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Sample records for healthy volunteers received

  1. Dose-dependent pharmacokinetics of delavirdine in combination with amprenavir in healthy volunteers

    DEFF Research Database (Denmark)

    Justesen, Ulrik S; Klitgaard, Niels A; Brosen, Kim

    2004-01-01

    OBJECTIVES: To investigate different dose combinations of amprenavir and delavirdine in order to assess an optimal dose suitable for clinical use. METHODS: This was a prospective, open-label, controlled, three-period, multiple-dose study with nine healthy volunteers. The volunteers received three...

  2. Physiologic effects of intravenous fluid administration in healthy volunteers

    DEFF Research Database (Denmark)

    Holte, Kathrine; Jensen, Peter; Kehlet, Henrik

    2003-01-01

    Dose regimens in perioperative fluid management are rarely evidence based. Therefore, we investigated responses to an IV fluid infusion in healthy volunteers to assess basic physiologic effects of a fluid infusion per se. In a prospective, double-blinded, cross-randomized study, 12 healthy...... volunteers with a median age of 63 yr (range, 59-67 yr) received an infusion of lactated Ringer's solution 40 mL/kg (median, 2820 mL) or 5 mL/kg (median, 353 mL; background infusion) in random order on two separate occasions. The study was designed to mimic the perioperative course with preoperative fasting...... by fluid administration. These findings may serve as a basis for clinical studies applying the same type of fluid in different amounts to determine the optimal amount of perioperative fluid in various surgical procedures. IMPLICATIONS: Infusion of 40 mL/kg of lactated Ringer's solution in volunteers led...

  3. Safety Evaluation of Crocin (a constituent of saffron Tablets in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Amir Houshang Mohamadpour

    2013-01-01

    Full Text Available Objective(s: Crocin is the chemical ingredient primarily responsible for the color of saffron. It has different pharmacological effects such as antioxidant, anticancer and memory improving activities. Crocin tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. Materials and Methods: The study was a randomized, double-blind, placebo-controlled design consisting of one month treatment of crocin tablets. Volunteers who fulfilled inclusion and exclusion criteria were randomized into 2 groups of 22 each (males and females and received 20 mg crocin tablets or placebo. General measures of health were recorded during the study such as hematological, biochemical, hormonal and urinary parameters in pre and post-treatment periods. Results: No major adverse events were reported during the trial. Crocin tablets did not change the above parameters except that it decreased amylase, mixed white blood cells and PTT in healthy volunteers after one month. Conclusion: This clinical safety evaluation showed a relatively safe and normal profile for crocin in healthy volunteers at the given doses within the trial period.

  4. [Drug evaluation in healthy volunteers. Legislative and ethical aspects].

    Science.gov (United States)

    Warot, D

    1991-01-01

    Studies in healthy volunteers have been legalized since December 20th 1988 in France. The healthy volunteer is employed for a variety of studies in phases I and IV of drug development. This type of research can equally be called nontherapeutic in nature. Every experiment involving healthy volunteers should be approved by the Ethics Committee. Using volunteers within the department, company or other organisation, while offering advantages for the investigator should be prohibited as freedom of concept might not be safeguarded. As well, financial incentives may over-persuade individuals, including students, who have low incomes and promote the "professional volunteer". To avoid this problem, French law planned a national register. The potential benefits of such a disposition are still unknown. Having been given appropriate information concerning the drug trial, his obligations and rights, the healthy volunteer gives his written consent. Specific recommendations for nontherapeutic assessments of drug effects are given concerning prisoners, the mentally handicapped, women with a risk of frequency, children. Ethical considerations concerning research on a healthy population must go beyond the law recently promulgated in France.

  5. Pharmacokinetics of oral and intravenous melatonin in healthy volunteers

    DEFF Research Database (Denmark)

    Andersen, Lars Peter Holst; Werner, Mads Utke; Rosenkilde, Mette Marie

    2016-01-01

    BACKGROUND: The aim was to investigate the pharmacokinetics of oral and iv melatonin in healthy volunteers. METHODS: The study was performed as a cohort crossover study. The volunteers received either 10 mg oral melatonin or 10 mg intravenous melatonin on two separate study days. Blood samples were...... collected at different time points following oral administration and short iv infusion, respectively. Plasma melatonin concentrations were determined by RIA technique. Pharmacokinetic analyses were performed by "the method of residuals" and compartmental analysis. The pharmacokinetic variables: k a, t 1....../2 absorption, t max, C max, t 1/2 elimination, AUC 0-∞, and bioavailability were determined for oral melatonin. C max, t 1/2 elimination, V d, CL and AUC 0-∞ were determined for intravenous melatonin. RESULTS: Twelve male volunteers completed the study. Baseline melatonin plasma levels did not differ...

  6. The acute (immediate) effects of reflexology on arterial compliance in healthy volunteers: A randomised study.

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    Rollinson, K; Jones, J; Scott, N; Megson, IL; Leslie, SJ

    2016-01-01

    BACKGROUND: Reflexology is a widely used complementary therapy. The effects of reflexology on the cardiovascular system are not well characterised. Arterial stiffness (compliance) is a marker of vascular health. This study aimed to evaluate the effects of reflexology on arterial compliance in healthy volunteers. METHODS: 12 healthy volunteers (1 male; 11 female; mean age 44.8 ± 10.8 yrs) received 10 min of reflexology on each foot in a single-blind randomised study. The main outcome measures ...

  7. Lack of association between joint hyperlaxity and, I: panic disorder, and II: reactivity to carbon dioxide in healthy volunteers.

    Science.gov (United States)

    Benjamin, Jonathan; Ben-Zion, Itzhak Z; Dannon, Pinhas; Schreiber, Shaul; Meiri, Gal; Ofek, Andre; Palatnik, Alex

    2001-03-01

    This study attempted to replicate previous reports of associations between panic disorder and joint hyperlaxity. The authors also examined possible associations between reacitivity to carbon dioxide (CO(2)), a model for panic vulnerability, and hyperlaxity in healthy volunteers. One hundred and one patients with DSM-IV panic disorder and 39 healthy volunteers were assessed for hyperlaxity by Beighton's criteria. Healthy volunteers also received two vital capacity inhalations of CO(2). Thirteen (13%) patients had five or more hyperlax joints. This rate did not differ from that in the healthy volunteers. Anxiety in healthy volunteers, as measured by the NIMH self-rating scale, DSM-IV panic symptom scores, and 100 mm visual analog scales of anxiety, increased after CO(2) from a mean of 1.8 to 2.8 (not significant); from 0.5 to 4 ( p < 0.001) and from 8.7 to 11.6 mm ( p < 0.1), respectively. There were no associations between responses to CO(2) and hyperlaxity. Copyright 2001 John Wiley & Sons, Ltd.

  8. Dark chocolate inhibits platelet aggregation in healthy volunteers.

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    Innes, Andrew J; Kennedy, Gwen; McLaren, Margaret; Bancroft, Anne J; Belch, Jill J F

    2003-08-01

    Cardiovascular disease is a leading cause of death in the UK. The flavonoids found in cocoa may produce a cardio-protective role for chocolate with a high cocoa content. Thirty healthy volunteers were randomised to receive 100 g of white, milk or dark chocolate, and assessments of platelet function were undertaken on venous blood samples before and after chocolate consumption. White and milk chocolate had no significant effect on platelets. However dark chocolate inhibited collagen-induced platelet aggregation in platelet rich plasma. In the future dark chocolate may have a role in prevention of cardiovascular and thromboembolic diseases.

  9. The acute (immediate) effects of reflexology on arterial compliance in healthy volunteers: A randomised study.

    Science.gov (United States)

    Rollinson, Kirsty; Jones, Jenny; Scott, Norma; Megson, Ian L; Leslie, Stephen J

    2016-02-01

    Reflexology is a widely used complementary therapy. The effects of reflexology on the cardiovascular system are not well characterised. Arterial stiffness (compliance) is a marker of vascular health. This study aimed to evaluate the effects of reflexology on arterial compliance in healthy volunteers. 12 healthy volunteers (1 male; 11 female; mean age 44.8 ± 10.8 yrs) received 10 min of reflexology on each foot in a single-blind randomised study. The main outcome measures were measurements of cardiovascular parameters including heart rate, blood pressure and arterial compliance (augmentation index). Reflexology had no significant effect on heart rate, blood pressure or augmentation index (all p > 0.05). In healthy volunteers, there were no consistent changes in haemodynamic parameters with a single brief reflexology treatment. Thus from a cardiovascular point of view, reflexology (as delivered) would appear to have a limited (if any) effect on the cardiovascular system. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Effect of tamsulosin on the pharmacokinetics of dutasteride in Chinese male healthy volunteers.

    Science.gov (United States)

    Li, Huafang; Yang, Jiansong; Zhao, Hongxin; Fossler, Michael J; Wang, Chunrong

    2015-11-01

    The purpose of this study was to evaluate the effect of tamsulosin (0.2 mg) on the pharmacokinetics of dutasteride (0.5 mg) in a group of healthy Chinese male volunteers. This was an open-label, single-sequence, 3-period, drug-drug interaction phase 1 study. Twenty-four healthy Chinese male volunteers were enrolled and administered a single dose of 0.5 mg dutasteride and, following a 28- to 30-day washout period, 0.2 mg tamsulosin once daily for 7 days. On day 5, subjects received 0.2 mg tamsulosin coadministered with 0.5 mg dutasteride. Serum dutasteride and tamsulosin concentrations were monitored. In the presence or absence of tamsulosin, there were no apparent changes in dutasteride AUC and Cmax . Adverse events reported were mild to moderate in intensity and resolved by the end of the study. In healthy Chinese male volunteers, tamsulosin 0.2 mg at steady state had no apparent effect on dutasteride pharmacokinetics. Dutasteride and tamsulosin when administered alone or in combination were well tolerated. © 2015, The American College of Clinical Pharmacology.

  11. Safety evaluation of Elixir Paregorico in healthy volunteers: a phase I study.

    Science.gov (United States)

    de Moraes, Mea; Bezerra, Mm; Bezerra, Faf; de Moraes, Ra; Cavalcanti, Pp; Uchoa, Cra; Lima, Fav; Odorico de Moraes, M

    2008-10-01

    A liquid alcoholic extract of Papaver somniferum named Elixir Paregorico is extensively used for diarrheal diseases in Brazil. Its increased popularity has brought concerns and fears over the safety of this herbal product. Given the lack of investigative clinical studies, in this regard, this study investigated whether Elixir Paregorico administration causes any noticeable toxic effects in healthy volunteers. In all, 28 middle-aged healthy male (n = 14) and female (n = 14) were enrolled. After screening and a washout period, eligible subjects received four oral doses per day of Elixir Paregorico (3 mL diluted in 30 mL of water) over a 10-day period. Altogether, all 28 participants completed the study. The results of hematological and biochemical tests performed pre and post-treatment were within the normal range. In both male and female volunteers, there were no statistical differences (P > 0.05) in the results of clinical and laboratory tests performed at screening, on 5th and 10th day visits, and at final assessment. Although mild adverse events were related, which subsided spontaneously, no serious untoward reactions were reported following Elixir Paregorico administration. To our knowledge, this is the first demonstration that Elixir Paregorico administered four times a day for 10 days is safe and does not cause any noticeable toxic effect in healthy volunteers.

  12. Safeguards for healthy volunteers in drug studies.

    Science.gov (United States)

    Smith, R N

    1975-09-06

    Safeguards for healthy volunteers in drug studies have not been as strict as those involving patients. The shortcomings include the lack of surveillance over the scientific validity of the protocol and its ethical review, and over the financial inducements to volunteers. Recruitment is open to abuse because the volunteers may have some allegiance to the investigators. There is an urgent need to institute checks on these aspects. Most important, however, is the lack of legal safeguards for volunteers taking part in research done outside the pharmaceutical industry. The suggested procedure for obtaining consent, for health checks, and for providing compensation can be equitable to all concerned, and yet not restrict initiative, nor curtail research aims.

  13. Intestinal Microbial Community Differs between Acute Pancreatitis Patients and Healthy Volunteers.

    Science.gov (United States)

    Zhang, Xi Mei; Zhang, Zheng Yu; Zhang, Chen Huan; Wu, Jing; Wang, You Xin; Zhang, Guo Xin

    2018-01-01

    A case control study including 45 acute pancreatitis and 44 healthy volunteers was performed to investigate the association between intestinal microbial community and acute pancreatitis. High-throughput 16S rRNA gene amplicon sequencing was used to profile the microbiological composition of the samples. In total, 27 microbial phyla were detected and the samples of pancreatitis patients contained fewer phyla. Samples from acute pancreatitis patients contained more Bacteroidetes and Proteobacteria and fewer Firmicutes and Actinobacteria than those from healthy volunteers. PCoA analyses distinguished the fecal microbial communities of acute pancreatitis patients from those of healthy volunteers. The intestinal microbes of acute pancreatitis patients are different from those of healthy volunteers. Modulation of the intestinal microbiome may serve as an alternative strategy for treating acute pancreatitis. Copyright © 2018 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

  14. Sensation seeking amongst healthy volunteers participating in phase I clinical trials.

    Science.gov (United States)

    Farré, M; Lamas, X; Camí, J

    1995-01-01

    1. Phase I clinical trials are usually carried out in healthy volunteers. In addition to economic gain, factors that may influence willingness to participate include scientific interest, curiosity and choice for risky activities. 2. We assessed the relationship between personality variables and volunteering for clinical pharmacology research. Two personality questionnaires, the Sensation Seeking Scale (SSS, form V) and the Eysenck Personality Questionnaire (EPQ), were administered to 48 male healthy university students who volunteered to participate in a phase I clinical trial and to 43 male university students who were not willing to participate in phase I clinical trials. General norm data were also used for the comparison of results. 3. When healthy volunteers were compared with unwilling subjects, significant differences were found in thrill-and-adventure seeking (7.9 vs 6.7, P = 0.0034), experience seeking (6.4 vs 5.2, P = 0.0012), disinhibition (6.2 vs 4.3, P personality profile of healthy volunteers was characterized by a higher sensation seeking trait and extraversion as compared with individuals who were not willing to participate in phase I clinical trials and general norm data. PMID:7640147

  15. Reflexology has an acute (immediate) haemodynamic effect in healthy volunteers: a double-blind randomised controlled trial.

    Science.gov (United States)

    Jones, Jenny; Thomson, Patricia; Lauder, William; Howie, Kate; Leslie, Stephen J

    2012-11-01

    Reflexologists claim that massage to specific points of the feet increases blood supply to internal organs. This study measured changes in cardiovascular parameters in subjects receiving reflexology to areas of their feet thought to correspond to the heart (intervention) compared with other areas which are not (control). 16 reflexology-naive healthy volunteers received an active and control reflexology treatment in an RCT, double-blind repeated measures study. 'Beat-to-beat' continuous measurement of selected cardiovascular parameters, State Anxiety Inventory. Cardiac index decreased significantly in the intervention group during left foot treatment (LFT) (baseline mean 2.6; standard deviation (SD) 0.75; 95% CI ± 0.38 vs. LFT mean 2.45; SD 0.68; CI 0.35), effect size (p = 0.035, omega squared effect (w2) = 0.002; w = 0.045). Reflexology massage applied to the upper part of the left foot may have a modest specific effect on the cardiac index of healthy volunteers. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. A single high dose of escitalopram disrupts sensory gating and habituation, but not sensorimotor gating in healthy volunteers

    DEFF Research Database (Denmark)

    Oranje, Bob; Wienberg, Malene; Glenthøj, Birte Yding

    2011-01-01

    Early mechanisms to limit the input of sensory information to higher brain areas are important for a healthy individual. In previous studies, we found that a low dose of 10mg escitalopram (SSRI) disrupts habituation, without affecting sensory and sensorimotor gating in healthy volunteers. In the ......Early mechanisms to limit the input of sensory information to higher brain areas are important for a healthy individual. In previous studies, we found that a low dose of 10mg escitalopram (SSRI) disrupts habituation, without affecting sensory and sensorimotor gating in healthy volunteers....... In the current study a higher dose of 15mg was used. The hypothesis was that this higher dose of escitalopram would not only disrupt habituation, but also sensory and sensorimotor gating. Twenty healthy male volunteers received either placebo or 15mg escitalopram, after which they were tested in a P50...... suppression, and a habituation and prepulse inhibition (PPI) of the startle reflex paradigm. Escitalopram significantly decreased P50 suppression and habituation, but had no effect on PPI. The results indicate that habituation and sensory gating are disrupted by increased serotonergic activity, while...

  17. Psilocybin-Induced Decrease in Amygdala Reactivity Correlates with Enhanced Positive Mood in Healthy Volunteers.

    Science.gov (United States)

    Kraehenmann, Rainer; Preller, Katrin H; Scheidegger, Milan; Pokorny, Thomas; Bosch, Oliver G; Seifritz, Erich; Vollenweider, Franz X

    2015-10-15

    The amygdala is a key structure in serotonergic emotion-processing circuits. In healthy volunteers, acute administration of the serotonin 1A/2A/2C receptor agonist psilocybin reduces neural responses to negative stimuli and induces mood changes toward positive states. However, it is little-known whether psilocybin reduces amygdala reactivity to negative stimuli and whether any change in amygdala reactivity is related to mood change. This study assessed the effects of acute administration of the hallucinogen psilocybin (.16 mg/kg) versus placebo on amygdala reactivity to negative stimuli in 25 healthy volunteers using blood oxygen level-dependent functional magnetic resonance imaging. Mood changes were assessed using the Positive and Negative Affect Schedule and the state portion of the State-Trait Anxiety Inventory. A double-blind, randomized, cross-over design was used with volunteers counterbalanced to receive psilocybin and placebo in two separate sessions at least 14 days apart. Amygdala reactivity to negative and neutral stimuli was lower after psilocybin administration than after placebo administration. The psilocybin-induced attenuation of right amygdala reactivity in response to negative stimuli was related to the psilocybin-induced increase in positive mood state. These results demonstrate that acute treatment with psilocybin decreased amygdala reactivity during emotion processing and that this was associated with an increase of positive mood in healthy volunteers. These findings may be relevant to the normalization of amygdala hyperactivity and negative mood states in patients with major depression. Copyright © 2015 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  18. Effect of Terbinafine on Theophylline Pharmacokinetics in Healthy Volunteers

    Science.gov (United States)

    Trépanier, Eric F.; Nafziger, Anne N.; Amsden, Guy W.

    1998-01-01

    Twelve healthy volunteers were enrolled in an open-label, randomized, crossover study. Subjects received single doses of theophylline (5 mg/kg) with and without multiple-dose terbinafine, and 11 blood samples were collected over 24 h. The study phases were separated by a 4-week washout period. Theophylline serum data were modeled via noncompartmental analysis. When the control phase (i.e., no terbinafine) was compared to the treatment phase (terbinafine), theophylline exposure (the area under the serum concentration-time curve from time zero to infinity) increased by 16% (P = 0.03), oral clearance decreased by 14% (P = 0.04), and half-life increased by 24% (P = 0.002). No significant changes in other theophylline pharmacokinetic parameters were evident. PMID:9517954

  19. Lactose Intolerance and Symptom Pattern of Lactose Intolerance among Healthy Volunteers.

    Science.gov (United States)

    Saha, Madhusudan; Parveen, Irin; Shil, Bimal Chandra; Saha, Shasanka Kumar; Banik, Ranjit Kumar; Majumder, Monojit; Salam, Mahjuba Umme; Islam, Asm Nazmul

    2016-01-01

    To see the prevalence of lactose intolerance (LI) and related symptoms following oral lactose challenge in healthy volunteers. Symptoms of abdominal pain, nausea, borborygmi, flatulence, and diarrhea were noted for 24 hours and blood glucose was estimated at 0 hour and 30 minutes after 25 gm oral lactose load to healthy volunteers. Failure to rise blood glucose level ≥ 1.1 mmol/l at 30 minutes after lactose intake from fasting level was taken as lactose malabsorption (LM), i.e., LI. A total of 166 volunteers (123 males, 43 females) with a mean age 34.78 ± 11.45 years participated in this study. Lactose intolerance was found among 85.54% (n = 142, M = 104, F = 38). The main symptoms of LI were diarrhea (n = 83, 58.4.0%), borborygmi (n = 81, 57.04%), abdominal pain (n = 35, 24.65%), and flatulence (n = 27, 19.0%). Lactose intolerance among healthy adults may be common in Bangladesh. Diarrhea and borborygmi were mostly associated symptoms of LI. Saha M, Parveen I, Shil BC, Saha SK, Banik RK, Majumder M, Salam MU, Nazmul Islam ASM. Lactose Intolerance and Symptom Pattern of Lactose Intolerance among Healthy Volunteers. Euroasian J Hepato-Gastroenterol 2016;6(1):5-7.

  20. Pharmacokinetics and -dynamics of intramuscular and intranasal naloxone: an explorative study in healthy volunteers.

    Science.gov (United States)

    Skulberg, Arne Kristian; Tylleskar, Ida; Nilsen, Turid; Skarra, Sissel; Salvesen, Øyvind; Sand, Trond; Loftsson, Thorsteinn; Dale, Ola

    2018-03-22

    This study aimed to develop a model for pharmacodynamic and pharmacokinetic studies of naloxone antagonism under steady-state opioid agonism and to compare a high-concentration/low-volume intranasal naloxone formulation 8 mg/ml to intramuscular 0.8 mg. Two-way crossover in 12 healthy volunteers receiving naloxone while receiving remifentanil by a target-controlled infusion for 102 min. The group were subdivided into three different doses of remifentanil. Blood samples for serum naloxone concentrations, pupillometry and heat pain threshold were measured. The relative bioavailability of intranasal to intramuscular naloxone was 0.75. Pupillometry showed difference in antagonism; the effect was significant in the data set as a whole (p < 0.001) and in all three subgroups (p < 0.02-p < 0.001). Heat pain threshold showed no statistical difference. A target-controlled infusion of remifentanil provides good conditions for studying the pharmacodynamics of naloxone, and pupillometry was a better modality than heat pain threshold. Intranasal naloxone 0.8 mg is inferior for a similar dose intramuscular. Our design may help to bridge the gap between studies in healthy volunteers and the patient population in need of naloxone for opioid overdose. clinicaltrials.gov : NCT02307721.

  1. Endostatin concentration in plasma of healthy human volunteers

    International Nuclear Information System (INIS)

    Shah, I.; Malik, M.O.; Khan, M.J.; Fatima, S.; Habib, S.H.

    2017-01-01

    Angiogenesis is involved in many cardiovascular and cancerous diseases, including atherosclerosis and is controlled by a fine balance between angiogenic and angiostatic mediators. Endostatin is one of the main angiostatic mediators, and inhibits angiogenesis and prevents progression of atherosclerosis. The available literature shows a broad range of concentrations in relatively small samples of healthy controls and is calculated by using different techniques. This study was aimed to determine the basal endostatin concentration in plasma of healthy volunteers, to fully understand its physiological role. Methods: Fifty healthy adult volunteers were recruited to the study. Participants were advised not to participate in any physical activity on the day before the blood sampling. The volunteers' physical activity, height, weight, heart rate and blood pressure were recorded. The samples were analysed for plasma endostatin concentration, using ELISA. The participants were divided by gender and ethnic groups to calculate any difference. Results: Endostatin and other variables were normally distributed. Most of the participants had a moderate level of physical activity with no gender related difference (p=0.370). The mean value for plasma endostatin in all samples was 105+-12 ng/ml with range of 81-132 ng/ml. For males, it was 107+-13 ng/ml, while for females; 102+-12 ng/ml. There were no significant gender or ethnicity related differences in endostatin concentration. Moreover, endostatin was not significantly related with any anthropometric and physical variable. Conclusion: This study gives endostatin levels in normal healthy people and show no gender and ethnicity related differences in endostatin levels. Endostatin was not related with any anthropometric and physical variable. (author)

  2. Effects of botropase on clotting factors in healthy human volunteers

    Directory of Open Access Journals (Sweden)

    Ashok K Shenoy

    2014-01-01

    Full Text Available Objective: To evaluate the effects of botropase on various clotting factors in human volunteers. Materials and Methods: It was a prospective open label study conducted on human healthy volunteers. After the baseline screening, subjects fulfilling inclusion criteria were enrolled. On the study day, 1 ml of botropase was administered intravenously and after an hour same dose of botropase (1 ml was given by intramuscular (IM route. The efficacy and safety parameters were monitored up to 72 h from the time of intravenous (IV administration. Results: A total of 15 volunteers, belonging to 24-35 years of age were included in the study. Botropase significantly reduced the plasma level of fibrinogen and fibrin degradation products after 5 min of IV administration (P < 0.05. In addition, factor X was observed to reduce constantly by botropase administration suggesting enhanced turnover between 5 and 20 min of IV administration. Although botropase reduced clotting and bleeding time in all the volunteers, the data remains to be statistically insignificant. Conclusion: Present study demonstrated the safety and efficacy of botropase in human healthy volunteers. The study has shown that it is a factor X activator and reduces effectively clotting and bleeding time.

  3. Normal range values for thromboelastography in healthy adult volunteers

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    S. Scarpelini

    2009-12-01

    Full Text Available Thromboelastography (TEG® provides a functional evaluation of coagulation. It has characteristics of an ideal coagulation test for trauma, but is not frequently used, partially due to lack of both standardized techniques and normal values. We determined normal values for our population, compared them to those of the manufacturer and evaluated the effect of gender, age, blood type, and ethnicity. The technique was standardized using citrated blood, kaolin and was performed on a Haemoscope 5000 device. Volunteers were interviewed and excluded if pregnant, on anticoagulants or having a bleeding disorder. The TEG® parameters analyzed were R, K, α, MA, LY30, and coagulation index. All volunteers outside the manufacturer’s normal range underwent extensive coagulation investigations. Reference ranges for 95% for 118 healthy volunteers were R: 3.8-9.8 min, K: 0.7-3.4 min, α: 47.8-77.7 degrees, MA: 49.7-72.7 mm, LY30: -2.3-5.77%, coagulation index: -5.1-3.6. Most values were significantly different from those of the manufacturer, which would have diagnosed coagulopathy in 10 volunteers, for whom additional investigation revealed no disease (81% specificity. Healthy women were significantly more hypercoagulable than men. Aging was not associated with hypercoagulability and East Asian ethnicity was not with hypocoagulability. In our population, the manufacturer’s normal values for citrated blood-kaolin had a specificity of 81% and would incorrectly identify 8.5% of the healthy volunteers as coagulopathic. This study supports the manufacturer’s recommendation that each institution should determine its own normal values before adopting TEG®, a procedure which may be impractical. Consideration should be given to a multi-institutional study to establish wide standard values for TEG®.

  4. In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers.

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    Sandhya Vasan

    Full Text Available DNA-based vaccines have been safe but weakly immunogenic in humans to date.We sought to determine the safety, tolerability, and immunogenicity of ADVAX, a multigenic HIV-1 DNA vaccine candidate, injected intramuscularly by in vivo electroporation (EP in a Phase-1, double-blind, randomized placebo-controlled trial in healthy volunteers. Eight volunteers each received 0.2 mg, 1 mg, or 4 mg ADVAX or saline placebo via EP, or 4 mg ADVAX via standard intramuscular injection at weeks 0 and 8. A third vaccination was administered to eleven volunteers at week 36. EP was safe, well-tolerated and considered acceptable for a prophylactic vaccine. EP delivery of ADVAX increased the magnitude of HIV-1-specific cell mediated immunity by up to 70-fold over IM injection, as measured by gamma interferon ELISpot. The number of antigens to which the response was detected improved with EP and increasing dosage. Intracellular cytokine staining analysis of ELISpot responders revealed both CD4+ and CD8+ T cell responses, with co-secretion of multiple cytokines.This is the first demonstration in healthy volunteers that EP is safe, tolerable, and effective in improving the magnitude, breadth and durability of cellular immune responses to a DNA vaccine candidate.ClinicalTrials.gov NCT00545987.

  5. Bioequivalence studies of two brands of meloxicam tablets in healthy Pakistani volunteers.

    Science.gov (United States)

    Hasan, Syed Muhammad Farid; Shoaib, Muhammad Harris; Hassan, Fouzia; Rehman, Inam-Ur

    2009-04-01

    The pharmacokinetic parameters of two oral formulations of meloxicam tablets were compared in a randomized, single oral dose; two treatments cross over design in 12 healthy male volunteers belonging to Pakistan under fasting conditions. After an overnight fast, the volunteers received 30 mg meloxicam and the blood samples were collected up to 96 hours and drug concentrations were determined by a validated HPLC method. Various pharmacokinetic parameters were determined from the plasma concentration-time curves of both formulations. The 90% confidence intervals obtained by analysis of variance were 87-94% for C(max) and 88-97% for AUC(0-t), that fell well within the acceptance range of 80-125%. Also, no significant difference (a=0.05, Wilcoxon Signed rank test) were detected between T(max) of both formulations. The two formulations were well tolerated and no adverse effect was reported during the study.

  6. Population pharmacokinetics of adefovir dipivoxil tablets in healthy Chinese volunteers.

    Science.gov (United States)

    Huang, Jihan; Zhang, Yaping; Huang, Xiaohui; Li, Lujin; Li, Yunfei; Wang, Kun; Yang, Juan; He, Yingchun; Lv, Yinghua; Zheng, Qingshan

    2014-01-01

    To develop a population pharmacokinetic model of adefovir dipivoxil in healthy volunteers and evaluate the effect of individual factors on the pharmacokinetics of adefovir dipivoxil. Plasma concentration data collected from 32 healthy Chinese subjects in a Phase I clinical study was pooled. Subjects received a single oral dose of 10 mg, 20 mg, or 30 mg adefovir dipivoxil, or multiple doses of 10 mg once a day for 9 days. Plasma concentrations of adefovir dipivoxil were measured using a validated liquid chromatography-mass spectrometric method. A nonlinear mixed-effect model was used to analyze the plasma concentration data of adefovir dipivoxil in healthy volunteers and to calculate the relevant parameters as well as inter- and intra-individual variability. The time course of adefovir dipivoxil concentration is best described by a first-order absorption and first-order elimination two-compartment model with lag time. The final estimate of total body clearance (CL) is 56.9 L/h and 78.7 L/h for single and multiple dosing regimen, respectively; the volume distribution of the central compartment (V2) is 106 L; inter-compartmental clearance (Q) is 220 L/h; volume distribution of the peripheral compartment (V3) is 498 L and 800 L for single and multiple dosing regimen, respectively; absorption rate is 0.509 h-1; and lag time is 0.315 hours. The inter-individual variabilities of CL and V2 were 22.4% and 58.9%, respectively. The proportional error of residual variability is 14.1% and the additive error is 0.30 ng/L. The final pharmacokinetic model was evaluated using a bootstrap method. A nonlinear mixed effect model for oral adefovir dipivoxil formulations was developed in healthy Chinese subjects. A multiple dosing regimen may significantly increase the body clearance and volume distribution of the peripheral compartment compared to a single dosing regimen. *These authors contribute equally to this work.

  7. Radiosensitiviness of blood lymphocytes from skin cancer patients and healthy volunteers as determined by micronucleus assay

    International Nuclear Information System (INIS)

    Lohmann, Tania Helena Ochi.

    1995-01-01

    Cancer, a major death cause in developed countries, has been related to somatic mutations that could be detected by cytogenetic analysis. Among the tools used in these tests, the micronucleus assay has been largely applied at population surveillance, biological dosimetry and early detection of groups with higher risks to developing cancers. In this study, we analysed the chromosome susceptibility of blood lymphocytes from basocellular skin cancer patients and healthy volunteers. The cytogenetic analysis was performed by a micronucleus assay, using progressive doses of ionizing radiation from a 60 Co source as mutagen. Briefly, the blood lymphocytes were irradiated in vitro, as processed by the cytokinesis-blocked method. The micronucleus frequency and distribution, cell cycle kinetics, nucleation index and dose-response relationship were determined in each patient. The results showed that the basocellular skin cancer patients lymphocytes presented higher spontaneous micronucleus frequency as compared with those from healthy young volunteers but lower than healthy now young volunteers . The radiation-induced micronucleus analysis showed that the basocellular skin cancer patients' lymphocytes presented similar proportion of damage lymphocytes as compared with those from healthy volunteers. Nevertheless, the magnitude of this damage was higher in this group with doses. Higher than 400 c Gy, which was not occurred in healthy volunteers. Cell cycle kinetics, as determined by the nucleation index, was lower in basocellular skin cancer patients as compared with healthy volunteers, indicating a more slow cell cycle. Our data showed that the lymphocytes from carcinoma basocellular patients were more radiosensitive as compared with those form healthy volunteers. (author). 159 refs., 21 figs., 16 tabs

  8. Evaluation of the functional efficacy of an antioxidative probiotic in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Hütt Pirje

    2005-08-01

    Full Text Available Abstract Background In persons without clinical symptom it is difficult to assess an impact of probiotics regarding its effect on health. We evaluated the functional efficacy of the probiotic Lactobacillus fermentum ME-3 in healthy volunteers by measuring the influence of two different formulations on intestinal lactoflora, fecal recovery of the probiotic strain and oxidative stress markers of blood and urine after 3 weeks consumption. Methods Two 3-week healthy volunteer trials were performed. Open placebo controlled (OPC study participants (n = 21 consumed either goat milk or by L. fermentum ME-3 fermented goat milk (daily dose 11.8 log CFU (Colony Forming Units. Double blind randomised placebo controlled (DBRP study participants (n = 24 received either capsules with L. fermentum ME-3 (daily of dose 9.2 CFU or placebo capsules. The faecal lactoflora composition, faecal ME-3 recovery, effect of the consumption on intestinal lactoflora, and oxidative stress markers of blood (total antioxidative activity; total antioxidative status and glutathione red-ox ratio was measured. Results ME-3 was well tolerated and a significant increase in total faecal lactobacilli yet no predominance of ME-3 was detected in all study groups. Faecal recovery of ME-3 was documented by molecular methods only in fermented milk group, however the significant improvement of blood TAA (Total Antioxidative Activity and TAS (Total Antioxidative Status indices was seen both in case of fermented goat milk and capsules", yet glutathione re-ox ratio values decreased only in case of fermented by ME-3 goat milk. Conclusion The functional efficacy of both consumed formulations of an antioxidative probiotic L. fermentum ME-3 is proved by the increase of the intestinal lactobacilli counts providing putative defence against enteric infections and by reduction of the oxidative stress indices of blood and urine of healthy volunteers. In non-diseased host the probiotic health claims can

  9. Transient Elastographic Values of Healthy Volunteers in a Tertiary Care Hospital

    Directory of Open Access Journals (Sweden)

    Bhupendra Kumar Basnet

    2014-03-01

    Full Text Available Introduction:Transient elastography is a very promising non invasive procedure to determine liver stiffness for diagnosis of fibrosis in various chronic liver diseases. However, studies on normal values of liver stiffness in apparently healthy subjects are still few. We aimed to determine liver stiffness values in healthy Nepalese volunteers. Methods:Transient elastography (FibroScanR, Echosens, Paris, France was performed to find out liver stiffness values in 45 apparently healthy volunteers after explaining study protocol. Complete medical examination with routine laboratory tests was performed. Subjects with normal liver biochemistries and normal liver ultrasonography were taken for analysis. Results:Mean liver stiffness value of study subjects was 4.24±0.70 kPa. Liver stiffness value was found higher in males than in females (4.32±0.74 vs 4.07±0.61 kPa, respectively, P=0.26 but not statistically significant. Similarly, comparison between age and liver stiffness also showed positive correlation (r=0.211 but not statistically significant (P=0.164 Conclusions: Our study showed that the mean liver stiffness value was 4.24±0.70 kPa in our population and influence of age, gender and body mass index were not significant. Keywords: chronic liver disease; FibroScanR; healthy volunteers; liver stiffness valve; transient elastography.

  10. Quantitative MRI comparison of systemic hemodynamics in Mustard/Senning repaired patients and healthy volunteers at rest

    International Nuclear Information System (INIS)

    Laffon, Eric; Jimenez, Maria; Choussat, Alain; Latrabe, Valerie; Ducassou, Dominique; Marthan, Roger; Laurent, Francois

    2004-01-01

    The purpose of the present study was to non-invasively compare ascending aortic blood flow and cross-sectional area (CSA) variations vs time in Mustard or Senning repaired (MSR) patients against those of healthy volunteers at rest. Velocity-encoded MR imaging was performed in 10 male patients (age range 18-24 years, median age 20.5 years) late after a Mustard or Senning correction, and in 10 male healthy volunteers (age range 21-25 years, median age 22.5 years), at the upper part of the ascending aorta. Both aortic cross-sectional area (CSA) and blood-flow variations were recorded over a complete cardiac cycle, with a 30-ms time of resolution. The body-surface area (BSA), the mean CSA over the systolic phase, and the BSA-normalized systemic ventricle power and work were significantly lower in the patient series compared with those of the volunteer series. The BSA-normalized right ventricle (RV) power and work of MSR patients were equal to 87 and 83% on average of those of the left ventricle (LV) of healthy volunteers. We conclude that, at rest, the mechanical performance of the systemic RV in MSR patients is significantly lower than that of the LV in healthy volunteers. Furthermore, the significantly lower aortic CSA found in MSR patients than in healthy volunteers may reveal an increase in the vasomotor tone. (orig.)

  11. Study on influence of piperine treatment on the pharmacokinetics of diclofenac in healthy volunteers.

    Science.gov (United States)

    Bedada, Satish Kumar; Boga, Praveen Kumar; Kotakonda, Harish Kaushik

    2017-02-01

    1. Diclofenac sodium (DIC) is a widely used anti-inflammatory drug and its administration in humans receiving long-term therapy with herbal drugs containing piperine (PIP) may occur, which leads to drug-phytochemical interactions. The purpose of the present study was to investigate the influence of PIP treatment on the pharmacokinetics of DIC in healthy volunteers. 2. The open-label, two period, sequential study was conducted in 12 healthy volunteers. PIP 20 mg was administered once daily for 10 days during treatment phase. A single dose of DIC 100 mg was administered during control and after treatment phases under fasting conditions. The blood samples were collected after DIC dosing at predetermined time intervals and analyzed by HPLC. 3. Treatment with PIP significantly enhanced maximum plasma concentration (C max ) (2.24-3.68 μg/mL, p pharmacokinetics of DIC might be attributed to PIP mediated inhibition of CYP2C9 enzyme, which indicates the clinically significant interaction present between DIC and PIP. Therefore, the combination therapy of DIC along with PIP may represent a novel approach to reduce dosage and result in reduced incidence of gastrointestinal side effects seen with DIC alone at higher doses.

  12. Effects of different sleep deprivation protocols on sleep perception in healthy volunteers.

    Science.gov (United States)

    Goulart, Leonardo I; Pinto, Luciano R; Perlis, Michael L; Martins, Raquel; Caboclo, Luis Otavio; Tufik, Sergio; Andersen, Monica L

    2014-10-01

    To investigate whether different protocols of sleep deprivation modify sleep perception. The effects of total sleep deprivation (TD) and selective rapid eye movement (REM) sleep deprivation (RD) on sleep perception were analyzed in normal volunteers. Thirty-one healthy males with normal sleep were randomized to one of three conditions: (i) normal uninterrupted sleep; (ii) four nights of RD; or (iii) two nights of TD. Morning perception of total sleep time was evaluated for each condition. Sleep perception was estimated using total sleep time (in hours) as perceived by the volunteer divided by the total sleep time (in hours) measured by polysomnography (PSG). The final value of this calculation was defined as the perception index (PI). There were no significant differences among the three groups of volunteers in the total sleep time measured by PSG or in the perception of total sleep time at baseline condition. Volunteers submitted to RD exhibited lower sleep PI scores as compared with controls during the sleep deprivation period (P sleep deprivation reduced the ability of healthy young volunteers to perceive their total sleep time when compared with time measured by PSG. The data reinforce the influence of sleep deprivation on sleep perception. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. The Survey on Knowledge of Shiraz District Health Volunteers Over Healthy Life Style in Aging

    Directory of Open Access Journals (Sweden)

    Masoomeh Saffari

    2006-10-01

    infection disease but also problems and deaths are now consider regarding to unhealthy life styles, so elder people as an important population subgroup should receive healthy life style education and so to their families. This study reveals that volunteer's knowledge level about health life style in satisfaction (85.4% of them were abbot weak to moderate level. The worst result in their knowledge is about nutritional information (only 5.9% were in good level, and the best result were over health advices regarding to matters of exercise appropriate way of sleeping, sitting and prevention of osteoporosis (18.2% were in good level. This by attention to importance of matter of elderly age, education of health volunteers and employees and by tum the different subgroup of community should be programmed.

  14. Magnetic resonance elastography: Feasibility of liver stiffness measurements in healthy volunteers at 3 T

    International Nuclear Information System (INIS)

    Mannelli, L.; Godfrey, E.; Graves, M.J.; Patterson, A.J.; Beddy, P.; Bowden, D.; Joubert, I.; Priest, A.N.; Lomas, D.J.

    2012-01-01

    Aim: To demonstrate the feasibility of obtaining liver stiffness measurements with magnetic resonance elastography (MRE) at 3 T in normal healthy volunteers using the same technique that has been successfully applied at 1.5 T. Methods and materials: The study was approved by the local ethics committee and written informed consent was obtained from all volunteers. Eleven volunteers (mean age 35 ± 9 years) with no history of gastrointestinal, hepatobiliary, or cardiovascular disease were recruited. The magnetic resonance imaging (MRI) protocol included a gradient echo-based MRE sequence using a 60 Hz pneumatic excitation. The MRE images were processed using a local frequency estimation inversion algorithm to provide quantitative stiffness maps. Adequate image quality was assessed subjectively by demonstrating the presence of visible propagating waves within the liver parenchyma underlying the driver location. Liver stiffness values were obtained using manually placed regions of interest (ROI) outlining the liver margins on the gradient echo wave images, which were then mapped onto the corresponding stiffness image. The mean stiffness values from two adjacent sections were recorded. Results: Eleven volunteers underwent MRE. The quality of the MRE images was adequate in all the volunteers. The mean liver stiffness for the group was 2.3 ± 0.38 kPa (ranging from 1.7–2.8 kPa). Conclusions: This preliminary work using MRE at 3 T in healthy volunteers demonstrates the feasibility of liver stiffness evaluation at 3 T without modification of the approach used at 1.5 T. Adequate image quality and normal MRE values were obtained in all volunteers. The obtained stiffness values were in the range of those reported for healthy volunteers in previous studies at 1.5 T. There was good interobserver reproducibility in the stiffness measurements.

  15. Magnetic resonance elastography: Feasibility of liver stiffness measurements in healthy volunteers at 3 T

    Energy Technology Data Exchange (ETDEWEB)

    Mannelli, L., E-mail: mannellilorenzo@yahoo.it [Department of Radiology, Addenbrooke' s Hospital and University of Cambridge, Cambridge (United Kingdom); Department of Radiology, University of Washington, Seattle, WA (United States); Godfrey, E.; Graves, M.J.; Patterson, A.J.; Beddy, P.; Bowden, D.; Joubert, I.; Priest, A.N.; Lomas, D.J. [Department of Radiology, Addenbrooke' s Hospital and University of Cambridge, Cambridge (United Kingdom)

    2012-03-15

    Aim: To demonstrate the feasibility of obtaining liver stiffness measurements with magnetic resonance elastography (MRE) at 3 T in normal healthy volunteers using the same technique that has been successfully applied at 1.5 T. Methods and materials: The study was approved by the local ethics committee and written informed consent was obtained from all volunteers. Eleven volunteers (mean age 35 {+-} 9 years) with no history of gastrointestinal, hepatobiliary, or cardiovascular disease were recruited. The magnetic resonance imaging (MRI) protocol included a gradient echo-based MRE sequence using a 60 Hz pneumatic excitation. The MRE images were processed using a local frequency estimation inversion algorithm to provide quantitative stiffness maps. Adequate image quality was assessed subjectively by demonstrating the presence of visible propagating waves within the liver parenchyma underlying the driver location. Liver stiffness values were obtained using manually placed regions of interest (ROI) outlining the liver margins on the gradient echo wave images, which were then mapped onto the corresponding stiffness image. The mean stiffness values from two adjacent sections were recorded. Results: Eleven volunteers underwent MRE. The quality of the MRE images was adequate in all the volunteers. The mean liver stiffness for the group was 2.3 {+-} 0.38 kPa (ranging from 1.7-2.8 kPa). Conclusions: This preliminary work using MRE at 3 T in healthy volunteers demonstrates the feasibility of liver stiffness evaluation at 3 T without modification of the approach used at 1.5 T. Adequate image quality and normal MRE values were obtained in all volunteers. The obtained stiffness values were in the range of those reported for healthy volunteers in previous studies at 1.5 T. There was good interobserver reproducibility in the stiffness measurements.

  16. The haemodynamic effects of intravenous paracetamol (acetaminophen) in healthy volunteers: a double-blind, randomized, triple crossover trial.

    Science.gov (United States)

    Chiam, Elizabeth; Weinberg, Laurence; Bailey, Michael; McNicol, Larry; Bellomo, Rinaldo

    2016-04-01

    The haemodynamic effects of intravenous paracetamol have not been systematically investigated. We compared the physiological effects of intravenous mannitol-containing paracetamol, and an equivalent dosage of mannitol, and normal saline 0.9% in healthy volunteers. We performed a blinded, triple crossover, randomized trial of 24 adult healthy volunteers. Participants received i.v. paracetamol (1 g paracetamol +3.91 g mannitol 100 ml(-1) ), i.v. mannitol (3.91 g mannitol 100 ml(-1) ) and i.v. normal saline (100 ml). Composite primary end points were changes in mean arterial pressure (MAP), systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured pre-infusion, during a 15 min infusion period and over a 45 min observation period. Systemic vascular resistance index (SVRI) and cardiac index were measured at the same time points. Infusion of paracetamol induced a transient yet significant decrease in blood pressures from pre-infusion values (MAP -1.85 mmHg, 95% CI -2.6, -1.1, SBP -0.54 mmHg, 95% CI -1.7, 0.6 and DBP -1.92 mmHg, 95% CI -2.6, -1.2, P paracetamol caused a transient decrease in blood pressure immediately after infusion. These effects were not seen with mannitol or normal saline. The physiological mechanism was consistent with vasodilatation. This study provides plausible physiological data in a healthy volunteer setting, supporting transient changes in haemodynamic variables with i.v. paracetamol and justifies controlled studies in the peri-operative and critical care setting. © 2015 The British Pharmacological Society.

  17. Differences in gluten metabolism among healthy volunteers, coeliac disease patients and first-degree relatives.

    Science.gov (United States)

    Caminero, Alberto; Nistal, Esther; Herrán, Alexandra R; Pérez-Andrés, Jénifer; Ferrero, Miguel A; Vaquero Ayala, Luis; Vivas, Santiago; Ruiz de Morales, José M G; Albillos, Silvia M; Casqueiro, Francisco Javier

    2015-10-28

    Coeliac disease (CD) is an immune-mediated enteropathy resulting from exposure to gluten in genetically predisposed individuals. Gluten proteins are partially digested by human proteases generating immunogenic peptides that cause inflammation in patients carrying HLA-DQ2 and DQ8 genes. Although intestinal dysbiosis has been associated with patients with CD, bacterial metabolism of gluten has not been studied in depth thus far. The aim of this study was to analyse the metabolic activity of intestinal bacteria associated with gluten intake in healthy individuals, CD patients and first-degree relatives of CD patients. Faecal samples belonging to twenty-two untreated CD patients, twenty treated CD patients, sixteen healthy volunteers on normal diet, eleven healthy volunteers on gluten-free diet (GFD), seventy-one relatives of CD patients on normal diet and sixty-nine relatives on GFD were tested for several proteolytic activities, cultivable bacteria involved in gluten metabolism, SCFA and the amount of gluten in faeces. We detected faecal peptidasic activity against the gluten-derived peptide 33-mer. CD patients showed differences in faecal glutenasic activity (FGA), faecal tryptic activity (FTA), SCFA and faecal gluten content with respect to healthy volunteers. Alterations in specific bacterial groups metabolising gluten such as Clostridium or Lactobacillus were reported in CD patients. Relatives showed similar parameters to CD patients (SCFA) and healthy volunteers (FTA and FGA). Our data support the fact that commensal microbial activity is an important factor in the metabolism of gluten proteins and that this activity is altered in CD patients.

  18. Haloperidol increases false recognition memory of thematically related pictures in healthy volunteers.

    Science.gov (United States)

    Guarnieri, Regina V; Buratto, Luciano G; Gomes, Carlos F A; Ribeiro, Rafaela L; de Souza, Altay A Lino; Stein, Lilian M; Galduróz, José C; Bueno, Orlando F A

    2017-01-01

    Dopamine can modulate long-term episodic memory. Its potential role on the generation of false memories, however, is less well known. In a randomized, double-blind, placebo-controlled experiment, 24 young healthy volunteers ingested a 4-mg oral dose of haloperidol, a dopamine D 2 -receptor antagonist, or placebo, before taking part in a recognition memory task. Haloperidol was active during both study and test phases of the experiment. Participants in the haloperidol group produced more false recognition responses than those in the placebo group, despite similar levels of correct recognition. These findings show that dopamine blockade in healthy volunteers can specifically increase false recognition memory. Copyright © 2016 John Wiley & Sons, Ltd.

  19. Performance on a probabilistic inference task in healthy subjects receiving ketamine compared with patients with schizophrenia

    Science.gov (United States)

    Almahdi, Basil; Sultan, Pervez; Sohanpal, Imrat; Brandner, Brigitta; Collier, Tracey; Shergill, Sukhi S; Cregg, Roman; Averbeck, Bruno B

    2012-01-01

    Evidence suggests that some aspects of schizophrenia can be induced in healthy volunteers through acute administration of the non-competitive NMDA-receptor antagonist, ketamine. In probabilistic inference tasks, patients with schizophrenia have been shown to ‘jump to conclusions’ (JTC) when asked to make a decision. We aimed to test whether healthy participants receiving ketamine would adopt a JTC response pattern resembling that of patients. The paradigmatic task used to investigate JTC has been the ‘urn’ task, where participants are shown a sequence of beads drawn from one of two ‘urns’, each containing coloured beads in different proportions. Participants make a decision when they think they know the urn from which beads are being drawn. We compared performance on the urn task between controls receiving acute ketamine or placebo with that of patients with schizophrenia and another group of controls matched to the patient group. Patients were shown to exhibit a JTC response pattern relative to their matched controls, whereas JTC was not evident in controls receiving ketamine relative to placebo. Ketamine does not appear to promote JTC in healthy controls, suggesting that ketamine does not affect probabilistic inferences. PMID:22389244

  20. The Associations between Pain Sensitivity and Knee Muscle Strength in Healthy Volunteers

    DEFF Research Database (Denmark)

    Henriksen, Marius; Klokker, Louise; Bartholdy, Cecilie

    2013-01-01

    lateralis, deltoid, and infrapatellar fat pad. Quadriceps and hamstring muscle strength was assessed isometrically at 60-degree knee flexion using a dynamometer. Associations between pain sensitivity and muscle strength were investigated using multiple regressions including age, gender, and body mass index...... as covariates. Results. Knee extension strength was associated with computer-controlled PPT on the vastus lateralis muscle. Computer-controlled PPTs were significantly correlated between sites (r > 0.72) and with cuff PPT (r > 0.4). Saline induced pain intensity and duration were correlated between sites (r > 0......Objectives. To investigate associations between muscle strength and pain sensitivity among healthy volunteers and associations between different pain sensitivity measures. Methods. Twenty-eight healthy volunteers (21 females) participated. Pressure pain thresholds (PPTs) were obtained from 1...

  1. Bioavailability of ibuprofen following oral administration of standard ibuprofen, sodium ibuprofen or ibuprofen acid incorporating poloxamer in healthy volunteers

    OpenAIRE

    Dewland, Peter M; Reader, Sandie; Berry, Phillip

    2009-01-01

    Background The aim of this study was to compare the pharmacokinetic properties of sodium ibuprofen and ibuprofen acid incorporating poloxamer with standard ibuprofen acid tablets. Methods Twenty-two healthy volunteers were enrolled into this randomised, single-dose, 3-way crossover, open-label, single-centre, pharmacokinetic study. After 14 hours' fasting, participants received a single dose of 2 × 200 mg ibuprofen acid tablets (standard ibuprofen), 2 × 256 mg ibuprofen sodium dihydrate table...

