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At least 1,081 records · Page 60Linked to original sources
PubMed1989

4-Ipomeanol: a novel investigational new drug for lung cancer.

4-Ipomeanol (IPO) is the first agent to undergo preclinical development at the National Cancer Institute (NCI) based principally on a specific biochemical-biological rationale for clinical investigation as an antineoplastic agent targeted against lung cancer. This disease-specific development of IPO was initially stimulated by observations that the compound was activated by metabolism, preferentially within the mammalian lung, specifically within bronchiolar Clara cells, and that its predominant toxicity was to the lung in most species. IPO is inactive or only minimally active against most conventional antitumor test systems. However, some human lung cancer cell lines, as well as a variety of fresh human lung tumor biopsy specimens, have been shown to be capable of mediating the in situ biotransformation of IPO to a potentially cytotoxic intermediate. In this report, the biochemistry, metabolism, preclinical pharmacology, and toxicology of IPO are reviewed and the clinical development plans for this unique and challenging new agent are presented.

Animals↗
PubMed2004

Accelerated approval of oncology products: a decade of experience.

We review the regulatory history of the accelerated approval process and summarize the U.S. Food and Drug Administration experience with accelerated approvals in oncology. The accelerated approval regulations, promulgated in 1992, allow approval of drugs for serious or life-threatening diseases on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, such as survival or symptom benefit, pending completion of studies designed to confirm clinical benefit, referred to as phase 4 commitments, which are required to be conducted with due diligence. From 1992 to 2004, 22 applications involving anticancer drugs or biologics were approved. Of these 22 applications, accelerated approval was granted to 15 on the basis of findings from studies without an active comparator (i.e., single-arm studies or studies comparing two dose levels) and to the remaining seven on the basis of one or more randomized studies. Of the 22 approved applications, six (i.e., applications for dexrazoxane, irinotecan, capecitabine, docetaxel, imatinib mesylate, and oxaliplatin) have had one or more indications converted to regular approval. This review reports information that was presented at an Oncologic Drugs Advisory Committee meeting held in March 2003; it also presents a discussion of accelerated approval study designs, the study populations evaluated in the accelerated approval and confirmatory settings, and the integration of accelerated approval into a comprehensive drug development plan.

Antineoplastic Agents↗
PubMed2002

The public costs of mental health response: lessons from the New York City post-9/11 needs assessment.

There is evidence of increased rates of psychiatric disorder in New York City in the period following September 11th. Public mental health services need to develop plans to respond to these higher rates of disorder. This article describes what we know and do not know with respect to the costs of such response. We examine evidence on the demand for mental health services, the nature of services to be provided, the characteristics of providers, and the likely sources of payment for care in the context of the attacks of September 11th in New York City.

Disasters↗
PubMed2006

ParameciumDB: a community resource that integrates the Paramecium tetraurelia genome sequence with genetic data.

ParameciumDB (http://paramecium.cgm.cnrs-gif.fr) is a new model organism database associated with the genome sequencing project of the unicellular eukaryote Paramecium tetraurelia. Built with the core components of the Generic Model Organism Database (GMOD) project, ParameciumDB currently contains the genome sequence and annotations, linked to available genetic data including the Gif Paramecium stock collection. It is thus possible to navigate between sequences and stocks via the genes and alleles. Phenotypes, of mutant strains and of knockdowns obtained by RNA interference, are captured using controlled vocabularies according to the Entity-Attribute-Value model. ParameciumDB currently supports browsing of phenotypes, alleles and stocks as well as querying of sequence features (genes, UniProt matches, InterPro domains, Gene Ontology terms) and of genetic data (phenotypes, stocks, RNA interference experiments). Forms allow submission of RNA interference data and some bioinformatics services are available. Future ParameciumDB development plans include coordination of human curation of the near 40 000 gene models by members of the research community.

Alleles↗
PubMed1993

Palliative care of patients with terminal cancer.

Palliative (terminal) care is now recognized worldwide as an important, multidisciplinary aspect of the continuing care of patients with incurable cancer. Symptom control and quality-of-life are of the essence. Various treatment methods are available, and radiotherapy and chemotherapy (used appropriately) are important modalities. Palliative care has to be set against a background of planning, development, and cost-benefit analyses.

Humans↗
PubMed1979

Developing the medical curriculum at King Abdulaziz University.

The kingdom of Saudi Arabia has placed a high priority on medical education. King Abdulaziz University is developing a medical curriculum aimed at being responsive to the health needs of the people of the kingdom. In creating the curriculum, planners devoted considerable time and effort to studying health manpower resources and needs, regional developments, demographic patterns, socioeconomic and cultural factors, general education development plans, vital statistics, and existing and projected health facilities. These and many other factors played a role in determining the format and the content of the curriculum, which is intended to produce individuals for leadership roles as medical educators, medical practitioners, and researchers.

