CDISC Code http://www.clinicaltrials.gov/ct2/about-studies/glossary A group of participants that receives an intervention that is considered to be effective. Active comparator Chow, S. C., & Liu, J. P. (2013). Design and analysis of clinical trials: concepts and methodologies (Vol. 979). John Wiley & Sons. An active control trial is necessarily conducted to establish the efficacy of a new drug when the patients under study are very ill. Active control trial D. Harrington. designs for clinical trials: perspectives on current issues. Springer, 2011. Adaptive design combines prospective development of a gene expression-based classifier to select sensitive patients with a properly powered test for overall effect. Adaptive design C66781 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Those units of time that are routinely used to express the age of a subject. Age unit C2868 CDISC Glossary A disorder characterized by the localized or diffuse accumulation of amyloid protein in various anatomic sites. It may be primary, due to clonal plasma cell proliferations; secondary, due to long standing infections, chronic inflammatory disorders, or malignancies; or familial. It may affect the nerves, skin, tongue, joints, heart, liver, spleen, kidneys and adrenal glands. Amyloidosis http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials Study designed to examine associations, with the final object usually of identifying or measuring the effects of risk factors or specific interventions on health. Analytical study http://www.clinicaltrials.gov/ct2/about-studies/glossary Applies to an Expanded Access program. The intervention has been approved for sale to the public. Approved for marketing http://www.clinicaltrials.gov/ct2/about-studies/glossary An Expanded Access program is currently available for this study intervention. Available for expanded access C90363 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls The mean value of the amount of weight change over a period of time, relative to the beginning of the collection period. Average body weight gain http://www.clinicaltrials.gov/ct2/about-studies/glossary Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. Baseline characteristics C49068 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. A characteristic of experimental design in which one or more groups involved (receiving, administering, or evaluating intervention) are unaware of which intervention any particular subject is receiving. Blinded Everitt, B., & George, S. (2004). Textbook of clinical trials. D. Machin, S. Day, & S. B. Green (Eds.). Wiley. In clinical trials, blindness usually refers to two aspects of trials. The first relates to the allocation of participants to the diferent treatment limbs independently. The second relates to the concealment of which treatment the participant received. Blindness C62754 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls A change in overall body weight, relative to the beginning of the collection period. Body weight gain case referent retrospective study Case-control www.clinicaltrials.gov/ct2/about-studies/glossary 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. Outcome measure Clinical trial trial design Clinical trial design Clinical trial ethics Clinical trial operation Clinical trial type http://www.clinicaltrials.gov/ct2/about-studies/glossary 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. Closed study Chow, S. C., & Liu, J. P. (2013). Design and analysis of clinical trials: concepts and methodologies (Vol. 979). John Wiley & Sons. A trial to assess the treatment effect by taking into account the potential for drug-to-drug interaction. Combination trial http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials Clinical trial in which the elements allocated randomly are communities or populations, instead of individuals. Community trial Meinert, C. L. (2012). ClinicalTrials: Design, Conduct and Analysis. Oxford University Press. An outcome comprised of two or more outcome measures. Composite outcome measure http://www.cancer.gov/dictionary?cdrid=44014 A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. Controlled trial Senn, S. (2002). Cross-over trials in clinical research (Vol. 5). John Wiley & Sons. cross-over trial Cross-over trials are experiments in which subjects are each given a number of treatments with the object of studying differences between these treatments. Cross-over design C25301 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four hours. This also refers to a specific day. (NCI) Day C2982 A melancholy feeling of sadness and despair. Depression http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials Study designed solely for describing the distribution of certain variables, but which is not concerned about the associations between them. Descriptive study descriptive design C18226 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. A measurable result or effect of treatment on a disease. Examples of outcomes include decreased pain, reduced tumor size, or worsening of disease. Disease outcome C99554 CDISC Glossary disease condition The compilation of symptoms and/or clinical manifestation of any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the person affected or those in contact with the person. The term is often used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function. Disease presentation Chow, S. C., & Liu, J. P. (2013). Design and analysis of clinical trials: concepts and methodologies (Vol. 979). John Wiley & Sons. Trials that are usually conducted to determine the therapeutic window of the test drug and the relationship between the efficacy/safety and doses within the therapeutic window. Dose-response trial http://www.clinicaltrials.gov/ct2/about-studies/glossary A 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. Enrolling by invitation http://www.clinicaltrials.gov/ct2/about-studies/glossary A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. Expanded access http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials In epidemiology, controlled clinical trial or community trial with random distribution. The researcher manipulates the research conditions and randomly distributes the groups. The objective of experimental studies is to estimate the efficacy of a preventive, curative or rehabilitative intervention. Experimental study http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials explanatory clinical trial The trial whose aim is fundamentally to acquire scientific knowledge and biological explanations about efficacy. Explanatory trial Chin, R., & Lee, B. Y. (2008). Principles and practice of clinical trial medicine. Elsevier. Testing two or more different interventions on the same group at the same time. Factorial design http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials Preliminary study with the objective of determining whether a programme, procedure or study protocol is practicable, as well as finding out data to help in determining the sample size for a definitive study. Feasibility study Friedman, L. M., Furberg, C., & DeMets, D. L. (1998). Fundamentals of clinical trials (Vol. 3). New York: Springer. cluster allocation design A group of individuals, a clinic or a community are randomized to a particular intervention or control. Group allocation design retrospective cohort study Historical observational cohort C25529 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. (NCI) Hour D. Harrington. designs for clinical trials: perspectives on current issues. Springer, 2011. A design powered to detect differences in outcomes only in the marker subgroup that is randomized to treatment choices based on marker status. Hybrid design http://www.clinicaltrials.gov/ct2/about-studies/glossary A unique identification code given to each clinical study registered on ClinicalTrials.gov. The format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419). Identifier R. Chappell. Classification and bias of clinical research. Department of Biostatistics and Medical Informatics, University of Wisconsin Medical School. [Course slides] Two or more populations are instantaneeously compared through the prevalences of both exposure and disease. Instantaneous study Chin, R., & Lee, B. Y. (2008). Principles and practice of clinical trial medicine. Elsevier. Clinical trials frequently employ sites from different countries. International site http://www.clinicaltrials.gov/ct2/about-studies/glossary The last verified date is the most recent date that all of a clinical study's information on ClinicalTrials.gov was confirmed as accurate and up to date. This date may be different from the last updated date. Last verified date R. Chappell. Classification and bias of clinical research. Department of Biostatistics and Medical Informatics, University of Wisconsin Medical School. [Course slides] A longitudinal study observes exposures and events for individuals over a period of time. Longitudinal study C29846 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. (NCI) Month Chin, R., & Lee, B. Y. (2008). Principles and practice of clinical trial medicine. Elsevier. Trials including many different locations increasing the number and diversity of patients. Multiple site http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials Trial in which the total population is a single patient and in which the order of administration of the treatments compared is determined in a random way. N-of-1 clinical trial http://www.clinicaltrials.gov/ct2/about-studies/glossary A group of participants that does not receive any interventions during a clinical study. No intervention arm http://www.clinicaltrials.gov/ct2/about-studies/glossary An Expanded Access program was available for this study intervention previously but is not currently available and will not be available in the future. No longer available for expanded access E.M. Antman. cardiovascuar therapeutics: a companion to Braunwald's heart disease. Elsevier, 2013. Non-randomized Trials in which the investigator selects the subjects to be allocated to the control and treatment groups. Non-randomized concurrent control study http://www.clinicaltrials.gov/ct2/about-studies/glossary The study has not started recruiting participants. Not yet recruiting http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials Analytical epidemiological study in which the researcher does not determine the allocation of the subjects to each group, but simply records (observes) what actually happens. Observational study design http://www.clinicaltrials.gov/ct2/about-studies/glossary Studies that are currently recruiting participants, will be recruiting participants in the future, or involve drugs that are available for expanded access. Recruitment statuses for open studies appear in green text in ClinicalTrials.gov search results and study records. Open study C85494 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Units of measure needed for pharmacokinetic parameters. PK parameter units of measure http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials Clinical trial in which each group of patients receives a single treatment simultaneously. Parallel trial C90434 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls The amount of weight change over a period of time in relation to the total weight, relative to the beginning of the collection period. Percentage body weight gain C101250 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. Sensory or motor loss of peripheral nerve function due to a traumatic event. Peripheral nerve injury Wikipedia A pivotal trial can refer to a clinical trial or study intended to provide evidence for a drug marketing approval. Pivotal trial Wikipedia A prospective cohort study is a cohort study that follows over time a group of similar individuals who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome. Prospective observational cohort Glossary of Methodologic Terms. Elsevier. www.elsevier.com/__data/promis_misc/apmrglossary.pdf‎ cohort analytic study Prospective investigation of the factors that may cause a disorder by comparing a cohort of individuals who do not have evidence of an outcome of interest but who are exposed to the putative cause with a concurrent cohort who are also free of the outcome but not exposed to the putative cause. Prospective study Dobkin, B. H. (2003). The clinical science of neurologic rehabilitation. Oxford University Press, USA. Randomized blinded block Dobkin, B. H. (2003). The clinical science of neurologic rehabilitation. Oxford University Press, USA. Randomized blinded cross-over Dobkin, B. H. (2003). The clinical science of neurologic rehabilitation. Oxford University Press, USA. Randomized blinded factorial Dobkin, B. H. (2003). The clinical science of neurologic rehabilitation. Oxford University Press, USA. Randomized blinded matched pairs Dobkin, B. H. (2003). The clinical science of neurologic rehabilitation. Oxford University Press, USA. Randomized blinded withdrawal P. Solomon, M. Cavanaugh, E. Draine. Randomized Controlled Trials: Design and Implementation for Community-Based Psychosocial Interventions. Oxford University