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Capnia Announces Enrollment First Patient Clinical Trial Treatment PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Capnia Announces Enrollment First Patient Clinical Trial Treatment articles that have been published worldwide.
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Fortunately >80% of children diagnosed with cancer become long-term survivors; however, this population is at a significantly increased risk of morbidity and mortality as a result of their previous cancer therapy, and long-term follow-up (LTFU) is critical. Multiple barriers to receiving adequate LTFU care have been studied. We investigated whether lack of enrollment in a therapeutic clinical trial may be a barrier to receiving LTFU care. We conducted a review of 353 patient records at the Children's Hospit...
Multicenter clinical trials of high-acuity, low-frequency emergencies are expensive and resource intensive. Current standards for trial preparation have significant limitations. Our objective is to describe our use of in situ simulation (ISS) to identify and mitigate threats to enrollment, protocol adherence, and patient safety in preparation for a multicenter clinical trial of antiepileptics for status epilepticus in the emergency department.
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.
Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation.
Although immune checkpoint inhibitors have shown significant survival benefits in the treatment of several cancers, optimal outcomes have been limited to certain subsets of patients. In a previous study, we found that the addition of metformin to nivolumab, an anti-programmed cell death protein 1 (PD-1) antibody, yielded substantial tumor regression in mouse models. Further analysis revealed that the number of tumor-infiltrating CD8 T cells had increased markedly. Based on this result, we have launched an i...
An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management).
Patient participation in clinical research is low, in part because of the length and complexity of the informed consent process. Video informed consent may enhance the appeal of research and help break down barriers to participation.
Time-to-event end points are the most frequent primary end points in phase III oncology trials, both in the adjuvant and advanced settings. The evaluation of these end points is important to inform clinical practice. However, although different measures can be used to describe the effect of treatment on these end points, we believe that any treatment benefit in a given trial is best reported using various absolute and relative measures. Our goal is to help clinicians understand the strengths and limitations...
For the past two decades, the National Cancer Institute (NCI) has supported the involvement of patient advocates in both internal advisory activities and funded research projects to provide a patient perspective. Implementation of the inclusion of patient advocates has varied considerably, with inconsistent involvement of patient advocates in key phases of research such as concept development. Despite this, there is agreement that patient advocates have improved the patient focus of many cancer research stu...
Hair concentrations of antiretrovirals are associated with virologic outcomes in cohorts of HIV-positive individuals but have never before been examined in a clinical trial. We show for the first time the predictive utility of hair antiretroviral concentrations in a large HIV treatment-naïve trial, AIDS Clinical Trials Group (ACTG) protocol A5257.
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 ...
Spinal cord stimulation has been proven highly effective in the treatment of Complex Regional Pain Syndrome (CRPS). The definitive implantation of a neurostimulator is usually preceded by a therapeutic test (trial), which has the purpose of identifying whether the patient would respond positively to neuromodulation or not. The present study aims to analyze the surgical results of spinal cord stimulation in type 1 CRPS patients who have not undergone trial.
Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classif...
An emerging framework for multimodal assessment of addictions (Kwako et al., 2016), and expanded definitions of acceptable endpoints for alcohol treatment trials (Food and Drug Administration, 2006) are informing efforts toward personalized treatment of alcohol use disorder (AUD). A critical issue in determining for whom an intervention will work lies in the definition of clinical trial endpoints. The six articles in this virtual issue of Alcoholism: Clinical and Experimental Research illustrate recent pro...
The aims of this randomized clinical trial were to investigate the influence of the suturing technique and the thickness of the pre- and postoperative palatal and flap mucosa on the early healing of the palate after harvesting a connective tissue graft. Furthermore, patient pain perception was evaluated.
Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver.
The aim of this clinical trial was to establish a proof of concept that the adjunctive use of systemic azithromycin (AZM) in conjunction with mechanical debridement has an increased benefit in reducing soft tissue inflammation in the treatment of peri-implantitis.
Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodologi...
We are presenting the case of a 37-year-old male with schizoaffective disorder who developed myocarditis within three weeks of starting on clozapine for his treatment-resistant psychosis. The patient also had a positive titer for Influenza A, which makes it a diagnostic dilemma regarding the cause of his myocarditis. It may be possible that the myocarditis was caused by the Influenza A virus or synergistically exacerbated the clozapine's propensity to cause it. Currently, there are no studies establishing t...
Clinical trials are vital for evidence-based cancer care. Oncologist engagement in clinical trials has an effect on patient recruitment, which in turn can affect trial success. Identifying barriers to clinical trial participation might enable interventions that could help to increase physician participation.
The traditional approach to clinical trial design requires assuming precise values for multiple unknown parameters, resulting is a trial design that is unlikely to perform well if one or more of those assumptions turn out to be incorrect. During conduct of the trial, trial characteristics are often held fixed, even if incoming data suggest that one or more design assumptions were incorrect. This leads to an increased risk of a failed trial. In contrast, an adaptive clinical trial is designed to take advanta...
Advanced and metastatic melanoma has historically been one of the most difficult cancers to treat, with few treatment options. For over 20 years, dacarbazine chemotherapy was the only treatment approved by the US Food and Drug Administration for melanoma. In recent years, breakthroughs have been made in the areas of monoclonal antibody immunotherapies and genetically targeted therapies, leading to FDA approval of several new drugs for metastatic melanoma that have demonstrated improved patient response and ...
As new cancer treatment regimens demonstrate increased potential to improve patients' survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute's Patient-Reported Outcomes version of the Common Term...
The initial management of atypical meningiomas poses a distinct clinical challenge in that treatment protocols have not been fully established, and outcomes, especially differences by patient age, have not been broadly measured. The National Cancer Database (NCDB) allows for analysis of a large, diverse patient population to determine clinical parameters and survival outcomes based on the initial treatment of patients with atypical meningiomas.
RP is the most common manifestation of SSc and a major cause of disease-related morbidity. This review provides a detailed appraisal of the patient experience of SSc-RP and potential implications for disease classification, patient-reported outcome instrument development and SSc-RP clinical trial design. The review explores the clinical features of SSc-RP, the severity and burden of SSc-RP symptoms and the impact of SSc-RP on function, work and social participation, body image dissatisfaction and health-rel...
Purpose Overall survival (OS) is the definitive and best-established primary efficacy end point to evaluate diffuse large B-cell lymphoma (DLBCL) therapies, but it requires prolonged follow-up. An earlier end point assessed post-treatment would expedite clinical trial conduct and accelerate patient access to effective new therapies. Our objective was to formally evaluate progression-free survival (PFS) and PFS at 24 months (PFS24) as surrogate end points for OS in first-line DLBCL. Patients and Methods Indi...