Science.gov

Sample records for efficacy supplement approvals

  1. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... drug product. (ix) A change in statements regarding side effects, warnings, precautions, and... effect) that give increased assurance that the drug will have the characteristics of identity, strength... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Approval of supplemental applications....

  2. 21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A...

  3. Efficacy and Safety of Saffron Supplementation: Current Clinical Findings.

    PubMed

    Broadhead, G K; Chang, A; Grigg, J; McCluskey, P

    2016-12-09

    Saffron (Crocus savitus) is a Middle-Eastern herb with strong antioxidant properties. Its major constituents, safranal, crocin, and crocetin, are also antioxidants and bear structural similarities to other well-known natural antixodant substances, such as zeaxanthin. Given the role of oxidative stress in many diseases, considerable interest has been shown into the potential role of saffron supplementation as a treatment for a range of diseases. In vitro and animal studies have provided evidence that saffron and its constituents may be potent therapies for a range of pathologies, including Alzheimer's disease, age-related macular degeneration (AMD) and cardiac ischemia. Whether these findings translate into clinical efficacy, however, has as of yet been incompletely assessed. This makes assessing the role of saffron supplementation in these diseases difficult. Here, we review the current human clinical evidence supporting saffron supplementation as a treatment for a range of pathologies and the underlying science supporting its use.

  4. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... effectiveness data in the parent application. Category I supplements include the following: (i) A corporate... II. Supplements that may require a reevaluation of certain safety or effectiveness data in the parent... prescription drug advertising. (x) A change in the drug withdrawal period prior to slaughter or in the...

  5. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... application. 514.8 Section 514.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUG APPLICATIONS General Provisions § 514.8 Supplements and other changes to an approved application. (a) Definitions. (1)...

  6. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... prescription drug, any mailing or promotional piece used after the drug is placed on the market is labeling... permitted labeling. (3) Prescription drug labeling not requiring an approved supplemental application is... labeling, promotional labeling, or prescription drug advertising of additional warning,...

  7. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... prescription drug, any mailing or promotional piece used after the drug is placed on the market is labeling... permitted labeling. (3) Prescription drug labeling not requiring an approved supplemental application is... labeling, promotional labeling, or prescription drug advertising of additional warning,...

  8. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... prescription drug, any mailing or promotional piece used after the drug is placed on the market is labeling... permitted labeling. (3) Prescription drug labeling not requiring an approved supplemental application is... labeling, promotional labeling, or prescription drug advertising of additional warning,...

  9. 30 CFR 250.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... discharged; (6) Request a new H2S area classification, or increase the concentration of H2S to a... supplement your approved EP, DPP, or DOCD when you propose to conduct activities on your lease(s) or...

  10. Efficacy of twice weekly iron supplementation in anemic adolescent girls.

    PubMed

    Shobha, S; Sharada, D

    2003-12-01

    Two hundred and forty four girls with different hemoglobin levels were selected, of which forty-one were non-anemic. The rest were graded as mildly, moderately or severely anemic and supplemented with 60 mg of iron daily or twice weekly for twelve weeks. There was no significant difference in the increase in hemoglobin levels between daily and twice weekly-supplemented subjects at the end of the study. Unpleasant side effects of supplementation were experienced by 57.8% of the daily supplemented subjects as against 5.9% of twice weekly-supplemented ones. Twice weekly supplementation could be recommended for overcoming anemia in adolescent girls.

  11. Examining the Mediating Effect of Self-Efficacy on Approval of Aggression and Proactive Aggression

    ERIC Educational Resources Information Center

    Hadley, Jade; Mowbray, Tony; Jacobs, Nicky

    2017-01-01

    Proactive aggression (PA) is goal-directed, hostile social behavior that has been linked to detrimental outcomes. It has been theorized that adolescents who believe aggression is a normal and acceptable social response (approval of aggression) are more likely to show PA. Confidence in one's ability to behave aggressively (self-efficacy about…

  12. Efficacy comparison of medications approved for chronic weight management.

    PubMed

    Kumar, Rekha B; Aronne, Louis J

    2015-04-01

    For the first time, patients who are obese are able to benefit from 5 different FDA approved pharmacologic agents for chronic weight management. Although weight loss from all of these medications was limited to 5% to 10% of total body weight loss in the Phase III clinical trials, patients are capable of losing more weight when a cumulative approach of diet, exercise, and multiple medications are used. A pilot study of adding phentermine to lorcaserin yielded double the weight loss than lorcaserin alone. A higher percentage of total body weight is lost with use of combination phentermine/topiramate compared to orlistat, lorcaserin, and bupropion/naltrexone but there are more contraindications to its use and potential cardiovascular adverse effects due to adrenergic agonism. Lorcaserin and bupropion/naltrexone yielded similar weight loss but carry different adverse effect profiles and interactions with other psychiatric medications may preclude use of one over the other. When choosing a medication for obesity, several factors need to be considered, such as comorbidities, medication interactions, and risk of potential adverse effects.

  13. Efficacy of Ginseng Supplements on Fatigue and Physical Performance: a Meta-analysis

    PubMed Central

    2016-01-01

    We conducted a meta-analysis to investigate the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement as reported by randomized controlled trials (RCTs). RCTs that investigated the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement compared with placebos were included. The main outcome measures were fatigue reduction and physical performance enhancement. Out of 155 articles meeting initial criteria, 12 RCTs involving 630 participants (311 participants in the intervention group and 319 participants in the placebo group) were included in the final analysis. In the fixed-effect meta-analysis of four RCTs, there was a statistically significant efficacy of ginseng supplements on fatigue reduction (standardized mean difference, SMD = 0.34; 95% confidence interval [CI] = 0.16 to 0.52). However, ginseng supplements were not associated with physical performance enhancement in the fixed-effect meta-analysis of eight RCTs (SMD = −0.01; 95% CI = −0.29 to 0.27). We found that there was insufficient clinical evidence to support the use of ginseng supplements on reducing fatigue and enhancing physical performance because only few RCTs with a small sample size have been published so far. Further lager RCTs are required to confirm the efficacy of ginseng supplements on fatigue reduction. PMID:27822924

  14. Efficacy of Ginseng Supplements on Fatigue and Physical Performance: a Meta-analysis.

    PubMed

    Bach, Hoang Viet; Kim, Jeongseon; Myung, Seung Kwon; Cho, Young Ae

    2016-12-01

    We conducted a meta-analysis to investigate the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement as reported by randomized controlled trials (RCTs). RCTs that investigated the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement compared with placebos were included. The main outcome measures were fatigue reduction and physical performance enhancement. Out of 155 articles meeting initial criteria, 12 RCTs involving 630 participants (311 participants in the intervention group and 319 participants in the placebo group) were included in the final analysis. In the fixed-effect meta-analysis of four RCTs, there was a statistically significant efficacy of ginseng supplements on fatigue reduction (standardized mean difference, SMD = 0.34; 95% confidence interval [CI] = 0.16 to 0.52). However, ginseng supplements were not associated with physical performance enhancement in the fixed-effect meta-analysis of eight RCTs (SMD = -0.01; 95% CI = -0.29 to 0.27). We found that there was insufficient clinical evidence to support the use of ginseng supplements on reducing fatigue and enhancing physical performance because only few RCTs with a small sample size have been published so far. Further lager RCTs are required to confirm the efficacy of ginseng supplements on fatigue reduction.

  15. Daily iron supplementation is more efficacious than twice weekly iron supplementation for the treatment of childhood anemia in western Kenya.

    PubMed

    Desai, Meghna R; Dhar, Ritesh; Rosen, Daniel H; Kariuki, Simon K; Shi, Ya Ping; Kager, Piet A; Ter Kuile, Feiko O

    2004-05-01

    A recent meta-analysis of 14 clinical trials indicated that daily compared with intermittent iron supplementation resulted in significantly greater hematological improvement in pregnant women. No such definitive beneficial effect was demonstrated in preschool children. We compared the efficacy of daily and twice weekly iron supplementation for 6 wk under supervised and unsupervised conditions in the treatment of mild and moderate anemia [hemoglobin (Hb) 50-109 g/L] in children aged 2-59 mo living in a malaria-endemic area of western Kenya. The study was a cluster-randomized trial using a factorial design; participants were aware of the treatment assigned. All children (n = 1049) were administered a single dose of sulfadoxine-pyrimethamine at enrollment followed by 6 wk of daily supervised iron supplementation [3-6 mg/(kg.d)], twice weekly supervised iron supplementation [6-12 mg/(kg.wk)], daily unsupervised iron supplementation, or twice weekly unsupervised iron supplementation. In the supervised groups, Hb concentrations at 6 and 12 wk (6 wk postsupplementation) were significantly higher in children given iron daily rather than twice weekly [mean (95% CI) difference at 6-wk: 4.2 g/L (2.1, 6.4); 12-wk: 4.4 g/L (1.8, 7.0)]. Among the unsupervised groups, Hb concentrations were not different at 6 wk [mean (95% CI) difference: 0.86 g/L (-1.4, 3.1)], but significantly higher at 12 wk for those assigned daily iron [mean (95% CI) difference: 3.4 g/L (0.79, 6.0), P = 0.02]. In this malarious area and after initial antimalarial treatment, 6 wk of daily iron supplementation results in better hematological responses than twice weekly iron supplementation in the treatment of anemia in preschool children, regardless of whether adherence can be ensured.

  16. Iron supplements: scientific issues concerning efficacy and implications for research and programs.

    PubMed

    Allen, Lindsay H

    2002-04-01

    Iron supplementation remains an important strategy for the prevention and treatment of iron deficiency anemia and can produce substantial improvements in the functional performance of iron deficient individuals and populations. Many potential benefits of iron supplementation require further exploration, including its effect on vitamin A and iodine metabolism. There is strong evidence that vitamin A and riboflavin deficiencies affect iron utilization from supplements and are important on a global scale, but little evidence that folate and vitamin B-12 deficiencies play a major causal role in the global burden of anemia. The efficacy of multiple micronutrient supplements for the prevention and treatment of anemia must be further evaluated. Because weekly supplementation with iron is effective at improving iron status, this option should be thoroughly explored and evaluated in the context of programs for the prevention and the treatment of iron deficiency and anemia. More conformation is warranted concerning the number of tablets that must be consumed in different situations, and the efficacy of supplying other micronutrients weekly with iron. Weekly supplementation programs may improve the logistical and economic constraints that currently limit the provision of supplements to the many target population groups for whom they are recommended, but usually fail to reach. Further work is required to clarify the purpose, delivery and outcomes of iron supplementation programs.

  17. Safety, Efficacy, and Legal Issues Related to Dietary Supplements

    ERIC Educational Resources Information Center

    Powers, Michael

    2004-01-01

    This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

  18. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

  19. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ..., Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical... active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to... pharmaceutical ingredient DMFs to be made available for reference. GDUFA directs FDA to establish each year...

  20. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

  1. Efficacy trials of a micronutrient dietary supplement in schoolchildren and pregnant women in Tanzania.

    PubMed

    Latham, Michael C; Ash, Deborah M; Makola, Diklar; Tatala, Simon R; Ndossi, Godwin D; Mehansho, Haile

    2003-12-01

    Traditionally, the main strategies used to control micronutrient deficiencies have been food diversification, consumption of medicinal supplements, and food fortification. In Tanzania, we conducted efficacy trials using a dietary supplement as a fourth approach. These were randomized, double-blind, placebo-controlled efficacy trials conducted separately first in children and later in pregnant women. The dietary supplement was a powder used to prepare an orange-flavored beverage. In the school trial, children consumed 25 g per school day attended. In the pregnancy trial, women consumed the contents of two 25-g sachets per day with meals. This dietary supplement, unlike most medicinal supplements, provided 11 micronutrients, including iron and vitamin A, in physiologic amounts. In both trials we compared changes in subjects consuming either the fortified or the nonfortified supplement. Measures of iron and vitamin A status were similar in the groups at the baseline examination, but significantly different at follow-up, always in favor of the fortified groups. Children receiving the fortified supplement had significantly improved anthropometric measures when compared with controls. At four weeks postpartum, the breast milk of a supplemented group of women had significantly higher mean retinol content than did the milk of mothers consuming the nonfortified supplement. The advantages of using a fortified dietary supplement, compared with other approaches, include its ability to control several micronutrient deficiencies simultaneously; the use of physiologic amounts of nutrients, rather than megadoses that require medical supervision; and the likelihood of better compliance than with the use of pills because subjects liked the beverage used in these trials.

  2. A Review of the Efficacy, Safety, and Clinical Implications of Naturally Derived Dietary Supplements for Dyslipidemia.

    PubMed

    Thaipitakwong, Thanchanit; Aramwit, Pornanong

    2017-02-01

    Dyslipidemia is recognized as a major cause of cardiovascular disease. A number of evidence-based guidelines recommend conventional synthetic drugs as standard therapy for dyslipidemia in clinical practice. However, antihyperlipidemic drugs have some serious side effects. Naturally derived dietary supplements are becoming attractive as an alternative strategy because of their high efficacy and safety, as supported by numerous data. Moreover, they could be considered an initial treatment for dyslipidemia. The aims of this literature review were to demonstrate the efficacy, safety, and clinical implications of dietary supplements for treating dyslipidemia. We reviewed the literature, including data from in vitro, in vivo, and human studies, and clinical guideline recommendations. We classified dietary supplements by their proposed mechanisms of action on lipid metabolism and also collected daily dosage recommendations, interactions with concurrent drugs and/or foods, dosage forms, and examples of commercially available products. Various types of naturally derived dietary supplements exhibit lipid-improving properties. Efficacy and safety are acceptable; however, their use in clinical practice will require further well-designed investigations and the support of scientific data.

  3. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs.

    PubMed

    Ross, Joseph S; Dzara, Kristina; Downing, Nicholas S

    2015-04-01

    The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients' access to new and effective therapeutics. We used qualitative methods to characterize the safety and efficacy reasons why applications for novel therapeutics approved by the FDA between 2001 and 2011 required multiple review cycles prior to approval. Among ninety-six applications approved between 2001 and 2011 that required multiple review cycles, safety concerns contributed to seventy-four (77.1 percent) and efficacy concerns to forty-three (44.8 percent). Our study suggests that multiple review cycles appear to play an important role in allowing the FDA to protect public health and in ensuring adequate understanding of clinical benefits and risks prior to approval.

  4. 78 FR 67985 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). All drugs have risks, and health care... previously approved under section 505(c) of the FD&C Act (the RLD) with respect to active ingredient(s... Labeling B. Current Requirements Related to Changes to Approved Drug Labeling C. Specific...

  5. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and meets the criteria in the Act and implementing regulations and the assurances in the State plan... program component and OSHA needs additional information on its compliance with the criteria in section 18... Act. (d) If the plan change meets the approval criteria, OSHA shall approve it and shall...

  6. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of... holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule...

  7. A Study on the Self-Efficacy and Competence of Approved Clinical Instructors on Athletic Training Educational Competencies

    ERIC Educational Resources Information Center

    Ludwig, Christopher M.

    2014-01-01

    The purpose of this research was to survey allied healthcare and medical practitioners who were approved clinical instructors (ACIs) of an accredited Athletic Training Education Program to gain insight into their self-efficacy and competence on the acute care of pulmonary injuries and illnesses category in the 5th edition of the Athletic Training…

  8. Efficacious Action and Social Approval as Interacting Dimensions of Self-Esteem: A Tentative Formulation Through Construct Validation

    ERIC Educational Resources Information Center

    Franks, David D.; Marolla, Joseph

    1976-01-01

    A theoretical and operational rationale is presented for the development of multidimensional measures of self-esteem. Self-esteem is conceptualized as a function of two processes reflected appraisals of significant others in one's social environment in the form of social approval, and the individual's feelings of efficacy and competence derived…

  9. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... application under section 512 of the act must assess the effects of the change before distributing a drug made...) that do not decrease safety of drug use proposed in supplemental applications may be placed into effect... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Supplements and other changes to an...

  10. 78 FR 65219 - Defense Federal Acquisition Regulation Supplement: Approval of Rental Waiver Requests (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... Security Cooperation Agency from the approval process for waiver or reduction of charges for the use of... Defense Security Cooperation Agency (DSCA) has seen a significant increase in the number of requests...

  11. Expectancy, self-efficacy, and placebo effect of a sham supplement for weight loss in obese subjects

    PubMed Central

    Tippens, Kimberly M; Purnell, Jonathan Q; Gregory, William L; Connelly, Erin; Hanes, Douglas; Oken, Barry; Calabrese, Carlo

    2014-01-01

    This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults. All participants received lifestyle education and were randomized to one of three conditions: 1) a daily placebo capsule and told that they were taking an active weight loss supplement; 2) daily placebo and told they had a 50% random chance of receiving either the active or placebo; or 3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the three groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy. PMID:24695007

  12. Expectancy, Self-Efficacy, and Placebo Effect of a Sham Supplement for Weight Loss in Obese Adults.

    PubMed

    Tippens, Kimberly M; Purnell, Jonathan Q; Gregory, William L; Connelly, Erin; Hanes, Douglas; Oken, Barry; Calabrese, Carlo

    2014-07-01

    This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults with metabolic syndrome. All participants received lifestyle education and were randomized to 1 of 3 conditions: (1) a daily placebo capsule and told that they were taking an active weight loss supplement, (2) daily placebo and told they had a 50% random chance of receiving either the active or placebo, or (3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the 3 groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy.

  13. Efficacy of daily and weekly iron supplementation on iron status in exclusively breast-fed infants.

    PubMed

    Yurdakök, Kadriye; Temiz, Fatih; Yalçin, S Songül; Gümrük, Fatma

    2004-05-01

    Iron deficiency anemia (IDA) remains the most prevalent nutritional deficiency in infants worldwide. The purpose of this study was to determine the efficacy of daily and weekly iron supplementation for 3 months to improve the iron status in 4-month-old, exclusively breast-fed healthy infants. Infants 4 months of age were eligible for the open, randomized controlled trial if their mothers intended to continue exclusive breast-feeding until the infants were 6 months of age. Infants or mothers with iron deficiency (ID) or IDA on admission were excluded. The infants (n = 79) were randomly assigned to three groups, the first group receiving daily (1 mg/kg daily), the second group weekly (7 mg/kg weekly), and the third group no iron supplementation. Anthropometric measurements were taken on admission and at 6 and 7 months of age. Iron status was analyzed on admission and monthly for 3 months. Both hematologic parameters and anthropometric measurements were found to be similar among the three groups during the study period. Seven infants (31.8%) in the control group, six (26.0%) in the daily group, and three (13.6%) in the weekly group developed ID or IDA (P > 0.05). Infants whose mothers had ID or IDA during the study period were more likely to develop ID or IDA independently from iron supplementation. Serum ferritin levels decreased between 4 and 6 months of age in the control and daily groups; the weekly group showed no such decrease. In all groups, the mean levels of serum ferritin were significantly increased from 6 months to 7 months of age during the weaning period. In this study, which had a limited number of cases, weekly or daily iron supplementation was not found to decrease the likelihood of IDA. In conclusion, exclusively breast-fed infants with maternal IDA appeared to be at increased risk of developing IDA.

  14. Efficacy and safety of protein supplements for U.S. Armed Forces personnel: consensus statement.

    PubMed

    Pasiakos, Stefan M; Austin, Krista G; Lieberman, Harris R; Askew, E Wayne

    2013-11-01

    To provide evidence-based guidance regarding the efficacy and safety of dietary protein supplement (PS) use by members of the U.S. Armed Forces, a panel of internationally recognized experts in the fields of protein metabolism and dietary supplement research was convened by the Department of Defense Center Alliance for Dietary Supplement Research and the U.S. Army Medical Research and Material Command. To develop a consensus statement, potential benefits, risks, and strategies to optimize military performance through PS use were considered in the context of specific warfighter populations and occupational demands. To maintain muscle mass, strength, and performance during periods of substantial metabolic demand and concomitant negative energy balance the panel recommended that warfighters consume 1.5-2.0 g · kg(-1) · d(-1) of protein. However, if metabolic demand is low, such as in garrison, protein intake should equal the current Military Dietary Reference Intake (0.8-1.5 g · kg(-1) · d(-1)). Although PS use generally appears to be safe for healthy adults, warfighters should be educated on PS quality, given quality-control and contamination concerns with commercial dietary supplements. To achieve recommended protein intakes, the panel strongly urges consumption of high-quality protein-containing whole foods. However, when impractical, the use of PSs (20-25 g per serving or 0.25-0.3 g · kg(-1) per meal), particularly after periods of strenuous physical activity (e.g., military training, combat patrols, and exercise), is acceptable. The committee acknowledges the need for further study of protein requirements for extreme, military-specific environmental conditions and whether unique metabolic stressors associated with military service alter protein requirements for aging warfighters.

  15. 77 FR 14480 - Defense Federal Acquisition Regulation Supplement: Commercial Determination Approval (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... a type'' or ``offered for sale'' language contained in the definition of commercial item. The rule also clarifies approval requirements for determinations for acquisitions of services exceeding $1 million using part 12 procedures but which do not meet the definition of commercial item. DATES: March...

  16. 78 FR 11754 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplement Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ..., through the Tennessee Department of Environment and Conservation (TDEC). Tennessee's December 13, 2012... California) must use MOVES in conformity determinations for TIPs. As stated above, MOBILE6.2 was the... Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in...

  17. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application. 314.70 Section 314.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... profile of the drug product. (vii) Changes solely affecting a natural product, a recombinant...

  18. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... application. 314.70 Section 314.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... profile of the drug product. (vii) Changes solely affecting a natural product, a recombinant...

  19. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... application. 314.70 Section 314.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... profile of the drug product. (vii) Changes solely affecting a natural product, a recombinant...

  20. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... Supplemental Budget Request To Establish an Office of Outreach and Small Business Liaison in 2010 The Sarbanes... Commission, auditing and related attestation, quality control, ethics, and independence standards to be used... its outreach function by establishing a new Office of Outreach and Small Business Liaison (``Office...

  1. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... by Month Approvals, tentative approvals, and supplements Original New Drug Approvals (NDAs and BLAs) by Month All applications ... FDA. Does not include tentative approvals. Original Abbreviated New Drug Approvals (ANDAs) by Month Generic Drug Approvals. Does ...

  2. Belimumab efficacy is 'mild' but market potential still great†: anticipating us approval of the first lupus drug since 1957.

    PubMed

    Weintraub, Ben

    2011-06-01

    Speaking for the inThought Expert Discussion Series in February, Dr George Tsokos mirrored the opinion of many lupus thought leaders: Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) belimumab (Benlysta®) was likely to be approved by the US FDA and, despite modest efficacy, will be used by a large proportion of lupus patients. Dr Tsokos praised HGS and GSK's clinical trial program for belimumab, noting that huge trials and unique trial endpoints were needed to demonstrate the drug's efficacy, allowing it to succeed where so many other lupus drugs have failed. Still, belimumab's trial design may not become standard in future lupus trials - questions about identification of appropriate lupus patients with active disease, trial endpoints, and subgrouping lupus patients remain. Although Dr Tsokos does not expect other agents currently being tested in lupus trials to be significantly more efficacious than belimumab, his research suggests that significantly better results could be obtained using agents targeting interleukin-17, spleen tyrosine kinase (SYK), and calcium/calmodulin-dependent protein kinase type IV (CaMKIV). In line with Dr Tsokos' comments and consistent with inThought's outlook for belimumab, the US FDA granted approval for belimumab in March 2011, making it the first new lupus drug to be approved in more than 50 years. inThought projects US sales of $1.1 billion for belimumab by 2017. † Adapted and reproduced from Weintraub B. Benlysta Efficacy is "Mild" but Market Potential Still Great: Anticipating U.S. Approval of the First Lupus Drug Since 1957. inThought Research, 2011 Feb 24.

  3. Efficacy of an oral hyaluronate and collagen supplement as a preventive treatment of elbow dysplasia.

    PubMed

    Martí-Angulo, Simón; García-López, Núria; Díaz-Ramos, Ana

    2014-12-01

    One hundred and five Labrador dogs were randomly divided into two groups to determine the number of animals that develop elbow dysplasia when treated with an oral supplement compared to untreated ones. Efficacy of the oral treatment was also evaluated once illness was diagnosed. The supplement (Hyaloral) contained hyaluronic acid, hydrolysed collagen, glucosamine, chondroitin sulphate, and gamma oryzanol. Clinical evaluation of the elbow joints was completed at months 3, 6, 12, and 20 by orthopaedic evaluations, radiography, serologic and blood analysis, and veterinarian evaluation of dysplasia symptoms. All side effects were recorded. In the control group, 33.3% of the dogs developed radiographic evidence of elbow dysplasia compared to 18.5% in the treated group. Symptoms of dysplasia at 12 months differed between the treated (12.5%) and control (61.5%) animals, and were significantly different at 20 months (p < 0.05). Differences in lameness along with movement and swelling of the elbows between groups were observed after 12 months. The treated group had improved significantly by the last visit (p < 0.05). No adverse side effects were reported. In conclusion, oral treatment with Hyaloral may have a potential cumulative action that provides protection against dysplasia and significantly improves symptoms of elbow dysplasia.

  4. The Efficacy of Supplemental Early Literacy Instruction by Community-Based Tutors for Preschoolers Enrolled in Head Start

    ERIC Educational Resources Information Center

    Nelson, J. Ron; Sanders, Elizabeth A.; Gonzalez, Jorge

    2010-01-01

    The purpose of the current study was to test the efficacy of a supplemental phonological awareness focused intervention delivered by community-based paraeducators with preschool children (M = 4.73 years) in eight Head Start classrooms in the rural Midwest. Participating children were randomly assigned to small groups within classrooms, which were…

  5. The efficacy of vitamin D supplementation during a prolonged submarine patrol.

    PubMed

    Gasier, Heath G; Gaffney-Stomberg, Erin; Young, Colin R; McAdams, Douglas C; Lutz, Laura J; McClung, James P

    2014-09-01

    Submariners spend prolonged periods submerged without sunlight exposure and may benefit from vitamin D supplementation to maintain vitamin D status. The primary objective of this study was to determine the efficacy of daily vitamin D supplementation on maintenance of 25-hydroxyvitamin D (25(OH)D) during a 3-month submarine patrol. Submariners were randomly divided into three groups: placebo (n = 16), 1,000 IU/day (n = 20), or 2,000 IU/day (n = 17). Anthropometrics, self-reported dietary calcium and vitamin D intake, serum markers of vitamin D and bone metabolism, and peripheral quantitative computed tomography (pQCT) parameters of the tibia were determined before and after the patrol. Prior to departure, 49 % of the subjects were vitamin D insufficient (<50 nmol/L). Following the patrol, 25(OH)D increased in all groups (p < 0.001): 3.3 ± 13.1 (placebo), 4.6 ± 11.3 (1,000 IU/day), and 13 ± 14 nmol/L (2,000 IU/day). The changes in 25(OH)D levels were dependent upon the baseline concentration of 25(OH)D and body mass (p < 0.001). Osteocalcin increased by 38 % (p < 0.01), and pQCT analyses revealed small, yet significant increases in indices of tibial structure and strength (p < 0.05) that were independent of supplementation. These data suggest that vitamin D status was low prior to the patrol, and the subsequent changes in vitamin D status were dependent on the baseline 25(OH)D levels and body mass. Furthermore, short-term skeletal health does not appear to be negatively affected by 3 months of submergence in spite of a suboptimal response to vitamin D supplementation.

  6. Efficacy of dietary supplementation with botanicals on carbohydrate metabolism in humans.

    PubMed

    Cefalu, William T; Ye, Jianping; Wang, Zhong Q

    2008-06-01

    Botanical products are widely used in nutritional supplementation for promotion of health or prevention of diseases. With the high prevalence of obesity and type 2 diabetes, abnormalities in carbohydrate metabolism are common in the general population and obtaining glycemic control is important in reducing the complications of diabetes. If shown to be effective, botanical products have a unique position in potentially aiding the general public in regard to obesity and diabetes. They can be obtained "over-the-counter" and may have less side effects compared to many synthetic drugs. Although most of the popular botanicals have a long history in folk medicine, there is paucity of data regarding their efficacy and safety, particularly as it relates to human studies. In this review, we discuss the data that was available in the literature for nine botanicals that are frequently promoted to help manage blood glucose. They are Bitter Melon (Momordica charantia), Fenugreek (trigonella foenum graecum), Gymnema Sylvestre, Ivy Gourd (Coccinia indica), Nopal or Prickly Pear Cactus (Opuntia streptacantha), Ginseng, Aloe Vera, Russian Tarragon (Artemisia dracunculus), and Garlic (Allium sativum). The discussion is emphasized on the clinical aspect of these botanicals. Due to the lack of sufficient evidence from clinical studies for any of the botanicals reviewed, it is premature to actively recommend use of any particular herb to treat either glucose or other risk factors. Thus, well defined randomized clinical trials are warranted in this area.

  7. [Comparison of the efficacy of two different iron supplements for anemia prevention in piglets].

    PubMed

    Vermeer, J E M; Kuijpers, A H C; Elbers, A R W

    2002-02-15

    In a randomized, confirmatory study performed between July and October 2000 the efficacy of two iron products in preventing iron deficiency anaemia was compared. A total of 102 newborn piglets from ten litters were treated intramuscularly with 200 mg iron as iron dextran per ml, or 200 mg iron as gleptoferron per ml. For true comparison, piglets within a litter of a sow were subdivided into pairs on the basis of birth weight (one pair of the two heaviest piglets, et cetera). Within a pair, treatment with the iron supplements was randomly allocated. One group of piglets was injected at an age of 1 day (experiment 1) and the other group of piglets was injected at an age of 3 days (experiment 2). The piglets were weighed and blood samples were taken at an age of 18 days (experiment 1) or at an age of 19 days (experiment 2). Average daily weight gain and haemoglobin concentrations of both treatment groups were compared. Both products were very effective in preventing anaemia. No significant differences could be found between the two formulations. It can be concluded that iron-dextran and gleptoferron can be used with similar effect for anaemia prevention in piglets.

  8. Efficacy of some antioxidants supplementation in reducing oxidative stress post sodium tungstate exposure in male wistar rats.

    PubMed

    Sachdeva, S; Flora, S J S

    2014-04-01

    This study aimed to evaluate the protective efficacy of some antioxidants against sodium tungstate induced oxidative stress in male wistar rats. Animals were sub-chronically exposed to sodium tungstate (100ppm in drinking water) for three months except for control group. In the same time, many rats were supplemented orally with different antioxidants (alpha-lipoic acid (ALA), n-acetylcysteine (NAC), quercetin or naringenin (0.30mM)) for five consecutive days a week for the same mentioned period before. Exposure to sodium tungstate significantly (P<0.05) inhibit blood δ-aminolevulinic acid dehydratase (ALAD) activity, liver and blood reduced glutathione (GSH) levels and an increase in oxidized glutathione (GSSG) and thiobarbituric acid reactive species (TBARS) levels in tissues. ALA acid and NAC supplementation post sodium tungstate exposure increased GSH and also, was beneficial in the recovery of altered superoxide dismutase and catalase activity, besides, significantly reducing blood and tissue reactive oxygen species and TBARS levels. The results suggest a more pronounced efficacy of ALA acid and NAC supplementation than quercetin or naringenin supplementation post sodium tungstate exposure in preventing induced oxidative stress in rats.

  9. Review: efficacy of alginate supplementation in relation to appetite regulation and metabolic risk factors: evidence from animal and human studies.

    PubMed

    Georg Jensen, M; Pedersen, C; Kristensen, M; Frost, G; Astrup, A

    2013-02-01

    This review provides a critical update on human and animal studies investigating the effect of alginate supplementation on appetite regulation, glycaemic and insulinemic responses, and lipid metabolism with discussion of the evidence on potential mechanisms, efficacy and tolerability. Dependent on vehicle applied for alginate supplementation, the majority of animal and human studies suggest that alginate consumption does suppress satiety and to some extent energy intake. Only one long-term intervention trial found effects on weight loss. In addition, alginates seem to exhibit beneficial influence on postprandial glucose absorption and insulin response in animals and humans. However, alginate supplementation was only found to have cholesterol-lowering properties in animals. Several mechanisms have been suggested for the positive effect observed, which involve delayed gastric emptying, increased viscosity of digesta and slowed nutrient absorption in the small intestine upon alginate gel formation. Despite reasonable efficacy and tolerability from the acute or short-term studies, we still realize there is a critical need for development of optimal alginate types and vehicles as well as studies on further long-term investigation on alginate supplementation in humans before inferring that it could be useful in the management of obesity and the metabolic syndrome.

