the FDA. This is also known as compassionate use.
Source: ClinicalTrials.gov
In clinical trials, refers to a drug or procedure that has undergone basic laboratory testing and received approval from the U.S. FDA to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but experimental in another. Also called investigational.
Source: NCI
A group of participants that receives the intervention that is the focus of the study.
Source: ClinicalTrials.gov
A substance that has been tested in the laboratory and has been approved by the US FDA for testing in people. Clinical trials test how well experimental drugs work and if they are safe to use. An experimental drug can be approved for one disease but considered investigational in another. Also called IND, investigational agent, investigational drug, and investigational new drug.
Source: NCI
The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is also called the intervention group and investigational group.
Source: NCI
The solid or liquid material that is produced by and surrounds the cells of connective tissues.
Describes a clinical study in which groups of participants receive one of several combinations of interventions. For example, a two-by-two factorial design involves four groups of participants. Each group receives one of the following pairs of interventions: 1) drug A and drug B, 2) drug A and a placebo, 3) a placebo and drug B, or 4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and placebos are given to different groups of participants.
Source: ClinicalTrials.gov
Fatigue is different from drowsiness. Drowsiness is feeling the need to sleep. Fatigue is a lack of energy and motivation. Drowsiness and apathy (a feeling of not caring about what happens) can be symptoms that go along with fatigue. Fatigue can be a normal and important response to physical activity, emotional stress, boredom, or lack of sleep. Fatigue is a common symptom, and it is usually not due to a serious disease. But it can be a sign of a more serious mental or physical condition. When fatigue is not relieved by enough sleep, good nutrition, or a low-stress environment, it should be evaluated by your doctor.
Source: NIH.gov
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
Source: FDA.gov
The term ferroptosis is derived from the Greek word ptosis, meaning “a fall,” and ferrum, the Latin word for iron. It describes a form of regulated cell death in which iron appears to be a factor.
Many lupus experts believe that ferroptosis may play an important role in lupus nephritis.
An abnormal elevation of temperature. The normal temperature taken orally ranges from about 97.6° to 99.6°F (36.3°C to 37.6°C). Rectal temperature is 0.5° to 1.0°F higher than oral temperature. Normal temperature fluctuates during the day and is lowest in the morning and highest in the late afternoon; these variations are maintained during a fever. The expended basal energy is estimated to be increased about 12% for each degree centigrade of fever.
A fibroblast is the most common type of cell found in connective tissue. Fibroblasts secrete collagen proteins that are used to maintain a structural framework for many tissues. They also play an important role in healing wounds.
Source: Genome.gov
Fibromyalgia is a disorder of unknown etiology characterized by widespread pain, abnormal pain processing, sleep disturbance, fatigue and often psychological distress. People with fibromyalgia may also have other symptoms; such as headaches, sleep disturbances, cognitive problems with thinking and memory (sometimes called “fibro fog”)
Source: CDC.gov
An exacerbation of any inflammatory condition or disease, such as the sudden worsening of rheumatoid arthritis or systemic lupus erythematosis (SLE).
An injury that upon assessment is painful, swollen, and deformed.
A break of a bone.
Associated with human disease, free radicals are the natural by products of chemical processes, such as metabolism. Yet, free radicals are essential to the body’s ability to turn air and food into chemical energy. Crucial to the immune system, free radicals attack foreign invaders.
The danger of free radical activity occurs when they provoke a chain reaction response. The first free radical pulls an electron from a molecule, which destabilizes the molecule and turns it into a free radical. A domino effect is set in motion that can eventually disrupt and damage the whole cell.
This free radical activity can alter what enters and exits the cell. The damaged molecules may mutate, grow tumors, even damage the DNA code.
B cells obtain help from T cells in the antibody response by acting as antigen-specific antigen presenting cells. A direct signal through binding of antigen to membrane Ig can enhance B cell antigen presentation and T-dependent B cell activation, but is not required for a productive interaction between a small resting B cell and a differentiated helper T cell.
Source: NIH.gov
The pattern of how a person walks is called the gait. Different types of walking problems occur without a person’s control. Most, but not all, are due to a physical condition.
Source: NIH.gov
The branch of medical science concerned with the study of the anatomy, physiology, and diseases of the digestive organs and their treatment. The digestive organs include the stomach, intestines, and related structures (e.g., esophagus, liver, gallbladder, and pancreas).
Pertaining to the entire digestive tract, from the mouth to the anus.
The gene is the basic physical unit of inheritance. Genes are passed from parents to offspring and contain the information needed to specify traits. Genes are arranged, one after another, on structures called chromosomes. A chromosome contains a single, long DNA molecule, only a portion of which corresponds to a single gene. Humans have approximately 20,000 genes arranged on their chromosomes.
Source: Genome.gov
Gene expression is the process by which the information encoded in a gene is used to direct the assembly of a protein molecule. The cell reads the sequence of the gene in groups of three bases. Each group of three bases (codon) corresponds to one of 20 different amino acids used to build the protein.
Source: Genome.gov
Gene regulation is the process of turning genes on and off. During early development, cells begin to take on specific functions. Gene regulation ensures that the appropriate genes are expressed at the proper times. Gene regulation can also help an organism respond to its environment. Gene regulation is accomplished by a variety of mechanisms including chemically modifying genes and using regulatory proteins to turn genes on or off.
Source: Genome.gov
A genetic disorder is a disease caused in whole or in part by a change in the DNA sequence away from the normal sequence. Genetic disorders can be caused by a mutation in one gene (monogenic disorder), by mutations in multiple genes (multifactorial inheritance disorder), by a combination of gene mutations and environmental factors, or by damage to chromosomes (changes in the number or structure of entire chromosomes, the structures that carry genes).
Source: NIH.gov
Genetic linkage analysis is a powerful tool to detect the chromosomal location of disease genes. It is based on the observation that genes that reside physically close on a chromosome remain linked during meiosis.
Source: NIH.gov
Glomerulonephritis is a type of kidney disease in which the part of your kidneys that helps filter waste and fluids from the blood is damaged. Damage to the glomeruli causes blood and protein to be lost in the urine. A quarter of people with chronic glomerulonephritis have no history of kidney disease.
Source: NIH.gov
A substance (generally a protein, polypeptide, or peptide) that stimulates the differentiation, division, development, and maintenance of cells and the tissues they make up. Growth factors are signaling molecules released by certain groups of cells, e.g., lymphocytes, to influence the activities of other cells. Growth factors can be divided into families, e.g., platelet-derived GFs, transforming GFs, and angiogenic GFs. They are released normally during fetal and embryonic development, wound healing, and tissue maturation. Massive releases of GFs are characteristic of some types of cancer cells. Artificial GFs, e.g., granulocyte colony-stimulating factor, are used in health care to restore depressed levels of cells to normal values, e.g., in patients who have received chemotherapy.
Microbiota refers to the entire population of microorganisms that colonizes a particular location; and includes not just bacteria, but also other microbes such as fungi, archaea, viruses, and protozoans.
Source: NIH.gov
A national or international health organization that has authority over the clinical study.
Source: ClinicalTrials.gov
In a clinical study, a person who does not have the disorder or disease being studied. Results from healthy controls are compared to results from the group being studied.
Source: NCI
A heart attack occurs if the flow of oxygen-rich blood to a section of heart muscle suddenly becomes blocked. If blood flow isn’t restored quickly, the section of heart muscle begins to die.
Source: NIH.gov
A measure that tells what portion of a blood sample consists of red blood cells. Low hematocrit suggests anemia or massive blood loss.
