Science.gov

Sample records for efficacy supplement approvals

  1. Efficacy of nutritional supplements used by athletes.

    PubMed

    Beltz, S D; Doering, P L

    1993-12-01

    Findings on the efficacy of nutritional supplements used by athletes are reviewed. Many athletes have turned away from anabolic steroids and toward nutritional supplements in the hope of gaining a competitive edge without threatening their health. Athletes may require slightly more protein than sedentary people do to maintain positive nitrogen balance, but it is dubious whether extra dietary protein will help someone to achieve athletic goals. Purified amino acids have become a popular if expensive form of protein supplementation; there is no scientific evidence, however, to support their use. Excessive protein supplementation can lead to dehydration, gout, liver and kidney damage, calcium loss, and gastrointestinal effects. Supplementation with vitamins and minerals in excess of recommended daily allowances appears to have no effect on muscle mass or athletic performance. Other substances touted as having ergogenic properties are carnitine, cobamamide, growth hormone releasers, octacosanol, and ginseng; again, there is no reliable scientific evidence to support claims that products containing these compounds have ergogenic potential, and heavy supplementation may lead to adverse effects. Nutritional supplements are promoted through unsubstantiated claims by magazine advertisements, health food stores, coaches, and other sources. The FDA considers nutritional supplements to be foodstuffs, not drugs, and therefore has not required that they be proved safe and effective. Dosage guidelines are inadequate, and quality control is poor. The FDA has begun to revise regulations governing labeling and health claims for these products. There is little if any evidence that nutritional supplements have ergogenic effects in athletes consuming a balanced diet, and some products have the potential for harm.

  2. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application. (1) Category I. Supplements that ordinarily do not require a reevaluation of any of the safety or... drug residues. (xiii) A revised method of synthesis or fermentation of the new drug substance. (xiv... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Approval of supplemental applications....

  3. Efficacy of Supplementation in Filipino Children

    PubMed Central

    Tayao, Charisse Marie S.

    2015-01-01

    Introduction: At present, in the absence of an anemia prevention and screening program in Barangay Vasra, this will aid in the formation of programs that would teach about this health related issue, with an intervention that could be used efficiently by the health workers at the non-government organization run center. Objective: The aim of the following study is to establish the efficacy of iron supplementation alone versus iron and ascorbic acid supplementation in improving the hemoglobin (Hgb), hematocrit (Hct), reticulocyte count and red cell indices of anemic undernourished children 5-10 years of age at Lingap Center, Barangay Vasra, Quezon City. Methodology: Anemic undernourished male and female children 5-10 years of age enrolled in the Supplementary Feeding Program of Lingap Center, Barangay Vasra, Quezon City. Study Design: Prospective, experimental trial comparing two interventions-iron supplementation alone versus iron and ascorbic acid supplementation. Results: A total of 25 children participated in this study, with a majority being female at 52% (13/25) of the total. Those who received iron supplementation alone for 6 months, while there were 50% (6/12) of either sex, whereas subjects who took iron and ascorbic acid supplementation for 6 months were predominantly female at 53.85% (7/13). Data obtained before and after iron supplementation alone revealed that there was an increase among the levels of Hgb, Hct, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and reticulocyte count, with the rise statistically significant. Hematological values gained before and after iron and ascorbic acid supplementation uncovered that there was an augmentation among the levels of Hct, MCV, MCH, MCHC and reticulocyte count, with the improvement statistically significant. Encompassing both interventions, the differences in findings were statistically significant in red blood cell (RBC) count, with the level

  4. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... labeling (color, style, format, addition, deletion, or revision of certain statements, e.g., trade...

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

    PubMed

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

    2016-12-01

    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.

  6. 76 FR 46820 - Proposal To Refuse To Approve a Supplemental New Drug Application for Bromday (Bromfenac...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ...-664 to market Xibrom (bromfenac sodium ophthalmic solution), 0.09%. On October 16, 2010, FDA approved... of a recent reorganization in the Office of Antimicrobial Products, the Division of Transplant and... approval of supplement 15. Officials from CDER, including the Director of the Office of...

  7. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  8. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  9. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in...

  10. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in...

  11. 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

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in...

  12. 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

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in...

  13. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in...

  14. Analysis of Selection Activities to Supplement Approval Plans.

    ERIC Educational Resources Information Center

    Loup, Jean L.; Snoke, Helen Lloyd

    1991-01-01

    Describes two surveys of libraries by the Association of Research Libraries (ARL) that were conducted to compare approval plans and to determine alternative acquisitions methods for materials in philosophy and political science. Time spent by selectors is examined, collection evaluation activities are described, and implications for resource…

  15. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-25

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013 AGENCY: Food and Drug... the Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master...

  16. Antimicrobial efficacy of gutta-percha supplemented with cetylpyridinium chloride.

    PubMed

    Tomino, Masafumi; Nagano, Keiji; Hayashi, Tatsuhide; Kuroki, Kenjiro; Kawai, Tatsushi

    2016-01-01

    To develop a root canal filling material with high antimicrobial activity, we prepared gutta-percha supplemented with the cationic surfactant cetylpyridinium chloride (CPC). Thermoplastic gutta-percha was supplemented with 0.05%, 0.2%, or 0.8% CPC. The gutta-percha containing CPC was tightly packed at the bottom of a 24-well plate. Its antimicrobial activity against eight representative endodontic pathogens-including gram-positive and gram-negative bacteria and fungi-was evaluated by adding 0.5 mL of liquid samples containing pathogens to the wells. After 24 h of cultivation under appropriate conditions, microbial growth was analyzed by counting colony-forming units (CFU). Gutta-percha alone (without CPC) partially inhibited microbial growth, probably through the antimicrobial effect of some of its components, such as zinc oxide. Addition of CPC dose-dependently increased the antimicrobial efficacy of gutta-percha. Addition of 0.05%, 0.2%, and 0.8% CPC reduced the viable microbial number to below the lower limit of detection (20 CFU/mL) for all tested pathogens except Pseudomonas aeruginosa, which was detected in 0.8% CPC-containing gutta-percha, although the viable number significantly decreased. Gutta-percha with CPC might be useful for preventing microbial infections during root canal therapy. (J Oral Sci 58, 277-282, 2016).

  17. Antimicrobial efficacy of gutta-percha supplemented with cetylpyridinium chloride.

    PubMed

    Tomino, Masafumi; Nagano, Keiji; Hayashi, Tatsuhide; Kuroki, Kenjiro; Kawai, Tatsushi

    2016-01-01

    To develop a root canal filling material with high antimicrobial activity, we prepared gutta-percha supplemented with the cationic surfactant cetylpyridinium chloride (CPC). Thermoplastic gutta-percha was supplemented with 0.05%, 0.2%, or 0.8% CPC. The gutta-percha containing CPC was tightly packed at the bottom of a 24-well plate. Its antimicrobial activity against eight representative endodontic pathogens-including gram-positive and gram-negative bacteria and fungi-was evaluated by adding 0.5 mL of liquid samples containing pathogens to the wells. After 24 h of cultivation under appropriate conditions, microbial growth was analyzed by counting colony-forming units (CFU). Gutta-percha alone (without CPC) partially inhibited microbial growth, probably through the antimicrobial effect of some of its components, such as zinc oxide. Addition of CPC dose-dependently increased the antimicrobial efficacy of gutta-percha. Addition of 0.05%, 0.2%, and 0.8% CPC reduced the viable microbial number to below the lower limit of detection (20 CFU/mL) for all tested pathogens except Pseudomonas aeruginosa, which was detected in 0.8% CPC-containing gutta-percha, although the viable number significantly decreased. Gutta-percha with CPC might be useful for preventing microbial infections during root canal therapy. (J Oral Sci 58, 277-282, 2016). PMID:27349551

  18. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... distribution of the drug(s) made with the manufacturing change. (4) Changes and updated stability data to be... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Supplements and other changes to an approved application. 514.8 Section 514.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  19. 77 FR 14480 - Defense Federal Acquisition Regulation Supplement: Commercial Determination Approval (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... acquisitions made pursuant to Federal Acquisition Regulation (FAR) 12.102(f)(1).'' This language clarifies that... Defense Acquisition Regulations System 48 CFR Part 212 RIN 0750-AH61 Defense Federal Acquisition Regulation Supplement: Commercial Determination Approval (DFARS Case 2011-D041) AGENCY: Defense...

  20. 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

    ... new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The supplemental NADA provides... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G procaine... supplemental NADA is approved as of April 23, 2010. In accordance with the freedom of information provisions...

  1. 78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION... oxides and volatile organic compounds for Knox County to account for changes in the emissions model and vehicle miles traveled projection model. EPA is approving this SIP revision because the State...

  2. 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. PMID:25900871

  3. 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…

  4. Evidence of clinically relevant efficacy for dietary supplements and nutraceuticals.

    PubMed

    Cicero, Arrigo F G; Borghi, Claudio

    2013-06-01

    Beyond the well-known effects on blood pressure (BP) of the DASH and the Mediterranean diets, a large number of studies have investigated the possible a BP-lowering effect from different dietary supplements and nutraceuticals, mostly antioxidant agents with a high tolerability and safety profile. In particular, a relatively large body of evidence support the use of potassium, L-arginine, vitamin C, cocoa flavonoids, coenzyme Q10, controlled-release melatonin, and aged garlic extract. However there is a need for data about the long-term safety of a large part of these products. Moreover, further clinical research is advisable to identify between the available active nutraceuticals and those with the best cost-effectiveness and risk-benefit ratio for widespread use in a general population with low added cardiovascular risk related to uncomplicated hypertension. PMID:23430658

  5. 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…

  6. 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…

  7. Efficacy of Vitamin C Supplements in Prevention of Cancer: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Lee, Bobae; Oh, Seung-Won

    2015-01-01

    Background Previous randomized controlled trials (RCTs) have reported inconsistent findings regarding the association between vitamin C supplementation and the risk of cancer. Methods We performed a meta-analysis of RCTs to investigate the efficacy of vitamin C supplements for prevention of cancer. We searched the PubMed, EMBASE, and Cochrane Library databases in November 2014 using common keywords related to vitamin C supplements and cancer. Results Among 785 articles, a total of seven trials were identified, which included 62,619 participants; 31,326 and 31,293 were randomized to vitamin C supplementation and control or placebo groups, respectively, which were included in the final analysis. A fixed-effects meta-analysis of all seven RCTs revealed no significant association between vitamin C supplementation and cancer (relative risk, 1.00; 95% confidence intervals, 0.95-1.05). Similarly, subgroup meta-analysis by dose of vitamin C administered singly or in combination with other supplements, follow-up period, methodological quality, cancer mortality, gender, smoking status, country, and type of cancer also showed no efficacy of vitamin C supplementation for cancer prevention. Conclusion This meta-analysis shows that there is no evidence to support the use of vitamin C supplements for prevention of cancer. PMID:26634093

  8. 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

  9. 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. PMID:24027189

  10. Efficacy of Vitamin and Antioxidant Supplements in Prevention of Esophageal Cancer: Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Myung, Seung-Kwon; Yang, Hyo Jin

    2013-01-01

    Background: Observational epidemiological studies have shown that higher intakes of vitamins or antioxidants were inversely associated with the risk of esophageal cancer. However, randomized controlled trials (RCTs) have reported no preventive efficacy of vitamin or antioxidant supplements on esophageal cancer. This meta-analysis aimed to investigate the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer as reported by RCTs. Methods: We searched PubMed, EMBASE, and the Cochrane Library in May 2013. Two authors independently reviewed and selected eligible articles based on predetermined selection criteria. Results: Of 171 articles searched from three databases and relevant bibliographies, 10 RCTs were included in the final analyses. In a fixed-effect meta-analysis of 10 trials, there was no efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer (relative risk [RR], 1.04; 95% confidence interval [CI], 0.86–1.25; I2=0.0%). Also, subgroup meta-analyses showed that vitamin and antioxidant supplements had no preventive efficacy on esophageal cancer both in the high risk (RR, 1.04; 95% CI, 0.85–1.28; n=4) and non-high risk (RR, 1.01; 95% CI, 0.65–1.56; n=6) groups for esophageal cancer. Further, subgroup meta-analyses revealed no preventive efficacy on esophageal cancer by type of methodological quality and type of vitamin and antioxidant supplements. Conclusions: Unlike observational epidemiological studies, this meta-analysis of RCTs suggests that there is no clinical evidence to support the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer. PMID:25337539

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

    PubMed Central

    García-López, Núria; Díaz-Ramos, Ana

    2014-01-01

    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. PMID:25234322

  12. 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…

  13. Efficacy of a Tier 2 Supplemental Root Word Vocabulary and Decoding Intervention with Kindergarten Spanish-Speaking English Learners

    ERIC Educational Resources Information Center

    Nelson, J. Ron; Vadasy, Patricia F.; Sanders, Elizabeth A.

    2011-01-01

    The purpose of this study was to test the efficacy of a Tier 2 standard protocol supplemental intervention designed simultaneously to develop root word vocabulary and reinforce decoding skills being taught to all students in the core beginning reading program with kindergarten Spanish-speaking English learners (ELs). Participating students were…

  14. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA... this section; (B) Changes solely affecting a natural protein, a recombinant DNA-derived...

  15. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA... this section; (B) Changes solely affecting a natural protein, a recombinant DNA-derived...

  16. 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. PMID:25005834

  17. 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... December 22, 2009.\\3\\ \\2\\ 17 CFR 202.190. See Release No. 33-8724 (July 18, 2006) [71 FR 41998 (July 24... Commission, auditing and related attestation, quality control, ethics, and independence standards to be...

  18. 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. PMID:18537692

  19. Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Dong, Hongli; Pi, Fuhua; Ding, Zan; Chen, Wei; Pang, Shaojie; Dong, Wenya; Zhang, Qingying

    2015-01-01

    Background Supplementation with B vitamins for stroke prevention has been evaluated over the years, but which combination of B vitamins is optimal for stroke prevention is unclear. We performed a network meta-analysis to assess the impact of different combinations of B vitamins on risk of stroke. Methods A total of 17 trials (86 393 patients) comparing 7 treatment strategies and placebo were included. A network meta-analysis combined all available direct and indirect treatment comparisons to evaluate the efficacy of B vitamin supplementation for all interventions. Results B vitamin supplementation was associated with reduced risk of stroke and cerebral hemorrhage. The risk of stroke was lower with folic acid plus vitamin B6 as compared with folic acid plus vitamin B12 and was lower with folic acid plus vitamin B6 plus vitamin B12 as compared with placebo or folic acid plus vitamin B12. The treatments ranked in order of efficacy for stroke, from higher to lower, were folic acid plus vitamin B6 > folic acid > folic acid plus vitamin B6 plus vitamin B12 > vitamin B6 plus vitamin B12 > niacin > vitamin B6 > placebo > folic acid plus vitamin B12. Conclusions B vitamin supplementation was associated with reduced risk of stroke; different B vitamins and their combined treatments had different efficacy on stroke prevention. Folic acid plus vitamin B6 might be the optimal therapy for stroke prevention. Folic acid and vitamin B6 were both valuable for stroke prevention. The efficacy of vitamin B12 remains to be studied. PMID:26355679

  20. Review of the efficacy of green tea, isoflavones and aloe vera supplements based on randomised controlled trials.

    PubMed

    Williamson, Gary; Coppens, Patrick; Serra-Majem, Lluís; Dew, Tristan

    2011-12-01

    We assess the evidence for health benefits of three commonly consumed plant food supplements (PFS), green tea, isoflavone and aloe vera, based on published systematic reviews of randomised controlled trials (RCTs). Whilst the potential benefits of green tea have been reported in a wide range of health areas, it is only in the area of the metabolic syndrome that the number of RCTs is approaching sufficient to judge such efficacy. Isoflavone supplements are widely used, and RCTs indicate that they affect bone resorption at lower doses in postmenopausal women undergoing estrogen-related bone loss, but this is only translated to attenuation of bone loss at higher doses of isoflavones. A systematic review on RCTs concluded that the effects of isoflavones on hot flashes in postmenopausal women were highly variable and no conclusions could be drawn. Despite the popularity of aloe vera as a PFS, the evaluation of its efficacy as a coadjuvant therapy for certain metabolic or digestive pathologies remains scarce; it constitutes a typical example of a naturally occurring ingredient whose efficacy in topical applications presupposes its efficacy in systemic applications. Nevertheless, its possible toxic effects on oral consumption call for caution in its utility as a PFS. Since 2007, efficacy evaluation of PFS in Europe has been covered by European Union Nutrition and Health Claims legislation. The European Food Safety Authority has adopted an approach relying on RCTs, while medicinal effects are accepted based on traditional use. In general, there are insufficient RCTs for claims to be made, and conclusive results on PFS should be obtained in the future by conducting studies with more homogeneous populations, by using supplements with optimised and measured bioavailability, and by conducting larger RCTs.

  1. Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy

    PubMed Central

    Petróczi, Andrea; Naughton, Declan P; Pearce, Gemma; Bailey, Richard; Bloodworth, Andrew; McNamee, Michael

    2008-01-01

    Background The objective was to study nutritional supplement use among young elite UK athletes to establish whether a rationale versus practice incongruence exists, and to investigate the sources of information. Survey data were analysed for association between supplements used and motives for using such substances among young athletes along with the sources of advice and literature precedents on supplement effects. Methods Participants were elite UK male and female athletes, within the age range between 12 and 21 (n = 403), mean age 17.66 ± 1.99. Associations between type of supplements and reasons for using supplements were tested by calculating Pearson's χ2 and the strength of these symmetric associations shown by phi (ϕ) association coefficients. Results Single supplement use was reported by 48.1%, with energy drinks being the most popular, consumed by 41.7% of all athletes and 86.6% of the supplement users in the sample. No agreement was observed between athletes' rationale and behaviour in relation to nutritional supplements except for creatine. Among health professionals, nutritionists and physiotherapists, followed by coaches, were most frequently consulted. Answers regarding reasons and supplements used showed incongruence and suggest widespread misinformation regarding supplements and their effects is an issue for the young athlete. Conclusion Widespread supplement taking behaviour was evidenced in the young elite athlete population with the most notable congruence between rationale and practice among young athletes being performance-related. Young athletes in the present sample appear to be less 'health conscious' and more 'performance focused' than their adult counterparts. Further research, using a full list of supplements, is warranted to test the hypothesis that health consciousness is less dominant in supplement choice by young athletes. PMID:19077317

  2. Efficacy of a crosslinked hyaluronic acid-based hydrogel as a tear film supplement: a masked controlled study.

    PubMed

    Williams, David L; Mann, Brenda K

    2014-01-01

    Keratoconjunctivitis sicca (KCS), or dry eye, is a significant medical problem in both humans and dogs. Treating KCS often requires the daily application of more than one type of eye drop in order to both stimulate tear prodcution and provide a tear supplement to increase hydration and lubrication. A previous study demonstrated the potential for a crosslinked hyaluronic acid-based hydrogel (xCMHA-S) to reduce the clinical signs associated with KCS in dogs while using a reduced dosing regimen of only twice-daily administration. The present study extended those results by comparing the use of the xCMHA-S to a standard HA-containing tear supplement in a masked, randomized clinical study in dogs with a clinical diagnosis of KCS. The xCMHA-S was found to significantly improve ocular surface health (conjunctival hyperaemia, ocular irritation, and ocular discharge) to a greater degree than the alternative tear supplement (P = 0.0003). Further, owners reported the xCMHA-S treatment as being more highly effective than the alternative tear supplement (P = 0.0024). These results further demonstrate the efficacy of the xCMHA-S in reducing the clinical signs associated with KCS, thereby improving patient health and owner happiness.

  3. Efficacy of a Crosslinked Hyaluronic Acid-Based Hydrogel as a Tear Film Supplement: A Masked Controlled Study

    PubMed Central

    Williams, David L.; Mann, Brenda K.

    2014-01-01

    Keratoconjunctivitis sicca (KCS), or dry eye, is a significant medical problem in both humans and dogs. Treating KCS often requires the daily application of more than one type of eye drop in order to both stimulate tear prodcution and provide a tear supplement to increase hydration and lubrication. A previous study demonstrated the potential for a crosslinked hyaluronic acid-based hydrogel (xCMHA-S) to reduce the clinical signs associated with KCS in dogs while using a reduced dosing regimen of only twice-daily administration. The present study extended those results by comparing the use of the xCMHA-S to a standard HA-containing tear supplement in a masked, randomized clinical study in dogs with a clinical diagnosis of KCS. The xCMHA-S was found to significantly improve ocular surface health (conjunctival hyperaemia, ocular irritation, and ocular discharge) to a greater degree than the alternative tear supplement (P = 0.0003). Further, owners reported the xCMHA-S treatment as being more highly effective than the alternative tear supplement (P = 0.0024). These results further demonstrate the efficacy of the xCMHA-S in reducing the clinical signs associated with KCS, thereby improving patient health and owner happiness. PMID:24914681

  4. Dronedarone for the treatment of atrial fibrillation and atrial flutter: approval and efficacy

    PubMed Central

    Wolbrette, Deborah; Gonzalez, Mario; Samii, Soraya; Banchs, Javier; Penny-Peterson, Erica; Naccarelli, Gerald

    2010-01-01

    Dronedarone, a new Class III antiarrhythmic agent, has now been approved by the US Food and Drug Administration for use in patients with atrial fibrillation or atrial flutter. Approval came in March 2009 due to the positive results of the ATHENA trial showing significant reductions in all-cause mortality and cardiovascular hospitalization with dronedarone use. A post hoc analysis of the ATHENA data also suggested a decrease in stroke risk with this agent. However, due to safety concerns in the heart failure population in the earlier ANDROMEDA trial, dronedarone is not recommended for patients with an ejection fraction <35% and recent decompensated heart failure. Dronedarone is an amiodarone analog with multichannel blocking electrophysiologic properties similar to those of amiodarone, but several structural differences. Dronedarone’s lack of the iodine moiety reduces its potential for thyroid and pulmonary toxicity. Preliminary data from the DIONYSOS trial, and an indirect meta-analysis comparing amiodarone with dronedarone, showed amiodarone to be more effective in maintaining sinus rhythm, while dronedarone was associated with fewer adverse effects resulting in early termination of the drug. Dronedarone is the first antiarrhythmic drug for the treatment of atrial fibrillation and atrial flutter shown to reduce cardiovascular hospitalizations. In patients with structural heart disease who have an ejection fraction >35% and no recent decompensated heart failure, dronedarone should be considered earlier than amiodarone in the treatment algorithm. PMID:20730068

  5. Efficacy of Parenteral Nutrition Supplemented With Glutamine Dipeptide to Decrease Hospital Infections in Critically Ill Surgical Patients

    PubMed Central

    Estívariz, Concepción F.; Griffith, Daniel P.; Luo, Menghua; Szeszycki, Elaina E.; Bazargan, Niloofar; Dave, Nisha; Daignault, Nicole M.; Bergman, Glen F.; McNally, Therese; Battey, Cindy H.; Furr, Celeste E.; Hao, Li; Ramsay, James G.; Accardi, Carolyn R.; Cotsonis, George A.; Jones, Dean P.; Galloway, John R.; Ziegler, Thomas R.

