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Volume 2, 2013 | In This Issue
Lupus Clinical Trials - People Advancing Science >
Insights into Clinical Trials - One Doctor's Perspective >
Faces of Lupus - Transforming Personal Loss into Hope for Others >
Lupus News Corner >
Insights into Clinical Trials
One Doctor's Perspective
Dr. Andras Perl is in a unique position — he is a leading autoimmune disease expert whose clinical trials benefit from invaluable decades-long experience that bridges both scientific research and patient care.
Direct contact with patients allows Dr. Perl to see the benefits, shortcomings, and side effects of treatments firsthand. One of the things he looks for in patients is the effect a particular intervention has on the signaling pathways that are involved in abnormal immune system function.
"We can see to what extent we can normalize them and how treatment relates to improved disease activity," said Dr. Perl. "I find it very instructive to do clinical work and laboratory investigations — it's really informative. Without clinical trials, everything is completely uncontrolled."
In his more than 30 years of studying various aspects of autoimmune disease, Dr. Perl has been involved in a number of clinical trials organized by pharmaceutical companies. Recently, however, he is the designer and lead investigator of two lupus clinical trials based on the laboratory research that he has been conducting for the past 10 to 15 years.
In his latest clinical trial, Dr. Perl and his team at the Upstate Medical University of the State University of New York are looking at ways to replenish a lost natural antioxidant called glutathione (GSH) in the T cells of patients with lupus.
Recent research suggests that metabolic abnormalities in T-cell differentiation and activation play a key role in autoimmunity and lupus.
Dr. Perl's trial involves treatment with the amino acid N-acetycysteine (NAC). "The reason I chose NAC is that it is one of the amino acid components of GSH — and GSH is the primary antioxidant within all living cells," he explained.
Dr. Perl has done extensive research into new treatments for lupus that avoid the significant side effects of existing therapies. In his current trial, he seeks to prove that NAC improves lupus disease activity by blocking mTOR — a protein that may control signaling pathways in metabolism and the differentiation of lymphocytes within the immune system. mTOR activation may play a central part in abnormal signaling in lupus.
The early findings of Dr. Perl's work — which were published in Arthritis and Rheumatismin September 2012 — hold great promise. Within the context of this clinical trial, Dr. Perl was able to show that NAC gets absorbed into lymphocytes and reverses the depletion of GSH.
The invaluable information gained in understanding lupus would not have been possible without this clinical trial. "You get a straight answer in clinical trials. And working with an agent like NAC is really great because it doesn't have any side effects. I am so encouraged by our initial findings," said Dr. Perl.
Although the ALR does not currently fund clinical trials, the organization has been critical to Dr. Perl's laboratory work by granting him two of our Target Identification in Lupus grants. "The ALR has been instrumental. With its funding, we discovered more about mitrochrondrial dysfunction in lupus. We further characterized it. We discovered mTOR activation in lupus and the vital role that NAC may play," Dr. Perl expressed with gratitude.
The clinical study stopped before enrolling its first participant.
Source: Clinicaltrials.gov
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.org
Uremia is a term used to loosely describe the illness accompanying kidney failure (also called renal failure), in particular the nitrogenous waste products associated with the failure of this organ.This is not to be confused with uricemia, or hyperuricemia, a build up of uric acid in the blood.
In kidney failure, urea and other waste products, which are normally excreted into the urine, are retained in the blood. Early symptoms include anorexia and lethargy, and late symptoms can include decreased mental acuity and coma. Other symptoms include fatigue, nausea, vomiting, cold, bone pain, itch, shortness of breath, and seizures. It is usually diagnosed in kidney dialysis patients when the glomerular filtration rate, a measure of kidney function, is below 50% of normal.
Source: Wikipedia.org
Undifferentiated connective tissue diseases
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
Playing a unique role in the immune system, Tregs — or Regulatory T cells — are crucial in suppressing aberrant pathological immune responses in autoimmune diseases like lupus. These cells help the immune system from attacking healthy tissue.
Acting as a system of checks and balances, Tregs prevent excessive reactions within the body.
Transcription fators
Transcription factors are proteins involved in the process of converting, or transcribing, DNA into RNA. Transcription factors include a wide number of proteins, excluding RNA polymerase, that initiate and regulate the transcription of genes. One distinct feature of transcription factors is that they have DNA-binding domains that give them the ability to bind to specific sequences of DNA called enhancer or promoter sequences. Some transcription factors bind to a DNA promoter sequence near the transcription start site and help form the transcription initiation complex. Other transcription factors bind to regulatory sequences, such as enhancer sequences, and can either stimulate or repress transcription of the related gene. These regulatory sequences can be thousands of base pairs upstream or downstream from the gene being transcribed. Regulation of transcription is the most common form of gene control. The action of transcription factors allows for unique expression of each gene in different cell types and during development.
Source: Scitable, by Nature Education
Total Joint Replaement
An arthritic or damaged joint is removed and replaced with an artificial joint, called a prosthesis. The goal is to relieve the pain in the joint caused by the damage done to the cartilage. The pain may be so severe, a person will avoid using the joint, weakening the muscles around the joint and making it even more difficult to move the joint. A physical examination, and possibly some laboratory tests and X-rays, will show the extent of damage to the joint. Total joint replacement will be considered if other treatment options will not relieve the pain and disability.
Source: American Academy of Orthopaedic Surgeons
Toll-Like Receptors
Toll- like receptors (TLR) play a critical role in early immune response to invading pathogens. The signaling by TLRs result in a variety of cellular responses including the production of interferons and pro-inflammatory cytokines that direct immune response.
Capable of producing immunological tolerance.
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
T Follicular Helper cells (TFH)
T follicular helper cells (TFH) are a type of helper T cells that direct the development of antibodies. TFH cells normally function to direct B cells to make antibodies against pathogens.
However, an increase in their number or function is associated with lupus, and their accelerated development or persistence is believed to drive the production of those dangerous autoantibodies. The ALR is currently funding a study to better understand the function of TFH.
T cells
T cells are a type of blood cell that belong to a group of white blood cells (WBCs) called lymphocytes, which help the body fight infection. T cells play a major role in protecting the immune system by identifying, directly attacking, and destroying infectious agents.
Like B cells, T cells are produced in bone marrow. But unlike B cells, they mature and develop in the thymus, an organ in the chest — hence the name, T cells. When fully matured, T cells are present in the blood and lymph nodes.
The function of B cells and T cells is vital to the immune system, allowing humans to ward off and better cope with often-hostile bacteria, viruses, and other foreign matter.
Systemic Lupus Erytematosus (SLE)
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: US National Library of Medicine
Systemic refers to something that is spread throughout, system-wide, affecting a group or system such as a body, economy, market or society as a whole.