  2. The haemodynamic effects of intravenous paracetamol (acetaminophen) in healthy volunteers: a double‐blind, randomized, triple crossover trial

    Science.gov (United States)

    Chiam, Elizabeth; Bailey, Michael; McNicol, Larry; Bellomo, Rinaldo

    2016-01-01

    Aim The haemodynamic effects of intravenous paracetamol have not been systematically investigated. We compared the physiological effects of intravenous mannitol‐containing paracetamol, and an equivalent dosage of mannitol, and normal saline 0.9% in healthy volunteers. Methods We performed a blinded, triple crossover, randomized trial of 24 adult healthy volunteers. Participants received i.v. paracetamol (1 g paracetamol +3.91 g mannitol 100 ml–1), i.v. mannitol (3.91 g mannitol 100 ml–1) and i.v. normal saline (100 ml). Composite primary end points were changes in mean arterial pressure (MAP), systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured pre‐infusion, during a 15 min infusion period and over a 45 min observation period. Systemic vascular resistance index (SVRI) and cardiac index were measured at the same time points. Results Infusion of paracetamol induced a transient yet significant decrease in blood pressures from pre‐infusion values (MAP –1.85 mmHg, 95% CI –2.6, –1.1, SBP –0.54 mmHg, 95% CI –1.7, 0.6 and DBP −1.92 mmHg, 95% CI –2.6, –1.2, P paracetamol caused a transient decrease in blood pressure immediately after infusion. These effects were not seen with mannitol or normal saline. The physiological mechanism was consistent with vasodilatation. This study provides plausible physiological data in a healthy volunteer setting, supporting transient changes in haemodynamic variables with i.v. paracetamol and justifies controlled studies in the peri‐operative and critical care setting. PMID:26606263

  3. Lack of interaction between a new antihistamine, mizolastine, and lorazepam on psychomotor performance and memory in healthy volunteers.

    OpenAIRE

    Patat, A; Perault, M C; Vandel, B; Ulliac, N; Zieleniuk, I; Rosenzweig, P

    1995-01-01

    1. The possible interaction between a new H1 antihistamine, mizolastine, and lorazepam was assessed in a randomised, double-blind, cross-over, placebo-controlled study involving 16 healthy young male volunteers who received mizolastine 10 mg or placebo once daily for 8 days with a 1 week wash-out interval. The interaction of mizolastine, at steady-state, with a single oral dose of lorazepam or placebo was assessed on days 6 or 8 of each treatment period. 2. Psychomotor performance and cogniti...

  4. The effect of titrated fentanyl on suppressed cough reflex in healthy adult volunteers.

    Science.gov (United States)

    Kelly, H E; Shaw, G M; Brett, C N; Greenwood, F M; Huckabee, M L

    2016-05-01

    Cough suppression is part of the pharmacodynamic profile of opioids. We investigated the impact of clinical doses of fentanyl on suppressing the cough reflex. Thirteen volunteers received 2 μg.kg(-1) of fentanyl in a divided administration protocol. Three minutes after each administration and at 10 min intervals during washout, suppressed cough reflex testing with nebulised citric acid was performed and compared with fentanyl effect-site concentration. Mean (SD) citric acid concentration provoking cough increased from 0.5 (0.28) mol.l(-1) at baseline to 1.2 (0.50) mol.l(-1) after 2 μg.kg(-1) of fentanyl (p = 0.01). Mean (SD) fentanyl effect-site concentration after the final dose of fentanyl was 1.89 (0.05) ng.ml(-1) . A strong positive correlation was found between suppressed cough reflex thresholds and fentanyl effect-site concentrations during both fentanyl administration and washout phases of the study (r(2) = 0.79, p = 0.01). The mean (SD) length of time for return of suppressed cough response was 44.6 (18.8) min. Clinically relevant doses of fentanyl produced cough reflex suppression in healthy volunteers. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

  5. Brain Magnetic Resonance Elastography on Healthy Volunteers: A Safety Study

    International Nuclear Information System (INIS)

    Guang-Rui Liu; Pei-Yi Gao; Yan Lin; Jing Xue; Xiao-Chun Wang; Bin-Bin Sui; Li Ma; Zhi-Nong Xi; Qin Bai; Hao Shen

    2009-01-01

    Background: Magnetic resonance elastography (MRE) is a recently developed imaging technique that can directly visualize and quantitatively measure tissue elasticity. Purpose: To evaluate the safety of brain MRE on human subjects. Material and Methods: The study included 20 healthy volunteers. MRE sequence scan (drive signal not applied to external force actuator) and MRE study were separately performed on each volunteer at an interval of more than 24 hours. The heart rate and blood pressure of each volunteer were measured immediately before and after MRE sequence scan and MRE study. Electroencephalography (EEG) was also performed within 2 hours after each scan. The volunteers were asked about their experience of the two scans. Randomized-block analysis of variance (ANOVA) was used to analyze the data of blood pressure and heart rate. Paired t test was used to analyze the data of the two EEG examinations. The volunteers were followed up 1 week after the examination. Results: All procedures were performed on each volunteer, and no one complained of obvious discomfort. No related adverse events were reported during follow-up. There was no statistically significant difference in heart rate or blood pressure. There was a statistically significant difference (P<0.05) in EEG results in the right temporoparietal region. Increased power was found in the theta, delta, alpha, and beta2 bands. No brain injury was detected by the EEG examinations. Conclusion: Based on the study results, brain MRE examinations are safe to perform on human subjects

  6. Prevalence of Desloratadine Slow-metabolizer Phenotype and Food-dependent Pharmacokinetics of Desloratadine in Healthy Chinese Volunteers.

    Science.gov (United States)

    Wang, Ting; Zhang, Kun; Li, Tingting; He, Lin; Xie, Huiru; Jiang, Xuehua; Wang, Ling

    2015-12-01

    Desloratadine, the major active metabolite of loratadine, is a non-sedating long-acting antihistamine that is widely used in the treatment of allergic rhinitis and chronic idiopathic urticaria. This study aimed to investigate the prevalence of desloratadine slow-metabolizer (DSM) phenotype and the effects of food on the pharmacokinetics of desloratadine and its active metabolite 3-OH-desloratadine in healthy Chinese volunteers. A total of 46 healthy Chinese male volunteers were included in this investigation. All subjects received a single dose of a 5-mg desloratadine tablet under fasting or fed conditions and the plasma concentrations of desloratadine and 3-OH-desloratadine were measured by liquid chromatography-tandem mass spectrometry. The pharmacokinetic profiles were analyzed using a non-compartmental method in the Phoenix WinNonlin program. The individuals with a 3-OH-desloratadine-to-desloratadine exposure ratio lower than 10 % or a desloratadine half-life (t 1/2) of ≥50 h were supposed to be DSM. There was only one DSM among the 46 volunteers, with a prevalence of 2.2 %. Moreover, administration in a fed state resulted in 34.07 and 32.06 % decreases in maximum plasma concentration and area under the concentration-time curve from time zero to infinity for desloratadine and 47.26 and 48.46 % for 3-OH-desloratadine compared with those values under fasting conditions. Taken together, these results indicated that the incidence of the DSM phenotype in the Chinese population was low and that food intake could significantly decrease the absorption rate and extent of desloratadine.

  7. Acetylsalicylic Acid Daily vs Acetylsalicylic Acid Every 3 Days in Healthy Volunteers: Effect on Platelet Aggregation, Gastric Mucosa, and Prostaglandin E2 Synthesis.

    Science.gov (United States)

    Ferreira, Plinio Minghin Freitas; Gagliano-Jucá, Thiago; Zaminelli, Tiago; Sampaio, Marinalva Ferreira; Blackler, Rory Willian; Trevisan, Miriam da Silva; Novaes Magalhães, Antônio Frederico; De Nucci, Gilberto

    2016-07-01

    Substantial platelet inhibition was observed 3 days after a single administration of acetylsalicylic acid 81 mg to healthy volunteers. Here we investigate prostaglandin E2 (PGE2 ) antrum concentrations and gastrointestinal symptoms in two treatment groups: one receiving losartan and acetylsalicylic acid every day and the other receiving losartan every day and acetylsalicylic acid every 3 days. Twenty-eight healthy volunteers from both sexes received either 50 mg losartan and acetylsalicylic acid 81 mg daily or 50 mg losartan and acetylsalicylic acid 81 every 3 days with placebo on the other days. Therapy was delivered for 30 days for both groups. Gastric endoscopy was performed before and after treatment period. Biopsies were collected for PGE2 quantification. Platelet function tests were carried out before and during treatment and TXB2 release on platelet rich plasma was measured. The every 3 day low-dose acetylsalicylic acid regimen produced complete inhibition of platelet aggregation compared to the daily treatment. Thromboxane B2 release was substantially abolished for both groups during treatment. There was no significant difference on the endoscopic score of both treatment groups after the 30-day treatment (P = .215). There was over 50% suppression of antrum PGE2 content on volunteers receiving acetylsalicylic acid daily (P = .0016), while for the every 3 day dose regimen there was no significant difference between pre and post-treatment antrum PGE2 dosages (P = .4193). Since PGE2 is involved in gastric healing, we understand that this new approach could be safer and as efficient as the standard daily therapy on a long-term basis. © 2015, The American College of Clinical Pharmacology.

  8. Population pharmacokinetics of olprinone in healthy male volunteers

    Directory of Open Access Journals (Sweden)

    Kunisawa T

    2014-03-01

    Full Text Available Takayuki Kunisawa,1 Hidefumi Kasai,2 Makoto Suda,2 Manabu Yoshimura,3 Ami Sugawara,3 Yuki Izumi,3 Takafumi Iida,3 Atsushi Kurosawa,3 Hiroshi Iwasaki3 1Surgical Operation Department, Asahikawa Medical University Hospital, Hokkaido, Japan; 2Clinical Study Management Division, Bell Medical Solutions Inc, Tokyo, Japan; 3Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Hokkaido, Japan Background: Olprinone decreases the cardiac preload and/or afterload because of its vasodilatory effect and increases myocardial contractility by inhibiting phosphodiesterase III. Purpose: The objective of this study was to characterize the population pharmacokinetics of olprinone after a single continuous infusion in healthy male volunteers. Methods: We used 500 plasma concentration data points collected from nine healthy male volunteers for the study. The population pharmacokinetic analysis was performed using the nonlinear mixed effect model (NONMEM® software. Results: The time course of plasma concentration of olprinone was best described using a two-compartment model. The final pharmacokinetic parameters were total clearance (7.37 mL/minute/kg, distribution volume of the central compartment (134 mL/kg, intercompartmental clearance (7.75 mL/minute/kg, and distribution volume of the peripheral compartment (275 mL/kg. The interindividual variability in the total clearance was 12.4%, and the residual error variability (exponential and additive were 22.2% and 0.129 (standard deviation. The final pharmacokinetic model was assessed using a bootstrap method and visual predictive check. Conclusion: We developed a population pharmacokinetic model of olprinone in healthy male adults. The bootstrap method and visual predictive check showed that this model was appropriate. Our results might be used to develop the population pharmacokinetic model in patients. Keywords: phosphodiesterase III inhibitor, men, pharmacokinetic model

  9. Pain perception in healthy volunteers

    DEFF Research Database (Denmark)

    Janum, Susanne; Nielsen, Signe Tellerup; Werner, Mads U

    2016-01-01

    We aimed to study the relationship between pain perception and cytokine release during systemic inflammation. We present a randomized crossover trial in healthy volunteers (n = 17) in 37 individual trials. Systemic inflammation was induced by an i.v. bolus of Escherichia coli LPS (2 ng/kg) on two...... separate trial days, with or without a nicotine patch applied 10 h previously. Pain perception at baseline, and 2 and 6 h after LPS was assessed by pressure algometry and tonic heat stimulation at an increasing temperature (45-48℃) during both trials. Compared with baseline, pain pressure threshold...... was reduced 2 and 6 h after LPS, while heat pain perception was accentuated at all testing temperatures after 2 but not 6 h. The magnitude of changes in pain perception did not correlate to cytokine release. No effect of transdermal nicotine or training status was observed. In conclusion, LPS administration...

  10. Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Ashwinikumar A Raut

    2012-01-01

    Full Text Available Ashwagandha (Withania somnifera (WS, a "rasayana" drug, is recommended for balavardhan and mamsavardhan. The study was intended to evaluate dose-related tolerability, safety, and activity of WS formulation in normal individuals. The design was prospective, open-labeled, variable doses in volunteers. Eighteen apparently healthy volunteers (12M:6F, age:18-30 years, and BMI: 19-30 were enrolled. After baseline investigations, they received WS capsules (Rx (aqueous extract, 8:1 daily in two divided doses with increase in daily dosage every 10 days for 30 days (750 mg/day x10 days, 1 000 mg/day x 10 days, 1 250 mg/day x 10 days. Volunteers were assessed for symptoms/signs, vital functions, hematological and biochemical organ function tests. Muscle activity was measured by hand grip strength, quadriceps strength, and back extensor force. Exercise tolerance was determined using cycle ergometry. Lean body weight and fat% were computed from skin fold thickness measurement. Adverse events were recorded, as volunteered by the subjects. Repeated measures ANOVA, McNemar′s test, and paired t test were employed. All but one volunteer tolerated WS without any adverse event. One volunteer showed increased appetite, libido, and hallucinogenic effects with vertigo at the lowest dose and was withdrawn from study. In six subjects, improvement in quality of sleep was found. Organ function tests were in normal range before and after the intervention. Reduction in total- and LDL- cholesterol and increase of strength in muscle activity was significant. Total body fat percentage showed a reduction trend. WS, in escalated dose, was tolerated well. The formulation appeared safe and strengthened muscle activity. In view of its traditional Rasayana use, further studies are planned to evaluate potential of this drug in patients of sarcopenia.

  11. Effect of Fresh Orange Juice Intake on Physiological Characteristics in Healthy Volunteers

    OpenAIRE

    Asgary, Sedigheh; Keshvari, Mahtab; Afshani, Mohammad Reza; Amiri, Masoud; Laher, Ismail; Javanmard, Shaghayegh Haghjooy

    2014-01-01

    Background. Impaired endothelial function is a predictor of cardiovascular events. Orange juice (OJ) is rich in dietary flavonoids and could inhibit oxidative stress and inflammatory responses. We examined the effects of commercial (COJ) and fresh orange juice (FOJ) on endothelial function and physiological characteristics in healthy humans. Materials and Methods. Twenty-two healthy volunteers years were enrolled in a single blind randomized crossover controlled trial. The two groups consumed...

  12. Age dependent white matter lesions and brain volume changes in healthy volunteers

    DEFF Research Database (Denmark)

    Christiansen, P; Larsson, H B; Thomsen, C

    1994-01-01

    The brain of 142 healthy volunteers aged 21 to 80 years were investigated using MR imaging. The number and size of the white matter hyperintensity lesions (WMHL) in the cerebral hemispheres were determined. Furthermore, the volume of the cerebral hemispheres and of the lateral ventricles was meas......The brain of 142 healthy volunteers aged 21 to 80 years were investigated using MR imaging. The number and size of the white matter hyperintensity lesions (WMHL) in the cerebral hemispheres were determined. Furthermore, the volume of the cerebral hemispheres and of the lateral ventricles...... was measured. An almost linear increase in the number of volunteers with WMHL was seen with aging for males and females. With aging a significant decrease in the volume of the cerebral hemispheres was found for males, and a significant increase in the volume of the lateral ventricles was seen for both males...... and females. Our results suggest that with aging central atrophy increases more (relatively) than cortical atrophy. No correlation was found between the decreasing volume of the cerebral hemispheres and the increasing number and size of WMHL, nor between the increasing volume of the lateral ventricles...

  13. In-vivo Kinetics of Silymarin (Milk Thistle) on Healthy Male Volunteers

    African Journals Online (AJOL)

    ... as the test product while another silymarin tablet brand, Silliver® (Abbott Laboratories Pak Ltd) was the reference product. The tablets were administered to healthy male volunteers orally at a dose of 200 mg following an overnight fast according to a randomized cross-over design. Scheduled blood samples were collected ...

  14. MR elastography study of the brain in healthy volunteers

    International Nuclear Information System (INIS)

    Liu Guangrui; Gao Peiyi; Lin Yan; Wang Xiaochun; Xue Jing; Sui Bingbing; Ma Li; Wang Chen; Shen Mi

    2009-01-01

    Objective: To evaluate the shear stiffness of brain by MR elastography (MRE) in healthy Chinese volunteers and to assess the association between the cerebral shear stiffness and age. Methods: Brain MRE studies were performed on 105 healthy volunteers. The shear stiffness of brain parenchyma was measured by local frequency estimation (LFE) algorithm. The differences of the shear stiffness between white matter (WM) and grey matter (GM) were analyzed by independent sample t test; the differences of brain parenchyma shear stiffness between male and female were estimated by independent sample t test. Spearman test was used to analyze the correlation between age and the shear stiffness of parenchyma; the volunteers were divided into two groups (age ≤40 and age > 40) and the correlation between age and shear stiffness of parenchyma in each group were analyzed separately. Results: The shear stiffness of whiter matter [(23.1±5.7) kPa] was higher than that of grey matter [(11.3±2.6) kPa], and the difference was significant (t=19.34, P 0.05). An age-dependent trend was observed in the stiffness of grey matter (r= 0.315, P 0.05). When the shear stiffness of subjects no more than 40 years old was analysed, the age-dependent trend of shear stiffness was found both in white matter and gray matter (r=0.251, 0.235, P 0.05). Conclusions: The shear stiffness of WM is significantly higher than that of GM. No obvious sex difference was found in the stiffness of brain parenchyma. The shear stiffness of GM increases with age; the age-related increase of shear stiffness of WM was only found in subjects under 40 years old. (authors)

  15. Sufentanil does not increase cerebral blood flow in healthy human volunteers

    International Nuclear Information System (INIS)

    Mayer, N.; Weinstabl, C.; Podreka, I.; Spiss, C.K.

    1990-01-01

    The effect of sufentanil on human cerebral blood flow (CBF) was studied in seven unpremedicated, healthy volunteers 31 +/- 3.5 yr of age (mean +/- SD) and either sex. CBF (ml.100 g-1.min-1) was measured noninvasively with the 133Xe clearance technique and a scintillation camera before and after sufentanil 0.5 micrograms/kg administered intravenously. This technique provides values for global blood flow and for gray and white matter blood flow, and from 13 preselected regions in one hemisphere. After the administration of sufentanil, the volunteers were stimulated verbally in order to prevent their loss of consciousness and hypercarbia. Heart rate (HR), arterial pressure, oxyhemoglobin saturation, and end-tidal CO2 ETCO2 were recorded during the measurements. Neither global CBF (46.1 +/- 1.6 control and 43 +/- 1.9 after sufentanil, mean +/- SEM) nor gray (76.5 +/- 3.2 and 70.9 +/- 6.1) or white (22.7 +/- 1.5 and 24.2 +/- 1.6) matter blood flow changed significantly after sufentanil administration. As well, no significant differences in HR (72 +/- 4 control and 79 +/- 4 beats per min after sufentanil) and ETCO2 (39.8 +/- 1.4 and 41.1 +/- 1.1 mmHg) were observed. It is concluded that sufentanil has no significant effect on CBF in healthy human volunteers

  16. The effect of grape seed extract on the pharmacokinetics of dextromethorphan in healthy volunteers.

    Science.gov (United States)

    Goey, Andrew K L; Meijerman, Irma; Beijnen, Jos H; Schellens, Jan H M

    2013-11-01

    Grape seed extract (GSE) has been shown to inhibit the cytochrome P450 (CYP) 2D6 isoenzyme in vitro. To determine the clinical effect of GSE on CYP2D6, the pharmacokinetic interaction between GSE and the sensitive CYP2D6 probe dextromethorphan in healthy adult volunteers was examined. In this open label, randomized, cross-over study, 30 subjects were assigned to cohort A or B. Both cohorts ingested 30 mg dextromethorphan hydrobromide on day 1 and day 10. Cohort A received 100 mg GSE capsules three times daily on days 8, 9 and 10, while cohort B started with GSE on day -1 until day 1. After urine collection (0-8 h) on day 1 and day 10, the urinary dextromethorphan to dextrorphan metabolic ratio was determined. Among 28 evaluable subjects, an increase of the urinary metabolic ratio was observed in 16 subjects (57 %). The mean metabolic ratio (± standard deviation) before and after GSE supplementation was 0.41 (± 0.56) and 0.48 (± 0.59), respectively. This result was neither statistically (P = 0.342) nor clinically [geometric mean ratio 1.10, 90 % CI (0.93-1.30)] significant. Further, the majority (73 %) of the included subjects did not experience any adverse events after intake of dextromethorphan or GSE. Supplementation of GSE did not significantly affect the urinary dextromethorphan to dextrorphan metabolic ratio in healthy volunteers. The results of this clinical study indicate that GSE appears to be safe to combine with drugs extensively metabolized by CYP2D6, such as dextromethorphan and tamoxifen.

  17. Disposition of nasal, intravenous, and oral methadone in healthy volunteers.

    Science.gov (United States)

    Dale, Ola; Hoffer, Christine; Sheffels, Pamela; Kharasch, Evan D

    2002-11-01

    Nasal administration of many opioids demonstrates rapid uptake and fast onset of action. Nasal administration may be an alternative to intravenous and oral administration of methadone and was therefore studied in human volunteers. The study was approved by the Institutional Review Board of the University of Washington, Seattle. Eight healthy volunteers (6 men and 2 women) aged 19 to 33 years were enrolled after informed written consent was obtained. Subjects received 10 mg methadone hydrochloride nasally, orally, or intravenously on 3 separate occasions in a crossover design. Nasal methadone (50 mg/mL in aqueous solution) was given as a 100-microL spray in each nostril (Pfeiffer BiDose sprayer). Blood samples for liquid chromatography-mass spectrometry analyses of methadone and the metabolite 2-ethyl-1,5-dimethyl-3,3-diphenylpyrrolinium were drawn for up to 96 hours. The methadone effect was measured by noninvasive infrared pupilometry coincident with blood sampling. Nasal uptake of methadone was rapid, with maximum plasma concentrations occurring within 7 minutes. The maximum effects of intravenous, nasal, and oral methadone, on the basis of dark-adapted pupil diameter, were reached in about 15 minutes, 30 minutes, and 2 hours, respectively. The respective durations were 24, 10, and 8 hours. Both nasal and oral bioavailabilities were 0.85. Subjects reported that nasal methadone caused a burning sensation. Nasal administration of methadone results in rapid absorption and onset of effect and high bioavailability, which was greater than that reported for other nasal opioids, with a similar duration of effect. Nasal administration may be an alternative route of methadone administration; however, improved formulations are desirable to reduce nasal irritation.

  18. Albendazole-praziquantel interaction in healthy volunteers: kinetic disposition, metabolism and enantioselectivity

    Science.gov (United States)

    Lima, Renata Monteiro; Ferreira, Maria Augusta Drago; de Jesus Ponte Carvalho, Teresa Maria; Dumêt Fernandes, Bruno José; Takayanagui, Osvaldo Massaiti; Garcia, Hector Hugo; Coelho, Eduardo Barbosa; Lanchote, Vera Lucia

    2011-01-01

    AIM This study investigated the kinetic disposition, metabolism and enantioselectivity of albendazole (ABZ) and praziquantel (PZQ) administered alone and in combination to healthy volunteers. METHODS A randomized crossover study was carried out in three phases (n = 9), in which some volunteers started in phase 1 (400 mg ABZ), others in phase 2 (1500 mg PZQ), and the remaining volunteers in phase 3 (400 mg ABZ + 1500 mg PZQ). Serial blood samples were collected from 0–48 h after drug administration. Pharmacokinetic parameters were calculated using a monocompartmental model with lag time and were analyzed using the Wilcoxon test; P≤ 0.05. RESULTS The administration of PZQ increased the plasma concentrations of (+)-ASOX (albendazole sulphoxide) by 264% (AUC 0.99 vs. 2.59 µg ml−1 h), (−)-ASOX by 358% (0.14 vs. 0.50 µg ml−1 h) and albendazole sulfone (ASON) by 187% (0.17 vs. 0.32 µg ml−1 h). The administration of ABZ did not change the kinetic disposition of (+)-(S)-PZQ (–)-(R)-4-OHPZQ or (+)-(S)-4-OHPZQ, but increased the plasma concentration of (–)-(R)-PZQ by 64.77% (AUC 0.52 vs. 0.86 µg ml−1 h). CONCLUSIONS The pharmacokinetic interaction between ABZ and PZQ in healthy volunteers was demonstrated by the observation of increased plasma concentrations of ASON, both ASOX enantiomers and (–)-(R)-PZQ. Clinically, the combination of ABZ and PZQ may improve the therapeutic efficacy as a consequence of higher concentration of both active drugs. On the other hand, the magnitude of this elevation may represent an increased risk of side effects, requiring, certainly, reduction of the dosage. However, further studies are necessary to evaluate the efficacy and safety of this combination. PMID:21395645

  19. [The enantioselective pharmacokinetic study of desvenlafaxine sustained release tablet in Chinese healthy male volunteers after oral administration].

    Science.gov (United States)

    Chen, Yin-xia; Du, Jiang-bo; Zhang, Yi-fan; Chen, Xiao-yan; Zhong, Da-fang

    2015-04-01

    A chiral LC-MS/MS method for the simultaneous analysis of desvenlafaxine (DVS) enantiomers in human plasma was developed and applied to a pharmacokinetic study on 12 Chinese healthy volunteers. d6-Desvenlafaxine was used as internal standard (IS). Chromatographic separation was performed on the Astec Chirobiotic V chiral column (150 mm x 4.6 mm, 5 μm). The assay was linear over the concentration range of 0.500-150 ng x mL(-1) for both enantiomers (r2 > 0.99). The method was successfully applied to a stereoselective pharmacokinetic study of 100 mg desvenlafaxine sustained release tablets on 12 Chinese healthy volunteers under fasting conditions. The results showed that the pharmacokinetic parameters were similar to both enantiomers in Chinese healthy volunteers. The AUC(0-t), and C(max) of the two enantiomers were about 1.5 times higher than those of blacks and whites reported in the literature.

  20. Hypoglycemic and hypolipidemic activities of crude seeds of Centratherum anthelminticum in healthy volunteers and type 2 diabetic patients.

    Science.gov (United States)

    Mudassir, Hina Akram; Qureshi, Shamim Akhter; Azmi, Muhammad Bilal; Ahsan, Muhammad; Kamran, Musab; Jafar, Sakina

    2018-05-01

    This study first time reports the hypoglycaemic activity of crude seeds powder (CSP) of Centratherum anthelminticum in healthy and type 2 diabetic volunteers. In addition, hypolipidemic effect of same CSP was also determined in healthy volunteers. Healthy individuals were divided into control and two test groups T1 and T2 treated with 200 & 400mg of CSP. Similarly, type 2 diabetic patients were also divided into positive control (PC) treated with metformin 600mg and two test groups DT1 (CSP 400mg + metformin 600mg) & DT2 (CSP 400mg). Each group has 6 individuals and each treatment was done orally. CSP 400mg was found more hypoglycaemic on all time intervals from 30 to 120min when oral glucose tolerance test was conducted in healthy volunteers. Both test quantities of CSP 200 & 400 mg were found successful in same healthy persons in decreasing the levels of triglycerides & total cholesterol (pDT2) -24.99% and -20.62% respectively as compared to diabetic group only treated with metformin (PC), (p<0.01). Therefore, CSP of C antheminticum proves effective hypoglycaemic and hypolipidemic agent by possibly inducing glucose tolerance in healthy individuals and type 2 diabetic patients.

  1. Methylphenidate produces selective enhancement of declarative memory consolidation in healthy volunteers.

    Science.gov (United States)

    Linssen, A M W; Vuurman, E F P M; Sambeth, A; Riedel, W J

    2012-06-01

    Methylphenidate inhibits the reuptake of dopamine and noradrenaline and is used to treat children with attention deficit hyperactivity disorder (ADHD). Besides reducing behavioral symptoms, it improves their cognitive function. There are also observations of methylphenidate-induced cognition enhancement in healthy adults, although studies in this area are relatively sparse. We assessed the possible memory-enhancing properties of methylphenidate. In the current study, the possible enhancing effects of three doses of methylphenidate on declarative and working memory, attention, response inhibition and planning were investigated in healthy volunteers. In a double blind placebo-controlled crossover study, 19 healthy young male volunteers were tested after a single dose of placebo or 10, 20 or 40 mg of methylphenidate. Cognitive performance testing included a word learning test as a measure of declarative memory, a spatial working memory test, a set-shifting test, a stop signal test and a computerized version of the Tower of London planning test. Declarative memory consolidation was significantly improved relative to placebo after 20 and 40 mg of methylphenidate. Methylphenidate also improved set shifting and stopped signal task performance but did not affect spatial working memory or planning. To the best of our knowledge, this is the first study reporting enhanced declarative memory consolidation after methylphenidate in a dose-related fashion over a dose range that is presumed to reflect a wide range of dopamine reuptake inhibition.

  2. Functional MR imaging of the motor cortex in healthy volunteers and patients with brain tumours: qualitative and quantitative results

    International Nuclear Information System (INIS)

    Fellner, C.; Friedrich-Alexander-Univ., Erlangen-Nuernberg; Schlaier, J.; Schwerdtner, J.; Brawanski, A.; Fellner, F.; Oberoesterreichische Landesnervenklinik, Linz; Held, P.; Blank, M.; Kalender, W.A.

    1999-01-01

    The purpose of this study was to compare functional magnetic resonance (MR) imaging of the motor cortex in healthy volunteers and patients with brain tumours. Functional MR imaging was performed in 14 healthy volunteers and 14 patients with tumours in or near the primary motor cortex with groups being matched for age, sex, and handedness. Functional images were acquired during motion of the right and left hand. Time courses of signal intensity within the contralateral, ipsilateral, and supplementary motor cortex as well as z-maps were calculated, their quality being assessed visually. Mean signal increase between activation and rest were evaluated within the contralateral, ipsilateral, and supplementary motor cortex, the activated area in those regions of interest was measured using z-maps. The quality of functional MR experiments was generally lower in patients than in volunteers. The quantitative results showed a trend towards increased ipsilateral activation in volunteers during left hand compared to right hand motion and in patients during motion of the affected compared to the non-affected hand. Considering quantitative and qualitative results, significantly increased ipsilateral activation was found in patients compared to healthy volunteers. In conclusion, functional MR imaging quality was significantly reduced in patient studies compared to healthy volunteers, even if influences of age, sex, and handedness were excluded. Increased ipsilateral activation was found in patients with brain tumours which can be interpreted by an improved connectivity between both hemispheres. (orig.) [de

  3. Exercise increases endostatin in circulation of healthy volunteers

    Directory of Open Access Journals (Sweden)

    Makey Ian

    2004-01-01

    Full Text Available Abstract Background Physical inactivity increases the risk of atherosclerosis. However, the molecular mechanisms of this relation are poorly understood. A recent report indicates that endostatin, an endogenous angiostatic factor, inhibits the progression of atherosclerosis, and suggests that reducing intimal and atherosclerotic plaque tissue neovascularization can inhibit the progression atherosclerosis in animal models. We hypothesize that exercise can elevate the circulatory endostatin level. Hence, exercise can protect against one of the mechanisms of atherosclerosis. Results We examined treadmill exercise tests in healthy volunteers to determine the effect of exercise on plasma levels of endostatin and other angiogenic regulators. Oxygen consumption (VO2 was calculated. Plasma levels of endostatin, vascular endothelial growth factor (VEGF, and basic fibroblast growth factor (bFGF were determined using ELISA. The total peak VO2 (L in 7 male subjects was 29.5 ± 17.8 over a 4–10 minute interval of exercise. Basal plasma levels of endostatin (immediately before exercise were 20.3 ± 3.2 pg/ml, the plasma levels increased to 29.3 ± 4.2, 35.2 ± 1.8, and 27.1 ± 2.2 ng/ml, at 0.5, 2, and 6 h, respectively, after exercise. There was a strong linear correlation between increased plasma levels of endostatin (% and the total peak VO2 (L related to exercise (R2 = 0.9388; P Conclusions The results suggest that circulating endostatin can be significantly increased by exercise in proportion to the peak oxygen consumption under physiological conditions in healthy volunteers. These findings may provide new insights into the molecular links between physical inactivity and the risk of angiogenesis dependent diseases such as atherosclerosis.

  4. LSD enhances suggestibility in healthy volunteers.

    Science.gov (United States)

    Carhart-Harris, R L; Kaelen, M; Whalley, M G; Bolstridge, M; Feilding, A; Nutt, D J

    2015-02-01

    Lysergic acid diethylamide (LSD) has a history of use as a psychotherapeutic aid in the treatment of mood disorders and addiction, and it was also explored as an enhancer of mind control. The present study sought to test the effect of LSD on suggestibility in a modern research study. Ten healthy volunteers were administered with intravenous (i.v.) LSD (40-80 μg) in a within-subject placebo-controlled design. Suggestibility and cued mental imagery were assessed using the Creative Imagination Scale (CIS) and a mental imagery test (MIT). CIS and MIT items were split into two versions (A and B), balanced for 'efficacy' (i.e. A ≈ B) and counterbalanced across conditions (i.e. 50 % completed version 'A' under LSD). The MIT and CIS were issued 110 and 140 min, respectively, post-infusion, corresponding with the peak drug effects. Volunteers gave significantly higher ratings for the CIS (p = 0.018), but not the MIT (p = 0.11), after LSD than placebo. The magnitude of suggestibility enhancement under LSD was positively correlated with trait conscientiousness measured at baseline (p = 0.0005). These results imply that the influence of suggestion is enhanced by LSD. Enhanced suggestibility under LSD may have implications for its use as an adjunct to psychotherapy, where suggestibility plays a major role. That cued imagery was unaffected by LSD implies that suggestions must be of a sufficient duration and level of detail to be enhanced by the drug. The results also imply that individuals with high trait conscientiousness are especially sensitive to the suggestibility-enhancing effects of LSD.

  5. Pharmacokinetics of sugammadex 16 mg/kg in healthy Chinese volunteers.

    Science.gov (United States)

    de Kam, Pieter-Jan; Hou, Jie; Wang, Zaiqi; Lin, Wen Hong; van den Heuvel, Michiel

    2015-06-01

    Elimination of sugammadex occurs predominantly via the kidneys, with the majority of the drug excreted unchanged in the urine. To date, most studies with sugammadex have been performed in non-Asian populations. The objectives of this open-label study were to determine the pharmacokinetics (PK) and safety of single-dose sugammadex (16 mg/kg) in healthy Chinese adult volunteers. 12 Chinese subjects (6 male; 6 female) received intravenous sugammadex (16 mg/kg) as a 10-second bolus infusion. Blood samples were collected pre-sugammadex and at regular intervals up to 24 hours post-sugammadex for PK assessment. Safety was assessed via AEs, vital signs, electrocardiogram, and laboratory parameters. Following sugammadex 16 mg/kg infusion, peak sugammadex concentration was 197 μg/mL, clearance was 99.7 mL/min, and apparent volume of distribution at equilibrium was 10.5 L. Plasma sugammadex concentrations showed a polyexponential decline over time, with an overall geometric mean (CV%) terminal half-life of 145 minutes (17.9%) (139 minutes (17.7%) for males; 152 minutes (18.6%) for females). No influence of gender on the PK of sugammadex was observed. Three subjects experienced an adverse events (AE) (dysgeusia of mild intensity), which was considered possibly or probably related to sugammadex. There were no clinically significant changes in vital signs, electrocardiography or laboratory parameters. PK of sugammadex (16 mg/kg) was characterized in healthy Chinese subjects. Overall between-subject variability on clearance and apparent volume of distribution was ~ 10%. Sugammadex was generally well tolerated.

  6. Pharmacokinetic drug interaction between gemfibrozil and sitagliptin in healthy Indian male volunteers.

    Science.gov (United States)

    K P, Arun; Meda, Venkata Subbaiah; Kucherlapati, V S P Raj; Dubala, Anil; M, Deepalakshmi; P R, Anand VijayaKumar; K, Elango; B, Suresh

    2012-05-01

    To study the impact of gemfibrozil co-administration on the pharmacokinetics of sitagliptin in healthy Indian male volunteers. A randomized open label two-period crossover study involving 12 healthy Indian male volunteers was conducted at a single center. In each phase, the volunteers were administered sitagliptin as 100 mg tablets, either alone or co-administered with gemfibrozil as 600 mg tablets twice daily for 3 days. There was a 2-week washout period between phases. The venous blood samples were serially collected at 0-12 h post-dose, and plasma concentrations of the study drugs were estimated by a validated high-performance liquid chromatography-ultraviolet method. Relative to the administration of sitagliptin alone, co-administration with gemfibrozil increased the AUC₀₋₁₂ (2,167 ± 82.9 vs. 2,970 ± 76.4 ng h/ml; p gemfibrozil, this interaction may not have any clinical significance as sitagliptin has a wide therapeutic index. Hence, in clinical practice, sitagliptin as 100 mg tablets and gemfibrozil as 600 mg tablets may be co-prescribed without much threat of sitagliptin toxicity. However, these results may not hold if the dose of sitagliptin is increased or if is co-prescribed with other antidiabetic drugs and/or cytochrome P450 2C8/human organic anion transporter-3 inhibitors. Further studies are needed to confirm these results in patients.

  7. Unstimulated salivary flow rate, pH and buffer capacity of saliva in healthy volunteers.

    Science.gov (United States)

    Fenoll-Palomares, C; Muñoz Montagud, J V; Sanchiz, V; Herreros, B; Hernández, V; Mínguez, M; Benages, A

    2004-11-01

    To assess the salivary flow rate, pH, and buffer capacity of healthy volunteers, and their relationships with age, gender, obesity, smoking, and alcohol consumption, and to establish the lower-end value of normal salivary flow (oligosialia). A prospective study was conducted in 159 healthy volunteers (age > 18 years, absence of medical conditions that could decrease salivary flow). Unstimulated whole saliva was collected during ten minutes, and salivary flow rate (ml/min), pH, and bicarbonate concentration (mmol/l) were measured using a Radiometer ABL 520. The 5 percentile of salivary flow rate and bicarbonate concentration was considered the lower limit of normality. Median salivary flow rate was 0.48 ml/min (range: 0.1-2 ml/min). Age younger than 44 years was associated with higher flow rates (OR 2.10). Compared with women, men presented a higher flow rate (OR 3.19) and buffer capacity (OR 2.81). Bicarbonate concentration correlated with salivary flow rate. The lower-end values of normal flow rate and bicarbonate concentration were 0.15 ml/min and 1.800 mmol/l, respectively. The presence of obesity, smoking, and alcohol consumption did not influence salivary parameters. In healthy volunteers, salivary flow rate depends on age and gender, and correlates with buffer capacity. Obesity, smoking, and alcohol use do not influence salivary secretion.

  8. Associations between personality traits and CCK-4-induced panic attacks in healthy volunteers.

    Science.gov (United States)

    Tõru, Innar; Aluoja, Anu; Võhma, Ulle; Raag, Mait; Vasar, Veiko; Maron, Eduard; Shlik, Jakov

    2010-07-30

    In this study we examined how personality disposition may affect the response to cholecystokinin tetrapeptide (CCK-4; 50 microg) challenge in healthy volunteers (n=105). Personality traits were assessed with the Swedish universities Scales of Personality (SSP). Statistical methods employed were correlation analysis and logistic regression. The results showed that the occurrence of CCK-4-induced panic attacks was best predicted by baseline diastolic blood pressure, preceding anxiety and SSP-defined traits of lack of assertiveness, detachment, embitterment and verbal aggression. Significant interactions were noted between the above mentioned variables, modifying their individual effects. For different subsets of CCK-4-induced symptoms, the traits of physical aggression, irritability, somatic anxiety and stress susceptibility also appeared related to panic manifestations. These findings suggest that some personality traits and their interactions may influence vulnerability to CCK-4-induced panic attacks in healthy volunteers. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

  9. Effect of calyx capsule-ethanol extract Hibiscus sabdariffa L. on renal function of healthy volunteers

    Science.gov (United States)

    Harun, N.; Darmawan, E.; Nurani, L. H.

    2017-11-01

    Hibiscus sabdariffa contains flavonoid, triterpenoid, anthocyanin which function as immunostimulant. H. sabdariffa is considered safe for animal renal; nonetheless, there are known side effects of which need to be further investigated for human renal. This research aims to investigate the effect of calyx capsule-ethanol extract H. sabdariffa for renal function of healthy male and female for 30 days period by monitoring Scr and Clcr component in their blood samples. The method of this experimental research was by pre and post-treatment by involving 20 healthy volunteers who have met inclusion and exclusion criteria. The volunteers have completed the informed consent for this experiment. Furthermore, volunteers were divided into two groups (10 male and 10 female). Each group was given orally 500 mg of calyx capsule-ethanol extract H. sabdariffa per day for 30 days period. Blood tests were taken on day 0, day 30 after consuming the capsule and day 45 (15 days after the last day of capsule intake) in order to measure the Scr and Clcr concentration in the blood samples by using Jaffe dan Cockcroft-Gault method. The results of each sampling day were further analyzed statistically and compared using Repeated ANOVA dan Friedman test. The results suggest that there was a difference in the renal function on day 0, 30 and 45 samplings. However, there was no significant difference in Scr dan Clcr concentrations on female and male volunteers (p>0.05). Specifically, the type of gender affects Scr concentration (p0.05). In addition, age and Body Mass Index (BMI) does not affect Scr and Clcr concentrations (p>0.05). The side effects discovered through the monitoring increased in mixturition and bloatedness. Calyx capsule-ethanol extract H. sabdariffa does not affect on renal function of healthy volunteers.

  10. Opioid-induced bowel dysfunction in healthy volunteers assessed with questionnaires and MRI

    DEFF Research Database (Denmark)

    Nilsson, Matias; Poulsen, Jakob Lykke; Brock, Christina

    2016-01-01

    Twenty-five healthy men were assigned randomly to oxycodone or placebo for 5 days in a cross-over design. The analgesic effect was assessed with muscle pressure algometry and adverse effects were measured using questionnaires including the bowel function index, gastrointestinal symptom rating scale....../ascending colon by 41% (P =0.005) and in the transverse colon by 20% (P= 0.005). No associations were detected between questionnaire scores and colorectal volumes. Conclusion Experimental OIBD in healthy volunteers was induced during oxycodone treatment. This model has potential for future interventional studies...

  11. Moringa Oleifera leaf extract increases plasma antioxidant status associated with reduced plasma malondialdehyde concentration without hypoglycemia in fasting healthy volunteers.

    Science.gov (United States)

    Ngamukote, Sathaporn; Khannongpho, Teerawat; Siriwatanapaiboon, Marent; Sirikwanpong, Sukrit; Dahlan, Winai; Adisakwattana, Sirichai

    2016-12-29

    To investigate the effect of Moringa Oleifera leaf extract (MOLE) on plasma glucose concentration and antioxidant status in healthy volunteers. A randomized crossover design was used in this study. Healthy volunteers were randomly assigned to receive either 200 mL of warm water (10 cases) or 200 mL of MOLE (500 mg dried extract, 10 cases). Blood samples were drawn at 0, 30, 60, 90, and 120 min for measuring fasting plasma glucose (FPG), ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC) and malondialdehyde (MDA). FPG concentration was not signifificantly different between warm water and MOLE. The consumption of MOLE acutely improved both FRAP and TEAC, with increases after 30 min of 30 μmol/L FeSO 4 equivalents and 0.18 μmol/L Trolox equivalents, respectively. The change in MDA level from baseline was signifificantly lowered after the ingestion of MOLE at 30, 60, and 90 min. In addition, FRAP level was negatively correlated with plasma MDA level after an intake of MOLE. MOLE increased plasma antioxidant capacity without hypoglycemia in human. The consumption of MOLE may reduce the risk factors associated with chronic degenerative diseases.

  12. Influence of ondansetron on gastric sensorimotor responses to short duodenal acid infusion in healthy volunteers.

    Science.gov (United States)

    Vanuytsel, T; Karamanolis, G; Van Oudenhove, L; Oudenhove, L V; Vos, R; Tack, J

    2011-03-01

    Duodenal acid infusion induces gastric relaxation and sensitization to distension in healthy volunteers. The acid-sensitive mechanism is still unknown. We hypothesized that 5HT(3)-blockade can inhibit the acid-induced duodenogastric sensorimotor reflex in healthy volunteers. Fourteen healthy volunteers were included in a randomized, double-blind placebo-controlled cross-over trial. An infusion tube with attached pH-electrode was positioned in the duodenum and a barostat balloon was located in the gastric fundus. Proximal gastric volume and sensitivity to distension were assessed before and during duodenal acid infusion and after pretreatment with intravenous (i.v.) ondansetron (a 5HT(3)-receptor antagonist, 8 mg) or saline. An overall perception score (0-6) and an assessment of nine dyspeptic symptoms by visual analogue scales (VAS) were obtained. Results are given as mean ± SEM. Ondansetron had no effect on duodenal pH and on the acid-induced increase of proximal gastric volume (increase of 80 ± 20 vs 83 ± 15 mL after ondansetron and placebo; effect of acid acid infusion and gastric distension. 5HT(3)-receptors are involved in acid-induced duodenogastric sensitization, but not in the duodenogastric inhibitory motor reflex. © 2010 Blackwell Publishing Ltd.

  13. Shirodhara : A psycho-physiological profile in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Kalpana D Dhuri

    2013-01-01

    Full Text Available Background: Shirodhara is a classical and a well-established ayurvedic procedure of slowly and steadily dripping medicated oil or other liquids on the forehead. This procedure induces a relaxed state of awareness that results in a dynamic psycho-somatic balance. Objectives: The objective of the study is to evaluate the psychological and physiological effects of Shirodhara in healthy volunteers by monitoring the rating of mood and levels of stress, electrocardiogram (ECG, electroencephalogram (EEG, and selected biochemical markers of stress. Materials and Methods: The study was conducted in the human pharmacology laboratory. The study design was open labeled, comparing the baseline variables with values after Shirodhara. The subjects (n = 16 chosen were healthy human volunteers who gave an informed consent. Shirodhara was preceded by Abhyanga - whole body massage. The Shirodhara method was standardized for rate of dripping with peristaltic pump and temperature was controlled with a thermostat. Mood and stress levels were assessed by validated rating scales. The pre- and post-Shirodhara ECG and EEG records were evaluated. Results: Student′s paired "t" test was applied to the means + SE of the variables to calculate statistical significance at P <0.05. There was a significant improvement in mood scores and the level of stress (P <0.001. These changes were accompanied by significant decrease in rate of breathing and reduction in diastolic blood pressure along with reduction in heart rate. The relaxed alert state, after Shirodhara, was co-related with an increase in alfa rhythm in EEG. Conclusion : A standardized Shirodhara leads to a state of alert calmness similar to the relaxation response observed in meditation. The clinical benefits observed with Shirodhara in anxiety neurosis, hypertension, and stress aggravation due to chronic degenerative diseases could be mediated through these adaptive physiological effects.

  14. Effect of an acidic beverage (Coca-Cola) on the pharmacokinetics of carbamazepine in healthy volunteers.

    Science.gov (United States)

    Malhotra, S; Dixit, R K; Garg, S K

    2002-01-01

    The effect of an acidic beverage (Coca-Cola) on the pharmacokinetics of a single dose of carbamazepine was studied. In a two-way cross-over design with a 1 week washout period, 10 healthy volunteers were randomized to received 200 mg carbamazepine orally with 300 ml of Coca-Cola or water. Blood samples were collected at 0, 0.5, 1, 2, 3, 6, 9, 12, 24, 48 and 72 h after drug administration. Plasma carbamazepine levels were higher with Coca-Cola as compared to water. The AUC0-infinity and Cmax of carbamazepine were significantly enhanced after Coca-Cola while tmax was achieved earlier with Coca-Cola. The results of the study indicate that concomitant administration of Coca-Cola enhances the rate and extent of absorption of carbamazepine.

  15. Pharmacokinetics and Bioavailability of Inhaled Esketamine in Healthy Volunteers.

    Science.gov (United States)

    Jonkman, Kelly; Duma, Andreas; Olofsen, Erik; Henthorn, Thomas; van Velzen, Monique; Mooren, René; Siebers, Liesbeth; van den Beukel, Jojanneke; Aarts, Leon; Niesters, Marieke; Dahan, Albert

    2017-10-01

    Esketamine is traditionally administered via intravenous or intramuscular routes. In this study we developed a pharmacokinetic model of inhalation of nebulized esketamine with special emphasis on pulmonary absorption and bioavailability. Three increasing doses of inhaled esketamine (dose escalation from 25 to 100 mg) were applied followed by a single intravenous dose (20 mg) in 19 healthy volunteers using a nebulizer system and arterial concentrations of esketamine and esnorketamine were obtained. A multicompartmental pharmacokinetic model was developed using population nonlinear mixed-effects analyses. The pharmacokinetic model consisted of three esketamine, two esnorketamine disposition and three metabolism compartments. The inhalation data were best described by adding two absorption pathways, an immediate and a slower pathway, with rate constant 0.05 ± 0.01 min (median ± SE of the estimate). The amount of esketamine inhaled was reduced due to dose-independent and dose-dependent reduced bioavailability. The former was 70% ± 5%, and the latter was described by a sigmoid EMAX model characterized by the plasma concentration at which absorption was impaired by 50% (406 ± 46 ng/ml). Over the concentration range tested, up to 50% of inhaled esketamine is lost due to the reduced dose-independent and dose-dependent bioavailability. We successfully modeled the inhalation of nebulized esketamine in healthy volunteers. Nebulized esketamine is inhaled with a substantial reduction in bioavailability. Although the reduction in dose-independent bioavailability is best explained by retention of drug and particle exhalation, the reduction in dose-dependent bioavailability is probably due to sedation-related loss of drug into the air.

  16. Effect of a high dose of simvastatin on muscle mitochondrial metabolism and calcium signaling in healthy volunteers

    International Nuclear Information System (INIS)

    Galtier, F.; Mura, T.; Raynaud de Mauverger, E.; Chevassus, H.; Farret, A.; Gagnol, J.-P.; Costa, F.; Dupuy, A.

    2012-01-01

    Statin use may be limited by muscle side effects. Although incompletely understood to date, their pathophysiology may involve oxidative stress and impairments of mitochondrial function and of muscle Ca 2+ homeostasis. In order to simultaneously assess these mechanisms, 24 male healthy volunteers were randomized to receive either simvastatin for 80 mg daily or placebo for 8 weeks. Blood and urine samples and a stress test were performed at baseline and at follow-up, and mitochondrial respiration and Ca 2+ spark properties were evaluated on a muscle biopsy 4 days before the second stress test. Simvastatin-treated subjects were separated according to their median creatine kinase (CK) increase. Simvastatin treatment induced a significant elevation of aspartate amino transferase (3.38 ± 5.68 vs − 1.15 ± 4.32 UI/L, P 2+ sparks. However, among statin-treated subjects, those with the highest CK increase displayed a significantly lower Vmax rotenone succinate and an increase in Ca 2+ spark amplitude vs both subjects with the lowest CK increase and placebo-treated subjects. Moreover, Ca 2+ spark amplitude was positively correlated with treatment-induced CK increase in the whole group (r = 0.71, P = 0.0045). In conclusion, this study further supports that statin induced muscular toxicity may be related to alterations in mitochondrial respiration and muscle calcium homeostasis independently of underlying disease or concomitant medication. -- Highlights: ► Statin use may be limited by side effects, particularly myopathy. ► Statins might impair mitochondrial function and muscle Ca2+ signaling in muscle. ► This was tested among healthy volunteers receiving simvastatin 80 mg daily for 8 weeks. ► CK increase was associated with alterations in Ca2+ sparks and mitochondrial function.

  17. Quantitative thallium-201 scintigraphy after dipyridamole infusion combined with low level exercise in healthy volunteers

    International Nuclear Information System (INIS)

    Laarman, G.J.; Niemeyer, M.G.; Ascoop, C.A.P.L.; Bruschke, A.V.G.; Wall, E.E. van der; Verzijlbergen, F.J.; Liam Go, T.

    1989-01-01

    To establish test specific normal limits for quantitative analysis of uptake and washout of 201 Tl after dipyridamole infusion combined with low level exercise, 20 healthy volunteers were studied with low likelihood of coronary artery disease (CAD) assessed by a stepwise probability analysis based on age, sex, symptoms, resting electrocardiogram, and exercise electrocardiography. Likelihood of CAD in these volunteers was calculated as ≤ 1%. After dipyridamole infusion combined with low level exercise, one volunteer complained of headache; no other side effects were observed. There were no chest pain complaints. Maximal hemodynamic changes were achieved during the 6th and 7th min of the test. No ST segment depression was recorded. Visual analysis of the 201 Tl scintigrams was normal in all volunteers. Mean regional washout at 4 h was 44.37%±2.11%. The regional washout in the 70 0 LAO view (46.65%±1.10%) was significantly higher than in the anterior and 30 0 LAO views (43.44%±1.50% and 43.02%±1.45%, respectively). Profiles of uptake and washout of 201 Tl were different after dipyridamole infusion combined with low level exercise as compared to maximal exercise. Thus, in quantitative analysis of 201 Tl scintigraphy after dipyridamole infusion in conjunction with low level exercise as applied in the present study, it is mandatory to use normal limits of uptake and washout of 201 Tl derived from healthy volunteers who underwent the same combined protocol. (orig.)

