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Sample records for adult human subjects

  1. Sweet taste and chorda tympani transection alter capsaicin-induced lingual pain perception in adult human subjects.

    PubMed

    Schöbel, N; Kyereme, J; Minovi, A; Dazert, S; Bartoshuk, L; Hatt, H

    2012-10-10

    Sweetness signals the nutritional value of food and may moreover be accompanied by a sensory suppression that leads to higher pain tolerance. This effect is well documented in infant rats and humans. However, it is still debated whether sensory suppression is also present in adult humans. Thus, we investigated the effects of sweet taste on the perception of the painful trigeminal stimulus capsaicin in two groups of healthy adult human subjects. A solution of 100 μM capsaicin was applied to the tip of the subject's tongues in order to stimulate trigeminal Aδ- and C-fiber nociceptors. When swallowed, 1M sucrose reduced the capsaicin-induced burning sensation by 29% (p ≤ 0.05) whereas a solution of similar taste intensity containing 1 μM quinine did not. Similarly, sucrose application to the frontal hemitongue suppressed the perception of the burning sensation induced by contralaterally applied capsaicin by 25% (p ≤ 0.01). We furthermore investigated the effects of documented unilateral transection of the chorda tympani nerve on capsaicin perception. In accordance with the ipsi-to-contralateral effect of sucrose on capsaicin perception in healthy subjects, hemiageusic subjects were more sensitive for capsaicin on the tongue contralateral to the taste nerve lesion (+38%; p ≤ 0.01). Taken together, these results argue I) for the existence of food intake-induced sensory suppression, if not analgesia, in adult humans and II) a centrally mediated suppression of trigeminal sensation by taste inputs that III) becomes disinhibited upon peripheral taste nerve lesion.

  2. Pharmacokinetics of Fosamprenavir plus Ritonavir in Human Immunodeficiency Virus Type 1-Infected Adult Subjects with Hepatic Impairment▿

    PubMed Central

    Pérez-Elías, María J.; Morellon, María Larrousse; Ortega, Enrique; Hernández-Quero, José; Rodríguez-Torres, Maribel; Clotet, Bonaventura; Felizarta, Franco; Gutiérrez, Felix; Pineda, Juan A.; Nichols, Garrett; Lou, Yu; Wire, Mary Beth

    2009-01-01

    The effect of hepatic impairment on fosamprenavir/ritonavir pharmacokinetics was investigated. Sixty human immunodeficiency virus type 1-infected subjects, including 13, 20, and 10 subjects with mild, moderate, and severe hepatic impairment, respectively, and a comparator group of 17 subjects with normal hepatic function, were enrolled. Subjects with normal hepatic function received fosamprenavir at 700 mg plus ritonavir at 100 mg twice daily, whereas subjects with hepatic impairment received adjusted doses in anticipation of increased exposures. For subjects with mild hepatic impairment, the studied regimen of fosamprenavir 700 mg twice daily plus ritonavir 100 mg once daily delivered 17% higher values for the maximum plasma amprenavir concentration at the steady state (Cmax), 22% higher values for the area under the plasma concentration versus time curve over the dosing interval at the steady state [AUC(0-τ)], similar values for the concentration at the end of the dosing interval (Cτ), and 114% higher unbound Cτ values. For subjects with moderate hepatic impairment, the studied dosage regimen of fosamprenavir at 300 mg twice daily plus ritonavir at 100 mg once daily delivered 27% lower plasma amprenavir Cmax values, 27% lower AUC(0-24) values, 57% lower Cτ values, and 21% higher unbound amprenavir Cτ values. For subjects with severe hepatic impairment, the studied dosage regimen of fosamprenavir at 300 mg twice daily plus ritonavir at 100 mg once daily delivered 19% lower plasma amprenavir Cmax values, 23% lower AUC(0-24) values, 38% lower Cτ values, and similar unbound amprenavir Cτ values. With a reduced ritonavir dosing frequency of 100 mg once daily, the plasma ritonavir AUC(0-24) values were 39% lower, similar, and 40% higher for subjects with mild, moderate, and severe hepatic impairment, respectively. The results of the study support the use of reduced fosamprenavir/ritonavir doses or dosing frequencies in the treatment of patients with hepatic

  3. Human subjects research handbook: Protecting human research subjects. Second edition

    SciTech Connect

    1996-01-30

    This handbook serves as a guide to understanding and implementing the Federal regulations and US DOE Orders established to protect human research subjects. Material in this handbook is directed towards new and continuing institutional review board (IRB) members, researchers, institutional administrators, DOE officials, and others who may be involved or interested in human subjects research. It offers comprehensive overview of the various requirements, procedures, and issues relating to human subject research today.

  4. Adult Playfulness, Humor Styles, and Subjective Happiness.

    PubMed

    Yue, Xiao D; Leung, Chun-Lok; Hiranandani, Neelam A

    2016-12-01

    Playfulness has been referred to as a disposition that involves reframing a situation to amuse others and to make the situation more stimulating and enjoyable. It may serve to shift one's perspective when dealing with environmental threats. Despite all the benefits of playfulness towards psychological well-being, it remains a largely understudied subject in psychology, particularly in Chinese societies. Hence, this study examined the association between adult playfulness, humor styles, and subjective happiness among a sample of 166 university students in Hong Kong and 159 students in Guangzhou, who completed a self-administered questionnaire, including the Short Measure for Adult Playfulness, the Chinese Humor Styles Questionnaire, and the Subjective Happiness Scale. Results showed that adult playfulness was positively correlated with affiliative humor, self-enhancing humor, and subjective happiness in both Hong Kong and Guangzhou samples. By its implication, highly playful Chinese students preferred using affiliative and self-enhancing humor to amuse themselves and others.

  5. Subjective adult identity and casual sexual behavior

    PubMed Central

    Lyons, Heidi Ann

    2015-01-01

    A majority of Americans have a casual sexual experience before transitioning to adulthood. Little research has yet to examine how identity influences causal sexual behavior. The current study fills this gap in the literature by examining if subjective adult identity predicts casual sexual behavior net of life course transitions in a national sample of Americans. To answer this research question, the Longitudinal Study of Adolescent to Adult Health is utilized. Structural equation modeling results show the older and more adult-like individuals feel the less likely they are to report a recent casual sexual partner. Once life course factors are included in the model, subjective identity is no longer associated with casual sex. Practitioners who work with adult populations need to consider how life course transitions influence casual sexual behavior. PMID:27065759

  6. Subjective adult identity and casual sexual behavior.

    PubMed

    Lyons, Heidi Ann

    2015-12-01

    A majority of Americans have a casual sexual experience before transitioning to adulthood. Little research has yet to examine how identity influences causal sexual behavior. The current study fills this gap in the literature by examining if subjective adult identity predicts casual sexual behavior net of life course transitions in a national sample of Americans. To answer this research question, the Longitudinal Study of Adolescent to Adult Health is utilized. Structural equation modeling results show the older and more adult-like individuals feel the less likely they are to report a recent casual sexual partner. Once life course factors are included in the model, subjective identity is no longer associated with casual sex. Practitioners who work with adult populations need to consider how life course transitions influence casual sexual behavior.

  7. A randomized, double-blind placebo-controlled study on acceptability, safety and efficacy of oral administration of sacha inchi oil (Plukenetia volubilis L.) in adult human subjects.

    PubMed

    Gonzales, Gustavo F; Gonzales, Carla

    2014-03-01

    The study was designed to assess acceptability and side-effects of consumption of sacha inchi oil, rich in α-linolenic acid and sunflower oil, rich in linoleic acid, in adult human subjects. Thirty subjects received 10 or 15ml daily of sacha inchi or sunflower oil for 4months. Acceptability was assessed with daily self-report and with a Likert test at the end of the study. Safety was assessed with self- recording of side-effects and with hepatic and renal markers. Primary efficacy variables were the change in lipid profile. Subjects reported low acceptability of sacha inchi oil at week-1 (37.5%). However, since week-6, acceptability was significantly increased to 81.25-93.75%. No differences were observed in acceptability with respect to sex or oil volume (P>0.05). Most frequent adverse effects during first weeks of consuming sacha inchi oil or sunflower oil were nauseas. The side-effects were reduced with time. Biochemical markers of hepatic and kidney function were maintained unchanged. Serum total cholesterol and LDL cholesterol levels and arterial blood pressure were lowered with both oils (P<0.05). Higher HDL-cholesterol was observed with sacha inchi oil at month-4. In conclusion, sacha inchi oil consumed has good acceptability after week-1 of consumption and it is safety.

  8. Gastric digestion of α-lactalbumin in adult human subjects using capsule endoscopy and nasogastric tube sampling.

    PubMed

    Sullivan, Louise M; Kehoe, Joseph J; Barry, Lillian; Buckley, Martin J M; Shanahan, Fergus; Mok, K H; Brodkorb, André

    2014-08-28

    In the present study, structural changes in the milk protein α-lactalbumin (α-LA) and its proteolysis were investigated for the potential formation of protein-fatty acid complexes during in vivo gastric digestion. Capsule endoscopy allowed visualisation of the digestion of the test drinks, with nasogastric tubes allowing sampling of the gastric contents. A total of ten healthy volunteers had nasogastric tubes inserted into the stomach and ingested test drinks containing 50 g/l of sucrose and 25 g/l of α-LA with and without 4 g/l of oleic acid (OA). The samples of gastric contents were collected for analysis at 3 min intervals. The results revealed a rapid decrease in the pH of the stomach of the subjects. The fasting pH of 2·31 (SD 1·19) increased to a pH maxima of pH 6·54 (SD 0·29) after ingestion, with a subsequent decrease to pH 2·22 (SD 1·91) after 21 min (n 8). Fluorescence spectroscopy and Fourier transform IR spectroscopy revealed partial protein unfolding, coinciding with the decrease in pH below the isoelectric point of α-LA. The activity of pepsin in the fasting state was found to be 39 (SD 12) units/ml of gastric juice. Rapid digestion of the protein occurred: after 15 min, no native protein was detected using SDS-PAGE; HPLC revealed the presence of small amounts of native protein after 24 min of gastric digestion. Mirocam® capsule endoscopy imaging and video clips (see the online supplementary material) revealed that gastric peristalsis resulted in a heterogeneous mixture during gastric digestion. Unfolding of α-LA was observed during gastric transit; however, there was no evidence of a cytotoxic complex being formed between α-LA and OA.

  9. Human Subjects and Informed Consent.

    ERIC Educational Resources Information Center

    Smith, Arthur A.

    1988-01-01

    The doctrine of informed consent has been enumerated to protect the rights of human subjects involved in biomedical research. The elements of informed consent are summarized along with the changes of emphasis that have evolved. The issue of liability and means for minimizing its impact are discussed. (Author/MLW)

  10. Human research subjects as human research workers.

    PubMed

    Lynch, Holly Fernandez

    2014-01-01

    Biomedical research involving human subjects has traditionally been treated as a unique endeavor, presenting special risks and demanding special protections. But in several ways, the regulatory scheme governing human subjects research is counter-intuitively less protective than the labor and employment laws applicable to many workers. This Article relies on analogical and legal reasoning to demonstrate that this should not be the case; in a number of ways, human research subjects ought to be fundamentally recast as human research workers. Like other workers protected under worklaw, biomedical research subjects often have interests that diverge from those in positions of control but little bargaining power for change. Bearing these important similarities in mind, the question becomes whether there is any good reason to treat subjects and protected workers differently as a matter of law. With regard to unrestricted payment, eligibility for a minimum wage, compensation for injury, and rights to engage in concerted activity, the answer is no and human subjects regulations ought to be revised accordingly.

  11. Aerodynamic estimates of induced anterior orifice openings in human subjects.

    PubMed

    Guyette, T W; Smith, B E; Reisberg, D J

    1994-05-01

    This study first examined the accuracy of pressure-flow area estimates of experimental openings in anterior palatal obturators of three adult subjects. Second, we evaluated pressure-flow measures of the same experimental openings using a model. Results indicated that percent error in orifice estimates was slightly higher for induced openings in human subjects (13%) versus those in the model (11%). Results for our human subjects were similar to those reported by previous investigators.

  12. Human metapneumovirus in adults.

    PubMed

    Haas, Lenneke E M; Thijsen, Steven F T; van Elden, Leontine; Heemstra, Karen A

    2013-01-08

    Human metapneumovirus (HMPV) is a relative newly described virus. It was first isolated in 2001 and currently appears to be one of the most significant and common human viral infections. Retrospective serologic studies demonstrated the presence of HMPV antibodies in humans more than 50 years earlier. Although the virus was primarily known as causative agent of respiratory tract infections in children, HMPV is an important cause of respiratory infections in adults as well. Almost all children are infected by HMPV below the age of five; the repeated infections throughout life indicate transient immunity. HMPV infections usually are mild and self-limiting, but in the frail elderly and the immunocompromised patients, the clinical course can be complicated. Since culturing the virus is relatively difficult, diagnosis is mostly based on a nucleic acid amplification test, such as reverse transcriptase polymerase chain reaction. To date, no vaccine is available and treatment is supportive. However, ongoing research shows encouraging results. The aim of this paper is to review the current literature concerning HMPV infections in adults, and discuss recent development in treatment and vaccination.

  13. Human Metapneumovirus in Adults

    PubMed Central

    Haas, Lenneke E. M.; Thijsen, Steven F. T.; van Elden, Leontine; Heemstra, Karen A.

    2013-01-01

    Human metapneumovirus (HMPV) is a relative newly described virus. It was first isolated in 2001 and currently appears to be one of the most significant and common human viral infections. Retrospective serologic studies demonstrated the presence of HMPV antibodies in humans more than 50 years earlier. Although the virus was primarily known as causative agent of respiratory tract infections in children, HMPV is an important cause of respiratory infections in adults as well. Almost all children are infected by HMPV below the age of five; the repeated infections throughout life indicate transient immunity. HMPV infections usually are mild and self-limiting, but in the frail elderly and the immunocompromised patients, the clinical course can be complicated. Since culturing the virus is relatively difficult, diagnosis is mostly based on a nucleic acid amplification test, such as reverse transcriptase polymerase chain reaction. To date, no vaccine is available and treatment is supportive. However, ongoing research shows encouraging results. The aim of this paper is to review the current literature concerning HMPV infections in adults, and discuss recent development in treatment and vaccination. PMID:23299785

  14. Giftedness and Subjective Well-Being: A Study with Adults

    ERIC Educational Resources Information Center

    Wirthwein, Linda; Rost, Detlef H.

    2011-01-01

    Studies on the well-being of gifted adults are rare, and the available studies are often limited by methodological shortcomings. In a longitudinal project 101 intellectually gifted adults (mean IQ = 136) were compared to 91 adults of average intelligence (mean IQ = 103). Subjective well-being was operationalized by positive and negative…

  15. Neuroamine condensations in human subjects.

    PubMed

    Collins, M A

    1980-01-01

    Non-enzymatic products of neuroamines and endogenous carbonyl compounds are apparent "normal" products in human metabolism, and their levels become increased during pathological conditions. DA condensation products--salsolinol, its O-methylated derivative, and methylated derivatives of 1-carboxyl-THP--are found normally in human urine, and the last TIQ is in human brain. Potential beta-carboline condensation products also occur in (aging) human lens tissue. Chronic drinking in alcoholics causes significant increases in urinary salsolinol and O-methyl-salsolinol, presumably due to the increased AcH which is made available. L-DOPA therapy (in Parkinson's disease) elevates urinary and tissue levels of the carboxylated THP derivatives, as well as of salsolinol and THP itself; hyperphenylalaninemia during PKU also increases tissue levels of a DA/phenylpyruvate-derived TIQ and an imine condensate of phenylethylamine and vitamin B6. These unusual products may interfere with neural dynamic processes, and produce cytotoxic metabolites.

  16. Unequal treatment of human research subjects.

    PubMed

    Resnik, David B

    2015-02-01

    Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the appropriateness of equal treatment. Allegedly unequal treatment will probably always occur in research with human subjects due to disagreements about fundamental questions of justice. The best way to deal with allegedly unequal treatment is to promote honest and open discussions of the issues at stake. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, ethical review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Federal agencies have provided interpretive guidance that can help promote consistent review and oversight of human subjects research. Additional direction may be needed on topics that are not adequately covered by current guidance or regulations. International guidelines can help promote equal treatment of human subjects around the globe. While minor variations in the treatment of research subjects should be tolerated and even welcomed, major ones (i.e. those that significantly impact human rights or welfare) should be avoided or minimized.

  17. Ethical genetic research on human subjects.

    PubMed

    Harris, J

    1999-01-01

    Since the Nuremberg trials and the Nazi doctors trial following World War II, international ethics protocols have emerged designed to protect human subjects from the atrocities of medical experimentation that were literally routine under the Nazis. Some of the apparent "lessons" from the Nazi period have been encapsulated in the Declaration of Helsinki, perhaps the leading medical ethics protocol. This paper argues that these protocols have not been notably conducive to human welfare or to the protection of human rights in the field of human genetics research. The paper proposes new protocols and a new approach to the ethics of research on human subjects.

  18. Human Subjects Issues in AIDS Research.

    ERIC Educational Resources Information Center

    Bayer, Ronald, Ed.

    1990-01-01

    Six articles are presented on the use of human subjects in research on acquired immune deficiency syndrome (AIDS). Topics include the ethics of human experimentation, female and pediatric AIDS patients, Human Immunodeficiency Virus (HIV) infection and AIDS among correctional inmates, community-based AIDS research, and clinical trials of HIV…

  19. Arts & Humanities in Adult Education.

    ERIC Educational Resources Information Center

    Word's Worth: A Quarterly Newsletter of the Lifelong Learning Network, 1998

    1998-01-01

    This issue of a quarterly newsletter on lifelong learning focuses on the theme of the arts and humanities in adult literacy education. The following articles are included: (1) "In Defense of a Practical Education" (Earl Shorris); (2) "From the Program Director" (Elizabeth Bryant McCrary); (3) "Vermont Council on the Humanities: Book Discussion…

  20. Unequal Treatment of Human Research Subjects

    PubMed Central

    Resnik, David B.

    2015-01-01

    Unequal treatment of human research subjects is a significant ethical concern, because justice requires that equals be treated equally. If two research subjects are the same in the relevant respects, they should be treated equally. However, not all human subjects are the same in relevant respects: people differ with respect to age, health, gender, race, mental abilities, socioeconomic status, and other characteristics. Disputes sometimes arise concerning the issue of whether subjects are the same in relevant respects and should therefore be treated equally. Allegedly unequal treatment occurs when subjects are treated differently and there is a serious dispute about whether subjects are the same in relevant respects. Patently unequal treatment occurs when there is no significant dispute about whether subjects are the same in relevant respects and they are treated unequally. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, institutional review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Additional guidance may be necessary to minimize patently unequal treatment of research subjects. PMID:24879129

  1. Comparative estimates of density and species diversity in adult mosquito populations landing on a human subject and captured using light and suction traps.

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Comparative responses of 21 species of mosquitoes to light traps (LT) and suction traps (ST) and captured using the human landing collection method (HL) varied in accordance with collection technique but data analyses for most species revealed significant interaction between collection method and th...

  2. Synchronicity of frequently sampled thyrotropin (TSH) and leptin concentrations in healthy adults and leptin-deficient subjects: evidence for possible partial TSH regulation by leptin in humans.

    PubMed

    Mantzoros, C S; Ozata, M; Negrao, A B; Suchard, M A; Ziotopoulou, M; Caglayan, S; Elashoff, R M; Cogswell, R J; Negro, P; Liberty, V; Wong, M L; Veldhuis, J; Ozdemir, I C; Gold, P W; Flier, J S; Licinio, J

    2001-07-01

    Leptin signals the status of energy reserves to the brain. Leptin stimulates biosynthesis of TRH in vitro and influences the activity of the hypothalamic-pituitary-thyroid axis in vivo in rodents. Because blood levels of both leptin and TSH display diurnal variation with a distinct nocturnal rise, we sought to determine whether a relationship exists between fluctuations in circulating leptin and TSH. We measured serum leptin and TSH levels every 7 min for 24 h in five healthy men and found that both leptin and TSH levels are highly organized and pulsatile. A similar pattern of leptin and TSH rhythms was observed, with TSH and leptin levels reaching a nadir in late morning and a peak in the early morning hours. Importantly, cosinor analysis on the absolute leptin and TSH levels revealed a statistically significant fit for a 24-h period and the two hormones showed similar probabilities of rhythm and superimposable peak values. Furthermore, this study shows a strong positive Pearson correlation between the 24-h patterns of variability of leptin and TSH in healthy subjects. Finally, the ultradian fluctuations in leptin levels showed pattern synchrony with those of TSH as determined by cross-correlation analysis, by cross-approximate enthropy and Bayessian analysis applied independently. To further explore whether these associations could reflect an underlying regulation of TSH secretion by leptin, we also studied frequently sampled leptin and TSH levels in four brothers, members of a family with leptin deficiency (one normal homozygote, two heterozygotes, and one leptin-deficient homozygote). Leptin levels of the homozygous leptin-deficient subject are detectable but bioinactive, and the rhythm of his TSH is disorganized. 24-h pattern of leptin and TSH variability in the heterozygous subjects, although significantly correlated, showed a weaker correlation compared with the strong correlation in the normal subjects. These data are consistent with the possibility that

  3. Human Subjects Research and the Physics Classroom

    NASA Astrophysics Data System (ADS)

    Kubitskey, Beth W.; Thomsen, Marshall

    2012-09-01

    Physics Education Research is a form of social science research in that it uses human subjects. As physicists we need to be aware of the ethical and legal ramifications of performing this research, taking into account the fundamental differences between working with substances and working with people. For several decades, the federal government has regulated research involving human subjects. With current procedures, a proposal soliciting federal funds for a research project involving human subjects will be flagged by the applicants institution and checked for compliance with appropriate regulations. However, there is a large body of Physics Education Research that is not federally funded and thus may not be flagged. Nevertheless, there are ethical standards that apply to this research. This paper outlines the preliminary considerations for conducting such research.

  4. Human Subjects Research and the Physics Classroom

    ERIC Educational Resources Information Center

    Kubitskey, Beth W.; Thomsen, Marshall

    2012-01-01

    Physics Education Research is a form of social science research in that it uses human subjects. As physicists we need to be aware of the ethical and legal ramifications of performing this research, taking into account the fundamental differences between working with substances and working with people. For several decades, the federal government…

  5. Protection of Human Subjects: Proposed Policy.

    ERIC Educational Resources Information Center

    Federal Register, 1974

    1974-01-01

    In the Federal Register of May 30, 1974, regulations were published as Part 46 of Title 45 of the Code of Federal Regulations providing generally for the protection of human subjects involved in research, development, or related activities supported by Department of Health, Education, and Welfare grants or contracts. This notice of proposed…

  6. Photodegradation of carotenoids in human subjects

    SciTech Connect

    Roe, D.A.

    1987-04-01

    Photodegradation of vitamins in vitro is responsible for large losses of these nutrients in foods, beverages, and semisynthetic liquid formula diets. In vivo photodegradation of vitamins has been reported for riboflavin in jaundiced infants exposed to blue light and for folate in patients with chronic psoriasis given photochemotherapy. Two recent studies of normal subjects have also shown that photodegradation of carotenoids in plasma occurs with cumulative exposure of the skin to an artificial light source having maximal spectral emission in the UVA range. Females showed a larger effect of the UV light on their plasma carotenoid levels than males. These observations have identified a need for further investigation of the role of sunlight exposure as a determinant of plasma carotenoid levels and vitamin A status in human subjects.

  7. Pharmacodynamics of Promethazine in Human Subjects

    NASA Technical Reports Server (NTRS)

    Gatlin, K. T.; Boyd, J. L.; Wang, Z.; Das, H.; Putcha, L.

    2005-01-01

    Promethazine (PMZ) is the drug of choice for the treatment of symptoms associated with space motion sickness in astronauts. Side effects of PMZ include sedation, dizziness and cognitive performance impairment. In this study, we examined pharmacodynamics (PD) in human subjects and validated methods for evaluating cognitive performance effects of medications in space. METHODS: PMZ (12.5,25, and 50 mg) or placebo was administered by IM injection to human subjects in a randomized double-blind treatment design. Samples and data were collected for 72 h post dose. PD evaluation was performed using a battery of performance tests administered using WinSCAT (Windows based Space Cognitive Assessment Test) on a laptop computer, and ARES (ANAM Readiness Evaluation System) on a PDA, plasma concentrations of PMZ were measured using a LC-MS method. RESULTS: Results indicate a linear correlation between PMZ concentration and cognitive performance parameters (p<0.01). Test accuracy decreased and test completion time and response time increased significantly with increasing plasma PMZ concentration. CONCLUSIONS: These results suggest a concentration dependent decrement in cognitive performance associated with PMZ. WinSCAT and ARES are sensitive tools for the assessment PMZ PD and may be applicable for such evaluations with other neurocognitive drugs.

  8. Environmental Health Research Involving Human Subjects: Ethical Issues.

    PubMed

    Resnik, David B

    2008-07-14

    This article reviews some of the ethical issues that arise in environmental health research with human subjects, such as minimizing risks to subjects, balancing benefits and risks in research, intentional exposure studies with human subjects, protecting third parties in research, informing subjects about environmental hazards, communicating health information to subjects, and protecting privacy and confidentiality.

  9. Environmental Health Research Involving Human Subjects: Ethical Issues

    PubMed Central

    Resnik, David B.

    2008-01-01

    This article reviews some of the ethical issues that arise in environmental health research with human subjects, such as minimizing risks to subjects, balancing benefits and risks in research, intentional exposure studies with human subjects, protecting third parties in research, informing subjects about environmental hazards, communicating health information to subjects, and protecting privacy and confidentiality. PMID:20401332

  10. 48 CFR 1552.223-70 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a)...

  11. 48 CFR 1352.235-70 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Protection of human... Protection of human subjects. As prescribed in 48 CFR 1335.006(a), insert the following provision: Protection of Human Subjects (APR 2010) (a) Research involving human subjects is not permitted under this...

  12. 48 CFR 1552.223-70 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a)...

  13. 48 CFR 1352.235-70 - Protection of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Protection of human... Protection of human subjects. As prescribed in 48 CFR 1335.006(a), insert the following provision: Protection of Human Subjects (APR 2010) (a) Research involving human subjects is not permitted under this...

  14. 48 CFR 1552.223-70 - Protection of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a)...

  15. 48 CFR 1352.235-70 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Protection of human... Protection of human subjects. As prescribed in 48 CFR 1335.006(a), insert the following provision: Protection of Human Subjects (APR 2010) (a) Research involving human subjects is not permitted under this...

  16. Human intestinal lipoproteins. Studies in chyluric subjects.

    PubMed

    Green, P H; Glickman, R M; Saudek, C D; Blum, C B; Tall, A R

    1979-07-01

    To explore the role of the human intestine as a source of apolipoproteins, we have studied intestinal lipoproteins and apoprotein secretion in two subjects with chyluria (mesenteric lymphatic-urinary fistulae). After oral corn oil, apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II) output in urine increased in parallel to urinary triglyceride. One subject, on two occasions, after 40 g of corn oil, excreted 8.4 and 8.6 g of triglyceride together with 196 and 199 mg apoA-I and on one occasion, 56 mg apoA-II. The other subject, after 40 g corn oil, excreted 0.3 g triglyceride and 17.5 mg apoA-I, and, after 100 g of corn oil, excreted 44.8 mg apoA-I and 5.8 mg apoA-II. 14.5+/-2.1% of apoA-I and 17.7+/-4.3% of apoA-II in chylous urine was in the d < 1.006 fraction (chylomicrons and very low density lipoprotein). Calculations based on the amount of apoA-I and apoA-II excreted on triglyceride-rich lipoproteins revealed that for these lipid loads, intestinal secretion could account for 50 and 33% of the calculated daily synthetic rate of apoA-I and apoA-II, respectively. Similarly, subject 2 excreted 48-70% and 14% of the calculated daily synthetic rate of apoA-I and apoA-II, respectively. Chylous urine contained chylomicrons, very low density lipoproteins and high density lipoproteins, all of which contained apoA-I. Chylomicrons and very low density lipoproteins contained a previously unreported human apoprotein of 46,000 mol wt. We have called this apoprotein apoA-IV because of the similarity of its molecular weight and amino acid composition to rat apoA-IV. In sodium dodecyl sulfate gels, chylomicron apoproteins consisted of apoB 3.4+/-0.7%, apoA-IV 10.0+/-3.3%, apoE 4.4+/-0.3%, apoA-I 15.0+/-1.8%, and apoC and apoA-II 43.3+/-11.3%. Very low density lipoprotein contained more apoB and apoA-IV and less apoC than chylomicrons. Ouchterlony immunodiffusion of chylomicron apoproteins revealed the presence of apoC-I, apoC-II, and apoC-III. In contrast, plasma

  17. Protections for Subjects in Human Research with Pesticides

    EPA Pesticide Factsheets

    All pesticide research using human subjects must meet our strict protective standards before we would consider using them in evaluating pesticides. EPA's regulation “Protections for Subjects in Human Research” was promulgated in 2006 and amended in 2013.

  18. Parental Perspectives on a Pediatric Human Non-Subjects Biobank

    PubMed Central

    Brothers, Kyle B.; Clayton, Ellen Wright

    2012-01-01

    Background Genomic biorepositories will be important tools to help unravel the effect of common genetic variants on risk for common pediatric diseases. Our objective was to explore how parents would respond to the inclusion of children in an opt-out model biobank. Methods We conducted semi-structured interviews with parents in hospital-based pediatric clinics. Participants responded to a description of a biorepository already collecting samples from adults. Two coders independently analyzed and coded interviews using framework analysis. Opt-out forms were later piloted in a clinic area. Parental opt-out choices were recorded electronically, with opt-out rates reported here. Results Parents strongly supported medical research in general and expressed a high level of trust that Vanderbilt University would keep their child’s medical information private. Parents were more likely to allow their child’s sample to be included in the biorepository than to allow their child to participate in a hypothetical study that would not help or harm their child, but might help other children. Only a minority were able to volunteer a concern raised by the description of the biobank. The opt-out rate was initially high compared with the opt-out rate in the adult biorepository, but after the first week decreased to near the baseline in adult clinics. Conclusion Parents in our study generally support an opt-out model biobank in children. Most would allow their own child’s sample to be included. Institutions seeking to build pediatric biobanks may consider the human non-subjects model as a viable alternative to traditional human-subjects biobanks. PMID:23181193

  19. Subjective Experiences of Older Adults Practicing Taiji and Qigong

    PubMed Central

    Yang, Yang; DeCelle, Sharon; Reed, Mike; Rosengren, Karl; Schlagal, Robert; Greene, Jennifer

    2011-01-01

    This article presents a qualitative study following a 6-month Taiji (T'ai Chi)/Qigong (Ch'i Kung) intervention for older adults. The researchers conducted in-depth interviews of eight selected participants who elected to continue practicing Taiji after the intervention ended, in order to explore their subjective experiences of Taiji's effects and their motivations for continuing to practice. We created a Layers Model to capture the significance and meaning of the multidimensionality of their reported experiences. Participants not only reported simple benefits along five dimensions of experience (physical, mental, emotional, social and spiritual) but also described complex multidimensional experiences. Overall findings indicate that participants derived a very wide variety of perceived benefits, the most meaningful being a felt sense of body-mind-spirit integration. Our results support the important role of qualitative studies in researching the effects of Taiji and Qigong. PMID:21773028

  20. 34 CFR 76.681 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the...

  1. 34 CFR 75.681 - Protection of human research subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect...

  2. 45 CFR 63.31 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions...

  3. 34 CFR 76.681 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the...

  4. 45 CFR 63.31 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions...

  5. 34 CFR 75.681 - Protection of human research subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect...

  6. 34 CFR 76.681 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the...

  7. 34 CFR 75.681 - Protection of human research subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect...

  8. 45 CFR 63.31 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions...

  9. 34 CFR 75.681 - Protection of human research subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect...

  10. 34 CFR 76.681 - Protection of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the...

  11. 45 CFR 63.31 - Protection of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions...

  12. 34 CFR 75.681 - Protection of human research subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect...

  13. 34 CFR 76.681 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the...

  14. 45 CFR 63.31 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions...

  15. [Ethics and laws related to human subject research].

    PubMed

    Chiu, Hui-Ju; Lee, Ya-Ling; Chang, Su-Fen

    2011-10-01

    Advances in medical technology rely on human subject research to test the effects on real patients of unproven new drugs, equipment and techniques. Illegal human subject research happens occasionally and has led to subject injury and medical disputes. Familiarity with the laws and established ethics related to human subject research can minimize both injury and disputes. History is a mirror that permits reflection today on past experience. Discussing the Nuremberg Code, the Declaration of Helsinki and Belmont Report, this article describes the laws, ethics, history and news related to human subject research as well as the current definition and characteristics of human subject research. Increasing numbers of nurses serve as research nurses and participate in human subject research. The authors hope this article can increase research nurse knowledge regarding laws and ethics in order to protect human research subjects adequately.

  16. Acceptability, Safety, and Efficacy of Oral Administration of Extracts of Black or Red Maca (Lepidium meyenii) in Adult Human Subjects: A Randomized, Double-Blind, Placebo-Controlled Study.

    PubMed

    Gonzales-Arimborgo, Carla; Yupanqui, Irma; Montero, Elsa; Alarcón-Yaquetto, Dulce E; Zevallos-Concha, Alisson; Caballero, Lidia; Gasco, Manuel; Zhao, Jianping; Khan, Ikhlas A; Gonzales, Gustavo F

    2016-08-18

    The plant maca, grown at 4000 m altitude in the Peruvian Central Andes, contains hypocotyls that have been used as food and in traditional medicine for centuries. The aim of this research was to provide results on some health effects of oral administration of spray-dried extracts of black or red maca (Lepidium meyenii) in adult human subjects living at low (LA) and high altitude (HA). A total of 175 participants were given 3 g of either placebo, black, or red maca extract daily for 12 weeks. Primary outcomes were changes in sexual desire, mood, energy, health-related quality of life score (HRQL), and chronic mountain sickness (CMS) score, or in glycaemia, blood pressure, and hemoglobin levels. Secondary outcomes were acceptability and safety, assessed using the Likert test and side effect self-recording, respectively, and the effect of altitude. At low altitude, 32, 30, and 32 participants started the study receiving placebo, red maca, or black maca, respectively. At high altitudes, 33, 35, and 31 participants started the study receiving placebo, red maca, and black maca, respectively. Consumption of spray-dried extracts of red and black maca resulted in improvement in mood, energy, and health status, and reduced CMS score. Fatty acids and macamides were higher in spray-dried extracts of black maca than in red maca. GABA predominated in spray-dried extracts of red maca. Effects on mood, energy, and CMS score were better with red maca. Black maca and, in smaller proportions, red maca reduced hemoglobin levels only in highlanders with abnormally high hemoglobin levels; neither variety of maca reduced hemoglobin levels in lowlanders. Black maca reduced blood glucose levels. Both varieties produced similar responses in mood, and HRQL score. Maca extracts consumed at LA or HA had good acceptability and did not show serious adverse effects. In conclusion, maca extract consumption relative to the placebo improved quality of life parameters. Differences in the level of

  17. Acceptability, Safety, and Efficacy of Oral Administration of Extracts of Black or Red Maca (Lepidium meyenii) in Adult Human Subjects: A Randomized, Double-Blind, Placebo-Controlled Study

    PubMed Central

    Gonzales-Arimborgo, Carla; Yupanqui, Irma; Montero, Elsa; Alarcón-Yaquetto, Dulce E.; Zevallos-Concha, Alisson; Caballero, Lidia; Gasco, Manuel; Zhao, Jianping; Khan, Ikhlas A.; Gonzales, Gustavo F.

    2016-01-01

    The plant maca, grown at 4000 m altitude in the Peruvian Central Andes, contains hypocotyls that have been used as food and in traditional medicine for centuries. The aim of this research was to provide results on some health effects of oral administration of spray-dried extracts of black or red maca (Lepidium meyenii) in adult human subjects living at low (LA) and high altitude (HA). A total of 175 participants were given 3 g of either placebo, black, or red maca extract daily for 12 weeks. Primary outcomes were changes in sexual desire, mood, energy, health-related quality of life score (HRQL), and chronic mountain sickness (CMS) score, or in glycaemia, blood pressure, and hemoglobin levels. Secondary outcomes were acceptability and safety, assessed using the Likert test and side effect self-recording, respectively, and the effect of altitude. At low altitude, 32, 30, and 32 participants started the study receiving placebo, red maca, or black maca, respectively. At high altitudes, 33, 35, and 31 participants started the study receiving placebo, red maca, and black maca, respectively. Consumption of spray-dried extracts of red and black maca resulted in improvement in mood, energy, and health status, and reduced CMS score. Fatty acids and macamides were higher in spray-dried extracts of black maca than in red maca. GABA predominated in spray-dried extracts of red maca. Effects on mood, energy, and CMS score were better with red maca. Black maca and, in smaller proportions, red maca reduced hemoglobin levels only in highlanders with abnormally high hemoglobin levels; neither variety of maca reduced hemoglobin levels in lowlanders. Black maca reduced blood glucose levels. Both varieties produced similar responses in mood, and HRQL score. Maca extracts consumed at LA or HA had good acceptability and did not show serious adverse effects. In conclusion, maca extract consumption relative to the placebo improved quality of life parameters. Differences in the level of

  18. 76 FR 54408 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

    ... Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Parts 50 and 56 Human Subjects Research Protections: Enhancing Protections for Research Subjects...

  19. 48 CFR 1252.223-72 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Traffic Safety Administration (NHTSA) policies and procedures for the protection of human subjects... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Protection of human....223-72 Protection of human subjects. As prescribed in (TAR) 48 CFR 1223.7000(b), insert the...

  20. 48 CFR 3424.170 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a...

  1. 48 CFR 352.270-4 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Protection of human subjects. (a) As prescribed in 370.303(a), the Contracting Officer shall insert...

  2. 48 CFR 352.270-4 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Protection of human subjects. (a) As prescribed in 370.303(a), the Contracting Officer shall insert...

  3. 48 CFR 352.270-4 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Protection of human subjects. (a) As prescribed in 370.303(a), the Contracting Officer shall insert...

  4. 48 CFR 1252.223-72 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Protection of human....223-72 Protection of human subjects. As prescribed in (TAR) 48 CFR 1223.7000(b), insert the following clause: Protection of Human Subjects (APR 2005) The Contractor shall comply with the National...

  5. 48 CFR 3424.170 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a...

  6. 48 CFR 3424.170 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a...

  7. 48 CFR 352.270-4 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Protection of human subjects. (a) As prescribed in 370.303(a), the Contracting Officer shall insert...

  8. 42 CFR 86.19 - Human subjects; animal welfare.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Human subjects; animal welfare. 86.19 Section 86.19 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND... Occupational Safety and Health Training Grants § 86.19 Human subjects; animal welfare. No grant award may...

  9. 42 CFR 86.19 - Human subjects; animal welfare.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Human subjects; animal welfare. 86.19 Section 86.19 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND... Occupational Safety and Health Training Grants § 86.19 Human subjects; animal welfare. No grant award may...

  10. 48 CFR 1252.223-72 - Protection of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Protection of human....223-72 Protection of human subjects. As prescribed in (TAR) 48 CFR 1223.7000(b), insert the following clause: Protection of Human Subjects (APR 2005) The Contractor shall comply with the National...

  11. 42 CFR 86.33 - Human subjects; animal welfare.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Human subjects; animal welfare. 86.33 Section 86.33 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND... Occupational Safety and Health Direct Traineeships § 86.33 Human subjects; animal welfare. Where...

  12. 48 CFR 352.270-4 - Protection of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Protection of human subjects. (a) As prescribed in 370.303(a), the Contracting Officer shall insert...

  13. 48 CFR 252.235-7004 - Protection of Human Subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Protection of Human... of Provisions And Clauses 252.235-7004 Protection of Human Subjects. As prescribed in 235.072(e), use the following clause: Protection of Human Subjects (JUL 2009) (a) Definitions. As used in this...

  14. 48 CFR 1523.303-70 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects....

  15. 48 CFR 3424.170 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a...

  16. 42 CFR 86.33 - Human subjects; animal welfare.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Human subjects; animal welfare. 86.33 Section 86.33 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND... Occupational Safety and Health Direct Traineeships § 86.33 Human subjects; animal welfare. Where...

  17. 48 CFR 252.235-7004 - Protection of Human Subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Protection of Human... of Provisions And Clauses 252.235-7004 Protection of Human Subjects. As prescribed in 235.072(e), use the following clause: Protection of Human Subjects (JUL 2009) (a) Definitions. As used in this...

  18. 48 CFR 1252.223-72 - Protection of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Protection of human....223-72 Protection of human subjects. As prescribed in (TAR) 48 CFR 1223.7000(b), insert the following clause: Protection of Human Subjects (APR 2005) The Contractor shall comply with the National...

  19. 48 CFR 1523.303-70 - Protection of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects....

  20. Braille character discrimination in blindfolded human subjects.

    PubMed

    Kauffman, Thomas; Théoret, Hugo; Pascual-Leone, Alvaro

    2002-04-16

    Visual deprivation may lead to enhanced performance in other sensory modalities. Whether this is the case in the tactile modality is controversial and may depend upon specific training and experience. We compared the performance of sighted subjects on a Braille character discrimination task to that of normal individuals blindfolded for a period of five days. Some participants in each group (blindfolded and sighted) received intensive Braille training to offset the effects of experience. Blindfolded subjects performed better than sighted subjects in the Braille discrimination task, irrespective of tactile training. For the left index finger, which had not been used in the formal Braille classes, blindfolding had no effect on performance while subjects who underwent tactile training outperformed non-stimulated participants. These results suggest that visual deprivation speeds up Braille learning and may be associated with behaviorally relevant neuroplastic changes.