Source: Wikipedia.org
Synovitis is the medical term for inflammation of the synovial membrane. This membrane lines joints which possess cavities, known as synovial joints. The condition is usually painful, particularly when the joint is moved. The joint usually swells due to synovial fluid collection.
Synovitis may occur in association with arthritis as well as lupus, gout, and other conditions. Synovitis is more commonly found in rheumatoid arthritis than in other forms of arthritis, and can thus serve as a distinguishing factor, although it can be present to a lesser degree in osteoarthritis. Long term occurrence of synovitis can result in degeneration of the joint.
Source: Wikipedia.org
The clinical study has stopped recruiting or enrolling participants early, but it may start again.
Source: Clinicaltrials.gov
Sub-acute Cutaneous Lupus Erythematosus (SCLE)
Sub-acute cutaneous lupus (SCLE) is one of three subsets of the general lupus skin disorder called cutaneous lupus erythematosus.
Characterized by lesions that appear on parts of the body that are exposed to sun, SCLE makes up approximately 10 percent of lupus cases. Lesions from SCLE do not cause permanent scarring.
Study completion date
The date that the final data for a clinical study were collected because the last study participant has made the final visit to the study location (that is, "last subject, last visit"). The "estimated study completion date" is the date that researchers think will be the completion date for the study.
Source: Clinicaltrials.gov
Classification of a mass of data (obtained from research or survey) into categories and sub-categories on the basis of one or more chosen criteria.
Steroids is the shortened term for corticosteroids, a drug commonly used to reduce inflammation in lupus. The term steroids is not to be confused with the male hormone-related steroid compounds designed to enhance athletic performance.
SLP76 an adaptor protein involved in signaling through the T cell antigen receptor complex and signaling in other hematopoietic lineages including platelets. Platelets deficient in SLP76 do not couple GPVI engagement with the signaling cascade that induces degranulation and aggregation in response to collagen.
Source: PhosphoSitePlus
A disease activity index for lupus patients- Find here
Sjogren's syndrome
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:
- Dry eyes
- Dry mouth
Treatment focuses on relieving symptoms.
Source: NIH.gov
Signal Transduction
A basic process in molecular cell biology involving the conversion of a signal from outside the cell to a functional change within the cell. A signal (such as a hormone or neurotransmitter) interacts with a receptor on the cell surface; this interaction causes a change in a second messenger (such calcium); and, eventually, a change is triggered in the cell's function (for example, the cell divides).
Source: MedicineNet.com
Sham comparator arm
A group of participants that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components.
Source: Clinicaltrials.gov
Serositis refers to inflammation of the serous tissues of the body, the tissues lining the lungs (pleura), heart (pericardium), and the inner lining of the abdomen (peritoneum) and organs within. It is commonly found with fat wrapping or creeping fat.
Source: Wikipedia.org
Serious adverse event
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
Secondary outcome measure
A planned outcome measure in the protocol that is not as important as the primary outcome measure, but is still of interest in evaluating the effect of an intervention. Most clinical studies have more than one secondary outcome measure.
Source: Clinicaltrials.gov
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
Rheumatoid arthritis
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
Rheumatism or rheumatic disorder is a non-specific term for medical problems affecting the joints and connective tissue. The study of, and therapeutic interventions in, such disorders is called rheumatology.
Source: Wikipedia.org
Renal disorder
Renal disorder, or nephropathy, means damage to or disease of a kidney. Nephrosis is non-inflammatory nephropathy. Nephritis is inflammatory kidney disease.
Source: Wikipedia.org
Raynaud's phenomenon
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
Randomized Allocation
A strategy in which participants are assigned to arms of a clinical trial by chance.
Source: Clinicaltrials.gov
Pulmonary hypertension
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
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
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
Proteoglycans are glycosylated proteins which have covalently attached highly anionic glycosaminoglycans. Many forms of proteoglycans are present in virtually all extracellular matrices of connective tissues. The major biological function of proteoglycans derives from the physicochemical characteristics of the glycosaminoglycan component of the molecule, which provides hydration and swelling pressure to the tissue enabling it to withstand compressional forces. This function is best illustrated by the most abundant proteoglycan in cartilage tissues, aggrecan.
Source: National Center for Biotechnology Information
Proteoglycans are glycosylated proteins which have covalently attached highly anionic glycosaminoglycans. Many forms of proteoglycans are present in virtually all extracellular matrices of connective tissues. The major biological function of proteoglycans derives from the physicochemical characteristics of the glycosaminoglycan component of the molecule, which provides hydration and swelling pressure to the tissue enabling it to withstand compressional forces. This function is best illustrated by the most abundant proteoglycan in cartilage tissues, aggrecan.
Source: National Center for Biotechnology Information
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.
Sources: NIH.gov
Proliferative lupus nephritis
The term for severe stages of lupus nephritis — or inflammation of the kidneys due to lupus – is proliferative lupus nephritis. Lupus nephritis is a serious condition, which occurs when autoantibodies affect the filtering structure of the kidneys. Proliferative lupus nephritis may lead to blood or protein in the urine, impaired kidney function, or even kidney failure.
At any stage of lupus nephritis, early diagnosis and treatment can greatly improve outcomes.
Primary outcome measure
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
Pleurisy 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:
- Asbestos-related disease
- Certain cancers
- Chest trauma
- Pulmonary embolus
- Rheumatoid arthritis
- Lupus
Source: NIH.gov
Pleural effusion
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
The phenomenon of one gene being responsible for or affecting more than one phenotypic characteristic.
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
Photosensitivity is an abnormal reaction to sunlight
Source: NIH.gov
Phopholipases are a group of enzymes that catalyze the cleavage of phospholipids. While some phospholipases possess substrate specificity for certain phospholipid species, some can catalyze the cleavage of other lipophillic molecules (such as triacylglycerols) in addition to phospholipids.
Source: AOCS Lipid Library
Phlebitis is an inflammation of a vein, usually in the legs.
When phlebitis is associated with the formation of blood clots (thrombosis), usually in the deep veins of the legs, the condition is called thrombophlebitis. These clots can travel to the lungs, causing pulmonary embolisms that can be fatal.
Source: Wikipedia.org
The term phenotype refers to the physical or biochemical characteristics of an organism as determined by its genetic makeup.
A cell that can engulf particles, such as bacteria and other microorganisms or foreign matter. The principal phagocytes include the neutrophils and monocytes, both of which are types of white blood cells.
Source: MedicineNet.com
PGA, short for "Physician's Global Assessment," is a term that refers to the scale of a patient's well being based on the impression of the clinician. Ratings are made on a scale from 0 to 3, measuring the severity of disease (0 = inactive, 1 = mild, 2 = moderate, 3 = severe).