  10. Efficacy of Lactic Acid Bacteria (LAB) supplement in management of constipation among nursing home residents

    PubMed Central

    2010-01-01

    Background Constipation is a significant problem in the elderly, specifically nursing home and/or extended-care facility residents are reported to suffer from constipation. Lactic acid bacteria (LAB) are beneficial probiotic organisms that contribute to improved nutrition, microbial balance, and immuno-enhancement of the intestinal tract, as well as diarrhea and constipation effect. The objective of this study was to investigate the efficacy of this LAB supplement in the management of nursing home residents. Methods Nineteen subjects (8M, 11F; mean age 77.1 ± 10.1) suffering with chronic constipation were assigned to receive LAB (3.0 × 1011 CFU/g) twice (to be taken 30 minutes after breakfast and dinner) a day for 2 weeks in November 2008. Subjects draw up a questionnaire on defecation habits (frequency of defecation, amount and state of stool), and we collected fecal samples from the subjects both before entering and after ending the trial, to investigate LAB levels and inhibition of harmful enzyme activities. Results were tested with SAS and Student's t-test. Results Analysis of questionnaire showed that there was an increase in the frequency of defecation and amount of stool excreted in defecation habit after LAB treatment, but there were no significant changes. And it also affects the intestinal environment, through significantly increase (p < 0.05) fecal LAB levels. In addition, tryptophanase and urease among harmful enzyme activities of intestinal microflora were significantly decreased (p < 0.05) after LAB treatment. Conclusion LAB, when added to the standard treatment regimen for nursing home residents with chronic constipation, increased defecation habit such as frequency of defecation, amount and state of stool. So, it may be used as functional probiotics to improve human health by helping to prevent constipation. PMID:20137076

  11. Confidence in the Efficacy and Safety of Dietary Supplements Among United States Active Duty Army Personnel

    DTIC Science & Technology

    2012-10-10

    including vitamins, minerals, combination products, antioxidants, herbals , protein and amino acid supplements , and purported steroid analogs) and...rarely or never” harm the user. Likewise, individuals who use herbal supplements or OTC weight-loss aids were found to be more likely to perceive...Sun C, Willsie SK: Herbal products and dietary supplements : a survey of use, attitudes, and knowledge among older adults. J Am Osteopath Assoc 2007

  12. Efficacy of daily vs. weekly supplementation of iron in schoolchildren with low iron status.

    PubMed

    Siddiqui, Imran Akhtar; Rahman, M Ataur; Jaleel, Anila

    2004-10-01

    Iron deficiency anemia (IDA) is still a major nutritional and public health problem in developing countries. The prevalence among young children and pregnant women is particularly high. Daily oral supplementation with medicinal iron is considered an effective strategy for reducing the incidence of IDA but non-compliance is a major problem with this strategy. We undertook this study to compare the results of once-weekly vs. daily oral iron supplementation in schoolchildren. Sixty children ranging between 5 and 10 years with iron deficiency anemia were selected from a school in Karachi, Pakistan and were divided into two equal groups, i.e., daily and weekly supplementation groups. Hemoglobin (Hb), hematocrit (Hct), serum iron, total iron binding capacity (TIBC), and serum ferritin were determined before the start of the study. Ferrous sulfate (200 mg) was given daily to the daily supplementation group and once-weekly to the weekly supplementation group for 2 months. When post-supplementation values of the above-mentioned parameters were determined, a significant improvement was observed in all parameters in both groups. It is concluded that once-weekly iron supplementation is as effective as daily supplementation for the treatment of iron deficiency anemia. Moreover, weekly iron supplementation is cost effective and has no or fewer side-effects.

  13. Vitamin D Status and Efficacy of Vitamin D Supplementation in Atopic Dermatitis: A Systematic Review and Meta-Analysis

    PubMed Central

    Kim, Min Jung; Kim, Soo-Nyung; Lee, Yang Won; Choe, Yong Beom; Ahn, Kyu Joong

    2016-01-01

    Recent literature has highlighted the possible role of vitamin D in atopic dermatitis (AD), and that vitamin D supplementation might help to treat AD. This study determined the relationship between vitamin D level and AD, and assessed the efficacy of vitamin D supplementation. We searched the MEDLINE, EMBASE, and Cochrane databases up to May 2015. Observational studies and randomized controlled trials were included based on the available data on the serum 25-hydroxyvitamin D (25(OH)D) level and quantified data available for severity assessed using the Scoring Atopic Dermatitis (SCORAD) index or Eczema Area and Severity Index (EASI) score. Compared with healthy controls, the serum 25(OH)D level was lower in the AD patients of all ages (standardized mean difference = −2.03 ng/mL; 95% confidence interval (CI) = −2.52 to −0.78), and predominantly in the pediatric AD patients (standardized mean difference = −3.03 ng/mL; 95% CI = −4.76 to −1.29). In addition, the SCORAD index and EASI score decreased after vitamin D supplementation (standardized mean difference = −5.85; 95% CI = −7.66 to −4.05). This meta-analysis showed that serum vitamin D level was lower in the AD patients and vitamin D supplementation could be a new therapeutic option for AD. PMID:27918470

  14. Efficacy of a Supplemental Phonemic Awareness Curriculum to Instruct Preschoolers with Delays in Early Literacy Development

    ERIC Educational Resources Information Center

    Goldstein, Howard; Olszewski, Arnold; Haring, Christa; Greenwood, Charles R.; McCune, Luke; Carta, Judith; Atwater, Jane; Guerrero, Gabriela; Schneider, Naomi; McCarthy, Tanya; Kelley, Elizabeth S.

    2017-01-01

    Purpose: Children who do not develop early literacy skills, especially phonological awareness (PA) and alphabet knowledge, prior to kindergarten are at risk for reading difficulties. We investigated a supplemental curriculum with children demonstrating delays in these skills. Method: A cluster randomized design with 104 preschool-age children in…

  15. Efficacy of progesterone supplementation during early pregnancy in cows: A meta-analysis.

    PubMed

    Yan, Leyan; Robinson, Robert; Shi, Zhendan; Mann, George

    2016-05-01

    Progesterone is a critical hormone during early pregnancy in the cow. As a result, a number of studies have investigated the effects of progesterone supplementation on pregnancy rates. In this study, a meta-analysis using a univariate binary random effects model was carried out on 84 specific treatments reported in 53 publications involving control (n = 9905) and progesterone-treated (n = 9135) cows. Although the results of individual studies showed wide variations (-40% to +50% point changes), progesterone treatment resulted in an overall increase in pregnancy rate odds ratio (OR = 1.12; P < 0.01). Improvements in pregnancy rate were only observed in cows treated at natural estrus (OR = 1.41, P < 0.01) and not following synchronization of estrus or ovulation. Although treatment between Days 3 to 7 postinsemination was beneficial (OR = 1.15; P < 0.01), treatment earlier or later than this was not. Progesterone supplementation was beneficial in cows of lower fertility (<45% control pregnancy rate) but not in cows with higher fertility. These results indicated that the benefit of progesterone supplementation on fertility of cows required exogenous progesterone supplementation to start between Day 3 to 7 and the appropriate reproductive status (i.e., lower fertility, natural estrus) of the treated cows.

  16. 30 CFR 250.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... revise your approved EP, DPP, or DOCD when you propose to: (1) Change the type of drilling rig (e.g., jack-up, platform rig, barge, submersible, semisubmersible, or drillship), production facility...

  17. Efficacy of Probiotic Supplementation Therapy for Helicobacter pylori Eradication: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Deng, Jiaqi; Yan, Qiong; Yang, Chun; Xia, Guodong; Zhou, Xian

    2016-01-01

    Background Traditional Helicobacter pylori (H. pylori) eradication therapies have shown efficacies below 80% in several studies, and their use has been accompanied by antibiotic-related side effects. Some recent studies have reported that supplementing standard therapies with probiotics can improve the efficacy and tolerability of Helicobacter pylori eradication therapy. Objective To assess the effects of probiotic supplementation on the eradication rates and therapy-related adverse event rates of anti-Helicobacter pylori regimens. Methods We searched PubMed, Medline, the Cochrane Central Registry of Controlled Trials and the Chinese Biomedical Database for eligible randomized controlled trials published through July, 2015. Review Manager 5.3 was used for all statistical analyses. Results Thirteen randomized controlled trials involving a total of 2306 patients were included in our analysis. Intent-to-treat (ITT) analysis performed using a fixed-effects model (test for heterogeneity I2 = 45%) showed that the pooled relative risk (RR) of eradication was significantly higher in the probiotic supplementation group than in the control group [RR 1.15, 95% confidence interval (CI): 1.10–1.20, P<0.00001]. The incidence of total antibiotic-related side effects was lower in the probiotic supplementation group than in the control group, and the pooled RR (studies n = 9) was 0.71 (95% CI: 0.54–0.94, P = 0.02), as determined using a random-effects model (heterogeneity test I2 = 59%). Certain adverse events, such as nausea and vomiting (RR = 0.58, 95% CI 0.35–0.95, P = 0.03), diarrhea (RR = 0.51, 95% CI: 0.31–0.84, P = 0.008) and constipation (RR = 0.47, 95% CI: 0.28–0.80, P = 0.005), were reported at lower rates in the probiotic supplementation group than in the control group. Subgroup analysis showed that eradication rates were significantly improved in both adults (RR = 1.14, 95% CI: 1.09–1.19, P<0.00001) and children (RR = 1.24, 95% CI: 1.05–1.47, P = 0.01) in

  18. Measuring the Impact of a Supplemental Civic Education Program on Students' Civic Attitude and Efficacy Beliefs

    ERIC Educational Resources Information Center

    Piñgul, Ferdinand S.

    2015-01-01

    This study examines the impact of Project Citizen Philippines, an extra-classroom civic education program, on its 3rd and 4th year high school participants' civic attitude and efficacy beliefs. Three hundred forty three participants and 107 non-participants from various public high schools in the Philippines' National Capital Region were compared…

  19. Fish oil supplementation enhanced CPT-11 (irinotecan) efficacy against MCF7 breast carcinoma xenografts and ameliorated intestinal side-effects

    PubMed Central

    Hardman, W E; Moyer, M P; Cameron, I L

    1999-01-01

    The cancer chemotherapeutic efficacy of the topoisomerase I inhibitor, CPT-11 (irinotecan) is often limited by the induction of severe delayed diarrhoea. In animal studies, CPT-11 use is associated with histopathological damage to the mucosa of the small and large intestines. Results from the present study demonstrate that 60 mg CPT-11 per kg body weight (i.v. q4d × 6) halted the growth, but did not cause significant regression, of MCF7 human breast carcinoma xenografts in mice fed a diet containing 7% corn oil. However, when the diet of the MCF7-bearing mice was supplemented with 3% or 6% fish oil, the same CPT-11 treatment caused significant regression of the MCF7 xenograft. Histomorphometric analyses of intestinal mucosa of mice treated with CPT-11 and fed the diet containing 7% corn oil indicated that treatment with CPT-11 induced structural changes in the intestinal mucosa which persisted at least 5 days after the last dose of CPT-11. The intestinal mucosal architecture of mice that were treated with CPT-11 and fed the diets containing fish oil was largely unchanged from the architecture of the group of mice which did not receive CPT-11. These findings indicate that fish oil supplements may be a useful adjunct to CPT-11 treatment. © 1999 Cancer Research Campaign PMID:10507768

  20. Ascorbic acid supplementation does not improve efficacy of meso-dimercaptosuccinic acid treatment in lead-exposed suckling rats.

    PubMed

    Varnai, Veda Marija; Piasek, Martina; Blanusa, Maja; Juresa, Dijana; Sarić, Marija; Kostial, Krista

    2003-10-01

    It was suggested that ascorbic acid as a natural chelating agent can influence lead toxicokinetics and improve chelating properties of dimercaptosuccinic acid (DMSA) in adult rats. In this paper potential benefits of ascorbic acid supplementation, alone or combined with DMSA, in decreasing lead retention in suckling rats were evaluated. Such data in young mammals are not available. L-Ascorbic acid (daily dose 650 mg/kg b.wt.) and/or DMSA (daily dose 91 mg/kg b.wt.) were administered orally to suckling Wistar rats either during ongoing 8-day oral lead exposure (as acetate; daily dose 2 mg lead/kg b.wt.) or after 3-day lead exposure (total dose 12 mg lead/kg b.wt.). Lead concentrations were analysed in the carcass (skeleton), liver, kidneys and brain by atomic absorption spectrometry. By ascorbic acid supplementation lead retention was not reduced under either lead exposure condition. Lead concentration was even increased in the carcass. Treatment with DMSA under both exposure conditions significantly reduced lead in all analysed tissues. Combined treatment with ascorbic acid and DMSA during ongoing lead exposure was substantially less effective than DMSA treatment alone, and did not affect DMSA efficacy when administered after lead exposure. It was concluded that ascorbic acid administered either during or after lead exposure in suckling rats has no beneficial effect on either lead retention or DMSA chelation effectiveness.

  1. Efficacy of Systemic Vitamin C Supplementation in Reducing Corneal Opacity Resulting from Infectious Keratitis

    PubMed Central

    Cho, Yong-Wun; Yoo, Woong-Sun; Kim, Seong-Jae; Chung, In-Young; Seo, Seong-Wook; Yoo, Ji-Myong

    2014-01-01

    Abstract The objective of this study was to determine the effect of vitamin C supplementation on reducing the size of corneal opacity resulting from infectious keratitis. The study included 82 patients (82 affected eyes), admitted for infectious keratitis from January 2009 to August 2013, who were followed for more than 3 months. Patients were divided into control, oral vitamin C (3 g/d), and intravenous vitamin C (20 g/d) groups during hospitalization. Corneal opacity sizes were measured using anterior segment photographs and Image J program (version 1.27; National Institutes of Health, Jinju, South Korea) at admission, discharge, and final follow-up. The corneal opacity size used for analysis was the measured opacity size divided by the size of the whole cornea. The corneal opacity size decreased by 0.03 ± 0.10 in the oral vitamin C group, 0.07 ± 0.22 in the intravenous vitamin C group, and 0.02 ± 0.15 in the control group. Intravenous vitamin C reduced the corneal opacity size more than oral vitamin C (P = 0.043). Intravenous vitamin C produced greater reduction in corneal opacity size in younger patients (P = 0.015) and those with a hypopyon (P = 0.036). Systemic vitamin C supplementation reduced the size of corneal opacity resulting from infectious keratitis. Intravenous vitamin C was more beneficial than oral supplementation, especially in younger patients and those with hypopyon. PMID:25415664

  2. SAFETY AND EFFICACY OF HIGH DOSE DAILY VITAMIN D3 SUPPLEMENTATION IN CHILDREN AND YOUNG ADULTS WITH SICKLE CELL DISEASE

    PubMed Central

    Dougherty, Kelly A.; Bertolaso, Chiara; Schall, Joan I.; Smith-Whitley, Kim; Stallings, Virginia A.

    2015-01-01

    Suboptimal vitamin D (vitD) status (<32 ng/ml) is ubiquitous among African American children with type SS sickle cell disease (SCD-SS). The vitD supplemental dose to normalize vitD status is unknown. Five to 20-year-old African-American children with (n=21) and without (n=23) SCD-SS were randomized to vitD3 supplementation (4,000 or 7,000 IU/day) and evaluated at 6- and 12-weeks for changes in vitD and SCD status. A dose was considered unsafe if serum calcium was elevated associated with elevated serum 25 hydroxyvitamin D (25(OH)D)). At baseline 95% of subjects with SCD-SS and 87% of healthy controls had suboptimal vitD status (mean ± SD, 19.2 ± 7.2 and 22.3 ± 9.3 ng/ml, respectively). After 12-weeks supplementation, both D3 doses were safe and well tolerated. Neither group achieved the a priori efficacy criterion of 25(OH)D ≥ 32 ng/ml in >80% of subjects (45% in SCD-SS and 63% in controls). However for both subjects with SCD-SS and healthy subjects by 12-weeks, deficient (< 20 ng/ml) vitD status was eliminated only in those receiving 7,000 IU/d. For subjects with SCD-SS, by 12-weeks there was a significant (all P<0.05) increase in fetal hemoglobin, decrease in HS-CRP, and reduction in the percentage of subjects with a high platelet count. PMID:25985241

  3. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose–response double-blinded placebo-controlled randomised trial

    PubMed Central

    Shen, Chwan-Li; Mo, Huanbiao; Yang, Shengping; Wang, Shu; Felton, Carol K; Tomison, Michael D; Soelaiman, Ima Nirwana

    2016-01-01

    Introduction Osteoporosis is a major health concern in postmenopausal women, and oxidative stress contributes to the development of bone loss. Cellular studies and ovariectomised rat model mimicking bone loss in postmenopausal women show the bone-protective effect of tocotrienols (TTs) with antioxidant capability. We aim to access the safety and efficacy of TT consumption for bone health in postmenopausal women. Methods and analysis In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinary N-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2’-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. ‘Intent-to-treat’ principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ2 analysis and regression will be used for comparisons. Ethics and dissemination This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or

  4. An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.

    PubMed

    Cohen, Pieter A; Bloszies, Clayton; Yee, Caleb; Gerona, Roy

    2016-01-01

    The amphetamine isomer β-methylphenylethylamine (BMPEA) was first synthesized in the early 1930s, but its efficacy and safety in humans has not been studied. Recently, the United States Food and Drug Administration (FDA) detected BMPEA in dietary supplements labelled as containing Acacia rigidula. Over a year after the FDA reported its findings, we analyzed Acacia rigidula dietary supplements to determine if BMPEA had been removed. Supplements were analyzed using liquid chromatography-quadrupole time-of-flight mass spectrometry. Diluted methanolic extract from each supplement was run three times and each data set obtained was analyzed using Agilent MassHunter Qualitative Analysis. The presence of BMPEA was confirmed by accurate mass, retention time and mass spectra match against a reference standard. Quantification of BMPEA was determined using an eight-point calibration curve of spiked standard to a matrix blank. Twenty-one brands of Acacia rigidula supplements were analyzed. More than half (11/21; 52.4%) of the Acacia rigidula supplement brands contained BMPEA. The stimulant was present at quantities such that consumers following recommended maximum daily servings would consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd.

  5. A Bridge to Developing Efficacious Science Teachers of "All" Students: Community-Based Service-Learning Supplemented with Explicit Discussions and Activities about Diversity

    ERIC Educational Resources Information Center

    Cone, Neporcha

    2009-01-01

    This study explored the effects of community-based service-learning (CBSL), supplemented with discussions and activities about diversity, on the self-efficacy beliefs of preservice elementary teachers regarding equitable science teaching and learning for diverse student groups. The study was conducted with 81 preservice teachers enrolled in four…

  6. 76 FR 20435 - Notice of Approval of the Supplemental Finding of No Significant Impact and Record of Decision...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-12

    ... Environmental Assessment (EA) for changes proposed to the construction of a new land-based airport in Akutan, AK... and Record of Decision for the Supplemental Environmental Assessment (EA) for Proposed Changes to the Construction of a New Land- Based Airport in Akutan, AK AGENCY: Federal Aviation Administration...

  7. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... Application; Penicillin G Procaine Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Notice... for a revised formulation of penicillin G procaine injectable suspension that includes lecithin as a... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G...

  8. Sago supplementation for exercise performed in a thermally stressful environment: Rationale, efficacy and opportunity

    PubMed Central

    Che Jusoh, Mohd Rahimi; Stannard, Stephen R.; Mündel, Toby

    2016-01-01

    ABSTRACT Sago (Metroxylin sagu), a carbohydrate (CHO) based dietary staple of Southeast Asia is easily digestible and quickly absorbed, and thus has potential to be prescribed as an affordable pre-and post-exercise food in this part of the world. Compared to other CHO staples, research into the physiological response to sago ingestion is sparse, and only a few recent studies have investigated its value before, during, and after exercise. The purpose of this review is to describe the published literature pertaining to sago, particularly as a supplement in the peri-exercise period, and suggest further avenues of research, principally in an environment/climate which would be experienced in Southeast Asia i.e. hot/humid. PMID:28349080

  9. Confiscated black market products and nutritional supplements with non-approved ingredients analyzed in the Cologne Doping Control Laboratory 2009.

    PubMed

    Kohler, Maxie; Thomas, Andreas; Geyer, Hans; Petrou, Michael; Schänzer, Wilhelm; Thevis, Mario

    2010-01-01

    Doping control laboratories are frequently confronted with new substances that may be misused by athletes. Besides new pharmaceuticals, where method development for their detection is dependent on the availability of the substance and corresponding administration studies, some professional and amateur athletes are using illicit 'black market' products, which either differ from known pharmaceuticals but cause similar effects or still are undergoing clinical trials and are therefore rarely available to doping control laboratories. In the Cologne Doping Control Laboratory, different confiscated products and legally obtained nutritional supplements were analyzed in 2009, and various findings were reported including GH-labelled injection vials without any pharmacologically active content; combinations of products indicating the attempt to mask growth hormone abuse; unpurified long-R(3) -IGF-1; nutritional supplements containing the growth hormone releasing peptide-2 (GHRP-2); and ampoules containing the selective androgen receptor modulator Andarine (S-4). This review provides an overview on the substances that were analyzed in 2009. Ingredients relevant for doping control were identified by means of liquid chromatography and mass spectrometry methods. The awareness of new products on the black market and in nutritional supplements is of utmost importance for laboratories to develop detection methods accordingly and screen for new substances as early as possible.

  10. Efficacy and safety of fortification and supplementation with vitamin B12: biochemical and physiological effects.

    PubMed

    Carmel, Ralph

    2008-06-01

    Long known as an uncommon but serious medical disorder requiring medical management, vitamin B12 deficiency is now seen to be common worldwide, but it is in a quite different form than traditionally envisioned. Most of the newly recognized deficiency is subclinical in nature, its health impact and natural history are uncertain, and its prevalence has been greatly inflated by also including persons with "low-normal" vitamin B12 levels, few of whom are deficient. The spread of folic acid fortification has also introduced concerns about folate's potentially adverse neurologic consequences in persons with undetected vitamin B12 deficiency. Fortification with vitamin B12 may prove more complicated than fortification with folic acid, however, because the bioavailability of vitamin B12 is limited. Bioavailability for those who need the vitamin B12 the most is especially poor, because they often have malabsorption affecting either classical intrinsic factor-mediated absorption or food-vitamin B12 absorption. Moreover, new evidence shows that many elderly persons respond poorly to daily oral doses under 500 microg (1 microg = 0.74 nmol), even if they do not have classical malabsorption, which suggests that proposed fortification with 1 to 10 microg may be ineffective. Those least in need of vitamin B12 usually have normal absorption and are thus at greatest risk for whatever unknown adverse effects of high-dose fortification might emerge, such as the effects of excess accumulation of cyanocobalamin. Studies are needed to define the still unproven health benefits of vitamin B12 fortification, the optimal levels of fortification, the stability of such fortification, interactions with other nutrients, and any possible adverse effects on healthy persons. The answers will permit formulation of appropriately informed decisions about mandatory fortification or (because fortification may prove a poor choice) about targeted supplementation in subpopulations with special needs for

  11. Efficacy of vitamins B supplementation on mild cognitive impairment and Alzheimer's disease: a systematic review and meta-analysis.

    PubMed

    Li, Meng-Meng; Yu, Jin-Tai; Wang, Hui-Fu; Jiang, Teng; Wang, Jun; Meng, Xiang-Fei; Tan, Chen-Chen; Wang, Chong; Tan, Lan

    2014-01-01

    Despite B vitamin supplementation playing an important role in cognitive function, the exact effect remains unknown. The aim of this study was to systematically review and quantitatively synthesize the efficacy of treatment with vitamins B supplementation in slowing the rate of cognitive, behavioral, functional and global decline in individuals with MCI or AD. A systematic literature search in PubMed, EMBASE, International Pharmaceutical Abstracts, clinicaltrials. gov, the Cochrane Controlled Trials Register, the Cochrane Database of Systematic Reviews, and the Cochrane Cognitive Improvement Group specialized registry was conducted on April 2014, with no limit of date. Five trials met the eligibility criteria and were selected for this meta-analysis. Meta-analysis showed moderate beneficial effects of vitamins B supplementation on memory (SMD 0.60, 95% CI 0.20, 1.00), whereas no significant difference on general cognitive function (WMD -0.10, 95% CI -0.80, 0.59), executive function (SMD 0.05, 95% CI -0.11, 0.21) and attention (WMD -0.03, 95% CI -1.20, 1.14) were found in MCI patients. In addition, no significantly cognitive benefits on the Alzheimer's Disease Assessment Scale (ADAS-cog) (WMD 1.01, 95% CI -0.68, 2.70) and Mini Mental State Examination (MMSE) (WMD -0.22, 95% CI -1.00, 0.57), functional (SMD 0.13, 95% CI -0.05, 0.31), behavioral (SMD 0.04, 95% CI -0.16, 0.25) or global (WMD 0.07, 95% CI -0.48, 0.62) change were observed in AD patients. Collectively, weak evidence of benefits was observed for the domains of memory in patients with MCI. Nevertheless, future standard RCTs are still needed to determine whether it was still significant in larger populations. However, the data does not yet provide adequate evidence of an effect of vitamins B on general cognitive function, executive function and attention in people with MCI. Similarly, folic acid alone or vitamins B in combination are unable to stabilize or slow decline in cognition, function, behavior, and

  12. Efficacy of supplementation of selected medicinal mushrooms with inorganic selenium salts.

    PubMed

    Niedzielski, Przemysław; Mleczek, Mirosław; Siwulski, Marek; Gąsecka, Monika; Kozak, Lidia; Rissmann, Iwona; Mikołajczak, Patrycja

    2014-01-01

    The aim of the study was to evaluate the possibility of supplementation with inorganic forms of selenium (Na2SeO4 and Na2SeO3) in concentrations of 0, 0.1, 0.2, 0.4, 0.6, 0.8, 1.0 and 1.5 mM of three medicinal mushroom species: Agrocybe aegerita, Hericium erinaceus and Ganoderma lucidum. Tested mushroom species grew in Se additions of 0-0.6 mM (A. aegerita and H. erinaceus), while growth of G. lucidum bodies was observed for 0-0.8 mM. For the latter mushroom species, the total Se content was the highest. Content of Seorg was diverse; for control bodies it was the highest for G. lucidum (only organic forms were present), lower for A. aegerita (84% organic forms) and the lowest for H. erinaceus (56% organic forms). Accumulation of Se(IV) was generally significantly higher than Se(VI) for all tested mushroom species. There was no significant decrease of A. aegerita or G. lucidum biomass with the exception of G. lucidum bodies growing under 0.8 mM of Se species addition (15.51 ± 6.53 g). Biomass of H. erinaceus bodies was the highest under 0.2 (197.04 ± 8.73 g), control (191.80 ± 6.06 g) and 0.1 mM (185.04 ± 8.73 g) of both inorganic salts. The addition to the medium of Se salts brought about macroscopic changes in the fruiting bodies of the examined mushrooms. Concentrations exceeding 0.4 mM caused diminution of carpophores or even their total absence. In addition, colour changes of fruiting bodies were also recorded. At Se concentrations of 0.4 and 0.6 mM, A. aegerita fruiting bodies were distinctly lighter and those of H. erinaceus changed colour from purely white to white-pink.

  13. Efficacy of phytosterols and fish-oil supplemented high-oleic-sunflower oil rich diets in hypercholesterolemic growing rats.

    PubMed

    Alsina, Estefania; Macri, Elisa V; Lifshitz, Fima; Bozzini, Clarisa; Rodriguez, Patricia N; Boyer, Patricia M; Friedman, Silvia M

    2016-06-01

    Phytosterols (P) and fish-oil (F) efficacy on high-oleic-sunflower oil (HOSO) diets were assessed in hypercholesterolemic growing rats. Controls (C) received a standard diet for 8 weeks; experimental rats were fed an atherogenic diet (AT) for 3 weeks, thereafter were divided into four groups fed for 5 weeks a monounsaturated fatty acid diet (MUFA) containing either: extra virgin olive oil (OO), HOSO or HOSO supplemented with P or F. The diets did not alter body weight or growth. HOSO-P and HOSO-F rats showed reduced total cholesterol (T-chol), non-high-density lipoprotein-cholesterol (non-HDL-chol) and triglycerides and increased HDL-chol levels, comparably to the OO rats. Total body fat (%) was similar among all rats; but HOSO-F showed the lowest intestinal, epididymal and perirenal fat. However, bone mineral content and density, and bone yield stress and modulus of elasticity were unchanged. Growing hypercholesterolemic rats fed HOSO with P or F improved serum lipids and fat distribution, but did not influence material bone quality.

  14. A Bridge to Developing Efficacious Science Teachers of All Students: Community-Based Service-Learning Supplemented with Explicit Discussions and Activities about Diversity

    NASA Astrophysics Data System (ADS)

    Cone, Neporcha

    2009-08-01

    This study explored the effects of community-based service-learning (CBSL), supplemented with discussions and activities about diversity, on the self-efficacy beliefs of preservice elementary teachers regarding equitable science teaching and learning for diverse student groups. The study was conducted with 81 preservice teachers enrolled in four sections of an elementary science methods course over a semester. Employing a mixed-methods research design, data were collected using pretests-posttests with the study sample and semistructured interviews with a subsample. The results support the value of preservice teachers engaging in CBSL experiences, supplemented with discussions and activities about diversity, as a way to improve their self-efficacy beliefs regarding equitable science teaching and learning of all students.

  15. Efficacy of vitamin and antioxidant supplements in prevention of cardiovascular disease: systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Ju, Woong; Oh, Seung-Won; Park, Sang Min; Koo, Bon-Kwon; Park, Byung-Joo

    2013-01-01

    Objective To assess the efficacy of vitamin and antioxidant supplements in the prevention of cardiovascular diseases. Design Meta-analysis of randomised controlled trials. Data sources and study selection PubMed, EMBASE, the Cochrane Library, Scopus, CINAHL, and ClinicalTrials.gov searched in June and November 2012. Two authors independently reviewed and selected eligible randomised controlled trials, based on predetermined selection criteria. Results Out of 2240 articles retrieved from databases and relevant bibliographies, 50 randomised controlled trials with 294 478 participants (156 663 in intervention groups and 137 815 in control groups) were included in the final analyses. In a fixed effect meta-analysis of the 50 trials, supplementation with vitamins and antioxidants was not associated with reductions in the risk of major cardiovascular events (relative risk 1.00, 95% confidence interval 0.98 to 1.02; I2=42%). Overall, there was no beneficial effect of these supplements in the subgroup meta-analyses by type of prevention, type of vitamins and antioxidants, type of cardiovascular outcomes, study design, methodological quality, duration of treatment, funding source, provider of supplements, type of control, number of participants in each trial, and supplements given singly or in combination with other supplements. Among the subgroup meta-analyses by type of cardiovascular outcomes, vitamin and antioxidant supplementation was associated with a marginally increased risk of angina pectoris, while low dose vitamin B6 supplementation was associated with a slightly decreased risk of major cardiovascular events. Those beneficial or harmful effects disappeared in subgroup meta-analysis of high quality randomised controlled trials within each category. Also, even though supplementation with vitamin B6 was associated with a decreased risk of cardiovascular death in high quality trials, and vitamin E supplementation with a decreased risk of myocardial infarction

  16. Evaluation Series on Safety and Efficacy of Nutritional Supplements in Newly Diagnosed Hyperglycemia: A Placebo-Controlled, Randomized Study

    PubMed Central

    Thacker, Hemant; Bantwal, Ganapati; Jain, Sunil; Kalra, Sanjay; Kale, Shailaja; Saboo, Banshi; Gupta, Jugal B.; Sivam, Sakthivel

    2016-01-01

    Background: Diabetes is endemic with developing economies contributing to the bulk of this pandemic. Despite the evidence of incremental benefit of glycemic control starting early in life, acceptance of and adherence to modern medications remain suboptimal. Aims: To determine the hemoglobin A1c (HbA1c)-lowering efficacy and safety of nutritional supplement, PreCrea®, in adult Indians with newly diagnosed hyperglycemia. Materials and Methods: Double-blind, randomized study conducted in six diabetes centers in India. A total of 193 treatment-naïve subjects with newly diagnosed hyperglycemia and fasting plasma glucose (FPG) >100 mg/dL were randomized into either PreCrea® 600 mg (n = 90) or matched placebo (n = 89) capsules twice daily, along with lifestyle modification, for 12 weeks. The main outcomes were changes in HbA1c and FPG levels, attainment of the American Diabetes Association (ADA)-defined goals for HbA1c, and clinical and biochemical measures of safety. Results: At 12 weeks, mean HbA1c in PreCrea® group reduced by 0.91% compared with 0.08% increase in the placebo group (P < .001). The reductions in the mean FPG at week 4 (P < .001) and week 12 (P = 0.04) were significant compared to the baseline. ADA goal of HbA1c <7% increased from 15.5% at the baseline to 35.6% at week 12 in PreCrea® subjects. Clinical safety and biochemical safety did not change. Hypoglycemia and weight gain were not observed with PreCrea®. Conclusions: Nearly 1% point reduction in HbA1c at week 12 with PreCrea® is comparable with most first-line glucose-lowering drugs. The safety and tolerability of PreCrea® highlights its potential as a first-line therapy in newly detected hyperglycemia. PMID:27042609

  17. Smear layer removal efficacy of combination of herbal extracts in two different ratios either alone or supplemented with sonic agitation: An in vitro scanning electron microscope study

    PubMed Central

    Chhabra, Naveen; Gyanani, Hitesh; Kamatagi, Laxmikant

    2015-01-01

    Objectives: The study aimed to evaluate the effectiveness of the combination of two natural extracts in varying ratios for removal of smear layer either alone or supplemented with sonic agitation. Materials and Methods: Fifty extracted single-rooted teeth were collected, disinfected and decoronated below the cementoenamel junction to obtain standardized root length of 10 mm. Root canals were instrumented using rotary files at working length 1 mm short of the apex. Specimens were divided into six groups according to the irrigation protocol as follows: Group A – Distilled water, Group B – 17% ethylenediaminetetraacetic acid, Group C – Herbal extracts in 1:1 ratio, Group D – Herbal extracts in 1:1 ratio supplemented with sonic agitation, Group E – Herbal extracts in 2:1 ratio, Group F – Herbal extracts in 2:1 ratio supplemented with sonic agitation. Specimens were longitudinally sectioned and evaluated under scanning electron microscope for smear layer removal efficacy. Obtained scores were statistically analyzed using one-way analysis of variance and post-hoc test. Results: Among all, Group B showed the best results followed by Group F. Remaining other groups showed inferior outcome (P < 0.05). Conclusion: The combination of two extracts in 2:1 ratio was slightly better than 1:1 ratio and the smear layer removal efficacy was further improved when accompanied with sonic agitation. PMID:26430300

  18. Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials

    PubMed Central

    Strand, Vibeke; McIntyre, Louis F; Beach, William R; Miller, Larry E; Block, Jon E

    2015-01-01

    Background Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA). The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA. Methods We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up. Results A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193) were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001). Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P<0.001). There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: −0.2 to 1.5%) for serious adverse events, 0% (95% CI: −0.4 to 0.4%) for treatment-related serious adverse events, 0% (95% CI: −1.6 to 1.6%) for patient withdrawal, and 0.2% (95% CI: −0.4 to 0.8%) for adverse event-related patient withdrawal. Conclusion Intra-articular injection of US-approved viscosupplements is safe and efficacious through 26 weeks in patients with symptomatic knee OA. PMID:26005358

  19. Drugs, Herbs and Supplements: MedlinePlus

    MedlinePlus

    ... this page: https://medlineplus.gov/druginformation.html Drugs, Herbs and Supplements To use the sharing features on ... approved labels included in drug packages, see DailyMed . Herbs and Supplements Browse dietary supplements and herbal remedies ...