    2011-01-01

    Background Nosocomial infections are an important cause of morbidity and mortality in the surgical intensive care unit (SICU). Clinical benefits of glutamine-supplemented parenteral nutrition may occur in hospitalized surgical patients, but efficacy data in different surgical subgroups are lacking. The objective was to determine whether glutamine-supplemented parenteral nutrition differentially affects nosocomial infection rates in selected subgroups of SICU patients. Methods This was a double-blind, randomized, controlled study of alanyl-glutamine dipeptide-supplemented parenteral nutrition in SICU patients requiring parenteral nutrition and SICU care after surgery for pancreatic necrosis, cardiac, vascular, or colonic surgery. Subjects (n = 59) received isocaloric/isonitrogenous parenteral nutrition, providing 1.5 g/kg/d standard glutamine-free amino acids (STD-PN) or 1.0 g/kg/d standard amino acids + 0.5 g/kg/d glutamine dipeptide (GLN-PN). Enteral feedings were advanced as tolerated. Nosocomial infections were determined until hospital discharge. Results Baseline clinical/metabolic data were similar between groups. Plasma glutamine concentrations were low in all groups and were increased by GLN-PN. GLN-PN did not alter infection rates after pancreatic necrosis surgery (17 STD-PN and 15 GLN-PN patients). In nonpancreatic surgery patients (12 STD-PN and 15 GLN-PN), GLN-PN was associated with significantly decreased total nosocomial infections (STD-PN 36 vs GLN-PN 13, P < .030), bloodstream infections (7 vs 0, P < .01), pneumonias (16 vs 6, P < .05), and infections attributed to Staphylococcus aureus (P < .01), fungi, and enteric Gram-negative bacteria (each P < .05). Conclusions Glutamine dipeptide-supplemented parenteral nutrition did not alter infection rates following pancreatic necrosis surgery but significantly decreased infections in SICU patients after cardiac, vascular, and colonic surgery. PMID:18596310

  6. 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

  7. Dosing and efficacy of glutamine supplementation in human exercise and sport training.

    PubMed

    Gleeson, Michael

    2008-10-01

    Some athletes can have high intakes of l-glutamine because of their high energy and protein intakes and also because they consume protein supplements, protein hydrolysates, and free amino acids. Prolonged exercise and periods of heavy training are associated with a decrease in the plasma glutamine concentration and this has been suggested to be a potential cause of the exercise-induced immune impairment and increased susceptibility to infection in athletes. However, several recent glutamine feeding intervention studies indicate that although the plasma glutamine concentration can be kept constant during and after prolonged strenuous exercise, the glutamine supplementation does not prevent the postexercise changes in several aspects of immune function. Although glutamine is essential for lymphocyte proliferation, the plasma glutamine concentration does not fall sufficiently low after exercise to compromise the rate of proliferation. Acute intakes of glutamine of approximately 20-30 g seem to be without ill effect in healthy adult humans and no harm was reported in 1 study in which athletes consumed 28 g glutamine every day for 14 d. Doses of up to 0.65 g/kg body mass of glutamine (in solution or as a suspension) have been reported to be tolerated by patients and did not result in abnormal plasma ammonia levels. However, the suggested reasons for taking glutamine supplements (support for immune system, increased glycogen synthesis, anticatabolic effect) have received little support from well-controlled scientific studies in healthy, well-nourished humans.

  8. Dosing and efficacy of glutamine supplementation in human exercise and sport training.

    PubMed

    Gleeson, Michael

    2008-10-01

    Some athletes can have high intakes of l-glutamine because of their high energy and protein intakes and also because they consume protein supplements, protein hydrolysates, and free amino acids. Prolonged exercise and periods of heavy training are associated with a decrease in the plasma glutamine concentration and this has been suggested to be a potential cause of the exercise-induced immune impairment and increased susceptibility to infection in athletes. However, several recent glutamine feeding intervention studies indicate that although the plasma glutamine concentration can be kept constant during and after prolonged strenuous exercise, the glutamine supplementation does not prevent the postexercise changes in several aspects of immune function. Although glutamine is essential for lymphocyte proliferation, the plasma glutamine concentration does not fall sufficiently low after exercise to compromise the rate of proliferation. Acute intakes of glutamine of approximately 20-30 g seem to be without ill effect in healthy adult humans and no harm was reported in 1 study in which athletes consumed 28 g glutamine every day for 14 d. Doses of up to 0.65 g/kg body mass of glutamine (in solution or as a suspension) have been reported to be tolerated by patients and did not result in abnormal plasma ammonia levels. However, the suggested reasons for taking glutamine supplements (support for immune system, increased glycogen synthesis, anticatabolic effect) have received little support from well-controlled scientific studies in healthy, well-nourished humans. PMID:18806122

  9. Efficacy and Interaction of Antioxidant Supplements as Adjuvant Therapy in Cancer Treatment: A Systematic Review.

    PubMed

    Yasueda, Asuka; Urushima, Hayato; Ito, Toshinori

    2016-03-01

    Oxidative stress is a key component in carcinogenesis. Although radiation produces reactive oxygen species, some anticancer agents such as alkylating agents, platinum and antitumor antibiotics exert cytotoxicity by generating free radicals. Nonenzymatic exogenous antioxidants such as vitamins, minerals, and polyphenols can quench ROS activity. However, whether antioxidants alter antitumor effects during radiotherapy and some types of chemotherapy remains unclear. In the present study, we reviewed antioxidants as an adjuvant therapy for cancer patients during chemotherapy or radiotherapy. Electronic literature searches were performed to select all randomized controlled clinical trials (RCTs) in which antioxidants were administered to cancer patients along with chemotherapy or radiotherapy. Articles or abstracts written in English were included. In total, 399 reports received primary screening. Duplicated articles and those meeting the exclusion criteria (not RCT, not human, and no oral administration) were excluded. Finally, 49 reports matching the inclusion criteria were included. It was difficult to determine whether antioxidants affect treatment outcomes or whether antioxidants ameliorate adverse effects induced by chemotherapy and radiotherapy. It is desirable to use an evidence-based method to select supplements best suited to cancer patients. Although there are many opinions about risks or benefits of antioxidant supplementation, we could mostly conclude that the harm caused by antioxidant supplementation remains unclear for patients during cancer therapy, except for smokers undergoing radiotherapy. PMID:26503419

  10. 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…

  11. 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

  12. [Chemical composition and efficacy of the multimixture as a dietary supplement: a literature review].

    PubMed

    Ferreira, Haroldo Silva; Cavalcante, Sybelle Araújo; Assunção, Monica Lopes de

    2010-10-01

    The aim of this work was to identify all papers already published on the nutritional supplement known as multimixture (MM) in journals with high level of scientific rigor and to evaluate the effectiveness of this product as a food supplement. The methodology was based on searching at Medline and Scielo databases, without limit of date, using the keyword multimixture. Thirty one articles were analyzed. Because of the small portion that is recommended for daily consumption, the MM cannot be considered an important source of energy, protein and minerals. Its high proportion of magnesium and/or calcium can impair the absorption of iron. Its use increases the fiber content of the diet, which can reduce the absorption of nutrients, which is not interesting in the case of malnourished children. Its high amount of phytate seems to be no problem because the prior treatment to which the bran is submitted reduces the chelating power of this compound. The possibility of poisoning by cyanide come from the cassava leaf is not discarded. Regarding the ability to promote the nutritional state, 12 out of 15 studies concluded its ineffectiveness. Considering risks and benefits and the available evidence in the literature, is not justified the use of MM as a strategy for prevention and control of malnutrition.

  13. 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…

  14. 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.

  15. Efficacy of micronutrient supplementation on skin aging and seasonal variation: a randomized, placebo-controlled, double-blind study

    PubMed Central

    Fanian, Ferial; Mac-Mary, Sophie; Jeudy, Adeline; Lihoreau, Thomas; Messikh, Rafat; Ortonne, Jean-Paul; Sainthillier, Jean-Marie; Elkhyat, Ahmed; Guichard, Alexandre; Kenari, Kamran Hejazi; Humbert, Philippe

    2013-01-01

    Background Several studies have confirmed dramatic changes in skin surface parameters during the winter months. Although there are many studies supporting the positive effects of topical treatment, there are no published studies demonstrating the effects of oral supplementation in the prevention of negative skin changes during winter. The purpose of this study was to evaluate the efficacy of an oral micronutrient supplement in preventing the negative effects of winter weather on skin quality using noninvasive biometrologic instruments. Methods This study included 80 healthy female volunteers aged 35–55 years with phototype II–IV skin. Randomization was balanced. Two tablets of a micronutrient supplement (Perfectil® Platinum) or placebo were administered once daily for 4 months. The volunteers were examined at baseline, after 4 months, and 6 weeks after termination of treatment (month 5.5). The evaluation included skin microrelief by Visioscan® as the main outcome, and the secondary outcomes were results on standard macrophotography, skin tension by Reviscometer®, skin high-frequency ultrasound, and self-assessment. Results For all pseudoroughness and microrelief indicators, there was a significant increase from baseline to month 4 in the placebo group (P<0.05) but no change in the active group. Descriptive statistics for the mean minimum, mean maximum, and minimum to maximum ratio on the nonexposed study zone showed a significant and dramatic difference between baseline and month 4 and between baseline and month 5.5 (P<0.05) in the active group, indicating decreasing anisotropy of the skin. High-frequency ultrasound on the exposed study zone revealed that skin thickness was significantly decreased in the placebo group during winter but was stable in the treated group (P<0.01). The photography scaling and self-assessment questionnaire revealed no significant changes in either group. Conclusion These results indicate that the skin is prone to seasonal changes

  16. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  17. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  18. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  19. 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...

  20. 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

  1. 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

  2. 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. PMID:25310808

  3. 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.

  4. Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies. Trial Registration Ghana: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000582055; India: CLINICALTRIALS.GOV - NCT01138449; Tanzania: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000636055. PMID:22361251

  5. 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

  6. Efficacy of Bio-Catalyzer alpha.rho no.11 (Bio-Normalizer) supplementation against peroxyl radical-induced oxidative damage in rat organ homogenates.

    PubMed

    Marcocci, L; D'Anna, R; Yan, L J; Haramaki, N; Packer, L

    1996-03-01

    To better delineate the antioxidant potential of Bio-Catalyzer alpha.rho No.11 (Bio-Normalizer), a natural food supplement recently proposed as an antioxidant agent, we investigated the efficacy of Bio-Normalizer supplementation to protect rat organ homogenates against oxidative damage induced in vitro by peroxyl radicals generated in the hydrophobic or in the hydrophilic phase. Bio-Normalizer supplementation efficiently protected rat kidney homogenates against the accumulation of thiobarbituric reactive substances (TBARS), the formation of protein carbonyl derivatives and the depletion of alpha-tocopherol induced by peroxyl radicals generated from the hydrophobic azo-initiator 2,2'-azobis (2,4-dimethylvaleronitrile) (AMVN). It also protected the heart but not the liver or the brain homogenates. Bio-Normalizer supplementation did not have effect in any organ homogenates when peroxyl radicals were generated from the hydrophilic azo-initiator 2,2'-azobis (2-amidinopropane) dihydrochloride) (AAPH). In vitro direct addition of aqueous solutions of Bio-Normalizer to the organ homogenates was ineffective against AMVN or AAPH-induced oxidative damage. Our findings expand previous reports on the antioxidant activity of Bio-Normalizer. They confirm that supplemented Bio-Normalizer protects against peroxyl radical-induced oxidative damage and suggest that its antioxidant action depends on in vivo bioactivation, it is organ specific and it is limited to damage induced by peroxyl radicals generated in the hydrophobic phase.

  7. 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

  8. The efficacy of Phaseolus vulgaris as a weight-loss supplement: a systematic review and meta-analysis of randomised clinical trials.

    PubMed

    Onakpoya, Igho; Aldaas, Salsabil; Terry, Rohini; Ernst, Edzard

    2011-07-01

    A variety of dietary supplements are presently available as slimming aids, but their efficacy has not been proven. One such slimming aid is the bean extract, Phaseolus vulgaris. The aim of the present systematic review is to evaluate the evidence for or against the efficacy of P. vulgaris. Electronic and non-electronic searches were conducted to identify relevant human randomised clinical trials (RCT). Hand searches of bibliographies were also conducted. No age, time or language restrictions were imposed. The eligibility of studies was determined by two reviewers independently, and the methodological quality of the included studies was assessed. We identified eleven eligible trials, and six were included. All the included RCT had serious methodological flaws. A meta-analysis revealed a statistically non-significant difference in weight loss between P. vulgaris and placebo groups (mean difference (MD) − 1.77 kg, 95 % CI − 3.33, 0.33). A further meta-analysis revealed a statistically significant reduction in body fat favouring P. vulgaris over placebo (MD − 1.86 kg, 95 % CI − 3.39, − 0.32). Heterogeneity was evident in both analyses. The poor quality of the included RCT prevents us from drawing any firm conclusions about the effects of P. vulgaris supplementation on body weight. Larger and more rigorous trials are needed to objectively assess the effects of this herbal supplement. PMID:22844674

  9. 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.

  10. 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

  11. 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 ...

  12. 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

  13. Efficacy of calcium supplementation for human bone health by mass spectrometry profiling and cathepsin K measurement in plasma samples.

    PubMed

    Zhao, Yingchun; Cao, Rui; Ma, Danjun; Zhang, Hengwei; Lappe, Joan; Recker, Robert R; Xiao, Gary Guishan

    2011-09-01

    Osteoporosis is a common disease among older people, especially postmenopausal women. Calcium supplementation is effective in decreasing the occurrence of osteoporosis. We tested the effect of different calcium sources (i.e., calcium carbonate chew, milk mineral chew, milk drink and placebo chew) by direct mass spectrometry (dMS) profiling and cathepsin K measurement in the serum of subjects. The dMS method is promising for plasma biomarker discovery, and cathepsin K level in the plasma is an indicator for osteoporosis. Our result shows that dMS detected characteristic ion peaks after different calcium supplement interventions; ion peak 4281.0 m/z was commonly inhibited by all three treatments. This ion peak was identified to be a fragment of follistatin-related protein 3 precursor by means of the "Lift" mode of MS/MS. The other differential ion peaks were also successfully identified: 1786.5 m/z (upregulated after calcium carbonate chew) was shown to be one fragment of transcription factor jun-B; the parent protein of 3504.7 m/z (upregulated after milk drink) was a collagen alpha-2 (type I) chain precursor; the ion peak of 3359.6 m/z (downregulated after milk mineral chew) was one fragment of family 31 glucosidase. Cathepsin K is significantly inhibited only by calcium carbonate chew treatment, indicating this form of calcium supplement has some advantage over other sources of supplementation.

  14. Efficacy of Removal of Sucrose-Supplemented Interproximal Plaque by Electric Toothbrushes in an In Vitro Model

    PubMed Central

    Hope, C. K.; Petrie, A.; Wilson, M.

    2005-01-01

    Electric toothbrushes were evaluated using a model of plaque removal by fluid shear forces. Sucrose supplementation during plaque development did not affect the removal of bacteria from biofilm exposed to low-energy shear but did increase their resistance to high-energy shear. The toothbrush supplying high-energy shear forces removed significantly more viable bacteria. PMID:15691977

  15. Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus

    PubMed Central

    Dougherty, Kelly A.; Schall, Joan I.; Zemel, Babette S.; Tuluc, Florin; Hou, Xiaoling; Rutstein, Richard M.; Stallings, Virginia A.

    2014-01-01

    Background Suboptimal vitamin D (vitD) status is common in children and young adults infected with human immunodeficiency virus (HIV). The vitD supplemental dose needed to normalize vitD status in this population is unknown. Methods In this double-blind trial, subjects infected with HIV ages 8.3 to 24.9 years were randomized to vitD3 supplementation of 4000 IU/day or 7000 IU/day and evaluated at 6 and 12 week for changes in vitD status and HIV indicators. A dose was considered unsafe if serum calcium was elevated (above age and sex-specific range) associated with elevated serum 25 hydroxyvitamin D (25(OH)D); >160 ng/mL). Results At baseline, 95% of subjects (n = 44; 43% with perinatally acquired HIV, 57% with behaviorally acquired HIV) had a suboptimal serum 25(OH)D concentration of <32 ng/mL (mean ± standard deviation, 19.3 ± 7.4; range, 4.4–33.6 ng/mL). After 12 weeks (main outcome) of D3 supplementation, both D3 doses were safe and well tolerated, with no evidence of elevation of serum calcium concentrations or deterioration in HIV immunologic or virologic status. Sufficient vitD status, defined as serum 25(OH)D ≥32 ng/mL, was achieved in 81% of all subjects, and only the 7000 IU/day group (86%) achieved this a priori efficacy criterion in >80% of subjects. Change in serum 25(OH)D did not differ between HIV acquisition groups. Conclusions A 7000 IU/day D3 supplementation was safe and effective in children and young adults infected with HIV. PMID:26625449

  16. Supplementation of host response by targeting nitric oxide to the macrophage cytosol is efficacious in the hamster model of visceral leishmaniasis and adds to efficacy of amphotericin B.

    PubMed

    Pandya, Sanketkumar; Verma, Rahul Kumar; Khare, Prashant; Tiwari, Brajendra; Srinivasarao, Dadi A; Dube, Anuradha; Goyal, Neena; Misra, Amit

    2016-08-01

    We investigated efficacy of nitric oxide (NO) against Leishmania donovani. NO is a mediator of host response to infection, with direct parasiticidal activity in addition to its role in signalling to evoke innate macrophage responses. However, it is short-lived and volatile, and is therefore difficult to introduce into infected cells and maintain inracellular concentrations for meaningful periods of time. We incorporated diethylenetriamine NO adduct (DETA/NO), a prodrug, into poly(lactide-co-glycolide) particles of ∼200 nm, with or without amphotericin B (AMB). These particles sustained NO levels in mouse macrophage culture supernatants, generating an area under curve (AUC0.08-24h) of 591.2 ± 95.1 mM × h. Free DETA/NO resulted in NO peaking at 3 h and declining rapidly to yield an AUC of 462.5 ± 193.4. Particles containing AMB and DETA/NO were able to kill ∼98% of promastigotes and ∼76% of amastigotes in 12 h when tested in vitro. Promastigotes and amastigotes were killed less efficiently by particles containing a single drug- either DETA/NO (∼42%, 35%) or AMB (∼90%, 50%) alone, or by equivalent concentrations of drugs in solution. In a pre-clinical efficacy study of power >0.95 in the hamster model, DETA/NO particles were non-inferior to Fungizone® but not Ambisome®, resulting in significant (∼73%) reduction in spleen parasites in 7 days. Particles containing both DETA/NO and AMB were superior (∼93% reduction) to Ambisome®. We conclude that NO delivered to the cytosol of macrophages infected with Leishmania possesses intrinsic activity and adds significantly to the efficacy of AMB. PMID:27183429

  17. Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012).

    PubMed

    Bansal, Dipika; Bhagat, Anil; Schifano, Fabrizio; Gudala, Kapil

    2015-12-01

    The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency. PMID:26031612

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

    PubMed

    Mezzasalma, Valerio; Manfrini, Enrico; Ferri, Emanuele; Sandionigi, Anna; La Ferla, Barbara; Schiano, Irene; Michelotti, Angela; Nobile, Vincenzo; Labra, Massimo; Di Gennaro, Patrizia

    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

  19. 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.

  20. 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

  1. 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

  2. Efficacy of protein, symbiotic and probiotic supplementation on production performance and egg quality characteristics in molted layers.

    PubMed

    Anwar, Haseeb; Rahman, Zia Ur

    2016-10-01

    Two hundred white leg horn layers at 70 weeks of age were induced to molt with high dietary zinc (3 g/kg of feed); thereafter, birds were equally and randomly divided (n = 50 each) into four groups keeping G1 as control (CP 16 % diet, no other supplement), G2 (CP 18 % diet), G3 (CP 16 % diet + symbiotic; Perfectin® at 85 mg/L in drinking water daily), and G4 (CP 16 % diet + probiotic; Protexin® at 85 mg/L in drinking water daily). The egg production record was maintained throughout the experiment period, and egg quality parameters were performed at 5 %, peak, and end of post molt production stage. The overall egg production was highest in G2 (74.51 %) followed by G3 (64.95 %) and G4 (65.03 %) and lowest in G1 (58.51 %). The overall egg weight, length, diameter, weight and diameter of albumin and yolk, egg shell thickness as well as egg shell breaking strength increased (P ≤ 0.01) in G2 and G3 as compared to G1. The albumin height, yolk height, yolk index, and haugh unit score decreased (P ≤ 0.01) in G2 and G3 as compared to G1. FCR/12 eggs improved in all the supplemented groups as compared to control (G1). The bacterial contamination of eggs was seen in G1. Conclusively, it was observed in the current experiment that the supplementation with protein, probiotic, and symbiotic did improve the production quality and potential in molted layers. PMID:27312596

  3. Safety and Efficacy of High-dose Daily Vitamin D3 Supplementation in Children and Young Adults With Sickle Cell Disease.

    PubMed

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

    2015-07-01

    Suboptimal vitamin D (vit D) status (<32 ng/mL) is ubiquitous among African American children with type SS sickle cell disease (SCD-SS). The vit D supplemental dose to normalize vit D status is unknown. Five to 20-year-old African American children with (n=21) and without (n=23) SCD-SS were randomized to vit D3 supplementation (4000 or 7000 IU/d) and evaluated at 6 and 12 weeks for changes in vit D 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 vit D 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) vit D status was eliminated only in those receiving 7000 IU/d. For subjects with SCD-SS, by 12 weeks there was a significant (all P<0.05) increase in fetal hemoglobin, decrease in high-sensitivity C-reactive protein, and reduction in the percentage of subjects with a high platelet count.

  4. 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

    2016-01-01

    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

  5. 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.

  6. 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

  7. Preliminary assessment of the efficacy of supplementing knee extension capability in a lower limb exoskeleton with FES.

    PubMed

    Quintero, Hugo A; Farris, Ryan J; Ha, Kevin; Goldfarb, Michael

    2012-01-01

    The authors describe a cooperative controller that combines the knee joint actuation of an externally powered lower limb exoskeleton with the torque and power contribution from the electrically stimulated quadriceps muscle group. The efficacy of combining these efforts is experimentally validated with a series of weighted leg lift maneuvers. Measurements from these experiments indicate that the control approach effectively combines the respective efforts of the motor and muscle, such that good control performance is achieved, with substantial torque and energy contributions from both the biological and non-biological actuators. PMID:23366646

  8. A review of the pharmacology, efficacy and tolerability of recently approved and upcoming oral antipsychotics: an evidence-based medicine approach.