Adolescent↗
PubMed2000

Putting it all together: building a four-year curriculum.

A four-year curriculum in preventive medicine would require planning, but all the components are already available. This article outlines a four-part plan: develop the desired objectives or competencies; present the basics in years one and two of the curriculum; in years three and four make health promotion/disease prevention (HPDP) and the population perspective relevant to the practice of medicine; and, finally, develop a mechanism to track the curriculum and then improve it. Core competencies have already been developed, through joint activities of the Association of Teachers of Preventive Medicine (ATPM) and the Bureau of the Health Professions of the Health Resources and Services Administration (HRSA), and articles about teaching preventive medicine in multiple disciplines throughout the curriculum are published elsewhere in this supplement. Schools across the United States and Canada have innovative programs in place that can serve as models, and there are feasible approaches to monitoring the programs.

Canada↗
PubMed2001

Pain management strategies used by patients with breast and gynecologic cancer with postoperative pain.

Many people with cancer will experience pain when they are outside of structured care settings. Patients must provide their own self-care, drawing on instructions from healthcare providers and on independently developed plans for pain management. With growing interest in complementary therapies, the scope of nonpharmacologic interventions used by patients with cancer to manage pain may be very different than 10-15 years ago. The purpose of this study was to describe steps taken by patients with breast and gynecologic cancer to manage pain after discharge from a surgical hospitalization. A secondary analysis was completed using data from 34 women who participated in a randomized trial of guided imagery. Techniques used included positioning, distraction, relaxation, heat, and eating/drinking. Compared to results of previous studies, increased use of relaxation strategies (breathing, imagery, music, meditation) was noted in the current study. The majority of participants used nonpharmacologic strategies in addition to analgesic medications. Pain-related outcomes were similar among persons who used analgesic medications alone and those who used a combination of analgesics and nonpharmacologic strategies. Nurses may benefit from knowing which pain management strategies patients find helpful so that they can encourage their use and teach similar strategies to the patients who find them useful.

Adult↗
PubMed2004

Implementing a pediatric asthma program: enabling self-care management through education.

This article provides an overview of asthma prevalence among children, presents a summary of asthma triggers based on past research, outlines the essential components of a pediatric asthma home care model implemented by a large urban home health agency, and details the types of clinical documentation needed for care plan development and monitoring of asthma in the home.

Administration, Inhalation↗
PubMed2005

Two approaches to maternal depression screening during well child visits.

The US Preventive Services Task Force (USPSTF) has recommended depression screening for adults. Screening mothers has special importance to pediatricians because of the impact of maternal depression on children. The two screening questions endorsed by the USPSTF may allow pediatricians to screen mothers during routine well child care. This study explores the feasibility and yield of interview- and paper-based pediatric screening for maternal depression during well child visits. A structured interview script was developed to inquire about maternal depression. It included the two-question screen and required less than 1 minute to administer. An alternative paper-based screen asked the two questions after a brief written introduction providing the rationale. Four community pediatric practices in New Hampshire and Maine were trained in both screening approaches and developed plans on how to respond to positive screens (either question positive). The 11 providers at these sites tested the two approaches on two different series of mothers at well child visits. The pediatricians also reported barriers to the screening inquiries, maternal responses, and subsequent clinician actions and referrals. The pediatricians screened 250 mothers via the scripted interview. In a second trial, 223 women had paper-based depression screening. Yields from the paper-based screen were 22.9% versus 5.7% for the interview-based screener. Pediatricians also took on the new role of discussion of possible depression in about two thirds of cases. Subsequently, 7.6% of all women with paper-based screening were referred to mental health versus 1.6% with the interview-based screening. With the interview, mothers of children younger than 1 year of age were less likely to screen positive than those with older children (1.9% vs. 8.5%, p = .04). With the paper-based screener, no age differences in positive screen rates occurred. While both approaches to screening were feasible in primary care, the yield from the two different approaches differed substantially. This finding deserves exploration in future studies. With either of these screening approaches, pediatricians could enhance their detection of mothers at risk of depression. The outcomes of pediatrician screening and the best approach to follow-up care still need to be determined.

Adolescent↗
PubMed2005

Combination nonviral interleukin-2 gene immunotherapy for head and neck cancer: from bench top to bedside.

