Study Population definition

Study Population. This includes a clear description of the populations impacted by each hypothesis, as well as the comparison population, if applicable. The discussion may include the sampling methodology for the selected population, as well as support that a statistically reliable sample size is available. Access, Service Delivery Improvement, Health Outcome, Satisfaction and Cost Measures: This includes identification, for each hypothesis, of quantitative and/or qualitative process and/or outcome measures that adequately assess the effectiveness of the Demonstration. Nationally recognized measures may be used where appropriate. Measures will be clearly stated and described, with the numerator and dominator clearly defined. To the extent possible, the State may incorporate comparisons to national data and/or measure sets. A broad set of performance metrics may be selected from nationally recognized metrics, for example from sets developed by the Center for Medicare and Medicaid Innovation, for meaningful use under HIT, and from the Medicaid Core Adult sets. Among considerations in selecting the metrics shall be opportunities identified by the State for improving quality of care and health outcomes, and controlling cost of care.
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Study Population. A total of 4 healthy male volunteers between 18 and 65 years of age will be enrolled in the study. • Study Endpoints: Safety, pharmacokinetic profiling. •
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Study Population. A multi-center, randomized, double-blind trial will involve a total of about 300 patients, aged 18 years and above, with chronic bacterial prostatitis. • Study Design: Patients will be randomized to receive either NM441 (600 mg qd) or levofloxacin (500 mg qd). Each subject will receive one capsule each morning. 30 Laboratory assessments and clinical evaluations will be performed at screening and Days 21 and 42 of the 42-day study period. Microbiological assessment (the four-glass test) will be performed at screening and on Day 42. In addition, clinical evaluation and microbiological assessment will be performed on Day 70, four weeks after the final antibiotic dose. • Inclusion criteria
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Examples of Study Population in a sentence

  • Study Population: This includes a clear description of the populations impacted by each hypothesis, as well as the comparison population, if applicable.

  • Provide a detailed description of the purpose and objectives of the study.7. Study Population.

  • Energy Affordability Study Population Characterization Report [Table 8.7].

  • Cohort Profile: The HealthNuts Study: Population prevalence and environmental/genetic predictors of food allergy.

  • Study Population Demographics and Baseline ParametersDemographic and baseline clinical characteristics of patients enrolled in the AURA3 clinical study (FAS) were categorized relative to the Guardant360 CDx EGFR T790M bridging study populations as defined by Guardant360 results (gCEAS) and assessed for treatment arm balance.

  • Characteristics of Survey Respondents Compared to the Study Population 36Table 4-2.

  • Characteristics of the Study Population in Meta-Analyses of Effects of Lead on Blood Pressure 513-3.

  • Attachment 10: Request for Information (RFI) on Study Population (if applicable).

  • Study Population Participant selection was based upon employment in a K-12, urban school and the following conditions:• Completion of Urban IMPACT mentor training - The teachers who received the Project INQUIRE training are expected to mentor new and experienced teachers in the process of using inquiry.

  • Demographic Data of the Study Population ParameterMeanStandard DeviationRangeAge (years)72.547.840 to 86Follow-up (years)5.061.552 to 11VF number6.191.445 to 11Basal MD (dB)-6.263.02-13.14 to -1.49Basal PSD (dB)5.243.040.87 to 15.40Basal VFI (%)87.138.955 to 99 MD = mean deviation; PSD = pattern standard deviation; dB = decibel; VFI = visual field index.