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:
- Viral infections that cause a chest cold or pneumonia, such as the echovirus or coxsackie virus (which are common in children), as well as influenza
- Infections with bacteria (much less common) and some fungal infections (even more rare)
Other causes include:
- Heart attack
- Heart surgery or trauma to the chest, esophagus, or heart
- Certain medications and some drugs used to treat cancer or suppress the immune system
- Swelling or inflammation of the heart muscle
Source: NIH.gov
Pericardial effusion
Pericardial effusion is the buildup of fluid in the sac
Source: NIH.gov
Peer Review
The field of medicine that is concerned with the health of infants, children, and adolescents; their growth and development; and their opportunity to achieve full potential as adults.
Source: MedicineNet.com
Parallel Design
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
Outcomes Research
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: US Dept. of Health & Human Services, Agency for Heathcare Research and Quality
Outcome measure
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
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: The National Institutes of Health
A cell that makes bone. It does so by producing a matrix that then becomes mineralized. Bone mass is maintained by a balance between the activity of osteoblasts that form bone and other cells called osteoclasts that break it down.
Source: MedicineNet.com
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: Mayo Clinic
Oral ulcers
Oral ulcers are sores or open lesions in the mouth.
Source: NIH.gov
Open studies
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
Open Label
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: Clinicaltrial.gov
Observational Study
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: Clinicaltrial.gov
Nucleic Acid Binding Polymers (NABPs)
Nucleic acids are molecules that are essential to the structure of DNA, RNA, and all forms of life. A polymer is a large molecule composed of many smaller molecules lined together.
NABPs inhibit toll-like receptor (TLRs) activation and subsequent cytokine production of dendritic cells and B cells. In lupus, TLRs play a critical role in innate and adaptive immune responses by responding to pathogenic nucleic acids.
With funding from the Alliance for Lupus Research, David Pisetsky, MD, PhD, from Duke University Medical Center, NC is looking at ways that NABPs can be used in lupus treatment. "These polymers can bind tightly to DNA and RNA and prevent the formation of immune complexes and the resulting stimulation of internal receptors. The hope is that the polymers will be able to block the ability of extracellular nucleic acids to stimulate immune system activity that can underlie autoimmunity," said Dr. Pisetsky.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
The muscle and joint pain associated with lupus—as well as other chronic conditions where inflammation is present—are most often treated with non-steroidal anti-inflammatory drugs (NSAIDs). Examples of over-the-counter NSAIDs are aspirin and ibuprofen.
NSAIDs work by preventing an enzyme called cyclooxygenase from functioning. This enzyme protects the stomach lining, which is why NSAIDs can cause stomach upset and bleeding.
The most abundant type of white blood cells in humans, neutrophils are important for the defense against infection. Neutrophils are fast acting, arriving at the site of infection within an hour. They can ingest and kill bacteria and are the main component of pus.
More than 50 percent of all white blood cells occurring in the human body are neutrophils.
With ALR funding Michael Denny, PhD, at Temple University in Philadelphia, PA, worked to broaden the understanding of the relationship between neutrophils and lupus. Dr. Denny and his team identified an abnormal pool of neutrophils in people with the disease. "These cells may contribute to disease manifestation like skin rashes," explained Dr. Denny.
Neutrophil extracellular traps (NETs)
Neutrophil extracellular traps (NETs) are chromatin structures loaded with antimicrobial molecules. They can trap and kill various bacterial, fungal and protozoal pathogens, and their release is one of the first lines of defense against pathogens.
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
Neurologic disorders
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
When, in the living body of a plant or animal, NETs are released during a form of pathogen-induced cell death.
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
Neonatal lupus
Neonatal lupus is a rare condition – about 1 to 2 percent of babies born to mothers who have autoimmune disease or carry the antibodies to SSA/Ro and/or SSB/La [1,2] will develop neonatal lupus. The disease is presumed to be the result of these antibodies crossing the placenta in pregnancy from mother to her developing baby.
Neonatal lupus is usually benign and the signs — such as skin rash, liver problems, and low blood cell counts —are generally short lived. Symptoms usually disappear within months after birth, when infants begin to develop their own immune system — and, the mother's antibodies leave the baby's body.
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
Sources: NIH.gov
Myeloid Cells
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: National Center for Biotechnology Information
Monoclonal antibodies
Naturally occurring in the human body, antibodies are a "sticky" protein that targets a specific antigen. These antibodies circulate in the body, find and attach to the antigen, and recruit other parts of the immune system to destroy the cells containing the antigen.
A monoclonal antibody is a man-made, laboratory-produced protein that is designed to target a certain antigen. The advantage of infection-fighting proteins is that they are highly specific, identical, and can be produced in large quantities.
Monoclonal antibodies are now used as therapies for a number of diseases.
Mixed connective tissue disease
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
Mitogen-activated Protein Kinase (MAPK)
Signal transduction networks allow cells to perceive changes in the extracellular environment and to mount an appropriate response. Mitogen-activated protein kinase (MAPK) cascades are among the most thoroughly studied of signal transduction systems and have been shown to participate in a diverse array of cellular programs, including cell differentiation, cell movement, cell division, and cell death.
Source: American Society for Microbiology
Found in plants and mammals, microRNAs (miRNA) are small RNA molecules, which increase or decrease the production of specific gene protein or RNA. Aberrant expression of miRNA has been seen in numerous disease states.
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: National Cancer Institute, National Institutes of Health
The whole range of biochemical processes that occur within a living organism. Metabolism consists of anabolism (the buildup of substances) and catabolism (the breakdown of substances). The term metabolism is commonly used to refer specifically to the breakdown of food and its transformation into energy.
Source: MedicineNet.com
Medical Informatics
Health or Medical Informatics is the "scientific field that deals with biomedical information, data, and knowledge - their storage, retrieval, and optimal use for problem solving and decision making. It accordingly touches on all basic and applied fields in biomedical science and is closely tied to modern information technologies, notably in the areas of computing and communication (medical computer science)"
Source: Opencllinical.org
Major Histocompatibility Complex (MHC)
Cells continually break apart a few of their old, obsolete proteins and display the pieces on their surfaces. The small peptides are held in MHC, the major histocompatibility complex, which grips the peptides and allow the immune system to examine them. In this way, the immune system can monitor what is going on inside the cell. If all the peptides displayed on the cell surface are normal, the immune system leaves the cell alone. But if there is a virus multiplying inside the cell, many of the MHC molecules carry unusual peptides from viral proteins, and the immune system kills the cell.
Source: Protein Data Bank
The role of microphages is not completely known, but scientific research has shown that these cells attack foreign substances and infectious microbes through destruction and ingestion. Derived from Greek, macrophages translates as "big eaters."
Recent research suggests that macrophages in people with lupus may have intrinsic defects that hamper its normal function.
A lymphocyte is a type of white blood cell that is responsible for immune responses.