    PubMed

    Citrome, Leslie

    2013-11-01

    Evidence-based medicine (EBM) is a broad concept, but the key elements include the incorporation of clinical judgment (which requires clinical experience) together with relevant scientific evidence while remaining mindful of the individual patient's values and preferences. Using the framework and philosophy of EBM, this systematic review summarizes the pharmacology, efficacy, and tolerability of newly approved oral antipsychotics, including iloperidone, asenapine, and lurasidone, and outlines what is known about agents that are in late-stage clinical development, such as cariprazine, brexpiprazole, zicronapine, bitopertin, and EVP-6124. Potential advantages and disadvantages of these agents over existing antipsychotics are outlined, centered on clinically relevant issues such as the potential for weight gain and metabolic abnormalities, potential association with somnolence/sedation, extra-pyramidal side effects, akathisia, and prolongation of the electrocardiogram (ECG) QT interval, as well as practical issues regarding dosing instructions, titration requirements, and drug-drug interactions. Lurasidone appears to be best in class in terms of minimizing untoward alterations in body weight and metabolic variables. However, iloperidone, asenapine, lurasidone, and cariprazine differ among themselves in terms of on-label dosing frequency (once daily for lurasidone and, presumably, cariprazine versus twice daily for iloperidone and asenapine), the need for initial titration to a therapeutic dose for iloperidone and possibly cariprazine, requirement to be taken sublingually for asenapine, requirement for administration with food for lurasidone, lengthening of the ECG QT interval (greater for iloperidone than for asenapine and no effect observed with lurasidone), and adverse effects such as akathisia (seen with cariprazine, lurasidone, and asenapine but not with iloperidone) and sedation (most notable with asenapine).

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

    PubMed

    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

  10. 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

  11. Comparative evaluation of efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients with diabetic nephropathy.

    PubMed

    Khan, Irfan Ahmad; Nasiruddin, Mohammad; Haque, Shahzad F; Khan, Rahat A

    2016-01-01

    To determine the efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients of diabetic nephropathy (DN), we studied 96 patients of DN attending a tertiary care center of the North India. The patients were randomly divided into three equal interventional groups. Group I (control) that received conservative management along with placebo, Group II (rhubarb) that received conservative management along with rhubarb capsule (350 mg, thrice daily), and Group III [keto amino acid (KAA)] that received conservative management along with α-keto analogs of essential amino acids (600 mg, thrice daily). The treatment was continued for 12 weeks. Clinical and biochemical parameters were assessed at 0, 4, 8, and 12 weeks of treatment. A progressive improvement in clinical features and biochemical parameters was seen in all three groups after 12 weeks of treatment. The KAA group showed more marked improvement in clinical features as well as biochemical parameters compared to the rhubarb group. There was a reduction in blood glucose, blood urea, serum creatinine, and 24 h total urine protein. There was an increase in hemoglobin, 24 h total urine volume, and glomerular filtration rate. There was no statistical difference between the rhubarb and KAA groups with respect to side effects (P > 0.05). Our study suggests that KAA is more effective than rhubarb as add-on therapy with conservative management in patients of DN. PMID:27424687

  12. Ingesting a preworkout supplement containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days is both safe and efficacious in recreationally active men.

    PubMed

    Kendall, Kristina L; Moon, Jordan R; Fairman, Ciaran M; Spradley, Brandon D; Tai, Chih-Yin; Falcone, Paul H; Carson, Laura R; Mosman, Matt M; Joy, Jordan M; Kim, Michael P; Serrano, Eric R; Esposito, Enrico N

    2014-05-01

    The purpose of this study was to determine the safety and efficacy of consuming a preworkout supplement (SUP) containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days. We hypothesized that little to no changes in kidney and liver clinical blood markers or resting heart rate and blood pressure (BP) would be observed. In addition, we hypothesized that body composition and performance would improve in recreationally active males after 28 days of supplementation. In a double-blind, placebo-controlled study, participants were randomly assigned to ingest one scoop of either the SUP or placebo every day for 28 days, either 20 minutes before exercise or ad libitum on nonexercise days. Resting heart rate and BP, body composition, and fasting blood samples were collected before and after supplementation. Aerobic capacity as well as muscular strength and endurance were also measured. Significant (P < .05) main effects for time were observed for resting heart rate (presupplementation, 67.59 ± 7.90 beats per minute; postsupplementation, 66.18 ± 7.63 beats per minute), systolic BP (presupplementation, 122.41 ± 11.25 mm Hg; postsupplementation, 118.35 ± 11.58 mm Hg), blood urea nitrogen (presupplementation, 13.12 ± 2.55 mg/dL; postsupplementation, 15.24 ± 4.47 mg/dL), aspartate aminotransferase (presupplementation, 34.29 ± 16.48 IU/L; postsupplementation, 24.76 ± 4.71 IU/L), and alanine aminotransferase (presupplementation, 32.76 ± 19.72 IU/L; postsupplementation, 24.88 ± 9.68 IU/L). Significant main effects for time were observed for body fat percentage (presupplementation, 15.55% ± 5.79%; postsupplementation, 14.21% ± 5.38%; P = .004) and fat-free mass (presupplementation, 70.80 ± 9.21 kg; postsupplementation, 71.98 ± 9.27 kg; P = .006). A significant decrease in maximal oxygen consumption (presupplementation, 47.28 ± 2.69 mL/kg per minute; postsupplementation, 45.60 ± 2.81 mL/kg per minute) and a significant increase in percentage of

  13. Ingesting a preworkout supplement containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days is both safe and efficacious in recreationally active men.

    PubMed

    Kendall, Kristina L; Moon, Jordan R; Fairman, Ciaran M; Spradley, Brandon D; Tai, Chih-Yin; Falcone, Paul H; Carson, Laura R; Mosman, Matt M; Joy, Jordan M; Kim, Michael P; Serrano, Eric R; Esposito, Enrico N

    2014-05-01

    The purpose of this study was to determine the safety and efficacy of consuming a preworkout supplement (SUP) containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days. We hypothesized that little to no changes in kidney and liver clinical blood markers or resting heart rate and blood pressure (BP) would be observed. In addition, we hypothesized that body composition and performance would improve in recreationally active males after 28 days of supplementation. In a double-blind, placebo-controlled study, participants were randomly assigned to ingest one scoop of either the SUP or placebo every day for 28 days, either 20 minutes before exercise or ad libitum on nonexercise days. Resting heart rate and BP, body composition, and fasting blood samples were collected before and after supplementation. Aerobic capacity as well as muscular strength and endurance were also measured. Significant (P < .05) main effects for time were observed for resting heart rate (presupplementation, 67.59 ± 7.90 beats per minute; postsupplementation, 66.18 ± 7.63 beats per minute), systolic BP (presupplementation, 122.41 ± 11.25 mm Hg; postsupplementation, 118.35 ± 11.58 mm Hg), blood urea nitrogen (presupplementation, 13.12 ± 2.55 mg/dL; postsupplementation, 15.24 ± 4.47 mg/dL), aspartate aminotransferase (presupplementation, 34.29 ± 16.48 IU/L; postsupplementation, 24.76 ± 4.71 IU/L), and alanine aminotransferase (presupplementation, 32.76 ± 19.72 IU/L; postsupplementation, 24.88 ± 9.68 IU/L). Significant main effects for time were observed for body fat percentage (presupplementation, 15.55% ± 5.79%; postsupplementation, 14.21% ± 5.38%; P = .004) and fat-free mass (presupplementation, 70.80 ± 9.21 kg; postsupplementation, 71.98 ± 9.27 kg; P = .006). A significant decrease in maximal oxygen consumption (presupplementation, 47.28 ± 2.69 mL/kg per minute; postsupplementation, 45.60 ± 2.81 mL/kg per minute) and a significant increase in percentage of

  14. Consumers' perceptions of the dietary supplement health and education act: implications and recommendations.

    PubMed

    Dodge, Tonya

    2016-01-01

    In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd.

  15. Consumers' perceptions of the dietary supplement health and education act: implications and recommendations.

    PubMed

    Dodge, Tonya

    2016-01-01

    In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd. PMID:27072844

  16. 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.

  17. 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

    2016-01-01

    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

  18. 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

  19. Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products.

    PubMed

    Fialkow, Jonathan

    2016-08-01

    Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters, omega-3-acid ethyl esters A, omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Most dietary supplements and all but one prescription formulation contain mixtures of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Products containing both EPA and DHA may raise low-density lipoprotein cholesterol (LDL-C). In clinical trials, the EPA-only prescription product, icosapent ethyl, did not raise LDL-C compared with placebo. To correct a common misconception, it is important to note that omega-3 fatty acid dietary supplements are not US FDA-approved over-the-counter drugs and are not required to demonstrate safety and efficacy prior to marketing. Conversely, prescription products are supported by extensive clinical safety and efficacy investigations required for FDA approval and have active and ongoing safety monitoring programs. While omega-3 fatty acid dietary supplements may have a place in the supplementation of diet, they generally contain lower levels of EPA and DHA than prescription products and are not approved or intended to treat disease. Perhaps due to the lack of regulation of dietary supplements, EPA and DHA levels may vary widely within and between brands, and products may also contain unwanted cholesterol or fats or potentially harmful components, including toxins and oxidized fatty acids. Accordingly, omega-3 fatty acid dietary supplements should not be substituted for prescription products. Similarly, prescription products containing DHA and EPA should not be substituted for the EPA-only prescription product, as DHA may raise LDL-C and thereby complicate the management of patients with dyslipidemia.

  20. Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products.

    PubMed

    Fialkow, Jonathan

    2016-08-01

    Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters, omega-3-acid ethyl esters A, omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Most dietary supplements and all but one prescription formulation contain mixtures of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Products containing both EPA and DHA may raise low-density lipoprotein cholesterol (LDL-C). In clinical trials, the EPA-only prescription product, icosapent ethyl, did not raise LDL-C compared with placebo. To correct a common misconception, it is important to note that omega-3 fatty acid dietary supplements are not US FDA-approved over-the-counter drugs and are not required to demonstrate safety and efficacy prior to marketing. Conversely, prescription products are supported by extensive clinical safety and efficacy investigations required for FDA approval and have active and ongoing safety monitoring programs. While omega-3 fatty acid dietary supplements may have a place in the supplementation of diet, they generally contain lower levels of EPA and DHA than prescription products and are not approved or intended to treat disease. Perhaps due to the lack of regulation of dietary supplements, EPA and DHA levels may vary widely within and between brands, and products may also contain unwanted cholesterol or fats or potentially harmful components, including toxins and oxidized fatty acids. Accordingly, omega-3 fatty acid dietary supplements should not be substituted for prescription products. Similarly, prescription products containing DHA and EPA should not be substituted for the EPA-only prescription product, as DHA may raise LDL-C and thereby complicate the management of patients with dyslipidemia. PMID:27138439

  1. 5 CFR 7601.102 - Prior approval of outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 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... prohibited by statute or Federal regulation, including 5 CFR part 2635. (c) Scope of approval. Approval...

  2. Dietary Supplements for Weight Loss

    MedlinePlus

    ... supplements, they won’t be listed on the product label and they could harm you. Weight-loss supplements can be sold without being tested or approved by the U.S. Food and Drug ... can recall that product. Visit this website to view the FDA’s public ...

  3. 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...

  4. Brivaracetam: First Global Approval.

    PubMed

    Markham, Anthony

    2016-03-01

    Brivaracetam (Briviact(®)), a 4-n-propyl analogue of levetiracetam developed by UCB Pharma, has been approved in the EU as an adjunctive therapy for the treatment of partial-onset seizures. Brivaracetam binds to synaptic vesicle glycoprotein 2a (SV2A) in the brain with greater selectivity and 15- to 30-fold higher affinity than levetiracetam, as demonstrated in preclinical models, and has demonstrated efficacy in reducing the frequency of partial onset seizures in clinical trials. This article summarizes the milestones in the development of brivaracetam leading to this first approval for use as adjunctive therapy for uncontrolled partial-onset seizures in adults with epilepsy. PMID:26899665

  5. 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®...

  6. 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

  7. 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.

  8. 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.

  9. 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…

  10. 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...

  11. Efficacy of Multivitamin/mineral Supplementation to Reduce Chronic Disease Risk: A Critical Review of the Evidence from Observational Studies and Randomized Controlled Trials.

    PubMed

    Angelo, Giana; Drake, Victoria J; Frei, Balz

    2015-01-01

    We reviewed recent scientific evidence regarding the effects of multivitamin/mineral (MVM) supplements on risk of chronic diseases, including cancer, cardiovascular disease, and age-related eye diseases. Data from randomized controlled trials (RCTs) and observational, prospective cohort studies were examined. The majority of scientific studies investigating the use of MVM supplements in chronic disease risk reduction reported no significant effect. However, the largest and longest RCT of MVM supplements conducted to date, the Physicians' Health Study II (PHS II), found a modest and significant reduction in total and epithelial cancer incidence in male physicians, consistent with the Supplémentation en Vitamines et Minéraux Antioxydants (SU.VI.MAX) trial. In addition, PHS II found a modest and significant reduction in the incidence of nuclear cataract, in agreement with several other RCTs and observational, prospective cohort studies. The effects of MVM use on other subtypes of cataract and age-related macular degeneration remain unclear. Neither RCTs nor prospective cohort studies are without their limitations. The placebo-controlled trial design of RCTs may be inadequate for nutrient interventions, and residual confounding, measurement error, and the possibility of reverse causality are inherent to any observational study. National surveys show that micronutrient inadequacies are widespread in the US and that dietary supplements, of which MVMs are the most common type, help fulfill micronutrient requirements in adults and children. PMID:24941429

  12. 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…

  13. 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 ...

  14. Ergogenic Aids and Supplements.

    PubMed

    Porrini, Marisa; Del Boʼ, Cristian

    2016-01-01

    Great interest is currently shown for the contribution of nutrition to optimize training and athletic performance, and a considerable debate exists about the potential ergogenic value of several dietary supplements. However, most of the products used by athletes do not provide sufficient scientific evidence regarding their efficacy in enhancing physical performance as well as their specificity of action and safety. For this reason, sport nutrition professionals need skills in evaluating the scientific value of papers and advertisements on ergogenic aids and supplements in order to support athletes in their choice. In the present chapter, the efficacy of some of the most popular supplements used by athletes and sport practitioners will be discussed. Particular attention will be devoted to amino acids and derivatives, caffeine and caffeinated energy drinks, and some antioxidants.

  15. Ergogenic Aids and Supplements.

    PubMed

    Porrini, Marisa; Del Boʼ, Cristian

    2016-01-01

    Great interest is currently shown for the contribution of nutrition to optimize training and athletic performance, and a considerable debate exists about the potential ergogenic value of several dietary supplements. However, most of the products used by athletes do not provide sufficient scientific evidence regarding their efficacy in enhancing physical performance as well as their specificity of action and safety. For this reason, sport nutrition professionals need skills in evaluating the scientific value of papers and advertisements on ergogenic aids and supplements in order to support athletes in their choice. In the present chapter, the efficacy of some of the most popular supplements used by athletes and sport practitioners will be discussed. Particular attention will be devoted to amino acids and derivatives, caffeine and caffeinated energy drinks, and some antioxidants. PMID:27348226

  16. 29 CFR 1952.357 - Changes to approved plans.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Arizona § 1952.357 Changes to approved... Arizona's plan supplement, which is generally identical to the Federal Voluntary Protection Programs with... 29, 1994, the Assistant Secretary approved Arizona's revised statutory penalty levels which are...

  17. 29 CFR 1952.357 - Changes to approved plans.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Arizona § 1952.357 Changes to approved... Arizona's plan supplement, which is generally identical to the Federal Voluntary Protection Programs with... 29, 1994, the Assistant Secretary approved Arizona's revised statutory penalty levels which are...

  18. 29 CFR 1952.357 - Changes to approved plans.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Arizona § 1952.357 Changes to approved... Arizona's plan supplement, which is generally identical to the Federal Voluntary Protection Programs with... 29, 1994, the Assistant Secretary approved Arizona's revised statutory penalty levels which are...

  19. 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.

  20. PA02.15. Validation of ayurvedic concept of anthropometry and clinical evaluation of efficacy of “Suktyadi Yog” as a calcium supplementation in children

    PubMed Central

    Kumar, S Vinod; Kumar, N Rakesh

    2013-01-01

    Purpose: The present study aims to validate the ayurvedic anthropometical parameter for assessment of proper growth & devlopment and also to identify any disease linkage. For proper bony growth adequate calcium supplement is necessary. Evaluation of role of an ayurvedic compound containing calcium preparation needed therefore included in the second phase of the study. In calcium deficiency Ayurvedic Managment “Suktyadi Yog” may be useful. It is a rich source of calcium and have deepaniya drugs. Deepaniya drugs is useful for absorption of calcium. Method: Validations of Ayurvedic Sharir pramana on the basis of modern concept (Parameters) in children and Peer review journals were searched to list content of “Suktyadi yog” with calcium supplementation activities, particularly acting in calcium deficient and healthy children. Result: Result of the study show Sharir praman of children found almost equal to as explained in ayurvedic texts. Out of all research Sukti bhasma, Godanti bhasma, yasad bhasma and Trikatu was found potent to reduce Calcium deficiency. It is very cost effective, easily available with highest calcium supplementation properties. Conclusion: Calcium deficiency is a major problem in children and “Suktyadi yog” is a best option to reduce it.

  1. 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

    2015-01-01

    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. PMID:25896576

  2. 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.

  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. Effect of Currently Approved Carriers and Adjuvants on the Pre-Clinical Efficacy of a Conjugate Vaccine against Oxycodone in Mice and Rats

    PubMed Central

    Pravetoni, Marco; Vervacke, Jeffrey S.; Distefano, Mark D.; Tucker, Ashli M.; Laudenbach, Megan; Pentel, Paul R.

    2014-01-01

    Vaccination against the highly abused prescription opioid oxycodone has shown pre-clinical efficacy for blocking oxycodone effects. The current study further evaluated a candidate vaccine composed of oxycodone derivatized at the C6 position (6OXY) conjugated to the native keyhole limpet hemocyanin (nKLH) carrier protein. To provide an oxycodone vaccine formulation suitable for human studies, we studied the effect of alternative carriers and adjuvants on the generation of oxycodone-specific serum antibody and B cell responses, and the effect of immunization on oxycodone distribution and oxycodone-induced antinociception in mice and rats. 6OXY conjugated to tetanus toxoid (TT) or a GMP grade KLH dimer (dKLH) was as effective as 6OXY conjugated to the nKLH decamer in mice and rats, while the 6OXY hapten conjugated to a TT-derived peptide was not effective in preventing oxycodone-induced antinociception in mice. Immunization with 6OXY-TT s.c. absorbed on alum adjuvant provided similar protection to 6OXY-TT administered i.p. with Freund’s adjuvant in rats. The toll-like receptor 4 (TLR4) agonist monophosphoryl lipid A (MPLA) adjuvant, alone or in combination with alum, offered no advantage over alum alone for generating oxycodone-specific serum antibodies or 6OXY-specific antibody secreting B cells in mice vaccinated with 6OXY-nKLH or 6OXY-TT. The immunogenicity of oxycodone vaccines may be modulated by TLR4 signaling since responses to 6OXY-nKLH in alum were decreased in TLR4-deficient mice. These data suggest that TT, nKLH and dKLH carriers provide consistent 6OXY conjugate vaccine immunogenicity across species, strains and via different routes of administration, while adjuvant formulations may need to be tailored to individual immunogens or patient populations. PMID:24797666

  5. 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

  6. 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.

  7. 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

  8. Nutrition and dietary supplements.

    PubMed

    Fillmore, C M; Bartoli, L; Bach, R; Park, Y

    1999-08-01

    Quality and number of subjects in blinded controlled clinical trials about the nutrition and dietary supplements discussed here is variable. Glucosamine sulfate and chondroitin sulfate have sufficient controlled trials to warrant their use in osteoarthritis, having less side effects than currently used nonsteroidal anti-inflammatory drugs, and are the only treatment shown to prevent progression of the disease. Dietary supplements of ephedrine plus caffeine for weight loss (weight loss being the current first line recommendation of physicians for osteoporosis) show some promise, but are not sufficient in number of study subjects. Phenylpropanolamine is proven successful in weight loss. Both ephedrine and phenylpropanolamine have resulted in deaths and hence are worrisome [table: see text] as an over-the-counter dietary supplement. Other commonly used weight loss supplements like Cola acuminata, dwarf elder, Yohimbine, and Garcinia camborgia are either lacking controlled clinical trials, or in the case of the last two supplements, have clinical trials showing lack of effectiveness (although Garcinia has been successful in trials as part of a mixture with other substances, it is unclear if it was a necessary part of the mixture). Safety of these weight loss supplements is unknown. Chromium as a body building supplement for athletes appears to have no efficacy. Creatine may help more in weight lifting than sprinting, but insufficient study subjects and safety information make more studies necessary. Carbohydrate loading is used commonly before endurance competitions, but may be underused as it may be beneficial for other sport performances. Supplements for muscle injury or cramps have had too few studies to determine efficacy. Although proper rehydration with fluids and electrolytes is necessary, a paucity of actual studies to maximize prophylactic treatment for exercise induced cramping still exists. Nutritional supplements for cardiovascular disorders are generally

  9. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA organization may require Medicare enrollees of an MA plan (other than an MSA plan) to accept or pay for services in addition to Medicare-covered services described in § 422.101. (2) If the MA organization imposes...

  10. Dietary Supplements

    MedlinePlus

    Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, ... possible Tell your health care provider about any dietary supplements you use Do not take a bigger dose ...

  11. 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. PMID:26871553

  12. 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.

  13. 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...

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

    PubMed

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

    2015-04-01

    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/cm(2) ± 24.26, control: 10.35 n/cm(2) ± 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.

  15. 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

  16. 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

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

    PubMed

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

    2015-04-01

    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/cm(2) ± 24.26, control: 10.35 n/cm(2) ± 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

  18. β-Alanine supplementation.

    PubMed

    Hoffman, Jay R; Emerson, Nadia S; Stout, Jeffrey R

    2012-01-01

    β-Alanine is rapidly developing as one of the most popular sport supplements used by strength/power athletes worldwide. The popularity of β-alanine stems from its unique ability to enhance intramuscular buffering capacity and thereby attenuating fatigue. This review will provide an overview of the physiology that underlies the mechanisms of action behind β-alanine, examine dosing schemes, and examine the studies that have been conducted on the efficacy of this supplement. In addition, the effect that β-alanine has on body mass changes or whether it can stimulate changes in aerobic capacity also will be discussed. The review also will begin to explore the potential health benefits that β-alanine may have on older adult populations. Discussion will examine the potential adverse effects associated with this supplement as well as the added benefits of combining β-alanine with creatine.