More Definitions of Study Population

Study Population. The sample consisted of two cohorts of adult patients transported by EMS to Xxxxx Memorial Hospital in Atlanta, GA between January 2011 and December 2012. Patients were excluded for cardiac arrest, trauma, toxic ingestion, pregnancy, or psychiatric emergency and were stratified into two groups at either high or low risk of sepsis. Patients whose EMS vitals included heart rate greater than 90 beats/min, respiratory rate greater than 20 breaths/min, and systolic blood pressure less than 110 mm Hg were considered high-risk; all else were low-risk. METHODS AND RESULTS: Thirty-one (27%) of high-risk patients and 12 (2.2%) of low- risk patients had sepsis (p-value <.0001), determined by inpatient diagnosis within 48 hours of hospital arrival. For both cohorts, patient vitals changed between the field and ED, though Glasgow Coma Scale scores did not change (p-values .42 and .81). We retrospectively screened patients with a modified version of PRESS in the field and qSOFA in the ED. Among high-risk patients, PRESS was 90% sensitive and 22% specific; in low- risk patients it was 83% sensitive and 17% specific. qSOFA was 41% sensitive and 88% specific in high-risk patients, and 17% sensitive and 98% specific in low-risk patients. Agreement between screening tools was low, but best for high-risk patients with sepsis (Kappa=0.15, p-value <.0001). Among patients misclassified by either tool, mean heart rate was the most common difference between those with and without sepsis. CONCLUSION: Further studies are needed to validate PRESS and qSOFA for emergency sepsis screening. PRESS is limited by low specificity, and qSOFA may be unreliable in patients transported by EMS due to low sensitivity. By Xxxxxxx Xxxx Bachelor of Science Middle Tennessee State University 2014 Faculty Thesis Advisor: Xxxxxxx Xxxxxx, MPH, PhD Field Thesis Advisor: Xxxxxx Xxxxxx, MD, MSc A thesis submitted to the Faculty of the Xxxxxxx School of Public Health of Emory University in partial fulfillment of the requirements for the degree of Master of Public Health in Epidemiology 2017 First I thank the members of my committee, whose guidance and expertise were instrumental in the writing of this thesis. To Xx. Xxxxxx Xxxxxx, your ongoing research in critical care medicine has made my own possible, and I thank you for the opportunity to work with you and your team. I am honored to have been part of a project which may so directly and profoundly impact patient lives. To Xx. Xxxxxx, my faculty adviser, yo...
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Study Population. MLIU sub-populations identified in DSRIP performing provider systems (adults) Measure Xxxxxxx or Source AHRQ xxxxx://xxx.xxxxxxxxxxxxxxxxx.xxxx.xxx/Modules/PQI_Tech Spec_ICD10_v70.aspx Technical Specifications This measure was developed by the AHRQ. Performing providers will report the numerator and denominator necessary to calculate this adult composite measure: Numerator: Number of discharges for clients 18 years and older in DSRIP attributed target population for the provider system, that meet the inclusion and exclusion rules for the numerator in any of the following PQIs: • PQI #10 Dehydration Admission Rate • PQI #11 Bacterial Pneumonia Admission Rate • PQI #12 Urinary Tract Infection Admission Rate Discharges are only counted once in the numerator, even if they qualify for more than one PQI listed above. Denominator: DSRIP attributed target population for the provider system (18 years and older) Rate: (numerator / denominator) * 100 Exclusion Criteria Numerator excludes obstetric discharges, along with specific exclusion criteria listed in the PQI 10, 11, and 12 specifications Data Source(s)/ Data Collection Method(s) • DSRIP reporting: Provider reported rate • RHP plan update: Provider and RHP characteristics for HLM model • DSRIP administrative data: Provider and RHP characteristics for HLM model Comparison Group(s)/ Subgroup(s) • RHP subgroups Analytic Methods • Descriptive trend analysis o Paired t-test or Xxxxxxxx signed-rank test • Hierarchical linear modeling or growth curve modeling, if feasible Benchmark • Baseline established CY17 • DY7 goal of 2.5% improvement over baseline • DY8 goal of 10% improvement over baseline Note. PQI=Prevention Quality Indicator; MLIU=Medicaid and low-income uninsured; DSRIP=Delivery System Reform Incentive Payment; AHRQ=Agency for Healthcare Research and Quality; RHP=Regional Healthcare Partnership; HLM=Hierarchical linear model; CY=Calendar year; DY=Demonstration year, October 1-September 30. *Selected Category C measure from the Measure Bundle Protocol (Texas Health and Human Services Commission, 2018).
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Study Population. Key Exclusion Criteria (see Section 7.2 for a complete list): • Type 1 diabetes; • Congenital heart disease; clinically significant ECG abnormality; • Physical exam, xxxxx xxxxx, or laboratory abnormality; clinically significant hepatic or renal disease; • Creatinine clearance (Xxxxxxxx formula) < 60 mL/minute; • Clinically significant thyroid dysfunction as evidenced by signs, symptoms, or TSH > 1.5 x ULN; • Obesity of known genetic or endocrine origin; • History of bipolar disorder or psychosis, greater than one lifetime episode of major depressive disorder, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation; • Recent weight instability, or prior bariatric surgery; • History of glaucoma or increased intraocular pressure; • Current smoker or smoking cessation within 3 months of screening; • Currently taking or plan on taking any of following medications during the study: o Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, GABA analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate); o Tricyclic antidepressants, MAOIs, lithium, levodopa, and dopamine receptor agonists; o Carbonic anhydrase inhibitors; o Insulin, SFUs, GLP-1 agonists, SGLT-1, and SGLT-2 inhibitors; o Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives; o Treatment for hyperactivity disorder; or o OTC, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight. Study Drug Form and Strength: • Low-dose (for titration purposes only): One PHEN/TPM 3.75/23 mg capsule administered daily • Mid-dose: One PHEN/TPM 7.5/46 mg capsule administered daily • ¾-dose (for titration purposes only): One PHEN/TPM 11.25/69 mg capsule administered daily • Top-dose: One PHEN/TPM 15/92 mg capsule administered daily Study drug will be packaged into 2 types of kits; titration kits (blister cards) for use during the first 4 weeks of dosing and the first 4 weeks following up-titration for subjects randomized to the top-dose (Weeks 13-16), and treatment kits (bottles), for use once subjects have been titrated to their assigned dosage. Regimen/Administration: Each capsule of study drug will be taken orally in the morning, with or without food, and with water.
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Study Population. Primary HLH patients • Patients can be naïve to HLH treatment (first line patients), or may have already received conventional HLH therapy (second line patients) without having obtained a satisfactory response according to the treating physician or having shown signs of intolerance to it. • Patients who receive NI-0501 as second line treatment for HLH will represent the pivotal cohort of the study.
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Related to Study Population