Source: NIH.gov
Hematologic disorders affect one or more parts of the blood and prevent your blood from doing its job. They can be acute or chronic. Many blood disorders are inherited. Other causes include other diseases, side effects of medicines, and a lack of certain nutrients in your diet.
Types of blood disorders include:
Source: NIH.gov
A physician who specializes in the diagnosis and treatment of disorders of blood and blood-forming tissues.
The production and development of blood cells, normally in the bone marrow.
Hematuria is blood in the urine. Two types of blood in the urine exist. Blood that can be seen in the urine is called gross hematuria. Blood that cannot be seen in the urine, except when examined with a microscope, is called microscopic hematuria.
Source: NIH.gov
Weakness or paralysis affecting only one side of the body.
Source: NIH.gov
Hemoglobin is a protein in red blood cells that carries oxygen.
Source: MedlinePlus.gov
Hemolytic anemia is a condition in which red blood cells are destroyed and removed from the bloodstream before their normal lifespan is over. Hemolytic anemia can lead to many health problems, such as fatigue (tiredness), pain, irregular heartbeats called arrhythmias (ah-RITH-me-ahs), an enlarged heart, and heart failure.
Source: NIH.gov
The study of the microscopic structure of tissue.
The microscopic study of diseased tissues.
A group of people who review, approve, and monitor the clinical study protocol. Their role is to protect the rights and welfare of human research subjects participating in a study. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also known as an institutional review board (IRB) or ethics committee.
Source: ClinicalTrials.gov
An increase in the size of an organ, structure, or the body due to growth rather than tumor formation. This term is generally restricted to an increase in size or bulk that results not from an increase in the number of cells but from an increase in a cellular component, e.g., proteins. It applies to any increase in size as a result of functional activity.
The principal immunoglobulin in human serum. Because IgG moves across the placental barrier, it is important in producing immunity in the infant before birth. It is the major antibody for antitoxins, viruses, and bacteria. It also activates complement and serves as an opsonin. As gamma globulin, IgG may be given to provide temporary resistance to hepatitis or other disease.
An immunoglobulin formed in almost every immune response during the early period of the reaction. IgM controls the A, B, and O blood group antibody responses and is the most efficient antibody in stimulating complement activity. Its size prevents it from moving across the placenta to the fetus.
An antibody bound to an antigen. Immune complexes are part of a normal immune response. However, when immune complexes accumulate in the blood, they can cause autoimmune disorders, infections, and malignancies.
Source: NIH.gov
The immune response is how your body recognizes and defends itself against bacteria, viruses, and substances that appear foreign and harmful.The immune system protects the body from possibly harmful substances by recognizing and responding to antigens. Antigens are substances (usually proteins) on the surface of cells, viruses, fungi, or bacteria. Nonliving substances such as toxins, chemicals, drugs, and foreign particles (such as a splinter) can also be antigens. The immune system recognizes and destroys substances that contain antigens. Your own body’s cells have proteins that are antigens. These include a group of antigens called HLA antigens. Your immune system learns to see these antigens as normal and usually does not react against them.
Source: NIH.gov
The body’s system for protecting itself from viruses and bacteria or any foreign substances.
The capacity to induce a detectable immune response.
Any of a diverse group of plasma polypeptides that bind antigenic proteins and serve as one of the body’s primary defenses against disease. Two different forms exist. The first group of immunoglobulins lies on the surface of mature B cells, enabling them to bind to thousands of antigens. When the antigens are bound, the B plasma cells secrete the second type of immunoglobulins, antigen-specific antibodies, which circulate in the blood and accumulate in lymphoid tissue, esp. the spleen and lymph nodes, binding and destroying specific foreign antigens and stimulating other immune activity. Antibodies also activate the complement cascade, neutralize bacterial toxins and viruses, and function as opsonins, stimulating phagocytosis.
Immunoglobulins are formed by light and heavy (depending on molecular weight) chains of polypeptides made up of about 100 amino acids. These chains determine the structure of antigen-binding sites and, therefore, the specificity of the antibody to one antigen. The five types of immunoglobulins (IgA, IgD, IgE, IgG, IgM) account for approximately 30% of all plasma proteins. Antibodies are one of the three classes of globulins (plasma proteins) in the blood that contribute to maintaining colloidal oncotic pressure.
For some patients whose kidneys or central nervous systems are affected by lupus, a type of drug called an immunosuppressive may be used. Immunosuppressives, such as cyclophosphamide and mycophenolate mofetil, restrain the overactive immune system by blocking the production of immune cells. These drugs may be given by mouth or by IV infusion. The risk for side effects increases with the length of treatment.
Source: NIAMS.NIH.gov
The factors (or reasons) that allow a person to participate in a clinical study.
Source: ClinicalTrials.gov
Multiprotein complexes that mediate the activation of the enzyme CASPASE-1 involved in inflammation. Dysregulation of inflammasomes has also been linked to a number of autoinflammatory and autoimmune disorders.
Source: Medical Dictionary Online
An inflammatory response (inflammation) occurs when tissues are injured by bacteria, trauma, toxins, heat, or any other cause. The damaged cells release chemicals including histamine, bradykinin, and prostaglandins. These chemicals cause blood vessels to leak fluid into the tissues, causing swelling. This helps isolate the foreign substance from further contact with body tissues.
Source: NIH.gov
The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends. The researcher and potential participant have discussions that include answering the participant’s questions about the research. All the important information about the study must also be given to the potential participant in a written document that is clear and easy to understand. This informed consent document is reviewed and approved by the human subjects review board for a study before it is given to potential participants. Generally, a person must sign an informed consent document to enroll in a study.
Source: ClinicalTrials.gov
ICF, the document used in the informed consent process
Source: ClinicalTrials.gov
During the first critical hours and days of exposure to a new pathogen, we rely on our innate immune system to protect us from infection.
Innate immune responses are not specific to a particular pathogen in the way that the adaptive immune responses are. They depend on a group of proteins and phagocytic cells that recognize conserved features of pathogens and become quickly activated to help destroy invaders.
Source: NIH.gov
A group of scientists, doctors, clergy, and patient advocates that reviews and approves the detailed plan for a clinical trial. IRBs are meant to protect the individuals who take part in a clinical trial. They make sure that the trial is well designed, legal, ethical, does not involve unneeded risks, and includes a safety plan for patients. There is an IRB at every health care facility that does clinical research, and every trial is reviewed by an IRB before the trial begins.
Source: NCI
The principal receptors on animal cells for binding most extracellular matrix proteins—including collagens, fibronectin, and laminins—are the integrins. Integrins, like other cell adhesion molecules, differ from cell-surface receptors for hormones and for other extracellular soluble signal molecules in that they usually bind their ligand with lower affinity and are usually present at about tenfold to a hundredfold higher concentration on the cell surface. If the binding were too tight, cells would presumably become irreversibly glued to the matrix and would be unable to move—a problem that does not arise if attachment depends on large numbers of weak adhesions. This is an example of the “Velcro principle” mentioned earlier. Like other transmembrane cell adhesion proteins, however, integrins do more than just attach a cell to its surroundings. They also activate intracellular signaling pathways that communicate to the cell the character of the extracellular matrix that is bound.