Lymph nodes
Lymph nodes are small organs of the immune system spread throughout the body. They behave as filters or traps for foreign particles. Lymph nodes contain cells that become lymphocytes and are important in the proper functioning of the immune system.
Lyme Disease
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 migrans. 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: Centers for Disease Control and Prevention
Lupus Mouse Model
Mouse models have significantly contributed to our understanding of the pathogenesis of SLE (Systemic lupus erythematosus). Unlike most other mouse models of autoimmunity and inflammation, SLE in mice closely resembles human SLE, including autoantibody production and renal disease. Congenic strains have allowed researchers to study the complicated genetics of SLE, both polygenic and at the single-gene level. There are many mouse models of SLE, and choosing the most appropriate for a question of interest requires an understanding of the clinical, pathological, and genetic features of each model. There are two main categories of mouse models of SLE: spontaneous (and their congenic counterparts) and induced (which includes gene targeting).
Source: Sage Journals, Veterinary Pathology
Lupus is one of many disorders of the immune system known as autoimmune diseases. In autoimmune diseases, the immune system turns against parts of the body it is designed to protect. This leads to inflammation and damage to various body tissues. Lupus can affect many parts of the body, including the joints, skin, kidneys, heart, lungs, blood vessels, and brain. Although people with the disease may have many different symptoms, some of the most common ones include extreme fatigue, painful or swollen joints (arthritis), unexplained fever, skin rashes, and kidney problems.
Another word for "fat." A lipid is chemically defined as a substance that is insoluble in water and soluble in alcohol, ether, and chloroform. Lipids are an important component of living cells. Together with carbohydrates and proteins, lipids are the main constituents of plant and animal cells. Cholesterol and triglycerides are lipids. Lipids are easily stored in the body. They serve as a source of fuel and are an important constituent of the structure of cells. Lipids include fatty acids, neutral fats, waxes and steroids (like cortisone). Compound lipids (lipids complexed with another type of chemical compound) comprise the lipoproteins, glycolipids and phospholipids.
Source: MedicineNet.com
Leukopenia is an abnormal reduction of circulating white blood cells, especially the granulocytes. The term leukopenia is often used interchangeably with neutropenia. It may result from reduced production of white blood cells or increased utilization and destruction, or both. Infection, drugs, malignancy, megaloblastosis, hypersplenism and immunoneutropenia are responsible for most cases of neutropenia. Primary neutropenia is very rare. Sometimes, particularly in children, primary neutropenia is hereditary and may be associated with other developmental defects. The major danger of neutropenia is the risk of infection. Management requires identification of the cause and effective antimicrobial therapy, especially when serious systemic infection is present.
Source: NIH.gov
A lesion is any abnormality in the tissue of an organism (in layman's terms, "damage"), usually caused by disease or trauma. Lesion is derived from the Latin word laesio which means injury.
Source: Wikipedia.org
Kinase inhibitor
A protein kinase inhibitor is a type of enzyme inhibitor that blocks the action of one or more protein kinases. Protein kinases are enzymes that add a phosphate (PO4) group to a protein or other organic molecule. Phosphate groups can turn a protein off.
Juvenile Idiopathic Arthritis (JIA)
The most prevalent form of juvenile arthritis is juvenile idiopathic arthritis (JIA) (also known as juvenile rheumatoid arthritis, or JRA). Arthritis is an inflammation of the joints that is characterized by swelling, heat, and pain. Nearly 300,000 children in the United States have some sort of arthritis. Arthritis can be short-term — lasting for just a few weeks or months, then going away forever — or it can be chronic and last for months or years. In rare cases, it can last a lifetime. JIA usually appears in kids between 6 months and 16 years old. The first signs often are joint pain or swelling and reddened or warm joints. Many rheumatologists (doctors specializing in joint disorders) find that the greater the number of joints affected, the more severe the disease and the less likely that the symptoms will eventually go into total remission.
Source: Kidshealth.org
Janus Kinase Inhibitors (JAK)
Janus kinase inhibitors also known as JAK inhibitors are a type of medication that functions by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2), thereby interfering with the JAK-STAT signaling pathway. These inhibitors have therapeutic application in the treatment of cancer and inflammatory diseases.
Intravenous (IV) infusion
Intravenous infusion or IV infusion is a medical term that describes the way certain kinds of medicines or other substances, such as nutrition, are delivered to the body. This method is often used when the substance cannot be taken orally. Sometimes the therapy must bypass the gut or go directly into the veins.
Many therapies are delivered via IV infusion—including intravenous steroids and chemotherapeutic agents for people with lupus.
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
Interferon Regulatory Factor 5 (IRF 5)
IRF5 is one of the interferon regulatory factors, a group of transcription factors with diverse roles within the body. Among its many functions, IRF-5 influences virus-mediated activation of interferon, the modulation of cell growth, differentiation, apoptosis, and immune system activity.
It acts as a molecular switch that controls whether macrophages will promote or inhibit inflammation. The ALR has funded investigations to better grasp an understanding of RF5 in regard to lupus manifestation.
Interferons (IFNs) are proteins made and released by host cells in response to the presence of pathogens such as viruses, bacteria, parasites or tumor cells. They allow for communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors.
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: National Center for Biotechnology Information
Innate Immunity
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: National Center for Biotechnology Information
Informed Consent
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
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
Inclusion Criteria
The factors (or reasons) that allow a person to participate in a clinical study.
Source: Clincaltrials.gov
Immunosuppressive is a term that refers to the lowering of the body's normal immune response. It can occur naturally through the aging process, as the side effect of medical therapy, or it can be deliberately induced to treat diseases like lupus.
In lupus, immunosuppressive drugs are sometimes used to address the hyperactivity of the immune system, which triggers the inflammatory response and can cause severe pain in the joints, skin, and kidneys of patients with the disease.
Immunosuppressive drugs are also used to prevent the body from rejecting a transplanted organ. Along the same lines, this therapy is used in lupus to prevent the from body attacking or rejecting healthy tissue.
Alteration of the immune system or of an immune response by agents that activate or suppress its function.
Immunologic disorder
An immunologic disorder is a dysfunction of the immune system. These disorders can be characterized in several different ways:
- By the component(s) of the immune system affected
- By whether the immune system is overactive or underactive
- By whether the condition is congenital or acquired
It has been suggested that most people have at least one primary immunodeficiency. Due to redundancies in the immune system, though, many of these are never detected.
Source: Wikipedia.org
(see antibodies)
Immune system
The human immune system is a complicated organization of cells and pathways within the body that seeks and responds to foreign invaders such as bacteria, viruses, and other infectious agents — as well as foreign material such as pollen. Composed of numerous and varied cells—each with a specific task — the immune system is the body's defense mechanism.
Immune Response
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: US National Library of Medicine
Immune complex
Immune complex occurs when an antibody binds to an antigen, such as toxins, microorganisms, and proteins that are foreign to the body. Immune complex molecules help fight disease—but in lupus, individuals form autoantibodies that attack the person's own tissue and organs.