  • Population means the population as ascertained at the last preceding census of which the relevant figures have been published;

  • Target Population means persons with low incomes who have one or more disabilities, including mental illness, HIV or AIDS, substance abuse, or other chronic health condition, or individuals eligible for services provided pursuant to the Lanterman Developmental Disabilities Services Act (Division 4.5 (commencing with Section 4500) of the Welfare and Institutions Code) and may include, among other populations, adults, emancipated minors, families with children, elderly persons, young adults aging out of the foster care system, individuals exiting from institutional settings, veterans, and homeless people.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Screening means the evaluation process used to identify an individual's ability to perform activities of daily living and address health and safety concerns.

  • Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Sexual penetration means vaginal intercourse, cunnilingus, fellatio, or anal intercourse between persons or insertion of the hand, finger, or object into the anus or vagina either by the actor or upon the actor's instruction. The depth of insertion shall not be relevant to the question of commission of the crime;

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.

  • Step therapy protocol means a protocol or program that establishes the specific

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Endpoint means any Federal Reserve Bank, financial institution, local clearing house, courier or other entity or location for the delivery of cash letters or other presentment of Imaged Items or Substitute Checks.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Medical Specialist means any medical practitioner who is vocationally registered by the Medical Council under the Health Practitioners Competence Assurance Act 2003 in one of the approved branches of medicine and who is employed in either that branch of medicine or in a similar capacity with minimal oversight.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Prosthesis means an artificial substitute for a missing body part.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Objective medical evidence means reports of examinations or treatments; medical

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.