Source: NIH.gov
Any of a group of glycoproteins with antiviral activity. The antiviral type I interferons (alpha and beta interferons) are produced by leukocytes and fibroblasts in response to invasion by a pathogen, particularly a virus. These interferons enable invaded cells to produce class I major histocompatibility complex surface antigens, increasing their ability to be recognized and killed by T lymphocytes. They also inhibit virus production within infected cells. Type I alpha interferon is used to treat condyloma acuminatum, chronic hepatitis B and C, and Kaposi’s sarcoma. Type I beta interferon is used to treat multiple sclerosis. Type II gamma interferon is distinctly different from and less antiviral than the other interferons. It is a lymphokine, excreted primarily by CD8+ T cells and the helper T subset of CD4+ cells that stimulates several types of antigen-presenting cells, particularly macrophages, to release class II MHC antigens that enhance CD4+ activity. It is used to treat chronic granulomatous disease.
This gene encodes a member of the interferon regulatory factor (IRF) family, a group of transcription factors with diverse roles, including virus-mediated activation of interferon, and modulation of cell growth, differentiation, apoptosis, and immune system activity. Members of the IRF family are characterized by a conserved N-terminal DNA-binding domain containing tryptophan (W) repeats. Alternative promoter use and alternative splicing result in multiple transcript variants, and a 30-nt indel polymorphism (SNP rs60344245) can result in loss of a 10-aa segment.
Source: NIH.gov
Interstitial lung disease describes a large group of disorders, most of which cause progressive scarring of lung tissue. The scarring associated with interstitial lung disease eventually affects your ability to breathe and get enough oxygen into your bloodstream.
Pneumonitis is a general term that refers to inflammation of lung tissue. Although pneumonia is technically a type of pneumonitis because the infection causes inflammation, most doctors are referring to other causes of lung inflammation when they use the term “pneumonitis.”
Factors that can cause pneumonitis include exposure to airborne irritants at your job or from your hobbies. In addition, some types of cancer treatments and dozens of drugs can cause pneumonitis.
The most common symptom of pneumonitis is shortness of breath, which may be accompanied by a dry cough. If pneumonitis is undetected or left untreated, you may gradually develop chronic pneumonitis, which can result in scarring (fibrosis) in the lungs.
Source: MayoClinic.org
A process or action that is the focus of a clinical study. This can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches such as surveys, education, and interviews.
Source: ClinicalTrials.gov
The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is also called the experimental group and investigational group.
Source: NIH.gov
Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called IV.
Source: NIH.gov
An intravenous pyelogram (IVP) is a special x-ray examination of the kidneys, bladder, and ureters (the tubes that carry urine from the kidneys to the bladder). An intravenous pyelogram is performed by injecting contrast material into a vein in the arm. A series of x-rays are taken at timed intervals as the contrast material goes through the kidneys, the ureters, and the bladder. The procedure helps to evaluate the condition of those organs.
Source: MedlinePlus.gov
A substance that has been tested in the laboratory and has been approved by the US FDA for testing in people. Clinical trials test how well experimental drugs work and if they are safe to use. An experimental drug can be approved for one disease but considered investigational in another. Also called experimental drug, IND, investigational agent, investigational new drug.
Source: NCI
The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is also called the intervention group and experimental group.
Source: NCI
A substance that has been tested in the laboratory and has been approved by the U.S. FDA for testing in people. Clinical trials test how well experimental drugs work and if they are safe to use. An experimental drug can be approved for one disease but considered investigational in another. Also called experimental drug, IND, investigational agent, investigational drug.
Source: NCI
Any of a group of related inflammatory joint diseases of childhood, the most severe of which is also the most common variety.
Your kidneys are two bean-shaped organs, each about the size of your fists. They are located near the middle of your back, just below the rib cage. Inside each kidney about a million tiny structures called nephrons filter blood. They remove waste products and extra water, which become urine. The urine flows through tubes called ureters to your bladder, which stores the urine until you go to the bathroom. Most kidney diseases attack the nephrons. This damage may leave kidneys unable to remove wastes. Causes can include genetic problems, injuries, or medicines.
Lupus Nephritis is the form of SLE that causes the kidneys to become inflamed.
Source: NIH.gov
A substance that blocks a type of enzyme called a kinase. Human cells have many different kinases, and they help control important functions, such as cell signaling, metabolism, division, and survival. Certain kinases are more active in some types of cancer cells and blocking them may help keep the cancer cells from growing. Kinase inhibitors may also block the growth of new blood vessels that tumors need to grow.
Source: Cancer.gov
Ligands are small molecules that transmit signals in between or within cells. They exert their effects by binding to cellular proteins called receptors. The ligand is like a baton, and the receptor is like the next runner in line. After binding to the ligand, the receptor can then send additional signals to other parts of the cell.
There are two main types of ligands: ligands that bind to receptors inside the cell, called intracellular ligands, and ligands that bind to receptors outside the cell, called extracellular ligands.
Lyme disease is caused by the bacterium Borrelia burgdorferi and is transmitted to humans through the bite of infected blacklegged ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migraines. If left untreated, infection can spread to joints, the heart, and the nervous system. Lyme disease is diagnosed based on symptoms, physical findings (e.g., rash), and the possibility of exposure to infected ticks; laboratory testing is helpful if used correctly and performed with validated methods. Most cases of Lyme disease can be treated successfully with a few weeks of antibiotics. Steps to prevent Lyme disease include using insect repellent, removing ticks promptly, applying pesticides, and reducing tick habitat. The ticks that transmit Lyme disease can occasionally transmit other tickborne diseases as well.
Source: CDC.gov
A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.
Source: NIH.gov
A lymphocyte is a type of white blood cell that is part of the immune system. There are two main types of lymphocytes: B cells and T cells. The B cells produce antibodies that are used to attack invading bacteria, viruses, and toxins. The T cells destroy the body’s own cells that have themselves been taken over by viruses or become cancerous.
Source: NIH.gov
Lymphopenia (also known as lymphocytopenia) is a disorder in which your blood doesn’t have enough white blood cells called lymphocytes. These cells are made in the bone marrow along with other kinds of blood cells. Lymphocytes help protect your body from infection. Low numbers of lymphocytes can raise your risk of infection.
Source: NIH.gov
A type of white blood cell that surrounds and kills microorganisms, removes dead cells, and stimulates the action of other immune system cells.
Source: NIH.gov
A complex of genes on chromosome 6 that code for the antigens that determine tissue and blood compatibility. In humans, histocompatibility antigens are called human leukocyte antigens (HLA) because they were originally discovered in large numbers on lymphocytes. There are thousands of combinations of HLA antigens. Class I MHC antigens (HLA-A, HLA-B, and HLA-C) are found on all nucleated cells and platelets. Class II antigens (HLA-DR, HLA-DQ, and HLA-DP) are found on lymphocytes and antigen processing cells and are important in the specific immune response. In tissue and organ transplantation, the extent to which the HLA or “tissue type” of the donor and recipient match is a major determinant of the success of the transplant.
The malar rash, or butterfly rash, is a red flat facial rash involving the malar region bilaterally and the bridge of the nose. The presence of a butterfly rash is generally a sign of lupus erythematosus (LE), but it can also include a plethora of conditions.
Source: NIH.gov
Informatics applied to medical knowledge, practice, management, education, and research. This process includes computer technology, internet access, and electronic applications and devices.
All of the energy and material transformations that occur within living cells. It includes material changes undergone by substances during all periods of life (growth, maturity, and senescence) and energy changes (transformations of chemical energy of foodstuffs to mechanical energy or heat). Metabolism involves the two fundamental processes of anabolism and catabolism.
A metabolite is any substance produced during metabolism (digestion or other bodily chemical processes). The term metabolite may also refer to the product that remains after a drug is broken down (metabolized) by the body.
Source: NIH.gov
A member of a group of enzymes that can break down proteins, such as collagen, that are normally found in the spaces between cells in tissues (i.e., extracellular matrix proteins). Because these enzymes need zinc or calcium atoms to work properly, they are called metalloproteinases. Matrix metalloproteinases are involved in wound healing, angiogenesis, and tumor cell metastasis.