  19. Obiltoxaximab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-05-01

    Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. PMID:27085536

  20. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... requiring a supplemental environmental review that affect the physical environment until Fund approval for... 12 Banks and Banking 9 2012-01-01 2012-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  1. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... requiring a supplemental environmental review that affect the physical environment until Fund approval for... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  2. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... requiring a supplemental environmental review that affect the physical environment until Fund approval for... 12 Banks and Banking 10 2014-01-01 2014-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  3. Chronic Supplementation of Curcumin Enhances the Efficacy of Antidepressants in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

    PubMed

    Yu, Jing-Jie; Pei, Liu-Bao; Zhang, Yong; Wen, Zi-Yu; Yang, Jian-Li

    2015-08-01

    Major depressive disorder is a devastating mental illness leading to a lifetime prevalence of higher than 16% on individuals. The treatment delay and inevitable adverse effects are major limitations of current depression interventions. Emerging evidence indicates that curcumin produced significant antidepressant properties in depression in both rodents and humans without adverse effects. Therefore, it is necessary to further clarify the antidepressant actions of curcumin and the underlying mechanism in depressed patients. A total of 108 male adults aged between 31 and 59 years were systematically recruited in Tianjin Anding Hospital. Subjects were administered the Chinese version of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale that measures different scores of depressive symptoms. The subjects were asked to take 2 capsules containing either 1000 mg of curcumin or placebo soybean powder daily for 6 weeks on the basis of their current antidepressant medications. The plasma levels of interleukin 1β, tumor necrosis factor α, brain-derived neurotrophic factor, and salivary cortisol were measured by enzyme-linked immunosorbent assay before and after curcumin or placebo treatment during the 6-week procedure. Chronic supplementation with curcumin produced significant antidepressant behavioral response in depressed patients by reduction of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale scores. Furthermore, curcumin decreases inflammatory cytokines interleukin 1β and tumor necrosis factor α level, increases plasma brain-derived neurotrophic factor levels, and decreases salivary cortisol concentrations compared with placebo group. These findings indicate the potential benefits of further implications of supplementary administration of curcumin to reverse the development of depression and enhance the outcome of antidepressants treatment in major depressive disorder.

  4. Chronic Supplementation of Curcumin Enhances the Efficacy of Antidepressants in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

    PubMed

    Yu, Jing-Jie; Pei, Liu-Bao; Zhang, Yong; Wen, Zi-Yu; Yang, Jian-Li

    2015-08-01

    Major depressive disorder is a devastating mental illness leading to a lifetime prevalence of higher than 16% on individuals. The treatment delay and inevitable adverse effects are major limitations of current depression interventions. Emerging evidence indicates that curcumin produced significant antidepressant properties in depression in both rodents and humans without adverse effects. Therefore, it is necessary to further clarify the antidepressant actions of curcumin and the underlying mechanism in depressed patients. A total of 108 male adults aged between 31 and 59 years were systematically recruited in Tianjin Anding Hospital. Subjects were administered the Chinese version of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale that measures different scores of depressive symptoms. The subjects were asked to take 2 capsules containing either 1000 mg of curcumin or placebo soybean powder daily for 6 weeks on the basis of their current antidepressant medications. The plasma levels of interleukin 1β, tumor necrosis factor α, brain-derived neurotrophic factor, and salivary cortisol were measured by enzyme-linked immunosorbent assay before and after curcumin or placebo treatment during the 6-week procedure. Chronic supplementation with curcumin produced significant antidepressant behavioral response in depressed patients by reduction of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale scores. Furthermore, curcumin decreases inflammatory cytokines interleukin 1β and tumor necrosis factor α level, increases plasma brain-derived neurotrophic factor levels, and decreases salivary cortisol concentrations compared with placebo group. These findings indicate the potential benefits of further implications of supplementary administration of curcumin to reverse the development of depression and enhance the outcome of antidepressants treatment in major depressive disorder. PMID:26066335

  5. Efficacy of Resveratrol Supplementation against Non-Alcoholic Fatty Liver Disease: A Meta-Analysis of Placebo-Controlled Clinical Trials.

    PubMed

    Zhang, Chongyang; Yuan, Weigang; Fang, Jianguo; Wang, Wenqing; He, Pei; Lei, Jiahui; Wang, Chunxu

    2016-01-01

    Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease with rising prevalence. Increasing evidence has demonstrated that resveratrol, a dietary phytochemical, is capable of attenuating NAFLD development and progression; however, results from clinical studies are inconsistent and inconclusive. Here, we conducted a meta-analysis to evaluate the efficacy of resveratrol on NAFLD, using several parameters to provide new insights for clinical application. We systematically searched EMBASE, PubMed, Science Citation Index, Elsevier, and Cochrane Library databases for studies published up to date (July 2016), in English, to identify and screen eligible, relevant studies. Either a fixed-effect model or random model was used to estimate mean difference (MD) and 95% confidence intervals (CIs) for the effect of resveratrol on NAFLD. Four randomized, double-blinded, placebo-controlled trials involving 156 patients were included in the meta-analysis. Levels of low-density lipoprotein (MD = 0.47, 95% CI: 0.21, 0.74, P < 0.05) and total cholesterol (MD = 0.49, 95% CI: 0.18, 0.80, P < 0.05) were higher in the resveratrol treatment groups than in placebo control groups, whereas other parameters were not altered. Overall, this study indicates that resveratrol treatment has negligible effects on attenuating NAFLD, given the small improvement in NAFLD features. More high-quality clinical trials of resveratrol for NAFLD are required to confirm these results. PMID:27560482

  6. Efficacy of Resveratrol Supplementation against Non-Alcoholic Fatty Liver Disease: A Meta-Analysis of Placebo-Controlled Clinical Trials

    PubMed Central

    Fang, Jianguo; Wang, Wenqing; He, Pei; Lei, Jiahui; Wang, Chunxu

    2016-01-01

    Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease with rising prevalence. Increasing evidence has demonstrated that resveratrol, a dietary phytochemical, is capable of attenuating NAFLD development and progression; however, results from clinical studies are inconsistent and inconclusive. Here, we conducted a meta-analysis to evaluate the efficacy of resveratrol on NAFLD, using several parameters to provide new insights for clinical application. We systematically searched EMBASE, PubMed, Science Citation Index, Elsevier, and Cochrane Library databases for studies published up to date (July 2016), in English, to identify and screen eligible, relevant studies. Either a fixed-effect model or random model was used to estimate mean difference (MD) and 95% confidence intervals (CIs) for the effect of resveratrol on NAFLD. Four randomized, double-blinded, placebo-controlled trials involving 156 patients were included in the meta-analysis. Levels of low-density lipoprotein (MD = 0.47, 95% CI: 0.21, 0.74, P < 0.05) and total cholesterol (MD = 0.49, 95% CI: 0.18, 0.80, P < 0.05) were higher in the resveratrol treatment groups than in placebo control groups, whereas other parameters were not altered. Overall, this study indicates that resveratrol treatment has negligible effects on attenuating NAFLD, given the small improvement in NAFLD features. More high-quality clinical trials of resveratrol for NAFLD are required to confirm these results. PMID:27560482

  7. 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.

  8. Effect of vitamin D supplementation on inflammation: protocol for a systematic review

    PubMed Central

    Mousa, Aya; Misso, Marie; Teede, Helena; Scragg, Robert; de Courten, Barbora

    2016-01-01

    Introduction The extraskeletal role of vitamin D is being increasingly recognised. This has important clinical implications, as vitamin D deficiency has reached epidemic proportions worldwide. Vitamin D has proposed anti-inflammatory properties, yet the role of vitamin D supplementation in reducing inflammation remains largely unknown. The purpose of this review is to investigate the impact of vitamin D supplementation on inflammation, and to identify relevant knowledge gaps in the field. Methods and analysis Medline, CINAHL, EMBASE and All EBM will be systematically searched for randomised controlled trials (RCTs) and systematic reviews of RCTs, comparing vitamin D supplementation with placebo, usual care or other pharmacological or non-pharmacological interventions. One reviewer will assess articles for eligibility according to prespecified selection criteria, after which 2 independent reviewers will perform data extraction and quality appraisal. Meta-analyses will be conducted where appropriate. Ethics and dissemination Formal ethical approval is not required as no primary data is collected. This systematic review will identify potential clinical implications of vitamin D deficiency and supplementation, and will be disseminated through a peer-reviewed publication and at conference meetings, to inform future research on the efficacy of vitamin D supplementation for inflammation and inflammatory diseases. PROSPERO registration number CRD42016037104. PMID:27048637

  9. 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

  10. 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

  11. 76 FR 33027 - Agency Information Collection (Supplemental Income Questionnaire (For Philippine Claims Only...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ... AFFAIRS Agency Information Collection (Supplemental Income Questionnaire (For Philippine Claims Only.... 2900-0668.'' SUPPLEMENTARY INFORMATION: Title: Supplemental Income Questionnaire (For Philippine Claims... approved collection. Abstract: Claimants residing in the Philippines complete VA Form 21-0784 to...

  12. 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...

  13. 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...

  14. 27 CFR 26.225 - Previously approved formulas.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Previously approved formulas. 26.225 Section 26.225 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... approved formula on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained...

  15. 5 CFR 5701.101 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 5701.101 Section 5701.101 Administrative Personnel FEDERAL TRADE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL TRADE COMMISSION § 5701.101 Prior approval for outside... the Federal Trade Commission, other than a Commissioner, must obtain the written approval of his...

  16. 5 CFR 5701.101 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 5701.101 Section 5701.101 Administrative Personnel FEDERAL TRADE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL TRADE COMMISSION § 5701.101 Prior approval for outside... the Federal Trade Commission, other than a Commissioner, must obtain the written approval of his...

  17. 5 CFR 5701.101 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 5701.101 Section 5701.101 Administrative Personnel FEDERAL TRADE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL TRADE COMMISSION § 5701.101 Prior approval for outside... the Federal Trade Commission, other than a Commissioner, must obtain the written approval of his...

  18. 5 CFR 5701.101 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 5701.101 Section 5701.101 Administrative Personnel FEDERAL TRADE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL TRADE COMMISSION § 5701.101 Prior approval for outside... the Federal Trade Commission, other than a Commissioner, must obtain the written approval of his...

  19. 5 CFR 5701.101 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 5701.101 Section 5701.101 Administrative Personnel FEDERAL TRADE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL TRADE COMMISSION § 5701.101 Prior approval for outside... the Federal Trade Commission, other than a Commissioner, must obtain the written approval of his...

  20. 27 CFR 26.225 - Previously approved formulas.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Previously approved formulas. 26.225 Section 26.225 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... approved formula on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained...

  1. 27 CFR 26.225 - Previously approved formulas.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Previously approved formulas. 26.225 Section 26.225 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... approved formula on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained...

  2. 27 CFR 26.225 - Previously approved formulas.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Previously approved formulas. 26.225 Section 26.225 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... approved formula on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained...

  3. 27 CFR 26.225 - Previously approved formulas.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Previously approved formulas. 26.225 Section 26.225 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... approved formula on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained...

  4. 29 CFR 1952.294 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... State plan approval in section 18(e) of the Act and implementing regulations at 29 CFR Part 1902... under the Federal program; to submit plan supplements in accordance with 29 CFR Part 1953; to...

  5. 29 CFR 1952.313 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... for final State plan approval in section 18(e) of the Act and implementing regulations at 29 CFR part... supplements in accordance with 29 CFR part 1953; to allocate sufficient safety and health enforcement staff...

  6. 29 CFR 1952.294 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... State plan approval in section 18(e) of the Act and implementing regulations at 29 CFR Part 1902... under the Federal program; to submit plan supplements in accordance with 29 CFR Part 1953; to...

  7. 46 CFR 221.13 - General approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... consistent with the requirements of 46 CFR parts 252 and 294, this approval excludes and does not apply to... listed by the Department of Commerce in 15 CFR part 740, Supplement 1, Country Group E, unless such... States to ports in the geographic area formerly known as the Union of Soviet Socialist Republics, or...

  8. 46 CFR 221.13 - General approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... requirements of 46 CFR parts 252 and 294, this approval excludes and does not apply to Transfers to a Person... Department of Commerce in 15 CFR part 740, Supplement 1, Country Group E, unless such transferee is an... ports in the geographic area formerly known as the Union of Soviet Socialist Republics, or to...

  9. 46 CFR 221.13 - General approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... requirements of 46 CFR parts 252 and 294, this approval excludes and does not apply to Transfers to a Person... Department of Commerce in 15 CFR part 740, Supplement 1, Country Group E, unless such transferee is an... ports in the geographic area formerly known as the Union of Soviet Socialist Republics, or to...

  10. 46 CFR 221.13 - General approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... consistent with the requirements of 46 CFR parts 252 and 294, this approval excludes and does not apply to... listed by the Department of Commerce in 15 CFR part 740, Supplement 1, Country Group E, unless such... States to ports in the geographic area formerly known as the Union of Soviet Socialist Republics, or...

  11. 7 CFR 1717.901 - Early approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Environmental Impact Statement is required, additional time beyond the 90 days may be required to prepare these... for Supplemental Financing Required by 7 CFR 1710.110 § 1717.901 Early approval. (a) Conditions. If... loan meets the requirements for an insured loan, as set forth in 7 CFR part 1710, subparts A through...

  12. Thalidomide approved.

    PubMed

    1998-01-01

    The FDA has approved the use of Thalidomide (Thalomid) for treating a leprosy-associated condition. However, Thalidomide can also be used for HIV-related conditions if a physician prescribes it for "off-label use". In HIV-positive people, Thalidomide has been shown effective in treating mouth, throat, vaginal, and rectal ulcers, and has also been successful in clearing severe diarrhea-causing microsporidiosis infections. The FDA has also granted permission to use Thalidomide for treating AIDS-related wasting and mycobacterial infections by giving Thalidomide an "orphan drug status". Severe restrictions have been established for use of Thalidomide by women, because of the drug's association with birth defects. Contact information is provided.

  13. Macitentan: first global approval.

    PubMed

    Patel, Trina; McKeage, Kate

    2014-01-01

    Macitentan (Opsumit®) is a novel dual endothelin receptor antagonist (ERA) with sustained receptor binding properties developed by Actelion Pharmaceuticals Ltd. In October 2013, oral macitentan 10 mg once daily received its first global approval in the US, followed closely by Canada, for the treatment of pulmonary arterial hypertension (PAH). The drug has also received a positive opinion in the EU from the Committee for Medicinal Products for Human Use for the treatment of PAH, and is under regulatory review in several other countries for the same indication. Endothelin (ET)-1 influences pathological changes via two ET receptor subtypes (ETA and ETB), to which it binds with high affinity. ET-1 is implicated in several forms of vascular disease making it a valid target for the treatment of pulmonary vascular diseases such as PAH. Clinical development is underway for other indications, including Eisenmenger syndrome, ischaemic digital ulcers secondary to systemic sclerosis, and glioblastoma. Macitentan was also evaluated in idiopathic pulmonary fibrosis; however, a phase 2 trial did not meet its primary endpoint and further investigation in this indication was discontinued. Macitentan was developed by modifying the structure of bosentan in the search for an optimal dual ERA with improved efficacy and tolerability compared with other ERAs. This article summarizes the milestones in the development of macitentan leading to this first approval for PAH.

  14. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial123456

    PubMed Central

    Gannon, Bryan; Kaliwile, Chisela; Arscott, Sara A; Schmaelzle, Samantha; Chileshe, Justin; Kalungwana, Ngándwe; Mosonda, Mofu; Pixley, Kevin; Masi, Cassim; Tanumihardjo, Sherry A

    2014-01-01

    Background: Biofortification is a strategy to relieve vitamin A (VA) deficiency. Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies. Objective: The study sought to determine changes in total body reserves (TBRs) of vitamin A with consumption of biofortified maize. Design: A randomized, placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children. The paired 13C-retinol isotope dilution test, a sensitive biomarker for VA status, was used to measure TBRs before and after a 90-d intervention. Treatments were white maize with placebo oil (VA−), orange maize with placebo (orange), and white maize with VA in oil [400 μg retinol activity equivalents (RAEs) in 214 μL daily] (VA+). Results: In total, 133 children completed the trial and were analyzed for TBRs (n = 44 or 45/group). Change in TBR residuals were not normally distributed (P < 0.0001); median changes (95% CI) were as follows: VA−, 13 (−19, 44) μmol; orange, 84 (21, 146) μmol; and VA+, 98 (24, 171) μmol. Nonparametric analysis showed no statistical difference between VA+ and orange (P = 0.34); both were higher than VA− (P = 0.0034). Median (95% CI) calculated liver reserves at baseline were 1.04 (0.97, 1.12) μmol/g liver, with 59% >1 μmol/g, the subtoxicity cutoff; none were <0.1 μmol/g, the deficiency cutoff. The calculated bioconversion factor was 10.4 μg β-carotene equivalents/1 μg retinol by using the middle 3 quintiles of change in TBRs from each group. Serum retinol did not change in response to intervention (P = 0.16) but was reduced with elevated C-reactive protein (P = 0.0029) and α-1-acid glycoprotein (P = 0.0023) at baseline. Conclusions: β-Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification. Use of

  15. Drugs Approved for Leukemia

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) Arranon (Nelarabine) Asparaginase Erwinia chrysanthemi ...

  16. 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. ...

  17. Dietary Supplements

    MedlinePlus

    ... are not intended to treat, diagnose, prevent, or cure diseases. Do not take supplements instead of your ... Partners Women's Health Topics Mammography Women and Diabetes HPV, HIV, Birth Control Heart Health for Women Pregnancy ...

  18. 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)

  19. Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

    PubMed

    Gibson, James E; Taylor, David A

    2005-09-01

    The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

  20. 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. PMID:15554492

  1. Dietary supplement drug therapies for depression.

    PubMed

    Howland, Robert H

    2012-06-01

    Many dietary supplements are readily accessible and commonly used for the treatment of depression. A dietary supplement is a product intended to supplement the diet but is not intended to treat, diagnose, prevent, or cure disease. The U.S. Food and Drug Administration can take action against dietary supplement manufacturers for products only after they are marketed, mainly if the product is found to be unsafe or if false or misleading claims are made about the product. Few dietary supplement products have been adequately studied for their safety and efficacy. Of the five products reviewed in this article (L-methylfolate, S-adenosyl-L-methionine [SAM-e], omega-3 fatty acids, L-tryptophan, and inositol), only omega-3 fatty acids and SAM-e have sufficient supporting evidence for their efficacy to warrant safe use. PMID:22589230

  2. Dietary supplement drug therapies for depression.

    PubMed

    Howland, Robert H

    2012-06-01

    Many dietary supplements are readily accessible and commonly used for the treatment of depression. A dietary supplement is a product intended to supplement the diet but is not intended to treat, diagnose, prevent, or cure disease. The U.S. Food and Drug Administration can take action against dietary supplement manufacturers for products only after they are marketed, mainly if the product is found to be unsafe or if false or misleading claims are made about the product. Few dietary supplement products have been adequately studied for their safety and efficacy. Of the five products reviewed in this article (L-methylfolate, S-adenosyl-L-methionine [SAM-e], omega-3 fatty acids, L-tryptophan, and inositol), only omega-3 fatty acids and SAM-e have sufficient supporting evidence for their efficacy to warrant safe use.

  3. 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.

  4. 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…

  5. 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

  6. Glutamine supplementation.

    PubMed

    Wernerman, Jan

    2011-07-18

    Intravenous glutamine supplementation is standard care when parenteral nutrition is given for critical illness. There are data of a reduced mortality when glutamine supplementation is given. In addition, standard commercial products for parenteral nutrition do not contain any glutamine due to glutamine instability in aqueous solutions. For the majority of critical ill patients who are fed enterally, the available evidence is insufficient to recommend glutamine supplementation. Standard formulation of enteral nutrition contains some glutamine: 2-4 g/L. However, this dose is insufficient to normalize glutamine plasma concentration.Plasma concentration of glutamine is low in many patients with critical illness and a low level is an independent risk factor for mortality. A low plasma glutamine concentration is the best indicator of glutamine depletion. Data are emerging about how the endogenous production of glutamine is regulated. We know that skeletal muscle is the major producer of glutamine and that a part of the profound depletion of skeletal muscle seen in critical illness is a reflection of the need to produce glutamine.Glutamine is utilized in rapidly dividing cells in the splanchnic area. Quantitatively most glutamine is oxidized, but the availability of glutamine in surplus is important for the de novo synthesis of nucleotides and necessary for cell division and protein synthesis. More knowledge about the regulation of the endogenous production of glutamine is needed to outline better guidelines for glutamine supplementation in the future.

  7. Sports Supplements

    MedlinePlus

    ... specialist. The doc will be able to offer alternatives to supplements based on your body and sport. Reviewed by: Mary L. Gavin, MD Date reviewed: January 2015 previous 1 • 2 • 3 For Teens For Kids For Parents MORE ON THIS TOPIC Sports Center Energy Drinks and Food Bars: Power or Hype? A ...

  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, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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. 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...

  12. 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...

  13. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing...

  14. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing...

  15. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing...

  16. 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.

  17. 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...

  18. Evidence for supplemental treatments in androgenetic alopecia.

    PubMed

    Famenini, Shannon; Goh, Carolyn

    2014-07-01

    Currently, topical minoxidil and finasteride are the only treatments that have been FDA approved for the treatment of female pattern hair loss and androgenetic alopecia. Given the incomplete efficacy and sife effect profile of these medications, some patients utilize alternative treatments to help improve this condition. In this review, we illustrate the scientific evidence underlying the efficacy of these alternative approaches, including biotin, caffeine, melatonin, a marine extract, and zinc. PMID:25007363

  19. Do dietary supplements help promote weight loss?

    PubMed

    Bell, Stacey J; Van Ausdal, Wendy; Grochoski, Greg

    2009-01-01

    As two-thirds of the US population is overweight or obese, new strategies are needed to help individuals safely and effectively lose weight. One option is to use dietary supplements, but not all supplements that are touted for weight loss have published clinical support for efficacy. The purpose of this article was to identify all published articles on dietary supplements for weight loss. Effectiveness of these supplements was defined as promoting 1-2 lb of weight loss each week. Although several dozen different dietary supplements are sold, only 14 published studies were identified. Four individual ingredients and three blends of ingredients were considered to be effective. Additionally, we compared weight loss from these dietary supplements to over-the-counter (OTC) orlistat (alli™, GlaxoSmithKline, Brentford, UK). Five single ingredients and three blends of ingredients produced more weight loss than OTC orlistat. Persons who use dietary supplements for weight management, counsel patients on how to lose weight, and retailers who sell dietary supplements, should become familiar with those supplements only that are effective at producing weight loss to assure the best results. PMID:22435353

  20. Ospemifene: first global approval.

    PubMed

    Elkinson, Shelley; Yang, Lily P H

    2013-05-01

    Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), with tissue-specific estrogenic agonist/antagonist effects. QuatRx Pharmaceuticals conducted the global development of the agent before licensing it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene is the first non-estrogen treatment approved for moderate to severe dyspareunia in women with menopause-related vulvar and vaginal atrophy. The drug is approved in the USA, and application for EU regulatory approval is underway. This article summarizes the milestones in the development of ospemifene leading to this first approval for moderate to severe dyspareunia, a symptom of postmenopausal vulvar and vaginal atrophy.