  1. 48 CFR 1352.235-70 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms..., questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB; (3) Documentation of... . (f) In addition, if the contractor modifies a human subjects research protocol, questionnaire,...

  2. Inhalation of road dust by human subjects.

    PubMed

    Takishima, T; Nakamura, M; Sasaki, M; Miyano, M; Yamaya, M; Sasaki, H

    1987-11-01

    We measured pneumomagnetic field strength (PMFS) in 42 healthy control subjects living in districts of Northern Japan with low levels of road dust pollution and in 39 healthy subjects living in areas with high levels of road dust pollution. Suspended road dust produced by studded tires increases from 30 micrograms/m3 during the summer season to levels as high as 400 micrograms/m3 during the snow season in the downtown areas of Sendai, Japan. Road dust retained in the lungs, containing 3% iron, was magnetized from the surface of the chest wall, and PMFS was measured. Three to 5 sequential PMFS measurements were made in each subject in March and October of 1984 and 1985, and in March 1986. The PMFS in control subjects in March 1984 was 37 +/- 14 pico-Tesla (mean +/- SD) and did not significantly differ from the PMFS in October 1984 or that in March 1985. In March 1984, the PMFS of the subjects in highly polluted areas was 95 +/- 100 pico-Tesla (mean +/- SD) and was significantly higher than that of control subjects (p less than 0.01) and subsequently decreased in March 1985 and in March 1986, corresponding to a decrease in suspended road dust brought about by a campaign to eliminate the use of studded tires. Our findings suggest that some road dust caused by studded tires is retained in the lungs.

  3. Condylar volume and surface in Caucasian young adult subjects

    PubMed Central

    2010-01-01

    Background There have been no quantitative standards for volumetric and surface measurements of the mandibular condyle in Caucasian population. However, the recently developed cone-beam computed tomography (CBCT) system allows measurement of these parameters with high accuracy. Methods CBCT was used to measure the condylar volume, surface and the volume to surface ratio, called the Morphometric Index (MI), of 300 temporo-mandibular joints (TMJ) in 150 Caucasian young adult subjects, with varied malocclusions, without pain or dysfunction of TMJs. Results The condylar volume was 691.26 ± 54.52 mm3 in males and 669.65 ± 58.80 mm3 in, and was significantly higher (p< 0.001) in the males. The same was observed for the condylar surface, although without statistical significance (406.02 ± 55.22 mm2 in males and 394.77 ± 60.73 mm2 in females). Furthermore, the condylar volume (693.61 ± 62.82 mm3 ) in the right TMJ was significantly higher than in the left (666.99 ± 48.67 mm3, p < 0.001) as was the condylar surface (411.24 ± 57.99 mm2 in the right TMJ and 389.41 ± 56.63 mm2 in the left TMJ; t = 3.29; p < 0.01). The MI is 1.72 ± 0.17 for the whole sample, with no significant difference between males and females or the right and left sides. Conclusion These data from temporomandibular joints of patients without pain or clinical dysfunction might serve as examples of normal TMJ's in the general population not seeking orthodontic care. PMID:21194477

  4. Morphological Uniformity and the Null Subject Parameter in Adult SLA.

    ERIC Educational Resources Information Center

    Davies, William D.

    1996-01-01

    Focuses on the application of the Null Subject Parameter. Data reveals that some second-language learners exhibit knowledge that English is morphologically nonuniform yet still accept English null subject sentences. Findings disprove the Morphological Uniformity Hypothesis, indicating that any reformulation of the Null Subject Parameter must…

  5. 42 CFR 86.33 - Human subjects; animal welfare.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Human subjects; animal welfare. 86.33 Section 86.33... Occupational Safety and Health Direct Traineeships § 86.33 Human subjects; animal welfare. Where the...) Chapter 1-43 of the Department Grants Administration Manual 2 068 concerning animal welfare. 2...

  6. 42 CFR 86.19 - Human subjects; animal welfare.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Human subjects; animal welfare. 86.19 Section 86.19... Occupational Safety and Health Training Grants § 86.19 Human subjects; animal welfare. No grant award may be... concerning animal welfare. 2 The Department Grants Administration Manual is available for inspection at...

  7. 42 CFR 86.19 - Human subjects; animal welfare.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Human subjects; animal welfare. 86.19 Section 86.19... Occupational Safety and Health Training Grants § 86.19 Human subjects; animal welfare. No grant award may be... concerning animal welfare. 2 The Department Grants Administration Manual is available for inspection at...

  8. 42 CFR 86.33 - Human subjects; animal welfare.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Human subjects; animal welfare. 86.33 Section 86.33... Occupational Safety and Health Direct Traineeships § 86.33 Human subjects; animal welfare. Where the...) Chapter 1-43 of the Department Grants Administration Manual 2 068 concerning animal welfare. 2...

  9. 42 CFR 86.19 - Human subjects; animal welfare.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Human subjects; animal welfare. 86.19 Section 86.19... Occupational Safety and Health Training Grants § 86.19 Human subjects; animal welfare. No grant award may be... concerning animal welfare. 2 The Department Grants Administration Manual is available for inspection at...

  10. 42 CFR 86.33 - Human subjects; animal welfare.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Human subjects; animal welfare. 86.33 Section 86.33... Occupational Safety and Health Direct Traineeships § 86.33 Human subjects; animal welfare. Where the...) Chapter 1-43 of the Department Grants Administration Manual 2 068 concerning animal welfare. 2...

  11. Interrelations between Subjective Health and Episodic Memory Change in Swedish and Canadian Samples of Older Adults

    ERIC Educational Resources Information Center

    Wahlin, Ake; Maitland, Scott B.; Backman, Lars; Dixon, Roger A.

    2003-01-01

    Recent research has documented associations between subjective health ratings and objective indicators of disease and death. Less is known about relations between subjective health ratings and level of cognitive performance in older adults. In this study, we explored whether subjective health ratings are related to episodic memory performance,…

  12. 48 CFR 1552.223-70 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Contractor shall protect the rights and welfare of human subjects in accordance with the procedures specified... Contractor shall bear full responsibility for the proper and safe performance of all work and...

  13. 48 CFR 1552.223-70 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Contractor shall protect the rights and welfare of human subjects in accordance with the procedures specified... Contractor shall bear full responsibility for the proper and safe performance of all work and...

  14. Comparative analysis of NK cell receptor repertoire in adults and very elderly subjects with cytomegalovirus infection.

    PubMed

    Juárez-Vega, Guillermo; Rangel-Ramírez, Velia; Monsiváis-Urenda, Adriana; Niño-Moreno, Perla; Garcia-Sepúlveda, Christian; Noyola, Daniel E; González-Amaro, Roberto

    2017-01-16

    Human cytomegalovirus (HCMV) infection in children and young adults has been associated with changes in the innate immune system. We herein analyzed the possible effect of very long term HCMV infection on the expression of several NK cell receptors. Ninety HCMV-seropositive individuals were included and classified as young adults (n=30), elderly (n=30) and very elderly subjects (n=30). A peripheral blood sample was obtained and the expression of NK cell receptors (NKG2A, NKG2C, ILT2, CD161, KIR2DL1, KIR3DL1, and KIR3DL2) by NK and other lymphocyte subsets was assessed by flow cytometry. In addition, the frequency of the sixteen KIR genes was analyzed by polymerase chain reaction. We found a significant increase in the number of NKG2C+ NK and T cells in elderly individuals compared to young adults accompanied by an opposite trend in the number of NKG2A+ lymphocytes, and ILT2+ cells were also increased in elderly individuals. A significant increase in the levels of CD3-CD56+NKG2C+CD57+ cells was also detected in the elderly groups. Finally, KIR gene analysis revealed that the KIR genotype 2 was significantly less frequent in the elderly individuals. Our results support that long-term infection by HCMV exerts a significant progressive effect on the innate immune system.

  15. Federal Policy for the Protection of Human Subjects. Final rule.

    PubMed

    2017-01-19

    The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.

  16. Subject Retrieval from Full-Text Databases in the Humanities

    ERIC Educational Resources Information Center

    East, John W.

    2007-01-01

    This paper examines the problems involved in subject retrieval from full-text databases of secondary materials in the humanities. Ten such databases were studied and their search functionality evaluated, focusing on factors such as Boolean operators, document surrogates, limiting by subject area, proximity operators, phrase searching, wildcards,…

  17. Financial conflicts of interest in biomedical human subject research.

    PubMed

    Goldstein, Nathan

    2006-01-01

    The purpose of this paper is to examine the past, present and future of financial conflict of interest regulation in biomedical human subject testing. Part I will briefly review the forces giving rise to the current controversy. Part II will examine the more influential ethical codes on human subject testing and argue that they are inconclusive on the subject of financial conflicts of interest. Part III will examine the various regulations now in place and identify their serious flaws. Part IV will critique the leading proposals for reform. The Conclusion will synthesize the best features of the various proposals for reform and suggest improvements left unaddressed by these proposals.

  18. Ethics Review of Research Projects Involving Human Subjects.

    ERIC Educational Resources Information Center

    Olivier, Steve

    2002-01-01

    Maltreatment of subjects has led to the introduction of an ethics review process for research involving humans. Institutional Review Boards (IRBs) require investigators to justify their human research to peers prior to recruiting participants. This paper describes the composition, functions, and duties of IRBs; the effectiveness and…

  19. Protection of Human Subjects: A Primer for the New Administrator.

    ERIC Educational Resources Information Center

    Steinert, Bruce W.

    2002-01-01

    Discusses clinical trials in general, protecting human research subjects, and the role the research administrator can play in facilitating the process. The discussion is not intended to be a thorough treatise on clinical trials, but is an overview of new and lesser known human protection issues that are better handled prospectively. (EV)

  20. Adapting and Vibration: Empirical Evidence from Human Subjects Experiments

    NASA Astrophysics Data System (ADS)

    Wang, Zhijian; Xu, Bin; Yan, Dadong

    2010-03-01

    We report a vibration-like social phenomenon (mass behavior of human subjects) in the experiments of experimental economics. vibration is a long existed concept and a widely existed phenomenon in natural and in social phenomena. Usually, the causal of social phenomena is unclear, but recently developed experimental economics studies in laboratory make it possible. During a game in a laboratory experiment, the human subjects are interacting with each other by the strategies of the game, and as a phenomena, the society is keeping evolution. In strategy space, the variables as velocity, accelerant and speed of the subjects can be measured from the detail records of the human subjects from the experiments. Data from the human subjects experiments, which are from Public Goods Game (Chen and Tang, Journal Political Economics, 1998), 2x2 Games (Hyndman, et al, Experimental Economics, 2009) and Prisoners' Dilemma (Duffy and Ochs, Game and Economics behavior, 2009), is implicitly analysis, and harmonic-vibration-like phenomena is shown. This might be helpful to understand the dynamical proceeding of the adaption of a society of human subjects.

  1. Research involving human subjects: ethical and regulatory issues.

    PubMed

    Menikoff, Jerry

    2013-01-01

    A history of past abuses on research with human subjects has led to various sets of rules that are designed to insure ethical practices to protect research subjects appropriately. To understand these rules, it is important to appreciate the significant differences between being a patient, where protecting the best interests of that patient is the primary goal, and being a research subject, where that is generally not the case. In the research setting, there can be a conflict between attempting to answer the research question, and doing what is best for the subject. The rules for conducting research with human subjects attempt to manage this conflict in an ethically acceptable manner. This chapter provides an overview of those rules, including a somewhat extended discussion of the U.S. "Common Rule" as a particular example.

  2. Adult Female Victims of Child Sexual Abuse: Multitype Maltreatment and Disclosure Characteristics Related to Subjective Health

    ERIC Educational Resources Information Center

    Jonzon, Eva; Lindblad, Frank

    2005-01-01

    This study examined the impact of child sexual abuse and disclosure characteristics on adult psychological and psychosomatic symptoms. Data on abuse characteristics, disclosure-related events, and subjective health were collected through semistructured interviews and questionnaires from 123 adult women reporting having been sexually abused in…

  3. Adults' Autonomic and Subjective Emotional Responses to Infant Vocalizations: The Role of Secure Base Script Knowledge

    ERIC Educational Resources Information Center

    Groh, Ashley M.; Roisman, Glenn I.

    2009-01-01

    This article examines the extent to which secure base script knowledge--as reflected in an adult's ability to generate narratives in which attachment-related threats are recognized, competent help is provided, and the problem is resolved--is associated with adults' autonomic and subjective emotional responses to infant distress and nondistress…

  4. The place of the human subject in the operant laboratory

    PubMed Central

    Baron, Alan; Perone, Michael

    1982-01-01

    Although laboratory study of human behavior seems an obvious vehicle for strengthening the scientific base of behavior analysis, the place of the human subject within the operant laboratory remains problematic. The prevailing research strategy has been to link principles developed with animals to human affairs, either through interpretation of naturally occurring human behaviors or through application of the principles to the solution of human problems. The paucity of laboratory research on human operant behavior derives from several misconceptions: the possibility that experimental demand characteristics and pre-experimental behavioral dispositions of human subjects contaminate the results; that ethical considerations place undue constraint on research topics and experimental designs; and that uncontrollable variation in subjects' histories and other relevant personal characteristics prevents observation of reliable functional relations. We argue that these problems do not pose insurmountable obstacles to the experimental analysis of human behavior; that adequate methods of control and analysis are available; and that operant techniques, by emphasizing experimentally imposed contingencies, are well suited for the laboratory study of human behavior. PMID:22478566

  5. Measuring the exhaled breath of a manikin and human subjects.

    PubMed

    Xu, C; Nielsen, P V; Gong, G; Liu, L; Jensen, R L

    2015-04-01

    Due to scarcity of accurate information and available data of actual human breathing, this investigation focuses on characterizing the breathing dynamic process based on the measurement of healthy human subjects. The similarities and differences between one breathing thermal manikin and the human subjects, including geometry and breathing functions, were thoroughly studied. As expected, actual human breathing is more complicated than that of the manikin in terms of airflow fluctuations, individual differences, and exhaled flow directions. The simplification of manikin mouth structure could result in overestimated exhaled velocity and contaminant concentration. Furthermore, actual human breathing appears to be relatively stable and reproducible for an individual person in several conditions and is also accompanied by some uncertainties simultaneously. The averaged values are used to analyze the overall characteristics of actual human breathing. There are different characteristics of the exhaled breath between male and female subjects with or without wearing a nose clip. The experimental results obtained from the measurement of human subjects may be helpful for manikin specification or validation and accuracy assessment of CFD simulations.

  6. 76 FR 44512 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or... fundamental ethical principles for all human subjects research--respect for persons, beneficence, and justice... some other person of such minimal risk exempt studies is neither required nor even recommended;...

  7. Assessing Subjective Well-Being in Chinese Older Adults: The Chinese Aging Well Profile

    ERIC Educational Resources Information Center

    Ku, Po-Wen; Fox, Kenneth R.; McKenna, Jim

    2008-01-01

    Subjective well-being has increasingly been used as a key indicator of quality of life in older people. Existing evidence shows that it is likely that eastern cultures carry different life values and so the Chinese Aging Well Profile was devised for measuring subjective well-being in Chinese adults (50+). Data was collected from 1,906…

  8. Do Social Networks Improve Chinese Adults' Subjective Well-being?

    PubMed

    Lei, Xiaoyan; Shen, Yan; Smith, James P; Zhou, Guangsu

    2015-12-01

    This paper studies relationships between social networks, health and subjective well-being (SWB) using nationally representative data of the Chinese Population-the Chinese Family Panel Studies (CFPS). Our data contain SWB indicators in two widely used variants-happiness and life-satisfaction. Social network variables used include kinship relationships measured by marital status, family size, and having a genealogy; ties with friends/relatives/neighbors measured by holiday visitation, frequency of contacts, and whether and value gifts given and received; total number and time spent in social activities, and engagement in organizations including the communist party, religious groups, and other types. We find that giving and receiving gifts has a larger impact on SWB than either just giving or receiving them. Similarly the number of friends is more important than number of relatives, and marriage is associated with higher levels of SWB. Time spent in social activities and varieties of activities both matter for SWB but varieties matter more. Participation in organizations is associated with higher SWB across such diverse groups as being a member of the communist party or a religious organization. China represents an interesting test since it is simultaneously a traditional society with long-established norms about appropriate social networks and a rapidly changing society due to substantial economic and demographic changes. We find that it is better to both give and receive, to engage in more types of social activities, and that participation in groups all improve well-being of Chinese people.

  9. Reporting results of research involving human subjects: an ethical obligation.

    PubMed

    Alley, Allison Baer; Seo, Jeong-Wook; Hong, Sung-Tae

    2015-06-01

    Researchers have an ethical responsibility to report the results of research involving human subjects. Dissemination of results ensures that patient care is based on good science and that the field of medicine advances based on complete and accurate knowledge. However, current evidence suggests that publication is often neglected or substantially delayed, especially in the case of negative and inconclusive results. Researchers, editors and reviewers should value all high-quality research regardless of the conclusiveness of the results and ensure that all research involving human subjects is registered in a publicly accessible database.

  10. Federal policy for the protection of human subjects. Final rule.

    PubMed

    1991-06-18

    This document sets forth a common Federal Policy for the Protection of Human Subjects (Model Policy) accepted by the Office of Science and Technology Policy and promulgated in regulation by each of the listed Departments and Agencies. A Proposed Federal Policy for the Protection of Human Subjects published November 10, 1988 (53 FR 45661) has been revised in response to public comments. The Policy as revised is now set forth as a common final rule. For related documents, see other sections of this Federal Register part.

  11. Angiogenic properties of adult human thymus fat.

    PubMed

    Salas, Julián; Montiel, Mercedes; Jiménez, Eugenio; Valenzuela, Miguel; Valderrama, José Francisco; Castillo, Rafael; González, Sergio; El Bekay, Rajaa

    2009-11-01

    The endogenous proangiogenic properties of adipose tissue are well recognized. Although the adult human thymus has long been known to degenerate into fat tissue, it has never been considered as a potential source of angiogenic factors. We have investigated the expression of diverse angiogenic factors, including vascular endothelial growth factor A and B, angiopoietin 1, and tyrosine-protein kinase receptor-2 (an angiopoietin receptor), and then analyzed their physiological role on endothelial cell migration and proliferation, two relevant events in angiogenesis. The detection of the gene and protein expression of the various proteins has been performed by immunohistochemistry, Western blotting, and quantitative real-time polymerase chain reaction. We show, for the first time, that adult thymus fat produces a variety of angiogenic factors and induces the proliferation and migration of human umbilical cord endothelial cells. Based on these findings, we suggest that this fat has a potential angiogenic function that might affect thymic function and ongoing adipogenesis within the thymus.

  12. Demystifying the IRB: Human Subjects Research in Academic Libraries

    ERIC Educational Resources Information Center

    Smale, Maura A.

    2010-01-01

    Many academic librarians are interested in pursuing research studies that involve students, faculty, and other library patrons; these projects must be approved by an institutional review board (IRB). This article reviews federal requirements and regulations for human subjects research and explains the IRB application process. The author discusses…

  13. Human Subjects Research by Business Students: Beyond the Red Tape.

    ERIC Educational Resources Information Center

    Jenson, Jill D.; Mackiewicz, Jo; Riley, Kathryn

    2003-01-01

    Suggests business communication faculty will benefit from an understanding of three areas related to Institutional Review Board (IRB) review of class projects involving human subjects research: (1) whether their institution requires such class projects to be reviewed by the IRB; (2) how they can adapt classroom activities, materials, and…

  14. Can Human Subject Pool Participation Benefit Sociology Students?

    ERIC Educational Resources Information Center

    Chin, Lynn Gencianeo; Gibbs Stayte, Patricia

    2015-01-01

    Instructors at non-research institutions are less able to expose their students to research firsthand. Utilizing human subject pools (HSPs) in class may be a solution. Given that HSPs tend to be used in introduction to psychology classes at research institutions, we examine a community college HSP to answer three questions: (1) Do community…

  15. 48 CFR 1523.303-70 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Protection of human subjects. 1523.303-70 Section 1523.303-70 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SOCIOECONOMIC PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE...

  16. 48 CFR 1523.303-70 - Protection of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Protection of human subjects. 1523.303-70 Section 1523.303-70 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SOCIOECONOMIC PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE...

  17. 48 CFR 1523.303-70 - Protection of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Protection of human subjects. 1523.303-70 Section 1523.303-70 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SOCIOECONOMIC PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE...

  18. Attachment, self-compassion, empathy, and subjective well-being among college students and community adults.

    PubMed

    Wei, Meifen; Liao, Kelly Yu-Hsin; Ku, Tsun-Yao; Shaffer, Phillip A

    2011-02-01

    Research on subjective well-being suggests that it is only partly a function of environmental circumstances. There may be a personality characteristic or a resilient disposition toward experiencing high levels of well-being even in unfavorable circumstances. Adult attachment may contribute to this resilient disposition. This study examined whether the association between attachment anxiety and subjective well-being was mediated by Neff's (2003a, 2003b) concept of self-compassion. It also examined empathy toward others as a mediator in the association between attachment avoidance and subjective well-being. In Study 1, 195 college students completed self-report surveys. In Study 2, 136 community adults provided a cross-validation of the results. As expected, across these 2 samples, findings suggested that self-compassion mediated the association between attachment anxiety and subjective well-being, and emotional empathy toward others mediated the association between attachment avoidance and subjective well-being.

  19. Uniquely hominid features of adult human astrocytes.

    PubMed

    Oberheim, Nancy Ann; Takano, Takahiro; Han, Xiaoning; He, Wei; Lin, Jane H C; Wang, Fushun; Xu, Qiwu; Wyatt, Jeffrey D; Pilcher, Webster; Ojemann, Jeffrey G; Ransom, Bruce R; Goldman, Steven A; Nedergaard, Maiken

    2009-03-11

    Defining the microanatomic differences between the human brain and that of other mammals is key to understanding its unique computational power. Although much effort has been devoted to comparative studies of neurons, astrocytes have received far less attention. We report here that protoplasmic astrocytes in human neocortex are 2.6-fold larger in diameter and extend 10-fold more GFAP (glial fibrillary acidic protein)-positive primary processes than their rodent counterparts. In cortical slices prepared from acutely resected surgical tissue, protoplasmic astrocytes propagate Ca(2+) waves with a speed of 36 microm/s, approximately fourfold faster than rodent. Human astrocytes also transiently increase cystosolic Ca(2+) in response to glutamatergic and purinergic receptor agonists. The human neocortex also harbors several anatomically defined subclasses of astrocytes not represented in rodents. These include a population of astrocytes that reside in layers 5-6 and extend long fibers characterized by regularly spaced varicosities. Another specialized type of astrocyte, the interlaminar astrocyte, abundantly populates the superficial cortical layers and extends long processes without varicosities to cortical layers 3 and 4. Human fibrous astrocytes resemble their rodent counterpart but are larger in diameter. Thus, human cortical astrocytes are both larger, and structurally both more complex and more diverse, than those of rodents. On this basis, we posit that this astrocytic complexity has permitted the increased functional competence of the adult human brain.

  20. Aging 5 years in 5 minutes: the effect of taking a memory test on older adults' subjective age.

    PubMed

    Hughes, Matthew L; Geraci, Lisa; De Forrest, Ross L

    2013-12-01

    How old one feels-one's subjective age-has been shown to predict important psychological and health outcomes. The current studies examined the effect of taking a standard memory test on older adults' subjective age. Study 1 showed that older adults felt older after taking a standard neuropsychological screening test and participating in a free-recall experiment than they felt at baseline. Study 2 showed that the effect was selective to older adults: Younger adults' subjective age was not affected by participating in the memory experiment. Study 3 showed that the subjective-aging effect was specific to memory, as taking a vocabulary test for a similar amount of time did not affect older adults' subjective age. Finally, Study 4 showed that simply expecting to take a memory test subjectively aged older adults. The results indicate that being in a memory-testing context affects older adults' self-perception by making them feel older.

  1. Beyond human subjects: risk, ethics, and clinical development of nanomedicines.

    PubMed

    Kimmelman, Jonathan

    2012-01-01

    Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena.

  2. Subjective health literacy and older adults' assessment of direct-to-consumer prescription drug ads.

    PubMed

    An, Soontae; Muturi, Nancy

    2011-01-01

    Older adults are increasingly the intended target of direct-to-consumer (DTC) prescription drug ads, but limited evidence exists as to how they assess the educational value of DTC ads and, more importantly, whether their assessment depends on their level of health literacy. In-person interviews of 170 older adults revealed that those with low subjective health literacy evaluated the educational value of DTC ads significantly lower than did those with high subjective health literacy. The results prompt us to pay more scholarly attention to determining how effectively DTC ads convey useful medical information, particularly to those with limited health literacy.

  3. 40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human...

  4. 45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the...

  5. 40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human...

  6. 40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human...

  7. 45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... involving human subjects. 46.119 Section 46.119 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the...

  8. 45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the...

  9. 45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the...

  10. 40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human...

  11. 40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human...

  12. 45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the...

  13. The effect of cognitive testing and feedback on older adults' subjective age.

    PubMed

    Geraci, Lisa; De Forrest, Ross; Hughes, Matthew; Saenz, Gabriel; Tirso, Robert

    2017-03-10

    Subjective age, or how old a person feels, is an important measure of self-perception that is associated with consequential cognitive and health outcomes. Recent research suggests that subjective age is affected by certain situations, including cognitive testing contexts. The current study examined whether cognitive testing and positive performance feedback affect subjective age and subsequent cognitive performance. Older adults took a series of neuropsychological and cognitive tests and subjective age was measured at various time points. Participants also either received positive or no feedback on an initial cognitive task, an analogies task. Results showed that participants felt older over the course of the testing session, particularly after taking a working memory test, relative to baseline. Positive feedback did not significantly mitigate this subjective aging effect. Results suggest that subjective age is malleable and that it can be affected by standard cognitive and neuropsychological test conditions.

  14. Help-Seeking Response to Subjective Memory Complaints in Older Adults: Toward a Conceptual Model

    ERIC Educational Resources Information Center

    Begum, Aysha; Whitley, Rob; Banerjee, Sube; Matthews, David; Stewart, Robert; Morgan, Craig

    2013-01-01

    Purpose: Subjective memory complaint is a term used to refer older adults who report memory problems. Extensive literature exists on its etiology and impact on long-term cognitive decline, and some physicians consider it important in the early detection of dementia. Despite the salient features reported by both patients and clinicians, few people…

  15. Neighborhood Disadvantage, Social Comparisons, and the Subjective Assessment of Ambient Problems among Older Adults

    ERIC Educational Resources Information Center

    Schieman, Scott; Pearlin, Leonard I.

    2006-01-01

    Using data from adults age 65 and older in the District of Columbia and two adjoining counties in Maryland, we examine the association between community-level structural disadvantage and individuals' subjective assessments of neighborhood problems. In addition, we test whether or not perceptions of relative financial equality or inequality with…

  16. False Memories in Children and Adults: Age, Distinctiveness, and Subjective Experience.

    ERIC Educational Resources Information Center

    Ghetti, Simona; Qin, Jianjian; Goodman, Gail S.

    2002-01-01

    Investigated developmental trends associated with the Deese/Roediger-McDermott false-memory effect, the role of distinctive information, and subjective experience of true/false memories. Found that 5-year-olds recalled more false memories than adults but no age differences in recognition of critical lures. Distinctive information reduced false…

  17. Subjective Social Status and Positive Indicators of Well-Being among Emerging Adult College Students

    ERIC Educational Resources Information Center

    Zorotovich, Jennifer; Johnson, Elizabeth I.; Linn, Rebekah

    2016-01-01

    The current study extends research on social status and well-being among young people by examining whether subjective social status (SSS) is related to life satisfaction and happiness. Emerging adults (n = 383) between 18 and 29 provided data on demographic characteristics, SSS, life satisfaction, and happiness via an online survey. Regression…

  18. Culture, Parental Conflict, Parental Marital Status, and the Subjective Well-Being of Young Adults.

    ERIC Educational Resources Information Center

    Gohm, Carol L.; Oishi, Shigehiro; Darlington, Janet; Diener, Ed

    1998-01-01

    Study 1 found that subjective well-being was negatively associated with marital conflict among offspring of never-divorced and remarried parents. Study 2 found that the negative association of divorce and of marital conflict with the life satisfaction of the offspring did not differ for adopted young adults. (Author/MKA)

  19. Objective and Subjective Quality of Life in Adults with Autism Spectrum Disorders in Southern Spain

    ERIC Educational Resources Information Center

    Saldana, David; Alvarez, Rosa M.; Lobaton, Silvia; Lopez, Ana M.; Moreno, Macarena; Rojano, Miguel

    2009-01-01

    Subjective and objective measures of quality of life (QoL) were obtained for adults with autism spectrum disorders (ASDs) living in Andalusia (Spain). Seventy-four families responded to questionnaires about objective QoL indicators such as employment, health, adaptive behaviour and social network, and were asked to act as proxies for subjective…

  20. Revisiting the Structure of Subjective Well-Being in Middle-Aged Adults

    ERIC Educational Resources Information Center

    Chmiel, Magda; Brunner, Martin; Martin, Romain; Schalke, Daniela

    2012-01-01

    Subjective well-being is a broad, multifaceted construct comprising general satisfaction with life, satisfaction with life domains (health, family, people, free time, self, housing, work, and finances), positive affect, and negative affect. Drawing on representative data from middle-aged adults (N = 738), the authors used three different…

  1. Sex Determination of Adult Human Maxillary Sinuses on Panoramic Radiographs.

    PubMed

    Leao de Queiroz, Cristhiane; Terada, Andrea Sayuri Silveira Dias; Dezem, Thais Uenoyama; Gomes de Araújo, Lais; Galo, Rodrigo; Oliveira-Santos, Christiano; Alves da Silva, Ricardo Henrique

    2016-09-01

    The purpose of this study was to evaluate dimensions of adult human maxillary sinuses on panoramic radiographs and their possible application on the sex determination for forensic purposes. The sample comprised 64 database panoramic radiographs from individuals aged 20 years or older (32 male and 32 female subjects), with complete permanent dentition (or absence of third molars). One examiner measured the width and height of the right and left maxillary sinuses using the software Image J 1.47v (National Institutes of Health, Bethesda, USA). Measurements were repeated to calculate intra-observer agreement. Chi-Square test, Kappa, ANOVA and T-Student were used for results analysis for p≤ 0.05. Intra-observer agreement with correlation Kappa ranged between 0.38 and 0.96. For female subjects, the mean height and width of the left maxillary sinus were 28.7856mm and 44.6178mm, respectively. And right maxillary sinus was 27.7163mm for height and 45.1850mm for width. Male subjects were found to have the mean height and width of the left maxillary sinus 30.9981mm and 48.7753mm, respectively. And right maxillary sinus was 30.7403mm for height and 48.5753mm for width. There was a statistically significant difference in the height and width of maxillary sinuses between males and females. It can be concluded that maxillary sinuses height and width on panoramic radiographs can be used to determine the gender of adult human subjects.

  2. Sex Determination of Adult Human Maxillary Sinuses on Panoramic Radiographs

    PubMed Central

    Leao de Queiroz, Cristhiane; Terada, Andrea Sayuri Silveira Dias; Dezem, Thais Uenoyama; Gomes de Araújo, Lais; Galo, Rodrigo; Oliveira-Santos, Christiano

    2016-01-01

    Absract The purpose of this study was to evaluate dimensions of adult human maxillary sinuses on panoramic radiographs and their possible application on the sex determination for forensic purposes. The sample comprised 64 database panoramic radiographs from individuals aged 20 years or older (32 male and 32 female subjects), with complete permanent dentition (or absence of third molars). One examiner measured the width and height of the right and left maxillary sinuses using the software Image J 1.47v (National Institutes of Health, Bethesda, USA). Measurements were repeated to calculate intra-observer agreement. Chi-Square test, Kappa, ANOVA and T-Student were used for results analysis for p≤ 0.05. Intra-observer agreement with correlation Kappa ranged between 0.38 and 0.96. For female subjects, the mean height and width of the left maxillary sinus were 28.7856mm and 44.6178mm, respectively. And right maxillary sinus was 27.7163mm for height and 45.1850mm for width. Male subjects were found to have the mean height and width of the left maxillary sinus 30.9981mm and 48.7753mm, respectively. And right maxillary sinus was 30.7403mm for height and 48.5753mm for width. There was a statistically significant difference in the height and width of maxillary sinuses between males and females. It can be concluded that maxillary sinuses height and width on panoramic radiographs can be used to determine the gender of adult human subjects. PMID:27847394

  3. OKN asymmetry in human subjects: a literature review.

    PubMed

    Knapp, Christopher M; Proudlock, Frank A; Gottlob, Irene

    2013-03-01

    Optokinetic nystagmus (OKN) is a reflex eye movement induced by motion of the whole or a large proportion of the visual field. It can be horizontal, vertical, and torsional in direction and consists of two basic components, a slow tracking movement and a rapid recovery saccade. Two forms of OKN exist: "look" and "stare" OKN. There is strong evidence that horizontal OKN is symmetrical in normal healthy adults and that the OKN gains can be influenced by a variety of different factors including target size, shape, contrast, and velocity. Vertical OKN on the other hand is less well understood, although there is a belief that vertical OKN is asymmetrical with an upward preference. Recent publications contradict this assertion. In this article a comprehensive literature review was carried out to determine whether a vertical OKN asymmetry exists in healthy subjects and to explain any anomalous findings.

  4. 10 CFR 745.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... human subjects. 745.119 Section 745.119 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve...

  5. 7 CFR 1c.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... human subjects. 1c.119 Section 1c.119 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later...

  6. 48 CFR 3452.224-72 - Research activities involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... involving human subjects. 3452.224-72 Section 3452.224-72 Federal Acquisition Regulations System DEPARTMENT... Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As prescribed... human subjects covered under 34 CFR part 97: Research Activities Involving Human Subjects (MAR 2011)...

  7. 10 CFR 745.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... human subjects. 745.119 Section 745.119 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve...

  8. 49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it...

  9. 49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it...

  10. 48 CFR 3452.224-72 - Research activities involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... involving human subjects. 3452.224-72 Section 3452.224-72 Federal Acquisition Regulations System DEPARTMENT... Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As prescribed... human subjects covered under 34 CFR part 97: Research Activities Involving Human Subjects (MAR 2011)...

  11. 22 CFR 225.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... involving human subjects. 225.119 Section 225.119 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it...

  12. 49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it...

  13. 10 CFR 745.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... human subjects. 745.119 Section 745.119 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve...

  14. 7 CFR 1c.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... human subjects. 1c.119 Section 1c.119 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later...

  15. 34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.119 Research undertaken without the intention of involving...

  16. 48 CFR 3452.224-72 - Research activities involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... involving human subjects. 3452.224-72 Section 3452.224-72 Federal Acquisition Regulations System DEPARTMENT... Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As prescribed... human subjects covered under 34 CFR part 97: Research Activities Involving Human Subjects (MAR 2011)...

  17. 22 CFR 225.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... involving human subjects. 225.119 Section 225.119 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it...

  18. 34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.119 Research undertaken without the intention of involving...

  19. 22 CFR 225.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... involving human subjects. 225.119 Section 225.119 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it...

  20. Generation of pluripotent stem cells from adult human testis.

    PubMed

    Conrad, Sabine; Renninger, Markus; Hennenlotter, Jörg; Wiesner, Tina; Just, Lothar; Bonin, Michael; Aicher, Wilhelm; Bühring, Hans-Jörg; Mattheus, Ulrich; Mack, Andreas; Wagner, Hans-Joachim; Minger, Stephen; Matzkies, Matthias; Reppel, Michael; Hescheler, Jürgen; Sievert, Karl-Dietrich; Stenzl, Arnulf; Skutella, Thomas

    2008-11-20

    Human primordial germ cells and mouse neonatal and adult germline stem cells are pluripotent and show similar properties to embryonic stem cells. Here we report the successful establishment of human adult germline stem cells derived from spermatogonial cells of adult human testis. Cellular and molecular characterization of these cells revealed many similarities to human embryonic stem cells, and the germline stem cells produced teratomas after transplantation into immunodeficient mice. The human adult germline stem cells differentiated into various types of somatic cells of all three germ layers when grown under conditions used to induce the differentiation of human embryonic stem cells. We conclude that the generation of human adult germline stem cells from testicular biopsies may provide simple and non-controversial access to individual cell-based therapy without the ethical and immunological problems associated with human embryonic stem cells.

  1. 16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data...

  2. 16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data...

  3. Community members as recruiters of human subjects: ethical considerations.

    PubMed

    Simon, Christian; Mosavel, Maghboeba

    2010-03-01

    Few studies have considered in detail the ethical issues surrounding research in which investigators ask community members to engage in research subject recruitment within their own communities. Peer-driven recruitment (PDR) and its variants are useful for accessing and including certain populations in research, but also have the potential to undermine the ethical and scientific integrity of community-based research. This paper examines the ethical implications of utilizing community members as recruiters of human subjects in the context of PDR, as well as the authors' experience with a variant of PDR in a research project in South Africa. The importance of situating PDR in a comprehensive community engagement process that is responsive to the constraints of science and local needs and interests is emphasized. The paper will have relevance to bioethicists, health researchers, and research regulators concerned about the appropriate use of peer-driven recruitment strategies in health research.

  4. THE CONCEPT OF RISK IN BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS

    PubMed Central

    VAN NESS, PETER H.

    2015-01-01

    An established ethical principle of biomedical research involving human subjects stipulates that risk to subjects should be proportionate to an experiment’s potential benefits. Sometimes this principle is imprecisely stated as a requirement that ‘risks and benefits’ be balanced. First, it is noted why this language is imprecise. Second, the persistence of such language is attributed to how it functions as a rhetorical trope. Finally, an argument is made that such a trope is infelicitous because it may not achieve its intended persuasive purposes. More importantly, it should be avoided because it masks the important role that chance plays in clinical research. Risk is the possibility of harm. As a precondition of harm it is unintended and undesirable in projects of biomedical research. It requires ethical vigilance. As a vehicle of chance, however, it is both intended and desirable. It requires methodological appreciation. PMID:11697390

  5. Metabolite alterations in the hippocampus of high-functioning adult subjects with autism.

    PubMed

    Suzuki, Katsuaki; Nishimura, Katsuhiko; Sugihara, Genichi; Nakamura, Kazuhiko; Tsuchiya, Kenji J; Matsumoto, Kaori; Takebayashi, Kiyokazu; Isoda, Haruo; Sakahara, Harumi; Sugiyama, Toshiro; Tsujii, Masatsugu; Takei, Nori; Mori, Norio

    2010-05-01

    The aim of the present study was to investigate metabolite alterations in the hippocampal formation as they relate to aggression in high-functioning adults with autism. We measured concentrations of N-acetylaspartate (NAA), choline-containing compounds (Cho), and creatine plus phosphocreatine (Cr+PCr) in the hippocampal formation by proton magnetic resonance spectroscopy in 12 non-medicated male subjects with autism and 12 age- and sex-matched controls. Aggression was scored in the autistic subjects using the Buss-Perry Aggression Questionnaire. The concentrations of Cho and Cr+PCr in the hippocampal formation in autistic subjects were significantly higher than the corresponding values in control subjects, and a significant positive correlation was observed between the concentrations of these metabolites in the hippocampal formation and scores on the Buss-Perry Aggression Questionnaire in autistic subjects. Results suggest that high-functioning adult subjects with autism have abnormal metabolite concentrations in the hippocampal formation, which may in part account for their aggression.

  6. Photographing human subjects in biomedical disciplines: an Islamic perspective.

    PubMed

    Saidun, Salilah

    2013-02-01

    Visual recording of human subjects is commonly used in biomedical disciplines for clinical, research, legal, academic and even personal purposes. Guidelines on practice standards of biomedical recording have been issued by certain health authorities, associations and journals, but none of the literature discusses this from an Islamic perspective. This article begins with a discussion on the general rules associated with visual recording in Islam, followed by modesty issues in biomedical recording and issues of informed consent and confidentiality. In order to be deemed ethical from the Islamic perspective, all the aforementioned criteria must conform to, or not contradict, Islamic teaching.

  7. Latent inhibition in human adults without masking.

    PubMed

    Escobar, Martha; Arcediano, Francisco; Miller, Ralph R

    2003-09-01

    Latent inhibition refers to attenuated responding to Cue X observed when the X-outcome pairings are preceded by X-alone presentations. It has proven difficult to obtain in human adults unless the preexposure (X-alone) presentations are embedded within a masking (i.e., distracting) task. The authors hypothesized that the difficulty in obtaining latent inhibition with unmasked tasks is related to the usual training procedures, in which the preexposure and conditioning experiences are separated by a set of instructions. Experiment 1 reports latent inhibition without masking in a task in which preexposure and conditioning occur without interruption. Experiments 2 and 3 demonstrate that this attenuation in responding to target Cue X does not pass a summation test for conditioned inhibition and is context specific, thereby confirming that it is latent inhibition. Experiments 3 and 4 confirm that introducing instructions between preexposure and conditioning disrupts latent inhibition.

  8. Human autonomic rhythms: vagal cardiac mechanisms in tetraplegic subjects

    NASA Technical Reports Server (NTRS)

    Koh, J.; Brown, T. E.; Beightol, L. A.; Ha, C. Y.; Eckberg, D. L.