Source: NIH.gov
Microbial metabolomics constitutes an integrated component of systems biology. By studying the complete set of metabolites within a microorganism and monitoring the global outcome of interactions between its development processes and the environment, metabolomics can potentially provide a more accurate snap shot of the actual physiological state of the cell.
Source: NIH.gov
Oligonucleotides that prevent a variety of messenger RNAs from being transcribed from DNA or translated into proteins. They typically consist of 21 to 25 linked nucleotides.
A signaling protein, i.e., a protein that circulates extracellularly influencing other cells to turn on the process of protein synthesis. These proteins have an effect on cellular replication and cellular death in inflammatory, ischemic, and malignant diseases.
Mixed connective tissue disease (MCTD) is a autoimmune disorder that causes overlapping features of three connective tissue disorders: lupus, scleroderma, and polymyositis. MCTD may also have features of rheumatoid arthritis. This condition is most often diagnosed in women in their 20’s and 30’s. Occasionally, children are affected. At this time the cause of this condition is unknown.
Source: NIH.gov
Antibodies produced by a single clone of cells; A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. There are many kinds of monoclonal antibodies. A monoclonal antibody is made so that it binds to only one substance. Monoclonal antibodies are being used to treat some types of cancer. They can be used alone or to carry drugs, toxins, or radioactive substances directly to cancer cells.
Source: NIH.gov
A mononuclear phagocytic white blood cell derived from myeloid stem cells. Monocytes circulate in the bloodstream for about 24 hr and then move into tissues, at which point they mature into macrophages, which are long lived. Monocytes and macrophages are one of the first lines of defense in the inflammatory process. This network of fixed and mobile phagocytes that engulf foreign antigens and cell debris previously was called the reticuloendothelial system and is now referred to as the mononuclear phagocyte system (MPS).
Pert. to the muscles and skeleton.
Myalgia is a term for muscle aches and pains. Muscle pain also can involve ligaments, tendons, and fascia, the soft tissues that connect muscles, bones, and organs.
Myalgia is most frequently related to tension, overuse, or muscle injury from exercise or physically-demanding work. In these situations, the pain tends to involve specific muscles and starts during or just after the activity. It is usually obvious which activity is causing the pain.
Muscle pain also can be a sign of conditions affecting your whole body, like some infections (including the flu) and disorders that affect connective tissues throughout the body (such as lupus).
Source: NIH.gov
An autoimmune motor disorder marked by muscular fatigue that develops with repetitive muscle use and improves with rest or with the application of a cold pack.
Granulocytes and monocytes, collectively called myeloid cells, are differentiated descendants from common progenitors derived from hematopoietic stem cells in the bone marrow. Commitment to either lineage of myeloid cells is controlled by distinct transcription factors followed by terminal differentiation in response to specific colony-stimulating factors and release into the circulation. Upon pathogen invasion, myeloid cells are rapidly recruited into local tissues via various chemokine receptors, where they are activated for phagocytosis as well as secretion of inflammatory cytokines, thereby playing major roles in innate immunity.
Source: NIH.gov
Death of tissue from deprivation of its blood supply.
Inflammation of the heart muscle, usually in the U.S. as a consequence of infections (viruses, esp. coxsackie virus, and occasionally as a consequence of bacterial, protozoan or fungal infections); immunological-rheumatological conditions (e.g., systemic lupus erythematosus, ulcerative colitis, hypersensitivity reactions, or transplant rejection); exposure to chemicals or toxins (e.g., cocaine, doxorubicin, methamphetamine); nutritional or metabolic abnormalities (e.g., thiamine deficiency or hypophosphatemia); or radiation. Myocarditis also is occasionally found in pregnancy and with advanced age. The myocardium is infiltrated by leukocytyes, lymphocytes, and macrophages, leading to inflammation, necrosis of muscle cells, and fibrosis. Inflammatory damage to heart muscle fibers may resolve spontaneously or may cause progressive deterioration of the heart with pericarditis, arrhythmias, chronic dilated cardiomyopathy, and heart failure.
Myositis is inflammation of your skeletal muscles, which are also called the voluntary muscles. These are the muscles you consciously control that help you move your body. An injury, infection or autoimmune disease can cause myositis.
The diseases dermatomyositis and polymyositis both involve myositis. Polymyositis causes muscle weakness, usually in the muscles closest to the trunk of your body. Dermatomyositis causes muscle weakness, plus a skin rash. Both diseases are usually treated with prednisone, a steroid medicine, and sometimes other medicines.
Source: NIH.gov
Neonatal lupus occurs when an infant passively acquires auto-antibodies from a mother with SLE. The skin, liver, and blood problems resolve by 6 months, but the most serious sign—congenital heart block—requires a pacemaker and has a mortality rate of about 20%
Source: CDC.gov
Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE or lupus). SLE is an autoimmune disease—a disorder in which the body’s immune system attacks the body’s own cells and organs. Up to 60 percent of people with SLE are diagnosed with lupus nephritis, which can lead to significant illness and even death.
Source: NIH.gov
The branch of medical science concerned with the structure and function of the kidneys and the prevention and treatment of kidney disease.
NETosis occurs when dying neutrophils release a web of DNA coated with anti-microbial proteins, forming a structure called a neutrophil extracellular trap (NET).
Source: NIAMS.NIH.gov
Neurologic disorders are diseases of the brain, spinal cord and nerves throughout your body. Together they control all the workings of the body. When something goes wrong with a part of your nervous system, you can have trouble moving, speaking, swallowing, breathing or learning. You can also have problems with your memory, senses or mood.
There are more than 600 neurologic diseases. Major types include Diseases caused by faulty genes, such as Huntington’s disease and muscular dystrophy
Problems with the way the nervous system develops, such as spina bifida Degenerative diseases, where nerve cells are damaged or die, such as Parkinson’s disease and Alzheimer’s disease
Diseases of the blood vessels that supply the brain, such as stroke
Injuries to the spinal cord and brain
Seizure disorders, such as epilepsy
Cancer, such as brain tumors infections, such as meningitis
Source: NIH.gov
A specialist in diseases of the nervous system.
Peripheral neuropathy describes damage to the peripheral nervous system, the vast communications network that transmits information from the brain and spinal cord (the central nervous system) to every other part of the body. Peripheral nerves also send sensory information back to the brain and spinal cord, such as a message that the feet are cold or a finger is burned. Damage to the peripheral nervous system interferes with these vital connections. Like static on a telephone line, peripheral neuropathy distorts and sometimes interrupts messages between the brain and the rest of the body.
Source: NIH.gov
Neuropsychiatric systemic lupus erythematosus (NPSLE) describes a wide range of brain-involved symptoms — symptoms like not thinking clearly, forgetting things or even seizures, stroke and psychosis—experienced by up to 95% of lupus patients.
Source: Schwartz, Noa, Ariel D. Stock, and Chaim Putterman. “Neuropsychiatric lupus: new mechanistic insights and future treatment directions.” Nature Reviews Rheumatology (2019): 1.
These extracellular, chromatin structures, which contain histones and neutrophil granule proteins, can trap and kill a broad spectrum of microbes, including Gram-positive and Gram-negative bacteria, fungi, protozoa and viruses.
Source: NIH.gov
A type of immune cell that is one of the first cell types to travel to the site of an infection. Neutrophils help fight infection by ingesting microorganisms and releasing enzymes that kill the microorganisms. A neutrophil is a type of white blood cell, a type of granulocyte, and a type of phagocyte.