Press, 2009. RCT randomised controlled trial randomized control trial The primary objection raised about a RCT is related to its central feature: the randomness of the decision regarding an individual's treatment regimen. Randomized controlled trial C102702 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. The reason the treatment was administered. Reason for treatment C102703 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. The reason the drug or therapy was temporarily ceased. Reason for treatment interruption C102704 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. The reason the treatment was not administered. Reason treatment not administered http://www.clinicaltrials.gov/ct2/about-studies/glossary The study is currently recruiting participants. Recruiting Chin, R., & Lee, B. Y. (2008). Principles and practice of clinical trial medicine. Elsevier. It involves identifying patients eligible for your study and convincing them to participate. Patient recruitment www.clinicaltrials.gov/ct2/about-studies/glossary The process of submitting and updating summary information about a clinical study protocol from its beginning to end, to a structured, Web-based registry that is accessible to the public, such as ClinicalTrials.gov. Registration Case-comparison study case-control study case-referent study Study generally used to test possible causes of a disease or disorder, in which individuals who have a designated disorder are compared with individuals who do not with respect to previous current exposure to a putative causal factor. Retrospective study Meinert, C. L. (2012). ClinicalTrials: Design, Conduct and Analysis. Oxford University Press. Any measure made on persons during a trial for use in deciding whether it is safe to continue treatment. Safety measure Chow, S. C., Wang, H., & Shao, J. (2007). Sample size calculations in clinical research. CRC press. In clinical research, a statistical evaluation for sample size calculation is often performed based on some statistical inference of the primary study endpoint with certain assurance. Sample size http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials sequential clinical trial Clinical trial in which the observations are assessed as they are produced and the total number of participants is not predetermined, but depends on the accumulated results. Sequential trial http://www.clinicaltrials.gov/ct2/about-studies/glossary 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. Sham comparator Chin, R., & Lee, B. Y. (2008). Principles and practice of clinical trial medicine. Elsevier. Clinical studies that take place at only one location. Single site Site selection concepts in biostatistics Statistical concept Structure of clinical trial http://www.clinicaltrials.gov/ct2/about-studies/glossary Describes the nature of a clinical study. Study type Chow, S. C., & Liu, J. P. (2013). Design and analysis of clinical trials: concepts and methodologies (Vol. 979). John Wiley & Sons. A trial whose objective is to show that the test treatment is better than a concurrent control in terms of its primary clinical endpoints. Superiority trial Meinert, C. L. (2012). ClinicalTrials: Design, Conduct and Analysis. Oxford University Press. An outcome measure used as substitute for some other outcome. Surrogate outcome measure ecological study population-correlation study survey Population-based study http://www.clinicaltrials.gov/ct2/about-studies/glossary An Expanded Access program is not currently available for this intervention but is expected to be available in the future. Temporarily not available for expanded access C90464 The weight of a subject at a specified end point. (NCI) Terminal body weight C102720 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. An indication of whether this is the individual's first time being treated for a disease or that they are receiving a subsequent treatment. Treatment episode C102721 CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. The reason the drug or therapy was unsuccessful in treating the condition. Treatment failure reason Wang, D., & Bakhai, A. (Eds.). (2006). Clinical trials: A practical guide to design, analysis, and reporting. Remedica. In triple-blinded studies, all members of the sponsor's project team are blinded. This makes evaluations of the results more objective. Triple blind Wang, D., & Bakhai, A. (Eds.). (2006). Clinical trials: A practical guide to design, analysis, and reporting. Remedica. open study On some occasions it might not be possible to use blinding. For example, if the new intervention is a surgical treatment and being compared with tablets then the difference between the two is difficult to hide. Unblinded Song, J. W., & Chung, K. C. (2010). Observational studies: cohort and case-control studies. Plastic and reconstructive surgery, 126(6), 2234. Trials without a control group for comparison. Uncontrolled trial CDISC's Clinical Data Element Glossary, http://evs.nci.nih.gov/ftp1/CDISC/Clinical_Data_Element_Glossary/Clinical%20Data%20Element%20Glossary.xls. Cerebrovascular Accident An acute episode of focal or global neurological dysfunction caused by presumed brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction but with insufficient information to allow categorization as ischemic or hemorrhagic. Undetermined stroke http://scientific-european-federation-osteopaths.org/en/different-types-of-clinical-trials A trial carried out by a single researcher or research team in one hospital or another type of centre. Unicenter trial C90484 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls A measurement of a subject's water intake. (NCI) Water consumption C29844 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Any period of seven consecutive days. (NCI) Week C29848 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls The period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days; a specific one year period. (NCI) Year C66966 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls per hour A rate of occurrences of something within a period of time equal to sixty minutes. /h Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Femtograms per milliliter. fg/mL C67372 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls A dose calculation unit expressed in gram(s) per period of time equal to twenty-four hours. g/day Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Gram per Milliliter A unit of mass concentration defined as the concentration of one kilogram of a substance in unit volume of the mixture equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one kilogram occupies the volume one liter.(NCI) g/mL Ontology1325521724189:ADAS-Cog clinicaltrials.gov/ct2/show/NCT00777608 ADAS-Cog (Alzheimer Disease Assessment Scale-Cognitive Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point AD assessment Scale. ADAS-Cog Ontology1325521724189:Abnormal_behavior medical-dictionary.thefreedictionary.com/abnormal+behavior www.ask.com/question-about/Causes-of-Abnormal-Behavior Includes any activity judged to be outside the normal behavior for animals of that particular class and age, including the vices, the fixed patterns of abnormality. It is behavior which is not normal. Abnormal behavior may be observed in patients, kid and animals too. It is caused due to various state of mind and body. Abnormal behavior Ontology1325521724189:Active_control Michael Stein, M.D, Guy Taylor. M.D " The Encyclopedia of Arthritis" 2004 active control group To decide if a treatment is effective, it is best to compare it with another treatment, and this is called a controlled trial. Controlled studies usually compare the new treatment against an inactive substance, like a dummy sugar pill, called a placebo control, or else against some treatment that is known to be effective, called an active control. Comparing the results of the new treatment with the results of the new treatment makes it much easier to determine if the new treatment is effective. Active control Ontology1325521724189:Adverse_Event_Action-Taken www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf Adverse event and actions taken It is the action we take to determine the adverse outcome that occurs during or after the use of a drug or other interventions. Adverse event action Ontology1325521724189:Adverse_Event_Outcome_Assessment de.dict.md/definition/Outcome Adverse Event Outcome Measures Assessment of Adverse Events This is the assessment of the adverse outcomes that occurs during or after the use of a drug or other interventions. Adverse event outcome assessment Ontology1325521724189:Adverse_Event_Sub-Domain bioportal.bioontology.org/ontologies/45400/?p=terms&conceptid=Adverse_Event_Sub-Domain adverse event The Adverse Event sub-domain is intended for those involved in safety related activities; such as detection, evaluation, follow-up and reporting. This includes safety issues involving people or products. It also includes activities during or after a research protocol. Adverse event Ontology1325521724189:Adverse_events www.clinicaltrials.gov/ct2/about-studies/glossary 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. Adverse event Ontology1325521724189:Age_group dictionary.reference.com/browse/age+group Age groups Persons of approximately the same age and often of the same sex, nationality, educational or social background. Age group Ontology1325521724189:Agitation_test medical-dictionary.thefreedictionary.com/agitation Restlessness Test extreme restlessness as manifested in depression and other mental disorders. Agitation test Ontology1325521724189:Agreement_to_perform bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 "Agreement to perform study activity" is a study administrative relation. It doesn,t mean performance of a specific study activity (e.g., administration of a drug) itself, but agreement to do so. Agreement to perform Ontology1325521724189:Agreement_to_perform_oversight bioportal.bioontologies.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Oversight Performance "Agreement to perform oversight" is a study administrative relation that entails agreement tpoperform some study activity". It doesn't mean performance of oversight per se (e.g., data safety monitoring), but agreement to do so. Agreement to perform oversight Ontology1325521724189:Agreement_to_perform_study_laboratory_processing bioportal.bioontology.org/ontologies/46378/?p=termsconceptid=study_design%3AOCRE100077 Study Laboratory process "Agreement to perform study laboratory processing" is a study administrative relation that entails to perform some some study activity. It doesn't mean performance of study laboratory processing per se (e.g., blood or urine tests), but agreement to do so. Agreement to perform study laboratory processing Ontology1325521724189:Agreement_to_perform_study_subject_assessment_or_intervent bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 SUBJECT ASSESSMENT "Agreement to perform study subject assessment" is a study administrative relation that entails agreement to perform some study subject assessment. It doesn't mean performance of study subject assessment per se (e.g., neorologic evaluation), but agreement to do so. Agreement to perform study subject assessment Ontology1325521724189:Alcohol_addiction www.stopaddiction.com/index.php/Rehab/Addiction/Alcohol-Addiction.html Addicted to alcohol Alcohol addiction is defined as prolonged and excessive intake of alcoholic drinks leading to a breakdown in health and an addiction to alcohol such that abrupt deprivation leads to severe withdrawal symptoms. Alcohol addiction Ontology1325521724189:Allocation_group_cardinality bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100002 Group cardinality In the context of the study where the main comparison is within experimental units, investigator assigns regimen of interventions to an allocation group made up of one (single) or of more than (multiple) experimental unit. Allocation group cardinality Ontology1325521724189:Allocation_scheme bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100021 Allocation scheme describes the way in which each experimental unit in an interventional trial is allocated to a treatment group. Allocation scheme Ontology1325521724189:Amyotrophic_Lateral_Scherosis www.nlm.nih.gov/medlineplus/amyotrophiclateralsclerosis.html ALS Amyotrophic lateral sclerosis is a nervous system disease that attacks nerve cells called neurons in your brain and spinal cord. These neurons transmit messages from your brain and spinal cord to your voluntary muscles- the ones you can control like in your arms and legs. Amyotrophic lateral sclerosis Ontology1325521724189:Anxiety www.medicalnewstoday.com/info/anxiety/ Anxiety is a general term for several disorders that cause nervousness, fear, apprehension, and worrying. These disorders affect how we feel and behave, and they can manifest real physical symptoms. Anxiety Ontology1325521724189:Anxiety_test medical-dictionary.thefreedictionary.com/anxiety Anxious Anxiety is a multisystem response to a perceived threat or danger. It reflects a combination of biomedical changes in the body, the patient's personal