  1. Nutritional supplements to increase muscle mass.

    PubMed

    Clarkson, P M; Rawson, E S

    1999-07-01

    Although nutritional supplements purported to increase muscle mass are widely available at health food stores, gyms, by mail order, and over the Internet, many of these supplements have little or no data to support their claims. This article reviews the theory and research behind popular nutritional supplements commonly marketed as muscle mass builders. Included are the minerals chromium, vanadyl sulfate, and boron, the steroid hormone dehydroepiandrosterone (DHEA), beta-methyl-hydroxy-beta-methylbutyrate (HMB), creatine, protein supplements, and amino acids. Research has shown that chromium vanadyl sulfate, and boron do not appear to be effective in increasing lean body mass. The few studies examining DHEA have not supported the claim of increased muscle gain. Preliminary work on HMB supports an anticatabolic effect, but only one human study is currently available. Many studies reported increased body mass and several have reported increased lean body mass following creatine ingestion. This weight gain is most likely water retention in muscle but could also be due to some new muscle protein. Although athletes have a greater protein requirement than sedentary individuals, this is easily obtained through the diet, negating the use of protein supplements. Studies on amino acids have not supported their claim to increase growth hormone or insulin secretion. Nutritional supplements can be marketed without FDA approval of safety or effectiveness. Athletes who choose to ingest these supplements should be concerned with unsubstantiated claims, questionable quality control, and safety of long-term use.

  2. Medication Treatment Efficacy and Chronic Orofacial Pain.

    PubMed

    Clark, Glenn T; Padilla, Mariela; Dionne, Raymond

    2016-08-01

    Chronic pain in the orofacial region has always been a vexing problem for dentists to diagnose and treat effectively. For trigeminal neuropathic pain, there are 3 medications (gabapentinoids, tricyclic antidepressants, and serotonin-norepinephrine reuptake inhibitors) to use plus topical anesthetics that have therapeutic efficacy. For chronic daily headaches (often migraine in origin), 3 prophylactic medications have reasonable therapeutic efficacy (β-blockers, tricyclic antidepressants, and antiepileptic drugs). The 3 Food and Drug Administration-approved drugs for fibromyalgia (pregabalin, duloxetine, and milnacipran) are not robust, with poor efficacy. For osteroarthritis, nonsteroidal anti-inflammatory drugs have therapeutic efficacy and when gastritis contraindicates them, corticosteriod injections are helpful. PMID:27475515

  3. 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....

  4. 20 CFR 416.1525 - Request for approval of a fee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 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....

  5. 78 FR 18973 - Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal 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 approval of rates for transportation...

  6. Efficacy of different anticoccidials against experimental coccidiosis in large white turkeys.

    PubMed

    Cabel, M C; Norton, R A; Yazwinski, T A; Waldroup, P W

    1991-02-01

    Two trials were conducted to compare the efficacy of currently approved anticoccidials for turkeys against challenge using a field isolate of mixed Eimeria species; E. adenoides, E. gallopavonis, and E. meleagrimitis. Poults in wire-floored cages were fed unmedicated diets from day-old to 3 wk of age. Diets were supplemented with either amprolium (AMP, 125 mg/kg), butynorate (BUT, 375 mg/kg), monensin (MON-60, 60 mg/kg; MON-100, 100 mg/kg), halofuginone (HAL; 3 mg/kg), zoalene (ZOA; 125 mg/kg), or sulfadimethoxine plus ormetoprim (SUL + ORM, 62.5 mg/kg and 37.5 mg/kg, respectively). After 2 days on the test diets, poults were individually weighed and inoculated with sporulated coccidial oocysts from the field isolate. Total fecal collections were obtained for Days 0 to 5 and 6 to 10 to estimate oocyst output. At 10 days postinoculation, the birds were individually weighed and killed to determine severity of intestinal lesions. The HAL and MON were most effective and AMP, ZOA, and SUL + ORM were least effective in maintaining weight and in reducing the severity of intestinal lesions. All the coccidiostats tested reduced oocyst passage, but poults fed HAL produced fewer oocysts. The results demonstrated differences in efficacy among anticoccidials with the more recently approved drugs providing the best protection against coccidiosis.

  7. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  8. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Previously approved formulas. 26.55 Section 26.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained in, still...

  9. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia...

  10. 29 CFR 1952.344 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Wyoming...

  11. 5 CFR 6501.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 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 approval... the meaning of 5 CFR 2635.203(d), whether or not for compensation, an employee other than a...

  12. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  13. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Previously approved formulas. 26.55 Section 26.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained in, still...

  14. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Previously approved formulas. 26.55 Section 26.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained in, still...

  15. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Previously approved formulas. 26.55 Section 26.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained in, still...

  16. 27 CFR 26.55 - Previously approved formulas.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Previously approved formulas. 26.55 Section 26.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... on Form 27-B Supplemental indicates that carbon dioxide will be added to, or retained in, still...

  17. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  18. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  19. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  20. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 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 approval... involves: (1) Consulting services; (2) The practice of a profession as defined in 5 CFR 2636.305(b)(1);...

  1. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 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 approval... involves: (1) Consulting services; (2) The practice of a profession as defined in 5 CFR 2636.305(b)(1);...

  2. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 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 approval... involves: (1) Consulting services; (2) The practice of a profession as defined in 5 CFR 2636.305(b)(1);...

  3. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 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 approval... involves: (1) Consulting services; (2) The practice of a profession as defined in 5 CFR 2636.305(b)(1);...

  4. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 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 approval... involves: (1) Consulting services; (2) The practice of a profession as defined in 5 CFR 2636.305(b)(1);...

  5. 29 CFR 1952.224 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Tennessee plan... Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate...

  6. 29 CFR 1952.214 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Maryland plan... plan supplements in accordance with 29 CFR part 1953; to allocate sufficient safety and...

  7. 29 CFR 1952.224 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Tennessee plan... Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate...

  8. 29 CFR 1952.214 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Maryland plan... plan supplements in accordance with 29 CFR part 1953; to allocate sufficient safety and...

  9. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  10. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  11. 29 CFR 1952.154 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... CFR part 1902, and after determination that the State met the “fully effective” compliance staffing... regulations at 29 CFR part 1902. Accordingly, the North Carolina plan was granted final approval and...; to submit plan supplements in accordance with 29 CFR part 1953; to allocate sufficient safety...

  12. 29 CFR 1952.154 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... CFR part 1902, and after determination that the State met the “fully effective” compliance staffing... regulations at 29 CFR part 1902. Accordingly, the North Carolina plan was granted final approval and...; to submit plan supplements in accordance with 29 CFR part 1953; to allocate sufficient safety...

  13. 29 CFR 1952.214 - Final approval determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Maryland plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... plan supplements in accordance with 29 CFR part 1953; to allocate sufficient safety and...

  14. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 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 approval... expected to involve conduct prohibited by statute or Federal regulation, including 5 CFR part 2635....

  15. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 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 approval... expected to involve conduct prohibited by statute or Federal regulation, including 5 CFR part 2635....

  16. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 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 approval... expected to involve conduct prohibited by statute or Federal regulation, including 5 CFR part 2635....

  17. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 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 approval... expected to involve conduct prohibited by statute or Federal regulation, including 5 CFR part 2635....

  18. A low-fat yoghurt supplemented with a rooster comb extract on muscle joint function in adults with mild knee pain: a randomized, double blind, parallel, placebo-controlled, clinical trial of efficacy.

    PubMed

    Solà, Rosa; Valls, Rosa-Maria; Martorell, Isabel; Giralt, Montserrat; Pedret, Anna; Taltavull, Núria; Romeu, Marta; Rodríguez, Àurea; Moriña, David; Lopez de Frutos, Victor; Montero, Manuel; Casajuana, Maria-Carmen; Pérez, Laura; Faba, Jenny; Bernal, Gloria; Astilleros, Anna; González, Roser; Puiggrós, Francesc; Arola, Lluís; Chetrit, Carlos; Martinez-Puig, Daniel

    2015-11-01

    Preliminary results suggested that oral-administration of rooster comb extract (RCE) rich in hyaluronic acid (HA) was associated with improved muscle strength. Following these promising results, the objective of the present study was to evaluate the effect of low-fat yoghurt supplemented with RCE rich in HA on muscle function in adults with mild knee pain; a symptom of early osteoarthritis. Participants (n = 40) received low-fat yoghurt (125 mL d(-1)) supplemented with 80 mg d(-1) of RCE and the placebo group (n = 40) consumed the same yoghurt without the RCE, in a randomized, controlled, double-blind, parallel trial over 12 weeks. Using an isokinetic dynamometer (Biodex System 4), RCE consumption, compared to control, increased the affected knee peak torque, total work and mean power at 180° s(-1), at least 11% in men (p < 0.05) with no differences in women. No dietary differences were noted. These results suggest that long-term consumption of low-fat yoghurt supplemented with RCE could be a dietary tool to improve muscle strength in men, associated with possible clinical significance. However, further studies are needed to elucidate reasons for these sex difference responses observed, and may provide further insight into muscle function.

  19. The use of dietary supplements in oncology.

    PubMed

    Frenkel, Moshe; Sierpina, Victor

    2014-11-01

    The use of dietary supplements among patients affected by cancer is extensive, with an estimated 20-90 % of patients using these products. Their use of these products is often not shared with the treating physician. This is because patients perceive or believe that their physicians are indifferent or negative toward the use of dietary supplements. As a result, patients may obtain information about dietary supplements from unreliable sources, exposing themselves to unnecessary risks. Since there are limited scientific data on the efficacy and safety of many dietary supplements, advising patients about when to use them during the course of illness is a clinical challenge. Improving the communication process between the health care team and their patients in this area is critical. We describe a practical patient-centered approach to managing dietary supplement use in cancer care. This approach makes use of all available scientific data relating to the safety and efficacy of these supplements combined with how to have an open, patient-centered discussion with patients about their needs and expectations.

  20. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

  1. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

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

    PubMed

    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.

  3. 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

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

    PubMed

    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. 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.

  6. 75 FR 6186 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 205...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 205, Publicizing Contract Actions AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  7. 75 FR 20825 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; DoD Pilot...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; DoD Pilot Mentor-Protege Program AGENCY: Defense Acquisition Regulations System... approved information collection requirement. ] SUMMARY: In compliance with section 3506(c)(2)(A) of...

  8. 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....

  9. 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....

  10. 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...

  11. 78 FR 70025 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Subcontracting Policies and Procedures AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with section 3506(c)(2)(A) of...

  12. 75 FR 26739 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 244...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 244, Subcontracting Policies and Procedures (OMB Control Number 0704-0253) AGENCY... regarding a proposed extension of an approved information collection requirement. SUMMARY: In...

  13. Drugs Approved for Thyroid Cancer

    MedlinePlus

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

  14. 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 ...

  15. Drugs Approved for Breast Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Keoxifene (Raloxifene Hydrochloride) Nolvadex (Tamoxifen ...

  16. 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) ...

  17. Drugs Approved for Bone Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Bone Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bone Cancer Abitrexate (Methotrexate) Cosmegen (Dactinomycin) Dactinomycin Denosumab Doxorubicin Hydrochloride ...

  18. Drugs Approved for Myeloproliferative Disorders

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Myeloproliferative Neoplasms This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Myeloproliferative Neoplasms Adriamycin PFS (Doxorubicin Hydrochloride) Adriamycin RDF (Doxorubicin Hydrochloride) ...

  19. 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.

  20. 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. PMID:27296599

  1. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... change that alters the identity or address of the sponsor of the new animal drug application (NADA). (ii) The sale, purchase, or construction of manufacturing facilities. (iii) The sale or purchase of an...

  2. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., 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...

  3. 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.

  4. 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.

  5. 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.

  6. Comparison of the clinical efficacy of two commercial fatty acid supplements (EfaVet and DVM Derm Caps), evening primrose oil, and cold water marine fish oil in the management of allergic pruritus in dogs: a double-blinded study.

    PubMed

    Scott, D W; Miller, W H; Decker, G A; Wellington, J R

    1992-07-01

    Twenty dogs with atopy or idiopathic pruritus were treated in a double-blinded clinical trial with computer-randomized and computer-generated sequences of 4 fatty acid-containing products: evening primrose oil, cold water marine fish oil, DVM Derm Caps, and EfaVet. Each dog received each product for a 2-week period. Five of 20 dogs (25%) had a good-to-excellent reduction in their level of pruritus with at least 1 of the products: evening primrose oil (2 dogs), DVM Derm Caps (1), EfaVet (1), DVM Derm Caps and cold water marine fish oil (1). Only 1 dog experienced a side effect (loose stools). Clinical response to fatty acid supplements appeared to be quite individualized, and independent of age, breed, sex, weight, duration of disease, specific diagnosis, or number of positive intradermal test reactions.

  7. 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... included in the request for Office of Management and Budget approval. All comments will be a matter of... eligibility of retail food stores and certain food service organizations to accept SNAP benefits and...

  8. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sufficiency of animal data, the agency may take into account other data, including human data, available to... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  9. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... new drug product for which safety has been established and for which the requirements of § 314.600 are... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  10. Multivitamin/Mineral Supplements

    MedlinePlus

    ... Nutrient recommendations: Dietary Reference Intakes (DRI) Online DRI tool Daily Value (DV) tables For more advice on buying dietary supplements: Office of Dietary Supplements Frequently Asked Questions: Which brand(s) ...

  11. 15 CFR Supplement No. 5 to Part 742 - Encryption Registration

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (Continued) BUREAU OF INDUSTRY AND SECURITY, DEPARTMENT OF COMMERCE EXPORT ADMINISTRATION REGULATIONS CONTROL POLICY-CCL BASED CONTROLS Pt. 742, Supp. 5 Supplement No. 5 to Part 742—Encryption Registration Certain... algorithms or protocols that have not been adopted or approved by a duly recognized international...

  12. 5 CFR 5502.103 - Content of annual supplemental reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 5502.103 Section 5502.103 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.103... part 5501 of this chapter that were approved pursuant to 5 CFR 5501.106(d) or undertaken within...

  13. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  14. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  15. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  16. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., 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...

  17. 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.

  18. Riociguat: first global approval.

    PubMed

    Conole, Daniel; Scott, Lesley J

    2013-11-01

    Riociguat (Adempas(®)), an oral first-in-class soluble guanylate cyclase (sGC) stimulator, is under global development by Bayer Healthcare Pharmaceuticals Inc. for the treatment of adult patients with inoperable or chronic/persistent chronic thromboembolic pulmonary hypertension (CTEPH) and for the treatment of adult patients with pulmonary arterial hypertension (PAH). The drug directly stimulates sGC in a nitric oxide independent manner, thereby increasing the sensitivity of sGC to nitric oxide, leading to increased cyclic guanosine monophosphate generation (a key signalling molecule involved in regulating vascular tone, proliferation, fibrosis and inflammation). Riociguat is the world's first approved pharmacotherapy for CTEPH, with its first global approval in this indication occurring in Canada. It has subsequently been approved in the USA for the treatment of patients with CTEPH and also received its first global approval in patients with PAH in the USA. It is undergoing regulatory review for these indications in Europe and for use in patients with CTEPH in Japan. This article summarizes the milestones in the development of riociguat, leading to its first global approvals in patients with CTEPH and PAH.

  19. Afatinib: first global approval.

    PubMed

    Dungo, Rosselle T; Keating, Gillian M

    2013-09-01

    Afatinib, an irreversible inhibitor of the ErbB family of tyrosine kinases, is under development with Boehringer Ingelheim for the once-daily, oral treatment of cancer. Afatinib downregulates ErbB signalling by covalently binding to epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER) 2 and HER4, irreversibly inhibiting tyrosine kinase autophosphorylation. It also inhibits transphosphorylation of HER3. Oral afatinib (Gilotrif™) has been approved in the US for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC) who have tumours with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a US FDA-approved test. Afatinib has also been approved in Taiwan for the first-line treatment of patients with EGFR mutation-positive NSCLC. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of afatinib (Giotrif®) for the treatment of patients with locally advanced or metastatic NSCLC with activating EGFR mutations who are EGFR tyrosine kinase inhibitor naïve. Afatinib is also under regulatory review in Canada, Japan and other Asian countries. This article summarizes the milestones in the development of afatinib, leading to this first approval in patients with metastatic NSCLC.

  20. Metreleptin: first global approval.

    PubMed

    Chou, Ken; Perry, Caroline M

    2013-06-01

    Metreleptin is an analogue of the human hormone leptin being developed by Amylin Pharmaceuticals (a subsidiary of Bristol-Myers Squibb) for the subcutaneous treatment of metabolic disorders including lipodystrophy. The compound is expected to improve insulin sensitivity, hypertriglyceridaemia and hyperglycaemia in patients with lipodystrophy who are unresponsive to conventional treatment. Metreleptin has been approved in Japan as a leptin therapy for the treatment of lipodystrophy. Amylin has also completed a submission for regulatory approval to the US FDA for metreleptin in the treatment of diabetes mellitus and/or hypertriglyceridaemia in patients with rare forms of lipodystrophy. Clinical development of the drug is also underway in the USA for the treatment of type 1 diabetes. Amgen was previously assessing the use of metreleptin as a treatment for amenorrhoea; however, it appears that development in this indication has been discontinued. This article summarizes the milestones in the development of metreleptin leading to this first approval for lipodystrophy.

  1. Olodaterol: first global approval.

    PubMed

    Gibb, Andrew; Yang, Lily P H

    2013-11-01

    Olodaterol (Striverdi(®) Respimat(®)) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat(®) Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD.

  2. Acotiamide: first global approval.

    PubMed

    Nowlan, Mary L; Nolan, Mary L; Scott, Lesley J

    2013-08-01

    Acotiamide (Acofide(®)), an oral first-in-class prokinetic drug, is under global development by Zeria Pharmaceutical Co. Ltd and Astellas Pharma Inc. for the treatment of patients with functional dyspepsia. The drug modulates upper gastrointestinal motility to alleviate abdominal symptoms resulting from hypomotility and delayed gastric emptying. It exerts its activity in the stomach via muscarinic receptor inhibition, resulting in enhanced acetylcholine release and inhibition of acetylcholinesterase activity. Unlike other prokinetic drugs that are utilized in the management of functional dyspepsia, acotiamide shows little/no affinity for serotonin or dopamine D2 receptors. Acotiamide is the world's first approved treatment for functional dyspepsia diagnosed by Rome III criteria, with its first approval occurring in Japan. Phase III trials in this patient population are in preparation in Europe, with phase II trials completed in the USA and Europe. This article summarizes the milestones in the development of acotiamide, leading to its first approval for use in patients with functional dyspepsia.

  3. Olodaterol: first global approval.

    PubMed

    Gibb, Andrew; Yang, Lily P H

    2013-11-01

    Olodaterol (Striverdi(®) Respimat(®)) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat(®) Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD. PMID:24158691

  4. Marketing approval of mogamulizumab

    PubMed Central

    Beck, Alain; Reichert, Janice M.

    2012-01-01

    Therapeutic properties of antibodies strongly depend on the composition of their glycans. Most of the currently approved antibodies are produced in mammalian cell lines, which yield mixtures of different glycoforms that are close to those of humans, but not fully identical. Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of mAbs. The recent approval in Japan of mogamulizumab (POTELIGEO®), the first glyco-engineered antibody to reach the market, is a landmark in the field of therapeutic antibodies. Mogamulizumab is a humanized mAb derived from Kyowa Hakko Kirin’s POTELLIGENT® technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. The approval was granted April 30, 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma. PMID:22699226

  5. Ramucirumab: first global approval.

    PubMed

    Poole, Raewyn M; Vaidya, Asha

    2014-06-01

    Ramucirumab (Cyramza™ [US]), a fully human immunoglobulin G1 (IgG1) monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), has been developed by Eli Lilly (formerly ImClone Systems) for the treatment of cancer. Ramucirumab has received its first global approval in the US for use as monotherapy in the treatment of advanced or metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in patients who experience disease progression on or after fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is the first treatment to be approved by the US FDA for this setting. This article summarizes the milestones in the development of ramucirumab leading to this first approval for the treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma.

  6. Pembrolizumab: first global approval.

    PubMed

    Poole, Raewyn M

    2014-10-01

    Pembrolizumab [Keytruda(®) (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.

  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. Efinaconazole: first global approval.

    PubMed

    Patel, Trina; Dhillon, Sohita

    2013-11-01

    A non-lacquer 10% topical solution of efinaconazole, developed by Valeant Pharmaceuticals International, received its first global approval in Canada in October 2013 for the treatment of onychomycosis. The product is under regulatory review in the US and Japan. The mechanism of anti-fungal activity of efinaconazole, a small-molecule triazole compound, appears to be similar to that of other anti-fungal triazoles, namely ergosterol synthesis inhibition. In particular, it appears to inhibit 14α demethylase, an enzyme involved in the conversion of lanosterol to ergosterol, resulting in secondary degenerative changes. This article summarizes the milestones in the development of efinaconazole leading to this first approval for onychomycosis.

  9. Brodalumab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-09-01

    Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis. PMID:27577550

  10. Migalastat: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Migalastat (Galafold™)-a small molecule drug developed by Amicus Therapeutics that restores the activity of specific mutant forms of α-galactosidase-has been approved for the treatment of Fabry disease in the EU in patients with amenable mutations. Fabry disease is a rare disorder that results in a deficiency or absence of α-galactosidase, leading to accumulation of globotriaosylceramide in the lysosomes of various cells. This article summarizes the milestones in the development of migalastat leading to this first approval in the EU for the long-term treatment of adults and adolescents aged ≥16 years with a confirmed diagnosis of Fabry disease. PMID:27351440

  11. Pimavanserin: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson's disease psychosis. Up to 60 % of patients with Parkinson's disease may develop Parkinson's disease psychosis, which is associated with increased morbidity and mortality and has few treatment options. This article summarizes the milestones in the development of pimavanserin leading to this first approval for the treatment of hallucinations and delusions in patients with Parkinson's disease psychosis. PMID:27262680

  12. 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.

  13. 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

  14. Development of Safe and Effective Botanical Dietary Supplements.

    PubMed

    van Breemen, Richard B

    2015-11-12

    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.

  15. Dietary supplements and health: the research agenda.

    PubMed

    Coates, Paul M

    2007-01-01

    Research needs to evaluate the role of dietary supplements in human health abound, yet funds to support all of the possible opportunities do not. Government agencies, such as the National Institutes of Health (NIH) in the USA, remain the chief sponsors of research in this area. They face the challenge of competing priorities, such as critical disease-oriented research, basic biomedical and technological development, and prevention-related research. Dietary supplements are widely used for health promotion and disease prevention, sometimes with minimal science to support their use. There is a need for focused research efforts to better address issues of efficacy, safety and quality of dietary supplements. At the same time, fundamental studies of their mechanisms of action are needed. In addition, resources to support research in this area are required: on the one hand, basic tools (analytical methods, characterization of ingredients) need to be developed and validated, and on the other, tools to understand patterns of supplement use in populations and study designs to assess their efficacy and safety need refining. These efforts benefit greatly from partnerships among government agencies and with the academic and private sectors.