Source: NIH.gov
For people with joint or chest pain or fever, drugs that decrease inflammation, called nonsteroidal anti-inflammatory drugs (NSAIDs), are often used. Although some NSAIDs, such as ibuprofen and naproxen, are available over the counter, a doctor’s prescription is necessary for others. NSAIDs may be used alone or in combination with other types of drugs to control pain, swelling, and fever. Even though some NSAIDs may be purchased without a prescription, it is important that they be taken under a doctor’s direction.
Source: NIAMS.NIH.gov
A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).
Source: ClinicalTrials.gov
Describes the legal use of a prescription drug to treat a disease or condition for which the drug has not been approved by the U.S. FDA.
Source: NCI
The Office within the U.S. Department of Health and Human Services that protects the rights, welfare, and well-being of people involved in clinical trials.
Source: NCI
Describes a clinical trial in which masking is not used. That means that all parties involved with the trial know which participants have been assigned which interventions.
Source: ClinicalTrials.gov
Studies that are currently recruiting participants, will be recruiting participants in the future, or involve drugs that are available for expanded access.
Source: ClinicalTrials.gov
A type of study in which both the health providers and the patients are aware of the drug or treatment being given.
Source: NCI
A physician who specializes in the treatment of disorders of the eye.
Oral ulcers are sores or open lesions in the mouth.
Source: NIH.gov
A part of the body that has a specific function, such as the lungs.
Source: NIH.gov
Osteoarthritis is the most common form of arthritis, affecting millions of people around the world. Often called wear-and-tear arthritis, osteoarthritis occurs when the protective cartilage on the ends of your bones wears down over time. While osteoarthritis can damage any joint in your body, the disorder most commonly affects joints in your hands, neck, lower back, knees and hips. Osteoarthritis gradually worsens with time, and no cure exists. But osteoarthritis treatments can slow the progression of the disease, relieve pain and improve joint function.
Source: MayoClinic.org
A cell derived from mesenchymal cells. It manufactures bone matrix.
A skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture. Bone strength reflects the integration of two main features: bone density and bone quality. Bone density is expressed as grams of mineral per area or volume and in any given individual is determined by peak bone mass and amount of bone loss. Bone quality refers to architecture, turnover, damage accumulation (e.g., microfractures) and mineralization. A fracture occurs when a failure-inducing force (e.g., trauma) is applied to osteoporotic bone. Thus, osteoporosis is a significant risk factor for fracture, and a distinction between risk factors that affect bone metabolism and risk factors for fracture must be made.
Source: NIH.gov
A specific result or effect that can be measured.
Source: NCI
A planned measurement described in the protocol that is used to determine the effect of interventions on participants in a clinical trial. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment.
Source: ClinicalTrials.gov
Outcomes research seeks to understand the end results of particular health care practices and interventions. End results include effects that people experience and care about, such as change in the ability to function. In particular, for individuals with chronic conditions—where cure is not always possible—end results include quality of life as well as mortality.
Source: HSS.edu
A rheumatological disorder with features suggestive of several kinds of connective tissue disease, but not definitively diagnostic of any single syndrome. Overlap syndromes typically have elements of systemic lupus erythematosus, rheumatoid arthritis, and progressive systemic sclerosis, among other illnesses.
Inflammation of subcutaneous fatty tissue. The most common form of the inflammation is erythema nodosum.
Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A “in parallel” to participants in the other group receiving drug B.
Source: ClinicalTrials.gov
The word pathology is derived from the Greek roots pathos, meaning “experience” or “suffering” and logia meaning “study of.” The word itself is commonly used in the broad sense of referring to the study of disease in general.
The care of children and the treatment of their diseases.
Peer review is the first stage of our grant decision-making process. All applications received are reviewed by top experts in the field, to determine whether or not those studies show great promise. After all, we only want to scrutinize the best projects most carefully. This crucial first step allows only the projects that have tremendous scientific merit and hold great promise for preventing, treating, and curing lupus, to advance to the second stage of the review process. That second stage is a process managed by our Scientific Advisory Board, where they take all of the top scoring applications, scrutinize them very carefully, and then make recommendations to our Board of Directors, for which ones we are actually going to fund.
Pericardial effusion is the buildup of fluid in the sac.
Source: NIH.gov
Pericarditis is a condition in which the sac-like covering around the heart (pericardium) becomes inflamed. The cause of pericarditis is often unknown or unproven, but is often the result of an infection such as:
Other causes include:
Source: NIH.gov
Peritonitis is inflammation of the peritoneum — a silk-like membrane that lines your inner abdominal wall and covers the organs within your abdomen — that is usually due to a bacterial or fungal infection. Peritonitis can result from any rupture (perforation) in your abdomen, or as a complication of other medical conditions.
Source: MayoClinic.org
Pernicious anemia is a condition in which the body can’t make enough healthy red blood cells because it doesn’t have enough vitamin B12.
Source: NIH.gov
Small, purplish, hemorrhagic spots on the skin that appear in patients with platelet deficiencies (thrombocytopenias) and in many febrile illnesses.
Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0–10 or 0–100 response. The content can vary and relates either to global health (e.g., how is your health overall) or to disease activity (e.g., how active is your arthritis).
Source: NIH.gov
White blood cells (neutrophils and macrophages) that can ingest and destroy microorganisms, cell debris, and other particles in the blood or tissues.
The stage of a clinical trial studying a drug or biological product, based on definitions by the FDA. The phase is based on the study’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4.
The first step in testing a new treatment in humans. A Phase I study tests the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment and how the treatment affects the body. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Phase I clinical trials include only a small number of patients who have not been helped by other treatments. Sometimes they include healthy volunteers.
Source: NCI
A study that tests the safety, side effects, and best dose of a new treatment. Phase I/II clinical trials also test how well a certain type of disease responds to a new treatment. In the phase II part of the clinical trial, patients usually receive the highest dose of treatment that did not cause harmful side effects in the phase I part of the clinical trial. Combining phases I and II may allow research questions to be answered more quickly or with fewer patients.
Source: NCI
A study that tests whether a new treatment works for a certain type of disease. Phase II clinical trials may also provide more information about the safety of the new treatment and how the treatment affects the body.
Source: NCI
A study that tests how well a new treatment works for a certain disease and compares the new treatment with a standard treatment. Phase II/III clinical trials may also provide more information about the safety and side effects of the new treatment. Combining phases II and III may allow research questions to be answered more quickly or with fewer patients.
Source: NCI
A study that tests the safety and how well a new treatment works compared with a standard treatment. In most cases, treatments move into phase III trials only after they meet the goals of phase I and II trials. Phase III clinical trials may include hundreds of people.
Source: NCI
A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time. Phase IV clinical trials may include thousands of people. Phase IV trials are also called post-marketing surveillance trials.
Source: NCI
A phenotype is an individual’s observable traits, such as height, eye color, and blood type. The genetic contribution to the phenotype is called the genotype. Some traits are largely determined by the genotype, while other traits are largely determined by environmental factors.
Source: NIH.gov
Inflammation of a vein.
An enzyme that catalyzes hydrolysis of a phospholipid.
Photosensitivity is an abnormal reaction to sunlight.
Source: NIH.gov
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.
Source: ClinicalTrials.gov
An inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial.
Source: NCI
Refers to a clinical study in which the patients in the control group receive a placebo.
Source: NCI
An antimalarial, antirheumatic drug, often used as a disease-modifying agent in rheumatoid arthritis, systemic lupus erythematosus, and some dermatological diseases.