  20. The effect of prebiotic supplementation with inulin on cardiometabolic health: Rationale, design, and methods of a controlled feeding efficacy trial in adults at risk of type 2 diabetes.

    PubMed

    Mitchell, Cassie M; Davy, Brenda M; Halliday, Tanya M; Hulver, Mathew W; Neilson, Andrew P; Ponder, Monica A; Davy, Kevin P

    2015-11-01

    Prediabetes is associated with low-grade chronic inflammation that increases the risk for developing type 2 diabetes (T2D) and cardiovascular disease (CVD). An elevated lipopolysaccharide concentration, associated with dysbiosis of the intestinal microbiota, has been implicated in the development of both T2D and CVD. Selective modulation of the intestinal microbiota with prebiotics reduces intestinal permeability and endotoxin concentrations, inflammation, and metabolic dysfunction in rodents. The effect of prebiotic supplementation on cardio-metabolic function in humans at risk for T2D is not known. The primary aim of this trial is to determine the influence of prebiotic supplementation with inulin on insulin sensitivity and skeletal muscle metabolic flexibility in adults at risk for T2D. We hypothesize that prebiotic supplementation with inulin will improve insulin sensitivity and skeletal muscle metabolic flexibility. We will randomize 48 adults (40-75 yrs) with prediabetes or a score ≥ 5 on the American Diabetes Association (ADA) risk screener to 6 weeks of prebiotic supplementation with inulin (10 g/day) or placebo. Subjects will be provided with all food for the duration of the study, to avoid potential confounding through differences in dietary intake between individuals. Intestinal permeability, serum endotoxin concentrations, insulin sensitivity, skeletal muscle metabolic flexibility, endothelial function, arterial stiffness, and fecal bacterial composition will be measured at baseline and following treatment. The identification of prebiotic supplementation with inulin as an efficacious strategy for reducing cardio-metabolic risk in individuals at risk of T2D could impact clinical practice by informing dietary recommendations and increasing acceptance of prebiotics by the scientific and medical community.

  1. The Effect of Prebiotic Supplementation with Inulin On Cardiometabolic Health: Rationale, Design, and Methods Of A Controlled Feeding Efficacy Trial in Adults at Risk of Type 2 Diabetes

    PubMed Central

    Mitchell, Cassie M.; Davy, Brenda M.; Halliday, Tanya M.; Hulver, Mathew W.; Neilson, Andrew P.; Ponder, Monica A.; Davy, Kevin P.

    2015-01-01

    Prediabetes is associated with low-grade chronic inflammation that increases the risk for developing type 2 diabetes (T2D) and cardiovascular disease (CVD). An elevated lipopolysaccharide concentration, associated with dysbiosis of the intestinal microbiota, has been implicated in the development of both T2D and CVD. Selective modulation of the intestinal microbiota with prebiotics reduces intestinal permeability and endotoxin concentrations, inflammation, and metabolic dysfunction in rodents. The effect of prebiotic supplementation on cardio-metabolic function in those at risk for T2D is not known. The primary aim of this trial is to determine the influence of prebiotic supplementation with inulin on insulin sensitivity and skeletal muscle metabolic flexibility in adults at risk for T2D. We hypothesize that prebiotic supplementation with inulin will improve insulin sensitivity and skeletal muscle metabolic flexibility. We will randomize 48 adults (40–75 yrs) with prediabetes or a score ≥5 on the American Diabetes Association (ADA) risk screener to 6 weeks of prebiotic supplementation with inulin (10 g/day) or placebo. Subjects will be provided with all food for the duration of the study, to avoid potential confounding through differences in dietary intake between individuals. Intestinal permeability, serum endotoxin concentrations, insulin sensitivity, skeletal muscle metabolic flexibility, endothelial function, arterial stiffness, and fecal bacterial composition will be measured at baseline and following treatment. The identification of prebiotic supplementation with inulin as an efficacious strategy for reducing cardio-metabolic risk in individuals at risk of T2M could impact clinical practice by informing dietary recommendations and increasing acceptance of prebiotics by the scientific and medical community. PMID:26520413

  2. Effect of Medicinal Plant By-products Supplementation to Total Mixed Ration on Growth Performance, Carcass Characteristics and Economic Efficacy in the Late Fattening Period of Hanwoo Steers

    PubMed Central

    Lee, S. J.; Kim, D. H.; Guan, Le Luo; Ahn, S. K.; Cho, K. W.; Lee, Sung S.

    2015-01-01

    This study was conducted to evaluate the effect of medicinal plant by-products (MPB) supplementation to a total mixed ration (TMR) on growth, carcass characteristics and economic efficacy in the late fattening period of Hanwoo steers. Twenty seven steers (body weight [BW], 573±57 kg) were assigned to 3 treatment groups so that each treatment based on BW contained 9 animals. All groups received ad libitum TMR throughout the feeding trial until slaughter (from 24 to 30 months of age) and treatments were as follows: control, 1,000 g/kg TMR; treatment 1 (T1), 970 g/kg TMR and 30 g/kg MPB; treatment 2 (T2), 950 g/kg TMR and 50 g/kg MPB. Initial and final BW were not different among treatments. Resultant data were analyzed using general linear models of SAS. Average daily gain and feed efficiency were higher (p<0.05) for T1 than control, but there was no difference between control and T2. Plasma albumin showed low-, intermediate- and high-level (p<0.05) for control, T1 and T2, whereas non-esterified fatty acid was high-, intermediate- and high-level (p<0.05) for control, T1 and T2, respectively. Carcass weight, carcass rate, backfat thickness and rib eye muscle area were not affected by MPB supplementation, whereas quality and yield grades were highest (p<0.05) for T1 and T2, respectively. Daily feed costs were decreased by 0.5% and 0.8% and carcass prices were increased by 18.1% and 7.6% for T1 and T2 compared to control, resulting from substituting TMR with 30 and 50 g/kg MPB, respectively. In conclusion, the substituting TMR by 30 g/kg MPB may be a potential feed supplement approach to improve economic efficacy in the late fattening period of Hanwoo steers. PMID:26580440

  3. Review of the safety and efficacy of vitamin A supplementation in the treatment of children with severe acute malnutrition

    Technology Transfer Automated Retrieval System (TEKTRAN)

    World Health Organization (WHO) guidelines recommend for children with severe acute malnutrition (SAM), high-dose vitamin A (VA) supplements be given on day 1 of admission, and on days 2 and 14 in the case of clinical signs of vitamin A deficiency (VAD). Daily low-dose VA follows, delivered in a pre...

  4. An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study

    PubMed Central

    Nichols, Anna J.; Hughes, Olivia Bosshardt; Canazza, Agnese

    2017-01-01

    Objective: To evaluate the effectiveness of a novel oral supplement, Forti5®, containing green tea extract, omega 3 and 6 fatty acids, cholecalciferol, melatonin, beta-sitosterol, and soy isoflavones, and in the management of subjects with androgenetic alopecia. Design: A prospective case series of 10 subjects. Setting: Open-label, evaluator-blinded, proof-of-concept study. Participants: Ten adult subjects with androgenetic alopecia completed the study. Subjects were not allowed to use oral or topical hair growth products in the 24 weeks preceding the study or during the study. The nutritional supplement was administered at a dosage of two tablets daily for 24 weeks. Measurements: Clinical evaluations were performed at baseline and at 24 weeks. Efficacy was evaluated using hair mass index measured by cross section trichometer, terminal hair count measured with dermoscopy and Investigator Global Photography Assessment. Results: Overall 80 percent of subjects (8/10) were rated as improved after 24 weeks of supplementation (mean change of +1.4 equivalent to slightly-to-moderately increased). Forty percent of subjects (4/10) were rated as moderately improved (2+), and 10 percent (1/10) were rated as greatly improved (3+). There was a significant improvement in terminal hair count (mean increase of 5.9% or 4.2 more terminal hairs in the area examined, p=0.014) and in Hair Mass Index (mean increase of 9.5% or 4.5 higher Hair Mass Index, p=0.003). Conclusion: These preliminary results indicate that Forti5® a novel nutritional supplement that contains cholecalciferol, omega 3 and 6 fatty acids, melatonin, antioxidants, and botanical 5-alpha reductase inhibitors, may be a useful adjunct in the treatment of androgenetic alopecia. PMID:28367262

  5. Basis for regulation of selenium supplements in animal diets.

    PubMed

    Ullrey, D E

    1992-12-01

    Selenium was discovered 174 yr ago but, until 1957, was given little notice by biologists or was vilified as an agent that caused toxicity in grazing ruminants and horses in the northern Great Plains. After its status as an essential nutrient was established, Se received intense scrutiny, and hundreds of papers have been published dealing with its metabolic functions and the consequences of a Se deficiency. Because regions of Se deficiency are so extensive in the United States, great efforts have been made to gain Food and Drug Administration (FDA) approval for Se supplementation of animal diets. Initially, these efforts were thwarted by concern that Se might be carcinogenic. After this concern was resolved, researchers established supplemental Se levels that were efficacious, safe for animals, safe for humans that eat animal products, and protective of the environment. First approval of Se supplements was given in 1974 for supplementation of swine or growing chicken diets at .1 ppm. Supplements for turkey diets were approved at .2 ppm. Ultimately, in 1987, levels of supplemental Se in diets for chickens, turkeys, ducks, swine, sheep, and cattle were approved at .3 ppm. However, FDA regulations do not mention horses or zoo animals, and those who would ensure the welfare of these species by supplementing Se-deficient diets may be in violation of FDA interpretation of the law. In addition, the association of Se with death and deformities in aquatic birds at the Kesterson Reservoir in California has led to pressure on the FDA to reverse the 1987 amendments to the feed additive regulation.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. The relationship between maternal self-efficacy, compliance and outcome in a trial of vitamin D supplementation in pregnancy.

    PubMed

    Barker, M; D'Angelo, S; Ntani, G; Lawrence, W; Baird, J; Jarman, M; Vogel, C; Inskip, H; Cooper, C; Harvey, N C

    2017-01-01

    In a randomised controlled trial of vitamin D during pregnancy, we demonstrated that women with lower self-efficacy were more likely to experience practical problems with taking the trial medication and that this was associated with lower compliance and achieved 25(OH)-vitamin D concentrations.

  7. A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation

    PubMed Central

    Manfrini, Enrico; Ferri, Emanuele; La Ferla, Barbara; Schiano, Irene; Michelotti, Angela; Nobile, Vincenzo

    2016-01-01

    Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219. PMID:27595104

  8. Efficacy of Enteral Supplementation Enriched with Glutamine, Fiber, and Oligosaccharide on Mucosal Injury following Hematopoietic Stem Cell Transplantation

    PubMed Central

    Iyama, Satoshi; Sato, Tsutomu; Tatsumi, Hiroomi; Hashimoto, Akari; Tatekoshi, Ayumi; Kamihara, Yusuke; Horiguchi, Hiroto; Ibata, Soushi; Ono, Kaoru; Murase, Kazuyuki; Takada, Kohichi; Sato, Yasushi; Hayashi, Tsuyoshi; Miyanishi, Koji; Akizuki, Emi; Nobuoka, Takayuki; Mizugichi, Toru; Takimoto, Rishu; Kobune, Masayoshi; Hirata, Koichi; Kato, Junji

    2014-01-01

    The combination of glutamine, fiber and oligosaccharides (GFO) is thought to be beneficial for alleviating gastrointestinal mucosal damage caused by chemotherapy. A commercial enteral supplementation product (GFO) enriched with these 3 components is available in Japan. We performed a retrospective study to test whether oral GFO decreased the severity of mucosal injury following hematopoietic stem cell transplantation (HSCT). Of 44 HSCT patients, 22 received GFO and 22 did not. Severity of diarrhea/mucositis, overall survival, weight loss, febrile illness/documented infection, intravenous hyperalimentation days/hospital days, engraftment, acute and chronic GVHD, and cumulative incidence of relapse were studied. Sex, age, performance status, diagnosis, disease status, and treatment variables were similar in both groups. There were fewer days of diarrhea grade 3–4 in patients receiving GFO than in those who did not (0.86 vs. 3.27 days); the same was true for days of mucositis grade 3–4 (3.86 vs. 6.00 days). Survival at day 100 was 100% in the GFO group, but only 77.3% for the patients not receiving GFO (p = 0.0091, log-rank test). Weight loss and the number of days of intravenous hyperalimentation were better in the GFO group (p < 0.001 and p = 0.0014, respectively). Although not significant, less gut bacterial translocation with Enterococcus species developed in the GFO group (p = 0.0728) than in the non-GFO group. Other outcomes were not affected. To the best of our knowledge, this is the first comparative clinical study of GFO supplementation to alleviate mucosal injury after allo-HSCT. We conclude that glutamine, fiber and oligosaccharide supplementation is an effective supportive therapy to decrease the severity of mucosal damage in HSCT. PMID:25493082

  9. Soaking increases the efficacy of supplemental microbial phytase in a low-phosphorus corn-soybean meal diet for growing pigs.

    PubMed

    Liu, J; Bollinger, D W; Ledoux, D R; Ellersieck, M R; Veum, T L

    1997-05-01

    Sixty-three crossbred barrows averaging 18.7 kg initial BW were used in a 6-wk study of the effects of soaking on the efficacy of supplemental microbial phytase (Natuphos, BASF) in a low-P corn-soybean meal diet. The basal corn-soybean meal diet contained .06% available P, .32% total P, and .55% Ca with no added inorganic P. The basal diet was supplemented with 0, 250, or 500 phytase units (PU)/kg of diet. The diet was fed dry or soaked (2 parts water:1 part diet and mixed for 2 h at 30 degrees C before feeding) in a 3 x 2 factorial arrangement. A positive control diet was supplemented with inorganic P and provided .23% available P, .48% total P, and .60% Ca. Pigs were individually penned and fed their respective diets to appetite in four equal meals daily. There were no soaking x phytase interactions (P > .1 to .6) for growth performance criteria. Daily gain and gain/feed ratio were increased (P < .01) by soaking and increased linearly (P < .01) by phytase. Daily feed intake was increased linearly (P < .01) by phytase. There were soaking x phytase quadratic interactions (P < .01) for apparent P absorption criteria because soaking the 250 PU/kg diet increased P absorption similar to that obtained with the 500 PU/kg diet fed dry. Apparent P absorption criteria were increased by soaking (P < .01) and were increased linearly (P < .001) and quadratically (P < .03) by phytase. Phytase reduced fecal P excretion 37 to 40% with dry feeding (P < .03) and 48 to 49% with soaking (P < .01).

  10. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial

    PubMed Central

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-01-01

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism. PMID:27338456

  11. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial.

    PubMed

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-06-07

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism.

  12. 7 CFR 1710.110 - Supplemental financing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... supplemental financing according to their plant revenue ratio (PRR), as defined in § 1710.2, based on the most recent year-end data available on the date of loan approval, as follows: PRR Supplemental loan...

  13. Efficacy of growth hormone supplementation with gonadotrophins in vitro fertilization for poor ovarian responders: an updated meta-analysis

    PubMed Central

    Yu, Xiaoying; Ruan, Jian; He, Lian-Ping; Hu, Weihua; Xu, Qinyang; Tang, Jingwen; Jiang, Jian; Han, Jun; Peng, Yi-Feng

    2015-01-01

    Growth hormone (GH) is involved in the regulation of male and female infertility. Several clinical studies reveal that adjuvant GH treatment has a possible role in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), especially in poor ovarian responders (POR) undergoing IVF/ICSI. Recent studies suggest that GH addition in POR patients significantly improves the rate of clinical pregnancy and live birth. Databases including PubMed, Embase, the Cochrane Central China National Knowledge Infrastructure (CNKI) and Google Scholar were searched for randomized controlled trials (RCTs) or controlled clinical trials (CCTs) on the effectiveness of GH supplementation with gonadotrophins in IVF/ICSI for POR. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality. Meta Analyst Beta 3.13 software was used to meta-analysis. Eleven studies (six RCTs and five CCTs) and 3788 subjects (613 subjects in cases group and 3175 subjects in controls group) were included in our study. The results of meta-analysis showed that GH addition significantly increased serum E2 level on the day of HCG (OR = 0.55; 95% CI = 0.127-0.973) and MII oocyte number (OR = 0.827; 95% CI = 0.470-1.184). Furthermore, GH addition significantly improved the number of 2PN (OR = 0.934; 95% CI = 0.206-1.661) and obtained embryos (OR = 0.934; 95% CI = 0.206-1.661). However, no significant difference was found for the overall implantation rate was 8.8% (95% CI = -0.062-0.237) and clinical pregnancy rate was 5.1% (95% CI = -0.033-0.134). The present result revel that GH supplementation for IVF/ICSI in POR increases the probability of serum E2 level on the day of HCG, the number of MII oocyte, 2PN and obtained embryos. However, GH addition does not increase implantation rate and clinical pregnancy rates. Due to the limited quantity and quality of the included studies as well as the difference in methodology, we

  14. Emerging Supplements in Sports

    PubMed Central

    Mason, Bryan C.; Lavallee, Mark E.

    2012-01-01

    Context: Nutritional supplements advertised as ergogenic are commonly used by athletes at all levels. Health care professionals have an opportunity and responsibility to counsel athletes concerning the safety and efficacy of supplements on the market. Evidence Acquisition: An Internet search of common fitness and bodybuilding sites was performed to identify supplement promotions. A search of MEDLINE (2000–August, 2011) was performed using the most commonly identified supplements, including glutamine, choline, methoxyisoflavone, quercetin, zinc/magnesium aspartate, and nitric oxide. The search terms supplement, ergogenic aid, and performance were also used. Results: Six common and newer supplements were identified, including glutamine, choline, methoxyisoflavone, quercetin, zinc/magnesium aspartate, and nitric oxide. Conclusions: Controlled studies have not determined the effects of these supplements on performance in athletes. Scientific evidence is not available to support the use of these supplements for performance enhancement. PMID:23016081

  15. Efficacy of an Exercise and Nutritional Supplement Program on Physical Performance and Nutritional Status in Older Adults With Mobility Limitations Residing at Senior Living Facilities.

    PubMed

    Corcoran, Michael P; Nelson, Miriam E; Sacheck, Jennifer M; Reid, Kieran F; Kirn, Dylan; Fielding, Roger A; Chui, Kenneth K H; Folta, Sara C

    2017-01-17

    This cluster-randomized trial was designed to determine the efficacy of a 6-month exercise-nutritional supplement program (ENP) on physical function and nutritional status for older adults and the feasibility of implementing this program in a senior living setting. Twenty senior living facilities were randomized to either a three day per week group-based ENP led by a trained facility staff member or a health education program (SAP). Participants (N=121) completed a short physical performance battery, 400 meter walk, handgrip strength test, and mini-nutrition assessment. 25-hydroxyvitamin D [25(OH)D], Insulin-like growth-factor 1 (IGF-1) and activity level were also measured. The ENP did not significantly improve physical function or nutritional status compared with the SAP. Compared with baseline, participants in the ENP engaged in 39 minutes less physical activity per week at 6-months. Several facility characteristics hindered implementation of the ENP. This study highlights the complexity of implementing an evidence-based program in a field setting.

  16. P30 Cancer Center Support Grant Administrative Supplements to support NCI Approved Clinical Trial Proposals from NCI-designated Cancer Centers not affiliated with the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) for Investigator-Initiated Trials Utilizing CTEP IND agents in the ETCTN

    Cancer.gov

    P30 Cancer Center Support Grant Administrative Supplements to support NCI Approved Clinical Trial Proposals from NCI-designated Cancer Centers not affiliated with the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) for Investigator-Initiated Trials Utilizing CTEP IND agents in the ETCTN

  17. Efficacy and safety of Vitamin D supplementation during pregnancy: A randomized trial of two different levels of dosing on maternal and neonatal Vitamin D outcome

    PubMed Central

    Mir, Shahnaz Ahmad; Masoodi, Shariq Rashid; Shafi, Shafia; Hameed, Iqra; Dar, Maqsood Ahmad; Bashir, Mir Iftikhar; Wani, Arshad Iqbal; Shah, Zaffar Amin; Parveen, Shameema; Zargar, Abdul Hamid; Shah, Parviz Ahmad

    2016-01-01

    Introduction: Pregnant women represent a typical group susceptible to dietary and mineral deficiencies. This study was sought to assess the efficacy and safety of various doses of 25-hydroxyvitamin D (25[OH]D) supplementation during pregnancy and ratify the inadequacy of the recommended daily allowance for Vitamin D in vulnerable groups. Materials and Methods: A total of 100 pregnant women were included in this open-label, parallel group, prospective, randomized, and controlled trial. Study subjects were assigned to four treatment groups: Group 1 (n = 26), 1000 IU of Vitamin D daily; Group 2 (n = 21), 30,000 IU of Vitamin D monthly; Group 3 (n = 27), 2000 IU of Vitamin D daily; and Group 4 (n = 26), 60,000 IU Vitamin D monthly. Group 1 and 2 were further analyzed together as Group 1K (1000 IU daily and 30,000 IU monthly), and Group 3 and 4 as Group 2K (2000 IU daily and 60,000 IU monthly). The analysis was done on an intention to treat basis. Results: A total of 87 patients completed the study; 21 in Group 1, 25 in Group 2, 18 in Group 3, and 23 in Group 4. The levels of 25(OH)D at baseline ranged from 1.3 to 58.0 with a mean of 24.2 ± 15.1 ng/ml. Postsupplementation, 25(OH)D levels ranged from 11.5 to 70.3 with a mean of 40.2 ± 12.2 ng/ml. The postsupplementation levels of 25(OH)D were higher in Group 2K (42.86 ± 12.83) than in Group 1K (36.96 ± 10.56) with P value of 0.023. Conclusion: We concluded that Vitamin D supplementation with 2000 IU/day or 60,000 IU/month is very effective and safe in achieving Vitamin D sufficiency in pregnant women. PMID:27186550

  18. 5 CFR 7601.102 - Prior approval of outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ARCHIVES AND RECORDS ADMINISTRATION... obtained from the NARA designated agency ethics official. (b) Standard of approval. Approval shall be... in the activities of a nonprofit charitable, religious, professional, social, fraternal,...

  19. Hepatoprotective efficacy of Nigella sativa seeds dietary supplementation against lead acetate-induced oxidative damage in rabbit - Purification and characterization of glutathione peroxidase.

    PubMed

    El-Far, Ali H; Korshom, Mahdy A; Mandour, Abdelwahab A; El-Bessoumy, Ashraf A; El-Sayed, Yasser S

    2017-03-03

    Lead (Pb) is a toxic ubiquitous environmental pollutant that induces hepatotoxicity in both animals and humans. The ability of Nigella saliva seeds (NSS) in ameliorating lead acetate (PbAc)-induced hepatic oxidative damage was investigated using a rabbit model. Forty New Zealand rabbits were given feed and water ad libitum. They were allocated randomly into four groups: control; PbAc (5g/L drinking water); NSS (20g/kg diet) and NSS+PbAc groups. After two months, liver samples were collected and analyzed for malondialdehyde (MDA), glutathione (GSH), glutathione S-transferase (GST) and glutathione peroxidase (GPx) contents. Purification and characterization of GPx were also evaluated. PbAc exposure significantly (p<0.05) increased MDA (lipid peroxidation biomarker) and reduced the GSH levels and the GST and GPx activities. Concurrently supplemented NSS significantly (p<0.05) decreased MDA levels and restored the GSH, GST, and GPx contents successfully. Electrophoretically, the homogeneous GPx preparation from the liver had a specific activity of 30.44 U/mg protein and a yield of 1.31%. The Km values for cumene hydroperoxide were 4.76μM in control, PbAc and NSS+PbAc groups, and 4.09μM in NSS group. The GPx reaction had a temperature optimum 40°C, pH optimum 8 and molecular weight 21 kDa. The obtained data indicated the potent efficacy of NSS against PbAc-induced oxidative stress; that was mediated through induction and activation of antioxidants, particularly GPx and scavenging free radicals. Moreover, the purified hepatic GPx is characterized as a selenoprotein (Se-GPx).

  20. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-06-23

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: -30.05 mg/dL; 95% confidence interval [CI]: -54.87 to -5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: -0.41%; 95% CI: -0.55% to -0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue.

  1. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-01-01

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: −30.05 mg/dL; 95% confidence interval [CI]: −54.87 to −5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: −0.41%; 95% CI: −0.55% to −0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue. PMID:27347994

  2. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  3. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  4. Supplements and athletes.

    PubMed

    Lombardo, John A

    2004-09-01

    Supplements have become a staple with athletes. Athletes take supplements to enhance their performance through replenishment of real and perceived deficiencies, anabolic action of stimulants, increased energy and alertness, and for weight control. Physicians who deal with athletes should be aware of the supplements being utilized by athletes, the athletes' desired effects and the efficacy of the supplement, the adverse effects, and whether the supplement is banned by leagues or organizations in which the athletes are competing. For those athletes who are regularly drug tested for performance enhancers, it is important to remember that one cannot be 100% sure that any supplement will not result in a positive drug test, because there is no independent agency certifying purity.

  5. The efficacy of bait supplements for improving the rate of discovery of bait stations in the field by the formosan subterranean termite (Isoptera: Rhinotermitidae)

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Field tests of four different bait supplements were conducted in City Park, New Orleans, Louisiana. The four bait supplements tested included two different formulations of decayed material, a sports drink, and the combination of an application of an aqueous solution of Summon Preferred Food SourceTM...

  6. A Pilot Randomized Controlled Clinical Trial to Assess Tolerance and Efficacy of Navy Bean and Rice Bran Supplementation for Lowering Cholesterol in Children

    PubMed Central

    Borresen, Erica C.; Jenkins-Puccetti, NaNet; Schmitz, Katie; Brown, Dustin G.; Pollack, Austin; Fairbanks, Amanda; Wdowik, Melissa; Rao, Sangeeta; Nelson, Tracy L.; Luckasen, Gary; Ryan, Elizabeth P.

    2017-01-01

    Background: Navy beans and rice bran demonstrate efficacy to regulate serum cholesterol in hypercholesterolemic adults; however, the cardiovascular disease (CVD) protective properties of these foods in children are unknown and merit investigation. Objective: The objectives were to determine whether cooked navy bean powder (NBP) and/or heat-stabilized rice bran (RB) supplementation is tolerable, improves dietary fiber intake in children, and modulates lipid profiles. Methods: Children aged 8 to 13 years at risk for CVD due to abnormal lipids were recruited. Elevated cholesterol levels were defined as total cholesterol ≥180 mg/dL and high-density lipoprotein (HDL) <60 mg/dL; low-density lipoprotein (LDL) ≥100 mg/dL and HDL <60 mg/dL; or non-HDL >100 mg/dL and HDL <60 mg/dL. Participants completed a pilot 4-week, randomized controlled, 4-arm dietary intervention. They consumed study-provided muffins or a smoothie daily that included 0 g NBP or RB (control), 17.5 g NBP, 15 g RB, or a combination 9 g NBP + 8 g RB. Fasting blood was collected at baseline and week 4. Participants also completed 3-day food logs and gastrointestinal health questionnaires. Results: Thirty-eight children completed the trial (n = 9 control, n = 10 NBP, n = 9 RB, and n = 10 NBP + RB groups). Only 3 participants withdrew due to noncompliance of required food consumption. Participants in the intervention groups significantly increased intake of NBP and RB at week 4 (p≤.01). The NBP and NBP + RB groups increased total fiber intake from baseline to week 4 (p=.02 and p=<.01, respectively). HDL-cholesterol was higher in NBP-group participants compared to control at week 4 (P = .02). Conclusion: Increasing NBP and/or RB intake is tolerable for children, and our findings suggest higher daily intakes are needed for a longer duration to induce favorable changes across multiple serum lipid parameters. PMID:28345013

  7. Pomalidomide: first global approval.

    PubMed

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  8. 75 FR 8035 - Agency Information Collection Activities: Proposed Collection; Comment Request-Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... Request--Supplemental Nutrition Assistance Program: Federal Collection of State Plan of Operations... currently approved for State Agency Supplemental Nutrition Assistance Program (SNAP), formerly the Food... information collection to ] Jane Duffield, Chief, State Administration Branch, Supplemental...

  9. Evaluating the efficacy of three USDA-approved antimicrobial sprays for reducing surrogate Shiga toxin-producing cells of "Escherichia coli on bob veal carcasses

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Shiga toxin-producing Escherichia coli (STEC) have recently been recognized as a problem for the veal industry, suggesting the need for effective antimicrobial intervention strategies throughout processing. Therefore, we evaluated the efficacy of lactic acid (4.5%), Citrilow™ (pH 1.2), and Beefxide®...

  10. Efficacy of β-mannanase supplementation to corn-soya bean meal-based diets on growth performance, nutrient digestibility, blood urea nitrogen, faecal coliform and lactic acid bacteria and faecal noxious gas emission in growing pigs.

    PubMed

    Upadhaya, Santi Devi; Park, Jae Won; Lee, Jae Hwan; Kim, In Ho

    2016-01-01

    A study was conducted to determine the efficacy of β-mannanase supplementation to a diet based on corn and soya bean meal (SBM) on growth performance, nutrient digestibility, blood urea nitrogen (BUN), faecal coliforms and lactic acid bacteria, and noxious gas emission in growing pigs. A total of 140 pigs [(Landrace × Yorkshire) × Duroc; average body weight 25 ± 3 kg] were randomly allotted to a 2 × 2 factorial arrangement with dietary treatments consisting of hulled or dehulled SBM without or with supplementation of 400 U β-mannanase/kg. During the 6 weeks of experimental feeding, β-mannanase supplementation had no effect on body weight gain, feed intake and gain:feed (G:F) ratio. Compared with dehulled SBM, feeding hulled SBM caused an increased feed intake of pigs in the entire trial (p = 0.05). The G:F ratio was improved in pigs receiving dehulled SBM (p < 0.05). Dietary treatments did not influence the total tract digestibility of dry matter, nitrogen and gross energy. Enzyme supplementation reduced (p < 0.05) the population of faecal coliforms and tended to reduce the NH3 concentration after 24 h of fermentation in a closed box containing faecal slurry. Feeding hulled SBM tended to reduce NH3 emission on days 3 and 5 of fermentation. In conclusion, mannanase supplementation had no influence on growth performance and nutrient digestibility but showed a positive effect on reducing coliform population and tended to reduce NH3 emission. Dehulled SBM increased G:F ratio and hulled SBM tended to reduce NH3 emission.

  11. A Randomized, Double-blind, Placebo-controlled, Multi-center, Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair

    PubMed Central

    Dayan, Steven

    2015-01-01

    Objective: The purpose of this six-month, randomized, double-blind, multi-center, placebo-controlled study was to determine if the administration of a new oral supplement will promote terminal hair growth. Design: A randomized, double-blind study. Setting: Two private practices (dermatology and facial plastics). Participants: Women 21 to 75 years of age with self-perceived thinning hair. Measurements: The primary efficacy endpoint was the change in terminal and vellus hairs in a 4cm2 target area of the scalp after 90 and 180 days of treatment. Secondary endpoints were change in hair diameter and responses to Quality of Life and Self-Assessment questionnaires. Results: Subjects treated with the new oral supplement achieved a significant increase in the number of baseline terminal hairs at 90 and 180 days (for each, p<0.0001, respectively) and were significantly greater then placebo (p<0.0001). Treatment with the new oral supplement was also associated with a significant increase in baseline terminal hair diameter after 90 (p=0.006) and 180 days of treatment (p=0.001) which was significantly greater than placebo at the end of the study (p=0.003). Improvements in hair growth and hair diameter were associated with significant improvement in most responses to Self-Assessment and Quality of Life Questionnaire responses. There were no adverse events. Conclusion: The daily administration of a new oral supplement was associated with significant increases in the number of terminal and vellus hairs and hair diameter. Most study participants believed the use of the oral supplement resulted in significant improvement in skin and hair quality and quality of life. PMID:26705444

  12. Efficacy of using a combination of rendered protein products as an undegradable intake protein supplement for lactating, winter-calving, beef cows fed bromegrass hay.