  18. The effects of Andrographis paniculata (Burm.f. Nees on the pharmacokinetics and pharmacodynamics of midazolam in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Malinee Wongnawa

    2012-11-01

    Full Text Available Andrographis paniculata (Burm.f. Nees has been widely used for centuries in Asia for the treatment of common coldand diarrhea. Although it was previously reported to inhibit cytochrome P450 in vitro, the potential to cause herb-druginteraction has been questioned. The purpose of this study was to evaluate the effects of A. paniculata on the pharmacokineticsand pharmacodynamics of midazolam, a CYP3A4 probe drug, in normal healthy volunteers. The study was anopen-label, randomized, 2-phase crossover design with a 2-weeks washout period. Twelve healthy male volunteers received4 capsules of 250 mg A. paniculata 3 times a day orally for 7 days. Midazolam plasma concentration time profiles werecharacterized after a single oral dose of 7.5 mg midazolam on the day before and after A. paniculata medication. Pharmacodynamicsof midazolam were also evaluated. The results demonstrated that pretreatment with A. paniculata did not changemean pharmacokinetic parameters (Cmax, Tmax, AUC0-12, AUC0-”, T1/2, Cl/F of oral midazolam. Since midazolam is the mostsensitive substrate for CYP3A4, thus, herb-drug interaction caused by CYP3A4 inhibition after A. paniculata in healthyvolunteers was considered not clinically relevant. However, A. paniculata potentiated the effect of midazolam in loweringblood pressure and pulse rate. Therefore, co-administration of A. paniculata with midazolam should be warranted.

  19. Bioavailability of four oral Coenzyme Q formulations in healthy volunteers

    DEFF Research Database (Denmark)

    Weis, M.; Mortensen, S.A.; Rassing, M.R.

    1994-01-01

    The bioavailability of four different Coenzyme Q (CoQ) formulations was compared in ten healthy volunteers in a four-way randomised cross-over trial. The included formulations were: A hard gelatine capsule containing 100 mg of CoQ and 400 mg of Emcompress. Three soft gelatine capsules containing......Q (Bioquinon has the highest bioavailability. A difference in basic AUC and AUC after p.o.administration of CoQ was observed with respect to sex. A characteristic two peak-pattern was observed at the concentration-time profile....

  20. Quantitative assessment of the microcirculation in healthy volunteers and in patients with septic shock

    NARCIS (Netherlands)

    Edul, Vanina S. Kanoore; Enrico, Carolina; Laviolle, Bruno; Vazquez, Alejandro Risso; Ince, Can; Dubin, Arnaldo

    2012-01-01

    The microcirculation of septic patients has been characterized only semiquantitatively. Our goal was to characterize the sublingual microcirculation in healthy volunteers and patients with septic shock quantitatively. Our hypotheses were that 1) hyperdynamic blood flow is absent in septic shock; 2)

  1. Verbal learning in schizopsychotic outpatients and healthy volunteers as a function of cognitive performance levels.

    Science.gov (United States)

    Karilampi, Ulla; Helldin, Lars; Hjärthag, Fredrik; Norlander, Torsten; Archer, Trevor

    2007-02-01

    The aim was to analyze and compare neurocognitive test profiles related to different levels of verbal learning performance among schizopsychotic patients and healthy volunteers. A single-center patient cohort of 196 participants was compared with an equal-sized volunteer group to form three cognitive subgroups based on the shared verbal learning performance. 43.9% of the patients had normal learning ability. Despite this, all patients underperformed the volunteers on all subtests with the exception of working memory, and, for those with high learning ability, even verbal facility. All patients also presented equally poor visuomotor processing speed/efficacy. A global neurocognitive retardation of speed-related processing in schizophrenia is suggested.

  2. Effects of sibutramine alone and with alcohol on cognitive function in healthy volunteers

    Science.gov (United States)

    Wesnes, K A; Garratt, C; Wickens, M; Gudgeon, A; Oliver, S

    2000-01-01

    Aims To investigate the effects of sibutramine in combination with alcohol in a double-blind, randomised, placebo-controlled, four-way crossover study in 20 healthy volunteers. Methods On each study day each volunteer received either: sibutramine 20 mg+0.5 g kg−1 alcohol; sibutramine 20 mg+placebo alcohol; placebo capsules+0.5 g kg−1 alcohol; or placebo capsules+placebo alcohol. Alcohol was administered 2 h following ingestion of the study capsules. During each study day, assessments of cognitive performance were made prior to dosing, and at 3, 4.5, 6 and 10 h post dosing. Blood alcohol concentration was estimated using a breath alcometer immediately prior to each cognitive performance test session. Each study day was followed by a minimum 7 day washout period. Results Alcohol was found to produce statistically significant impairments in tests of attention (maximum impairment to speed of digit vigilance=49 ms) and episodic memory (maximum impairment to speed of word recognition=74 ms). Alcohol also increased body sway (maximum increase 17.4 units) and lowered self rated alertness (maximum decrease 13.6 mm). These effects were produced by an inferred blood alcohol level of 53.2 mg dl−1.Sibutramine was not found to potentiate any of the effects of alcohol. There was a small, yet statistically significant, interaction effect observed on the sensitivity index of the picture recognition task. In this test, the combined effects of sibutramine and alcohol were smaller than the impairments produced by alcohol alone. Sibutramine, when dosed alone, was associated with improved performance on several tasks. Sibutramine improved attention (mean speed of digit vigilance improved by 21 ms), picture recognition speed (improvement at 3=81) and motor control (tracking error at 3 h reduced by 1.58 mm). Also sibutramine improved postural stability (reducing body sway at 3 h by 14.2 units). Adverse events reported were unremarkable and consistent with the known pharmacology of

  3. Bright-light intervention induces a dose-dependent increase in striatal response to risk in healthy volunteers

    DEFF Research Database (Denmark)

    Macoveanu, Julian; Fisher, Patrick M; Madsen, Martin K

    2016-01-01

    Bright-light interventions have successfully been used to reduce depression symptoms in patients with seasonal affective disorder, a depressive disorder most frequently occurring during seasons with reduced daylight availability. Yet, little is known about how light exposure impacts human brain...... function, for instance on risk taking, a process affected in depressive disorders. Here we examined the modulatory effects of bright-light exposure on brain activity during a risk-taking task. Thirty-two healthy male volunteers living in the greater Copenhagen area received 3weeks of bright......-light intervention during the winter season. Adopting a double-blinded dose-response design, bright-light was applied for 30minutes continuously every morning. The individual dose varied between 100 and 11.000lx. Whole-brain functional MRI was performed before and after bright-light intervention to probe how...

  4. Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

    Science.gov (United States)

    Roberts, Laura Weiss; Kim, Jane Paik

    2014-09-01

    Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical

  5. Exercise increases endostatin in circulation of healthy volunteers.

    Science.gov (United States)

    Gu, Jian-Wei; Gadonski, Giovani; Wang, Julie; Makey, Ian; Adair, Thomas H

    2004-01-16

    Physical inactivity increases the risk of atherosclerosis. However, the molecular mechanisms of this relation are poorly understood. A recent report indicates that endostatin, an endogenous angiostatic factor, inhibits the progression of atherosclerosis, and suggests that reducing intimal and atherosclerotic plaque tissue neovascularization can inhibit the progression atherosclerosis in animal models. We hypothesize that exercise can elevate the circulatory endostatin level. Hence, exercise can protect against one of the mechanisms of atherosclerosis. We examined treadmill exercise tests in healthy volunteers to determine the effect of exercise on plasma levels of endostatin and other angiogenic regulators. Oxygen consumption (VO2) was calculated. Plasma levels of endostatin, vascular endothelial growth factor (VEGF), and basic fibroblast growth factor (bFGF) were determined using ELISA. The total peak VO2 (L) in 7 male subjects was 29.5 +/- 17.8 over a 4-10 minute interval of exercise. Basal plasma levels of endostatin (immediately before exercise) were 20.3 +/- 3.2 pg/ml, the plasma levels increased to 29.3 +/- 4.2, 35.2 +/- 1.8, and 27.1 +/- 2.2 ng/ml, at 0.5, 2, and 6 h, respectively, after exercise. There was a strong linear correlation between increased plasma levels of endostatin (%) and the total peak VO2 (L) related to exercise (R2 = 0.9388; P < 0.01). Concurrently, VEGF levels decreased to 28.3 +/- 6.4, 17.6 +/- 2.4, and 26.5 +/- 12.5 pg/ml, at 0.5, 2, and 6 h, respectively, after exercise. There were no significant changes in plasma bFGF levels in those subjects before and after exercise. The results suggest that circulating endostatin can be significantly increased by exercise in proportion to the peak oxygen consumption under physiological conditions in healthy volunteers. These findings may provide new insights into the molecular links between physical inactivity and the risk of angiogenesis dependent diseases such as atherosclerosis.

  6. Allium sativum L. Improves Visual Memory and Attention in Healthy Human Volunteers

    Science.gov (United States)

    Tasnim, Sara; Haque, Parsa Sanjana; Bari, Md. Sazzadul; Hossain, Md. Monir; Islam, Sardar Mohd. Ashraful; Shahriar, Mohammad; Bhuiyan, Mohiuddin Ahmed; Bin Sayeed, Muhammad Shahdaat

    2015-01-01

    Studies have shown that Allium sativum L. (AS) protects amyloid-beta peptide-induced apoptosis, prevents oxidative insults to neurons and synapses, and thus prevent Alzheimer's disease progression in experimental animals. However, there is no experimental evidence in human regarding its putative role in memory and cognition. We have studied the effect of AS consumption by healthy human volunteers on visual memory, verbal memory, attention, and executive function in comparison to control subjects taking placebo. The study was conducted over five weeks and twenty volunteers of both genders were recruited and divided randomly into two groups: A (AS) and B (placebo). Both groups participated in the 6 computerized neuropsychological tests of the Cambridge Neuropsychological Test Automated Battery (CANTAB) twice: at the beginning and after five weeks of the study. We found statistically significant difference (p 0.05) beneficial effects on verbal memory and executive function within a short period of time among the volunteers. Study for a longer period of time with patients suffering from neurodegenerative diseases might yield more relevant results regarding the potential therapeutic role of AS. PMID:26351508

  7. Steady-state pharmacokinetics of metformin is independent of the OCT1 genotype in healthy volunteers

    DEFF Research Database (Denmark)

    Christensen, Mette Marie Hougaard; Højlund, Kurt; Hother-Nielsen, Ole

    2015-01-01

    PURPOSE: The aim of the study was to determine the steady-state pharmacokinetics of metformin in healthy volunteers with different numbers of reduced-function alleles in the organic cation transporter 1 gene (OCT1). METHODS: The study was conducted as part of a randomized cross-over trial. Thirty......-four healthy volunteers with known OCT1 genotypes (12 with two wild-type alleles, 13 with one and 9 with two reduced-function alleles) were included. In one of the study periods, they were titrated to steady-state with 1 g metformin twice daily. RESULTS: Neither AUC(0-12), C(max) nor Cl(renal) were...... statistically significantly affected by the number of reduced-function alleles (0, 1 or 2) in OCT1: (AUC(0-12): 0, 1, 2: 14, 13 and 14 h ng/L (P = 0.61)); (C(max): 0, 1, 2: 2192, 1934 and 2233 ng/mL, (P = 0.26)) and (Cl(renal): 0, 1, 2: 31, 28 and 30 L/h (P = 0.57)) CONCLUSIONS: In a cohort of healthy...

  8. Reproducibility of urodynamic filling sensation at weekly interval in healthy volunteers and in women with detrusor overactivity.

    Science.gov (United States)

    Van Meel, Tom David; Wyndaele, Jean-Jacques

    2011-11-01

    To evaluate the reproducibility of bladder sensation during standardized filling cystometry in female volunteers and overactive bladder (OAB) patients, repeated with weekly interval. We recruited 13 female nulliparous volunteers (age 21-47) and 17 female patients with OAB between (age 18-72). They participated in three investigation periods, each separated by 7 days to assess reproducibility of sensation related to standardized cystometry. Subjects were asked to report all sensations they felt during bladder filling. The previously described pattern of sensation was reported during bladder filling in all. Consecutive sensations corresponded to statistically higher bladder volumes. Volumes, at which different sensations of bladder filling were reported, were significantly higher in controls than in OAB patients [first sensation of filling (FSF) P = 0.003, first desire to void (FDV) P sensation/volume ratios were significantly higher in patients with OAB than in the healthy volunteers: FSF occurred at mean 46% and FDV at mean 73% of SDV in OAB patients, compared to 36% and 64% in healthy volunteers. Sensations proved highly reproducible when determined with weekly interval. Our data demonstrate that cystometric filling sensation determined in a standardized way with weekly interval is highly reproducible in healthy and in OAB patients. This finding has, in our opinion, clinical importance as it shows that the technique is reliable both for a sensory evaluation of the LUT as to study influence of treatment aimed at changing this sensation. Copyright © 2011 Wiley Periodicals, Inc.

  9. Effect of tumor necrosis factor-alpha infusion on the incretin effect in healthy volunteers

    DEFF Research Database (Denmark)

    Nielsen, Signe Tellerup; Lehrskov-Schmidt, Louise; Krogh-Madsen, Rikke

    2013-01-01

    Type 2 diabetes mellitus (T2DM) is associated with peripheral insulin resistance, impaired incretin effect, and increased plasma levels of tumor necrosis factor-alpha (TNF-α). Whereas TNF-α infusion at a dose that induces systemic inflammation in healthy volunteers has been demonstrated to induce...

  10. Pharmacokinetic and bioequivalence study of itopride HCl in healthy volunteers.

    Science.gov (United States)

    Cho, Kyung-Jin; Cho, Wonkyung; Cha, Kwang-Ho; Park, Junsung; Kim, Min-Soo; Kim, Jeong-Soo; Hwang, Sung-Joo

    2010-01-01

    In the present study two different formulations containing 50 mg itopride HCl (N-[4-12-(dimethylamino)ethoxylbenzyl]-3,4-dimethoxybenzamide HCl, CAS 122898-67-3) were compared in 28 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, crossover design in 28 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 24 h. The serum concentrations of itopride HCl were determined using a specific and sensitive HPLC method with fluorescence detection. The detection limit of itopride HCl was 5 ng/ml and no endogenous compounds were found to interfere with analysis. The mean AUC(0-4h), AUC(0 --> infinity), C(max), T(max) and T1/2 were 865.28 ng x h/ml, 873.04 ng x h/ml, 303.72 ng/ml, 0.75 h, and 2.95 h, respectively, for the test formulations, and 833.00 ng x h/ml, 830.97 ng x h/ml, 268.01 ng/ml, 0.78 h, and 2.83 h, respectively, for the reference formulation. Both primary target parameters AUC(0 --> infinity) and C(max) were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of AUC(0 --> infinity) and C(max) were 100.57%-109.56% and 105.46%-121.18%, respectively, and were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of itopride HCl are considered to be bioequivalent.

  11. Comparison of antiplatelet activity of garlic tablets with cardio-protective dose of aspirin in healthy volunteers: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mojtaba Shafiekhani

    2016-08-01

    Full Text Available Objective: Some of the adverse effects of aspirin including peptic ulcers, gastrointestinal bleeding and aspirin resistance compelled researchers to find a suitable alternative with fewer adverse effects. In this clinical trial, we aimed to find the effective antiplatelet dose of garlic. Materials and Methods: This randomized controlled clinical trial (RCT was conducted on 62 healthy volunteers of 20-50 years old. All volunteers used 80 mg aspirin per day for 1 week and at the end of this time, platelet aggregation (PA induced by 4 agonists acting in aggregation pathway including adenosinediphosphate (20 μmol/l, epinephrine (20 μmol/l, collagen(0.19 mg/ ml and arachidonic acid (0.5mg/ ml was measured by Light Transmittance Aggregometry (LTA in all participants. After one month washout period, volunteers were randomized into 3 groups and each received 1, 2 or 3 garlic tablets (1250 mg a day for 1 month. After one month, PA was examined in all groups. Results: The mean ±SD of the age of all volunteers was 28.60 ± 9.00 years. In addition, 52.00 % of our volunteers were male and 48.00% of them were female. Garlic tablet didnot have significant effect on PA at any dose. However, 30% of volunteers in the group that used 3 garlic tablets/day reported adverse effect (i.e. bleeding. No significant association between sex, age and PA was observed. Conclusion:  In this study, we were unable to determine the effective anti-platelet dose of garlic which that could be equal to that of aspirin anti-platelet activity, as assessed LTA method.

  12. Effect of venous and lymphatic congestion on lymph capillary pressure of the skin in healthy volunteers and patients with lymph edema.

    Science.gov (United States)

    Gretener, S B; Läuchli, S; Leu, A J; Koppensteiner, R; Franzeck, U K

    2000-01-01

    The aim of the present study was to assess the influence of venous and lymphatic congestion on lymph capillary pressure (LCP) in the skin of the foot dorsum of healthy volunteers and of patients with lymph edema. LCP was measured at the foot dorsum of 12 patients with lymph edema and 18 healthy volunteers using the servo-nulling technique. Glass micropipettes (7-9 microm) were inserted under microscopic control into lymphatic microvessels visualized by fluorescence microlymphography before and during venous congestion. Venous and lymphatic congestion was attained by cuff compression (50 mm Hg) at the thigh level. Simultaneously, the capillary filtration rate was measured using strain gauge plethysmography. The mean LCP in patients with lymph edema increased significantly (p < 0.05) during congestion (15.7 +/- 8.8 mm Hg) compared to the control value (12.2 +/- 8.9 mm Hg). The corresponding values of LCP in healthy volunteers were 4.3 +/- 2.6 mm Hg during congestion and 2.6 +/- 2.8 mm Hg during control conditions (p < 0.01). The mean increase in LCP in patients with lymph edema was 3.4 +/- 4.1 mm Hg, and 1.7 +/- 2.0 mm Hg in healthy volunteers (NS). The maximum spread of the lymph capillary network in patients increased from 13.9 +/- 6.8 mm before congestion to 18.8 +/- 8.2 mm during thigh compression (p < 0.05). No increase could be observed in healthy subjects. In summary, venous and lymphatic congestion by cuff compression at the thigh level results in a significant increase in LCP in healthy volunteers as well as in patients with lymph edema. The increased spread of the contrast medium in the superficial microlymphatics in lymph edema patients indicates a compensatory mechanism for lymphatic drainage during congestion of the veins and lymph collectors of the leg. Copyright 2000 S. Karger AG, Basel

  13. Pharmacokinetics of lidocaine and bupivacaine and stable isotope labelled analogues : a study in healthy volunteers

    NARCIS (Netherlands)

    Burm, A.G.D.; de Boer, A G; van Kleef, J.W.; Vermeulen, N P; de Leede, L G; Spierdijk, J; Breimer, D D

    1988-01-01

    The pharmacokinetics of lidocaine and bupivacaine and tri-deuteromethyl-labelled lidocaine and bupivacaine were investigated in healthy volunteers. The deuterium-labelled and the unlabelled form of the drug to be investigated were simultaneously infused in 10 min. Plasma concentrations were

  14. Inhibition of cytokine production by methotrexate. Studies in healthy volunteers and patients with rheumatoid arthritis.

    NARCIS (Netherlands)

    Gerards, A.H.; Lathouder, de S; Groot, E.R.; Dijkmans, B.A.C.; Aarden, L.A.

    2003-01-01

    OBJECTIVES: To analyse whether the beneficial effects of methotrexate in rheumatoid arthritis (RA) could be due to inhibition of inflammatory cytokine production. METHODS: Cytokine production was studied using whole blood (WB) and mononuclear cells (MNC) of healthy volunteers and RA patients.

  15. Inhibition of cytokine production by methotrexate. Studies in healthy volunteers and patients with rheumatoid arthritis

    NARCIS (Netherlands)

    Gerards, A. H.; de Lathouder, S.; de Groot, E. R.; Dijkmans, B. A. C.; Aarden, L. A.

    2003-01-01

    Objectives. To analyse whether the beneficial effects of methotrexate in rheumatoid arthritis (RA) could be due to inhibition of inflammatory cytokine production. Methods. Cytokine production was studied using whole blood (WB) and mononuclear cells (MNC) of healthy volunteers and RA patients.

  16. Modification of a sonographic enthesitis score to differentiate between psoriatic arthritis and young healthy volunteers

    NARCIS (Netherlands)

    Wervers, K. (K.); M. Vis (M.); Rasappu, N. (N.); M. van der Ven (Myrthe); I. Tchetverikov (Ilja); Kok, M. (M.); A.H. Gerards (Andreas); J.M.W. Hazes (Mieke); J.J. Luime (Jolanda)

    2017-01-01

    textabstractObjectives: We aimed to describe sonographic structural and inflammatory changes in entheses of patients with recently diagnosed psoriatic arthritis (PsA), patients with established PsA, and young healthy volunteers, and to investigate whether the MAdrid Sonographic Enthesitis Index

  17. Pharmacokinetic and bioequivalence study of two brands of valsartan tablets in healthy male volunteers.

    Science.gov (United States)

    Zakeri-Milani, Parvin; Valizadeh, Hadi; Islambulchilar, Ziba; Nemati, Mahboob

    2010-01-01

    Valsartan (CAS 137862-53-4) is an antihypertensive drug belonging to the family of angiotensin II receptor antagonists acting at the AT1 receptor, which mediates all known effects of angiotensin II on the cardiovascular system. In the present study, the pharmacokinetic parameters of two oral formulations of valsartan tablets were compared in a randomized, single oral dose, two-treatment crossover design in 24 healthy male volunteers under fasting conditions. After an overnight fast, the volunteers received 80 mg valsartan. Blood samples were collected up to 48 h and drug concentrations were determined by a reverse-phase HPLC method with fluorescence detection. Various pharmacokinetic parameters were determined from the plasma concentration-time curves of both formulations. The obtained values for test and reference products were 3067.7 +/- 1,281.7 and 3,304.3 +/- 1,196.4 ng/ml for Cmax; 17,834.4 +/- 7,083.8 and 18,319.1 +/- 7,800.7 ng x h/ml for AUC0-48; 18,825.7 +/- 7,553.2 and 19,172.2 +/- 8,307.2 ng x h/ml for AUC0-infinity, respectively. The 90% confidence intervals obtained by analysis of variance were 86.84-100.87% for Cmax and 93.43-115.54% for AUC0-t, which are within the acceptance range of 80-125%. Therefore it can be concluded that both products are bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable.

  18. Piroxicam immediate release formulations: A fasting randomized open-label crossover bioequivalence study in healthy volunteers.

    Science.gov (United States)

    Helmy, Sally A; El-Bedaiwy, Heba M

    2014-11-01

    Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144-hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters Cmax , tmax , AUC0-t , AUC0-∞ , Vd /F, Cl/F, and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUC0-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20-mg piroxicam and both formulations were well-tolerated. © 2014, The American College of Clinical Pharmacology.

  19. Effect of fresh orange juice intake on physiological characteristics in healthy volunteers.

    Science.gov (United States)

    Asgary, Sedigheh; Keshvari, Mahtab; Afshani, Mohammad Reza; Amiri, Masoud; Laher, Ismail; Javanmard, Shaghayegh Haghjooy

    2014-01-01

    Background. Impaired endothelial function is a predictor of cardiovascular events. Orange juice (OJ) is rich in dietary flavonoids and could inhibit oxidative stress and inflammatory responses. We examined the effects of commercial (COJ) and fresh orange juice (FOJ) on endothelial function and physiological characteristics in healthy humans. Materials and Methods. Twenty-two healthy volunteers years were enrolled in a single blind randomized crossover controlled trial. The two groups consumed either COJ for the first 4 weeks and then FOJ (CFOJ, 4 weeks), or FOJ for the first 4 weeks and then COJ (FCOJ, 4 weeks). We assessed endothelial function by measuring flow-mediated dilation, serum concentrations of lipids, apolipoproteins A and B (apo A-1 and apo B), and inflammatory markers such as vascular endothelial adhesion molecule 1 (VCAM-1), E-selectin, high-sensitivity C-reactive protein (hs-CRP), and interleukin-6. Results. Consumption of both juices decreased VCAM, hs-CRP, and E-selectin but increased apo A-1. A decline in LDL occurred in the FOJ group. There were no differences between the characteristics of two groups, with the exception of apo A-1 levels that were increased with both forms of OJ. The largest variations occurred with hs-CRP, VCAM in both groups. Conclusion. Consumption of COJ and FOJ produced beneficial effects on the physiological characteristics of healthy volunteers. Although these results could encourage the consumption of OJ, intervention studies are needed to determine the long-term effects of these types of OJ on metabolic and cardiovascular endpoints.

  20. Language mapping in healthy volunteers and brain tumor patients with a novel navigated TMS system: evidence of tumor-induced plasticity.

    Science.gov (United States)

    Rösler, J; Niraula, B; Strack, V; Zdunczyk, A; Schilt, S; Savolainen, P; Lioumis, P; Mäkelä, J; Vajkoczy, P; Frey, D; Picht, T

    2014-03-01

    This article explores the feasibility of a novel repetitive navigated transcranial magnetic stimulation (rnTMS) system and compares language mapping results obtained by rnTMS in healthy volunteers and brain tumor patients. Fifteen right-handed healthy volunteers and 50 right-handed consecutive patients with left-sided gliomas were examined with a picture-naming task combined with time-locked rnTMS (5-10 Hz and 80-120% resting motor threshold) applied over both hemispheres. Induced errors were classified into four psycholinguistic types and assigned to their respective cortical areas according to the coil position during stimulation. In healthy volunteers, language disturbances were almost exclusively induced in the left hemisphere. In patients errors were more frequent and induced at a comparative rate over both hemispheres. Predominantly dysarthric errors were induced in volunteers, whereas semantic errors were most frequent in the patient group. The right hemisphere's increased sensitivity to rnTMS suggests reorganization in language representation in brain tumor patients. rnTMS is a novel technology for exploring cortical language representation. This study proves the feasibility and safety of rnTMS in patients with brain tumor. Copyright © 2013 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

  1. Effect of a high dose of simvastatin on muscle mitochondrial metabolism and calcium signaling in healthy volunteers

    Energy Technology Data Exchange (ETDEWEB)

    Galtier, F., E-mail: f-galtier@chu-montpellier.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); INSERM, CIC 1001, 80 Avenue Augustin Fliche, 34295 Montpellier Cedex 5 (France); CPID, Faculté de Pharmacie, 15 Av. Charles Flahault, BP 14491, 34093 Montpellier Cedex 5, Montpellier (France); Mura, T., E-mail: t-mura@chu-montpellier.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); INSERM, CIC 1001, 80 Avenue Augustin Fliche, 34295 Montpellier Cedex 5 (France); Raynaud de Mauverger, E., E-mail: eric.raynaud-de-mauverger@chu-montpellier.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); Université Montpellier 1, 5 bd Henri IV CS 19044, 34967 Montpellier Cedex 2 (France); Université Montpellier 2, Place Eugène Bataillon, 34095 Montpellier Cedex 5 (France); INSERM, U1046, 371 Avenue du Doyen G. Giraud, CHU Arnaud de Villeneuve, Bâtiment INSERM Crastes de Paulet, 34295 Montpellier Cedex 5 (France); Chevassus, H., E-mail: h-chevassus@chu-montpellier.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); INSERM, CIC 1001, 80 Avenue Augustin Fliche, 34295 Montpellier Cedex 5 (France); Farret, A., E-mail: a-farret@chu-montpellier.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); INSERM, CIC 1001, 80 Avenue Augustin Fliche, 34295 Montpellier Cedex 5 (France); Gagnol, J.-P., E-mail: jp-gagnol@chu-montpellier.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); INSERM, CIC 1001, 80 Avenue Augustin Fliche, 34295 Montpellier Cedex 5 (France); Costa, F., E-mail: francoisecosta@sfr.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); INSERM, CIC 1001, 80 Avenue Augustin Fliche, 34295 Montpellier Cedex 5 (France); Dupuy, A., E-mail: am-dupuy@chu-montpellier.fr [CHRU Montpellier, 34295 Montpellier Cedex 5 (France); and others

    2012-09-15

    Statin use may be limited by muscle side effects. Although incompletely understood to date, their pathophysiology may involve oxidative stress and impairments of mitochondrial function and of muscle Ca{sup 2+} homeostasis. In order to simultaneously assess these mechanisms, 24 male healthy volunteers were randomized to receive either simvastatin for 80 mg daily or placebo for 8 weeks. Blood and urine samples and a stress test were performed at baseline and at follow-up, and mitochondrial respiration and Ca{sup 2+} spark properties were evaluated on a muscle biopsy 4 days before the second stress test. Simvastatin-treated subjects were separated according to their median creatine kinase (CK) increase. Simvastatin treatment induced a significant elevation of aspartate amino transferase (3.38 ± 5.68 vs − 1.15 ± 4.32 UI/L, P < 0.001) and CK (− 24.3 ± 99.1 ± 189.3vs 48.3 UI/L, P = 0.01) and a trend to an elevation of isoprostanes (193 ± 408 vs12 ± 53 pmol/mmol creatinine, P = 0.09) with no global change in mitochondrial respiration, lactate/pyruvate ratio or Ca{sup 2+} sparks. However, among statin-treated subjects, those with the highest CK increase displayed a significantly lower Vmax rotenone succinate and an increase in Ca{sup 2+} spark amplitude vs both subjects with the lowest CK increase and placebo-treated subjects. Moreover, Ca{sup 2+} spark amplitude was positively correlated with treatment-induced CK increase in the whole group (r = 0.71, P = 0.0045). In conclusion, this study further supports that statin induced muscular toxicity may be related to alterations in mitochondrial respiration and muscle calcium homeostasis independently of underlying disease or concomitant medication. -- Highlights: ► Statin use may be limited by side effects, particularly myopathy. ► Statins might impair mitochondrial function and muscle Ca2+ signaling in muscle. ► This was tested among healthy volunteers receiving simvastatin 80 mg daily for 8 weeks. ► CK

  2. The human plasma-metabolome: Reference values in 800 French healthy volunteers; impact of cholesterol, gender and age.

    Science.gov (United States)

    Trabado, Séverine; Al-Salameh, Abdallah; Croixmarie, Vincent; Masson, Perrine; Corruble, Emmanuelle; Fève, Bruno; Colle, Romain; Ripoll, Laurent; Walther, Bernard; Boursier-Neyret, Claire; Werner, Erwan; Becquemont, Laurent; Chanson, Philippe

    2017-01-01

    Metabolomic approaches are increasingly used to identify new disease biomarkers, yet normal values of many plasma metabolites remain poorly defined. The aim of this study was to define the "normal" metabolome in healthy volunteers. We included 800 French volunteers aged between 18 and 86, equally distributed according to sex, free of any medication and considered healthy on the basis of their medical history, clinical examination and standard laboratory tests. We quantified 185 plasma metabolites, including amino acids, biogenic amines, acylcarnitines, phosphatidylcholines, sphingomyelins and hexose, using tandem mass spectrometry with the Biocrates AbsoluteIDQ p180 kit. Principal components analysis was applied to identify the main factors responsible for metabolome variability and orthogonal projection to latent structures analysis was employed to confirm the observed patterns and identify pattern-related metabolites. We established a plasma metabolite reference dataset for 144/185 metabolites. Total blood cholesterol, gender and age were identified as the principal factors explaining metabolome variability. High total blood cholesterol levels were associated with higher plasma sphingomyelins and phosphatidylcholines concentrations. Compared to women, men had higher concentrations of creatinine, branched-chain amino acids and lysophosphatidylcholines, and lower concentrations of sphingomyelins and phosphatidylcholines. Elderly healthy subjects had higher sphingomyelins and phosphatidylcholines plasma levels than young subjects. We established reference human metabolome values in a large and well-defined population of French healthy volunteers. This study provides an essential baseline for defining the "normal" metabolome and its main sources of variation.

  3. A phase I pharmacokinetic study of ursolic acid nanoliposomes in healthy volunteers and patients with advanced solid tumors

    Directory of Open Access Journals (Sweden)

    Ying G

    2013-01-01

    Full Text Available Zhongling Zhu,1,4 Zhengzi Qian,2,4 Zhao Yan,1,4 Cuicui Zhao,2,4 Huaqing Wang,2,4 Guoguang Ying3,41Department of Clinical Pharmacology, 2Department of Lymphoma, 3Laboratory of Tumor Cell Biology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China; 4Key Laboratory of Cancer Prevention and Therapy, Tianjin, People’s Republic of ChinaBackground: Ursolic acid is a promising anticancer agent. The current study aims to evaluate the single- and multiple-dose pharmacokinetics (PK as well as the safety of ursolic acid nanoliposomes (UANL in healthy volunteers and in patients with advanced solid tumors.Methods: Twenty-four healthy volunteers in the single-dose PK study were divided into three different groups, which received 37, 74, and 98 mg/m2 of UANL. Eight patients in the multiple-dose PK study were administered with 74 mg/m2 of UANL daily for 14 days. The UA plasma concentrations were determined using ultra-performance liquid chromatograph-tandem mass spectrometry.Results: The plasma concentration profiles of all subjects were characterized by a biexponential decline after infusion. The mean peak plasma concentration (Cmax increased linearly as a function of the dose (r = 0.999. The mean area under the plasma concentration-time curve (AUC from 0 to 16 hours also increased proportionally with dose escalation (r = 0.998. However, the clearance was constant over the specific dose interval. In the multiple-dose PK study, the trough and average concentrations remained low. The mean AUC, half-life, Cmax, time to Cmax, and the volume of distribution on the first day were similar to those on the last day. All subjects tolerated the treatments well. Most UANL-associated adverse events varied from mild to moderate.Conclusions: UANL exhibits relatively linear PK behavior with dose levels from 37 mg/m2 to 98 mg/m2. No drug accumulation was observed with repeated doses of UANL. The intravenous infusion of UANL was well

  4. Cine MRI of Tracheal Dynamics in Healthy Volunteers and Patients With Tracheobronchomalacia.

    Science.gov (United States)

    Ciet, Pierluigi; Boiselle, Phillip M; Heidinger, Benedikt; Andrinopoulou, Eleni-Rosalina; O'Donnel, Carl; Alsop, David C; Litmanovich, Diana E

    2017-10-01

    Bronchoscopy and MDCT are routinely used to assess tracheobronchomalacia (TBM). Recently, dynamic MRI (cine MRI) has been proposed as a radiation-free alternative to MDCT. In this study, we tested cine MRI assessment of airway dynamics during various breathing conditions and compared cine MRI and MDCT measurements in healthy volunteers and patients with suspected TBM. Cine MRI was found to be a technically feasible alternative to MDCT for assessing central airway dynamics.

  5. Relative bioavailability of three newly developed albendazole formulations : a randomized crossover study with healthy volunteers

    NARCIS (Netherlands)

    Rigter, I M; Schipper, H G; Koopmans, R P; van Kan, H J M; Frijlink, H W; Kager, P A; Guchelaar, H-J

    2004-01-01

    This study of healthy volunteers shows that the relative bioavailability of albendazole formulations that use arachis oil-polysorbate 80 or hydroxypropyl-beta-cyclodextrin as an excipient was enhanced 4.3- and 9.7-fold compared to the results seen with commercial tablets. Administration of macrogol

  6. Relative bioavailability of three newly developed albendazole formulations: a randomized crossover study with healthy volunteers

    NARCIS (Netherlands)

    Rigter, I. M.; Schipper, H. G.; Koopmans, R. P.; van Kan, H. J. M.; Frijlink, H. W.; Kager, P. A.; Guchelaar, H.-J.

    2004-01-01

    This study of healthy volunteers shows that the relative bioavailability of albendazole formulations that use arachis oil-polysorbate 80 or hydroxypropyl-beta-cyclodextrin as an excipient was enhanced 4.3- and 9.7-fold compared to the results seen with commercial tablets. Administration of macrogol

  7. Modafinil and cognitive enhancement in schizophrenia and healthy volunteers: the effects of test battery in a randomised controlled trial.

    Science.gov (United States)

    Lees, J; Michalopoulou, P G; Lewis, S W; Preston, S; Bamford, C; Collier, T; Kalpakidou, A; Wykes, T; Emsley, R; Pandina, G; Kapur, S; Drake, R J

    2017-10-01

    Cognitive deficits in schizophrenia have major functional impacts. Modafinil is a cognitive enhancer whose effect in healthy volunteers is well-described, but whose effects on the cognitive deficits of schizophrenia appear to be inconsistent. Two possible reasons for this are that cognitive test batteries vary in their sensitivity, or that the phase of illness may be important, with patients early in their illness responding better. A double-blind, randomised, placebo-controlled single-dose crossover study of modafinil 200 mg examined this with two cognitive batteries [MATRICS Consensus Cognitive Battery (MCCB) and Cambridge Neuropsychological Test Automated Battery (CANTAB)] in 46 participants with under 3 years' duration of DSM-IV schizophrenia, on stable antipsychotic medication. In parallel, the same design was used in 28 age-, sex-, and education-matched healthy volunteers. Uncorrected p values were calculated using mixed effects models. In patients, modafinil significantly improved CANTAB Paired Associate Learning, non-significantly improved efficiency and significantly slowed performance of the CANTAB Stockings of Cambridge spatial planning task. There was no significant effect on any MCCB domain. In healthy volunteers, modafinil significantly increased CANTAB Rapid Visual Processing, Intra-Extra Dimensional Set Shifting and verbal recall accuracy, and MCCB social cognition performance. The only significant differences between groups were in MCCB visual learning. As in earlier chronic schizophrenia studies, modafinil failed to produce changes in cognition in early psychosis as measured by MCCB. CANTAB proved more sensitive to the effects of modafinil in participants with early schizophrenia and in healthy volunteers. This confirms the importance of selecting the appropriate test battery in treatment studies of cognition in schizophrenia.

  8. Healthy volunteers can be phenotyped using cutaneous sensitization pain models.

    Directory of Open Access Journals (Sweden)

    Mads U Werner

    Full Text Available BACKGROUND: Human experimental pain models leading to development of secondary hyperalgesia are used to estimate efficacy of analgesics and antihyperalgesics. The ability to develop an area of secondary hyperalgesia varies substantially between subjects, but little is known about the agreement following repeated measurements. The aim of this study was to determine if the areas of secondary hyperalgesia were consistently robust to be useful for phenotyping subjects, based on their pattern of sensitization by the heat pain models. METHODS: We performed post-hoc analyses of 10 completed healthy volunteer studies (n = 342 [409 repeated measurements]. Three different models were used to induce secondary hyperalgesia to monofilament stimulation: the heat/capsaicin sensitization (H/C, the brief thermal sensitization (BTS, and the burn injury (BI models. Three studies included both the H/C and BTS models. RESULTS: Within-subject compared to between-subject variability was low, and there was substantial strength of agreement between repeated induction-sessions in most studies. The intraclass correlation coefficient (ICC improved little with repeated testing beyond two sessions. There was good agreement in categorizing subjects into 'small area' (1(st quartile [75%] responders: 56-76% of subjects consistently fell into same 'small-area' or 'large-area' category on two consecutive study days. There was moderate to substantial agreement between the areas of secondary hyperalgesia induced on the same day using the H/C (forearm and BTS (thigh models. CONCLUSION: Secondary hyperalgesia induced by experimental heat pain models seem a consistent measure of sensitization in pharmacodynamic and physiological research. The analysis indicates that healthy volunteers can be phenotyped based on their pattern of sensitization by the heat [and heat plus capsaicin] pain models.

  9. Pharmacokinetics of morphine-6-glucuronide following oral administration in healthy volunteers

    DEFF Research Database (Denmark)

    Villesen, Hanne H.; Kristensen, Kim; Hansen, Steen Honoré

    2007-01-01

    After oral administration, morphine-6-glucuronide (M6G) displays an atypical absorption profile with two peak plasma concentrations. A proposed explanation is that M6G is hydrolysed to morphine in the colon, which is then absorbed and subsequently undergoes metabolism in the liver to morphine-3-g......-glucuronide (M3G) and M6G. The aims of this study were to confirm and elucidate the biphasic absorption profile as well as clarify the conversion of M6G to morphine after a single oral administration of M6G in healthy volunteers....

  10. Pharyngeal swallowing and oesophageal motility during a solid meal test: a prospective study in healthy volunteers and patients with major motility disorders.

    Science.gov (United States)

    Hollenstein, Michael; Thwaites, Philip; Bütikofer, Simon; Heinrich, Henriette; Sauter, Matthias; Ulmer, Irina; Pohl, Daniel; Ang, Daphne; Eberli, Daniel; Schwizer, Werner; Fried, Michael; Distler, Oliver; Fox, Mark; Misselwitz, Benjamin

    2017-09-01

    The factors that determine how people eat when they are healthy or have disease have not been defined. We used high resolution manometry (HRM) to assess pharyngeal swallowing and oesophageal motility during ingestion of a solid test meal (STM) in healthy volunteers and patients with motility disorders. This study was based at University Hospital Zurich (Zürich, Switzerland). Healthy volunteers who responded to an advertisement completed HRM with ten single water swallows (SWS) in recumbent and upright positions followed by a 200 g rice STM in the upright position. Healthy volunteers were stratified for age and sex to ensure a representative population. For comparison, consecutive patients with major motility disorders on SWS and patients with dysphagia but no major motility disorders on SWS (disease controls) were selected from a database that was assembled prospectively; the rice meal data were analysed retrospectively. During STM, pharyngeal swallows were timed and oesophageal contractions were classified as representing normal motility or different types of abnormal motility in accordance with established metrics. Factors that could potentially be associated with eating speed were investigated, including age, sex, body-mass index, and presence of motility disorder. We compared diagnoses based on SWS findings, assessed with the Chicago Classification v3.0, with those based on STM findings, assessed with the Chicago Classification adapted for solids. These studies are registered with ClinicalTrials.gov, numbers NCT02407938 and NCT02397616. Between April 2, 2014, and May 13, 2015, 72 healthy volunteers were recruited and underwent HRM. Additionally, we analysed data from 54 consecutive patients with major motility disorders and 53 with dysphagia but no major motility disorders recruited between April 2, 2013, and Dec 18, 2014. We found important variations in oesophageal motility and eating speed during meal ingestion in healthy volunteers and patients. Increased

  11. The role of serotonin in nonnormative risky choice: the effects of tryptophan supplements on the "reflection effect" in healthy adult volunteers.

    Science.gov (United States)

    Murphy, Susannah E; Longhitano, Carlo; Ayres, Rachael E; Cowen, Philip J; Harmer, Catherine J; Rogers, Robert D

    2009-09-01

    Risky decision-making involves weighing good and bad outcomes against their probabilities in order to determine the relative values of candidate actions. Although human decision-making sometimes conforms to rational models of how this weighting is achieved, irrational (or nonnormative) patterns of risky choice, including shifts between risk-averse and risk-seeking choices involving equivalent-value gambles (the "reflection effect"), are frequently observed. In the present experiment, we investigated the role of serotonin in decision-making under conditions of uncertainty. Fifteen healthy adult volunteers received a treatment of 3 g per day of the serotonin precursor, tryptophan, in the form of dietary supplements over a 14-day period, whereas 15 age- and IQ-matched control volunteers received a matched placebo substance. At test, all participants completed a risky decision-making task involving a series of choices between two simultaneously presented gambles, differing in the magnitude of their possible gains, the magnitude of their possible losses, and the probabilities with which these outcomes were delivered. Tryptophan supplements were associated with alterations in the weighting of gains and small losses perhaps reflecting reduced loss-aversion, and a marked and significant diminution of the reflection effect. We conclude that serotonin activity plays a significant role in nonnormative risky decision-making under conditions of uncertainty.

  12. Anatomical and metabolic assessment of prostate using a 3-Tesla MR scanner with a custom-made external transceive coil: healthy volunteer study.

    Science.gov (United States)

    Kaji, Yasushi; Kuroda, Kagayaki; Maeda, Takaki; Kitamura, Yuri; Fujiwara, Toshitaka; Matsuoka, Yuichiro; Tamura, Mitsuru; Takei, Naoyuki; Matsuda, Tsuyoshi; Sugimura, Kazuro

    2007-03-01

    To examine the possibility of using a 3 Tesla (T) magnetic resonance (MR) scanner with a custom-made external coil to obtain ductal details of the prostate, high-quality spectra, and metabolite mapping corresponding to prostate zonal anatomy in healthy volunteers. MRI and two-dimensional (2D) chemical shift imaging (CSI) were performed in 16 healthy volunteers using a 3T scanner with a custom-made external transmit-receive (transceive) coil. Visualization of the prostatic duct-like structure was analyzed on T2-weighted (T2W) images. The resolution of the metabolite peaks and the distribution of metabolites in CSI were also assessed. In the axial plane, 3-mm-thick images were better than 4-mm-thick images with the same voxel volume for assessing duct-like structures and prostatic urethra. Differentiation between inner and outer citrate (Cit) peaks was frequently observed (29 out of 30). The mean peak area ratio of choline (Cho) plus creatine (Cr) over Cit in the peripheral zone (PZ) was significantly lower than in the transition zone (TZ) (P = 0.014). 3T MR examinations of the prostate using an external coil allow information to be collected about the details of duct-like structures, the high-quality spectra of Cit, and the zone-specific distribution of metabolites.

  13. Tumour necrosis factor-alpha infusion produced insulin resistance but no change in the incretin effect in healthy volunteers.

    Science.gov (United States)

    Nielsen, Signe Tellerup; Lehrskov-Schmidt, Louise; Krogh-Madsen, Rikke; Solomon, Thomas P J; Lehrskov-Schmidt, Lars; Holst, Jens Juul; Møller, Kirsten

    2013-11-01

    Type 2 diabetes mellitus (T2DM) is associated with peripheral insulin resistance, impaired incretin effect, and increased plasma levels of tumour necrosis factor-alpha (TNF-α). Although TNF-α infusion at a dose that induces systemic inflammation in healthy volunteers has been demonstrated to induce peripheral insulin resistance, the influence of this cytokine on the incretin effect is unknown. We investigated whether systemic inflammation induced by TNF-α infusion in healthy volunteers alters the incretin hormone response to oral and intravenous glucose loads in a crossover study design with ten healthy male volunteers (mean age 24 years, mean body mass index 23.7 kg/m(2) ). The study consisted of four study days: days 1 and 2, 6-h infusion of saline; days 3 and 4, 6-h infusion of TNF-α; days 1 and 3, 4-h oral glucose tolerance test; and days 2 and 4, 4-h corresponding intravenous isoglycaemic glucose tolerance test. Glucose tolerance tests were initiated after 2 h of saline/TNF-α infusion. Plasma concentrations of TNF-α, interleukin 6, glucose, incretin hormones, and cortisol, and serum concentrations of C-peptide and insulin were measured throughout the study days. Insulin sensitivity was estimated by the Matsuda index and homeostasis model assessment of insulin resistance (HOMA-IR). Prehepatic insulin secretion rates were calculated. TNF-α infusion induced symptoms of systemic inflammation; increased plasma levels of cortisol, TNF-α, and interleukin 6; and increased the HOMA-IR. The secretion of incretin hormones as well as the incretin effect remained unchanged. In healthy young male volunteers, acute systemic inflammation induced by infusion of TNF-α is associated with insulin resistance with no change in the incretin effect. Copyright © 2013 John Wiley & Sons, Ltd.

  14. Effect of DA-9701 on Gastric Motor Function Assessed by Magnetic Resonance Imaging in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Min, Yang Won; Min, Byung-Hoon; Kim, Seonwoo; Choi, Dongil; Rhee, Poong-Lyul

    2015-01-01

    Improving gastric accommodation and gastric emptying is an attractive physiological treatment target in patients with functional dyspepsia (FD). We evaluated the effect of DA-9701, a new drug for FD, on gastric motor function after a meal in healthy volunteers using magnetic resonance imaging (MRI). Forty healthy volunteers were randomly allocated to receive either DA-9701 or placebo. After 5 days of treatment, subjects underwent gastric MRI (60 min before and 15, 30, 45, 60, 90, and 120 min after a liquid test meal). Gastric volume was measured through 3-dimensional reconstruction from MRI data. We analyzed 4 outcome variables including changes in total gastric volume (TGV), proximal TGV, and proximal to distal TGV ratio after a meal and gastric emptying rates after adjusting values at the pre-test meal. Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively). However, pre-treatment with DA-9701 increased postprandial proximal to distal TGV ratio more than placebo (difference between groups 0.93, 95% CI 0.08 to 1.79, P = 0.034). In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures). Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers. Further studies to confirm whether DA-9701 enhances these gastric motor functions in patients with FD are warranted. ClinicalTrials.gov NCT02091635.

  15. Effect of DA-9701 on Gastric Motor Function Assessed by Magnetic Resonance Imaging in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Yang Won Min

    Full Text Available Improving gastric accommodation and gastric emptying is an attractive physiological treatment target in patients with functional dyspepsia (FD. We evaluated the effect of DA-9701, a new drug for FD, on gastric motor function after a meal in healthy volunteers using magnetic resonance imaging (MRI.Forty healthy volunteers were randomly allocated to receive either DA-9701 or placebo. After 5 days of treatment, subjects underwent gastric MRI (60 min before and 15, 30, 45, 60, 90, and 120 min after a liquid test meal. Gastric volume was measured through 3-dimensional reconstruction from MRI data. We analyzed 4 outcome variables including changes in total gastric volume (TGV, proximal TGV, and proximal to distal TGV ratio after a meal and gastric emptying rates after adjusting values at the pre-test meal.Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively. However, pre-treatment with DA-9701 increased postprandial proximal to distal TGV ratio more than placebo (difference between groups 0.93, 95% CI 0.08 to 1.79, P = 0.034. In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures.Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers. Further studies to confirm whether DA-9701 enhances these gastric motor functions in patients with FD are warranted.ClinicalTrials.gov NCT02091635.

  16. Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers.

    Science.gov (United States)

    Pickering, Gisèle; Macian, Nicolas; Dubray, Claude; Pereira, Bruno

    2016-01-01

    Acetaminophen (APAP, paracetamol) mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467) was carried out from May 30, 2011 to July 12, 2011. Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature), and a battery of cognitive tests were recorded before and after oral APAP (2 g) or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P memory initial thinking time were decreased ( P =0.04). All other tests were not modified by APAP. APAP had an antinociceptive effect ( P body temperature did not change. This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance and antinociception are independent of APAP effect on thermogenesis. We suggest that cognitive performance mirrors the analgesic rather than thermic cascade of events, with possibly a central role for serotonergic and cannabinoid systems that need to be explored further in the context of pain and cognition.

  17. Reproducibility of the heat/capsaicin skin sensitization model in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Cavallone LF

    2013-11-01

    Full Text Available Laura F Cavallone,1 Karen Frey,1 Michael C Montana,1 Jeremy Joyal,1 Karen J Regina,1 Karin L Petersen,2 Robert W Gereau IV11Department of Anesthesiology, Washington University in St Louis, School of Medicine, St Louis, MO, USA; 2California Pacific Medical Center Research Institute, San Francisco, CA, USAIntroduction: Heat/capsaicin skin sensitization is a well-characterized human experimental model to induce hyperalgesia and allodynia. Using this model, gabapentin, among other drugs, was shown to significantly reduce cutaneous hyperalgesia compared to placebo. Since the larger thermal probes used in the original studies to produce heat sensitization are now commercially unavailable, we decided to assess whether previous findings could be replicated with a currently available smaller probe (heated area 9 cm2 versus 12.5–15.7 cm2.Study design and methods: After Institutional Review Board approval, 15 adult healthy volunteers participated in two study sessions, scheduled 1 week apart (Part A. In both sessions, subjects were exposed to the heat/capsaicin cutaneous sensitization model. Areas of hypersensitivity to brush stroke and von Frey (VF filament stimulation were measured at baseline and after rekindling of skin sensitization. Another group of 15 volunteers was exposed to an identical schedule and set of sensitization procedures, but, in each session, received either gabapentin or placebo (Part B.Results: Unlike previous reports, a similar reduction of areas of hyperalgesia was observed in all groups/sessions. Fading of areas of hyperalgesia over time was observed in Part A. In Part B, there was no difference in area reduction after gabapentin compared to placebo.Conclusion: When using smaller thermal probes than originally proposed, modifications of other parameters of sensitization and/or rekindling process may be needed to allow the heat/capsaicin sensitization protocol to be used as initially intended. Standardization and validation of

  18. The Area of Secondary Hyperalgesia following Heat Stimulation in Healthy Male Volunteers: Inter- and Intra-Individual Variance and Reproducibility.

    Directory of Open Access Journals (Sweden)

    Morten Sejer Hansen

    Full Text Available Clinical pain models can be applied when investigating basic physiologic pain responses in healthy volunteers. Several pain models exist; however, only few have been adequately validated. Our primary aim with this prospective study was to investigate the intra- and inter-individual variation in secondary hyperalgesia elicited by brief thermal sensitization (45°C for 3 min in healthy volunteers.Fifty healthy volunteers were included. Areas of secondary hyperalgesia following brief thermal sensitization were investigated by 2 observers on 4 experimental days, with a minimum interval of 7 days. Additionally, heat pain detection threshold and pain during thermal stimulation (45°C for 1 min., and the psychological tests Pain Catastrophizing Scale and Hospital Anxiety and Depression Score were applied.For areas of secondary hyperalgesia, an intra-observer intra-person correlation of 0.85, 95% CI [0.78, 0.90], an intra-observer inter-person correlation of 0.03, 95% CI [0.00, 0.16], and a coefficient of variation of 0.17, 95% CI [0.14, 0.21] was demonstrated. Four percent of the study population had areas of secondary hyperalgesia both below the 1st and above the 3rd quartile considering all included participants. Heat pain detection threshold predicted area of secondary hyperalgesia with an adjusted R2 of 0.20 (P = 0.0006.We have demonstrated a low intra-individual, and a high inter-individual variation in thermally induced secondary hyperalgesia. We conclude that brief thermal sensitization produce secondary hyperalgesia with a high level of reproducibility, which can be applied to investigate different phenotypes related to secondary hyperalgesia in healthy volunteers.clinicaltrials.gov NCT02166164.