  16. Introduction to the supplement.

    PubMed

    Rappuoli, Rino

    2015-06-01

    In July of 2014, a symposium entitled "Enhancing Vaccine Immunity and Value" was held in Siena, Italy. The focus of the symposium was on how to best meet the challenge of developing and implementing vaccines for future disease targets. Vaccination has been responsible for averting estimated 3 billion cases of disease and more than 500 million lives to date through the prevention of infectious diseases. This has largely been responsible for dramatic increases in life span in developed countries. However, with the demographics of the world's population are changing, with many adults now surviving into their 80s, we now face the challenge of protecting the aging and other underserved populations not only against infectious diseases but also against cancer and other chronic conditions that occur in older adults. To face this challenge, we must harness new technologies derived from recent advances in the fields of immunology, structural biology, synthetic biology and genomics that promise a revolution in the vaccine field. Specifically, vaccine adjuvants have the potential to harness the immune system to provide protection against new types of diseases, improve protection in young children and expand this protection to adults and the elderly. However, in order to succeed, we need to overcome the non-technical challenges that could limit the implementation of innovative vaccines, including controversies regarding the safety of adjuvants, increasing regulatory complexity, the inadequate methods used to assess the value of novel vaccines, and the resulting industry alienation from future investment. In this supplement, we have assembled manuscripts from lectures and discussions of the symposium last July that addressed two related questions: how to improve vaccine efficacy using breakthrough technologies and how to capture the full potential of novel vaccines.

  17. Simeprevir: first global approval.

    PubMed

    Vaidya, Asha; Perry, Caroline M

    2013-12-01

    Simeprevir (Sovriad(TM)) is a new direct-acting antiviral drug and a second-generation small-molecule NS3/4A serine protease inhibitor developed by Janssen and Medivir for the oral treatment of adults with genotype 1 and/or genotype 4 chronic hepatitis C virus (HCV) infection (chronic hepatitis C). Simeprevir antiviral activity is achieved by its non-covalent binding to HCV protease, with a fast association and slow dissociation rate. The capsule formulation is approved in Japan and Canada for use in combination with pegylated interferon (peginterferon) and ribavirin for genotype 1 chronic hepatitis C, and has been filed for approval in the US in this indication. In addition, the capsule formulation has been filed for approval in the EU for use in combination with peginterferon and ribavirin for genotype 1 and 4 chronic hepatitis C. Phase III trials of the capsule formulation of simeprevir are underway in several other regions, including China. In the pivotal phase III trials, simeprevir was administered once daily for 12 weeks in combination with peginterferon and ribavirin for 24 or 48 weeks. This article summarizes the milestones in the development of simeprevir leading to this first approval for chronic hepatitis C.

  18. 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.

  19. GI Course Approvals.

    ERIC Educational Resources Information Center

    Orlans, Harold; And Others

    The process by which institutions and courses are approved for veterans educational benefits is examined in this study mandated by Public Law 95-202. The legislative background of the investigation is described as well as the history of the Servicemen's Readjustment Act of 1944, the Korean Bill of 1952, and P.L. 94-502 of 1976. A summary guide to…

  20. Drugs Approved for Lung Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer ... in lung cancer that are not listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate ( ...

  1. Drugs Approved for Bladder Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Bladder Cancer This page lists cancer ... in bladder cancer that are not listed here. Drugs Approved for Bladder Cancer Atezolizumab Cisplatin Doxorubicin Hydrochloride ...

  2. Drugs Approved for Hodgkin Lymphoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Hodgkin Lymphoma This page lists cancer ... in Hodgkin lymphoma that are not listed here. Drugs Approved for Hodgkin Lymphoma Adcetris (Brentuximab Vedotin) Ambochlorin ( ...

  3. Drugs Approved for Pancreatic Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Pancreatic Cancer This page lists cancer ... in pancreatic cancer that are not listed here. Drugs Approved for Pancreatic Cancer Abraxane (Paclitaxel Albumin-stabilized ...

  4. Drugs Approved for Testicular Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Testicular Cancer This page lists cancer ... in testicular cancer that are not listed here. Drugs Approved for Testicular Cancer Blenoxane (Bleomycin) Bleomycin Cisplatin ...

  5. Drugs Approved for Malignant Mesothelioma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Malignant Mesothelioma This page lists cancer ... in malignant mesothelioma that are not listed here. Drugs Approved for Malignant Mesothelioma Alimta (Pemetrexed Disodium) Pemetrexed ...

  6. Drugs Approved for Vulvar Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Vulvar Cancer This page lists cancer ... in vulvar cancer that are not listed here. Drugs Approved to Prevent Vulvar Cancer Gardasil (Recombinant HPV ...

  7. Drugs Approved for Cervical Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Cervical Cancer This page lists cancer ... in cervical cancer that are not listed here. Drugs Approved to Prevent Cervical Cancer Cervarix (Recombinant HPV ...

  8. Drugs Approved for Skin Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Skin Cancer This page lists cancer ... in skin cancer that are not listed here. Drugs Approved for Basal Cell Carcinoma Aldara (Imiquimod) Efudex ( ...

  9. Is It Really FDA Approved?

    MedlinePlus

    ... and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the ... and many types of catheters) are cleared for marketing based on an FDA determination that they are ...

  10. Head Injury Screening Tests Approved

    MedlinePlus

    ... 160556.html Head Injury Screening Tests Approved Assess brain function after possible concussions To use the sharing features ... HealthDay News) -- New computer software to assess the brain's function after a traumatic head injury have been approved ...

  11. 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

  12. β-Alanine supplementation and military performance.

    PubMed

    Hoffman, Jay R; Stout, Jeffrey R; Harris, Roger C; Moran, Daniel S

    2015-12-01

    During sustained high-intensity military training or simulated combat exercises, significant decreases in physical performance measures are often seen. The use of dietary supplements is becoming increasingly popular among military personnel, with more than half of the US soldiers deployed or garrisoned reported to using dietary supplements. β-Alanine is a popular supplement used primarily by strength and power athletes to enhance performance, as well as training aimed at improving muscle growth, strength and power. However, there is limited research examining the efficacy of β-alanine in soldiers conducting operationally relevant tasks. The gains brought about by β-alanine use by selected competitive athletes appears to be relevant also for certain physiological demands common to military personnel during part of their training program. Medical and health personnel within the military are expected to extrapolate and implement relevant knowledge and doctrine from research performed on other population groups. The evidence supporting the use of β-alanine in competitive and recreational athletic populations suggests that similar benefits would also be observed among tactical athletes. However, recent studies in military personnel have provided direct evidence supporting the use of β-alanine supplementation for enhancing combat-specific performance. This appears to be most relevant for high-intensity activities lasting 60-300 s. Further, limited evidence has recently been presented suggesting that β-alanine supplementation may enhance cognitive function and promote resiliency during highly stressful situations.

  13. 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

  14. [Efficacy studies].

    PubMed

    Pedro-Botet, Juan; Flores-Le Roux, Juana A

    2014-07-01

    Pravafenix(®) is a fixed-dose combination of 40mg of pravastatin and 160 mg of fenofibrate. The rationale behind the use of Pravafenix(®) is based on the increased residual cardiovascular risk observed in high risk patients with hypertriglyceridemia and/or low HDL cholesterol levels despite treatment with statins in monotherapy. In this article, we review the available evidence on the clinical efficacy of Pravafenix(®), which shows complementary benefits in the overall lipid profile of high risk patients with mixed dyslipidemia not controlled with 40-mg pravastatin or 20-mg simvastatin. PMID:25043542

  15. [Efficacy studies].

    PubMed

    Pedro-Botet, Juan; Flores-Le Roux, Juana A

    2014-07-01

    Pravafenix(®) is a fixed-dose combination of 40mg of pravastatin and 160 mg of fenofibrate. The rationale behind the use of Pravafenix(®) is based on the increased residual cardiovascular risk observed in high risk patients with hypertriglyceridemia and/or low HDL cholesterol levels despite treatment with statins in monotherapy. In this article, we review the available evidence on the clinical efficacy of Pravafenix(®), which shows complementary benefits in the overall lipid profile of high risk patients with mixed dyslipidemia not controlled with 40-mg pravastatin or 20-mg simvastatin.

  16. 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

  17. 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.

  18. 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.

  19. Too little, too late: ineffective regulation of dietary supplements in the United States.

    PubMed

    Starr, Ranjani R

    2015-03-01

    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.

  20. Linaclotide: first global approval.

    PubMed

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch. PMID:23083112

  1. Linaclotide: first global approval.

    PubMed

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  2. Lixisenatide: first global approval.

    PubMed

    Elkinson, Shelley; Keating, Gillian M

    2013-03-01

    The selective once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Lyxumia(®)) is under development with Sanofi for the treatment of type 2 diabetes mellitus. Lixisenatide belongs to a class of GLP-1 compounds designed to mimic the endogenous hormone GLP-1. Native GLP-1 stimulates insulin secretion in a glucose-dependent manner, as well as suppressing glucagon production and slowing gastric emptying. A once-daily subcutaneous formulation of lixisenatide has been approved in the EU, Iceland, Liechtenstein, Norway and Mexico for the treatment of type 2 diabetes, and is under regulatory review in the USA, Switzerland, Brazil, Canada, Ukraine, South Africa, Japan and Australia. This article summarizes the milestones in the development of lixisenatide, leading to this first approval for use in adults with type 2 diabetes.

  3. Canagliflozin: first global approval.

    PubMed

    Elkinson, Shelley; Scott, Lesley J

    2013-06-01

    Canagliflozin (Invokana™), an oral selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, is under global development with Mitsubishi Tanabe Pharma and Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, for the treatment of type 2 diabetes mellitus. SGLT2 are mainly located in the proximal tubule of the kidney and are involved in the reabsorption of filtered glucose from the glomeruli into the body. Inhibition of SGLT2 lowers blood glucose in an insulin independent manner as a consequence of blocking reabsorption of filtered glucose in the glomeruli, thereby increasing urinary excretion of glucose and, in turn, potentially reducing bodyweight. Canagliflozin is the first SGLT2 inhibitor to be approved in the USA and is under regulatory review in the EU. This article summarizes the milestones in the development of canagliflozin, leading to its first approval for use in adults with type 2 diabetes.

  4. 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. PMID:27438291

  5. Alirocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Alirocumab (Praluent®) is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi that has been approved in the US as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a down regulator of liver low-density lipoprotein (LDL)-receptors-thereby increasing the ability of the liver to bind LDL-cholesterol (LDL-C) and reducing levels of LDL-C in blood. It has been shown to reduce LDL-C levels in patients with hypercholesterolaemia, including HeFH, both as monotherapy and in conjunction with statin therapy. This article summarizes the milestones in the development of alirocumab leading to this first approval. PMID:26370210

  6. 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...

  7. Calcium supplements: benefits and risks.

    PubMed

    Reid, I R; Bristow, S M; Bolland, M J

    2015-10-01

    Calcium is an essential element in the diet, but there is continuing controversy regarding its optimal intake, and its role in the pathogenesis of osteoporosis. Most studies show little evidence of a relationship between calcium intake and bone density, or the rate of bone loss. Re-analysis of data from the placebo group from the Auckland Calcium Study demonstrates no relationship between dietary calcium intake and rate of bone loss over 5 years in healthy older women with intakes varying from <400 to >1500 mg day(-1) . Thus, supplements are not needed within this range of intakes to compensate for a demonstrable dietary deficiency, but might be acting as weak anti-resorptive agents via effects on parathyroid hormone and calcitonin. Consistent with this, supplements do acutely reduce bone resorption and produce small short-term effects on bone density, without evidence of a cumulative density benefit. As a result, anti-fracture efficacy remains unproven, with no evidence to support hip fracture prevention (other than in a cohort with severe vitamin D deficiency) and total fracture numbers are reduced by 0-10%, depending on which meta-analysis is considered. Five recent large studies have failed to demonstrate fracture prevention in their primary analyses. This must be balanced against an increase in gastrointestinal side effects (including a doubling of hospital admissions for these problems), a 17% increase in renal calculi and a 20-40% increase in risk of myocardial infarction. Each of these adverse events alone neutralizes any possible benefit in fracture prevention. Thus, calcium supplements appear to have a negative risk-benefit effect, and so should not be used routinely in the prevention or treatment of osteoporosis. PMID:26174589

  8. Calcium supplements: benefits and risks.

    PubMed

    Reid, I R; Bristow, S M; Bolland, M J

    2015-10-01

    Calcium is an essential element in the diet, but there is continuing controversy regarding its optimal intake, and its role in the pathogenesis of osteoporosis. Most studies show little evidence of a relationship between calcium intake and bone density, or the rate of bone loss. Re-analysis of data from the placebo group from the Auckland Calcium Study demonstrates no relationship between dietary calcium intake and rate of bone loss over 5 years in healthy older women with intakes varying from <400 to >1500 mg day(-1) . Thus, supplements are not needed within this range of intakes to compensate for a demonstrable dietary deficiency, but might be acting as weak anti-resorptive agents via effects on parathyroid hormone and calcitonin. Consistent with this, supplements do acutely reduce bone resorption and produce small short-term effects on bone density, without evidence of a cumulative density benefit. As a result, anti-fracture efficacy remains unproven, with no evidence to support hip fracture prevention (other than in a cohort with severe vitamin D deficiency) and total fracture numbers are reduced by 0-10%, depending on which meta-analysis is considered. Five recent large studies have failed to demonstrate fracture prevention in their primary analyses. This must be balanced against an increase in gastrointestinal side effects (including a doubling of hospital admissions for these problems), a 17% increase in renal calculi and a 20-40% increase in risk of myocardial infarction. Each of these adverse events alone neutralizes any possible benefit in fracture prevention. Thus, calcium supplements appear to have a negative risk-benefit effect, and so should not be used routinely in the prevention or treatment of osteoporosis.

  9. Dabrafenib: first global approval.

    PubMed

    Ballantyne, Anita D; Garnock-Jones, Karly P

    2013-08-01

    Dabrafenib (Tafinlar®), a mutant-BRAF kinase inhibitor, emerged from GlaxoSmithKline's research programme for the discovery of selective inhibitors of mutant BRAF kinase activity, for the treatment of solid tumours; mutations in the BRAF gene are associated with increased growth and proliferation of cancer cells. GlaxoSmithKline has focused the development of dabrafenib on the treatment of malignant melanoma, as BRAF mutations are present in 50 % of these cancers. Dabrafenib is approved in the US as a single agent treatment for unresectable or metastatic melanoma in patients with the BRAF V600E mutation, and has received a positive opinion in the EU in this indication. Submissions have also been made in the US and the EU for the use of dabrafenib in combination with trametinib for the treatment of metastatic melanoma with a BRAF V600E/K mutation. Global phase III development of dabrafenib as a monotherapy and as a combination therapy is ongoing in the treatment of malignant melanoma. Phase II development is ongoing for the treatment of malignant melanoma that has metastasised to the brain, and for colorectal and non-small cell lung cancers. Dabrafenib is intended to treat the patient population with a BRAF V600E/K mutation. GlaxoSmithKline's dabrafenib application in the US included the treatment of this population as detected by a US FDA-approved test. GlaxoSmithKline, in collaboration with bioMérieux and Response Genetics, has developed a molecular theranostic test to identify BRAF V600E/K mutations. Pre-Market approval of the test has been granted by the FDA. This article summarises the milestones in the development of dabrafenib leading to this first approval as a single agent treatment for unresectable or metastatic melanoma in patients with the BRAF V600E mutation.

  10. Yucca Mountain repository approved

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    At a quiet White House ceremony on 23 July, U.S. President George W. Bush signed into law House Joint Resolution 87, which approves the site at Yucca Mountain, Nevada, for the development of a repository for disposing of high-level radioactive waste and spent nuclear fuel.White House spokesman Ari Fleischer called the signing “an important step forward on the way to a comprehensive policy for dealing with our nation's nuclear waste.”

  11. Mogamulizumab: first global approval.

    PubMed

    Subramaniam, Joshuan M; Whiteside, Glenn; McKeage, Kate; Croxtall, Jamie C

    2012-06-18

    Mogamulizumab (Poteligeo®) is a defucosylated, humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Development is being carried out by its owner Kyowa Hakko Kirin for various haematological malignancies, and by licensee Amgen for asthma. Mogamulizumab was conceived through Kyowa Hakko Kirin's Potelligent® technology, which produces antibodies with enhanced antibody-dependent cellular cytotoxicity. This is achieved largely by reducing fucose content in the oligosaccharide structure of the Fc region. Mogamulizumab has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukaemia-lymphoma (ATL) and is the first Potelligent® antibody to receive marketing approval anywhere in the world. Phase II development is underway for adult T-cell leukaemia-lymphoma (ATL) and cutaneous T-cell lymphoma in the US, and for peripheral T-cell lymphoma in the US and Europe. Amgen is conducting a phase I US-based study in patients with asthma. This article summarizes the milestones in the development of intravenous mogamulizumab leading to this first approval. PMID:22686619

  12. Istradefylline: first global approval.

    PubMed

    Dungo, Rosselle; Deeks, Emma D

    2013-06-01

    Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A2A receptor antagonist, for the once-daily oral treatment of Parkinson's disease (PD). Adenosine A2A receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observed in PD is believed to occur in the basal ganglia, which is recognized to play a significant role in motor control. Commercially available dopamine replacement therapies effectively treat the early motor symptoms of PD; however, these agents are associated with development of motor complications, limiting usefulness in late stages of the disease. Istradefylline is proposed to possess a clearly distinct action site from existing agents which act on dopamine metabolism or dopamine receptors. Kyowa Hakko Kirin has received approval for istradefylline in the adjunctive treatment of PD in Japan. A New Drug Application was filed in the USA, but the FDA issued a non-approvable letter in February 2008. This article summarizes the milestones in the development of istradefylline leading to its first approval for the treatment of patients with PD.

  13. 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.

  14. Mogamulizumab: first global approval.

    PubMed

    Subramaniam, Joshuan M; Whiteside, Glenn; McKeage, Kate; Croxtall, Jamie C

    2012-06-18

    Mogamulizumab (Poteligeo®) is a defucosylated, humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Development is being carried out by its owner Kyowa Hakko Kirin for various haematological malignancies, and by licensee Amgen for asthma. Mogamulizumab was conceived through Kyowa Hakko Kirin's Potelligent® technology, which produces antibodies with enhanced antibody-dependent cellular cytotoxicity. This is achieved largely by reducing fucose content in the oligosaccharide structure of the Fc region. Mogamulizumab has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukaemia-lymphoma (ATL) and is the first Potelligent® antibody to receive marketing approval anywhere in the world. Phase II development is underway for adult T-cell leukaemia-lymphoma (ATL) and cutaneous T-cell lymphoma in the US, and for peripheral T-cell lymphoma in the US and Europe. Amgen is conducting a phase I US-based study in patients with asthma. This article summarizes the milestones in the development of intravenous mogamulizumab leading to this first approval.

  15. Dolutegravir: first global approval.

    PubMed

    Ballantyne, Anita D; Perry, Caroline M

    2013-09-01

    Dolutegravir, an orally administered HIV-1 integrase strand transfer inhibitor (INSTI), is under development by ViiV Healthcare. Like other drugs belonging in the INSTI class of antiretroviral agents, dolutegravir binds to the integrase site of HIV-1 and blocks the strand transfer integration step, thereby preventing the replication of HIV-1. Dolutegravir is being developed as an unboosted once-daily therapy for use in combination with other antiretroviral agents for the treatment of both treatment-naïve and treatment-experienced patients with HIV-1 infection. Dolutegravir has been approved in the USA for the treatment of HIV-1 infection in combination with other antiretroviral agents and has been filed for approval in the EU and Canada. Phase III development is underway in North America, Europe, South Africa, South America, Australia and Taiwan. This article summarizes the milestones in the development of dolutegravir leading to this first approval for the treatment of HIV-1 infection in both therapy-naïve and -experienced patients.

  16. Evolocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a negative regulator of low-density lipoprotein (LDL)-receptors-thereby improving the ability of the liver to bind LDL-cholesterol (LDL-C), leading to reduced LDL-C blood levels. The drug reduces LDL-C levels in patients with hypercholesterolaemia when used as monotherapy or in conjunction with a statin. This article summarizes the milestones in the development of evolocumab leading to this approval for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet with or without a statin and/or other lipid lowering therapies, and in adults and adolescents aged ≥12 years with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

  17. 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).

  18. 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

  19. Dietary supplements in the Department of Defense: possible solutions to optimizing force readiness.

    PubMed

    Gonsalves, Stephen; Stavinoha, Trisha; Hite, Linda; Costa, Janelle; Dilly, George; Deuster, Patricia A

    2012-12-01

    Dietary supplement use is common among military service members; approximately 17 to 20% report using high-risk weight-loss, performance-enhancing, and bodybuilding supplements. To date, no overarching policy or program has been approved or implemented to inform service members or educate health care providers on the potential adverse consequences of using multiple combinations of supplements or the pros and cons of supplements per se. A review of regulations, concerns, and possible solutions is provided. Importantly, the role of third-party certification and education is emphasized.

  20. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

    PubMed

    Wallace, Taylor C

    2015-08-01

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. PMID:26063064

  1. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

    PubMed

    Wallace, Taylor C

    2015-08-01

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting.

  2. 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…

  3. 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.

  4. 14 CFR 26.47 - Holders of and applicants for a supplemental type certificate-Alterations and repairs to...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...) Fatigue critical alteration structure. For existing structural alteration data approved under a supplemental certificate, the holder of the supplemental certificate must— (1) Review the alteration data and... IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance Data for Repairs...

  5. 75 FR 37820 - Agency Information Collection Activities: Form I-485 and Supplements A and E, Extension of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

    ... comments by e- mail please add the OMB Control Number 1615-0023 in the subject box. Written comments and... Supplements A and E, Extension of a Currently Approved Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Form I- 485 and Supplements A and E, Application...

  6. 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.

  7. Trametinib: first global approval.

    PubMed

    Wright, Cameron J M; McCormack, Paul L

    2013-07-01

    Trametinib is an orally bioavailable mitogen-activated protein kinase (MAPK) kinase (MEK) inhibitor with antineoplastic activity. The compound specifically binds to MEK1 and MEK2, resulting in inhibition of growth factor-mediated cell signalling and cellular proliferation in various cancers. Originally developed by Japan Tobacco, GlaxoSmithKline has licensed exclusive worldwide rights to the compound and conducted development in a number of different cancer types. Trametinib, as a monotherapy, has been approved in the US for the treatment of unresectable or metastatic malignant melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. The compound, as a monotherapy, has also been submitted for regulatory review in the EU for BRAF mutation-positive malignant melanoma, and is in phase III development in Europe, Argentina, Canada and Oceania. Phase II development is underway for pancreatic cancer, non-small cell lung cancer and relapsed or refractory leukaemias. GlaxoSmithKline is also developing trametinib for use in combination with dabrafenib in BRAF V600 mutation-positive metastatic cutaneous melanoma; the combination is at the preregistration stage in the EU and a phase III clinical programme is underway worldwide. Phase II development for this combination is also underway in colorectal cancer. Several phase I trials have also been initiated to evaluate trametinib in combination with other drugs for the treatment of various solid tumours and haematological malignancies. A paediatric oral solution formulation has been assessed against the oral tablet formulation in a phase I trial. This article summarizes the milestones in the development of trametinib leading to this first approval for unresectable or metastatic BRAF mutation-positive malignant melanoma.

  8. 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.