IgG (Immunoglobulin G)
IgG is a type of antibody. Found in all body fluids — and the main antibody found in blood — IgG protects against bacterial and viral infections.
Measuring immunoglobulin levels is useful in evaluating patients for autoimmune conditions such as lupus, rheumatoid arthritis, and celiac disease.
Enlargement or overgrowth of an organ or part of the body due to the increased size of the constituent cells.
Source: MEdicineNet.com
Human Subjects Review Board
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
The production of all types of blood cells including formation, development, and differentiation of blood cells. Prenatally, hematopoiesis occurs in the yolk sack, then in the liver, and lastly in the bone marrow. In the normal situation, hematopoiesis in adults occurs in the bone marrow and lymphatic tissues. All types of blood cells are derived from primitive cells (stem cells) that are pluripotent (they have the potential to develop into all types of blood cells).
Source: MedicineNet.com
Hematologic disorders
Hematolic 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
- Platelet disorders, excessive clotting, and bleeding problems, which affect how your blood clots
- Anemia, which happens when your blood does not carry enough oxygen to the rest of your body
- Cancers of the blood, such as leukemia and myeloma
- Eosinophilic disorders, which are problems with one type of white blood cell.
Source: NIH.gov
Health Authority
A national or international health organization that has authority over the clinical study.
Source: Clincialtrials.gov
Growth Factor
A growth factor is a naturally occurring substance capable of stimulating cellular growth, proliferation, healing, and cellular differentiation. Usually it is a protein or a steroid hormone.
Source: Dorland's Medical Dictionary
Glycosaminoglycans (GAGs) or mucopolysaccharides are long unbranched polysaccharides consisting of a repeating disaccharide unit. The repeating unit (except for keratan) consists of an amino sugar (N-acetylglucosamine or N-acetylgalactosamine) along with a uronic sugar (glucuronic acid or iduronic acid) or galactose. Glycosaminoglycans are highly polar and attract water. They are therefore useful to the body as a lubricant or as a shock absorber.
Source: Dorland's Medical Dictionary
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
Genetic Linkage Analysis
Traditionally, the search for a disease gene begins with linkage analysis. In this approach, the aim is to find out the rough location of the gene relative to another DNA sequence called a genetic marker, which has its position already known. The principle of linkage analysis is simple. All our chromosomes come in pairs, one inherited from our mother and one from our father. Each pair of chromosomes contains the same genes in the same order, but the sequences are not identical. This means it should be easy to find out whether a particular sequence comes from our mother or father. These sequence variants are called maternal and paternal alleles.
In the case of the disease gene, the alternative alleles will be the normal allele and the disease allele, and they can be distinguished by looking for occurrences of the disease in a family tree or pedigree. Genetic markers are DNA sequences that show polymorphism (variations in size or sequence) in the population.
Source: Genome.Wellcome.au.uk, Richard Twyman
Gene Regulation
- 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: National Human Genome Researh Institute
Gene Expression
- 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: National Human Genome Research Institue
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: US National Library of Medicine
Function of B-cells and T-cells
B-cells and T-cells work together. When a T-cell recognizes an antigen, it will produce chemicals known as cytokines that cause B-cells to multiply and release many immune proteins (antibodies). Circulating widely in the bloodstream, antibodies recognize foreign particles and trigger inflammation to help the body rid itself of the virus or bacteria.
B-cells and T-cells play a vital role in protecting the immune system.
A fracture is a broken bone. A bone may be completely fractured or partially fractured in any number of ways (crosswise, lengthwise, in multiple pieces).
Source: American Academy of Orthopaedic Surgeons
Flares can refer to either the recurrence of symptoms or an onset of more severe symptoms.
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")
- Problems with thinking and memory (sometimes called "fibro fog")
Source: CDC.gov
- 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: Naational Human Genome Research Institute
The FDA (or Food and Drug Administration) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products.
Source: Wikipedia.org
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: US National Library of Mdicine
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: US National Library of Mdicine
Factorial Desgin
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.
Extracellular Matrix (ECM) proteins
The complex extracellular matrix (ECM) surrounds and supports cells. In mammalian tissues the ECM is most commonly found in connective tissues such as tendon, cartilage, bone or dermis of the skin. Structural ECM proteins consist primarily of the collagen and elastin families of proteins. Collagen fibers strengthen and organize the matrix; elastin fibers provide flexibility and resilience. Nonstructural ECM proteins, such as fibronectin, laminin, and tenascin, serve more of an adhesive or integral role; these proteins allow for cell attachment and form crosslinks within the matrix gel. Finally, numerous proteoglycans and heparan sulfate-containing proteins form the hydrated, gel-like mixture that stabilizes the matrix within its aqueous environment.
Source: Millipore
Experimental Arm
A group of participants that receives the intervention that is the focus of the study.
Source: Clinicaltrials.gov
Exclusion Criteria
The factors (or reasons) that prevent a person from participating in a clinical study.
Source: Clinicaltrials.gov
Ex Vivo
Means that which takes place outside an organism. In science, ex vivo refers to experimentation or measurements done in or on tissue from an organism in an external environment with the minimum alteration of natural conditions. Ex vivo conditions allow experimentation on an organisms cells or tissue under more controlled conditions than is possible in in vivo experiments (in the intact organism), at the expense of altering the "natural" environment.
Examples of ex vivo specimen use include: assays; realistic models for surgical procedure development; investigations into the interaction of different energy types with tissues;
Epidemiology is the study of the distribution and determinants of health-related states or events (including disease), and the application of this study to the control of diseases and other health problems. Various methods can be used to carry out epidemiological investigations: surveillance and descriptive studies can be used to study distribution; analytical studies are used to study determinants.
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
Enrolling by Invitation
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
Eligibility Criteria
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
Drug-Induced Lupus (DIL)
Drug-induced lupus (DIL) is an autoimmune disorder similar to systemic lupus erythematosus (SLE). As with SLE, the body mistakenly attacks healthy tissue. DIL is caused by an overreaction to a medication.
People with DIL may have symptoms that affect the joints, heart, and lungs. Lupus nephritis and other symptoms associated with SLE are rare in people with DIL.
Once the medication that caused DIL is stopped, symptoms may go away over time. Treatment usually involves nonsteroidal anti-inflammatory drugs, corticosteroids, or antimalarial drugs.
Diuretics are sometimes called "water pills" because they increase the rate of the body's urine output. They are prescribed to treat congestive heart failure, high blood pressure, edema (water retention), and certain kinds of kidney or liver disease.
For lupus patients, diuretics are used to treat nephritis, or inflammation of the kidneys.
Discoid rash
Discoid rash is red, scaly patches on skin that cause scarring.