  19. Can homeopathically prepared mercury cause symptoms in healthy volunteers? A randomized, double-blind placebo-controlled trial.

    Science.gov (United States)

    Vickers, A J; van Haselen, R; Heger, M

    2001-04-01

    To pilot a method for determining whether homeopathically prepared mercury causes more symptoms (a "drug proving") in healthy volunteers than placebo. One hundred and eighteen (118) healthy volunteers ages 18 to 65 were recruited by local advertising. Subjects unfamiliar with homeopathy undertook a 1-week single-blind placebo run-in, a 1-week of double-blind, randomized treatment on either homeopathically prepared mercury 12C or placebo, and a third week of placebo run-out. Each day, symptoms were recorded on a checklist that included both true mercury symptoms and symptoms not expected to be caused by mercury (false symptoms). Additional symptoms were assessed by open reporting. Outcome was assessed by calculating a score for each day as the number of true symptoms minus the number of false symptoms. The mean score during placebo was then subtracted from the mean score for weeks two and three of the trial. Fourteen (14) subjects dropped out during placebo run-in. The remaining 104 completed the trial. Baseline comparability was good. Mean difference score was -0.125 (SD 3.47) for mercury and -0.221 (SD 3.01) for placebo (p > 0.2). No significant differences between groups were found for the number of subjects meeting predefined criteria for a drug-proving reaction. This pilot study failed to find evidence that mercury 12C causes significantly more symptoms in healthy volunteers than placebo. Questionnaires with a limited number of gross symptoms do not seem to be an appropriate methodological technique in drug proving research. If drug-proving phenomena exist, they appear to be rare.

  20. Effects of sulpiride on true and false memories of thematically related pictures and associated words in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Regina V Guarnieri

    2016-03-01

    Full Text Available Episodic memory, working memory, emotional memory and attention are subject to dopaminergic modulation. However, the potential role of dopamine on the generation of false memories is unknown. This study defined the role of the dopamine D2 receptor on true and false memories. Twenty-four young, healthy volunteers ingested a single dose of placebo or 400 mg oral sulpiride, a dopamine D2-receptor antagonist, just before starting the recognition memory task in a randomized, double-blind, placebo-controlled trial. The sulpiride group made more false recognitions during visual and verbal processing than the placebo group although both groups had the same indices of true memory. These findings demonstrate that dopamine blockade in healthy volunteers can specifically increase the rate of false recognitions.

  1. Pharmacogenetics of healthy volunteers in Puerto Rico

    Science.gov (United States)

    Claudio-Campos, Karla; Orengo-Mercado, Carmelo; Renta, Jessicca Y.; Peguero, Muriel; García, Ricardo; Hernández, Gabriel; Corey, Susan; Cadilla, Carmen L.; Duconge, Jorge

    2016-01-01

    Puerto Ricans are a unique Hispanic population with European, Native American (Taino), and higher West African ancestral contributions than other non-Caribbean Hispanics. In admixed populations, such as Puerto Ricans, genetic variants can be found at different frequencies when compared to parental populations and uniquely combined and distributed. Therefore, in this review, we aimed to collect data from studies conducted in healthy Puerto Ricans and to report the frequencies of genetic polymorphisms with major relevance in drug response. Filtering for healthy volunteers or individuals, we performed a search of pharmacogenetic studies in academic literature databases without limiting the period of the results. The search was limited to Puerto Ricans living in the island, excluding those studies performed in mainland (United States). We found that the genetic markers impacting pharmacological therapy in the areas of cardiovascular, oncology, and neurology are the most frequently investigated. Coincidently, the top causes of mortality in the island are cardiovascular diseases, cancer, diabetes, Alzheimer’s disease, and stroke. In addition, polymorphisms in genes that encode for members of the CYP450 family (CYP2C9, CYP2C19, and CYP2D6) are also available due to their relevance in the metabolism of drugs. The complex genetic background of Puerto Ricans is responsible for the divergence in the reported allele frequencies when compared to parental populations (Africans, East Asians, and Europeans). The importance of reporting the findings of pharmacogenetic studies conducted in Puerto Ricans is to identify genetic variants with potential utility among this genetically complex population and eventually move forward the adoption of personalized medicine in the island. PMID:26501165

  2. Pharmacogenetics of healthy volunteers in Puerto Rico.

    Science.gov (United States)

    Claudio-Campos, Karla; Orengo-Mercado, Carmelo; Renta, Jessicca Y; Peguero, Muriel; García, Ricardo; Hernández, Gabriel; Corey, Susan; Cadilla, Carmen L; Duconge, Jorge

    2015-12-01

    Puerto Ricans are a unique Hispanic population with European, Native American (Taino), and higher West African ancestral contributions than other non-Caribbean Hispanics. In admixed populations, such as Puerto Ricans, genetic variants can be found at different frequencies when compared to parental populations and uniquely combined and distributed. Therefore, in this review, we aimed to collect data from studies conducted in healthy Puerto Ricans and to report the frequencies of genetic polymorphisms with major relevance in drug response. Filtering for healthy volunteers or individuals, we performed a search of pharmacogenetic studies in academic literature databases without limiting the period of the results. The search was limited to Puerto Ricans living in the island, excluding those studies performed in mainland (United States). We found that the genetic markers impacting pharmacological therapy in the areas of cardiovascular, oncology, and neurology are the most frequently investigated. Coincidently, the top causes of mortality in the island are cardiovascular diseases, cancer, diabetes, Alzheimer's disease, and stroke. In addition, polymorphisms in genes that encode for members of the CYP450 family (CYP2C9, CYP2C19, and CYP2D6) are also available due to their relevance in the metabolism of drugs. The complex genetic background of Puerto Ricans is responsible for the divergence in the reported allele frequencies when compared to parental populations (Africans, East Asians, and Europeans). The importance of reporting the findings of pharmacogenetic studies conducted in Puerto Ricans is to identify genetic variants with potential utility among this genetically complex population and eventually move forward the adoption of personalized medicine in the island.

  3. Effect of two-linked mutations of the FMO3 gene on itopride metabolism in Chinese healthy volunteers.

    Science.gov (United States)

    Zhou, Li-Ping; Tan, Zhi-Rong; Chen, Hao; Guo, Dong; Chen, Yao; Huang, Wei-Hua; Wang, Lian-Sheng; Zhang, Guo-Gang

    2014-11-01

    Itopride is an effective gastroprokinetic agent mainly used for the treatment of functional dyspepsia. Flavin-containing monooxygenase 3 (FMO3) has been confirmed to be the key enzyme involved in the main itopride metabolic pathway. We investigated whether the FMO3 genotypes can affect itopride metabolism in Chinese healthy volunteers. Twelve healthy volunteers who had been genotyped for FMO3 gene were selected to participate in our study. Volunteers were given 50 mg itopride orally and then blood samples were collected from 0 to 24 h. The plasma concentrations of itopride and itopride N-oxide were determined by HPLC-MS/MS method. Itopride and itopride N-oxide both exhibit FMO3 genotype-dependent pharmacokinetic profiles. The area under the plasma concentration-time curve (AUC) of itopride increased by 127.82 ± 41.99 % (P itopride N-oxide decreased by 30.30 ± 25.70 % (P itopride and itopride N-oxide were observed between these two genotypes. The FMO3 allele can significantly affect the metabolism of itopride. The pharmacokinetic parameters of both itopride and itopride N-oxide were significantly different between these two genotypes.

  4. Holding on to what you have got: keeping hospice palliative care volunteers volunteering.

    Science.gov (United States)

    Claxton-Oldfield, Stephen; Jones, Richard

    2013-08-01

    In all, 119 hospice palliative care volunteers from 3 community-based hospice programs completed the Volunteer Retention Questionnaire (VRQ), a 33-item survey designed for this study. The VRQ asks volunteers to rate the importance of each item to their decision to continue volunteering. The items that received the highest mean importance ratings included enjoying the work they do, feeling adequately prepared/trained to perform their role, and learning from their patients' experiences/listening to their patients' life stories. Being recognized (eg, pins for years of service or being profiled in the hospice newsletter), receiving phone calls/cards from their volunteer coordinator on special occasions, and being reimbursed for out-of-pocket expenses were among the items that received the lowest mean importance ratings. Suggestions for improving volunteer retention are provided.

  5. Safety and Immunogenicity Testing of an Intranasal Group B Meningococcal Native Outer Membrane Vesicle Vaccine in Healthy Volunteers

    National Research Council Canada - National Science Library

    Drabick, Joseph

    1998-01-01

    An intranasal vaccine composed of native outer membrane vesicles (NOMV) not exposed to detergent or denaturing agents was prepared from the group B meningococcal strain and tested in 32 healthy adult volunteers...

  6. Evaluation of a Potential Metabolism-Mediated Drug-Drug Interaction Between Atomoxetine and Bupropion in Healthy Volunteers.

    Science.gov (United States)

    Todor, Ioana; Popa, Adina; Neag, Maria; Muntean, Dana; Bocsan, Corina; Buzoianu, Anca; Vlase, Laurian; Gheldiu, Ana-Maria; Briciu, Corina

    2016-01-01

    To evaluate the impact of bupropion on the pharmacokinetic profile of atomoxetine and its main active metabolite (glucuronidated form), 4-hydroxyatomoxetine-O-glucuronide, in healthy volunteers. An open-label, non-randomized, two-period, sequential clinical trial was conducted as follows: during Period I (Reference), each volunteer received a single oral dose of 25 mg atomoxetine, whilst during Period II (Test), a combination of 25 mg atomoxetine and 300 mg bupropion was administered to all volunteers, after a pretreatment regimen with bupropion for 7 days. Next, after determining atomoxetine and 4-hydroxyatomoxetine-O-glucuronide plasma concentrations, their pharmacokinetic parameters were calculated using a noncompartmental method and subsequently compared to determine any statistically significant differences between the two periods. Bupropion intake influenced all the pharmacokinetic parameters of both atomoxetine and its metabolite. For atomoxetine, Cmax increased from 226±96.1 to 386±137 ng/mL and more importantly, AUC0-∞ was significantly increasedfrom 1580±1040 to 8060±4160 ng*h/mL, while the mean t1/2 was prolonged after bupropion pretreatment. For 4-hydroxyatomoxetine-O-glucuronide, Cmax and AUC0-∞  were decreased from 707±269 to 212±145 ng/mL and from 5750±1240 to 3860±1220 ng*h/mL, respectively. These results demonstrated that the effect of bupropion on CYP2D6 activity was responsible for an increased systemic exposure to atomoxetine (5.1-fold) and also for a decreased exposure to its main metabolite (1.5-fold). Additional studies are required in order to evaluate the clinical relevance of this pharmacokinetic drug interaction.This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

  7. MR-imaging of the breast at 0.5 Tesla: menstrual-cycle dependency of parenchymal contrast enhancement in healthy volunteers with oral contraceptive use?

    International Nuclear Information System (INIS)

    Lorenzen, J.; Welger, J.; Krupski, G.; Adam, G.; Lisboa, B.W.

    2003-01-01

    Introduction: To evaluate changes of contrast medium enhancement of the breast parenchyma due to menstrual cycle in healthy volunteers with oral contraceptive use in MR-imaging of the breast. Material and Methods: 15 healthy volunteers (age: 22 - 36, mean 28,2) without breast disease were examined two times during one menstrual cycle (days 7 - 14 and days 21 - 2). Two volunteers were examined only in the second part of the cycle (days 21 - 2). All volunteers used oral contraceptives for more than 6 month continuously. Examinations were performed with a 0,5 T magnet (dynamic 3D-gradient echo protocol with subtraction postprocessing). We evaluated the number of enhancing foci and the parenchymal contrast medium enhancement during the different phases of the cycle by region of interest. Results: Only a total of two enhancing foci were found in 2 of 17 volunteers. Time/signal intensity diagrams in these both cases were not suspicious ( [de

  8. Effect of the CYP2C19 genotype on the pharmacokinetics of icotinib in healthy male volunteers.

    Science.gov (United States)

    Ruan, Can-Jun; Liu, Dong-Yang; Jiang, Ji; Hu, Pei

    2012-12-01

    Icotinib hydrochloride {4-[(3-ethynylphenyl)amino]-6,7-benzo-12-crown-4-quinazoline hydrochloride}, a novel epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), was designed for the treatment of non-small cell lung cancer (NSCLC). In the present study, we investigated the influence of the CYP2C19*2 and CYP2C19*3 alleles on the pharmacokinetics of icotinib in healthy Chinese volunteers. In a single-dose pharmacokinetic study, 12 healthy Chinese volunteers received an oral dose of 600 mg of icotinib. Plasma was sampled for up to 72 h post-dose, followed by quantification of icotinib by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS-MS). Five subjects genotyped as homozygous extensive metabolizers (CYP2C19*1/*1), 6 subjects genotyped as heterozygous extensive metabolizers (CYP2C19*1/*2 or CYP2C19*1/*3), and 1 subject genotyped as a poor metabolizer (CYP2C19*2/*3) and was withdrawn from the research because of urticaria. The mean icotinib AUC(0-∞) and C(max) (14.56 ±5.31 h mg/L and 2.32 ± 0.49 μg/mL) in homozygous EMs was 1.56 and 1.41-fold lower than that in heterozygous EMs (22.7 ± 6.11 and 3.28 ± 0.48, P = 0.046 and 0.047). The mean CL/F (44.18 ± 12.17 L/h) in homozygous EMs was 1.55-fold higher than that in heterozygous EMs (28.42 ± 9.23 L/h, P = 0.013). The data showed that the pharmacokinetics of icotinib differ significantly between homozygous EMs and heterozygous EMs in CYP2C19.

  9. Biological and haematological safety profile of oral amodiaquine and chloroquine in healthy volunteers with or without Plasmodium falciparum infection in northeast Tanzania.

    Science.gov (United States)

    Massaga, J J; Lusingu, J P; Makunde, R; Malebo, H M; Chile, M M; Akida, J A; Lemnge, M M; Rønn, A M; Theander, T G; Bygbjerg, I C; Kitua, A Y

    2008-07-01

    Amodiaquine (AQ), an effective antimalarial drug for uncomplicated malaria, has been greatly restricted after cases of life-threatening agranulocytosis and hepatic toxicity during prophylactic use. We conducted a hospital based open-label randomised clinical trial in 40 indigenous semi-immune healthy adult male volunteers with and without malaria parasites. The objective was to collect data on biological and haematological safety, tolerability, and parasitological efficacy to serve as baseline in the evaluation of the effectiveness of AQ preventive intermittent treatment against malaria morbidity in infants. Volunteers were stratified according to parasitaemia status and randomly assigned 20 participants each arm to three days treatment with either AQ or chloroquine (CQ). The level of difference of selected haematological and hepatological values pre-and post-trial were marginal and within the normal limits. Clinical adverse effects mostly mild and transient were noticed in 33.3% CQ treated-aparasitaemic, 23.8% of CQ treated-parasitaemic, 28.6% ofAQ-treated parasitaemic and 14.3% of aparasitaemic receiving AQ. Amodiaquine attained 100% parasitological clearance rate versus 70% in CQ-treated volunteers. The findings indicate that there was no agranulocytosis or hepatic toxicity suggesting that AQ may pose no public health risk in its wide therapeutic dosage uses. Larger studies are needed to exclude rare adverse effects.

  10. Anatomically standardised 99mTc-ECD brain perfusion SPET allows accurate differentiation between healthy volunteers, multiple system atrophy and idiopathic Parkinson's disease

    International Nuclear Information System (INIS)

    Bosman, Tommy; Van Laere, Koen; Santens, Patrick

    2003-01-01

    The clinical differentiation between typical idiopathic Parkinson's disease (IPD) and atypical parkinsonian disorders such as multiple system atrophy (MSA) is complicated by the presence of signs and symptoms common to both forms. The goal of this study was to re-evaluate the contribution of brain perfusion single-photon emission tomography (SPET) with anatomical standardisation and automated analysis in the differentiation of IPD and MSA. This was achieved by discriminant analysis in comparison with a large set of age- and gender-matched healthy volunteers. Technetium-99m ethyl cysteinate dimer SPET was performed on 140 subjects: 81 IPD patients (age 62.6±10.2 years; disease duration 11.0±6.4 years; 50 males/31 females), 15 MSA patients (61.5±9.2 years; disease duration 3.0±2.2 years; 9 males/6 females) and 44 age- and gender-matched healthy volunteers (age 59.2±11.9 years; 27 males/17 females). Patients were matched for severity (Hoehn and Yahr stage). Automated predefined volume of interest (VOI) analysis was carried out after anatomical standardisation. Stepwise discriminant analysis with cross-validation using the leave-one-out method was used to determine the subgroup of variables giving the highest accuracy for this differential diagnosis. Between MSA and IPD, the only regions with highly significant differences in uptake after Bonferroni correction were the putamen VOIs. Comparing MSA versus normals and IPD, with putamen VOI values as discriminating variables, cross-validated performance showed correct classification of MSA patients with a sensitivity of 73.3%, a specificity of 84% and an accuracy of 83.6%. Additional input from the right caudate head and the left prefrontal and left mesial temporal cortex allowed 100% discrimination even after cross-validation. Discrimination between the IPD group alone and healthy volunteers was accurate in 94% of the cases after cross-validation, with a sensitivity of 91.4% and a specificity of 100%. The three

  11. A phase I trial to evaluate the safety and pharmacokinetics of low-dose methotrexate as an anti-malarial drug in Kenyan adult healthy volunteers

    Directory of Open Access Journals (Sweden)

    Oyoo George O

    2011-03-01

    Full Text Available Abstract Background Previous investigations indicate that methotrexate, an old anticancer drug, could be used at low doses to treat malaria. A phase I evaluation was conducted to assess the safety and pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers. Methods Twenty five healthy adult volunteers were recruited and admitted to receive a 5 mg dose of methotrexate/day/5 days. Pharmacokinetics blood sampling was carried out at 2, 4, 6, 12 and 24 hours following each dose. Nausea, vomiting, oral ulcers and other adverse events were solicited during follow up of 42 days. Results The mean age of participants was 23.9 ± 3.3 years. Adherence to protocol was 100%. No grade 3 solicited adverse events were observed. However, one case of transiently elevated liver enzymes, and one serious adverse event (not related to the product were reported. The maximum concentration (Cmax was 160-200 nM and after 6 hours, the effective concentration (Ceff was Conclusion Low-dose methotraxate had an acceptable safety profile. However, methotrexate blood levels did not reach the desirable Ceff of 250-400-nM required to clear malaria infection in vivo. Further dose finding and safety studies are necessary to confirm suitability of this drug as an anti-malarial agent.

  12. Lack of modulation of gastric emptying by dietary nitrate in healthy volunteers.

    Science.gov (United States)

    Terai, Shiho; Iijima, Katsunori; Asanuma, Kiyotaka; Ara, Nobuyuki; Uno, Kaname; Abe, Yasuhiko; Koike, Tomoyuki; Imatani, Akira; Ohara, Shuichi; Shimosegawa, Tooru

    2009-05-01

    Nitric oxide produced endogenously in vagal neurons modulates gastrointestinal motor activity as an important non-adrenergic and non-cholinergic neurotransmitter. Other than through endogenous biosynthesis, a high concentration of nitric oxide also occurs by chemical reactions within the stomach in the presence of gastric acid through the entero-salivary re-circulation of dietary nitrate. Although dietary nitrate can be a potential source of nitric oxide in the human stomach, there has been no report on the effect of dietary nitrate on gastric motor function. The aim of this study is to investigate the effect of dietary nitrate on gastric emptying, one of the major parameters for the gastric motor function. Fifteen healthy volunteers underwent a placebo-controlled (310 mg sodium nitrate or placebo), double-blind, crossover trial. Since a sufficient amount of gastric acid is essential for dietary nitrate-derived nitric oxide generation in the stomach, the same protocol was repeated after 1-week treatment with a proton pump inhibitor, rabeprazole. Gastric emptying was evaluated by (13)C-octanoate breath test. The sodium nitrate ingestion did not affect gastric emptying either prior to or during rabeprazole treatment, although rabeprazole treatment itself significantly delayed gastric emptying, being independent of the dietary nitrate load. Confirmation of the delayed gastric emptying with rabeprazole indicates the sensitivity of the breath test employed in the present study. In conclusion, despite the potential nitrogen source of exogenous nitric oxide, the ingestion of 310 mg sodium nitrate, which is equivalent to the average daily intake of Japanese adults, does not affect gastric emptying in healthy volunteers.

  13. Effect of ensure on the oral bioavailability of gatifloxacin in healthy volunteers.

    Science.gov (United States)

    Kays, Michael B; Overholser, Brian R; Lagvankar, Seema; Goldman, Mitchell; Sowinski, Kevin M

    2005-11-01

    To determine the effect of Ensure on the relative oral bioavailability of gatifloxacin in healthy volunteers. Single-dose, randomized, crossover study. University-affiliated research center. Twelve healthy volunteers (six men, six women) aged 18 years or older with no clinically significant abnormal findings on physical examination or in medical history. Intervention. Subjects consumed 120 ml of study liquid-water or Ensure-every 30 minutes for five doses. With the second dose, subjects ingested a single gatifloxacin 400-mg tablet that had been uniformly crushed and mixed into the study liquid. Serial blood samples were collected for 48 hours, and gatifloxacin concentrations were determined by high-performance liquid chromatography. Pharmacokinetic data were analyzed by using noncompartmental methods. Maximum serum concentration (Cmax) and area under the serum concentration-time curve from zero to infinity (AUC0-infinity) were tested for bioequivalence after log-transformation of the data. Comparison of parameters for gatifloxacin administered with water versus those with Ensure showed that Cmax (4.35 +/- 0.90 vs 2.41 +/- 0.58 mug/ml, pinfinity) (42.4 +/- 10.1 vs 31.3 +/- 8.3 mg*hr/L, pinfinity. The median time to reach Cmax was significantly prolonged when gatifloxacin was administered with Ensure versus that with water (2.5 hrs vs 1.0 hr, p=0.006). The Cmax and AUC0-infinity of gatifloxacin were significantly decreased when the drug was administered with Ensure. The clinical significance of these findings will depend on the offending pathogen and its susceptibility to gatifloxacin.

  14. A comparative bioavailability study of two ibuprofen formulations after single-dose administration in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Metta S.S. Wiria

    2007-09-01

    Full Text Available This study was aimed to investigate the bioequivalence of ibuprofen 125 mg suppository formulation (Ibukal®, test formulation from PT. Kalbe Farma, Tbk., Jakarta and the ibuprofen suppository comparative formulation (Proris®, from PT. Pharos Indonesia, Jakarta in 12 healthy volunteers. The pharmacokinetic parameters used in this study were the area under the concentration-time curve from time zero to hour 10 (AUC0-t, the area under the concentration-time curve from time zero to infinite (AUC0-inf, the maximum concentration (Cmax, and the time needed to reach the maximum concentration (tmax. The study was designed as a random cross-over fashion, single-blinded which included 12 healthy adult volunteers. The volunteers were fasted overnight and in the morning they received a suppository of the test drug (Ibukal® or a suppository of the comparative drug (Proris®. Blood samples were withdrawn on hour 0 (control, 20 min; 40 min; 1; 1.5; 2; 2.5; 3; 4; 6; 8; and 10 time points after the administration of the drug. Following a wash-out period of 1 week, this procedure was repeated using the other drug. The serum concentration of the drug was determined by means of high-performance liquid chromatography with ultraviolet detection. The results of the study showed that, the mean (SD of AUC0-t, AUC0-inf, Cmax and tmax of the test drug were, respectively, 28.59(3.37 μg.h.mL-1, 30.47(3.56 μg.h.mL-1, 8.24(1.44 μg/mL, and 1.33(0.44 h. The mean (SD of AUC0-t, AUC0-inf, Cmax and tmax of the comparative drug were, respectively, 28.13(8.14 μg.h.mL-1, 30.56(8.05 μg.h.mL-1, 8.27(2.88 μg/mL, and 1.79(0.33 h. The geometric means ratio of the test to the comparative drug were 104.38% (CI 90%: 90.38-120.54% for AUC0-t, 101.97% (CI 90%: 89.51-116.16% for AUC0-inf, and 104.02% (CI 90%: 85.73-126.16% for Cmax. There was no side effect of the drug detected in this study. From the results we can conclude that the 125 mg of ibuprofen suppository of PT Kalbe Farma

  15. Evaluation of the Pharmacokinetics of Single- and Multiple-dose Buprenorphine Buccal Film in Healthy Volunteers.

    Science.gov (United States)

    Bai, Stephen A; Xiang, Qinfang; Finn, Andrew

    2016-02-01

    Buprenorphine, a partial μ-receptor agonist, is approved for the management of moderate to severe pain, but it has low oral bioavailability. Two open-label studies were performed to determine the pharmacokinetic profile of buprenorphine from buccal film formulations of buprenorphine. Both studies enrolled healthy volunteers, aged 18 to 55 years, who received concurrent oral naltrexone to reduce adverse events (AEs); subjects with a history or evidence of substance abuse or current use of any product affecting cytochrome P450 3A4 activity were excluded. The first study (n = 25) was a 5-period crossover trial with 4 single doses (75 and 300 and 300 and 1200 μg) of 2 formulations (F14 and F24) of buccal buprenorphine (BBUP) and a 300-μg intravenous dose of buprenorphine with a 7-day washout between periods. In the second study, each subject (n = 10) received 6 doses of 4 BBUP strengths (60, 120, 180, and 240 μg BID) in a dose-escalation design. Plasma concentrations of buprenorphine and norbuprenorphine were assayed, and pharmacokinetics were summarized with descriptive statistics and analyzed by using a linear mixed effects model (single-dose study). AEs were recorded. In the single-dose study, the 2 formulations exhibited comparable bioavailability of 46% to 51% that was independent of dose, with a single buprenorphine peak concentration from each BBUP dose occurring at 2.5 to 3 hours. The mean buprenorphine Cmax across the doses ranged from 0.17 ng/mL for the 75-µg dose to 1.43 ng/mL for the 1200-µg dose. AUC0-∞, AUC0-last, and Cmax were proportional to the dose of BBUP administered. Cmax of norbuprenorphine after BBUP administration was approximately one tenth that of buprenorphine Cmax. In the multiple-dose study, steady state was reached within 3 days of BID dosing. There was a linear increase in exposure across the dose range from 60 to 240 μg BID. Treatment-emergent AEs in both studies were consistent with those reported with opiate administration to

  16. Investigating pulmonary and systemic pharmacokinetics of inhaled olodaterol in healthy volunteers using a population pharmacokinetic approach.

    Science.gov (United States)

    Borghardt, Jens Markus; Weber, Benjamin; Staab, Alexander; Kunz, Christina; Formella, Stephan; Kloft, Charlotte

    2016-03-01

    Olodaterol, a novel β2-adrenergic receptor agonist, is a long-acting, once-daily inhaled bronchodilator approved for the treatment of chronic obstructive pulmonary disease. The aim of the present study was to describe the plasma and urine pharmacokinetics of olodaterol after intravenous administration and oral inhalation in healthy volunteers by population pharmacokinetic modelling and thereby to infer its pulmonary fate. Plasma and urine data after intravenous administration (0.5-25 μg) and oral inhalation (2.5-70 μg via the Respimat® inhaler) were available from a total of 148 healthy volunteers (single and multiple dosing). A stepwise model building approach was applied, using population pharmacokinetic modelling. Systemic disposition parameters were fixed to estimates obtained from intravenous data when modelling data after inhalation. A pharmacokinetic model, including three depot compartments with associated parallel first-order absorption processes (pulmonary model) on top of a four-compartment body model (systemic disposition model), was found to describe the data the best. The dose reaching the lung (pulmonary bioavailable fraction) was estimated to be 49.4% [95% confidence interval (CI) 46.1, 52.7%] of the dose released from the device. A large proportion of the pulmonary bioavailable fraction [70.1% (95% CI 66.8, 73.3%)] was absorbed with a half-life of 21.8 h (95% CI 19.7, 24.4 h). The plasma and urine pharmacokinetics of olodaterol after intravenous administration and oral inhalation in healthy volunteers were adequately described. The key finding was that a high proportion of the pulmonary bioavailable fraction had an extended pulmonary residence time. This finding was not expected based on the physicochemical properties of olodaterol. © 2015 The British Pharmacological Society.

  17. The effect of Nigella sativa Linn. seed on memory, attention and cognition in healthy human volunteers.

    Science.gov (United States)

    Bin Sayeed, Muhammad Shahdaat; Asaduzzaman, Md; Morshed, Helal; Hossain, Md Monir; Kadir, Mohammad Fahim; Rahman, Md Rezowanur

    2013-07-30

    Experimental evidences have demonstrated that Nigella sativa Linn. seed (NS) has positive modulation effects on aged rats with memory impairments, prevents against hippocampal pyramidal cell loss and enhances consolidation of recall capability of stored information and spatial memory in rats. NS has neuroprotective, nephroprotective, lung protective, cardioprotective, hepatoprotective activities as established by previous studies on animals. Several clinical trials with NS on human have also demonstrated beneficial effect. The present study was designed to investigate the effects of NS on memory, attention and cognition in healthy elderly volunteers. Furthermore, safety profile of NS was assessed during the nine-week study period. Forty elderly volunteers were recruited and divided randomly into group A and group B--each consisting of 20 volunteers. The treatment procedure for group A was 500 mg NS capsule twice daily for nine weeks and Group B received placebo instead of NS in the similar manner. All the volunteers were assessed for neuropsychological state and safety profile twice before treatment and after nine weeks. The neuropsychological tests were logical memory test, digit span test, Rey-Osterrieth complex figure test, letter cancellation test, trail making test and stroop test. Safety profile was assessed by measuring biochemical markers of Cardiac (total cholesterol, triglycerides and high density lipoprotein cholesterol, very low density lipoprotein, low density lipoprotein cholesterol, creatine kinase-MB); Liver (aspartate aminotransferase, alanin aminotransferase, alkaline phosphatase, total protein, albumin, bilirubin) and Kidney (creatinine and blood urea nitrogen) through using commercial kits. There was significant difference (p0.05) in any of the biochemical markers of cardiac, liver, kidney function during this nine-week study period. The current study demonstrates the role of NS in enhancing memory, attention and cognition. Therefore, whether NS

  18. A comparative bioavailability study of two formulations of pregabalin in healthy Chilean volunteers.

    Science.gov (United States)

    Quiñones, Luis; Sasso, Jaime; Tamayo, Evelyn; Catalán, Johanna; González, Juan Paplo; Escala, Mario; Varela, Nelson; León, Jorge; Cáceres, Dante Daniel; Saavedra, Iván

    2010-07-01

    The aim of this study was to compare the pharmacokinetic parameters between two brands of pregabalin in healthy Chilean volunteers. A randomized, single-dose, two-period, two-sequence, crossover study design with a 2-week washout period was conducted in healthy Chilean males. Plasma samples were collected over a 12-hour period after administration of 150 mg pregabalin in each period. A validated ultra-performance liquid chromatography with positive ionization mass spectrometric detection method was used to analyze pregabalin concentration in plasma. Pharmacokinetic parameters were determined using a noncompartmental method. Bioequivalence between the test and reference products was determined when the ratio for the 90% confidence intervals (CIs) of the difference in the means of the log-transformed area under the curve (AUC)(0-t), AUC(0-∞), and maximum concentration (C(max)) of the two products were within 0.80 and 1.25. The study was carried out on 22 healthy Chilean volunteers. The mean (SD) C(max), AUC(0-t) and AUC(0-∞) of the test formulation (Pregobin™) of pregabalin were 2.10 (0.56) μg/ml, 10.35 (2.00) μgxh/ml and 13.92 (2.74) μgxh/ml, respectively. The mean (SD) C(max), AUC(0-t) and AUC(0-∞) of the reference formulation (Lyrica™) of pregabalin were 2.15 (0.52) μg/ml, 10.31 (1.85) μgxh/ml and 13.78 (2.25) μgxh/ml, respectively. The parametric 90% CIs for C(max), AUC(0-t), and AUC(0-∞) were 0.97-1.13, 1.01-1.04, and 0.98-1.02, respectively. These results suggest that both products are bioequivalent and can be used as interchangeable options in the clinical setting.

  19. Disposition kinetics of selenium in healthy volunteers following therapeutic shampoo treatment.

    Science.gov (United States)

    Noisel, Nolwenn; Bouchard, Michèle; Carrier, Gaétan

    2010-05-01

    This study was aimed at documenting the kinetic time courses of selenium (Se) in accessible biological matrices of volunteers following controlled applications of therapeutic shampoo containing Se, to better elucidate the mechanisms by which shampoo-Se accumulates in hair and hence estimate the contribution of this source to total Se body burden. Ten healthy volunteers were exposed to Se-shampoo three times a week over a month. Blood, hair and toenail concentrations along with daily urinary excretions were repeatedly measured over an 18-month period following the onset of application. Over the entire study period, blood concentrations of Se (range: 127-233μg/l) and daily urinary excretions (range: 11.9-150μg/d) remained within baseline range of the general population. Conversely, during shampoo application, mean Se concentrations in hair reached transitional levels of 89μg/g while, following cessation of treatment, a mono-exponential decrease was observed with a mean half-life of 4.5 weeks. Two of the volunteers also exhibited an increase in toenail concentrations of Se during the study period. Results show that Se-shampoo does not contribute significantly to total Se body burden, as assessed from blood and urine levels. Differences observed between blood and urine time courses as compared to hair profiles and the presence of Se on hair grown before treatment indicates an adsorption on hair; however, the gradual decrease in Se concentrations in successive centimeters of hair grown following the application period suggests a concomitant absorption from the scalp during treatment with subsequent excretion in hair. Copyright © 2010 Elsevier B.V. All rights reserved.

  20. Effects of a new motilide, ABT-229, on gastric emptying and postprandial antroduodenal motility in healthy volunteers

    NARCIS (Netherlands)

    Verhagen, M. A.; Samsom, M.; Maes, B.; Geypens, B. J.; Ghoos, Y. F.; Smout, A. J.

    1997-01-01

    BACKGROUND: ABT-229 is a recently developed derivative of erythromycin, devoid of antibiotic activity. We studied the effect of ABT-229 on gastric emptying and postprandial antroduodenal motility in healthy volunteers. METHODS: Placebo, 4 and 16 mg ABT-229 were given as a single oral dose to nine

  1. Measuring tongue volumes and visualizing the chewing and swallowing process using real-time TrueFISP imaging - initial clinical experience in healthy volunteers and patients with acromegaly

    International Nuclear Information System (INIS)

    Ajaj, W.; Goyen, M.; Herrmann, B.; Massing, S.; Goehde, S.; Lauenstein, T.; Ruehm, S.G.

    2005-01-01

    This study assessed both two-dimensional (2D) TrueFISP imaging for quantifying tongue volume and real-time TrueFISP imaging for evaluating chewing and swallowing in healthy volunteers and patients with acromegaly. In 50 healthy volunteers, tongue volumes were measured using a 2D TrueFISP sequence. Chewing and swallowing were visualized using a real-time TrueFISP sequence. Ten patients with acromegaly were examined twice with the same magnetic resonance imaging protocol: once prior to therapy and a second time 6 months after therapy. Prior to therapy, healthy volunteers had an average tongue volume of 140 ml for men and 90 ml for women, and patients with acromegaly had an average tongue volume of 180 ml for men and 145 ml for women. However, 6 months after therapy the mean tongue volumes in patients with acromegaly had decreased to 154 ml in the men and to 125 ml in the women. The chewing and swallowing process was normal in all volunteers. Prior to therapy, just two patients showed a chewing and swallowing pathology, which disappeared after therapy. Patients with acromegaly had larger tongue volumes than healthy volunteers, and TrueFISP imaging proved feasible for visualizing chewing and swallowing in real time and is capable of detecting possible pathologies. Furthermore, TrueFISP imaging can be used to monitor therapeutic approaches in patients with acromegaly. (orig.)

  2. Measuring tongue volumes and visualizing the chewing and swallowing process using real-time TrueFISP imaging - initial clinical experience in healthy volunteers and patients with acromegaly

    Energy Technology Data Exchange (ETDEWEB)

    Ajaj, W.; Goyen, M.; Herrmann, B.; Massing, S.; Goehde, S.; Lauenstein, T.; Ruehm, S.G. [University Hospital, Department of Diagnostic and Interventional Radiology, Essen (Germany)

    2005-05-01

    This study assessed both two-dimensional (2D) TrueFISP imaging for quantifying tongue volume and real-time TrueFISP imaging for evaluating chewing and swallowing in healthy volunteers and patients with acromegaly. In 50 healthy volunteers, tongue volumes were measured using a 2D TrueFISP sequence. Chewing and swallowing were visualized using a real-time TrueFISP sequence. Ten patients with acromegaly were examined twice with the same magnetic resonance imaging protocol: once prior to therapy and a second time 6 months after therapy. Prior to therapy, healthy volunteers had an average tongue volume of 140 ml for men and 90 ml for women, and patients with acromegaly had an average tongue volume of 180 ml for men and 145 ml for women. However, 6 months after therapy the mean tongue volumes in patients with acromegaly had decreased to 154 ml in the men and to 125 ml in the women. The chewing and swallowing process was normal in all volunteers. Prior to therapy, just two patients showed a chewing and swallowing pathology, which disappeared after therapy. Patients with acromegaly had larger tongue volumes than healthy volunteers, and TrueFISP imaging proved feasible for visualizing chewing and swallowing in real time and is capable of detecting possible pathologies. Furthermore, TrueFISP imaging can be used to monitor therapeutic approaches in patients with acromegaly. (orig.)

  3. Health effects of a subway environment in healthy volunteers.

    Science.gov (United States)

    Klepczyńska Nyström, A; Svartengren, M; Grunewald, J; Pousette, C; Rödin, I; Lundin, A; Sköld, C M; Eklund, A; Larsson, B-M

    2010-08-01

    Environmental particle exposure, often estimated as the particulate mass of particles with a diameter subway environment. 20 healthy volunteers were exposed to a subway and a control environment for 2 h, followed by measurements of lung function and the inflammatory response in the lower airways (bronchoscopy) and in the peripheral blood. No cellular response was found in the airways after exposure to the subway environment. In the blood, we found a statistically significant increase in fibrinogen and regulatory T-cells expressing CD4/CD25/FOXP3. Subway and road tunnel environments have similar levels of PM(10) and PM(2.5), whilst the concentrations of ultrafine particles, nitrogen monoxide and dioxide are lower in the subway. Although no cellular response was detected, the findings indicate a biological response to the subway environment. Our studies show that using gravimetric estimates of ambient particulate air pollution alone may have clear limitations in health-risk assessment.

  4. Relative bioavailability of generic and branded acetylcysteine effervescent tablets: A single-dose, open-label, randomized-sequence, two-period crossover study in fasting healthy Chinese male volunteers.

    Science.gov (United States)

    Liu, Yan-Mei; Liu, Yun; Lu, Chuan; Jia, Jing-Ying; Liu, Gang-Yi; Weng, Li-Ping; Wang, Jia-Yan; Li, Guo-Xiu; Wang, Wei; Li, Shui-Jun; Yu, Chen

    2010-11-01

    Acetylcysteine may be used as a muco- lytic agent for the treatment of chronic bronchitis, chronic obstructive pulmonary disease, and other pulmonary diseases complicated by the production of viscous mucus. However, little is known of its pharmacokinetic properties when given orally in healthy volunteers, particularly in a Chinese Han population. This study was conducted to provide support for the marketing of a generic product in China. The purpose of this study was to compare the pharmacokinetics and relative bioavailability of a generic test formulation and a branded reference formulation of acetylcysteine in fasting healthy Chinese male volunteers. A single-dose, open-label, randomized-sequence, 2-period crossover design with a 7-day washout period between doses was used in this study. Healthy Chinese male nonsmokers aged 18 to 40 years with a body mass index (BMI) of 19 to 25 kg/m(2) were selected. Eligible volunteers were randomly assigned to receive acetylcysteine 600 mg PO as either the test formulation (3 tablets of 200 mg each) or reference formulation (1 tablet of 600 mg) under fasting conditions. A total of 15 serial blood samples were collected over a 24-hour interval, and total plasma acetylcysteine concentrations were analyzed by a validated liquid chromatography-isotopic dilution mass spectrometry method. Pharmacokinetic parameters (C(max), T(max), t(½) AUC(0-t), and AUC(0-∞) were calculated and analyzed statistically. The 2 formulations were considered bioequivalent if the 90% CIs of the log-transformed ratios (test/reference) of C(max) and AUC were within the predetermined bioequivalence ranges (70%-143% for C(max); 80%-125% for AUC), as established by the State Food and Drug Administration of China. Tolerability was determined by vital signs, clinical laboratory tests, 12-lead ECGs, physical examinations, and interviews with the subjects about adverse events (AEs). A total of 24 healthy Chinese Han male volunteers were enrolled in and

  5. Frequency of functional bowel disorders among healthy volunteers in Mexico City.

    Science.gov (United States)

    Schmulson, Max; Ortíz, Orianna; Santiago-Lomeli, Mariana; Gutiérrez-Reyes, Gabriela; Gutiérrez-Ruiz, María Concepción; Robles-Díaz, Guillermo; Morgan, Douglas

    2006-01-01

    The frequency of functional bowel disorders (FBD) in Mexico using the Rome II criteria is unknown. The Rome II Modular Questionnaire (RII-MQ) was translated into Spanish in coordination with the Rome Committee and their Latin American program. Volunteers were recruited by advertisement in Mexico City, and administered the RII-MQ. The study population consisted of 324 healthy volunteers, with a mean age of 35.7; 66% were female. The most prevalent disorders were heartburn 35%, irritable bowel syndrome (IBS) 35%, functional bloating 21%, proctalgia fugax 21%, and functional constipation 19%. Based on gender, IBS-C was 4 times more frequent in females than males (19 vs. 4.6%) and functional bloating 3 times more frequent (10 vs. 3.7%). Differences according to occupation included a higher prevalence of ulcer-like dyspepsia (p = 0.04), IBS-C (p = 0.018) and proctalgia fugax (p = 0.034) among students. This is the first study to use RII-MQ to determine the prevalence of FBD in urban Mexico. The prevalence of IBS was significant and is related to a number of factors, including the stress of living in an overpopulated city. Selection bias is likely operative. A community-based study is warranted. Copyright 2006 S. Karger AG, Basel

  6. Hyperpolarized 3He apparent diffusion coefficient MRI of the lung: reproducibility and volume dependency in healthy volunteers and patients with emphysema

    DEFF Research Database (Denmark)

    Diaz, S.; Casselbrant, I.; Piitulainen, E.

    2008-01-01

    PURPOSE: To measure the apparent diffusion coefficient (ADC) of hyperpolarized (HP) (3)He gas using diffusion weighted MRI in healthy volunteers and patients with emphysema and examine the reproducibility and volume dependency. MATERIALS AND METHODS: A total of eight healthy volunteers and 16...... patients with emphysema were examined after inhalation of HP (3)He gas mixed with nitrogen (N(2)) during breathhold starting from functional residual capacity (FRC) in supine position. Coronal diffusion-sensitized MR images were acquired. Each subject was imaged on three separate days over a seven...... in mean ADC with increased inhaled gas volume was observed in both groups. CONCLUSION: Mean ADC and SD of HP (3)He MRI is reproducible and discriminates well between healthy controls and patients with emphysema at the higher gas volume. This method is robust and may be useful to gain new insights...

  7. Influence of kinnow juice on the bioavailability of carbamazepine in healthy male volunteers.

    Science.gov (United States)

    Garg, S K; Bhargava, V K; James, H; KuJan-Mar, N; Prabhakar, S; Naresh, Ku

    1998-01-01

    Kinnow juice produces a marked and variable increase in carbamazepine bioavailability. The pharmacokinetics of carbamazepine was studied after drug administration with 300 ml water or kinnow juice in a randomized cross over trial on nine healthy male volunteers. With kinnow juice peak serum concentration (Cmax) and area under the serum concentration time curve (AUC) was significantly (P kinnow juice enhances carbamazepine bioavailability could be due to inhibition of cytochrome P-450 enzyme, since kinnow juice contains naringin which is considered to be inhibitor of liver microsomal dihydropyridine oxidation.

  8. Topical administration of regorafenib eye drops: phase I dose-escalation study in healthy volunteers.

    Science.gov (United States)

    Zimmermann, Torsten; Höchel, Joachim; Becka, Michael; Boettger, Michael K; Rohde, Beate; Schug, Barbara; Kunert, Kathleen S; Donath, Frank

    2018-05-01

    Regorafenib is a multikinase inhibitor under investigation for use in neovascular age-related macular degeneration. In this phase I study, regorafenib eye drops were administered to healthy volunteers to provide information on safety, tolerability and systemic exposure. This was a single-centre, randomized, double-masked, parallel-group, dose-escalation, placebo-controlled study. Subjects received regorafenib eye drops (30 mg ml -1 , 25 μl) as a 0.75 mg single dose (Cohort 1), 0.75 mg twice daily (bid) or thrice daily (tid) over 14 days (Cohorts 2 and 3, respectively), 1.5 mg tid unilaterally for 3 days, then bilaterally for up to 14 days (Cohort 4), or placebo. Plasma samples were taken to estimate systemic exposure. Safety and functional assessments were performed throughout the study. Thirty-six subjects received regorafenib and 12 received placebo. Regorafenib was safe and well tolerated over the dose range. No pathological changes occurred in the anterior, vitreous or posterior eye compartments. Mild eyelid redness, oedema and conjunctival hyperaemia were observed across all regorafenib cohorts; these were comparable with the effects seen with placebo. Predominant symptoms were blurred vision in the active and placebo groups. Systemic safety evaluations showed no clinically relevant findings. Absolute systemic exposure after multiple administrations of regorafenib eye drops at a dose of 0.75 mg was 600-700-fold lower than after multiple oral administration of 160 mg day -1 , the dose approved in cancer indications. These results indicate a favourable safety and tolerability profile of regorafenib eye drops up to 30 mg ml -1 tid for use in clinical studies. © 2018 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

  9. Effect of age and gender on dopamine transporter imaging with [123I]FP-CIT SPET in healthy volunteers

    International Nuclear Information System (INIS)

    Lavalaye, J.; Booij, J.; Reneman, L.; Habraken, J.B.A.; Royen, E.A. van

    2000-01-01

    Dopamine transporter imaging is a valuable tool to investigate the integrity of the dopaminergic neurons. To date, several reports have shown an age-associated decline in dopamine transporters in healthy volunteers. Although animal studies suggest an effect of gender on dopamine transporter density, this gender effect has not yet been confirmed in human studies. To study the influence of age and gender on dopamine transporter imaging in healthy volunteers, we performed single-photon emission tomography imaging with [ 123 I]FP-CIT to quantify dopamine transporters. Forty-five healthy volunteers (23 males and 22 females) were included, ranging in age from 18 to 83 years. SPET imaging was performed 3 h after injection of ±110 MBq [ 123 I]FP-CIT. An operator-independent volume of interest analysis was used for quantification of [ 123 I]FP-CIT binding in the striatum. The ratio of specific striatal to non-specific [ 123 I]FP-CIT binding was found to decrease significantly with age. Moreover, we found a high variance in [ 123 I]FP-CIT binding in young adults. Finally, females were found to have significantly higher [ 123 I]FP-CIT binding ratios than males. This effect of gender on [ 123 I]FP-CIT binding ratios was not related to age. The results of this study are consistent with findings from previous studies, which showed that dopamine transporter density declines with age. The intriguing finding of a higher dopamine transporter density in females than in males is in line with findings from animal studies. (orig.)

  10. Digestive tract microbiota in healthy volunteers Microbiota no trato digestivo em voluntários saudáveis

    Directory of Open Access Journals (Sweden)

    Bruno Zilberstein

    2007-02-01

    Full Text Available PURPOSE: The aim of this study was to standardize the methods of sample collection of mucus from the digestive tract and to determine the microbiota in healthy volunteers from Brazil, collecting samples from the mouth, esophagus, stomach, duodenum, jejunum, ileum, colon, and rectum. METHODS: Microbiota of selected healthy volunteers from the oral cavity (n=10, the esophagus (n=10, the upper digestive tract (n=20, and the lower digestive tract (n=24 were evaluated through distinct collection methods. Collection methods took into account the different sites, using basic scraping and swabbing techniques, stimulated saliva from the oral cavity, irrigation-aspiration with sterile catheters especially designed for the esophagus, a probe especially designed for upper digestive tract, and a special catheter for the lower digestive tract. RESULTS: (i Mixed microbiota were identified in the oral cavity, predominantly Gram-positive aerobic and anaerobic cocci; (ii transitional flora mainly in the esophagus; (iii Veillonella sp, Lactobacillus sp, and Clostridium sp in the stomach and duodenum; (iv in the jejunum and upper ileum, we observed Bacteroides sp, Proteus sp, and Staphylococcus sp, in addition to Veillonella sp; (v in the colon, the presence of "nonpathogenic" anaerobic bacteria Veillonella sp (average 10(5 UFC indicates the existence of a low oxidation-reduction potential environment, which suggests the possibility of adoption of these bacteria as biological markers of total digestive tract health. CONCLUSIONS: The collection methods were efficient in obtaining adequate samples from each segment of the total digestive tract to reveal the normal microbiota. These procedures are safe and easily reproducible for microbiological studies.OBJETIVO: Padronizar os métodos de coleta do muco do trato digestivo e determinar a microbiota, em voluntários saudáveis no Brasil, coletando amostras da boca, esôfago, estômago, duodeno, jejunos e íleo, c

  11. Effect of eslicarbazepine acetate and oxcarbazepine on cognition and psychomotor function in healthy volunteers.

    Science.gov (United States)

    Milovan, Denise; Almeida, Luis; Romach, Myroslava K; Nunes, Teresa; Rocha, José Francisco; Sokowloska, Marta; Sellers, Edward M; Soares-da-Silva, Patrício

    2010-08-01

    The results of two single-blind studies conducted to evaluate the cognitive and psychomotor effects of eslicarbazepine acetate and oxcarbazepine following single and repeated administration in healthy volunteers are reported. The cognitive and psychomotor evaluation consisted of several computerized and paper-and-pencil measures. Eslicarbazepine acetate and oxcarbazepine had similar overall cognitive profiles and did not cause clinically relevant cognitive impairment. The incidence of adverse events was lower with eslicarbazepine acetate than with oxcarbazepine. Copyright 2010. Published by Elsevier Inc.

  12. Prediction of psilocybin response in healthy volunteers.

    Science.gov (United States)

    Studerus, Erich; Gamma, Alex; Kometer, Michael; Vollenweider, Franz X

    2012-01-01

    Responses to hallucinogenic drugs, such as psilocybin, are believed to be critically dependent on the user's personality, current mood state, drug pre-experiences, expectancies, and social and environmental variables. However, little is known about the order of importance of these variables and their effect sizes in comparison to drug dose. Hence, this study investigated the effects of 24 predictor variables, including age, sex, education, personality traits, drug pre-experience, mental state before drug intake, experimental setting, and drug dose on the acute response to psilocybin. The analysis was based on the pooled data of 23 controlled experimental studies involving 409 psilocybin administrations to 261 healthy volunteers. Multiple linear mixed effects models were fitted for each of 15 response variables. Although drug dose was clearly the most important predictor for all measured response variables, several non-pharmacological variables significantly contributed to the effects of psilocybin. Specifically, having a high score in the personality trait of Absorption, being in an emotionally excitable and active state immediately before drug intake, and having experienced few psychological problems in past weeks were most strongly associated with pleasant and mystical-type experiences, whereas high Emotional Excitability, low age, and an experimental setting involving positron emission tomography most strongly predicted unpleasant and/or anxious reactions to psilocybin. The results confirm that non-pharmacological variables play an important role in the effects of psilocybin.

  13. Prediction of psilocybin response in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Erich Studerus

    Full Text Available Responses to hallucinogenic drugs, such as psilocybin, are believed to be critically dependent on the user's personality, current mood state, drug pre-experiences, expectancies, and social and environmental variables. However, little is known about the order of importance of these variables and their effect sizes in comparison to drug dose. Hence, this study investigated the effects of 24 predictor variables, including age, sex, education, personality traits, drug pre-experience, mental state before drug intake, experimental setting, and drug dose on the acute response to psilocybin. The analysis was based on the pooled data of 23 controlled experimental studies involving 409 psilocybin administrations to 261 healthy volunteers. Multiple linear mixed effects models were fitted for each of 15 response variables. Although drug dose was clearly the most important predictor for all measured response variables, several non-pharmacological variables significantly contributed to the effects of psilocybin. Specifically, having a high score in the personality trait of Absorption, being in an emotionally excitable and active state immediately before drug intake, and having experienced few psychological problems in past weeks were most strongly associated with pleasant and mystical-type experiences, whereas high Emotional Excitability, low age, and an experimental setting involving positron emission tomography most strongly predicted unpleasant and/or anxious reactions to psilocybin. The results confirm that non-pharmacological variables play an important role in the effects of psilocybin.