OBJECTIVE/HYPOTHESIS: Intralesional delivery of cytokine genes has emerged as a promising therapeutic strategy for the treatment of cancer. In addition to the therapeutic effect of the delivered cytokine gene, the components of the gene delivery system also have been shown to induce beneficial immune responses. On the basis of these principles, we hypothesized that a molecular therapy could be developed that would provide synergistic antitumor activity by way of intralesional expression of interleukin (IL)-2 from a recombinant plasmid combined with induction of endogenous interferon (IFN)-gamma and IL-12 cytokines by immunostimulatory DNA. Our objective in these studies was to create and optimize a novel formulation of cationic lipid and DNA that generates local production of IL-2 protein within a targeted tumor environment with concomitant induction of the antitumor cytokines IFN-gamma and IL-12. STUDY DESIGN: Prospective laboratory drug development plan that would produce human clinical trials. MATERIALS AND METHODS: Engineered bacterial plasmids containing a cytomegalovirus promoter (CMV)-IL-2 expression cassette were specifically formulated with cationic lipids and optimized for antitumor effect in a floor of mouth murine tumor model. The treated tumors were assayed for local expression of IL-2 and concurrent expression of secondary cytokines IFN-gamma and IL-12. Established tumors in C3H/HeJ mice were treated with various IL-2 gene formulations, and clinical and immunologic responses were evaluated. Immunologic studies were performed and included cytolytic T-cell assays and cytokine expression profiles. For human clinical trials, a phase I 10 patient formulated IL-2 gene therapy study was completed. Subsequently, two large scale, phase II multi-institutional and multi-international studies were initiated comparing non-viral IL-2 gene therapy to palliative methotrexate chemotherapy or in combination with cisplatin. RESULTS: In the preclinical stage, maximum tumor inhibition in animal models was obtained using IL-2 plasmid formulated with 1,2-dioleyloxypropyl-3-trimethyl ammonium chloride (DOTMA):cholesterol (1:1 mol:mol) at a plasmid:lipid charge ratio of 1:0.5 (-/+). Cationic lipid formulated IL-2 plasmid significantly inhibited tumor growth compared with formulated control plasmid (P < .01) or vehicle (lactose; P < .01). Consistent with previously reported studies of the immunostimulatory activity of DNA of bacterial origin, treatment of tumors with control plasmid in cationic lipid formulation induced production of endogenous IFN-gamma and IL-12 but not IL-2. Treatment of tumors with formulated IL-2 plasmid produced IL-2 protein levels that were 5-fold over background and increased IFN-gamma by 32-fold (P < .001) and IL-12 by 5.5-fold (P < .001) compared with control plasmid formulations. The phase I human trial demonstrated dose escalation safety, which was its primary objective, and there was one anecdotal reduction in tumor size. The phase II studies have been initiated and focus on either comparing the novel nonviral IL-2 gene immunotherapy formulation alone to methotrexate or comparing IL-2 gene therapy in combination with cisplatin in recurrent or unresectable patients with head and neck squamous cell carcinoma. CONCLUSIONS: The preclinical data provided proof of principle for matching a delivered IL-2 transgene with an immunostimulatory nonviral formulation to enhance intralesional production of therapeutic cytokines for the maximization of antitumor response. Human clinical trials have demonstrated this novel therapy to be safe in the human clinical setting. Phase II trials have been initiated to assess efficacy and feasibility as a single or combination therapy for head and neck cancer.

Animals↗
PubMed1997

American College of Sports Medicine position stand. The Female Athlete Triad.

The Female Athlete Triad is a syndrome occurring in physically active girls and women. Its interrelated components are disordered eating, amenorrhea, and osteoporosis. Pressure placed on young women to achieve or maintain unrealistically low body weight underlies development of the Triad. Adolescents and women training in sports in which low body weight is emphasized for athletic activity or appearance are at greatest risk. Girls and women with one component of the Triad should be screened for the others. Alone or in combination, Female Athlete Triad disorders can decrease physical performance and cause morbidity and mortality. More research is needed on its causes, prevalence, treatment, and consequences. All individuals working with physically active girls and women should be educated about the Female Athlete Triad and develop plans to prevent, recognize, treat, and reduce its risks.

Adolescent↗
PubMed1997

Strategies for the nurse executive to keep the rural hospitals open.

Rural hospitals are confronted with multiple challenges to survive in the competitive health care environment of today's world. Declining population, corporate mergers and downsizing, transportation, cost of technology, and health manpower shortages are only a few of the issues rural hospitals must be prepared to address in order to survive. Federal- and state-administered programs are available that can contribute to the survival of the rural hospital. The nurse executive has a key role in contributing to the planning, development, and implementation of survival strategies.

Health Facility Closure↗
PubMed2002

Skeletal muscle damage and recovery.