history and memory, and the social situation. Anxiety test Ontology1325521724189:Apathy_Evaluation_Scale www.tbims.org/combi/aes/index.html AES Apathy Evaluation Scale is a method for measuring apathy resulting from brain-related pathology. Apathy is the "lack of motivation not attributable to diminished level of consciousness, cognitive impairment, or emotional distress. Apathy evaluation scale Ontology1325521724189:Apathy_test medical-dictionary.thefreedictionary.com/apathy test apathy Apathy test is a test that measures lack of interest, concern, or emotion; indifference in patients or individuals. Apathy test Ontology1325521724189:Apparent_dose clinicaltrials.gov/ct2/show/NCT01059903 evident dose manifest dose plain dose Apparent dose is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose. Apparent dose Ontology1325521724189:Assessment_Scale-cognitive_subscale www.ncbi.nlm.nih.gov/pubmed/15592137 ADAS-cog The alzheimer's Disease Assessment Scale-Cognitive subsclae (ADAS-Cog) is commonly used to assess cognitive dysfunction in individuals with Alzheimer's disease and other dementias. Assessment scale-cognitive subscale Ontology1325521724189:Assessment_method_specification bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study%3AOCRE100077 Method for assessing an outcome, such as a questionaire or laboratory test. Assessment method specification Ontology1325521724189:Assignment_characteristics bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100048 Characteristics of assignment Characteristics of the assignment experiment experimental units (e.g., participant, eye) to a regimen of interventions. Assignment characteristics Ontology1325521724189:Attention_test medical-dictionary.thefreedictionary.com/attention Vigilance tracking Attention is the element of cognitive functioning in which the mental focus is patients is maintained on a specific issue, object, or activity. Attention test measures the mental focus of patients. There are numerous tasks that measure attention, but the most widely used are Trail Making and Digit Span. Other span tests, using letters, words and blocks are also available, as are continuous performance measures. In addition, cancellation tasks, using letters, numbers and shapes, are employed as measures of attention. Attention test Ontology1325521724189:Basic_science prinfo.clinicaltrials.gov/definitions.html Science Protocol designed to examine the basic mechanism of action (e.g.., physiology, biomechanics) of an intervention. Basic science Ontology1325521724189:Bio-alvailability_study prinfo.clinicaltrials.gov/definitions.html bio-alvailability Scientific basis for comparing generic and brand name drugs Bioavailability trial Ontology1325521724189:Bio-equivalence_study prinfo.clinicaltrials.gov/definitions.html bio-equivalence Rate and extent to which a drug is absorbed or otherwise available to the treatment site in the body. Bioequivalence trial Ontology1325521724189:Biochemical_biomarkers_identified_in_cerebrospinal_fluid_and_serum Gisele Silva, Karen Furie. " Biomarkers in Neurology". Front Neurol Neurosci. Basel ,karger, 2009, vol 25, pp 55-61 Biomedical markers Decrease in the A42 peptide in AD. Increase in total protein in AD and decrease in FTD. Reduction in orexin in CSF of HD. Biochemical biomarker Ontology1325521724189:Biological_Laboratory_variables medind.nic.in/iab/t10/iabt10i1p40.pdf Biological variables laboratory variables Biological variables such as blood and urine that are being analyzed in the laboratory. Biological laboratory variable Ontology1325521724189:Biological_Readouts www.greenfacts.org/glossary/def/endpoint.htm biological endpoint biological outcome biological readout A biological endpoint is a direct marker of disease progression. e.g disease symptoms or death- used to describe a health effect (or a probability of that health effect) resulting from exposure to a chemical. Biological outcome Ontology1325521724189:Biological_Specimen bioportal.bioontology.oeg/ontologies/45400?p=terms&conceptid=Biospecimen Biospecimen Bio-Specimen Sample BiologicSpecimen BiologicalSecimen Specimen Any material sample taken from a biological entity for testing, diagnostic, propagation, treatment or research purposes, including a sample obtained from a living organism or taken from the biological object after halting of all its life functions. Biospecimen can contain one or more components including but not limited to cellular molecules, cells, tissues, organs, body fluids, embryos, and body excretory products. Specimen Ontology1325521724189:Biomarkers_in_Neurology Gisele silva, Karen Furie. " Biomarkers in Neurology". Front Neurol Neurosci. Basel,karger,2009,vol 25, pp 55-61 Biomarkers in Neurodegenerative Diseases A biomarkers Definitions Working Group that included members from the FDA, NIH, universities and industries recently refined definitions for surrogate outcomes, biomarkers, pharmacodynamic markers and clinical endpoints. A biological marker (Biomarker) can be defined as a characteristics that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic process or pharmacologic responses to a therapeutic intervention. Biomarkers in neurology Ontology1325521724189:Block_randomization bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 randomized block Blocking randomization is used to ensure close balance of the numbers in each group at any time during the study. After every block the number of participants in each group would be eual. Of course blocking tends to reduce the unpredictability of randomization. Therefore it is recommended to use random block sizes when using block randomization. Block randomization Ontology1325521724189:Blood www.thefreedictionary.com/blood The fluid consisting of plasma, blood cells, and platelets that is circulated by the heart through the vertebrate vascular system, carrying oxygen and nutrients to and waste materials away from all body tissues. Blood Ontology1325521724189:Body_Fluids www.thefreedictionary.com/body+fluid biofluids bodily fluids A natural bodily fluid or secretion of fluid such as blood, semen, or saliva. Total body water, contained principally in blood plasma and in intracellular and interstitial fluids. Body fluid Ontology1325521724189:Body_weight C81328 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Bodyweight The weight of a subject. (NCI) Body weight Ontology1325521724189:Brief_summary prinfo.clinicaltrials.gov/definitions.html Summary Short description of the protocol intended for the lay public. Include a brief statement of the study hypothsis. Brief summary Ontology1325521724189:CSF www.medterms.com/script/main/art.asp?articlekey=7530 Cerebrospinal fluid A watery fluid, continuously produced and absorbed, which flows in the ventricles (cavities) within the brain and around the surface of the brain and spinal cord. CSF Ontology1325521724189:CSF_Alpha_beta_42_level www.ncbi.nlm.gov/pubmed/20157306 CSF level of alpha/beta The levels of cerebrospinal fluid (CSF) beta-amyloid 42 beta-amyloid42 in CSF The level of 42 amino acids form of amyloid beta as a cerebrospinal fluid biomarkers for predicting future cognitive decline in healthy individuals and the progression to dementia in patients who are cognitively impaired. CSF Alpha beta 42 level Ontology1325521724189:CSF_concentrations backandneck.about.com/od/c/g/cerebrospinalfl.htm concentration of cerebrospinal fluid The concentration of a fluid that circulates throughut the central nervous system. The cerebrospinal fluid is located between the brain and the skull. CSF concentration Ontology1325521724189:CSF_markers www.ncbi.nlm.nih.gov/pubmed/20157306 cerebrospinal fluid marker A marker for the prediction of cognitive decline in healthy individuals and the progression to dementia in patients who are cognitively declined. CSF marker Ontology1325521724189:CSF_total_tau_level www.ncbi.nlm.nih.gov/pubmed/20157306 CSF total tau concentrations Cerebrospinal fluid levels of total-tau The level of total and phosphorylated tau as a cerebrospinal fluids for the prediction of cognitive declinne in healthy individuals and the progression of dementia in patients who are cognitive impaired. CSF total tau level Ontology1325521724189:Cardiac www.thefreedictionary.com/cardiac cardiac heart disease Cardiac arrest A person suffering from heart disease or disorder Cardiac symptom Ontology1325521724189:Case-control prinfo.clinicaltrials.gov/definitions.html case referent study Single group of individuals with specific characteristics (e.g.., conditions or exposures). Case-control Ontology1325521724189:Case-crossover_study_design bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100015 Case-Crossover Study A case-crossover study is an observational study that aims to answer the question, "was this event trggered by something unusual that happened just before?" The key feature of the design is that each case serves as its own control. the method is analogous to a crossover experiment viewed retrospectively, except that the investigator does not control when an experimental unit starts and stops being exposed to the potential trigger. Also, the exposure frequency unit was at risk of the injury or disease onset. thus it usually resembles a case-control study more than a retrospective cohort study. Case-control study design Ontology1325521724189:Causal_Assessment www.cochrane.org/glossary Causality Assessment An adverse event for which the causal relation between the drug/intervention and the event is assess and is at least a reasonable possibility. Causal assessment Ontology1325521724189:Change_from_baseline www.ata-divisions.org/GLD/docs/48_konferenz/Glossary_clinical_trials_EN-GE.pdf Change from values, findings etc. before treatment. Change from baseline Ontology1325521724189:Clinical_Dementia_Rating_Scale-sum_of_boxes Roberto R., Emiliano A. " Cholinesterase Inhibitors in Mild Cognitive Impairement: A systematic Review of Randomised Trials. " PLoS Medicine 2007 CDR-SB Clinical Dementia Rating-Sum of the boxes; Its variant, the CDR sum of the boxes (CDR-SB), is a more quantitative numerical rating (it merely sums up the scores of the six individual domains of the CDR) Clinical dementia rating scale-sum of the boxes Ontology1325521724189:Clinical_Global_Impression_of_Change Roberto Raschetti, Emiliano Albanese, Nicola Vanacore, Marina Maggini " Cholinesterase Inhibitora in Mild Cognitive Impairement: A systematic Review of Randomised Trials". PLoS Medicine. 2007 CGIC Clinical global impression of change scale is a clinical measures that are use for patients with aMCL, based on semistructured interviews from both the subject and the informant. Cinical global impression of change Ontology1325521724189:Clinical_Global_Impressions_scale www.personal.kent.edu/~dFresco_papers/Zaider_et_al_CGI.pdf CGI Clinical Global Impression scale is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his or her functioning over time. It is commonly used as primary outcomes measure in studies evaluating the efficacy of treatments for anxiety disorders. Clinical global impression scale Ontology1325521724189:Clinical_Trial_Readouts clinicaltrials.gov/ct2/info/glossary clinical endpoint clinical trial endpoint clinical trial readout readout in clinical trials Overall outcomes that the protocol is designed to evaluate. Common enpoints are severe toxicity, disease progression, or death. Clinical trial outcome Ontology1325521724189:Clinical_Trial_Study http://www.clinicaltrials.gov/ct2/about-studies/glossary A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. Clinical trial study Ontology1325521724189:Clinical_Trial_measurement_Units Measurement units These are units use for the measurement of clinical trial study. Clinical trial measurement unit Ontology1325521724189:Clinical_biomarkers Gisele Silva, Karen Furie. "biomarkers in Neurology" Front Neurol, Neurosci, Basels, karger, 2009, vol 25, pp 55-61 Cognitive dysfunction evaluation in PD. Attention and executive function testing for disease progression in HD. Visual and verbal memory span acores to identify the earliest cognitive deficits in elderly patients at genetic risk of AD. Clinical biomarker Ontology1325521724189:Clinical_event bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 A clinical event is an event during which an assyssment of, or intervention on a study subject occures. Clinical event Ontology1325521724189:Clinical_imagings www.elsevier.com/wps/find/journaldescription.cws_home/505753/description#description Imagings Clinical imaging is a neuroimaging measures. It provides comprehensive coverage of new technology, new application, and important issues concerning all diagnostic imaging methods. Ontology1325521724189:Clinical_trial_methods Peace, K. E., & Chen, D. G. D. (2010). Clinical Trial Methodology. CRC Press. Clinical trial method Clinical trial methodology comprises all methods required for the protection of participants in a clinical trial and all methods necessary to provide a valid inference. Clinical trial methodology Ontology1325521724189:CogState clinicaltrials.gov/ct2/show/NCT00777608 CogState ClinicalTrials CogState is a simple , brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's