    1994-01-01

    1. We studied eight young men (age range: 20-37 years) with chronic, clinically complete high cervical spinal cord injuries and ten age-matched healthy men to determine how interruption of connections between the central nervous system and spinal sympathetic motoneurones affects autonomic cardiovascular control. 2. Baseline diastolic pressures and R-R intervals (heart periods) were similar in the two groups. Slopes of R-R interval responses to brief neck pressure changes were significantly lower in tetraplegic than in healthy subjects, but slopes of R-R interval responses to steady-state arterial pressure reductions and increases were comparable. Plasma noradrenaline levels did not change significantly during steady-state arterial pressure reductions in tetraplegic patients, but rose sharply in healthy subjects. The range of arterial pressure and R-R interval responses to vasoactive drugs (nitroprusside and phenylephrine) was significantly greater in tetraplegic than healthy subjects. 3. Resting R-R interval spectral power at respiratory and low frequencies was similar in the two groups. During infusions of vasoactive drugs, low-frequency R-R interval spectral power was directly proportional to arterial pressure in tetraplegic patients, but was unrelated to arterial pressure in healthy subjects. Vagolytic doses of atropine nearly abolished both low- and respiratory-frequency R-R interval spectral power in both groups. 4. Our conclusions are as follows. First, since tetraplegic patients have significant levels of low-frequency arterial pressure and R-R interval spectral power, human Mayer arterial pressure waves may result from mechanisms that do not involve stimulation of spinal sympathetic motoneurones by brainstem neurones. Second, since in tetraplegic patients, low-frequency R-R interval spectral power is proportional to arterial pressure, it is likely to be mediated by a baroreflex mechanism. Third, since low-frequency R-R interval rhythms were nearly abolished

  9. Subject-specific computational modeling of human phonation

    PubMed Central

    Xue, Qian; Zheng, Xudong; Mittal, Rajat; Bielamowicz, Steven

    2014-01-01

    A direct numerical simulation of flow-structure interaction is carried out in a subject-specific larynx model to study human phonation under physiological conditions. The simulation results compare well to the established human data. The resulting glottal flow and waveform are found to be within the normal physiological ranges. The effects of realistic geometry on the vocal fold dynamics and the glottal flow are extensively examined. It is found that the asymmetric anterior-posterior laryngeal configuration produces strong anterior-posterior asymmetries in both vocal fold vibration and glottal flow which has not been captured in the simplified models. It needs to be pointed out that the observations from the current numerical simulation are only valid for the flow conditions investigated. The limitations of the study are also discussed. PMID:24606281

  10. Morphometric analysis of arteriolar tortuosity in human cerebral white matter of preterm, young, and aged subjects.

    PubMed

    Thore, Clara R; Anstrom, John A; Moody, Dixon M; Challa, Venkata R; Marion, Miranda C; Brown, William R

    2007-05-01

    Arteriolar tortuousities, consisting of vascular coils, loops, and spirals, appear in white matter in a subset of human cerebral vessels. Computerized morphometry was used to analyze brain sections from a broad age range of subjects to determine whether tortuosity is a phenomenon of aging or is associated with leukoaraiosis (LA) or Alzheimer disease (AD). Autopsy brains were studied from 55 subjects ranging in age from 23 weeks postconception to 102 years. Fourteen aged subjects were diagnosed with LA and 7 with AD. By using computerized morphometry, vascular curl (curvilinear length/straight length) was measured in white matter arterioles in 100-microm-thick, alkaline phosphatase-stained sections. Aging subjects, compared with young subjects, showed significant increases in both the prevalence and severity of tortuosity. Curl scores in aged subjects with LA or AD were not significantly different from aged controls without LA or AD. We conclude that 1) tortuous vessels are extremely rare in preterm babies, children, or young adults; 2) significant tortuosity, as indicated by elevated curl scores, begins in middle age; 3) tortuosity does not appear in a subset of aged individuals regardless of longevity; and 4) tortuosity does not appear in a subset of individuals with either LA or AD.

  11. Bioavailability and Pharmacodynamics of Promethazine in Human Subjects

    NASA Technical Reports Server (NTRS)

    Boyd, J. L.; Boster, B.; Wang, Z.; Shah, V.; Berens, K. L.; Sipes, W. E.; Anderson, K. E.; Putcha, L.

    2004-01-01

    The acute effects of exposure to microgravity include the development of space motion sickness, which usually requires therapeutic intervention. The current drug of choice, promethazine (PMZ), is available to astronauts in three different dosage forms during space flight; its side effects include nausea, dizziness, sedation and impaired psychomotor performance. This ground-based study is designed to validate flight-suitable methods for pharmacodynamic evaluation of PMZ and to estimate bioavailability and pharmacodynamics of PMZ. Experimental design consists of intramuscular administration of three doses of PMZ (12.5,25 and 50 mg) and placebo in a randomized double blind fashion to human subjects and collecting blood, urine and saliva samples for 72 h. Subjects also complete cognitive performance test batteries, WinSCAT (Windows based Space Cognitive Assessment Test) and ARES (ANAM Readiness Evaluation System). Preliminary results indicate a significant relationship (p=9.88e-05) between circulating PMZ levels and cognitive performance parameters. Time to accurately complete memory tasks increases significantly with concentrations; higher concentrations also increase response time and decrease accuracy of substitution and matching tasks. AUC and half-life estimates for PMZ ranged between 0.12 and 1.7 mg.h/L and 15 and 50 h, respectively. These preliminary results indicate that PMZ may exhibit dose-dependent pharmacokinetics in humans; also, WinSCAT and ARES are sensitive for pharmacodynamic assessment of PMZ, and may be applicable for assessing the pharmacodynamics of other neurocognitive drugs.

  12. Subjective and Objective Cancer Screening Knowledge Among White- and Blue-Collar Chinese Midlife Adults.

    PubMed

    Hou, Su-I

    2016-08-26

    Cancer is the leading cause of death among Chinese, yet little is known about cancer knowledge among this population. The study described the subjective and objective cancer screening knowledge among white- versus blue-collar Chinese midlife adults. A convenient sample of white-collar adults age 40+ years was recruited from government and academic agencies; and blue-collar adults age 40+ years were recruited from manufactory companies in Taiwan. An eight-item cancer screening knowledge test (CSKT) was used to measure objective knowledge and one five-point Likert scale item for assessing subjective (perceived) cancer screening knowledge. A total of 208 white- and 533 blue-collar workers completed the survey during 2008-2011. Mean ages between groups were comparable (41.1 versus 46.3 years), as well as family cancer history (41.5 %). About 76 % of the white-collar and 43 % of the blue-collar adults had college education. The mean score of the CSKT was lower in the blue-collar versus white-collar workers, 5.4 (SD = 1.76) versus 6.1 (SD = 1.40), indicating on average, 68 versus 76 % of the participants answered the cancer knowledge correctly. The subjective knowledge levels were, however, higher among the blue-collar workers (mean rating of 3.22 versus 2.78). The CSKT showed a good mix of relatively easy and moderately difficult items in both groups. Study showed that overall cancer screening knowledge was low among Chinese midlife adults. Although blue-collar workers scored lower on CSKT, the perceived knowledge level was higher. Results also suggest attention to communicating cancer screening information among Chinese blue-collar midlife workers in particular.

  13. Astrocitary niches in human adult medulla oblongata.

    PubMed

    Rusu, Mugurel Constantin; Dermengiu, Dan; Loreto, Carla; Motoc, Andrei Gheorghe Marius; Pop, Elena

    2013-04-01

    Astrocytes are considered as neuromodulators of the CNS. Whereas experimental studies on astrocitary functions are gaining importance, the anatomy of the astrocitary niches in the human CNS has been overlooked. The study was performed on the brainstem of 10 adult cadavers. We aimed to determine astrocitary niches in the human medulla oblongata using immunohistochemical labeling with vimentin and also CD34 immunostaining to accurately diagnose associated microvessels. Niches rich in astrocytes were identified as follows: (a) the superficial layer of astrocytes, ventral and ventrolateral, in the rostral medulla oblongata; (b) the median raphe; (c) medullary nuclei: arcuate nucleus, area postrema, nucleus of the solitary tract; (d) the subependymal zone (SEZ, caudal medulla) and subventricular zone (SVZ, rostral medulla). Astrocytes were scarce in the ventrolateral medulla, and mostly present within the pyramidal tract and the olivary nucleus. Apart from the SEZ and SVZ, the brainstem niches of astrocytes mostly overlap those regions known to perform roles as central respiratory chemoreceptors. The astrocytes of the SEZ and SVZ, which are known as stem cell niches, are related to an increased microvascular density.

  14. 16 CFR 1028.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... plans for involvement of human subjects. 1028.118 Section 1028.118 Commercial Practices CONSUMER PRODUCT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... subjects remain to be selected; and projects in which human subjects' involvement will depend...

  15. 10 CFR 745.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... involvement of human subjects. 745.118 Section 745.118 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.118 Applications and proposals lacking definite plans for involvement of human subjects... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  16. 10 CFR 745.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... involvement of human subjects. 745.118 Section 745.118 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.118 Applications and proposals lacking definite plans for involvement of human subjects... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  17. 10 CFR 745.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... involvement of human subjects. 745.118 Section 745.118 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.118 Applications and proposals lacking definite plans for involvement of human subjects... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  18. 10 CFR 745.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... involvement of human subjects. 745.118 Section 745.118 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.118 Applications and proposals lacking definite plans for involvement of human subjects... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  19. 10 CFR 745.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... involvement of human subjects. 745.118 Section 745.118 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.118 Applications and proposals lacking definite plans for involvement of human subjects... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  20. Penetration of Ceftaroline into the Epithelial Lining Fluid of Healthy Adult Subjects

    PubMed Central

    Pushkin, Richard; Jandourek, Alena; Knebel, William; Khariton, Tatiana

    2016-01-01

    Ceftaroline, the active metabolite of the prodrug ceftaroline fosamil, is a cephalosporin with bactericidal activity against Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). This study aimed to (i) evaluate ceftaroline concentrations in human plasma and epithelial lining fluid (ELF) and (ii) develop a population pharmacokinetic (PK) model for plasma and ELF to be used in PK/pharmacodynamic (PD) target attainment simulations. Ceftaroline concentrations in ELF and plasma at steady state (day 4) were measured in healthy adult subjects for two dosages: 600 mg every 12 h (q12h) and 600 mg every 8 h (q8h). Both were well tolerated with no serious adverse events. The penetration of free ceftaroline into ELF, assuming 20% protein binding in plasma and no protein binding in ELF, was ≈23%. The population PK model utilized a two-compartment model for both ceftaroline fosamil and ceftaroline. Goodness-of-fit criteria revealed the model was consistent with observed data and no systematic bias remained. At 600 mg q12h and a MIC of 1 mg/liter, 98.1% of simulated patients would be expected to achieve a target free drug concentration above the MIC (fT>MIC) in plasma of 42%, and in ELF 81.7% would be expected to achieve a target fT>MIC of 17%; at 600 mg q8h, 100% were predicted to achieve an fT>MIC in plasma of 42% and 94.7% to achieve an fT>MIC of 17% in ELF. The literature and data suggest the 600 mg q12h dose is adequate for MICs of ≤1 mg/liter. There is a need for clinical data in patients with MRSA pneumonia and data to correlate PK/PD relationships in ELF with clinical outcomes. PMID:27431215

  1. Penetration of Ceftaroline into the Epithelial Lining Fluid of Healthy Adult Subjects.

    PubMed

    Riccobene, Todd A; Pushkin, Richard; Jandourek, Alena; Knebel, William; Khariton, Tatiana

    2016-10-01

    Ceftaroline, the active metabolite of the prodrug ceftaroline fosamil, is a cephalosporin with bactericidal activity against Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). This study aimed to (i) evaluate ceftaroline concentrations in human plasma and epithelial lining fluid (ELF) and (ii) develop a population pharmacokinetic (PK) model for plasma and ELF to be used in PK/pharmacodynamic (PD) target attainment simulations. Ceftaroline concentrations in ELF and plasma at steady state (day 4) were measured in healthy adult subjects for two dosages: 600 mg every 12 h (q12h) and 600 mg every 8 h (q8h). Both were well tolerated with no serious adverse events. The penetration of free ceftaroline into ELF, assuming 20% protein binding in plasma and no protein binding in ELF, was ≈23%. The population PK model utilized a two-compartment model for both ceftaroline fosamil and ceftaroline. Goodness-of-fit criteria revealed the model was consistent with observed data and no systematic bias remained. At 600 mg q12h and a MIC of 1 mg/liter, 98.1% of simulated patients would be expected to achieve a target free drug concentration above the MIC (fT>MIC) in plasma of 42%, and in ELF 81.7% would be expected to achieve a target fT>MIC of 17%; at 600 mg q8h, 100% were predicted to achieve an fT>MIC in plasma of 42% and 94.7% to achieve an fT>MIC of 17% in ELF. The literature and data suggest the 600 mg q12h dose is adequate for MICs of ≤1 mg/liter. There is a need for clinical data in patients with MRSA pneumonia and data to correlate PK/PD relationships in ELF with clinical outcomes.

  2. Have you got any cholesterol? Adults' views of human nutrition

    NASA Astrophysics Data System (ADS)

    Schibeci, Renato; Wong, Khoon Yoong

    1994-12-01

    The general aim of our human nutrition project is to develop a health education model grounded in ‘everyday’ or ‘situated’ cognition (Hennessey, 1993). In 1993, we began pilot work to document adult understanding of human nutrition. We used a HyperCard stack as the basis for a series of interviews with 50 adults (25 university students, and 25 adults from offcampus). The interviews were transcribed and analysed using the NUDIST computer program. A summary of the views of these 50 adults on selected aspects of human nutrition is presented in this paper.

  3. Encephalitis-Associated Human Metapneumovirus Pneumonia in Adult, Australia.

    PubMed

    Fok, Anthony; Mateevici, Cristina; Lin, Belinda; Chandra, Ronil V; Chong, Victor H T

    2015-11-01

    Human metapneumovirus pneumonia, most commonly found in children, was diagnosed in an adult with encephalitis. This case suggests that testing for human metapneumovirus RNA in nasopharyngeal aspirate and cerebrospinal fluid samples should be considered in adults with encephalitis who have a preceding respiratory infection.

  4. Adult Education & Human Resource Development: Overlapping and Disparate Fields

    ERIC Educational Resources Information Center

    Watkins, Karen E.; Marsick, Victoria J.

    2014-01-01

    Adult education and human resource development as fields of practice and study share some roots in common but have grown in different directions in their histories. Adult education's roots focused initially on citizenship for a democratic society, whereas human resource development's roots are in performance at work. While they have…

  5. 16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON...

  6. 16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON...

  7. 16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON...

  8. 48 CFR 352.270-6 - Restriction on use of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR...

  9. 16 CFR 1028.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... involving human subjects. 1028.119 Section 1028.119 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  10. 48 CFR 352.270-6 - Restriction on use of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR...

  11. 16 CFR 1028.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... involving human subjects. 1028.119 Section 1028.119 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  12. 28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  13. 28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  14. 28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  15. 48 CFR 352.270-6 - Restriction on use of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR...

  16. 78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 807, 812, and 814 RIN 0910-AG48 Human Subject... ensure the protection of human subjects and the quality and integrity of data obtained from these studies... the protection of human subjects and the quality and integrity of data obtained from these...

  17. 14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  18. 48 CFR 352.270-6 - Restriction on use of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR...

  19. 28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  20. 28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  1. 48 CFR 352.270-6 - Restriction on use of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR...

  2. 78 FR 10538 - Protections for Subjects in Human Research Involving Pesticides

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... AGENCY 40 CFR Part 26 RIN 2070-AJ76 Protections for Subjects in Human Research Involving Pesticides... tailored amendments to the portions of its rules for the protection of human subjects of research applying... human subjects and to persons who submit the results of human research with pesticides to EPA....

  3. 16 CFR 1028.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... involving human subjects. 1028.119 Section 1028.119 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

  4. Subjective Memory Complaint and Depressive Symptoms among Older Adults in Portugal

    PubMed Central

    Sousa, Mónica; Costa, Rui

    2015-01-01

    Background. Older adults report subjective memory complaints (SMCs) but whether these are related to depression remains controversial. In this study we investigated the relationship between the SMCs and depression and their predictors in a sample of old adults. Methods. This cross-sectional study enrolled 620 participants aged 55 to 96 years (74.04 ± 10.41). Outcome measures included a sociodemographic and clinical questionnaire, a SMC scale (QSM), a Geriatric Depression Scale (GDS), a Mini-Mental Status Examination (MMSE), and a Montreal Cognitive Assessment (MoCA). Results. The QSM mean total score for the main results suggests that SMCs are higher in old adults with depressed symptoms, comparatively to nondepressed old adults. The GDS scores were positively associated with QSM but negatively associated with education, MMSE, and MoCA. GDS scores predicted almost 63.4% of variance. Scores on QSM and MoCA are significantly predicted by depression symptomatology. Conclusion. Depression symptoms, lower education level, and older age may be crucial to the comprehension of SMCs. The present study suggested that depression might play a role in the SMCs of the older adults and its treatment should be considered. PMID:26880907

  5. Human autonomic rhythms: vagal cardiac mechanisms in tetraplegic subjects.

    PubMed Central

    Koh, J; Brown, T E; Beightol, L A; Ha, C Y; Eckberg, D L

    1994-01-01

    1. We studied eight young men (age range: 20-37 years) with chronic, clinically complete high cervical spinal cord injuries and ten age-matched healthy men to determine how interruption of connections between the central nervous system and spinal sympathetic motoneurones affects autonomic cardiovascular control. 2. Baseline diastolic pressures and R-R intervals (heart periods) were similar in the two groups. Slopes of R-R interval responses to brief neck pressure changes were significantly lower in tetraplegic than in healthy subjects, but slopes of R-R interval responses to steady-state arterial pressure reductions and increases were comparable. Plasma noradrenaline levels did not change significantly during steady-state arterial pressure reductions in tetraplegic patients, but rose sharply in healthy subjects. The range of arterial pressure and R-R interval responses to vasoactive drugs (nitroprusside and phenylephrine) was significantly greater in tetraplegic than healthy subjects. 3. Resting R-R interval spectral power at respiratory and low frequencies was similar in the two groups. During infusions of vasoactive drugs, low-frequency R-R interval spectral power was directly proportional to arterial pressure in tetraplegic patients, but was unrelated to arterial pressure in healthy subjects. Vagolytic doses of atropine nearly abolished both low- and respiratory-frequency R-R interval spectral power in both groups. 4. Our conclusions are as follows. First, since tetraplegic patients have significant levels of low-frequency arterial pressure and R-R interval spectral power, human Mayer arterial pressure waves may result from mechanisms that do not involve stimulation of spinal sympathetic motoneurones by brainstem neurones. Second, since in tetraplegic patients, low-frequency R-R interval spectral power is proportional to arterial pressure, it is likely to be mediated by a baroreflex mechanism. Third, since low-frequency R-R interval rhythms were nearly abolished

  6. Objective and subjective quality of life in adults with autism spectrum disorders in southern Spain.

    PubMed

    Saldaña, David; Alvarez, Rosa M; Lobatón, Silvia; Lopez, Ana M; Moreno, Macarena; Rojano, Miguel

    2009-05-01

    Subjective and objective measures of quality of life (QoL) were obtained for adults with autism spectrum disorders (ASDs) living in Andalusia (Spain). Seventy-four families responded to questionnaires about objective QoL indicators such as employment, health, adaptive behaviour and social network, and were asked to act as proxies for subjective QoL measures. Outcome on objective QoL was extremely poor. Social networks were most frequently composed of family members. Community-oriented resources were absent in most cases. For two-thirds of the families, the ability to act as proxies for subjective QoL was seriously limited by the participants' poor social and communicative abilities. The results are indicative of the need for additional support to families of adults with ASD and increased community-based resources. Further conceptualization of indicators and measurement of subjective QoL in individuals with severe disabilities and ASD is also needed in order to include their own perspective in the evaluation of service provision.

  7. Adult human brain cell culture for neuroscience research.

    PubMed

    Gibbons, Hannah M; Dragunow, Mike

    2010-06-01

    Studies of the brain have progressed enormously through the use of in vivo and in vitro non-human models. However, it is unlikely such studies alone will unravel the complexities of the human brain and so far no neuroprotective treatment developed in animals has worked in humans. In this review we discuss the use of adult human brain cell culture methods in brain research to unravel the biology of the normal and diseased human brain. The advantages of using adult human brain cells as tools to study human brain function from both historical and future perspectives are discussed. In particular, studies using dissociated cultures of adult human microglia, astrocytes, oligodendrocytes and neurons are described and the applications of these types of study are evaluated. Alternative sources of human brain cells such as adult neural stem cells, induced pluripotent stem cells and slice cultures of adult human brain tissue are also reviewed. These adult human brain cell culture methods could benefit basic research and more importantly, facilitate the translation of basic neuroscience research to the clinic for the treatment of brain disorders.

  8. Stimulation at the cervicomedullary junction in human subjects.

    PubMed

    Taylor, Janet L

    2006-06-01

    In awake human subjects, corticospinal axons can be activated at the level of the cervicomedullary junction by electrical or magnetic stimulation. Such stimuli evoke single descending volleys which activate motoneurones and elicit responses in muscles of the upper limb. These responses (cervicomedullary motor evoked potentials, CMEPs) have a large monosynaptic component and can be used to test motoneurone excitability in a variety of tasks. CMEPs can be elicited in resting muscle and during all strengths of voluntary contraction. Examination of CMEPs during and after voluntary contractions reveals changes in motoneurone excitability but also suggests activity-dependent changes in the efficacy of the corticospinal pathway. Because they test the same subcortical pathway as transcranial magnetic stimulation, but are unaffected by altered excitability at a cortical level, CMEPs often offer the most appropriate comparison to allow interpretation of changes in motor evoked potentials. The advantages and disadvantages of stimulation at the cervicomedullary junction as a test of motoneurone excitability are reviewed.

  9. Toxicokinetics of inhaled bromotrifluoromethane (Halon 1301) in human subjects

    NASA Technical Reports Server (NTRS)

    Lam, C. W.; Weir, F. W.; Williams-Cavender, K.; Tan, M. N.; Galen, T. J.; Pierson, D. L.

    1993-01-01

    Bromotrifluoromethane (Halon 1301, CBrF3), is used as a fire extinguishant in the Space Shuttle, where several scenarios, such as a fire or a faulty alarm, could lead to its discharge resulting in a Halon 1301 concentration of up to 1 percent in the cabin atmosphere. The effect of Halon 1301 on mental performance and physiologic function was investigated in a NASA-sponsored human inhalation study in which four pairs of male subjects were each exposed in a double-blind fashion for 24 hr to 1 percent Halon 1301 and to air in two exposures about 1 week apart. Blood and breath samples from the exposed subjects were collected to provide dosimetric and toxicokinetic information. Halon 1301 blood levels increased rapidly and approached a steady state within 2 hr of the beginning the exposure; the steady-state concentration was approximately 3-4.5 microg/ml. Breath samples collected during exposures closely reflected chamber concentrations. Analysis of postexposure blood samples revealed that Halon 1301 was eliminated biphasically with an average t(1/2) alpha and t(1/2) beta of 4.5 min and 200 min, respectively.

  10. Comparison of cognitive performance for promethazine pharmacodynamics in human subjects

    NASA Astrophysics Data System (ADS)

    Vaksman, Z.; Boyd, J. L.; Wang, Z.; Putcha, L.

    2005-08-01

    The objective of this study is to compare cognitive function tests, Automated Neurological Assessment Metrics (ANAM) based Readiness Evaluation System (ARES®) on a Palm Pilot and Windows based Space- flight Cognitive Assessment Tool (WinSCAT®) on a personal computer (PC) to assess performance effects of promethazine (PMZ) after administration to human subjects. In a randomized placebo-controlled cross-over design, subjects received 12.5, 25, and 50 mg intramuscular (IM) PMZ or a placebo and completed 14 sessions with WinSCAT® (v. 1.2.6) and ARES® (v. 1.27) consecutively for 72 h post dose. Maximum plasma concentrations (4.25, 6.25 and 13.33 ng/ml) were linear with dose and were achieved by 0.75, 8, and 24 h after dosing for the three doses, respectively. No significant differences in cognitive function after PMZ dosing were detected using WinSCAT®, however, tests from ARES® demonstrated concentration dependent decrements in reaction time associated with PMZ dose.

  11. Subjective-objective sleep discrepancy among older adults: associations with insomnia diagnosis and insomnia treatment.

    PubMed

    Kay, Daniel B; Buysse, Daniel J; Germain, Anne; Hall, Martica; Monk, Timothy H

    2015-02-01

    Discrepancy between subjective and objective measures of sleep is associated with insomnia and increasing age. Cognitive behavioural therapy for insomnia improves sleep quality and decreases subjective-objective sleep discrepancy. This study describes differences between older adults with insomnia and controls in sleep discrepancy, and tests the hypothesis that reduced sleep discrepancy following cognitive behavioural therapy for insomnia correlates with the magnitude of symptom improvement reported by older adults with insomnia. Participants were 63 adults >60 years of age with insomnia, and 51 controls. At baseline, participants completed sleep diaries for 7 days while wearing wrist actigraphs. After receiving cognitive behavioural therapy for insomnia, insomnia patients repeated this sleep assessment. Sleep discrepancy variables were calculated by subtracting actigraphic sleep onset latency and wake after sleep onset from respective self-reported estimates, pre- and post-treatment. Mean level and night-to-night variability in sleep discrepancy were investigated. Baseline sleep discrepancies were compared between groups. Pre-post-treatment changes in Insomnia Severity Index score and sleep discrepancy variables were investigated within older adults with insomnia. Sleep discrepancy was significantly greater and more variable across nights in older adults with insomnia than controls, P ≤ 0.001 for all. Treatment with cognitive behavioural therapy for insomnia was associated with significant reduction in the Insomnia Severity Index score that correlated with changes in mean level and night-to-night variability in wake after sleep onset discrepancy, P < 0.001 for all. Study of sleep discrepancy patterns may guide more targeted treatments for late-life insomnia.

  12. The dynamics of adult neurogenesis in human hippocampus

    PubMed Central

    Ihunwo, Amadi O.; Tembo, Lackson H.; Dzamalala, Charles

    2016-01-01

    The phenomenon of adult neurogenesis is now an accepted occurrence in mammals and also in humans. At least two discrete places house stem cells for generation of neurons in adult brain. These are olfactory system and the hippocampus. In animals, newly generated neurons have been directly or indirectly demonstrated to generate a significant amount of new neurons to have a functional role. However, the data in humans on the extent of this process is still scanty and such as difficult to comprehend its functional role in humans. This paper explores the available data on as extent of adult hippocampal neurogenesis in humans and makes comparison to animal data. PMID:28197172

  13. 40 CFR 26.1704 - Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults. 26.1704 Section 26.1704 Protection of Environment... research with non-pregnant, non-nursing adults. (a) This section applies to research subject to...

  14. 40 CFR 26.1704 - Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults. 26.1704 Section 26.1704 Protection of Environment... research with non-pregnant, non-nursing adults. (a) This section applies to research subject to...

  15. Adult Human Neurogenesis: From Microscopy to Magnetic Resonance Imaging

    PubMed Central

    Sierra, Amanda; Encinas, Juan M.; Maletic-Savatic, Mirjana

    2011-01-01

    Neural stem cells reside in well-defined areas of the adult human brain and are capable of generating new neurons throughout the life span. In rodents, it is well established that the new born neurons are involved in olfaction as well as in certain forms of memory and learning. In humans, the functional relevance of adult human neurogenesis is being investigated, in particular its implication in the etiopathology of a variety of brain disorders. Adult neurogenesis in the human brain was discovered by utilizing methodologies directly imported from the rodent research, such as immunohistological detection of proliferation and cell-type specific biomarkers in postmortem or biopsy tissue. However, in the vast majority of cases, these methods do not support longitudinal studies; thus, the capacity of the putative stem cells to form new neurons under different disease conditions cannot be tested. More recently, new technologies have been specifically developed for the detection and quantification of neural stem cells in the living human brain. These technologies rely on the use of magnetic resonance imaging, available in hospitals worldwide. Although they require further validation in rodents and primates, these new methods hold the potential to test the contribution of adult human neurogenesis to brain function in both health and disease. This review reports on the current knowledge on adult human neurogenesis. We first review the different methods available to assess human neurogenesis, both ex vivo and in vivo and then appraise the changes of adult neurogenesis in human diseases. PMID:21519376

  16. Adult human neurogenesis: from microscopy to magnetic resonance imaging.

    PubMed

    Sierra, Amanda; Encinas, Juan M; Maletic-Savatic, Mirjana

    2011-01-01

    Neural stem cells reside in well-defined areas of the adult human brain and are capable of generating new neurons throughout the life span. In rodents, it is well established that the new born neurons are involved in olfaction as well as in certain forms of memory and learning. In humans, the functional relevance of adult human neurogenesis is being investigated, in particular its implication in the etiopathology of a variety of brain disorders. Adult neurogenesis in the human brain was discovered by utilizing methodologies directly imported from the rodent research, such as immunohistological detection of proliferation and cell-type specific biomarkers in postmortem or biopsy tissue. However, in the vast majority of cases, these methods do not support longitudinal studies; thus, the capacity of the putative stem cells to form new neurons under different disease conditions cannot be tested. More recently, new technologies have been specifically developed for the detection and quantification of neural stem cells in the living human brain. These technologies rely on the use of magnetic resonance imaging, available in hospitals worldwide. Although they require further validation in rodents and primates, these new methods hold the potential to test the contribution of adult human neurogenesis to brain function in both health and disease. This review reports on the current knowledge on adult human neurogenesis. We first review the different methods available to assess human neurogenesis, both ex vivo and in vivo and then appraise the changes of adult neurogenesis in human diseases.

  17. Is subjective hyperhidrosis assessment sufficient enough? prevalence of hyperhidrosis among young Polish adults.

    PubMed

    Stefaniak, Tomasz; Tomaszewski, Krzysztof A; Proczko-Markuszewska, Monika; Idestal, Anette; Royton, Anders; Abi-Khalil, Christian

    2013-10-01

    The aim of this work was to assess the prevalence of palmar and axillary hyperhidrosis among young Polish adults. Additionally, this work aimed at comparing the subjective and objective (gravimetric) method of hyperhidrosis assessment. Healthy medical students, volunteering to take part in this study, were included. The participants filled out a questionnaire assessing the occurrence and subjective intensity of hyperhidrosis in different areas of the body. Additionally, the students were subjected to gravimetric assessment in four localizations: the face, palms, axillae and abdomino-lumbar area. Two hundred and fifty-three students (102 males and 151 females, mean age 24.3 ± 3.21 years) were included in the study. Forty-two (16.7%) participants declared that they suffer from hyperhidrosis. Out of the 42 students declaring any type of hyperhidrosis, only 20 (47.6%) exceeded the gravimetric reference values. From among the students that exceeded the normative values for palmar hyperhidrosis, only 10 (55.6%) were aware of their hyperhidrosis. In the group of students that exceeded the normative values for axillary hyperhidrosis, 16 (39%) were aware of their hyperhidrosis. Subjectively declared hyperhidrosis incidence may significantly exceed the real-life occurrence of this disease. Basing studies solely on data gathered from questionnaires, may lead to false results. It is imperative, when assessing patients suffering from hyperhidrosis, to use both objective and subjective methods of evaluation.

  18. Genetic Influences on Physiological and Subjective Responses to an Aerobic Exercise Session among Sedentary Adults

    PubMed Central

    Karoly, Hollis C.; Stevens, Courtney J.; Magnan, Renee E.; Harlaar, Nicole; Hutchison, Kent E.; Bryan, Angela D.

    2012-01-01

    Objective. To determine whether genetic variants suggested by the literature to be associated with physiology and fitness phenotypes predicted differential physiological and subjective responses to a bout of aerobic exercise among inactive but otherwise healthy adults. Method. Participants completed a 30-minute submaximal aerobic exercise session. Measures of physiological and subjective responding were taken before, during, and after exercise. 14 single nucleotide polymorphisms (SNPs) that have been previously associated with various exercise phenotypes were tested for associations with physiological and subjective response to exercise phenotypes. Results. We found that two SNPs in the FTO gene (rs8044769 and rs3751812) were related to positive affect change during exercise. Two SNPs in the CREB1 gene (rs2253206 and 2360969) were related to change in temperature during exercise and with maximal oxygen capacity (VO2 max). The SLIT2 SNP rs1379659 and the FAM5C SNP rs1935881 were associated with norepinephrine change during exercise. Finally, the OPRM1 SNP rs1799971 was related to changes in norepinephrine, lactate, and rate of perceived exertion (RPE) during exercise. Conclusion. Genetic factors influence both physiological and subjective responses to exercise. A better understanding of genetic factors underlying physiological and subjective responses to aerobic exercise has implications for development and potential tailoring of exercise interventions. PMID:22899923

  19. Mood Influences the Concordance of Subjective and Objective Measures of Sleep Duration in Older Adults

    PubMed Central

    Baillet, Marion; Cosin, Charlotte; Schweitzer, Pierre; Pérès, Karine; Catheline, Gwenaëlle; Swendsen, Joel; Mayo, Willy

    2016-01-01

    Objective/Background: Sleep plays a central role in maintaining health and cognition. In most epidemiologic studies, sleep is evaluated by self-report questionnaires but several reports suggest that these evaluations might be less accurate than objective measures such as polysomnography or actigraphy. Determinants of the discrepancy between objective and subjective measures remain to be investigated. The aim of this pilot-study was to examine the role of mood states in determining the discrepancy observed between objective and subjective measures of sleep duration in older adults. Patients/Methods: Objective sleep quantity and quality were recorded by actigraphy in a sample of 45 elderly subjects over at least three consecutive nights. Subjective sleep duration and supplementary data, such as mood status and memory, were evaluated using ecological momentary assessment (EMA). Results: A significant discrepancy was observed between EMA and actigraphic measures of sleep duration (p < 0.001). The magnitude of this difference was explained by the patient’s mood status (p = 0.020). No association was found between the magnitude of this discrepancy and age, sex, sleep quality or memory performance. Conclusion: The discrepancy classically observed between objective and subjective measures of sleep duration can be explained by mood status at the time of awakening. These results have potential implications for epidemiologic and clinical studies examining sleep as a risk factor for morbidity or mortality. PMID:27507944

  20. A comparison of older adults' subjective experience with virtual and real environments during dynamic balance activities

    PubMed Central

    Proffitt, Rachel; Lange, Belinda; Chen, Christina; Winstein, Carolee

    2014-01-01

    The purpose of this study was to explore the subjective experience of older adults interacting with both virtual and real environments. Thirty healthy older adults engaged with real and virtual tasks of similar motor demands: reaching to a target in standing and stepping stance. Immersive tendencies and absorption scales were administered before the session. Game engagement and experience questionnaires were completed after each task, followed by a semi-structured interview at the end of the testing session. Data were analyzed respectively using paired t-tests and grounded theory methodology. Participants preferred the virtual task over the real task. They also reported an increase in presence and absorption with the virtual task, describing an external focus of attention. Findings will be used to inform future development of appropriate game-based balance training applications that could be embedded in the home or community settings as part of evidence-based fall prevention programs. PMID:24334299

  1. Human Amygdala Represents the Complete Spectrum of Subjective Valence

    PubMed Central

    Jin, Jingwen; Zelano, Christina; Gottfried, Jay A.

    2015-01-01

    Although the amygdala is a major locus for hedonic processing, how it encodes valence information is poorly understood. Given the hedonic potency of odor stimuli and the amygdala's anatomical proximity to the peripheral olfactory system, we combined high-resolution fMRI with pattern-based multivariate techniques to examine how valence information is encoded in the amygdala. Ten human subjects underwent fMRI scanning while smelling 9 odorants that systematically varied in perceived valence. Representational similarity analyses showed that amygdala codes the entire dimension of valence, ranging from pleasantness to unpleasantness. This unidimensional representation significantly correlated with self-reported valence ratings but not with intensity ratings. Furthermore, within-trial valence representations evolved over time, prioritizing earlier differentiation of unpleasant stimuli. Together, these findings underscore the idea that both spatial and temporal features uniquely encode pleasant and unpleasant odor valence in the amygdala. The availability of a unidimensional valence code in the amygdala, distributed in both space and time, would create greater flexibility in determining the pleasantness or unpleasantness of stimuli, providing a mechanism by which expectation, context, attention, and learning could influence affective boundaries for guiding behavior. SIGNIFICANCE STATEMENT Our findings elucidate the mechanisms of affective processing in the amygdala by demonstrating that this brain region represents the entire valence dimension from pleasant to unpleasant. An important implication of this unidimensional valence code is that pleasant and unpleasant valence cannot coexist in the amygdale because overlap of fMRI ensemble patterns for these two valence extremes obscures their unique content. This functional architecture, whereby subjective valence maps onto a pattern continuum between pleasant and unpleasant poles, offers a robust mechanism by which context

  2. 34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 97.118 Section 97.118 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED...

  3. 34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 97.118 Section 97.118 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED...

  4. 34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 97.118 Section 97.118 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED...

  5. 34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Research undertaken without the intention of involving human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy...

  6. 34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Research undertaken without the intention of involving human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy...

  7. 34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Research undertaken without the intention of involving human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy...

  8. 34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 97.118 Section 97.118 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED...

  9. 34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 97.118 Section 97.118 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED...

  10. Historic Preservation An unusual way to protect human subjects in research

    SciTech Connect

    Prendergast, Ellen L.

    2001-09-15

    The Hanford Cultural Resources Laboratory (HCRL) at the Hanford Site interacts with human subjects in a variety of ways, some of which constitute human subjects research. A key element in this work is determining what constitutes 'research' and thus requires application of special measures to protect human subjects.

  11. 38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  12. 38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  13. 45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  14. 45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  15. 15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

  16. 32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without...

  17. 14 CFR § 1230.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... of involving human subjects. § 1230.119 Section § 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS (Eff. until 2-14-14) § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without...

  18. 45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human... for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  19. 45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human... for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  20. 45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human... for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  1. 45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human... for involvement of human subjects. 46.118 Section 46.118 Public Welfare Department of Health and Human... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  2. 48 CFR 1352.235-72 - Protection of human subjects-institutional approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... following specific involvement of human subjects in research is hereby approved by the Contracting Officer... modification approved by the Contracting Officer, no other involvement of human subjects in research under this...) This contract/order includes non-exempt human subjects research that must be conducted pursuant to...

  3. 15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

  4. 45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  5. 14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of...

  6. 48 CFR 3452.224-71 - Notice about research activities involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... activities involving human subjects. 3452.224-71 Section 3452.224-71 Federal Acquisition Regulations System... Text of Provisions and Clauses 3452.224-71 Notice about research activities involving human subjects... contract will include, or is likely to include, research activities involving human subjects covered...

  7. 45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  8. 32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without...

  9. 38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  10. 38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  11. 15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

  12. 32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without...

  13. 45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  14. 38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

  15. 32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without...

  16. Assessing the abuse potential of methylphenidate in nonhuman and human subjects: a review.

    PubMed

    Kollins, S H; MacDonald, E K; Rush, C R

    2001-03-01

    Methylphenidate (MPH) is widely used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults. Methylphenidate is clearly effective for the treatment of ADHD, but there is controversy as to whether it has significant abuse potential like other psychostimulants (e.g., D-amphetamine and cocaine). In general, the drug is believed to be abused at rates much lower than those for other stimulants. The present review examines studies that investigated the behavioral pharmacological profile of methylphenidate and discusses how results from these studies address its abuse liability. Using MEDLINE search terms methylphenidate, drug discrimination, reinforcement, self-administration, subjective effects, subject-rated effects, abuse potential, and abuse liability, along with a review of the references from identified articles, 60 studies were located in which the reinforcing, discriminative-stimulus, or subjective effects of methylphenidate were directly assessed in nonhumans or humans. Forty-eight (80.0%) of the studies reviewed indicate that methylphenidate either functions in a manner similar to D-amphetamine or cocaine (e.g., functions as a reinforcer, substitutes fully in drug discrimination experiments), or produces a pattern of subjective effects suggestive of abuse potential. The results are discussed as they pertain to factors that may account for the apparent discrepancy in abuse rates between methylphenidate and other stimulants, including characterization of actual abuse rates, defining abuse and misuse, pharmacokinetic factors, and validity of abuse liability assays.

  17. Global and local processing in adult humans (Homo sapiens), 5-year-old children (Homo sapiens), and adult cotton-top tamarins (Saguinus oedipus).

    PubMed

    Neiworth, Julie J; Gleichman, Amy J; Olinick, Anne S; Lamp, Kristen E

    2006-11-01

    This study compared adults (Homo sapiens), young children (Homo sapiens), and adult tamarins (Saguinus oedipus) while they discriminated global and local properties of stimuli. Subjects were trained to discriminate a circle made of circle elements from a square made of square elements and were tested with circles made of squares and squares made of circles. Adult humans showed a global bias in testing that was unaffected by the density of the elements in the stimuli. Children showed a global bias with dense displays but discriminated by both local and global properties with sparse displays. Adult tamarins' biases matched those of the children. The striking similarity between the perceptual processing of adult monkeys and humans diagnosed with autism and the difference between this and normatively developing human perception is discussed.