  14. Closed and open breathing circuit function in healthy volunteers during exercise at Mount Everest base camp (5300 m)

    NARCIS (Netherlands)

    McMorrow, R. C. N.; Windsor, J. S.; Hart, N. D.; Richards, P.; Rodway, G. W.; Ahuja, V. Y.; O'Dwyer, M. J.; Mythen, M. G.; Grocott, M. P. W.; Ahuja, V.; Aref-Adib, G.; Burnham, R.; Chisholm, A.; Clarke, K.; Coates, D.; Coates, M.; Cook, D.; Cox, M.; Dhillon, S.; Dougall, C.; Doyle, P.; Duncan, P.; Edsell, M.; Edwards, L.; Evans, L.; Gardiner, P.; Grocott, M.; Gunning, P.; Hart, N.; Harrington, J.; Harvey, J.; Holloway, C.; Howard, D.; Hurlbut, D.; Imray, C.; Ince, C.; Jonas, M.; van der Kaaij, J.; Khosravi, M.; Kolfschoten, N.; Levett, D.; Luery, H.; Luks, A.; Martin, D.; McMorrow, R.; Meale, P.; Mitchell, K.; Montgomery, H.; Morgan, G.; Morgan, J.

    2012-01-01

    We present a randomised, controlled, crossover trial of the Caudwell Xtreme Everest (CXE) closed circuit breathing system vs an open circuit and ambient air control in six healthy, hypoxic volunteers at rest and exercise at Everest Base Camp, at 5300 m. Compared with control, arterial oxygen

  15. Calcineurin inhibitors acutely improve insulin sensitivity without affecting insulin secretion in healthy human volunteers

    DEFF Research Database (Denmark)

    Øzbay, Aygen; Møller, Niels; Juhl, Claus

    2012-01-01

    and tacrolimus has been attributed to both beta cell dysfunction and impaired insulin sensitivity. WHAT THIS STUDY ADDS: This is the first trial to investigate beta cell function and insulin sensitivity using gold standard methodology in healthy human volunteers treated with clinically relevant doses...... of ciclosporin and tacrolimus. We document that both drugs acutely increase insulin sensitivity, while first phase and pulsatile insulin secretion remain unaffected. This study demonstrates that ciclosporin and tacrolimus have similar acute effects on glucose metabolism in healthy humans. AIM The introduction...... of calcineurin inhibitors (CNIs) ciclosporin (CsA) and tacrolimus (Tac) has improved the outcome of organ transplants, but complications such as new onset diabetes mellitus after transplantation (NODAT) cause impairment of survival rates. The relative contribution of each CNI to the pathogenesis and development...

  16. Improved lipid profile and increased serum antioxidant capacity in healthy volunteers after Sambucus ebulus L. fruit infusion consumption.

    Science.gov (United States)

    Ivanova, Diana; Tasinov, Oskan; Kiselova-Kaneva, Yoana

    2014-09-01

    This study aimed to establish the effect of Sambucus ebulus L. (SE) ripe fruit infusion on body weight, blood pressure, glucose levels, lipid profile and antioxidant markers in healthy volunteers in respect of its possible protective activity against cardiovascular diseases and other oxidative stress-related diseases. The study involved 21 healthy volunteers, aged between 20 and 59, BMI 23.12 ± 1.31, who consumed 200 ml SE infusion/day for a period of 30 d. Blood samples were collected before and at the end of the intervention. Significant decrease in triglycerides (14.92%), total cholesterol (15.04%) and LDL-C (24.67%) was established at the end of the study. In addition, HDL-C/LDL-C ratio increased by 42.77%. Improved serum antioxidant capacity and total thiol levels were also established. The results presented in this first human intervention study with SE fruit infusion indicate the potential of the plant to improve lipid profile and serum antioxidant capacity in humans.

  17. Inhibition of cytokine production by methotrexate. Studies in healthy volunteers and patients with rheumatoid arthritis.

    OpenAIRE

    Gerards, A.H.; Lathouder, de, S; Groot, E.R.; Dijkmans, B.A.C.; Aarden, L.A.

    2003-01-01

    OBJECTIVES: To analyse whether the beneficial effects of methotrexate in rheumatoid arthritis (RA) could be due to inhibition of inflammatory cytokine production. METHODS: Cytokine production was studied using whole blood (WB) and mononuclear cells (MNC) of healthy volunteers and RA patients. Cultures were stimulated with either bacterial products such as lipo-oligosaccharide (LOS) or Staphylococcus aureus Cowan I (SAC) to activate monocytes or with monoclonal antibodies to CD3 and CD28 to in...

  18. Effect of Resveratrol Treatment on the Pharmacokinetics of Diclofenac in Healthy Human Volunteers.

    Science.gov (United States)

    Bedada, Satish Kumar; Yellu, Narsimha Reddy; Neerati, Prasad

    2016-03-01

    The purpose of the present study was to assess the effect of resveratrol (RSV) treatment on the pharmacokinetics of diclofenac (DIC) in healthy human volunteers. The open-label, two period, sequential study was conducted in 12 healthy human volunteers. A single dose of RSV 500 mg was administered daily for 10 days during treatment phase. A single dose of DIC 100 mg was administered during control and after treatment phases under fasting conditions. The blood samples were collected after DIC dosing and analyzed by HPLC. Treatment with RSV significantly enhanced maximum plasma concentration (Cmax) (1.73 to 2.91 µg/mL), area under the curve (AUC) (5.05 to 9.95 g h/mL), half life (T1/2) (1.12 to 1.76 h) and significantly decreased elimination rate constant (Kel ) (0.71 to 0.41 h(-1)), apparent oral clearance (CL/F) (14.58 to 6.48 L/h) of DIC as compared to control. The geometric mean ratios for Cmax, AUC, T1/2, Kel and CL/F of DIC were 1.75, 2.12, 1.65, 0.61 and 0.47, respectively were outside the limits of 0.8-1.25, which indicates clinically significant interaction between DIC and RSV. The results suggest that the altered pharmacokinetics of DIC might be attributed to RSV mediated inhibition of CYP2C9 enzyme. Therefore, combination therapy of DIC along with RSV may represent a novel approach to reduce dosage and results in reduced gastrointestinal side effects of DIC. Copyright © 2015 John Wiley & Sons, Ltd.

  19. A simplified ingestion procedure for esophageal capsule endoscopy: initial evaluation in healthy volunteers.

    Science.gov (United States)

    Gralnek, I M; Rabinovitz, R; Afik, D; Eliakim, R

    2006-09-01

    Initial studies on esophageal capsule endoscopy (PillCam ESO) reported excellent sensitivity and specificity, but these were followed by mixed results in several subsequent studies, probably due to deviations from the recommended ingestion protocol and the inconvenience of capsule ingestion in the supine position. The aim of this study was therefore to test a simplified ingestion procedure (SIP) for PillCam ESO. Using a cross-over study design, the SIP was prospectively compared with the original ingestion procedure for PillCam ESO in 24 healthy volunteers (15 men, nine women; mean age 44, range 27 - 70) and evaluated for: bubbles/saliva interference at the Z-line, Z-line circumferential visualization (quadrants), and convenience and ease of the ingestion procedure. All Rapid 4 videos were reviewed in a randomized manner and read by an experienced PillCam ESO reader blinded to the ingestion procedure used. It was found that the SIP significantly improved visualization in comparison with the original ingestion procedure, with less interference due to bubbles/saliva observed at the gastroesophageal junction ( P = 0.002) and improved visualization of the Z-line ( P = 0.025). Although the esophageal transit time was significantly faster with the SIP (3 : 45 min vs. 0 : 38 min; P = 0.0001), there were no differences in the number of Z-line frames/images captured. This new, simplified ingestion procedure for PillCam ESO provides significantly improved visualization of the Z-line in healthy volunteers. The overall test characteristics of PillCam ESO using SIP should be tested in patients with esophageal disease.

  20. Red wine intake but not other alcoholic beverages increases total antioxidant capacity and improves pro-inflammatory profile after an oral fat diet in healthy volunteers.

    Science.gov (United States)

    Torres, A; Cachofeiro, V; Millán, J; Lahera, V; Nieto, M L; Martín, R; Bello, E; Alvarez-Sala, L A

    2015-12-01

    Different alcoholic beverages exert different effects on inflammation and oxidative stress but these results are controversial and scanty in some aspects. We analyze the effect of different alcoholic beverages after a fat-enriched diet on lipid profile, inflammatory factors and oxidative stress in healthy people in a controlled environment. We have performed a cross-over design in five different weeks. Sixteen healthy volunteers have received the same oral fat-enriched diet (1486kcal/m(2)) and a daily total amount of 16g/m(2) of alcohol, of different beverages (red wine, vodka, brandy or rum) and equivalent caloric intakes as sugar with water in the control group. We have measured the levels of serum lipids, high sensitivity C-reactive protein (hsCRP), tumor necrosis factor α (TNFα), interleukin 6 (IL-6), soluble phospholipase A2 (sPLA2), lipid peroxidation (LPO) and total antioxidant capacity (TAC). Red wine intake was associated with decreased of mean concentrations of hsCRP, TNFα and IL-6 induced by fat-enriched diet (p<0.05); nevertheless, sPLA2 concentrations were not significantly modified. After a fat-enriched diet added with red wine, TAC increased as compared to the same diet supplemented with rum, brandy, vodka or the control (water with sugar) (p<0.05). Moderate red wine intake, but not other alcoholic beverages, decreased pro-inflammatory factors and increased total antioxidant capacity despite a fat-enriched diet intake in healthy young volunteers. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  1. Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Pickering G

    2016-12-01

    Full Text Available Gisèle Pickering,1–3 Nicolas Macian,1,2 Claude Dubray,1–3 Bruno Pereira4 1University Hospital, CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Inserm, CIC 1405, UMR Neurodol 1107, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU de Clermont-Ferrand, Délégation Recherche Clinique Innovation, Clermont-Ferrand, France Background: Acetaminophen (APAP, paracetamol mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467 was carried out from May 30, 2011 to July 12, 2011. Methods: Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature, and a battery of cognitive tests were recorded before and after oral APAP (2 g or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. Results: APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P<0.05. Spatial planning and working memory initial thinking time were decreased (P=0.04. All other tests were not modified by APAP. APAP had an antinociceptive effect (P<0.01 and body temperature did not change. Conclusion: This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance

  2. Immediate effect of suryanadi pranayama on pulmonary function (ventilatory volumes and capacities) in healthy volunteers

    OpenAIRE

    Shravya Keerthi G, Hari Krishna Bandi, Suresh M, Mallikarjuna Reddy N

    2013-01-01

    Objectives: we found only effects of at least a short term practice extended over a period of a few days to weeks of pranayama (alternate nostril breathing) rather than acute effects of unilateral right nostril breathing (suryanadi pranayama). Keeping this in mind the present study was designed to test the hypothesis that 10 min. of right nostril breathing have any immediate effect on ventilatory volumes and capacities in healthy volunteers. Methodology: Forced vital capacity (FVC), Forced ex...

  3. Modafinil combined with cognitive training is associated with improved learning in healthy volunteers--a randomised controlled trial.

    Science.gov (United States)

    Gilleen, J; Michalopoulou, P G; Reichenberg, A; Drake, R; Wykes, T; Lewis, S W; Kapur, S

    2014-04-01

    Improving cognition in people with neuropsychiatric disorders remains a major clinical target. By themselves pharmacological and non-pharmacological approaches have shown only modest effects in improving cognition. In the present study we tested a recently-proposed methodology to combine CT with a 'cognitive-enhancing' drug to improve cognitive test scores and expanded on previous approaches by delivering combination drug and CT, over a long intervention of repeated sessions, and used multiple tasks to reveal the cognitive processes being enhanced. We also aimed to determine whether gains from this combination approach generalised to untrained tests. In this proof of principle randomised-controlled trial thirty-three healthy volunteers were randomised to receive either modafinil or placebo combined with daily cognitive training over two weeks. Volunteers were trained on tasks of new-language learning, working memory and verbal learning following 200 mg modafinil or placebo for ten days. Improvements in trained and untrained tasks were measured. Rate of new-language learning was significantly enhanced with modafinil, and effects were greatest over the first five sessions. Modafinil improved within-day learning rather than between-day retention. No enhancement of gains with modafinil was observed in working memory nor rate of verbal learning. Gains in all tasks were retained post drug-administration, but transfer effects to broad cognitive abilities were not seen. This study shows that combining CT with modafinil specifically elevates learning over early training sessions compared to CT with placebo and provides a proof of principle experimental paradigm for pharmacological enhancement of cognitive remediation. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  4. Quantitative assessment of global and regional air trappings using non-rigid registration and regional specific volume change of inspiratory/expiratory CT scans: Studies on healthy volunteers and asthmatics

    International Nuclear Information System (INIS)

    Lee, Eun Sol; Seo, Joon Beom; Lee, Hyun Joo; Chae, Eun Jin; Lee, Sang Min; Oh, Sang Young; Kim, Nam Kug

    2015-01-01

    The purpose of this study was to compare air trapping in healthy volunteers with asthmatics using pulmonary function test and quantitative data, such as specific volume change from paired inspiratory CT and registered expiratory CT. Sixteen healthy volunteers and 9 asthmatics underwent paired inspiratory/expiratory CT. DeltaSV, which represents the ratio of air fraction released after exhalation, was measured with paired inspiratory and anatomically registered expiratory CT scans. Air trapping indexes, DeltaSV0.4 and DeltaSV0.5, were defined as volume fraction of lung below 0.4 and 0.5 DeltaSV, respectively. To assess the gravity effect of air-trapping, DeltaSV values of anterior and posterior lung at three different levels were measured and DeltaSV ratio of anterior lung to posterior lung was calculated. Color-coded DeltaSV map of the whole lung was generated and visually assessed. Mean DeltaSV, DeltaSV0.4, and DeltaSV0.5 were compared between healthy volunteers and asthmatics. In asthmatics, correlation between air trapping indexes and clinical parameters were assessed. Mean DeltaSV, DeltaSV0.4, and DeltaSV0.5 in asthmatics were significantly higher than those in healthy volunteer group (all p < 0.05). DeltaSV values in posterior lung in asthmatics were significantly higher than those in healthy volunteer group (p = 0.049). In asthmatics, air trapping indexes, such as DeltaSV0.5 and DeltaSV0.4, showed negative strong correlation with FEF25-75, FEV1, and FEV1/FVC. DeltaSV map of asthmatics showed abnormal geographic pattern in 5 patients (55.6%) and disappearance of anterior-posterior gradient in 3 patients (33.3%). Quantitative assessment of DeltaSV (the ratio of air fraction released after exhalation) shows the difference in extent of air trapping between health volunteers and asthmatics.

  5. Quantitative assessment of global and regional air trappings using non-rigid registration and regional specific volume change of inspiratory/expiratory CT scans: Studies on healthy volunteers and asthmatics

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun Sol; Seo, Joon Beom; Lee, Hyun Joo; Chae, Eun Jin; Lee, Sang Min; Oh, Sang Young; Kim, Nam Kug [Dept. of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of)

    2015-06-15

    The purpose of this study was to compare air trapping in healthy volunteers with asthmatics using pulmonary function test and quantitative data, such as specific volume change from paired inspiratory CT and registered expiratory CT. Sixteen healthy volunteers and 9 asthmatics underwent paired inspiratory/expiratory CT. DeltaSV, which represents the ratio of air fraction released after exhalation, was measured with paired inspiratory and anatomically registered expiratory CT scans. Air trapping indexes, DeltaSV0.4 and DeltaSV0.5, were defined as volume fraction of lung below 0.4 and 0.5 DeltaSV, respectively. To assess the gravity effect of air-trapping, DeltaSV values of anterior and posterior lung at three different levels were measured and DeltaSV ratio of anterior lung to posterior lung was calculated. Color-coded DeltaSV map of the whole lung was generated and visually assessed. Mean DeltaSV, DeltaSV0.4, and DeltaSV0.5 were compared between healthy volunteers and asthmatics. In asthmatics, correlation between air trapping indexes and clinical parameters were assessed. Mean DeltaSV, DeltaSV0.4, and DeltaSV0.5 in asthmatics were significantly higher than those in healthy volunteer group (all p < 0.05). DeltaSV values in posterior lung in asthmatics were significantly higher than those in healthy volunteer group (p = 0.049). In asthmatics, air trapping indexes, such as DeltaSV0.5 and DeltaSV0.4, showed negative strong correlation with FEF25-75, FEV1, and FEV1/FVC. DeltaSV map of asthmatics showed abnormal geographic pattern in 5 patients (55.6%) and disappearance of anterior-posterior gradient in 3 patients (33.3%). Quantitative assessment of DeltaSV (the ratio of air fraction released after exhalation) shows the difference in extent of air trapping between health volunteers and asthmatics.

  6. Anatomically standardised {sup 99m}Tc-ECD brain perfusion SPET allows accurate differentiation between healthy volunteers, multiple system atrophy and idiopathic Parkinson's disease

    Energy Technology Data Exchange (ETDEWEB)

    Bosman, Tommy [Division of Nuclear Medicine, P7, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Van Laere, Koen [Department of Nuclear Medicine, Leuven University Hospital, Herestraat 49, 3000 Leuven (Belgium); Santens, Patrick [Department of Neurology, Ghent University Hospital, Ghent (Belgium)

    2003-01-01

    The clinical differentiation between typical idiopathic Parkinson's disease (IPD) and atypical parkinsonian disorders such as multiple system atrophy (MSA) is complicated by the presence of signs and symptoms common to both forms. The goal of this study was to re-evaluate the contribution of brain perfusion single-photon emission tomography (SPET) with anatomical standardisation and automated analysis in the differentiation of IPD and MSA. This was achieved by discriminant analysis in comparison with a large set of age- and gender-matched healthy volunteers. Technetium-99m ethyl cysteinate dimer SPET was performed on 140 subjects: 81 IPD patients (age 62.6{+-}10.2 years; disease duration 11.0{+-}6.4 years; 50 males/31 females), 15 MSA patients (61.5{+-}9.2 years; disease duration 3.0{+-}2.2 years; 9 males/6 females) and 44 age- and gender-matched healthy volunteers (age 59.2{+-}11.9 years; 27 males/17 females). Patients were matched for severity (Hoehn and Yahr stage). Automated predefined volume of interest (VOI) analysis was carried out after anatomical standardisation. Stepwise discriminant analysis with cross-validation using the leave-one-out method was used to determine the subgroup of variables giving the highest accuracy for this differential diagnosis. Between MSA and IPD, the only regions with highly significant differences in uptake after Bonferroni correction were the putamen VOIs. Comparing MSA versus normals and IPD, with putamen VOI values as discriminating variables, cross-validated performance showed correct classification of MSA patients with a sensitivity of 73.3%, a specificity of 84% and an accuracy of 83.6%. Additional input from the right caudate head and the left prefrontal and left mesial temporal cortex allowed 100% discrimination even after cross-validation. Discrimination between the IPD group alone and healthy volunteers was accurate in 94% of the cases after cross-validation, with a sensitivity of 91.4% and a specificity of 100

  7. Effects of Blueberry and Cranberry Juice Consumption on the Plasma Antioxidant Capacity of Healthy Female Volunteers

    DEFF Research Database (Denmark)

    Pedersen(Vægter), Christian Bjerggaard; Kyle, J; Jenkinson, AM

    2000-01-01

    OBJECTIVE: To assess whether consumption of 500 ml of blueberry juice or cranberry juice by healthy female subjects increased plasma phenolic content and antioxidant capacity. DESIGN: Latin square arrangement to eliminate ordering effects. After an overnight fast, nine volunteers consumed 500 ml...... of blueberry juice, cranberry juice or a sucrose solution (control); each volunteer participated on three occasions one week apart, consuming one of the beverages each time. Blood samples were obtained by venipuncture at intervals up to four hours after consumption of the juices. Urine samples were also......-120 min. This corresponded to a 30% increase in vitamin C and a small but significant increase in total phenols in plasma. Consumption of blueberry juice had no such effects. CONCLUSION: The increase in plasma antioxidant capacity following consumption of cranberry juice could mainly be accounted...

  8. Normal spectrum of pulmonary parametric response map to differentiate lung collapsibility: distribution of densitometric classifications in healthy adult volunteers

    International Nuclear Information System (INIS)

    Silva, Mario; Nemec, Stefan F.; Dufresne, Valerie; Occhipinti, Mariaelena; Heidinger, Benedikt H.; Bankier, Alexander A.; Chamberlain, Ryan

    2016-01-01

    Pulmonary parametric response map (PRM) was proposed for quantitative densitometric phenotypization of chronic obstructive pulmonary disease. However, little is known about this technique in healthy subjects. The purpose of this study was to describe the normal spectrum of densitometric classification of pulmonary PRM in a group of healthy adults. 15 healthy volunteers underwent spirometrically monitored chest CT at total lung capacity (TLC) and functional residual capacity (FRC). The paired CT scans were analyzed by PRM for voxel-by-voxel characterization of lung parenchyma according to 4 densitometric classifications: normal lung (TLC ≥ -950 HU, FRC ≥ -856 HU); expiratory low attenuation area (LAA) (TLC ≥ -950 HU, FRC < -856 HU); dual LAA (TLC<-950 HU, FRC < -856 HU); uncharacterized (TLC < -950 HU, FRC ≥ -856 HU). PRM spectrum was 78 % ± 10 % normal lung, 20 % ± 8 % expiratory LAA, and 1 % ± 1 % dual LAA. PRM was similar between genders, there was moderate correlation between dual LAA and spirometrically assessed TLC (R = 0.531; p = 0.042), and between expiratory LAA and Vol Exp/Insp ratio (R = -0.572; p = 0.026). PRM reflects the predominance of normal lung parenchyma in a group of healthy volunteers. However, PRM also confirms the presence of physiological expiratory LAA seemingly related to air trapping and a minimal amount of dual LAA likely reflecting emphysema. (orig.)

  9. Clinical Pharmacokinetics of IPX066: Evaluation of Dose Proportionality and Effect of Food in Healthy Volunteers.

    Science.gov (United States)

    Yao, Hsuan-Ming; Hsu, Ann; Gupta, Suneel; Modi, Nishit B

    2016-01-01

    IPX066 is an oral, extended-release capsule formulation of carbidopa-levodopa (CD-LD) available in 4 strengths. The goals of this investigation were to assess the dose proportionality of IPX066 and to study the effects of a high-fat, high-calorie meal and of sprinkling the capsule contents on applesauce on the pharmacokinetics of IPX066 in healthy volunteers. Three open-label studies were conducted. In the first study, subjects received 1 capsule of each IPX066 strength (23.75-95, 36.25-145, 48.75-195, and 61.25-245 mg of CD-LD). In the second study, subjects received 1 and 2 capsules of IPX066 245-mg LD under fasting conditions. In the third study, subjects received 2 capsules of IPX066 245-mg LD under 3 conditions: fasting; following a high-fat, high-calorie breakfast; and with the capsule contents sprinkled on applesauce under fasting conditions. Peak plasma concentrations (Cmax) and systemic exposure (AUCt, AUCinf) for LD and CD increased dose-proportionally over the range of the IPX066 capsule strengths. Comparison of 1 and 2 IPX066 245-mg LD capsules showed dose-proportional pharmacokinetics for Cmax and AUCt. Sprinkling the capsule contents on applesauce did not affect the pharmacokinetics. A high-fat, high-calorie meal delayed the initial increase in LD concentration by approximately 1 to 2 hours, reduced Cmax by 21%, and increased AUCinf by 13% compared with the fasted state. IPX066 shows dose-proportional pharmacokinetics. Sprinkling the capsule contents on applesauce does not affect the pharmacokinetics; a high-fat, high-calorie meal delayed absorption by 1 to 2 hours, slightly reduced Cmax, and slightly increased extent of absorption.

  10. Non-uniform versus uniform attenuation correction in brain perfusion SPET of healthy volunteers

    International Nuclear Information System (INIS)

    Van Laere, K.; Versijpt, J.; Dierckx, R.; Koole, M.

    2001-01-01

    Although non-uniform attenuation correction (NUAC) can supply more accurate absolute quantification, it is not entirely clear whether NUAC provides clear-cut benefits in the routine clinical practice of brain SPET imaging. The aim of this study was to compare the effect of NUAC versus uniform attenuation correction (UAC) on volume of interest (VOI)-based semi-quantification of a large age- and gender-stratified brain perfusion normal database. Eighty-nine healthy volunteers (46 females and 43 males, aged 20-81 years) underwent standardised high-resolution single-photon emission tomography (SPET) with 925 MBq 99m Tc-ethyl cysteinate dimer (ECD) on a Toshiba GCA-9300A camera with 153 Gd or 99m Tc transmission CT scanning. Emission images were reconstructed by filtered back-projection and scatter corrected using the triple-energy window correction method. Both non-uniform Chang attenuation correction (one iteration) and uniform Sorenson correction (attenuation coefficient 0.09 cm -1 ) were applied. Images were automatically re-oriented to a stereotactic template on which 35 predefined VOIs were defined for semi-quantification (normalisation on total VOI counts). Small but significant differences between relative VOI uptake values for NUAC versus UAC in the infratentorial region were found. VOI standard deviations were significantly smaller for UAC, 4.5% (range 2.6-7.5), than for NUAC, 5.0% (2.3-9.0) (P 99m Tc-ECD uptake values in healthy volunteers to those obtained with NUAC, although values for the infratentorial region are slightly lower. NUAC produces a slight increase in inter-subject variability. Further study is necessary in various patient populations to establish the full clinical impact of NUAC in brain perfusion SPET. (orig.)

  11. Plantar fascia evaluation with a dedicated magnetic resonance scanner in weight-bearing position: our experience in patients with plantar fasciitis and in healthy volunteers.

    Science.gov (United States)

    Sutera, R; Iovane, A; Sorrentino, F; Candela, F; Mularo, V; La Tona, G; Midiri, M

    2010-03-01

    This study assessed the usefulness of upright weight-bearing examination of the ankle/hind foot performed with a dedicated magnetic resonance (MR) imaging scanner in the evaluation of the plantar fascia in healthy volunteers and in patients with clinical evidence of plantar fasciitis. Between January and March 2009, 20 patients with clinical evidence of plantar fasciitis (group A) and a similar number of healthy volunteers (group B) underwent MR imaging of the ankle/hind foot in the upright weight-bearing and conventional supine position. A 0.25-Tesla MR scanner (G-Scan, Esaote SpA, Genoa, Italy) was used with a dedicated receiving coil for the ankle/hind foot. Three radiologists, blinded to patients' history and clinical findings, assessed in consensus morphological and dimensional changes and signal intensity alterations on images acquired in both positions, in different sequences and in different planes. In group A, MR imaging confirmed the diagnosis in 15/20 cases; in 4/15 cases, a partial tear of the plantar fascia was identified in the upright weight-bearing position alone. In the remaining 5/20 cases in group A and in all cases in group B, the plantar fascia showed no abnormal signal intensity. Because of the increased stretching of the plantar fascia, in all cases in group A and B, thickness in the proximal third was significantly reduced (pplantar fascia, which could be overlooked in the supine position.

  12. Effects of subanaesthetic and anaesthetic doses of sevoflurane on regional cerebral blood flow in healthy volunteers. A positron emission tomographic study

    DEFF Research Database (Denmark)

    Schlünzen, L; Vafaee, M S; Cold, G E

    2004-01-01

    in the thalamus. At the last level (0.4 MAC vs. 1 MAC) the rCBF was increased in the insula and decreased in the posterior cingulate, the lingual gyrus, precuneus and in the frontal cortex. CONCLUSION: At sevoflurane concentrations at 0.7% and 2.0% a significant decrease in relative rCBF was detected...... escalating doses using 0.4%, 0.7% and 2.0% end-tidal sevoflurane inhalation. During baseline and each of the three levels of anaesthesia one PET scan was performed after injection of . Cardiovascular and respiratory parameters were monitored and electroencephalography and bispectral index (BIS) were......BACKGROUND: We tested the hypothesis that escalating drug concentrations of sevoflurane are associated with a significant decline of cerebral blood flow in regions subserving conscious brain activity, including specifically the thalamus. METHODS: Nine healthy human volunteers received three...

  13. A single high dose of escitalopram increases mismatch negativity without affecting processing negativity or P300 amplitude in healthy volunteers

    DEFF Research Database (Denmark)

    Wienberg, M; Glenthøj, Birte Yding; Jensen, K S

    2009-01-01

    processing. The present study was designed to replicate and further extent the results of our initial study on the effects of a low dose of escitalopram (10 mg) on MMN, PN and P300 amplitude. In a randomised, double-blind, cross-over experiment, 20 healthy male volunteers received either a single, orally...... administered dose of 15 mg escitalopram (a highly selective serotonin reuptake inhibitor (SSRI)) or placebo, after which their PN, MMN and P300 amplitude were assessed. Similar to our initial study with 10 mg escitalopram, 15 mg escitalopram significantly increased MMN, while it did not affect P300 amplitude....... In contrast to our initial study, however, the currently higher dose of escitalopram did not increase PN. Results support the view that a broad range of increased serotonergic activity enhances MMN, while the relationship between serotonin and PN seems more complex. The current study does not support...

  14. Assessment of Tandem Measurements of pH and Total Gut Transit Time in Healthy Volunteers

    OpenAIRE

    Mikolajczyk, Adam E; Watson, Sydeaka; Surma, Bonnie L; Rubin, David T

    2015-01-01

    Objectives: The variation of luminal pH and transit time in an individual is unknown, yet is necessary to interpret single measurements. This study aimed to assess the intrasubject variability of gut pH and transit time in healthy volunteers using SmartPill devices (Covidien, Minneapolis, MN). Methods: Each subject (n=10) ingested two SmartPill devices separated by 24?h. Mean pH values were calculated for 30?min after gastric emptying (AGE), before the ileocecal (BIC) valve, after the ileocec...

  15. Functional MR imaging of the motor cortex in healthy volunteers and patients with brain tumours: qualitative and quantitative results

    Energy Technology Data Exchange (ETDEWEB)

    Fellner, C. [Friedrich-Alexander-Univ., Erlangen-Nuernberg (Germany). Inst. of Medical Physics]|[Friedrich-Alexander-Univ., Erlangen-Nuernberg (Germany). Dept. of Diagnostic Radiology; Schlaier, J.; Schwerdtner, J.; Brawanski, A. [Regensburg Univ. (Germany). Dept. of Radiology; Fellner, F. [Regensburg Univ. (Germany). Dept. of Neurosurgery]|[Oberoesterreichische Landesnervenklinik, Linz (Austria). Dept. of Neuroradiology; Held, P. [Friedrich-Alexander-Univ., Erlangen-Nuernberg (Germany). Dept. of Diagnostic Radiology; Blank, M.; Kalender, W.A. [Friedrich-Alexander-Univ., Erlangen-Nuernberg (Germany). Inst. of Medical Physics

    1999-06-01

    The purpose of this study was to compare functional magnetic resonance (MR) imaging of the motor cortex in healthy volunteers and patients with brain tumours. Functional MR imaging was performed in 14 healthy volunteers and 14 patients with tumours in or near the primary motor cortex with groups being matched for age, sex, and handedness. Functional images were acquired during motion of the right and left hand. Time courses of signal intensity within the contralateral, ipsilateral, and supplementary motor cortex as well as z-maps were calculated, their quality being assessed visually. Mean signal increase between activation and rest were evaluated within the contralateral, ipsilateral, and supplementary motor cortex, the activated area in those regions of interest was measured using z-maps. The quality of functional MR experiments was generally lower in patients than in volunteers. The quantitative results showed a trend towards increased ipsilateral activation in volunteers during left hand compared to right hand motion and in patients during motion of the affected compared to the non-affected hand. Considering quantitative and qualitative results, significantly increased ipsilateral activation was found in patients compared to healthy volunteers. In conclusion, functional MR imaging quality was significantly reduced in patient studies compared to healthy volunteers, even if influences of age, sex, and handedness were excluded. Increased ipsilateral activation was found in patients with brain tumours which can be interpreted by an improved connectivity between both hemispheres. (orig.) [Deutsch] Das Ziel der vorliegenden Studie war ein Vergleich der funktionellen MR-Bildgebung (fMRI: Functional magnetic resonance imaging) des Motorkortex bei gesunden Probanden und Patienten mit Hirntumor. Die funktionelle MR-Bildgebung wurde bei 14 gesunden Probanden und bei 14 Patienten mit einem Tumor im oder nahe des primaeren Motorkortex durchgefuehrt, wobei beide Kollektive

  16. Gender Differences in Cerebral Regional Homogeneity of Adult Healthy Volunteers: A Resting-State fMRI Study

    Directory of Open Access Journals (Sweden)

    Chunsheng Xu

    2015-01-01

    Full Text Available Objective. We sought to use the regional homogeneity (ReHo approach as an index in the resting-state functional MRI to investigate the gender differences of spontaneous brain activity within cerebral cortex and resting-state networks (RSNs in young adult healthy volunteers. Methods. One hundred and twelve healthy volunteers (56 males, 56 females participated in the resting-state fMRI scan. The ReHo mappings in the cerebral cortex and twelve RSNs of the male and female groups were compared. Results. We found statistically significant gender differences in the primary visual network (PVN (P<0.004, with Bonferroni correction and left attention network (LAtN, default mode network (DMN, sensorimotor network (SMN, executive network (EN, and dorsal medial prefrontal network (DMPFC as well (P<0.05, uncorrected. The male group showed higher ReHo in the left precuneus, while the female group showed higher ReHo in the right middle cingulate gyrus, fusiform gyrus, left inferior parietal lobule, precentral gyrus, supramarginal gyrus, and postcentral gyrus. Conclusions. Our results suggested that men and women had regional specific differences during the resting-state. The findings may improve our understanding of the gender differences in behavior and cognition from the perspective of resting-state brain function.

  17. Recognition of facial emotion and perceived parental bonding styles in healthy volunteers and personality disorder patients.

    Science.gov (United States)

    Zheng, Leilei; Chai, Hao; Chen, Wanzhen; Yu, Rongrong; He, Wei; Jiang, Zhengyan; Yu, Shaohua; Li, Huichun; Wang, Wei

    2011-12-01

    Early parental bonding experiences play a role in emotion recognition and expression in later adulthood, and patients with personality disorder frequently experience inappropriate parental bonding styles, therefore the aim of the present study was to explore whether parental bonding style is correlated with recognition of facial emotion in personality disorder patients. The Parental Bonding Instrument (PBI) and the Matsumoto and Ekman Japanese and Caucasian Facial Expressions of Emotion (JACFEE) photo set tests were carried out in 289 participants. Patients scored lower on parental Care but higher on parental Freedom Control and Autonomy Denial subscales, and they displayed less accuracy when recognizing contempt, disgust and happiness than the healthy volunteers. In healthy volunteers, maternal Autonomy Denial significantly predicted accuracy when recognizing fear, and maternal Care predicted the accuracy of recognizing sadness. In patients, paternal Care negatively predicted the accuracy of recognizing anger, paternal Freedom Control predicted the perceived intensity of contempt, maternal Care predicted the accuracy of recognizing sadness, and the intensity of disgust. Parenting bonding styles have an impact on the decoding process and sensitivity when recognizing facial emotions, especially in personality disorder patients. © 2011 The Authors. Psychiatry and Clinical Neurosciences © 2011 Japanese Society of Psychiatry and Neurology.

  18. Effects of low to moderate acute doses of pramipexole on impulsivity and cognition in healthy volunteers.

    Science.gov (United States)

    Hamidovic, Ajna; Kang, Un Jung; de Wit, Harriet

    2008-02-01

    The neurotransmitter dopamine is integrally involved in the rewarding effects of drugs, and it has also been thought to mediate impulsive behaviors in animal models. Most of the studies of drug effects on impulsive behaviors in humans have involved drugs with complex actions on different transmitter systems and different receptor subtypes. The present study was designed to characterize the effect of single doses of pramipexole, a D2/D3 agonist, on measures of cognitive and impulsive behavior, as well as on mood in healthy volunteers. Healthy men and women (N = 10) received placebo and 2 doses of pramipexole, 0.25 and 0.50 mg, in a within-subject, double-blinded study. Outcome measures included changes in cognitive performance, assessed by the Automated Neuropsychological Assessment Metrics, several behavioral measures related to impulsive behavior, including the Balloon Analogue Risk Task, Delay Discounting Task, Go/No-Go Task, Card Perseveration Task, and subjective ratings of mood assessed by Addiction Research Center Inventory, Profile of Mood States, and Drug Effects Questionnaire. Pramipexole decreased positive ratings of mood (euphoria, intellectual efficiency, and energy) and increased both subjectively reported sedation and behavioral sedation indicated by impaired cognitive performance on several measures of the Automated Neuropsychological Assessment Metrics. Single low to medium doses of this drug did not produce a decrease in impulsive responding on behavioral measures included in this study. The sedative-like effects observed in this study may reflect presynaptic actions of the drug. Higher doses with postsynaptic actions may be needed to produce either behavioral or subjective stimulant-like effects.

  19. Short-term serotonergic but not noradrenergic antidepressant administration reduces attentional vigilance to threat in healthy volunteers

    OpenAIRE

    Murphy, Susannah E; Yiend, Jenny; Lester, Kathryn J; Cowen, Philip J; Harmer, Catherine J

    2009-01-01

    Anxiety is associated with threat-related biases in information processing such as heightened attentional vigilance to potential threat. Such biases are an important focus of psychological treatments for anxiety disorders. Selective serotonin reuptake inhibitors (SSRIs) are effective in the treatment of a range of anxiety disorders. The aim of this study was to assess the effect of an SSRI on the processing of threat in healthy volunteers. A selective noradrenergic reuptake inhibitor (SNRI), ...

  20. Quantitative MRI comparison of pulmonary hemodynamics in mustard/senning-repaired patients suffering from transposition of the great arteries and healthy volunteers at rest

    International Nuclear Information System (INIS)

    Laffon, Eric; Latrabe, Valerie; Jimenez, Maria; Ducassou, Dominique; Laurent, Francois; Marthan, Roger

    2006-01-01

    In Mustard/Senning-repaired (MSR) patients, the right and left ventricles (RV, LV) act as the systemic and pulmonary ventricle, respectively. The purpose of the study was to compare non-invasively, at rest, pulmonary ventricle systolic function and hemodynamics in MSR patients with those of healthy volunteers. Velocity-encoded MR imaging was performed at the level of the main pulmonary artery (MPA) in ten male patients late after a Mustard/Senning correction performed early in infancy and in ten male volunteers. Both blood flow and MPA cross-sectional area variations were recorded over a complete cardiac cycle. MPA distensibility, body surface area (BSA)-normalized pulmonary ventricle systolic power and work were significantly lower in the MSR patients compared to volunteers. In particular, BSA-normalized LV systolic power and work in MSR patients were equal to 82 and 77% on average of those of the RV in volunteers (0.32 vs. 0.39 W/m 2 and 0.10 vs. 0.13 J/m 2 ), respectively. We conclude that in MSR patients at rest two unrelated findings were observed: (1) a reduced MPA distensibility and (2) a significantly lower systolic mechanical performance of the pulmonary LV compared to that of the RV in healthy volunteers. The latter quantification indirectly confirms the lowest systemic RV systolic mechanical performance previously published. (orig.)

  1. Comparison of the effects of dopamine, dobutamine, and dopexamine upon renal blood flow: a study in normal healthy volunteers.

    OpenAIRE

    Mousdale, S; Clyburn, P A; Mackie, A M; Groves, N D; Rosen, M

    1988-01-01

    1. We compared the effects of dopexamine, dopamine and dobutamine on the heart rate, blood pressure and renal blood flow of six healthy volunteers in an open triple crossover trial. 2. The results suggest that at the dose ranges investigated dopamine was the most effective agent for increasing renal blood flow.

  2. A randomised trial of the effect of the glycine reuptake inhibitor Org 25935 on cognitive performance in healthy male volunteers.

    Science.gov (United States)

    Christmas, David; Diaper, Alison; Wilson, Sue; Rich, Ann; Phillips, Suzanne; Udo de Haes, Joanna; Sjogren, Magnus; Nutt, David

    2014-03-01

    Cognitive impairment is integral to many neurological illnesses. Specific enhancement of glutamatergic transmission may improve memory and learning. Org 25935 increases the synaptic availability of glycine, an obligate co-agonist with glutamate at N-methyl-D-aspartate receptors. We hypothesised that Org 25935 would acutely improve the learning and memory of healthy volunteers. A randomised, double-blind, parallel-group, single-dose study of Org 25935 and placebo was carried out. Thirty-two healthy male volunteers took either 12-mg Org 25935 or matching placebo and were later assessed with the manikin task, digit span and verbal memory tests. Systematic assessments of cardiovascular and adverse events were also taken. There was no effect of Org 25935 on reaction time, number of correct responses or learning (greater or slower improvement over successive tasks) compared with placebo. Org 25935 caused significantly more dizziness and drowsiness compared with placebo; these side effects were mainly mild. A single dose of Org 25935 does not improve learning or memory in healthy male individuals. However, the drug was well tolerated, and it remains to be seen whether it would have a positive effect on cognition in patient groups with pre-existing cognitive deficits.

  3. Investigation of a Potential Pharmacokinetic Interaction Between Nebivolol and Fluvoxamine in Healthy Volunteers.

    Science.gov (United States)

    Gheldiu, Ana-Maria; Vlase, Laurian; Popa, Adina; Briciu, Corina; Muntean, Dana; Bocsan, Corina; Buzoianu, Anca; Achim, Marcela; Tomuta, Ioan; Todor, Ioana; Neag, Maria

    2017-01-01

    To investigate whether fluvoxamine coadministration can influence the pharmacokinetic properties of nebivolol and its active hydroxylated metabolite (4-OH-nebivolol) and to assess the consequences of this potential pharmacokinetic interaction upon nebivolol pharmacodynamics. This open-label, non-randomized, sequential clinical trial consisted of two periods: Period 1 (Reference), during which each volunteer received a single dose of 5 mg nebivolol and Period 2 (Test), when a combination of 5 mg nebivolol and 100 mg fluvoxamine was given to all subjects, after a 6-days pretreatment regimen with fluvoxamine (50-100 mg/day). Non-compartmental analysis was used to determine the pharmacokinetic parameters of nebivolol and its active metabolite. The pharmacodynamic parameters (blood pressure and heart rate) were assessed at rest after each nebivolol intake, during both study periods. Fluvoxamine pretreatment increased Cmax and AUC0-∞  of nebivolol (Cmax: 1.67 ± 0.690  vs 2.20 ± 0.970  ng/mL; AUC0-∞: 12.1 ± 11.0  vs 19.3 ± 19.5  ng*h/mL ) and of its active metabolite (Cmax: 0.680  ± 0.220  vs 0.960 ± 0.290  ng/mL; AUC0-∞: 17.6 ±20.1  vs 25.5 ± 29.9  ng*h/mL). Apart from Cmax,AUC0-t and AUC0-∞, the other pharmacokinetic parameters (tmax, kel and t½) were not significantly different between study periods. As for the pharmacodynamic analysis, decreases in blood pressure and heart rate after nebivolol administration were similar with and without fluvoxamine concomitant intake. Due to enzymatic inhibition, fluvoxamine increases the exposure to nebivolol and its active hydroxylated metabolite in healthy volunteers. This did not influence the blood pressure and heart-rate lowering effects of the beta-blocker administered as single-dose. However, more detail studies involving actual patients are required to further investigate the clinical relevance of this drug interaction. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For

  4. Effects of dexamethasone coadministered with oseltamivir on the pharmacokinetics of oseltamivir in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Jang K

    2017-03-01

    Full Text Available Kyungho Jang,1,2,* Min-Kyoung Kim,3,4,* Jaeseong Oh,1 SeungHwan Lee,1 Joo-Youn Cho,1 Kyung-Sang Yu,1 Tai Kiu Choi,3 Sang-Hyuk Lee,3,4 Kyoung Soo Lim4 1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, 2Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Medical School, Jeonju, 3Department of Psychiatry, 4Department of Clinical Pharmacology and Therapeutics, CHA University School of Medicine and CHA Bundang Medical Center, Seongnam, Republic of Korea *These authors contributed equally to this work Purpose: Oseltamivir is widely used in the treatment and prophylaxis of influenza A and B viral infections. It is ingested as an oral prodrug that is rapidly metabolized by carboxylesterase 1 (CES1 to its active form, oseltamivir carboxylate. Dexamethasone is also used in the treatment of acute respiratory distress syndrome, a severe complication of influenza; however, its influence on the pharmacokinetics (PK of oseltamivir is controversial. The aim of this study was to investigate the effects of coadministering oseltamivir and dexamethasone on the PK of oseltamivir in healthy volunteers. Methods: An open-label, two-period, one-sequence, multiple-dose study was conducted in 19 healthy male volunteers. Oseltamivir (75 mg was orally administered on Day 1 and Day 8, and dexamethasone (1.5 mg was administered once daily from Day 3 to Day 8. Serial blood and urine samples were collected for PK analysis of oseltamivir and oseltamivir carboxylate on Day 1 and Day 8. Oseltamivir and oseltamivir carboxylate concentrations in plasma and urine were determined using liquid chromatography–tandem mass spectrometry. Results: Area under the plasma concentration–time curve (AUC of oseltamivir and oseltamivir carboxylate decreased after dexamethasone treatment for 6 days. The geometric mean ratio (90% confidence interval of the metabolic ratio

  5. Effect of Steady-State Faldaprevir on Pharmacokinetics of Atorvastatin or Rosuvastatin in Healthy Volunteers: A Prospective Open-Label, Fixed-Sequence Crossover Study.

    Science.gov (United States)

    Huang, Fenglei; Marzin, Kristell; Koenen, Rüdiger; Kammerer, Klaus Peter; Strelkowa, Natalja; Elgadi, Mabrouk; Quinson, Anne-Marie; Haertter, Sebastian

    2017-10-01

    Faldaprevir (FDV) is a potent, orally administered inhibitor of hepatitis C virus protease. It inhibits multiple cytochrome P-450 enzymes and multiple membrane transporters. The objective of this study was to evaluate the effect of steady-state faldaprevir on the pharmacokinetics (PK) of a single dose of atorvastatin or rosuvastatin. In this single-center, open-label, fixed-sequence crossover study, 33 healthy adult male and female volunteers were given either atorvastatin 10 mg (n = 16) or rosuvastatin 10 mg (n = 17) on day 1. Subjects subsequently received 240 mg twice daily of faldaprevir (loading dose) on day 5, followed by 240 mg faldaprevir once daily from day 6 to day 10, with an additional single dose of atorvastatin (10 mg) or rosuvastatin (10 mg) given on day 10. PK samples for the statins were collected on days 1-3 and days 10-12. Concomitant administration with faldaprevir led to approximately 9-fold and 34-fold increases in AUC 0-∞ and C max , respectively, of atorvastatin and approximately 15-fold and 33-fold increases in AUC 0-∞ and C max , respectively, of rosuvastatin, compared with the statins given alone. Exposure to the major metabolites (ortho-hydroxyatorvastatin and N-desmethylrosuvastatin) was increased to a similar magnitude as that of the parent compounds. The marked drug-drug interaction observed is most likely related to the inhibitory effects of faldaprevir on transporters, particularly hepatic uptake transporters such as OTAP1B1 and OATP1B3. Given the significant increase in exposure to statins in healthy volunteers, coadministration of faldaprevir with statins should be avoided. © 2017, The American College of Clinical Pharmacology.

  6. Qualitative and quantitative assessment of nailfold capillaries by capillaroscopy in healthy volunteers.

    Science.gov (United States)

    Hoerth, Christian; Kundi, Michael; Katzenschlager, Reinhold; Hirschl, Mirko

    2012-01-01

    Nailfold capillaroscopy (NVC) is a diagnostic tool particularly useful in the differential diagnosis of rheumatic and connective tissue diseases. Although successfully applied since many years, little is known about prevalence and distribution of NVC changes in healthy individuals. NVC was performed in 120 individuals (57 men and 63 women; age 18 to 70 years) randomly selected according to predefined age and sex strata. Diseases associated with NVC changes were excluded. The nailfolds of eight fingers were assessed according to standardized procedures. A scoring system was developed based on the distribution of the number of morphologically deviating capillaries, microhaemorrhages, and capillary density. Only 18 individuals (15 %) had no deviation in morphology, haemorrhages, or capillary density on any finger. Overall 67 % had morphological changes, 48 % had microhaemorrhages, and 40 % of volunteers below 40 years of age and 18 % above age 40 had less than 8 capillaries/mm. Among morphological changes tortous (43 %), ramified (47 %), and bushy capillaries (27 %) were the most frequently altered capillary types. A semiquantitative scoring system was developed in such a way that a score above 1 indicates an extreme position (above the 90th percentile) in the distribution of scores among healthy individuals. Altered capillaries occur frequently among healthy individuals and should be interpreted as normal unless a suspicious increase in their frequency is determined by reference to the scoring system. Megacapillaries and diffuse loss of capillaries were not found and seem to be of specific diagnostic value.

  7. Arterial Injury and Endothelial Repair: Rapid Recovery of Function after Mechanical Injury in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Lindsey Tilling

    2014-01-01

    Full Text Available Objective. Previous studies suggest a protracted course of recovery after mechanical endothelial injury; confounders may include degree of injury and concomitant endothelial dysfunction. We sought to define the time course of endothelial function recovery using flow-mediated dilation (FMD, after ischaemia-reperfusion (IR and mechanical injury in patients and healthy volunteers. The contribution of circulating CD133+/CD34+/VEGFR2+ “endothelial progenitor” (EPC or repair cells to endothelial repair was also examined. Methods. 28 healthy volunteers aged 18–35 years underwent transient forearm ischaemia induced by cuff inflation around the proximal biceps and radial artery mechanical injury induced by inserting a wire through a cannula. A more severe mechanical injury was induced using an arterial sheath and catheter inserted into the radial artery of 18 patients undergoing angiography. Results. IR and mechanical injury produced immediate impairment of FMD (from 6.5 ± 1.2% to 2.9 ± 2.2% and from 7.4 ± 2.3% to 1.5 ± 1.6% for IR and injury, resp., each P<0.001 but recovered within 6 hours and 2 days, respectively. FMD took up to 4 months to recover in patients. Circulating EPC did not change significantly during the injury/recovery period in all subjects. Conclusions. Recovery of endothelial function after IR and mechanical injury is rapid and not associated with a change in circulating EPC.

  8. Reproducibility of resting state spinal cord networks in healthy volunteers at 7 Tesla.

    Science.gov (United States)

    Barry, Robert L; Rogers, Baxter P; Conrad, Benjamin N; Smith, Seth A; Gore, John C

    2016-06-01

    We recently reported our findings of resting state functional connectivity in the human spinal cord: in a cohort of healthy volunteers we observed robust functional connectivity between left and right ventral (motor) horns and between left and right dorsal (sensory) horns (Barry et al., 2014). Building upon these results, we now quantify the within-subject reproducibility of bilateral motor and sensory networks (intraclass correlation coefficient=0.54-0.56) and explore the impact of including frequencies up to 0.13Hz. Our results suggest that frequencies above 0.08Hz may enhance the detectability of these resting state networks, which would be beneficial for practical studies of spinal cord functional connectivity. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Transcranial Direct Current Stimulation (tDCS) Targeting Left Dorsolateral Prefrontal Cortex Modulates Task-Induced Acute Pain in Healthy Volunteers.

    Science.gov (United States)

    Mariano, Timothy Y; Van't Wout, Mascha; Garnaat, Sarah L; Rasmussen, Steven A; Greenberg, Benjamin D

    2016-04-01

    Current chronic pain treatments target nociception rather than affective "suffering" and its associated functional and psychiatric comorbidities. The left dorsolateral prefrontal cortex (DLPFC) has been implicated in affective, cognitive, and attentional aspects of pain and is a primary target of neuromodulation for affective disorders. Transcranial direct current stimulation (tDCS) can non-invasively modulate cortical activity. The present study tests whether anodal tDCS targeting the left DLPFC will increase tolerability of acute painful stimuli vs cathodal tDCS. Forty tDCS-naive healthy volunteers received anodal and cathodal stimulation targeting the left DLPFC in two randomized and counterbalanced sessions. During stimulation, each participant performed cold pressor (CP) and breath holding (BH) tasks. We measured pain intensity with the Defense and Veterans Pain Rating Scale (DVPRS) before and after each task. Mixed ANOVA revealed no main effect of stimulation polarity for mean CP threshold, tolerance, or endurance, or mean BH time (allP > 0.27). However, DVPRS rise associated with CP was significantly smaller with anodal vs cathodal tDCS (P = 0.024). We further observed a significant tDCS polarity × stimulation order interaction (P = 0.042) on CP threshold, suggesting task sensitization. Although our results do not suggest that polarity of tDCS targeting the left DLPFC differentially modulates the tolerability of CP- and BH-related pain distress in healthy volunteers, there was a significant effect on DVPRS pain ratings. This contrasts with our previous findings that tDCS targeting the left dorsal anterior cingulate cortex showed a trend toward higher mean CP tolerance with cathodal vs anodal stimulation. The present results may suggest tDCS-related effects on nociception or DLPFC-mediated attention, or preferential modulation of the affective valence of pain as captured by the DVPRS. Sham-controlled clinical studies are needed. © 2015

  10. Bioavailability of two single-dose oral formulations of omeprazole 20 mg: an open-label, randomized sequence, two-period crossover comparison in healthy Mexican adult volunteers.