disease. CogState Ontology1325521724189:Cognitive_Readouts medical-dictionary.thefreedictionary.com/cognition Cognitive endpoint Cognitive readout Overall outcome measures of the mental faculty of knowing, which includes perceiving, recognizing, conceiving, judging, reasoning and imagining. Cognitive outcome Ontology1325521724189:Cognitive_tests encyclopedia.thefreedictionary.com/cognitive+tests Cognitive ability tests Cognitive tests are assessments of the cognitive capabilities of humans and animals. Tests administered to humans include various forms of IQ tests. Cognitive test Ontology1325521724189:Cohort prinfo.clinicaltrials.gov/definitions.html Group of individuals, initially defined and composed, with common characteristics (e.g.., condition, birth year), who are examined or traced over a given period. Cohort Ontology1325521724189:Cohort_study_design prinfo.clinicaltrials.gov/definitions.html follow-up study design Group of individuals, initially and composed, with common characteristics (e.g.., condition, birth year), who are examined or traced over a given time period. Cohort study design Ontology1325521724189:Committees_for_Multicenter_Clinical_Trials Harold P. Adams Jr. " Committees for Multicenter Clinical Trials". Woodburg-Harris KM, Coull BM(eds): Clinical Trials in the Neurosciences. Front Neurol Neurosci. Basel, Karger, 2009, Vol 25, pp 124-126. executive committee Most large clinical trials also have a committee structure that provides advice to the principal investigator, help in the overall conduct of the study, performs some components of the research, organizes and supervises publications, and executes independent safety monitoring. Committee for multicenter clinical trial Ontology1325521724189:Comparator www.cochrane.org/glossary/5#term116 comparator group The arm that acts as a comparator for one or more experimental interventions. Comparator arm Ontology1325521724189:Completed prinfo.clinicaltrials.gov/definitions.html completed The study has concluded normally; participants are no longer examined or treated. Recruitment completed Ontology1325521724189:Completion_Date grants.nih.gov/clinicaltrials_fdaaa/definitions.htm date of completion Final date on which data were (or are expected to be) collected. Completion date Ontology1325521724189:Computed_tomography www.ndt-ed.org/EducationResources/CommunityCollege/Radiography/AdvancedTechniues/computedtomography.htm (CT) This is a powerful nondestructive evaluation (NDE) techniue for producing 2-D and 3-D cross sectional images of an object from flat X-ray images. Computed tomography Ontology1325521724189:Concomitant_Agent www.medaphile.com/medical-dictionary/concomitant-agent CONTRT Concomitant therapy concomitant agent A pharmaceutical agent other than agent(s) tested in a given protocol that is administered to or used by a subject either prior to or during the study. Concomitant medication Ontology1325521724189:Concomitant_medication www.barkerstats.com/PDFs/concomitant.pdf Concomitant drugs Concomitant Medications are medications used by patients in a clinical trial, other than the investigational drug. Concomitant medication Ontology1325521724189:Confidence_interval www.cochrane.org/glossary/5#letterh A measure of the uncertainty around the main finding of a statistical analysis- Estimates of unknown quantities such as the odds ratio comparing an experimental intervention with a control, are usually presented as a point estimate and a 95% confidence interval. this means that if someone were to keep repeating a study in other samples from the same population, 95% of the confidence intervals from those studies would contain the true value of the unknown quantity. Confidence interval Ontology1325521724189:Confusion dictionary.reference.com/browse/confusion distraction The state of being confused. Confusion Ontology1325521724189:Control www.sahealthinfo.org/evidence/c.htm control group In a clinical trial comparing two or more interventions, a control is a person in the comparison group that recieves a placebo, no intervention, usual care or another form of care. Control Ontology1325521724189:Cross-sectional_study_design prinfo.clinicaltrials.gov/definitions.html Cross-sectional study prevalence study Observations or measurements made at a single point in time, usually at subject enrollment. Cross-sectional study design Ontology1325521724189:Crossover_assignment www.clinicaltrials.gov/ct2/about-studies/glossary 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. Crossover design Ontology1325521724189:Crossover_study_design www.sahealthinfo-org/evidence/c.htm CROSSOVER TRIAL A type of clinical trial comparing two or more interventions in which the participants, upon completion of the course of one treatment are switched to another. Cross-over study Ontology1325521724189:Data_Management_and_Quality_Assurance Dejuran Richardson, Selma Kunitz. " Data Management and Quality Assurance". Front Neurol Neurosci. Basel, karger, 2009, vol 25, pp 98-105 study data management activities Data management emcompasses the acquisition and maintenance of study data. Data management activites are important to any study because data are the medium by which the study results are processed, interpreted and reported. the conduct of any clinical study requires a substantial investment of financial and human capital. A comprehensive data management strategy represents thoughtful stewardship of these limited resources. The quality of any study rests heavily on the quality of its data management effort. stdy data management activities should focus ensuring that: - data are of the highest quality - participant safety and confidentiality are protected and - study staff has tools that facilitate efficient and effective conduct of the study. Quality assurance, as applied to clinical trials, is any method or procedure for collecting, processing or analyzing data that is aimed at maintaining or enhancing their reliability or validity. Quality assurance encompasses internal quality control, study monitoring and external audits or assessments. Data management Ontology1325521724189:Data_analysis_within_experimental_units bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100046 In the context of a study where the main comparison is within experimental units, whether data is analyzed within a single study experimental unit or within multiple experimental units. Data analysis within experimental units Ontology1325521724189:Data_analyzed_within_multiple_experimental_units bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100063 Many Experimental unit data is analyzed within multiple study experimental units. Data analyzed within multiple experimental units Ontology1325521724189:Data_analyzed_within_single_experimental_units bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100085 One experimental unit Data is analyzed within a single study experimental unit. Data analyzed within single experimental unit Ontology1325521724189:Date_of_registration www.unmc.edu/irb/index.cfm?L1_ID=15&CONREF=18 Registration date Registration date is defined as the date the study was registered in ClinicalTrials.gov. Date of registration Ontology1325521724189:Delusion medical-dictionary.thefreedictionary.com/Delusion deception A false belief strongly held in spite of invalidating evidence, especially as a symptom of mental illness. Delusion Ontology1325521724189:Diabetes www.medicalnewstoday.com/info/diabetes/ diabetes mellitus Diabetes is classed as a metabolism disorder. Metabolish refers to the way our bodies use digested food for energy and growth. Most of what we eat is broken down into glucose, a form of sugar. Diabetes Ontology1325521724189:Diagnostic pr.clinicaltrials.goy/definitions.html Diagnose Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition. Diagnostic Ontology1325521724189:Dizziness theraurus.com/browse/dizziness dysequilibrium faintness giddiness lightheadedness unsteadiness vertigo wooziness Dizziness refers to an impairment in spatial perception and stability. Dizziness Ontology1325521724189:Double_blind prinfo.clinicaltrials.gov/definitions.html double-masked study Two or more parties are unware of the intervention assignment. Double blind Ontology1325521724189:Drug_addiction www.ehow.com/facts_5127985_drug-addiction_.html?ref=Track2&utm_source=ask addicted to drug An addiction to drugs is a compulsion to take a substance, regardless of its physical or emotional harm to oneself or others. Drug addiction Ontology1325521724189:Drug_allergy www.nlm.gov/medlineplus/ency/article/000819.htm Allergic reaction Drug allergies Reactions to drugs Drug allergy are symptoms caused by an allergic reaction to a drug (medication). Drug allergy Ontology1325521724189:Efficacy_study prinfo.clinicaltrials.gov/definitions.html Efficacy Efficacy: measure of an intervention's influence on a disease or health condition. Efficacy study Ontology1325521724189:Encephalitis www.nlm.nih.gov/medlineplus/encephalitis.html Encephalitis is an inflammation of the brain. The usual cause is a vival infection, but bacteria can also cause it. Cases can range from mild to severe. Encephalitis Ontology1325521724189:Epilepsy www.nlm.nih.gov/medlineplus/epilepsy.html Epilepsy is a brain disorder that causes people to have recurring seizures. The seizures happen when clusters of nerve cells, or neurons, in the brain send out the wrong signals. People may have strange sensations and emotions or behave strangely. They may have violent muscles spasms orlose consciousness. Epilepsy Ontology1325521724189:Epworth_Sleepiness_Scale www.umm.edu/sleep/epworth_sleep.htm ESS The Epworth Sleepiness Scale is a scale used to determine the level of daytime sleepiness. the score of 10 or more is considered sleepy. A score of 18 or more is very sleepy. Epworth sleepiness scale Ontology1325521724189:Estimated_Enrollment www.syncardia.com/Medical-professionals/clinicaltrials.html Enrollment estimates This is the estimated number of participants that are being enrolled in a clinical trial studies. Estimated enrollment Ontology1325521724189:Ethics_approval_process bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Ethical approval The ethivs approval process is a study administrative relation whereby a study is submitted to a committee that is formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. Ethichs approval process Ontology1325521724189:Evaluated_Activity Activity Evaluation Determining the efficacy of a particular activity. Evaluated activity Ontology1325521724189:Evaluated_Result bioportal.bioontology.org/ontologies/46116/?p=terms&conceptid=363109007 Evaluation of test results Determining the efficacy of a particular result. Evaluated result Ontology1325521724189:Events bioportal.bioontologies.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 An event is a processual entity that is a maximally connected spatiotemporal whole and has beginings and endings corresponding to real discontinuities. Example: the life of an organism, the porcess of sleeping, the process of cell-devision. Events Ontology1325521724189:Exclusion_criteria bioportal.bioontology.org/ontologies/46317/?p=terms&conceptid=Exclusion_Criteria criterion for exclusion Elements of a personal medical history which would prevent an individual from participating in a specific clinical trial. Exclusion criteria Ontology1325521724189:Executive_Functions Bonnie E. Levin. "Behavioral/Neuropsychological outcomes and uality of life Endpoints". Front neurol neurosci. Basel karger, 2009, vol 25, pp 78-92 command and control function Executive functions refer to the complex of behaviors involved in antipating, planning and formulating goals, self-monitoring as well as using feedback to guide and modify behavior. This domain is considered to be an essential component of neuropsychological testing. Specific executive functions include verbal and conceptual reasoning, generating problem-solving strategies, planning and formulating abstractions, managing multiple tasks at the same time, set shifting and the ability to ignore competing stimuli while focusing on relevant task demands. Executive function Ontology1325521724189:Experimental www.cancer.gov/clinicaltrials/conducting/ncictrp/resources/glossary Experimental Arm An arm or group in which an experimental drug or regimen is being administered. This will be used when the trial specifies that one arm is a control arm and the other is experimental, or when the other arm is a placebo arm. In cases where patients are not randomized but assigned to groups according to certain characteristics (e.g., risk characteristics, age, diagnosis), use "experimental" for all group/strata because they are not being compared. Experimental arm Ontology1325521724189:Exploratory_Clinical_Trials wiki.answers.com/Q/What_is_exploratory_clinical_trial Exploratory Clinical Trial is defined as those intended to be conducted early in phase I, involving limited human explosure, have no therapeutic intent, and not intended to examine clinical tolerability. Exploratory approaches for first in human studies have been developed in order to drive the selection of compounds or targeted