Study 1 definition

Study 1 has the meaning set forth in Section 7.1(b)(ii).
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Study 1. ▇▇▇▇▇, et al. published a placebo-controlled, randomized, double blind study evaluating the impact of oral glutathione on growth parameters in an Italian pediatric CF cohort [6]. In this study, 44 children ages 18 months to 10 years, receiving pancreatic enzyme replacement therapy (PERT), were randomized to receive either placebo or oral glutathione daily for 6 months. Patients received 65mg/kg/day of oral GSH or placebo of calcium citrate at 65mg/kg/day. This dose was divided into three doses with one being given at each meal. The subjects receiving oral glutathione gained an average of 0.67 weight-for-age z-score over the course of the 6 month trial while the placebo group showed an average increase in weight z-score of 0.10. The overall difference between the two groups in the 6-month change from baseline was statistically significant with a p value of < 0.0001. Similarly, the overall difference between groups in the 6-month change from baseline for BMI-for age z-score was statistically significant (glutathione mean change: 0.60, placebo mean change: 0.22, p < 0.0001) (See Figure A below) [6]. Noticably, there was a difference between the two treatment groups in both weight-for- age z-score at baseline (-0.84 in the treated group versus -0.54 in the placebo group) and BMI-for-age z-score at baseline (-0.76 in the treated group versus -0.57 in the placebo group). Although these differences were not statistically significant, the treated group had greater opportunity for improvement than the group treated with placebo. Secondary outcome measures in this study included blood alanine aminotransferase (ALT), WBC, Vitamin E, and CRP. Each of these improved significantly in the glutathione treated group compared to placebo (See Table 3 below). The impact of glutathione on gut inflammation measured as fecal calprotectin levels before and after the treatment period was also evaluated. Interestingly, there was improvement in fecal calprotectin in subjects treated with glutathione which was found to be statistically significant (difference from baseline in the glutathione group -52.0 µg/g vs. placebo 0.5 µg/g, p<0.0001), however, treatment groups were significantly different at baseline (glutathione group 113.2 µg/g vs. placebo 76.1 µg/g, p = 0.008). This is illustrated in the figures below. A gastrointestinal symptom index was used to evaluate improvement, worsening, or development of new gastrointestinal symptoms while subjects received study drug or placebo. In...
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Study 1. The Effects of Women’s Fertility on their Empowerment in Bangladesh Abstract
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Examples of Study 1 in a sentence

  • Study 1 data collection was supported by grant number 9534900 from the Stichting Kinderpostzegels Nederland to the third and fourth authors.

  • The effects varied between studies; differences between inclusion and exclusion were greater for certain types of missingness in Study 1 and greater in one school versus another in Study 2.

  • Study 1 also indicated that, when the inclusion and exclusion conditions differed noticeably, exclusion consistently yielded lower reliability and different corre- lations than inclusion.

  • Study 1 Absolute Differences in r Following Different Types of Simulated Participant Removal.

  • It is likely that the inclusion condition is providing more accurate results than the exclusion condition, given that (a) the exclusion condition uses less data, (b) inclusion of nonparticipants as nominees is a general requirement of peer nomination measurement, and (c) the results of Study 1 indicated that including nonparticipants as nominees pro- vided results that were closer to the full sample.

  • We conducted the same bootstrapped significance tests as in Study 1; that is, we created a 99% confidence interval around reliability estimates and intercor- relations by resampling random nominee removal in the same pro- portion that nominators were missing in each school.

  • Courses that the University of Maryland Eastern Shore will accept credits for towards completion of the Bachelor of Science in Hospitality and Tourism Management include: SDV 100 Fundamentals of College Study 1 GNST 100 First Year Experience or waive 1 General Education HMR 101 Intro to Hospitality Industry 3 HMGT 101 Analysis of Hospitality Industry 3 Program/ Major Req.

  • The current analyses focused on the same eight constructs as Study 1: friendship (1 item), popularity (most popular minus least popular), social preference (like most minus like least), overt aggression (1 item), relational aggression (2 items, summed), overt victimization (2 items, summed), relational victimization (2 items, summed), and prosocial behavior (2 items, summed).

  • Study 2 Given the simulated nature of missingness in Study 1, Study 2 investigated the difference between including versus excluding nonparticipants as nominees in a dataset that already had nonparti- cipation.

  • The following conditions apply to the performance of a Group Study: (1) Eligible Customer(s) participating in a Group Study waive the right to have individual Studies performed.


More Definitions of Study 1

Study 1. The Effects of Women’s Fertility on their Empowerment in Bangladesh 46 Study 1, Table 1: Sample Characteristics 62 Study 1, Table 2: Effects of Fertility on Household Decision Making, Generalized Ordered Logistic Regression (constrained) 63 Study 1, Figure 1: Predicted Probabilities of Women’s Involvement in Household Decision Making for Individual and Relative Fertility 64 Study 2: Effects of Women’s Fertility on Empowerment and Intimate Partner Violence: A Mediation Analysis 71 Study 2, Figure 1: Conceptual Fertility-IPV-Empowerment Model 86 Study 2, Table 1: Sample Characteristics 87 Study 2, Table 2: Fertility-IPV-Empowerment Mediation Models 88 Study 3: Resources for Women’s Empowerment via Household Decision Making in Bangladesh 95 Study 3, Table 1: Household Decision Making, Individual Indicators 112 Study 3, Table 2: Sample Characteristics 113 Study 3, Table 3: Resources for Women’s Empowerment via Household Decision Making in Bangladesh 114 Conclusion 123
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Related to Study 1

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

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.