Study Design means a description of the manner in which the clinical trial will be conducted, including the following information:
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.
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Study Design: A survey of vaccination, practices, beliefs, and attitudes was sent to all dialysis centers in ESRD Networks 6, 11, and 15.
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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
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. Cross sectional descriptive study.
Study Design. A group-randomized evaluation of a multicomponent intervention to increase influenza vaccination rates in poorly performing dialysis centers in ESRD Networks 6, 11, and 15. Setting & Participants: Facilities with the lowest immunization percentages in 2006-07 were selected from each Network and randomly-assigned to a “standard intervention” (n=39) or “intensive intervention” (n=38). Standard intervention included a feedback report with comparison to other centers in their Network and educational materials for staff and patients. Intensive intervention centers also received 3 educational seminars, assistance with and review of center-specific action plans, and monthly monitoring of vaccination plan and rates. Results: There was an 8.9% (p=0.041) mean absolute difference in improvement between intervention centers (+28.2%) and standard intervention centers (+19.2%). Limitations: Some vaccinations were self-reported by patients. The vaccination data form does not have option for patient data unavailable, which may have caused patients without data to be coded as unvaccinated.
Study Design. This is a Phase 1, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral doses of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks Dose Escalation for subjects with the following relapsed/refractory malignancies: Dose Expansion at the MTD or the RP2D: Number of Subjects (planned): Dose Escalation: Approximately 48 subjects with relapsed/refractory selected solid tumors and CNS tumors will be enrolled using a “Rolling 6” dose escalation design (subjects who discontinue in absence of a dose-limiting toxicity [DLT] prior to the completing of the DLT evaluation period may be replaced). Dose Expansion: Approximately 72 subjects will be enrolled into the dose expansion into the following cohorts: Diagnosis and Main Criteria for Inclusion: Inclusion Criteria For All Subjects: Subjects must meet ALL of the following criteria to be eligible for enrollment in this study.
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. This was a secondary analysis of data collected from women (n=263) who presented to Justinien University Hospital in Cap-Haïtien, Haiti from July 2013 - January 2014. Binary logistic regression analyses were run to examine factors associated with pregnancy intention and prior pregnancy outcomes among participants who attempted a self-managed abortion in the current pregnancy, and among those with an ever-attempt of a self-managed abortion. Results: Women who had completed some secondary school (OR=6.993) and women who had no prenatal visits were more likely to have attempted a self-managed abortion in the current pregnancy as compared to women who completed some primary school or less and women who had one prenatal visit (OR=3.745) or two prenatal visits (OR=4.237). Women who either certain they don’t or unsure if they do want children in the future were more likely to have ever- attempted a self-managed abortion (OR=6.067). Having used any method of family planning up to the current pregnancy was a significant risk factor having ever-attempted a self-managed abortion (OR=9.071). Pregnancy intention was not statistically significant among women who attempted a self-managed abortion in the current pregnancy however, women who characterized their current pregnancy as unintended had higher odds of ever-attempting a self-managed abortion as compared with women who characterized her pregnancy as intended (OR=50.0).