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Only an estimated 5 percent of rare pediatric diseases have a treatment, although collectively they affect more than ten million children in the US. To stimulate drug development for rare pediatric diseases, Congress expanded the priority review voucher (PRV) program in 2012. A pediatric PRV, which can be sold to another manufacturer, requires the FDA to provide priority six-month review rather than the standard ten-month review to another drug of the company's choosing. We compared rare pediatric disease ...
Whilst the diagnosis of Parkinson's disease (PD) relies on the motor triad of bradykinesia, rigidity and tremor, the underlying pathological process starts many years before these signs are overt. In this prodromal phase of PD, a diverse range of non-motor and motor features can occur. Individually they do not allow a diagnosis of PD, but when considered together, they reflect the gradual development of the clinical syndrome. Different subgroups within the prodromal phase may exist and reflect different und...
The purpose of this article is to describe the findings of a 5-year program evaluation of a hospital-based Evidence-Based Practice (EBP) Scholars Program. The EBP Scholars Program was developed in 2011 to (a) educate and engage staff in the EBP process and (b) develop a cadre of EBP mentors within each clinical unit of the organization. The evaluation of the EBP Scholars Program examined both the feasibility and the impact of the program. The findings suggest that not only is the program feasible to impleme...
At its core, evaluation involves the generation of value judgments. These evaluative judgments are based on comparing an evaluand's performance to what the evaluand is supposed to do (criteria) and how well it is supposed to do it (standards). The aim of this four-phase study was to test whether criteria and standards can be set via crowdsourcing, a potentially cost- and time-effective approach to collecting public opinion data. In the first three phases, participants were presented with a program descripti...
Interprofessional education (IPE) is a critical component of medical education and is affected by the characteristics of the clinical teams in which students and residents train. However, clinical teams are often shaped by professional silos and hierarchies which may hinder interprofessional collaborative practice (IPCP). Narrative medicine, a branch of health humanities that focuses on close reading, reflective writing, and sharing in groups, could be an innovative approach for improving IPE and IPCP. In...
The main goal of this study was to evaluate the effectiveness of a cognitive motivational treatment program.
This retrospective study evaluated the impact of a psychosocial program on individuals with severe and chronic psychiatric disorders. This study also examined potential modifiable predictors of hospitalization.
Effects are reported of the Family Bereavement Program (FBP) on the mental health of bereaved youth and their surviving parent 15 years following the program.
The platinum-based, two-drug, 3-week regimen is currently the main first-line chemotherapy program for the treatment of advanced squamous cell lung cancer. The aim of this phase II clinical study was to evaluate the efficacy and adverse events of the bi-weekly program of liposomal paclitaxel combined with nedaplatin as a first-line treatment for advanced squamous cell lung cancer. A total of 52 cases of advanced squamous cell lung cancer were included in this phase II clinical trial. Patients received intra...
The Diabetes Prevention Program (DPP) is an evidence-based lifestyle change program for prediabetes that is associated with a 58% reduction in 3-year diabetes incidence, and it has been supported by the American Medical Association and the Centers for Disease Control and Prevention. However, 9 in 10 patients are unaware they have the condition.
To create a standardized home exercise therapy program that could be implemented by international sites to provide a consistent level of therapeutic intervention for pediatric patients participating in an ongoing Phase-III, randomized, controlled trial of repeat abobotulinumtoxinA injections for pediatric upper limb spasticity (NCT02106351).
Early phase clinical trials evaluate the safety and efficacy of new treatments. The exclusion/inclusion criteria in these trials are usually rigorous and may exclude many patients seen in clinical practice. Our objective was to study the comorbidities limiting the participation of patients with breast, colorectal, or lung cancer in clinical trials.
The incidence and clinical significance of electrolyte abnormalities (EAs) in phase I clinical trials are unknown. The objective of this study is to evaluate the incidence and severity of EAs, graded according to CTCAE, v4.03, to identify variables associated with EAs and their prognostic significance in a phase I population.
Guidelines increasingly highlight the importance of multifactorial management in type 2 diabetes, in contrast to the more traditional focus on glycemic control. Semaglutide, a recently approved glucagon-like peptide-1 receptor agonist, is indicated in Canada for adults with type 2 diabetes to improve glycemic control as monotherapy with diet and exercise when metformin is inappropriate or as an add-on to either metformin alone or metformin plus a sulfonylurea or basal insulin. The Semaglutide Unabated Susta...