    PubMed

    Encinias, A M; Lardy, G P; Leupp, J L; Encinias, H B; Reynolds, L P; Caton, J S

    2005-01-01

    Seventy-two (36 in each of two consecutive years) lactating, British-crossbred cows (609 +/- 19 kg) were used to evaluate effects of feeding a feather meal-blood meal combination on performance by beef cows fed grass hay. Bromegrass hay (9.6% CP, DM basis) was offered ad libitum and intake was measured daily in individual Calan electronic headgates. Acclimation to Calan gates began approximately 20 d after parturition, and treatments were initiated 21 d later. Cows were assigned randomly to one of four treatments (DM basis) for 60 d: 1) nonsupplemented control (CON), 2) energy control (ENG; 790 g/d; 100% beet pulp), 3) degradable intake protein (DIP; 870 g/d; 22% beet pulp and 78% sunflower meal), or 4) undegradable intake protein (UIP; 800 g/d; 62.5% sunflower meal, 30% hydrolyzed feather meal, and 7.5% blood meal). Net energy concentrations of supplements were formulated to provide similar NE(m) intakes (1.36 Mcal/d). The DIP and UIP supplements were calculated to supply similar amounts of DIP (168 g/d) and to supply 64 and 224 g/d of UIP, respectively. Forage DMI (kg/d) decreased in supplemented vs. nonsupplemented (P = 0.03) and DIP vs. UIP (P = 0.001); however, when expressed as a percentage of BW, forage DMI was not different (P = 0.23). Supplemented cows tended (P = 0.17) to lose less BW than CON. Body condition change was not affected (P = 0.60) by postpartum supplementation. No differences were noted in milk production (P = 0.29) or in calf gain during the supplementation period (P = 0.74). Circulating insulin concentrations were not affected by treatment (P = 0.42). In addition, supplementation did not affect circulating concentrations of NEFA (P = 0.18) or plasma urea nitrogen (P = 0.38). Results of the current study indicate that supplementation had little effect on BW, BCS, milk production, or calf BW when a moderate-quality forage (9.6% CP) was fed to postpartum, winter-calving cows in optimal body condition (BCS > 5). Supplemental UIP did not enhance

  13. Sports Supplements

    MedlinePlus

    ... for Parents for Kids for Teens Teens Home Body Mind Sexual Health Food & Fitness Diseases & Conditions Infections Q& ... Sports Supplements? How Some Common Supplements Affect the Body Will Supplements ... improving your sports performance is probably on your mind. Lots of people wonder if taking sports supplements ...

  14. Efficacy of whey protein supplementation on resistance exercise-induced changes in muscle strength, lean mass, and function in mobility-limited older adults

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Whey protein supplementation may augment resistance exercise-induced increases in muscle strength and mass. Further studies are required to determine whether this effect extends to functionally compromised older adults. The objectives of the study were to compare the effects of whey protein concent...

  15. Antimicrobial effect of the Biotronic® Top3 supplement and efficacy in protecting rainbow trout (Oncorhynchus mykiss) from infection by Aeromonas salmonicida subsp. salmonicida.

    PubMed

    Menanteau-Ledouble, Simon; Krauss, Ines; Goncalves, Rui Alexandre; Weber, Barbara; Santos, Gonçalo Abreu; El-Matbouli, Mansour

    2017-03-18

    Demand for more environmentally friendly practices have led to the adoption of several feed supplements by the fish farming industry. In the present study, we investigated a commercially available formula that includes a mixture of three compounds: organic acids, a phytochemical and Biomin® Permeabilizing Complex. This mixture demonstrated antimicrobial properties in vitro and was able to inhibit growth of multiple species of aquatic bacterial pathogens, including Aeromonas salmonicida. Bacterial challenge was performed using A. salmonicida and three exposure routes: intra-peritoneal injection, immersion, and cohabitation. Mortality rates following infection by injection were significantly decreased in the fish that had received the supplemented feed. Fish infected through the other routes did not show a significant difference in mortality. In term of farming performance, while the fish that had received the feed supplement showed an improvement in weight gain and final weight, these changes were not found to be statistically significant. Similarly, no significant difference was observed in the feed conversion ratio. The results of this study suggest that this feed supplement may be effective at protecting rainbow trout from fish furunculosis.

  16. The efficacy of micronutrient supplementation in reducing the prevalence of anaemia and deficiencies of zinc and iron among adolescents in Sri Lanka

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Objective: To determine the effectiveness of combined iron and zinc over the iron- or zinc-only supplementation in correcting deficiency and possible interactive effects in a group of adolescent school children. Subjects and methods: Schoolchildren (n=821) of 12–16 years of age were randomized into ...

  17. The Efficacy of Instructor-Guided Supplemental Instruction as a Strategy for Helping Reading-Deficient College Students Improve Testing and Assessment Outcomes

    ERIC Educational Resources Information Center

    Bartley-Lukula, Audrey

    2013-01-01

    This research project examined whether the use of Instructor-guided Supplemental Instruction as a classroom scaffolding technique, might help improve testing and assessment reading outcomes for reading-deficient college students. The study was completed at Tennessee State University in Nashville, Tennessee over the 16-week Fall, 2012 semester…

  18. Folate/Folic Acid Knowledge, Intake, and Self-Efficacy of College-Aged Women: Impact of Text Messaging and Availability of a Folic Acid-Containing Supplement

    ERIC Educational Resources Information Center

    Rampersaud, Gail C.; Sokolow, Andrew; Gruspe, Abigail; Colee, James C.; Kauwell, Gail P. A.

    2016-01-01

    Objective: To evaluate the impact of educational text messages (TMs) on folate/folic acid knowledge and consumption among college-aged women, and to evaluate the impact of providing folic acid supplements on folate/folic acid intake among college-aged women. Participants: A total of 162 women (18-24 years) recruited from a university. Methods: The…

  19. An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series.

    PubMed

    Brown, Amy Christine

    2016-11-03

    This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (20%; herbs), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs, and zero deaths due to DS. Less than 1 percent of Americans experience adverse events related to DS, and the majority was classified as minor, with many of these related to caffeine, yohimbe, or other stimulant ingredients. The number one adulterant in DS is drugs, followed by New Dietary Ingredients (NDI) not submitted to the FDA - both are illegal and not DS, but rather "tainted products marketed as dietary supplements." The three main categories of DS prone to medical problems are those for sexual enhancement, weight loss, and sports performance/body building. DS are regulated in the U.S. by several federal agencies with overlapping jurisdiction - the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); enforced by the State Attorneys General Offices (AGO) and Department of Justice (DOJ); and monitored (not regulated) by the Centers for Disease Control and Prevention (CDC). The FDA can remove a DS from the market for phase IV post-marketing surveillance adverse event reports, adulteration (drugs, NDI, synthetic substances), contamination, misidentification, mislabeling or false claims, and not meeting good manufacturing practices (GMP). The FTC and state AGO can also enforce laws against deceptive marketing practices. Suggested improvements to current regulatory requirements are included along with online DS Toxic Tables in the

  20. Efficacy of L-carnitine supplementation on frailty status and its biomarkers, nutritional status, and physical and cognitive function among prefrail older adults: a double-blind, randomized, placebo-controlled clinical trial

    PubMed Central

    Badrasawi, M; Shahar, Suzana; Zahara, AM; Nor Fadilah, R; Singh, Devinder Kaur Ajit

    2016-01-01

    Background Frailty is a biological syndrome of decreased reserve and resistance to stressors due to decline in multiple physiological systems. Amino acid deficiency, including L-carnitine, has been proposed to be associated with its pathophysiology. Nevertheless, the efficacy of L-carnitine supplementation on frailty status has not been documented. Thus, this study aimed to determine the effect of 10-week L-carnitine supplement (1.5 g/day) on frailty status and its biomarkers and also physical function, cognition, and nutritional status among prefrail older adults in Klang Valley, Malaysia. Methodology This study is a randomized, double-blind, placebo-controlled clinical trial conducted among 50 prefrail subjects randomized into two groups (26 in L-carnitine group and 24 in placebo group). Outcome measures include frailty status using Fried criteria and Frailty Index accumulation of deficit, selected frailty biomarkers (interleukin-6, tumor necrosis factor-alpha, and insulin-like growth factor-1), physical function, cognitive function, nutritional status and biochemical profile. Results The results indicated that the mean scores of Frailty Index score and hand grip test were significantly improved in subjects supplemented with L-carnitine (P<0.05 for both parameters) as compared to no change in the placebo group. Based on Fried criteria, four subjects (three from the L-carnitine group and one from the control group) transited from prefrail status to robust after the intervention. Conclusion L-carnitine supplementation has a favorable effect on the functional status and fatigue in prefrail older adults. PMID:27895474

  1. The efficacy of vitamin E (DL-alpha-tocopheryl acetate) supplementation in hen diets to alleviate egg quality deterioration associated with high temperature exposure.

    PubMed

    Kirunda, D F; Scheideler, S E; McKee, S R

    2001-09-01

    Supplementation of hen diets with vitamin E was investigated as a means to alleviate egg quality deterioration associated with high temperature exposure. One hundred eighty layers (60 birds/diet) were randomly placed on diets supplemented with vitamin E at 20, 60, and 120 IU/kg feed. After 2 wk on feed, one-half of the birds were maintained at environmental temperatures of 21 C, whereas the other half were acclimated over 3 d to increasing environmental temperatures reaching 34 C. Birds were exposed to 21 or 34 C for 2 wk (five hens per cage x six replications). Egg production, feed intake, and egg weights were determined daily. Twenty eggs were collected from each treatment group and analyzed for vitamin E content in yolk, percentage egg solids, yolk color, yolk pH, albumen pH, foaming ability of albumen proteins, emulsification capacity of yolk, yolk viscosity, yolk color, and vitelline membrane strength (VMS). Results suggested that high temperature exposure (HTE) caused a reduction in feed intake, egg production, Haugh units, egg weights, VMS, yolk and albumen solids, foam stability, angel cake volume, yolk color, and emulsification capacity. Supplementation of HTE hen diets with 60 IU vitamin E/kg feed improved feed intake, egg production, VMS, yolk and albumen solids, foam stability, and angel cake volume. However, egg weight, emulsification capacity, yolk color, yolk index, and yolk viscosity were not improved by vitamin E supplementation of HTE hens. Vitamin E levels in the yolk were lower from HTE hens compared with controls at all levels of vitamin E supplementation.

  2. Parenteral iron supplementation.

    PubMed

    Kumpf, V J

    1996-08-01

    Indications for the use of parenteral iron are limited to conditions in which the oral supplementation of iron is not possible or fails. An overview of iron balance and iron requirements is presented to describe situations in which iron supplementation may be required. When parenteral iron supplementation is required, careful attention to proper dosing and administration is necessary to optimize efficacy and safety. The purpose of this article is to review the literature regarding the clinical use of parenteral iron therapy and provide guidelines on dosing and administration. Methods of iron dextran administration, including the IV and intramuscular injection of undiluted drug and total dose infusion, are compared. Complications associated with the use of parenteral iron are also be reviewed. Finally, the use of iron supplementation in patients receiving parenteral nutrition care explored.

  3. 75 FR 11166 - Enbridge Pipelines (North Dakota) LLC; Notice of Motion to Approve Modification of Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... Energy Regulatory Commission Enbridge Pipelines (North Dakota) LLC; Notice of Motion to Approve..., Enbridge Pipelines (North Dakota) LLC (Enbridge), with the support of twelve Shippers and a Connecting Pipeline, submitted a modification to the Offer of Settlement (Supplement) approved in Docket No....

  4. Efficacy of bait supplements for improving the rate of discovery of bait stations in the field by formosan subterranean termites (Isoptera: Rhinotermitidae).

    PubMed

    Cornelius, Mary L; Lyn, Margaret; Williams, Kelley S; Lovisa, Mary P; De Lucca, Anthony J; Lax, Alan R

    2009-06-01

    Field tests of four different bait supplements were conducted in City Park, New Orleans, LA. The four bait supplements tested included two different formulations of decayed material, a sports drink, and the combination of an application of an aqueous solution of Summon Preferred Food Source disks with the disk itself. Although all the bait supplements in this study resulted in a slightly greater number of treated stations discovered compared with control stations, only the application of the aqueous solution combined with the disk caused a significant increase in the number of stations discovered by termites. This treatment resulted in a significantly greater rate of discovery of treated stations versus control stations after only 14 d in the field. Termites were able to discover six times as many treated as control stations after 14 d, 9 times as many after 28 d, and 12 times as many after 42 d. These findings provide evidence that the diffusion of an aqueous solution into the soil underneath monitoring stations significantly decreased the length of time required for termites to infest stations.

  5. Chitinolytic Streptomyces vinaceusdrappus S5MW2 isolated from Chilika lake, India enhances plant growth and biocontrol efficacy through chitin supplementation against Rhizoctonia solani.

    PubMed

    Yandigeri, Mahesh S; Malviya, Nityanand; Solanki, Manoj Kumar; Shrivastava, Pooja; Sivakumar, G

    2015-08-01

    A chitinolytic actinomycete Streptomyces vinaceusdrappus S5MW2 was isolated from water sample of Chilika lake, India and identified using 16S rRNA gene sequencing. It showed in vitro antifungal activity against the sclerotia producing pathogen Rhizoctonia solani in a dual culture assay and by chitinase enzyme production in a chitin supplemented minimal broth. Moreover, isolate S5MW2 was further characterized for biocontrol (BC) and plant growth promoting features in a greenhouse experiment with or without colloidal chitin (CC). Results of greenhouse experiment showed that CC supplementation with S5MW2 showed a significant growth of tomato plants and superior disease reduction as compared to untreated control and without CC treated plants. Moreover, higher accumulation of chitinase also recovered in the CC supplemented plants. Significant effect of CC also concurred with the Analysis of Variance of greenhouse parameters. These results show that the a marine antagonist S5MW2 has BC efficiency against R. solani and chitinase enzyme played important role in plant resistance.

  6. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    PubMed

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  7. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  8. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a... before making a change affecting the safety or effectiveness of the device for which the applicant has...

  9. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders.

    PubMed

    Belendiuk, Katherine A; Baldini, Lisa L; Bonn-Miller, Marcel O

    2015-04-21

    The present investigation aimed to provide an objective narrative review of the existing literature pertaining to the benefits and harms of marijuana use for the treatment of the most common medical and psychological conditions for which it has been allowed at the state level. Common medical conditions for which marijuana is allowed (i.e., those conditions shared by at least 80 percent of medical marijuana states) were identified as: Alzheimer's disease, amyotrophic lateral sclerosis, cachexia/wasting syndrome, cancer, Crohn's disease, epilepsy and seizures, glaucoma, hepatitis C virus, human immunodeficiency virus/acquired immunodeficiency syndrome, multiple sclerosis and muscle spasticity, severe and chronic pain, and severe nausea. Post-traumatic stress disorder was also included in the review, as it is the sole psychological disorder for which medical marijuana has been allowed. Studies for this narrative review were included based on a literature search in PsycINFO, MEDLINE, and Google Scholar. Findings indicate that, for the majority of these conditions, there is insufficient evidence to support the recommendation of medical marijuana at this time. A significant amount of rigorous research is needed to definitively ascertain the potential implications of marijuana for these conditions. It is important for such work to not only examine the effects of smoked marijuana preparations, but also to compare its safety, tolerability, and efficacy in relation to existing pharmacological treatments.

  10. A family 11 carbohydrate-binding module (CBM) improves the efficacy of a recombinant cellulase used to supplement barley-based diets for broilers at lower dosage rates.

    PubMed

    Ribeiro, T; Ponte, P I P; Guerreiro, C I P D; Santos, H M; Falcão, L; Freire, J P B; Ferreira, L M A; Prates, J A M; Fontes, C M G A; Lordelo, M M

    2008-09-01

    1. Exogenous microbial beta-1,3-1,4-glucanases and hemicellulases contribute to improving the nutritive value of cereals rich in soluble non-starch polysaccharides for poultry. 2. In general, plant cell wall hydrolases display a modular structure comprising a catalytic module linked to one or more non-catalytic carbohydrate-binding modules (CBMs). Based on primary structure similarity, CBMs have been classified in 50 different families. CBMs anchor cellulases and hemicellulases into their target substrates, therefore eliciting efficient hydrolysis of recalcitrant polysaccharides. 3. A study was undertaken to investigate the effects of a family 11 beta-glucan-binding domain in the function of recombinant derivatives of cellulase CtLic26A-Cel5E of Clostridium thermocellum that were used to supplement a barley-based diet at lower dosage rates. 4. The results showed that birds fed on diets supplemented with the recombinant CtLic26A-Cel5E modular derivative containing the family 11 CBM or the commercial enzyme mixture Rovabio Excel AP tended to display improved performance when compared to birds fed diets not supplemented with exogenous enzymes. 5. It is suggested that at lower than previously reported enzyme dosage (10 U/kg vs 30 U/kg of basal diet), the beta-glucan-binding domain also elicits the function of the recombinant CtLic26A-Cel5E derivatives. 6. Finally, the data suggest that exogenous enzymes added to barley-based diets act primarily in the proximal section of the gastrointestinal tract.

  11. 30 CFR 250.285 - How do I submit revised and supplemental EPs, DPPs, and DOCDs?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I submit revised and supplemental EPs... supplemental EPs, DPPs, and DOCDs? (a) Submittal. You must submit to the Regional Supervisor any revisions and supplements to approved EPs, DPPs, or DOCDs for approval, whether you initiate them or the Regional...

  12. The Effect of Probiotic Plus Prebiotic Supplementation on the Tolerance and Efficacy of Helicobacter Pylori Eradication Quadruple Therapy: a Randomized Prospective Double Blind Controlled Trial

    PubMed Central

    Shafaghi, Afshin; Pourkazemi, Aydin; Khosravani, Mohsen; Fakhrie Asl, Saba; Amir Maafi, Alireza; Atrkar Roshan, Zahra; Abaspour Rahimabad, Jafar

    2016-01-01

    BACKGROUND Standard anti-Helicobacter pylori (H. pylori) treatment fails in the eradication of the organism in almost 10-35% of the patients and has different side effects. Recent studies have proposed that probiotic supplementations with or without prebiotic may improve the eradication rate and diminish the side effects, although it is still a controversial issue. We aimed to investigate the effect of probiotic with prebiotic supplementation on the eradication rate and side effects of anti H. pylori quadruple therapy. METHODS 76 patients with a positive biopsy specimen for H. pylori were enrolled. They were randomized to receive quadruple therapy of bismuth, clarithromycin, amoxicillin, and omeprazole for 14 days and also the synbiotic or the placebo. We asked them to answer study questionnaires at the beginning and during the treatment. Finally, urea breath test was done 8 weeks after the treatment. RESULTS The eradication rate was significantly better in the synbiotic group by intention-to-treat analysis (p<0.05). Treatment side effects such as diarrhea, nausea, vomiting, epigastric pain, flatulence, constipation, and taste abnormality were similar in both groups but anorexia was significantly better in the synbiotic group (p <0.05). CONCLUSION The eradication rate was significantly better in the synbiotic group by intention-to-treat analysis (p<0.05). Treatment side effects such as diarrhea, nausea, vomiting, epigastric pain, flatulence, but could improve the eradication by augmenting the treatment tolerance and compliance. PMID:27698967

  13. Safety and Efficacy of Banaba-Moringa oleifera-Green Coffee Bean Extracts and Vitamin D3 in a Sustained Release Weight Management Supplement.

    PubMed

    Stohs, Sidney J; Kaats, Gilbert R; Preuss, Harry G

    2016-04-01

    This 60-day, 30-subject pilot study examined a novel combination of ingredients in a unique sustained release (Carbopol matrix) tablet consumed twice daily. The product was composed of extracts of banaba leaf, green coffee bean, and Moringa oleifera leaf and vitamin D3. Safety was assessed using a 45-measurement blood chemistry panel, an 86-item self-reported Quality of Life Inventory, bone mineral density, and cardiovascular changes. Efficacy was assessed by calculating a body composition improvement index (BCI) based on changes in dual energy X-ray absorptiometry measured fat mass (FM) and fat-free mass (FFM) as well as between the study group (SG) and a historical placebo group. No changes occurred in any blood chemistry measurements. Positive changes were found in the Quality of Life (QOL) inventory composite scores. No adverse effects were observed. Decreases occurred in FM (p = 0.004) and increases in FFM (p = 0.009). Relative to the historical placebo group, the SG lost more FM (p < 0.0001), gained more FFM (p = <0.0001), and had a negative BCI of -2.7 lb. compared with a positive BCI in the SG of 3.4 lb., a 6.1 discordance (p = 0.0009). The data support the safety and efficacy of this unique product and demonstrate importance of using changes in body composition versus scale weight and BMI.

  14. Safety and Efficacy of Banaba–Moringa oleifera–Green Coffee Bean Extracts and Vitamin D3 in a Sustained Release Weight Management Supplement

    PubMed Central

    Kaats, Gilbert R.; Preuss, Harry G.

    2016-01-01

    This 60‐day, 30‐subject pilot study examined a novel combination of ingredients in a unique sustained release (Carbopol matrix) tablet consumed twice daily. The product was composed of extracts of banaba leaf, green coffee bean, and Moringa oleifera leaf and vitamin D3. Safety was assessed using a 45‐measurement blood chemistry panel, an 86‐item self‐reported Quality of Life Inventory, bone mineral density, and cardiovascular changes. Efficacy was assessed by calculating a body composition improvement index (BCI) based on changes in dual energy X‐ray absorptiometry measured fat mass (FM) and fat‐free mass (FFM) as well as between the study group (SG) and a historical placebo group. No changes occurred in any blood chemistry measurements. Positive changes were found in the Quality of Life (QOL) inventory composite scores. No adverse effects were observed. Decreases occurred in FM (p = 0.004) and increases in FFM (p = 0.009). Relative to the historical placebo group, the SG lost more FM (p < 0.0001), gained more FFM (p = <0.0001), and had a negative BCI of −2.7 lb. compared with a positive BCI in the SG of 3.4 lb., a 6.1 discordance (p = 0.0009). The data support the safety and efficacy of this unique product and demonstrate importance of using changes in body composition versus scale weight and BMI. © 2016 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd PMID:26871553

  15. Efficacy of Cistanche Tubulosa and Laminaria Japonica Extracts (MK-R7) Supplement in Preventing Patterned Hair Loss and Promoting Scalp Health

    PubMed Central

    Seok, Joon; Kim, Tae Su; Kwon, Hyun Jung; Lee, Sung Pyo; Kang, Myung Hwa; Kim, Myeung Nam

    2015-01-01

    Cistanche tubulosa and Laminaria japonica have been reported to have anti-oxidative, anticoagulant, anti-cancer and anti-inflammatory properties. They are expected to be a promising candidates for promoting hair growth and treating dandruff and scalp inflammation as a consequence. In this double-blinded, placebo-controlled clinical trial, we investigated the efficacy of Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) in promoting hair health in patients with mild to moderate patterned hair loss. Using phototrichogram (Folliscope 4.0, LeadM, Seoul, Korea), we compared the density and diameter of hairs in patients receiving a placebo or Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) at baseline, 8 and 16 weeks of the study. In order to determine the efficacy of treatment on dandruff and scalp inflammation, investigator's assessment score and patient's subjective score were also performed. We found a statistically significant increase in the hair density of the test group (n = 45, MK-R7 400 mg) after 16 weeks of consuming the MK-R7 (test group: 23.29 n/cm2 ± 24.26, control: 10.35 n/cm2 ± 20.08, p < 0.05). In addition, we found a statistically significant increase in hair diameter in the test group compared to control group at week 16 (test group: 0.018 mm ± 0.015, control: 0.003 mm ± 0.013, p < 0.05). There were also significant outcomes regarding the investigator's visual assessment and patient's subjective score of dandruff and scalp inflammation in the test group compared to those in control group. Based on the results of this clinical study, we conclude that Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) are promising substances for promoting health of the scalp and hair. PMID:25954733

  16. 76 FR 35424 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... Regulation Supplement; Acquisition of Information Technology AGENCY: Defense Acquisition Regulations System... technology. The Office of Management and Budget (OMB) has approved this information collection requirement... Supplement (DFARS) Part 239, Acquisition of Information Technology, and the associated clauses at DFARS...

  17. 78 FR 44092 - Agency Information Collection Activities; Proposed Collection; Comment Request: Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Food and Nutrition Service Agency Information Collection Activities; Proposed Collection; Comment Request: Supplemental Nutrition Assistance Program: State Agency Options AGENCY: Food and Nutrition... is a revision ] of the currently approved burden for the Supplemental Nutrition Assistance...

  18. 78 FR 30844 - Agency Information Collection Activities; Proposed Collection; Comment Request: Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... Request: Supplemental Nutrition Assistance Program Regulations, Quality Control AGENCY: Food and Nutrition... the Supplemental Nutrition Assistance Program's Regulations, Part 275--Quality Control. Specifically...: Revision of a currently approved collection. Abstract: There are three components of the Quality...

  19. The efficacy of vitamin C supplementation on reducing total serum cholesterol in human subjects: a review and analysis of 51 experimental trials

    PubMed Central

    McRae, Marc P.

    2006-01-01

    Abstract Objective Observational studies in humans have shown an inverse relationship between plasma vitamin C concentration and total serum cholesterol. However, experimental studies have shown inconsistent results regarding the ability of vitamin C to reduce total serum cholesterol. Methods Published reports of trials studying the effects of vitamin C on serum lipids were identified by a search of Medline from 1966 to 2004. Data from 51 experimental studies comprising of 1666 pooled subjects were selected for analysis. Results A very strong negative association was observed between baseline total serum cholesterol and the percent change in cholesterol (r = −0.585, p<0.001). When subjects were divided into 4 groups based on their baseline total serum cholesterol levels, the following weighted mean percent changes in cholesterol from baseline were observed: normal cholesterol (<199mg/dl): 0.91±6.8% (n=508); borderline high cholesterol (200–239mg/dl): 3.90±5.78% (n=605); high cholesterol (240–279mg/dl): 11.40±7.96% (n=300); severe cholesterol (>280mg/dl): 14.30±8.36% (n=253). A significant inverse relationship was found between the baseline plasma vitamin C concentrations and mean percent change in total cholesterol from baseline (r = −0.500, p<0.005). It was also observed that the high and severe baseline cholesterol groups possessed lower baseline plasma vitamin C concentrations than those in the normal cholesterol groups (0.79 and 0.55 versus 1.24 mg/dl respectively). Conclusion This finding strengthens the hypothesis that the cholesterol lowering and cardio-protective benefit of vitamin C supplementation may be in its ability to elevate plasma vitamin C concentrations in those patients who initially possess lower than normal vitamin C plasma concentrations. PMID:19674666

  20. Dietary Supplements

    MedlinePlus

    ... other products. They can come as pills, capsules, powders, drinks, and energy bars. Supplements do not have to go through the testing that drugs do. Some supplements can play an important role in health. For example, calcium and vitamin D are important for keeping bones ...

  1. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  2. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  3. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  4. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  5. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  6. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  7. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  8. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  9. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  10. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an...

  11. A randomized controlled study of the efficacy of six-month supplementation with concentrated fish oil rich in omega-3 polyunsaturated fatty acids in first episode schizophrenia.

    PubMed

    Pawełczyk, Tomasz; Grancow-Grabka, Marta; Kotlicka-Antczak, Magdalena; Trafalska, Elżbieta; Pawełczyk, Agnieszka

    2016-02-01

    Short-term clinical trials of omega-3 polyunsaturated fatty acids (n-3 PUFA) as add-on therapy in patients with schizophrenia revealed mixed results. The majority of these studies used an 8- to 12-week intervention based on ethyl-eicosapentaenoic acid. A randomized placebo-controlled trial was designed to compare the efficacy of 26-week intervention, composed of either 2.2 g/day of n-3 PUFA, or olive oil placebo, with regard to symptom severity in first-episode schizophrenia patients. Seventy-one patients (aged 16-35) were enrolled in the study and randomly assigned to the study arms. The primary outcome measure of the clinical evaluation was schizophrenia symptom severity change measured by the Positive and Negative Syndrome Scale (PANSS). Mixed models repeated measures analysis revealed significant differences between the study arms regarding total PANSS score change favouring n-3 PUFA (p = 0.016; effect size (ES) = 0.29). A fifty-percent improvement in symptom severity was achieved significantly more frequently in the n-3 PUFA group than in the placebo group (69.4 vs 40.0%; p = 0.017). N-3 PUFA intervention was also associated with an improvement in general psychopathology, measured by means of PANSS (p = 0.009; ES = 0.32), depressive symptoms (p = 0.006; ES = 0.34), the level of functioning (p = 0.01; ES = 0.31) and clinical global impression (p = 0.046; ES = 0.29). The findings suggest that 6-month intervention with n-3 PUFA may be a valuable add-on therapy able to decrease the intensity of symptoms and improve the level of functioning in first-episode schizophrenia patients.

  12. Dietary Supplements and Sports Performance: Herbals

    PubMed Central

    Williams, Melvin

    2006-01-01

    This is the fourth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance. PMID:18500959

  13. Efficacy of a supplemental candy coproduct as an alternative carbohydrate source to lactose on growth performance of newly weaned pigs in a commercial farm condition.

    PubMed

    Guo, J Y; Phillips, C E; Coffey, M T; Kim, S W

    2015-11-01

    The experiment investigated the effects of a supplemental candy coproduct (Chocolate Candy Feed [CCF]; International Ingredient Corp., St. Louis, MO), an alternative carbohydrate source to dietary lactose, on growth performance and on health status of nursery pigs. Crossbred pigs ( = 1,408; 21 d of age and 7.1 ± 0.3 kg BW; Smithfield Premium Genetics, Rose Hill, NC) were randomly assigned to 4 treatments (16 pens/treatment and 22 pigs/pen) in a randomized complete block design: 0, 15, 30, and 45% of lactose replaced by CCF based on equal amounts of total sugars. The experimental period was divided into 3 phases: phase I (1.8 kg diet/pig for 11 ± 1 d), phase II (6.8 kg diet/pig for 17 ± 2 d), and phase III (until 49 d after weaning). Pigs received a common phase III diet. The levels of lactose, supplied by whey permeate (79.3 ± 0.8% lactose), were 20, 8, and 0% in phase I, II, and III, respectively. All experimental diets contained the same levels of essential AA and energy (ME) for each phase. Fecal scores were observed on d 5, 7, and 9 after weaning. Blood samples were taken at the end of phase I and II to measure blood urea N. The duration of phase I tended to linearly decrease ( = 0.063) with increasing CCF. In phase I, the ADFI increased ( < 0.05) with increasing CCF whereas ADG and G:F did not change. In phase II, the duration and ADFI did not change whereas ADG linearly decreased ( < 0.05) with increasing CCF. However, the G:F was not changed as CCF increased. During phase I and II together, the duration was linearly decreased ( < 0.05) as CCF increased, whereas no difference in growth performance was observed. Overall, ADFI, ADG, and G:F were not affected by replacing whey permeate with CCF in diets, indicating no adverse effects of a candy coproduct as a carbohydrate substitute to lactose on growth performance of nursery pigs. Blood urea N did not change in phase I but tended to linearly increase ( = 0.088) in phase II as CCF increased. There were no

  14. Nepali Supplements.

    ERIC Educational Resources Information Center

    Peace Corps, Washington, DC.

    This volume is intended as a supplement to Nepali language instruction. It contains songs, numerals, dialogues in Devanagari script, a Nepali-English, English-Nepali glossary, and an English-Nepali surveyor technical glossary. (AM)

  15. Calcium supplements

    MedlinePlus

    ... TYPES OF CALCIUM SUPPLEMENTS Forms of calcium include: Calcium carbonate: Over-the-counter (OTC) antacid products, such as Tums and Rolaids, contain calcium carbonate. These sources of calcium do not cost much. ...

  16. Marketing Approval of Ethical Kampo Medicines.

    PubMed

    Hakamatsuka, Takashi

    2017-01-01

     Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  17. Drugs Approved for Melanoma

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Melanoma This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome ( ...

  18. Creatine supplementation.

    PubMed

    Hall, Matthew; Trojian, Thomas H

    2013-01-01

    Creatine monohydrate is a dietary supplement that increases muscle performance in short-duration, high-intensity resistance exercises, which rely on the phosphocreatine shuttle for adenosine triphosphate. The effective dosing for creatine supplementation includes loading with 0.3 g·kg·d for 5 to 7 days, followed by maintenance dosing at 0.03 g·kg·d most commonly for 4 to 6 wk. However loading doses are not necessary to increase the intramuscular stores of creatine. Creatine monohydrate is the most studied; other forms such as creatine ethyl ester have not shown added benefits. Creatine is a relatively safe supplement with few adverse effects reported. The most common adverse effect is transient water retention in the early stages of supplementation. When combined with other supplements or taken at higher than recommended doses for several months, there have been cases of liver and renal complications with creatine. Further studies are needed to evaluate the remote and potential future adverse effects from prolonged creatine supplementation.