    Science.gov (United States)

    Poo, Jorge Luis; Galán, Juan Francisco; Rosete, Alejandra; de Lago, Alberto; Oliva, Iván; González-de la Parra, Mario; Jiménez, Patricia; Burke-Fraga, Victoria; Namur, Salvador

    2008-04-01

    Omeprazole is a proton-pump inhibitor that acts to reduce acid secretion in the stomach and is used for treating various acid-related gastrointestinal disorders. There are several generic formulations of omeprazole available in Mexico; however, a literature search failed to identify published data concerning the bioavailability of these formulations in the Mexican population. The aim of this study was to compare the bioavailability of 2 oral formulations of omeprazole 20-mg capsules, marketed for use in Mexico, in healthy volunteers: Inhibitron (test formulation) and LosecA 20 mg (reference formulation). This study used a single-dose, open-label, randomized sequence, 2 x 2 crossover (2 administration periods x 2 treatments) design to compare the 2 formulations. Eligible subjects were healthy adult Mexican volunteers of both sexes. Subjects were randomly assigned in a 1:1 ratio to receive a single 20-mg dose of the test formulation followed by the reference formulation, or vice versa, with a 7-day washout period between administration periods. After a 12-hour (overnight) fast, subjects received a single, 20-mg dose of the corresponding formulation. Plasma samples were obtained over a 12-hour period after administration. Plasma omeprazole concentrations were analyzed by a nonstereospecific high-performance liquid chromatography method. For analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to time t (AUC(0-t)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were drawn at baseline and 0.17, 0.33, 0.50, 0.75, 1, 1.25, 1.50, 1.75, 2, 2.50, 3, 4, 6, 8, and 12 hours after administration. The formulations were considered bioequivalent if the natural log (ln)-transformed ratios of C(max) and AUC were within the predetermined equivalence range of 80% to 125%, and if P disability, or required intervention to prevent permanent impairment or damage. Thirty-four subjects were enrolled and completed the study (25 men and 9

  11. Comparative study of dihydroartemisinin and artesunate safety in healthy Thai volunteers.

    Science.gov (United States)

    Kongpatanakul, S; Chatsiricharoenkul, S; Khuhapinant, A; Atipas, S; Kaewkungwal, J

    2009-09-01

    As part of new drug development initiatives in Thailand, a new tablet formulation of dihydroartemisinin (DHA, an antimalarial drug) has been developed. Our previous bioequivalence study indicated that the new and reference DHA formulations were well tolerated; however, a significant decrease in hemoglobin was detected after a single 200-mg oral dose. To explore further, a clinical study with an emphasis on hematological parameters was conducted. A single-center, randomized, single-blind, cross-over clinical study was conducted in 18 healthy volunteers with a dosage of 300 mg daily for 2 days. Artesunate was used as a comparator. Adverse events were monitored and laboratory parameters on study Days 0, 2, 5, and 7 post drug administrations were analyzed. Eighteen volunteers completed both rounds of the study. Both drugs were well tolerated. All adverse events were mild. Significant decrease in hemoglobin compared to baseline was detected for both drugs 7 days after administration (DHA: 0.48 g/dl, p = 0.007; artesunate 0.38 g/dl, p = 0.001). Transient bone marrow suppression was evidenced by reduction of reticulocytes with a lowest number on study Day 5 (artesunate 75% reduction in reticulocyte count; DHA 47%, p < 0.001 for both drugs compared to baseline). The present study confirmed our previous finding on significant decrease in hemoglobin. Artesunate appeared to have more negative effects on the numbers of reticulocytes and white blood cells than DHA. Systemic laboratory and toxicity profiles presented in this study may be used as a framework for future clinical studies of artemisinin and its derivatives.

  12. Gender differences of heart rate variability in healthy volunteers

    International Nuclear Information System (INIS)

    Saleem, S.; Majeed, S.M.I.; Khan, M.A.

    2012-01-01

    Objective: To identify the basic values of heart rate variability in Pakistani population and to verify our hypothesis that there are gender differences in cardiovascular autonomic modulation. Methods: The descriptive cross sectional study based on convenience probability sampling was conducted at Armed Forces Institute of Cardiology/National Institute of Heart Diseases (AFIC/NIHD) Pakistan. The duration of the study was from December 2009 to July 2010. It involved 24-hour holter monitoring of 45 healthy individuals using holter electrocardiography (ECG) recorder. Heart rate variability was analysed in time (SDNN, SDANN, SDNNi, rMSSD, pNN50) and frequency domains (power, VLF, LF, and HF). Results: The time domain indices; SDNN (male=140 +- 36 ms vs. females=122 +- 33 ms; p =0.09), SDANN (male=123 +- 34 ms vs. females=111+- 34 ms; P= 0.23), SDNNi (male=64 +-19 ms vs. females=52 +- 14 ms; P= 0.03), and pNN50 (male=14 +- 10 ms vs. females=12 +- 7 ms; P= 0.43) were decreased in female volunteers when compared with males. Comparison of frequency domain indices; Total power (male=4041 +- 3150 ms/sup 2/ vs. females=2750 +- 1439 ms/sup 2/; P= 0.07), VLF (male=291 2675 ms/sup 2/ vs. females=1843 +- 928 ms/sup 2/; P= 0.06), LF (male=788 +- 397 ms/sup 2/ vs. females=556 +- 346 ms/sup 2/; P= 0.04) and HF (male=318 +- 251 ms/sup 2/ vs. females=31 277 ms/sup 2/; P= 0.94) amongst males and females showed attenuated heart rate variability in females. Of all the observed values, SDNNi and LF were found significantly (p <0.05) decreased in women. Conclusion: In healthy population, heart rate variability is low in women than men. It reflects sympathetic dominance in women in our population. (author)

  13. Study of GABA in healthy volunteers: pharmacokinetics and pharmacodynamics

    Directory of Open Access Journals (Sweden)

    Junfeng eLi

    2015-11-01

    Full Text Available Preclinical studies show that GABA exerts anti-diabetic effects in rodent models of type 1 diabetes. Because little is known about its absorption and effects in humans, we investigated the pharmacokinetics and pharmacodynamics of GABA in healthy volunteers. Twelve subjects were subjected to an open-labeled, three-period trial involving sequential oral administration of placebo, 2g GABA once, and 2g GABA three times/day for seven days, with a 7-day washout between each period. GABA was rapidly absorbed (Tmax: 0.5~1 h with the half-life (t1/2 of 5 h. No accumulation was observed after repeated oral GABA administration for 7 days. Remarkably, GABA significantly increased circulating insulin levels in the subjects under either fasting (1.6-fold, single dose; 2.0-fold, repeated dose; p<0.01 or fed conditions (1.4-fold, single dose; 1.6-fold, repeated dose; p<0.01. GABA also increased glucagon levels only under fasting conditions (1.3-fold, single dose, p<0.05; 1.5-fold, repeated dose, p<0.01. However, there were no significant differences in the insulin-to-glucagon ratio and no significant change in glucose levels in these healthy subjects during the study period. Importantly, GABA significantly decreased glycated albumin levels in the repeated dosing period. Subjects with repeated dosing showed an elevated incidence of minor adverse events in comparison to placebo or the single dosing period, most notably transitional discomforts such as dizziness and sore throat. However, there were no serious adverse events observed throughout the study. Our data show that GABA is rapidly absorbed and tolerated in human beings; its endocrine effects, exemplified by increasing islet hormonal secretion, suggest potential therapeutic benefits for diabetes.

  14. Preliminary study of relationships between hypnotic susceptibility and personality disorder functioning styles in healthy volunteers and personality disorder patients

    Directory of Open Access Journals (Sweden)

    He Wei

    2011-07-01

    Full Text Available Abstract Background Hypnotic susceptibility is one of the stable characteristics of individuals, but not closely related to the personality traits such as those measured by the five-factor model in the general population. Whether it is related to the personality disorder functioning styles remains unanswered. Methods In 77 patients with personality disorders and 154 healthy volunteers, we administered the Stanford Hypnotic Susceptibility Scale: Form C (SHSSC and the Parker Personality Measure (PERM tests. Results Patients with personality disorders showed higher passing rates on SHSSC Dream and Posthypnotic Amnesia items. No significant correlation was found in healthy volunteers. In the patients however, SHSSC Taste hallucination (β = 0.26 and Anosmia to Ammonia (β = -0.23 were significantly correlated with the PERM Borderline style; SHSSC Posthypnotic Amnesia was correlated with the PERM Schizoid style (β = 0.25 but negatively the PERM Narcissistic style (β = -0.23. Conclusions Our results provide limited evidence that could help to understand the abnormal cognitions in personality disorders, such as their hallucination and memory distortions.

  15. Effect of serotonin on small intestinal contractility in healthy volunteers

    DEFF Research Database (Denmark)

    Hansen, M.B.; Arif, F.; Gregersen, H.

    2008-01-01

    The physiological significance of serotonin released into the intestinal lumen for the regulation of motility is unknown in humans. The aim of this study was to evaluate the effect of serotonin infused into the lumen of the gastric antrum, duodenum or the jejunum, on antro-duodeno-jejunal contrac......The physiological significance of serotonin released into the intestinal lumen for the regulation of motility is unknown in humans. The aim of this study was to evaluate the effect of serotonin infused into the lumen of the gastric antrum, duodenum or the jejunum, on antro......-duodeno-jejunal contractility in healthy human volunteers. Manometric recordings were obtained and the effects of either a standard meal, continuous intravenous infusion of serotonin (20 nmol/kg/min) or intraluminal bolus infusions of graded doses of serotonin (2.5, 25 or 250 nmol) were compared. In addition, platelet......-depleted plasma levels of serotonin, blood pressure, heart rate and electrocardiogram were evaluated. All subjects showed similar results. Intravenous serotonin increased migrating motor complex phase In frequency 3-fold and migrating velocity 2-fold. Intraluminal infusion of serotonin did not change contractile...

  16. Doppler Ultrasound Triggering for Cardiovascular MRI at 3T in a Healthy Volunteer Study.

    Science.gov (United States)

    Kording, Fabian; Yamamura, Jin; Lund, Gunnar; Ueberle, Friedrich; Jung, Caroline; Adam, Gerhard; Schoennagel, Bjoern Philip

    2017-04-10

    Electrocardiogram (ECG) triggering for cardiac magnetic resonance (CMR) may be influenced by electromagnetic interferences with increasing magnetic field strength. The aim of this study was to evaluate the performance of Doppler ultrasound (DUS) as an alternative trigger technique for CMR in comparison to ECG and pulse oximetry (POX) at 3T and using different sequence types. Balanced turbo field echo two-dimensional (2D) short axis cine CMR and 2D phase-contrast angiography of the ascending aorta was performed in 11 healthy volunteers at 3T using ECG, DUS, and POX for cardiac triggering. DUS and POX triggering were compared to the reference standard of ECG in terms of trigger quality (trigger detection and temporal variability), image quality [endocardial blurring (EB)], and functional measurements [left ventricular (LV) volumetry and aortic blood flow velocimetry]. Trigger signal detection and temporal variability did not differ significantly between ECG/DUS (I = 0.6) and ECG/POX (P = 0.4). Averaged EB was similar for ECG, DUS, and POX (p ECG/DUS = 0.4, p ECG/POX = 0.9). Diastolic EB was significantly decreased for DUS in comparison to ECG (P = 0.02) and POX (P = 0.04). The LV function assessment and aortic blood flow were not significantly different. This study demonstrated the feasibility of DUS for gating human CMR at 3T. The magnetohydrodynamic effect did not significantly disturb ECG triggering in this small healthy volunteer study. DUS showed a significant improvement in diastolic EB but could not be identified as a superior trigger method. The potential benefit of DUS has to be evaluated in a larger clinical patient population.

  17. Efficacy and safety of topical depigmenting agent in healthy human fair skin female volunteers: A single-arm study.

    Science.gov (United States)

    Shah, Saurabh; Chew, Soon-Keong

    2017-11-28

    Skin hyperpigmentation is the darkening of skin due to the increased production of melanin in the body. To evaluate the efficacy and safety of a botanical-based Rosa E pigmentation serum in healthy fair skin female volunteers with wrinkles, skin tone, and pigmentation. This was a single-arm, open label study conducted in healthy Indian females; 18 subjects aged 30-55, having fair Caucasian-like skin with at least 2 dark skin pigments with facial wrinkles diagnosed by dermatologist were selected. Rosa E pigmentation serum was applied twice a day for 84 days. Effect was evaluated by (i) instrumental technique (spectrophotometer ® 2600D), (ii) clinically by dermatologist regarding product efficacy (skin tone, antiwrinkle, pigmentation), and (iii) volunteers self-evaluation. The L* value of spectrophotometer reading represents lightness in the skin pigment. Reduction in the pigment was reported from day 14, with significant reductions observed till day 84 compared with baseline. Significant (P < .0001) skin pigmentation lightening was seen on day 14 (1.11) vastly improving on day 84 (1.94) based on photographic assessments. The significant reduction in skin pigment was 76.85%, Felix von Luschan skin color score was 30.24% (P < .0001) with a 7.38-fold reduction in skin tone and 57% reduction in facial wrinkles at day 84 from baseline. Rosa E pigmentation serum was found safe and effective in significant reduction in skin pigments, improvement of skin tone, and antiwrinkle properties instrumentally, clinically, and self-evaluation by volunteers. In these evaluations, best results were seen the longer the Rosa E was used. © 2017 Wiley Periodicals, Inc.

  18. Scarce Evidence of Yogurt Lactic Acid Bacteria in Human Feces after Daily Yogurt Consumption by Healthy Volunteers

    OpenAIRE

    del Campo, Rosa; Bravo, Daniel; Cantón, Rafael; Ruiz-Garbajosa, Patricia; García-Albiach, Raimundo; Montesi-Libois, Alejandra; Yuste, Francisco-Javier; Abraira, Victor; Baquero, Fernando

    2005-01-01

    In a double-blind prospective study including 114 healthy young volunteers, the presence in human feces of the yogurt organisms Lactobacillus delbrueckii and Streptococcus thermophilus after repeated yogurt consumption (15 days) was analyzed by culture, specific PCR, and DNA hybridization of total fecal DNA. Detection of yogurt lactic acid bacteria in total fecal DNA by bacterial culture and PCR assay was consistently negative. DNA compatible with yogurt bacteria was found by hybridization ex...

  19. Effect of nonabsorbed amounts of a fructose-sorbitol mixture on small intestinal transit in healthy volunteers

    DEFF Research Database (Denmark)

    Madsen, Jan L; Linnet, Jan; Rumessen, Jüri J

    2006-01-01

    Although malabsorption of small amounts of fructose-sorbitol mixtures occurs frequently in healthy humans, insights into their effects on gastrointestinal motility are poor. The present study addresses the hypothesis that malabsorption of a fructose-sorbitol challenge changes the small intestinal...... transit rate. Eleven healthy volunteers participated in a double-blind crossover investigation. In random order, the subjects ingested 30 g glucose or a mixture of 25 g fructose and 5 g sorbitol as 10% solutions. As a radiolabeled marker, (99m)Tc-diethylenetriaminepentaacetic acid was added to each test...... solution. Breath hydrogen and methane concentrations and gastrointestinal progress of the radiolabeled marker were followed for the next 6-hr period. Malabsorption of small amounts of the fructose-sorbitol mixture was evident in all subjects. The area under the gastric radioactivity-time curve after...

  20. Effect of nonabsorbed amounts of a fructose-sorbitol mixture on small intestinal transit in healthy volunteers

    DEFF Research Database (Denmark)

    Madsen, Jan L; Linnet, Jan; Rumessen, Jüri J

    2006-01-01

    transit rate. Eleven healthy volunteers participated in a double-blind crossover investigation. In random order, the subjects ingested 30 g glucose or a mixture of 25 g fructose and 5 g sorbitol as 10% solutions. As a radiolabeled marker, (99m)Tc-diethylenetriaminepentaacetic acid was added to each test......Although malabsorption of small amounts of fructose-sorbitol mixtures occurs frequently in healthy humans, insights into their effects on gastrointestinal motility are poor. The present study addresses the hypothesis that malabsorption of a fructose-sorbitol challenge changes the small intestinal...... solution. Breath hydrogen and methane concentrations and gastrointestinal progress of the radiolabeled marker were followed for the next 6-hr period. Malabsorption of small amounts of the fructose-sorbitol mixture was evident in all subjects. The area under the gastric radioactivity-time curve after...

  1. Population pharmacokinetics of olmesartan following oral administration of its prodrug, olmesartan medoxomil: in healthy volunteers and hypertensive patients.

    Science.gov (United States)

    Yoshihara, Kazutaka; Gao, Yuying; Shiga, Hiroshi; Wada, D Russell; Hisaoka, Masafumi

    2005-01-01

    Olmesartan medoxomil (CS-866) is a new orally active angiotensin II receptor antagonist that is highly selective for the AT1 receptor subtype. To develop a population pharmacokinetic model for olmesartan (RNH-6270), the active metabolite of olmesartan medoxomil, in healthy volunteers and hypertensive patients, and to evaluate effects of covariates on the apparent oral clearance (CL/F), with particular emphasis on the effect of race. Retrospective analysis of data from 12 phase I-III trials in the US, Europe and Japan. Eighty-nine healthy volunteers and 383 hypertensive patients. Nonlinear mixed-effects modelling was used to evaluate 7911 olmesartan plasma sample concentrations. The covariates included age, bodyweight, sex, race (Westerners [including Caucasians and Hispanics] versus Japanese), patient status (hypertensive patients versus healthy volunteers), serum creatinine level as an index of renal function and serum chemistry data as indices of hepatic function. The pharmacokinetic data of olmesartan were well described by a two-compartment linear model with first-order absorption and an absorption lag-time, parameterised in terms of CL/F (6.66 L/h for a typical male Western hypertensive patient), absorption rate constant (1.46h-1), elimination rate constant (0.193h-1), rate constant from the central to peripheral compartment (0.061h-1), rate constant from the peripheral to central compartment (0.079h-1) and absorption lag-time (0.427h). Analysis of covariates showed that age, bodyweight, sex, patient status and renal function were factors influencing the clearance of olmesartan. The population pharmacokinetic analysis of olmesartan showed that: (i) severe renal impairment (serum creatinine >265 micromol/L [approximately 3 mg/dL]) could cause a clearance decrease of > or =30%; (ii) older age, lower bodyweight and being female were determinants of lower clearance but their effects on olmesartan clearance were within 20%; (iii) no statistically significant

  2. Parallel Volunteer Learning during Youth Programs

    Science.gov (United States)

    Lesmeister, Marilyn K.; Green, Jeremy; Derby, Amy; Bothum, Candi

    2012-01-01

    Lack of time is a hindrance for volunteers to participate in educational opportunities, yet volunteer success in an organization is tied to the orientation and education they receive. Meeting diverse educational needs of volunteers can be a challenge for program managers. Scheduling a Volunteer Learning Track for chaperones that is parallel to a…

  3. SPIRONOLACTONE IN BIOFEEDBACK SESSIONS IN THE LOOP OF PACED BREATHING AND HEART RATE VARIABILITY IN HEALTHY VOLUNTEERS

    Directory of Open Access Journals (Sweden)

    E. Nazarenko

    2015-12-01

    Full Text Available In 7 conditionally healthy volunteers, aged from 19 to 21 years (average age is 19,53 ± 1,55 years, influence of spironolactone on alterations of regulatory systems state of the organism combined with biofeedback (BFB sessions in the loop of paced breathing (PB and heart rate variability (HRV parameters was evaluated. All volunteers were conducted 2 series of everyday BFB sessions in analyzed loop for 5 days with a 3 months interval between them, 2nd series of sessions were conducted 6 hours after oral application of 25 mg spironolactone. The data was analyzed using non-parametric statistical methods. Optimization of regulatory systems state under influence of BFB sessions in the loop of PB and HRV parameters was found. Spironolactone in studied dose had no significant effect on optimization of regulatory systems state.

  4. Pharmacokinetic-pharmacodynamic analysis of mnesic effects of lorazepam in healthy volunteers.

    Science.gov (United States)

    Blin, O; Jacquet, A; Callamand, S; Jouve, E; Habib, M; Gayraud, D; Durand, A; Bruguerolle, B; Pisano, P

    1999-10-01

    To describe the pharmacokinetic-pharmacodynamic modelling of the psychomotor and mnesic effects of a single 2 mg oral dose of lorazepam in healthy volunteers. This was a randomized double-blind, placebo-controlled two-way cross-over study. The effect of lorazepam was examined with the following tasks: choice reaction time, immediate and delayed cued recall of paired words and immediate and delayed free recall and recognition of pictures. The mean calculated EC50 values derived from the PK/PD modelling of the different tests ranged from 12.2 to 15.3 ng ml-1. On the basis of the statistical comparison of the EC50 values, the delayed recall trials seemed to be more impaired than the immediate recall trials; similar observations were made concerning the recognition vs recall tasks. The parameter values derived from PK/PD modelling, and especially the EC50 values, may provide sensitive indices that can be used, rather than the raw data derived from pharmacodynamic measurements, to compare CNS effects of benzodiazepines.

  5. Human dosimetry and preliminary tumor distribution of 18F-fluoropaclitaxel in healthy volunteers and newly diagnosed breast cancer patients using PET/CT.

    Science.gov (United States)

    Kurdziel, Karen A; Kalen, Joseph D; Hirsch, Jerry I; Wilson, John D; Bear, Harry D; Logan, Jean; McCumisky, James; Moorman-Sykes, Kathy; Adler, Stephen; Choyke, Peter L

    2011-09-01

    (18)F-fluoropaclitaxel is a radiolabeled form of paclitaxel, a widely used chemotherapy agent. Preclinical data suggest that (18)F-fluoropaclitaxel may be a reasonable surrogate for measuring the uptake of paclitaxel. As a substrate of P-glycoprotein, a drug efflux pump associated with multidrug resistance, (18)F-fluoropaclitaxel may also be useful in identifying multidrug resistance and predicting tumor response for drugs other than paclitaxel. After informed consent was obtained, 3 healthy volunteers and 3 patients with untreated breast cancer (neoadjuvant chemotherapy candidates, tumor size > 2 cm) received an intravenous infusion of (18)F-fluoropaclitaxel and then underwent PET/CT. Healthy volunteers underwent serial whole-body imaging over an approximately 3-h interval, and organ (18)F residence times were determined from the time-activity curves uncorrected for decay to determine dosimetry. Radiation dose estimates were calculated using OLINDA/EXM software. For breast cancer patients, dynamic imaging of the primary tumor was performed for 60 min, followed by static whole-body scans at 1 and 2 h after injection. Dosimetry calculations showed that the gallbladder received the highest dose (229.50 μGy/MBq [0.849 rad/mCi]), followed by the small and large intestines (161.26 μGy/MBq [0.597 rad/mCi] and 184.59 μGy/MBq [0.683 rad/mCi]). The resultant effective dose was 28.79 μGy/MBq (0.107 rem/mCi). At approximately 1 h after injection, an average of 42% of the decay-corrected activity was in the gastrointestinal system, with a mean of 0.01% in the tumor. All 3 breast cancer patients showed retention of (18)F-fluoropaclitaxel and ultimately demonstrated a complete pathologic response (no invasive cancer in the breast or axillary nodes) to chemotherapy that included a taxane (either paclitaxel or docetaxel) at surgical resection. The tumor-to-background ratio increased with time to a maximum of 7.7 at 20 min. This study demonstrates the feasibility of using (18)F

  6. Human Dosimetry and Preliminary Tumor Distribution of 18F-Fluoropaclitaxel in Healthy Volunteers and Newly Diagnosed Breast Cancer Patients Using PET/CT

    International Nuclear Information System (INIS)

    Kurdziel, K.A.; Logan, J.; Kalen, J.D.; Hirsch, J.I.; Wilson, J.D.; Bear, H.D.; McCumisky, J.; Moorman-Sykes, K.; Adler, S.; Choyke, P.L.

    2011-01-01

    18 F-fluoropaclitaxel is a radiolabeled form of paclitaxel, a widely used chemotherapy agent. Preclinical data suggest that 18 F-fluoropaclitaxel may be a reasonable surrogate for measuring the uptake of paclitaxel. As a substrate of P-glycoprotein, a drug efflux pump associated with multidrug resistance, 18 F-fluoropaclitaxel may also be useful in identifying multidrug resistance and predicting tumor response for drugs other than paclitaxel. After informed consent was obtained, 3 healthy volunteers and 3 patients with untreated breast cancer (neoadjuvant chemotherapy candidates, tumor size > 2 cm) received an intravenous infusion of 18 F-fluoropaclitaxel and then underwent PET/CT. Healthy volunteers underwent serial whole-body imaging over an approximately 3-h interval, and organ 18 F residence times were determined from the time-activity curves uncorrected for decay to determine dosimetry. Radiation dose estimates were calculated using OLINDA/EXM software. For breast cancer patients, dynamic imaging of the primary tumor was performed for 60 min, followed by static whole-body scans at 1 and 2 h after injection. Dosimetry calculations showed that the gallbladder received the highest dose (229.50 μGy/MBq [0.849 rad/mCi]), followed by the small and large intestines (161.26 μGy/MBq [0.597 rad/mCi] and 184.59 μGy/MBq [0.683 rad/mCi]). The resultant effective dose was 28.79 μGy/MBq (0.107 rem/mCi). At approximately 1 h after injection, an average of 42% of the decay-corrected activity was in the gastrointestinal system, with a mean of 0.01% in the tumor. All 3 breast cancer patients showed retention of 18 F-fluoropaclitaxel and ultimately demonstrated a complete pathologic response (no invasive cancer in the breast or axillary nodes) to chemotherapy that included a taxane (either paclitaxel or docetaxel) at surgical resection. The tumor-to-background ratio increased with time to a maximum of 7.7 at 20 min. This study demonstrates the feasibility of using 18 F

  7. Effects of Blueberry and Cranberry Juice Consumption on the Plasma Antioxidant Capacity of Healthy Female Volunteers

    DEFF Research Database (Denmark)

    Pedersen(Vægter), Christian Bjerggaard; Kyle, J; Jenkinson, AM

    2000-01-01

    OBJECTIVE: To assess whether consumption of 500 ml of blueberry juice or cranberry juice by healthy female subjects increased plasma phenolic content and antioxidant capacity. DESIGN: Latin square arrangement to eliminate ordering effects. After an overnight fast, nine volunteers consumed 500 ml ...... for by an increase in vitamin C rather than phenolics. This also accounted for the lack of an effect of the phenolic-rich but vitamin C-low blueberry juice. Sponsorship: Funded by the Scottish Executive Rural Affairs Department and the Danish Government....

  8. The effect of intravenous PACAP38 on cerebral hemodynamics in healthy volunteers

    DEFF Research Database (Denmark)

    Birk, Steffen; Sitarz, John Thomas; Petersen, Kenneth Ahrend

    2007-01-01

    .9+/-22.4% (Peffect on rCBF in healthy volunteers. The marked increase in heart rate and the reduction in rCBF caused by decreased P(et)CO(2) are important dose-limiting factors to consider in future clinical studies.......PACAP38 is an endogenous peptide located in trigeminal perivascular nerve fibers in the brain. It reduces neuronal loss and infarct size in animal stroke models and has been proposed a candidate substance for human clinical studies of stroke. The effect on systemic hemodynamics and regional......CBF was measured with SPECT and (133)Xe inhalation and mean blood flow velocity in the middle cerebral artery was measured with transcranial Doppler ultrasonography. End tidal partial pressure of CO(2) (P(et)CO(2)) and vital parameters were recorded throughout the 2 hour study period. PACAP38 decreased rCBF in all...

  9. Comparison of three-factor and four-factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers

    NARCIS (Netherlands)

    Levi, M. [=Marcel M.; Moore, K. T.; Castillejos, C. F.; Kubitza, D.; Berkowitz, S. D.; Goldhaber, S. Z.; Raghoebar, M.; Patel, M. R.; Weitz, J. I.; Levy, J. H.

    2014-01-01

    Four-factor prothrombin complex concentrates (PCCs), which contain factor II, FVII, FIX, and FX, have shown the potential to reverse the anticoagulant effect of rivaroxaban in healthy volunteers. The purpose of this study was to determine whether a three-factor PCC, which contains little FVII, has a

  10. Evaluation of metabolite profiles as biomarkers for the pharmacological effects of thiazolidinediones in type 2 diabetes mellitus patients and healthy volunteers

    NARCIS (Netherlands)

    Doorn, M. van; Vogels, J.; Tas, A.; Hoogdalem, E.J. van; Burggraaf, J.; Cohen, A.; Greef, J. van der

    2007-01-01

    Aims: To explore the usefulness of metabolomics as a method to obtain a broad array of biomarkers for the pharmacological effects of rosiglitazone (RSG) in plasma and urine samples from patients with type 2 diabetes mellitus (T2DM) and healthy volunteers (HVs). Additionally, we explored the

  11. Comparison of Quantitative Cartilage T2 Measurements and Qualitative MR Imaging between Professional Ballet Dancers and Healthy Volunteers.

    Science.gov (United States)

    Cha, Jang Gyu; Yi, Ji Sook; Han, Jong Kyu; Lee, Young Koo

    2015-07-01

    To compare qualitative magnetic resonance (MR) images and quantitative T2 measurements of the tibiotalar cartilage between ballerinas and healthy volunteers. Institutional review board approval for this study and informed consent (from all participants) were obtained. MR examinations were performed by using a 3-T MR imaging system with 21 professional female ballet dancers and 20 healthy female volunteers. Two musculoskeletal radiologists qualitatively measured tibiotalar cartilage T2 values in the anterior zones, middle zones, and posterior zones of cartilage. MR findings were also qualitatively analyzed in both groups. The tibial cartilage T2 values measured in the anterior and posterior zones and the talar cartilage T2 values measured in all three zones were significantly higher in the ballerina group than in the control group (P The posterior zones exhibited the highest T2 values among the three tibiotalar cartilage zones in both groups (P the presence of posterior soft-tissue edema (P = .001) and flexor hallucis longus tenosynovitis (P The findings showed a trend toward increasing cartilage T2 values in ballerinas when compared with control subjects, indicating that quantitative T2 measurement may potentially be used as a noninvasive imaging tool for early detection of cartilage lesions in the tibiotalar joint.

  12. Prostaglandin E(2) mediates acid-induced heartburn in healthy volunteers.

    Science.gov (United States)

    Kondo, Takashi; Oshima, Tadayuki; Tomita, Toshihiko; Fukui, Hirokazu; Watari, Jiro; Okada, Hiroki; Kikuchi, Shojiro; Sasako, Mitsuru; Matsumoto, Takayuki; Knowles, Charles H; Miwa, Hiroto

    2013-03-15

    Prostaglandin E(2) (PGE(2)) plays a major role in pain processing and hypersensitivity. This study investigated whether PGE(2) levels are increased in the esophageal mucosa after acid infusion and whether increases in PGE(2) are associated with heartburn. Furthermore, expression of the PGE(2) receptor EP1 was investigated in human esophageal mucosa. Fourteen healthy male volunteers were randomized to 30-min lower esophageal acid (1% HCl) or saline perfusion. Before and after acid perfusion, endoscopic biopsies were taken from the distal esophagus. PGE(2) concentration (pg/mg protein) and EP1 mRNA and protein in biopsy samples were measured by ELISA, RT-PCR, and Western blotting. Symptom status of heartburn was evaluated with a validated categorical rating scale with a higher values corresponding to increasing intensity. PGE(2) levels in the esophageal mucosa significantly increased after acid infusion (before vs. after acid infusion: 23.2 ± 8.6 vs. 68.6 ± 18.3, P heartburn in the acid-infusion group was also significantly greater compared with saline (saline vs. acid infusion: 54.3 ± 13.1 vs. 178.5 ± 22.8, P heartburn.

  13. Assessment of olfactory nerve by SPECT-MRI image with nasal thallium-201 administration in patients with olfactory impairments in comparison to healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Hideaki Shiga

    Full Text Available PURPOSE: The aim of this study was to assess whether migration of thallium-201 ((201Tl to the olfactory bulb were reduced in patients with olfactory impairments in comparison to healthy volunteers after nasal administration of (201Tl. PROCEDURES: 10 healthy volunteers and 21 patients enrolled in the study (19 males and 12 females; 26-71 years old. The causes of olfactory dysfunction in the patients were head trauma (n = 7, upper respiratory tract infection (n = 7, and chronic rhinosinusitis (n = 7. (201TlCl was administered unilaterally to the olfactory cleft, and SPECT-CT was conducted 24 h later. Separate MRI images were merged with the SPECT images. (201Tl olfactory migration was also correlated with the volume of the olfactory bulb determined from MRI images, as well as with odor recognition thresholds measured by using T&T olfactometry. RESULTS: Nasal (201Tl migration to the olfactory bulb was significantly lower in the olfactory-impaired patients than in healthy volunteers. The migration of (201Tl to the olfactory bulb was significantly correlated with odor recognition thresholds obtained with T&T olfactometry and correlated with the volume of the olfactory bulb determined from MRI images when all subjects were included. CONCLUSIONS: Assessment of the (201Tl migration to the olfactory bulb was the new method for the evaluation of the olfactory nerve connectivity in patients with impaired olfaction.

  14. Cooking Healthy, Eating Smart (CHES): Evaluating the feasibility of using volunteers to deliver nutrition and food safety education to rural older adults

    Science.gov (United States)

    Getty, Morgan

    Due to their limited resources, rural, older adults in the United States are at risk for poor diet-related health outcomes. Nutrition education is a key component in improving health outcomes in older adults. Cooking Healthy, Eating Smart (CHES) is a nine-lesson curriculum designed to teach rural, older adults culturally appropriate nutrition and food safety information. Funding to hire health professionals to deliver such a curriculum is limited, presenting the need to explore a less expensive mode of dissemination. In this community-based, participatory research study, a formative evaluation and feasibility study were conducted to examine the use of volunteers to deliver a nutrition and food safety curriculum to rural, older adults in South Carolina. Seven focus groups were conducted with members of the South Carolina Family and Community Leaders (SCFCL) and members of the American Association of Retired Persons (AARP) in the four regions of South Carolina to explore barriers and facilitators of volunteers delivering CHES (N=65 participants). The focus group findings informed the development of the volunteer training manual. A comparative case study method was used to examine the feasibility of a volunteer-based approach by observing and describing the delivery of CHES by two groups of volunteers in SC. The case study findings, including volunteer knowledge change, self-efficacy change, curriculum experience, program experience, and project team observations of volunteers indicated that using volunteers to deliver CHES is a plausible approach with the assistance of paid staff or project team members.

  15. Pharmacokinetics of Cromolyn and Ibuprofen in Healthy Elderly Volunteers.

    Science.gov (United States)

    Brazier, David; Perry, Robert; Keane, Jim; Barrett, Katie; Elmaleh, David R

    2017-11-01

    BACKGROUND AND OBJECTIVES: The combination of cromolyn and ibuprofen is being investigated as a treatment for early Alzheimer's disease (AD). This study investigated the pharmacokinetics, safety, and tolerability of cromolyn and ibuprofen co-administration in healthy elderly adult volunteers. In this open-labeled study, 26 subjects, aged 55-75 years, received co-administration of inhaled cromolyn (single dose 17.1 mg; double dose 34.2 mg total) and oral ibuprofen (single dose 10 mg; double dose 20 mg total). Blood sampling was performed for 6 h after co-administration in all subjects; cerebrospinal fluid (CSF) was collected in three to four subjects per cohort for 4 h following co-administration. Safety parameters, including adverse events (AEs), were monitored throughout the study. For cromolyn, the mean (±SD) maximum observed concentration (C max ) in plasma was 46.69 ± 32.97 and 96.75 ± 46.22 ng/ml after single- and double-dose inhalation, respectively [time to C max (t max ) ~22 min for each; terminal elimination half-life (t ½ ) ~1.8 h for each]. For ibuprofen, the plasma C max was 1090.98 ± 474.64 ng/ml and 2062.96 ± 655.13 ng/ml after single- and double-dose oral administration, respectively (t max ~1.6-1.8 h; t ½ ~1.9 h for each). For cromolyn, the CSF C max was 0.24 ± 0.08 ng/ml at 3.72 ± 0.70 h after single-dose administration and 0.34 ± 0.17 ng/ml at 3.45 ± 0.95 h after double-dose administration, and for ibuprofen, the CSF C max was 3.94 ± 1.29 ng/ml at 2.55 ± 0.96 h after single-dose administration and 8.93 ± 3.29 ng/ml at 3.15 ± 1.05 h after double-dose administration. Three (12%) subjects reported mild or moderate AEs which were unlikely to be related to study drug. The combination of cromolyn and ibuprofen was safe and well tolerated. The concentrations of cromolyn and ibuprofen observed in the CSF are considered sufficient to titrate the estimated daily amyloid production and the associated inflammatory response

  16. Quantitative pulmonary perfusion imaging with 3-dimensional, contrast-enhanced MR: regional difference in the perfusion parameters of healthy volunteers

    International Nuclear Information System (INIS)

    Kim, Song Soo; Seo, Joon Beom; Kim, Nam Kuk; Do, Kyung Hyun; Lee, Young Kyung; Song, Jae Woo; Lee, Jin Seong; Kim, Jin Hwan

    2007-01-01

    We wanted to evaluate the regional differences in such perfusion parameters as pulmonary blood flow (PBF), mean transit time (MTT) and pulmonary blood volume (PBV) in the entire lung of healthy volunteers with using three-dimensional, contrast-enhanced MR imaging (3D CEMRI). Six healthy volunteers underwent dynamic 3D CEMRI (TR/TE 2.7/0.6 msec; flip angle 40 .deg. ; matrix 128 x 96; reconstructed matrix 256 x 192; rectangular field of view 450 x 315 mm; coronal 100-150mm-thick x 10 slabs; temporal resolution 1.0 sec; 35 dynamic phases) For all subjects, 2 mL of Gd-DTPA mixed with 3 ml of physiologic saline was administered as a bolus at a rate of 5 mL/sec, and this was followed by 20 mL of physiologic saline flush. From the signal intensity-time curves, the PBF, MTT and PBV maps were generated using indicator dilution theories and the central volume principle on a pixel-by-pixel basis. A total of 54 round, 1-cm sized ROIs were placed in the lung in each subject (6 ROIs per slab x 9 slices except for the most posterior slab). The regional differences of the measured parameters were statistically evaluated in the gravitational direction and in the upper-mid-lower direction by one-way ANOVA tests. The calculated PBF, MTT and PBV in the entire lung were 141.8 ± 53.4 mL/100 mL/min (mean ± SD), 5.35 ± 1.38 sec, and 13.4 ± 6.48 mL/100mL, respectively. In the gravitational direction, there was a significant increase in the PBF and PBV as it goes to the posterior direction (ρ < 0.05). No statistical difference was found in PBF or PBV between the upper, mid and lower lung zone areas. Regional difference in the various perfusion parameters of the lung in healthy volunteers can be quantitatively assessed with performing 3D CEMRI

  17. Independent effects of age and levodopa on reversal learning in healthy volunteers.

    Science.gov (United States)

    Vo, Andrew; Seergobin, Ken N; MacDonald, Penny A

    2018-05-18

    The dopamine overdose hypothesis has provided an important theoretical framework for understanding cognition in Parkinson's disease. It posits that effects of dopaminergic therapy on cognition in Parkinson's disease depend on baseline dopamine levels in brain regions that support different functions. Although functions performed by more severely dopamine-depleted brain regions improve with medication, those associated with less dopamine deficient areas are actually worsened. It is presumed that medication-related worsening of cognition owes to dopamine overdose. We investigated whether age-related changes in baseline dopamine levels would modulate effects of dopaminergic therapy on reward learning in healthy volunteers. In a double-blind, crossover design, healthy younger and older adults completed a probabilistic reversal learning task after treatment with 100/25 mg of levodopa/carbidopa versus placebo. Older adults learned more poorly than younger adults at baseline, being more likely to shift responses after misleading punishment. Levodopa worsened stimulus-reward learning relative to placebo to the same extent in both groups, irrespective of differences in baseline performance and expected dopamine levels. When order effects were eliminated, levodopa induced response shifts after reward more often than placebo. Our results reveal independent deleterious effects of age group and exogenous dopamine on reward learning, suggesting a more complex scenario than predicted by the dopamine overdose hypothesis. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. Effects of melatonin on prepulse inhibition, habituation and sensitization of the human startle reflex in healthy volunteers

    DEFF Research Database (Denmark)

    Lehtinen, Emilia K; Ucar, Ebru; Glenthøj, Birte Y

    2014-01-01

    Prepulse inhibition of the startle reflex (PPI) is an operational measure of sensorimotor gating, which is demonstrated to be impaired in patients with schizophrenia. In addition, a disruption of the circadian rhythm together with blunted melatonin secretion is regularly found in patients...... with schizophrenia and it is theorized that these may contribute to their attentional deficits. The aim of this study was to assess the effects of acute melatonin on healthy human sensorimotor gating. Twenty-one healthy male volunteers were administered melatonin or placebo after which their levels of PPI were...... assessed. Melatonin significantly reduced startle magnitude and ratings of alertness, but did not influence PPI, nor sensitization and habituation. However, when taking baseline scores in consideration, melatonin significantly increased PPI in low scoring individuals while significantly decreasing...

  19. Bioequivalence of a single 400-mg dose of imatinib 100-mg oral tablets and a 400-mg tablet in healthy adult Korean volunteers.

    Science.gov (United States)

    Lee, Hae Won; Seong, Sook Jin; Park, Sung Min; Lee, Joomi; Gwon, Mi-Ri; Kim, Hyun-Ju; Lim, Sung Mook; Lim, Mi-Sun; Kim, Woomi; Yang, Dong Heon; Yoon, Young-Ran

    2015-06-01

    Imatinib mesylate (IM) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. A new once-daily 400-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea. The present study was designed to assess and compare the PK parameters, bioavailability, and bioequivalence of the new imatinib 400-mg formulation (test) versus the conventional 100-mg formulation (reference) administered as a single 400-mg dose in healthy adult male volunteers. This randomized, open-label, single-dose, two-way crossover study was conducted in healthy Korean male volunteers. Eligible subjects were randomly assigned in a 1 : 1 ratio to receive 400 mg of the test (one 400-mg tablet) or reference (four 100-mg tablets) formulation, followed by a 2-week washout period and administration of the alternate formulation. Serial blood samples were collected at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours after administration. Plasma imatinib concentrations were determined using liquid chromatography coupled with tandem mass spectrometry. The formulations were to be considered bioequivalent if the 90% confidence intervals (CIs) of the adjusted geometric mean ratios for Cmax, AUC(0-t), and AUC(0-∞)ž were within the predetermined range of 0.80 - 1.25. In total, 35 subjects completed the study. No serious adverse event was reported during the study. The 90% CIs of the adjusted geometric mean ratios of the test formulation to the reference formulation for C(max), AUC(0-t) and AUC(0-∞)ž of imatinib were all within the bioequivalence criteria range of 0.8 - 1.25. The test formulation of imatinib met the Korean regulatory requirements for bioequivalence. Both imatinib formulations were well-tolerated in all subjects.

  20. Effects of cocoa extract and dark chocolate on angiotensin-converting enzyme and nitric oxide in human endothelial cells and healthy volunteers--a nutrigenomics perspective.

    Science.gov (United States)

    Persson, Ingrid A L; Persson, Karin; Hägg, Staffan; Andersson, Rolf G G

    2011-01-01

    Evidence suggests that cocoa from the bean of Theobroma cacao L. has beneficial effects on cardiovascular disease. The aim of this study was to investigate if cocoa extract and dark chocolate influence angiotensin-converting enzyme (ACE) and nitric oxide (NO) in human endothelial cells (in vitro) and in healthy volunteers (in vivo). ACE activity was analyzed with a commercial radioenzymatic assay and measured in human endothelial cells from umbilical veins (HUVEC) after 10 minutes of incubation with cocoa extract. NO was measured after 24 hours of incubation. ACE activity and NO were measured at baseline and after 30, 60, and 180 minutes in 16 healthy volunteers after a single intake of 75 g of dark chocolate containing 72% cocoa. Significant inhibition of ACE activity (P cocoa inhibits ACE activity in vitro and in vivo.

  1. Thickness of the retinal photoreceptor outer segment layer in healthy volunteers and in patients with diabetes mellitus without retinopathy, diabetic retinopathy, or diabetic macular edema

    Directory of Open Access Journals (Sweden)

    Abdullah Ozkaya

    2017-04-01

    Conclusion: The PROS layer at the foveal center was thinner in patients who had diabetic retinopathy or diabetic macular edema than both the healthy volunteers and diabetic patients without retinopathy.

  2. comparison of various cholesterol lowering diets in young healthy volunteers : effects on serum lipoproteins and on other risk indicators for cardiovascular diseases

    NARCIS (Netherlands)

    Brussaard, J.H.

    1981-01-01

    This thesis deals with the effect of type and amount of dietary fat on the concentration and composition of serum lipoproteins, colonic function, plasma glucose and serum insulin levels and blood pressure in healthy human volunteers.

    Two experiments were carried out. In the first experiment

  3. Characterizing functional connectivity during rest in multiple sclerosis patients versus healthy volunteers using independent component analysis

    Energy Technology Data Exchange (ETDEWEB)

    Palacio Garcia, L.; Andrzejak, R.; Prchkovska, V.; Rodrigues, P.

    2016-07-01

    It is commonly thought that our brain is not active when it does not receive any external input. However, during rest, there are still certain distant regions of the brain that are functionally correlated between them: the so-called resting-state networks. This functional connectivity of the brain is disrupted in many neurological diseases. In particular, it has been shown that one of the most studied resting-state networks (the default-mode network) is affected in multiple sclerosis, which is the most common disabling neurological condition affecting the central nervous system of young adults. In this work, I focus on the study of the differences in the resting-state networks between multiple sclerosis patients and healthy volunteers. In order to study the effects of multiple sclerosis on the functional connectivity of the brain, a numerical method known as independent component analysis (ICA) is applied. This technique divides the resting-state fMRI data into independent components. Nonetheless, noise, which could be due to head motion or physiological artifacts, may corrupt the data by indicating a false activation. Therefore, I create a web user interface that allows the user to manually classify all the independent components for a given subject. Eventually, the components classified as noise should be removed from the functional data in order to prevent them from taking part in any further analysis. (Author)

  4. Short-term serotonergic but not noradrenergic antidepressant administration reduces attentional vigilance to threat in healthy volunteers.

    Science.gov (United States)

    Murphy, Susannah E; Yiend, Jenny; Lester, Kathryn J; Cowen, Philip J; Harmer, Catherine J

    2009-03-01

    Anxiety is associated with threat-related biases in information processing such as heightened attentional vigilance to potential threat. Such biases are an important focus of psychological treatments for anxiety disorders. Selective serotonin reuptake inhibitors (SSRIs) are effective in the treatment of a range of anxiety disorders. The aim of this study was to assess the effect of an SSRI on the processing of threat in healthy volunteers. A selective noradrenergic reuptake inhibitor (SNRI), which is not generally used in the treatment of anxiety, was used as a contrast to assess the specificity of SSRI effects on threat processing. Forty-two healthy volunteers were randomly assigned to 7 d double-blind intervention with the SSRI citalopram (20 mg/d), the SNRI reboxetine (8 mg/d), or placebo. On the final day, attentional and interpretative bias to threat was assessed using the attentional probe and the homograph primed lexical decision tasks. Citalopram reduced attentional vigilance towards fearful faces but did not affect the interpretation of ambiguous homographs as threatening. Reboxetine had no significant effect on either of these measures. Citalopram reduces attentional orienting to threatening stimuli, which is potentially relevant to its clinical use in the treatment of anxiety disorders. This finding supports a growing literature suggesting that an important mechanism through which pharmacological agents may exert their effects on mood is by reversing the cognitive biases that characterize the disorders that they treat. Future studies are needed to clarify the neural mechanisms through which these effects on threat processing are mediated.

  5. Patterns in the Parathyroid Response to Sodium Bicarbonate Infusion Test in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Theodossis S. Papavramidis

    2014-01-01

    Full Text Available Background. The sodium bicarbonate infusion test evaluates the function of the parathyroid glands. The present study aims to evaluate the range of parathyroid response in healthy individuals and the potential influence of various factors. Methods. Fifty healthy volunteers were subjected to the test. Levels of vitamin D, calcium, albumin, and PTH were measured before infusion. PTH was measured at 3, 5, 10, 30, and 60 minutes after infusion. Results. A curve describing the response of parathyroids to the test was drawn. Twenty percent of the subjects had blunted PTH response. No significant difference was observed between normal and blunted responders concerning age, BMI, baseline PTH, or calcium levels. Nonetheless, there was a significant difference in vitamin D levels (P=0.024. Interpretation. The test is easy to perform and may be used for everyday screening. It has to be clarified whether our observations are, at least partly, produced due to the presence of individuals with a constitutively blunted response or if low levels of vitamin D decrease the ability of the parathyroids to respond. Whichever the case, PTH response of normal individuals to sodium bicarbonate infusion test is more varied than previously thought and vitamin D levels influence it.

  6. Methodical principles of assessment of financial compensation for clinical trial volunteer participants

    Directory of Open Access Journals (Sweden)

    V. Ye. Dobrova

    2013-10-01

    Full Text Available Introduction. Due to the necessity to obtain the reliable results of a clinical trial and to distribute it to the general population of patients the problem of recruiting the adequate number of individuals to participate in the study as objects of observation in the group receiving the investigational medicinal product or as a member of the control group should to be solved. Aim of study. The aim of our study was to research and to justify practically the methodological approaches to determining financial compensation for participation of volunteers in the clinical trials and the appropriate methods of its calculation. Material and methods. For the purpose of determining the baseline factors for calculating the hourly compensation the survey of healthy volunteers and of expert professionals as well as the analysis of its results have been done. Questioning healthy volunteers regarding their attitudes towards inconvenience and discomfort during participation in clinical trials was held at the Ukrainian clinical research centers. Survey participants number was 99, they were healthy volunteers who took part in the first phase clinical trial or bioequivalence studies. The expert survey included questioning of the 193 professionals from Ukrainian clinical research centers, CRO, pharmaceutical manufacturers – research sponsors and collaborators State Expert Center Ministry of Health of Ukraine, who were involved in the planning, organization, implementation and evaluation of clinical trials as well as their regulatory control. Results of study. Using the method of pairwise comparisons and iterative refinement procedures the collective estimate of experts questionnaire results has been performed, by the results of which the nine indicators have been identified and the importance of each of them as units of discomfort have been established. Motivational factors of voluntary participation in clinical trials have been studied. Motivation system for

  7. 76 FR 29720 - Information Collection: Volunteer Programs

    Science.gov (United States)

    2011-05-23

    ... designed to provide educationally related work assignments for students in non-pay status. The volunteer... DEPARTMENT OF AGRICULTURE Farm Service Agency Information Collection: Volunteer Programs AGENCY... the Volunteer Programs. DATES: We will consider comment that we received by July 22, 2011. ADDRESSES...

  8. Pharmacokinetics and bioequivalence study of a fixed dose combination of rabeprazole and itopride in healthy Indian volunteers.

    Science.gov (United States)

    Sahoo, Bijay Kumar; Das, Ayan; Agarwal, Sangita; Bhaumik, Uttam; Bose, Anirbandeep; Ghosh, Debotri; Roy, Bikash; Pal, Tapan Kumar

    2009-01-01

    The aim of the present study was to compare the pharmacokinetics of rabeprazole (CAS 117976-89-3) and itopride (CAS 122898-67-3) after oral administration of a rabeprazole (20 mg)-itopride (150 mg) fixed dose combination (FDC) in healthy human volunteers. The bioequivalence of two formulations (test and reference) was determined in 12 healthy Indian male volunteers (age: 25.25 +/- 4.69 years; weight: 60.50 +/- 5.04 kg) in a randomized, single-dose, two-period, two-treatment crossover study. Both formulations were administered orally as a single dose, with the treatments separated by a washout period of 1 week. Rabeprazole and itopride plasma levels were determined by a validated HPLC method using UV detection. The formulations were compared using the pharmacokinetic parameters area under the plasma concentration-time curve (AUC(0-t)), area under the plasma concentration-time curve from zero to infinity (AUC(0-infinity)) and peak plasma concentration (Cmax). General linear model (GLM) procedures were used in which sources of variation were subject, treatment and period. The results indicated that there were no statistically significant differences (P > 0.05) between the logarithmically transformed AUC(0-infinity) and Cmax values between test and reference formulation. The 90% confidence interval for the ratio of the logarithmically transformed AUC(0-t), AUC(0-infinity) and Cmax were within the bioequivalence limits of 0.8-1.25 and the relative bioavailability of rabeprazole and itopride test and reference formulations was 98.24 and 93.65%, respectively.

