Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Human Life Amendment”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 343 records · Page 19Linked to original sources
PubMed2004

Quality of life assessment of second-line docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: results of a prospective, randomized phase III trial.

PURPOSE AND METHODS: Docetaxel second-line chemotherapy for non-small-cell lung cancer (NSCLC) has previously been shown to improve survival significantly compared with best supportive care (BSC). This multicenter phase III trial prospectively investigated quality of life (QOL) in NSCLC patients treated with either second-line docetaxel or BSC. Patients with stage IIIB/IV NSCLC, performance status < or =2, and adequate biochemistry and hematology were eligible if they had received > or =1 platinum-based chemotherapy regimens. Patients were randomized to docetaxel 100 mg/m2 (n=49) or, after protocol amendment, to docetaxel 75 mg/m2 (n=55), or to BSC (n=100), with Lung Cancer Symptom Scale (LCSS) and/or QLQ-C30 (with LC13 module) assessment every 3 weeks. RESULTS: Longitudinal analysis including all available assessments over time showed statistically significant differences in patient-rated pain scores in favor of docetaxel overall (P=0.005) or docetaxel 100 mg/m2 (P=0.003) compared to BSC. Trends in favor of docetaxel were noted on observer-rated scales for fatigue and pain for all docetaxel patients, and for total LCSS score, appetite and fatigue with docetaxel 100 mg/m2. Changes from baseline to the last available assessment (end point) showed significantly (P<0.05) less deterioration in LCSS pain score in patients with docetaxel (75 and 100 mg/m2 combined) than with BSC. An improved mean pain score with docetaxel 100 mg/m2 was contrasted with a deterioration in mean pain score with BSC (P<0.01). There was also significantly less deterioration in the global QOL today score with docetaxel 100 mg/m2 (P<0.01). Similar trends were recorded with QLQ-C30 assessments. CONCLUSIONS: Second-line docetaxel therapy for advanced NSCLC significantly improves survival with a trend towards less deterioration in QOL compared with BSC.

Adult↗
PubMed1990

Federal nutrition services for American Indian and Alaska native elders.

American Indian and Alaska native elders have a poverty rate of 61% and a life expectancy between 3 and 4 years less than that of the general older U.S. population. In 1978, Congress enacted a separate title under the Older Americans Act to address some of the special needs of American Indian elders. Since enactment of specific provisions for American Indians, Congress has continued to amend the Older Americans Act to ensure that the nutritional needs of American Indian elders are addressed. Currently, federal nutrition services are provided to American Indian and Alaska native elders through both Title III, Grants for State and Community Programs on Aging, Part C, Nutrition Services, and Title VI, Grants for Native Americans, of the Older Americans Act. In fiscal year 1987, more than 52,000 American Indian and Alaska elders received meals from congregate nutrition sites and/or home-delivered meals.

Aged↗
PubMed2004

Marijuana odor perception: studies modeled from probable cause cases.

The 4th Amendment of the United States Constitution protects American citizens against unreasonable search and seizure without probable cause. Although law enforcement officials routinely rely solely on the sense of smell to justify probable cause when entering vehicles and dwellings to search for illicit drugs, the accuracy of their perception in this regard has rarely been questioned and, to our knowledge, never tested. In this paper, we present data from two empirical studies based upon actual legal cases in which the odor of marijuana was used as probable cause for search. In the first, we simulated a situation in which, during a routine traffic stop, the odor of packaged marijuana located in the trunk of an automobile was said to be detected through the driver's window. In the second, we investigated a report that marijuana odor was discernable from a considerable distance from the chimney effluence of diesel exhaust emanating from an illicit California grow room. Our findings suggest that the odor of marijuana was not reliably discernable by persons with an excellent sense of smell in either case. These studies are the first to examine the ability of humans to detect marijuana in simulated real-life situations encountered by law enforcement officials, and are particularly relevant to the issue of probable cause.

Adult↗
PubMed2006

Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen.

BACKGROUND: The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG). PATIENTS AND METHODS: This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment). RESULTS: The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2-4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P<0.03). CONCLUSIONS: The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.

Adolescent↗
PubMed2004

Further commentary on Denmark's 1952-53 poliomyelitis epidemic, especially regarding mortality; with a correction.