  19. 15 CFR 921.31 - Supplemental acquisition and development awards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AND COASTAL RESOURCE MANAGEMENT NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS Reserve Designation and Subsequent Operation § 921.31 Supplemental acquisition and development awards. After National Estuarine Research Reserve designation, and as specified in the approved management plan, a coastal...

  20. 77 FR 9529 - Approval and Promulgation of Implementation Plans; State of Missouri

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ...EPA is granting full approval of Missouri's attainment demonstration State Implementation Plan (SIP) and control strategy for the lead National Ambient Air Quality Standard (NAAQS) nonattainment area of Herculaneum, Missouri. This action is based on a proposed conditional approval of the SIP published on October 8, 2008, and a proposed approval of the supplemental SIP submittal received by EPA......

  1. Dietary supplements in weight reduction.

    PubMed

    Dwyer, Johanna T; Allison, David B; Coates, Paul M

    2005-05-01

    We summarize evidence on the role of dietary supplements in weight reduction, with particular attention to their safety and benefits. Dietary supplements are used for two purposes in weight reduction: (a) providing nutrients that may be inadequate in calorie-restricted diets and (b) for their potential benefits in stimulating weight loss. The goal in planning weight-reduction diets is that total intake from food and supplements should meet recommended dietary allowance/adequate intake levels without greatly exceeding them for all nutrients, except energy. If nutrient amounts from food sources in the reducing diet fall short, dietary supplements containing a single nutrient/element or a multivitamin-mineral combination may be helpful. On hypocaloric diets, the addition of dietary supplements providing nutrients at a level equal to or below recommended dietary allowance/adequate intake levels or 100% daily value, as stated in a supplement's facts box on the label, may help dieters to achieve nutrient adequacy and maintain electrolyte balance while avoiding the risk of excessive nutrient intakes. Many botanical and other types of dietary supplements are purported to be useful for stimulating or enhancing weight loss. Evidence of their efficacy in stimulating weight loss is inconclusive at present. Although there are few examples of safety concerns related to products that are legal and on the market for this purpose, there is also a paucity of evidence on safety for this intended use. Ephedra and ephedrine-containing supplements, with or without caffeine, have been singled out in recent alerts from the Food and Drug Administration because of safety concerns, and use of products containing these substances cannot be recommended. Dietitians should periodically check the Food and Drug Administration Web site ( www.cfsan.fda.gov ) for updates and warnings and alert patients/clients to safety concerns. Dietetics professionals should also consult authoritative sources for

  2. Weight Loss Nutritional Supplements

    NASA Astrophysics Data System (ADS)

    Eckerson, Joan M.

    Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children. Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight loss industry has responded by offering a variety of products that generates billions of dollars each year in sales. Most nutritional weight loss supplements are purported to work by increasing energy expenditure, modulating carbohydrate or fat metabolism, increasing satiety, inducing diuresis, or blocking fat absorption. To review the literally hundreds of nutritional weight loss supplements available on the market today is well beyond the scope of this chapter. Therefore, several of the most commonly used supplements were selected for critical review, and practical recommendations are provided based on the findings of well controlled, randomized clinical trials that examined their efficacy. In most cases, the nutritional supplements reviewed either elicited no meaningful effect or resulted in changes in body weight and composition that are similar to what occurs through a restricted diet and exercise program. Although there is some evidence to suggest that herbal forms of ephedrine, such as ma huang, combined with caffeine or caffeine and aspirin (i.e., ECA stack) is effective for inducing moderate weight loss in overweight adults, because of the recent ban on ephedra manufacturers must now use ephedra-free ingredients, such as bitter orange, which do not appear to be as effective. The dietary fiber, glucomannan, also appears to hold some promise as a possible treatment for weight loss, but other related forms of dietary fiber, including guar gum and psyllium, are ineffective.

  3. Common dietary supplements for weight loss.

    PubMed

    Saper, Robert B; Eisenberg, David M; Phillips, Russell S

    2004-11-01

    Over-the-counter dietary supplements to treat obesity appeal to many patients who desire a "magic bullet" for weight loss. Asking overweight patients about their use of weight-loss supplements and understanding the evidence for the efficacy, safety, and quality of these supplements are critical when counseling patients regarding weight loss. A schema for whether physicians should recommend, caution, or discourage use of a particular weight-loss supplement is presented in this article. More than 50 individual dietary supplements and more than 125 commercial combination products are available for weight loss. Currently, no weight-loss supplements meet criteria for recommended use. Although evidence of modest weight loss secondary to ephedra-caffeine ingestion exists, potentially serious adverse effects have led the U.S. Food and Drug Administration to ban the sale of these products. Chromium is a popular weight-loss supplement, but its efficacy and long-term safety are uncertain. Guar gum and chitosan appear to be ineffective; therefore, use of these products should be discouraged. Because of insufficient or conflicting evidence regarding the efficacy of conjugated linoleic acid, ginseng, glucomannan, green tea, hydroxycitric acid, L-carnitine, psyllium, pyruvate, and St. John's wort in weight loss, physicians should caution patients about the use of these supplements and closely monitor those who choose to use these products.

  4. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Is ERFO funding supplemental to IRR Program funding? 170... IRR Program funding? Yes. If ERFO funds are approved and available, they can be used to supplement IRR construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are...

  5. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Is ERFO funding supplemental to IRR Program funding? 170... IRR Program funding? Yes. If ERFO funds are approved and available, they can be used to supplement IRR construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are...

  6. Supplemental Educational Services: An Action Science Research Study of Achieving State Standards for Provider Effectiveness

    ERIC Educational Resources Information Center

    McClintock, Cynthia Collette

    2012-01-01

    Supplemental educational services are designed to contribute tremendous support to local school districts and communities through state-approved provider programs. The state, however, prior to approving supplemental educational services provider programs, must utilize all available resources to assist in the process of screening and approving…

  7. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  8. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  9. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  10. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  11. 47 CFR 87.347 - Supplemental eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Aeronautical Utility Mobile Stations § 87.347 Supplemental eligibility. (a) Aeronautical utility stations may transmit on unicom frequencies only at airports which have a unicom and a part-time or no control tower, an... the airport control tower approves the requested use of the tower or RCO frequency....

  12. 47 CFR 87.347 - Supplemental eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Aeronautical Utility Mobile Stations § 87.347 Supplemental eligibility. (a) Aeronautical utility stations may transmit on unicom frequencies only at airports which have a unicom and a part-time or no control tower, an... the airport control tower approves the requested use of the tower or RCO frequency....

  13. Specialty Engineering Supplement to IEEE-15288.1

    DTIC Science & Technology

    2015-05-15

    MISSILE SYSTEMS CENTER TAILORING SPECIALTY ENGINEERING SUPPLEMENT TO IEEE -15288.1 APPROVED FOR PUBLIC RELEASE; DISTRIBUTION...IS UNLIMITED 1 Tailoring of IEEE 15288.1: Specialty Engineering Supplement. 1. Intent of this Tailoring Document This tailoring document is...historically deemed valuable to mission assurance/success of high-reliability space systems. This tailoring document supplements IEEE 15288.1-2015 Annex E

  14. Cardiovascular effects of calcium supplements.

    PubMed

    Reid, Ian R

    2013-07-05

    Calcium supplements reduce bone turnover and slow the rate of bone loss. However, few studies have demonstrated reduced fracture incidence with calcium supplements, and meta-analyses show only a 10% decrease in fractures, which is of borderline statistical and clinical significance. Trials in normal older women and in patients with renal impairment suggest that calcium supplements increase the risk of cardiovascular disease. To further assess their safety, we recently conducted a meta-analysis of trials of calcium supplements, and found a 27%-31% increase in risk of myocardial infarction, and a 12%-20% increase in risk of stroke. These findings are robust because they are based on pre-specified analyses of randomized, placebo-controlled trials and are consistent across the trials. Co-administration of vitamin D with calcium does not lessen these adverse effects. The increased cardiovascular risk with calcium supplements is consistent with epidemiological data relating higher circulating calcium concentrations to cardiovascular disease in normal populations. There are several possible pathophysiological mechanisms for these effects, including effects on vascular calcification, vascular cells, blood coagulation and calcium-sensing receptors. Thus, the non-skeletal risks of calcium supplements appear to outweigh any skeletal benefits, and are they appear to be unnecessary for the efficacy of other osteoporosis treatments.

  15. Podophyllum hexandrum as a potential botanical supplement for the medical management of nuclear and radiological emergencies (NREs) and free radical-mediated ailments: leads from in vitro/in vivo radioprotective efficacy evaluation.

    PubMed

    Arora, Rajesh; Chawla, Raman; Dhaker, Atlar Singh; Adhikari, Manish; Sharma, Jyoti; Singh, Shikha; Gupta, Damodar; Kumar, Raj; Sharma, Ashok; Sharma, Rakesh K; Tripathi, Rajender P

    2010-03-01

    Management of radiation-induced reactive oxygen/nitrogen species requires a holistic approach to mitigate the deleterious effects of free radicals. Flora of the Himalayas, which prevails under extreme climatic conditions, has been explored for its potential utility to develop radioprotective drugs. The Himalayan high altitude medicinal plant, Podophyllum hexandrum Royle, was selected on the basis of its unique properties, and a novel fractionated nonpolar extract (REC-2003) was prepared and evaluated for radioprotective efficacy, in vitro as well as in vivo. The free radical scavenging activity of REC-2003 was found to be > 75% (20 μg/ml) with maximum superoxide scavenging activity (57.56 ± 1.38%) recorded at 1 mg/ml concentration (tetrazolium-based estimation). More than 30% inhibition of nitric oxide radicals was observed at concentrations > 0.5 mg/ml, while hydroxyl radical scavenging activity (deoxy-D-ribose assay) exhibited a dose-dependent (100-600 μg/ml) increase. Significantly high (90%) protection to human erythrocytes was observed at 75 μg/ml, which was found to be the most optimized dose. Similarly, more than 90% inhibition was observed against lipid peroxidation (evaluated by estimating levels of malondialdehyde). The significant antihemolytic potential of REC-2003 could be attributed to its ability to scavenge free radicals, reduce peroxidative stress on lipid membranes, and render protection to DNA (evaluated using plasmid relaxation assay). All these activities holistically contributed toward the radioprotective ability. REC-2003 (8 mg/kg BW; intraperitoneal (i.p.), -30 min) rendered > 80% total-body protection in Swiss Albino Strain 'A' mice [against lethal radiation (10 Gy)] in a 30-day survival assay. Phytochemical characterization of the constituents of REC-2003 revealed the presence of polyphenolics (flavonoids). The characterized constituents also included the aryl-tetralin lignans like podophyllotoxin, its glycoside, 4'-demethyl derivative

  16. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  17. 76 FR 34739 - Agency Information Collection Activities: HRIFA Instructions for Form I-485, Supplement C...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ... Instructions for Form I-485, Supplement C; Extension of a Currently Approved Information Collection; Comment.../Collection: HRIFA Instructions for Form I- 485, Supplement C. (3) Agency form number, if any, and the... provided on the Form I-485 Supplement C, in combination with the information collected on Form...

  18. 30 CFR 250.285 - How do I submit revised and supplemental EPs, DPPs, and DOCDs?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false How do I submit revised and supplemental EPs....285 How do I submit revised and supplemental EPs, DPPs, and DOCDs? (a) Submittal. You must submit to the Regional Supervisor any revisions and supplements to approved EPs, DPPs, or DOCDs for...

  19. Biosimilars approval process.

    PubMed

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier.

  20. Redfield Energy Approval

    EPA Pesticide Factsheets

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

  1. Herbal supplements: Facts and myths--talking to your patients about herbal supplements.

    PubMed

    Messina, Barbara Ann M

    2006-08-01

    The use of herbal supplements in the United States is steadily growing and raises concerns about safety, efficacy, and how they affect safe patient care. The direct health risks associated with herbal supplements include hypertension, prolonged bleeding, and the potential for drug-herb interactions. These potential drug interactions are of particular concern for patients undergoing anesthesia. This article provides a review of literature on the 10 most popular herbal supplements and addresses the herbal supplements' reported use, possible adverse effect(s), patient teaching, possible drug interaction(s), and recommendations regarding discontinuation before surgery.

  2. Herbal Products and Supplements

    MedlinePlus

    ... of dietary supplement that contains one or more herbs.Herbal health products and supplements are available in ... wort.Are herbal health products and supplements safe?Herbs aren't necessarily safer than the ingredients in ...

  3. More New Medication Approvals.

    PubMed

    Turkoski, Beatrice B

    2016-01-01

    In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures.

  4. 77 FR 48523 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... comments from the public on this ICR during the review and approval period. DATES: Deadline: Comments on... attention. The information gathered will supplement two other data collection efforts which received... collected once from the CHIP program administrators. We are seeking a 1 year approval period....

  5. 20 CFR 416.1525 - Request for approval of a fee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Request for approval of a fee. 416.1525 Section 416.1525 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Representation of Parties § 416.1525 Request for approval of a fee....

  6. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  7. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  8. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  9. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  10. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  11. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  12. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  13. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  14. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  15. 5 CFR 6501.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 6501.102 Section 6501.102 Administrative Personnel NATIONAL ENDOWMENT FOR THE ARTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE ARTS § 6501.102 Prior...

  16. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  17. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  18. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  19. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  20. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  1. Rare cancer trial design: lessons from FDA approvals.

    PubMed

    Gaddipati, Himabindu; Liu, Ke; Pariser, Anne; Pazdur, Richard

    2012-10-01

    A systematic analysis of clinical trials supporting rare cancer drug approvals may identify concepts and terms that can inform the effective design of prospective clinical trials for rare cancers. In this article, using annual incidence ≤6 of 100,000 individuals to define "rare cancer," we identified clinical trials for rare cancers, supporting U.S. Food and Drug Administration (FDA) drug approvals for rare cancer indications between December 1987 and May 2011. We characterized each selected trial for study design, sample size, primary efficacy endpoints, and statistical comparisons. We also profiled trials with regard to type of submission, review designation, and approval type. Our results indicated that, of 99 trials that supported the approvals of 45 drugs for 68 rare cancer indications, one third of these trials were randomized; 69% of approvals relied on objective response rate as the primary efficacy endpoint; and 63% were based on a single trial. Drugs granted accelerated approval appeared more likely to be associated with postmarketing safety findings, relative to drugs approved under the regular approval. Data collected across clinical trials were robust: Use of different lower incidence rates in analyzing these trials did not have effects on trial characteristics. The absolute number of drug approvals for rare cancer indications increased markedly over time. We concluded that one third of clinical trials supporting drug approvals for rare cancer indications were randomized, affirming the feasibility and value of randomized trial design to evaluate drugs for rare cancers. Postmarketing safety data may relate to trial design and approval type. An operational definition of "rare cancer" can be useful for the analysis of trial data and for the path toward harmonizing the terminology in the area of clinical research on rare cancers.

  2. Venetoclax Approved for CLL.

    PubMed

    2016-06-01

    Venetoclax, a BCL2 inhibitor, has been approved for patients with chronic lymphocytic leukemia (CLL) who lack part of chromosome 17. The FDA also approved a companion diagnostic, the Vysis CLL FISH probe kit, to detect the 17p deletion in patients' peripheral blood.

  3. PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property

    EPA Pesticide Factsheets

    This notice explains EPA procedures in approving pesticide labels that include claims relating to the efficacy of agricultural pesticides and provides a warning to growers regarding reliance on label statements regarding pesticide efficacy.

  4. Five Supplements and Multiple Psychotic Symptoms: A Case Report

    PubMed Central

    Wong, Michelle K.; Darvishzadeh, Ayeh; Maler, Neal A.; Bota, Robert G.

    2016-01-01

    Dietary supplements, including vitamins, minerals, herbs, amino acids, and enzymes, have become increasingly more common and are used by approximately half of the US population. About three-fourths of supplements are obtained with no prescription from a physician, which raises medical concerns regarding safety as these products do not require US Food and Drug Administration approval. Common reasons for taking dietary supplements include improved mood, improved mental function, depression relief, anxiety reduction, and treatment of simple and migraine headaches. The use of herbs for medicinal purposes has a long-standing history among many cultures. We present the case of a 43-year-old man, who was taking dietary supplements, with a 6-month history of psychotic symptoms that increasingly caused impairment in functioning and eventually led to involuntary hospitalization. The published data with regard to supplements causing psychosis, herb-to-herb interaction, and reliability of herbal supplement manufacturers are discussed. PMID:27247830

  5. 78 FR 70294 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Administrative Matters AGENCY: Defense Acquisition Regulations System, Department of... technology. The Office of Management and Budget (OMB) has approved this information collection under...

  6. 78 FR 67133 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Publicizing Contract Actions AGENCY: Defense Acquisition Regulation System, Department... technology. The Office of Management and Budget (OMB) has approved this information collection...

  7. 78 FR 67132 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Contract...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Contract Pricing AGENCY: Defense Acquisition Regulations System, Department of Defense... technology. The Office of Management and Budget (OMB) has approved this information collection under...

  8. 77 FR 58817 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Contract Financing AGENCY: Defense Acquisition Regulations System, Department... technology. The Office of Management and Budget (OMB) has approved this information collection for...

  9. 46 CFR 8.430 - U.S. Supplement to class rules.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... authorization to participate in the ACP, a recognized classification society must prepare, and receive Commandant (CG-521) approval of, a U.S. Supplement to the recognized classification society's class rules... of that classification society or applicable international regulations....

  10. 46 CFR 8.430 - U.S. Supplement to class rules.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... authorization to participate in the ACP, a recognized classification society must prepare, and receive Commandant (CG-ENG) approval of, a U.S. Supplement to the recognized classification society's class rules... of that classification society or applicable international regulations....

  11. [Insufficient evidence supporting iron supplementation in anaemia during pregnancy].

    PubMed

    Wiegerinck, Melanie M; Mol, Ben Willem J

    2012-01-01

    The Royal Dutch Organization of Midwives (KNOV) recently presented their practice guideline 'Anaemia in midwifery practice'. The guideline identified available evidence on diagnosis, prognosis and treatment of anaemia in pregnancy. Anaemia based on iron deficiency and subsequent treatment with iron supplementation are probably the most frequent aspects of care for pregnant women. However, there is surprisingly enough no evidence of the efficacy of iron supplementation treatment on relevant clinical outcomes in pregnant women with anaemia. We plead to make the next guideline a multidisciplinary one. Such a guideline may lead to a large pragmatic trial evaluating the efficacy of iron supplementation treatment for patients with anaemia.

  12. Drugs Approved for Brain Tumors

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

  13. Drugs Approved for Prostate Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Prostate Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Prostate Cancer Abiraterone Acetate Bicalutamide Cabazitaxel Casodex (Bicalutamide) Degarelix Docetaxel ...

  14. Is It Really FDA Approved?

    MedlinePlus

    ... FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers ... dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device ...

  15. Drugs Approved for Thyroid Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  16. Tyrosine Supplementation Attenuates Cognitive and Psychomotor Deficits in Cold Environments

    DTIC Science & Technology

    2009-01-01

    with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1...Approved for public release; distribution unlimited In rats, dietary supplementation with the amino acid tyrosine (TYR) prevented depletion of central...that cold exposure degrades cognitive performance and supplementation with TYR alleviates working memory decrements, even with a reduced core

  17. Nutritional supplements and ergogenic AIDS.

    PubMed

    Liddle, David G; Connor, Douglas J

    2013-06-01

    Performance enhancing drugs, ergogenic aids, and supplements come in many forms. The financial, personal, social, and health-related impact of these substances has wide and varied consequences. This article reviews common substances and practices used by athletes. It discusses the history, use, effects, and adverse effects of androgenic anabolic steroids, peptide hormones, growth factors, masking agents, diuretics, volume expanders, β-blockers, amphetamines, caffeine, other stimulants, and creatine. The evidence base behind the use, safety, and efficacy of these items as well as testing for these substances is discussed.

  18. Doctor-patient communication and cancer patients' choice of alternative therapies as supplement or alternative to conventional care.

    PubMed

    Salamonsen, Anita

    2013-03-01

    Cancer patients' use of complementary and alternative medicine (CAM) is widespread, despite the fact that clinical studies validating the efficacy of CAM remain sparse in the Nordic countries. The purpose of this study was to explore possible connections between cancer patients' communication experiences with doctors and the decision to use CAM as either supplement or alternative to conventional treatment (CT). The Regional Committee for Medical and Health Research Ethics and the Norwegian Data Inspectorate approved the study. From a group of 52 cancer patients with self-reported positive experiences from use of CAM, 13 were selected for qualitative interviews. Six used CAM as supplement, and seven as alternative to CT, periodically or permanently. Communication experiences with 46 doctors were described. The analysis revealed three connections between doctor-patient communication and patients' treatment decisions: (i) negative communication experiences because of the use of CAM; (ii) negative communication experiences resulted in the decision to use CAM, and in some cases to decline CT; and (iii) positive communication experiences led to the decision to use CAM as supplement, not alternative to CT. The patients, including the decliners of CT, wanted to discuss treatment decisions in well-functioning interpersonal processes with supportive doctors. In doctors' practices and education of doctors, a greater awareness of potential positive and negative outcomes of doctor-patient communication that concern CAM issues could be of importance. More research is needed to safeguard CAM users' treatment decisions and their relationship to conventional health care.

  19. Drugs Approved for Neuroblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  20. Drugs Approved for Retinoblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  1. Drugs Approved for Leukemia

    Cancer.gov

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  2. Kansas Ethanol Lyons Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Kansas Ethanol, LLC, Lyons facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  3. Poet Marion Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  4. Poet Alexandria Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  5. Poet North Manchester Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  6. Poet Portland Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  7. Newborn Screening Tests Approved

    MedlinePlus

    ... The screens are used to detect four rare metabolic disorders To use the sharing features on this page, ... of screening tests designed to detect four rare metabolic disorders in newborns has been approved by the U.S. ...

  8. 21 CFR 314.60 - Amendments to an unapproved application, supplement, or resubmission.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...) FDA generally assumes that when an original application, supplement to an approved application, or... the “initial review cycle.”) FDA may instead defer review of the amendment until the subsequent...

  9. 78 FR 45116 - Approval and Promulgation of Air Quality Implementation Plans and Designation of Areas for Air...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-26

    ... proposing to approve the ammonia, Volatile Organic Compound (VOC), nitrogen oxide (NO X ), direct PM 2.5... provided ammonia and VOC emissions inventories to ] supplement the comprehensive emissions...

  10. Approved drugs and their problems in patient care: routes of administration and dosing.

    PubMed

    Cook, Stuart D

    2007-08-15

    Problems in patient care with regard to route of administration and dosing of currently approved drugs are reviewed. Dose, frequency and route of administration can make a difference in efficacy, side effects, quality of life, antigenicity, cost, and compliance.

  11. Punishments: What Predicts Adult Approval.

    ERIC Educational Resources Information Center

    Buntain-Ricklefs, Joanne J.; And Others

    1994-01-01

    A survey of 449 parents found that 24% experienced uncommon punishments (such as burning) during their childhoods and 6% approved; 45% experienced and 17% approved of common punishments (shaking); and 94% experienced and 88% approved of very common punishments (spanking). Approval of each punishment was related to experience. Race, income, and…

  12. 21 CFR 515.11 - Supplemental medicated feed mill license applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Supplemental medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Applications § 515.11 Supplemental medicated feed mill license applications. (a) After approval of a medicated...

  13. Evaluating the Efficacy of Three U.S. Department of Agriculture-Approved Antimicrobial Sprays for Reducing Shiga Toxin-Producing Escherichia coli Surrogate Populations on Bob Veal Carcasses.

    PubMed

    2016-06-01

    Effective antimicrobial intervention strategies to reduce Shiga toxin-producing Escherichia coli (STEC) risks associated with veal are needed. This study evaluated the efficacy of lactic acid (4.5%, pH 2.0), Citrilow (pH 1.2), and Beefxide (2.25%, pH 2.3) for reducing STEC surrogates on prerigor and chilled bob veal carcasses and monitored the effects of these interventions on chilled carcass color. Dehided bob veal carcasses were inoculated with a five-strain cocktail of rifampin-resistant, surrogate E. coli bacteria.E. coli surrogates were enumerated after inoculation, after water wash, after prechill carcass antimicrobial spray application, after chilling for 24 h, and after postchill carcass antimicrobial spray application; carcass color was measured throughout the process. A standard carcass water wash (∼50°C) reduced the STEC surrogate population by 0.9 log CFU/cm(2) (P ≤ 0.05). All three antimicrobial sprays applied to prerigor carcasses delivered an additional ∼0.5-log reduction (P ≤ 0.05) of the surrogates. Chilling of carcasses for 24 h reduced (P ≤ 0.05) the surrogate population by an additional ∼0.4 log cycles. The postchill application of the antimicrobial sprays provided no further reductions. Carcass L*, a*, and b* color values were not different (P > 0.05) among carcass treatments. Generally, the types and concentrations of the antimicrobial sprays evaluated herein did not negatively impact visual or instrumental color of chilled veal carcasses. This study demonstrates that warm water washing, followed by a prechill spray treatment with a low-pH chemical intervention, can effectively reduce STEC risks associated with veal carcasses; this provides processors a validated control point in slaughter operations.

  14. [Isoflavone-containing dietary supplements].

    PubMed

    Lehmann, Leane; Soukup, Sebastian T; Gerhäuser, Clarissa; Vollmer, Günter; Kulling, Sabine E

    2017-03-01

    Isoflavones (IFs) from soy and other legumes have weak estrogenic properties. Isolated IFs are available as dietary supplements and advertised to alleviate symptoms of menopause. The present chapter provides an overview of the occurrence, the chemical structure of IFs and their metabolites, the market situation and reviews the current evidence on the efficacy and safety of IF-containing dietary supplements.The biological effectiveness of IFs is attributable to the activation of the estrogen receptor (ER). Studies on the influence of IFs on endogenous estrogen levels in women show inconsistent results. So far, the European Food Safety Authority (EFSA) has rejected all submitted health claims for IFs due to insufficient scientific evidence for any of the postulated health effects. Based on the results of their recent risk assessment, the EFSA concluded that the available human studies did not support the hypothesis of adverse effects of isolated IFs on the human mammary gland, uterus or thyroid in healthy postmenopausal women. However, the assessment does not allow a general statement on the safety of IF-containing dietary supplements. Studies in animal models are often not comparable with the complex interactions in humans due to differences in the metabolism of IFs, in the developmental stage at time of consumption and in the temporarily restricted uptake of IFs during certain stages of life.

  15. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a biological product for which safety has... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  16. 40 CFR 40.145 - Supplemental grant conditions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... officer is required for project changes which may (1) alter the approved scope of the project, (2... ASSISTANCE RESEARCH AND DEMONSTRATION GRANTS § 40.145 Supplemental grant conditions. In addition to the EPA... requirements: (a) The project will be conducted in an environmentally sound manner. (b) In addition to...

  17. 40 CFR 40.145 - Supplemental grant conditions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... officer is required for project changes which may (1) alter the approved scope of the project, (2... ASSISTANCE RESEARCH AND DEMONSTRATION GRANTS § 40.145 Supplemental grant conditions. In addition to the EPA... requirements: (a) The project will be conducted in an environmentally sound manner. (b) In addition to...

  18. Risk Management Supplement to IEEE-15288.1

    DTIC Science & Technology

    2015-05-15

    AND MISSILE SYSTEMS CENTER TAILORING RISK MANAGEMENT SUPPLEMENT TO IEEE -15288.1 APPROVED FOR PUBLIC RELEASE...IEC- IEEE -15288: 2015, SYSTEMS AND SOFTWARE ENGINEERING — SYSTEM LIFE CYCLE PROCESSES...1 2.2. IEEE -15288.1: 2015, STANDARD FOR APPLICATION OF SYSTEMS ENGINEERING ON DEFENSE PROGRAMS

  19. Efficacy of High-Dose Supplementation With Oral Vitamin D3 on Depressive Symptoms in Dialysis Patients With Vitamin D3 Insufficiency: A Prospective, Randomized, Double-Blind Study.

    PubMed

    Wang, Ying; Liu, Ying; Lian, Yueying; Li, Ning; Liu, Hong; Li, Guanzeng

    2016-06-01

    Psychological problems are common among end-stage renal disease patients undergoing dialysis. We aim to evaluate whether high-dose vitamin D3 (VD3) supplementation has beneficial effects on depressive symptoms in dialysis patients. This prospective, randomized, and double-blind trial includes 746 dialysis patients with depression treated in 3 hospitals in Southeast China. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders criteria. Patients were randomly assigned to 52-week treatment of oral 50,000 IU/wk VD3 (cholecalciferol) (test group) or a placebo (control group). The presence of depressive symptoms was evaluated using the Chinese version of Beck Depression Inventory (BDI) II both before and after treatment. Sociodemographic data, clinical data, nutritional indexes, inflammatory biomarkers, and plasma VD3 concentrations were also determined. Finally, 726 patients completed the experiments, including 362 tested patients and 364 controls. After 52 weeks, the depressive symptoms were not significantly improved in the test group (mean BDI II scores changed from -1.1 ± 0.3 to -3.1 ± 0.6) versus the control group. Multivariable logistic regression showed BDI scores were not significantly improved in the test group versus the control group with adjustment for age, sex, comorbidity index, dialysis modality, or (OH)D levels (multivariable-adjusted mean change or MAMC [95% confidence interval (CI)], -2.3 [-2.48 to -1.83]) in the whole dialysis population. After stratification by depression types, the findings do support a significant relationship between the VD3 supplementation and the improvement in BDI II scores in dialysis patients with vascular depression (MAMC [95% CI], -4.4 [-5.08 to -2.76]), but the effect was not significant for major depressive disorders (MAMC [95% CI], -0.9 [-1.52 to -0.63]). The high-dose VD3 supplementation did not significantly reduce the depressive symptoms in our total dialysis population, but

  20. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... shall forward the completed application form and other data to Approval and Certification Center which..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  1. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... shall forward the completed application form and other data to Approval and Certification Center which..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  2. Ibrutinib: first global approval.

    PubMed

    Cameron, Fiona; Sanford, Mark

    2014-02-01

    Ibrutinib (Imbruvica™) is a small molecule, first-in-class, once-daily, orally available, Bruton's tyrosine kinase inhibitor that is under development for the treatment of B cell malignancies, including chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL), as well as multiple myeloma (MM), follicular lymphoma (FL) and Waldenstrom's macroglobulinemia (WM). It has been developed by Pharmacyclics, Inc. and Janssen Biotech, Inc. Ibrutinib acts by blocking B-cell antigen receptor signalling, thereby reducing malignant proliferation of B cells and inducing cell death. Based chiefly on findings from a phase Ib/II study, ibrutinib has been approved in the USA for the treatment of MCL in previously treated patients and is one of the first approvals through the US FDA's Breakthrough Therapy Designation Pathway. An application has been filed in the EU seeking regulatory approval in this indication. In both the USA and EU, further applications have been filed with regulatory bodies seeking approval for the use of ibrutinib in patients with previously treated CLL/small lymphocytic lymphoma (SLL). Phase III trials are underway worldwide to evaluate ibrutinib in the treatment of patients with CLL/SLL, DLBCL and MCL, and the agent is in phase II development for use in WM, FL and MM. This article summarizes the milestones in the development of ibrutinib leading to its first approval in MCL.

  3. 78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... INFORMATION CONTACT: Kelly Sheckler, Air Quality Modeling and Transportation Section, Air Planning Branch, Air... revised ozone National Ambient Air Quality Standards (NAAQS). See 73 FR 16436. The current action, however... demonstrated that it is consistent with the Clean Air Act. DATES: Written comments must be received on...

  4. Apremilast: first global approval.

    PubMed

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

    Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

  5. Blinatumomab: first global approval.

    PubMed

    Sanford, Mark

    2015-02-01

    Blinatumomab (BLINCYTO™) is a novel, bispecific T-cell engaging antibody that binds cluster of differentiation (CD) 19 antigens on blast cells while also binding and activating the CD3/T cell receptor complex, causing cell lysis. The antibody is being developed by Amgen as a treatment for haematological cancers that originate from B cell lines. Blinatumomab was approved by the US FDA in December 2014 for the treatment of adults with Philadelphia chromosome (Ph)-negative relapsed/refractory B-cell precursor acute lymphoblastic leukaemia (BCP-ALL). It is awaiting approval for this indication in the EU and is in phase III development in various countries. This article summarizes the milestones in the development of blinatumomab leading to its first approval for the treatment of Ph-negative BCP-ALL.

  6. Plecanatide: First Global Approval.

    PubMed

    Al-Salama, Zaina T; Syed, Yahiya Y

    2017-03-03

    Plecanatide (Trulance(TM)) is an oral guanylate cyclase-C agonist that is being developed by Synergy Pharmaceuticals for the treatment of gastrointestinal disorders, such as chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). It is a synthetic analogue of human uroguanylin, a 16 amino acid peptide that regulates ion and fluid transport in the gastrointestinal tract. In January 2017, plecanatide received its first global approval in the USA for the treatment of adult patients with CIC. Plecanatide is undergoing phase III investigation in IBS-C. This article summarizes the milestones in the development of plecanatide leading to this first approval in CIC.