The removal of plasma from a patient (usually to treat an immmunologically mediated illness such as thrombotic thrombocytopenic purpura or myasthenia gravis) and its replacement with normal plasma. Plasma exchange therapy can also be used to replace excessively viscous plasma in patients with Waldenström macroglobulinemia. Pathological antibodies, immune complexes, and protein-bound toxins are removed from the plasma by plasma exchange. Immunoglobulin infusions are an alternative to plasma exchange when treating some immunological illnesses, including Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy.
A round or oval disk, 2 to 4 μm in diameter, found in the blood of vertebrates. Platelets number 130,000 to 400,000/mm3. They are fragments of megakaryocytes, large cells found in the bone marrow.
Multiple, sometimes seemingly unrelated, effects produced by a single gene.
A serous membrane that enfolds both lungs and is reflected upon the walls of the thorax and diaphragm. The pleurae are moistened with a serous secretion that reduces friction during respiratory movements of the lungs.
A pleural effusion is a buildup of fluid between the layers of tissue that line the lungs and chest cavity.
Your body produces pleural fluid in small amounts to lubricate the surfaces of the pleura, the thin tissue that lines the chest cavity and surrounds the lungs. A pleural effusion is an abnormal, excessive collection of this fluid.
There are two different types:
Transudative pleural effusions are caused by fluid leaking into the pleural space. This is caused by increased pressure in the blood vessels or a low blood protein count. Congestive heart failure is the most common cause. Exudative effusions are caused by blocked blood vessels or lymph vessels, inflammation, lung injury, and tumors.
Source: NIH.gov
Pleurisy, also called pleuritis, is inflammation of the lining of the lungs and chest (the pleura) that leads to chest pain (usually sharp) when you take a breath or cough. Pleurisy may develop when you have lung inflammation due to infections such as pneumonia or tuberculosis. This inflammation also causes the sharp chest pain of pleurisy.
It may also occur with:
Source: NIH.gov
Vasculitis affecting medium and small arteries, particularly at the point of bifurcation and branching. Segmental inflammation and fibrinoid necrosis of blood vessels lead to ischemia of the areas normally supplied by these arteries. Signs and symptoms depend on the location of the affected vessels and organs, but patients usually present with symptoms of multisystem disease, including fever, malaise, weight loss, hypertension, renal failure, myalgia, peripheral neuritis, and gastrointestinal bleeding; these may occur episodically. Unlike most types of vasculitis, PAN does not affect glomerular capillaries although other renal vessels are involved. The disease is associated with hepatitis B and C.
A rheumatologic illness marked by fevers, malaise, weight loss, muscle pain, stiffness (esp. of the shoulders and pelvis), and morning stiffness. It occurs primarily, but not exclusively, in white people over 60. The cause of PMR is unknown. Although there is no single diagnostic test for PMR, patients typically have a markedly elevated erythrocyte sedimentation rate (>50 mm/hr) and no evidence of another disease (such as infection, cancer, rheumatoid arthritis, or lupus). Patients obtain rapid and durable relief from corticosteroids but usually require a course of treatment lasting 6 to 18 months. Pathologically, and sometimes clinically, PMR is related to giant cell arteritis. Mild cases may sometimes respond to nonsteroidal anti-inflammatory drugs.
A relatively uncommon inflammatory disease of skeletal muscles, marked by symmetrical weakness of the proximal muscles of the limbs, elevated serum muscle enzymes, evidence of muscle necrosis on biopsy, and electromyographic abnormalities.
A study of a group of individuals taken from the general population who share a common characteristic, such as age, sex, or health condition. This group may be studied for different reasons, such as their response to a drug or their risk of getting a disease.
Source: NCI
Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.
Source: NCI
Prednisone is used alone or with other medications to treat the symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Prednisone is also used to treat other conditions in patients with normal corticosteroid levels. These conditions include lupus, certain types of arthritis; severe allergic reactions; multiple sclerosis (a disease in which the nerves do not function properly); and certain conditions that affect the lungs, skin, eyes, kidneys blood, thyroid, stomach, and intestines. Prednisone is also sometimes used to treat the symptoms of certain types of cancer.
Prednisone is in a class of medications called corticosteroids. It works to treat patients with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It works to treat other conditions by reducing swelling and redness and by changing the way the immune system works.
Source: MedlinePlus.gov
The main result that is measured at the end of a study to see if a given treatment worked. What the primary endpoint will be is decided before the study begins.
Source: NCI
The planned outcome measure in the protocol that is the most important for evaluating the effect of an intervention. Most clinical studies have one primary outcome measure, but some may have more than one.
Source: ClinicalTrials.gov
The main reason for the clinical trial. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.
Source: ClinicalTrials.gov
The person who is responsible for the scientific and technical direction of the entire clinical study.
Source: ClinicalTrials.gov
Inflammation of the kidneys caused by an autoimmune disease called systemic lupus erythematosus. The condition can cause hematuria and proteinuria, and it may progress to end-stage renal disease. The most severe form of lupus nephritis, called diffuse proliferative nephritis, can cause scars to form in the kidneys. Scars are permanent, and kidney function often declines as more scars form. Early diagnosis and treatment may help prevent long-lasting damage.
Source: NIH.gov
Proteinuria (also called albuminuria or urine albumin) is a condition in which urine contains an abnormal amount of protein. Albumin is the main protein in the blood. Proteins are the building blocks for all body parts, including muscles, bones, hair, and nails. Proteins in the blood also perform a number of important functions. They protect the body from infection, help blood clot, and keep the right amount of fluid circulating throughout the body.
Proteinuria is a sign of chronic kidney disease (CKD). If CKD progresses, it can lead to end-stage renal disease (ESRD), when the kidneys fail completely. A person with ESRD must receive a kidney transplant or regular blood-cleansing treatments called dialysis.
Source: NIH.gov
Any of a family of molecules that are fundamental components of mucus and connective tissues. They are composed of sugars linked to polypeptides and are found in organs and tissues throughout the body.
The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.
Source: ClinicalTrials.gov
Psychosis is a loss of contact with reality, possibly including hallucinations or delusions. While neuropsychiatric manifestations are fairly common in systemic lupus erythematosus, psychosis is uncommon.
Source: NIH.gov
Published scientific articles or abstracts about a clinical study. A publication reference, also called a citation, may be submitted to ClinicalTrials.gov at any time. It can also be automatically identified by the NCT Number, which is indexed in MEDLINE®, a database of biomedical and life sciences journal citations.
Source: ClinicalTrials.gov
One of several different tests used to evaluate the condition of the respiratory system. Measures of expiratory flow and lung volumes and capacities are obtained. The forced vital capacity is one of the more important pulmonary function tests; it provides a measure of the amount of air that can be maximally exhaled after a maximum inspiration and the time required for that expiration. Pulmonary function tests can also determine the diffusion ability of the alveolar-capillary membrane.
Pulmonary hypertension occurs when the blood pressure in the pulmonary arteries, which carry oxygen and blood from the heart to the lungs, is much higher than normal.
Pulmonary hypertension usually occurs along with another disease or condition, such as pregnancy, heart and blood vessel diseases, lung diseases, liver diseases, sleep apnea, connective tissue diseases such as lupus and scleroderma, thyroid diseases, HIV infection, or use of certain diet medicines or illicit drugs.
In 2002, pulmonary hypertension led to 15,668 deaths and 260,000 hospital visits in the United States.
Pulmonary hypertension can affect men and women of all ages and racial/ethnic groups. However, the majority of people who have this condition are older women.