  18. Social network types among older Korean adults: Associations with subjective health.

    PubMed

    Sohn, Sung Yun; Joo, Won-Tak; Kim, Woo Jung; Kim, Se Joo; Youm, Yoosik; Kim, Hyeon Chang; Park, Yeong-Ran; Lee, Eun

    2017-01-01

    With population aging now a global phenomenon, the health of older adults is becoming an increasingly important issue. Because the Korean population is aging at an unprecedented rate, preparing for public health problems associated with old age is particularly salient in this country. As the physical and mental health of older adults is related to their social relationships, investigating the social networks of older adults and their relationship to health status is important for establishing public health policies. The aims of this study were to identify social network types among older adults in South Korea and to examine the relationship of these social network types with self-rated health and depression. Data from the Korean Social Life, Health, and Aging Project were analyzed. Model-based clustering using finite normal mixture modeling was conducted to identify the social network types based on ten criterion variables of social relationships and activities: marital status, number of children, number of close relatives, number of friends, frequency of attendance at religious services, attendance at organized group meetings, in-degree centrality, out-degree centrality, closeness centrality, and betweenness centrality. Multivariate regression analysis was conducted to examine associations between the identified social network types and self-rated health and depression. The model-based clustering analysis revealed that social networks clustered into five types: diverse, family, congregant, congregant-restricted, and restricted. Diverse or family social network types were significantly associated with more favorable subjective mental health, whereas the restricted network type was significantly associated with poorer ratings of mental and physical health. In addition, our analysis identified unique social network types related to religious activities. In summary, we developed a comprehensive social network typology for older Korean adults.

  19. [The age-specific features of palm dermatoglyphics in the adults subjects].

    PubMed

    Teplov, K V; Bozhchenko, A P; Tolmachev, I A; Moiseenko, S A

    2016-01-01

    This article was designed to consider the congenital age-specific features of palm dermatoglyphics in the adults subjects (including the type of the papillary patterns, axial tri-radii, the termini of palmar main lines, the rudiments of palmar lines, the dermatoglyphic ridge count between the stable anatomical structures). The objective of the study was to look for the new diagnostic markers of the biological age. It included the identification of the palm prints obtained from 180 Caucasoid men and 120 women at the age varying from 16 to 80 years. The results of the mathematical and statistical analysis provided the basis for drawing up the list of 18 attributes of palm dermatoglyphics significantly (p<0.05) differing in the frequency of occurrence between the representatives of individual age groups. The methods are proposed allowing to use these findings for the expert evaluation of the age of unknown subjects.

  20. Single-dose pharmacokinetics of intravenous ampicillin plus sulbactam in healthy elderly and young adult subjects.

    PubMed

    Rho, J P; Jones, A; Woo, M; Castle, S; Smith, K; Bawdon, R E; Norman, D C

    1989-10-01

    The pharmacokinetics of intravenous ampicillin and sulbactam, a beta-lactamase inhibitor, were evaluated in two different age groups. Twelve healthy elderly subjects (age 65-93 years) and 12 healthy young adult subjects (age 20-35 years) received both a dose of ampicillin 1 g plus sulbactam 0.5 g and a higher dose of ampicillin 2 g plus sulbactam 1 g after a one-week period between doses. A reverse-phase high-pressure liquid chromatography method was used for the quantitation of ampicillin and sulbactam in serum and urine. The pharmacokinetic parameters for both ampicillin and sulbactam were calculated by computer-based two-compartment nonlinear model. After a 30-min infusion, serum concentrations of both drugs declined in a biexponential manner for both doses. Elderly subjects demonstrated significantly lower total clearances (Clt) than young adult subjects of ampicillin 1 g (220.0 +/- 104.2 vs 360.0 +/- 95.8 ml/min/1.73 m2), ampicillin 2 g (72.6 +/- 36.6 vs 306.8 +/- 109.77 ml/min/1.73 m2), sulbactam 0.5 g (122.3 +/- 47.8 vs 263.9 +/- 93.7 ml/min/1.73 m2), and sulbactam 1 g (171.2 +/- 85.8 vs 391.7 +/- 70.8 ml/min/1.73 m2), respectively. Significance was defined as P less than 0.05. Renal clearance was also significantly reduced in the elderly subjects. Area under the curve was found to be significantly increased in the elderly subjects compared to the young subjects for both ampicillin and sulbactam as were the beta elimination half-lives. No significant difference in the apparent volume of distribution, when adjusted for body weight, was found for either sulbactam (P greater than 0.95) or ampicillin (P greater than 0.95) between the two groups. Linear regression analysis revealed that age was significantly correlated with the Clt of ampicillin 1 g (r = 0.85, P less than 0.001), ampicillin 2 g (r = 0.90, P less than 0.001), sulbactam 0.5 g (r = 0.80, P less than 0.001), and sulbactam 1 g (r = 0.93, P less than 0.001). A multivariate analysis showed a slight

  1. Facial soft tissue thickness among various vertical facial patterns in adult Pakistani subjects.

    PubMed

    Jeelani, Waqar; Fida, Mubassar; Shaikh, Attiya

    2015-12-01

    Facial reconstruction techniques are used to obtain an approximation of an individual's appearance thus helping identification of unidentified decedents from their dried skeletal remains. Many of these techniques rely on the sets of average facial soft tissue thickness (FST) values at different anatomical landmarks provided by the previous studies. FST is influenced by the age, sex, ethnicity and the body mass index of the individual. Recent literature has shown that the anthropological variations of the skull may also affect FST at certain points. This study was designed to evaluate the effect of such variations in vertical skull morphology on FST as around one third of different population groups have either a long or short facial pattern as compared to the average facial pattern. Moreover, this study also provides a FST database for the adult Pakistani subjects that may have potential implications in the facial reconstruction of the local subjects. A retrospective analysis of 276 lateral cephalograms of adult subjects having normal sagittal facial pattern was performed. Subjects were categorized into three vertical facial patterns (long face=95, average face=102, short face=79) according to the vertical dimensions of the skull and the FST was measured at 11 midline points. To compare the FST between males and females Mann-Whitney U test was used. Kruskal-Wallis test was applied to compare FST among three vertical facial patterns. The results of our study revealed significant differences in FST at nine landmarks between males and females. These sex-based differences were more pronounced in the long and short facial patterns as compared to the average facial pattern. FST at stomion, pogonion, gnathion and menton was significantly greater in the short facial pattern as compared to the long facial pattern in both the sexes. The results of the present study highlight the importance of anthropological analysis of the skull and taking the vertical skeletal dimension

  2. Developing Resourceful Humans. Adult Education within the Economic Context.

    ERIC Educational Resources Information Center

    Burton, Lynn Elen, Ed.

    This book, which explores the shifting paradigm from human resource development to developing resourceful humans, establishes the historical position of adult education within the economic context, discusses human capital propositions, and examines the learning dimensions of economic and educational change. The following chapters are included:…

  3. Adult Literacy Education and Human Rights: A View from Afghanistan

    ERIC Educational Resources Information Center

    Andersen, Susan M.; Kooij, Christina S.

    2007-01-01

    In this article, we argue that adult literacy as part of international development is an issue of both human rights and women's rights. We explore this by presenting a case study of the effects of one innovative adult literacy program in Afghanistan that places men and women, as well as various ethnicities, together in the same classroom as…

  4. 76 FR 5735 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-02

    ...EPA proposes to amend the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The proposed amendments would broaden the applicability of the rules to cover human testing with......

  5. Effects of a single, oral 60 mg caffeine dose on attention in healthy adult subjects.

    PubMed

    Wilhelmus, Micha Mm; Hay, Justin L; Zuiker, Rob Gja; Okkerse, Pieter; Perdrieu, Christelle; Sauser, Julien; Beaumont, Maurice; Schmitt, Jeroen; van Gerven, Joop Ma; Silber, Beata Y

    2017-02-01

    Caffeine induces positive effects on sustained attention, although studies assessing the acute effects of low caffeine dose (<75 mg) on sustained attention are limited and use short-term tests. Therefore, we investigated the acute effects of a 60 mg dose of caffeine on sustained attention in tests lasting up to 45 minutes using 82 low or non-caffeine-consuming healthy male ( n=41) and female ( n=41) adults aged between 40 and 60 years. Vigilance was measured using Mackworth Clock test, Rapid Visual Information Processing Test, adaptive tracking test, saccadic eye movement and attention switch test. Effects on mood and fatigue were analysed using Bond and Lader and Caffeine Research visual analogue scales, and Samn-Perelli questionnaire. Saliva sampling was performed for both compliance and caffeine pharmacokinetic analysis. Administration of a 60 mg caffeine dose resulted in a significant improvement in sustained attention compared with the placebo. Also a significantly improved peak saccadic velocity and reaction time performance was found, and decreased error rate. Significantly increased feelings of alertness, contentment and overall mood after caffeine treatment compared with placebo were observed. This study demonstrated that in healthy adult subjects oral administration of a single 60 mg caffeine dose elicited a clear enhancement of sustained attention and alertness, measured both in multiple objective performances and in subjective scales.

  6. Measurement of neural respiratory drive via parasternal intercostal electromyography in healthy adult subjects.

    PubMed

    MacBean, V; Hughes, C; Nicol, G; Reilly, C C; Rafferty, G F

    2016-11-01

    Neural respiratory drive, quantified by the parasternal intercostal muscle electromyogram (EMGpara), provides a sensitive measure of respiratory system load-capacity balance. Reference values for EMGpara-based measures are lacking and the influence of individual anthropometric characteristics is not known. EMGpara is conventionally expressed as a percentage of that obtained during a maximal inspiratory effort (EMGpara%max), leading to difficulty in applying the technique in subjects unable to reliably perform such manoeuvres. To measure EMGpara in a large, unselected cohort of healthy adult subjects in order to evaluate relevant technical and anthropometric factors. Surface second intercostal space EMGpara was measured during resting breathing and maximal inspiratory efforts in 63 healthy adult subjects, median (IQR) age 31.0 (25.0-47.0) years, 28 males. Detailed anthropometry, spirometry and respiratory muscle strength were also recorded. Median (IQR EMGpara was 4.95 (3.35-6.93) µV, EMGpara%max 4.95 (3.39-8.65)% and neural respiratory drive index (NRDI, the product of EMGpara%max and respiratory rate) was 73.62 (46.41-143.92) %.breath/min. EMGpara increased significantly to 6.28 (4.26-9.93) µV (p  <  0.001) with a mouthpiece, noseclip and pneumotachograph in situ. Median (IQR) EMGpara was higher in female subjects (5.79 (4.42-7.98) µV versus 3.56 (2.81-5.35) µV, p  =  0.003); after controlling for sex neither EMGpara, EMGpara%max or NRDI were significantly related to anthropometrics, age or respiratory muscle strength. In subjects undergoing repeat measurements within the same testing session (n  =  48) or on a separate occasion (n  =  19) similar repeatability was observed for both EMGpara and EMGpara%max. EMGpara is higher in female subjects than males, without influence of other anthropometric characteristics. Reference values are provided for EMGpara-derived measures. Expressing EMGpara as a percentage of maximum confers no

  7. Factors Associated with Subjective Quality of Life of Adults with Autism Spectrum Disorder: Self-Report versus Maternal Reports

    ERIC Educational Resources Information Center

    Hong, Jinkuk; Bishop-Fitzpatrick, Lauren; Smith, Leann E.; Greenberg, Jan S.; Mailick, Marsha R.

    2016-01-01

    We examined factors related to subjective quality of life (QoL) of adults with autism spectrum disorder (ASD) aged 25-55 (n = 60), using the World Health Organization Quality of Life measure (WHOQOL-BREF). We used three different assessment methods: adult self-report, maternal proxy-report, and maternal report. Reliability analysis showed that…

  8. Adult Daughters' Influence on Mothers' Health-Related Decision Making: An Expansion of the Subjective Norms Construct

    ERIC Educational Resources Information Center

    Washington, Pamela K.; Burke, Nancy J.; Joseph, Galen; Guerra, Claudia; Pasick, Rena J.

    2009-01-01

    This study of mother-adult daughter communication uses qualitative methods to explore the appropriateness of including adult daughters as referents in the measurement of subjective norms (a behavioral theory construct) related to the use of mammography and other health-related tests and services. The methods were chosen to approximate as closely…

  9. The Effect of Body Mass on Outdoor Adult Human Decomposition.

    PubMed

    Roberts, Lindsey G; Spencer, Jessica R; Dabbs, Gretchen R

    2017-02-23

    Forensic taphonomy explores factors impacting human decomposition. This study investigated the effect of body mass on the rate and pattern of adult human decomposition. Nine males and three females aged 49-95 years ranging in mass from 73 to 159 kg who were donated to the Complex for Forensic Anthropology Research between December 2012 and September 2015 were included in this study. Kelvin accumulated degree days (KADD) were used to assess the thermal energy required for subjects to reach several total body score (TBS) thresholds: early decomposition (TBS ≥6.0), TBS ≥12.5, advanced decomposition (TBS ≥19.0), TBS ≥23.0, and skeletonization (TBS ≥27.0). Results indicate no significant correlation between body mass and KADD at any TBS threshold. Body mass accounted for up to 24.0% of variation in decomposition rate depending on stage, and minor differences in decomposition pattern were observed. Body mass likely has a minimal impact on postmortem interval estimation.

  10. A comparative study of bifidobacteria in human babies and adults

    PubMed Central

    KHONSARI, Shadi; SUGANTHY, Mayuran; BURCZYNSKA, Beata; DANG, Vu; CHOUDHURY, Manika; PACHENARI, Azra

    2015-01-01

    The composition and diversity of the gut microbiota are known to be different between babies and adults. The aim of this project was to compare the level of bifidobacteria between babies and adults and to investigate the influence of lifestyle factors on the level of this bacterium in the gut. During this study, the levels of bifidobacteria in 10 human babies below 2 years of age were compared with that of 10 human adults above 40 years. The level of bifidobacteria proved to be significantly higher in babies in comparison with adults. This investigation concluded that a combination of several factors, such as age, diet, and BMI, has an important effect on the level of bifidobacteria in adults, while in babies, a combination of diet and age may influence the level of intestinal bifidobacteria. PMID:27200263

  11. Human Preferences for Symmetry: Subjective Experience, Cognitive Conflict and Cortical Brain Activity

    PubMed Central

    Evans, David W.; Orr, Patrick T.; Lazar, Steven M.; Breton, Daniel; Gerard, Jennifer; Ledbetter, David H.; Janosco, Kathleen; Dotts, Jessica; Batchelder, Holly

    2012-01-01

    This study examines the links between human perceptions, cognitive biases and neural processing of symmetrical stimuli. While preferences for symmetry have largely been examined in the context of disorders such as obsessive-compulsive disorder and autism spectrum disorders, we examine various these phenomena in non-clinical subjects and suggest that such preferences are distributed throughout the typical population as part of our cognitive and neural architecture. In Experiment 1, 82 young adults reported on the frequency of their obsessive-compulsive spectrum behaviors. Subjects also performed an emotional Stroop or variant of an Implicit Association Task (the OC-CIT) developed to assess cognitive biases for symmetry. Data not only reveal that subjects evidence a cognitive conflict when asked to match images of positive affect with asymmetrical stimuli, and disgust with symmetry, but also that their slowed reaction times when asked to do so were predicted by reports of OC behavior, particularly checking behavior. In Experiment 2, 26 participants were administered an oddball Event-Related Potential task specifically designed to assess sensitivity to symmetry as well as the OC-CIT. These data revealed that reaction times on the OC-CIT were strongly predicted by frontal electrode sites indicating faster processing of an asymmetrical stimulus (unparallel lines) relative to a symmetrical stimulus (parallel lines). The results point to an overall cognitive bias linking disgust with asymmetry and suggest that such cognitive biases are reflected in neural responses to symmetrical/asymmetrical stimuli. PMID:22720004

  12. Human preferences for symmetry: subjective experience, cognitive conflict and cortical brain activity.

    PubMed

    Evans, David W; Orr, Patrick T; Lazar, Steven M; Breton, Daniel; Gerard, Jennifer; Ledbetter, David H; Janosco, Kathleen; Dotts, Jessica; Batchelder, Holly

    2012-01-01

    This study examines the links between human perceptions, cognitive biases and neural processing of symmetrical stimuli. While preferences for symmetry have largely been examined in the context of disorders such as obsessive-compulsive disorder and autism spectrum disorders, we examine various these phenomena in non-clinical subjects and suggest that such preferences are distributed throughout the typical population as part of our cognitive and neural architecture. In Experiment 1, 82 young adults reported on the frequency of their obsessive-compulsive spectrum behaviors. Subjects also performed an emotional Stroop or variant of an Implicit Association Task (the OC-CIT) developed to assess cognitive biases for symmetry. Data not only reveal that subjects evidence a cognitive conflict when asked to match images of positive affect with asymmetrical stimuli, and disgust with symmetry, but also that their slowed reaction times when asked to do so were predicted by reports of OC behavior, particularly checking behavior. In Experiment 2, 26 participants were administered an oddball Event-Related Potential task specifically designed to assess sensitivity to symmetry as well as the OC-CIT. These data revealed that reaction times on the OC-CIT were strongly predicted by frontal electrode sites indicating faster processing of an asymmetrical stimulus (unparallel lines) relative to a symmetrical stimulus (parallel lines). The results point to an overall cognitive bias linking disgust with asymmetry and suggest that such cognitive biases are reflected in neural responses to symmetrical/asymmetrical stimuli.

  13. Developmental Reprogramming in Mesenchymal Stromal Cells of Human Subjects with Idiopathic Pulmonary Fibrosis

    PubMed Central

    Chanda, Diptiman; Kurundkar, Ashish; Rangarajan, Sunad; Locy, Morgan; Bernard, Karen; Sharma, Nirmal S.; Logsdon, Naomi J.; Liu, Hui; Crossman, David K.; Horowitz, Jeffrey C.; De Langhe, Stijn; Thannickal, Victor J.

    2016-01-01

    Cellular plasticity and de-differentiation are hallmarks of tissue/organ regenerative capacity in diverse species. Despite a more restricted capacity for regeneration, humans with age-related chronic diseases, such as cancer and fibrosis, show evidence of a recapitulation of developmental gene programs. We have previously identified a resident population of mesenchymal stromal cells (MSCs) in the terminal airways-alveoli by bronchoalveolar lavage (BAL) of human adult lungs. In this study, we characterized MSCs from BAL of patients with stable and progressive idiopathic pulmonary fibrosis (IPF), defined as <5% and ≥10% decline, respectively, in forced vital capacity over the preceding 6-month period. Gene expression profiles of MSCs from IPF subjects with progressive disease were enriched for genes regulating lung development. Most notably, genes regulating early tissue patterning and branching morphogenesis were differentially regulated. Network interactive modeling of a set of these genes indicated central roles for TGF-β and SHH signaling. Importantly, fibroblast growth factor-10 (FGF-10) was markedly suppressed in IPF subjects with progressive disease, and both TGF-β1 and SHH signaling were identified as critical mediators of this effect in MSCs. These findings support the concept of developmental gene re-activation in IPF, and FGF-10 deficiency as a potentially critical factor in disease progression. PMID:27869174

  14. 7 CFR 1c.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... involvement of human subjects. 1c.118 Section 1c.118 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.118 Applications and proposals lacking definite plans for involvement of... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  15. 7 CFR 1c.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... involvement of human subjects. 1c.118 Section 1c.118 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.118 Applications and proposals lacking definite plans for involvement of... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  16. 49 CFR 11.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... for involvement of human subjects. 11.118 Section 11.118 Transportation Office of the Secretary of... involvement of human subjects. Certain types of applications for grants, cooperative agreements, or contracts... institution's responsibility; research training grants in which the activities involving subjects remain to...

  17. 7 CFR 1c.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... involvement of human subjects. 1c.118 Section 1c.118 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.118 Applications and proposals lacking definite plans for involvement of... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  18. 49 CFR 11.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... for involvement of human subjects. 11.118 Section 11.118 Transportation Office of the Secretary of... involvement of human subjects. Certain types of applications for grants, cooperative agreements, or contracts... institution's responsibility; research training grants in which the activities involving subjects remain to...

  19. 49 CFR 11.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... for involvement of human subjects. 11.118 Section 11.118 Transportation Office of the Secretary of... involvement of human subjects. Certain types of applications for grants, cooperative agreements, or contracts... institution's responsibility; research training grants in which the activities involving subjects remain to...

  20. 49 CFR 11.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... for involvement of human subjects. 11.118 Section 11.118 Transportation Office of the Secretary of... involvement of human subjects. Certain types of applications for grants, cooperative agreements, or contracts... institution's responsibility; research training grants in which the activities involving subjects remain to...

  1. 7 CFR 1c.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... involvement of human subjects. 1c.118 Section 1c.118 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.118 Applications and proposals lacking definite plans for involvement of... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  2. 7 CFR 1c.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... involvement of human subjects. 1c.118 Section 1c.118 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.118 Applications and proposals lacking definite plans for involvement of... responsibility; research training grants in which the activities involving subjects remain to be selected;...

  3. Brain stem auditory evoked responses in human infants and adults

    NASA Technical Reports Server (NTRS)

    Hecox, K.; Galambos, R.

    1974-01-01

    Brain stem evoked potentials were recorded by conventional scalp electrodes in infants (3 weeks to 3 years of age) and adults. The latency of one of the major response components (wave V) is shown to be a function both of click intensity and the age of the subject; this latency at a given signal strength shortens postnatally to reach the adult value (about 6 msec) by 12 to 18 months of age. The demonstrated reliability and limited variability of these brain stem electrophysiological responses provide the basis for an optimistic estimate of their usefulness as an objective method for assessing hearing in infants and adults.

  4. From the Philosophy of Consciousness to the Philosophy of Difference: The Subject for Education after Humanism

    ERIC Educational Resources Information Center

    Zhao, Guoping

    2015-01-01

    Biesta has suggested that education after humanism should be interested in existence, not essence, in what the subject can do, not in what the subject is--the truth about the subject--and this is the way inspired by Foucault and Levinas. In this article, I analyze Foucault's alleged deconstruction and reconfiguration of the subject and Levinas'…

  5. Condylar volume and condylar area in class I, class II and class III young adult subjects

    PubMed Central

    2012-01-01

    Aim Aim of this study was to compare the volume and the shape of mandibular condyles in a Caucasian young adult population, with different skeletal pattern. Material and methods 200 Caucasian patients (15–30 years old, 95 male and 105 females) were classified in three groups on the base of ANB angle: skeletal class I (65 patients), skeletal class II (70 patients) and skeletal class III (65 patients). Left and right TMJs of each subject were evaluated independently with CBCT (Iluma). TMJ evaluation included: condylar volume; condylar area; morphological index (MI). Condylar volumes were calculated by using the Mimics software. The condylar volume, the area and the morphological index (MI) were compared among the three groups, by using non-parametric tests. Results The Kruskal-Wallis test and the Mann Whitney test revealed that: no significant difference was observed in the whole sample between the right and the left condylar volume; subjects in skeletal class III showed a significantly higher condylar volume, respect to class I and class II subjects (p < 0.05); significantly lower condylar volume was observed in class II subjects, respect to class I and class III (p < 0.05). In the whole sample condylar volume (699.8 ± 63.07 mm3 in males and 663.5 ± 81.3 mm3 in females; p < 0.01) as well as condylar surface (423.24 ± 63.03 mm2 in males and 389.76 ± 61.15 mm2 in females; p < 0.01) were significantly higher in males than in females. Conclusion Skeletal class appeared to be associated to the mandibular condylar volume and to the mandibular condylar area in the Caucasian orthodontic population. PMID:23241136

  6. Compensation for injured study subjects in clinical trials: an ethical obligation in human subjects research.

    PubMed

    Buechner, Bianca

    2012-01-01

    The Presidential Commission for the Study of Bioethical Issues suggested in its report "Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues" that the United States should implement a system to compensate research subjects for research-related injuries. This article not only analyzes the Commission's recommendation critically, but also discusses if an ethical obligation exists to compensate study subjects for research-related injuries. In addition, the article compares the status quo of the United States to the one in Germany. Germany is one of the countries, which has an established insurance system for research-related injuries based on a non-fault system.

  7. Humanities and the Adult Learner in an Information Society.

    ERIC Educational Resources Information Center

    Myers, Dale; Kamholtz, Jonathan

    Humanities courses have often been given little attention in continuing education for adults, possibly because they have been viewed as not "practical" or not "job-oriented" enough in our career-oriented, technologically advanced society. However, the humanities should be an integral part of our culture and of the lives of…

  8. 45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of...

  9. 48 CFR 3452.224-71 - Notice about research activities involving human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... about the regulations for the protection of human subjects and related policies and guidelines... activities involving human subjects. 3452.224-71 Section 3452.224-71 Federal Acquisition Regulations System... Text of Provisions and Clauses 3452.224-71 Notice about research activities involving human...

  10. 40 CFR 26.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... definite plans for involvement of human subjects. 26.118 Section 26.118 Protection of Environment... in Human Research Conducted or Supported by EPA § 26.118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types of applications for grants,...

  11. 40 CFR 26.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... definite plans for involvement of human subjects. 26.118 Section 26.118 Protection of Environment... in Human Research Conducted or Supported by EPA § 26.118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types of applications for grants,...

  12. 40 CFR 26.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... definite plans for involvement of human subjects. 26.118 Section 26.118 Protection of Environment... in Human Research Conducted or Supported by EPA § 26.118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types of applications for grants,...

  13. 40 CFR 26.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... definite plans for involvement of human subjects. 26.118 Section 26.118 Protection of Environment... in Human Research Conducted or Supported by EPA § 26.118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types of applications for grants,...

  14. Effect of hydration on nitrogen washout in human subjects

    NASA Technical Reports Server (NTRS)

    Waligora, J.; Horrigan, D. J., Jr.; Conkin, J.

    1983-01-01

    Five subjects were tested to assess the influence of drinking hypotonic water (distilled water) on whole body tissue nitrogen washout. During the test, the subjects breathed aviators' oxygen for three hours. Each subject performed two baseline nitrogen washouts in a two-week period. The third washout, in the third week, was done under a transient hydrated condition. This was accomplished by having the subjects drink 1.5 liters of hypotonic water 30 minutes before the washout. Five-minute plots of tissue nitrogen removal from the three separate washouts were analyzed to ascertain if the hydration technique had any effect. Our results clearly indicate that the hydration technique did not alter the tissue nitrogen washout characteristics to any degree over three hours. An increase in tissue nitrogen washout under a transient hydrated condition using hypotonic fluid was not demonstrated to be the mechanism responsible for the reported benefit of this technique in preventing Type I altitude decompression pain in man.

  15. Successful Aging and Subjective Well-Being Among Oldest-Old Adults

    PubMed Central

    Cho, Jinmyoung; Martin, Peter; Poon, Leonard W.

    2015-01-01

    Purpose of the Study: This research integrates successful aging and developmental adaptation models to empirically define the direct and indirect effects of 2 distal (i.e., education and past life experiences) and 5 proximal influences (i.e., physical functioning, cognitive functioning, physical health impairment, social resources, and perceived economic status) on subjective well-being. The proximal influences involved predictors outlined in most extant models of successful aging (e.g., Rowe & Kahn, 1998 [Rowe, J. W., & Kahn, R. L. (1998). Successful aging. New York: Pantheon Books.]). Our model extends such models by including distal impact as well as interactions between distal and proximal impacts. Design and Methods: Data were obtained from 234 centenarians and 72 octogenarians in the Georgia Centenarian Study. Structural equation modeling was conducted with Mplus 6.1. Results: Results showed significant direct effects of physical health impairment and social resources on positive aspects of subjective well-being among oldest-old adults. We also found significant indirect effects of cognitive functioning and education on positive affect among oldest-old adults. Social resources mediated the relationship between cognitive functioning and positive affect; and cognitive functioning and social resources mediated the relationship between education and positive affect. In addition, physical health impairment mediated the relationship between cognitive functioning and positive affect; and cognitive functioning and physical health impairment mediated the relationship between education and positive affect. Implications: Integrating 2 different models (i.e., successful aging and developmental adaptation) provided a comprehensive view of adaptation from a developmental perspective. PMID:25112594

  16. Social Inequalities and Depressive Symptoms in Adults: The Role of Objective and Subjective Socioeconomic Status

    PubMed Central

    Maske, Ulrike E.; Zeeb, Hajo; Lampert, Thomas

    2017-01-01

    Background There is substantial evidence that lower objective socioeconomic status (SES)—as measured by education, occupation, and income—is associated with a higher risk of depression. Less is known, however, about associations between perceptions of social status and the prevalence of depression. This study investigated associations of both objective SES and subjective social status (SSS) with depressive symptoms among adults in Germany. Methods Data were obtained from the 2013 special wave of the German Health Update study, a national health survey of the adult population in Germany. Objective SES was determined using a composite index based on education, occupation, and income. The three single dimensions of the index were also used individually. SSS was measured using the MacArthur Scale, which asks respondents to place themselves on a 10-rung ‘social ladder’. Regression models were employed to examine associations of objective SES and SSS with current depressive symptoms, as assessed with the eight-item Patient Health Questionnaire depression scale (PHQ-8 sum score ≥10). Results After mutual adjustment, lower objective SES and lower SSS were independently associated with current depressive symptoms. The associations were found in both sexes and persisted after further adjustment for sociodemographic factors, long-term chronic conditions, and functional limitations. Mediation analyses revealed a significant indirect relationship between objective SES and depressive symptoms through SSS. When the three individual dimensions of objective SES were mutually adjusted, occupation and income were independently associated with depressive symptoms. After additional adjustment for SSS, these associations attenuated but remained significant. Conclusions The findings suggest that perceptions of low social status in adults may be involved in the pathogenesis of depression and play a mediating role in the relationship between objective SES and depressive symptoms

  17. Apparent mass of the human body in the vertical direction: Inter-subject variability

    NASA Astrophysics Data System (ADS)

    Toward, Martin G. R.; Griffin, Michael J.

    2011-02-01

    The biodynamic responses of the seated human body to whole-body vibration vary considerably between people, but the reasons for the variability are not well understood. This study was designed to determine how the physical characteristics of people affect their apparent mass and whether inter-subject variability is influenced by the magnitude of vibration and the support of a seat backrest. The vertical apparent masses of 80 seated adults (41 males and 39 females aged 18-65) were measured at frequencies between 0.6 and 20 Hz with four backrest conditions (no backrest, upright rigid backrest, reclined rigid backrest, reclined foam backrest) and with three magnitudes of random vibration (0.5, 1.0 and 1.5 m s -2 rms). Relationships between subject physical characteristics (age, gender, weight, and anthropometry) and subject apparent mass were investigated with multiple regression models. The strongest predictor of the modulus of the vertical apparent mass at 0.6 Hz, at resonance, and at 12 Hz was body weight, with other factors having only a marginal effect. After correction for other variables, the principal resonance frequency was most consistently associated with age and body mass index. As age increased from 18 to 65 years, the resonance frequency increased by up to 1.7 Hz, and when the body mass index was increased from 18 to 34 kg m -2 the resonance frequency decreased by up to 1.7 Hz. These changes were greater than the 0.9-Hz increase in resonance frequency between sitting without a backrest and sitting with a reclined rigid backrest, and greater than the 1.0-Hz reduction in resonance frequency when the magnitude of vibration increased from 0.5 to 1.5 m s -2 rms. It is concluded that the effects of age, body mass index, posture, vibration magnitude, and weight should be taken into account when defining the vertical apparent mass of the seated human body.

  18. The historical, ethical, and legal background of human-subjects research.

    PubMed

    Rice, Todd W

    2008-10-01

    The current system of human-subject-research oversight and protections has developed over the last 5 decades. The principles of conducting human research were first developed as the Nuremberg code to try Nazi war criminals. The 3 basic elements of the Nuremberg Code (voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions) became the foundation for subsequent ethical codes and research regulations. In 1964 the World Medical Association released the Declaration of Helsinki, which built on the principles of the Nuremberg Code. Numerous research improprieties between 1950 and 1974 in the United States prompted Congressional deliberations about human-subject-research oversight. Congress's first legislation to protect the rights and welfare of human subjects was the National Research Act of 1974, which created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report. The Belmont Report stated 3 fundamental principles for conducting human-subjects research: respect for persons, beneficence, and justice. The Office of Human Research Protections oversees Title 45, Part 46 of the Code for Federal Regulations, which pertains to human-subjects research. That office indirectly oversees human-subjects research through local institutional review boards (IRB). Since their inception, the principles of conducting human research, IRBs, and the Code for Federal Regulations have all advanced substantially. This paper describes the history and current status of human-subjects-research regulations.

  19. Minocycline attenuates subjective-rewarding effects of dextroamphetamine in humans

    PubMed Central

    Sofuoglu, Mehmet; Mooney, Marc; Kosten, Thomas; Waters, Andrew; Hashimoto, Kenji

    2010-01-01

    Rationale Minocycline, a tetracycline antibiotic, interacts with brain glutamate and dopamine neurotransmission. In preclinical studies, minocycline attenuated amphetamine-induced acute dopamine release and subsequent behavioral sensitization. The goal of this study was to determine minocycline’s effects on the acute physiological, behavioral, and subjective responses to dextroamphetamine (DAMP) in healthy volunteers. Methods Ten healthy volunteers participated in an outpatient double-blind, placebo-controlled, crossover study. Subjects had a 5-day treatment period with either minocycline (200 mg/day) or placebo and then were crossed over for 5-days of the other treatment. After two days of taking the study medication, on days 3 and 4, subjects were randomly assigned to double-blind acute challenge with either 20 mg/70 kg DAMP or placebo DAMP (randomly labeled as drug A or B) and then crossed-over to the other challenge. On Day 5 (Experimental Session 3), subjects had the opportunity to self-administer either placebo or DAMP capsules by working on a progressive ratio computer task. Results Minocycline attenuated DAMP-induced subjective-rewarding effects but did not change DAMP choice behavior. Minocycline treatment speeded reaction times on a Go No-Go task and reduced plasma cortisol levels. Conclusions These findings warrant further studies examining the potential use of minocycline for stimulant addiction. PMID:20838775

  20. 48 CFR 252.235-7004 - Protection of Human Subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103). (2) Human Research Protection Official (HRPO) means the individual designated...

  1. 48 CFR 252.235-7004 - Protection of Human Subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103). (2) Human Research Protection Official (HRPO) means the individual designated...

  2. 48 CFR 252.235-7004 - Protection of Human Subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103). (2) Human Research Protection Official (HRPO) means the individual designated...

  3. Improved Glycemic Control in Intensively Treated Adult Subjects with Type 1 Diabetes Using Insulin Guidance Software

    PubMed Central

    Bookout, Tevin R.; McFann, Kim K.; Kelly, William C.; Beatson, Christie; Ellis, Samuel L.; Gutin, Raymond S.; Gottlieb, Peter A.

    2008-01-01

    Abstract Background Management of type 1 diabetes could be significantly improved with the availability of computerized insulin algorithms for home use. Methods This was a 1-year open label randomized control trial involving 123 adult subjects with type 1 diabetes (hemoglobin A1c values 7.5–11%) assigned to either the insulin guidance software (ACCU-CHEK® [Roche, Indianapolis, IN] Advisor) for personal data assistant (experimental group) or the control group. The primary aim of the study was to see if subjects using insulin dosing advisor software will improve glucose control over 1 year. The principal end point was an improvement in A1c at 6 and 12 months by ≥0.4%. Results Baseline demographics were similar in the two groups. Mean A1c was 8.54 ± 0.11% in the control group and 8.42 ± 0.11% (P = 0.4265) in the experimental group. The mean A1c was significantly lower from 3 to 12 months in the experimental group (P < 0.02). A1c reduction of ≥0.6% was maintained at 12 months in the experimental group. Also, a significantly higher number of subjects achieved A1c <7.5% in the experimental group from 3 to 9 months. Within target range glycemia (70–150 mg/dL) was higher in the experimental group at 3–9 months without any change in insulin dose or weight. Above target range glycemia was lower in the experimental group throughout the study. Frequency of testing per day was higher in the experimental group. Nocturnal hypoglycemia was not different between groups; however, the experimental group experienced more severe hypoglycemic events. Conclusions This is the first report that shows improved glycemic control can be maintained over 12 months in patients with type 1 diabetes by using Advisor with no change in insulin dose and weight. PMID:18715213

  4. Differences in physical fitness and subjectively rated physical health in Vietnamese and German older adults.

    PubMed

    Nguyen, Hung M; Cihlar, Volker

    2013-06-01

    This cross-sectional study aims to investigate the differences in physical fitness and subjectively rated physical health of Vietnamese and German older adults in a community dwelling. The Vietnamese sample was a random sample of 96 community-dwelling individuals aged 60 to 80 years; 50 % were women. Education is 0 % less than 5 years, 23.95 % 5 to 9 years, 47.91 % 10 to 12 years, and 28.12 % more than 12 years. The German sample was a random sample of 159 community-dwelling persons aged 59 to 90 years; 79.8 % were women. Education is 1.25 % less than 5 years, 40.25 % 5 to 9 years, 38.84 % 10 to 12 years, and 21.38 % more than 12 years. Senior Fitness Test and Short Form-36 were used as outcome measures. The Vietnamese sample shows significantly higher performance levels in motor abilities, i.e., aerobic fitness, strength, and flexibility. The Vietnamese sample indicates a lower difference in performance levels between age groups than the German sample. No differences in subjectively rated physical health factors were found. The higher performance levels of the Vietnamese sample might reflect a more active lifestyle throughout the life span, especially in socially mediated domains like living arrangements or labor work. Lower performance levels in the studied age groups of the German sample might lead to higher risks of cardiovascular diseases and proneness of falls. A more active lifestyle after retirement could contribute to a healthier, more capable, and more independent individual and collective aging. Subjectively rated health stated is a culturally mitigated domain and therefore might be independent of actual physical fitness levels.

  5. Plasma and serum lipidomics of healthy white adults shows characteristic profiles by subjects' gender and age.

    PubMed

    Ishikawa, Masaki; Maekawa, Keiko; Saito, Kosuke; Senoo, Yuya; Urata, Masayo; Murayama, Mayumi; Tajima, Yoko; Kumagai, Yuji; Saito, Yoshiro

    2014-01-01

    Blood is a commonly used biofluid for biomarker discovery. Although blood lipid metabolites are considered to be potential biomarker candidates, their fundamental properties are not well characterized. We aimed to (1) investigate the matrix type (serum vs. plasma) that may be preferable for lipid biomarker exploration, (2) elucidate age- and gender-associated differences in lipid metabolite levels, and (3) examine the stability of lipid metabolites in matrix samples subjected to repeated freeze-thaw cycles. Using liquid chromatography-mass spectrometry, we performed lipidomic analyses for fasting plasma and serum samples for four groups (15 subjects/group) of young and elderly (25-34 and 55-64 years old, respectively) males and females and for an additional aliquot of samples from young males, which were subjected to repeated freeze-thaw cycles. Lysophosphatidylcholine and diacylglycerol levels were higher in serum than in plasma samples, suggesting that the clotting process influences serum lipid metabolite levels. Gender-associated differences highlighted that the levels of many sphingomyelin species were significantly higher in females than in males, irrespective of age and matrix (plasma and serum). Age-associated differences were more prominent in females than in males, and in both matrices, levels of many triacylglycerols were significantly higher in elderly females than in young females. Plasma and serum levels of most lipid metabolites were reduced by freeze-thawing. Our results indicate that plasma is an optimal matrix for exploring lipid biomarkers because it represents the original properties of an individual's blood sample. In addition, the levels of some blood lipid species of healthy adults showed gender- and age-associated differences; thus, this should be considered during biomarker exploration and its application in diagnostics. Our fundamental findings on sample selection and handling procedures for measuring blood lipid metabolites is important

  6. 48 CFR 1252.223-72 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... informed consent of subjects shall be obtained by methods that are adequate and appropriate. (c) Committee... active role or a conflict of interests. (d) Continuing constructive communication between the committee... shall maintain records of committee review of applications and active projects, of documentation...

  7. 48 CFR 1352.235-70 - Protection of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... subjects. 1352.235-70 Section 1352.235-70 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE... Department of Commerce at 15 CFR part 27, requires contractors to maintain appropriate policies and... verify that contractor has a valid Federal-wide Assurance (FWA) issued by OHRP. (e) Prior to starting...

  8. Informed Consent, Disclosure, and Performance of Human Research Subjects.

    ERIC Educational Resources Information Center

    Mason, Emanuel J.; Remer, Rory

    The effects of conditions of informed consent and disclosure on the performance of 84 students doing a statistics laboratory assignment for an introductory graduate course in statistics at a state university in the southeast were studied. Four separate classes taught by three instructors were included. Subjects ranged in age from 22 to 47 years,…

  9. Differentiated human stem cells resemble fetal, not adult, β cells.

    PubMed

    Hrvatin, Sinisa; O'Donnell, Charles W; Deng, Francis; Millman, Jeffrey R; Pagliuca, Felicia Walton; DiIorio, Philip; Rezania, Alireza; Gifford, David K; Melton, Douglas A

    2014-02-25

    Human pluripotent stem cells (hPSCs) have the potential to generate any human cell type, and one widely recognized goal is to make pancreatic β cells. To this end, comparisons between differentiated cell types produced in vitro and their in vivo counterparts are essential to validate hPSC-derived cells. Genome-wide transcriptional analysis of sorted insulin-expressing (INS(+)) cells derived from three independent hPSC lines, human fetal pancreata, and adult human islets points to two major conclusions: (i) Different hPSC lines produce highly similar INS(+) cells and (ii) hPSC-derived INS(+) (hPSC-INS(+)) cells more closely resemble human fetal β cells than adult β cells. This study provides a direct comparison of transcriptional programs between pure hPSC-INS(+) cells and true β cells and provides a catalog of genes whose manipulation may convert hPSC-INS(+) cells into functional β cells.