Source: Wikipedia.org
Discoid lupus
Discoid lupus is the most common manifestation of the skin disorder chronic cutaneous lupus. It is characterized characterized by red, inflamed disc-like patches that have a scaling, crusty appearance. Discoid lupus usually occurs on the scalp, face, and neck. The condition can strike at any age among people of all ethnic groups.
Discoid lupus lesions can be induced or exacerbated by exposure to the sun. Early diagnosis and treatment and precautionary measures greatly improve outcomes. Untreated, discoid lupus can lead to scarring and permanent hair loss.
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.
Source: National Institute of Mental Health
Dendritic cells
Dendritic cells play a critical role in the regulation of the immune response in humans. They are antigen-presenting cells, meaning that their main function is to process antigen material and present it on the surface of other cells of the immune system.
These cells can be found in tissue that is exposed to the external environment, such as skin, the inner lining of the nose, lungs, stomach, and intestines.
The part that dendritic cells play in the manifestation of lupus is uncertain, which is why the ALR has funded several studies to grasp a better understanding of how these cells work.
The DCN gene provides instructions for making a protein called decorin. 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: US National Library of Medicine
Data Monitoring Committee (DMC)
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, if it is causing harm to participants, or if it is not likely to serve its scientific purpose. Committee members are chosen based on the scientific skills and knowledge needed to monitor the particular study. Also referred to as a data safety and monitoring board (DSMB).
Cytokines are chemicals produced by T-cells in response to the presence of an antigen. Cytokines cause B-cells to release antibodies.
Cyclophosphamide is an immunosupressive medication used to treat cancer, severe SLE and lupus nephritis. In lupus, cyclophosphamide is used when other drugs prove ineffective or are too invasive. However, cyclophosphamide can cause an adverse drug reactions.
Cutaneous lupus erythematosus
Lupus is a serious disease that can affect multiple organs and systems of the body — including the skin, which may lead to eruptions of hives and lesions. There are three lupus-specific lesions and non-specific lesions — and cutaneous lupus may be divided into three categories: chronic cutaneous lupus (CCLE), subacute cutaneous lupus (SCLE) and acute cutaneous lupus (ACLE). All three subsets are aggravated by exposure to sunlight.
- Chronic cutaneous lupus (CCLE): The most common form of CCLE is discoid lupus. It is a painful chronic skin condition characterized by red, inflamed disc-like patches that have a scaling, crusty appearance. Discoid lupus usually occurs on the scalp, face, and neck. The condition can strike at any age among people of all ethnic groups.
Discoid lupus lesions can be induced or exacerbated by exposure to the sun. Early diagnosis and treatment and precautionary measures greatly improve outcomes. Untreated, discoid lupus can lead to scarring and permanent hair loss.
- Sub-acute cutaneous lupus erythematosus (SCLE): Characterized by lesions that appear on parts of the body that are exposed to sun, SCLE makes up approximately 10 percent of all lupus cases. Lesions from SCLE do not cause permanent scarring.
- Acute cutaneous lupus (ACLE): This skin condition occurs when lupus is active and is generally characterized by rash and lesions. Often localized across the bridge of the nose and spreading to both sides of the face, it appears in a butterfly pattern.
But ACLE is not restricted to the face. It can appear on other parts of the body, as well. ACLE usually occurs as a result of exposure to ultraviolet light.
CRP (C-Reactive Protein)
CRP is a blood protein that is produced by the liver. High levels of CRP are caused by inflammation and infections. Levels of CRP can dramatically elevate in a period of hours and are usually present in people with SLE. Measuring the amount of CRP in the body is a screen for infectious and inflammatory diseases like lupus.
Crossover Desgin
Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two crossover design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A during a later phase. So during the study, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the study, but in a different order, depending on the group to which they are assigned.
Source: Clinicaltrial.gov
Corticosteroids are drugs that closely resemble cortisol, a hormone that is naturally produced in the adrenal glands.
In one of the most common treatments for lupus, corticosteroids—or steroids as they are more commonly termed—are used to reduce the production of inflammation and reduce the activity of the immune system in order to minimize tissue damage. A physician's decision to prescribe steroids is based on the potential benefits and risks, which vary from patient to patient.
Controlled Trial
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: ClinicalTrial.gov
Connective tissue
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
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
In medicine, comorbidity is the presence of one or more additional disorders (or diseases)co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. The additional disorder may also be a behavioral or mental disorder.
Source: Wikipedia
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 (Table 22-3). 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: Natiional Center for Biotechnology Information
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
A group of people used in a study who have something (such as lupus) in common.
Closed Study
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
Closed Study
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: Clinicaltrial.gov
Clinical trial
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
Clinical Trial
A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
Source: ClinicalTrial.gov
Clinical study
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: Clinicaltrial.gov
Clinical Immunology
Clinical immunology is the study of diseases caused by disorders of the immune system (failure, aberrant action, and malignant growth of the cellular elements of the system). It also involves diseases of other systems, where immune reactions play a part in the pathology and clinical features.
Chronic Pain
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: National Institute of Neurological Disorders and Stroke
Chronic Fatigue Syndrome
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:
- Feeling unwell for more than 24 hours after physical activity
- Muscle pain
- Memory problems
- Headaches
- Pain in multiple joints
- Sleep problems
- Sore throat
- Tender lymph nodes
Source: US National Library of Medicine
Chronic disease
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 Cutaneous Lupus (CCLE)
Chronic cutaneous lupus (CCLE) is one of three subsets of the general lupus skin disorder called cutaneous lupus erythematosus.
The most common type of CCLE is discoid lupus, a painful chronic skin condition characterized by red, inflamed disc-like patches that have a scaling, crusty appearance. Discoid lupus usually occurs on the scalp, face, and neck. The condition can strike at all ages and among all ethnic groups.
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: Mayo Clinic
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: National Center for Biotechnology Information
Certain Agreements
As required by Section 801 of the Food and Drug Administration Amendments Act, in general, a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or to publish the study results in a scientific or academic journal after the trial is completed. (This does not apply if the PI is an employee of the sponsor.)
source clinicaltrials.gov
Cellular Metabolism
A cell's daily operations are accomplished through the biochemical reactions that take place within the cell. Reactions are turned on and off or sped up and slowed down according to the cell's immediate needs and overall functions. At any given time, the numerous pathways involved in building up and breaking down cellular components must be monitored and balanced in a coordinated fashion. To achieve this goal, cells organize reactions into various enzyme-powered pathways.
Source: Scitable, by Nature Education
Cell Culture
In its simplest form, cell culture involves the dispersal of cells in an artificial environment composed of nutrient solutions, a suitable surface to support the growth of cells, and ideal conditions of temperature, humidity, and gaseous atmosphere. In such a system, a researcher can precisely measure the response of the cell's alterations in culture alterations, prospective drugs, the presence or absence of other kinds of cells, carcinogenic agents, and viruses.