Berthelsen and Cronqvist recently published an article in Acta Anaesthesiologica Scandinavica including aspects which could lead on to further discussion about the Danish 1952-53 poliomyelitis epidemic. This paper considers how Bjørn Ibsen's initial approach to treatment during the epidemic was successful, as well as how it could have failed; the roles played by ventilatory failure vs. gross neurologic destruction in causing deaths; and compilations from publications of statistics concerning mortality of the epidemic. The Blegdam Hospital concept of 'life-threatening poliomyelitis' is revisited, along with its division into six anatomico-clinical categories for the 345 patients so classified. Attention is drawn to the severity of assorted cerebral lesions demonstrated in 114 of the 115 autopsies conducted from the 144 fatal cases. Despite an overall mortality rate of 41.6% among the entire epidemic's sickest patients, a lowest mortality rate of 11% in the last 18 of such patients is identified. Note is made of the difficulty in reconciling various sources for certain features -- for which the 1956 book on the epidemic, edited by H.C.A. Lassen, has been freely used. Some folklore about aspects of management is mentioned. In the light of other recent research by Dr Berthelsen an essential correction is needed in dating 'Bjørn Ibsen's Day', amending 26 August 1952 to the 27th.

Anesthesiology↗
PubMed1986

Severely handicapped infants with life-threatening conditions: federal intrusions into the decision not to treat.

In recent years the federal government has attempted to intervene in certain family-medical decisions to withhold treatment from seriously handicapped newborns with life-threatening conditions. Invoking section 504 of the Rehabilitation Act of 1973, which prohibits discrimination against "otherwise qualified handicapped" individuals, the Reagan Administration promulgated regulations allowing federal government investigations of such decisions. Recently, the U.S. Supreme Court upheld lower court decisions invalidating these "Baby Doe" regulations. The federal government's fall-back position is reflected in the Child Abuse Prevention and Treatment Amendments of 1984, requiring states accepting funds under the Child Abuse Prevention and Treatment Act to establish and maintain procedures to assure that cases of medical neglect of handicapped infants are investigated by the states. Although the primary oversight of parental decision-making has been returned to the states where it has traditionally belonged, the federal government's definition of medical neglect of handicapped infants with life-threatening conditions is an ethically inadequate response to the complex needs of the handicapped child, the family, the medical profession, and society as a whole. After examining the relevance of Kantian, utilitarian, and Rawlsian ethical positions, the author contends that an effective governmental policy, capable of enforcement and acceptance by the public, must utilize the strengths of each philosophy and reflect the pragmatism of American society.

Persons with Disabilities↗
PubMed1992

The oncology nurse's role in patient advance directives.

In December 1991, Patient Self-Determination Amendment (PSDA) legislation was implemented. The PSDA requires facilities funded by Medicare/Medicaid to inform patients of their decision-making rights regarding medical care. An advance directive (AD), a living will, or a durable power of attorney for health care contains statements made by competent people directing their medical care if they should become incompetent. Oncology nurses are in an advantageous position to educate and advocate for their patients with respect to end-of-life decisions. They are qualified to facilitate the AD process by virtue of their ability to relate to patients and families their extensive experience with the terminally ill and their expertise as liasons between patients, families, and the multidisciplinary team. A clear understanding of the patient's wishes regarding life-sustaining treatments enables the oncology nurse to advocate more effectively on the patient's behalf. This article highlights definitions of ADs, advantages and disadvantages of each, and recommendations for the oncology nurse's practice.

Advance Directives↗
PubMedDate not supplied

Public benefits and costs of government funding for abortion.

In state referenda to end public funding of abortions for poor women, one of the most successful tactics of abortion foes has been to charge that abortion funding increases the burden on taxpayers. A state-by-state analysis by The Alan Guttmacher Institute (AGI) shows that the opposite is the case. For every tax dollar spent to pay for abortions for poor women, about four dollars is saved in public medical and welfare expenditures. The savings are in public expenditures that otherwise would have to be incurred because of the babies that poor women would have borne. On the basis of earlier research, it was assumed that 20 percent of Medicaid-eligible women who could not obtain abortions would give birth. Public costs examined in the AGI analysis include Medicaid expenditures for prenatal care, delivery and postnatal care for the mother, and for newborn care, neonatal intensive care and pediatric care for the child for the first two years of life; as well as expenditures for Aid to Families with Dependent Children (AFDC), food stamps and the Special Supplemental Food Program for Women, Infants and Children (WIC) during those first two years. The benefit-to-cost ratio varies from about 9:1 in Massachusetts to 2:1 in Hawaii and Pennsylvania. The net savings for the nation as a whole over a two-year period if abortions were publicly funded in every state would total at least $339.6 million.

