Study Design definition
Study Design. We conducted a prospective cross-sectional study of children aged 2 to 17 years evaluated at 3 tertiary-care pediatric EDs for non-traumatic headaches. Two clinicians independently completed a standardized assessment of each child and documented the presence or absence of history and physical examination variables. Unweighted κ statistics were determined for 68 history and 24 physical examination variables. Results: We analyzed 191 paired observations; median age was 12 years, with 19 (9.9%) children less than 7 years. Interrater reliability was at least moderate (κ ≥ 0.41) for 41 (60.3%) of history variables. Eleven (61.1%) of 18 physical examination variables for which κ statistics could be calculated had a that was at least moderate. Author Manuscript
Study Design. A comparative cross-sectional study. Place and Duration of Study: Department of Prosthodontics, College of Dentistry, King Saud University, Riyadh, KSA, from February till August 2013. Methodology: Ninety four male participants aged 18 - 35 years were randomly recruited for the study. Full-face and anterior teeth (intraoral) digital photographs in the frontal plane were recorded. The outline tracings of the face and the tooth were obtained using Autocad (version 2010) software. The outline of the tooth was enlarged proportionately, without altering the length to width ratio to fit the face outline. The outlines were then evaluated visually by 6 prosthodontists and results were tabulated. Results: The most common type of face form (49.65%) and tooth form (56.38%) was square tapering. Using the visual method, a good relationship (31.41%), moderate relationship (35.31%), weak relationship (19.68%) and no relationship (13.65%) between the tooth form and face form was found by the observers. Overall kappa for inter observer agreement on face form, tooth form and their relationship was 0.24, 0.17 and 0.26 respectively. The kappa values showed a fair agreement between the observers. Conclusion: The study results indicated that there was no highly defined relationship between the tooth form and face form in the studied Saudi subpopulation. A fair agreement was found between the observers for classifying the tooth forms, face froms and their relationship.
Study Design. A multicenter, randomized, placebo-controlled, double-blind study was conducted. Results: At start, mean (±SD) voice frequency SDS was high for age (1.0±1.2, p<0.001), but normal for height. Compared with GH+Pl, voices tended to lower on GH+Ox 0.03 (P=0.09), and significantly lowered on GH+Ox 0.06 (P=0.007). At the last measurement, voice frequency SDS was still relatively high in group GH+Pl (0.6±0.7, p=0.002), but similar to healthy girls in both GH+Ox groups. Voice frequency became Conclusions: Untreated girls with TS have relatively high-pitched voices. The addition of Ox to GH decreases voice frequency in a dose-dependent way. Although most voice frequencies remain within the normal range, they may occasionally become lower than -2 SDS, especially on GH+Ox 0.06 mg/kg/day. Introduction Materials and Methods Study setting and participants
Examples of Study Design in a sentence
Professional services for this Project shall be provided in the Phase/Task sequence shown below and shall be rendered in accordance with the Professional’s attached Project Study, Design, and Proposed Construction Schedule.
Apply critical target dates to the Professional’s Project Study, Design and Proposed Construction Schedule and submit to the Department for their review and approval.
Professional services for the assigned projects under this contract shall be provided in the Phase/Task sequence shown below and shall be rendered in accordance with the Professional’s proposed and approved Project Study, Design, and Proposed Construction Schedule.
Professional services for this Project shall be provided in the Phase/Task sequence shown below and shall be rendered in accordance with the Professional firm’s attached Appendix 3 – Project Study, Design and Proposed Construction Schedule duration.
The Contractor shall provide updated budget estimates for the project as a part of the Study, Design Development, and Construction Document phases.