Muscular strength is essential for recovery after an acute illness. Disuse atrophy of muscle begins within 4 hours of the start of bed rest resulting in decreases in muscle mass, muscle cell diameter, and the number of muscle fibers. Strenuous exercise of atrophic muscle can lead to muscle damage including sarcolemmal disruption, distortion of the myofibrils' contractile components, and cytoskeletal damage. Assessment of skeletal muscle for disuse atrophy is done clinically at the bedside through strength assessment. Examination of the muscle itself can be conducted through the use of nuclear magnetic resonance imaging, whereas muscle strength can be quantified with a computerized dynamometer. Biochemical markers, including creatine kinase and troponin, also are available for the assessment of skeletal muscle damage. Activity management in the critical care environment focuses on an individualized plan, developed in cooperation with the recovering patient, with the goal of preserving and improving atrophic skeletal muscle.

Disease Management↗
PubMedDate not supplied

Implementing performance management in the Irish Health Sector.

To realize the goals of successive health strategies, managers in the Irish Health Sector will have to proactively facilitate optimal employee performance in line with policy objectives. Along with developing employee and teams' capabilities, these managers have begun to implement performance management to achieve the latter. However, there typically are a variety of foundational organizational characteristics required for the successful implementation of performance management. These include providing top-down support for line management buy-in, providing ongoing managerial and performance management training so that trusting relationships and a culture of consensus and cooperation are developed, and appropriately managing expectations. Agreement on employee role definitions and provision of team-based conflict resolution training is also needed to facilitate performance management. There is a need for negotiated performance indicators that are of various types, specific, measurable, and aligned with strategy objectives. Associated reward systems need to be holistic and imaginative, and personal development plans need to have a broader focus than merely improving current job skills and performance. Performance review needs to be ongoing, conducted in a transparent manner, and allocated sufficient discussion time. Managers also need to be mindful of managing overperformance.

Cooperative Behavior↗
PubMed2003

Hypertension and renal dysfunction: NHANES III.

The incidence rate of end-stage renal disease has increased in many countries in the past 20 yr, including the United States and Singapore. The increase in ESRD incidence in the United States is primarily attributable to diabetes and to hypertension. In Singapore the major cause of ESRD is diabetes, however the prevalence of hypertension in the Singapore population is rising rapidly, and renal complications of hypertension may become more common in the future. Information on the association of hypertension with renal dysfunction and ESRD in the United States may be useful in predicting future trends in the incidence of ESRD due to hypertension in Singapore. This paper describes published and unpublished data presented at a conference to assist in developing plans for a comprehensive renal disease prevention program in Singapore. It compares recent data on the reported prevalence of hypertension in the United States and Singapore; and presents information on the association of hypertension with serum creatinine, urinary albumin excretion, and ESRD in the United States.

Adolescent↗
PubMed2005

Neuropsychological test performance in healthy elderly volunteers before and after donepezil administration: a randomized, controlled study.

Neuropsychological performance was examined in healthy elderly participants administered the cholinesterase inhibitor donepezil. Of principal interest was examination of the sensitivity of a series of neuropsychological measures to detect cognitive changes after drug administration using typical phase I research parameters (eg, a small sample over a short treatment period). In this double-blind parallel study over a period of 6 weeks, 26 healthy elderly participants (aged 55 to 75 years) were randomized into 1 of 2 arms (14 donepezil and 12 placebo) and completed 14 days of donepezil (5 mg, twice a day) or placebo (twice a day). A battery of neuropsychological tests was administered on days 0, 14 (prerandomization), 28 (end of treatment), and 42 (washout). After 2 weeks of donepezil treatment (day 28), subjects in the donepezil group performed slightly but significantly worse on 2 tests of speed, attention, and short-term memory (P < 0.05) compared with the placebo group. No significant improvement in performance was present on any test during treatment with donepezil. These results are consistent with a previous study in healthy young participants in which transient mild worsening on some cognitive tests during donepezil administration was observed, possibly caused by perturbation of an already optimized cholinergic system in healthy participants. These results are important to consider when designing clinical development plans for putative cognitive-enhancing drugs; in addition, these results raise questions about when the optimal point to begin treatment is for patients who have not yet met criteria for dementia.

Aged↗
PubMedDate not supplied

The pedipump: development status of a new pediatric ventricular assist device.

The PediPump is a new rotary dynamic ventricular assist device designed specifically for pediatric applications. Although it is capable of providing support for adults, the small size of the PediPump makes it suitable for newborn circulatory support while retaining excellent hemodynamics. Current and future development plans include: (1) determination of the basic engineering requirements for hardware and control logic, including design analysis for system sizing, evaluation of control concepts and bench testing of prototypes; (2) performance of preclinical anatomical fitting studies using computed tomography-based three-dimensional modeling; and, (3) evaluation with animal studies to provide characterization and reliability testing of the device.

Child↗