drug approaches based on human data rather than sloely animal and in vitro data. Exploratory clinical trial Ontology1325521724189:Fasted_state www.epidemic.org/theFacts/theLiver/fedAndFasting/ fasting state This is the state where drugs or medications are administered by patients or participants without eating for a while. Fested state Ontology1325521724189:Feasibility_assessment www.businessdictionary.com/definition/feasibility-analysis.html feasibility analysis feasibility study An anylysis and evaluation of a proposed project to determine if it (1) is technically feasible, (2) is feasible within the estimated cost, and (3) will be profitable. Feasiblity studies are almost always conducted where large sums are at stake. Feasibility assessment Ontology1325521724189:Fed_state www.epidemic.org/theFacts/theLiver/fedAndFasting/ This is the state where drugs or medications are administered by patients or individuals where the patients have been eating. A period following a meal and is characterized by high levels of nutrients in the blood. Fed state Ontology1325521724189:First_recieved_Date http://www.clinicaltrials.gov/ct2/about-studies/glossary date received The first received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry. First received date Ontology1325521724189:Fluctuations_in_attention www.neurology.org/content/59/11/1714.abstract fluctuations of attention Fluctuations in the way we actively process specific information present in our enviroment. Fluctuation in attention Ontology1325521724189:Food_effect C90384 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls effects of food food consumption A measurement of a subject's nutritional intake. (NCI) Food effect Ontology1325521724189:Freezing theraurus.com/browse/freezing chill, shevery,frosty very cold Freezing Ontology1325521724189:Frontotemporal_dementia www.mayoclinic.com/health/frontotemporal-dementia/DS00874 Frontotemporal lobar degeneration Frontotemporal dementia is an umbrella term for a diverse group of uncommon disorders that primarily affect the frontal and temporal lobes of the brain- the areas generally associated with personality, behavior and language. Frontotemporal dementia Ontology1325521724189:Functional_imaging_fMRI Gisele Silva, Karen Furie. " Biomarkers in Neurology" Front Neurol Neurosci. Basel, karger, 2009, vol 25, pp 55-61 Functional Magnetic Resonance Imaging fMRI BOLD responses in presymptomatic gene carriers in HD. BOLD activation in the hippocampal and parahippocampal regions in MCI. Functional imaging Ontology1325521724189:Funding bioportal.bioontologies.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Financing Fiscal support for research from industry, government, or non-commercial. non-governmental organizations. EXAMPLE(S): Funding from pharmaceutical, device or biotechnology companies, the US NIH or the Gates Foundation. Funding Ontology1325521724189:Gender www.who.int/gender/whatisgender/en/ Sex Gender refers to the socially constructed roles, behaviors, activities, ans attribute that a given society considers appropriate for men and women. Gender Ontology1325521724189:Genetic_Brain_disorders www.nlm.nih.gov/medlineplus/gentocbrainisorders.html A genetic disorder is a disease caused by a difficult form of a gene, called a variable, or a change in a gene, called a mutation. Genetic brain disorders specifically affect the development and function of the brain. Genetic brain disorder Ontology1325521724189:Haemopoietic medical-dictionary.thefreedictionary.com/hematopoietic blood cell formation haemopoietic An agent that promotes the formation of blood cells Haemopoietic symptom Ontology1325521724189:Hallucination dictionary.reference.com/browse/hallucination phantasm aberration A perception of something with no external cause usually arising from a disorder of the nervous system or in response to drugs. It can also be define as false or distorted sensory experience that appear to be perceptions. These sensory impressions are generated by the mind rather than by any external stimuli and may be seen, heard,felt, and even smelled or tasted. Hallucination Ontology1325521724189:Hazard_ratio www.cochrane.org/glossary/5#letterh A measure of effect produced by a survival analysis. this represents the increased risk with which one group is likely to experience the outcome of interest. For example, if the hazard ratio for death for a treatment is 0.5, less than we can say that treated patients are likely to die at half the rate of untreated patients. Hazard ratio Ontology1325521724189:Health_Services prinfo.clinicaltrials.gov/definitions.html Protocol designed to evaluate the delivery, processes ,management, organization or financing of health care. Health services Ontology1325521724189:Hepatic dictionary.reference.com/browse/hepatic hepatic Liver-colored; dark reddish-brown Hepatic symptom Ontology1325521724189:Hohen_and_Yahr_Scale parkinsonsdisease.myguideusa.com/answers-to-my-questions/what-is-the-hohn-and-yahr-scale?/ Hohen and yahr scale is a common used system for describing the symptoms of parkinson's disease progression. The scale allocates stages from 0 to 5 to indicae the relative level of disability as follows: - stage one: symptoms on one side of the body only. - stage two: symptoms on both sides of the body. No impairment of balance. - Stage three: Balance disability. Mild to moderate disease. Physically independent. - Stage four: Severe disability, but still able to walk or stand unassisted. - Stage five: wheelchair-bound or bedridden unless assisted. Hohen and Yahr scale Ontology1325521724189:Hydrocephalus www.ninds.nih.gov/disorders/hydrocephalus/hydrocephalus.htm Hydrocephalus is a condition in which the primary characteristic is excessive accumulation of cerebrospinal (CSF) fluid in the brain. Hydrocephalus Ontology1325521724189:Inclusion_criteria www.cdisc.org/stuff/contentmgr/files/0/be650811feb46f381f0af41ca40ade2e/misc/cdisc_2009_glossary.pdf The criteria in a protocol that prospective subjects must meet to be eligable for participation in a study. Inclusion criteria Ontology1325521724189:Informations_of_study bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 study informations Informations of study is a structure whose purpose is to hold information. Study information Ontology1325521724189:Informed_consent http://www.clinicaltrials.gov/ct2/about-studies/glossary A process in which researchers communicate with potential and enrolled participants about a clinical study. Informed consent Ontology1325521724189:Inpatient dictionary.reference.com/browse/inpatient In-patient A patient who stays in a hospital while recieving medical care or treatment. Inpatient Ontology1325521724189:Intervention_assignment_scheme bioportal-bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100003 Intervention assignment The scheme used to assign regimens of interventions: single factor or factorial. Intervention assignment scheme Ontology1325521724189:Intervention_model http://www.clinicaltrials.gov/ct2/about-studies/glossary Model of Intervention The general design describing the strategy in which interventions will be assigned to participants in a clinical study. Intervention model Ontology1325521724189:Interventional_study_design bioportal.bioontology.org/ontologies/46378/?p=terms%conceptid=study_design%3AOCRE100007 Intervention studies An interventional study is a quantitative study that prospectively assigns experimental units to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive, etc. Interventional study Ontology1325521724189:Investigator_assignment_role bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100058 Investigator Assignment The role investigator plays in the assignment of study experimental units to one or more regimens of interventions (each including one or more interventions, or no intervention). Investigator assignment role Ontology1325521724189:Investigator_assigns_intervention bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100026 Investigators assign the intervention The investigator actively assigns the study experimental units to one or more regimen of interventions (each including one or more interventions, or no intervention). Investigator assigns intervention Ontology1325521724189:Investigator_assigns_no_intervention bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100009 Investigator does not assign specific interventions The investigator does not actively assign study experimental units to regimens of interventions. Investigator assigns no intervention Ontology1325521724189:Irritability_test crankiness test medical-dictionary.thefreedictionary.com/irritability Irritability test measures the abnormal excitability or sensitivity of patients. Irritability test Ontology1325521724189:Last_updated_Date http://www.clinicaltrials.gov/ct2/about-studies/glossary Last Update Date The last updated date is the most recent date that changes to study information were submitted to ClinicalTrials.gov. There may be a delay of a few days to a few weeks before the updated study information is available on ClinicalTrials.gov. Last updated date Ontology1325521724189:Lewy_body_disease www.nlm.nih.gov/medlineplus/lewybodydisease.html Lewy body desiase is one of the most common causes of dementia in the elderly. Dementia is the loss of mental functions severe enough to affect normal activities and relationships.Lewy body disease happens when abnormal structures, called Lewy bodies, build in areas of the brain. Lewy body Ontology1325521724189:Magnetic_Resonance_imaging www.mritutor.org/mritutor/WhatisMR.html (MRI) MRI is a way of getting pictures of various parts of your body without the use of x-rays, unlike regular x-rays pictures and CAT scans Magnetic resonance imaging Ontology1325521724189:Magnetic_resonance_spectroscopy Gisele Silva, Karen Furie. " Biomarkers in Neurology". Front neurol Neurosci, Basel, karger, 2009, vol 25, pp 55-61 MRS N-acetyalaspartate to creating ratio in conversion from MCI to AD and in cognitive decline in PD. Magnetic resonance spectroscopy Ontology1325521724189:Masking clinicaltrials.ifpma.org/clinicaltrials/en/tips/glossary/index.htm#b-link Masking is a orocedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the subject(s) being unaware , and double blinding usually refers to the subject(s), investigato(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). In an open-label trial the identity of treatment is known to all. Masking Ontology1325521724189:Memory_and_learning Bonnie E. Levin. "Behavioral/Neuropsychological Outcomes and Quality of Life Endpoints". Front Neurol Neurosci. Basel,karger, 2009, vol 25, pp 78-92 Memory involves the ability to store, retain and retrieve information. It is not unitary skill; rather, memory is assessed on multiple levels, using a wide range of stimuli presented under different conditions. A mnemonic measure may utilize visual, auditory, tactile or other sensory stimili to assess one or more memory abilities, which are referred to in the literature as working memory, learning and learning efficiency, immefiate and delayed recall, remote memory, recognition memory, autobiographical memory and source memory. Memory Ontology1325521724189:Mini_Mental_State_Examination Roberto R, Emiliano A. " Cholinestinase Inhibitors in Mild Cognitive Impairement: A systemtic Review of Randomised Trials". PLoS Medical. 2007 MMSE Mini mental State Examination is a brief, uantitative measure of cognitive status in adults. Mini-mental state examination Ontology1325521724189:Minimization bioporta.bioontology.org/ontologies/56378/?p=terms&conceptid=study_design%3AOCRE100077 Minimization is not a method of randomization. Indeed it is the only non-random method which is an acceptable alternative to randomization. Minmization ensures balance between intervention groupd for several patient factors. Randomization lists are not set up in advance. the first patient is truly randomly allocated; for each subsequent patient, the treatment allocation is identified, which minimizes the imbalance between groups at that time. Minimization Ontology1325521724189:Molecular_Readouts clinicaltrials.gov/ct2/show/NCT01216085 molecular clinical endpoint molecular endpoint molecular readout overall outcomes measure of molecules in the body. Molecular outcome Ontology1325521724189:Mortality_rate www.cs.colunbia.edu/digigov/LEXING/CDCEPI/gloss.html Rate of mortality A measure of the freuency of occurence of death in a defined population during a specified interval of time. Mortality rate Ontology1325521724189:Multicentered_Trials www.cdisc.org/stuff/contentmgr/files/0/be650811fed46f381f0af41ca40ade2e/misc/cdisc_2009_glossary.pdf Multicenter trial is defined as clinical trial conducted according to a single protocol but at more than one site and , therefore, carried out by more than one investigator. Multicenter trial Ontology1325521724189:Multiple_Sclerosis ec.europa.eu/health/major_chronic_diseases/diseases/brain_neurological/index_en.htm MS Multiple sclerosis is a disorder of the central nervous system (brain and spinal cord) caused by lesions in the white matter of the central nervous system that degeneate the myeli sheath , marked by lack of the muscle coordination, muscle weakness, speech problems, paresthesia and visual impairments. Multiple sclerosis Ontology1325521724189:Multiple_experimental_unit_allocation_group bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study%3AOCRE100029 In the context of a study where the main comparison is within experimental units, investigator assigns regimen of interventions to all allocation group made up of more than one experimental unit. Multiple experimental unit allocation group Ontology1325521724189:Multiple_regimen bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100035 Multiple regimens of intervention, each including one or more individual interventions (treatments) or no treatment, each assigned to one allocation group. This means the study has at least one contemporaneous comparison group. Multiple regimen Ontology1325521724189:N_of_1_crossover_study_design bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%AOCRE100024 N-of-1 crossover study design An N-of-1 crossover study ia an interventional study where the population is a single human subject and in which at least two regimens of interventions are given alternatingly. Regimens are assigned to and data are analyzed within one participant at a time. N-of-1 crossover study Ontology1325521724189:Neuro-Psychiatric_Inventory Roberto R., Emiliano A., " Cholinesterase Inhibitors in Mild Cognitive Impairement: A systematic Review of Randomised Trials" PLoS Medicine. 