Source: CDC.gov
High dose pulse intravenous steroids with 1 g of methylprednisolone (MEP) given daily, usually for three days, is an accepted practice to treat severe manifestations of systemic lupus erythematosus (SLE) or systemic vasculitides, despite the lack of definitive data.
Source: NIH.gov
Any rash in which blood cells leak into the skin or mucous membranes, usually at multiple sites. Purpuric rashes often are associated with disorders of coagulation or thrombosis. Pinpoint purpuric lesions are called petechiae; larger hemorrhages into the skin are called ecchymoses.
When referring to an experiment or clinical trial, the process by which animal or human subjects are assigned by chance to separate groups that compare different treatments or other interventions. Randomization gives each participant an equal chance of being assigned to any of the groups.
A strategy in which participants are assigned to arms of a clinical trial by chance.
Source: ClinicalTrials.gov
A study in which participates are divided by chance into separate groups that compare treatments or other interventions. Using chance to divide people into groups means the groups will be similar and the potential effects of the treatment can be compared more fairly. At the time of the trial it is not known which treatment is best.
Source: NIH.gov
Raynaud’s Phenomenon is a rare disorder that affects the arteries. Arteries are blood vessels that carry blood from your heart to different parts of your body.
Raynaud’s sometimes is called a disease, syndrome, or phenomenon. The disorder is marked by brief episodes of vasospasm (VA-so-spazm), which is a narrowing of the blood vessels.
Vasospasm of the arteries reduces blood flow to the fingers and toes. In people who have Raynaud’s, the disorder usually affects the fingers. In about 40 percent of people who have Raynaud’s, it affects the toes. Rarely, the disorder affects the nose, ears, nipples, and lips.
Source: NIH.gov
A period of wellness, in which symptoms seem to be mild or absent.
Source: NIAMS.NIH.gov
Damage to or disease of a kidney.
Source: NIH.gov
A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes or groups of people by looking at data collected in the past or future.
Source: NCI
Looking back at events that have already taken place.
Source: NCI
A research study in which the past medical records of groups of individuals who are alike in many ways but differ by a certain characteristic are compared for a particular outcome. Also called historic cohort study.
Source: NCI
A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that that the other group was not exposed to. This is also called a case-control study.
Source: NCI
A general, imprecise, colloquial, and somewhat old-fashioned term for acute and chronic conditions marked by inflammation, muscle soreness and stiffness, and pain in joints and associated structures. It includes inflammatory arthritis (infectious, rheumatoid, gouty), arthritis due to rheumatic fever or trauma, degenerative joint disease, neurogenic arthropathy, hydroarthrosis, myositis, bursitis, and fibromyalgia.
Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness and loss of function in your joints. It can affect any joint but is common in the wrist and fingers. You might have the disease for only a short time, or symptoms might come and go. The severe form can last a lifetime.
Rheumatoid arthritis is different from osteoarthritis, the common arthritis that often comes with older age. RA can affect body parts besides joints, such as your eyes, mouth and lungs.
No one knows what causes rheumatoid arthritis. Genes, environment and hormones might contribute. Treatments include medicine, lifestyle changes and surgery.
Source: NIH.gov
Rheumatologist: A physician who specializes in rheumatic diseases. Rheumatology: Pert. to connective tissue disease (rheumatism).
The Scientific Advisory Board is comprised of leading lupus experts. Following the first stage of the peer review process, the Scientific Advisory Board conducts a second level of detailed analysis of the projects that are submitted to our organization. The goal is to make a determination about which of these excellent projects should actually be recommended to our board of directors for funding.
Any painful inflammatory disease of the sclera of the eye. It may result in degeneration or destruction of the sclera and neighboring tissues and is often associated with systemic inflammatory disease. It occurs much more commonly in the anterior sclera than in the posterior.
Scleroderma is a connective tissue disease that involves changes in the skin, blood vessels, muscles, and internal organs. It is a type of autoimmune disorder, a condition that occurs when the immune system mistakenly attacks and destroys healthy body tissue.
The cause of scleroderma is unknown. People with this condition have a buildup of a substance called collagen in the skin and other organs. This buildup leads to the symptoms of the disease.
The disease usually affects people 30 to 50 years old. Women get scleroderma more often than men do. Some people with scleroderma have a history of being around silica dust and polyvinyl chloride, but most do not.
Widespread scleroderma can occur with other autoimmune diseases, including systemic lupus erythematosus and polymyositis. In such cases, the disorder is referred to as mixed connective disease.
Source: NIH.gov
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. Most clinical studies have more than one secondary outcome measure.
Source: ClinicalTrials.gov
Sed rate, or erythrocyte sedimentation rate (ESR), is a blood test that can reveal inflammatory activity in your body. A sed rate test isn’t a stand-alone diagnostic tool, but it can help your doctor diagnose or monitor the progress of an inflammatory disease.
Source: MayoClinic.org
An error in choosing the individuals or groups to take part in a study. Ideally, the subjects in a study should be very similar to one another and to the larger population from which they are drawn. If there are important differences, the results of the study may not be valid.
Source: NCI
An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
Source: ClinicalTrials.gov
An inflammation of a serous membrane, such as the pleura, pericardium, or peritoneum. Serositis is one of the cardinal findings in connective tissue diseases like systemic lupus erythematosus.
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.
Source: ClinicalTrials.gov
Sialic acids are a family of sugar molecules that are often attached to proteins or fat molecules throughout the body. Sialic acids play a role in many of the body’s functions, including brain activity, interactions between immune cells, and kidney function.
A problem that occurs when treatment affects healthy tissues or organs.
Source: NCI
Biochemical conversion that is part of a process, such as the docking of hormone to receptor, stimulating cellular production of specific enzymes or other proteins.
Sjogren’s syndrome is a disease that causes dryness in your mouth and eyes. It can also lead to dryness in other places that need moisture, such as your nose, throat and skin. Most people who get Sjogren’s syndrome are older than 40. Nine of 10 are women. Sjogren’s syndrome is sometimes linked to rheumatic problems such as rheumatoid arthritis. In Sjogren’s syndrome, your immune system attacks the glands that make tears and saliva. It may also affect your joints, lungs, kidneys, blood vessels, digestive organs and nerves. The main symptoms are:
Treatment focuses on relieving symptoms.
Source: NIH.gov
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index. The widely used tool measures lupus activity including symptoms, lab results and complications.
This gene encodes an adapter protein that acts as a substrate of the T cell antigen receptor (TCR)-activated protein tyrosine kinase pathway. The encoded protein associates with growth factor receptor bound protein 2, and is thought to play a role TCR-mediated intracellular signal transduction. A similar protein in mouse plays a role in normal T-cell development and activation. Mice lacking this gene show subcutaneous and intraperitoneal fetal hemorrhaging, dysfunctional platelets and impaired viability.
Source: NIH.gov
The organization or person who initiates the study and who has authority and control over the study.
Source: ClinicalTrials.gov
The classification of objects into a hierarchy; the making of an ordered series of categories.
A medicine, vitamin, mineral, food supplement, or a combination of them that is being tested in a clinical trial.
Source: NCI
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”). The “estimated study completion date” is the date that researchers think will be the completion date for the study.
Source: ClinicalTrials.gov
Refers to the type of documents that the study sponsor or PI may add to their study record. These include a study protocol, statistical analysis plan, and an informed consent form.
Source: ClinicalTrials.gov
Describes the nature of a clinical study, such as interventional studies (also called clinical trials), observational studies, and expanded access.
Source: NCI
As with SLE, Subacute Cutaneous Lupus Erythematosus (SCLE) occurs primarily in young to middle aged women. SCLE is highly photosensitive, with 70-90% of patients meeting the ACR definition of abnormal photosensitivity.
