Clinical Trials About "MilliporeSigma ReForm licensing deal excipients" RSS

11:35 EDT 5th April 2020 | BioPortfolio

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Showing "MilliporeSigma ReForm licensing deal excipients" Clinical Trials 1–25 of 226


Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

The WHO-PEN@Scale project is a three-arm cluster-randomized trial that is investigating the population-level effects of a healthcare reform in Eswatini, which aims to strengthen primary care for diabetes and hypertension. Prior to the reform, healthcare for diabetes and hypertension was mostly provided through physician-led teams in hospital outpatient departments. The healthcare reform aims to strengthen the provision of nurse-led care for diabetes and hypertension in primary ...

Physical Activity in Schools After the Reform

In 2014 the Danish Government introduced a wide-ranging school reform that applies to all public schools in Denmark. In a physical activity promotion perspective, a distinctive feature of the school reform is that it has become mandatory to integrate an average of 45 minutes of daily physical activity in the regular school day. The overarching objective of the PHASAR study is to evaluate the implementation of this ambitious policy-driven physical activity promotion initiative a...

The Safety and Utility of Skin Testing With Xolair (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

The study will be conducted at up to three investigational sites in the United States in 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study will examine the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.

Optimizing the Resources of Psychotherapy as a Tool for Implementing the Mental Health Reform

Psychotherapy is one of the cornerstones in public and private mental health services. Despite the tremendous investment in psychotherapy, its efficiency ranges from 40% to 60%. Given the Mental health Reform (2015), aimed at increasing the quality, availability, and accessibility of mental health services, there is an urgent need to manage and maximize psychotherapy services in Israel.

Phase 1 Norwalk Vaccine Study

Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls Primary Objective: - Safety as determined by occurrence of local intranasal symptoms or other symptoms as reported by a self-administered memory aid for 7 days after each vaccination and hematology, blood chemistry and physical examinations performed by the clinical ...

Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen. This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossov...

Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors

This study involves an emergency department (ED)-based intervention utilizing Motivational Interviewing (MI) techniques and patient-centered eHealth materials (e.g., a tailored, mobile-friendly website and text messages) to promote the correct and consistent use of size-appropriate child passenger restraints (car seats, booster seats, and seat belts). This study is designed as an adaptive randomized controlled trial.

Annual Study for Fluarix Registration

A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/ Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).

Behavioral Health Services for Women Receiving Public Assistance

The purpose of this study is to determine whether access to behavioral health services has been affected by welfare reform.

Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital

Demographic changes in the industrialized world are expected to prompt a need for better organized and more efficient health care services. In order to curb costs, health care providers in many countries are searching for viable alternatives to hospitalizations. Norwegian white papers and reform documents presume that the municipalities will play a central role in meeting the growth in demand for health services. Central public policy documents and national research strategies ...

Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, without the previously used excipients.

Yearly Strain Variation Study, 2010/2011

The purpose of the study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season for yearly licensing application.

A Post-Marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children

Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).

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Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers

The primary objective of this study is to evaluate the safety and tolerability of RP-1127 (glyburide for injection), administered as a bolus dose followed by a 3 day continuous infusion. The secondary objectives are to assess the pharmacokinetics of RP-1127 and blood glucose and serum insulin PD responses to RP-1127.

StaphVAX Immunogenicity in Orthopedic Implant Patients

S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.

Yearly Strain Variation Study, 2009/2010

The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.

Patient-Centred Innovations for Persons With Multimorbidity - Quebec

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (...

Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms

The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®- Plus, is able to prevent or minimize the induction of nasal symptoms during allergen challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on soluble and cellular inflammatory markers induced by the allergic reaction will be assessed. Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical excipients.

Determinants of Post-Exercise Eating Patterns

This study examines potential physiological and psychological determinants of food intake in response to exercise. Specifically, beyond measuring actual food consumption and physiological markers typically assessed during exercise and appetite work (i.e. appetite hormones, blood glucose), the investigators wish to investigate the influence of individual behavioural differences (attitudes towards eating, licensing/compensatory health beliefs, self-regulation, and exercise-associ...

Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination

Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells

Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform

UPRIGHT-HTM will compare risk stratification, treatment efficiency and health economic outcomes of a diagnostic approach based on home blood pressure telemonitoring combined with urinary proteomic profiling with home blood pressure telemonitoring alone

Preventing Motor Vehicle Crashes Among Young Drivers: Evaluation of the Checkpoints Program Presented by the American Automobile Association

Background: - Automobile crash risks are highest right after licensure and decline rapidly for about 6 months and then gradually for years, regardless of the amount of supervised practice driving or age at licensure. The only approaches to this problem that have demonstrated effectiveness are Graduated Driver Licensing (GDL) and parental management. - The Checkpoints Program consists of persuasive messages and materials designed to increase ado...

The Impact of Bundled Payments on Quality and Cost of Care

Bundled payment is a new payment reform that encourages health care providers to improve quality and contain costs of care. These arrangements are being rapidly expanded across the country, but evidence about their impact are lacking. This study will use Medicare claims data to evaluate the effect of participation in a large Medicare bundled payment program on the quality and costs of care for common medical and surgical conditions.

Post ACA Reform: Evaluation of Community Health Center Care of Diabetes (PREVENT D)

This innovative and timely study will measure the impact of Affordable Care Act (ACA) Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health outcomes. To assess this natural policy experiment, the investigators will use electronic health record data from the ADVANCE clinical data research network (CDRN) of the National Patient-Centered Clinical Research Network (PCORnet).

Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms

The involvement of family members is crucial and improves the prognosis of psychiatric patients and reinforces therapeutic adherence and reduces the frequency of relapses. For schizophrenia, the scientific literature clearly shows that it's in the interest of the patient to offer to his family a psychoeducational program. Therapeutic education programs are now part of the recommendations of good clinical practice and in the French health through the law n ° 2009-879 of July 2...

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