Falls and fractures are extremely frequent in long-term care facilities (LTCFs). Therefore, a fall and fracture prevention program was started in nearly 1000 LTCFs in Bavaria/Germany between 2007 and 2010. The components of the program were exercise classes, the documentation of falls, environmental adaptations, medication reviews, the recommendation to use hip protectors and education of staff. The present study aimed to provide a comprehensive evaluation of the implementation process of the program regard...
Targeted synthesis of piezoresponsive small molecules and in-depth understanding of their mechanism is of utmost importance for the development of smart devices. Here, we report the synthesis, structure and piezosensitivity of a bola-amphiphile 1,4-bis(pentyloxy)-2,5-bis(2-pyridineethynyl)-benzene (C5-PPB). Depending on the rate of compression, two different phases in C5-PPB can be generated. The ambient-pressure α-phase is stable up to 0.8 GPa, beyond which it undergoes an isostructural transformation to ...
The program Buccaneer, a well known fast and efficient automatic model-building program, is also a tool for phase refinement: indeed, input phases are used to calculate electron-density maps that are interpreted in terms of a molecular model, from which new phase estimates may be obtained. This specific property is shared by all other automatic model-building programs and allows their cyclic use, as is usually performed in other phase-refinement methods (for example electron-density modification techniques)...
Chronic kidney disease (CKD) is a significant health problem in Japan, and prevention programs to slow disease progression are necessary. In this study, we evaluated the effectiveness of a 1-week inpatient education program, delivered during the predialysis stage of CKD, in slowing the deterioration in renal function over the subsequent 2 years, and identified factors influencing the program's effectiveness.
To develop a training program designed to meet the specific needs of medical physicists as they transition into a clinical role with direct patient care responsibilities.
Rehabilitative stroke interventions based on principles of multimodal stimulation have the potential to profoundly affect neuroplastic processes beyond the sub-acute phase. In order to identify important core mechanisms, there is a need to explore how interventions that combine physical, social, sensory, and cognitively challenging activities are perceived and experienced by the participants. This qualitative study, based on an interpretive interactionist perspective, explored the experiences of stroke surv...
Young adults suffering from chronic diseases represent a critical subgroup of patients that after reaching legal age have to be transferred to the colleagues from adult medicine. Thus in this patient group two evident problems come together: first, the adolescence phase that presents a challenge for any young adult and second, the transition to the novel structure and environment of adult medicine. It has been recognized for Germany that there are significant deficits for this transition phase. These defi...
This program investigated topical regorafenib, a multikinase inhibitor, in patients with neovascular age-related macular degeneration (nAMD).
The study aimed to design and evaluate a program for the prevention of childhood depression ("Pozik-Bizi" [in English, "Live-Happily"]), comparing its effects with a socio-emotional intervention program based on cooperative play. The sample comprised 420 students aged 7 to 10 years from the Basque Country, 51.9% were randomly assigned to the experimental condition ("Pozik-Bizi") program and 48.1% to the control group ("Play program"). Using a pretest-posttest repeated measures experimental design, 7 evalu...
Osimertinib, a third-generation irreversible mutant-selective inhibitor of EGFR kinase activity was clinically evaluated in the AURA trials, where it showed high clinical efficacy and a favorable toxicity profile in patients with acquired exon 20-EGFR pT790M mutation. We provide the clinical data of the German expanded access program that further characterizes the efficacy and safety of osimertinib in a heterogeneous patient population outside clinical trials.
A strategy of immobilizing lead in the framework of ferrite-ceramic matrix, to reduce its environmental hazard was explored in this study. The mechanisms of incorporating lead into lead ferrites (δ-phase (2PbO·FeO), γ-phase (PbO·(2-2.5)FeO) and β-phase (PbO·(5-6)FeO)) was revealed by observing the phase transformation in the products. The δ-phase was dominantly formed at low temperature of 700-800 °C at Pb/Fe of 1/1-1/3. The significant growth of γ-phase was observed at 750-850 °C and Pb/Fe of...