PubMed Journals Articles About "Capnia Announces Enrollment First Patient Clinical Trial Treatment" RSS

18:52 EST 10th December 2018 | BioPortfolio

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Showing "Capnia Announces Enrollment First Patient Clinical Trial Treatment" PubMed Articles 1–25 of 58,000+

A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children's hospital.

Low cancer clinical trial (CCT) enrollment may contribute to survival disparities affecting adolescents and young adults (AYAs) (ages 15-39 years). The objective of this study was to evaluate whether differences in CCT availability related to treatment site could explain the low CCT enrollment.

Enrollment on clinical trials does not improve survival for children with acute myeloid leukemia: A population-based study.

It is questionable whether enrollment on clinical trials offers any survival advantage at the population level over standard-of-care treatment. The objectives of this study were to describe the impact of trial enrollment on event-free survival and overall survival in pediatric acute myeloid leukemia (AML) using the Cancer in Young People in Canada (CYP-C) database.

Increased clinical trial enrollment among adolescent and young adult cancer patients between 2006 and 2012-2013 in the United States.

Stagnant outcomes for adolescents and young adults (AYAs) 15-39 years of age with cancer are partly attributed to poor enrollment onto clinical trials. Initiatives have focused on increasing accrual, but changes at the population-level are unknown. We examined patterns of clinical trial participation over time in AYA patients with cancer.

A Time-and-Motion Study of Clinical Trial Eligibility Screening in a Pediatric Emergency Department.

Challenges with efficient patient recruitment including sociotechnical barriers for clinical trials are major barriers to the timely and efficacious conduct of translational studies. We conducted a time-and-motion study to investigate the workflow of clinical trial enrollment in a pediatric emergency department.

In Situ Simulation to Mitigate Threats to Participation in a Multicenter Clinical Trial in High-Acuity, Low-Frequency Setting.

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.

Will My Child Do Better if She Enrolls in a Clinical Trial?

The question of whether children with cancer who enroll in clinical trials have superior outcomes compared with those who do not participate has been pursued for more than 4 decades, and recent studies have provided conflicting answers. Whether clinical trial participation influences outcome has important implications for how clinicians should present trial participation to patients and families. Methodological challenges limit generalizations about the impact of clinical trial participation on outcome comp...

Study Protocol: Phase-Ib Trial of Nivolumab Combined With Metformin for Refractory/Recurrent Solid Tumors.

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...

A Demographic Analysis of Racial/Ethnic Minority Enrollment Into HVTN Preventive Early Phase HIV Vaccine Clinical Trials Conducted in the United States, 2002-2016.

Racial/ethnic minority communities in the United States are overrepresented among new HIV diagnoses, yet their inclusion in preventive HIV vaccine clinical trials is inadequate. An analysis of enrollment demographic characteristics from US preventive HIV vaccine clinical trials from 1988 through 2002 showed that enrollment of racial/ethnic minority groups increased. We analyzed enrollment in preventive HIV vaccine clinical trials from 2002 through 2016 and compared our data with data from the previous study...

Low Clinical Trial Accrual of Patients With Myelodysplastic Syndromes: Causes and Potential Solutions.

Despite few effective therapies, only a small percentage of patients diagnosed with myelodysplastic syndromes (MDS) in the United States are enrolled in prospective, interventional clinical trials. MDS-specific barriers to trial accrual include a high frequency of elderly patients with comorbid conditions, atypical disease features and uncertainty regarding the diagnosis (because other nonclonal processes also can cause dysplasia and cytopenias), a history of another nonmyeloid neoplasm resulting in therapy...

Interpreting clinical trial data in multiple myeloma: translating findings to the real-world setting.

Substantial improvements in survival have been seen in multiple myeloma (MM) over recent years, associated with the introduction and widespread use of multiple novel agents and regimens, as well as the emerging treatment paradigm of continuous or long-term therapy. However, these therapies and approaches may have limitations in the community setting, associated with toxicity burden, patient burden, and other factors including cost. Consequently, despite improvements in efficacy in the rigorously controlled ...

Clinical trials in developing countries - ethical considerations.

When designing clinical trial or considering decision to take part in particular clinical trial as investigators, even before submission to responsible Central Ethic Committee, we always make certain private assessment about ethical justification of this clinical trial. When making assessment if any clinical trial is ethically justifiable, there should make no difference in which country this clinical trial will be executed. Physicians coming from developing countries must ensure that patient population of ...

Understanding and Communicating Measures of Treatment Effect on Survival: Can We Do Better?

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...

Extensive Molecular and Clinical Heterogeneity in Patients With Histologically Diagnosed CNS-PNET Treated as a Single Entity: A Report From the Children's Oncology Group Randomized ACNS0332 Trial.

Children with histologically diagnosed high-risk medulloblastoma, supratentorial primitive neuroectodermal tumor of the CNS (CNS-PNET), and pineoblastoma (PBL) have had poor survival despite intensive treatment. We included these patients in this Children's Oncology Group trial. Molecular profiling later revealed tumor heterogeneity that was not detectable at protocol inception. Enrollment of patients with CNS-PNET/PBL was subsequently discontinued, and outcomes for this part of the study are reported here.

Reducing overestimation of the treatment effect by interim analysis when designing clinical trials.

Several researchers in the statistical and medical communities have noted the overestimation of the treatment effect when a trial is stopped early in the interim analysis for efficacy; however, methods to reduce this overestimation are rarely used because the overestimation mechanisms are not well understood by many in clinical trial practice. A trial design that leads to less overestimation is needed.

Antiretroviral concentrations in hair strongly predict virologic response in a large HIV treatment-naive clinical trial.

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 in the treatment of complex regional pain syndrome type 1: Is trial truly required?

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.

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

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...

Treatment for Alcohol Use Disorder: Progress in Predicting Treatment Outcome and Validating Non-Abstinent Endpoints.

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...

Influence of suturing technique on wound healing and patient morbidity after connective tissue harvesting. A randomized clinical trial.

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.

The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors.

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.

Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol.

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...

The Val158Met polymorphism of the catechol-O-methyltransference gene is not associated with long-term treatment outcomes in carpal tunnel syndrome: A randomized clinical trial.

Randomized clinical trial.

Myocarditis in a Patient on Clozapine: What did it?

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...

Barriers to participation in clinical trials: a physician survey.

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.

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