  9. Cardiac MRI. Estimation of changes in normalized myocardial gadolinium accumulation over time after contrast injection in patients with acute myocarditis and healthy volunteers

    International Nuclear Information System (INIS)

    Breuckmann, F.; Buhr, C.; Maderwald, S.; Bruder, O.; Schlosser, T.; Nassenstein, K.; Erbel, R.; Barkhausen, J.

    2011-01-01

    An increased normalized gadolinium accumulation (NGA) in the myocardium during early washout has been used for the diagnosis of acute myocarditis (AM). Due to the fact that the pharmacokinetics of contrast agents are complex, time-related changes in NGA after contrast injection are likely. Because knowledge about time-related changes of NGA may improve the diagnostic accuracy of MR, our study aimed to estimate the time course of NGA after contrast injection in patients as well as in healthy volunteers. An ECG-triggered inversion recovery SSFP sequence with incrementally increasing inversion times was repetitively acquired over the 15 minutes after injection of 0.2 Gd-DTPA per kg body weight in a 4-chamber view in 15 patients with AM and 20 volunteers. The T 1relaxation times and the longitudinal relaxation rates (R1) of the myocardium and skeletal musculature were calculated for each point in time after contrast injection. The time course of NGA was estimated based on the linear relationship between R 1 and tissue Gd concentration. NGA decreased over time in the form of a negative power function in patients with AM and in healthy controls. NGA in AM tended to be higher than in controls (p > 0.05). NGA rapidly changes after contrast injection, which must be considered when measuring NGA. Although we observed a trend towards higher NGA values in patients with AM with a maximum difference one minute after contrast injection, NGA did not allow us to differentiate patients with AM from healthy volunteers, because the observed differences did not reach a level of significance. (orig.)

  10. Scan-rescan reproducibility of segmental aortic wall shear stress as assessed by phase-specific segmentation with 4D flow MRI in healthy volunteers.

    Science.gov (United States)

    van der Palen, Roel L F; Roest, Arno A W; van den Boogaard, Pieter J; de Roos, Albert; Blom, Nico A; Westenberg, Jos J M

    2018-05-26

    The aim was to investigate scan-rescan reproducibility and observer variability of segmental aortic 3D systolic wall shear stress (WSS) by phase-specific segmentation with 4D flow MRI in healthy volunteers. Ten healthy volunteers (age 26.5 ± 2.6 years) underwent aortic 4D flow MRI twice. Maximum 3D systolic WSS (WSSmax) and mean 3D systolic WSS (WSSmean) for five thoracic aortic segments over five systolic cardiac phases by phase-specific segmentations were calculated. Scan-rescan analysis and observer reproducibility analysis were performed. Scan-rescan data showed overall good reproducibility for WSSmean (coefficient of variation, COV 10-15%) with moderate-to-strong intraclass correlation coefficient (ICC 0.63-0.89). The variability in WSSmax was high (COV 16-31%) with moderate-to-good ICC (0.55-0.79) for different aortic segments. Intra- and interobserver reproducibility was good-to-excellent for regional aortic WSSmax (ICC ≥ 0.78; COV ≤ 17%) and strong-to-excellent for WSSmean (ICC ≥ 0.86; COV ≤ 11%). In general, ascending aortic segments showed more WSSmax/WSSmean variability compared to aortic arch or descending aortic segments for scan-rescan, intraobserver and interobserver comparison. Scan-rescan reproducibility was good for WSSmean and moderate for WSSmax for all thoracic aortic segments over multiple systolic phases in healthy volunteers. Intra/interobserver reproducibility for segmental WSS assessment was good-to-excellent. Variability of WSSmax is higher and should be taken into account in case of individual follow-up or in comparative rest-stress studies to avoid misinterpretation.

  11. Diffusion-weighted MRI of kidneys in healthy volunteers and living kidney donors

    International Nuclear Information System (INIS)

    Sulkowska, K.; Palczewski, P.; Duda-Zysk, A.; Szeszkowski, W.; Wojcik, D.; Kownacka-Piotrowska, D.; Gołebiowski, M.

    2015-01-01

    Aim: To establish the normal apparent diffusion coefficient (ADC) values in healthy kidneys, comparing them with the literature, and assessing the correlation between ADC values, creatinine blood level, and glomerular filtration rate (GFR). Materials and methods: Twenty-four healthy volunteers and 26 living kidney donors were examined on a 1.5 T magnetic resonance imaging (MRI) unit. Two diffusion-weighted imaging (DWI) sequences were included in the study protocol (protocol 1 with 16 b-values, protocol 2 with 10 b-values) before the examination blood and urine samples were collected. The GFR was calculated using Cockcroft & Gault and MDRD (Modification of Diet In Renal Disease) formulas and the ADC values were measured separately for the cortex and medulla of each kidney by two independent observers. All statistical analyses were performed using the STATISTICA (version 10.0) software package. Data were analysed using an unpaired t-test; p<0.05 indicated a statistically significant difference. Results: The average ADC value for protocol 1 for the cortex was 2.26×10 −3  mm 2 /s, for the medulla 2.21×10 −3  mm 2 /s. In protocol 2, the respective values were 2.13×10 −3  mm 2 /s and 2.06×10 −3  mm 2 /s. Neither statistically significant interobserver differences nor correlation between ADC values, GFR, and creatinine serum level were observed. Conclusion: The reference ADC values were established. The measurements show high interobserver consistency. The differences in ADC values reported in the literature suggest dependence on the equipment and methodology and point to the necessity of obtaining ADC norms for each MRI unit. -- Highlights: •Magnetic resonance diffusion-weighted imaging of kidneys. •Apparent diffusion coefficient in healthy individuals. •Monoexponential model of diffusion

  12. The ADRA2B gene in the production of false memories for affective information in healthy female volunteers.

    Science.gov (United States)

    Fairfield, Beth; Mammarella, Nicola; Di Domenico, Alberto; D'Aurora, Marco; Stuppia, Liborio; Gatta, Valentina

    2017-08-30

    False memories are common memory distortions in everyday life and seem to increase with affectively connoted complex information. In line with recent studies showing a significant interaction between the noradrenergic system and emotional memory, we investigated whether healthy volunteer carriers of the deletion variant of the ADRA2B gene that codes for the α2b-adrenergic receptor are more prone to false memories than non-carriers. In this study, we collected genotype data from 212 healthy female volunteers; 91 ADRA2B carriers and 121 non-carriers. To assess gene effects on false memories for affective information, factorial mixed model analysis of variances (ANOVAs) were conducted with genotype as the between-subjects factor and type of memory error as the within-subjects factor. We found that although carriers and non-carriers made comparable numbers of false memory errors, they showed differences in the direction of valence biases, especially for inferential causal errors. Specifically, carriers produced fewer causal false memory errors for scripts with a negative outcome, whereas non-carriers showed a more general emotional effect and made fewer causal errors with both positive and negative outcomes. These findings suggest that putatively higher levels of noradrenaline in deletion carriers may enhance short-term consolidation of negative information and lead to fewer memory distortions when facing negative events. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Reproducibility, and age, body-weight and gender dependency of candidate skeletal muscle MRI outcome measures in healthy volunteers

    International Nuclear Information System (INIS)

    Morrow, Jasper M.; Reilly, Mary M.; Hanna, Michael G.; Sinclair, Christopher D.J.; Yousry, Tarek A.; Thornton, John S.; Fischmann, Arne

    2014-01-01

    Quantitative magnetic resonance imaging (MRI) can potentially meet the pressing need for objective, sensitive, reproducible outcome measures in neuromuscular disease trials. We tested, in healthy volunteers, the consistency, reliability and sensitivity to normal inter-subject variation of MRI methods targeted to lower limb muscle pathology to inform the design of practical but comprehensive MRI outcome measure protocols for use in imminent patient studies. Forty-seven healthy volunteers, age 21-81 years, were subject at 3T to three-point Dixon fat-fraction measurement, T 1 -relaxometry, T 2 -relaxometry and magnetisation transfer ratio (MTR) imaging at mid-thigh and mid-calf level bilaterally. Fifteen subjects underwent repeat imaging at 2 weeks. Mean between-muscle fat fraction and T 2 differences were small, but significant (p 2 correlated positively, and MTR negatively with subject age in both the thigh and calf, with similar significant correlations with weight at thigh level only (p < 0.001 to p < 0.05). Scan-rescan and inter-observer intra-class correlation coefficients ranged between 0.62-0.84 and 0.79-0.99 respectively. Quantitative lower-limb muscle MRI using readily implementable methods was sensitive enough to demonstrate inter-muscle differences (small in health), and correlations with subject age and weight. In combination with high reliability, this strongly supports the suitability of these methods to provide longitudinal outcome measures in neuromuscular disease treatment trials. (orig.)

  14. Effects of the Chinese herbal formula "Zuojin Pill" on the pharmacokinetics of dextromethorphan in healthy Chinese volunteers with CYP2D6*10 genotype.

    Science.gov (United States)

    Qiu, Furong; Liu, Songcan; Miao, Ping; Zeng, Jin; Zhu, Leilei; Zhao, TongFang; Ye, Yujie; Jiang, Jian

    2016-06-01

    Zuojin Pill has been shown to inhibit the cytochrome P450 (CYP) 2D6 isoenzyme in vitro. In Chinese individuals, CYP 2D6*10 is the most common allele with reduced enzyme activity. In this study, we investigated the pharmacokinetic interaction between Zuojin Pill and the sensitive CYP2D6 probe dextromethorphan in healthy Chinese volunteers with CYP2D6*10 genotype. A pharmacokinetics interaction study was carried out in three groups with CYP2D6*1/*1 (n = 6), CYP2D6*1/*10 (n = 6), and CYP2D6*10/*10 (n = 6) genotypes. Each participant received a single oral dose of dextromethorphan (15 mg) followed by Zuojin Pill (3 g twice daily) for 7 days, and received 3 g Zuojin Pill with 15 mg dextromethorphan in the last day. Blood samples (0-24 h) and urine samples (0-12 h) were collected at baseline and after the administration of Zuojin Pill, and the samples' concentration of dextromethorphan and its main metabolite dextrorphan was determined. Compared to baseline values, co-administration of Zuojin Pill (3 g twice daily) for 7 days increased the AUC0-24 of dextromethorphan [mean (90 % CI)] by 3.00-fold (2.49∼3.61) and 1.71-fold (1.42∼2.06), and decreased oral clearance(CL/F) by 0.27-fold (0.2-0.40) and 0.57-fold (0.48-0.67) in the participants with CYP2D6*1/*1 and CYP2D6*1/*10 genotypes, respectively. In contrast, no significant change was observed in these pharmacokinetic parameters of the participants with CYP2D6*10/*10 genotype. These data demonstrated that administration of Zuojin Pill inhibited moderately CYP2D6-mediated metabolism of dextromethorphan in healthy volunteers. The inhibitory influence of CYP2D6 was greater in CYP2D6*1/*1 and CYP2D6*1/*10 groups than CYP2D6 *10/*10 group.

  15. Right-sided cardiac function in healthy volunteers measured by first-pass radionuclide ventriculography and gated blood-pool SPECT: comparison with cine MRI

    DEFF Research Database (Denmark)

    Kjaer, Andreas; Lebech, Anne-Mette; Hesse, Birger

    2005-01-01

    for evaluation of right-sided cardiac function. The aim of our study was to compare the agreement between these methods when measuring right-sided cardiac function. METHODS: Twenty-four healthy volunteers were included. Mean age was 44 years (range: 25-60) and 29% were females. All participants had FP, GBPS...

  16. 18F-Alfatide II PET/CT in healthy human volunteers and patients with brain metastases

    International Nuclear Information System (INIS)

    Yu, Chunjing; Mi, Baoming; Wan, Weixing; Pan, Donghui; Xu, Yuping; Yang, Min; Lang, Lixin; Niu, Gang; Chen, Xiaoyuan

    2015-01-01

    We report the biodistribution and radiation dosimetry of an integrin α v β 3 specific PET tracer 18 F-AlF-NOTA-E[PEG 4 -c(RGDfk)] 2 (denoted as 18 F-Alfatide II). We also assessed the value of 18 F-Alfatide II in patients with brain metastases. A series of torso (from the skull to the thigh) static images were acquired in five healthy volunteers (3 M, 2 F) at 5, 10, 15, 30, 45, and 60 min after injection of 18 F-Alfatide II (257 ± 48 MBq). Regions of interest (ROIs) were drawn manually, and the time-activity curves (TACs) were obtained for major organs. Nine patients with brain metastases were examined by static PET imaging with 18 F-FDG (5.55 MBq/kg) and 18 F-Alfatide II. Injection of 18 F-Alfatide II was well tolerated in all healthy volunteers, with no serious tracer-related adverse events found. 18 F-Alfatide II showed rapid clearance from the blood pool and kidneys. The total effective dose equivalent (EDE) and effective dose (ED) were 0.0277 ± 0.003 mSv/MBq and 0.0198 ± 0.002 mSv/MBq, respectively. The organs with the highest absorbed dose were the kidneys and the spleen. Nine patients with 20 brain metastatic lesions identified by MRI and/or CT were enrolled in this study. All 20 brain lesions were visualized by 18 F-Alfatide II PET, while only ten lesions were visualized by 18 F-FDG, and 13 by CT. F-Alfatide II is a safe PET tracer with a favorable dosimetry profile. The observed ED suggests that 18 F-Alfatide II is feasible for human studies. 18 F-Alfatide II has potential value in finding brain metastases of different cancers as a biomarker of angiogenesis. (orig.)

  17. Better sexual acceptability of agomelatine (25 and 50 mg) compared to escitalopram (20 mg) in healthy volunteers. A 9-week, placebo-controlled study using the PRSexDQ scale.

    Science.gov (United States)

    Montejo, Angel L; Deakin, J F W; Gaillard, Raphael; Harmer, Catherine; Meyniel, Florent; Jabourian, Artin; Gabriel, Cecilia; Gruget, Celine; Klinge, Corinna; MacFayden, Christine; Milligan, Holly; Mullings, Emma; Goodwin, Guy

    2015-10-01

    The present double-blind, placebo-controlled study evaluates the effects of agomelatine and the selective serotonin reuptake inhibitor escitalopram on sexual dysfunction in healthy men and women. A total of 133 healthy volunteers (67 men, 66 women) were randomly assigned to agomelatine (25 or 50 mg) or escitalopram (20 mg) or placebo for nine weeks. Sexual acceptability was evaluated by using the psychotropic-related sexual dysfunction questionnaire 5-items total score and sexual dysfunction relative to each sub-score (in 110 volunteers with sexual activity). Sexual dysfunction was evaluated at baseline and after two, five and eight weeks of treatment and one week after drug discontinuation. The psychotropic-related sexual dysfunction questionnaire 5-items total score was significantly lower in both agomelatine groups versus escitalopram at all visits (p escitalopram group than in the placebo group at each post-baseline visit (p escitalopram significantly impaired dysfunction relative to "delayed orgasm or ejaculation" (p escitalopram group than in agomelatine groups (p escitalopram. Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers. ISRCTN75872983. © The Author(s) 2015.

  18. Characterization of immune response to killed leishmania major promastigotes plus BCG vaccine in Sudanese volunteers: a double-blind placebo controlled study

    International Nuclear Information System (INIS)

    Sati, Iman Nasr Eldin

    1996-12-01

    This work was examined whether intradermal immunization of healthy adult Sudanese volunteers with killed leishmania major (KLM) promastigotes plus BCG would induce antigen-specific T cell responses. Only healthy Sudanese volunteers with negative reactivity to leishmania skin test and with ≤20 mm induration of reactivity to purified protein derivative (PPD) were included in the trial. Group (A) (n=3): received a single dose (0.1ml) at a concentration of 10 mg protein of a whole cell component of KLM promastigotes/ml BCG, group (B) (n=12): received as a single dose of viable attenuated BCG alone (0.1 ml) at a concentration of 1 mg protein/ml diluent, group (C) (n=11): received the vaccine diluent only (Placebo) (o.1 ml). Study subjects were tested for their immunological and clinical responses before intervention, . Following vaccination 65% of group (A) subjects converted in their reactivity to leishmanin skin testing,non of the BCG vaccinated subjects converted in leishmanin skin test and only one subject of group (C) became leishmanin positive. Levels of Interferon-gamma (IFN-γ), interleukin-5 (IL-5) and interleukin-10 (IL-10) were measured by a double sandwich enzyme-linked immunosorbent assay (ELISA). A vaccine was considered as a positive responder in terms of cytokine production when the level of the produced cytokine was equal to the 80th percentile of the levels produced by the volunteers in the placebo group. 92% of the group vaccinated with KLM=BCG had circulating T cells. No significant of IL-5 or Il-10 was reported in any of the volunteers in the three group. Levels of anti l eishmania specific IgG were measured by ELISA in optical densities. Volunteers with mean antibody titre above the cut-off point (mean=3X standard deviation) were considered to have positive scores. Accordingly after vaccination 7.69% one volunteers in group (A) had a positive antibody response corresponding to 0% in the other two groups. No serious side effects were reported

  19. Muscle Activation During Grasping With and Without Motor Imagery in Healthy Volunteers and Patients After Stroke or With Parkinson's Disease

    Directory of Open Access Journals (Sweden)

    Manuela Kobelt

    2018-04-01

    Full Text Available Introduction: The present study assessed whether motor imagery (MI produces electromyographic activation in specific muscles of the upper limb during a hand grasping and arm-lifting task in healthy volunteers, patients after stroke, or with Parkinson's disease. Electromyographic (EMG activation was compared under three conditions: MI, physical execution (PE, and rest. The task is clinically relevant unilateral executed movement using open muscle chains.Methods: In a cross-sectional study EMG activation was measured in four muscles: M. deltoideus pars clavicularis, M. biceps brachii, M. extensor digitorum, M. flexor carpi radialis. MI ability was evaluated with mental rotation, mental chronometry and the Kinaesthetic and Visual Imagery Questionnaire. Cognitive performance was screened with the Mini-Mental State Examination.Results: Twenty-two participants (11 females, age 52.6 ±15.8, age range 21 to 72 were included: ten healthy volunteers, seven patients after stroke (time after stroke onset 16.3 ± 24.8 months, and five patients with Parkinson's disease (disease duration 60.4 ± 24.5 months. Overall Mini-Mental State Examination scores ranged between 27 and 30. An increased EMG activation during MI compared to rest condition was observed in M. deltoideus pars clavicularis and M. biceps brachii across all participants (p-value = 0.001, p = 0.007. Seven participants (two healthy volunteers, three patients after stroke and two patients with Parkinson's disease showed a EMG activation during MI of the hand grasping and arm-lifting task in at least one of the target muscles. No correlation between EMG activation during MI and scores of three MI ability assessments were found.Conclusions: The findings suggest that MI can yield subliminal EMG activation. However, that might vary on individual basis. It remains unclear what parameters contribute to or inhibit an EMG activation during MI. Future investigations should determine factors that influence

  20. Tibiofemoral and patellofemoral joint 3D-kinematics in patients with posterior cruciate ligament deficiency compared to healthy volunteers

    Directory of Open Access Journals (Sweden)

    von Eisenhart-Rothe Ruediger

    2012-11-01

    Full Text Available Abstract Background The posterior cruciate ligament (PCL plays an important role in maintaining physiological kinematics and function of the knee joint. To date mainly in-vitro models or combined magnetic resonance and fluoroscopic systems have been used for quantifying the importance of the PCL. We hypothesized, that both tibiofemoral and patellofemoral kinematic patterns are changed in PCL-deficient knees, which is increased by isometric muscle flexion. Therefore the aim of this study was to simultaneously investigate tibiofemoral and patellofemoral 3D kinematics in patients suffering from PCL deficiency during different knee flexion angles and under neuromuscular activation. Methods We enrolled 12 patients with isolated PCL-insufficiency as well as 20 healthy volunteers. Sagittal MR-images of the knee joint were acquired in different positions of the knee joint (0°, 30°, 90° flexion, with and without flexing isometric muscle activity on a 0.2 Tesla open MR-scanner. After segmentation of the patella, femur and tibia local coordinate systems were established to define the spatial position of these structures in relation to each other. Results At full extension and 30° flexion no significant difference was observed in PCL-deficient knee joints neither for tibiofemoral nor for patellofemoral kinematics. At 90° flexion the femur of PCL-deficient patients was positioned significantly more anteriorly in relation to the tibia and both, the patellar tilt and the patellar shift to the lateral side, significantly increased compared to healthy knee joints. While no significant effect of isometric flexing muscle activity was observed in healthy individuals, in PCL-deficient knee joints an increased paradoxical anterior translation of the femur was observed at 90° flexion compared to the status of muscle relaxation. Conclusions Significant changes in tibiofemoral and patellofemoral joint kinematics occur in patients with isolated PCL

  1. Tibiofemoral and patellofemoral joint 3D-kinematics in patients with posterior cruciate ligament deficiency compared to healthy volunteers.

    Science.gov (United States)

    von Eisenhart-Rothe, Ruediger; Lenze, Ulrich; Hinterwimmer, Stefan; Pohlig, Florian; Graichen, Heiko; Stein, Thomas; Welsch, Frederic; Burgkart, Rainer

    2012-11-26

    The posterior cruciate ligament (PCL) plays an important role in maintaining physiological kinematics and function of the knee joint. To date mainly in-vitro models or combined magnetic resonance and fluoroscopic systems have been used for quantifying the importance of the PCL. We hypothesized, that both tibiofemoral and patellofemoral kinematic patterns are changed in PCL-deficient knees, which is increased by isometric muscle flexion. Therefore the aim of this study was to simultaneously investigate tibiofemoral and patellofemoral 3D kinematics in patients suffering from PCL deficiency during different knee flexion angles and under neuromuscular activation. We enrolled 12 patients with isolated PCL-insufficiency as well as 20 healthy volunteers. Sagittal MR-images of the knee joint were acquired in different positions of the knee joint (0°, 30°, 90° flexion, with and without flexing isometric muscle activity) on a 0.2 Tesla open MR-scanner. After segmentation of the patella, femur and tibia local coordinate systems were established to define the spatial position of these structures in relation to each other. At full extension and 30° flexion no significant difference was observed in PCL-deficient knee joints neither for tibiofemoral nor for patellofemoral kinematics. At 90° flexion the femur of PCL-deficient patients was positioned significantly more anteriorly in relation to the tibia and both, the patellar tilt and the patellar shift to the lateral side, significantly increased compared to healthy knee joints. While no significant effect of isometric flexing muscle activity was observed in healthy individuals, in PCL-deficient knee joints an increased paradoxical anterior translation of the femur was observed at 90° flexion compared to the status of muscle relaxation. Significant changes in tibiofemoral and patellofemoral joint kinematics occur in patients with isolated PCL-insufficiency above 30 degrees of flexion compared to healthy volunteers. Since

  2. Proton-pump inhibitor therapy induces acid-related symptoms in healthy volunteers after withdrawal of therapy

    DEFF Research Database (Denmark)

    Reimer, Christina; Søndergaard, Bo; Hilsted, Linda

    2009-01-01

    -controlled trial with 120 healthy volunteers was conducted. Participants were randomized to 12 weeks of placebo or 8 weeks of esomeprazole 40 mg/d followed by 4 weeks with placebo. The Gastrointestinal Symptom Rating Scale (GSRS) was filled out weekly. A score of >2 on 1 of the questions regarding heartburn, acid...... dyspepsia, heartburn, or acid regurgitation in the PPI group was 13 of 59 (22%) at week 10, 13 of 59 (22%) at week 11, and 12 of 58 (21%) at week 12. Corresponding figures in the placebo group were 7% at week 10 (P = .034), 5% at week 11 (P = .013), and 2% at week 12 (P = .001). CONCLUSIONS: PPI therapy...

  3. Unstimulated salivary flow rate, pH and buffer capacity of saliva in healthy volunteers Débito basal, pH y capacidad tampón de la secreción salivar en sujetos sanos

    OpenAIRE

    C. Fenoll-Palomares; J. V. Muñoz-Montagud; V. Sanchiz; B. Herreros; V. Hernández; M. Mínguez; A. Benages

    2004-01-01

    Objectives: to assess the salivary flow rate, pH, and buffer capacity of healthy volunteers, and their relationships with age, gender, obesity, smoking, and alcohol consumption, and to establish the lower-end value of normal salivary flow (oligosialia). Methods: a prospective study was conducted in 159 healthy volunteers (age > 18 years, absence of medical conditions that could decrease salivary flow). Unstimulated whole saliva was collected during ten minutes, and salivary flow rate (ml/min)...

  4. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Udani Jay K

    2010-08-01

    Full Text Available Abstract Background Arabinogalactan from Larch tree (Larix spp. bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia vaccine in healthy adults. Methods This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g at the screening visit (V1-Day 0 and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2. They were monitored the following day (V3-Day 31, as well as 21 days (V4-Day 51 and 42 days (V5-Day 72 after vaccination. Responses by the adaptive immune system (antigen specific were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F and salivary IgA levels. Responses by the innate immune system (non-specific were measured via white blood cell counts, inflammatory cytokines and the complement system. Results Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F at both Day 51 (p = 0.006 and p = 0.002 and at Day 72 (p = 0.008 and p = 0.041. These same subtypes (18C and 23F also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001 and at Day 72 (p = 0.012 and p = 0.003. Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There

  5. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers.

    Science.gov (United States)

    Udani, Jay K; Singh, Betsy B; Barrett, Marilyn L; Singh, Vijay J

    2010-08-26

    Arabinogalactan from Larch tree (Larix spp.) bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia) vaccine in healthy adults. This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g) at the screening visit (V1-Day 0) and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2). They were monitored the following day (V3-Day 31), as well as 21 days (V4-Day 51) and 42 days (V5-Day 72) after vaccination. Responses by the adaptive immune system (antigen specific) were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and salivary IgA levels. Responses by the innate immune system (non-specific) were measured via white blood cell counts, inflammatory cytokines and the complement system. Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F) at both Day 51 (p = 0.006 and p = 0.002) and at Day 72 (p = 0.008 and p = 0.041). These same subtypes (18C and 23F) also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001) and at Day 72 (p = 0.012 and p = 0.003). Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There was no effect from the vaccine or

  6. The effect of whisky and wine consumption on total phenol content and antioxidant capacity of plasma from healthy volunteers

    DEFF Research Database (Denmark)

    Duthie, GG; Pedersen, M W; PC, Morrice

    1998-01-01

    wine, malt whisky or unmatured 'new make'spirit. Each volunteer participated on three occasions one week apart, consuming one of the beverages each time. Bloodsamples were obtained from the anticubital vein at intervals up to 4h after consumption of the beverages when a urinesample was also obtained....... RESULTS: Within 30 min of consumption of the wine and whisky, there was a similar andsignificant increase in plasma total phenol content and antioxidant capacity as determined by the ferric reducing capacityof plasma (FRAP). No changes were observed following consumption of 'new make' spirit. CONCLUSIONS......OBJECTIVE: To assess whether consumption of 100 ml of whisky or red wine by healthy male subjects increasedplasma total phenol content and antioxidant capacity. DESIGN: A Latin square arrangement to eliminate ordering effectswhereby, after an overnight fast, nine volunteers consumed 100 ml of red...

  7. Comparative bioavailability and tolerability of a single 20-mg dose of two fluoxetine hydrochloride dispersible tablet formulations in fasting, healthy Chinese male volunteers: an open-label, randomized-sequence, two-period crossover study.

    Science.gov (United States)

    Shi, Shaojun; Liu, Yani; Wu, Jianhong; Li, Zhongfang; Zhao, Yan; Zhong, Dafang; Zeng, Fandian

    2010-10-01

    The proprietary formulation of fluoxetine hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor class. Pharmacokinetic studies investigating the bioequivalence of generic and branded formulations are needed to market generic fluoxetine in China. The aim of this study was to compare the bioavailability and tolerability of the proposed generic formulation with the established reference formulation of fluoxetine hydrochloride 20 mg in a fasting, healthy Chinese male population. This 10-week, open-label, randomized-sequence, single-dose, 2-period crossover study was conducted in healthy native Han Chinese male volunteers. Eligible subjects were randomly assigned in a 1:1 ratio to receive a single 20-mg dose of the test or reference formulation, followed by a 35-day washout period and administration of the alternate formulation. Doses were administered after a 12-hour overnight fast. For analysis of pharmacokinetic properties (including C(max), T(max), AUC(0-t), AUC(0-∞), and t(½)), blood samples were obtained over a 672-hour period after dosing. Plasma concentrations of fluoxetine and its active metabolite, norfluoxetine, were analyzed using a validated LC-MS/MS method. The formulations were to be considered bioequivalent if the ln-transformed ratios (test/ reference) of C(max) and AUC were within the predetermined bioequivalence range of 80% to 125%, as established by the US Food and Drug Administration, and if the P values were fasting, healthy Chinese male volunteers. Both formulations appeared to be well tolerated. Copyright © 2010 Excerpta Medica Inc. All rights reserved.

  8. Heart rate variability in healthy population

    International Nuclear Information System (INIS)

    Alamgir, M.; Hussain, M.M.

    2010-01-01

    Background: Heart rate variability has been considered as an indicator of autonomic status. Little work has been done on heart rate variability in normal healthy volunteers. We aimed at evolving the reference values of heart rate variability in our healthy population. Methods: Twenty-four hour holter monitoring of 37 healthy individuals was done using Holter ECG recorder 'Life card CF' from 'Reynolds Medical'. Heart rate variability in both time and frequency domains was analysed with 'Reynolds Medical Pathfinder Digital/700'. Results: The heart rate variability in normal healthy volunteers of our population was found in time domain using standard deviation of R-R intervals (SDNN), standard deviation of average NN intervals (SDANN), and Square root of the mean squared differences of successive NN intervals (RMSSD). Variation in heart rate variability indices was observed between local and foreign volunteers and RMSSD was found significantly increased (p<0.05) in local population. Conclusions: The values of heart rate variability (RMSSD) in healthy Pakistani volunteers were found increased compared to the foreign data reflecting parasympathetic dominance in our population. (author)

  9. Thoracodorsal artery examination with doppler ultrasound in healthy volunteers in a level three hospital

    International Nuclear Information System (INIS)

    Vasquez Rangel, Wolfgang Ignacio; Daza, Gabriel Fernando; Escobar Rojas, William

    2011-01-01

    Introduction: The thoracodorsal artery is a branch of the subscapular artery, which in turn is a branch of the axillary artery. The importance of this artery is that it supplies the latissimus dorsi muscle, used as a muscle-skin flap for breast reconstruction after mastectomy, mainly in patients with poor local tissues, in particular after receiving radiotherapy. Objective: to describe the physical characteristics of the thoracodorsal artery using Doppler ultrasound evaluation in healthy volunteers at Hospital Universitario del Valle. Materials and methods: We conducted a descriptive pilot study, because, after reviewing the medical literature, we did not find any reports assessing the thoracodorsal artery with the use of Doppler ultrasound. Results: we evaluated 51 patients, 50.9% female. The average age of the patients was 28.78 years. the axillary, subscapular and thoracodorsal arteries were identified in all patients. The characteristics of the thoracodorsal artery were as follows: Diameter 1.88 mm, peak systolic velocity 28.45 cm/s, peak diastolic velocity 2.03 cm/s, resistance index 0.94, pulsatility index 4.02. Although the study did not include anthropometric measurements, we found that the artery was more conspicuous in patients with developed muscle mass and in patients with low adiposity. Conclusions: The thoracodorsal artery was identified in all patients, and ultrasound localization is a procedure that is easy to perform and provides vital information about the presence of the vascular pedicle required to perform a latissimus dorsi muscle-skin flap. Additional studies in post mastectomy patients are required in order to assess postoperative changes associated with the presence and physical characteristics of the thoracodorsal artery.

  10. Pressure pain thresholds in volunteers and herniorrhaphy patients

    DEFF Research Database (Denmark)

    Dahl, J B; Rosenberg, J; Molke Jensen, F

    1990-01-01

    surgery. PPT was determined in 20 healthy volunteers on two separate examinations, and in 14 patients at the incisional site before and following inguinal herniotomy. In volunteers, PPT was higher for men than for women, and no difference was observed between the first and second day of examination...

  11. Effect of heat-induced pain stimuli on pulse transit time and pulse wave amplitude in healthy volunteers.

    Science.gov (United States)

    van Velzen, Marit H N; Loeve, Arjo J; Kortekaas, Minke C; Niehof, Sjoerd P; Mik, Egbert G; Stolker, Robert J

    2016-01-01

    Pain is commonly assessed subjectively by interpretations of patient behaviour and/or reports from patients. When this is impossible the availability of a quantitative objective pain assessment tool based on objective physiological parameters would greatly benefit clinical practice and research beside the standard self-report tests. Vasoconstriction is one of the physiological responses to pain. The aim of this study was to investigate whether pulse transit time (PTT) and pulse wave amplitude (PWA) decrease in response to this vasoconstriction when caused by heat-induced pain. The PTT and PWA were measured in healthy volunteers, on both index fingers using photoplethysmography and electrocardiography. Each subject received 3 heat-induced pain stimuli using a Temperature-Sensory Analyzer thermode block to apply a controlled, increasing temperature from 32.0 °C to 50.0 °C to the skin. After reaching 50.0 °C, the thermode was immediately cooled down to 32.0 °C. The study population was divided into 2 groups with a time-interval between the stimuli 20s or 60s. The results showed a significant (p  Heat-induced pain causes a decrease of PTT and PWA. Consequently, it is expected that, in the future, PTT and PWA may be applied as objective indicators of pain, either beside the standard self-report test, or when self-report testing is impossible.

  12. Effect of isoproterenol, phenylephrine, and sodium nitroprusside on fundus pulsations in healthy volunteers.

    Science.gov (United States)

    Schmetterer, L; Wolzt, M; Salomon, A; Rheinberger, A; Unfried, C; Zanaschka, G; Fercher, A F

    1996-03-01

    Recently a laser interferometric method for topical measurement of fundus pulsations has been developed. Fundus pulsations in the macular region are caused by the inflow and outflow of blood into the choroid. The purpose of this work was to study the influence of a peripheral vasoconstricting (the alpha 1 adrenoceptor agonist phenylephrine), a predominantly positive inotropic (the non-specific beta adrenoceptor agonist isoproterenol), and a non-specific vasodilating (sodium nitroprusside) model drug on ocular fundus pulsations to determine reproducibility and sensitivity of the method. In a double masked randomised crossover study the drugs were administered in stepwise increasing doses to 10 male and nine female healthy volunteers. Systemic haemodynamic variables and fundus pulsations were measured at all infusion steps. Fundus pulsation increased during infusion of isoproterenol with statistical significance versus baseline at the lowest dose of 0.1 microgram/min. Neither peripheral vasoconstriction nor peripheral vasodilatation affected the ocular fundus pulsations. Measurements of fundus pulsations is a highly reproducible method in healthy subjects with low ametropy. Changes of local pulsatile ocular blood flow were detectable with our method following the infusion of isoproterenol. As systemic pharmacological vasodilatation or vasoconstriction did not change fundus pulsations, further experimental work has to be done to evaluate the sensitivity of the laser interferometric fundus pulsation measurement in various eye diseases.

  13. The pharmacokinetic profile of crocetin in healthy adult human volunteers after a single oral administration.

    Science.gov (United States)

    Umigai, N; Murakami, K; Ulit, M V; Antonio, L S; Shirotori, M; Morikawa, H; Nakano, T

    2011-05-15

    Crocetin, a unique carotenoid with a short carbon chain length, is an active compound of saffron and Gardenia jasminoides Ellis used as traditional herbal medicine. The present study was undertaken to investigate the pharmacokinetic profiles of crocetin in healthy adult subjects. The study was conducted as an open-label, single dose escalation with 10 Filipino volunteers (5 men and 5 women). The subjects received a single dose of crocetin at three doses (7.5, 15 and 22.5 mg) in one week interval. Blood samples were collected from the brachial vein before and at 1, 2, 4, 6, 8, 10 and 24 h after administration. Plasma concentrations of crocetin were determined by high-performance liquid chromatography (HPLC). Crocetin was rapidly absorbed and detected within an hour of administration with a mean time to reach maximum concentration (T(max)) of crocetin ranging from 4.0 to 4.8 h. The mean values of C(max) and AUC(0-24h) ranged from 100.9 to 279.7 ng/ml and 556.5 to 1720.8 ng. h/ml respectively. C(max) and AUC values increased with dose proportional manner. Crocetin was eliminated from human plasma with a mean elimination half life (T(½) of 6.1 to 7.5 h. In summary, there were no serious adverse events up to 22.5 mg dose of crocetin while crocetin was found to be absorbed more quickly than the other carotenoids such as β-carotene, lutein and lycopene. Copyright © 2010 Elsevier GmbH. All rights reserved.

  14. Pharmacokinetics of acetaminophen and ibuprofen when coadministered with telmisartan in healthy volunteers.

    Science.gov (United States)

    Stangier, J; Su, C A; Fraunhofer, A; Tetzloff, W

    2000-12-01

    Two open-label, two-way, crossover studies were performed to assess any pharmacokinetic interaction of telmisartan with either acetaminophen or ibuprofen. Healthy male adult volunteers (n = 12) received a single oral dose of acetaminophen 1 g alone and with oral telmisartan 120 mg in one study. Oral ibuprofen 400 mg three times daily with and without oral once-daily telmisartan 120 mg was given for 7 days in the other study conducted in 6 males and 6 females. In both studies, there was a washout period of > or = 13 days between single and combination medication administration. The primary end points Cmax and AUC were compared between combination (acetaminophen or ibuprofen + telmisartan) and single-agent medication (acetaminophen or ibuprofen). Pharmacokinetic drug interaction was assessed by analysis of variance (ANOVA) and calculation of 90% confidence intervals (CI) for treatment ratios using log-transformed parameters. Bioequivalence (i.e., lack of interaction) was concluded if the 90% CI of the ratios for both Cmax and AUC were within the acceptance limit of 0.80 to 1.25. Geometric mean Cmax values for acetaminophen and R-(-)- and S-(+)-ibuprofen enantiomers were similar with and without telmisartan coadministration (12.6 micrograms/mL vs. 14.1 micrograms/mL; 17.3 micrograms/mL vs. 16.7 micrograms/mL; 19.4 micrograms/mL vs. 19.5 micrograms/mL, respectively), and values for R-(-)- as well as S-(+)-ibuprofen were bioequivalent. Geometric mean AUC values for acetaminophen and R-(-)- and S-(+)-ibuprofen were also bioequivalent with and without telmisartan. The distribution and elimination parameters of both acetaminophen and ibuprofen were comparable in the presence or absence of telmisartan. The concomitant and single-agent medications were all well tolerated. In conclusion, the long half-life and excellent safety profile of telmisartan were unaffected by concurrent acetaminophen or ibuprofen medication; thus, once-daily dosing of telmisartan can be maintained

  15. Travoprost lowers intraocular pressure in healthy student volunteers ...

    African Journals Online (AJOL)

    ... African volunteers in a randomized double masked, placebo controlled, crossover, single centre study. Pulse rate, systolic and diastolic blood pressure, and respiratory rate were also measured. Mean IOP was lower than baseline values up to 72 hours after instillation but the mean IOP was significantly lower in the eyes ...

  16. Effects of bathing on cerebral blood flow in healthy volunteers. Using Patlak plot method with technetium-99m ethyl cysteinate dimer

    International Nuclear Information System (INIS)

    Watanabe, Hiromi; Yorizumi, Kouji

    1997-01-01

    We studied the effects of bathing in warm water on cerebral blood flow (CBF). Seven healthy male volunteers were subjected to experiments. The subjects were bathed in warm water at 39degC for 20 minutes in a sitting position immersed up to the neck. Each subject received two CBF examinations: one under normal conditions and the other after taking a bath mentioned above. There was an interval of at least seven days between the two examinations. To measure CBF, we used the Patlak plot method with technetium-99m ethyl cysteinate dimer (99m-Tc ECD). To examine CBF after bathing, 99m-Tc ECD was injected within 10 minutes after bathing. Brain perfusion index (BPI) and regional CBF (rCBF) were used as indexes for evaluating CBF. The body temperature, pulse, blood pressure, arterial oxygen and carbon dioxide pressure, and hematocrit were also measured. Wilcoxon's signed rank test was used for statistical analyses. The following were observed: BPI increased significantly after bathing (p<0.05). rCBF in the cerebral cortex, particularly in the frontal lobe, tended to increase after bathing (p<0.05). No definite changes were observed in the cerebellar cortex, caudate nucleus, or thalamus. The body temperature and pulse increased significantly after bathing. No definite changes were observed in blood pressure, arterial oxygen and carbon dioxide pressure, or hematocrit. From the above, we conclude that bathing in warm water causes the cerebral blood flow to increase in healthy subjects. (author)

  17. Feasibility of navigator setting on the left diaphragm for whole-heart coronary MRA. A study in healthy volunteers

    International Nuclear Information System (INIS)

    Watanabe, Kunihiro; Suzuki, Takayoshi; Maruyama, Kazuhiro; Noda, Mayumi; Fujita, Mitsuo; Morita, Satoru; Ohnishi, Takahiro

    2009-01-01

    We prospectively compared the quality of images obtained by navigator setting on the left and right diaphragm on whole-heart coronary magnetic resonance angiography (WHCMRA). In 10 healthy volunteers, we performed free-breathing, 3-dimensional segmented true fast imaging with steady-state precession (trueFISP) WHCMRA by setting the navigator on the left and right diaphragm in random order. For the left diaphragm, we set the navigator outside the scope of the heart to avoid the influence on coronary arteries. We compared image acquisition time and visible length of coronary arteries using paired t-test and subjective image quality on a 4-point scale (1, poor; 4, excellent) using Wilcoxon signed-rank test. Mean overall subjective image quality was significantly better in the left diaphragm than the right (3.3±0.7 versus 2.9±0.9, P=0.02). Mean overall visible length of the coronary arteries was significantly better in the left diaphragm than the right (115.4±31.1 vs. 112.6±29.9 mm, P=0.02). Mean acquisition time between the left and right diaphragm was not significantly different (15.6±5.0 versus 16.0±5.7 min, P=0.79). In this small group of healthy volunteers, navigator setting for WHCMRA was superior on the left diaphragm than the right; however, feasibility of the technique requires additional consideration in a larger group of actual patients. (author)

  18. Reproducibility, and age, body-weight and gender dependency of candidate skeletal muscle MRI outcome measures in healthy volunteers

    Energy Technology Data Exchange (ETDEWEB)

    Morrow, Jasper M.; Reilly, Mary M.; Hanna, Michael G. [UCL Institute of Neurology, Medical Research Council Centre for Neuromuscular Diseases, Department of Molecular Neuroscience, London (United Kingdom); Sinclair, Christopher D.J.; Yousry, Tarek A.; Thornton, John S. [UCL Institute of Neurology, Medical Research Council Centre for Neuromuscular Diseases, Department of Molecular Neuroscience, London (United Kingdom); UCL Institute of Neurology, Neuroradiological Academic Unit, Department of Brain Repair and Rehabilitation, London (United Kingdom); Fischmann, Arne [University of Basel Hospital, Department of Radiology, Division of Diagnostic and Interventional Neuroradiology, Basel (Switzerland)

    2014-07-15

    Quantitative magnetic resonance imaging (MRI) can potentially meet the pressing need for objective, sensitive, reproducible outcome measures in neuromuscular disease trials. We tested, in healthy volunteers, the consistency, reliability and sensitivity to normal inter-subject variation of MRI methods targeted to lower limb muscle pathology to inform the design of practical but comprehensive MRI outcome measure protocols for use in imminent patient studies. Forty-seven healthy volunteers, age 21-81 years, were subject at 3T to three-point Dixon fat-fraction measurement, T{sub 1}-relaxometry, T{sub 2}-relaxometry and magnetisation transfer ratio (MTR) imaging at mid-thigh and mid-calf level bilaterally. Fifteen subjects underwent repeat imaging at 2 weeks. Mean between-muscle fat fraction and T{sub 2} differences were small, but significant (p < 0.001). Fat fraction and T{sub 2} correlated positively, and MTR negatively with subject age in both the thigh and calf, with similar significant correlations with weight at thigh level only (p < 0.001 to p < 0.05). Scan-rescan and inter-observer intra-class correlation coefficients ranged between 0.62-0.84 and 0.79-0.99 respectively. Quantitative lower-limb muscle MRI using readily implementable methods was sensitive enough to demonstrate inter-muscle differences (small in health), and correlations with subject age and weight. In combination with high reliability, this strongly supports the suitability of these methods to provide longitudinal outcome measures in neuromuscular disease treatment trials. (orig.)

  19. ColoPulse tablets perform comparably in healthy volunteers and Crohn's patients and show no influence of food and time of food intake on bioavailability

    NARCIS (Netherlands)

    Maurer, J.M.; Schellekens, R.C.A.; Van Rieke, H.M.; Stellaard, F.; Wutzke, K.D.; Buurman, D.J.; Dijkstra, G.; Woerdenbag, H.J.; Frijlink, H.W.; Kosterink, J.G.W.

    2013-01-01

    ColoPulse tablets are an innovative development in the field of oral drug delivery and are characterized by a colon-specific release. Until now ColoPulse dosage forms (only capsules) have been studied in healthy volunteers having a standardized breakfast three hours after administration but not in

  20. Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers.

    Science.gov (United States)

    Noh, Yook-Hwan; Lim, Hyeong-Seok; Kim, Mi Jo; Kim, Yo Han; Choi, Hee Youn; Sung, Hye Ryoung; Jin, Seok-Joon; Lim, Jonglae; Bae, Kyun-Seop

    2012-07-01

    Telmisartan belongs to a class of orally active angiotensin II receptor blockers (ARBs), and S-amlodipine is an enantiomer of amlodipine. Amlodipine is a racemic mixture and the calcium channel blocking (CCB) effect is confined to S-amlodipine, whereas R-amlodipine has a 1000-fold lower activity and no racemization occurs in vivo in human plasma. Combination therapy of ARBs with CCBs provides advantages for blood pressure control and vascular protection over monotherapy. To investigate the effects of coadministration of telmisartan and S-amlodipine on the steady-state pharmacokinetic properties of each drug as a drug-drug interaction study required before developing the fixed-dose combination agent. This study comprised 2 separate parts, A and B; each was a multiple-dose, open-label, 2-sequence, 2-period, crossover study in healthy male Korean volunteers. In part A, volunteers were administered 80 mg of telmisartan, either alone or with 5 mg of S-amlodipine. In part B, volunteers were administered 5 mg of S-amlodipine, either alone or with 80 mg of telmisartan. Blood samples were taken on days 9 and 37, following the final dose of each treatment, and at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours after administration in part A, and were taken at 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, and 24 hours after administration in part B. Plasma concentrations were determined using LC-MS/MS. The pharmacokinetic properties of each drug after coadministration of telmisartan and S-amlodipine were compared with those of each drug administered alone. Tolerability was assessed using measurements of vital signs, clinical chemistry tests, and interviews. Fifty-six volunteers were enrolled (32 in part A and 24 in part B), and all completed except 4 volunteers (3 withdrawn in part A and 1 withdrawn in part B). The geometric mean ratios (GMRs) (90% CI) for the C(max,ss) and AUC(τ,ss) of telmisartan (with or without S-amlodipine) were 1.039 (0

  1. Bioavailability of an R-α-Lipoic Acid/γ-Cyclodextrin Complex in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Naoko Ikuta

    2016-06-01

    Full Text Available R-α-lipoic acid (R-LA is a cofactor of mitochondrial enzymes and a very strong antioxidant. R-LA is available as a functional food ingredient but is unstable against heat or acid. Stabilized R-LA was prepared through complexation with γ-cyclodextrin (CD, yielding R-LA/CD. R-LA/CD was orally administered to six healthy volunteers and showed higher plasma levels with an area under the plasma concentration-time curve that was 2.5 times higher than that after oral administration of non-complexed R-LA, although the time to reach the maximum plasma concentration and half-life did not differ. Furthermore, the plasma glucose level after a single oral administration of R-LA/CD or R-LA was not affected and no side effects were observed. These results indicate that R-LA/CD could be easily absorbed in the intestine. In conclusion, γ-CD complexation is a promising technology for delivering functional but unstable ingredients like R-LA.

  2. Ocular effects of acute ingestion of Cola nitida(Linn on healthy adult volunteers

    Directory of Open Access Journals (Sweden)

    S. A. Igwe

    2007-12-01

    Full Text Available Cola nitida Linn (Sterculiaceae is an economic plant widely distributed throughout West Africa and possibly other parts of Africa.Members are malvalves because of their lobular nature. Because of its ubiquity, the plant plays an important role in commerce, and in social activities where it is casually eaten without prescription or restriction. The ethnopharmacological effects of bolus ingestion of 30g of Cola nitida was investigated on visually acute and healthy volunteers in order to determine its ocular implications or effects. Results showed that Cola nitida had no effecton the pupil diameter, visual acuity and intraocular pressure but improved the near point of convergence by 43% and increased the amplitude of accommodation by 11% while existing heterophorias are ameliorated. The stimulating effect of Cola nitida might overcome asthenopic symptoms with convergence insufficiency and allows near work to be donewithout stress. Somnolence and ocular muscle imbalance common features of the elderly canbe ameliorated or relieved.

  3. Cardiopulmonary and Metabolic Effects of Yoga in Healthy Volunteers.

    Science.gov (United States)

    Divya, T Satheesh; Vijayalakshmi, M T; Mini, K; Asish, K; Pushpalatha, M; Suresh, Varun

    2017-01-01

    Yoga the spiritual union of mind with the divine intelligence of the universe aims to liberate a human being from conflicts of body-mind duality. Beneficial cardiovascular and pulmonary effects of yoga are in par with aerobic exercise, even amounting to replace the exercise model. We conducted an interventional study in healthy volunteers, to analyze the impact of short-term yoga training on cardiovascular, pulmonary, autonomic function tests, lipid profile, and thyroid function tests. A sample of fifty new recruits attending the district yoga center was subject to 75 min yoga practice a day for 41 days. Basal values of cardiovascular, pulmonary, autonomic function tests, lipid profile, and thyroid function tests were recorded before yoga training and were reassessed for postyoga changes after 41 days. After yoga practice there was a significant reduction in the resting heart rate, systolic blood pressure, diastolic blood pressure, and mean blood pressure of the participants. Effects on autonomic function tests were variable and inconclusive. There was a significant increase in forced vital capacity, forced expiratory volume in 1 s, and peak expiratory flow rate after yoga. A significant reduction in body mass index was observed. Effects on metabolic parameters were promising with a significant reduction in fasting blood sugar level, serum total cholesterol, serum triglycerides serum low-density lipoprotein levels, and significant increase in high-density lipoprotein. There was no significant change in thyroid function tests after yoga. Short-term yoga practice has no effect on thyroid functions. Yoga practice was found beneficial in maintaining physiological milieu pertaining to cardiovascular and other metabolic parameters.

  4. Single-Dose pharmacokinetics of sustained-release fampridine (Fampridine-SR) in healthy volunteers and adults with renal impairment.

    Science.gov (United States)

    Smith, William; Swan, Suzanne; Marbury, Thomas; Henney, Herbert

    2010-02-01

    Fampridine-SR is a sustained-release formulation of fampridine (4-aminopyridine), a potassium channel blocker demonstrated to improve walking ability in patients with multiple sclerosis. This study evaluated the pharmacokinetics of fampridine and its metabolites after administration of fampridine-SR 10 mg in healthy volunteers and in subjects with mild, moderate, or severe renal impairment (5 per group). Analysis of variance was used to calculate 90% confidence intervals (CIs) for the ratios (impaired/healthy) of least squares mean in maximum plasma concentration (C(max)) and area under the plasma concentration-time curve (AUC). Clearance was primarily through urinary excretion. In renally impaired subjects, fampridine plasma concentrations were consistently higher than in healthy individuals: ratios for C(max) ranged from 166.5% to 199.9% for mild and severe renal impairment, respectively. AUC(0-infinity) ratios ranged from 175.3% to 398.7%, respectively, for mild and severe renal impairment. Mean terminal disposition half-life was 6.4 hours in healthy individuals, compared with 7.4, 8.1, and 14.3 hours in patients with mild, moderate, and severe renal impairment, respectively. Regression analysis confirmed the significant relationship between creatinine clearance and extent of exposure as quantified by AUC for fampridine and its metabolites, suggesting cautious use in patients with mild renal impairment and avoidance in cases of moderate or severe renal impairment.