Source: NIH.gov
The clinical study has stopped recruiting or enrolling participants early, but it may start again.
Source: ClinicalTrials.gov
Synovitis is an inflammation of the joint lining, called synovium. The symptoms are often of short duration and may change location although when caused by overuse tend to remain in one joint. The pain is usually more severe than expected based on the appearance of the joint on examination. In fact, sometimes there is pain without swelling or even tenderness in the joint, in which case the symptom is called “arthralgias” (literally meaning “joint pain” in Greek). Although synovitis has many different causes, the most common cause in an active healthy person is overuse.
A rheumatologist will try to determine the origin of pain, whether it is in the joint itself, true synovitis, or the tendons, referred to as tendonitis. Treatment usually consists of anti-inflammatory medications and rest.
Source: HSS.edu
Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs.
The underlying cause of autoimmune diseases is not fully known.
SLE is much more common in women than men. It may occur at any age, but appears most often in people between the ages of 10 and 50. African Americans and Asians are affected more often than people from other races.
SLE may also be caused by certain drugs.
Source: NIH.gov
A type of white blood cell. T-lymphocytes are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and may help fight cancer.
Follicular helper T (Tfh) cells are specialized providers of T cell help to B cells, and are essential for germinal center formation, affinity maturation, and the development of most high affinity antibodies and memory B cells.
Source: NIH.gov
A chronic inflammation of large arteries, usually the temporal, occipital, or ophthalmic arteries, identified on pathological specimens by the presence of giant cells. It causes thickening of the intima, with narrowing and eventual occlusion of the lumen. It typically occurs after age 50. Symptoms include headache, tenderness over the affected artery, loss of vision, and facial pain. The cause is unknown, but there may be a genetic predisposition in some families. Corticosteroids are usually administered.
The clinical study has stopped recruiting or enrolling participants early and will not start again. Participants are no longer being examined or treated.
Source: ClinicalTrials.gov
Thrombocytopenia is a condition in which your blood has a lower than normal number of blood cell fragments called platelets. When your blood has too few platelets, mild to serious bleeding can occur. Bleeding can occur inside your body (internal bleeding) or underneath your skin or from the surface of your skin (external bleeding).
Source: NIH.gov
A primary lymphoid organ located in the mediastinal cavity anterior to and above the heart, where it lies over the superior vena cava, aortic arch, and trachea. The thymus comprises two fused lobes, the right larger than the left. The lobes are partially divided into lobules, each of which has an outer cortex packed with immature and developing T lymphocytes (thymocytes) and an inner medulla containing a looser arrangement of mature T lymphocytes.
Antibody titer is a laboratory test that measures the level of antibodies in a blood sample.
The antibody level in the blood tells your doctor whether or not you have been exposed to an antigen or something that the body thinks is foreign. The body uses antibodies to attack and remove foreign substances.
Abnormal results may be due to:
Source: MedlinePlus.gov
Tolerance is the prevention of an immune response against a particular antigen. For instance, the immune system is generally tolerant of self-antigens, so it does not usually attack the body’s own cells, tissues, and organs. However, when tolerance is lost, disorders like autoimmune disease or food allergy may occur.
Source: NIH.gov
Producing immunological tolerance.
Toll-like receptors (TLRs) are an essential arm of the innate immune response to bacteria, viruses and fungi and link recognition of distinct features of these microbes to the induction of pro-inflammatory signaling pathways. These receptors are able to respond to broad classes of pathogens because each TLR recognizes specific conserved microbial features.
Source: NIH.gov
Surgical removal of a diseased or injured joint and its replacement with an orthosis.
A protein that regulates the activity of RNA polymerase
Source: NIH.gov
Regulatory T cells (Tregs) are a population of CD4+ T cells with a unique role in the immune response. Tregs are crucial in suppressing aberrant pathological immune responses in autoimmune diseases, transplantation, and graft-vs-host disease after allogeneic hematopoietic stem cell transplantation. Tregs are activated through the specific T-cell receptor, but their effector function is nonspecific and they regulate the local inflammatory response through cell-to-cell contact and cytokine secretion. Tregs secrete interleukin (IL)-9 (IL-9), IL-10, and transforming growth factor-beta 1 (TGF-beta 1), which aid in the mediation of immunosuppressive activity.
Source: MayoClinic.org
A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called clinical trial sponsor.
Source: NCI
A lesion of the skin or mucous membranes marked by inflammation, necrosis, and sloughing of damaged tissues. A wide variety of insults may produce ulcers, including trauma, caustic chemicals, intense heat or cold, arterial or venous stasis, cancers, drugs (such as nonsteroidal anti-inflammatory drugs [NSAIDs]), and infectious agents such as Herpes simplex or Helicobact
A clinical study that lacks a comparison (i.e. a control) group.
Source: NCI
The term undifferentiated connective tissue diseases is used to define conditions characterized by the presence of signs and symptoms suggestive of a systemic autoimmune disease that do not satisfy the classificative criteria for defined connective tissue diseases (CTD) such as systemic lupus erythematosus (SLE), Sjögren’s syndrome (SS), rheumatoid arthritis (RA) and others. A small percentage of patients presenting with an undifferentiated profile will develop during the first year follow up of a full blown CTD, however an average of 75% will maintain an undifferentiated clinical course. These patients may be defined as having a stable undifferentiated connective tissue diseases (UCTD). The most characteristic symptoms of UCTD are represented by arthritis and arthralgias, Raynaud’s phenomenon, leukopenia, while neurological and kidney involvement are virtually absent. Eighty percent of these patients have a single autoantibody specificity, more frequently anti-Ro and anti-RNP antibodies. Stable UCTD are considered as distinct clinical entities and therefore it has been proposed to define those conditions as UCTD. Classificative criteria have also been proposed and a work to better define them is still under way.
Source: NIH.gov
Intoxication caused by the body’s accumulation of metabolic by-products normally excreted by healthy kidneys.
Analysis of the urine.
Vasculitis is a condition that involves inflammation in the blood vessels. The condition occurs if your immune system attacks your blood vessels by mistake. This may happen as the result of an infection, a medicine, or another disease or condition.
Vasculitis can affect any of the body’s blood vessels. These include arteries, veins, and capillaries. Arteries carry blood from your heart to your body’s organs. Veins carry blood from your organs and limbs back to your heart. Capillaries connect the small arteries and veins.
Source: NIH.gov
Any of several kinds of colorless or nearly colorless cells of the immune system that circulate in the blood and lymph. Leukocytes comprise granulocytes and agranulocytes.
Neutrophils, 55% to 70% of all leukocytes, are the most numerous phagocytic cells and are a primary effector cell in inflammation. Eosinophils, 1% to 3% of total leukocytes, destroy parasites and are involved in allergic reactions. Basophils, less than 1% of all leukocytes, contain granules of histamine and heparin and are part of the inflammatory response to injury. Monocytes, 3% to 8% of all leukocytes, become macrophages and phagocytize pathogens and damaged cells, esp. in the tissue fluid. Lymphocytes, 20% to 35% of all leukocytes, have several functions: recognizing foreign antigens, producing antibodies, suppressing the immune response to prevent excess tissue damage, and becoming memory cells.
Leukocytes are formed from the undifferentiated stem cells that give rise to all blood cells. Those in the red bone marrow may become any of the five kinds of leukocytes. Those in the spleen and lymph nodes may become lymphocytes or monocytes. Those in the thymus become lymphocytes called T lymphocytes.
Source: MedlinePlus.gov
The clinical study stopped before enrolling its first participant.
Source: ClinicalTrials.gov