  7. DIETARY SUPPLEMENT HYMECROMONE AND SORAFENIB: A NOVEL COMBINATION FOR THE CONTROL OF RENAL CELL CARCINOMA

    PubMed Central

    Benitez, Anaid; Yates, Travis J; Shamaldevi, N.; Bowen, Tim; Lokeshwar, Vinata B.

    2016-01-01

    PURPOSE Current treatments for metastatic RCC (mRCC) do not extend survival beyond a few months. Sorafenib (SF) is a targeted drug approved for mRCC, but it has modest efficacy. Hymecromone is a nontoxic dietary supplement with some antitumor activity at high doses (450 – 3000 mg/day). HC inhibits hyaluronic acid (HA) synthesis. HA promotes tumor growth and metastasis. We recently showed that HA-receptors CD44 and RHAMM are potential predictors of mRCC. We examined the anti-tumor properties of HC, SF, and their combination in RCC models. METHODS Using proliferation, clonogenic and apoptosis assays, effects of HC (0–32 μg/ml), SF (0–3.2 μg/ml) and HC+SF were examined in RCC cells (Caki–1, 786–O, ACHN, A498) and endothelial cells (HMVEC–L, HUVEC). Boyden chamber was used for motility and invasion assays. Apoptosis indicators, HA receptors, EGFR and c-Met were evaluated by immunoblotting. Efficacy of HC, SF and HC+SF was evaluated in the SF-resistant Caki–1 xenograft model. RESULTS HC+SF synergistically inhibited proliferation (>95%), motility/invasion (65%) and capillary formation (76%) in RCC and/or endothelial cells, and induced apoptosis by 8-fold (P<0.001). HC+SF inhibited HA synthesis and HA addition reversed the cytotoxicity of HC+SF. HC+SF up-regulated pro-apoptotic indicators and downregulated Mcl-1, CD44, RHAMM, phospho-EGFR and phospho-cMet levels. In all assays, HC and SF alone were ineffective. Oral administration of HC (50–200mg/kg) plus SF (30mg/kg) eradicated Caki–1 tumor growth without toxicity. HC and SF alone were ineffective. CONCLUSION This is the first study that demonstrates combination of SF with HC a non–toxic dietary supplement is highly effective in controlling RCC. PMID:23228386

  8. Food modification versus oral liquid nutrition supplementation.

    PubMed

    Silver, Heidi J

    2009-01-01

    Oral liquid nutrition supplements (ONS) are widely used in community, residential and healthcare settings. ONS are intended for individuals whose nutrient requirements cannot be achieved by conventional diet or food modification, or for the management of distinctive nutrient needs resulting from specific diseases and/or conditions. ONS appear to be most effective in patients with a body mass index of efficacy of food-based versus ONS nutrition interventions.

  9. Development of Safe and Effective Botanical Dietary Supplements

    PubMed Central

    2015-01-01

    Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug–botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements. PMID:26125082

  10. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  11. Heartland Winthrop Approval

    EPA Pesticide Factsheets

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  12. Poet Leipsic Approval

    EPA Pesticide Factsheets

    This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

  13. Poet Fostoria Approval

    EPA Pesticide Factsheets

    This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

  14. CORN, LP Goldfield Approval

    EPA Pesticide Factsheets

    This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

  15. Poet Lake Crystal Approval

    EPA Pesticide Factsheets

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

  16. FHR Iowa Falls Approval

    EPA Pesticide Factsheets

    This October 22, 2015, letter from EPA approves the petition from Flint Hills Resources, LLC, regarding non-grandfathered ethanol produced through the FHR Iowa Falls Process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the R

  17. Venetoclax: First Global Approval.

    PubMed

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL.

  18. Gevo, Inc. Approval

    EPA Pesticide Factsheets

    This December 22, 2016 letter from EPA approves the petition from Gevo, Inc. for butanol produced from corn starch and/or grain sorghum as renewable fuel and in some cases advanced biofuel under the Clean Air Act and the Renewable Fuel Standard Program.

  19. 40 CFR 52.1272 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Mississippi § 52.1272 Approval status. With the exceptions set forth in this subpart, the Administrator approves Mississippi's plan for...

  20. Dietary supplement research portfolio at the NIH, 2009-2011.

    PubMed

    Garcia-Cazarin, Mary L; Wambogo, Edwina A; Regan, Karen S; Davis, Cindy D

    2014-04-01

    The U.S. dietary supplement market increased by 7.5% in 2012 compared with 2011, reaching $32.5 billion in sales. Therefore, federally supported research on dietary supplements is important to determine their health effects, safety, and efficacy. A portfolio analysis was performed across the NIH and the Office of Dietary Supplements (ODS) for fiscal years (FYs) 2009-2011 by using the databases Human Nutrition Research Information Management (HNRIM) and Computer Access to Research on Dietary Supplements (CARDS). The results indicated that total NIH dietary supplement-related funding for FYs 2009-2011 was $855 million ($295 million in 2009, $311 million in 2010, and $249 million in 2011). The institutes and centers with the highest investment in dietary supplement research were as follows: the National Heart, Lung, and Blood Institute ($135 million); the National Cancer Institute ($188 million); the National Center for Complementary and Alternative Medicine ($99 million); the National Institute of Diabetes and Digestive and Kidney Diseases ($68 million); the National Institute of Environmental Health Sciences ($58 million); and the ODS ($32 million). The dietary supplement ingredients receiving the most funding were botanicals (22%), vitamins (20%), lipids (14%), and minerals and trace elements (10%). The top 3 outcome research areas were cancer (61% of total dietary supplement investment), cardiovascular disease (47%), and women's reproductive health (38%). In FYs 2009, 2010, and 2011, the ODS provided 3.5%, 3.6%, and 4.1%, respectively, of the NIH investment in dietary supplement research. ODS funding focused on cellular, enzymatic, or molecular mechanisms (64% of total ODS funding). This portfolio analysis demonstrates that the NIH has committed substantial funding to dietary supplement research in an effort to expand the scientific knowledge base on the efficacy and safety of dietary supplements.

  1. Supplementation in the Columbia Basin : Summary Report Series : Final Report.

    SciTech Connect

    United States. Bonneville Power Administration.

    1992-12-01

    of Supplementation Project (RASP) was initiated as a result of a request by NPPC to address long-standing concerns about the need to coordinate supplementation research, monitoring and evaluation. Such coordination was also recommended by the Supplementation Technical Work Group. In August 1990, the NPPC gave conditional approval to proceed with the final design of the Yakima Production Project. The Council called on the Bonneville Power Administration (BPA) to fund immediately a supplementation assessment to reevaluate, prioritize and coordinate all existing and planned supplementation monitoring and evaluation activities in the basin. Providing for the participation of the fishery agencies and tribes and others having expertise in this area. RASP addresses four principal objectives: (1) provide an overview of ongoing and planned supplementation activities and identify critical uncertainties associated with supplementation, (2) construct a conceptual framework and model which estimates the potential benefits and risks of supplementation and prioritizes uncertainties, (3) provide guidelines for the development of supplementation projects, (4) develop a plan for regional coordination of research and monitoring. These objectives, once attained, will provide the technical tools fishery managers need to carry out the Council's direction to protect and enhance salmon and steelhead. RASP has further divided the four broad objectives into 12 technical topics: (1) definition of supplementation; (2) description of the diversity of supplementation projects; (3) objectives and performance standards; (4) identification of uncertainties; (5) supplementation theory; (6) development of a conceptual model of supplemented populations; (7) development of spreadsheet model of risks and benefits of supplementation; (8) classification of stocks, streams, and supplementation strategies; (9) regional design of supplementation evaluation and monitoring; (10) guidelines for planning

  2. Pitolisant: First Global Approval.

    PubMed

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.

  3. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health

    PubMed Central

    Allen, Katrina J; Panjari, Mary; Koplin, Jennifer J; Ponsonby, Anne-Louise; Vuillermin, Peter; Gurrin, Lyle C; Greaves, Ronda; Carvalho, Natalie; Dalziel, Kim; Tang, Mimi L K; Lee, Katherine J; Wake, Melissa; Curtis, Nigel; Dharmage, Shyamali C

    2015-01-01

    Introduction Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6–8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. Methods nd analysis Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited. Ethics and dissemination The VITALITY study is approved by the Royal Children's Hospital (RCH) Human Research Ethics Committee (#34168). Outcomes will be disseminated through publication and will be presented at scientific conferences. Trial registration numbers ANZCTR12614000334606 and NCT02112734; pre-results. PMID:26674499

  4. Integrating dietary supplements into cancer care.

    PubMed

    Frenkel, Moshe; Abrams, Donald I; Ladas, Elena J; Deng, Gary; Hardy, Mary; Capodice, Jillian L; Winegardner, Mary F; Gubili, J K; Yeung, K Simon; Kussmann, Heidi; Block, Keith I

    2013-09-01

    Many studies confirm that a majority of patients undergoing cancer therapy use self-selected forms of complementary therapies, mainly dietary supplements. Unfortunately, patients often do not report their use of supplements to their providers. The failure of physicians to communicate effectively with patients on this use may result in a loss of trust within the therapeutic relationship and in the selection by patients of harmful, useless, or ineffective and costly nonconventional therapies when effective integrative interventions may exist. Poor communication may also lead to diminishment of patient autonomy and self-efficacy and thereby interfere with the healing response. To be open to the patient's perspective, and sensitive to his or her need for autonomy and empowerment, physicians may need a shift in their own perspectives. Perhaps the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. Today's informed patients truly value physicians who appreciate them as equal participants in making their own health care choices. To reach a mutually informed decision about the use of these supplements, the Clinical Practice Committee of The Society of Integrative Oncology undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of leading supplements that have the best suggestions of benefit was constructed by leading researchers and clinicians who have experience in using these supplements. This list includes curcumin, glutamine, vitamin D, Maitake mushrooms, fish oil, green tea, milk thistle, Astragalus, melatonin, and probiotics. The list includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would

  5. Fatty acid and phytosterol content of commercial saw palmetto supplements.

    PubMed

    Penugonda, Kavitha; Lindshield, Brian L

    2013-09-13

    Saw palmetto supplements are one of the most commonly consumed supplements by men with prostate cancer and/or benign prostatic hyperplasia (BPH). Some studies have found significant improvements in BPH and lower urinary tract symptoms (LUTS) with saw palmetto supplementation, whereas others found no benefits. The variation in the efficacy in these trials may be a result of differences in the putative active components, fatty acids and phytosterols, of the saw palmetto supplements. To this end, we quantified the major fatty acids (laurate, myristate, palmitate, stearate, oleate, linoleate) and phytosterols (campesterol, stigmasterol, β-sitosterol) in 20 commercially available saw palmetto supplements using GC-FID and GC-MS, respectively. Samples were classified into liquids, powders, dried berries, and tinctures. Liquid saw palmetto supplements contained significantly higher (p < 0.05) concentrations of total fatty acids (908.5 mg/g), individual fatty acids, total phytosterols (2.04 mg/g), and individual phytosterols, than the other supplement categories. Powders contained significantly higher (p < 0.05) concentrations of total fatty acids than tinctures, which contain negligible amounts of fatty acids (46.3 mg/g) and phytosterols (0.10 mg/g). Our findings suggest that liquid saw palmetto supplements may be the best choice for individuals who want to take a saw palmetto supplement with the highest concentrations of both fatty acids and phytosterols.

  6. Fatty Acid and Phytosterol Content of Commercial Saw Palmetto Supplements

    PubMed Central

    Penugonda, Kavitha; Lindshield, Brian L.

    2013-01-01

    Saw palmetto supplements are one of the most commonly consumed supplements by men with prostate cancer and/or benign prostatic hyperplasia (BPH). Some studies have found significant improvements in BPH and lower urinary tract symptoms (LUTS) with saw palmetto supplementation, whereas others found no benefits. The variation in the efficacy in these trials may be a result of differences in the putative active components, fatty acids and phytosterols, of the saw palmetto supplements. To this end, we quantified the major fatty acids (laurate, myristate, palmitate, stearate, oleate, linoleate) and phytosterols (campesterol, stigmasterol, β-sitosterol) in 20 commercially available saw palmetto supplements using GC-FID and GC-MS, respectively. Samples were classified into liquids, powders, dried berries, and tinctures. Liquid saw palmetto supplements contained significantly higher (p < 0.05) concentrations of total fatty acids (908.5 mg/g), individual fatty acids, total phytosterols (2.04 mg/g), and individual phytosterols, than the other supplement categories. Powders contained significantly higher (p < 0.05) concentrations of total fatty acids than tinctures, which contain negligible amounts of fatty acids (46.3 mg/g) and phytosterols (0.10 mg/g). Our findings suggest that liquid saw palmetto supplements may be the best choice for individuals who want to take a saw palmetto supplement with the highest concentrations of both fatty acids and phytosterols. PMID:24067389

  7. Vortioxetine: first global approval.

    PubMed

    Gibb, Andrew; Deeks, Emma D

    2014-01-01

    Vortioxetine is an orally administered small molecule developed by Lundbeck A/S for the once-daily treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Vortioxetine received its first global approval for MDD in the USA in September 2013 and regulatory approval for its use in this indication in the EU (where it has received a positive opinion) and Canada is awaited. The drug is a bis-aryl-sulphanyl amine compound that combines serotonin (5-HT) reuptake inhibition with other characteristics, including receptor activity modulation. In vitro studies indicate that vortioxetine is an inhibitor of the 5-HT transporter and is a 5-HT(1D), 5-HT₃ and 5-HT₇ receptor antagonist, a 5-HT(1A) receptor agonist and a 5-HT(1B) receptor partial agonist. Animal and in vitro studies indicate that several neurotransmitter systems may be impacted by vortioxetine, with the drug enhancing levels of 5-HT, noradrenaline, dopamine, acetylcholine and histamine in certain areas of the brain, as well as modulating γ-aminobutyric acid and glutamate neurotransmission. Phase III trials of vortioxetine in both MDD and GAD have been conducted worldwide. This article summarizes the milestones in the development of vortioxetine leading to this first approval for MDD.

  8. Osimertinib: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-02-01

    Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC.

  9. Baricitinib: First Global Approval.

    PubMed

    Markham, Anthony

    2017-03-13

    Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Regulatory approval to market baricitinib as a treatment for RA has also been sought in the USA and Japan. This article summarizes the milestones in the development of baricitinib leading to this first global approval for the treatment for moderate to severe active RA in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

  10. Calcium supplements and cardiovascular risk: 5 years on.

    PubMed

    Bolland, Mark J; Grey, Andrew; Reid, Ian R

    2013-10-01

    Calcium supplements have been widely used by older men and women. However, in little more than a decade, authoritative recommendations have changed from encouraging the widespread use of calcium supplements to stating that they should not be used for primary prevention of fractures. This substantial shift in recommendations has occurred as a result of accumulated evidence of marginal antifracture efficacy, and important adverse effects from large randomized controlled trials of calcium or coadministered calcium and vitamin D supplements. In this review, we discuss this evidence, with a particular focus on increased cardiovascular risk with calcium supplements, which we first described 5 years ago. Calcium supplements with or without vitamin D marginally reduce total fractures but do not prevent hip fractures in community-dwelling individuals. They also cause kidney stones, acute gastrointestinal events, and increase the risk of myocardial infarction and stroke. Any benefit of calcium supplements on preventing fracture is outweighed by increased cardiovascular events. While there is little evidence to suggest that dietary calcium intake is associated with cardiovascular risk, there is also little evidence that it is associated with fracture risk. Therefore, for the majority of people, dietary calcium intake does not require close scrutiny. Because of the unfavorable risk/benefit profile, widespread prescribing of calcium supplements to prevent fractures should be abandoned. Patients at high risk of fracture should be encouraged to take agents with proven efficacy in preventing vertebral and nonvertebral fractures.

  11. Supplements for Diabetes Mellitus: A Review of the Literature.

    PubMed

    Yilmaz, Zera; Piracha, Fawad; Anderson, Leeann; Mazzola, Nissa

    2016-09-11

    The primary approach to controlling diabetes involves diet and lifestyle modification combined with pharmacologic interventions. Patients who are interested in exploring dietary supplements in the management of diabetes may have questions about which supplement to choose and whether any issues will arise with their current medication regimen. After reading this review, the pharmacist should be able to identify supplements that may provide benefit to improve diabetes management, understand what potential harm to the patient may occur, and be able to assist the patient in choosing high-quality supplements. This review will focus on the safety and efficacy data surrounding nicotinamide, ginseng, fenugreek, vitamin D, chromium, and cinnamon. These supplements are commonly listed in general circulation periodicals with claims to improve blood sugar management. Efficacy data showed a modest decrease in fasting plasma glucose of -0.96 mmol/dL (-17.29 mg/dL) for fenugreek and -24.59 mg/dL for cinnamon. It remains to be seen whether supplementation with these products can affect outcomes such as morbidity and mortality. Despite many studies being available, the majority lack uniformity across multiple dimensions, including varying participant characteristics, inconsistent formulations of supplement and dose, and differing study durations. This, coupled with variation in quality and purity of commercially available products, prevents universal recommendation for use in diabetes management.

  12. Dietary supplements and team-sport performance.

    PubMed

    Bishop, David

    2010-12-01

    highlighted in this review needs to be conducted using team-sport athletes and using team-sport-relevant testing (e.g. single- and multiple-sprint performance). It should also be considered that there is no guarantee that dietary supplements that improve isolated performance (i.e. single-sprint or jump performance) will remain effective in the context of a team-sport match. Thus, more research is also required to investigate the effects of dietary supplements on simulated or actual team-sport performance. A second aim of this review was to investigate any health issues associated with the ingestion of the more commonly promoted dietary supplements. While most of the supplements described in the review appear safe when using the recommended dose, the effects of higher doses (as often taken by athletes) on indices of health remain unknown, and further research is warranted. Finally, anecdotal reports suggest that team-sport athletes often ingest more than one dietary supplement and very little is known about the potential adverse effects of ingesting multiple supplements. Supplements that have been demonstrated to be safe and efficacious when ingested on their own may have adverse effects when combined with other supplements. More research is required to investigate the effects of ingesting multiple supplements (both on performance and health).

  13. Approved and experimental countermeasures against pestiviral diseases: Bovine viral diarrhea, classical swine fever and border disease.

    PubMed

    Newcomer, Benjamin W; Givens, M Daniel

    2013-10-01

    The pestiviruses, bovine viral diarrhea virus (BVDV), classical swine fever (CSFV) and border disease virus, are important livestock pathogens in many countries, but current vaccines do not completely prevent the spread of infection. Control of pestiviral diseases is especially difficult due to the constant viremia and viral shedding of persistently infected (PI) animals, which must be identified and eliminated to prevent disease transmission. Existing vaccines are limited by the delay between vaccination and the onset of protection, the difficulty of differentiating serologically between vaccinated and naturally infected animals and the need for broad vaccine cross-protection against diverse virus strains. Antiviral therapy could potentially supplement vaccination by providing immediate protection in the case of an outbreak. Numerous compounds with in vitro antiviral activity against BVDV have been identified through its role as a surrogate for hepatitis C virus. Fewer drugs active against CSFV have been identified, but many compounds that are effective against BVDV will likely inhibit CSFV, given their similar genomic sequences. While in vitro research has been promising, the paucity of efficacy studies in animals has hindered the commercial development of effective antiviral drugs against the pestiviruses. In this article, we summarize the clinical syndromes and routes of transmission of BVD, CSF and border disease, discuss currently approved vaccines, review efforts to develop antiviral therapies for use in outbreak control and suggest promising directions for future research.

  14. Will iron supplementation given during menstruation improve iron status better than weekly supplementation?

    PubMed

    Februhartanty, Judhiastuty; Dillon, Drupadi; Khusun, Helda

    2002-01-01

    To investigate the efficacy of two different iron supplements administered either on a weekly basis or during menstruation, a 16-week community experimental study was carried out among postmenarcheal female adolescent students in Kupang, East Nusa Tenggara, Indonesia. Forty eight students received a placebo tablet weekly, 48 other students got an iron tablet weekly and 41 students took an iron tablet for four consecutive days during their menstruation cycle. All subjects were given deworming tablets before supplementation. Haemoglobin, serum ferritin, height, weight, mid-upper arm circumference and dietary intake were assessed before and after intervention. The supplementation contributed to a significant improvement in the iron status of the intervention groups compared to the placebo group (P < 0.05). In the menstruation group, the haemoglobin concentrations of the anaemic subjects improved significantly (P < 0.05) while for the non-anaemic subjects, serum ferritin concentrations also increased significantly (P < 0.05). In the weekly group for anaemic and nonanaemic subjects, there was a significant increase in both haemoglobin and serum ferritin concentrations (P < 0.05). This study revealed that weekly supplementation of iron tablets continued for 16 weeks contributed a higher improvement to haemoglobin concentration, compared with supplementing iron tablets for four consecutive days during menstruation for four menstrual cycles. This suggests that weekly iron supplementation is preferable.

  15. Family Living Supplement.

    ERIC Educational Resources Information Center

    Truitt, Debbie

    This family living supplement contains 125 supplemental ideas and strategies designed to help vocational home economics teachers increase student motivation and enrich the teaching process. Ideas and strategies are organized into seven sections. These are career planning, securing a job, and career success; managing financial resources, buying…

  16. In sickness and in health: the widespread application of creatine supplementation.

    PubMed

    Gualano, Bruno; Roschel, Hamilton; Lancha-Jr, Antonio Herbert; Brightbill, Charles E; Rawson, Eric S

    2012-08-01

    There is an extensive and still growing body of the literature supporting the efficacy of creatine (Cr) supplementation. In sports, creatine has been recognized as the most effective nutritional supplement in enhancing exercise tolerance, muscle strength and lean body mass. From a clinical perspective, the application of Cr supplementation is indeed exciting. Evidences of benefits from this supplement have been reported in a broad range of diseases, including myopathies, neurodegenerative disorders, cancer, rheumatic diseases, and type 2 diabetes. In addition, after hundreds of published studies and millions of exposures creatine supplementation maintains an excellent safety profile. Thus, we contend that the widespread application of this supplement may benefit athletes, elderly people and various patient populations. In this narrative review, we aimed to summarize both the ergogenic and therapeutic effects of Cr supplementation. Furthermore, we reviewed the impact of Cr supplementation on kidney function.

  17. Should supplemental antioxidant administration be avoided during chemotherapy and radiation therapy?

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Despite nearly two decades of research investigating the use of dietary antioxidant supplementation during conventional chemotherapy and radiation therapy, controversy remains about the efficacy and safety of this complementary treatment. Several studies of concurrent antioxidant administration with...

  18. Supplemental instruction in chemistry

    NASA Astrophysics Data System (ADS)

    Lundeberg, Mary A.

    This study was designed to measure some effects of supplemental instruction in chemistry. Supplemental instruction is a peer-led cooperative learning program that encourages students to develop conceptual understanding by articulating both understandings and misconceptions in a think-aloud fashion. Supplemental instruction was offered three hours weekly outside of class and lab time for students in four classes of General Organic and Biological Chemistry. Over a two-year period 108 students volunteered to participate in this program; 45 students did not participate. As measured by final grades in chemistry and responses to a questionnaire, supplemental instruction was effective in increasing students' achievement in chemistry. Further research is needed to determine the in-depth effects of supplemental instruction on students' learning, problem solving, and self-esteem.

  19. 76 FR 30738 - Agency Information Collection Activities: Form G-845 and Form G-845 Supplement, Revision of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form G-845 and Form G- 845 Supplement, Revision of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection under Review: Form G- 845 and Form G-845 Supplement,...

  20. Beware of Fraudulent 'Dietary Supplements'

    MedlinePlus

    ... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers ... Supplements Dietary Supplements More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical ...

  1. Herbs, Supplements and Alternative Medicines

    MedlinePlus

    ... Living With Diabetes > Treatment and Care > Medication > Other Treatments > Herbs, Supplements, and Alternative Medicines Share: Print Page Text ... magazine: meds-other, In this section Medication Other Treatments Herbs, Supplements, and Alternative Medicines Types of Dietary Supplements ...

  2. Supplemental design requirements document, Project W026. Revision 3

    SciTech Connect

    Weidert, J.R.

    1993-10-08

    This document supplements and extends the Functional Design Criteria, SP-W026-FDC-001, for the Waste Receiving and Processing Facility (WRAP), Module 1. It provides additional detailed requirements, summarizes key Westinghouse Hanford Company design guidance, and establishes baseline technical agreements to be used in definitive design of the WRAP-1 facility. Revision 3 of the Supplemental Design Requirements Document has been assigned an Impact Level of 3ESQ based on the content of the entire revision. The actual changes made from Revision 2 have an Impact Level of 3S and the basis for these changes was previously reviewed and approved per WHC correspondence No. 9355770.

  3. The dilemma of approving antidotes.

    PubMed

    Steffen, Christian

    2007-04-20

    Clinical trials with antidotes are difficult to perform for a variety of practical, ethical, and financial reasons. As acute poisoning is a rare event, the commercial interest in basic and clinical research is low. Poisoned patients are usually not available for normal clinical trial procedures and, if they are, they cannot give informed consent. This situation results in a dilemma: antidotes are essential drugs. A resolution of the Council of Europe requests to guarantee the optimal availability of antidotes and the improvement of their use. As comprehensive data on the efficacy of antidotes are often missing, a marketing authorisation under exceptional circumstances according to Article 14(8) of Regulation (EC) No. 276/2004, will often be the only way to get an approval, as: (1) the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence ("orphan drug"), (2) in the present state of scientific knowledge, comprehensive information cannot be provided, or (3) it would be contrary to generally accepted principles of medical ethics to collect such data. Typically, data on antidotes are obtained from a patchwork of studies with animals, human tissue and a few observations from human poisoning corroborated with data from clinical observations and biochemistry. Generalisations from chemical and mechanistic similarities between groups of poisons are usual, but often lack scientific evidence. Current standards of good clinical practice can rarely be observed. Therefore, public funding and other financial support are necessary incentives to initiate trials in this important area.

  4. Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

    PubMed

    Sax, Joanna K

    2015-01-01

    Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

  5. Supplements for exotic pets.

    PubMed

    Mejia-Fava, Johanna; Colitz, Carmen M H

    2014-09-01

    The use of supplements has become commonplace in an effort to complement traditional therapy and as part of long-term preventive health plans. This article discusses historical and present uses of antioxidants, vitamins, and herbs. By complementing traditional medicine with holistic and alternative nutrition and supplements, the overall health and wellness of exotic pets can be enhanced and balanced. Further research is needed for understanding the strengths and uses of supplements in exotic species. Going back to the animals' origin and roots bring clinicians closer to nature and its healing powers.

  6. Safinamide: first global approval.

    PubMed

    Deeks, Emma D

    2015-04-01

    Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson's disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

  7. Lesinurad: First Global Approval.

    PubMed

    Hoy, Sheridan M

    2016-03-01

    Lesinurad (ZURAMPIC(®)) is an oral urate-anion exchanger transporter 1 (URAT1) inhibitor developed by Ardea Biosciences (a subsidiary of AstraZeneca) for the treatment of hyperuricaemia associated with gout. It reduces serum uric acid (sUA) levels by inhibiting the function of the transporter proteins (URAT1 and organic anion transporter 4) involved in uric acid reabsorption in the kidney. In December 2015, lesinurad was approved in the USA as combination therapy with a xanthine oxidase inhibitor for the treatment of hyperuricaemia associated with gout in patients who have not achieved sUA target levels with a xanthine oxidase inhibitor alone. Lesinurad has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for this indication and is in phase III development as a combination therapy in several other countries. This article summarizes the milestones in the development of lesinurad leading to this first approval for hyperuricaemia associated with gout.

  8. Lenvatinib: first global approval.

    PubMed

    Scott, Lesley J

    2015-04-01

    Lenvatinib (Lenvima™) is a multitargeted receptor kinase inhibitor that inhibits the kinase activities of vascular endothelial-derived growth factor receptors 1, 2 and 3, fibroblast growth factor receptors 1, 2, 3 and 4, platelet-derived growth factor receptor α, RET and KIT. In addition to their role in normal cellular function, these kinases have been implicated in pathogenic angiogenesis, tumour growth and cancer progression. Lenvatinib is being developed by Eisai Co. Ltd for the treatment of solid tumours, primarily for differentiated thyroid cancer, and other malignancies. A capsule formulation of the drug has received approval in the USA for use in locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvatinib is in pre-registration for this indication in the EU, Australia, Brazil, Canada, Japan, South Korea, Russia, Singapore and Switzerland, and is in phase 3 development in Argentina, Chile and Thailand. Lenvatinib has orphan designation in the EU and Japan for use in differentiated thyroid cancer. In addition, an ongoing global, phase 3 trial is evaluating the use of lenvatinib as first-line treatment in unresectable hepatocellular carcinoma. This article summarizes the milestones in the development of lenvatinib leading to this first approval in locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

  9. Obinutuzumab: first global approval.

    PubMed

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  10. FDA 101: Dietary Supplements

    MedlinePlus

    ... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers ... Knowledge About Vitamins More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical ...

  11. Breastfeeding: Vitamin D Supplementation

    MedlinePlus

    ... able to synthesize additional vitamin D through routine sunlight exposure. However, published reports of cases of vitamin ... a vitamin supplement or from adequate exposure to sunlight. A number of factors decrease the amount of ...

  12. Supplements to Textbook Materials.

    ERIC Educational Resources Information Center

    Holmes, Ken

    1994-01-01

    Describes the many kinds of materials that English teachers can draw upon to enrich and expand students' experiences with literature. Outlines ancillary materials used to supplement the study of William Shakespeare's "Julius Caesar." (HB)

  13. Dietary Supplements for Toddlers

    MedlinePlus

    ... about which supplements are needed and the amounts. Iron Deficiency Iron deficiency does occur among some young children and ... need to receive at least 15 milligrams of iron a day in their food, but many fail ...

  14. Iron supplements (image)

    MedlinePlus

    The mineral iron is an essential nutrient for humans because it is part of blood cells, which carry oxygen to all body cells. There is no conclusive evidence that iron supplements contribute to heart attacks.

  15. Use of biomarkers for assessing radiation injury and efficacy of countermeasures

    PubMed Central

    Singh, Vijay K; Newman, Victoria L; Romaine, Patricia LP; Hauer-Jensen, Martin; Pollard, Harvey B

    2016-01-01

    Several candidate drugs for acute radiation syndrome (ARS) have been identified that have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation countermeasures for ARS are therefore presently based on animal studies and Phase I safety study in healthy volunteers. The Animal Efficacy Rule, which underlies the Food and Drug Administration approval pathway, requires a sound understanding of the mechanisms of injury, drug efficacy, and efficacy biomarkers. In this context, it is important to identify biomarkers for radiation injury and drug efficacy that can extrapolate animal efficacy results, and can be used to convert drug doses deduced from animal studies to those that can be efficacious when used in humans. Here, we summarize the progress of studies to identify candidate biomarkers for the extent of radiation injury and for evaluation of countermeasure efficacy. PMID:26568096

  16. Use of biomarkers for assessing radiation injury and efficacy of countermeasures.

    PubMed

    Singh, Vijay K; Newman, Victoria L; Romaine, Patricia Lp; Hauer-Jensen, Martin; Pollard, Harvey B

    2016-01-01

    Several candidate drugs for acute radiation syndrome (ARS) have been identified that have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation countermeasures for ARS are therefore presently based on animal studies and Phase I safety study in healthy volunteers. The Animal Efficacy Rule, which underlies the Food and Drug Administration approval pathway, requires a sound understanding of the mechanisms of injury, drug efficacy, and efficacy biomarkers. In this context, it is important to identify biomarkers for radiation injury and drug efficacy that can extrapolate animal efficacy results, and can be used to convert drug doses deduced from animal studies to those that can be efficacious when used in humans. Here, we summarize the progress of studies to identify candidate biomarkers for the extent of radiation injury and for evaluation of countermeasure efficacy.

  17. Bibliography of In-House and Contract Reports. Supplement 15.

    DTIC Science & Technology

    1988-04-01

    15 Annemarie Black E. James Books Karen Carroll April 1988 U- D" LECTE APPROVED FOR PUBLIC RELEASE; DISTRIBUTION IS UNLIMITED. U.S. ARMY CORPS OF...Security Classification) Bibliography of In-House and Contract Reports, Supplement 15 12. PERSONAL AUTHOR(S) Annemarie Black, E. James Books and Karen...this report. 13 ETL-0433 AD-A171 561 A PROGRAMMING ENVIRONMENT FOR PARALLEL VISION ALGORITHMS August 1986 0 Brown , Christopher University of Rochester

  18. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... poultry products inspection regulations to expand the circumstances in which FSIS will generically approve the labels of meat and poultry products. The Agency also is consolidating the regulations that provide for the approval of labels for meat products and poultry products into a new Code of...

  19. 76 FR 75809 - Prior Label Approval System: Generic Label Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... amend the meat and poultry products inspection regulations to expand the circumstances in which FSIS will generically approve the labels of meat and poultry products. The Agency also is proposing to combine the regulations that provide for the approval of labels for meat products and poultry...

  20. 78 FR 18973 - Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... Energy Regulatory Commission Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval Take notice that on February 28, 2013, as supplemented on March 12, 2013, Bridgeline Holdings, L.P. filed for... free). For TTY, call (202) 502-8659. Comment Date: 5:00 p.m. Eastern Time on Monday, April 1,...