Abortion, Legal↗
PubMed1998

Analytic decision-making in patients with critical limb ischaemia.

Patients with critical limb ischaemia have a relative short life expectancy. However, if the limb can be preserved or amputation postponed for at least 1-2 years there can be justification for revascularisation if it is possible. Published Scandinavian data indicate that of those operated on about one-third are primarily amputated and two-third revascularised. At least one-third in the revascularisation group are subjected to secondary amputation within six months, and about 50% are alive with the limb intact. Hence, prediction of successful reconstruction should be amended to reduce costs and reduce burden to the patients. In order to achieve statistical models, which preoperatively could predict outcome with an acceptable diagnostic accuracy, national as well as international cooperation with standardisation of predictors and appropriate use of statistical models should be strived for. Prediction, based on a statistical model, is always associated with some uncertainty, and will never replace qualified clinical judgement.

Amputation, Surgical↗
PubMed1999

Peripheral blood neutrophils of germ-free rats modified by in vivo granulocyte-colony-stimulating factor and exposure to natural environment.

Peripheral blood neutrophils from germ-free (GF), specific-pathogen-free (SPF) and conventional (CV) rats were compared. Besides neutropenia and impaired superoxide anion generation as previously reported, it was found that GF rats had lower phagocytic function (70%) and generated less nitric oxide than the other rats. GF and SPF rats were injected with recombinant human granulocyte-colony-stimulating factor (rhG-CSF), or were transferred to natural environment. It was found that total number, phagocytosis, intracellular killing, ratio of phagocytosis versus killing (killing efficiency) and nitric oxide production induced by recombinant rat interferon-gamma (rrIFN-gamma) were normalized upon injection of rhG-CSF. These results indicate that rhG-CSF may stimulate neutrophil production and induce the expression of neutrophil receptors for phagocytosis and nitric oxide production in GF rats. Although lower than in CV rats, the level of superoxide produced was sufficient for normal neutrophil-killing efficiency in SPF and GF rats. In SPF rats, this could be amended by exposure to natural environment. However, neither rhG-CSF injection nor transfer to natural environment could increase the generation of superoxide anion in GF rats.

Animals↗
PubMed1987

California Federal Savings and Loan Association v. Guerra, 13 January 1987.

The plaintiff employer and other similar employers challenged the constitutionality of a California law that required employers to provide female employees with up to four months unpaid pregnancy leave with reinstatement in the same or a substantially similar job. They claimed that the law was preempted by Title VII of the Civil Rights Act of 1964 because the 1964 Act, as amended by the Pregnancy Discrimination Act of 1978, required absolute neutrality in the treatment of pregnant employees with respect to other employees. Their position was that the California law discriminated in favor of pregnant employees. The Court rejected their claim. It held that the Pregnancy Discrimination Act was "a floor beneath which pregnancy disability benefits may not drop--not a ceiling above which they may not rise," and that the California law shared a common goal with the federal law of providing women with full rights in the workforce without denying them the right to full participation in family life. It ruled that there was nothing in the law that prevented employers from complying with the law and Title VII.

Americas↗
PubMed1991

[Blood transfusion and Jehovah's witnesses. Ethical and medicolegal aspects].

Jehovah's witnesses refuse transfusion of blood and blood products on the basis of religious convictions even when transfusion is considered necessary to save life. Medical treatment of these patients presents an ethical challenge for the physicians. The legal aspects of either administering blood to or withholding necessary blood transfusion from a Jehovah's witness are not clarified. Competent adult patients cannot be treated against their will. Children and unconscious patients must be treated according to "jus necessitatis". Whether a competent advance directive from a patient before an operation in general anaesthesia can be or must be respected is legally obscure. Final clarification of the patients' rights and the physicians' legal status could be obtained by an amendment to the existing Practice of Medicine Acts as proposed in the report (1184) from the Danish Ministry of Justice. The ethical aspects of administering blood to or withholding blood from these patients are also complex. It is recommended to determine one's own attitude individually and to inform the patient about this before an operation.

Blood Transfusion↗
PubMed2005

A phase II trial of weekly paclitaxel and gemctiabine infused at a constant rate in patients with advanced non-small cell lung cancer.