2007 NPI A battery including a standardised assessment of neuropsychiatric symptoms. Neuro-psychiatric inventory Ontology1325521724189:Neuroimaging_Structural Gisele Silva, Karen Furie. "Biomarkers in Neuology". Front neurol neurosci, Basel, karger, 2009, vol 25, pp 55-61 structural neuroimaging Medical temporal lobe measurement in Alzheimer's disease. Himispheric measurements in Alzheimer's disease. Ratio of the midbrain to pons areas. Rates of striatal atrophy in HD. Voxel-based morphometry for WMD measurement. Structural imaging Ontology1325521724189:Neuropsychiatric_Inventory clinicaltrials.gov/ct2/show/NCT01302340 NPI Improvement in behavior during long term treatment is measured with the NPI, which is the standard measured of Neuro Psychiatric Symptoms in most clinical trials. Neuropsychiatric inventory Ontology1325521724189:Neuropsychiatric_Test_Battery clinicaltrials.gov/ct2/show/NCT01265251 NTB Neuropsychological test battery is a test used as a standardised tool assessing the cognitive domains. Neuropsychiatric test battery Ontology1325521724189:Neuropsychiatric_symptoms book.google.de/books?id=uXMMHDN1pzkC&pg=definition+of+neuropsychiatric+synptoms+(NPS)&source=bl&ots=QOVSIP2sp-&sig=9jqGhraENawpJqF5dw700upAukc&hl=de&sa=X&ei=Q5QMT6_=CYfOswb02NyUBA&ved=OCFoQ6AEwBQ#v=onepage&q=definition of neuropsychiatric symptoms (NPS)&f=false Neuropsychiatric symptoms Neuropsychiatric symptoms (NPS) are the manifest behavior changes resulting from brain dysfunction or pathology. Neuropsychiatric symptom Ontology1325521724189:Neuropsychological_Test_Battery www4.parinc.com/products/product.aspx?productID=NAB NAB Neuropsychological Assessment Battery Neuropsychological test battery is a comprehensive, integrated, modular battery of 33 neuropsychological tests developed to assess a wide array of neuropsychological skills and functions in adults (ages 18-97 years) who have known or suspected disorders of the central nervous system. The individual tests are grouped into six modules: Attention, Language, Memory, Spatial, Executive Functions, and screening. Neuropsychological test battery Ontology1325521724189:Non_random_allocation bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Allocation, Non-random Non-random (or Deterministic) allocation is an allocation scheme that follows a non- random rule (e.g., sequential allocation)- Non-random allocation Ontology1325521724189:Number_of_responders www.jpsmjournal.com/article/S0885-3924(06)00048-0/abstract Responders This is the number of patients involved in a clinical studies that response to a treatment. Number of responders Ontology1325521724189:Observation bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 An observation is an activity whose intention is to obtain a result by observing, monitoring, measuring or otherwise qualitively or quantitatively gathering data or information about one or more aspects of a study subject's or experimental unit's physiologic or psychologic state. Examples: blood chemistry panel, body mass index calculation, blood pressure measurement. Observation Ontology1325521724189:Official_title_of_trial_study prsinfo.clinicaltrials.gov/definitions.html Clinical trial title Official name of the protocol provided by the study principal investigator or sponsor. Official title of trial study Ontology1325521724189:Open_label prinfo.clinicaltrials.gov/definitions.html Open-label No masking is used. All involved know the identity of the intervention assignment. Open label Ontology1325521724189:Outpatient dictionary.reference.com/browse/outpatient Out-patient A patient who recieves treatment at a hospital, as in an emergency room or clinic, but is not hospitalized. Outpatient Ontology1325521724189:P-Values www.disc.org/stuff/contentmgr/files/0/be650811feb46f381f0af41ca40ade2e/misc/cdisc_2009_glossary.pdf p values Study findings can also be assessed in terms of their statistical significance. the p-values represents the probability that the observed data (or a more extreme result) could have arisen b chance when the interventions did not differ. P-value Ontology1325521724189:Parallel_Assignment www.clinicaltrials.gov/ct2/about-studies/glossary Assignment, Parallel 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. Parallel design Ontology1325521724189:Parallel_group_study_design bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100027 A parallel group study is an interventional study that compares across at least two allocation groups concurrently, each receiving a regimen of interventions (which can be "no intervention"). Parallel group study Ontology1325521724189:Parkinson_disease www.nlm.gov/medlineplus/parkinsonsdisease.html PD Parkinson's disease Parkinson's disease is a disorder that affects nerve cells, or neurons, in a part of the brain that controls muscle movement. In Parkinson's neurons that make a chemical called dopamine die o do not work properly. Parkinson disease Ontology1325521724189:Pet_scan my.develandclinic.org/services/pet_scan/hic_pet_scan.aspx PET position emission tomography scan PET scan is a unique type of imaging test that helps doctors see how the organs and tissues inside your body are actually functioning. Positron emission tomography Ontology1325521724189:Pharmacodynamic_study prinfo.clinicaltrials.gov/definitions.html Pharmacodynamics Action of drugs in living systems Pharmacodynamic study Ontology1325521724189:Pharmacokinetic_study prinfo.clinicaltrials.gov/definitions.html pharmacokinetics The action of a drug in the body over a period of time including the process of absorption, distribution and localization in the tissue, biotransformation, and excretion of the compound. Pharmacokinetic study Ontology1325521724189:Phase_I prinfo.clinicaltrials.gov/definitions.html Phase 1 trial Phase I clinical trials Phase I trial phase I studies Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/ or patients. Phase I Ontology1325521724189:Phase_II prinfo.clinicaltrials.gov/definitions.html Phase 2 trial Phase II clinical trials phase II trial Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Phase II Ontology1325521724189:Phase_III prinfo.clinicaltrials.gov/definitions.html Phase 3 trial Phase III clinical trials phase III trial Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adeuate basis for physician labeling. Phase III Ontology1325521724189:Phase_O prinfo.clinicaltrials.gov/definitions.html Phase 0 trial Exploratory trials,involving very limited human exposure, with no therapeutic or diagnostic intent (e.g screening studies, microdose studies). Phase 0 Ontology1325521724189:Phase_VI prinfo.clinicaltrials.gov/definitions.html Phase 4 trial Phase VI clincal trials phase VI trial Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. Phase VI Ontology1325521724189:Phase_not_applicable prinfo.clinicaltrials.gov/definitions.html N/A For trials without phases Phase not applicatble Ontology1325521724189:Physical_Readouts www.bv.com.au/media/vanilla/file/Green exercise.pdf physical endpoint physical readout The overal outcome measured of the physical characteristics of an individual. Physical outcome Ontology1325521724189:Physical_examinations C20989 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Medical examination Physical Examination check-up clinical examination A systemic evaluation of the body and its functions using visual inspection, palpation, percussion and auscultation. The purpose is to determine the presence or absence of physical signs of disease or abnormality for an individual's health assessment. Physical exam Ontology1325521724189:Physical_symptoms www.answers.com/topic/symptom physical signs symptoms that are observed and noticed by the patients. Physical symptom Ontology1325521724189:Pilot_Trials http:// www.cirem.org.uk/definations.html www.biomedcentral.com/1471-2288/10/1 pilot study Pilot trial is defined as an experimental, exploratory,test,preliminary, trial or try out investigation.. It is a trial study carried out before a research design is finalised to assist in defining the research uestion or to test the feasibility,reiability and validity of the proposed study design. Pilot trial Ontology1325521724189:Placebo Michael Stein and Guy Taylor " The Encyclopedia of Arthritis" 2004 Inactive drugs A placebo-controlled study is generally more efficient in finding out whether a new treatment is effective, but for ethical reasons this design is not always appropriate. Most medical ethicists agree that it is not ethical to treat a patient in a clinical trial with placebo if an effective treatment is available for that particular condition and if treatment with placebo could result in irreversible, preventable problems for a patient. Placebo Ontology1325521724189:Placebo_comparator www.cancer.gov/clinicaltrials/conducting/ncictrp/resources/glossary PLACEBO COMPARATORS An arm or group in which ONLY a placebo is given. Placebo comparator Ontology1325521724189:Plasma www.wisegeek.com/what-is-blood-plasma.htm blood plasma Blood plasma is a liquid component of blood, consisting of around half of the total blood volume. Plasma itself is around 90% water, with the 10% remainder including proteins, minerals, waste products, clotting factors, hormones, and immunoglobins. Plasma Ontology1325521724189:Plasma_concentration wiki-answers.com/QMax_plasma_concentration_definition Plasma concentration is how much of a drug is in your blood. Plasma concentration Ontology1325521724189:Plasma_markers www.hindawi.com/journals/jbb/2010/927917/ plasma biomarkers These are biomarkers in blood plasma Plasma marker Ontology1325521724189:Pregnancy www.healia.com/healthguides/pregnancy/what-is-pregnancy pregnant Pregnancy is the state of carrying a growing embryo or fetus in the uterus.In mammals, pregnancy is defined as the period between implantation of a fertilized egg in wall of the uterus and delivery or other termination. Pregnancy Ontology1325521724189:Prevention prinfo.clinicaltrials.gov/definitions.html Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition. Prevention Ontology1325521724189:Primary_completion_Date www.clinicaltrials.gov/ct2/about-studies/glossary Completion Date The date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected. Whether the clinical study ended according to the protocol or was terminated does not affect this date. The "estimated primary completion date" is the date that the researchers think will be the primary completion date for the study. Primary completion date Ontology1325521724189:Primary_endpoint_measure prinfo.clinicaltrials.gov/definitions.html primary outcome measure Specific key measurememt (s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits orassociations with exposures, risk factors or reatment. Primary endpoint measure Ontology1325521724189:Primary_purpose www.clinicaltrials.gov/ct2/about-studies/glossary The one main reason for the clinical trial. Primary purpose Ontology1325521724189:Prion_diseases www.cdc.gov/ncidod/dvrd/prions/ transmissible spongiform encephalopathies (TSEs) Prion diseases are a family of rare progressive neurodegenerative disorders that affect both humans and animals. They are distinguished by long incubation periods, characteristic spongiform changes associated with neuronal loss, and a failure to include inflammatory response. Prion disease Ontology1325521724189:Protocol_Representation_Sub-Domain bioportal.bioontology.org/ontologies/45400/?p=terms&conceptid=protocol_Representation_sub-domain protocol development The protocol Representation sub-domain is intended for those involved in the planning and design of a research protocol. the majority of bussiness requirements have come from those involved in clinical trial protocols. It focuses on the characteristics of a study and the definition and association of activities within the protocols, including "arms" and "epochs". It also includes the definitions of the roles that participate in those activities. Protocol representation Ontology1325521724189:Psychiatric_symptoms www.merriam-webster.com/dictionary/psychiatry symptoms of mental health disorders Psychiatric disorders Psychiatric symptoms are symptoms such as mental , emotional, or behavioral disorders that occurs in a patient. Psychiatric symptom Ontology1325521724189:Qualitative_study_design bioportal.bioontology.org/ontologies/45378/?p=terms&concetid=study_design%3AOCRE100072 Designing the Qualitative Study Qualitative design Qualitative research design A qualitative study is an individual-human study whose primary mode of inquiry is qualitative. Qualitative study Ontology1325521724189:Quality_of_life www.medicine.ox.ac.uk/bandolier/painres/download/whatis/WhatisQOL.pdf "QoL" Quality of life is a ubiquitous concept that has different philophical, polotical and health-related definitions. Quality of life Ontology1325521724189:Quantitative_study_design bioportal.bioontology.org/ontologies/46378/?