PubMed Journals Articles About "AGTC Announces Completion Enrollment Phase Clinical Study Investigational" RSS

08:04 EDT 19th August 2018 | BioPortfolio

AGTC Announces Completion Enrollment Phase Clinical Study Investigational PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest AGTC Announces Completion Enrollment Phase Clinical Study Investigational articles that have been published worldwide.

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Showing "AGTC Announces Completion Enrollment Phase Clinical Study Investigational" PubMed Articles 1–25 of 83,000+

Extemporaneous Preparation Strategy for Early Phase Clinical Studies.

Extemporaneous preparations (EPs) of investigational drugs, which are compounded at the clinical study site by a pharmacist, are being increasingly used in early phase clinical studies to accelerate the development of new medicines. The successful application of EP strategies in clinical studies requires 'fit-for-purpose' formulation design and preparation processes, as well as administration procedures that are safe, flexible, cost-effective, and simple to adapt by a compounding pharmacist at the clinical ...

Consideration of older patients for enrollment in phase 1 clinical trials: Exploring treatment related toxicities and outcomes.

Age imposes a disparity in the treatment of and outcomes with gynecologic cancer. Older patients are underrepresented in primary treatment trials, but little is known about their ability to withstand trial-based treatment for recurrent or refractory disease. This study sought to examine treatment-related toxicities and outcomes of older versus younger patients participating in phase 1 clinical trials.

Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations. Extension of temporary moratoria.

This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non- emergency ground ambulance suppliers and home health agencies and branch locations in Medicaid and ...

Enrollment in early-phase clinical trials in pediatric oncology: The experience at Institut Curie.

The European Paediatric Regulation was introduced in 2007 to facilitate access to new medicines for children. Our study explored accessibility of early-phase trials in pediatric oncology, in line with the European Paediatric Regulation, to identify the reasons for not inviting patients to participate, parents' refusal, or inclusion failure.

Immune Responses to Booster Vaccination with Meningococcal ABCWY Vaccine Following Primary Vaccination with Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study.

Current meningococcal prime-boost vaccination schedules include separate vaccines for serogroups ACWY and B. An investigational combined serogroups ABCWY vaccine (MenABCWY) was developed to protect against clinically important Neisseria meningitidis serogroups.

A comparison between phase-III trials and a phase-IV study of nalmefene in alcohol use disorder patients. Is there a difference?

Concerns regarding the external validity of phase-III trials are common to many medical disciplines, with relevant discrepancies found between experimental and clinical samples in some diseases such as hypertension. The aim of this study was to compare the samples included in the pivotal, phase-III clinical trials of nalmefene with that of a recently conducted phase-IV trial. Baseline characteristics of the studies were compared through univariate analysis. Significant differences were found in the percenta...

Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola.

The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV∆G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support...

Nab-paclitaxel maintenance therapy following carboplatin + nab-paclitaxel combination therapy in chemotherapy naïve patients with advanced non-small cell lung cancer: multicenter, open-label, single-arm phase II trial.

Background A global multicenter study demonstrated superiority of carboplatin + nab-paclitaxel (PTX) therapy compared to carboplatin + PTX in terms of response rate (RR) and non-inferiority in terms of progression free survival (PFS) and overall survival (OS) in untreated patients with stage IIIB/IV non-small cell lung cancer; no clinical findings have so far been reported on maintenance therapies with nab-PTX. The aim of this study was to determine the efficacy and safety of maintenance therapy with nab-PT...

A Phase 1 Study of MEDI3902, an Investigational Anti-Pseudomonas aeruginosa PcrV and Psl Bispecific Human Monoclonal Antibody, in Healthy Adults.

MEDI3902 is a bivalent, bispecific human immunoglobulin G1κ monoclonal antibody that binds to both the Pseudomonas aeruginosa PcrV protein involved in host cell cytotoxicity and the Psl exopolysaccharide involved in P. aeruginosa colonization and tissue adherence. MEDI3902 is being developed for the prevention of nosocomial P. aeruginosa pneumonia in high-risk patients.

Statistical justification of expansion cohorts in phase 1 cancer trials.

Phase I cancer trials increasingly incorporate dose-expansion cohorts (DECs), reflecting a growing demand to acquire more information about investigational drugs. Protocols commonly fail to provide a sample-size justification or analysis plan for the DEC. In this study, we develop a statistical framework for the design of DECs.

Phase I and phase II clinical trials for the treatment of male sexual dysfunction - A systematic review of the literature.

Introduction - The prevalence of sexual dysfunctions has increased over the last decades; despite a number of available treatments for erectile dysfunction (ED), premature ejaculation (PE) and Peyronie's disease (PD), still several unmet therapeutic needs deserve to be fulfilled. The aim of this review is to detail on phase I and II clinical trials investigating novel medical treatments for ED, PE and PD. Areas covered - We conducted a systematic review of the literature including both published and on-goin...

Apalutamide: The established and emerging roles in the treatment of advanced prostate cancer.