BACKGROUND: Gemcitabine and paclitaxel both have significant single agent activity in non-small cell lung cancer (NSCLC). Because both are cell cycle and phase specific in their mechanism of action, frequent exposure should optimize activity. Phase I data support that gemcitabine is maximally converted to the active metabolite when it is infused at a rate of 10 mg/(m2 min). Based on this, we designed a phase II trial to examine gemcitabine 800 mg/m2 infused over 80 min with paclitaxel 110 mg/m2 infused over 3 h both on days 1, 8 and 15 every 28 days as first line therapy in patients with advanced NSCLC. The primary objectives were to assess the response rate, toxicity and survival of the combination in advanced NSCLC. Secondary objectives were to determine the effect of paclitaxel on the pharmacokinetic (PK) distribution of gemcitabine, the ability to achieve a concentration of 10-20 microM when gemcitabine was infused at a rate of 10 mg/(m2 min), as well as to assess the quality of life (QOL) with the functional assessment of cancer therapy-lung (FACT-L) questionnaire. METHODS: Patients with NSCLC, no prior treatment, ECOG performance status (PS) 0-1, adequate bone marrow, renal, and hepatic function were eligible for this trial. Paclitaxel 110 mg/m2 was infused over 3 h, followed by gemcitabine 800 mg/m2 infused over 80 min on days 1, 8, and 15 every 28 days for the first 2 patients, and then amended to days 1 and 8 every 21 days after the first 2 patients required day 15 dose omissions due to myelosupression. RESULTS: Thirty-nine patients were treated. Nine PS = 0; 28 PS = 1; Stage IIIB = 3, Stage IV = 36; median age 62 (range: 39-77). A median of six cycles (range: 0-10) was delivered. Grade 3-4 toxicities observed in > or =10% of patients included leucopenia in 26%, neutropenia in 28%, dyspnea in 13%, febrile neutropenia in 3% (1 patient). Fourteen of 39 (35%, 95% CI: 21-53%) patients had a partial response (PR), 14 of 39 (35%, 95% CI: 21-53%) had stable disease (SD) and 5 patients (13%, 95% CI: 4-27%) had progressive (PD). Median survival was 10.4 months (95% CI: 5.3-13.6). One-and two-year survival rates were 35% (95% CI: 21-53%) and 5% (95% CI: 0.6-17%), respectively. QOL as measured by the FACT-L and the trial outcome index (TOI) did not change significantly from baseline over the course of therapy. CONCLUSIONS: Paclitaxel and gemcitabine is an active and well-tolerated combination in advanced NSCLC. Patients on this trial had no significant change in their QOL as assessed by the FACT-L questionnaire.

Adult↗
PubMed1999

A confidential enquiry into methadone-related deaths.

AIM: To assess the acceptability and usefulness of the "confidential enquiry" process in examining methadone-related deaths. DESIGN: An audit of patient care. SETTING: Glasgow, Scotland, UK (population 915,000) Participants. All doctors who, in the final 14 days of the patient's life, had attended a patient who suffered a methadone-related death. MEASUREMENTS: The medical care of each case was assessed by peer review and the results of these assessments returned to the responsible clinician(s). FINDINGS: (1) The audit cycle was completed in 32 of the 34 reported cases (94%). (2) Twenty-eight of 33 doctors (85%) found the audit to be helpful. (3) As a result of the enquiry, the majority of doctors whose patient management had attracted criticism intended to amend their practice. (4) Shortcomings in clinical care were identified in 18 cases (56%) and problems in the organization of services in 22 (69%). CONCLUSIONS: (1) The model of audit piloted here was found to be highly acceptable to participants. (2) The episodes of substandard care that were uncovered provided useful opportunities to improve the future management of patients who were being prescribed methadone.

Confidentiality↗
PubMed2006

A preliminary psychometric evaluation of the Hospital Anxiety and Depression Scale (HADS) in 963 people living with a spinal cord injury.