=terms&conceptid=study_design%3AOCRE100044 Quantitative design A quantitative study is an individual-human study whose primary mode of inquiry is quantitative. Quantitative study Ontology1325521724189:Quasi_random_allocation www.sahealthinfo.org/evidence/q-rhtm#quasi-allocation Allocation, Quasi-random A method of allocating particpants to different forms of care that is not truly random; for example, allocation by date of birth, day of the week, medical record number, month of the year, or the order in which participants are included in the study (e.g. alternation). Quasi-random allocation Ontology1325521724189:Radiography www.etsu.edu/crhs/alliedhealth/radiography/whatis.aspx Radiography is the art science of using radiation to provide images of the tissues, organs, bones, and vessels that comprise the human body. These images may be recorded on film or as a computerized image. Radiography Ontology1325521724189:Random_allocation www.clinicaltrials.gov/ct2/about-studies/glossary Allocation, Random Randomized allocation A strategy in which participants are assigned to arms of a clinical trial by chance. Random allocation Ontology1325521724189:Randomized_to_active_treatment www.cancer.gov/clinicaltrials/conducting/ncictrp/resources/glossary An arm or group in which active drugs are given. This will include arms that are mixing active drugs and placebos. This will be used when the term "control arm" is specified in the protocol and when another arm is designated as the experimental arm. There can be more than one active comparator arm. Randomized to active treatment Ontology1325521724189:Rate_of_institutionalization glossary.adoption.com/institutionalization.html Institutionalization Rate Rates of institutionalization The measure of the short-term or long-term placment of children in institutions, such as hospitals, group homes. Placement in institutions during early critical development periods, and for lengthy periods of time, is often associated with developmental delays due to enviromental deprivation, poor staff to child ratios, or lack of early childhood stimulation. Rate of institutionalization Ontology1325521724189:Recruitment_active clinicaltrials.gov/ct2/info/glossary#recruitment Active recruitment Study is ongoing (i.e.., patients are being treated or examined), but enrolled as completed. Active, not recruiting Ontology1325521724189:Recruitment_criteria www.cdisc.org/stuff/contentmgr/files/0/be650811fed46f381f0 selection criteria Criteria used by sposors to identify,select, and arrange for investigators to serve in a clinical study. Recruitment criteria Ontology1325521724189:Recruitment_status prinfo.clinicaltrials.gov/definitions.html Recruitment Overall accrual activity for the protocol or study. Recruitment status Ontology1325521724189:Regimen_cardinality bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100042 The number of regimens of interventions in a study. Each regimen includes one or more individual interventions (treatments) or no intervention. Regimen cardinality Ontology1325521724189:Regulatory_Application stephan. A. Raymond. "CDISC Clinical Research Glossary". 2009 Application made to a health authority to investigate, market, or licence a new product or indication. Regulatory application Ontology1325521724189:Regulatory_Application_Sponsor The sponsor of the applcation made to a health authority to investigate, market, or licence a new product or indication. Regulatory application sponsor Ontology1325521724189:Regulatory_Assessment bioportal.bioontology.org/ontologies/45400/?p=terms&conceptid=Regulatory_Assessment RegulatoryAssessment A regulatory action or inaction undertaken by the regulatory authority as a result of a submission analysis and evaluation. Regulatory assessment Ontology1325521724189:Regulatory_Sub-Domain bioportal.bioontology.org/ontologies/45400/?p=terms&conceptid=Regulatory_sub-Domain The regulatory sub-domain is intended for those involved in the creation and review of submissions to regulatory authorities. The majority of bussiness requirements come from the regulatd product submission (RPS) message specification. It focuses on the documentation required for a product submission to the Food and Drug Administration (FDA). Regulatory aspect Ontology1325521724189:Regulatory_Submission bioportal.bioontology.org/ontologies/45400/?p=terms&conceptid=Regulatory_Submission RegulatorySubmission An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and /or effectiveness. Regulatory submission Ontology1325521724189:Renal dictionary.reference.com/browse/renal renal Relating to, involving, affecting, or located in the region of the kidneys. Renal symptom Ontology1325521724189:Resting_state_functional_network_activity clinicaltrials.gov/show/NCT00988117?displayxml=true "resting-state" functional networks resting state activity resting state network activity resting-state networks Degree of fit in the dorsolateral frontal-parietal network. Resting state functional network activity Ontology1325521724189:Restricted_randomization bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Randomization Restricted Restricted randomization is a random allocation scheme used to control the randomization to achieve balance between groups in size (or other characteristics). Restricted randomization Ontology1325521724189:Reviewable_Unit bioportal.bioontology.org/ontologies/45400/?p=terms&conceptid=Reviewable_Unit ReviewableUnit A predefined portion of an application that, by agreement between the application and the review division, can be submitted prior to submission of a complete application. Reviewable unit Ontology1325521724189:Safety_of_the_treatment www.tpna.com/research_development/pdf/ClinicalTrialsGlossary.pdf safety treatment This is the process in which the safety of the treatment in the patient population is being evaluated in a clinical trial study. Safety of the treatment Ontology1325521724189:Safety_study prinfo.clinicaltrials.gov/definitions.html Safety study is a study that show if the drug is safe under conditions of proposed use. Safety study Ontology1325521724189:Scale_for_Depression en.wikipedia.org/wiki/Rating_scales_for_depression Depression rating scale A depression rating scale is a psychiatric measuring intrument having descriptive words and phrases that indicate the severity of depression symptoms for a time period. Scale for depression Ontology1325521724189:Screening prinfo.clinicaltrials.gov/definitions.html Protocol designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are yet known to have the condition (or risk factor). Screening Ontology1325521724189:Secondary_endpoint_measure prinfo.clinicaltrials.gov/definitions.html secondary outcome measure Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Secondary endpoint measure Ontology1325521724189:Seizures www.nlm.nih.gov/medlineplus/seizures.html Seizures are symptoms of a brain problem. They happen because of sudden, abnormal electrical activity in the brain. when people think of seizures, they often think of convulsions in which a person's body shakes repidly and uncontrollably. Seizure Ontology1325521724189:Sever_Impairment_Battery www.testzentrale.ch/de/tests/tests-a-z/alphabet/S/flexShow/testDetail/testUid/878/ SIB The Severe Impairement Battery (SIB) has been developed to assess a range of cognitive functioning in individuals who are too impaired to complete standard neuropsychological tests. It was designed with the severely demented patient in mind and takes into account the specific behavioural and cognitive deficits associated with severe dementia. Severe impairment battery Ontology1325521724189:Simple_randomization bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Randomization Simple randomization is a random allocation scheme that has no restriction, i.e. a single sequence of random assignment. When the sample size is relatively large, simple randomization is produre equal sized treatment groups. Simple randomization Ontology1325521724189:Single_Group_Assignment http://www.clinicaltrials.gov/ct2/about-studies/glossary Single arm study Describes a clinical trial in which all participants receive the same intervention. Single-group design Ontology1325521724189:Single_blind prinfo.clinicaltrials.gov/definitions.html single-masked study One party, either the investigator or participant, is unaware of the intervention assignment. Single blind Ontology1325521724189:Single_experimental_unit_allocation_group bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100075 experimental units In the context of a study where the main comparison is within experimental units, investigator assigns regimen of interventions to all allocation group made up of a single experimental unit. Single experimental unit allocation group Ontology1325521724189:Single_group_study_design bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100052 Single group design A single group study is an interventional study that has only a single allocation group and no contemporaneous comparison group. A study in which an individual acts has his/her own comparison does not fall into this category, since an individual is not a group. Single group study Ontology1325521724189:Single_regimen bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100037 Regimen, Single A single regimen of intervention, which includes one or more individual interventions (treatments), is assigned to one allocation group. This means the study has no contemporaneous comparison group. Single regimen Ontology1325521724189:Sleep_disturbance_test medical-dictionary.thefreedictionary.com/Sleep+disturbance sleep disorders sleeping problems Sleep disturbance test, tests the disorder of sleep patterns which may be severe enough to interfere with a person's normal physical, mental and emtional functioning. Sleep disturbance Ontology1325521724189:Spinal_muscular_atrophy www.nlm.nih.gov/medlineplus/spinalmusculatrophy.html SMA Spinal muscular atrophy is a genetic disease that attacks nerve cells, called motor neurons, in your spinal cord. These neurons communicate with your voluntary muscles- the ones you can control, like in your arms and legs. As you lose the neurons, your muscles weaken. This can affect walking, craling, breathing, swallowing and head and neck control. Spinal muscular atrophy Ontology1325521724189:Sponsoring www.ata-divisions.org/GLD/docs/48_konferenz/Glossary_clinical_trials_EN-GE.pdf Sponsor An individual, company, institution or organization talking responsibility for initiation, management, and financing of a clinical study. Sponsoring Ontology1325521724189:Standard_Deviation www.cochrane.org/glossary A measurement of the spread or dispersion of a set of observations, calculated as the average difference from the mean value in the sample. Standard deviation Ontology1325521724189:Start_Date prinfo.clinicaltrials.gov/definitions.html Starting date Date that enrollment to the ptotocol begins Start date Ontology1325521724189:Statistical_significance www.cdisc.org/stuff/contentmgr/files/0/be65811feb46f381foaf41ca40caade2e/misc/cdisc_2009_glossary.pdf State that aoolies when a hypothesis ie rejected. Whether or not a given result is significant depends on the significance level adoped. It is the propability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance on the number of participants studied and the observations made, as well as the magnitude of differences observed. Statistical significance Ontology1325521724189:Status www.reference.com/browse/status The position of an individual in relation to another or others. Status Ontology1325521724189:Stratified_randomization bioportal.bioontologies.