  10. Metabolic benefits of dietary prebiotics in human subjects: a systematic review of randomised controlled trials.

    PubMed

    Kellow, Nicole J; Coughlan, Melinda T; Reid, Christopher M

    2014-04-14

    Complex relationships exist between the gut microflora and their human hosts. Emerging evidence suggests that bacterial dysbiosis within the colon may be involved in the pathogenesis of the metabolic syndrome, type 2 diabetes and CVD. The use of dietary prebiotic supplements to restore an optimal balance of intestinal flora may positively affect host metabolism, representing a potential treatment strategy for individuals with cardiometabolic disorders. The present review aimed to examine the current evidence supporting that dietary prebiotic supplementation in adults has beneficial effects on biochemical parameters associated with the development of metabolic abnormalities including obesity, glucose intolerance, dyslipidaemia, hepatic steatosis and low-grade chronic inflammation. Between January 2000 and September 2013, eight computer databases were searched for randomised controlled trials published in English. Human trials were included if at least one group received a dietary prebiotic intervention. In the present review, twenty-six randomised controlled trials involving 831 participants were included. Evidence indicated that dietary prebiotic supplementation increased self-reported feelings of satiety in healthy adults (standardised mean difference -0.57, 95% CI -1.13, -0.01). Prebiotic supplementation also significantly reduced postprandial glucose (-0.76, 95% CI -1.41, -0.12) and insulin (-0.77, 95% CI -1.50, -0.04) concentrations. The effects of dietary prebiotics on total energy intake, body weight, peptide YY and glucagon-like peptide-1 concentrations, gastric emptying times, insulin sensitivity, lipids, inflammatory markers and immune function were contradictory. Dietary prebiotic consumption was found to be associated with subjective improvements in satiety and reductions in postprandial glucose and insulin concentrations. Additional evidence is required before recommending prebiotic supplements to individuals with metabolic abnormalities. Large

  11. An Interleukin 13 Polymorphism Is Associated with Symptom Severity in Adult Subjects with Ever Asthma.

    PubMed

    Accordini, Simone; Calciano, Lucia; Bombieri, Cristina; Malerba, Giovanni; Belpinati, Francesca; Lo Presti, Anna Rita; Baldan, Alessandro; Ferrari, Marcello; Perbellini, Luigi; de Marco, Roberto

    2016-01-01

    Different genes are associated with categorical classifications of asthma severity. However, continuous outcomes should be used to catch the heterogeneity of asthma phenotypes and to increase the power in association studies. Accordingly, the aim of this study was to evaluate the association between single nucleotide polymorphisms (SNPs) in candidate gene regions and continuous measures of asthma severity, in adult patients from the general population. In the Gene Environment Interactions in Respiratory Diseases (GEIRD) study (www.geird.org), 326 subjects (aged 20-64) with ever asthma were identified from the general population in Verona (Italy) between 2007 and 2010. A panel of 236 SNPs tagging 51 candidate gene regions (including one or more genes) was analysed. A symptom and treatment score (STS) and pre-bronchodilator FEV1% predicted were used as continuous measures of asthma severity. The association of each SNP with STS and FEV1% predicted was tested by fitting quasi-gamma and linear regression models, respectively, with gender, body mass index and smoking habits as potential confounders. The Simes multiple-test procedure was used for controlling the false discovery rate (FDR). SNP rs848 in the IL13 gene region (IL5/RAD50/IL13/IL4) was associated with STS (TG/GG vs TT genotype: uncorrected p-value = 0.00006, FDR-corrected p-value = 0.04), whereas rs20541 in the same gene region, in linkage disequilibrium with rs848 (r(2) = 0.94) in our sample, did not reach the statistical significance after adjusting for multiple testing (TC/CC vs TT: uncorrected p-value = 0.0003, FDR-corrected p-value = 0.09). Polymorphisms in other gene regions showed a non-significant moderate association with STS (IL12B, TNS1) or lung function (SERPINE2, GATA3, IL5, NPNT, FAM13A) only. After adjusting for multiple testing and potential confounders, SNP rs848 in the IL13 gene region is significantly associated with a continuous measure of symptom severity in adult subjects with ever

  12. Late Pleistocene adult mortality patterns and modern human establishment

    PubMed Central

    Trinkaus, Erik

    2011-01-01

    The establishment of modern humans in the Late Pleistocene, subsequent to their emergence in eastern Africa, is likely to have involved substantial population increases, during their initial dispersal across southern Asia and their subsequent expansions throughout Africa and into more northern Eurasia. An assessment of younger (20–40 y) versus older (>40 y) adult mortality distributions for late archaic humans (principally Neandertals) and two samples of early modern humans (Middle Paleolithic and earlier Upper Paleolithic) provides little difference across the samples. All three Late Pleistocene samples have a dearth of older individuals compared with Holocene ethnographic/historical samples. They also lack older adults compared with Holocene paleodemographic profiles that have been critiqued for having too few older individuals for subsistence, social, and demographic viability. Although biased, probably through a combination of preservation, age assessment, and especially Pleistocene mobility requirements, these adult mortality distributions suggest low life expectancy and demographic instability across these Late Pleistocene human groups. They indicate only subtle and paleontologically invisible changes in human paleodemographics with the establishment of modern humans; they provide no support for a life history advantage among early modern humans. PMID:21220336

  13. 14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and...

  14. 14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Research undertaken without the intention of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the...

  15. 14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and...

  16. 14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Research undertaken without the intention of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the...

  17. 40 CFR 26.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.118 Applications and proposals lacking definite... projects is the institution's responsibility; research training grants in which the activities...

  18. 14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and...

  19. 14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and...

  20. 48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... System DEPARTMENT OF COMMERCE CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of... Protection of Human Subjects (the “Common Rule”), adopted by the Department of Commerce at 15 CFR part 27.... (e) Should research involving human subjects become necessary for carrying out this...

  1. 10 CFR 35.6 - Provisions for the protection of human research subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Provisions for the protection of human research subjects. 35.6 Section 35.6 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General... research involving human research subjects only if it uses the byproduct materials specified on its...

  2. 10 CFR 35.6 - Provisions for the protection of human research subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Provisions for the protection of human research subjects. 35.6 Section 35.6 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General... research involving human research subjects only if it uses the byproduct materials specified on its...

  3. 10 CFR 35.6 - Provisions for the protection of human research subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Provisions for the protection of human research subjects. 35.6 Section 35.6 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General... research involving human research subjects only if it uses the byproduct materials specified on its...

  4. 10 CFR 35.6 - Provisions for the protection of human research subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Provisions for the protection of human research subjects. 35.6 Section 35.6 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General... research involving human research subjects only if it uses the byproduct materials specified on its...

  5. 49 CFR 11.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 11.118 Section 11.118 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.118 Applications and proposals lacking definite plans...

  6. HEW Proposed Policy on the Protection of Human Subjects: Experimentation and the Institutionalized Mentally Disabled

    ERIC Educational Resources Information Center

    Washington University Law Quarterly, 1975

    1975-01-01

    Underlying bases for federal interest in experimentation on human subjects, including abuses of investigative processes and efforts at regulation, are explored. Focus is on recent HEW rules on the protection of human subjects, which will have a significant impact on many research institutions. (LBH)

  7. 45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... for involvement of human subjects. 690.118 Section 690.118 Public Welfare Regulations Relating to... Applications and proposals lacking definite plans for involvement of human subjects. Certain types of... grants when selection of specific projects is the institution's responsibility; research training...

  8. 22 CFR 225.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... plans for involvement of human subjects. 225.118 Section 225.118 Foreign Relations AGENCY FOR... plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  9. 32 CFR 219.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... plans for involvement of human subjects. 219.118 Section 219.118 National Defense Department of Defense....118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types... institutional type grants when selection of specific projects is the institution's responsibility;...

  10. 15 CFR 27.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... definite plans for involvement of human subjects. 27.118 Section 27.118 Commerce and Foreign Trade Office... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  11. 28 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... definite plans for involvement of human subjects. 46.118 Section 46.118 Judicial Administration DEPARTMENT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  12. 38 CFR 16.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... proposals lacking definite plans for involvement of human subjects. 16.118 Section 16.118 Pensions, Bonuses... and proposals lacking definite plans for involvement of human subjects. Certain types of applications... grants when selection of specific projects is the institution's responsibility; research training...

  13. 32 CFR 219.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... plans for involvement of human subjects. 219.118 Section 219.118 National Defense Department of Defense....118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types... institutional type grants when selection of specific projects is the institution's responsibility;...

  14. 16 CFR 1028.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... plans for involvement of human subjects. 1028.118 Section 1028.118 Commercial Practices CONSUMER PRODUCT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  15. 15 CFR 27.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... definite plans for involvement of human subjects. 27.118 Section 27.118 Commerce and Foreign Trade Office... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  16. 28 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... definite plans for involvement of human subjects. 46.118 Section 46.118 Judicial Administration DEPARTMENT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  17. 28 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... definite plans for involvement of human subjects. 46.118 Section 46.118 Judicial Administration DEPARTMENT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  18. 28 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... definite plans for involvement of human subjects. 46.118 Section 46.118 Judicial Administration DEPARTMENT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  19. 38 CFR 16.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... proposals lacking definite plans for involvement of human subjects. 16.118 Section 16.118 Pensions, Bonuses... and proposals lacking definite plans for involvement of human subjects. Certain types of applications... grants when selection of specific projects is the institution's responsibility; research training...

  20. 45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... for involvement of human subjects. 690.118 Section 690.118 Public Welfare Regulations Relating to... Applications and proposals lacking definite plans for involvement of human subjects. Certain types of... grants when selection of specific projects is the institution's responsibility; research training...

  1. 22 CFR 225.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... plans for involvement of human subjects. 225.118 Section 225.118 Foreign Relations AGENCY FOR... plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  2. 45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... for involvement of human subjects. 690.118 Section 690.118 Public Welfare Regulations Relating to... Applications and proposals lacking definite plans for involvement of human subjects. Certain types of... grants when selection of specific projects is the institution's responsibility; research training...

  3. 45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... for involvement of human subjects. 690.118 Section 690.118 Public Welfare Regulations Relating to... Applications and proposals lacking definite plans for involvement of human subjects. Certain types of... grants when selection of specific projects is the institution's responsibility; research training...

  4. 32 CFR 219.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... plans for involvement of human subjects. 219.118 Section 219.118 National Defense Department of Defense....118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types... institutional type grants when selection of specific projects is the institution's responsibility;...

  5. 22 CFR 225.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... plans for involvement of human subjects. 225.118 Section 225.118 Foreign Relations AGENCY FOR... plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  6. 38 CFR 16.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... proposals lacking definite plans for involvement of human subjects. 16.118 Section 16.118 Pensions, Bonuses... and proposals lacking definite plans for involvement of human subjects. Certain types of applications... grants when selection of specific projects is the institution's responsibility; research training...

  7. 22 CFR 225.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... plans for involvement of human subjects. 225.118 Section 225.118 Foreign Relations AGENCY FOR... plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  8. 32 CFR 219.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... plans for involvement of human subjects. 219.118 Section 219.118 National Defense Department of Defense....118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types... institutional type grants when selection of specific projects is the institution's responsibility;...

  9. 15 CFR 27.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... definite plans for involvement of human subjects. 27.118 Section 27.118 Commerce and Foreign Trade Office... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  10. 38 CFR 16.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... proposals lacking definite plans for involvement of human subjects. 16.118 Section 16.118 Pensions, Bonuses... and proposals lacking definite plans for involvement of human subjects. Certain types of applications... grants when selection of specific projects is the institution's responsibility; research training...

  11. 15 CFR 27.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... definite plans for involvement of human subjects. 27.118 Section 27.118 Commerce and Foreign Trade Office... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  12. 16 CFR 1028.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... plans for involvement of human subjects. 1028.118 Section 1028.118 Commercial Practices CONSUMER PRODUCT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  13. 22 CFR 225.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... plans for involvement of human subjects. 225.118 Section 225.118 Foreign Relations AGENCY FOR... plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  14. 16 CFR 1028.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... plans for involvement of human subjects. 1028.118 Section 1028.118 Commercial Practices CONSUMER PRODUCT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  15. 28 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... definite plans for involvement of human subjects. 46.118 Section 46.118 Judicial Administration DEPARTMENT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  16. 32 CFR 219.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... plans for involvement of human subjects. 219.118 Section 219.118 National Defense Department of Defense....118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types... institutional type grants when selection of specific projects is the institution's responsibility;...

  17. 45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... for involvement of human subjects. 690.118 Section 690.118 Public Welfare Regulations Relating to... Applications and proposals lacking definite plans for involvement of human subjects. Certain types of... grants when selection of specific projects is the institution's responsibility; research training...

  18. 16 CFR 1028.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... plans for involvement of human subjects. 1028.118 Section 1028.118 Commercial Practices CONSUMER PRODUCT... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  19. 15 CFR 27.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... definite plans for involvement of human subjects. 27.118 Section 27.118 Commerce and Foreign Trade Office... definite plans for involvement of human subjects. Certain types of applications for grants, cooperative... projects is the institution's responsibility; research training grants in which the activities...

  20. 38 CFR 16.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... proposals lacking definite plans for involvement of human subjects. 16.118 Section 16.118 Pensions, Bonuses... and proposals lacking definite plans for involvement of human subjects. Certain types of applications... grants when selection of specific projects is the institution's responsibility; research training...

  1. 38 CFR 17.85 - Treatment of research-related injuries to human subjects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Treatment of research-related injuries to human subjects. 17.85 Section 17.85 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a...

  2. 38 CFR 17.85 - Treatment of research-related injuries to human subjects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false Treatment of research-related injuries to human subjects. 17.85 Section 17.85 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a...

  3. Computer science security research and human subjects: emerging considerations for research ethics boards.

    PubMed

    Buchanan, Elizabeth; Aycock, John; Dexter, Scott; Dittrich, David; Hvizdak, Erin

    2011-06-01

    This paper explores the growing concerns with computer science research, and in particular, computer security research and its relationship with the committees that review human subjects research. It offers cases that review boards are likely to confront, and provides a context for appropriate consideration of such research, as issues of bots, clouds, and worms enter the discourse of human subjects review.

  4. 10 CFR 35.6 - Provisions for the protection of human research subjects.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Provisions for the protection of human research subjects. 35.6 Section 35.6 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.6 Provisions for the protection of human research subjects. (a) A licensee may...

  5. Subjective well-being in older adults: folate and vitamin B12 independently predict positive affect.

    PubMed

    Edney, Laura C; Burns, Nicholas R; Danthiir, Vanessa

    2015-10-28

    Vitamin B12, folate and homocysteine have long been implicated in mental illness, and growing evidence suggests that they may play a role in positive mental health. Elucidation of these relationships is confounded due to the dependence of homocysteine on available levels of vitamin B12 and folate. Cross-sectional and longitudinal relationships between vitamin B12, folate, homocysteine and subjective well-being were assessed in a sample of 391 older, community-living adults without clinically diagnosed depression. Levels of vitamin B12, but not folate, influenced homocysteine levels 18 months later. Vitamin B12, folate and their interaction significantly predicted levels of positive affect (PA) 18 months later, but had no impact on the levels of negative affect or life satisfaction. Cross-sectional relationships between homocysteine and PA were completely attenuated in the longitudinal analyses, suggesting that the cross-sectional relationship is driven by the dependence of homocysteine on vitamin B12 and folate. This is the first study to offer some evidence of a causal link between levels of folate and vitamin B12 on PA in a large, non-clinical population.

  6. Linking adult hippocampal neurogenesis with human physiology and disease.

    PubMed

    Bowers, Megan; Jessberger, Sebastian

    2016-07-01

    We here review the existing evidence linking adult hippocampal neurogenesis and human brain function in physiology and disease. Furthermore, we aim to point out where evidence is missing, highlight current promising avenues of investigation, and suggest future tools and approaches to foster the link between life-long neurogenesis and human brain function. Developmental Dynamics 245:702-709, 2016. © 2016 Wiley Periodicals, Inc.

  7. Robot Tracking of Human Subjects in Field Environments

    NASA Technical Reports Server (NTRS)

    Graham, Jeffrey; Shillcutt, Kimberly

    2003-01-01

    Future planetary exploration will involve both humans and robots. Understanding and improving their interaction is a main focus of research in the Intelligent Systems Branch at NASA's Johnson Space Center. By teaming intelligent robots with astronauts on surface extra-vehicular activities (EVAs), safety and productivity can be improved. The EVA Robotic Assistant (ERA) project was established to study the issues of human-robot teams, to develop a testbed robot to assist space-suited humans in exploration tasks, and to experimentally determine the effectiveness of an EVA assistant robot. A companion paper discusses the ERA project in general, its history starting with ASRO (Astronaut-Rover project), and the results of recent field tests in Arizona. This paper focuses on one aspect of the research, robot tracking, in greater detail: the software architecture and algorithms. The ERA robot is capable of moving towards and/or continuously following mobile or stationary targets or sequences of targets. The contributions made by this research include how the low-level pose data is assembled, normalized and communicated, how the tracking algorithm was generalized and implemented, and qualitative performance reports from recent field tests.

  8. Aging, Subjective Experience, and Cognitive Control: Dramatic False Remembering by Older Adults

    ERIC Educational Resources Information Center

    Jacoby, Larry L.; Bishara, Anthony J.; Hessels, Sandra; Toth, Jeffrey P.

    2005-01-01

    Recent research suggests that older adults are more susceptible to interference effects than are young adults; however, that research has failed to equate differences in original learning. In 4 experiments, the authors show that older adults are more susceptible to interference effects produced by a misleading prime. Even when original learning…

  9. The Subject-Person of Adult Education in the Crisis of Modernity.

    ERIC Educational Resources Information Center

    Finger, Mathias

    1990-01-01

    The crisis of modernity increases the tension between individual and societal development. Brookfield's critical thinking model of adult education tries to reduce societal dimensions into personal growth. Jarvis' adult learning model reduces personal development to adaptation to societal demands. Adult education needs new models to reconcile the…

  10. Expansion of Multipotent Stem Cells from the Adult Human Brain

    PubMed Central

    Murrell, Wayne; Palmero, Emily; Bianco, John; Stangeland, Biljana; Joel, Mrinal; Paulson, Linda; Thiede, Bernd; Grieg, Zanina; Ramsnes, Ingunn; Skjellegrind, Håvard K.; Nygård, Ståle; Brandal, Petter; Sandberg, Cecilie; Vik-Mo, Einar; Palmero, Sheryl; Langmoen, Iver A.

    2013-01-01

    The discovery of stem cells in the adult human brain has revealed new possible scenarios for treatment of the sick or injured brain. Both clinical use of and preclinical research on human adult neural stem cells have, however, been seriously hampered by the fact that it has been impossible to passage these cells more than a very few times and with little expansion of cell numbers. Having explored a number of alternative culturing conditions we here present an efficient method for the establishment and propagation of human brain stem cells from whatever brain tissue samples we have tried. We describe virtually unlimited expansion of an authentic stem cell phenotype. Pluripotency proteins Sox2 and Oct4 are expressed without artificial induction. For the first time multipotency of adult human brain-derived stem cells is demonstrated beyond tissue boundaries. We characterize these cells in detail in vitro including microarray and proteomic approaches. Whilst clarification of these cells’ behavior is ongoing, results so far portend well for the future repair of tissues by transplantation of an adult patient’s own-derived stem cells. PMID:23967194

  11. Impairment of auditory spatial localization in congenitally blind human subjects.

    PubMed

    Gori, Monica; Sandini, Giulio; Martinoli, Cristina; Burr, David C

    2014-01-01

    Several studies have demonstrated enhanced auditory processing in the blind, suggesting that they compensate their visual impairment in part with greater sensitivity of the other senses. However, several physiological studies show that early visual deprivation can impact negatively on auditory spatial localization. Here we report for the first time severely impaired auditory localization in the congenitally blind: thresholds for spatially bisecting three consecutive, spatially-distributed sound sources were seriously compromised, on average 4.2-fold typical thresholds, and half performing at random. In agreement with previous studies, these subjects showed no deficits on simpler auditory spatial tasks or with auditory temporal bisection, suggesting that the encoding of Euclidean auditory relationships is specifically compromised in the congenitally blind. It points to the importance of visual experience in the construction and calibration of auditory spatial maps, with implications for rehabilitation strategies for the congenitally blind.

  12. Maps of the adult human hypothalamus

    PubMed Central

    Lemaire, Jean-Jacques; Nezzar, Hachemi; Sakka, Laurent; Boirie, Yves; Fontaine, Denys; Coste, Aurélien; Coll, Guillaume; Sontheimer, Anna; Sarret, Catherine; Gabrillargues, Jean; De Salles, Antonio

    2013-01-01

    The human hypothalamus is a small deeply located region placed at the crossroad of neurovegetative, neuroendocrine, limbic, and optic systems. Although deep brain stimulation techniques have proven that it could be feasible to modulate these systems, targeting the hypothalamus and in particular specific nuclei and white bundles, is still challenging. Our goal was to make a synthesis of relevant topographical data of the human hypothalamus, under the form of magnetic resonance imaging maps useful for mastering its elaborated structure as well as its neighborhood. As from 1.5 Tesla, Inversion-Recovery sequence allows locating the hypothalamus and most of its components. Spotting hypothalamic compartments is possible according to specific landmarks: the anterior commissure, the mammillary bodies, the preoptic recess, the infundibular recess, the crest between the preoptic and the infundibular recesses, the optical tract, the fornix, and the mammillo-thalamic bundle. The identification of hypothalamus and most of its components could be useful to allow the quantification of local pathological processes and to target specific circuitry to alleviate severe symptoms, using physical or biological agents. PMID:23682342

  13. Facebook use predicts declines in subjective well-being in young adults.

    PubMed

    Kross, Ethan; Verduyn, Philippe; Demiralp, Emre; Park, Jiyoung; Lee, David Seungjae; Lin, Natalie; Shablack, Holly; Jonides, John; Ybarra, Oscar

    2013-01-01

    Over 500 million people interact daily with Facebook. Yet, whether Facebook use influences subjective well-being over time is unknown. We addressed this issue using experience-sampling, the most reliable method for measuring in-vivo behavior and psychological experience. We text-messaged people five times per day for two-weeks to examine how Facebook use influences the two components of subjective well-being: how people feel moment-to-moment and how satisfied they are with their lives. Our results indicate that Facebook use predicts negative shifts on both of these variables over time. The more people used Facebook at one time point, the worse they felt the next time we text-messaged them; the more they used Facebook over two-weeks, the more their life satisfaction levels declined over time. Interacting with other people "directly" did not predict these negative outcomes. They were also not moderated by the size of people's Facebook networks, their perceived supportiveness, motivation for using Facebook, gender, loneliness, self-esteem, or depression. On the surface, Facebook provides an invaluable resource for fulfilling the basic human need for social connection. Rather than enhancing well-being, however, these findings suggest that Facebook may undermine it.

  14. Correlation of lithium levels between drinking water obtained from different sources and scalp hair samples of adult male subjects.

    PubMed

    Baloch, Shahnawaz; Kazi, Tasneem Gul; Afridi, Hassan Imran; Baig, Jameel Ahmed; Talpur, Farah Naz; Arain, Muhammad Balal

    2016-10-18

    There is some evidence that natural levels of lithium (Li) in drinking water may have a protective effect on neurological health. In present study, we evaluate the Li levels in drinking water of different origin and bottled mineral water. To evaluate the association between lithium levels in drinking water with human health, the scalp hair samples of male subjects (25-45 years) consumed drinking water obtained from ground water (GW), municipal treated water (MTW) and bottled mineral water (BMW) from rural and urban areas of Sindh, Pakistan were selected. The water samples were pre-concentrated five to tenfold at 60 °C using temperature-controlled electric hot plate. While scalp hair samples were oxidized by acid in a microwave oven, prior to determined by flame atomic absorption spectrometry. The Li content in different types of drinking water, GW, MTW and BMW was found in the range of 5.12-22.6, 4.2-16.7 and 0.0-16.3 µg/L, respectively. It was observed that Li concentration in the scalp hair samples of adult males consuming ground water was found to be higher, ranged as 292-393 μg/kg, than those who are drinking municipal treated and bottle mineral water (212-268 and 145-208 μg/kg), respectively.

  15. Adult Daughters’ Influence on Mothers’ Health-Related Decision Making: An Expansion of the Subjective Norms Construct

    PubMed Central

    Washington, Pamela K.; Burke, Nancy J.; Joseph, Galen; Guerra, Claudia; Pasick, Rena J.

    2010-01-01

    This study of mother–adult daughter communication uses qualitative methods to explore the appropriateness of including adult daughters as referents in the measurement of subjective norms (a behavioral theory construct) related to the use of mammography and other health-related tests and services. The methods were chosen to approximate as closely as possible the mother–adult daughter relationship in the context of daily life. This inductive approach contrasts with the deductive origins of the construct. A sample of nine Mexican and Filipina immigrant and U.S.-born mothers and their adult daughters was recruited. Data were collected in two phases: (a) videotaped observations of mother–daughter dyads discussing health-related topics and (b) follow-up interviews designed to obtain an emic (insider) perspective of the videotaped interaction. Results show that adult daughters influence their mothers’ ability to navigate the health care system and contribute to health-related decision making and behavior, suggesting that it may be appropriate to include adult daughters in the assessment of subjective norms. PMID:19805795

  16. Discrimination of geometric angles by adult humans.

    PubMed

    Reichert, James F; Kelly, Debbie M

    2012-03-01

    Men and women learned to discriminate between two different size angles presented to them as objects within a real-world task. During Experiment 1, participants in group 50 were trained to choose a 50° angle and participants in group 75 were trained to choose a 75° angle. During testing, both groups were provided with a choice between their training angle and one of a set of test angles that was either smaller or larger than the training angle. Results showed a generalized pattern of responding, with group 50 showing increased responding to test angles smaller than 50° and group 75 showing increased responding to test angles larger than 75°. Further analysis of the response patterns revealed that participants in group 50 showed evidence of absolute learning, whereas participants in group 75 showed evidence of relational learning. During Experiment 2, a third group of participants (group 25) trained to choose a smaller angle (25°) was included in addition to group 50 and group 75. Participants were trained with three angles present and tested with just two, one being their training angle and the other being one of a set of novel test angles. Similar to the participants from Experiment 1, group 75 showed evidence of relational learning. Group 50, for which no relational rule could be applied during training, showed an absolute learning pattern with no response shift to test angles smaller or larger than their training angle. Group 25 showed evidence of absolute responding that was more pronounced than that found for the smallest training angle during Experiment 1. These findings suggest differential learning of geometric angles based on amplitude with smaller angles perceived as more distinct and thus more resistant to broader generalization than larger angles. Implications of these results are that certain geometric properties may be subject to different learning processes based on the specific magnitude of that property.

  17. Absorption and disposition kinetics of amoxicillin in normal human subjects.

    PubMed Central

    Arancibia, A; Guttmann, J; González, G; González, C

    1980-01-01

    Pharmacokinetic parameters of amoxicillin were studied in healthy fasted subjects afqer both oral and intravenous administration of a single 500-mg dose. Serum levels and urinary excretion rates were determined at various time intervals by a microbiological method. The conventional two-compartment model with elimination occurring from the central compartment was used to analyze the data. Mean values were 3.40 h-1 for alpha and 0.68 h-1 for beta. Distribution constants kappa 12 and kappa 21 were 0.92 h-1 and 1.99 h-1, respectively. The rate constant for elimination from the central compartment, kappa 10, was 1.16 h-1. The volume of distribution was 20.2 liters (0.30 liter/kg), and the serum clearance was 13.3 liters/h. The absorption rate constant, kappa a, in the oral study, calculated by the Loo-Riegelman method, was 1.02 h-1, and the absorption half-life was 0.72 h. Absolute bioavailability after the oral dose was determined by comparing both the areas under the curve (AUC) and fractions of the antibiotic excreted unchanged in the urine. The AUC after oral administration was 77.4% of the intravenous AUC. On the other hand, recovery from the urine was 43.4% after the oral dose and 57.4% after the intravenous dose, indicating 76.5% bioavailability. PMID:7387142

  18. Gastrointestinal Physiology During Head Down Tilt Bedrest in Human Subjects

    NASA Technical Reports Server (NTRS)

    Vaksman, Z.; Guthienz, J.; Putcha, L.

    2008-01-01

    Introduction: Gastrointestinal (GI) motility plays a key role in the physiology and function of the GI tract. It directly affects absorption of medications and nutrients taken by mouth, in addition to indirectly altering GI physiology by way of changes in the microfloral composition and biochemistry of the GI tract. Astronauts have reported nausea, loss of appetite and constipation during space flight all of which indicate a reduction in GI motility and function similar to the one seen in chronic bed rest patients. The purpose of this study is to determine GI motility and bacterial proliferation during -6 degree head down tilt bed rest (HTD). Methods: Healthy male and female subjects between the ages of 25-40 participated in a 60 day HTD study protocol. GI transit time (GITT) was determined using lactulose breath hydrogen test and bacterial overgrowth was measured using glucose breath hydrogen test. H. Pylori colonization was determined using C13-urea breath test (UBIT#). All three tests were conducted on 9 days before HDT, and repeated on HDT days 2, 28, 58, and again on day 7 after HDT. Results: GITT increased during HTD compared to the respective ambulatory control values; GITT was significantly lower on day 7 after HTD. A concomitant increase in bacterial colonization was also noticed during HDT starting after approximately 28 days of HDT. However, H. Pylori proliferation was not recorded during HDT as indicated by UBIT#. Conclusion: GITT significantly decreased during HDT with a concomitant increase in the proliferation of GI bacterial flora but not H. pylori.

  19. Physiology and biochemistry of human subjects during entrapment.

    PubMed

    Agapiou, A; Mikedi, K; Karma, S; Giotaki, Z K; Kolostoumbis, D; Papageorgiou, C; Zorba, E; Spiliopoulou, C; Amann, A; Statheropoulos, M

    2013-03-01

    A classification of various categories of entrapped people under the ruins of collapsed buildings after earthquakes, technical failures or explosions is proposed. Type and degree of injury at the moment of building collapse and duration of entrapment are the two basic parameters in this classification. The aim is to provide sources and types of volatile organic compounds (VOCs) that can be used for establishing a new method for locating entrapped victims based on human chemical signatures. Potential target compounds, among others, are ammonia, acetone, isoprene, dimethylsulfide, dimethyldisulfide and trimethylamine. In this context, the possible neuroendocrine, metabolic and physical responses of potential victims during the different types of entrapment are correlated with the sources of VOCs such as expired air, urine, blood and sweat. The proposed classification scheme was developed as part of an integrated research project which investigates the use of combined audio, video and chemical methods for the early location of entrapped people under the ruins of collapsed buildings.

  20. Olive leaf extract as a hypoglycemic agent in both human diabetic subjects and in rats.

    PubMed

    Wainstein, Julio; Ganz, Tali; Boaz, Mona; Bar Dayan, Yosefa; Dolev, Eran; Kerem, Zohar; Madar, Zecharia

    2012-07-01

    Olive tree (Olea europaea L.) leaves have been widely used in traditional remedies in European and Mediterranean countries as extracts, herbal teas, and powder. They contain several potentially bioactive compounds that may have hypoglycemic properties. To examine the efficacy of 500 mg oral olive leaf extract taken once daily in tablet form versus matching placebo in improving glucose homeostasis in adults with type 2 diabetes (T2DM). In this controlled clinical trial, 79 adults with T2DM were randomized to treatment with 500 mg olive leaf extract tablet taken orally once daily or matching placebo. The study duration was 14 weeks. Measures of glucose homeostasis including Hba1c and plasma insulin were measured and compared by treatment assignment. In a series of animal models, normal, streptozotocin (STZ) diabetic, and sand rats were used in the inverted sac model to determine the mechanism through which olive leaf extract affected starch digestion and absorption. In the randomized clinical trial, the subjects treated with olive leaf extract exhibited significantly lower HbA1c and fasting plasma insulin levels; however, postprandial plasma insulin levels did not differ significantly by treatment group. In the animal models, normal and STZ diabetic rats exhibited significantly reduced starch digestion and absorption after treatment with olive leaf extract compared with intestine without olive leaf treatment. Reduced digestion and absorption was observed in both the mucosal and serosal sides of the intestine. Though reduced, the decline in starch digestion and absorption did not reach statistical significance in the sand rats. Olive leaf extract is associated with improved glucose homeostasis in humans. Animal models indicate that this may be facilitated through the reduction of starch digestion and absorption. Olive leaf extract may represent an effective adjunct therapy that normalizes glucose homeostasis in individuals with diabetes.

  1. Air pollution and lung function among susceptible adult subjects: a panel study

    PubMed Central

    Lagorio, Susanna; Forastiere, Francesco; Pistelli, Riccardo; Iavarone, Ivano; Michelozzi, Paola; Fano, Valeria; Marconi, Achille; Ziemacki, Giovanni; Ostro, Bart D

    2006-01-01

    Background Adverse health effects at relatively low levels of ambient air pollution have consistently been reported in the last years. We conducted a time-series panel study of subjects with chronic obstructive pulmonary disease (COPD), asthma, and ischemic heart disease (IHD) to evaluate whether daily levels of air pollutants have a measurable impact on the lung function of adult subjects with pre-existing lung or heart diseases. Methods Twenty-nine patients with COPD, asthma, or IHD underwent repeated lung function tests by supervised spirometry in two one-month surveys. Daily samples of coarse (PM10–2.5) and fine (PM2.5) particulate matter were collected by means of dichotomous samplers, and the dust was gravimetrically analyzed. The particulate content of selected metals (cadmium, chrome, iron, nickel, lead, platinum, vanadium, and zinc) was determined by atomic absorption spectrometry. Ambient concentrations of nitrogen dioxide (NO2), carbon monoxide (CO), ozone (O3), and sulphur dioxide (SO2) were obtained from the regional air-quality monitoring network. The relationships between concentrations of air pollutants and lung function parameters were analyzed by generalized estimating equations (GEE) for panel data. Results Decrements in lung function indices (FVC and/or FEV1) associated with increasing concentrations of PM2.5, NO2 and some metals (especially zinc and iron) were observed in COPD cases. Among the asthmatics, NO2 was associated with a decrease in FEV1. No association between average ambient concentrations of any air pollutant and lung function was observed among IHD cases. Conclusion This study suggests that the short-term negative impact of exposure to air pollutants on respiratory volume and flow is limited to individuals with already impaired respiratory function. The fine fraction of ambient PM seems responsible for the observed effects among COPD cases, with zinc and iron having a potential role via oxidative stress. The respiratory function

  2. Interactions of manganese, iron, and copper in healthy human subjects

    SciTech Connect

    Lin, Paohwa.

    1989-01-01

    In study I, plasma levels of manganese and iron were measured after an oral load was ingested. Four hourly samples of plasma were collected postdose. The ingestion of a dose of 40 mg Mn alone produced a typical response in plasma manganese, which peaked at either the first or second hour postdose. When a combined dose of 40 mg inorganic Fe plus 40 mg Mn was given, the plasma uptake of manganese was substantially inhibited when compared to a dose of 40 mg Mn alone. When the same quantity of heme Fe was substituted for the inorganic Fe in the load of inorganic Fe plus Mn, no depression in plasma manganese was observed. In study II, eight healthy female subjects were fed a baseline Mn-adequate diet of conventional foods for 18 days, followed by a Mn-deficient semi-purified diet for 41 days. Dietary levels of iron and copper averaged 17.7 mg and 4.3 mg/day, respectively, for both diets. Mean iron balance increased significantly from initial levels of 2.20 {plus minus} 1.07 mg/d to 5.02 {plus minus} 1.14 mg/d at the end of the Mn-deficient period. Parameters of iron status were not influenced by the variations of dietary manganese. In contrast, mean copper balance decreased from 2.61 {plus minus} 0.1 mg/d to 0.91 {plus minus} 0.4 mg/d at the end of the Mn-deficient period. Correspondingly, plasma copper and serum ceruloplasmin decreased from 18.57 {plus minus} 1.1 {mu}mol/L to 15.27 {plus minus} 0.94 {mu}mol/L and 269.1 {plus minus} 14.6 mg/L to 205.6 {plus minus} 17.8 mg/L., respectively.

  3. Bioavailability and Pharmacodynamics of Promethazine in Human Subjects

    NASA Technical Reports Server (NTRS)

    Putcha, Lakshmi; Flynn, Chris; Paloski, W. H. (Technical Monitor)

    2000-01-01

    Space Motion Sickness (SMS) is often treated in space with promethazine (PMZ). Anecdotal reports indicate that the common side effects of drowsiness and decrements in cognitive performance that are associated with PMZ administration (50 mg IM on the ground, are absent or less pronounced in space suggesting I that-the bioavailability and/or pharmacodynamic behavior of PMZ may be altered during space flight. There are limited flight opportunities available for clinical research in space, the NRA-99, therefore, solicits research required to improve, or answer specific questions about in-flight diagnosis, therapy, and post-flight rehabilitation. We propose here, to establish a noninvasive method for pharmacodynamic and therapeutic assessment of PMZ. The specific objectives of the proposed research are to, 1. Establish a saliva to plasma ratio of PMZ after administration, 2. Estimate the relative bioavailability of the three flight-specific dosage forms of PMZ, and 3. Establish the dose-response relationship of PMZ. We will estimate the bioavailability of intramuscular injection (IM), oral tablets and rectal suppositories in normal subjects during ambulatory and antiorthostatic; bed rest (ABR) conditions using novel stable isotope techniques. Drowsiness, cognitive performance and salivary flow rate will be measured as a function of circulating drug concentrations after administration of three IM doses of PMZ. We will compare and contrast the bioavailability of PMZ during normal and ABR conditions to examine whether or not ABR can simulate changes in drug, absorption and availability similar to those anticipated in a microgravity environment. Results of this study will validate methods for an approved study with this medication awaiting a flight opportunity for manifestation. These data will also provide the much needed information on the dynamics and therapeutic index. of this medication and their implications on crew fatigue and performance in space. Key words

  4. Protein and calorie intakes in adult and pediatric subjects with urea cycle disorders participating in clinical trials of glycerol phenylbutyrate☆

    PubMed Central

    Hook, Debra; Diaz, George A.; Lee, Brendan; Bartley, James; Longo, Nicola; Berquist, William; Le Mons, Cynthia; Rudolph-Angelich, Ingrid; Porter, Marty; Scharschmidt, Bruce F.; Mokhtarani, Masoud

    2016-01-01

    Background Little prospectively collected data are available comparing the dietary intake of urea cycle disorder (UCD) patients to UCD treatment guidelines or to healthy individuals. Objective To examine the protein and calorie intakes of UCD subjects who participated in clinical trials of glycerol phenylbutyrate (GPB) and compare these data to published UCD dietary guidelines and nutritional surveys. Design Dietary data were recorded for 45 adult and 49 pediatric UCD subjects in metabolic control during participation in clinical trials of GPB. Protein and calorie intakes were compared to UCD treatment guidelines, average nutrient intakes of a healthy US population based on the National Health and Nutrition Examination Survey (NHANES) and Recommended Daily Allowances (RDA). Results In adults, mean protein intake was higher than UCD recommendations but lower than RDA and NHANES values, while calorie intake was lower than UCD recommendations, RDA and NHANES. In pediatric subjects, prescribed protein intake was higher than UCD guidelines, similar to RDA, and lower than NHANES data for all age groups, while calorie intake was at the lower end of the recommended UCD range and close to RDA and NHANES data. In pediatric subjects height, weight, and body mass index (BMI) Z-scores were within normal range (− 2 to 2). Conclusions Pediatric patients treated with phenylbutyrate derivatives exhibited normal height and weight. Protein and calorie intakes in adult and pediatric UCD subjects differed from UCD dietary guidelines, suggesting that these guidelines may need to be reconsidered. PMID:27014577

  5. 48 CFR 1352.235-71 - Protection of human subjects-exemption.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Protection of human....235-71 Protection of human subjects—exemption. As prescribed in 48 CFR 1335.006(b), insert the following clause: Protection of Human Subjects (APR 2010) (a) Contractor has satisfied the requirements...

  6. 48 CFR 1352.235-71 - Protection of human subjects-exemption.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Protection of human....235-71 Protection of human subjects—exemption. As prescribed in 48 CFR 1335.006(b), insert the following clause: Protection of Human Subjects (APR 2010) (a) Contractor has satisfied the requirements...

  7. 48 CFR 1352.235-71 - Protection of human subjects-exemption.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Protection of human....235-71 Protection of human subjects—exemption. As prescribed in 48 CFR 1335.006(b), insert the following clause: Protection of Human Subjects (APR 2010) (a) Contractor has satisfied the requirements...

  8. 48 CFR 1352.235-71 - Protection of human subjects-exemption.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Protection of human....235-71 Protection of human subjects—exemption. As prescribed in 48 CFR 1335.006(b), insert the following clause: Protection of Human Subjects (APR 2010) (a) Contractor has satisfied the requirements...

  9. GH safety workshop position paper: A critical appraisal of recombinant human GH therapy in children and adults

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Recombinant human Growth Hormone (rhGH) has been in use for 30 years, and over that time its safety and efficacy in children and adults has been subject to considerable scrutiny. In 2001, a statement from the GH Research Society (GRS) concluded that 'for approved indications, GH is safe'; however, t...

