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

02:24 EDT 22nd March 2018 | BioPortfolio

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Showing "Capnia Announces Enrollment First Patient Clinical Trial Treatment" PubMed Articles 1–25 of 56,000+

Non-small cell lung cancer clinical trials requiring biopsies with biomarker-specific results for enrollment provide unique challenges.

Clinical trials in lung cancer increasingly require patients to provide fresh tumor tissue as a prerequisite to enrollment. The effects of this requirement on enrollment rates, enrollment durations, and patient selection have not been fully elucidated.

Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015.

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibili...

A call for action: Increasing enrollment of untreated patients with higher-risk myelodysplastic syndromes in first-line clinical trials.

Hypomethylating agents (HMAs) have changed the landscape of the management of patients with higher-risk myelodysplastic syndromes (HR-MDS). HMAs have improved hematopoiesis and quality of life and, in the case of azacitidine, prolonged survival in a large randomized trial. However, multiple real-life and registry analyses have demonstrated minimal survival gains at the population level after the approval of HMAs. Furthermore, the 24-month median survival observed with azacitidine in the landmark AZA-001 tri...

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recr...

A prospective, observational cohort study comparing cancer clinical trial availability and enrollment between early adolescents/young adults and children.

Poor enrollment of adolescents and young adults (AYAs) (ages 15-39 years) onto cancer clinical trials (CCTs) may contribute to inferior survival gains compared with children. In this study, the authors assessed whether differences in CCT availability would explain lower CCT enrollment for early AYAs (eAYAs) (ages 15-21 years).

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.

Adding experimental arms to platform clinical trials: randomization procedures and interim analyses.

Multi-arm clinical trials use a single control arm to evaluate multiple experimental treatments. In most cases this feature makes multi-arm studies considerably more efficient than two-arm studies. A bottleneck for implementation of a multi-arm trial is the requirement that all experimental treatments have to be available at the enrollment of the first patient. New drugs are rarely at the same stage of development. These limitations motivate our study of statistical methods for adding new experimental arms ...

18F-FAZA PET/CT Hypoxia Imaging of High-Grade Glioma Before and After Radiotherapy.

A 57 year-old man underwent MRI with dynamic susceptibility contrast and dynamic contrast-enhanced perfusion for neurological symptoms suggesting the diagnosis of high-grade glioma. A F-FAZA PET/CT was performed because of the enrollment in a prospective clinical trial. Subsequent radiotherapy treatment has been planned based on conventional imaging; moreover, a F-FAZA PET/CT-guided treatment planning highlighting hypoxic regions has been simulated. After radiotherapy treatment, the man underwent MRI and F-...

Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews.

To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment.

Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis.

Given the recognition that disease-modifying therapies should focus on earlier Parkinson's disease stages, trial enrollment based purely on clinical criteria poses significant challenges. The goal herein was to determine the utility of dopamine transporter neuroimaging as an enrichment biomarker in early motor Parkinson's disease clinical trials. Patient-level longitudinal data of 672 subjects with early-stage Parkinson's disease in the Parkinson's Progression Markers Initiative (PPMI) observational study a...

Under-reporting of Research Biopsies from Clinical Trials in Oncology.

Research biopsies are frequently incorporated within clinical trials in oncology, and are often a mandatory requirement for trial enrollment. However, limited information is available regarding the extent and completeness of research biopsy reporting.Experimental Design: We identified a cohort of therapeutic clinical trials where non-diagnostic research biopsies were performed between January, 2005-October, 2010 from an IR database at our institution. Clinical trial protocols were compared with the highest ...

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, subunits, 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, subunits, and branch locatio...

Interim monitoring for non-inferiority trials: minimizing patient exposure to inferior therapies.

The goal of a non-inferiority randomized trial is to demonstrate that an experimental treatment is not unacceptably worse than a standard treatment. The experimental treatment is known to have less toxicity or other quality-of-life benefits as compared to the standard treatment, so that a small decrement in efficacy would be acceptable. Interim monitoring of randomized trials is used to stop trials early if the conclusions of the trial become definitive early. In the context of a non-inferiority trial, of s...

Cellular versus acellular grafts for diabetic foot ulcers: altering the protocol to improve recruitment to a comparative efficacy trial.

Diabetic foot ulcers (DFUs) have a substantial impact on public health. The standard of care (SOC) for DFUs consists of a multidisciplinary approach involving glycemic control, wound care with debridement of necrotic tissue, application of a moist dressing, infection control, use of off-loading devices, and patient education. New therapeutic devices aim to target the extracellular matrix (ECM) that is impaired in DFU; however, there is insufficient data on the effectiveness of such therapies along with lack...

Adaptive and Platform Trials in Remote Damage Control Resuscitation.

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...

Effectiveness of Optional Videoconferencing-Based Treatment of Alcohol Use Disorders: Randomized Controlled Trial.

Treatment of alcohol use disorders (AUDs) is characterized by an adherence rate below 50%. Clinical research has found that patient adherence enhances treatment effect; hence, health authorities, clinicians, and researchers strive to explore initiatives contributing to patients receiving treatment. Concurrently, videoconferencing-based treatment is gaining ground within other addiction and psychiatric areas.

Primary management of atypical meningioma: treatment patterns and survival outcomes by patient age.

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.

Surgical treatment of peri-implantitis. 3-year results from a randomized controlled clinical trial.

This study reports on the 3-year follow-up of patients enrolled in a randomized controlled clinical trial on surgical treatment of advanced peri-implantitis.

The patient experience of Raynaud's phenomenon in systemic sclerosis.

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...

Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes.

The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was...

A trial case of medical treatment for primary headache using telemedicine.

Video-based treatment in telemedicine is a potential alternative to face-to-face treatment. We describe our trial use of telemedicine to treat a patient with primary headache.

Clinical Trial Amendments: Development of a Process for Consistent Implementation

Clinical trials are responsible for the advancements made in cancer care. An interdepartmental work group at a major academic cancer hospital developed a process for the consistent communication and implementation of clinical trial amendments. This process ensures improved patient safety, as well as high-quality research. 

Bayesian sample size determination for a Phase III clinical trial with diluted treatment effect.

When Phase III treatment effect is diluted from what was observed from Phase II results, we propose to determine the Bayesian sample size for a Phase III clinical trial based on the normal, uniform, and truncated normal prior distributions of the treatment effects on an interval, which starts from an acceptable treatment effect to the observed treatment effect from Phase II. After incorporating the prior information of the treatment effects, the Bayesian sample size is the number of patients of the Phase II...

Incorporating Patient Preferences into Estimation of Optimal Individualized Treatment Rules.

Precision medicine seeks to provide treatment only if, when, to whom, and at the dose it is needed. Thus, precision medicine is a vehicle by which healthcare can be made both more effective and efficient. Individualized treatment rules operationalize precision medicine as a map from current patient information to a recommended treatment. An optimal individualized treatment rule is defined as maximizing the mean of a pre-specified scalar outcome. However, in settings with multiple outcomes, choosing a scalar...

Efficacy, Safety and Cost-Effectiveness of Thermotherapy in the Treatment of Leishmania donovani-Induced Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial.

Leishmania donovani causes cutaneous leishmaniasis (CL) in Sri Lanka. Standard treatment is multiple, painful doses of intralesional sodium stibogluconate (IL-SSG). Treatment failures are increasingly reported, hence the need to investigate alternatives. Efficacy, safety, and cost-effectiveness of thermotherapy were assessed for the first time for L. donovani CL. A single blinded noninferiority randomized controlled trial was conducted on new laboratory-confirmed CL patients with single lesions (N = 213). S...

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