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Randomization Stratified Stratification ensures that the numbers of participants recieving each intervention are closely balanced within each stratum. Stratified randmization is achieved by performing a separate randomization procedure within each of two or more subsets of participants. Stratified randomization Ontology1325521724189:Stratum_Group This is the process in which the research representation protocols are grouped into layers. Stratum group Ontology1325521724189:Stroke www.medicinet.com/stroke/article.htm#tocas Brain cell function requires a constant delivery of oxygen and glucose from the bloodstream. A stroke, or cerebrovascular accident, occurs when blood supply to part of the brain is disrupts. Stroke Ontology1325521724189:Study_Conduct_Sub-Domain bioportal.bioontology.org/ontologies/45400/?p=terms&conceptid=Study_Conduct_Sub-Domain Study Conduct The study Conducted sub-domain is intended for those involved in the execution of a research study. the majority of bussiness requirements have come form those involved in clinical trials. It focuses on the activities of conducting the study as well as the results from those activites. Conduct of the study Ontology1325521724189:Study_Investigator www.wisegeek.com/what-does-a-clinical-trial-investigator-do.htm clinical trial investigator Investigator Study investigator is a physician in private practice who participates in clinical trial studies. Study investigator Ontology1325521724189:Study_Legal_Sponsor www.lifesciencelegalupdate.com/2011/07/articles/product-liability/the-legal-duties-of-clinical-trial-sponsors/ The Legal Studies of Clinical Trial Sponsors Study legal sponsor are individuals that addresses the risks involved in human clinical trials and the responsibilities between the clinical study investigator and the manufacturer/sponsor. Study legal sponsor Ontology1325521724189:Study_Objective www.sil.org/lingualinks/literacy/referencematerials/glossaryofliteracyterms/whatisobjective.htm clinical trial objective Objective of study A study objective is a subgoal that identifies a short-term, measurable step within a designated period of time that is moving toward achieving a long-term goal. Study objective Ontology1325521724189:Study_Protocol_Document https://crawb.crab.org/txwb/CRA_MANUAL/vol1/chapter 14_Study protocol.pdf StudyProtocolDocument The study protocol is a written document detailing how a clinical trial is conducted. The elements of a protocol include: - Trial design and organization; - Study objectives; - Background information; - Patient population descriptions; and - - Treatment to be studied. Study protocol document Ontology1325521724189:Study_Resource www.roswellpark.edu/prevention/cancer-health-disparities/services-reach/research-study-resource Resource The research study resource offers services to those who are considering being a part of a research study. It also serves to remove barriers and obstacles that may make it difficult for you to participate in a research study. Study resource Ontology1325521724189:Study_Site bioportal.bioontology.org/ontologies/45400?p=terms&conceptid=Study_Site Investigative Site A facility in which study/protocol activities are conducted. Study site Ontology1325521724189:Study_administrative_relation bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=study_design%3AOCRE100077 Administrative Relations Study administrative relation is a kind of relationship that an entity enters into in the design, conduct, and analysis of a study. The relationship starts when the organization agrees to undertake the activity entailed by the relationship. "Agreement to perform study activity" doesn,t mean performance of a specific study activity (e.g., administration of a drug) itself, but agreement to do so. an organization becomes a "participating site" once it agrees to perform activities specified in the study protocol. It doesn,t have to perform any of activities yet. Study administrative relation Ontology1325521724189:Study_arms bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=obi%3AOBI_000842 study group A process in ehich the subject is made aware of which study arm they are participating in, for example whether they are recieving a placebo or a treatment with an investigational compound. Study arm Ontology1325521724189:Study_characteristics bioportal.bioontology.org/ontologies/46378/?p=terms&conceptid=OCRe%3AOCRE400047 characteristics of a study A meta-level characterization of a study. Study characteristics Ontology1325521724189:Study_contact www.bussinessdictionary.com/definition/contact.html Contact An individual private or personal information by which another person, or a study participant can be use to reach the individual. Study contact Ontology1325521724189:Study_design bioportal.bioontology.org/ontologies/1123/?p=terms&conceptid=obo:OBI_0500000 Experimental design A study design is a plan specification comprised of protocols (which may specify how and what kinds of data will be gathered) that are executed as part of an investigation and is realized during a study design execution. Basic study design Ontology1325521724189:Study_phases prinfo.clinicaltrials.gov/definitions.html Phases clinical trial phases Phase of investigation, for trials involving investigational new drugs. Phases of clinical trial Ontology1325521724189:Submission_Unit bioportal.bioontology.org/ajax_concepts/45400/?conceptid=Submission_Unit&callback=children&child_size=1 SubmissionUnit, Regulatory Submission Unit A colection of documents pertaining to a particular clinical study protocol and /or medical product accompanied by the associated reference information officially provided to the regulatory authority. This is usually done to comply with a specific regulatory purpose or decision. Submission unit Ontology1325521724189:Supportive_Care prinfo.clinicaltrials.gov/definitions.html Supportive Care Study Supportive Care Trial Protocol designed to evaluate one or more interventions where the primary intent ia a maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. Supportive care Ontology1325521724189:Suspended_study prinfor.clinicaltrials.gov/definitions.html Study suspended Suspended,Study Suspension of studies Suspension of study Recruitment suspended Recruiting or enrolling participants has halted prematurely but potentially will resume. Suspended Ontology1325521724189:Symptomatic_postural_hypotension www.answers.com/topc/orthostatic-hypotension-1 postural hypotension Orthostatic hypotension A fall in blood pressure that occurs on standing up after lying down. Symptomatic postural hypotension Ontology1325521724189:Syncope medical-dictionary.thefreedictionary.com/syncope collapse coma faint unconsciousness Syncope is define as a brief loss of consciousness caused by a sudden fall of blood pressure or failure of the cardiac systole, resulting in cerebral anemia. Syncope Ontology1325521724189:Terminated_study prinfo.clinicaltrials.gov/definitions.html Study terminated Terminated,Study Termination of studies Termination of study Recruitment terminated Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated. Terminated Ontology1325521724189:The_Randomized_Blinded_Trial clinicaltrials.org/ct2/info/glossary A randomized trial is the study in which participants are randomly assigned to one of two or more treatment arms of aclinical trial. A randomized trial is blind if the participant is not told of the trial he is on. A clinical trial is blind if the participants are unaware on whether they are in the experimental or control arm of the study. Randomized blinded trial Ontology1325521724189:Timing_of_outcome_measurement www.clinicaltrials.gov/ct2/about-studies/glossary Timing of Outcome Assessments The points in time at which the outcome measure is assessed. These are planned before the clinical study starts and listed in the protocol. Time frame for outcome measurement Ontology1325521724189:Toxicological_tests firstaid.webmd.com/toxicology-tests toxicity testing toxicological testing toxicology tests Toxicology test checks blood or urine for the presence of drugs or chemicals. In rare cases, stomach contents, sweat, or saliva may also be checked. Toxicological test Ontology1325521724189:Treatment prinfo.clinicaltrials.gov/definitions.html Therapy Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition. Treatment Ontology1325521724189:Ultrasound Ultrasound is acoustic (sound) energy in the form of waves having a frequency above the human hearing range. The highest frequency that the human ear can detect is approximately 20 thousand cycles per second (20,000Hz). Ultrasound Ontology1325521724189:Uncontrolled Michael Stein and Guy Taylor. " The Encyclopedia of Arthritis". 2004 Uncontrolled Group If a new treatment is studied alone, with no comparison group, it is called an uncontrolled study. Uncontrolled studies, although they can provide useful preliminary information, are not strong evidence in favour of a new treatment,even if the results of the trial are positive. Uncontrolled Ontology1325521724189:Urine www.thefreedictionary.com/urine The pale yellow slightly acid fluid excreted by the kidneys, containing waste products removed from the blood. It is store in the urinary bladder and discharged through the urethra. Urine Ontology1325521724189:Video_movement_analysis en.wikipedia.org/wiki/video_motion_analysis video motion analysis This is a technique used to get information about moving objects from video. Video movement analysis Ontology1325521724189:Vital_signs medicalcenter.osu.edu/patientcare/healthcare_services/emergency_services/non_traumatic_emergencies/vital_signs/pages/index.aspx Vital signs are measurements in the body's most basic functions. the fourmain main vital signs routinely monitored by medical professionals and healthcare providers include the following: - Body temperature - Pulse rate - respiration rate (rate of breathing) - blood pressure (blood pressure is not considered a vital sign, but is often measured along with the vital signs.) Vital sign Ontology1325521724189:Walk_test medical-dictionary.thefreedictionary.com/walk walking test This is test that pay attention to the characteristic ways in one walks. Walk test Ontology1325521724189:Withdrawn_study prinfo.clinicaltrials.gov/definitions.html Withdrawal of study Withdrawing from study Study withdrawal Study halted prematurely, prior to enrollment of first participant. Withdrawn Ontology1325521724189:_Pittsburgh_Agitation_Scale "Pittsburgh Agitation Scale (PAS)". UnitedHealthcare. Healinghealthcare Together PAS The PAS is used to assess agitation in people with dementia. There are four behavior areas measured on an intensity level of 0-4. The scale is administered by clinical staff who directly observe the patient's behavior. Pittsburgh agitation scale Ontology1325521724189:ml C28254 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls millilitre The unit of volume equal to one thousandth of a liter, one cubic centimeter, 10E-6 cubic meter, or approximately to 0.061 023 7 cubic inch.(NCI) mL Ontology13255217241893:_years Age group between 18 to 69 years of participants involved in a given trial. 18-69 years N:A_years Age group from 18 years to infinity of the participants involved in a trial study. 18-N/A years Ontology13255217241894:_years Age group from 50 to 80 years of participants involved in a trial study. 50-80 years Alzheimer:s_disease alzheimers.org.uk/site/scripts/documents_info.php?documentID=100 AD Alzheimer's disease Alzheimer's disease is a physical disease affecting the brain. During the course of the disease, protein plagues and tangles develop in the steucture of the brain, leading to the death of brain cells. Alzheimer's is a progressive disease, which means that gradually, over time, more parts of the brain are damaged. As this happens, the symptoms become more severe. Alzheimer disease Friedreich:s_ataxia www.nlm.nih.gov/medilineplus/friedreichsataxia.html Friedrich's ataxia Friedreich's ataxia is an inherited disease that damages your nervous system. The damage affects your spinal cord and the nerves that control muscle movement in your arms and legs. Symptoms usually begin between the ages of 5 and 15. Friedrich ataxia Huntington:s_disease www.nlm.gov/medlineplus/huntingtonsdisease.html HD Huntington's disease Huntington's disease is an inherited disease that causes certain nerve cells in the brain to waste away. Prople are born with the defective gene, but symptoms usually don,t appear until middle age. Huntington disease mg:dl C42576 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls Milligram per Milliliter milligram per decillitre A unit of mass concentration defined as the concentration of one kilogram of a substance per unit volume of the mixture equal to one cubic meter, or the concentration of one milligram of a substance per unit volume of the mixture equal to one milliliter, or one gram of a substance per one liter of the mixture. It is also a unit of mass density (volumic mass) defined as the density of substance which mass equal to one milligram occupies the volume one milliliter.(NCI) mg/mL ng:l C67306 Standard for the Exchange of Nonclinical Data (SEND), http://evs.nci.nih.gov/ftp1/CDISC/SEND/SEND%20Terminology.xls nanogram per litre A unit of mass concentration defined as the concentration of one microgram of a substance per unit volume of the mixture equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one microgram occupies the volume one liter.(NCI) ng/mL