Source: Coriell Institute for Medical Research
Butterfly rash
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. The case presented here is of a female with butterfly rash along with typical bright red discoloration of gingiva. The clinical, histopathological and biochemical investigations suggested the presence of rosacea.
Source: NIH.gov
BLyS-specific inhibitors
BLyS-specific inhibitors are a class of medications, such as belimumab, that prevent BLyS proteins from stimulating the growth of auto-reactive B cells.
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
Biomarkers are essentially proteins, enzymes, or other molecules in the body that can be used as tracers of diagnosis or indicators of disease activity. In the case of lupus, immune cells that are either more common in —or exclusive to — patients with lupus produce biomarkers.
Today, scientists are looking to at biomarkers as early predictors of lupus flares. Biomarkers also hold the promise of enhancing diagnostic accuracy, prognosis, and monitoring of treatment response.
Biologic is a process or phenomenon connected with life or living organisms.
Source: Wikipedia.org
Biochemical Pathway
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: National Human Genome Research Instiute
Belimumab, commonly known as Benlysta, is the first new drug therapy to be approved by the FDA in more than 50 years. Belimumab is a human antibody that inhibits B-cell activating factor (BAFF).
Significant decreases in the number of activated B cells have been observed in some patients. However, in testing, the drug was not effective with all types of lupus and showed little benefit among African Americans. More testing is planned for the more severe cases of lupus, including people with kidney and brain damage. Belimumab holds the promise of reduced disease manifestation and the sparing use of corticosteroid.
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
Is the acronym for the term B-cell activating factor.
B-lymphocyte stimulator
Also known as B-cell activating factor, or BAFF, B-lymphocyte stimulator (BLyS) is a cytokine that is vital for the survival of B cells. High levels or overproduction of BLyS is linked to lupus.
The BLyS protein is expressed by a wide variety of cell types, including monocytes, activated neutrophils, and T cells.
B cells
Like T cells, B cells are a type of blood cell that belong to a group of white blood cells (WBCs) called lymphocytes, which help the body fight infection.
When B cells encounter an antigen (infection or a foreign body), they become activated and produce molecules called antibodies that attach to the surface of the infectious agent. These antibodies either kill the infection-causing organism or make it vulnerable to attack by other WBCs. This process guards the body against infection.
These vital cells are called B cells because they are created in bone marrow. Once matured, B cells are present in the blood and lymph nodes.
The function of B cells and T cells is vital to the immune system, allowing humans to ward off and better cope with often-hostile bacteria, viruses, and other foreign matter.
Autoreactive B cells
B cells are a type of white blood cell that helps the body fight infection. In lupus this process malfunctions, causing the immune system to attack healthy tissue. Therefore, B cells are essential for the development and pathogenesis of autoimmune disease.
Autoreactive B cells are generally considered to be the source of autoantibodies, causing the body to secrete pro-inflammatory cytokines.
Autoimmunity is the failure of an organism in recognizing its own constituent parts as self, which allows an immune response against its own cells and tissues. Any disease that results from such an aberrant immune response is termed an autoimmune disease. Autoimmunity is often caused by a lack of germ development of a target body and as such the immune response acts against its own cells and tissues. Prominent examples include Celiac disease, diabetes mellitus type 1 (IDDM), Sarcoidosis, systemic lupus erythematosus (SLE), Sjögren's syndrome, Churg-Strauss Syndrome, Hashimoto's thyroiditis, Graves' disease, idiopathic thrombocytopenic purpura, Addison's Disease, rheumatoid arthritis (RA) and allergies. Autoimmune diseases are very often treated with steroids.
Source: Wikipedia.org
Autoimmune disease
An illness that occurs when the body tissues are attacked by its own immune system. The immune system is a complex organization within the body that is designed normally to "seek and destroy" invaders of the body, including infectious agents. Patients with autoimmune diseases frequently have unusual antibodies circulating in their blood that target their own body tissues.
An autoantibody is an antibody that works against one's own tissues or cells.
Atherosclerosis is a disease in which plaque builds up inside 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: National Heart, Lung, and Blood Institute
An assay is an investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology, and molecular biology for qualitatively assessing or quantitatively measuring the presence or amount or the functional activity of a target entity (the analyte) which can be a drug or biochemical substance or a cell in an organism or organic sample.
Articular Cartilage
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: National Center for Biotechnology Information
Arthroplasty is a surgical procedure to restore the integrity and function of a joint. A joint can be restored by resurfacing the bones. An artificial joint (called a prosthesis) may also be used.
Various types of arthritis may affect the joints. Osteoarthritis, or degenerative joint disease, is a loss of the cartilage or cushion in a joint, and is the most common reason for arthroplasty.
Source: Johns Hopkins Medicine, Health Library
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
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
Apoptosis is the natural process of cell death, which is a normal function of the body. When cells die, the debris is cleared by macrophages, or white blood cells within tissues. In people with lupus, however, apoptosis may play a role in disease manifestation.
Lupus patients may not be able to effectively clear apoptotic cells, which can evoke the production of cytokines. The cytokines cause B-cells to release antibodies—and in lupus, antibodies mistakenly attack healthy tissue and organs.
Antiphospholipid antibodies
Antiphospholipid antibodies (APLAs) are a type of protein that usually helps the body ward off infection. However, in lupus, APLAs mistakenly attack phospholipids, which is a type of fat found in in all living cells, including blood and the lining of blood vessels.
APLAs can interfere with blood vessels' normal function, potentially altering clotting and leading to strokes, blood clots, miscarriages, and low platelet counts.
APLAs are present in about one-third of people with SLE.
Antinuclear antibodies
Antinuclear antibodies are antibodies that target proteins within the nuclei of cells. In autoimmune diseases like lupus, antinuclear antibodies can signal the body to begin attacking itself.
Most people have autoantibodies, but the presence of large amounts of them may indicate an autoimmune disease. There is a test that measures pattern and amount of autoantibodies. More than 95 percent of people with lupus test positive.
Antigen Processing
Antigen processing is an immunological process that prepares antigens for presentation to special cells of the immune system called T lymphocytes. It is considered to be a stage of antigen presentation pathways. This process involves two distinct pathways for processing of antigens from an organism's own (self) proteins or intracellular pathogens (e.g. viruses), or from phagocytosed pathogens (e.g. bacteria); subsequent presentation of these antigens on class I or class II MHC molecules is dependent on which pathway is used. Both MHC class I and II are required to bind antigen before they are stably expressed on a cell surface. MHC I antigen presentation typically (considering cross-presentation) involves the endogenous pathway of antigen processing, and MHC II antigen presentation involves the exogenous pathway of antigen processing. Cross-presentation involves parts of the exogenous and the endogenous pathways but ultimately involves the latter portion of the endogenous pathway (e.g. proteolysis of antigens for binding to MHC I molecules).
