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Clinical Trials About "Responses Kako 1089 2019 0072 Niki 1089 2018" RSS

07:29 EST 21st January 2020 | BioPortfolio

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Showing "Responses Kako 1089 2019 0072 Niki 1089 2018" Clinical Trials 1–25 of 3,700+

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Safety, Reactogenicity and Immunogenicity of Two Quadrivalent Seasonal Influenza Vaccines (Fluzone(R) or Flublok(R)) With or Without One of Two Adjuvants (AF03 or Advax-CpG55.2) in Healthy Adults

This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two adjuvant formulations, AF03 or ...


Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations

The primary objectives of this study are: - To describe the immunogenicity of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to < 36 months of age and 3 to < 9 years of age, and in adults 18 to < 65 years of age, the immunogenicity of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to < 65 years of age, and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years o...

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A Descriptive, Prospective Clinical Study to Evaluate Full Dentures Fabricated by Additive Manufacturing

This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using Additive Manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for Additive Manufacturing (M2 series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of ...


Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019

• This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. The study population consists of approximately 22,500 subscri...

Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults

A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects will be randomized to seven treatment groups to receive Quad-NIV or an active comparator.

Professional Development Tools to Improve the Quality of Infant and Toddler Care

Mathematica Policy Research, funded by OPRE, ACF, DHHS, will conduct a field test of We Grow Together: The Q-CCIIT Professional Development System. These professional development (PD) tools and the interactive website featuring the materials were developed to promote high-quality caregiver-child interactions in non-parental care settings serving infants and toddlers. This field test aims to: (1) examine changes in caregiver practice that the investigators expect to be associate...

Diaphragm Training Ultrasound

Common neurological indications of intubation and initiation of mechanical ventilation (MV) include ischemic and hemorrhagic stroke, neurotrauma, and intracranial hemorrhage. Mechanical ventilation is frequently applied to protect the airway from the risk of aspiration and to prevent both hypoxemia and hypercapnia, which are two major systemic factors of secondary brain insult (Faez et al., 2016, 2016; Asehnoune, Roquilly and Cinotti, 2018). Mechanical ventilation after endotr...

Basic Hemodynamic Monitoring Reliability During Percutaneous Nephrolithotomy.

This prospective pre and post-quasi-descriptive single group interventional study will be done at urology and nephrology center -Mansoura University during the year 2019, for a 3-month duration, starting 1-2-2019 till 1-4-2019 after approval of IRB (Institutional Review Board) code no R/18.03.103 on 5/5/2018, Mansoura Faculty of Medicine. correlating Basic hemodynamics with noninvasive cardiac output for diagnostic reliability during percutaneous nephrolithotomy hidden bleeding...

Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years of Age

The primary objectives of the study are: - To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. - To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives of the study are: - To desc...

D2560C00015 FluMist Annual Safety Study 2018

This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.

Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP

This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used...

Pragmatic Assessment Study Influenza Vaccine Effectiveness in DoD

A total of 10,650 eligible subjects (or 3,550 subject distributed evenly between the 3 study arms) will be enrolled. eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over two influenza seasons (2018-2019, 2019-2020).

Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT Diarrhea Patients

This is a prospective single arm study with the study period from June 1st, 2019 to May 31st, 2020. An historical control group will be used in the study, which includes all patients received HSCT but not GI panel detection between June 1st, 2018 to May 31st, 2019. All patients receiving HSCT within the year at SCMC will be enrolled in the study. The stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (T1), 28+-3 days ...

Phase 1-2a Study of EBNA1 Inhibitor, VK-2019, in Patients With Epstein-Barr Virus-positive Nasopharyngeal Cancer

This study is a First-In-Human clinical trial to assess the safety and preliminary efficacy of VK-2019, an orally administered EBNA1 inhibitor, for the treatment of patients with advanced nasopharyngeal carcinoma.

Effects of a Walking Intervention on Health Outcomes in Older Adults

Medical condition or disease under investigation : Quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults (>55years) Purpose of clinical trial : To study the prospective effects of a walking intervention (Health promotion program) on quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults. Primary objective : Measure the effects of walking intervention on quant...

Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years

The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it is indicated. The 2018-2019 and 2019-2020 formulations of recombinant influenza vaccine (Flublok Quadrival...

Physiological Changes Throughout the Competitive Rugby Season.

Rugby union is a high intensity, intermittent team sport which is played over 80 minutes. Players are divided into two main positional groups, forwards and backs, with backs covering a larger distance and completing more sprints and forwards partaking in more static exertions. With the game of rugby union getting progressively faster, body composition and power to weight ratio are key determinants. Due to the demands placed on these players it is essential that they are in opti...

Non Invasive Ventilation in Bronchiolitis

It is decided to perform a prospective study in a non-selected population of infants with bronchiolitis during one year ( October.2018 to October.2019) to study the characteristics, clinical course and outcome of the use of Non invasive ventilation in the management and compare the results with those treated with invasive ventilation to assess safety and efficacy and inform guideline construction.

Lights, Camera and Action Against Dating Violence (Lights4Violence)

Lights4Violence aims to promote adolescents' capabilities to improve their intimate relationships with peers through different participation approach activities. In order to do that, it is planned to perform a longitudinal quasi-experimental educational intervention study with a quantitative evaluation in 5 different cities: Alicante (Spain), Cardiff (UK), Porto (Portugal), Iasi (Romania) and Lublin (Poland) between 2018 and 2019.

TITRE III: Influenza B Immunogenicity Investigation

Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" & "A/H3N2") and two kinds of influenza B ("B/Yamagata" & "B/Victoria") can cause illness. Historically, the yearly influenza vaccine that was recommended in children was designed to protect against both kinds of influenza A but only one kind of influenza B. In a series of trials conducted between 2008-09 and 2010-11 (TITRE I, II, and IIB), the TITRE investigators measured antibody response to influenza B in ch...

The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics

The goal of this study is to understand the impact on the human immune system's response to the 4 strain flu vaccine in individuals who have "imprinted" on specific influenza strains. It will also consider the effects of repeated prior annual influenza vaccination on the immune system.

Reduce Speed Limits From 90km/h to 80 km/h on French Roads: Impact on Mortality

On the first July 2018, the French government lowered the maximum authorized speeds on two-way roads without a central separator from 90 km/h to 80 km/h. The network concerned represents approximately 400 000 km of roads outside the built-up area, accounting for 55% of road deaths. The objective of the measure is to reduce the number of deaths on the roads concerned by encouraging the reduction of the average speed practiced by drivers. The analysis deals with a compari...

Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma

This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).

Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program

This study uses a randomized controlled trial (RCT) design to evaluate the impacts of the Future Foundation (FF) 2.0 Personal Responsibility Education Innovative Strategies (PREIS) program on reducing students' sexual activity (vaginal), recent risking sexual activity without condom use, and unprotected sex (no condoms/contraceptives). FF will implement the 2.0 PREIS Program with three cohorts of African-American youth in the 6th to 8th grades. FF aims to recruit and enroll 400...

Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients

1. Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS) 2. Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet) 3. Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU)...


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