  10. Guidelines for Documentation and Consent for Nonclinical, Nonresearch MRI in Human Subjects

    PubMed Central

    Reeder, Scott B.; Kimbrell, Vera; Owman, Titti; Steckner, Michael; Calamante, Fernando

    2016-01-01

    Magnetic resonance imaging (MRI) of human subjects is widely performed for clinical and research purposes. Clinical MRI requires a physician order, while research MRI typically requires an approved protocol from a local Institutional Review Board, as well as informed consent. However, there are several circumstances in which it is appropriate to perform MRI in human subjects, that constitute neither clinical nor research activities. Examples include clinical protocol development, training and teaching, and quality assurance testing. We refer to such activities as nonclinical, nonresearch MRI. The purpose of this document is to provide principles and guidelines for appropriate and safe use of MRI in human subjects for nonclinical, nonresearch purposes. PMID:27312969

  11. Ethics is for human subjects too: participant perspectives on responsibility in health research.

    PubMed

    Cox, Susan M; McDonald, Michael

    2013-12-01

    Despite the significant literature as well as energy devoted to ethical review of research involving human subjects, little attention has been given to understanding the experiences of those who volunteer as human subjects. Why and how do they decide to participate in research? Is research participation viewed as a form of social responsibility or as a way of obtaining individual benefits? What if anything do research subjects feel they are owed for participation? And what do they feel that they owe the researcher? Drawing on in-depth individual interviews conducted in 2006 and 2007 with 41 subjects who participated in a variety of types of health research in Canada, this paper focuses on subject perspectives on responsibility in research. Highlighting the range of ways that subjects describe their involvement in research and commitments to being a 'good' subject, we present a typology of narratives that sheds new light on the diverse meanings of research participation. These narratives are not mutually exclusive or prescriptive but are presented as ideal types typifying a set of circumstances and values. As such, they collectively illuminate a range of motivations expressed by human subjects as well as potential sources of vulnerability. The typology adds a new dimension to the literature in this area and has significant implications for researchers seeking more human-subject centred approaches to research recruitment and retention, as well as research ethics boards trying to better anticipate the perspectives of prospective participants.

  12. The 10-year course of adult aggression toward others in patients with borderline personality disorder and axis II comparison subjects.

    PubMed

    Zanarini, Mary C; Temes, Christina M; Ivey, Alexandra M; Cohn, Danielle M; Conkey, Lindsey C; Frankenburg, Frances R; Fitzmaurice, Garrett M

    2017-02-27

    This study had two aims. The first was to assess and compare various types of aggressive behavior toward others reported by borderline patients and axis II comparison subjects over time. The second was to determine the best baseline and time-varying predictors of aggressive behavior in these borderline patients. At baseline, a series of interviews and self-report measures were administered to 290 borderline patients and 72 axis II comparison subjects. Measures assessing aggression toward others, axis I and II disorders as well as adult adversity were re-administered every two years over the course of ten years. It was found that borderline patients reported significantly higher rates of verbal, emotional, and physical aggression toward others than comparison subjects but the rates of these forms of aggression toward others declined significantly for those in both study groups. Multivariate analyses indicated that the strongest predictors of adult aggression towards others were severity of adult adversity and a substance use disorder. Taken together, these results suggest that borderline patients commonly report aggression toward others but that this aggression declines significantly over time. These results also suggest that this aggression toward others is most strongly associated with adult experiences of adversity and concurrent substance abuse.

  13. Antibody responses to bacteriophage phi X-174 in human subjects exposed to the antarctic winter-over model of spaceflight

    NASA Technical Reports Server (NTRS)

    Shearer, W. T.; Lugg, D. J.; Rosenblatt, H. M.; Nickolls, P. M.; Sharp, R. M.; Reuben, J. M.; Ochs, H. D.

    2001-01-01

    BACKGROUND: It has been proposed that exposure to long-term spaceflight conditions (stress, isolation, sleep disruption, containment, microbial contamination, and solar radiation) or to ground-based models of spaceflight will alter human immune responses, but specific antibody responses have not been fully evaluated. OBJECTIVE: We sought to determine whether exposure to the 8-month Antarctic winter-over model of spaceflight would alter human antibody responses. METHODS: During the 1999 Australian National Antarctic Research Expeditions, 11 adult study subjects at Casey, Antarctica, and 7 control subjects at Macquarie Island, sub-Antarctica, received primary and secondary immunizations with the T cell-dependent neoantigen bacteriophage phi X-174. Periodic plasma samples were analyzed for specific antibody function. RESULTS: All of the subjects from Casey, Antarctica, cleared bacteriophage phi X-174 normally by 1 week after primary immunization, and all had normal primary and secondary antibody responses, including immunologic memory amplification and switch from IgM to IgG antibody production. One subject showed a high normal pattern, and one subject had a low normal pattern. The control subjects from Macquarie Island also had normal immune responses to bacteriophage phi X-174. CONCLUSIONS: These data do not support the hypothesis that de novo specific antibody responses of subjects become defective during the conditions of the Antarctic winter-over. Because the Antarctic winter-over model of spaceflight lacks the important factors of microgravity and solar radiation, caution must be used in interpreting these data to anticipate normal antibody responses in long-term spaceflight.

  14. Assessing Error Awareness as a Mediator of the Relationship between Subjective Concerns and Cognitive Performance in Older Adults

    PubMed Central

    Buckley, Rachel F.; Laming, Gemma; Chen, Li Peng Evelyn; Crole, Alice; Hester, Robert

    2016-01-01

    Objectives Subjective concerns of cognitive decline (SCD) often manifest in older adults who exhibit objectively normal cognitive functioning. This subjective-objective discrepancy is counter-intuitive when mounting evidence suggests that subjective concerns relate to future clinical progression to Alzheimer’s disease, and so possess the potential to be a sensitive early behavioural marker of disease. In the current study, we aimed to determine whether individual variability in conscious awareness of errors in daily life might mediate this subjective-objective relationship. Methods 67 cognitively-normal older adults underwent cognitive, SCD and mood tests, and an error awareness task. Results Poorer error awareness was not found to mediate a relationship between SCD and objective performance. Furthermore, non-clinical levels of depressive symptomatology were a primary driving factor of SCD and error awareness, and significantly mediated a relationship between the two. Discussion We were unable to show that poorer error awareness mediates SCD and cognitive performance in older adults. Our study does suggest, however, that underlying depressive symptoms influence both poorer error awareness and greater SCD severity. Error awareness is thus not recommended as a proxy for SCD, as reduced levels of error awareness do not seem to be reflected by greater SCD. PMID:27832173

  15. Notification: Evaluation of the Environmental Protection Agency's (EPA) Research on Human Subjects

    EPA Pesticide Factsheets

    October 22, 2012. The purpose of this memorandum is to notify you that the Office of Inspector General (OIG) plans to begin an evaluation of the Environmental Protection Agency’s (EPA’s) Research on Human Subjects.

  16. Bacteriology of moderate (chronic) periodontitis in mature adult humans.

    PubMed Central

    Moore, W E; Holdeman, L V; Cato, E P; Smibert, R M; Burmeister, J A; Ranney, R R

    1983-01-01

    A total of 171 taxa was represented among 1,900 bacterial isolates from 60 samples of sites affected with moderate periodontitis in 22 mature adult humans. The composition of the subgingival sulcus flora was statistically significantly different from that of the adjacent supragingival flora and the subgingival flora of 14 people with healthy gingiva, but was not significantly different from that of sulci affected with severe periodontitis in 21 young human adults. The sulcus floras of moderate periodontitis and severe periodontitis shared many of their predominant bacterial species, but there were differences in the relative proportions of some of these species. Similar relationships were found for seven taxa of treponemes that were cultured from the samples. PMID:6642641

  17. The development and validation of a digital peak respiratory pressure monitor and its characteristics in healthy human subjects.

    PubMed

    Maruthy, K N; Vaz, M

    1999-04-01

    A digital peak respiratory pressure (DPRP) monitor for determining maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) was developed using a pressure transducer and an analog to digital converter. It was calibrated using a mercury manometer. Human studies were conducted in healthy young adults in order to determine within-subject and inter-individual variability, as well as diurnal variations and gender differences in maximal respiratory pressures. The calibration studies for the instrument indicated that the instrument recorded accurate pressures, with little temporal drift. Within-subject variability was generally low while inter-individual variability was higher and significant. Gender differences were similar to those recorded in literature for other racial groups. The DPRP monitor described is inexpensive, accurate and portable, making it ideal for use at the patient's bedside.

  18. Comparison between elemental composition of human fingernails of healthy and opium-addicted subjects by laser-induced breakdown spectroscopy.

    PubMed

    Shadman, S; Bahreini, M; Tavassoli, S H

    2012-04-20

    The objective of the present work is to identify differences in elemental fingernail composition between opium-addicted and healthy adult human subjects using laser-induced breakdown spectroscopy. Thirty nails from normal, healthy male subjects and 30 nails from opium-addicted male individuals were analyzed. Measurements on 60 nail samples were carried out, identifying 13 key species including 11 neutral elements and 2 ions. Discriminant Function Analysis (DFA) was used to classify the samples between the two groups. Spectral line intensities of elements including Fe, C, Ti, Mg, Si, Al, Ca, H, K, O, and Na were considered variables in DFA. This analysis demonstrates the efficient discrimination between the two groups. However, the number of samples in this work is not sufficient for a decisive conclusion and further research is needed to generalize this idea.

  19. 38 CFR 17.85 - Treatment of research-related injuries to human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... OF VETERANS AFFAIRS MEDICAL Research-Related Injuries § 17.85 Treatment of research-related injuries to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a research... research subjects under this section shall be provided in VA medical facilities. (1) If VA...

  20. 38 CFR 17.85 - Treatment of research-related injuries to human subjects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... OF VETERANS AFFAIRS MEDICAL Research-Related Injuries § 17.85 Treatment of research-related injuries to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a research... research subjects under this section shall be provided in VA medical facilities. (1) If VA...

  1. 38 CFR 17.85 - Treatment of research-related injuries to human subjects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... OF VETERANS AFFAIRS MEDICAL Research-Related Injuries § 17.85 Treatment of research-related injuries to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a research... research subjects under this section shall be provided in VA medical facilities. (1) If VA...

  2. Lymphatic Stomata in the Adult Human Pulmonary Ligament

    PubMed Central

    Miura, Masahiro; Iobe, Hiroaki; Kudo, Tomoo; Shimazu, Yoshihito; Aoba, Takaaki; Okudela, Koji; Nagahama, Kiyotaka; Sakamaki, Kentaro; Yoshida, Maki; Nagao, Toshitaka; Nakaya, Takeo; Kurata, Atsushi; Ohtani, Osamu

    2015-01-01

    Abstract Background: Lymphatic stomata are small lymphatic openings in the serosal membrane that communicate with the serosal cavity. Although these stomata have primarily been studied in experimental mammals, little is known concerning the presence and properties of lymphatic stomata in the adult human pleura. Thus, adult human pleurae were examined for the presence or absence of lymphatic stomata. Methods and Results: A total of 26 pulmonary ligaments (13 left and 13 right) were obtained from 15 adult human autopsy cases and examined using electron and light microscopy. The microscopic studies revealed the presence of apertures fringed with D2-40-positive, CD31-positive, and cytokeratin-negative endothelial cells directly communicating with submesothelial lymphatics in all of the pulmonary ligaments. The apertures' sizes and densities varied from case to case according to the serial tissue section. The medians of these aperture sizes ranged from 2.25 to 8.75 μm in the left pulmonary ligaments and from 2.50 to 12.50 μm in the right pulmonary ligaments. The densities of the apertures ranged from 2 to 9 per mm2 in the left pulmonary ligaments and from 2 to 18 per mm2 in the right pulmonary ligaments. However, no significant differences were found regarding the aperture size (p=0.359) and density (p=0.438) between the left and the right pulmonary ligaments. Conclusions: Our study revealed that apertures exhibit structural adequacy as lymphatic stomata on the surface of the pulmonary ligament, thereby providing evidence that lymphatic stomata are present in the adult human pleura. PMID:25526320

  3. International note: temperament and character's relationship to subjective well-being in Salvadorian adolescents and young adults.

    PubMed

    Garcia, Danilo; Nima, Ali A; Archer, Trevor

    2013-12-01

    The present study investigated the relationship between personality and Subjective Well-Being in a sample of 135 Salvadorian adolescents and young adults (age mean = 21.88 sd. = 4.70). Personality was assessed through self-reports using the Temperament and Character Inventory-Revised. Subjective Well-Being was also self-reported using the Positive Affect Negative Affect Schedule and the Satisfaction With Life Scale. Structural equation modeling was used to determine relationships between personality and Subjective Well-Being. Regarding temperament dimensions, Harm Avoidance was positively associated to negative affect and negatively associated to positive affect, while Persistence was positively associated to positive affect. Regarding character dimensions, only Self-directedness was related to Subjective Well-Being: positively related to life satisfaction and positive affect. The results presented here mirror findings using the temperament and character model of personality among European and North American adolescents.

  4. Doublecortin expression in the normal and epileptic adult human brain.

    PubMed

    Liu, Y W J; Curtis, M A; Gibbons, H M; Mee, E W; Bergin, P S; Teoh, H H; Connor, B; Dragunow, M; Faull, R L M

    2008-12-01

    Mesial temporal lobe epilepsy (MTLE) is a neurological disorder associated with spontaneous recurrent complex partial seizures and hippocampal sclerosis. Although increased hippocampal neurogenesis has been reported in animal models of MTLE, increased neurogenesis has not been reported in the hippocampus of adult human MTLE cases. Here we showed that cells expressing doublecortin (Dcx), a microtubule-associated protein expressed in migrating neuroblasts, were present in the hippocampus and temporal cortex of the normal and MTLE adult human brain. In particular, increased numbers of Dcx-positive cells were observed in the epileptic compared with the normal temporal cortex. Importantly, 56% of Dcx-expressing cells in the epileptic temporal cortex coexpressed both the proliferative cell marker, proliferating cell nuclear antigen and early neuronal marker, TuJ1, suggesting that they may be newly generated neurons. A subpopulation of Dcx-positive cells in the epileptic temporal cortex also coexpressed the mature neuronal marker, NeuN, suggesting that epilepsy may promote the generation of new neurons in the temporal cortex. This study has identified, for the first time, a novel population of Dcx-positive cells in the adult human temporal cortex that can be upregulated by epilepsy and thus, raises the possibility that these cells may have functional significance in the pathophysiology of epilepsy.

  5. Enteric pathogens, immune status and therapeutic response in diarrhea in HIV/AIDS adult subjects from north India.

    PubMed

    Jha, Arun Kumar; Uppal, Beena; Chadha, Sanjim; Aggarwal, Prabhav; Ghosh, Roumi; Dewan, Richa

    2013-06-01

    Intestinal infection causing diarrheal disease is a dominant contributor to high morbidity and mortality in developing countries. This intervention study aimed to assess the response of specific anti-microbial and anti-retroviral therapy (ART) on enteropathogens identified in HIV/AIDS adult subjects from northern India. Seventy five ART naive (group 1) and seventy five ART adherent (group 2) HIV/AIDS adult subjects with diarrhea were enrolled. Stool samples from all subjects were examined for enteropathogens by wet mount, staining methods, culture and ELISA. Subjects with enteropathogens were started on specific therapy as per National AIDS Control Organisation, Government of India's guidelines. Follow-up stool samples were examined after 2-4 weeks of completion of therapy for persistence/clearing of enteropathogens. CD4+ T lymphocyte count was done for all subjects. At enrollment, group 1 had 26.13% bacterial, 57.66% parasitic & 16.22% fungal pathogens while group 2 had 11.9%, 69.05% & 19.05% pathogens, respectively. Parasitic diarrhea was more common than bacterial diarrhea. The coccidian parasites (Cryptosporidium spp. & Isospora belli) were the common parasites identified. Clearance of enteric pathogens was significant after specific anti-microbial therapy (p = 0.0001). Persistence of enteropathogens was seen primarily for coccidian parasites. Clearance of enteropathogens after specific therapy and the diagnostic yield of stool specimens were influenced by the CD4+ counts. Immune competence coupled with specific anti-microbial therapy displays the best response against enteric pathogens.

  6. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects.

    PubMed

    Guzzo, Cynthia A; Furtek, Christine I; Porras, Arturo G; Chen, Cong; Tipping, Robert; Clineschmidt, Coleen M; Sciberras, David G; Hsieh, John Y K; Lasseter, Kenneth C

    2002-10-01

    Safety and pharmacokinetics (PK) of the antiparasitic drug ivermectin, administered in higher and/or more frequent doses than currently approved for human use, were evaluated in a double-blind, placebo-controlled, dose escalation study. Subjects (n = 68) were assigned to one of four panels (3:1, ivermectin/placebo): 30 or 60 mg (three times a week) or 90 or 120 mg (single dose). The 30 mg panel (range: 34 7-594 microg/kg) also received a single dose with food after a 1-week washout. Safety assessments addressed both known ivermectin CNS effects and general toxicity. The primary safety endpoint was mydriasis, accurately quantitated by pupillometry. Ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose of 200 microg/kg. All dose regimens had a mydriatic effect similar to placebo. Adverse experiences were similar between ivermectin and placebo and did not increase with dose. Following single doses of 30 to 120 mg, AUC and Cmax were generally dose proportional, with t(max) approximately 4 hours and t1/2 approximately 18 hours. The geometric mean AUC of 30 mg ivermectin was 2.6 times higher when administered with food. Geometric mean AUC ratios (day 7/day 1) were 1.24 and 1.40 for the 30 and 60 mg doses, respectively, indicating that the accumulation of ivermectin given every fourth day is minimal. This study demonstrated that ivermectin is generally well tolerated at these higher doses and more frequent regimens.

  7. A Comparison of Pure Tone Auditory Thresholds in Human Infants and Adults.

    PubMed

    Sinnott, Joan M; Pisoni, David B; Aslin, Richard N

    1983-01-01

    Pure tone auditory thresholds for frequencies from .250 to 8.0 kHz were obtained from 277-to-11-month-old human infants and nine adults using a go-no-go operant head-turning technique combined with an adaptive staircase (tracking) discrimination procedure. New methods were devised for maintaining infants under stimulus control during threshold testing through the use of randomly interleaved "probe" and "catch" trials. Reliable threshold data were obtained from every infant studied, and identical threshold criteria were applied to infants and adults alike. Although infant thresholds were 17-27 dB higher than those of adults, infant inter-subject variability was no greater than that of adults. Adult audiograms were nearly flat between frequencies of .500 and 8.0 kHz with sensitivity ranging between 7 and 14 dB SPL. Infant audiograms were flat between frequencies of .500 and 4.0 kHz, with sensitivity ranging between 30 and 36 dB SPL. The most sensitive frequency for infants was 8.0 kHz (25 dB SPL).

  8. 76 FR 11482 - Request for Comments on Human Subjects Protections in Scientific Studies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

    ... HUMAN SERVICES Request for Comments on Human Subjects Protections in Scientific Studies AGENCY: The... well-being of participants in scientific studies supported by the Federal Government. DATES: To assure... policies and practices that assure ethically responsible conduct of scientific research,...

  9. Paying human subjects in research: where are we, how did we get here, and now what?

    PubMed

    VanderWalde, Ari; Kurzban, Seth

    2011-01-01

    Both international and federal regulations exist to ensure that scientists perform research on human subjects in an environment free of coercion and in which the benefits of the research are commensurate with the risks involved. Ensuring that these conditions hold is difficult, and perhaps even more so when protocols include the issue of monetary compensation of research subjects. The morality of paying human research subjects has been hotly debated for over 40 years, and the grounds for this debate have ranged from discussion of legal rights, economic rights, philosophical principles of vulnerability and altruism to bioethical concepts of consent, best-interest determination, and justice theory. However, the thought surrounding these issues has evolved over time, and the way we think about the role of the human research subject today is markedly different than the way we thought in the past. Society first thought of the research subject as an altruist, necessarily giving of his time to benefit society as a whole. As time progressed, many suggested that the subject should not need to sacrifice himself for research: if something goes wrong, someone should compensate the subject for injuries. The concept of redress evolved into a system in which subjects were offered money as an inducement to participate in research, sometimes merely to offset the monetary costs of participation, but sometimes even to mitigate the risks of the study. This article examines ethical and legal conversations regarding compensation from the 1960s through today, examining theories of the ethics of compensation both comparatively and critically. In conclusion, we put forward an ethical framework for treating paid research subjects, with an attempt to use this framework as a means of resolving some of the more difficult problems with paying human subjects in research.

  10. Covert spatial attention is functionally intact in amblyopic human adults

    PubMed Central

    Roberts, Mariel; Cymerman, Rachel; Smith, R. Theodore; Kiorpes, Lynne; Carrasco, Marisa

    2016-01-01

    Certain abnormalities in behavioral performance and neural signaling have been attributed to a deficit of visual attention in amblyopia, a neurodevelopmental disorder characterized by a diverse array of visual deficits following abnormal binocular childhood experience. Critically, most have inferred attention's role in their task without explicitly manipulating and measuring its effects against a baseline condition. Here, we directly investigate whether human amblyopic adults benefit from covert spatial attention—the selective processing of visual information in the absence of eye movements—to the same degree as neurotypical observers. We manipulated both involuntary (Experiment 1) and voluntary (Experiment 2) attention during an orientation discrimination task for which the effects of covert spatial attention have been well established in neurotypical and special populations. In both experiments, attention significantly improved accuracy and decreased reaction times to a similar extent (a) between the eyes of the amblyopic adults and (b) between the amblyopes and their age- and gender-matched controls. Moreover, deployment of voluntary attention away from the target location significantly impaired task performance (Experiment 2). The magnitudes of the involuntary and voluntary attention benefits did not correlate with amblyopic depth or severity. Both groups of observers showed canonical performance fields (better performance along the horizontal than vertical meridian and at the lower than upper vertical meridian) and similar effects of attention across locations. Despite their characteristic low-level vision impairments, covert spatial attention remains functionally intact in human amblyopic adults. PMID:28033433

  11. The nutrition intervention improved adult human capital and economic productivity.

    PubMed

    Martorell, Reynaldo; Melgar, Paul; Maluccio, John A; Stein, Aryeh D; Rivera, Juan A

    2010-02-01

    This article reviews key findings about the long-term impact of a nutrition intervention carried out by the Institute of Nutrition of Central America and Panama from 1969 to 1977. Results from follow-up studies in 1988-89 and 2002-04 show substantial impact on adult human capital and economic productivity. The 1988-89 study showed that adult body size and work capacity increased for those provided improved nutrition through age 3 y, whereas the 2002-04 follow-up showed that schooling was increased for women and reading comprehension and intelligence increased in both men and women. Participants were 26-42 y of age at the time of the 2002-04 follow-up, facilitating the assessment of economic productivity. Wages of men increased by 46% in those provided with improved nutrition through age 2 y. Findings for cardiovascular disease risk factors were heterogeneous; however, they suggest that improved nutrition in early life is unlikely to increase cardiovascular disease risk later in life and may indeed lower risk. In conclusion, the substantial improvement in adult human capital and economic productivity resulting from the nutrition intervention provides a powerful argument for promoting improvements in nutrition in pregnant women and young children.

  12. The language of geometry: Fast comprehension of geometrical primitives and rules in human adults and preschoolers.

    PubMed

    Amalric, Marie; Wang, Liping; Pica, Pierre; Figueira, Santiago; Sigman, Mariano; Dehaene, Stanislas

    2017-01-01

    During language processing, humans form complex embedded representations from sequential inputs. Here, we ask whether a "geometrical language" with recursive embedding also underlies the human ability to encode sequences of spatial locations. We introduce a novel paradigm in which subjects are exposed to a sequence of spatial locations on an octagon, and are asked to predict future locations. The sequences vary in complexity according to a well-defined language comprising elementary primitives and recursive rules. A detailed analysis of error patterns indicates that primitives of symmetry and rotation are spontaneously detected and used by adults, preschoolers, and adult members of an indigene group in the Amazon, the Munduruku, who have a restricted numerical and geometrical lexicon and limited access to schooling. Furthermore, subjects readily combine these geometrical primitives into hierarchically organized expressions. By evaluating a large set of such combinations, we obtained a first view of the language needed to account for the representation of visuospatial sequences in humans, and conclude that they encode visuospatial sequences by minimizing the complexity of the structured expressions that capture them.

  13. The language of geometry: Fast comprehension of geometrical primitives and rules in human adults and preschoolers

    PubMed Central

    Amalric, Marie; Wang, Liping; Figueira, Santiago; Sigman, Mariano; Dehaene, Stanislas

    2017-01-01

    During language processing, humans form complex embedded representations from sequential inputs. Here, we ask whether a “geometrical language” with recursive embedding also underlies the human ability to encode sequences of spatial locations. We introduce a novel paradigm in which subjects are exposed to a sequence of spatial locations on an octagon, and are asked to predict future locations. The sequences vary in complexity according to a well-defined language comprising elementary primitives and recursive rules. A detailed analysis of error patterns indicates that primitives of symmetry and rotation are spontaneously detected and used by adults, preschoolers, and adult members of an indigene group in the Amazon, the Munduruku, who have a restricted numerical and geometrical lexicon and limited access to schooling. Furthermore, subjects readily combine these geometrical primitives into hierarchically organized expressions. By evaluating a large set of such combinations, we obtained a first view of the language needed to account for the representation of visuospatial sequences in humans, and conclude that they encode visuospatial sequences by minimizing the complexity of the structured expressions that capture them. PMID:28125595

  14. Outcome over seven years of healthy adults with and without subjective cognitive impairment

    PubMed Central

    Reisberg, Barry; Shulman, Melanie B.; Torossian, Carol; Leng, Ling; Zhu, Wei

    2011-01-01

    Background Subjective cognitive impairment (SCI) in older persons without manifest symptomatology is a common condition with a largely unclear prognosis. We hypothesized that (1) examining outcome for a sufficient period by using conversion to mild cognitive impairment (MCI) or dementia would clarify SCI prognosis, and (2) with the aforementioned procedures, the prognosis of SCI subjects would differ significantly from that of demographically matched healthy subjects, free of SCI, termed no cognitive impairment (NCI) subjects. Methods A consecutive series of healthy subjects, aged ≥40 years, presenting with NCI or SCI to a brain aging and dementia research center during a 14-year interval, were studied and followed up during an 18-year observation window. The study population (60 NCI, 200 SCI, 60% female) had a mean age of 67.2 ± 9.1 years, was well-educated (mean, 15.5 ± 2.7 years), and cognitively normal (Mini-Mental State Examination, 29.1 ± 1.2). Results A total of 213 subjects (81.9% of the study population) were followed up. Follow-up occurred during a mean period of 6.8 ± 3.4 years, and subjects had a mean of 2.9 ± 1.6 follow-up visits. Seven NCI (14.9%) and 90 SCI (54.2%) subjects declined (P < .0001). Of NCI decliners, five declined to MCI and two to probable Alzheimer’s disease. Of SCI decliners, 71 declined to MCI and 19 to dementia diagnoses. Controlling for baseline demographic variables and follow-up time, Weibull proportional hazards model revealed increased decline in SCI subjects (hazard ratio, 4.5; 95% confidence interval, 1.9–10.3), whereas the accelerated failure time model analysis with an underlying Weibull survival function showed that SCI subjects declined more rapidly, at 60% of the rate of NCI subjects (95% confidence interval, 0.45–0.80). Furthermore, mean time to decline was 3.5 years longer for NCI than for SCI subjects (P = .0003). Conclusions These results indicate that SCI in subjects with normal cognition is a harbinger

  15. Analysis of reliability, accuracy, sensitivity and predictive value of a subjective method to classify facial pattern in adults

    PubMed Central

    Queiroz, Gilberto Vilanova; Rino, José; de Paiva, João Batista; Capelozza, Leopoldino

    2016-01-01

    ABSTRACT Introduction: Craniofacial pattern diagnosis is vital in Orthodontics, as it influences decision-making regarding treatment options and prognosis. Capelozza Filho proposed a subjective method for facial classification comprising five patterns: I, II, III, Long Face and Short Face. Objective: To investigate the accuracy of a subjective classification method of facial patterns applied to adults. Methods: A sample consisting of 52 adults was used for this study. Frontal and lateral view photographs were taken with subjects at rest position, including frontal smile. Lateral cephalometric radiographs were organized in a PowerPoint® presentation and submitted to 20 raters. Method performance was assessed by examining reproducibility with Kappa test and calculating accuracy, sensitivity and positive predictive values, for which 70% was set as critical value. The gold standard of the classification was personally set by the author of the method. Results: Reproducibility was considered moderate (Kappa = 0.501); while accuracy, sensitivity and positive predictive values yielded similar results, but below 70%. Conclusions: The subjective method of facial classification employed in the present study still needs to have its morphological criteria improved in order to be used to discriminate the five facial patterns. PMID:28125141

  16. Subjects to Citizens: Adult Learning and the Challenges of Democracy in the Twenty-First Century

    ERIC Educational Resources Information Center

    Welton, Michael

    2013-01-01

    Theme 1 of the "Hamburg Declaration on Adult Learning" boldly proclaimed that active citizenship and full participation of all citizens was the necessary foundation for "the creation of a learning society committed to social justice and general well-being" (UNESCO, 1997, p. 4). The "Declaration" advocated that future…

  17. Analysis of Exposure-Dose Variation of Inhaled Particles in Adult Subjects.

    EPA Science Inventory

    Although internal dose is a key factor for determining the health risk of inhaled pollutant particles, available dose information is largely limited to young healthy adults under a few typical exposure conditions. Extrapolation of the limited dose information to different populat...

  18. Psychosocial Development and Subjective Well-Being in an Age Cross-Section of Adults.

    ERIC Educational Resources Information Center

    Tesch, Stephanie A.

    1985-01-01

    Examined the internal consistency and construct validity of an expanded version of the Inventory of Psychosocial Development (E-IPD), which included the generativity and ego integrity scales creatd by Boylin et al. Total E-IPD scores from 79 adults were found to have high internal consistency, but many individual stage scales did not. (Author)

  19. Anxious Provision and Discourses of Certainty: The Sutured Subject of Mentally Ill Adult Learners

    ERIC Educational Resources Information Center

    Sagan, Olivia

    2009-01-01

    This paper reports on a five-year study which explored the engagement of a group of long-term mentally ill adults in community provision in which they learned basic, expressive literacy. The research mapped points in the learning, writing and auto/biographic engagement where set identities were being troubled, and frisson created in the challenge…

  20. Subject Bibliography of Supplementary Adult Literacy Materials Purchased through LSCA Title VI Funds.

    ERIC Educational Resources Information Center

    Mississippi Library Commission, Jackson.

    This annotated bibliography of supplementary materials for adult literacy students in Mississippi arranges the annotations in the following categories: automobiles; biography; communication skills; consumer information; coping skills; English as a second language; fiction; health, nutrition, and safety; history and government; insurance; job…

  1. Feeling Caught between Parents: Adult Children's Relations with Parents and Subjective Well-Being

    ERIC Educational Resources Information Center

    Amato, Paul R.; Afifi, Tamara D.

    2006-01-01

    Research on divorce has found that adolescents' feelings of being caught between parents are linked to internalizing problems and weak parent-child relationships. The present study estimates the effects of marital discord, as well as divorce, on young adult offspring's feelings of being caught in the middle (N=632). Children with parents in…

  2. CCM2 expression during prenatal development and adult human neocortex.

    PubMed

    Tanriover, Gamze; Sozen, Berna; Gunel, Murat; Demir, Necdet

    2011-08-01

    Cerebral cavernous malformation (CCM) is one of the most common types of vascular malformations of the central nervous system, affecting nearly one in 200 people. CCM lesions are characterized by grossly dilated vascular channels lined by a single layer of endothelium. Genetic linkage analyses have mapped three CCM loci to CCM1, CCM2 and CCM3. All three causative genes have now been identified allowing new insights into CCM pathophysiology. We focused on the CCM2 protein that might take place in blood vessel formation; we report here the expression patterns of CCM2 in prenatal development and adult human neocortex by means of immunohistochemistry and Western blot analysis. CCM2 was obviously detected in vascular endothelium and neuroglial precursor cells during development and also observed in arterial endothelium, neurons, some of the glial cells in adult neocortex. The expression patterns suggest that it could be one of the arterial markers whether this is a cause or a consequence of an altered vascular identity. CCM2 might play a role during vasculogenesis and angiogenesis during human brain development. Furthermore, with this study, CCM2 have been described for the first time in developing human neocortex.

  3. Factors associated with subjective burden in siblings of adults with severe mental illness.

    PubMed

    Greenberg, J S; Kim, H W; Greenley, J R

    1997-04-01

    Experiences of subjective burden were analyzed in a sample of 164 siblings of persons with serious mental illness. Findings indicated that the well sibling's experience of burden was consistently related to the symptomatology of the ill sibling. In addition, those who viewed the ill sibling's behavior as outside his or control exhibited lower levels of subjective burden than did those who viewed the behavior as within the sibling's control. Implications for research and clinical intervention are discussed.

  4. Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.

    PubMed

    Evers, David L; Fowler, Carol B; Mason, Jeffrey T; Mimnall, Rebecca K

    2015-08-01

    Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. These are the absence of maximum limits to risk and the potential for institutional review boards to include questionable benefits to subjects and society when weighing the risks and benefits of research protocols. The lack of a duty of medical care by physician-investigators to research subjects is likewise of concern. The transparency of microbial challenge experiments and the safety concerns raised in this work may stimulate further dialogue on the risks to participants of human experimentation.

  5. Anticipating risk for human subjects participating in clinical research: application of Failure Mode and Effects Analysis.

    PubMed

    Cody, Robert J

    2006-03-01

    Failure Mode and Effects Analysis (FMEA) is a method applied in various industries to anticipate and mitigate risk. This methodology can be more systematically applied to the protection of human subjects in research. The purpose of FMEA is simple: prevent problems before they occur. By applying FMEA process analysis to the elements of a specific research protocol, the failure severity, occurrence, and detection rates can be estimated for calculation of a "risk priority number" (RPN). Methods can then be identified to reduce the RPN to levels where the risk/benefit ratio favors human subject benefit, to a greater magnitude than existed in the pre-analysis risk profile. At the very least, the approach provides a checklist of issues that can be individualized for specific research protocols or human subject populations.

  6. Correlation of Respirator Fit Measured on Human Subjects and a Static Advanced Headform

    DTIC Science & Technology

    2016-04-19

    where both the test Address correspondence to: Ziqing Zhuang, Deputy Branch Chief, Technology Research Branch, National Personal Protective Technology ...Ziqing Zhuang1, Brian K. Heimbuch2, Ronald E. Shaffer1, Melanie Choe3, and Joseph D. Wander4 1National Personal Protective Technology Laboratory...Static Advanced Headform (StAH) and 10 human test subjects. Quantitative fit evaluations were performed on test subjects who made three visits to the

  7. Salivary alpha amylase activity in human beings of different age groups subjected to psychological stress.

    PubMed

    Sahu, Gopal K; Upadhyay, Seema; Panna, Shradha M

    2014-10-01

    Salivary alpha-amylase (sAA) has been proposed as a sensitive non-invasive biomarker for stress-induced changes in the body that reflect the activity of the sympathetic nervous system. Though several experiments have been conducted to determine the validity of this salivary component as a reliable stress marker in human subjects, the effect of stress induced changes on sAA level in different age groups is least studied. This article reports the activity of sAA in human subjects of different age groups subjected to psychological stress induced through stressful video clip. Differences in sAA level based on sex of different age groups under stress have also been studied. A total of 112 subjects consisting of both the male and female subjects, divided into two groups on basis of age were viewed a video clip of corneal transplant surgery as stressor. Activity of sAA from saliva samples of the stressed subjects were measured and compared with the activity of the samples collected from the subjects before viewing the clip. The age ranges of subjects were 18-25 and 40-60 years. The sAA level increased significantly in both the groups after viewing the stressful video. The increase was more pronounced in the younger subjects. The level of sAA was comparatively more in males than females in the respective groups. No significant change in sAA activity was observed after viewing the soothed video clip. Significant increase of sAA level in response to psychological stress suggests that it might act as a reliable sympathetic activity biochemical marker in different stages of human beings.

  8. The role of estradiol and progesterone in modulating the subjective effects of stimulants in humans.

    PubMed

    Evans, Suzette M

    2007-10-01

    Although stimulant abuse is a growing problem among women, few studies have focused on factors that may be implicated in potential sex differences. Numerous preclinical studies have indicated that female rodents are more sensitive than male rodents to the behavioral effects of stimulants and that the hormone estradiol is involved in these sex differences. In humans, the subjective response to stimulants is greater in the follicular phase (characterized by moderate estradiol levels and minimal progesterone levels) than in the luteal phase (characterized by elevated estradiol levels and elevated progesterone levels). Differences between men and women emerge only when men are compared with women in the luteal phase; the subjective response to stimulants is similar in men and women in the follicular phase. In contrast to rodents, there is minimal evidence that estradiol enhances the subjective response to stimulants in humans. Rather, the hormone progesterone has been shown to attenuate the subjective response to stimulants, particularly in women. Recent preclinical data confirm that progesterone reduces the behavioral response to stimulants. In summary, there is converging evidence from studies in humans that (a) men and women do differ in their subjective response to stimulants; (b) these sex differences are evident when women are in the luteal phase, when progesterone levels are elevated; and (c) progesterone administration attenuates the subjective response to stimulants. Therefore, the menstrual cycle should be addressed in mixed-gender studies. Moreover, the modulatory effects of progesterone on reducing the positive effects of cocaine may have some clinical utility in treating stimulant abusers.

  9. Linear and angular control of circular walking in healthy older adults and subjects with cerebellar ataxia.

    PubMed

    Goodworth, Adam D; Paquette, Caroline; Jones, Geoffrey Melvill; Block, Edward W; Fletcher, William A; Hu, Bin; Horak, Fay B

    2012-05-01

    Linear and angular control of trunk and leg motion during curvilinear navigation was investigated in subjects with cerebellar ataxia and age-matched control subjects. Subjects walked with eyes open around a 1.2-m circle. The relationship of linear to angular motion was quantified by determining the ratios of trunk linear velocity to trunk angular velocity and foot linear position to foot angular position. Errors in walking radius (the ratio of linear to angular motion) also were quantified continuously during the circular walk. Relative variability of linear and angular measures was compared using coefficients of variation (CoV). Patterns of variability were compared using power spectral analysis for the trunk and auto-covariance analysis for the feet. Errors in radius were significantly increased in patients with cerebellar damage as compared to controls. Cerebellar subjects had significantly larger CoV of feet and trunk in angular, but not linear, motion. Control subjects also showed larger CoV in angular compared to linear motion of the feet and trunk. Angular and linear components of stepping differed in that angular, but not linear, foot placement had a negative correlation from one stride to the next. Thus, walking in a circle was associated with more, and a different type of, variability in angular compared to linear motion. Results are consistent with increased difficulty of, and role of the cerebellum in, control of angular trunk and foot motion for curvilinear locomotion.

  10. Subjective Sexual Well-Being in Chilean Adults: Evaluation of a Predictive Model.

    PubMed

    Contreras, Daniela; Lillo, Sebastián; Vera-Villarroel, Pablo

    2016-05-18

    Research on sexuality has traditionally focused on sexual satisfaction, with studies into subjective sexual well-being being a recent phenomenon. This study sought to evaluate the relationship between sexual behavior, happiness, health, and subjective sexual well-being. The data were collected from 862 people aged between 18 and 50 years in Santiago, Chile, and were analyzed by logistic regression analysis. The results showed that sexual behavioral indicators (sexual frequency, sexual caresses, and touching), happiness, and perception of health taken as a whole predicted 47.4% of subjective sexual well-being (SSWB). Analysis of the four items of subjective sexual well-being separately showed that the dimension of physical satisfaction was associated with three variables of sexual behavior indicators with a prediction percentage of 33.5%, whereas emotional satisfaction was associated with three variables of sexual behavior indicators and happiness, with a percentage of prediction of 43.3%. Satisfaction with sexual function was associated with perception of health and one sexual behavior indicator, with a prediction percentage of 29.2% of this variable. The importance of sex was associated with three sexual behavior variables that predicted 26.2% of this variable. The results confirm that subjective sexual well-being can be predicted and that its four dimensions present a different behavior compared to the study predictors.

  11. When does meaning making predict subjective well-being? Examining young and older adults in two cultures.

    PubMed

    Alea, Nicole; Bluck, Susan

    2013-01-01

    Two studies in different cultures (Study 1: USA, N=174, Study 2: Trinidad, N=167) examined whether meaning making, (i.e., both searching for meaning, and directing behaviour) is positively related to subjective well-being (SWB) by age (younger, older adults). In both studies, participants self-reported engagement in meaning making, and SWB (e.g., affect, future time perspective, psychological well-being). In Study 1, young Americans (compared to older) more frequently used their past to direct behaviour but doing so was unrelated to SWB. In older Americans, both types of meaning making were positively associated with SWB. In Study 2, Trinidadian younger adults were again more likely than older adults to engage in meaning making. Unlike in the American sample, however, directing behaviour was positively related to SWB for both young and older adults. The studies demonstrate that whether meaning making shows benefits for SWB may depend on type of meaning, age and culture. Note that although meaning making was sometimes unrelated to SWB, no detrimental relations to meaning making were found. The discussion focuses on the role of moderators in understanding when meaning making should lead to benefits versus costs to SWB.

  12. Non-Pharmacologic Interventions for Older Adults with Subjective Cognitive Decline: Systematic Review, Meta-Analysis, and Preliminary Recommendations.

