Study Design means a description of the manner in which the clinical trial will be conducted, including the following information:
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. 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.
Examples of Study Design in a sentence
Qualitative Case Study Methodology: Study Design and Implementation for Novice Researchers.
Contacts and Locations Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
The Chronic Renal Insufficiency Cohort (CRIC) Study: Design and Methods.
Provide evidence or rationale that supports the objective/hypothesis.▪ Specific Aims: State concisely the specific aims of the study.▪ Study Design: Briefly describe the study design.▪ Relevance: Provide a brief statement explaining the potential relevance of the proposed work to the program’s goals.
Provide evidence or rationale that supports the objective/hypothesis.▪ Specific Aims: State concisely the specific aims of the study.▪ Study Design: Briefly describe the study design.▪ Relevance: Provide a brief statement explaining the relevance of the proposed work to the Program’s goals, for example, how the study will cure, prevent, or improve the detection or treatment of the disease.
More Definitions of Study Design
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. We conducted a nationwide cross-sectional web-based survey of pregnant women in the U.S. during June–July 2014. The primary outcome was self-reported vaccination status with Tdap during pregnancy, categorized as vaccinated, unvaccinated with intent to be vaccinated during current pregnancy, and unvaccinated with no intent to be vaccinated during current pregnancy. Secondary outcomes included factors that influenced women’s decision to get vaccinated or not and information needs on Tdap specifically for pregnant women. We used multivariable logistic regression models to estimate odds ratios for associations between race/ethnicity and the outcomes. Results: Among all pregnant women who completed the survey, 40% (95% CI 36%- 45%) reported that they had received Tdap vaccine during the current pregnancy. Hispanics had higher Tdap coverage than whites (52%, p<.05, compared with 38% among white non-Hispanics); black non-Hispanics did not have significantly different coverage (35%). In logistic regression models adjusting for maternal age, geographic region, education, and income, Hispanics were more than twice as likely to have been vaccinated with Tdap compared to white non-Hispanics (aOR=2.29, 95% CI 1.20-4.37). Tdap vaccination was also independently associated with higher income and residing in the western U.S. Twenty-six percent of women had not been vaccinated with Tdap yet but intended to receive the vaccine during the current pregnancy; this did not differ by race/ethnicity. The most common factor that influenced women to get vaccinated was a provider recommendation, followed by knowledge that babies can die from whooping cough and recommendations by family or friends. The most common reasons for not getting vaccinated were safety concerns.
Study Design means the detailed description of the Study scope, validated by AAA, that have to be performed in the Territory by FRI to support the Development in order to obtain the Marketing Authorization and ensure life-cycle management of the Product.
Study Design. Cross sectional descriptive study.
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).
Study Design. [Click here to enter text] [Do not insert page break. Click here to add schematic] 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 Drug for XXXXXXXX Medication Potency IP/Non-IP Study Assessments: [Click here to enter text] Statistical Considerations: Sample Size: [Click here to enter text] Endpoints: [Click here to enter text] Analyses: [Click here to enter text] *** 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. EXECUTION VERSION EXHIBIT C PRESS RELEASE Xxxxxxx-Xxxxx Squibb and Five Prime Therapeutics Announce Exclusive Clinical Collaboration to Evaluate the Combination of Investigational Immunotherapies Opdivo (nivolumab) and FPA008 in Six Tumor Types (NEW YORK and SOUTH SAN FRANCISCO, CA – November 24, 2014) - Xxxxxxx-Xxxxx Squibb Company (NYSE:BMY) and Five Prime Therapeutics, Inc. (Nasdaq:FPRX) today announced that they have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo (nivolumab), Xxxxxxx-Xxxxx Squibb’s investigational PD-1 immune checkpoint inhibitor, with FPA008, Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R). The Phase 1a/1b study will evaluate the combination of Opdivo and FPA008 as a potential treatment option for patients with non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. Xxxxxxx-Xxxxx Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab. Opdivo and FPA008 are part of a new class of cancer treatments known as immunotherapies that are designed to harness the body’s own immune system to fight cancer. Opdivo is approved in Japan for the treatment of patients with unresectable melanoma, and is being developed in multiple tumor types in more than 50 clinical trials. FPA008, in development as a potential treatment for rheumatoid arthritis (RA) and solid tumors, has initiated dosing for a Phase 1 clinical trial in RA. Preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead t...
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.