  1. 76 FR 2853 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure State...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-18

    ...; Infrastructure State Implementation Plan Requirement To Address Interstate Transport for the 2006 24-Hour PM2.5... supplemental submittal as another regulation imposing BACT level controls for PM2.5 precursors and SIP-approved... that the analysis required under section 5-501 of the Executive Order has the potential to...

  2. 78 FR 57487 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts; Regional Haze

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ...EPA is approving a revision to the Massachusetts State Implementation Plan (SIP) that addresses regional haze for the first planning period from 2008 through 2018. The revision was submitted by the Massachusetts Department of Environmental Protection (MassDEP) on December 30, 2011, with supplemental final submittals on August 9, 2012 and August 28, 2012. These submittals address the......

  3. 76 FR 59345 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ...EPA is proposing to approve SIP revisions submitted on December 18, 2009, and December 22, 2010 (supplemental submission) by the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (DAQ), to support North Carolina's request to redesignate the Greensboro-Winston-Salem-High Point fine particulate matter......

  4. 76 FR 28971 - Atlanta Gas Light Company; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ... Federal Energy Regulatory Commission Atlanta Gas Light Company; Notice of Petition for Rate Approval Take notice that on May 9, 2011, as supplemented on May 11, 2011, Atlanta Gas Light Company (Atlanta Gas Light... for transportation service. Atlanta Gas Light states the rate election consists of the maximum...

  5. 75 FR 38589 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Options on...

  6. 77 FR 48062 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... supplemented its request on September 16, 2011. In addition to approval of Illinois' ozone redesignation... certified its 2011 ozone data for the Indiana portion of the Greater Chicago area. In addition, Wisconsin... from the economic recession. In addition, the Chicago-Gary-Lake County, IL-IN area has continued...

  7. 78 FR 60704 - Approval and Promulgation of Air Quality Implementation Plan; Illinois; Redesignation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... Oxides (NO X ), Sulfur Dioxide (SO 2 ), Volatile Organic Compound (VOC), ammonia, and primary PM 2.5... supplemental submission to the EPA on May 6, 2013, the IEPA submitted VOC and ammonia emission inventories to... Chicago area; approve 2002 primary PM 2.5 , NO X , SO 2 , VOC, and ammonia emission inventories for...

  8. 76 FR 73955 - Approval and Promulgation of Air Quality Implementation Plans; Maine; Regional Haze

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ...EPA is proposing approval of a revision to the Maine State Implementation Plan (SIP) submitted by the Maine Department of Environmental Protection (Maine DEP) on December 9, 2010, with supplemental submittals on September 14, 2011 and November 9, 2011, that addresses regional haze for the first planning period from 2008 through 2018. This revision addresses the requirements of the Clean Air......

  9. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for certain outside activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior...

  10. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for certain outside activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior...

  11. 76 FR 3684 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Credit Default Options in,...

  12. CLSI performance standards for antimicrobial susceptibility testing of bacteria isoloated from aquatic animals; second information supplement. CLSI document VET03/VET04-S2

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The supplemental information presented in this document is intended for use with the antimicrobial susceptibility testing procedures published in the following Clinical and Laboratory Standards Institute (CLSI) approved documents VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacte...

  13. Senate approves energy bill

    NASA Astrophysics Data System (ADS)

    Bush, Susan

    The controversial National Energy Security Act of 1992 (S2166) was approved by the Senate in a 94-4 vote on February 19 after a circuitous route through the chamber. The original energy bill, SI220, was introduced last summer and was blocked from coming to the Senate floor by a filibuster. The new bill is considerably different from the original energy bill.The sponsor of the bill, S. Bennett Johnston (D-La.), and cosponsor Malcolm Wallop (R-Wyo.) agreed to abandon certain controversial components in order to keep the bill moving. The main program dropped is the proposal to open parts of the Arctic National Wildlife Refuge (ANWR) to oil and gas drilling. Environmentalists were opposed to the drilling and were able to block the entire bill last fall, so Johnston agreed to abandon the provision.

  14. The Influence of 8-Weeks of Whey Protein and Leucine Supplementation on Physical and Cognitive Performance

    DTIC Science & Technology

    2009-03-01

    extension resistance training than did a carbohydrate placebo (22%). Protein and branched chain amino acids ( BCAA ) supplementation may also improve... BCAAs scored better on both mood levels and 2 Approved for public release; distribution unlimited, Public Affairs Case File No. 09-189, 27 April 2009...supplemented subjects with whey and casein (WC), whey and BCAAs (WBC), or placebo (P) over 10 weeks of resistance training (RT). They observed a significant

  15. Dietary Supplements and Sports Performance: Minerals

    PubMed Central

    Williams, Melvin H

    2005-01-01

    Minerals are essential for a wide variety of metabolic and physiologic processes in the human body. Some of the physiologic roles of minerals important to athletes are their involvement in: muscle contraction, normal hearth rhythm, nerve impulse conduction, oxygen transport, oxidative phosphorylation, enzyme activation, immune functions, antioxidant activity, bone health, and acid-base balance of the blood. The two major classes of minerals are the macrominerals and the trace elements. The scope of this article will focus on the ergogenic theory and the efficacy of such mineral supplementation. PMID:18500950

  16. Dietary supplements and sports performance: minerals.

    PubMed

    Williams, Melvin H

    2005-06-11

    Minerals are essential for a wide variety of metabolic and physiologic processes in the human body. Some of the physiologic roles of minerals important to athletes are their involvement in: muscle contraction, normal hearth rhythm, nerve impulse conduction, oxygen transport, oxidative phosphorylation, enzyme activation, immune functions, antioxidant activity, bone health, and acid-base balance of the blood. The two major classes of minerals are the macrominerals and the trace elements. The scope of this article will focus on the ergogenic theory and the efficacy of such mineral supplementation.

  17. Knowledge, Attitudes and Practices (KAP) Relating to Dietary Supplements Among Health Sciences and Non-Health Sciences Students in One of The Universities of United Arab Emirates (UAE)

    PubMed Central

    Basil, Mohammed; Bondarev, Andrey

    2016-01-01

    Introduction The use of Dietary Supplements (DS) has increased substantially in the United Arab Emirates (UAE) in recent years, despite the fact that the efficacy and safety of these supplements are not proven yet. In addition, the practices of supplement users in the UAE remain undocumented. Aim To determine the usage of DS in health sciences and non-health sciences students; and to determine their knowledge, attitudes and practices (KAP) regarding these supplements. Materials and Methods A descriptive, cross-sectional, questionnaire-based study was conducted among university students. Based on the Raosoft online calculator, it was anticipated that the sample of 383 students would enable us to achieve the study objectives. Students were recruited from Ajman University of Science and Technology and identified by the academic staff through students’ records. All students who were registered at Ajman University of Science and Technology – including medical (i.e. dental, pharmacy and health sciences) and non-medical colleges (i.e. engineering, business administration, law, information technology, mass communications and humanities) – were invited to participate, after obtaining the approval of the Institutional Ethics Committee (IEC), (during the period of January-February 2015). This study used quantitative method approach. Therefore, data were analysed quantitatively using SPSS version 22.0. Results More than one-third of participants (39%) were found to consume DS. The most common reasons for consuming supplements were to maintain good health (58,21%) and ensure adequate nutrition (43,15%). Almost two-thirds of participants (65%) perceived that the best way to obtain nutrients is through food and DS together (49%), or DS alone (16%). Therefore, there was a relatively high amount of DS intake among participants in this study. With regard to medical and non-medical students’ use of DS, there were no significant differences in the use (p=0.139). However, other

  18. Methylsulfonylmethane: Applications and Safety of a Novel Dietary Supplement

    PubMed Central

    Butawan, Matthew; Benjamin, Rodney L.; Bloomer, Richard J.

    2017-01-01

    Methylsulfonylmethane (MSM) has become a popular dietary supplement used for a variety of purposes, including its most common use as an anti-inflammatory agent. It has been well-investigated in animal models, as well as in human clinical trials and experiments. A variety of health-specific outcome measures are improved with MSM supplementation, including inflammation, joint/muscle pain, oxidative stress, and antioxidant capacity. Initial evidence is available regarding the dose of MSM needed to provide benefit, although additional work is underway to determine the precise dose and time course of treatment needed to provide optimal benefits. As a Generally Recognized As Safe (GRAS) approved substance, MSM is well-tolerated by most individuals at dosages of up to four grams daily, with few known and mild side effects. This review provides an overview of MSM, with details regarding its common uses and applications as a dietary supplement, as well as its safety for consumption. PMID:28300758

  19. 40 CFR 52.1573 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Jersey § 52.1573 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Jersey's plans for...

  20. 40 CFR 52.1573 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Jersey § 52.1573 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Jersey's plans for...

  1. 40 CFR 52.1873 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Ohio § 52.1873 Approval status. With the exceptions set forth in this subpart the Administrator approves Ohio's plan for the attainment...

  2. 46 CFR 170.093 - Specific approvals.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Marine Safety Center. These approval determinations will be made as a part of the plan review process. ... REQUIREMENTS FOR ALL INSPECTED VESSELS Plan Approval § 170.093 Specific approvals. Certain rules in...

  3. 40 CFR 52.1272 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Mississippi § 52.1272 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Mississippi's plan for...

  4. 40 CFR 52.1472 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1472 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Nevada's plan for the...

  5. 40 CFR 52.1472 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1472 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Nevada's plan for the...

  6. 40 CFR 52.1472 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1472 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Nevada's plan for the...

  7. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    PubMed

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.

  8. Iron supplementation for the control of iron deficiency in populations at risk.

    PubMed

    Viteri, F E

    1997-06-01

    Iron supplementation, mostly with a therapeutic orientation, has been a key strategy for the short-term control of iron deficiency and ferropenic anemia. It has been used almost exclusively in antenatal clinics, but in spite of its confirmed efficacy in supervised trials, it has proven ineffective in practice in most developing countries. Poor effectiveness has been attributed to various factors including insufficient dose and time of supplementation and poor adherence. These problems have led to the administration of high iron doses, which have proven equally ineffective in practice. This paper introduces four concepts: (1) that iron supplementation targeted to pregnant women should cover the full reproductive cycle, from prepregnancy to at least the end of lactation instead of only the pregnant women; (2) that entering pregnancy with iron deficiency contributes to the failure of antenatal iron supplementation and that prepregnancy iron reserves increase the effectiveness of antenatal supplementation; (3) that medium- to long-term weekly ingestion of proper iron-folate supplements, with a preventive aim and directed to all risk groups, should be community based rather than health service based but supervised by the latter (in this sense, preventive supplementation is equal to targeted iron fortification); and (4) that preventive supplementation, based on weekly dosing, has proven efficacious. Problem-oriented research to evaluate the sustainability and medium- to long-term efficacy of these concepts is called for. The bases for the concepts and suggestions are summarized in this paper.

  9. Weekly iron supplementation does not block increases in serum zinc due to weekly zinc supplementation in Bangladeshi infants.

    PubMed

    Baqui, Abdullah H; Walker, Christa L Fischer; Zaman, K; El Arifeen, Shams; Chowdhury, Hafizur Rahman; Wahed, Mohammed A; Black, Robert E; Caulfield, Laura E

    2005-09-01

    Because infants and young children in many developing countries are deficient in both iron and zinc, and zinc can affect iron metabolism, evaluation of optimum strategies to simultaneously supplement iron and zinc is an important public health priority. This study evaluated the efficacy of weekly supplementation of iron or zinc or both on iron, zinc, and copper status in Bangladeshi infants. In a double-blind, randomized, controlled community trial, 6-mo-old infants were assigned to receive weekly supplements of 1 mg riboflavin (control, n = 82) or 1 mg riboflavin + 20 mg iron (n = 83), 20 mg zinc (n = 83), or both (n = 85) for 6 mo. Hemoglobin, serum ferritin, transferrin receptor, zinc, and copper concentrations were measured at baseline and at the end of intervention. Serum Zn increased in both groups receiving zinc; the increase was greatest among children with low baseline serum zinc concentration. Iron status indicators did not differ among the groups before or after 6 mo of supplementation. Supplementation with either zinc or iron decreased serum copper after 6 mo. Joint supplementation did not alter the individual effects of iron or zinc supplementation in these Bangladeshi children. However, the dosing regimen may not have been adequate to achieve the desired biochemical effects.

  10. [Regulation of food supplements in the European Union and its member states. Part 2].

    PubMed

    Petrenko, A S; Ponomareva, M N; Sukhanov, B P

    2014-01-01

    The article discusses various aspects of the regional (the European Union) and national (European countries) regulation related to food supplements. The use of botanicals and minor bioactive substances in food supplements, and their labelling are studied. The EU principle of mutual recognition is described in the context of current challenges that exist in the regulatory harmonisation between the EU member states. The concept of novel foods and novel ingredients is also presented, and the procedure of their pre-market approval is described in detail. Basic principles of using claims for food supplements are also outlined.

  11. Dietary Supplementation with Olive Oil or Fish Oil and Vascular Effects of Concentrated Ambient Particulate Matter Exposure in Human Volunteers

    EPA Science Inventory

    Background: Exposure to ambient particulate matter (PM) induces endothelial dysfunction, a risk factor for cardiovascular disease. Olive oil (OO) and fish oil (FO) supplements have beneficial effects on endothelial function. Objective: In this study we evaluated the efficacy of...

  12. Psychology: Teacher Supplement.

    ERIC Educational Resources Information Center

    Stark, Rebecca

    This supplement provides teachers with tests, quizzes, answers to questions in the text, and general teaching information for using the student text, "Psychology," by Rebecca Stark. Quizzes included are on the topics of human development; the nervous system; the brain; cognitive development; sensation and perception; conditioning; learning;…

  13. Drugs Approved for Vaginal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  14. Drugs Approved for Vulvar Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  15. FDA-Approved HIV Medicines

    MedlinePlus

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with ... 2007 Pharmacokinetic Enhancers Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine ...

  16. Drugs Approved for Bone Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  17. Drugs Approved for Kaposi Sarcoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  18. Drugs Approved for Liver Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  19. Drugs Approved for Esophageal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  20. Drugs Approved for Endometrial Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  1. Drugs Approved for Penile Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  2. Drugs Approved for Wilms Tumor

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  3. Drugs Approved for Skin Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  4. Drugs Approved for Malignant Mesothelioma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  5. Dupixent Approved to Treat Eczema

    MedlinePlus

    ... news/fullstory_164333.html Dupixent Approved to Treat Eczema When topical medication doesn't work To use ... and Drug Administration to treat moderate-to-severe eczema that isn't well controlled by topical medication. ...

  6. Drugs Approved for Lung Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  7. Drugs Approved for Bladder Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  8. Drugs Approved for Breast Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  9. Drugs Approved for Pancreatic Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  10. Elosulfase alfa: first global approval.

    PubMed

    Sanford, Mark; Lo, Jin Han

    2014-04-01

    Elosulfase alfa (Vimizim™) is a recombinant form of N-acetylgalactosamine-6-sulfatase (GALNS) that was developed by BioMarin Pharmaceutical Inc. as an enzyme replacement therapy for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Patients with MPS IVA have a GALNS deficiency, which results in serious musculoskeletal, cardiorespiratory and other system disturbances. Elosulfase alfa was approved by the US FDA on 14 February 2014 for the treatment of MPS IVA. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recently recommended that elosulfase alfa be approved for use in the EU in the same indication. Within the last year, the manufacturer has also filed applications for approval for the use of elosulfase alfa in MPS IVA in Brazil, Australia, Canada and Mexico. This article summarizes the milestones in the development of elosulfase alfa leading to its first global approval in MPS IVA.

  11. Print Product Development and Approval

    EPA Pesticide Factsheets

    Five phases in the process: concept development, concept review, draft development, draft review, and editing per comments with final review. Your concept should address purpose and target audience, and have approval from a Product Review Officer (PRO).

  12. Caffeine and Creatine Content of Dietary Supplements Consumed by Brazilian Soccer Players.

    PubMed

    Inácio, Suelen Galante; de Oliveira, Gustavo Vieira; Alvares, Thiago Silveira

    2016-08-01

    Caffeine and creatine are ingredients in the most popular dietary supplements consumed by soccer players. However, some products may not contain the disclosed amounts of the ingredients listed on the label, compromising the safe usage and the effectiveness of these supplements. Therefore, the aim of this study was to evaluate the content of caffeine and creatine in dietary supplements consumed by Brazilian soccer players. The results obtained were compared with the caffeine content listed on the product label. Two batches of the supplement brands consumed by ≥ 50% of the players were considered for analysis. The quantification of caffeine and creatine in the supplements was determined by a high-performance liquid chromatography system with UV detector. Nine supplements of caffeine and 7 supplements of creatine met the inclusion criteria for analysis. Eight brands of caffeine and five brands of creatine showed significantly different values (p < .05) as compared with the values stated on the label. There were no significant differences between the two batches of supplements analyzed, except for one caffeine supplement. It can be concluded that caffeine and creatine dietary supplements consumed by Brazilian soccer players present inaccurate values listed on the label, although most presented no difference among batches. To ensure consumer safety and product efficacy, accurate information on caffeine and creatine content should be provided on all dietary supplement labels.

  13. Examples of Dietary Supplement Interactions

    MedlinePlus

    ... is absorbed by the body.Supplement: Saw PalmettoPossible drug-supplement interaction with:Birth control pills. Can decrease effects of estrogen in the body, which can reduce the effectiveness of birth control ...

  14. Dietary Supplements: What Is Safe?

    MedlinePlus

    ... and side effects of dietary supplements Dietary supplement advertising and promotion Talking with your doctor about dietary ... Statistics Center Volunteer Learning Center Follow Us Twitter Facebook Instagram Cancer Information, Answers, and Hope. Available Every ...

  15. Vitamin Supplements: Healthy or Hoax?

    MedlinePlus

    ... Recognition & Awards Healthy Workplace Food and Beverage Toolkit Vitamin Supplements: Healthy or Hoax? Updated:Jun 12,2015 Can vitamin and mineral supplements really make you healthier? Overwhelmed ...

  16. 76 FR 38050 - Defense Federal Acquisition Regulation Supplement; Management of Manufacturing Risk in Major...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... Regulation Supplement; Management of Manufacturing Risk in Major Defense Acquisition Programs (DFARS Case... require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C... Government procurement. Mary Overstreet, Editor, Defense Acquisition Regulations System. Therefore, 48...

  17. 75 FR 80787 - Agency Information Collection Activities: Proposed Collection; Comment Request-Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... approved collection in the Supplemental Nutrition Assistance Program and concerns Retail Store Applications... eligibility of retail food stores and certain food service organizations to accept SNAP benefits and to... applications from retail food stores that wish to participate in SNAP, review the applications in order...

  18. 34 CFR 200.47 - SEA responsibilities for supplemental educational services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (2) The per-child amount for supplemental educational services calculated under § 200.48(c)(1). (2.... (3)(i) Maintain by LEA an updated list of approved providers, including any technology-based or... achievement of eligible children; and (D) Are secular, neutral, and nonideological; and (iii) Meet...

  19. 34 CFR 200.47 - SEA responsibilities for supplemental educational services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (2) The per-child amount for supplemental educational services calculated under § 200.48(c)(1). (2.... (3)(i) Maintain by LEA an updated list of approved providers, including any technology-based or... achievement of eligible children; and (D) Are secular, neutral, and nonideological; and (iii) Meet...

  20. 5 CFR 5502.107 - Supplemental disclosure of financial interests in substantially affected organizations applicable...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Health. 5502.107 Section 5502.107 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES... clinical study involving human subjects under a clinical research protocol approved by an...

  1. Motion and Collisions. A Supplement to the "Science 100, 101" Curriculum Guide. Curriculum Support Series.

    ERIC Educational Resources Information Center

    Manitoba Dept. of Education, Winnipeg.

    The tables, graphs, articles, and other sources of information in this document are designed to provide teachers with additional resources to supplement the unit "Motions and Collisions." The information is coordinated with the unit objectives specified in "Science 100, 101," the currently (1982) approved provincial guide for…

  2. 40 CFR 52.1573 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Jersey § 52.1573 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Jersey's plans for... approves the Regional Haze SIP revision submitted by the New Jersey Department of Environmental...

  3. 28 CFR 2.41 - Travel approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  4. 28 CFR 2.41 - Travel approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  5. 28 CFR 2.41 - Travel approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  6. 28 CFR 2.41 - Travel approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  7. 28 CFR 2.41 - Travel approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  8. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box....

  9. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box....

  10. 49 CFR 1182.7 - Interim approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Interim approval. 1182.7 Section 1182.7....7 Interim approval. (a) A party may request interim approval of the operation of the properties... additional filing fee is required, whether the request for interim approval is included in the application...

  11. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  12. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  13. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box....

  14. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box....

  15. An Evidence-Based Review of Fat Modifying Supplemental Weight Loss Products

    PubMed Central

    Egras, Amy M.; Hamilton, William R.; Lenz, Thomas L.; Monaghan, Michael S.

    2011-01-01

    Objective. To review the literature on fat modifying dietary supplements commonly used for weight loss. Methods. Recently published randomized, placebo-controlled trials were identified in PubMed, MEDLINE, International Pharmaceutical Abstracts, Cochrane Database, and Google Scholar using the search terms dietary supplement, herbal, weight loss, obesity, and individual supplement names. Discussion. Data for conjugated linoleic acid (CLA), Garcinia cambogia, chitosan, pyruvate, Irvingia gabonensis, and chia seed for weight loss were identified. CLA, chitosan, pyruvate, and Irvingia gabonensis appeared to be effective in weight loss via fat modifying mechanisms. However, the data on the use of these products is limited. Conclusion. Many obese people use dietary supplements for weight loss. To date, there is little clinical evidence to support their use. More data is necessary to determine the efficacy and safety of these supplements. Healthcare providers should assist patients in weighing the risks and benefits of dietary supplement use for weight loss. PMID:20847896

  16. Development of drug-approval regulations for medical countermeasures against CBRN agents in Japan.

    PubMed

    Shimazawa, Rumiko; Ikeda, Masayuki

    2015-01-01

    To develop approval regulations for drugs against chemical, biological, radiological, or nuclear (CBRN) agents in Japan, and to help inform arguments about the development of anti-CBRN agents, we analyzed documentation describing approval processes and data for drugs against CBRN agents. Sixteen countermeasure products against 10 CBRN agents have been approved in Japan. Approval schemes were grouped into 3 categories: application for off-label uses, expedited review for antiterrorism measures, and expedited review. Ten drug applications were designated "priority reviews," and the median review time was 4.4 months. No application relied exclusively on clinical trials to expose patients to CBRN threats. Clinical experience with drugs in victims of unexpected exposure was not necessarily important for approval. The United States is the most advanced country in terms of developing medical countermeasure products against CBRN agents. Japan has similarities with the US in approved products and application packages, but there were 3 unapproved products or indications that were approved under the Animal Rule in the US. The Animal Rule might encourage development of a novel product by providing efficacy evaluation in animal studies. The US also has regulations that do not exist in Japan that authorize administration of an investigational drug outside a clinical trial for patients. Introduction of the Animal Rule and expanded access of investigational drugs could contribute to development and approvals of novel countermeasure products and improve an emergency response in a crisis in Japan.

  17. Assessment of Self-Efficacy in Systems Engineering as an Indicator of Competency Level Achievement

    DTIC Science & Technology

    2014-06-01

    instruments that measured self -efficacy, career indecision, self - esteem , expressed vocational interests, and range of perceived vocational options in...NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release; distribution is unlimited ASSESSMENT OF SELF ...2014 3. REPORT TYPE AND DATES COVERED Master’s Thesis 4. TITLE AND SUBTITLE ASSESSMENT OF SELF -EFFICACY IN SYSTEMS ENGINEERING AS AN INDICATOR OF

  18. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Action by approval authority-approval by design... CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... manufacturer of any responsibility to maintain proper quality control. If a prototype container fails to...

  19. [ERGOGENIC SPORT SUPPLEMENTS FOR ATHLETES].

    PubMed

    Arieli, Rakefet; Lahav, Yair

    2016-06-01

    Use of performance-enhancing supplements occurs at all levels of sports, from recreational athletes to professional athletes. Although some supplements do enhance athletic performance, many have no proven benefits and have adverse effects. Nutritional supplements are categorized into the following categories: I. Apparently Effective. II. Possibly Effective. III. Too Early To Tell. IV. Apparently Ineffective. This article will review 4 ergogenic supplements which are categorized in the first category--"Apparently Effective"--1) Buffer agents 2) Creatine 3) Caffeine and 4 Nitric Oxide. Given the widespread use of performance enhancing supplements, physicians, and dietitians should be prepared to counsel athletes about their effectiveness, safety and legality.

  20. Effective Nutritional Supplement Combinations

    NASA Astrophysics Data System (ADS)

    Cooke, Matt; Cribb, Paul J.

    Few supplement combinations that are marketed to athletes are supported by scientific evidence of their effectiveness. Quite often, under the rigor of scientific investigation, the patented combination fails to provide any greater benefit than a group given the active (generic) ingredient. The focus of this chapter is supplement combinations and dosing strategies that are effective at promoting an acute physiological response that may improve/enhance exercise performance or influence chronic adaptations desired from training. In recent years, there has been a particular focus on two nutritional ergogenic aids—creatine monohydrate and protein/amino acids—in combination with specific nutrients in an effort to augment or add to their already established independent ergogenic effects. These combinations and others are discussed in this chapter.

  1. Implications of Recent Drug Approvals for Older Adults

    PubMed Central

    Eisenhower, Christine; Koronkowski, Michael; Marcum, Zachary

    2016-01-01

    More than 100 medications were approved by the US Food and Drug Administration as new drugs or for new indications in 2014 and 2015. Several of the new drugs may benefit older adults, but adverse events and pharmacokinetic changes due to aging must be considered. This article will focus on three recently approved drugs that are marketed for chronic conditions that can affect older adults: suvorexant, for treatment of insomnia; edoxaban, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of venous thromboembolism; and droxidopa, for treatment of symptomatic neurogenic orthostatic hypotension. Information about indications, mechanisms of action, dosing, efficacy, and safety are reviewed. The place of each agent in therapy for older adults is also discussed. PMID:27340374

  2. Supplementation patterns in marathon runners.

    PubMed

    Nieman, D C; Gates, J R; Butler, J V; Pollett, L M; Dietrich, S J; Lutz, R D

    1989-11-01

    The purpose of the present investigation was to study the use of supplements in a large group of endurance runners (no. = 347) who had participated in the 1987 Los Angeles Marathon. Three-day dietary records were analyzed for nutrient content and supplement usage. The runners' supplementation patterns with respect to demographics, dietary quality, training habits, and race performance were investigated. In general, no significant associations were found between supplement use and the aforementioned variables. Use of supplements, especially vitamins C and E, calcium, and zinc, increased with age (p less than .05). Daily use of at least one type of supplement was reported by 29% of the runners; 48% reported use of at least one type of supplement within the 3-day period.

  3. Current FDA-approved treatments for Helicobacter pylori and the FDA approval process.

    PubMed

    Hopkins, R J

    1997-12-01

    U.S. Food and Drug Administration (FDA) approval of new drugs expands treatment options and serves as a "safety net" of well-documented efficacy and safety. The information provided in the package insert facilitates physician education and provides some assurance that marketing information is accurate. As of February 1997, three Helicobacter pylori regimes have been FDA-approved for eradication of H. pylori in infected patients with active duodenal ulcers. Regimen 1, omeprazole + clarithromycin (O/C), was supported by two multicenter, controlled studies with a 6-month follow-up. Eradication rates were 74% (n = 53; 95% confidence interval [CI], 62-85) and 64% (n = 61; 95% CI, 52-76). Twenty-five of 26 patients with failed eradication therapy who were taking O/C with clarithromycin-susceptible strains before treatment and who had pretreatment and posttreatment susceptibility tests performed developed clarithromycin resistance after treatment. Regimen 2, ranitidine-bismuth-citrate + clarithromycin, was supported by two multicenter, placebo-controlled studies with a 6-month follow-up. Eradication rates were 84% (n = 19; 95% CI, 60-96) and 73% (n = 22; 95% CI, 50-88). Insufficient pretreatment and posttreatment susceptibility data were collected to assess antimicrobial resistance. Regimen 3, bismuth subsalicylate + metronidazole + tetracycline + an H2-receptor antagonist, was supported by two pivotal literature-based studies. Eradication rates in patients with duodenal ulcer were 82% (n = 51; 95% CI, 70-92) and 77% (n = 39; 95% CI, 61-89), respectively. When extrapolating the results of these three FDA-approved regimens to the clinical setting, particular aspects of the clinical trial should be kept in mind. These include the type of controls, primary end points used, population studied, and number and type of dropouts.

  4. Herbal medications and other dietary supplements. A clinical review for physicians caring for older people.

    PubMed

    Pitkälä, Kaisu H; Suominen, Merja H; Bell, J Simon; Strandberg, Timo E

    2016-12-01

    Evidence for the safety and effectiveness of dietary supplements is mixed. The extent to which older people use dietary supplements concomitantly with conventional medications is often under-appreciated by physicians. We conducted a literature review on clinical considerations associated with dietary supplement use, focusing on benefits and harms, motivations for use and contribution to polypharmacy among older people. Vitamin D ≥ 800 IU has demonstrated benefits in fracture prevention. Vitamins A, E, and β-carotene have been associated with an increase in total mortality in several meta-analyses. A range of non-vitamin dietary supplements have been studied in randomized controlled trials but their efficacy remains largely unclear. Supplement use has been associated with a range of adverse events and drug interactions yet physicians rarely initiate discussions about their use with older patients. Older people may take dietary supplements to exercise control over their health. Given the contribution of supplements to polypharmacy, supplements may be targeted for "deprescribing" if the risk of harm is judged to outweigh benefits. This is best done as part of a comprehensive, patient-centered approach. A respectful and non-judgmental discussion may result in a shared decision to reduce polypharmacy through cessation of dietary supplements. KEY MESSAGES Herbal medications and other dietary supplements are highly prevalent among older people. Physicians are often unaware that their patients use herbal medications and other dietary supplements concomitantly with conventional medications. Herbal medications and other dietary supplements contribute to high rates of polypharmacy, particularly among older people with multimorbidity. Herbal medications and other dietary supplements can interact with conventional medications and be associated with a range of adverse events. Physicians need to be patient-centered and non-judgmental when initiating discussions about

  5. The clinical content of preconception care: nutrition and dietary supplements.

    PubMed

    Gardiner, Paula M; Nelson, Lauren; Shellhaas, Cynthia S; Dunlop, Anne L; Long, Richard; Andrist, Sara; Jack, Brian W

    2008-12-01

    Women of child-bearing age should achieve and maintain good nutritional status prior to conception to help minimize health risks to both mothers and infants. Many women may not be aware of the importance of preconception nutrition and supplementation or have access to nutrition information. Health care providers should be knowledgeable about preconception/pregnancy-related nutrition and take the initiative to discuss this information during preconception counseling. Women of reproductive age should be counseled to consume a well-balanced diet including fruits and vegetables, iron and calcium-rich foods, and protein-containing foods as well as 400 microg of folic acid daily. More research is critically needed on the efficacy and safety of dietary supplements and the role of obesity in birth outcomes. Preconception counseling is the perfect opportunity for the health care provider to discuss a healthy eating guideline, dietary supplement intake, and maintaining a healthy weight status.

  6. Flavonoids, the emerging dietary supplement against cisplatin-induced nephrotoxicity.

    PubMed

    Athira, K V; Madhana, Rajaram Mohanrao; Lahkar, Mangala

    2016-03-25

    The letter illustrates the emerging potential of flavonoids as dietary supplement to ameliorate cisplatin-induced nephrotoxicity and refers to the recent article on ''Anti-apoptotic and anti-inflammatory effects of naringin on cisplatin-induced renal injury in the rat'' by Chtourou et al. They demonstrated that supplementation of naringin, a flavanone glycoside, found in grape and citrus fruit species, can attenuate cisplatin-induced renal dysfunction via restoration of redox balance and suppression of inflammation, NF-κB activation and apoptosis. The chemotherapeutic efficacy of cisplatin has always compelled the researchers to find solution to ameliorate its side effects. In recent years, numerous candidates have been evaluated for their protective potential against cisplatin-induced nephrotoxicity and flavonoids have come up with promising results. The future prospects might be promising with a proper refinement and collective integration of the preclinical and clinical research in the field of flavonoid supplementation to cisplatin therapy.

  7. 30 CFR 28.20 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Approval and Disapproval § 28.20 Certificates of approval;...

  8. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data.