    PubMed

    Smart, Colette M; Karr, Justin E; Areshenkoff, Corson N; Rabin, Laura A; Hudon, Carol; Gates, Nicola; Ali, Jordan I; Arenaza-Urquijo, Eider M; Buckley, Rachel F; Chetelat, Gael; Hampel, Harald; Jessen, Frank; Marchant, Natalie L; Sikkes, Sietske A M; Tales, Andrea; van der Flier, Wiesje M; Wesselman, Linda

    2017-03-07

    In subjective cognitive decline (SCD), older adults present with concerns about self-perceived cognitive decline but are found to have clinically normal function. However, a significant proportion of those adults are subsequently found to develop mild cognitive impairment, Alzheimer's dementia or other neurocognitive disorder. In other cases, SCD may be associated with mood, personality, and physical health concerns. Regardless of etiology, adults with SCD may benefit from interventions that could enhance current function or slow incipient cognitive decline. The objective of this systematic review and meta-analysis, conducted in accordance with the PRISMA guidelines, is to examine the benefits of non-pharmacologic intervention (NPI) in persons with SCD. Inclusion criteria were studies of adults aged 55 + with SCD defined using published criteria, receiving NPI or any control condition, with cognitive, behavioural, or psychological outcomes in controlled trails. Published empirical studies were obtained through a standardized search of CINAHL Complete, Cochrane Central Register of Controlled Trials, MEDLINE with Full Text, PsycINFO, and PsycARTICLES, supplemented by a manual retrieval of relevant articles. Study quality and bias was determined using PEDro. Nine studies were included in the review and meta-analysis. A wide range of study quality was observed. Overall, a small effect size was found on cognitive outcomes, greater for cognitive versus other intervention types. The available evidence suggests that NPI may benefit current cognitive function in persons with SCD. Recommendations are provided to improve future trials of NPI in SCD.

  13. Must research benefit human subjects if it is to be permissible?

    PubMed Central

    Wikler, Daniel

    2017-01-01

    Must medical experiments with human subjects offer them a ‘favourable risk-benefit ratio’, that is, more expectation of benefit than harm or burden, if they are to be judged as ethically justified? Ethical justification is easier for experiments that do offer net benefit to subjects, but ethical justification is possible also for some experiments that do not. Basic science experiments with healthy volunteers and ‘Phase I’ drug trials that seek to determine tolerable dosage levels are routinely approved by ethical review committees; moreover, guidance they receive from government funding agencies specifically asks them to weigh risks to subjects against benefits to subjects and also benefits to those who may benefit from the knowledge gained in the experiment. If a puzzle remains, it is why there remains any assumption that research ethics requires a ‘favourable risk-benefit ratio’ for the individual research subject. PMID:27573151

  14. Polarization sensitive optical low-coherence reflectometry for blood glucose monitoring in human subjects

    NASA Astrophysics Data System (ADS)

    Solanki, Jitendra; Choudhary, Om Prakash; Sen, P.; Andrews, J. T.

    2013-07-01

    A device based on polarization sensitive optical low-coherence reflectometry is developed to monitor blood glucose levels in human subjects. The device was initially tested with tissue phantom. The measurements with human subjects for various glucose concentration levels are found to be linearly dependent on the ellipticity obtainable from the home-made phase-sensitive optical low-coherence reflectometry device. The linearity obtained between glucose concentration and ellipticity are explained with theoretical calculations using Mie theory. A comparison of results with standard clinical methods establishes the utility of the present device for non-invasive glucose monitoring.

  15. Ontogeny of morningness-eveningness across the adult human lifespan

    NASA Astrophysics Data System (ADS)

    Randler, Christoph

    2016-02-01

    Sleep timing of humans can be classified alongside a continuum from early to late sleepers, with some people (larks) having an early activity, early bed, and rise times and others (owls) with a more nocturnally orientated activity. Only a few studies reported that morningness-eveningness changes significantly during the adult lifespan based on community samples. Here, I applied a different methodological approach to seek for evidence for the age-related changes in morningness-eveningness preferences by using a meta-data from all available studies. The new aspect of this cross-sectional approach is that only a few studies themselves address the age-related changes of the adult lifespan development, but that many studies are available that provide exactly the data needed. The studies came from 27 countries and included 36,939 participants. Age was highly significantly correlated with scores on the Composite Scale of Morningness ( r = 0.70). This relationship seems linear, because a linear regression explained nearly the same amount of variance compared to other models such as logarithmic, quadratic, or cubic models. The standard deviation of age correlated with the standard deviation of CSM scores ( r = 0.55), suggesting when there is much variance in age in a study; in turn, there is much variance in morningness. This meta-analytical approach shows that morningness-eveningness changes across the adult lifespan and that older age is related to higher morningness.

  16. Distinctive modulation of inflammatory and metabolic parameters in relation to zinc nutritional status in adult overweight/obese subjects.

    PubMed

    Costarelli, Laura; Muti, Elisa; Malavolta, Marco; Cipriano, Catia; Giacconi, Robertina; Tesei, Silvia; Piacenza, Francesco; Pierpaoli, Sara; Gasparini, Nazzarena; Faloia, Emanuela; Tirabassi, Giacomo; Boscaro, Marco; Polito, Angela; Mauro, Beatrice; Maiani, Francesca; Raguzzini, Anna; Marcellini, Fiorella; Giuli, Cinzia; Papa, Roberta; Emanuelli, Monica; Lattanzio, Fabrizia; Mocchegiani, Eugenio

    2010-05-01

    Overweight and obesity are associated with low grade of inflammation and chronic inflammatory response characterized by abnormal production and activation of some pro-inflammatory signalling pathways. Taking into account that obesity is the direct result of an imbalance between energy intake and energy expenditure, the nutritional factors in the diet, with particular focus on zinc, may play a pivotal role in the development of obesity-associated comorbidities. Considering the potential interactions among zinc nutritional status, inflammation, overweight/obesity and insulin secretion, the aim of the present work was to clarify the influence of zinc dietary intake on some metabolic, inflammatory and zinc status parameters in adult overweight/obese subjects. We found a close interrelationship between nutritional zinc and obesity. In particular, subjects with a lower zinc dietary intake display a deeper inflammatory status, general impairment of the zinc status, an altered lipid profile and increased insulin production with respect to obese subjects with normal zinc dietary intake. Moreover, in the presence of low dietary zinc intake, the obese subjects are less capable to respond to oxidative stress and to inflammation leading to the development of obesity or to a worsening of already preexisting obesity status. In conclusion, a possible zinc supplementation in obese subjects with a deeper inflammatory status and more altered zinc profile may be suggested in order to limit or reduce the inflammation, taking also into account that zinc supplementation normalizes "inflammaging" as well as zinc profile leading to a correct intra- and extracellular zinc homeostasis.

  17. A Method for Remotely Sensing Vital Signs of Human Subjects Outdoors.

    PubMed

    Li, Chuantao; Chen, Fuming; Jin, Jingxi; Lv, Hao; Li, Sheng; Lu, Guohua; Wang, Jianqi

    2015-06-24

    After chemical or nuclear leakage or explosions, finding survivors is a huge challenge. Although human bodies can be found by smart vehicles and drones equipped with cameras, it is difficult to verify if the person is alive or dead this way. This paper describes a continuous wave radar sensor for remotely sensing the vital signs of human subjects. Firstly, a compact and portable 24 GHz Doppler radar system is designed to conduct non-contact detection of respiration signal. Secondly, in order to improve the quality of the respiration signals, the self-correlation and adaptive line enhancer (ALE) methods are proposed to minimize the interferences of any moving objects around the human subject. Finally, the detection capabilities of the radar system and the signal processing method are verified through experiments which show that human respiration signals can be extracted when the subject is 7 m away outdoors. The method provided in this paper will be a promising way to search for human subjects outdoors.

  18. The challenges of IRB review and human subjects protections in practice-based research.

    PubMed

    Wolf, Leslie E; Croughan, Mary; Lo, Bernard

    2002-06-01

    Practice-based research raises unique challenges with respect to human subjects protections and institutional review board (IRB) review. In this paper, three challenges posed by practice-based research are analyzed: (1) IRB review for clinician investigators who are not affiliated with an institution that has an IRB; (2) multiple IRB review; and (3) required human subjects protection training of key personnel. Investigators should be proactive in addressing required IRB review in practice-based research. In particular, they need to ensure that appropriate IRB review is obtained for all performance sites and plan for review for unaffiliated investigators. Practice-based research investigators and professional societies should educate IRB members and policy makers and publish articles regarding how IRBs might best address human subjects concerns in practice-based research. Furthermore, practice-based research investigators and professional societies should work with IRBs and the Office for Human Research Protections to facilitate centralized or cooperative review of practice-based research. Finally, practice-based research investigators need to ensure that their clinician investigators receive appropriate training in human subjects protection. Practice-based research investigators and professional societies can facilitate this process by helping to define and implement the appropriate training for busy practice-based research clinicians and office staff.

  19. A Method for Remotely Sensing Vital Signs of Human Subjects Outdoors

    PubMed Central

    Li, Chuantao; Chen, Fuming; Jin, Jingxi; Lv, Hao; Li, Sheng; Lu, Guohua; Wang, Jianqi

    2015-01-01

    After chemical or nuclear leakage or explosions, finding survivors is a huge challenge. Although human bodies can be found by smart vehicles and drones equipped with cameras, it is difficult to verify if the person is alive or dead this way. This paper describes a continuous wave radar sensor for remotely sensing the vital signs of human subjects. Firstly, a compact and portable 24 GHz Doppler radar system is designed to conduct non-contact detection of respiration signal. Secondly, in order to improve the quality of the respiration signals, the self-correlation and adaptive line enhancer (ALE) methods are proposed to minimize the interferences of any moving objects around the human subject. Finally, the detection capabilities of the radar system and the signal processing method are verified through experiments which show that human respiration signals can be extracted when the subject is 7 m away outdoors. The method provided in this paper will be a promising way to search for human subjects outdoors. PMID:26115454

  20. Executive Functions in Older Adults with Autism Spectrum Disorder: Objective Performance and Subjective Complaints

    ERIC Educational Resources Information Center

    Davids, Roeliena C.; Groen, Yvonne; Berg, Ina J.; Tucha, Oliver M.; van Balkom, Ingrid D.

    2016-01-01

    Although deficits in Executive Functioning (EF) are reported frequently in young individuals with Autism Spectrum Disorders (ASD), they remain relatively unexplored later in life (>50 years). We studied objective performance on EF measures (Tower of London, Zoo map, phonetic/semantic fluency) as well as subjective complaints (self- and proxy…

  1. An Examination of the Relationship between Passion and Subjective Well-Being in Older Adults

    ERIC Educational Resources Information Center

    Rousseau, Francois L.; Vallerand, Robert J.

    2008-01-01

    Activity engagement has long been linked to improved subjective well-being (SWB) in old age. However, recent studies testing Vallerand et al.'s (2003) Dualistic Model of Passion suggest that the type of passionate activity that underlies activity engagement might influence the extent to which individuals benefit from an active lifestyle. In the…

  2. The Influence of Executive Functioning on Facial and Subjective Pain Responses in Older Adults

    PubMed Central

    2016-01-01

    Cognitive decline is known to reduce reliability of subjective pain reports. Although facial expressions of pain are generally considered to be less affected by this decline, empirical support for this assumption is sparse. The present study therefore examined how cognitive functioning relates to facial expressions of pain and whether cognition acts as a moderator between nociceptive intensity and facial reactivity. Facial and subjective responses of 51 elderly participants to mechanical stimulation at three intensities levels (50 kPa, 200 kPa, and 400 kPa) were assessed. Moreover, participants completed a neuropsychological examination of executive functioning (planning, cognitive inhibition, and working memory), episodic memory, and psychomotor speed. The results showed that executive functioning has a unique relationship with facial reactivity at low pain intensity levels (200 kPa). Moreover, cognitive inhibition (but not other executive functions) moderated the effect of pressure intensity on facial pain expressions, suggesting that the relationship between pressure intensity and facial reactivity was less pronounced in participants with high levels of cognitive inhibition. A similar interaction effect was found for cognitive inhibition and subjective pain report. Consequently, caution is needed when interpreting facial (as well as subjective) pain responses in individuals with a high level of cognitive inhibition. PMID:27274618

  3. Olfactory Sensitivity for Six Predator Odorants in CD-1 Mice, Human Subjects, and Spider Monkeys

    PubMed Central

    Sarrafchi, Amir; Odhammer, Anna M. E.; Hernandez Salazar, Laura Teresa; Laska, Matthias

    2013-01-01

    Using a conditioning paradigm, we assessed the olfactory sensitivity of six CD-1 mice (Mus musculus) for six sulfur-containing odorants known to be components of the odors of natural predators of the mouse. With all six odorants, the mice discriminated concentrations <0.1 ppm (parts per million) from the solvent, and with five of the six odorants the best-scoring animals were even able to detect concentrations <1 ppt (parts per trillion). Four female spider monkeys (Ateles geoffroyi) and twelve human subjects (Homo sapiens) tested in parallel were found to detect the same six odorants at concentrations <0.01 ppm, and with four of the six odorants the best-scoring animals and subjects even detected concentrations <10 ppt. With all three species, the threshold values obtained here are generally lower than (or in the lower range of) those reported for other chemical classes tested previously, suggesting that sulfur-containing odorants may play a special role in olfaction. Across-species comparisons showed that the mice were significantly more sensitive than the human subjects and the spider monkeys with four of the six predator odorants. However, the human subjects were significantly more sensitive than the mice with the remaining two odorants. Human subjects and spider monkeys significantly differed in their sensitivity with only two of the six odorants. These comparisons lend further support to the notion that the number of functional olfactory receptor genes or the relative or absolute size of the olfactory bulbs are poor predictors of a species’ olfactory sensitivity. Analysis of odor structure–activity relationships showed that in both mice and human subjects the type of alkyl rest attached to a thietane and the type of oxygen moiety attached to a thiol significantly affected olfactory sensitivity. PMID:24278296

  4. Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies

    NASA Astrophysics Data System (ADS)

    Wolf, Susan M.; Jones, Cortney M.

    2011-04-01

    The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.

  5. Population aging in local areas and subjective well-being of older adults: Findings from two studies in Japan.

    PubMed

    Saito, Tami; Sugisawa, Hidehiro; Harada, Ken; Kai, Ichiro

    2016-05-23

    Subjective well-being (SWB) of older adults could be affected by both individual and community characteristics. However, the effect of community characteristics, such as population aging in local areas, remains unclear. This study examined the cross-sectional and longitudinal associations between the area-level population aging and SWB of older individuals from two distinct surveys. Those analyzed were 572 respondents aged 75 years and older for a cross-sectional survey in a metropolitan area in Tokyo, Japan (Study 1) and 1,257 and 859 respondents for a cross-sectional and longitudinal analysis, respectively, for a 2-year longitudinal survey project in urban and rural areas of Fukui Prefecture (Study 2). Area-level population aging was assessed by the number of people aged 65 years or older per 100 residents. SWB was assessed with the Life Satisfaction Index-A (LSIA). Multilevel analysis was performed to examine unconditional and conditional associations between the area-level number of older adults per 100 residents and the individual-level LSIA scores. The area-level number of older adults per 100 residents was significantly and positively associated with the LSIA scores in Study 1 (p = 0.042), even after controlling for the area- and individual-level covariates. In Study 2, we also found a significant effect of the area-level number of older adults per 100 residents on LSIA scores in the longitudinal multivariate analysis (p = 0.049). Findings from two survey projects suggested cross-validity in the positive effect of area-level population aging on older adults' SWB. Policymakers should consider older citizens' SWB in the recent urban-to-rural migration governmental policy as well as in urban renovation planning.

  6. Distribution of Tight Junction Proteins in Adult Human Salivary Glands

    PubMed Central

    Maria, Ola M.; Kim, Jung-Wan Martin; Gerstenhaber, Jonathan A.; Baum, Bruce J.; Tran, Simon D.

    2008-01-01

    Tight junctions (TJs) are an essential structure of fluid-secreting cells, such as those in salivary glands. Three major families of integral membrane proteins have been identified as components of the TJ: claudins, occludin, and junctional adhesion molecules (JAMs), plus the cytosolic protein zonula occludens (ZO). We have been working to develop an orally implantable artificial salivary gland that would be suitable for treating patients lacking salivary parenchymal tissue. To date, little is known about the distribution of TJ proteins in adult human salivary cells and thus what key molecular components might be desirable for the cellular component of an artificial salivary gland device. Therefore, the aim of this study was to determine the distribution of TJ proteins in human salivary glands. Salivary gland samples were obtained from 10 patients. Frozen and formalin-fixed paraffin-embedded sections were stained using IHC methods. Claudin-1 was expressed in ductal, endothelial, and ∼25% of serous cells. Claudins-2, -3, and -4 and JAM-A were expressed in both ductal and acinar cells, whereas claudin-5 was expressed only in endothelial cells. Occludin and ZO-1 were expressed in acinar, ductal, and endothelial cells. These results provide new information on TJ proteins in two major human salivary glands and should serve as a reference for future studies to assess the presence of appropriate TJ proteins in a tissue-engineered human salivary gland. (J Histochem Cytochem 56:1093–1098, 2008) PMID:18765838

  7. Neural mechanisms underlying contextual dependency of subjective values: converging evidence from monkeys and humans.

    PubMed

    Abitbol, Raphaëlle; Lebreton, Maël; Hollard, Guillaume; Richmond, Barry J; Bouret, Sébastien; Pessiglione, Mathias

    2015-02-04

    A major challenge for decision theory is to account for the instability of expressed preferences across time and context. Such variability could arise from specific properties of the brain system used to assign subjective values. Growing evidence has identified the ventromedial prefrontal cortex (VMPFC) as a key node of the human brain valuation system. Here, we first replicate this observation with an fMRI study in humans showing that subjective values of painting pictures, as expressed in explicit pleasantness ratings, are specifically encoded in the VMPFC. We then establish a bridge with monkey electrophysiology, by comparing single-unit activity evoked by visual cues between the VMPFC and the orbitofrontal cortex. At the neural population level, expected reward magnitude was only encoded in the VMPFC, which also reflected subjective cue values, as expressed in Pavlovian appetitive responses. In addition, we demonstrate in both species that the additive effect of prestimulus activity on evoked activity has a significant impact on subjective values. In monkeys, the factor dominating prestimulus VMPFC activity was trial number, which likely indexed variations in internal dispositions related to fatigue or satiety. In humans, prestimulus VMPFC activity was externally manipulated through changes in the musical context, which induced a systematic bias in subjective values. Thus, the apparent stochasticity of preferences might relate to the VMPFC automatically aggregating the values of contextual features, which would bias subsequent valuation because of temporal autocorrelation in neural activity.

  8. Norovirus-Specific Memory T Cell Responses in Adult Human Donors

    PubMed Central

    Malm, Maria; Tamminen, Kirsi; Vesikari, Timo; Blazevic, Vesna

    2016-01-01

    Norovirus (NoV) is a leading cause of acute gastroenteritis in people of all ages worldwide. NoV-specific serum antibodies which block the binding of NoV virus-like particles (VLPs) to the cell receptors have been thoroughly investigated. In contrast, only a few publications are available on the NoV capsid VP1 protein-specific T cell responses in humans naturally infected with the virus. Freshly isolated peripheral blood mononuclear cells of eight healthy adult human donors previously exposed to NoV were stimulated with purified VLPs derived from NoV GII.4-1999, GII.4-2012 (Sydney), and GI.3, and IFN-γ production was measured by an ELISPOT assay. In addition, 76 overlapping synthetic peptides spanning the entire 539-amino acid sequence of GII.4 VP1 were pooled into two-dimensional matrices and used to identify putative T cell epitopes. Seven of the eight subjects produced IFN-γ in response to the peptides and five subjects produced IFN-γ in response to the VLPs of the same origin. In general, stronger T cell responses were induced with the peptides in each donor compared to the VLPs. A CD8+ T cell epitope in the shell domain of the VP1 (134SPSQVTMFPHIIVDVRQL151) was identified in two subjects, both having human leukocyte antigen (HLA)-A∗02:01 allele. To our knowledge, this is the first report using synthetic peptides to study NoV-specific T cell responses in human subjects and identify T cell epitopes. PMID:27752254

  9. Dose-related Behavioral, Subjective, Endocrine and Psychophysiological Effects Of the Kappa Opioid Agonist Salvinorin A in Humans

    PubMed Central

    Ranganathan, Mohini; Schnakenberg, Ashley; Skosnik, Patrick D.; Cohen, Bruce; Pittman, Brian; Sewell, R. Andrew; D’Souza, Deepak Cyril

    2012-01-01

    Background Salvia divinorum (Salvia) is an increasingly popular recreational drug amongst adolescents and young adults. Its primary active ingredient, Salvinorin A (SA), a highly selective agonist at the kappa opiate receptor (KOR), is believed to be one of the most potent naturally occurring hallucinogens. However, there is little experimental data on the effects of SA in humans. Methods In a 3-day, double-blind, randomized, crossover, counterbalanced study, the behavioral, subjective, cognitive, psychophysiological and endocrine effects of 0 mg, 8 mg and 12 mg of inhaled SA were characterized in 10 healthy individuals who had previously used Salvia. Results SA produced psychotomimetic effects and perceptual alterations including dissociative and somaesthetic effects, increased plasma cortisol and prolactin and reduced resting EEG spectral power. SA administration was associated with a rapid increase of its levels in the blood. SA did not produce euphoria, cognitive deficits or changes in vital signs. The effects were transient and not dose-related. SA administration was very well tolerated without acute or delayed adverse effects. Conclusions SA produced a wide range of transient effects in healthy subjects. The perceptual altering effects and lack of euphoric effects would explain its intermittent use pattern. Such a profile would also suggest a low addictive potential similar to other hallucinogens and consistent with KOR agonism. Further work is warranted to carefully characterize a full spectrum of its effects in humans, to elucidate the underlying mechanisms involved and to explore the basis for individual variability in its effects. PMID:22817868

  10. The Illinois White Paper: Improving the System for Protecting Human Subjects--Counteracting IRB "Mission Creep"

    ERIC Educational Resources Information Center

    Gunsalus, C. K.; Bruner, Edward M.; Burbules, Nicholas C.; Dash, Leon; Finkin, Matthew; Goldberg, Joseph P.; Greenough, William T.; Miller, Gregory A.; Pratt, Michael G.; Iriye, Masumi; Aronson, Deb

    2007-01-01

    Our system of research self-regulation, designed to provide internal checks and balances for those who participate in research involving human subjects, is under considerable stress. Much of this crisis has been caused by what we call mission creep, in which the workload of IRBs has expanded beyond their ability to handle effectively. Mission…

  11. Human Subjects Protection: A Source for Ethical Service-Learning Practice

    ERIC Educational Resources Information Center

    Wendler, Rachael

    2012-01-01

    Human subjects research ethics were developed to ensure responsible conduct when university researchers learn by interacting with community members. As service-learning students also learn by interacting with community members, a similar set of principles may strengthen the ethical practice of service-learning. This article identifies ethical…

  12. Brain-derived neurotrophic factor in human subjects with function-altering melanocortin-4 receptor variants

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In rodents, hypothalamic brain-derived neurotrophic factor (BDNF) expression appears to be regulated by melanocortin-4 receptor (MC4R) activity. The impact of MC4R genetic variation on circulating BDNF in humans is unknown. The objective of this study is to compare BDNF concentrations of subjects wi...

  13. Dose and effect of inhaled ozone in resting versus exercising human subjects: comparison with resting rats

    EPA Science Inventory

    Dose and effect of inhaled ozone in resting versus exercising human subjects: comparison with resting rats Authors: Gary E. Hatch, John McKee, James Brown, Bill McDonnell, Elston Seal, Joleen Soukup, Ralph Slade, Kay Crissman and Robert Devlin, National Health and Environmental...

  14. Ethical and Legal Considerations in Dental Caries Research Using Human Subjects: Conference Summary.

    ERIC Educational Resources Information Center

    Jenny, Joanna

    1980-01-01

    Guidelines of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research are discussed. It is concluded that dentistry must not uncritically accept guidelines meant for a broader class of research, that guidelines can be misapplied, and that researchers must educate themselves on the Commission…

  15. 48 CFR 3452.224-72 - Research activities involving human subjects.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Research activities... OF EDUCATION ACQUISITION REGULATION CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As...

  16. Marihuana attenuates the rise in plasma ethanol levels in human subjects.

    PubMed

    Lukas, S E; Benedikt, R; Mendelson, J H; Kouri, E; Sholar, M; Amass, L

    1992-08-01

    This study was conducted to determine if plasma ethanol levels are altered as a result of smoking marihuana. Fifteen healthy adult male volunteers who used ethanol and marihuana on a casual basis participated in this study. Subjects were randomly assigned to one of three groups: placebo, low-dose, or high-dose marihuana. The marihuana dose was held constant and each subject drank three different doses of ethanol on 3 separate days spaced at least 1 week apart. Subjects drank either placebo or ethanol at doses of 0.35 g/kg (7.60 mmol/kg) or 0.70 g/kg (15.19 mmol/kg). Thirty minutes after drinking they smoked either a placebo marihuana cigarette, or one containing either 1.26% or 2.53% delta 9-tetrahydrocannabinol. Plasma ethanol levels rose sharply after the 0.7 g/kg dose and peaked at 50 minutes after drinking began (78.25 +/- 4.95 mg/dl). When subjects smoked the high-dose marihuana cigarettes after the 0.7 g/kg dose of ethanol, peak plasma ethanols levels were only 54.80 +/- 8.32 mg/dl at 105 minutes after drinking began. These alterations in plasma ethanol levels paralleled a reduction in the duration of ethanol- and marihuana-induced subjective effects after high doses of both drugs. These data suggest that marihuana may alter ethanol bioavailability.

  17. The FDA's role in medical device clinical studies of human subjects

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

  18. Are adolescents more vulnerable to the harmful effects of cannabis than adults? A placebo-controlled study in human males

    PubMed Central

    Mokrysz, C; Freeman, T P; Korkki, S; Griffiths, K; Curran, H V

    2016-01-01

    Preclinical research demonstrates that cannabinoids have differing effects in adolescent and adult animals. Whether these findings translate to humans has not yet been investigated. Here we believe we conducted the first study to compare the acute effects of cannabis in human adolescent (n=20; 16–17 years old) and adult (n=20; 24–28 years old) male cannabis users, in a placebo-controlled, double-blind cross-over design. After inhaling vaporized active or placebo cannabis, participants completed tasks assessing spatial working memory, episodic memory and response inhibition, alongside measures of blood pressure and heart rate, psychotomimetic symptoms and subjective drug effects (for example, ‘stoned', ‘want to have cannabis'). Results showed that on active cannabis, adolescents felt less stoned and reported fewer psychotomimetic symptoms than adults. Further, adults but not adolescents were more anxious and less alert during the active cannabis session (both pre- and post-drug administration). Following cannabis, cognitive impairment (reaction time on spatial working memory and prose recall following a delay) was greater in adults than adolescents. By contrast, cannabis impaired response inhibition accuracy in adolescents but not in adults. Moreover, following drug administration, the adolescents did not show satiety; instead they wanted more cannabis regardless of whether they had taken active or placebo cannabis, while the opposite was seen for adults. These contrasting profiles of adolescent resilience (blunted subjective, memory, physiological and psychotomimetic effects) and vulnerability (lack of satiety, impaired inhibitory processes) show some degree of translation from preclinical findings, and may contribute to escalated cannabis use by human adolescents. PMID:27898071

  19. An adaptive breath sampler for use with human subjects with an impaired respiratory function.

    PubMed

    Basanta, M; Koimtzis, T; Singh, D; Wilson, I; Thomas, C L P

    2007-02-01

    An adaptive sampler for collecting 2.5 dm(3) samples of exhaled air from human subjects with an impaired respiratory function is described. Pressure in the upper respiratory tract is continuously monitored and the data used to control an automated system to collect select portions of the expired breathing cycle onto a mixed bed Tenax(trade mark) and Carbotrap(trade mark) adsorbent trap for analysis by GC-MS. The sampling approach is intended for use in metabolomic profiling of volatiles in human breath at concentrations greater than microg m(-3). The importance of experimental reproducibility in metabolomic data is emphasised and consequently a high purity air supply is used to maintain a stable exogenous volatile organic compound profile at concentrations in the range 5 to 30 microg m(-3). The results of a 90 day stability study showed that exogenous VOCs were maintained at significantly lower levels (40 times lower for isopropyl alcohol) and with significantly higher reproducibility (80 times lower standard deviation for isopropyl alcohol) than would have been be the case if ambient air had been used. The sampling system was evaluated with healthy controls alongside subjects with chronic obstructive pulmonary disease. Subjects were able to breathe normally with control subjects observed to breathe at a rate of 9 to 17 breaths per minute, compared to 16 to 30 breaths per minute for subjects with COPD. This study presents, for the first time, observations and estimates of intra-subject breath sample reproducibility from human subjects. These reproducibility studies indicated that VOCs in exhaled breath exhibit a variety of dynamic behaviours, with some species recovered with a RSD <30%, while other species were observed to have significantly more variable concentrations, 30 to 130% RSD. The approach was also demonstrated to reliably differentiate the differences in the VOC profiles between alveolar and dead space air.

  20. Are human subject volunteers still players in aeromedical research as we enter the 21st century?

    PubMed

    Popper, S E; Morris, C E

    1997-08-01

    The U.S. Air Force has enjoyed the luxury of having dedicated human volunteer subjects for sustained and impact acceleration research for over 50 yr. However, with today's world economy and budgetary cutbacks, this may no longer be a viable option. The onslaught of advanced medical technology, combined with an increasing performance envelope for aircraft and their ejection systems, have created an environment where the validity of research data and the ethics of human-use research are being challenged. Now is an opportune time to reevaluate the way human-use aeromedical research is conducted. The validity of using nonpilots in lieu of pilots in aeromedical research is discussed in light of the following: a) the increased emphasis on performance metrics within sustained acceleration; b) the matching of human subjects (nonpilots) to pilots in the appropriate attributes to ensure validity of data; c) degree of medical screening required given the ethics of human-use research and concerns of pilots; and d) the challenge of evaluating the "value added" of new technology for medical screening. It is concluded that volunteer panels should be maintained with nonpilots matched with pilots physically and psychologically such that operational performance characteristics are similar. Medical screening should be similar so that research data from subjects can be applied to the target population (pilots). Longitudinal data collection (e.g., spinal X-rays) on pilots would also be of great value as a basis for studying the occupational hazards of flying.

  1. Cold sore susceptibility gene-1 genotypes affect the expression of herpes labialis in unrelated human subjects.

    PubMed

    Kriesel, John D; Bhatia, Amiteshwar; Thomas, Alun

    2014-01-01

    Our group has recently described a gene on human chromosome 21, the Cold Sore Susceptibility Gene-1 (CSSG-1, also known as C21orf91), which may confer susceptibility to frequent cold sores in humans. We present here a genotype-phenotype analysis of CSSG-1 in a new, unrelated human population. Seven hundred fifty-eight human subjects were enrolled in a case/control Cold Sore Study. CSSG-1 genotyping, herpes simplex virus 1 (HSV1) serotyping, demographic and phenotypic data was available from 622 analyzed subjects. Six major alleles (H1-H6) were tested for associations with each of the self-reported phenotypes. The statistical analysis was adjusted for age, sex and ethnicity. Genotype-phenotype associations were analyzed from 388 HSV1-seropositive subjects. There were significant CSSG-1 haplotype effects on annual cold sore outbreaks (P=0.006), lifetime cold sores (P=0.012) and perceived cold sore severity (P=0.012). There were relatively consistent trends toward protection from frequent and severe cold sores among those with the H3 or H5/6 haplotypes, whereas those with H1, H2, and H4 haplotypes tended to have more frequent and more severe episodes. Different alleles of the newly described gene CSSG-1 affect the expression of cold sore phenotypes in this new, unrelated human population, confirming the findings of the previous family-based study.

  2. Pituitary-gonadal function in adult male rats subjected to chronic water restriction.

    PubMed

    Armario, A; Campmany, L; Lopez-Calderon, A

    1987-01-01

    The effect of water restriction on the pituitary-gonadal axis has been studied in adult male rats. Water restriction did not modify FSH, LH and testosterone levels. However, both LH and testosterone responses to acute noise stress were impaired by water restriction. It was unlikely that the inhibition of the pituitary-gonadal response to stress was due to an alteration of the circadian pattern of LH since no evidence for such a daily rhythm was found in either of the two experimental groups. The effects of water restriction on the pituitary-gonadal axis appear to be at least partially a consequence of the resulting reduction in food intake, so that the pituitary-gonadal response to stress would be a more sensitive index of abnormalities induced by protein-calorie deficit than basal concentrations of LH, FSH, or T.

  3. Development and validation of a computer crash simulation model of an occupied adult manual wheelchair subjected to a frontal impact.

    PubMed

    Dsouza, R; Bertocci, G

    2010-04-01

    Wheelchairs are primarily designed for mobility and are not necessarily intended for use as motor vehicle seats. However, many wheelchairs serve as vehicle seats for individuals unable to transfer to a vehicle seat. Subjecting wheelchairs to sled testing, in part establishes the crashworthiness of wheelchairs used as motor vehicle seats. Computer simulations provide a supplemental approach for sled testing, to assess wheelchair response and loading under crash conditions. In this study a nonlinear, dynamic, computer model was developed and validated to simulate a wheelchair and occupant subjected to a frontal impact test (ANSI/RESNA WC19). This simulation model was developed utilizing data from two frontal impact 20 g/48 km/h sled tests, which consisted of identical, adult manual wheelchairs secured with 4-point tiedowns, occupied with a 50th percentile adult male anthropomorphic test device (ATD), restrained with a 3-point occupant restraint system. Additionally, the model was validated against sled data using visual comparisons of wheelchair and occupant kinematics, along with statistical assessments of outcome measures. All statistical evaluations were found to be within the acceptance criteria, indicating the model's high predictability of the sled tests. This model provides a useful tool for the development of crashworthy wheelchair design guidelines, as well as the development of transit-safe wheelchair technologies.

  4. Prospective memory on a novel clinical task in older adults with mild cognitive impairment and subjective cognitive decline

    PubMed Central

    Rabin, Laura A.; Chi, Susan Y.; Wang, Cuiling; Fogel, Joshua; Kann, Sarah J.; Aronov, Avner

    2014-01-01

    Despite the relevance of prospective memory to everyday functioning and the ability to live independently, prospective memory tasks are rarely incorporated into clinical evaluations of older adults. We investigated the validity and clinical utility of a recently developed measure, the Royal Prince Alfred Prospective Memory Test (RPA-ProMem), in a demographically diverse, non-demented, community-dwelling sample of 257 older adults (mean age = 80.78 years, 67.7% female) with amnestic mild cognitive impairment (aMCI, n = 18), non-amestic mild cognitive impairment (naMCI, n = 38), subjective cognitive decline (SCD, n = 83) despite intact performance on traditional episodic memory tests, and healthy controls (HC, n = 118). Those with aMCI and naMCI performed significantly worse than controls on the RPA-ProMem and its subtasks (time-based, event-based, short-term, long-term). Also, those with SCD scored significantly lower than controls on long-term, more naturalistic subtasks. Additional results supported the validity and inter-rater reliability of the RPA-ProMem and demonstrated a relation between test scores and informant reports of real-world functioning. The RPA-ProMem may help detect subtle cognitive changes manifested by individuals in the earliest stages of dementia, which may be difficult to capture with traditional episodic memory tests. Also, assessment of prospective memory can help guide the development of cognitive interventions for older adults at risk for dementia. PMID:24875614

  5. Neural Correlates of Human Action Observation in Hearing and Deaf Subjects

    PubMed Central

    Corina, David; Chiu, Yi-Shiuan; Knapp, Heather; Greenwald, Ralf; Jose-Robertson, Lucia San; Braun, Allen

    2007-01-01

    Accumulating evidence has suggested the existence of a human action recognition system involving inferior frontal, parietal, and superior temporal regions that may participate in both the perception and execution of actions. However, little is known about the specificity of this system in response to different forms of human action. Here we present data from PET neuroimaging studies from passive viewing of three distinct action types, intransitive self-oriented actions (e.g., stretching, rubbing one’s eyes, etc.), transitive object-oriented actions (e.g., opening a door, lifting a cup to the lips to drink), and the abstract, symbolic actions–signs used in American Sign Language. Our results show that these different classes of human actions engage a frontal/parietal/STS human action recognition system in a highly similar fashion. However, the results indicate that this neural consistency across motion classes is true primarily for hearing subjects. Data from deaf signers shows a non-uniform response to different classes of human actions. As expected, deaf signers engaged left-hemisphere perisylvian language areas during the perception of signed language signs. Surprisingly, these subjects did not engage the expected frontal/parietal/STS circuitry during passive viewing of non-linguistic actions, but rather reliably activated middle-occipital temporal-ventral regions which are known to participate in the detection of human bodies, faces, and movements. Comparisons with data from hearing subjects establish statistically significant contributions of middle-occipital temporal-ventral during the processing of non-linguistic actions in deaf signers. These results suggest that during human motion processing, deaf individuals may engage specialized neural systems that allow for rapid, online differentiation of meaningful linguistic actions from non-linguistic human movements. PMID:17459349

  6. Neonatal Administration of Memantine Enhances Social Cognition in Adult Rats Subjected to Early Maternal Deprivation

    PubMed Central

    Sánchez-Mendoza, Eduardo; Nieves, Nayadoleni; Merchor, Gustavo

    2016-01-01

    Schizophrenia is considered a neurodevelopmental disorder; however, all the available treatment options are used when the disease becomes clinically significant in adolescence or early adulthood. Using a developmental rat model of schizophrenia, we examined whether neonatal treatment with memantine, an NMDA receptor modulator, can improve schizophrenic-like symptoms in adulthood. Early maternal deprivation in rats produces deficits in social interaction behaviors in adulthood. In contrast, memantine administrated in neonatal rats subjected to early maternal deprivation significantly reduces deficits in social interaction behaviors in adulthood. These results raise the possibility that pharmacological treatment with memantine at the early developmental stage helps people with a risk to develop schizophrenic-like symptoms. PMID:28035183

  7. Neuropeptide Y in the adult and fetal human pineal gland.

    PubMed

    Møller, Morten; Phansuwan-Pujito, Pansiri; Badiu, Corin

    2014-01-01

    Neuropeptide Y was isolated from the porcine brain in 1982 and shown to be colocalized with noradrenaline in sympathetic nerve terminals. The peptide has been demonstrated to be present in sympathetic nerve fibers innervating the pineal gland in many mammalian species. In this investigation, we show by use of immunohistochemistry that neuropeptide Y is present in nerve fibers of the adult human pineal gland. The fibers are classical neuropeptidergic fibers endowed with large boutons en passage and primarily located in a perifollicular position with some fibers entering the pineal parenchyma inside the follicle. The distance from the immunoreactive terminals to the pinealocytes indicates a modulatory function of neuropeptide Y for pineal physiology. Some of the immunoreactive fibers might originate from neurons located in the brain and be a part of the central innervation of the pineal gland. In a series of human fetuses, neuropeptide Y-containing nerve fibers was present and could be detected as early as in the pineal of four- to five-month-old fetuses. This early innervation of the human pineal is different from most rodents, where the innervation starts postnatally.

  8. Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

    PubMed

    Fadare, Joseph O; Porteri, Corinna

    2010-03-01

    Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

  9. The adult human pubic symphysis: a systematic review

    PubMed Central

    Becker, Ines; Woodley, Stephanie J; Stringer, Mark D

    2010-01-01

    The pubic symphysis is a unique joint consisting of a fibrocartilaginous disc sandwiched between the articular surfaces of the pubic bones. It resists tensile, shearing and compressive forces and is capable of a small amount of movement under physiological conditions in most adults (up to 2 mm shift and 1° rotation). During pregnancy, circulating hormones such as relaxin induce resorption of the symphyseal margins and structural changes in the fibrocartilaginous disc, increasing symphyseal width and mobility. This systematic review of the English, German and French literature focuses on the normal anatomy of the adult human pubic symphysis. Although scientific studies of the joint have yielded useful descriptive data, comparison of results is hampered by imprecise methodology and/or poorly controlled studies. Several aspects of the anatomy of the pubic symphysis remain unknown or unclear: the precise attachments of surrounding ligaments and muscles; the arrangement of connective tissue fibres within the interpubic disc and the origin, structure and function of its associated interpubic cleft; the biomechanical consequences of sexual dimorphism; potential ethnic variations in morphology; and its precise innervation and blood supply. These deficiencies hinder our understanding of the normal form and function of the joint, which is particularly relevant when attempting to understand the mechanisms underlying pregnancy-related pubic symphyseal pain, a neglected and relatively common cause of pubic pain. A better understanding of the normal anatomy of the human pubic symphysis should improve our understanding of such problems and contribute to better treatments for patients suffering from symphyseal pain and dysfunction. PMID:20840351

  10. Safety, tolerability, and pharmacokinetics of KNS-760704 (dexpramipexole) in healthy adult subjects.

    PubMed

    Bozik, Michael E; Mather, James L; Kramer, William G; Gribkoff, Valentin K; Ingersoll, Evan W

    2011-08-01

    Dexpramipexole (KNS-760704; [6R]-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine) is a novel synthetic amino-benzothiazole in development for the treatment of amyotrophic lateral sclerosis (ALS). Preclinical studies have shown that dexpramipexole is neuroprotective in vitro and in vivo, is highly orally bioavailable and water soluble, and rapidly achieves and maintains high central nervous system concentrations relative to plasma. Two phase 1 clinical studies were conducted to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple doses of dexpramipexole in 54 healthy male and female adults. The effect of food on the single-dose PK of dexpramipexole was also evaluated. Single doses (50 mg, 150 mg, or 300 mg) and multiple doses (50 mg twice daily, 100 mg twice daily, or 150 mg twice daily) of dexpramipexole over 4.5 days were safe and well tolerated. Dexpramipexole was rapidly absorbed, with time to maximum plasma concentration ranging from 1.8 to 2.6 hours and half-life ranging from 6.4 to 8.1 hours under fasted conditions, and was mostly eliminated in urine as unchanged parent drug (84%-90% of dose). Food had no effect on the single-dose PK of dexpramipexole. These findings support the ongoing development of dexpramipexole for the treatment of ALS and further evaluation of the compound's therapeutic potential in other neurodegenerative diseases.

