Study 1 definition

Study 1. Xxxxx, 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 has the meaning set forth in Section 7.1(b)(ii).
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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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Examples of Study 1 in a sentence

  • Miller, Attorney Fees in Class Action Settlements: An Empirical Study, 1 J.

  • A copy of the complete study can be found in Appendix C, Study 1.

  • Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving ≥ 10% of the body surface area who were ≥ 18 years old.

  • This chapter presents Study 1 on the conceptualization and instrument development of problematic use of massively multiplayer online games (MMOGs).

  • The sand flat off Louse Point dissipates some wave energy, and because of the amount of offshore sand there, it is unsurprising that the channel requires frequent dredging.

  • Going from a simple 2D model, as in Case Study 1 (Section 3.9.1) with 400 cells, to a full 3D model with 1.63 million cells to resolve the flow patterns illustrates the complexity of the simulation as well as a need for compute power for large models.

  • In order to implement Specific Appropriation 486 of the 2010- 2011 General Appropriations Act, and for the 2010-2011 fiscal year only, the following requirements shall govern Phase 2 of the Department of Health’s Florida Onsite Sewage Nitrogen Reduction Strategies Study: (1) The underlying contract for which the study was let shall remain in full force and effect with the Department of Health and funding the contract for Phase 2 of the study shall be through the Department of Health.

  • In a sample of 80 participants (60 women, 20 men), Study 1 examines the influence of broad affective personality characteristics using the NEO Five-Factor inventory, including neuroticism and extraversion subscales.

  • Study 1 found that affective personality traits (neuroticism and extraversion) were associated with diurnal patterns of cardiovascular functioning.

  • The case study below illustrates how that rorting has been occurring.Case Study #1 Lisa6 was a permanent full time employee in a Queensland plastic and reconstructive surgery clinic.


More Definitions of Study 1

Study 1. The Effects of Women’s Fertility on their Empowerment in Bangladesh Abstract In classic patriarchal settings, a woman’s fertility is often assumed to be both cause and consequence of her empowerment. However, there is limited empirical research examining fertility as a determinant of empowerment. I used nationally representative data to examine the effects of aspects of a woman’s fertility on a fundamental dimension of her empowerment, household decision making, in Bangladesh, a classic patriarchal setting undergoing substantial transformation with regard to societal gender norms. Findings indicate that women’s involvement in household decision making remains low. Aspects of increased fertility were negatively associated with women’s empowerment. Finally, fertility levels in a woman’s surrounding community may have greater impact on empowerment than individual fertility. Findings provide direction to reproductive health and empowerment programs. Additional research examining predictors of high levels of empowerment is necessary.
Sample 1

Related to Study 1

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

  • 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.

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Study Data shall have the meaning set forth in Section 8.1.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Study Centre means a centre established and maintained or recognized by the University for the purpose of advising, counselling or for rendering any other assistance required by the students in the context of distance education;

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.

  • 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).

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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 II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).