    PubMed

    Martineau, Adrian R; Jolliffe, David A; Hooper, Richard L; Greenberg, Lauren; Aloia, John F; Bergman, Peter; Dubnov-Raz, Gal; Esposito, Susanna; Ganmaa, Davaasambuu; Ginde, Adit A; Goodall, Emma C; Grant, Cameron C; Griffiths, Christopher J; Janssens, Wim; Laaksi, Ilkka; Manaseki-Holland, Semira; Mauger, David; Murdoch, David R; Neale, Rachel; Rees, Judy R; Simpson, Steve; Stelmach, Iwona; Kumar, Geeta Trilok; Urashima, Mitsuyoshi; Camargo, Carlos A

    2017-02-15

    Objectives To assess the overall effect of vitamin D supplementation on risk of acute respiratory tract infection, and to identify factors modifying this effect.Design Systematic review and meta-analysis of individual participant data (IPD) from randomised controlled trials.Data sources Medline, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, ClinicalTrials.gov, and the International Standard Randomised Controlled Trials Number registry from inception to December 2015.Eligibility criteria for study selection Randomised, double blind, placebo controlled trials of supplementation with vitamin D3 or vitamin D2 of any duration were eligible for inclusion if they had been approved by a research ethics committee and if data on incidence of acute respiratory tract infection were collected prospectively and prespecified as an efficacy outcome.Results 25 eligible randomised controlled trials (total 11 321 participants, aged 0 to 95 years) were identified. IPD were obtained for 10 933 (96.6%) participants. Vitamin D supplementation reduced the risk of acute respiratory tract infection among all participants (adjusted odds ratio 0.88, 95% confidence interval 0.81 to 0.96; P for heterogeneity <0.001). In subgroup analysis, protective effects were seen in those receiving daily or weekly vitamin D without additional bolus doses (adjusted odds ratio 0.81, 0.72 to 0.91) but not in those receiving one or more bolus doses (adjusted odds ratio 0.97, 0.86 to 1.10; P for interaction=0.05). Among those receiving daily or weekly vitamin D, protective effects were stronger in those with baseline 25-hydroxyvitamin D levels <25 nmol/L (adjusted odds ratio 0.30, 0.17 to 0.53) than in those with baseline 25-hydroxyvitamin D levels ≥25 nmol/L (adjusted odds ratio 0.75, 0.60 to 0.95; P for interaction=0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (adjusted odds ratio 0.98, 0.80 to 1.20, P

  9. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data

    PubMed Central

    Jolliffe, David A; Hooper, Richard L; Greenberg, Lauren; Aloia, John F; Bergman, Peter; Dubnov-Raz, Gal; Esposito, Susanna; Ganmaa, Davaasambuu; Ginde, Adit A; Goodall, Emma C; Grant, Cameron C; Griffiths, Christopher J; Janssens, Wim; Laaksi, Ilkka; Manaseki-Holland, Semira; Mauger, David; Murdoch, David R; Neale, Rachel; Rees, Judy R; Simpson, Steve; Stelmach, Iwona; Kumar, Geeta Trilok; Urashima, Mitsuyoshi; Camargo, Carlos A

    2017-01-01

    Objectives To assess the overall effect of vitamin D supplementation on risk of acute respiratory tract infection, and to identify factors modifying this effect. Design Systematic review and meta-analysis of individual participant data (IPD) from randomised controlled trials. Data sources Medline, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, ClinicalTrials.gov, and the International Standard Randomised Controlled Trials Number registry from inception to December 2015. Eligibility criteria for study selection Randomised, double blind, placebo controlled trials of supplementation with vitamin D3 or vitamin D2 of any duration were eligible for inclusion if they had been approved by a research ethics committee and if data on incidence of acute respiratory tract infection were collected prospectively and prespecified as an efficacy outcome. Results 25 eligible randomised controlled trials (total 11 321 participants, aged 0 to 95 years) were identified. IPD were obtained for 10 933 (96.6%) participants. Vitamin D supplementation reduced the risk of acute respiratory tract infection among all participants (adjusted odds ratio 0.88, 95% confidence interval 0.81 to 0.96; P for heterogeneity <0.001). In subgroup analysis, protective effects were seen in those receiving daily or weekly vitamin D without additional bolus doses (adjusted odds ratio 0.81, 0.72 to 0.91) but not in those receiving one or more bolus doses (adjusted odds ratio 0.97, 0.86 to 1.10; P for interaction=0.05). Among those receiving daily or weekly vitamin D, protective effects were stronger in those with baseline 25-hydroxyvitamin D levels <25 nmol/L (adjusted odds ratio 0.30, 0.17 to 0.53) than in those with baseline 25-hydroxyvitamin D levels ≥25 nmol/L (adjusted odds ratio 0.75, 0.60 to 0.95; P for interaction=0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (adjusted odds ratio 0.98, 0.80 to 1

  10. 77 FR 24793 - Approval and Promulgation of Air Quality Implementation Plans; State of New York; Regional Haze...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ...EPA is proposing to partially approve and partially disapprove the revision to the State Implementation Plan (SIP) addressing regional haze submitted by the State of New York on March 15, 2010, and supplemented on August 2, 2010. New York's revised SIP reduces regional haze during the first planning period from 2008 through 2018. This revision addresses the requirements of the Clean Air Act......

  11. 25 CFR 224.75 - What must the Secretary do upon approval or disapproval of a final proposed TERA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... INTERIOR ENERGY AND MINERALS TRIBAL ENERGY RESOURCE AGREEMENTS UNDER THE INDIAN TRIBAL ENERGY DEVELOPMENT AND SELF DETERMINATION ACT Approval of Tribal Energy Resource Agreements § 224.75 What must the... subsequent amendments or supplements to the TERA. (b) To disapprove the final proposed TERA Send the tribe...

  12. 78 FR 37122 - Approval and Promulgation of Implementation Plans; New York; Infrastructure SIP for the 1997 8...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... ``Environmental Conservation Law;'' 0 b. Adding a new heading for ``Public Officers Law'' and a new entry for... rulemaking action. New York's supplemental submittal includes: New York Public Officer's Law (POL) section 73... the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal...

  13. Nutritional Supplements for the Treatment of Attention-Deficit Hyperactivity Disorder

    PubMed Central

    Bloch, Michael H.; Mulqueen, Jilian

    2014-01-01

    Synopsis Polyunsaturated fatty acid supplementation has demonstrated evidence of efficacy in meta-analysis of randomized, placebo-controlled trials in ADHD. The benefits of polyunsaturated fatty acid appear small compared to the effect sizes observed for traditional pharmacological treatments of ADHD. Some evidence suggests that polyunsaturated fatty acid formulations with higher eicosapentaenoic acid may be more effective in improving ADHD symptoms. Melatonin appears to be effective in treating chronic insomnia in children with ADHD but appears to have minimal effects in reducing core ADHD symptoms. Iron and zinc supplementation may have benefit in reducing ADHD symptoms in children with or at high risk of deficiency. Data demonstrating efficacy of iron, zinc or magnesium in non-nutrient deficient ADHD populations is lacking. Many other natural supplements are widely utilized in the United States despite minimal evidence of efficacy and possible side-effects. PMID:25220092

  14. Herbals and natural dietary supplements in psychiatric practice.

    PubMed

    Chiappedi, Matteo; Bejor, Maurizio

    2010-06-01

    There is some evidence that links the increase of mental disorders' prevalence with a deterioration of Western countries' nutritional habits and it is found that the use of herbal and "natural" food supplements to treat different disorders is increasing. With factors such as chronic illness, poor health, emotional distress, and quality of life influencing the desire for complementary medicine, patients with comorbid medical and psychiatric problems seem likely to turn to this approach. We reviewed the most commonly used herbal and dietary supplements for which a certain efficacy on psychiatric symptoms or disorders has been claimed, checking current Pubmed-indexed literature (the most important being St. John's wort, Omega-3 fatty acids, valerian, Kava, Ginkgo, folate, B vitamins, SAMe, Inositol). There is an evidence of efficacy for some of these herbs an supplements, but current studies are often insufficient to reach a final conclusion; still patents are being requested and registered. Many different areas (including efficacy, tolerability, optimal dosing, adequate shelf life, drug and non-pharmacological interactions) need to be thoroughly studied; moreover political decisions need to be scientifically guided in order to best serve psychiatric patients' interests and to prevent the usage of expensive and sometimes un-useful therapies. This implies that a scientific strategy has to be used to rule out any third-part economical interest which could in any way influence therapeutic choices.

  15. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval....

  16. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval....

  17. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval....

  18. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval....

  19. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval....

  20. The approval process for biosimilar erythropoiesis-stimulating agents.

    PubMed

    Wish, Jay B

    2014-09-05

    A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well.

  1. Supplementing national menu labeling.

    PubMed

    Hodge, James G; White, Lexi C

    2012-12-01

    The US Food and Drug Administration's forthcoming national menu labeling regulations are designed to help curb the national obesity epidemic by requiring calorie counts on restaurants' menus. However, posted calories can be easily ignored or misunderstood by consumers and fail to accurately describe the healthiness of foods. We propose supplemental models that include nutritional information (e.g., fat, salt, sugar) or specific guidance (e.g., "heart-healthy" graphics). The goal is to empower restaurant patrons with better data to make healthier choices, and ultimately to reduce obesity prevalence.

  2. Hyperkalemia from Dietary Supplements

    PubMed Central

    Villgran, Vipin

    2016-01-01

    Hyperkalemia is a common electrolyte problem in patients with chronic kidney disease. It is typically caused by medications in patients with poor kidney function. Patients with comorbodities such as heart failure and diabetes are predisposed to electrolyte problems. Salt substitutes and dietary supplements are uncommon causes of hyperkalemia, but we propose that they are under-recognized and underdiagnosed causes in patients with chronic kidney disease. Our case report and literature review illustrates that a careful dietary history is essential in patients presenting with electrolyte disorders, especially hyperkalemia. PMID:27924248

  3. Supplementing managed competition.

    PubMed

    Higgins, W

    President Clinton's proposal for health care reform calls for managed competition within global expenditure targets. However, it is unlikely that health plans will have sufficient leverage with providers to negotiate arrangements consistent with expenditure targets in nonurban areas. This paper describes a reimbursement system based on competitive prospective payment and capitation (CPPC) which can supplement managed competition in less populous areas or replace managed competition should that strategy prove unsuccessful. The CPPC system is capable of enforcing an expenditure target while encouraging the formation of capitated networks and creating strong incentives for efficiency. It is generally compatible with the Clinton administration's version of managed competition.

  4. Special Supplement Introduction: Hallucinations

    PubMed Central

    Fernyhough, Charles; Waters, Flavie

    2014-01-01

    This Special Supplement presents reports from 11 working groups of the interdisciplinary International Consortium on Hallucination Research meeting in Durham, UK, September 2013. Topics include psychological therapies for auditory hallucinations, culture and hallucinations, hallucinations in children and adolescents, visual hallucinations, interdisciplinary approaches to the phenomenology of auditory verbal hallucinations (AVHs), AVHs in persons without need for care, a multisite study of the PSYRATS instrument, subtypes of AVHs, the Hearing Voices Movement, Research Domain Criteria for hallucinations, and cortical specialization as a route to understanding hallucinations. PMID:24936079

  5. Zinc supplementation in burn patients.

    PubMed

    Caldis-Coutris, Nancy; Gawaziuk, Justin P; Logsetty, Sarvesh

    2012-01-01

    Micronutrient supplementation is a common practice throughout many burn centers across North America; however, uncertainty pertaining to dose, duration, and side effects of such supplements persists. The authors prospectively collected data from 23 hospitalized patients with burn sizes ranging from 10 to 93% TBSA. Each patient received a daily multivitamin and mineral supplement, 50 mg zinc (Zn) daily, and 500 mg vitamin C twice daily. Supplements were administered orally or enterally. Albumin, prealbumin, C-reactive protein, serum Zn, and serum copper were measured weekly during hospital admission until levels were within normal reference range. Our study concluded that 50 mg daily dose of Zn resulted in normal serum levels in 19 of 23 patients at discharge; 50 mg Zn supplementation did not interfere with serum copper levels; and Zn supplements, regardless of administration route, did not result in gastrointestinal side effects.

  6. New Evaluation System Wins Approval

    ERIC Educational Resources Information Center

    Barrett, Laura

    2011-01-01

    All Massachusetts school districts will have to adopt new evaluation systems based on a state framework that was approved by the Board of Elementary and Secondary Education on June 28. The new system will be phased in over three years, beginning with Level 4 schools--those designated "underperforming" by the state--in the 2011-12 school…

  7. Drugs Approved for Multiple Myeloma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  8. Drugs Approved for Hodgkin Lymphoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Myeloproliferative Neoplasms

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  10. Drugs Approved for Cervical Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Testicular Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  12. Proposed rule: current good manufacturing practice in manufacturing, packing, or holding dietary ingredients and dietary supplements.

    PubMed

    Melethil, Srikumaran

    2006-03-27

    The Dietary Supplement Health and Education Act (DSHEA) was enacted in October 1994 to promote the health of Americans by ensuring easier access to safe dietary supplements. Many supplements such as vitamins, minerals, herbs and amino acids have been reported to be helpful in chronic conditions (i.e., heart disease, cancer and osteoporosis). Under DSHEA, dietary supplements can be marketed without prior FDA approval; the burden is on this agency to show that a marketed dietary supplement is unsafe. However, DSHEA retained the FDA's authority to issue regulations that require the manufacture of dietary supplements be in compliance with current good manufacturing practice (cGMP) standards, which are needed to ensure their quality. Several quality-related concerns of marketed dietary supplements that came to light since the passage of DSHEA prompted the FDA in 2003 to propose rules for cGMP for the manufacture, packaging and holding (storage) of dietary supplements. This review will present the highlights of these proposed rules, focusing on the legislative history of DSHEA, rationale for proposing cGMPs along with a general discussion of the specific requirements. Given the voluminous nature of the specific details, the reader is directed to the pertinent FDA publications for details. In this analysis, selected scientific and legal issues are also discussed to promote a better understanding and implications of these rules.

  13. MICROBIOLOGICAL QUALITY OF FOOD SUPPLEMENTS.

    PubMed

    Ratajczak, Magdalena; Kubicka, Marcelina M; Kamińska, Dorota; Długaszewska, Jolanta

    2015-01-01

    Many specialists note that the food offered today - as a result of very complex technological processing - is devoid of many components that are important for the organism and the shortages have to be supplemented. The simplest for it is to consume diet supplements that provide the missing element in a concentrated form. In accordance with the applicable law, medicinal products include all substances or mixtures of substances that are attributed with properties of preventing or treating diseases with humans or animals. Permits to admit supplements to the market are issued by the Chief Sanitary Inspector and the related authorities; permits for medicines are issued by the Chief Pharmaceutical Inspector and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Therefore, admittance of a supplement to the market is less costly and time consuming_than admittance of a medicine. Supplements and medicines may contain the same component but medicines will have a larger concentration than supplements. Sale of supplements at drug stores and in the form of tablets, capsules, liquids or powders makes consumer often confusing supplements with medicines. Now there are no normative documents specifying limits of microbiological impurities in diet supplements. In Polish legislation, diet supplements are subject to legal acts concerning food. Medicines have to comply with microbiological purity requirements specified in the Polish Pharmacopeia. As evidenced with the completed tests, the proportion of diet supplement samples with microbiological impurities is 6.5%. Sales of diet supplements have been growing each year, they are consumed by healthy people but also people with immunology deficiencies and by children and therefore consumers must be certain that they buy safe products.

  14. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  15. Bodybuilding supplementation and tooth decay.

    PubMed

    Ali, M S; Batley, H; Ahmed, F

    2015-07-10

    Supplementation is a key component in bodybuilding and is increasingly being used by amateur weight lifters and enthusiasts to build their ideal bodies. Bodybuilding supplements are advertised to provide nutrients needed to help optimise muscle building but they can contain high amounts of sugar. Supplement users are consuming these products, while not being aware of their high sugar content, putting them at a higher risk of developing dental caries. It is important for dental professionals to recognise the increased risk for supplement users and to raise awareness, provide appropriate preventative advice and be knowledgeable of alternative products to help bodybuilders reach their goals, without increasing the risk of dental caries.

  16. Nutritional Supplementation and Meal Timing

    NASA Astrophysics Data System (ADS)

    Farris, Jim

    For the competitive athlete and the serious recreational athlete, nutritional supplementation can have a positive effect on training and on performance. There are many fad supplements on the market, and many that have come and gone. However, two nutrients have withstood the test of time and many tests in research laboratories around the world, and they continue to have positive training- and performance-enhancing effects. Carbohydrates are commonly supplemented to improve energy availability and to replace valuable muscle and liver glycogen stores. Protein supplementation usually is associated with building muscle tissue.

  17. Dietary supplements for aquatic sports.

    PubMed

    Derave, Wim; Tipton, Kevin D

    2014-08-01

    Many athletes use dietary supplements, with use more prevalent among those competing at the highest level. Supplements are often self-prescribed, and their use is likely to be based on an inadequate understanding of the issues at stake. Supplementation with essential micronutrients may be useful when a diagnosed deficiency cannot be promptly and effectively corrected with food-based dietary solutions. When used in high doses, some supplements may do more harm than good: Iron supplementation, for example, is potentially harmful. There is good evidence from laboratory studies and some evidence from field studies to support health or performance benefits from appropriate use of a few supplements. The available evidence from studies of aquatic sports is small and is often contradictory. Evidence from elite performers is almost entirely absent, but some athletes may benefit from informed use of creatine, caffeine, and buffering agents. Poor quality assurance in some parts of the dietary supplements industry raises concerns about the safety of some products. Some do not contain the active ingredients listed on the label, and some contain toxic substances, including prescription drugs, that can cause health problems. Some supplements contain compounds that will cause an athlete to fail a doping test. Supplement quality assurance programs can reduce, but not entirely eliminate, this risk.

  18. Chromium picolinate supplementation for diabetes mellitus.

    PubMed

    Fox, G N; Sabovic, Z

    1998-01-01

    Chromium picolinate is a widely available nutritional supplement marketed for a plethora of afflictions. There is some evidence, including results from human studies, that it has a role in glucose homeostasis. We report the case of a 28-year-old woman with an 18-year history of type 1 diabetes mellitus whose glycosylated hemoglobin (Hb A1c) declined from 11.3% to 7.9% 3 months after initiation of chromium picolinate, 200 micrograms 3 times daily. Chromium picolinate continues to fall squarely within the scope of "alternative medicine," with both unproven benefits and unknown risks. It deserves closer scrutiny with additional prospective, randomized, double-blind, placebo-controlled trials to evaluate its efficacy in improving outcomes in patients with diabetes. A brief review of the literature was done to assist physicians who are being called upon to counsel and treat patients who are engaging in alternative therapies.

  19. Effects of vitamin D supplementation in pregnancy.

    PubMed

    Marya, R K; Rathee, S; Lata, V; Mudgil, S

    1981-01-01

    Serum calcium, inorganic phosphate and heat-labile alkaline phosphatase (HLAP) have been estimated in maternal and cord sera of 120 pregnant women at labour. 75 women who did not take any vitamin D supplements during pregnancy showed statistically significant hypocalcaemia, hypophosphataemia and elevation of HLAP. Hypocalcaemia and hypophosphataemia were present in cord blood, too. 25 women who had received 1,200 U vitamin D/day throughout the 3rd trimester, showed significantly lower HLAP levels and increased fetal birth weight but there was no other improvement in maternal or cord blood chemistry. Administration of vitamin D in two large doses of 600,000 U each in the 7th and 8th months of pregnancy in 20 women proved more efficacious. Statistically significant improvement was observed in all the three biochemical parameters in maternal as well as cord sera. Fetal birth weight was also significantly greater with this mode of therapy.

  20. 40 CFR 49.10702 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Shoshone-Bannock Tribes of the Fort Hall Indian Reservation of Idaho § 49.10702 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Fort Hall...

  1. 7 CFR 51.49 - Approved identifications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...) Grade marks. The approved shield mark with the appropriate U.S. grade designation may be used on... the shield. The shields with approved grade designation for use shall be similar in form and design...

  2. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned...

  3. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned...

  4. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned...

  5. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned...

  6. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval marking. (a) Approved brattice cloth shall be legibly and permanently marked with the assigned...

  7. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the Cow Creek Band of...

  8. 40 CFR 52.2522 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... SO2 per million BTU for the Harrison power plant until a permanent emission limitation is approved. (c... Mitchell and Harrison power stations. (d)-(f) (g) The Administrator approves West Virginia's November...

  9. 46 CFR 58.16-10 - Approvals.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... RELATED SYSTEMS Liquefied Petroleum Gases for Cooking and Heating § 58.16-10 Approvals. (a) Gas appliances. (1) All gas-consuming appliances used for cooking and heating shall be of a type approved by...

  10. 46 CFR 58.16-10 - Approvals.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... RELATED SYSTEMS Liquefied Petroleum Gases for Cooking and Heating § 58.16-10 Approvals. (a) Gas appliances. (1) All gas-consuming appliances used for cooking and heating shall be of a type approved by...

  11. 46 CFR 58.16-10 - Approvals.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... RELATED SYSTEMS Liquefied Petroleum Gases for Cooking and Heating § 58.16-10 Approvals. (a) Gas appliances. (1) All gas-consuming appliances used for cooking and heating shall be of a type approved by...

  12. 46 CFR 58.16-10 - Approvals.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... RELATED SYSTEMS Liquefied Petroleum Gases for Cooking and Heating § 58.16-10 Approvals. (a) Gas appliances. (1) All gas-consuming appliances used for cooking and heating shall be of a type approved by...

  13. 46 CFR 58.16-10 - Approvals.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... RELATED SYSTEMS Liquefied Petroleum Gases for Cooking and Heating § 58.16-10 Approvals. (a) Gas appliances. (1) All gas-consuming appliances used for cooking and heating shall be of a type approved by...

  14. 40 CFR 52.822 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Iowa § 52.822 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Iowa's plan for the attainment and maintenance of the...

  15. 40 CFR 52.822 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Iowa § 52.822 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Iowa's plan for the attainment and maintenance of the...

  16. 40 CFR 52.822 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Iowa § 52.822 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Iowa's plan for the attainment and maintenance of the...

  17. 40 CFR 52.822 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Iowa § 52.822 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Iowa's plan for the attainment and maintenance of the...

  18. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  19. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  20. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  1. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  2. 40 CFR 49.10162 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Jamestown S'klallam Tribe of Washington § 49.10162 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the Jamestown S'Klallam Tribe....

  3. 40 CFR 52.623 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Hawaii § 52.623 Approval status. With the exceptions set forth in this subpart, the Administrator approves Hawaii's plan for attainment and maintenance of the national...

  4. 40 CFR 52.623 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Hawaii § 52.623 Approval status. With the exceptions set forth in this subpart, the Administrator approves Hawaii's plan for attainment and maintenance of the national...

  5. 40 CFR 52.623 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Hawaii § 52.623 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Hawaii's plan for attainment and maintenance of the national...

  6. 40 CFR 52.623 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Hawaii § 52.623 Approval status. With the exceptions set forth in this subpart, the Administrator approves Hawaii's plan for attainment and maintenance of the national...

  7. 40 CFR 52.623 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Hawaii § 52.623 Approval status. With the exceptions set forth in this subpart, the Administrator approves Hawaii's plan for attainment and maintenance of the national...

  8. 40 CFR 49.11072 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Confederated Tribes of the Warm Springs Reservation of Oregon § 49.11072 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Warm Springs Reservation....

  9. Drugs Approved for Kidney (Renal Cell) Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs ... that are not listed here. Drugs Approved for Kidney (Renal Cell) Cancer Afinitor (Everolimus) Aldesleukin Avastin (Bevacizumab) ...

  10. 13 CFR 108.370 - Conditional approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.370 Conditional approval. From... Applicants and will conditionally approve such selected Applicants to participate in the NMVC program....

  11. 13 CFR 108.370 - Conditional approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.370 Conditional approval. From... Applicants and will conditionally approve such selected Applicants to participate in the NMVC program....

  12. 13 CFR 108.370 - Conditional approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.370 Conditional approval. From... Applicants and will conditionally approve such selected Applicants to participate in the NMVC program....

  13. 13 CFR 108.370 - Conditional approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.370 Conditional approval. From... Applicants and will conditionally approve such selected Applicants to participate in the NMVC program....

  14. 13 CFR 108.370 - Conditional approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.370 Conditional approval. From... Applicants and will conditionally approve such selected Applicants to participate in the NMVC program....

  15. 30 CFR 20.13 - Approval plate.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... manufacturer shall attach, stamp, or mold an approval plate on the battery container or housing of each... has been adjudged safe for use in gassy and dusty mines. (b) Use of approval plate. Permission...

  16. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 4 2012-07-01 2011-07-01 true Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents §...

  17. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 4 2014-07-01 2013-07-01 true Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents §...

  18. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents §...

  19. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 4 2011-07-01 2011-07-01 false Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents §...

  20. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 4 2013-07-01 2013-07-01 false Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents §...

  1. Approval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration “Animal Rule”

    PubMed Central

    Tsai, Chia-Wei; Morris, Stephen

    2015-01-01

    On December 14, 2012, the FDA approved Raxibacumab, the first monoclonal antibody product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or “Animal Rule”). Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate. The developmental process required for approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues. PMID:26648915

  2. Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States

    PubMed Central

    2015-01-01

    Millions of people in the United States consume dietary supplements hoping to maintain or improve their health; however, extensive research has failed to demonstrate the efficacy of numerous supplements in disease prevention. In addition, concerns about the safety of routine and high-dose supplementation have been raised. The Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and the Federal Trade Commission monitors advertisements and marketing; still, vast enforcement challenges remain, and optimal governmental oversight has not been achieved. If the composition and quality of ingredients cannot be reliably ensured, the validity of research on dietary supplements is questionable. Moreover, the health of the US public is put at risk. PMID:25602879

  3. Zinc Supplementation in Children with Asthma Exacerbation

    PubMed Central

    Rerksuppaphol, Sanguansak

    2016-01-01

    Zinc deficiency has demonstrated an association with the risk of asthma. This study aimed to evaluate the efficacy of zinc supplementation in reducing the severity of childhood asthma exacerbation. A number of 42 children with asthma exacerbation admitted to the hospital were randomized to receive either zinc bis-glycinate (30 mg elemental zinc/day) or a placebo in adjuvant to the standard treatment. The pediatric respiratory assessment measure (PRAM) was used to measure the asthma severity. The primary outcome was a change in asthma severity from the baseline to the end of study. The study found that PRAM score in the zinc group showed a more rapid decrease compared to the control group at the 24-hour (2.2±1.3 vs. 1.2±1.3; P = 0.015) and 48-hour (3.4±2.0 vs. 2.2±1.8; P = 0.042) intervals. At admission, overall mean serum zinc level was 63.8 mg/dL and 57.1% of children had zinc deficiency with no difference in prevalence between groups. PRAM scores did not differ between children with low and normal zinc status. In conclusion, zinc supplementation as the adjuvant therapy to the standard treatment during asthma exacerbation resulted in rapid lessening of severity. PMID:28058103

  4. 40 CFR 52.424 - Conditional approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Conditional approval. 52.424 Section 52.424 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Delaware § 52.424 Conditional approval. (a)-(d)...

  5. 7 CFR 22.308 - Project approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Project approval. 22.308 Section 22.308 Agriculture... Governments § 22.308 Project approval. State and multicounty jurisdictional planning is a State and local..., determination of eligibility and feasibility and final approval of individual projects involving Federal...

  6. 28 CFR 2.93 - Travel approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the...

  7. 28 CFR 2.93 - Travel approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the...

  8. 28 CFR 2.93 - Travel approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the...

  9. 28 CFR 2.93 - Travel approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the...

  10. 28 CFR 2.93 - Travel approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the...

  11. 30 CFR 7.51 - Approval checklist.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each battery assembly bearing an MSHA approval plate shall be accompanied by a description of what is necessary to maintain the battery assembly as approved....

  12. 30 CFR 7.51 - Approval checklist.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each battery assembly bearing an MSHA approval plate shall be accompanied by a description of what is necessary to maintain the battery assembly as approved....

  13. 32 CFR 552.77 - Suspension approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Suspension approval. 552.77 Section 552.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY MILITARY RESERVATIONS AND....77 Suspension approval. The installation commander will personally approve all cases in...

  14. 30 CFR 15.7 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... under the brand or trade name specified in the approval. (b) The wrapper of each cartridge and each case of approved explosives shall be legibly labeled with the following: the brand or trade name, “MSHA... legibly labeled with the following: the brand or trade name, “MSHA Approved Sheathed Explosive Unit”,...

  15. 25 CFR 522.9 - Substitute approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 2 2011-04-01 2011-04-01 false Substitute approval. 522.9 Section 522.9 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR APPROVAL OF CLASS II AND CLASS III ORDINANCES AND RESOLUTIONS SUBMISSION OF GAMING ORDINANCE OR RESOLUTION § 522.9 Substitute approval. If the Chairman fails...

  16. 25 CFR 522.9 - Substitute approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false Substitute approval. 522.9 Section 522.9 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR APPROVAL OF CLASS II AND CLASS III ORDINANCES AND RESOLUTIONS SUBMISSION OF GAMING ORDINANCE OR RESOLUTION § 522.9 Substitute approval. If the Chairman fails...

  17. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by manufacturers. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible methane... follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___...

  18. 50 CFR 260.86 - Approved identification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Fishery Products for Human Consumption Miscellaneous § 260.86 Approved identification. (a) Grade marks: The approved grade mark or identification may be used on containers, labels, or otherwise indicated... inspector as meeting the requirements of such grade, quality or classification. The grade marks approved...

  19. 40 CFR 52.2273 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Texas § 52.2273 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Texas' plan for the attainment and... 1977, except as noted below. (b) EPA is disapproving the Texas SIP revision submittals as follows:...

  20. 40 CFR 52.2273 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Texas § 52.2273 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Texas' plan for the attainment and... 1977, except as noted below. (b) EPA is disapproving the Texas SIP revision submittals as follows:...

  1. 40 CFR 52.2273 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Texas § 52.2273 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Texas' plan for the attainment and... 1977, except as noted below. (b) EPA is disapproving the Texas SIP revision submittals as follows:...

  2. 40 CFR 52.2273 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Texas § 52.2273 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Texas' plan for the attainment and... 1977, except as noted below. (b) EPA is disapproving the Texas SIP revision submittals as follows:...

  3. 7 CFR 22.308 - Project approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Project approval. 22.308 Section 22.308 Agriculture... Governments § 22.308 Project approval. State and multicounty jurisdictional planning is a State and local..., determination of eligibility and feasibility and final approval of individual projects involving Federal...

  4. 7 CFR 22.308 - Project approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false Project approval. 22.308 Section 22.308 Agriculture... Governments § 22.308 Project approval. State and multicounty jurisdictional planning is a State and local..., determination of eligibility and feasibility and final approval of individual projects involving Federal...

  5. 7 CFR 22.308 - Project approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false Project approval. 22.308 Section 22.308 Agriculture... Governments § 22.308 Project approval. State and multicounty jurisdictional planning is a State and local..., determination of eligibility and feasibility and final approval of individual projects involving Federal...

  6. 30 CFR 22.10 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by manufacturers. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible methane... follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___...

  7. 40 CFR 52.2062 - Plan approvals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Plan approvals. 52.2062 Section 52.2062... PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2062 Plan approvals. (a) Emission limitations and related provisions which are established in Pennsylvania plan approvals as...

  8. 40 CFR 52.2062 - Plan approvals.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 5 2012-07-01 2012-07-01 false Plan approvals. 52.2062 Section 52.2062... PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2062 Plan approvals. (a) Emission limitations and related provisions which are established in Pennsylvania plan approvals as...

  9. 40 CFR 52.1323 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290 as.... (c) The Administrator approves Rule 10 CSR 10-2.230 as identified under § 52.1320, paragraph (c)(70... SIP would be the emission limits stated in the rule. (d) The Administrator approves Rule 10 CSR...

  10. 30 CFR 7.51 - Approval checklist.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each battery assembly bearing an MSHA approval plate shall be accompanied by a description of what is necessary to maintain the battery assembly as approved....

  11. 30 CFR 7.51 - Approval checklist.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each battery assembly bearing an MSHA approval plate shall be accompanied by a description of what is necessary to maintain the battery assembly as approved....

  12. 30 CFR 7.309 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.309 Approval marking. Each approved motor assembly shall be identified by a legible and permanent approval plate inscribed.... The plate shall be securely attached to the motor assembly in a manner that does not impair...

  13. 30 CFR 7.311 - Approval checklist.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.311 Approval checklist. Each motor assembly bearing an MSHA approval marking shall be accompanied by a list of items necessary for maintenance of the motor assembly as approved....

  14. 76 FR 47531 - Approval of Classification Societies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ... SECURITY Coast Guard 46 CFR Part 2 RIN 1625-AB35 Approval of Classification Societies AGENCY: Coast Guard... comment period before issuing a final rule regarding the Approval of Classification Societies (USCG- 2007... and performance standards that classification societies must meet in order to obtain approval by...

  15. 7 CFR 1710.406 - Loan approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 11 2013-01-01 2013-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the...

  16. 7 CFR 1710.406 - Loan approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 11 2012-01-01 2012-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the...

  17. 7 CFR 1710.406 - Loan approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 11 2011-01-01 2011-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the...

  18. 7 CFR 1710.406 - Loan approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the...

  19. 40 CFR 52.2062 - Plan approvals.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Plan approvals. 52.2062 Section 52.2062... PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2062 Plan approvals. (a) Emission limitations and related provisions which are established in Pennsylvania plan approvals as...

  20. 12 CFR 611.510 - Approval procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Approval procedures. 611.510 Section 611.510 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Transfer of Authorities § 611.510 Approval procedures. (a) Upon receipt of approval of a resolution by the Farm...