Source: Wikipedia
Antigen Presentation
Antigen presentation is a process in the body's immune system by which macrophages, dendritic cells and other cell types capture antigens and then enable their recognition by T-cells.
The basis of adaptive immunity lies in the capacity of immune cells to distinguish between the body's own cells and infectious pathogens. The host's cells express "self" antigens that identify them as such. These antigens are different from those in bacteria ("non-self" antigens) or in virally infected host cells ("missing-self"). The ability of the adaptive immune system to survey for infection requires specialized pathways of enabling recognition of pathogen-derived antigens by T cells.
Source: Wikipedia
In immunology, an antigen is a substance that evokes the production of one or more antibodies. Each antibody binds to a specific antigen by way of an interaction similar to the fit between a lock and a key. The substance may be from the external environment or formed within the body. The immune system will try to destroy or neutralize any antigen that is recognized as a foreign and potentially harmful invader. The term originally came from antibody generator[1][2] and was a molecule that binds specifically to an antibody, but the term now also refers to any molecule or molecular fragment that can be bound by a major histocompatibility complex (MHC) and presented to a T-cell receptor.[3] "Self" antigens are usually tolerated by the immune system, whereas "non-self" antigens can be identified as invaders and can be attacked by the immune system.
Anticoagulants are substances that hinder blood from clotting by suppressing coagulation. Among their many benefits, anticoagulants are used in preventing stroke and thrombosis (formation of a blood clot in the heart). They are also used in drawing blood and flushing catheters.
Anticoagulant therapy is used to treat lupus patients. About one-third of people with the disease have antibodies to molecules that make them susceptible to blood clots.
Antibodies are the cells and molecules of the immune system that detect and attack invaders. In diseases like lupus, antibodies mistakenly attack a patient's own tissue and organs.
Anti-SM are antibodies closely associated with lupus. Nearly all individuals with anti-SM antibodies have lupus—but only 20 percent of people with lupus have these antibodies. Anti-SM is rarely found in people with other rheumatic diseases and its incidence in healthy individuals is less than 1 percent. The presence of anti-SM is an indication of systemic lupus and is a factor in diagnosing the disease.
Anti-RNP antibodies
Ribonucleprotein (RNP) is a protein that is structurally associated with DNA. Anti-RNP antibodies are autoantibodies that are associated with lupus and are detected in nearly 40 percent of lupus patients. Anti-RNP is also closely associated with mixed connective tissue disease (MCTD), which features signs and symptoms similar to those of lupus.
RNP is a factor in both lupus and MCTD, which leads to an abnormal immune reaction causing inflammation of and damage to various body parts and can affect joins, skin, kidneys, heart, lungs, blood vessels, and the brain.
The term anti-inflammatory refers to an agent or mechanism that counteracts or suppresses inflammation.
Anti-inflammatory drugs help to reduce the inflammatory response and are the most common type of medication used to treat the pain and discomfort of people living with lupus.
Anti-inflammatories are divided into two categories—non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids or steroids.
Anti-Cardiolipin Antibodies (ACA)
Anti-cardiolipin antibodies (ACA) are antibodies that are present in autoimmune diseases like lupus to directly attack cardiolipin, a protein that is very common in the body. As the name implies, cardiolipin is found mostly in the heart, and secondly in skeletal muscles.
Much remains unclear about the presence of ACA. Possible risks for pathological conditions in patients with lupus include: thrombosis (clotting), fetal loss, and thrombocytopenia (low platelets) – yet, ACA are also present in individuals with no apparent ill effects. It appears that more research is needed to grasp a better understanding of this antibody.
Ankylosing spondylitis
Ankylosing spondylitis is an inflammatory disease that can cause some of the vertebrae in your spine to fuse together. This fusing makes the spine less flexible and can result in a hunched-forward posture. If ribs are affected, it may be difficult to breathe deeply.
Ankylosing spondylitis affects men more often than women. Signs and symptoms of ankylosing spondylitis typically begin in early adulthood. Inflammation also can occur in other parts of your body — most commonly, your eyes.
There is no cure for ankylosing spondylitis, but treatments can decrease your pain and lessen your symptoms.
Source: Mayo Clinic
Animal Models
Except in the case of highly controlled and regulated clinical trials, geneticists and scientists do not use humans for their experimental investigations because of the obvious risk to life. Instead, they use various animal, fungal, bacterial, and plant species as model organisms for their studies.
When animal models are employed in the study of human disease, they are frequently selected because of their similarity to humans in terms of genetics, anatomy, and physiology. Also, animal models are often preferable for experimental disease research because of their unlimited supply and ease of manipulation. For example, to obtain scientifically valid research, the conditions associated with an experiment must be closely controlled. This often means manipulating only one variable while keeping others constant, and then observing the consequences of that change. In addition, to test hypotheses about how a disease develops, an adequate number of subjects must be used to statistically test the results of the experiment. Therefore, scientists cannot conduct research on just one animal or human, and it is easier for scientists to use sufficiently large numbers of animals (rather than people) to attain significant results.
Source: Scitable, by Nature Education
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: National Center for Biotechnology Information
AMP – Accelerating Medicines Partnership
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
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: National Center for Biotechnology Information
Image Source: Wikipeia
Adverse Event
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
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: US National Library of Medicine
Image Source: Wikipedia
Adapter Protein
Adapter protein: A protein acts as a connecting molecule. An adapter protein is critical to intermolecular interactions and plays a role in the regulation of signal transduction initiated by engagement of surface receptors on all cell types. Some adapter proteins are expressed in all tissues, while the expression of other adapter proteins is restricted to specific tissues.
Source: MedicineNet
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: New York State Dept. of Health
Acute Phase Reactants
Acute phase response is the sum of the systemic and metabolic changes occurred
by release of acute phase proteins in response to inflammatory stimulus.
The most important ones of these acute phase reactants are erythrocyte
sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen and ferritin. The
most widely used ones are ESR and CRP while fibrinogen and ferritin are rarely
used and other acute phase reactants have no place in routine clinical use.
Although ESR is clinically the most commonly used test, it is fairly nonspecific.
Even though CRP is more specific than ESR, because of the high cost of the
analysis it has clinically limited usage.
Source: Hacettepe University Medical School
Acute Cutaneous Lupus (ACLE)
Acute cutaneous lupus (ACLE) is one of three subsets of the general lupus skin disorder called cutaneous lupus erythematosus.
This condition occurs when lupus is active and is generally characterized by rash and lesions, often localized across the face in a butterfly pattern. However, ACLE can appear on other parts of the body, as well. ACLE usually occurs as a result of exposure to ultraviolet light. Without predictability, symptoms may come and go and severity varies greatly from person to person.
Active, Not Recruiting
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