This study aimed to evaluate the preliminary psychometric properties of the Hospital Anxiety and Depression Scale (HADS) in a community sample of adults living with a spinal cord injury (SCI). A cross-sectional design was used with 963 people living in the community with an SCI. Participants were recruited via three spinal centres in the United Kingdom. They completed the HADS and the Life Satisfaction Questionnaire. Psychometric analyses were conducted for the whole sample, by gender and level of injury. The HADS demonstrated good internal consistency, with promising content validity. Two factors, approximating to anxiety and depression were extracted via factor analysis for the whole sample, by gender and level of injury. In line with existing literature, females scored significantly higher than males on the anxiety subscale. Item 7 ("I can sit at ease and feel relaxed") was found to be a complex item, with a potentially different meaning within this population. This study presents preliminary findings, which support the psychometric integrity of the HADS within an outpatient population with SCI. Items that included potential somatic components revealed a more complex factor loading profile. Recommendations are made to further investigate this measure with amendments to such items, incorporating inpatients and independent measures of anxiety and depression to address validity directly.

Adult↗
PubMed1997

Deception, efficiency, and random groups. Psychology and the gradual origination of the random group design.

In the life sciences, psychology, and large parts of the other social sciences, the ideal experiment is a comparative experiment with randomly composed experimental and control groups. Historians and practitioners of these sciences generally attribute the invention of this "random group design" to the statistician R.A. Fisher, who developed it in the 1930s for agricultural research. This essay argues that the random group design was advanced in psychology before Fisher introduced it in agriculture and that in this context it was the unplanned outcome of a lengthy historical process rather than the instantaneous creation of a single genius. The article analyzes how the random group design came about bit by bit when methodological practices from nineteenth-century psychophysical laboratories were gradually adapted, extended, and codified by twentieth-century educational psychologists to support procedural objectivity in educational administration. In passing, the article also amends the received historiography of the separate elements of randomization and control groups.

Europe↗
PubMed1995

Criteria for investigation of the product equivalence of monoclonal antibodies for therapeutic and in vivo-diagnostic use in case of introduction of changes in the manufacturing process.

The development of a monoclonal antibody for therapeutic or in vivo-diagnostic use from the first description to clinical trials and compilation of the dossier for granting the license requires a time consuming and expensive program. Due to its long development time, a particular monoclonal antibody can be subjected to a series of changes and improvements in manufacturing technology before licensure. In addition, the application for marketing authorization of biotechnology-derived medicinal products is not to be considered as an endpoint of a drawn-out development process which ends with license, because changes, amendments or improvements of the manufacturing process occur after a marketing authorization for a monoclonal antibody has been granted. Most of these changes, even minor qualitative and quantitative changes in the active substance itself, would require a new application according to the legal regulations of the European Union and of the national drug laws of the Member States. The paper proposes a procedure to take previously evaluated development-related data into account by evaluation of the product equivalence of both antibody forms ascertained before and after introduction of changes in the manufacturing process. The thorough in vitro analysis of parameters such as isotype, subclass, affinity, microheterogeneity, molecular weight, primary and secondary structure, structural integrity of the antibody molecule, glycosylation pattern, specificity, cross-reactivity and biological potency with subsequently performed pharmacological/toxicological evaluation of biodistribution, half life and safety provide sufficient data for decision on the need for further clinical trials.

Animals↗
PubMed2002

Effectiveness of some recent antimicrobial packaging concepts.

A new type of active packaging is the combination of food-packaging materials with antimicrobial substances to control microbial surface contamination of foods. For both migrating and non-migrating antimicrobial materials, intensive contact between the food product and packaging material is required and therefore potential food applications include especially vacuum or skin-packaged products, e.g. vacuum-packaged meat, fish, poultry or cheese. Several antimicrobial compounds have been combined with different types of carriers (plastic and rubber articles, paper-based materials, textile fibrils and food-packaging materials). Until now, however, few antimicrobial concepts have found applications as a food-packaging material. Antimicrobial packaging materials cannot legally be used in the EU at the moment. The potential use would require amendments of several different legal texts involving areas such as food additives, food packaging, hygiene, etc. The main objective of this paper is to provide a state of the art about the different types of antimicrobial concepts, their experimental development and commercialization, and to present a case study summarizing the results of investigations on the feasibility of a low-density polyethylene (LDPE)-film containing triclosan to inhibit microbial growth on food surfaces and consequently prolong shelf-life or improve microbial food safety. In contrast with the strong antimicrobial effect in in-vitro simulated vacuum-packaged conditions against the psychrotrophic food pathogen L. monocytogenes, the 1000 mg kg(-1) containing triclosan film did not effectively reduce spoilage bacteria and growth of L. monocytogenes on refrigerated vacuum-packaged chicken breasts stored at 7 degrees C.

Animals↗