  11. Trail Making Test performance contributes to subjective judgment of visual efficiency in older adults

    PubMed Central

    Loughman, James; Savva, George M.; Kenny, RoseAnne

    2015-01-01

    Introduction. The determinant factors that influence self-reported quality of vision have yet to be fully elucidated. This study evaluated a range of contextual information, established psychophysical tests, and in particular, a series of cognitive tests as potentially novel determinant factors. Materials & Methods. Community dwelling adults (aged 50+) recruited to Wave 1 of The Irish Longitudinal Study on Ageing, excluding those registered blind, participated in this study (N = 5,021). Self-reports of vision were analysed in relation to visual acuity and contrast sensitivity, ocular pathology, visual (Choice Response Time task; Trail Making Test) and global cognition. Contextual factors such as having visited an optometrist and wearing glasses were also considered. Ordinal logistic regression was used to determine univariate and multivariate associations. Results and Discussion. Poor Trail Making Test performance (Odds ratio, OR = 1.36), visual acuity (OR = 1.72) and ocular pathology (OR = 2.25) were determinant factors for poor versus excellent vision in self-reports. Education, wealth, age, depressive symptoms and general cognitive fitness also contributed to determining self-reported vision. Conclusions. Trail Making Test contribution to self-reports may capture higher level visual processing and should be considered when using self-reports to assess vision and its role in cognitive and functional health. PMID:26664798

  12. Predictive modeling of human perception subjectivity: feasibility study of mammographic lesion similarity

    NASA Astrophysics Data System (ADS)

    Xu, Songhua; Hudson, Kathleen; Bradley, Yong; Daley, Brian J.; Frederick-Dyer, Katherine; Tourassi, Georgia

    2012-02-01

    The majority of clinical content-based image retrieval (CBIR) studies disregard human perception subjectivity, aiming to duplicate the consensus expert assessment of the visual similarity on example cases. The purpose of our study is twofold: i) discern better the extent of human perception subjectivity when assessing the visual similarity of two images with similar semantic content, and (ii) explore the feasibility of personalized predictive modeling of visual similarity. We conducted a human observer study in which five observers of various expertise were shown ninety-nine triplets of mammographic masses with similar BI-RADS descriptors and were asked to select the two masses with the highest visual relevance. Pairwise agreement ranged between poor and fair among the five observers, as assessed by the kappa statistic. The observers' self-consistency rate was remarkably low, based on repeated questions where either the orientation or the presentation order of a mass was changed. Various machine learning algorithms were explored to determine whether they can predict each observer's personalized selection using textural features. Many algorithms performed with accuracy that exceeded each observer's self-consistency rate, as determined using a cross-validation scheme. This accuracy was statistically significantly higher than would be expected by chance alone (two-tailed p-value ranged between 0.001 and 0.01 for all five personalized models). The study confirmed that human perception subjectivity should be taken into account when developing CBIR-based medical applications.

  13. Predictive Modeling of Human Perception Subjectivity: Feasibility Study of Mammographic Lesion Similarity

    SciTech Connect

    Xu, Songhua; Tourassi, Georgia

    2012-01-01

    The majority of clinical content-based image retrieval (CBIR) studies disregard human perception subjectivity, aiming to duplicate the consensus expert assessment of the visual similarity on example cases. The purpose of our study is twofold: (i) discern better the extent of human perception subjectivity when assessing the visual similarity of two images with similar semantic content, and (ii) explore the feasibility of personalized predictive modeling of visual similarity. We conducted a human observer study in which five observers of various expertise were shown ninety-nine triplets of mammographic masses with similar BI-RADS descriptors and were asked to select the two masses with the highest visual relevance. Pairwise agreement ranged between poor and fair among the five observers, as assessed by the kappa statistic. The observers' self-consistency rate was remarkably low, based on repeated questions where either the orientation or the presentation order of a mass was changed. Various machine learning algorithms were explored to determine whether they can predict each observer's personalized selection using textural features. Many algorithms performed with accuracy that exceeded each observer's self-consistency rate, as determined using a cross-validation scheme. This accuracy was statistically significantly higher than would be expected by chance alone (two-tailed p-value ranged between 0.001 and 0.01 for all five personalized models). The study confirmed that human perception subjectivity should be taken into account when developing CBIR-based medical applications.

  14. Development of human white matter fiber pathways: From newborn to adult ages.

    PubMed

    Cohen, Andrew H; Wang, Rongpin; Wilkinson, Molly; MacDonald, Patrick; Lim, Ashley R; Takahashi, Emi

    2016-05-01

    Major long-range white matter pathways (cingulum, fornix, uncinate fasciculus [UF], inferior fronto-occipital fasciculus [IFOF], inferior longitudinal fasciculus [ILF], thalamocortical [TC], and corpus callosal [CC] pathways) were identified in eighty-three healthy humans ranging from newborn to adult ages. We tracked developmental changes using high-angular resolution diffusion MR tractography. Fractional anisotropy (FA), apparent diffusion coefficient, number, length, and volume were measured in pathways in each subject. Newborns had fewer, and more sparse, pathways than those of the older subjects. FA, number, length, and volume of pathways gradually increased with age and reached a plateau between 3 and 5 years of age. Data were further analyzed by normalizing with mean adult values as well as with each subject's whole brain values. Comparing subjects of 3 years old and under to those over 3 years old, the studied pathways showed differential growth patterns. The CC, bilateral cingulum, bilateral TC, and the left IFOF pathways showed significant growth both in volume and length, while the bilateral fornix, bilateral ILF and bilateral UF showed significant growth only in volume. The TC and CC took similar growth patterns with the whole brain. FA values of the cingulum and IFOF, and the length of ILF showed leftward asymmetry. The fornix, ILF and UF occupied decreased space compared to the whole brain during development with higher FA values, likely corresponding to extensive maturation of the pathways compared to the mean whole brain maturation. We believe that the outcome of this study will provide an important database for future reference.

  15. [Subjective memory complaints in young adults: the influence of the emotional state].

    PubMed

    Pellicer-Porcar, Olga; Mirete-Fructuoso, Marcos; Molina-Rodríguez, Sergio; Soto-Amaya, Johnathan

    2014-12-16

    INTRODUCTION. Many young people today display memory complaints that are not linked to their real cognitive performance. A number of studies have sought to identify the factors involved in this problem, such as anxious-depressive symptoms, the variables of anxiety traditionally being measured as somatic or cognitive manifestations with an activation that is unspecific or not linked to any particular stimulus. AIMS. To perform an exploratory analysis to determine the role played by symptoms of depression and of various subtypes of specific and unspecific anxiety in memory complaints in young adults. PATIENTS AND METHODS. The sample used in this study was made of 193 university students, 71% of whom were females, with a mean age of 22.22 ± 3.67 years. The variable 'Memory complaints' was measured with the Memory Failures Questionnaire, and the Brief Symptom Check List was used to measure the variables 'Depression', 'Social anxiety', 'Obsessive-compulsive anxiety', 'Agoraphobic anxiety', 'Somatisation' and 'Insomnia'. RESULTS. The variables of specific anxiety show a greater correlation with memory complaints than unspecific anxiety. Multiple regression analysis explained 34.9% of the variance of memory complaints, although the only variable that made a significant contribution was 'Social anxiety', which alone explains 34.4%. CONCLUSIONS. A distinct influence between the different types of anxiety and memory complaints has been observed. The findings obtained are a novelty in this area of knowledge by pointing to a greater relevance of the variables of specific anxiety in comparison to unspecific anxiety in explaining memory complaints and the need to take a personalised approach.

  16. Anterior-posterior thoracic force-deflection characteristics measured during cardiopulmonary resuscitation: comparison to post-mortem human subject data.

    PubMed

    Arbogast, Kristy B; Maltese, Matthew R; Nadkarni, Vinay M; Steen, Petter Andreas; Nysaether, Jon B

    2006-11-01

    Comparative data of thoracic compression response between live vs. post mortem human subjects (PMHS) has been reported, but the live subject tests are often at low deflections and include the effects of muscle tensing. Novel technology has been developed that overcomes several of these limitations. Specifically, a load cell and accelerometer has been integrated into a clinical monitor-defibrillator to measure chest compression and applied force during live human cardio-pulmonary resuscitation (CPR). The sensor is interposed between the hands of the person administering CPR and the sternum of the patient. The objective of this study was to compare the thoracic force-deflection measured during adult CPR to that measured during hub-based loading of adult PMHS. CPR represents a unique setting in which to study the mechanics of the chest as the thorax is loaded to a maximum chest deflection similar to that seen in a frontal crash environment and the effects of muscle tensing are minimized. PMHS and CPR data were modeled with a progressive spring in parallel with a viscous damper. Statistical comparison of the model parameters used to describe the compliance of the thorax during large compressions revealed that under the specific loading conditions tested, chest compressions during CPR generated less force at equivalent deflections than the PMHS. Specifically, the spring force at 40 mm deflection was 286 N for the CPR data and 588 N for the PMHS. Differences in area of load application and thoracic structures engaged, however, may partially explain these differences. In addition, the chest response during CPR demonstrated more hysteresis than the PMHS suggesting that the viscoelastic nature of the thorax is more pronounced when tissues are naturally perfused and substantial tissue autolysis has not begun. This study presents fundamental biomechanical data on the mechanical response of the adult thorax that increases our understanding of any potential differences between

  17. Structure of the chromosomal gene and cDNAs coding for lactase-phlorizin hydrolase in humans with adult-type hypolactasia or persistence of lactase.

    PubMed Central

    Boll, W; Wagner, P; Mantei, N

    1991-01-01

    Lactase-phlorizin hydrolase (LPH) splits lactose in the small intestine. LPH activity is high in the suckling; in many human populations the activity declines in adults, leading to adult-type hypolactasia, whereas in other populations the high LPH activity persists in adults. In the present work, we compared LPH sequences at the gene and cDNA level among adult subjects with high and low LPH activity. The complete intron-exon organization, including the sequences of all 17 exons and of the borders of all introns (as well as about 1,000 bp of 5' flanking region), was established for the cloned chromosomal LPH gene of a subject with persistence of lactase. Using PCR, we directly sequenced the exons of a hypolactasic subject. Except for silent mutations and the unknown linkage phase at two heterozygous positions, both coding sequences were identical. We further examined the LPH mRNA of a hypolactasic subject by S1 mapping and by sequencing a set of overlapping PCR products produced from cDNA templates. Except for allelic differences, the LPH sequence of the hypolactasic subject was identical to that of the LPH cDNAs of three subjects with persistence of lactase (one cDNA isolated previously by cloning and two characterized in the present work by PCR). No allele was peculiar to the hypolactasic subject. We conclude that humans with high or low levels of lactase can code for identical LPH enzymes. Images Figure 5 Figure 2 Figure 4 PMID:1902057

  18. Pharmacokinetics of Dolutegravir When Administered With Mineral Supplements in Healthy Adult Subjects

    PubMed Central

    Song, Ivy; Borland, Julie; Arya, Niki; Wynne, Brian; Piscitelli, Stephen

    2015-01-01

    All commercially available integrase inhibitors are 2-metal binders and may be affected by co-administration with metal cations. The purpose of this study was to evaluate the effect of calcium and iron supplements on dolutegravir pharmacokinetics and strategies (dose separation and food) to attenuate the effects if significant reductions in dolutegravir exposure were observed. This was an open-label, crossover study that randomized 24 healthy subjects into 1 of 2 cohorts to receive 4 treatments: (1) dolutegravir alone, fasting; (2) dolutegravir with calcium carbonate or ferrous fumarate, fasting; (3) dolutegravir with calcium carbonate or ferrous fumarate with a moderate-fat meal; (4) dolutegravir administered 2 hours before calcium carbonate or ferrous fumarate, fasting. Plasma dolutegravir AUC(0–∞), Cmax, and C24 were reduced by 39%, 37%, and 39%, respectively, when co-administered with calcium carbonate while fasting and were reduced by 54%, 57%, and 56%, respectively, when co-administered with ferrous fumarate while fasting. Dolutegravir administration 2 hours before calcium or iron supplement administration (fasted), as well as administration with a meal, counteracted the effect. Dolutegravir and calcium or iron supplements can be co-administered if taken with a meal. Under fasted conditions, dolutegravir should be administered 2 hours before or 6 hours after calcium or iron supplements. PMID:25449994

  19. Adult human liver mesenchymal progenitor cells express phenylalanine hydroxylase.

    PubMed

    Baruteau, Julien; Nyabi, Omar; Najimi, Mustapha; Fauvart, Maarten; Sokal, Etienne

    2014-09-01

    Phenylketonuria (PKU) is one of the most prevalent inherited metabolic diseases and is accountable for a severe encephalopathy by progressive intoxication of the brain by phenylalanine. This results from an ineffective L-phenylalanine hydroxylase enzyme (PAH) due to a mutated phenylalanine hydroxylase (PAH) gene. Neonatal screening programs allow an early dietetic treatment with restrictive phenylalanine intake. This diet prevents most of the neuropsychological disabilities but remains challenging for lifelong compliance. Adult-derived human liver progenitor cells (ADHLPC) are a pool of precursors that can differentiate into hepatocytes. We aim to study PAH expression and PAH activity in a differenciated ADHLPC. ADHLPC were isolated from human hepatocyte primary culture of two different donors and differenciated under specific culture conditions. We demonstrated the high expression of PAH and a large increase of PAH activity in differenciated LPC. The age of the donor, the cellular viability after liver digestion and cryopreservation affects PAH activity. ADHLPC might therefore be considered as a suitable source for cell therapy in PKU.

  20. Ossified Ligamentum Longitudinale Anterius in Adult Human Dry Vertebrae

    PubMed Central

    Venumadhav, Nelluri; KS, Siddaraju

    2014-01-01

    Background: The ligamentum longitudinale anterius is a broad and strong band of fibrous tissue that runs along the anterior surfaces of the bodies of the vertebrae. Aim: The study was undertaken to evaluate the incidence of ossified ligamentum longitudinale anterius in adult dry human vertebra. Materials and Methods: This study was carried out on 95 sets of dry human vertebral columns irrespective of age and sex at Mayo Institute of Medical Sciences- Barabanki,-UP, Melaka Manipal Medical College-Manipal University and Department of Anatomy, KMCT Medical College, Manassery- Calicut, India. All the sets of vertebral columns were macroscopically inspected for the ossified ligamentum longitudinale anterius. Results: It was observed that out of 95 sets of vertebral columns, 27 (28.42%) vertebral columns showed ossification. Out of 27 vertebral columns, 17 (17.89%) vertebral columns showed segmental type of ossification, 2 (2.11%) vertebral columns showed continuous type of ossification and 8 (8.42%) vertebral columns showed mixed type of ossification at different vertebral level. Conclusion: Such type of ossification will affect the biomechanics of the spine and may result in stiff neck, low back pain, dysphagia, odynophagia, compression of the brachial plexus, aphonia, immobility or mucosal thickening of larynx. Hence, knowledge of such abnormalities should be kept in mind to minimise serious complications in any surgical intervention or investigative procedures in the region. PMID:25302180

  1. A biokinetic model for systemic technetium in adult humans

    SciTech Connect

    Leggett, Richard Wayne; Giussani, Augusto

    2015-04-10

    The International Commission on Radiological Protection (ICRP) currently is updating its biokinetic and dosimetric models for internally deposited radionuclides. Technetium (Tc), the lightest element that exists only in radioactive form, has two important isotopes from the standpoint of potential risk to humans: the long-lived isotope 99Tm(T1/2=2.1x105 y) is present in high concentration in nuclear waste, and the short-lived isotope 99mTc (T1/2=6.02 h) is the most commonly used radionuclide in diagnostic nuclear medicine. This paper reviews data on the biological behavior of technetium and proposes a biokinetic model for systemic technetium in the adult human body for use in radiation protection. Compared with the ICRP s current occupational model for systemic technetium, the proposed model provides a more realistic description of the paths of movement of technetium in the body; provides greater consistency with experimental and medical data; and, for most radiosensitive organs, yields substantially different estimates of cumulative activity (total radioactive decays within the organ) following uptake of 99Tm or 99mTc to blood.

  2. A biokinetic model for systemic technetium in adult humans

    DOE PAGES

    Leggett, Richard Wayne; Giussani, Augusto

    2015-04-10

    The International Commission on Radiological Protection (ICRP) currently is updating its biokinetic and dosimetric models for internally deposited radionuclides. Technetium (Tc), the lightest element that exists only in radioactive form, has two important isotopes from the standpoint of potential risk to humans: the long-lived isotope 99Tm(T1/2=2.1x105 y) is present in high concentration in nuclear waste, and the short-lived isotope 99mTc (T1/2=6.02 h) is the most commonly used radionuclide in diagnostic nuclear medicine. This paper reviews data on the biological behavior of technetium and proposes a biokinetic model for systemic technetium in the adult human body for use in radiation protection.more » Compared with the ICRP s current occupational model for systemic technetium, the proposed model provides a more realistic description of the paths of movement of technetium in the body; provides greater consistency with experimental and medical data; and, for most radiosensitive organs, yields substantially different estimates of cumulative activity (total radioactive decays within the organ) following uptake of 99Tm or 99mTc to blood.« less

  3. Comprehensive cellular‐resolution atlas of the adult human brain

    PubMed Central

    Royall, Joshua J.; Sunkin, Susan M.; Ng, Lydia; Facer, Benjamin A.C.; Lesnar, Phil; Guillozet‐Bongaarts, Angie; McMurray, Bergen; Szafer, Aaron; Dolbeare, Tim A.; Stevens, Allison; Tirrell, Lee; Benner, Thomas; Caldejon, Shiella; Dalley, Rachel A.; Dee, Nick; Lau, Christopher; Nyhus, Julie; Reding, Melissa; Riley, Zackery L.; Sandman, David; Shen, Elaine; van der Kouwe, Andre; Varjabedian, Ani; Write, Michelle; Zollei, Lilla; Dang, Chinh; Knowles, James A.; Koch, Christof; Phillips, John W.; Sestan, Nenad; Wohnoutka, Paul; Zielke, H. Ronald; Hohmann, John G.; Jones, Allan R.; Bernard, Amy; Hawrylycz, Michael J.; Hof, Patrick R.; Fischl, Bruce

    2016-01-01

    ABSTRACT Detailed anatomical understanding of the human brain is essential for unraveling its functional architecture, yet current reference atlases have major limitations such as lack of whole‐brain coverage, relatively low image resolution, and sparse structural annotation. We present the first digital human brain atlas to incorporate neuroimaging, high‐resolution histology, and chemoarchitecture across a complete adult female brain, consisting of magnetic resonance imaging (MRI), diffusion‐weighted imaging (DWI), and 1,356 large‐format cellular resolution (1 µm/pixel) Nissl and immunohistochemistry anatomical plates. The atlas is comprehensively annotated for 862 structures, including 117 white matter tracts and several novel cyto‐ and chemoarchitecturally defined structures, and these annotations were transferred onto the matching MRI dataset. Neocortical delineations were done for sulci, gyri, and modified Brodmann areas to link macroscopic anatomical and microscopic cytoarchitectural parcellations. Correlated neuroimaging and histological structural delineation allowed fine feature identification in MRI data and subsequent structural identification in MRI data from other brains. This interactive online digital atlas is integrated with existing Allen Institute for Brain Science gene expression atlases and is publicly accessible as a resource for the neuroscience community. J. Comp. Neurol. 524:3127–3481, 2016. © 2016 The Authors The Journal of Comparative Neurology Published by Wiley Periodicals, Inc. PMID:27418273

  4. Physics Education Research and Human Subjects: The PER Community and Institutional Review Boards

    NASA Astrophysics Data System (ADS)

    Aubrecht, Gordon J.

    2007-01-01

    This workshop was a discussion among participants about human subjects and Institutional Review Boards (IRBs) and dealt with the following questions: (1) What are the important human subjects issues facing physics education researchers? Do few, many, or most PER projects raise issues of confidentiality, liability, withholding of learning, differences in grading policy, impact of the student lack of informed consent, or other ethical issues? (2) Should PER physicists at each institution create a common IRB form to be used by all PER researchers at that institution? (3) Should the PER community as a group address the IRB issues as a community? If so, what might the outcome be? (4) Should all PER research be exempt from IRB approval, given the extreme unlikelihood of student physical or emotional damage? How could such global exemption be achieved?

  5. Human subjects concerns in ground based ECLSS testing - Managing uncertainty in closely recycled systems

    NASA Technical Reports Server (NTRS)

    Crump, William J.; Janik, Daniel S.; Thomas, L. Dale

    1990-01-01

    U.S. space missions have to this point used water either made on board or carried from earth and discarded after use. For Space Station Freedom, long duration life support will include air and water recycling using a series of physical-chemical subsystems. The Environmental Control and Life Support System (ECLSS) designed for this application must be tested extensively at all stages of hardware maturity. Human test subjects are required to conduct some of these tests, and the risks associated with the use of development hardware must be addressed. Federal guidelines for protection of human subjects require careful consideration of risks and potential benefits by an Institutional Review Board (IRB) before and during testing. This paper reviews the ethical principles guiding this consideration, details the problems and uncertainties inherent in current hardware testing, and presents an incremental approach to risk assessment for ECLSS testing.

  6. Complete attenuation of genetically engineered Plasmodium falciparum sporozoites in human subjects.

    PubMed

    Kublin, James G; Mikolajczak, Sebastian A; Sack, Brandon K; Fishbaugher, Matt E; Seilie, Annette; Shelton, Lisa; VonGoedert, Tracie; Firat, Melike; Magee, Sara; Fritzen, Emma; Betz, Will; Kain, Heather S; Dankwa, Dorender A; Steel, Ryan W J; Vaughan, Ashley M; Noah Sather, D; Murphy, Sean C; Kappe, Stefan H I

    2017-01-04

    Immunization of humans with whole sporozoites confers complete, sterilizing immunity against malaria infection. However, achieving consistent safety while maintaining immunogenicity of whole parasite vaccines remains a formidable challenge. We generated a genetically attenuated Plasmodium falciparum (Pf) malaria parasite by deleting three genes expressed in the pre-erythrocytic stage (Pf p52(-)/p36(-)/sap1(-)). We then tested the safety and immunogenicity of the genetically engineered (Pf GAP3KO) sporozoites in human volunteers. Pf GAP3KO sporozoites were delivered to 10 volunteers using infected mosquito bites with a single exposure consisting of 150 to 200 bites per subject. All subjects remained blood stage-negative and developed inhibitory antibodies to sporozoites. GAP3KO rodent malaria parasites engendered complete, protracted immunity against infectious sporozoite challenge in mice. The results warrant further clinical testing of Pf GAP3KO and its potential development into a vaccine strain.

  7. MR system operator: recommended minimum requirements for performing MRI in human subjects in a research setting.

    PubMed

    Calamante, Fernando; Faulkner, William H; Ittermann, Bernd; Kanal, Emanuel; Kimbrell, Vera; Owman, Titti; Reeder, Scott B; Sawyer, Anne M; Shellock, Frank G; van den Brink, Johan S

    2015-04-01

    This article is intended to provide guidelines for the minimum level of safety and operational knowledge that an MR system operator should exhibit in order to safely perform an MR procedure in a human subject in a research setting. This article represents the position of the International Society for Magnetic Resonance in Medicine (ISMRM) regarding this important topic and was developed by members of this society's MR Safety Committee.

  8. Ethical review of research on human subjects at Unilever: reflections on governance.

    PubMed

    Sheehan, Mark; Marti, Vernon; Roberts, Tony

    2014-07-01

    This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.

  9. Cholesterol-lowering potential in human subjects of fat from pigs fed rapeseed oil.

    PubMed

    Sandström, B; Bügel, S; Lauridsen, C; Nielsen, F; Jensen, C; Skibsted, L H

    2000-08-01

    The possibility of achieving blood-lipid-lowering characteristics of pig fat by increasing the content of unsaturated fat in pig feed was evaluated. Three pig feeding regimens were applied: basal feed (no added fat or vitamin E), basal feed + rapeseed oil (60 g/kg feed), and basal feed + rapeseed oil (60 g/kg) + vitamin E (200 mg/kg). Meat and meat products from the three pig groups were incorporated into diets providing 86 g pig fat/10 MJ. The diets were served to twelve healthy human male subjects for 3 weeks each in a randomised crossover design. The diets prepared from pigs fed rapeseed oil had a lower content of saturated fatty acids (approximately 9 v. 11% of energy) and a higher content of polyunsaturated fatty acids (approximately 6 v. 4% of energy) than the diet prepared from pigs fed the basal feed. Diets based on fat from pigs fed the rapeseed oil resulted in significantly lower (approximately 4%, P = 0.019) total serum cholesterol concentration compared with the diet from pigs fed the basal feed. No differences were observed in LDL-, HDL- or VLDL-cholesterol, or in triacylglycerol or VLDL-triacylglycerol concentrations. Addition of vitamin E to the pig feed resulted in only a minor increase in vitamin E content in the human subjects' diet and the vitamin E content was low in all three pig diets. Plasma vitamin E concentration in the human subjects at the end of the period with diets from pigs fed rapeseed oil without vitamin E was significantly lower (P = 0.04) than in the other two diet periods. In conclusion, an increased content of rapeseed oil in pig feed changes the fatty acid composition of the pig fat in a way that has a potential to reduce blood cholesterol concentrations in human subjects. However, intake of pig fat with a higher content of unsaturated fatty acids needs to be matched by a higher dietary intake of vitamin E.

  10. Effect of the artificial sweetener, sucralose, on small intestinal glucose absorption in healthy human subjects.

    PubMed

    Ma, Jing; Chang, Jessica; Checklin, Helen L; Young, Richard L; Jones, Karen L; Horowitz, Michael; Rayner, Christopher K

    2010-09-01

    It has been reported that the artificial sweetener, sucralose, stimulates glucose absorption in rodents by enhancing apical availability of the transporter GLUT2. We evaluated whether exposure of the proximal small intestine to sucralose affects glucose absorption and/or the glycaemic response to an intraduodenal (ID) glucose infusion in healthy human subjects. Ten healthy subjects were studied on two separate occasions in a single-blind, randomised order. Each subject received an ID infusion of sucralose (4 mM in 0.9% saline) or control (0.9% saline) at 4 ml/min for 150 min (T = - 30 to 120 min). After 30 min (T = 0), glucose (25 %) and its non-metabolised analogue, 3-O-methylglucose (3-OMG; 2.5 %), were co-infused intraduodenally (T = 0-120 min; 4.2 kJ/min (1 kcal/min)). Blood was sampled at frequent intervals. Blood glucose, plasma glucagon-like peptide-1 (GLP-1) and serum 3-OMG concentrations increased during ID glucose/3-OMG infusion (P < 0.005 for each). However, there were no differences in blood glucose, plasma GLP-1 or serum 3-OMG concentrations between sucralose and control infusions. In conclusion, sucralose does not appear to modify the rate of glucose absorption or the glycaemic or incretin response to ID glucose infusion when given acutely in healthy human subjects.

  11. Essential Microenvironment for Thymopoiesis is Preserved in Human Adult and Aged Thymus

    PubMed Central

    Shiraishi, J.; Utsuyama, M.; Seki, S.; Akamatsu, H.; Sunamori, M.; Kasai, M.; Hirokawa, K.

    2003-01-01

    Normal human thymuses at various ages were immunohistologically examined in order to determine whether adult or aged thymus maintained the microenvironment for the T cell development and thymopoiesis was really ongoing. To analyze the thymic microenvironment, two monoclonal antibodies (MoAb) were employed. One is MoAb to IL-1 receptor (IL-1R) recognizing medullary and subcapsular cortical epithelial cells of normal infant human thymus. The other is UH-1 MoAb recognizing thymic epithelial cells within the cortex, which are negative with IL-1R-MoAb. Thymus of subjects over 20 years of age was split into many fragments and dispersed in the fatty tissue. However, the microenvironment of each fragment was composed of both IL-1R positive and UH-1 positive epithelial cells, and the UH-1 positive portion was populated with lymphocytes showing a follicle-like appearance. Lymphocytes in these follicle-like portions were mostly CD4+CD8+ double positive cells and contained many proliferating cells as well as apoptotic cells. Thus these follicle-like portions in adult and aged thymus were considered to be functioning as cortex as in infant thymus. Proliferative activity of thymocytes in the thymic cortex and the follicle-like portions definitely declined with advance of age, while incidence of apoptotic thymocytes increased with aging. PMID:14575158

  12. Testosterone affects language areas of the adult human brain

    PubMed Central

    Hahn, Andreas; Kranz, Georg S.; Sladky, Ronald; Kaufmann, Ulrike; Ganger, Sebastian; Hummer, Allan; Seiger, Rene; Spies, Marie; Vanicek, Thomas; Winkler, Dietmar; Kasper, Siegfried; Windischberger, Christian; Swaab, Dick F.

    2016-01-01

    Abstract Although the sex steroid hormone testosterone is integrally involved in the development of language processing, ethical considerations mostly limit investigations to single hormone administrations. To circumvent this issue we assessed the influence of continuous high‐dose hormone application in adult female‐to‐male transsexuals. Subjects underwent magnetic resonance imaging before and after 4 weeks of testosterone treatment, with each scan including structural, diffusion weighted and functional imaging. Voxel‐based morphometry analysis showed decreased gray matter volume with increasing levels of bioavailable testosterone exclusively in Broca's and Wernicke's areas. Particularly, this may link known sex differences in language performance to the influence of testosterone on relevant brain regions. Using probabilistic tractography, we further observed that longitudinal changes in testosterone negatively predicted changes in mean diffusivity of the corresponding structural connection passing through the extreme capsule. Considering a related increase in myelin staining in rodents, this potentially reflects a strengthening of the fiber tract particularly involved in language comprehension. Finally, functional images at resting‐state were evaluated, showing increased functional connectivity between the two brain regions with increasing testosterone levels. These findings suggest testosterone‐dependent neuroplastic adaptations in adulthood within language‐specific brain regions and connections. Importantly, deteriorations in gray matter volume seem to be compensated by enhancement of corresponding structural and functional connectivity. Hum Brain Mapp 37:1738–1748, 2016. © 2016 Wiley Periodicals, Inc. PMID:26876303

  13. Testosterone affects language areas of the adult human brain.

    PubMed

    Hahn, Andreas; Kranz, Georg S; Sladky, Ronald; Kaufmann, Ulrike; Ganger, Sebastian; Hummer, Allan; Seiger, Rene; Spies, Marie; Vanicek, Thomas; Winkler, Dietmar; Kasper, Siegfried; Windischberger, Christian; Swaab, Dick F; Lanzenberger, Rupert

    2016-05-01

    Although the sex steroid hormone testosterone is integrally involved in the development of language processing, ethical considerations mostly limit investigations to single hormone administrations. To circumvent this issue we assessed the influence of continuous high-dose hormone application in adult female-to-male transsexuals. Subjects underwent magnetic resonance imaging before and after 4 weeks of testosterone treatment, with each scan including structural, diffusion weighted and functional imaging. Voxel-based morphometry analysis showed decreased gray matter volume with increasing levels of bioavailable testosterone exclusively in Broca's and Wernicke's areas. Particularly, this may link known sex differences in language performance to the influence of testosterone on relevant brain regions. Using probabilistic tractography, we further observed that longitudinal changes in testosterone negatively predicted changes in mean diffusivity of the corresponding structural connection passing through the extreme capsule. Considering a related increase in myelin staining in rodents, this potentially reflects a strengthening of the fiber tract particularly involved in language comprehension. Finally, functional images at resting-state were evaluated, showing increased functional connectivity between the two brain regions with increasing testosterone levels. These findings suggest testosterone-dependent neuroplastic adaptations in adulthood within language-specific brain regions and connections. Importantly, deteriorations in gray matter volume seem to be compensated by enhancement of corresponding structural and functional connectivity. Hum Brain Mapp 37:1738-1748, 2016. © 2016 Wiley Periodicals, Inc.

  14. Carnosine, taurine and enzyme activities of human skeletal muscle fibres from elderly subjects with osteoarthritis and young moderately active subjects.

    PubMed

    Tallon, Mark J; Harris, Roger C; Maffulli, Nicola; Tarnopolsky, Mark A

    2007-04-01

    Ageing is associated with a reduction in muscle carnosine (beta-alanyl-L-histidine), but there are no data on the changes specifically in type I and type II muscle fibres. Given the higher carnosine content of type II fibers, changes observed in whole muscle may be secondary to a shift in fibre composition. Carnosine, beta-alanine, histidine, taurine, and citrate synthase (CS) and glycogen phosphorylase (Phos), were measured in pools of single muscle fibres from freeze-dried muscle biopsies of vastus lateralis of nine elderly sedentary subjects (65-80 years) with osteoarthritis of the knee and undergoing total knee replacement, and nine young moderately active healthy subjects (20-35 years). Fibres were characterised as type I or II by myosin ATPase activity. Carnosine was 53.2% lower in type II fibres of older subjects resulting in an estimated 7% (and most probably still higher) decline in intracellular physico-chemical buffering capacity. Younger subjects showed higher CS activities in type I and higher Phos activities in type II fibres. These differences were less apparent in elderly subjects. Possible causes for the change in the carnosine content are reduced physical activity, reduced meat intake, or the result of progressive denervation.

  15. Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects.

    PubMed

    Clarke, Kieran; Tchabanenko, Kirill; Pawlosky, Robert; Carter, Emma; Todd King, M; Musa-Veloso, Kathy; Ho, Manki; Roberts, Ashley; Robertson, Jeremy; Vanitallie, Theodore B; Veech, Richard L

    2012-08-01

    Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1-2h, reaching 3.30 mM and 1.19 mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8-3.1h for β-hydroxybutyrate and 8-14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet.

  16. Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects

    PubMed Central

    Clarke, Kieran; Tchabanenko, Kirill; Pawlosky, Robert; Carter, Emma; King, M. Todd; Musa-Veloso, Kathy; Ho, Manki; Roberts, Ashley; Robertson, Jeremy; VanItallie, Theodore B.; Veech, Richard L.

    2013-01-01

    Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1–2 h, reaching 3.30 mM and 1.19 mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8–3.1 h for β-hydroxybutyrate and 8–14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. PMID:22561291

  17. Inter-Subject Variability in Human Atrial Action Potential in Sinus Rhythm versus Chronic Atrial Fibrillation

    PubMed Central

    Sánchez, Carlos; Bueno-Orovio, Alfonso; Wettwer, Erich; Loose, Simone; Simon, Jana; Ravens, Ursula; Pueyo, Esther; Rodriguez, Blanca

    2014-01-01

    Aims Human atrial electrophysiology exhibits high inter-subject variability in both sinus rhythm (SR) and chronic atrial fibrillation (cAF) patients. Variability is however rarely investigated in experimental and theoretical electrophysiological studies, thus hampering the understanding of its underlying causes but also its implications in explaining differences in the response to disease and treatment. In our study, we aim at investigating the ability of populations of human atrial cell models to capture the inter-subject variability in action potential (AP) recorded in 363 patients both under SR and cAF conditions. Methods and Results Human AP recordings in atrial trabeculae (n = 469) from SR and cAF patients were used to calibrate populations of computational SR and cAF atrial AP models. Three populations of over 2000 sampled models were generated, based on three different human atrial AP models. Experimental calibration selected populations of AP models yielding AP with morphology and duration in range with experimental recordings. Populations using the three original models can mimic variability in experimental AP in both SR and cAF, with median conductance values in SR for most ionic currents deviating less than 30% from their original peak values. All cAF populations show similar variations in GK1, GKur and Gto, consistent with AF-related remodeling as reported in experiments. In all SR and cAF model populations, inter-subject variability in IK1 and INaK underlies variability in APD90, variability in IKur, ICaL and INaK modulates variability in APD50 and combined variability in Ito and IKur determines variability in APD20. The large variability in human atrial AP triangulation is mostly determined by IK1 and either INaK or INaCa depending on the model. Conclusion Experimentally-calibrated human atrial AP models populations mimic AP variability in SR and cAF patient recordings, and identify potential ionic determinants of inter-subject variability in

  18. Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects

    PubMed Central

    Mohamed, Khadeeja; Goyal, Navin; Bouhired, Samia; Hussaini, Azra; Jones, Siôn W.; Koh, Gavin C. K. W.; Kostov, Ivan; Taylor, Maxine; Wolstenholm, Allen; Duparc, Stephan

    2016-01-01

    Tafenoquine is in development as a single-dose treatment for relapse prevention in individuals with Plasmodium vivax malaria. Tafenoquine must be coadministered with a blood schizonticide, either chloroquine or artemisinin-based combination therapy (ACT). This open-label, randomized, parallel-group study evaluated potential drug interactions between tafenoquine and two ACTs: dihydroartemisinin-piperaquine and artemether-lumefantrine. Healthy volunteers of either sex aged 18 to 65 years without glucose-6-phosphate dehydrogenase deficiency were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for 36 to <75 kg of body weight and 160 mg/1,280 mg for ≥75 to 100 kg of body weight), or plus artemether-lumefantrine (80 mg/480 mg) in two doses 8 h apart on day 1 and then twice daily on days 2 and 3, or each drug alone. The pharmacokinetic parameters of tafenoquine, piperaquine, lumefantrine, artemether, and dihydroartemisinin were determined by using noncompartmental methods. Point estimates and 90% confidence intervals were calculated for area under the concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) comparisons of tafenoquine plus ACT versus tafenoquine or ACT. All subjects receiving dihydroartemisinin-piperaquine experienced QTc prolongation (a known risk with this drug), but tafenoquine coadministration had no clinically relevant additional effect. Tafenoquine coadministration had no clinically relevant effects on dihydroartemisinin, piperaquine, artemether, or lumefantrine pharmacokinetics. Dihydroartemisinin-piperaquine coadministration increased the tafenoquine Cmax by 38% (90% confidence interval, 25 to 52%), the AUC from time zero to infinity (AUC0–∞) by 12% (1 to 26%), and the half-life (t1/2) by 29% (19 to 40%), with no effect on the AUC from time zero to the time of the last nonzero concentration (AUC0

  19. Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects.

    PubMed

    Green, Justin A; Mohamed, Khadeeja; Goyal, Navin; Bouhired, Samia; Hussaini, Azra; Jones, Siôn W; Koh, Gavin C K W; Kostov, Ivan; Taylor, Maxine; Wolstenholm, Allen; Duparc, Stephan

    2016-12-01

    Tafenoquine is in development as a single-dose treatment for relapse prevention in individuals with Plasmodium vivax malaria. Tafenoquine must be coadministered with a blood schizonticide, either chloroquine or artemisinin-based combination therapy (ACT). This open-label, randomized, parallel-group study evaluated potential drug interactions between tafenoquine and two ACTs: dihydroartemisinin-piperaquine and artemether-lumefantrine. Healthy volunteers of either sex aged 18 to 65 years without glucose-6-phosphate dehydrogenase deficiency were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for 36 to <75 kg of body weight and 160 mg/1,280 mg for ≥75 to 100 kg of body weight), or plus artemether-lumefantrine (80 mg/480 mg) in two doses 8 h apart on day 1 and then twice daily on days 2 and 3, or each drug alone. The pharmacokinetic parameters of tafenoquine, piperaquine, lumefantrine, artemether, and dihydroartemisinin were determined by using noncompartmental methods. Point estimates and 90% confidence intervals were calculated for area under the concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) comparisons of tafenoquine plus ACT versus tafenoquine or ACT. All subjects receiving dihydroartemisinin-piperaquine experienced QTc prolongation (a known risk with this drug), but tafenoquine coadministration had no clinically relevant additional effect. Tafenoquine coadministration had no clinically relevant effects on dihydroartemisinin, piperaquine, artemether, or lumefantrine pharmacokinetics. Dihydroartemisinin-piperaquine coadministration increased the tafenoquine Cmax by 38% (90% confidence interval, 25 to 52%), the AUC from time zero to infinity (AUC0-∞) by 12% (1 to 26%), and the half-life (t1/2) by 29% (19 to 40%), with no effect on the AUC from time zero to the time of the last nonzero concentration (AUC0

  20. Analysis of angiotensin II binding to human platelets: Differences in young and old subjects

    SciTech Connect

    Siebers, M.J.; Goodfriend, T.L.; Ball, D.; Elliott, M.E. )

    1990-03-01

    We examined the binding of radiolabeled angiotensin II (AII) to human platelets to characterize the apparent increase in AII receptors observed in older subjects. At 22{degrees}C, the amount of radioactivity associated with platelets from older subjects increased continuously for more than 2 hours. The same amount of radioactivity was displaced by addition of unlabeled AII at 30 min and 60 min. In the presence of phenylarsine oxide, in the cold, or when labeled antagonist was the ligand, binding came to equilibrium by 30 min. High pressure liquid chromatography demonstrated that {sup 125}I-AII was the major radioactive compound in the supernatant and platelets after incubation, but the platelets also contained radiolabeled AII fragments. Thus, some degradation accompanied interaction of AII and platelets. Phenylarsine oxide did not prevent degradation of bound AII, suggesting that degradation precedes internalization. On average, maximum binding was greater in older subjects whether platelets were incubated with {sup 125}I-AII alone, with {sup 125}I-AII and phenylarsine oxide to prevent internalization, or when the competitive inhibitor {sup 125}I-sar1,ile8-AII was the radioligand. Variability of binding among subjects also increased with age. Thus, platelets bind, degrade, and internalize AII, and the three processes occur to a greater extent in platelets from some, but not all older subjects.