  9. Glutamine supplementation in bone marrow transplantation.

    PubMed

    Ziegler, Thomas R

    2002-01-01

    An increasing number of clinical investigations have focused on supplementation of specialized enteral and parenteral nutrition with the amino acid glutamine. This interest derives from strong evidence in animal models and emerging clinical data on the efficacy of glutamine administration following chemotherapy, trauma, sepsis and other catabolic conditions. Glutamine has protein-anabolic effects in stressed patients and, among many key metabolic functions, is used as a major fuel/substrate by cells of the gastrointestinal epithelium and the immune system. These effects may be particularly advantageous in patients undergoing bone marrow transplantation (BMT), who exhibit post-transplant body protein wasting, gut mucosal injury and immunodeficiency. Studies to date indicate that enteral and parenteral glutamine supplementation is well tolerated and potentially efficacious after high-dose chemotherapy or BMT for cancer treatment. Although not all studies demonstrate benefits, sufficient positive data have been published to suggest that this nutrient should be considered as adjunctive metabolic support of some individuals undergoing marrow transplant. However, BMT is a rapidly evolving clinical procedure with regard to the conditioning and supportive protocols utilized. Thus, additional randomized, double-blind, controlled clinical trials are indicated to define the efficacy of glutamine with current BMT regimens.

  10. Japanese pill approval is bittersweet.

    PubMed

    Blankson-seck, N

    1999-01-01

    This article reports the controversy over the approval of a birth control pill in Japan. The birth control pill underwent a 9-year deliberation before it was approved in June as compared with the male impotence drug Viagra, which gained a quick approval from the government. Such quick approval made women's groups feel that this was characteristic of a societal bias. For years, the health ministers delayed the approval because supposedly more research was needed to determine the pill's safety and because of other reasons cited. What bothered these women's groups was the fact that the government kept citing the reason of safety as the cause of the delay, while, on the other hand, Viagra has claimed two lives since its approval. In this sense, many believe that culture still matters in Japan and such actions can be considered a gender issue.

  11. Dietary supplements in sport.

    PubMed

    Burke, L M; Read, R S

    1993-01-01

    Studies of the dietary practices of athletes report that nutritional supplements are commonly used. Supplementation practices vary between sports and individual athletes; however, there is evidence that at least some athletes use a large number of supplements concurrently, often in doses that are very high in comparison with normal dietary intakes. In exploring supplementation practices we propose a classification system separating the supplements into dietary supplements and nutritional erogogenic aids. The dietary supplement is characterised as a product which can be used to address physiological or nutritional issues arising in sport. It may provide a convenient or practical means of consuming special nutrient requirements for exercise, or it may be used to prevent/reverse nutritional deficiencies that commonly occur among athletes. The basis of the dietary supplement is an understanding of nutritional requirements and physiological effects of exercise. When the supplement is used to successfully meet a physiological/nutritional goal arising in sport it may be demonstrated to improve sports performance. While there is some interest in refining the composition or formulation of some dietary supplements, the real interest belongs to the use or application of the supplement; i.e. educating athletes to understand and achieve their nutritional needs in a specific sports situation. The sports drink (carbohydrate-electrolyte replacement drink) is a well known example of a dietary supplement. Scientific attitudes towards the sports drink have changed over the past 20 years. Initial caution that carbohydrate-electrolyte fluids compromise gastric emptying during exercise has now been shown to be unjustified. Numerous studies have shown that 5 to 10% solutions of glucose, glucose polymers (maltodextrins) and other simple sugars all have suitable gastric emptying characteristics for the delivery of fluid and moderate amounts of carbohydrate substrate. The optimal

  12. 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.

  13. Ripasudil: first global approval.

    PubMed

    Garnock-Jones, Karly P

    2014-12-01

    Ripasudil hydrochloride hydrate (Glanatec® ophthalmic solution 0.4 %; hereafter referred to as ripasudil) is a small-molecule, Rho-associated kinase inhibitor developed by Kowa Company, Ltd. for the treatment of glaucoma and ocular hypertension. This compound, which was originally discovered by D. Western Therapeutics Institute, Inc., reduces intraocular pressure (IOP) by directly acting on the trabecular meshwork, thereby increasing conventional outflow through the Schlemm's canal. As a result of this mechanism of action, ripasudil may offer additive effects in the treatment of glaucoma and ocular hypertension when used in combination with agents such as prostaglandin analogues (which increase uveoscleral outflow) and β blockers (which reduce aqueous production). The eye drop product has been approved in Japan for the twice-daily treatment of glaucoma and ocular hypertension, when other therapeutic agents are not effective or cannot be administered. Phase II study is underway for the treatment of diabetic retinopathy. This article summarises the milestones in the development of ripasudil leading to the first approval for glaucoma and ocular hypertension. PMID:25414122

  14. Dinutuximab: first global approval.

    PubMed

    Dhillon, Sohita

    2015-05-01

    United Therapeutics Corporation and the National Cancer Institute are developing dinutuximab (Unituxin™; ch14.18), a monoclonal antibody targeting GD2, for the treatment of neuroblastoma. GD2 is a glycolipid found on the surface of tumour cells, which is overexpressed in neuroblastoma. Dinutuximab, an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14G2a, binds to GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The US FDA has recently approved the use of dinutuximab combination therapy for the treatment of high-risk neuroblastoma in paediatric patients. The marketing authorization application for dinutuximab is under regulatory review in the EU, and phase I-III development is underway in several other countries. This article summarizes the milestones in the development of dinutuximab leading to this first approval for use (in combination with granulocyte macrophage colony-stimulating factor, interleukin-2 and 13-cis retinoic acid) in the treatment of paediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent, multimodality therapy. PMID:25940913

  15. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.

    PubMed

    Walter, Jessica R; Hayman, Emily; Tsai, Shelun; Ghobadi, Comeron W; Xu, Shuai

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices. PMID:27159747

  16. Vitamin B supplementation for diabetic peripheral neuropathy.

    PubMed

    Jayabalan, Bhavani; Low, Lian Leng

    2016-02-01

    Vitamin B12 deficiency has been associated with significant neurological pathology, especially peripheral neuropathy. This review aims to examine the existing evidence on the effectiveness of vitamin B12 supplementation for the treatment of diabetic peripheral neuropathy. A search of PubMed and the Cochrane Central Register of Controlled Trials for all relevant randomised controlled trials was conducted in December 2014. Any type of therapy using vitamin B12 or its coenzyme forms was assessed for efficacy and safety in diabetics with peripheral neuropathy. Changes in vibration perception thresholds, neuropathic symptoms and nerve conduction velocities, as well as the adverse effects of vitamin B12 therapy, were assessed. Four studies comprising 363 patients met the inclusion criteria. This review found no evidence that the use of oral vitamin B12 supplements is associated with improvement in the clinical symptoms of diabetic neuropathy. Furthermore, the majority of studies reported no improvement in the electrophysiological markers of nerve conduction. PMID:26892473

  17. Dietary supplements for osteoarthritis.

    PubMed

    Gregory, Philip J; Sperry, Morgan; Wilson, Amy Friedman

    2008-01-15

    A large number of dietary supplements are promoted to patients with osteoarthritis and as many as one third of those patients have used a supplement to treat their condition. Glucosamine-containing supplements are among the most commonly used products for osteoarthritis. Although the evidence is not entirely consistent, most research suggests that glucosamine sulfate can improve symptoms of pain related to osteoarthritis, as well as slow disease progression in patients with osteoarthritis of the knee. Chondroitin sulfate also appears to reduce osteoarthritis symptoms and is often combined with glucosamine, but there is no reliable evidence that the combination is more effective than either agent alone. S-adenosylmethionine may reduce pain but high costs and product quality issues limit its use. Several other supplements are promoted for treating osteoarthritis, such as methylsulfonylmethane, Harpagophytum procumbens (devil's claw), Curcuma longa (turmeric), and Zingiber officinale (ginger), but there is insufficient reliable evidence regarding long-term safety or effectiveness. PMID:18246887

  18. 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 ...

  19. FDA 101: Dietary Supplements

    MedlinePlus

    ... professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, ... the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports ...

  20. 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)

  1. Herbal Products and Supplements

    MedlinePlus

    ... and prescription medicines just because they come from nature. Although herbal health products and supplements are advertised as “natural,” their ingredients aren’t necessarily natural to the human body. They may have strong effects on your ...

  2. Vitamin supplementation in pregnancy.

    PubMed

    2016-07-01

    Ensuring that a woman is well-nourished, both before and during pregnancy, is crucial for the health of the woman and that of the unborn child.(1) Maternal deficiency in key nutrients has been linked to pre-eclampsia, restricted fetal growth, neural tube defects, skeletal deformity and low birth weight.(1,2) Many nutritional supplements containing vitamins, minerals and other micronutrients are heavily marketed to women for all stages of pregnancy. However, much of the evidence for vitamin supplementation in pregnancy comes from studies carried out in low-income countries,(3) where women are more likely to be undernourished or malnourished than within the UK population. The challenges lie in knowing which supplements are beneficial and in improving uptake among those at most need. Here we summarise current UK guidance for vitamin supplementation in pregnancy and review the evidence behind it. PMID:27405305

  3. 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.

  4. Breastfeeding: Vitamin D Supplementation

    MedlinePlus

    ... Breastfeeding Micronutrient Malnutrition State and Local Programs Vitamin D Supplementation Recommend on Facebook Tweet Share Compartir While ... provide infants with an adequate intake of vitamin D. Most breastfed infants are able to synthesize additional ...

  5. 5 CFR 3601.107 - Prior approval for outside employment and business activities.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... business activities. 3601.107 Section 3601.107 Administrative Personnel DEPARTMENT OF DEFENSE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF DEFENSE § 3601.107 Prior approval for outside employment and business activities. (a) A DoD employee, other than a special Government...

  6. 5 CFR 3601.107 - Prior approval for outside employment and business activities.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... business activities. 3601.107 Section 3601.107 Administrative Personnel DEPARTMENT OF DEFENSE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF DEFENSE § 3601.107 Prior approval for outside employment and business activities. (a) A DoD employee, other than a special Government...

  7. 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...

  8. 76 FR 77903 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-15

    ... action published on October 21, 2011 (76 FR 65458), EPA proposed approval of Kentucky's plan for..., proposal. \\1\\ On September 29, 2011, at 76 FR 60373, EPA determined that the Tri-state Cincinnati-Hamilton... finalized on January 5, 2005 (70 FR 944), and as supplemented on April 14, 2005 (70 FR 19844). EPA...

  9. 20 CFR 416.1225 - An approved plan to achieve self-support; general.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false An approved plan to achieve self-support; general. 416.1225 Section 416.1225 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... achieve self-support; general. If you are blind or disabled, we will pay you SSI benefits and will...

  10. 5 CFR 3601.107 - Prior approval for outside employment and business activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... business activities. 3601.107 Section 3601.107 Administrative Personnel DEPARTMENT OF DEFENSE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF DEFENSE § 3601.107 Prior approval for outside employment and business activities. (a) A DoD employee, other than a special Government...

  11. 75 FR 29779 - Agency Information Collection Activities: Form I-918, Extension of a Currently Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form I-918, Extension of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review: Form I- 918, Petition for U Nonimmigrant Status; and Supplement A and...

  12. 76 FR 70078 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... Particulate Matter and Ozone in 27 States; Correction of SIP Approvals for 22 States'' (76 FR 48208, August 8... FR 61144, EPA retained the annual average NAAQS at 15.0 g/m\\3\\ but revised the 24-hour NAAQS to 35 g... remanded 2006 Annual NAAQS. On January 5, 2005, at 70 FR 944, and supplemented on April 14, 2005, at 70...

  13. 77 FR 59679 - Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

    .... According to the application for approval filed by CVPS in connection with the merger of CVPS and GMP, CVPS... hearing was published in the Federal Register on July 20, 2012 (77 FR 42768). No comments or hearing... in writing. Upon review of the information in the application as supplemented and other...

  14. 42 CFR 403.222 - State with an approved regulatory program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 2 2014-10-01 2014-10-01 false State with an approved regulatory program. 403.222 Section 403.222 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Medicare Supplemental Policies State...

  15. Review: Evidence-based Clinical Research of Anti-obesity Supplements in Japan

    PubMed Central

    Yasueda, Asuka; Ito, Toshinori; Maeda, Kazuhisa

    2013-01-01

    Background: The prevalence of obesity has increased dramatically throughout the world, and weight reduction through lifestyle management is urgently warranted. At present, numerous supplements advertised for their anti-overweight property are available in the Japanese market, but most of these lack proper evidence. Thus, we investigated dietary supplements that have been tested in clinical trials. Search Strategy: We researched anti-obesity supplements in the Japanese market using the google search engine in Japanese with the key terms “anti-obesity supplements,” ”diet supplements,” and “weight reduction supplements.” Results: We listed 49 companies that supply anti-obesity supplements. Of these, 11 had published clinical evidence of the anti-obesity efficacy of their supplements. These products contain the following active ingredients: Angelica keiskei, bofu-tsusho-san, capsaishin, DHA/EPA, forskohlii, garcinia cambogia, lactoferrin, L-carnitine, oligonol, tea catechin, and yeast hydrolysate. Conclusion: We obtained 11 supplements for which clinical evidence was published in medical journals in English. We also found 10 products for which clinical or animal evidence was published in Japanese. We expect that many companies will produce evidence of the efficacy of their products in the near future, thereby validating the use of dietary anti-obesity supplements in Japan. PMID:26005506

  16. 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...

  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. Dietary supplements for athletes: emerging trends and recurring themes.

    PubMed

    Maughan, R J; Greenhaff, P L; Hespel, P

    2011-01-01

    Dietary supplements are widely used at all levels of sport. Changes in patterns of supplement use are taking place against a background of changes in the regulatory framework that governs the manufacture and distribution of supplements in the major markets. Market regulation is complicated by the increasing popularity of Internet sales. The need for quality control of products to ensure they contain the listed ingredients in the stated amount and to ensure the absence of potentially harmful substances is recognized. This latter category includes compounds prohibited under anti-doping regulations. Several certification programmes now provide testing facilities for manufacturers of both raw ingredients and end products to ensure the absence of prohibited substances. Athletes should carry out a cost-benefit analysis for any supplement they propose to use. For most supplements, the evidence is weak, or even completely absent. A few supplements, including caffeine, creatine, and bicarbonate, are supported by a strong research base. Difficulties arise when new evidence appears to support novel supplements: in recent years, β-alanine has become popular, and the use of nitrate and arginine is growing. Athletes seldom wait until there is convincing evidence of efficacy or of safety, but caution is necessary to minimize risk.

  19. 30 CFR 18.11 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension(s) of approval were based. (d) A completely assembled approved machine with an integral dust collector shall bear an approval plate indicating that the requirements of part 33 of this chapter...

  20. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  1. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  2. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  3. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  4. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  5. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  6. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  7. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  8. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  9. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  10. 40 CFR 52.1073 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1073 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Maryland's plans for...

  11. 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. PMID:24760423

  12. 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.

  13. 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...

  14. Supplements and sports.

    PubMed

    Jenkinson, David M; Harbert, Allison J

    2008-11-01

    Use of performance-enhancing supplements occurs at all levels of sports, from professional athletes to junior high school students. Although some supplements do enhance athletic performance, many have no proven benefits and have serious adverse effects. Anabolic steroids and ephedrine have life-threatening adverse effects and are prohibited by the International Olympic Committee and the National Collegiate Athletic Association for use in competition. Blood transfusions, androstenedione, and dehydroepiandrosterone are also prohibited in competition. Caffeine, creatine, and sodium bicarbonate have been shown to enhance performance in certain contexts and have few adverse effects. No performance benefit has been shown with amino acids, beta-hydroxy-beta-methylbutyrate, chromium, human growth hormone, and iron. Carbohydrate-electrolyte beverages have no serious adverse effects and can aid performance when used for fluid replacement. Given the widespread use of performance-enhancing supplements, physicians should be prepared to counsel athletes of all ages about their effectiveness, safety, and legality.

  15. Supplements and sports.

    PubMed

    Jenkinson, David M; Harbert, Allison J

    2008-11-01

    Use of performance-enhancing supplements occurs at all levels of sports, from professional athletes to junior high school students. Although some supplements do enhance athletic performance, many have no proven benefits and have serious adverse effects. Anabolic steroids and ephedrine have life-threatening adverse effects and are prohibited by the International Olympic Committee and the National Collegiate Athletic Association for use in competition. Blood transfusions, androstenedione, and dehydroepiandrosterone are also prohibited in competition. Caffeine, creatine, and sodium bicarbonate have been shown to enhance performance in certain contexts and have few adverse effects. No performance benefit has been shown with amino acids, beta-hydroxy-beta-methylbutyrate, chromium, human growth hormone, and iron. Carbohydrate-electrolyte beverages have no serious adverse effects and can aid performance when used for fluid replacement. Given the widespread use of performance-enhancing supplements, physicians should be prepared to counsel athletes of all ages about their effectiveness, safety, and legality. PMID:19007050

  16. Lead extraction using a laser system: Techniques, efficacy, and limitations.

    PubMed

    Okamura, Hideo

    2016-08-01

    Transvenous lead extraction is becoming popular in Japan since the approval of laser extraction system in 2010. The laser system seems to be the standard method used by most physicians, owing to its efficacy and ease of handling. The efficacy and safety of this technology has been well proven in many studies and the data suggest that it can be used for Japanese patients safely. However, lead extraction can cause serious complications. Thus, it is important to learn the limitations as well as the basic techniques and efficacy of this procedure. PMID:27588149

  17. Pharmacovigilance on sexual enhancing herbal supplements

    PubMed Central

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2015-01-01

    The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the

  18. 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.

  19. 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. PMID:26696650

  20. Supplement use by Young Athletes

    PubMed Central

    McDowall, Jill Anne

    2007-01-01

    This paper reviews studies of supplement use among child and adolescent athletes, focusing on prevalence and type of supplement use, as well as gender comparisons. Supplement use among adult athletes has been well documented however there are a limited number of studies investigating supplement use by child and adolescent athletes. A trend in the current literature revealed that the most frequently used supplements are in the form of vitamin and minerals. While health and illness prevention are the main reasons for taking supplements, enhanced athletic performance was also reported as a strong motivating factor. Generally, females are found to use supplements more frequently and are associated with reasons of health, recovery, and replacing an inadequate diet. Males are more likely to report taking supplements for enhanced performance. Both genders equally rated increased energy as another reason for engaging in supplement use. Many dietary supplements are highly accessible to young athletes and they are particularly vulnerable to pressures from the media and the prospect of playing sport at increasingly elite levels. Future research should provide more direct evidence regarding any physiological side effects of taking supplements, as well as the exact vitamin and mineral requirements for child and adolescent athletes. Increased education for young athletes regarding supplement use, parents and coaches should to be targeted to help the athletes make the appropriate choices. Key pointsSupplement use among the child and adolescent athlete population is widespread with the most frequently used supplement being a form of vitamin/mineral supplement.The effects of supplement use on the growth and development of children and adolescents remain unclear and thus use of supplements by this population should be discouraged.It is likely that there is a misunderstanding as to the role of vitamins and minerals in the diet, their function in maintaining overall health, their role

  1. 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.

  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 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.

  4. 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.

  5. 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.

  6. FDA-Approved HIV Medicines

    MedlinePlus

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  7. 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.

  8. 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.

  9. 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.

  10. Gaining approval for clinical research.

    PubMed

    Cobb, Vanessa; Srinivasan, Neil; Lambiase, Pier

    2016-07-01

    Set-up and delivery of a clinical research project can be complicated and difficult. This article introduces the regulatory processes involved in gaining approval for clinical research and discusses the obstacles that may be encountered. PMID:27388381

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. β-Alanine supplementation for athletic performance: an update.

    PubMed

    Bellinger, Phillip M

    2014-06-01

    β-alanine supplementation has become a common practice among competitive athletes participating in a range of different sports. Although the mechanism by which chronic β-alanine supplementation could have an ergogenic effect is widely debated, the popular view is that β-alanine supplementation augments intramuscular carnosine content, leading to an increase in muscle buffer capacity, a delay in the onset of muscular fatigue, and a facilitated recovery during repeated bouts of high-intensity exercise. β-alanine supplementation appears to be most effective for exercise tasks that rely heavily on ATP synthesis from anaerobic glycolysis. However, research investigating its efficacy as an ergogenic aid remains equivocal, making it difficult to draw conclusions as to its effectiveness for training and competition. The aim of this review was to update, summarize, and critically evaluate the findings associated with β-alanine supplementation and exercise performance with the most recent research available to allow the development of practical recommendations for coaches and athletes. A critical review of the literature reveals that when significant ergogenic effects have been found, they have been generally shown in untrained individuals performing exercise bouts under laboratory conditions. The body of scientific data available concerning highly trained athletes performing single competition-like exercise tasks indicates that this type of population receives modest but potentially worthwhile performance benefits from β-alanine supplementation. Recent data indicate that athletes may not only be using β-alanine supplementation to enhance sports performance but also as a training aid to augment bouts of high-intensity training. β-alanine supplementation has also been shown to increase resistance training performance and training volume in team-sport athletes, which may allow for greater overload and superior adaptations compared with training alone. The ergogenic

  19. 76 FR 27379 - Proposed Information Collection (Supplement to VA Forms 21-526, 21-534, and 21-535 (For...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ... AFFAIRS Proposed Information Collection (Supplement to VA Forms 21-526, 21-534, and 21-535 (For Philippine...: Supplement to VA Forms 21-526, 21-534, and 21-535 (For Philippine Claims), VA Form 21-4169. OMB Control Number: 2900-0094. Type of Review: Extension of a currently approved collection. Abstract: VA Form...

  20. National Athletic Trainers' Association Position Statement: Evaluation of Dietary Supplements for Performance Nutrition

    PubMed Central

    Buell, Jackie L; Franks, Rob; Ransone, Jack; Powers, Michael E; Laquale, Kathleen M; Carlson-Phillips, Amanda

    2013-01-01

    Objectives To help athletic trainers promote a “food-first” philosophy to support health and performance, understand federal and sport governing body rules and regulations regarding dietary supplements and banned substances, and become familiar with reliable resources for evaluating the safety, purity, and efficacy of dietary supplements. Background The dietary supplement industry is poorly regulated and takes in billions of dollars per year. Uneducated athletes need to gain a better understanding of the safety, eligibility, and efficacy concerns associated with choosing to take dietary supplements. The athletic trainer is a valuable athletic team member who can help in the educational process. In many cases, athletic trainers are asked to help evaluate the legality, safety, and efficacy of dietary supplements. For this position statement, our mission is to provide the athletic trainer with the necessary resources for these tasks. Recommendations Proper nutrition and changes in the athlete's habitual diet should be considered first when improved performance is the goal. Athletes need to understand the level of regulation (or lack thereof) governing the dietary supplement industry at the international, federal, state, and individual sport-participation levels. Athletes should not assume a product is safe simply because it is marketed over the counter. All products athletes are considering using should be evaluated for purity (ie, truth in labeling), safety, and efficacy. PMID:23672334

  1. 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;…

  2. Examples of Dietary Supplement Interactions

    MedlinePlus

    ... the risk of bruising and bleeding. Supplement: Goldenseal Root Possible drug-supplement interaction with: Cyclosporine. Can decrease ... using the liver's cytochrome P450 enzyme system. Goldenseal root may decrease how quickly the liver breaks down ...