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Study Design. This will be an open-label, single-center, single-dose pharmacokinetic study of orally administered NM441. A total of 8 male subjects will be enrolled in the study. They will be admitted on the evening prior to a morning administration of 600 mg NM441 (fasted or unfasted, in groups of four), and will maintained on site for 24 hours following dosing. Blood and urine samples will be collected at various time points to allow pharmacokinetic measurements. •
Study Design. To address these objectives, the study will use detection times from the existing PIT system (BO3), the replaced BO4 antennas (if available), and the new antennas at the ladder exit to calculate passage times. Passage time will be defined as the duration between a fish’s first detection at BO3 and subsequent detections up to and including the last detection at the ladder exit. A statistical approach will be used, incorporating mean and median values for fish of interest, grouped by species, year, and run. The following steps will guide the study design:
Study Design. This was a cross-sectional study. Information for this analysis was obtained from the data collected in the HPV Sentinel Surveillance (HSS) study which was a multi-center, national study. Enrollment methods for the HSS study have been published separately (13). Women who were due for screening Pap smears were enrolled from HIV care clinics from January 1, 2003 to December 31, 2005. Data was collected by the investigators through a standardized questionnaire which included demographic and behavioral data as well as data abstracted from the patients’ medical charts including Pap smear results. Two cervical specimens were obtained from all enrolled women for HR-HPV DNA testing and typing. Patients: Inclusion criteria were current age between 18 and 65 years of age and last Pap smear being at least 6 months prior to their visit. Patients were excluded if they had a history of a hysterectomy, treatment on the cervix less than 6 months prior to visit or if they were currently pregnant or menstruating. Predictor Variables were ethnicity, race, age, history of an abnormal Pap smear, history of treatment on the cervix, site, HIV viral load, CD4 count, current antiretroviral use, current smoker, parity, history of sexually transmitted infection, RLU, number of HR-HPV types, age at coitarche, and number of lifetime male sexual partners. RLU was obtained through the Hybrid Capture 2 test (Digene, Gaithersburg, Maryland) which is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent detection. The outcome variable for the bivariate and multivariate logistic regression was Pap test abnormality. This was defined as atypical squamous cells of unknown significance (ASC-US), atypical squamous cells of unknown significance- cannot exclude high grade squamous intraepithelial lesion (ASC-H), low grade squamous intraepithelial lesion (LSIL), or high grade squamous intraepithelial lesion (HSIL). Sample Size: Overall, 569 HIV-infected women were enrolled from six different cities- Boston, MA; Baltimore, MD; New Orleans, LA; Denver, CO; Seattle, WA; and Los Angeles, CA.
Study Design. Participants with primary progressive and secondary progressive multiple sclerosis (MS) will be randomized on a 1:1 basis to LA or placebo. Subjects will Synopsis 3 List of Abbreviations 4 Table of Contents 6 Protocol Title 9
Study Design. This will be a multi-center, prospective, randomized, controlled study with EBV treatment statistically evaluated using Intent-to-Treat (ITT) analyses. A maximum of 183 ITT study participants, who meet study entry criteria, consisting of screening eligibility criteria, baseline eligibility criteria, and procedure eligibility criteria, will be enrolled. Safety and effectiveness of bronchoscopic lung volume reduction (BLVR) using the Pulmonx EBV will be evaluated at 1 year. An interim analysis designed to evaluate effectiveness for continuing crossover of control participants at 1 year to EBV treatment will be performed when 74 study participants have completed the 1-year follow-up. For study participants who have been treated with EBV, a secondary valve intervention such as valve removal, replacement, or adjustment may be considered during the study follow-up. Long-term data will be collected annually for EBV-treated study participants through 5 years. Per the regulatory plan agreed to with FDA, 1 year of follow-up is required pre-approval and the remaining 4 years of follow-up will be conducted post-approval.
Study Design. This is a prospective, open-labelled study in patients with neovascular macular degeneration. All subjects will receive 6.0mg of intravitreal brolucizumab every 4 weeks between baseline and week 8. Following these loading doses, a disease activity assessment will be performed at week 16. Decrease in BCVA of ≥ 5 letters compared with Baseline Decrease in BCVA of ≥ 3 letters and CSFT increase ≥ 75μm compared with Week 12 Decrease in BCVA of ≥ 5 letters due to neovascular AMD disease activity compared with Week 12 New or worse intraretinal cysts (IRC) /intraretinal fluid (IRF) compared with Week 12 If a subject meets any of the above disease criteria at week 16, the subject will be assigned to receive injections every 8 weeks (q8w) thereafter, up to study exit (Week 16, 24, 32, 40 and 48). If a subject does not meet any of the above disease activity criteria, the subject will be injected every 12 weeks (q12w) up to study exit (week 20, 32 and 44).
Study Design. [Click here to enter text] Study Population: [Click here to enter text] Study Drug: includes both Investigational [Medicinal] Products (IP/IMP) and Non-investigational [Medicinal] Products (Non-IP/Non-IMP) as listed: Study Assessments: [Click here to enter text] Statistical Considerations: *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.