Prostate cancer (PCa) is the most common cancer in elderly males. Androgen deprivation therapy (ADT) is still the cornerstone of initial treatment, however the vast majority of patients develop castration resistant prostate cancer (CRPC). Several studies with numerous androgen receptor (AR)-directed agents have emerged since the approval of abiraterone acetate and enzalutamide. One of these agents is apalutamide, which seems to be a promising AR antagonist for the treatment of CRPC. Areas covered: The autho...

Investigational drugs for the treatment of endometriosis, an update on recent developments.

Endometriosis is a hormone-dependent benign chronic disease that requires a chronic medical therapy. Although currently available drugs are efficacious in treating endometriosis-related pain, some women experience partial or no improvement. Moreover, the recurrence of symptoms is expected after discontinuation of the therapies. Currently, new drugs are under intense clinical investigation for the treatment of endometriosis. Areas covered: This review aims to offer the reader a complete and updated overview ...

Investigational procedures in benign prostatic hypertrophy.

As benign prostatic hypertrophy (BPH) becomes a more common disease, there has been a dramatic rise in the number of investigational procedures being developed to manage it. We seek to present an overview of the most recently developed treatments and present clinical data related to application wherever available.

Site enrollment rate, outcomes, and study drug effects in a multicenter trial. Results from RELAX-AHF.

Site selection is critical in acute heart failure trials. We assessed whether the enrollment rate per site affects patients' characteristics, outcomes and treatment response.

Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery.

Investigational hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) for the treatment of anaemia associated with chronic kidney disease.

In the last decade, concerns have been raised around the use of erythropoiesis stimulating agents (ESA) and intravenous iron in CKD patients, especially when given at high doses. Moreover, treatment with ESA is expensive. Areas covered: We searched PubMed for original articles, reviews and editorials having as a topic anaemia, chronic kidney disease, hypoxia inducible factor, hepcidin, iron, hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI). HIF-PHI are a new class of small molecules activati...

Satisfactory Completion of End-of-Course Outcomes Using Simulation.

Simulation is replacing clinical hours in prelicensure nursing programs, and students must be evaluated to ensure that the end-of-course outcomes are met. The purpose of this study was to identify what an average score (or cutoff score) for high-fidelity simulation is for successful and satisfactory completion of end-of-course outcomes in a medical-surgical nursing course using the Lasater Clinical Judgment Rubric.

Pharmacokinetics and C-Reactive Protein Modelling of Anti-IL-6 Antibody (PF-04236921) in Healthy Volunteers and Patients with Autoimmune Disease.

The purpose of this study was to characterize pharmacokinetics (PK) of PF-04236921, a novel anti-IL-6 monoclonal antibody, and its pharmacokinetics/pharmacodynamics (PK/PD) relationship on serum C-Reactive Protein (CRP) in healthy volunteers and patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Crohn's disease (CD) METHODS: Population modelling analyses were conducted using nonlinear mixed effects modelling. Data from 2 phase 1 healthy volunteer studies, a phase 1 RA study, a ...

VA Announces Plan to Improve Worst-Performing Medical Centers.

Updated Performance of the Micra Transcatheter Pacemaker in the Real-World Setting: A Comparison to the Investigational Study and a Transvenous Historical Control.

Early results from the Micra investigational trial (IDE) and Micra post-approval registry (PAR) demonstrated excellent safety and efficacy performance; however, intermediate-term results across a large patient population in the real-world setting have not been evaluated.

Letter: Enrollment-To-Screening Ratio: An Undervalued Data in Randomized Clinical Trials.

Intraoperative Completion Angiogram May Be Superior to Transesophageal Echocardiogram for Detection of Pulmonary Artery Residual Lesions in Congenital Heart Surgery.

The purpose of this study was to assess the diagnostic capabilities of transesophageal echocardiography (TEE) compared to completion angiography for detection of residual post-operative pulmonary artery lesions. This is a retrospective review of 19 consecutive surgical cases involving the pulmonary arteries that had post-operative TEE and completion angiography from 2014 to 2017. The echocardiograms were reviewed by 2 blinded examiners and categorized as adequate or inadequate visualization of the surgical ...

Design and Patient Characteristics of the Chronic Graft-Versus-Host Disease Response Measures Validation Study.

In 2014, the National Institutes of Health sponsored the second Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-vs-Host (GVHD). The purpose was to update recommendations about key elements of chronic GVHD research, including definitions for diagnosis, severity scoring, and response measures, based on empirical data published since the first 2005 Consensus Conference. The most significant modifications were to the response assessments, since studies demonstrated difficulty with...

New Risk-Adjustment Policies Reduce But Do Not Eliminate Special Enrollment Period Underpayment.

Millions of uninsured Americans do not sign up for available coverage despite job loss or other factors that would make them eligible for special enrollment periods (SEPs). Such periods let people enroll in nongroup insurance outside the usual open enrollment period for Marketplace coverage. Concerned that risk adjustment results in underpayment for the health risks associated with SEP enrollees, carriers rarely market their products to consumers eligible for SEPs, and many do not pay agents and brokers to ...

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