  3. 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

  4. Performance of growing cattle on poor-quality rangelands supplemented with farm-formulated protein supplements in Zimbabwe.

    PubMed

    Gusha, J; Katsande, S; Zvinorova, P I; Halimani, T E; Chiuta, T

    2015-10-01

    Farmers use different non-conventional protein supplements and different feeding strategies to aid their animals survive the dry season in Zimbabwe. The strategies can be giving supplements once a week or once every other day up to very little supplement daily. Supplements are either legume crop residues or forage legumes. However, the efficacy of the use of non-conventional protein supplements in promoting growth and at the same time lowering the age at first calving is little understood. The study tested whether supplementing with farm-formulated non-conventional feeds could reduce live weight loss during the dry season and promote live weight gain as well as early development of sexual maturity in beef cattle. In a completely randomized design, thirty dams with calves on hooves were allocated to five different treatments which were repeated during the dry season for 3 years. The 3-year study results show that weight loss can be controlled, resulting in positive growth in both the pre-weaning and post-weaning phases of growing cattle. Yearlings fed solely on natural pasture lost significant weight during the dry season as compared to supplemented groups. The period to puberty and first calving was achieved at 18 and 27 months, respectively. Using non-conventional protein supplements could thus improve livestock productivity in resource-poor farming communities. It was concluded that smallholder farmers can supplement cattle with a kilogram per day of low-cost farm-based non-conventional legume meal to improve livestock productivity in semi-arid regions of Zimbabwe.

  5. 77 FR 74177 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Production...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Regulation Supplement; Production Surveillance and Reporting (OMB Control Number 0704-0250) AGENCY: Defense... or other forms of information technology. The Office of Management and Budget (OMB) has approved this... contract administration personnel to perform production surveillance to monitor contractor progress...

  6. 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...

  7. 78 FR 19467 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); DoD Pilot Mentor-Prot g Program AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... currently approved for State Agency Supplemental Nutrition Assistance Program (SNAP), formerly the Food... the manner in which SNAP will be conducted. The State Plan of Operations, in accordance with current... involved in each State agency's operation of the SNAP. Under corresponding SNAP regulations at 7 CFR...

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 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... (COI) which are not, in the opinion of the Commandant, adequately established by either the class...

  10. 36 CFR 9.12 - Supplementation or revision of plan of operations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... of plan of operations. 9.12 Section 9.12 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT Mining and Mining Claims § 9.12 Supplementation or revision of plan of operations. (a) An approved plan of operations may require reasonable revision...

  11. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... RESERVATION ROADS PROGRAM Miscellaneous Provisions Emergency Relief § 170.925 Is ERFO funding supplemental to... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used... used to reimburse the construction or maintenance funds expended....

  12. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... RESERVATION ROADS PROGRAM Miscellaneous Provisions Emergency Relief § 170.925 Is ERFO funding supplemental to... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used... used to reimburse the construction or maintenance funds expended....

  13. 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.

  14. 40 CFR 123.61 - Approval process.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a... § 123.21 the Administrator shall approve or disapprove the program based on the requirements of...

  15. 38 CFR 21.292 - Course approvals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only... rehabilitation services under Chapter 31. (Authority: 38 U.S.C. 3106) (b) General. VA staff in consultation with... approved by one of the agencies identified in paragraph (c) of this section, VR&E staff shall...

  16. 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...

  17. 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...

  18. 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...

  19. 40 CFR 52.373 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Approval status. 52.373 Section 52.373... PROMULGATION OF IMPLEMENTATION PLANS Connecticut § 52.373 Approval status. (a) The Administrator approves the... individual source approvals granted by the state under the Air Pollution Control/Energy Trade Option...

  20. 40 CFR 52.373 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Approval status. 52.373 Section 52.373... PROMULGATION OF IMPLEMENTATION PLANS Connecticut § 52.373 Approval status. (a) The Administrator approves the... individual source approvals granted by the state under the Air Pollution Control/Energy Trade Option...

  1. 40 CFR 52.373 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 3 2011-07-01 2011-07-01 false Approval status. 52.373 Section 52.373... PROMULGATION OF IMPLEMENTATION PLANS Connecticut § 52.373 Approval status. (a) The Administrator approves the... individual source approvals granted by the state under the Air Pollution Control/Energy Trade Option...

  2. 40 CFR 52.373 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Approval status. 52.373 Section 52.373... PROMULGATION OF IMPLEMENTATION PLANS Connecticut § 52.373 Approval status. (a) The Administrator approves the... individual source approvals granted by the state under the Air Pollution Control/Energy Trade Option...

  3. 40 CFR 52.1522 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status. 52.1522 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air...

  4. 40 CFR 52.422 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Approval status. 52.422 Section 52.422... PROMULGATION OF IMPLEMENTATION PLANS Delaware § 52.422 Approval status. Link to an amendment published at 78 FR... Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves...

  5. 40 CFR 52.1522 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 4 2012-07-01 2012-07-01 false Approval status. 52.1522 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air...

  6. 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....

  7. 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....

  8. 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....

  9. Herbs, Supplements and Alternative Medicines

    MedlinePlus

    ... not been able to prove that dietary or herbal supplements (including omega-3 supplements, cinnamon, and other herbs) ... of people with diabetes used some type of herbal therapy , while another study found that 31 percent used dietary supplements . Certain ethnic groups, such as Hispanics, Native Americans, ...

  10. Vitamin and Mineral Supplement Fact Sheets

    MedlinePlus

    ... Tables Online DRI Tool Daily Value (DV) Tables Vitamin and Mineral Supplement Fact Sheets Search the list ... Supplements: Background Information Botanical Dietary Supplements: Background Information Vitamin and Mineral Fact Sheets Botanical Supplement Fact Sheets ...

  11. 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

  12. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... 49 Transportation 6 2011-10-01 2011-10-01 false Action by approval authority-approval by design type. 451.13 Section 451.13 Transportation Other Regulations Relating to Transportation...

  13. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... 49 Transportation 6 2010-10-01 2010-10-01 false Action by approval authority-approval by design type. 451.13 Section 451.13 Transportation Other Regulations Relating to Transportation...

  14. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... 49 Transportation 6 2012-10-01 2012-10-01 false Action by approval authority-approval by design type. 451.13 Section 451.13 Transportation Other Regulations Relating to Transportation...

  15. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... 49 Transportation 6 2013-10-01 2013-10-01 false Action by approval authority-approval by design type. 451.13 Section 451.13 Transportation Other Regulations Relating to Transportation...

  16. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... 49 Transportation 6 2014-10-01 2014-10-01 false Action by approval authority-approval by design type. 451.13 Section 451.13 Transportation Other Regulations Relating to Transportation...

  17. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Action by approval authority-individual approval. 451.16 Section 451.16 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers §...

  18. [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.

  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. PMID:27544991

  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. The case for eliminating the use of dietary fluoride supplements for young children.

    PubMed

    Burt, B A

    1999-01-01

    Fluoride supplements have been used for years to prevent dental caries; nevertheless, there are three reasons why their use is inappropriate today among infants and young children in the United States. Evidence for the efficacy of fluoride supplements when used from birth or soon after is weak, supplements are a risk factor for dental fluorosis, and fluoride has little preeruptive effect in caries prevention. While there are many reports on the caries-preventive efficacy of supplements, few meet standards for acceptability as clinical trials, and those that do have tested chewable tablets or lozenges under supervision in school-aged children. North American children today are exposed to fluoride from many sources--drinking water, toothpaste, gels, rinses, and in processed foods and beverages. The additional cariostatic benefits that accrue from using supplements are marginal at best, while there is strong risk of fluorosis when young children use supplements. Available evidence suggests that the public is more aware of the milder forms of fluorosis than was previously thought; thus, it is prudent for caries-preventive policies to aim to maximizing caries reductions while minimizing the risk of fluorosis. It is therefore concluded that the risks of using supplements in infants and young children outweigh the benefits. Because alternative forms of fluoride for high-risk individuals exist, fluoride supplements should no longer be used for young children in North America. PMID:10682335

  2. Vitamin supplementation and megadoses.

    PubMed

    Blair, K A

    1986-07-01

    Almost one-third of American adults regularly take vitamins and supplements. If taken incorrectly or in excess, these vitamins may be a potential health hazard. Vitamins are essential nutrients which, in combination with other nutrients (e.g., fats, carbohydrates and proteins), foster normal metabolism. Vitamins also interact with each other. For example, vitamin C participates in the metabolism of folic acid, and vitamin E facilitates the absorption and storage of vitamin A. Because the biological functions of vitamins are interrelated, a diet poor in vitamins, carbohydrates, fats and proteins is not necessarily enhanced by vitamin supplementation. When vitamins are taken in excess of the Recommended Dietary Allowances or the individual's needs, the vitamins no longer function as vitamins but instead act as drugs, with such pharmacological effects as clinical toxicities and the abnormal utilization of vitamins. There are six categories that require vitamin supplements and, in some cases, megadoses. These will be discussed in detail. In addition, a brief table showing the Recommended Dietary Allowances will be given which the nurse practitioner can use in assessing nutritional needs of the client so that necessary adjustments can be made. Finally, a brief review of the potential risks and benefits of megadoses in normal, healthy adults will be given. PMID:3737019

  3. 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

  4. Leucine Supplementation Protects from Insulin Resistance by Regulating Adiposity Levels

    PubMed Central

    Binder, Elke; Bermúdez-Silva, Francisco J.; André, Caroline; Elie, Melissa; Romero-Zerbo, Silvana Y.; Leste-Lasserre, Thierry; Belluomo, llaria; Duchampt, Adeline; Clark, Samantha; Aubert, Agnes; Mezzullo, Marco; Fanelli, Flaminia; Pagotto, Uberto; Layé, Sophie; Mithieux, Gilles; Cota, Daniela

    2013-01-01

    Background Leucine supplementation might have therapeutic potential in preventing diet-induced obesity and improving insulin sensitivity. However, the underlying mechanisms are at present unclear. Additionally, it is unclear whether leucine supplementation might be equally efficacious once obesity has developed. Methodology/Principal Findings Male C57BL/6J mice were fed chow or a high-fat diet (HFD), supplemented or not with leucine for 17 weeks. Another group of HFD-fed mice (HFD-pairfat group) was food restricted in order to reach an adiposity level comparable to that of HFD-Leu mice. Finally, a third group of mice was exposed to HFD for 12 weeks before being chronically supplemented with leucine. Leucine supplementation in HFD-fed mice decreased body weight and fat mass by increasing energy expenditure, fatty acid oxidation and locomotor activity in vivo. The decreased adiposity in HFD-Leu mice was associated with increased expression of uncoupling protein 3 (UCP-3) in the brown adipose tissue, better insulin sensitivity, increased intestinal gluconeogenesis and preservation of islets of Langerhans histomorphology and function. HFD-pairfat mice had a comparable improvement in insulin sensitivity, without changes in islets physiology or intestinal gluconeogenesis. Remarkably, both HFD-Leu and HFD-pairfat mice had decreased hepatic lipid content, which likely helped improve insulin sensitivity. In contrast, when leucine was supplemented to already obese animals, no changes in body weight, body composition or glucose metabolism were observed. Conclusions/Significance These findings suggest that leucine improves insulin sensitivity in HFD-fed mice by primarily decreasing adiposity, rather than directly acting on peripheral target organs. However, beneficial effects of leucine on intestinal gluconeogenesis and islets of Langerhans's physiology might help prevent type 2 diabetes development. Differently, metabolic benefit of leucine supplementation is lacking in

  5. A review of creatine supplementation in age-related diseases: more than a supplement for athletes.

    PubMed

    Smith, Rachel N; Agharkar, Amruta S; Gonzales, Eric B

    2014-01-01

    Creatine is an endogenous compound synthesized from arginine, glycine and methionine. This dietary supplement can be acquired from food sources such as meat and fish, along with athlete supplement powders. Since the majority of creatine is stored in skeletal muscle, dietary creatine supplementation has traditionally been important for athletes and bodybuilders to increase the power, strength, and mass of the skeletal muscle. However, new uses for creatine have emerged suggesting that it may be important in preventing or delaying the onset of neurodegenerative diseases associated with aging. On average, 30% of muscle mass is lost by age 80, while muscular weakness remains a vital cause for loss of independence in the elderly population. In light of these new roles of creatine, the dietary supplement's usage has been studied to determine its efficacy in treating congestive heart failure, gyrate atrophy, insulin insensitivity, cancer, and high cholesterol. In relation to the brain, creatine has been shown to have antioxidant properties, reduce mental fatigue, protect the brain from neurotoxicity, and improve facets/components of neurological disorders like depression and bipolar disorder. The combination of these benefits has made creatine a leading candidate in the fight against age-related diseases, such as Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, long-term memory impairments associated with the progression of Alzheimer's disease, and stroke. In this review, we explore the normal mechanisms by which creatine is produced and its necessary physiology, while paying special attention to the importance of creatine supplementation in improving diseases and disorders associated with brain aging and outlining the clinical trials involving creatine to treat these diseases.

  6. The effect of citrulline and arginine supplementation on lactic acidemia in MELAS syndrome.

    PubMed

    El-Hattab, Ayman W; Emrick, Lisa T; Williamson, Kaitlin C; Craigen, William J; Scaglia, Fernando

    2013-12-01

    Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) syndrome is a mitochondrial disorder in which nitric oxide (NO) deficiency may play a role in the pathogenesis of several complications including stroke-like episodes and lactic acidosis. Supplementing the NO precursors arginine and citrulline restores NO production in MELAS syndrome. In this study we evaluated the effect of arginine or citrulline on lactic acidemia in adults with MELAS syndrome. Plasma lactate decreased significantly after citrulline supplementation, whereas the effect of arginine supplementation did not reach statistical significance. These results support the potential therapeutic utility of arginine and citrulline in MELAS syndrome and suggest that citrulline supplementation may be more efficacious. However, therapeutic efficacy of these compounds should be further evaluated in clinical trials.

  7. No benefit of glutamine supplementation on persistent diarrhea in Ugandan children.

    PubMed

    Kamuchaki, Justine M; Kiguli, Sarah; Wobudeya, Eric; Bortolussi, Robert

    2013-05-01

    We evaluated the efficacy of oral glutamine supplementation in children 2 to 60 months of age with persistent diarrhea by 1:1 randomization to standard treatment alone or together with twice daily glutamine. The failure rate was similar in both arms (relative risk: 1.8 [95% confidence interval: 0.8-3.7], P = 0.12). Glutamine supplementation showed no benefit on the outcome of persistent diarrhea.

  8. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... the Agency (76 FR 75809). FSIS also proposed to combine the regulations that provide for the approval... preamble (76 FR 75814), FSIS wrote: . . . statements on labels that are defined in FSIS's regulations or... ``Product Labeling: Definition of the Term ``Natural'' and related materials (71 FR 70503, Dec. 5, 2006)...

  9. 28 CFR 58.17 - Procedures for denying an application or removing an agency from the approved list, and the...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... credit counseling agency. (b) No administrative review will be granted to any applicant that submitted an... supplemented by, an interim directive, which may immediately remove an agency from the approved list. Such an interim directive may be issued if one or more of the following are specifically found: (1) The agency...

  10. 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...

  11. The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

    PubMed Central

    2014-01-01

    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. PMID

  12. 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....

  13. 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....

  14. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    PubMed

    Xu, Kui; Coté, Timothy R

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.

  15. Performance-enhancing supplements.

    PubMed

    Pecci, M A; Lombardo, J A

    2000-11-01

    Supplements that are marketed as ergogenic aids have achieved widespread use in the United States. In image-conscious society, these agents are not only being consumed by athletes, but also by those looking for a quick fix to enhance their appearance. Many assume that the performance claims made by the manufacturers are based on actual data, and that these agents must be safe because they are sold to the general public. Unfortunately, in most cases these assumptions are false. Creatine has become very popular, particularly among college and high school athletes. Studies within the last 5 years have shown that creatine does seem to have certain ergogenic benefits in a laboratory setting. It is not currently known whether these benefits actually can be transferred to the playing field. Although creatine has not consistently been shown to cause any major side effects, there is some question regarding creatine's effect on the kidneys, particularly with long-term use. Also, the safety of supplementation in children and adolescents has not been examined at all; its use in this population should be discouraged until there are more data. Androstenedione is an agent that has received a large amount of popular press in the last year, and this has led to an surge in its usage. It is believed to exert its ergogenic effects through conversion to testosterone. But what limited data are available suggest that at the recommended dosage, it does not cause any measurable change in testosterone levels, or provide any ergogenic benefit in inexperienced weight lifters. Also, it has yet to be determined whether androstenedione causes any of the side effects often attributed to use of the illegal anabolic steroids. Its mechanism of action suggests it has the potential to cause many of these negative effects. Studies are just beginning to appear in the literature, and certainly more data need to be gathered before androstenedione supplementation can be recommended for use as an ergogenic

  16. Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

    PubMed

    Park, Glen D; Mitchel, Jules T

    2016-06-01

    While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products. The FDA has published a regulation entitled "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible." This regulation, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics when efficacy studies in humans are not ethical or feasible. To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA's requirements for approval of the product. PMID:27336401

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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. PMID:26642690

  5. The effect of subacute supplementation of taurine on spatial learning and memory.

    PubMed

    Ito, Koichi; Arko, Matevz; Kawaguchi, Tomohiro; Kuwahara, Masayoshi; Tsubone, Hirokazu

    2009-04-01

    Although the effect of taurine on the heart and liver is well studied, there has been no direct observation concerning the effect of taurine on spatial learning and memory at the behavior level. In this study, we tested the effect of subacute taurine supplementation with evaluation by the Morris water maze method. Although swim distance to find the platform of taurine-supplemented rats was significantly longer than that of control rats due to increase of swimming velocity, escape latency and the efficacy of learning and memory was comparable in both groups. These results suggest that taurine supplemented orally does not affect the learning and memory function.

  6. 30 CFR 916.15 - Approval of Kansas regulatory program amendments.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Approval of Kansas regulatory program... Marshal. April 23, 1986 May 26, 1987 K.A.R. 47-1-4; 47-2-7, 17, 44, 53, a, 75; 47-3-2, 3, a, 4, 21, 40, 42... 429, 432, 433; K.S.A. 1987 Supplement 49-403, 406, 422a. January 26, 1988 October 7, 1988 K.A.R....

  7. Estimating vaccine efficacy using animal efficacy data.

    PubMed

    Yellowlees, Ann; Perry, Richard H J

    2015-07-15

    Animal models are used to predict the effect of an intervention in humans. An example is the prediction of the efficacy of a vaccine when it is considered unethical or infeasible to challenge humans with the target disease to assess the effect of the vaccine on the disease in humans directly. In such cases, data from animal studies are used to develop models relating antibody level to protection probability in the animal, and then data from a study or studies in human subjects vaccinated with the proposed vaccine regimen are used in combination with the relevant animal models to predict protection in humans, and hence estimate vaccine efficacy. We explain the statistical techniques required to provide an estimate of vaccine efficacy and its precision. We present simulated examples showing that precise estimation of the relationship between antibody levels and protection in animals, at levels likely to be induced in humans by the vaccine regimen, is key to precise estimation of the vaccine efficacy. Because the confidence interval for the estimate of vaccine efficacy cannot be expressed in analytical form, but must be estimated from resampling, or bootstrapping, it is not possible to design studies with required power analytically. Therefore we propose that a simulation-based design of experiments approach using preliminary data is used to maximise the power of further studies and thus minimise the human and animal experimentation required.

  8. 28 CFR 58.15 - Procedures all approved agencies shall follow when applying for approval to act as an approved...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Procedures all approved agencies shall follow when applying for approval to act as an approved agency for an additional one year period. 58.15... complying with all the requirements specified for agencies under 11 U.S.C. 109(h) and 111, and under...

  9. 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.

  10. 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.

  11. Supplemental fuel vapor system

    SciTech Connect

    Foster, P.M.

    1991-01-08

    This patent describes a supplemental fuel system utilizing fuel vapor. It comprises: an internal combustion engine including a carburetor and an intake manifold; a fuel tank provided with air vents; a fuel conduit having a first end connected to the fuel tank and in communication with liquid fuel in the tank and a second end connected to the carburetor; the fuel conduit delivering the liquid fuel to the carburetor from the fuel tank; a fuel vapor conduit having a first end connected to the fuel tank at a location displaced from contact with the liquid fuel and a second end connected to a carbon canister; a PCV conduit having a first end connected to a pollution control valve and a second end connected to the intake manifold; and, an intermediate fuel vapor conduit having a first end connected to the fuel vapor conduit and a second end connected to the PCV conduit; wherein the air vents continuously provide air to the tank to mix with the liquid fuel and form fuel vapor. The fuel vapor drawn from the fuel tank by vacuum developed in the intake manifold and flows through the fuel vapor conduit. The intermediate fuel vapor conduit and the intake manifold to combustion chambers of the internal combustion engine so as to supplement fuel delivered to the engine by the fuel conduit. The liquid fuel and the fuel vapor constantly delivered to the engine during normal operation.

  12. Epclusa Approved for Chronic Hepatitis C

    MedlinePlus

    ... news/fullstory_159609.html Epclusa Approved for Chronic Hepatitis C Combination drug treats six major forms of ... to treat the six major strains of chronic hepatitis C virus (HCV). Epclusa combines sofosbuvir, FDA-approved ...

  13. Drugs Approved for Soft Tissue Sarcoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Soft Tissue Sarcoma This page lists ... soft tissue sarcoma that are not listed here. Drugs Approved for Soft Tissue Sarcoma Cosmegen (Dactinomycin) Dactinomycin ...

  14. Drugs Approved for Head and Neck Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Head and Neck Cancer This page ... and neck cancer that are not listed here. Drugs Approved for Head and Neck Cancer Abitrexate (Methotrexate) ...

  15. Drugs Approved for Stomach (Gastric) Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Stomach (Gastric) Cancer This page lists ... stomach (gastric) cancer that are not listed here. Drugs Approved for Stomach (Gastric) Cancer Cyramza (Ramucirumab) Docetaxel ...

  16. Drugs Approved for Colon and Rectal Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Colon and Rectal Cancer This page ... and rectal cancer that are not listed here. Drugs Approved for Colon Cancer Avastin (Bevacizumab) Bevacizumab Camptosar ( ...

  17. Drugs Approved for Non-Hodgkin Lymphoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Non-Hodgkin Lymphoma This page lists ... non-Hodgkin lymphoma that are not listed here. Drugs Approved for Non-Hodgkin Lymphoma Abitrexate (Methotrexate) Adcetris ( ...

  18. 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) ...

  19. 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....

  20. FDA Approves New Weight-Loss Device

    MedlinePlus

    ... gov/news/fullstory_159362.html FDA Approves New Weight-Loss Device Surgically implanted port allows obese patients to ... have been unable to lose weight and maintain weight loss using nonsurgical treatments. The FDA approval is for ...