  5. Comparative pharmacokinetic and pharmacodynamic evaluation of branded and generic formulations of meloxicam in healthy male volunteers

    Directory of Open Access Journals (Sweden)

    Del Tacca M

    2013-07-01

    Full Text Available Mario Del Tacca,1,2 Giuseppe Pasqualetti,3 Giovanni Gori,1 Pasquale Pepe,1 Antonello Di Paolo,2 Marianna Lastella,2 Ferdinando De Negri,1 Corrado Blandizzi2 1Clinical Pharmacology Centre for Drug Experimentation, Pisa University Hospital, 2Department of Clinical and Experimental Medicine, 3Geriatrics Unit, University of Pisa, Pisa, Italy Purpose: The primary aim of the present study was to assess the pharmacokinetic bioequivalence between a generic formulation of meloxicam 15 mg tablets (Meloxicam Hexal and its respective brand product (Mobic, in order to verify whether the generic product conforms to the regulatory standards of bioequivalence in the postmarketing setting. As a secondary exploratory aim, the pharmacodynamic effects of the two formulations were also evaluated by means of rating scales following hyperalgesia induced by cutaneous freeze injury. Subjects and methods: A single 15 mg dose of generic or branded meloxicam tablets was administered to 24 healthy male volunteers in a crossover fashion. Plasma samples, collected for 24 hours after dosing, were assayed for meloxicam concentration by a validated high-performance liquid chromatography method. Results: The analysis of pharmacokinetic parameters did not show any significant difference between the two meloxicam formulations: the 90% confidence intervals fell within the acceptance range of 80%–125% (0.84–1.16 for area under the curve [0–24], and 0.89–1.23 for peak concentration. No difference in the pharmacodynamic end point was observed between the two groups. Conclusion: The pharmacokinetic profiles of the two meloxicam formulations confirm the regulatory criteria for bioequivalence; pharmacodynamic data indicate a similar antihyperalgesic effect. The two formulations can be used interchangeably in the clinical setting. Keywords: meloxicam, pharmacokinetics, healthy volunteers, generic drug, bioequivalence, postmarketing

  6. Reversibility of peripheral blood leukocyte phenotypic and functional changes after exposure to and withdrawal from tofacitinib, a Janus kinase inhibitor, in healthy volunteers.

    Science.gov (United States)

    Weinhold, Kent J; Bukowski, Jack F; Brennan, Todd V; Noveck, Robert J; Staats, Janet S; Lin, Liwen; Stempora, Linda; Hammond, Constance; Wouters, Ann; Mojcik, Christopher F; Cheng, John; Collinge, Mark; Jesson, Michael I; Hazra, Anasuya; Biswas, Pinaki; Lan, Shuping; Clark, James D; Hodge, Jennifer A

    2018-06-01

    This study evaluated the short-term effects of tofacitinib treatment on peripheral blood leukocyte phenotype and function, and the reversibility of any such effects following treatment withdrawal in healthy volunteers. Cytomegalovirus (CMV)-seropositive subjects received oral tofacitinib 10 mg twice daily for 4 weeks and were followed for 4 weeks after drug withdrawal. There were slight increases in total lymphocyte and total T-cell counts during tofacitinib treatment, and B-cell counts increased by up to 26%. There were no significant changes in granulocyte or monocyte counts, or granulocyte function. Naïve and central memory T-cell counts increased during treatment, while all subsets of activated T cells were decreased by up to 69%. T-cell subsets other than effector memory cluster of differentiation (CD)4+, activated naïve CD4+ and effector CD8+ T-cell counts and B-cell counts, normalized 4 weeks after withdrawal. Following ex vivo activation, measures of CMV-specific T-cell responses, and antigen non-specific T-cell-mediated cytotoxicity and interferon (IFN)-γ production, decreased slightly. These T-cell functional changes were most pronounced at Day 15, partially normalized while still on tofacitinib and returned to baseline after drug withdrawal. Total natural killer (NK)-cell counts decreased by 33%, returning towards baseline after drug withdrawal. NK-cell function decreased during tofacitinib treatment, but without a consistent time course across measured parameters. However, markers of NK-cell-mediated cytotoxicity, antibody-dependent cellular cytotoxicity and IFN-γ production were decreased up to 42% 1 month after drug withdrawal. CMV DNA was not detectable in whole blood, and there were no cases of herpes zoster reactivation. No new safety concerns arose. In conclusion, the effect of short-term tofacitinib treatment on leukocyte composition and function in healthy CMV+ volunteers is modest and largely reversible 4 weeks after withdrawal

  7. Difference of cerebral activation between healthy volunteers and MCI-patients during navigation in a virtual reality environment. A parametric study using O15 H2O-PET

    International Nuclear Information System (INIS)

    Drzezga, A.; Wermke, M.D.; Schwaiger, M.; Grimmer, T.; Foerstl, H.; Kurz, A.

    2002-01-01

    Aim: To assess the regional cerebral activation during navigation in a virtual reality (VR) environment in healthy volunteers and patients with mild cognitive impairment (MCI) to identify possible differences in cerebral processing of a complex cognitive task. Materials and Methods: A computer-based VR-system has been developed that allows movements in a virtual labyrinth using a special space-mouse and 3-dimensional perception by shutter-glasses. In 11 healthy, right-handed volunteers (3 female, age 66+/-9 years) and 9 patients with MCI (3 female, 69+/-10 years, diagnosis according to criteria of the Mayo-Clinic) twelve H215O PET-scans were performed (each 370 MBq i.v.-bolus). During the scan subjects had to navigate actively from startpoint to a predefined destination point. Three difficulty levels were presented, 4 times each, in randomized order. Test performance (speed, mistakes) was co-registered. PET data were analyzed using statistical parametric mapping (SPM99, Wellcome Inst., London, UK) including correlation analysis with the acquired test performance results. A significance threshold of p<0,001 uncorrected was applied. Results: In both groups a similar network of extended cerebral activation was identified during active navigation, including maxima in the cerebellum, premotor cortex (Brodmann area [BA] 6), parietal cortex (BA 7, 40) and posterior cingulate cortex (BA 31). However, in MCI-patients a significantly stronger activation of anterior cingulate cortex (BA 24), prefrontal cortex (BA 8) and parietal cortex (BA 40) was observed, as compared to healthy volunteers. Conclusion: The applied combination of PET and VR-technology allows to examine the processing of complex cognitive tasks in the brain. During active navigation significant differences have been observed between the activated cerebral networks in MCI-patients and healthy volunteers. In MCI-patients stronger activation has been identified in cerebral regions associated with attention and

  8. Diagnostic performance of the (1-3-β-D-glucan assay in patients with Pneumocystis jirovecii compared with those with candidiasis, aspergillosis, mucormycosis, and tuberculosis, and healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Hyo-Ju Son

    Full Text Available Diagnosis of pneumocystis pneumonia (PCP relies on microscopic visualization of P. jirovecii, or detection of Pneumocystis DNA in respiratory specimens, which involves invasive procedures such as bronchoalveolar lavage. The (1-3-β-D-glucan (BG assay has been proposed as a less invasive and less expensive diagnostic test to rule out PCP. We therefore compared blood levels of BG in patients with PCP with those of patients with candidemia, chronic disseminated candidiasis (CDC, invasive aspergillosis, mucormycosis, and tuberculosis and those of healthy volunteers.Adult patients who were diagnosed with PCP, candidemia, CDC, invasive aspergillosis, mucormycosis, and tuberculosis whose blood samples were available, and healthy volunteers were enrolled in a tertiary hospital in Seoul, South Korea, during a 21-month period. The blood samples were assayed with the Goldstream Fungus (1-3-β-D-glucan test (Gold Mountain River Tech Development, Beijing, China.A total of 136 individuals including 50 patients P. jirovecii,15 candidemia, 6 CDC, 15 invasive aspergillosis, 10 mucormycosis, and 40 controls (20 TB and 20 healthy volunteers were included. The mean±SD of the concentration of 1-3-β-D-glucan in the patients with PCP (290.08 pg/mL±199.98 were similar to those of patients with candidemia (314.14 pg/mL±205.60, p = 0.90 at an α = 0.005 and CDC (129.74 pg/mL±182.79, p = 0.03 at an α = 0.005, but higher than those of patients with invasive aspergillosis (131.62 pg/mL±161.67, p = 0.002 at an α = 0.005, mucormycosis (95.08 pg/mL±146.80, p 31.25 pg/mL, which is highly sensitive for PCP versus tuberculosis plus healthy volunteers at the expense of specificity, the BG assay had a sensitivity of 92% (95% CI 81%-98% and a specificity of 55% (95% CI 39%-71%.The BG assay appears to be a useful adjunct test for PCP.

  9. Risk of sensitization in healthy adults following repeated administration of rdESAT-6 skin test reagent by the Mantoux injection technique

    DEFF Research Database (Denmark)

    Lillebaek, Troels; Bergstedt, Winnie; Tingskov, Pernille N

    2009-01-01

    1 open clinical trial was to assess the sensitization risk and safety of repeated administration of rdESAT-6 reagent in 31 healthy adult volunteers. Three groups of volunteers received two fixed doses of 0.1 microg rdESAT-6 28, 56 or 112 days apart, respectively. After the second injection...... of 31 (3%) volunteers showed a positive skin reaction (sensitization) upon a second injection of rdESAT-6 after 28days and an increased IFN-gamma response to ESAT-6. For 7 (23%) of the volunteers, local adverse reactions related to the product were registered, but all reactions were mild and predictable...

  10. Inter-individual variation, seasonal variation and close correlation of OGG1 and ERCC1 mRNA levels in full blood from healthy volunteers

    DEFF Research Database (Denmark)

    Vogel, Ulla Birgitte; Møller, Peter; Dragsted, Lars

    2002-01-01

    The mRNA levels of the nucleotide excision DNA repair gene ERCC1 and the base excision DNA repair gene OGG1 were quantified in 43 healthy volunteers in a dietary intervention trial as markers for the DNA repair capacity. Nine samples were collected from each subject over a period of 52 days. Samp...

  11. Assessment of [18F]-fluoroacetate PET/CT as a tumor-imaging modality. Preclinical study in healthy volunteers and clinical evaluation in patients with liver tumor

    International Nuclear Information System (INIS)

    Takemoto, Kenji; Hatano, Etsuro; Nishii, Ryuichi

    2014-01-01

    Although [ 18 F]-FDG is a useful oncologic PET tracer, FDG uptake is known to be low in a certain type of hepatocellular carcinoma (HCC). [ 18 F]-fluoroacetate ( 18 F-FACE) is an [ 18 F] fluorinated acetate, which is known to be converted into fatty acids, incorporated in membrane and is expected to be a promising oncologic PET tracer. The aim of this study was to evaluate the usefulness of 18 F-FACE as an oncologic PET tracer in preclinical study in healthy volunteers and in patients with liver tumors. Twenty-four healthy volunteers (age 48.2 ± 12.9 years old; 15 male and 9 female) and ten patients with liver tumor (age 72.1 ± 7.0 years old; 6 male and 4 female) were included. We performed whole-body static PET/CT scan using 18 F-FACE (n=34) and 18 F-FDG (n=5 for volunteers, n=8 for patients) on each day, respectively. Qualitative analysis and quantitative analysis of tumors (5 HCCs, 1 cholangiocellular carcinoma, 4 metastatic tumors from colon cancer and P-NET) were performed using SUVmax and tumor-to-normal liver ratio (TNR). In healthy volunteers, 18 F-FACE was metabolically stable in vivo and its biodistribution was almost similar to blood pool, basically uniformly independent of age and gender during PET scan time (up to 3 h). Normal physiological uptake of 18 F-FACE at each organ including liver (SUVmean 1.8 ± 0.2) was lower than that of blood pool (SUVmean 2.3 ± 0.3) at 1 h after injection. Chronic inflammatory uptake around femur of post-operative state of femoral osteotomy and faint uptake of benign hemangioma were observed in a case of healthy volunteer. 18 F-FACE (SUVmax 2.7 ± 0.6, TNR 1.5 ± 0.4) of liver tumors was significantly lower than those of 18 F-FDG uptake (6.5 ± 4.2, 2.6 ± 1.7, respectively). In qualitative analysis, 18 F-FDG was positive in 4 tumors (3 HCCs, 1 CCC) and negative in the other 6 tumors, while 18 F-FACE was also positive in 4 tumors which were the same tumors with positive 18 F-FDG uptake. Biodistribution of 18 F-FACE was

  12. Evaluating automated dynamic contrast enhanced wrist 3 T MRI in healthy volunteers: One-year longitudinal observational study

    Energy Technology Data Exchange (ETDEWEB)

    Rastogi, Anshul, E-mail: anshul.rastogi@bartshealth.nhs.uk [Kennedy Institute of Rheumatology, Imperial College London (United Kingdom); Kubassova, Olga, E-mail: olga@imageanalysis.org.uk [Image Analysis, Leeds (United Kingdom); Krasnosselskaia, Lada V., E-mail: solaguz@yahoo.com [Imaging Sciences Department, Imperial College London (United Kingdom); Lim, Adrian K.P., E-mail: a.lim@imperial.ac.uk [Department of Radiology, Imperial College Healthcare NHS Trust, London (United Kingdom); Satchithananda, Keshthra, E-mail: keshthra.satchithananda@imperial.nhs.uk [Department of Radiology, Imperial College Healthcare NHS Trust, London (United Kingdom); Boesen, Mikael, E-mail: mikael.boesen@gmail.com [Department of Radiology and the Parker Institute, Frederiksberg and Bispebjerg Hospitals (Denmark); Binks, Michael, E-mail: michael.h.binks@gsk.com [GlaxoSmithKline, Stevenage, SG1 2NY (United Kingdom); Hajnal, Joseph V., E-mail: jo.hajnal@kcl.ac.uk [Imaging Sciences Department, Imperial College London (United Kingdom); Taylor, Peter C., E-mail: peter.taylor@kennedy.ox.ac.uk [Kennedy Institute of Rheumatology, Imperial College London (United Kingdom)

    2013-08-15

    Rational and Objective: Dynamic contrast enhanced (DCE)-MRI has great potential to provide quantitative measure of inflammatory activity in rheumatoid arthritis. There is no current benchmark to establish the stability of signal in the joints of healthy subjects when imaged with DCE-MRI longitudinally, which is crucial so as to differentiate changes induced by treatment from the inherent variability of perfusion measures. The objective of this study was to test a pixel-by-pixel parametric map based approach for analysis of DCE-MRI (Dynamika) and to investigate the variability in signal characteristics over time in healthy controls using longitudinally acquired images. Materials and Methods: 10 healthy volunteers enrolled, dominant wrists were imaged with contrast enhanced 3T MRI at baseline, week 12, 24 and 52 and scored with RAMRIS, DCE-MRI was analysed using a novel quantification parametric map based approach. Radiographs were obtained at baseline and week 52 and scored using modified Sharp van der Heidje method. RAMRIS scores and dynamic MRI measures were correlated. Results: No erosions were seen on radiographs, whereas MRI showed erosion-like changes, low grade bone marrow oedema and low-moderate synovial enhancement. The DCE-MRI parameters were stable (baseline scores, variability) (mean ± st.dev); in whole wrist analysis, ME{sub mean} (1.3 ± 0.07, −0.08 ± 0.1 at week 24) and IRE{sub mean} (0.008 ± 0.004, −0.002 ± 0.005 at week 12 and 24). In the rough wrist ROI, ME{sub mean} (1.2 ± 0.07, 0.04 ± 0.02 at week 52) and IRE{sub mean} (0.001 ± 0.0008, 0.0006 ± 0.0009 at week 52) and precise wrist ROI, ME{sub mean} (1.2 ± 0.09, 0.04 ± 0.04 at week 52) and IRE{sub mean} (0.001 ± 0.0008, 0.0008 ± 0.001 at week 24 and 52). The Dynamic parameters obtained using fully automated analysis demonstrated strong, statistically significant correlations with RAMRIS synovitis scores. Conclusion: The study demonstrated that contrast enhancement does occur in

  13. Scarce Evidence of Yogurt Lactic Acid Bacteria in Human Feces after Daily Yogurt Consumption by Healthy Volunteers

    Science.gov (United States)

    del Campo, Rosa; Bravo, Daniel; Cantón, Rafael; Ruiz-Garbajosa, Patricia; García-Albiach, Raimundo; Montesi-Libois, Alejandra; Yuste, Francisco-Javier; Abraira, Victor; Baquero, Fernando

    2005-01-01

    In a double-blind prospective study including 114 healthy young volunteers, the presence in human feces of the yogurt organisms Lactobacillus delbrueckii and Streptococcus thermophilus after repeated yogurt consumption (15 days) was analyzed by culture, specific PCR, and DNA hybridization of total fecal DNA. Detection of yogurt lactic acid bacteria in total fecal DNA by bacterial culture and PCR assay was consistently negative. DNA compatible with yogurt bacteria was found by hybridization experiments in only 10 (10.52%) of 96 individuals after consumption of fresh yogurt and in 2 (2.10%) of 96 individuals after consumption of pasteurized yogurt (P = 0.01). PMID:15640233

  14. Frequency of inflammatory-like MR imaging findings in asymptomatic fingers of healthy volunteers

    International Nuclear Information System (INIS)

    Agten, Christoph A.; Rosskopf, Andrea B.; Jonczy, Maciej; Pfirrmann, Christian W.A.; Buck, Florian M.; Brunner, Florian

    2018-01-01

    To describe the frequency of inflammatory-like findings on MR imaging in asymptomatic volunteers and compare them with patients with known rheumatoid arthritis and psoriatic arthritis. MR images of fingers in 42 asymptomatic volunteers and 33 patients with rheumatoid/psoriatic arthritis were analyzed. The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatoid/Psoriatic Arthritis MRI Scoring System (RAMRIS/PsAMRIS) and tenosynovitis scoring system were used to assess: bone marrow edema (BME), erosions, tendon sheath fluid/tenosynovitis, joint effusion, and soft-tissue edema. Findings and scores were compared between volunteers and patients. Inter-reader agreement was calculated (intraclass correlation coefficients, ICC). In volunteers, tendon sheath fluid was very common in at least one location (42/42 volunteers for reader 1, 34/42 volunteers for reader 2). BME, erosions, joint effusion, and soft-tissue edema were absent (except one BME in the 3rd proximal phalanx for reader 1). Tendon sheath fluid scores in volunteers and tenosynovitis scores in patients were high (reader 1, 7.17 and 5.39; reader 2, 2.31 and 5.45). Overall, inter-reader agreement was substantial (ICC = 0.696-0.844), except for tendon sheath fluid (ICC = 0.258). Fluid in the finger flexor tendon sheaths may be a normal finding and without gadolinium administration should not be interpreted as tenosynovitis. Bone marrow edema, erosions, joint effusion, and soft-tissue edema in the fingers most likely reflect pathology if present. (orig.)

  15. Frequency of inflammatory-like MR imaging findings in asymptomatic fingers of healthy volunteers

    Energy Technology Data Exchange (ETDEWEB)

    Agten, Christoph A.; Rosskopf, Andrea B.; Jonczy, Maciej; Pfirrmann, Christian W.A.; Buck, Florian M. [University Hospital Balgrist, Radiology, Zurich (Switzerland); University of Zurich, Faculty of Medicine, Zurich (Switzerland); Brunner, Florian [University of Zurich, Faculty of Medicine, Zurich (Switzerland); University Hospital Balgrist, Department of Physical Medicine and Rheumatology, Zurich (Switzerland)

    2018-02-15

    To describe the frequency of inflammatory-like findings on MR imaging in asymptomatic volunteers and compare them with patients with known rheumatoid arthritis and psoriatic arthritis. MR images of fingers in 42 asymptomatic volunteers and 33 patients with rheumatoid/psoriatic arthritis were analyzed. The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatoid/Psoriatic Arthritis MRI Scoring System (RAMRIS/PsAMRIS) and tenosynovitis scoring system were used to assess: bone marrow edema (BME), erosions, tendon sheath fluid/tenosynovitis, joint effusion, and soft-tissue edema. Findings and scores were compared between volunteers and patients. Inter-reader agreement was calculated (intraclass correlation coefficients, ICC). In volunteers, tendon sheath fluid was very common in at least one location (42/42 volunteers for reader 1, 34/42 volunteers for reader 2). BME, erosions, joint effusion, and soft-tissue edema were absent (except one BME in the 3rd proximal phalanx for reader 1). Tendon sheath fluid scores in volunteers and tenosynovitis scores in patients were high (reader 1, 7.17 and 5.39; reader 2, 2.31 and 5.45). Overall, inter-reader agreement was substantial (ICC = 0.696-0.844), except for tendon sheath fluid (ICC = 0.258). Fluid in the finger flexor tendon sheaths may be a normal finding and without gadolinium administration should not be interpreted as tenosynovitis. Bone marrow edema, erosions, joint effusion, and soft-tissue edema in the fingers most likely reflect pathology if present. (orig.)

  16. Lower limb ischaemia and reperfusion injury in healthy volunteers measured by oxidative and inflammatory biomarkers

    DEFF Research Database (Denmark)

    Halladin, N. L.; Busch, Sarah Victoria Ekeløf; Alamili, M.

    2015-01-01

    OBJECTIVE: Ischaemia-reperfusion (IR) injury is partly caused by the release of reactive oxygen species and cytokines and may result in remote organ injury. Surgical patients are exposed to surgical stress and anaesthesia, both of which can influence the IR response. An IR model without these int......OBJECTIVE: Ischaemia-reperfusion (IR) injury is partly caused by the release of reactive oxygen species and cytokines and may result in remote organ injury. Surgical patients are exposed to surgical stress and anaesthesia, both of which can influence the IR response. An IR model without...... at any sampling time. CONCLUSION: Twenty minutes of lower limb ischaemia does not result in an ischaemia-reperfusion injury in healthy volunteers, measurable by oxidative and pro- and anti-inflammatory biomarkers in muscle biopsies and in the systemic circulation....

  17. Ethical issues in recruitment of "healthy volunteers": study of a clinical research organisation in Hyderabad.

    Science.gov (United States)

    Krishna, Shilpa; Prasad, N Purendra

    2014-01-01

    This paper raises some of the ethical issues involved in the recruitment of healthy volunteers (HVs) by clinical research organizations (CROs) for bioavailability and bioequivalent (BA/BE) studies. It also explores the underlying reasons for the participation of the HVs and their interaction with the CROs. The findings are based on the data collected from 50 HVs participating in a BA/BE study conducted by a CRO in Hyderabad and from the key officials involved in it. The findings indicate the existence of various complex networks, throw some light on the role of middlemen ("Anna") and the negotiation process, and give us an insight into the social norms and values that compelled the HVs to participate in the study. The paper offers a critical analysis of a few ethical concerns.

  18. Physiological 18F-FDG uptake in the ovaries and uterus of healthy female volunteers

    International Nuclear Information System (INIS)

    Nishizawa, Sadahiko; Inubushi, Masayuki; Okada, Hiroyuki

    2005-01-01

    Good knowledge of physiological 18 F-fluorodeoxglucose ( 18 F-FDG) uptake in the healthy population is of great importance for the correct interpretation of 18 F-FDG positron emission tomography (PET) images of pathological processes. The purpose of this study was to investigate the physiological 18 F-FDG uptake in the ovaries and uterus of healthy female volunteers. One hundred and 33 healthy females, 78 of whom were premenopausal (age 37.2±6.9 years) and 55 postmenopausal (age 55.0±2.7 years), were examined using whole-body 18 F-FDG PET and pelvic magnetic resonance (MR) imaging. Focal 18 F-FDG uptake in the ovaries and uterus was evaluated visually and using standardised uptake value (SUVs). Anatomical and morphological information was obtained from MR images. Distinct ovarian 18 F-FDG uptake with an SUV of 3.9±0.7 was observed in 26 premenopausal women out of 32 examined during the late follicular to early luteal phase of the menstrual cycle. Eighteen of the 32 women also showed focal 18 F-FDG uptake in the endometrium, with an SUV of 3.3±0.3. On the other hand, all nine women in the first 3 days of the menstrual cycle demonstrated intense 18 F-FDG uptake in the endometrium, with an SUV of 4.6±1.0. No physiological 18 F-FDG uptake was observed in the ovaries or uterus of any postmenopausal women. In women of reproductive age, 18 F-FDG imaging should preferably be done within a week before or a few days after the menstrual flow phase to avoid any misinterpretation of pelvic 18 F-FDG PET images. (orig.)

  19. A novel protodioscin-enriched fenugreek seed extract (Trigonella foenum-graecum, family Fabaceae improves free testosterone level and sperm profile in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Debasis Bagchi

    2017-03-01

    Full Text Available Background: A novel, patent-pending 20% protodioscin-enriched extract has been developed in our laboratories from fenugreek seeds(Furosap®. We assessed the efficacy of Furosap®in 50 male volunteers (age: 35-65 yearson free and total increased testosterone levels, sperm profile, mental alertness, cardiovascular health, mood, libido,and quality of life. Methods: Furosap®(500 mg/day/subjectwas administered to the 50 male volunteers over a period of 12 weeks in aone-arm, open-labelled study, to determine the efficacy on free and total testosterone levels, sperm profile andsperm morphology, libido and erectile dysfunction, mood and mental alertness and broad spectrum safety parameters. Institution Review Board approval was obtained for this study and the study was registered at the clinicaltrials.gov(NCT02702882.Results: A statistically significant increase in freetestosterone levels were observed in these volunteers following supplementation of Furosap®. Sperm morphology, sperm counts, mental alertness, mood, cardiovascular health,and libidoperformancewere significantly improved. Extensive blood chemistry analyses revealed broad spectrum safety. No significant changes were observed in serum lipid function, cholesterol, triglyceride, HDL and LDLlevels,andhemogram.Conclusions: Results confirmedthat this protodioscin-enriched extract from fenugreek seeds (Furosapis safe and efficacious in boosting serum free testosterone levels, healthy sperm profile, mental alertness, cardiovascular health,and overall performance in male volunteers

  20. Advantages and disadvantages of graduated and inverse graduated compression hosiery in patients with chronic venous insufficiency and healthy volunteers: A prospective, mono-centric, blinded, open randomised, controlled and cross-over trial.

    Science.gov (United States)

    Riebe, Helene; Konschake, Wolfgang; Haase, Hermann; Jünger, Michael

    2018-02-01

    Background The therapeutic effectiveness of compression therapy depends on the selection of compression hosiery. Objectives To assess efficacy and tolerability of graduated elastic compression stockings (GECS) and inverse graduated elastic compression stockings (PECS). Methods Thirty-two healthy volunteers and thirty-two patients with chronic venous insufficiency were analysed; wear period: one week for each stocking type (randomised, blinded). volume reduction of 'Lower leg' (Image3D®) and 'Distal leg and foot' (water plethysmography). clinical symptoms of chronic venous insufficiency assessed by the Venous Clinical Severity Score, side effects and wear comfort in both groups. Results Volume of 'Lower leg': significant reduction in healthy volunteers (mean GECS: -37.5 mL, mean PECS: -37.2 mL) and in patients (mean GECS: -55.6 mL, mean PECS: -41.6 mL). Volume of 'Distal lower leg and foot': significant reduction in healthy volunteers (mean GECS: -27 mL, mean PECS: -16.7 mL), significant reduction in patients by GECS (mean: -43.4 mL), but non-significant reduction by PECS (mean: -22.6 mL). Clinical symptoms of chronic venous insufficiency were improved significantly better with GECS than with PECS, p < 0.001. GECS led to more painful constrictions, p = 0.047, PECS slipped down more often, p < 0.001. Conclusion GECS and PECS reduce volume of the segment 'Lower leg' in patients and healthy volunteers. Patients' volume of the 'Distal lower leg and foot', however, were diminished significantly only by GECS ( p = 0.0001). Patients' complaints were improved by both GECS and PECS, and GECS were superior to PECS.

  1. Paracetamol decreases steady-state exposure to lamotrigine by induction of glucuronidation in healthy subjects

    DEFF Research Database (Denmark)

    Gastrup, Sandra; Stage, Tore Bjerregaard; Fruekilde, Palle Bach Nielsen

    2016-01-01

    AIM: Patients receiving lamotrigine therapy frequently use paracetamol concomitantly. While one study suggests a possible, clinically relevant drug-drug interaction, practical recommendations of the concomitant use are inconsistent. We performed a systematic pharmacokinetic study in healthy...... volunteers to quantify the effect of 4-day treatment of paracetamol on the metabolism of steady-state lamotrigine. METHODS: Twelve healthy, male volunteers participated in an open-label, sequential interaction study. Lamotrigine was titrated to steady state (100 mg daily) over 36 days, and blood and urine...... sampling was performed in a non-randomised order with and without paracetamol (1 g four times daily). The primary endpoint was change in steady-state area under the plasma concentration-time curve of lamotrigine. Secondary endpoints were changes in total apparent oral clearance, renal clearance...

  2. Neuroprotective impact of a vitamin trace element composition - a randomized, double blind, placebo controlled clinical trial with healthy volunteers.

    Science.gov (United States)

    Muss, Claus; Mosgoeller, Wilhelm; Endler, Thomas

    2015-01-01

    Neurotoxic metabolites and oxidative and nitrosative stress reactions play a crucial role in the pathways leading to neuronal cell death and neurodegeneration. The bioavailability of the many antioxidant ingredients a vitamin and trace element composition was investigated, to reveal the neuroprotective (preventive) potential of the composition. We recruited 159 healthy volunteers, assigned them randomly and double blind to a placebo and verum group. Physicians excluded volunteers with severe chronic diseases or interfeering medications. 142 participants finished the six month trial. Laboratory parameters were determined 1) before participation, and 2) after three and 3) six months. We confirmed the bioavailability of ingredients, and determined metabolic parameters associated with the integrity of the blood brain barrier, mitochondrial deficiency (Q 10), neurodegeneration (homocystein), and antioxidative capacity (e.g. lipidperoxidation), and superoxiddismutase activity. Starting from baseleine, after three months neuroprotective ingredients increased within their physiological borders, folic acid (p<0.003), pyridoxin (p<0.001), cobalamin (p=0.001), and the fat soluble vitamin tocopherol (p<0.001). In parallel, homocytein decreased after 3 and 6 months (p<0.001, and p<0.025, respectively). Other paramters like zinc reacted slower, significant changes were observed only after 6 months. The observed metabolic changes and alteration of the oxidative status after 3 and six month of regular intake underlines the compositions' potential to ameliorate neurodegenerative processes. We conclude that the subsitution of vitamins and trace-elements with natural source in a proper manner may be effective for neuroprotection in healthy population.

  3. Cardiopulmonary and metabolic effects of yoga in healthy volunteers

    Directory of Open Access Journals (Sweden)

    T Satheesh Divya

    2017-01-01

    Full Text Available Background: Yoga the spiritual union of mind with the divine intelligence of the universe aims to liberate a human being from conflicts of body–mind duality. Beneficial cardiovascular and pulmonary effects of yoga are in par with aerobic exercise, even amounting to replace the exercise model. We conducted an interventional study in healthy volunteers, to analyze the impact of short-term yoga training on cardiovascular, pulmonary, autonomic function tests, lipid profile, and thyroid function tests. Materials and Methods: A sample of fifty new recruits attending the district yoga center was subject to 75 min yoga practice a day for 41 days. Basal values of cardiovascular, pulmonary, autonomic function tests, lipid profile, and thyroid function tests were recorded before yoga training and were reassessed for postyoga changes after 41 days. Results: After yoga practice there was a significant reduction in the resting heart rate, systolic blood pressure, diastolic blood pressure, and mean blood pressure of the participants. Effects on autonomic function tests were variable and inconclusive. There was a significant increase in forced vital capacity, forced expiratory volume in 1 s, and peak expiratory flow rate after yoga. A significant reduction in body mass index was observed. Effects on metabolic parameters were promising with a significant reduction in fasting blood sugar level, serum total cholesterol, serum triglycerides serum low-density lipoprotein levels, and significant increase in high-density lipoprotein. There was no significant change in thyroid function tests after yoga. Conclusion: Short-term yoga practice has no effect on thyroid functions. Yoga practice was found beneficial in maintaining physiological milieu pertaining to cardiovascular and other metabolic parameters.

  4. Effects of helium and air inhalation on the innate and early adaptive immune system in healthy volunteers ex vivo

    Directory of Open Access Journals (Sweden)

    Oei Gezina TML

    2012-09-01

    Full Text Available Abstract Background Helium inhalation protects myocardium, brain and endothelium against ischemia/reperfusion injury in animals and humans, when applied according to specific “conditioning” protocols. Before widespread use of this “conditioning” agent in clinical practice, negative side effects have to be ruled out. We investigated the effect of prolonged helium inhalation on the responsiveness of the human immune response in whole blood ex vivo. Methods Male healthy volunteers inhaled 30 minutes heliox (79%He/21%O2 or air in a cross over design, with two weeks between measurements. Blood was withdrawn at T0 (baseline, T1 (25 min inhalation and T2-T5 (1, 2, 6, 24 h after inhalation and incubated with lipopolysaccharide (LPS, lipoteichoic acid (LTA, T-cell stimuli anti-CD3/ anti-CD28 (TCS or RPMI (as control for 2, 4 and 24 hours or not incubated (0 h. An additional group of six volunteers inhaled 60 minutes of heliox or air, followed by blood incubation with LPS and RPMI. Tumor necrosis factor-α (TNF-α, interleukin-1β (IL-1β, interleukin-6 (IL-6, interleukin-8 (IL-8, interferon-γ (IFN-γ and interleukin-2 (IL-2 was analyzed by cytometric bead array. Statistical analysis was performed by the Wilcoxon test for matched samples. Results Incubation with LPS, LTA or TCS significantly increased TNF-α, IL-1β, IL-6, IL-8, IFN-γ and IL-2 in comparison to incubation with RPMI alone. Thirty min of helium inhalation did not influence the amounts of TNF-α, IL-1β, IL-6, IL-8, IFN-γ and IL-2 in comparison to air. Sixty min of helium inhalation did not affect cytokine production after LPS stimulation. Conclusions We conclude that 79% helium inhalation does not affect the responsiveness of the human immune system in healthy volunteers. Trial registration Dutch Trial Register: http://www.trialregister.nl/ NTR2152

  5. Tolerance and biochemical effects from intravenous injection of ioxaglate in healthy volunteers

    International Nuclear Information System (INIS)

    Nilsson, P.E.; Aspelin, P.; Nyman, U.; Hedner, U.; Malmoe Allmaenna Sjukhus

    1984-01-01

    The influence of intravenous injection of ioxaglate (Hexabrix, 320 mg I/ml) on various biochemical, coagulation and fibrinolytic parameters, fractionated plasma proteins, precordial ECG and blood pressure was prospectively and sequentially studied in 9 healthy volunteers. One ml/kg body weight of the contrast medium was injected within one minute into an antecubital vein. Small, but statistically significant, changes in some of the biochemical parameters were found during the observation period, 2 to 4 days. All values of the biochemical parameters were, however, within the normal reference range for each parameter. No significant alterations were seen in the coagulation parameters. Increased fibrinolysis was recorded in some subjects both before and after the injection. No fibrinolytic degradation products were found indicating that the fibrinolysis was nominal. No significant changes were observed in the fractionated plasma proteins. The heart rate decreased significantly 15 seconds after commencing the injection. No significant changes in blood pressure were recorded. Two participants became nauseated and one of them vomited during the injection. Apart from this, no adverse effects were noted. No clinically significant changes following the injections were found. (orig.)

  6. Human volunteer study with PGME: Eye irritation during vapour exposure

    NARCIS (Netherlands)

    Emmen, H.H.; Muijser, H.; Arts, J.H.E.; Prinsen, M.K.

    2003-01-01

    The objective of this study was to establish the possible occurrence of eye irritation and subjective symptoms in human volunteers exposed to propylene glycol monomethyl ether (PGME) vapour at concentrations of 0, 100 and 150 ppm. Testing was conducted in 12 healthy male volunteers using a repeated

  7. Optimal Fasting Time before Measurement of Serum Triglyceride Levels in Healthy Volunteers.

    Science.gov (United States)

    Pongsuthana, Surapun; Tivatunsakul, Naris

    2016-02-01

    Coronary heart disease is a major public health problem. Elevated triglyceride levels are a risk factor for atherosclerosis and coronary heart disease. Food intake interferes with the measurement of serum triglyceride levels, and in previous studies, fasting for 12 hours was recommended before blood sampling. In real-world practice, long fasting times cause patient discomfort and poor compliance, and the present study was, therefore, designed to determine the appropriate fasting time prior to measuring serum triglyceride levels. To determine the appropriate fasting time before measuring serum triglyceride levels. This was a pilot study performed using healthy volunteers aged between 20 and 30 years old from November 2013 to December 2013 at Rajavithi Hospital. The first blood sample was measured in the morning after fasting over 12 hours. The subjects then took their regular breakfast, after which they fasted for 8 hours. Blood samples were taken 6 and 8 hours later and sent to the laboratory for measurement of serum triglyceride levels. 40 volunteers, of whom 25 were female, were enrolled. Their mean age was 25.9 ± 2.81 years old, and their mean weight, height, and body mass index were 61.5 ± 12.5 kg, 167.2 ± 8.3 cm and 21.84 ± 3.1 kg/m2, respectively. Mean fasting serum triglyceride level at 12 hours was 80.23 ± 36.33 mg/dl, at 6 hours it was 110.65 ± 73.45 mg/dl, and at 8 hours it was 75.62 ± 46.81 mg/dl. The group fasting for 12 hours had significantly lower serum triglyceride levels than the group fasting for 6 hours (p-value = 0.003), but no significant difference was found between the group fasting for 12 hours and the one fasting for 8 hours (p-value = 0.493). The present study showed no significant difference in triglyceride levels in patients who had fasted or 8 hours and those who had done so for 12 hours. Fasting for only 8 hours before measurement of serum triglyceride may be sufficient.

  8. IVABRADINE AND QUALITY OF BIOFEEDBACK IN THE LOOP OF PACED BREATHING UNDER THE CONTROL OF HEART RATE VARIABILITY PARAMETERS IN HEALTHY VOLUNTEERS

    Directory of Open Access Journals (Sweden)

    S. A. S. Belal

    2013-06-01

    Full Text Available On 15 healthy volunteers aged from 18 to 22 years the effect of ivabradine on the quality of biofeedback in the loop of paced breathing under the control of heart rate variability parameters were estimated. It was found that ivabradine contributes to an earlier onset and more significant optimization of regulatory systems in systematic sessions of biofeedback that allows to expand the indications for its clinical use.

  9. Uncertainty in anticipation of uncomfortable rectal distension is modulated by the autonomic nervous system--a fMRI study in healthy volunteers.

    Science.gov (United States)

    Rubio, Amandine; Van Oudenhove, Lukas; Pellissier, Sonia; Ly, Huynh Giao; Dupont, Patrick; Lafaye de Micheaux, Hugo; Tack, Jan; Dantzer, Cécile; Delon-Martin, Chantal; Bonaz, Bruno

    2015-02-15

    The human brain responds both before and during the application of aversive stimuli. Anticipation allows the organism to prepare its nociceptive system to respond adequately to the subsequent stimulus. The context in which an uncomfortable stimulus is experienced may also influence neural processing. Uncertainty of occurrence, timing and intensity of an aversive event may lead to increased anticipatory anxiety, fear, physiological arousal and sensory perception. We aimed to identify, in healthy volunteers, the effects of uncertainty in the anticipation of uncomfortable rectal distension, and the impact of the autonomic nervous system (ANS) activity and anxiety-related psychological variables on neural mechanisms of anticipation of rectal distension using fMRI. Barostat-controlled uncomfortable rectal distensions were preceded by cued uncertain or certain anticipation in 15 healthy volunteers in a fMRI protocol at 3T. Electrocardiographic data were concurrently registered by MR scanner. The low frequency (LF)-component of the heart rate variability (HRV) time-series was extracted and inserted as a regressor in the fMRI model ('LF-HRV model'). The impact of ANS activity was analyzed by comparing the fMRI signal in the 'standard model' and in the 'LF-HRV model' across the different anticipation and distension conditions. The scores of the psychological questionnaires and the rating of perceived anticipatory anxiety were included as covariates in the fMRI data analysis. Our experiments led to the following key findings: 1) the subgenual anterior cingulate cortex (sgACC) is the only activation site that relates to uncertainty in healthy volunteers and is directly correlated to individual questionnaire score for pain-related anxiety; 2) uncertain anticipation of rectal distension involved several relevant brain regions, namely activation of sgACC and medial prefrontal cortex and deactivation of amygdala, insula, thalamus, secondary somatosensory cortex, supplementary

  10. [The effect of a single inhalation of mineral water on the blood hormonal status in healthy volunteers].

    Science.gov (United States)

    Khinchagov, B P; Polushina, N D; Frolkov, V K

    1998-01-01

    Concentrations of ACTH, TTH, STH, LH, PSH, hydrocortisone, insulin, glucagone, triiodthyronine, thyroxine, aldosterone, glucose and unesterified fatty acids (NEFA) were measured in the blood of 23 healthy male volunteers aged 18 to 35 years 15, 30 and 60 min after a single nose inhalation and oral intake of mineral water Essentuki No. 17. Inhalation of Essentuki No. 17 stimulated secretion of the hormones and some parameters of metabolic reactions: the levels of glucose, NEFA, hydrocortisone, aldosterone, TTH, PSH and LH rose while those of insulin and growth hormone decreased. Oral intake of this water brought about the same changes in the hormone status except blood insulin the levels of which went up.

  11. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers.

    Science.gov (United States)

    Othman, Ahmed A; Haig, George; Florian, Hana; Locke, Charles; Gertsik, Lev; Dutta, Sandeep

    2014-06-01

    ABT-288 is a potent and selective H3 receptor antagonist with procognitive effects in several preclinical models. In previous studies, 3 mg once daily was the maximal tolerated dose in healthy volunteers. This study characterized the safety, tolerability and pharmacokinetics of ABT-288 in stable subjects with schizophrenia. This was a randomized, double-blind, placebo-controlled, dose-escalating study of ABT-288 (10 dose levels, from 1 to 60 mg once daily for 14 days) in stable subjects with schizophrenia treated with an atypical antipsychotic. In each dose group, five to seven and two to three participants were assigned to ABT-288 and placebo, respectively. Of the 67 participants enrolled, nine participants (on ABT-288) were prematurely discontinued, in seven of these due to adverse events. ABT-288 was generally safe and tolerated at doses up to 45 mg once daily. The most common adverse events, in decreasing frequency (from 31 to 5%), were abnormal dreams, headache, insomnia, dizziness, somnolence, dysgeusia, dry mouth, psychotic disorder, parosmia and tachycardia. Adverse events causing early termination were psychotic events (four) and increased creatine phosphokinase, pyrexia and insomnia (one each). The half-life of ABT-288 ranged from 28 to 51 h, and steady state was achieved by day 12 of dosing. At comparable multiple doses, ABT-288 exposure in subjects with schizophrenia was 45% lower than that previously observed in healthy subjects. At trough, ABT-288 cerebrospinal fluid concentrations were 40% of the total plasma concentrations. ABT-288 was tolerated at a 15-fold higher dose and 12-fold higher exposures in subjects with schizophrenia than previously observed in healthy volunteers. The greater ABT-288 tolerability was not due to limited brain uptake. © 2013 The British Pharmacological Society.

  12. Perceptions of Equipoise, Risk-Benefit Ratios, and "Otherwise Healthy Volunteers" in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry.

    Science.gov (United States)

    Dubé, Karine; Dee, Lynda; Evans, David; Sylla, Laurie; Taylor, Jeff; Brown, Brandon; Miller, Veronica; Corneli, Amy; Skinner, Asheley; Greene, Sandra B; Tucker, Joseph D; Rennie, Stuart

    2018-02-01

    Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the context of HIV cure research-(a) equipoise, (b) risk-benefit ratios, and (c) "otherwise healthy volunteers"-we conducted 36 in-depth interviews (IDIs) with three groups of purposively selected key informants: clinician-researchers ( n = 11), policy-makers and bioethicists ( n = 13), and people living with HIV (PLWHIV; n = 12). Our analysis revealed variability in perceptions of equipoise. Second, most key informants believed there was no clear measure of risk-benefit ratios in HIV cure research, due in part to the complexity of weighing (sometimes unknown) risks to participants and (sometimes speculative) benefits to science and society. Third, most clinician-researchers and policy-makers/bioethicists viewed potential HIV cure study participants as "otherwise healthy volunteers," but this perception was not shared among PLWHIV in our study.

  13. Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers.

    Science.gov (United States)

    Berteau, Cecile; Schwarzenbach, Florence; Donazzolo, Yves; Latreille, Mathilde; Berube, Julie; Abry, Herve; Cotten, Joël; Feger, Celine; Laurent, Philippe E

    2010-10-05

    A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe. This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects' preferred system for a final study injection or future treatment. A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment. This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference.

  14. The effect of 8 days of strict bed rest on the incretin effect in healthy volunteers.

    Science.gov (United States)

    Nielsen, Signe Tellerup; Harder-Lauridsen, Nina Majlund; Benatti, Fabiana Braga; Wedell-Neergaard, Anne-Sophie; Lyngbæk, Mark Preben; Møller, Kirsten; Pedersen, Bente Klarlund; Krogh-Madsen, Rikke

    2016-03-15

    Bed rest and physical inactivity are the consequences of hospital admission for many patients. Physical inactivity induces changes in glucose metabolism, but its effect on the incretin effect, which is reduced in, e.g., Type 2 diabetes, is unknown. To investigate how 8 days of strict bed rest affects the incretin effect, 10 healthy nonobese male volunteers underwent 8 days of strict bed rest. Before and after the intervention, all volunteers underwent an oral glucose tolerance test (OGTT) followed by an intravenous glucose infusion (IVGI) on the following day to mimic the blood glucose profile from the OGTT. Blood glucose, serum insulin, serum C-peptide, plasma incretin hormones [glucagon-like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP)], and serum glucagon were measured serially during both the OGTT and the IVGI. The incretin effect is calculated as the relative difference between the area under the curve for the insulin response during the OGTT and that of the corresponding IVGI, respectively. Concentrations of glucose, insulin, C-peptide, and GIP measured during the OGTT were higher after the bed rest intervention (all P effect (P = 0.6). In conclusion, 8 days of bed rest induces insulin resistance, but we did not see evidence of an associated change in the incretin effect. Copyright © 2016 the American Physiological Society.

  15. [Genetic polymorphism in sparteine oxidation--occurrence in healthy volunteers in Slovakia].

    Science.gov (United States)

    Holomán, J; Glasa, J; Veningerová, M; Prachar, V; Lukácsová, M

    1997-02-01

    The aim of this study was to estimate the occurrence of the phenotype of poor metabolizers of sparteine (in the frame of sparteine-debrisoquine-dextromethorphane polymorphism) in Slovakia. The authors examined a group of 216 of healthy volunteers (73 women and 143 men, average age of the group 24, 9 +/- 0.4 years), university students coming from various regions of Slovakia. The test substance-sparteine (1 x 100 mg tbl.) was administered perorally to all probands, in the evening after fasting. A 12-hour gathering of urine was subsequently performed. A sample of urine was subdued to examination. Isolation, separation, identification and assessment of the concentration of sparteine and its metabolites (2- and 5-dehydrosparteine) were performed by the method of gas chromatography. The metabolic MR ratio calculated from the ratio of the detected concentrations of sparteine and (2- and 5-dehydrosparteine) served for the assessment of the phenotype of poor (MR > 20), or rapid (MR < 20) metabolizers of sparteine in 8 authors found the poor metabolizer phenotype of 216 examined probands (i.e. in 3.75%). Its prevalence of the presented phenotype was lower than that anticipated on the basis of epidemiologic studies performed in other European countries. Study represents the first data on the phenotype of poor sparteine metabolizers in Slovakia. (Tab. 4, Fig. 1, Ref. 24.)

  16. Healthy habits: what kind of guidance the elderly population is receiving from health professionals?

    Science.gov (United States)

    Flores, Thaynã Ramos; Nunes, Bruno Pereira; Assunção, Maria Cecília Formoso; Bertoldi, Andréa Dâmaso

    2016-03-01

    To describe the prevalence of guidance on healthy habits received from health professionals by elderly and its relation to socioeconomic demographic, behavioral and health indicators, and the type of services. Cross sectional population based study including individuals aged 60 years or more in the urban area of Pelotas, Rio Grande do Sul, Brazil. Seven guidance on healthy habits were evaluated: weight control, reduction in salt, sugar and fat intake, physical activity practice, not smoking and not drinking alcohol. Among the 1,451 elderly interviewed, 1,281 (88.3%) consulted in the last year. The orientations more refereed were to fat (61.7%) and salt (61.5%) intake reduction and physical activity (58.2%). Elderly who consulted three times or more and in services financed by the Unified Health System received more guidance. Those elderly from the socioeconomic classes A/B were more likely to receive guidance for weight control (RP = 1.27; 95%CI 1.06 - 1.70) and physical activity (RP = 1.34; 95%CI 1.06 - 1.69). The orientation from health professionals were uncommon and, in some cases, unfocused.

  17. {sup 18}F-Alfatide II PET/CT in healthy human volunteers and patients with brain metastases

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Chunjing; Mi, Baoming; Wan, Weixing [Affiliated Hospital of Jiangnan University (Wuxi No. 4 People' s Hospital), Department of Nuclear Medicine, Wuxi (China); Pan, Donghui; Xu, Yuping; Yang, Min [Jiangsu Institute of Nuclear Medicine, Key Laboratory of Nuclear Medicine, Ministry of Health, Jiangsu Key Laboratory of Molecular Nuclear Medicine, Wuxi (China); Lang, Lixin; Niu, Gang; Chen, Xiaoyuan [National Institutes of Health, Laboratory of Molecular Imaging and Nanomedicine, National Institute of Biomedical Imaging and Bioengineering, Bethesda, MD (United States)

    2015-12-15

    We report the biodistribution and radiation dosimetry of an integrin α{sub v}β{sub 3} specific PET tracer {sup 18}F-AlF-NOTA-E[PEG{sub 4}-c(RGDfk)]{sub 2} (denoted as {sup 18}F-Alfatide II). We also assessed the value of {sup 18}F-Alfatide II in patients with brain metastases. A series of torso (from the skull to the thigh) static images were acquired in five healthy volunteers (3 M, 2 F) at 5, 10, 15, 30, 45, and 60 min after injection of {sup 18}F-Alfatide II (257 ± 48 MBq). Regions of interest (ROIs) were drawn manually, and the time-activity curves (TACs) were obtained for major organs. Nine patients with brain metastases were examined by static PET imaging with {sup 18}F-FDG (5.55 MBq/kg) and {sup 18}F-Alfatide II. Injection of {sup 18}F-Alfatide II was well tolerated in all healthy volunteers, with no serious tracer-related adverse events found. {sup 18}F-Alfatide II showed rapid clearance from the blood pool and kidneys. The total effective dose equivalent (EDE) and effective dose (ED) were 0.0277 ± 0.003 mSv/MBq and 0.0198 ± 0.002 mSv/MBq, respectively. The organs with the highest absorbed dose were the kidneys and the spleen. Nine patients with 20 brain metastatic lesions identified by MRI and/or CT were enrolled in this study. All 20 brain lesions were visualized by {sup 18}F-Alfatide II PET, while only ten lesions were visualized by {sup 18}F-FDG, and 13 by CT. F-Alfatide II is a safe PET tracer with a favorable dosimetry profile. The observed ED suggests that {sup 18}F-Alfatide II is feasible for human studies. {sup 18}F-Alfatide II has potential value in finding brain metastases of different cancers as a biomarker of angiogenesis. (orig.)

  18. Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers.

    Science.gov (United States)

    Chandorkar, Gurudatt; Zhan, Qiao; Donovan, Julie; Rege, Shruta; Patino, Hernando

    2017-03-28

    Surotomycin, a novel, orally administered, cyclic, lipopeptide antibacterial in development for the treatment of Clostridium difficile-associated diarrhea, has demonstrated minimal intestinal absorption in animal models. Safety, tolerability, and plasma pharmacokinetics of single and multiple ascending oral doses (SAD/MAD) of surotomycin in healthy volunteers were characterized in two randomized, double-blind, placebo-controlled, phase 1 studies. Participants were sequentially enrolled into one of four SAD (500, 1000, 2000, 4000 mg surotomycin) or three MAD (250, 500, 1000 mg surotomycin twice/day for 14 days) cohorts. Ten subjects were randomized 4:1 into each cohort to receive surotomycin or placebo. Surotomycin plasma concentrations rose as dose increased (maximum plasma concentration [C max ]: 10.5, 21.5, 66.6, and 86.7 ng/mL). Systemic levels were generally low, with peak median surotomycin plasma concentrations observed 6-12 h after the first dose. In the MAD study, surotomycin plasma concentrations were higher on day 14 (C max : 25.5, 37.6, and 93.5 ng/mL) than on day 1 (C max : 6.8, 11.0, and 21.1 ng/mL for increasing doses), indicating accumulation. In the SAD study, <0.01% of the administered dose was recovered in urine. Mean surotomycin stool concentration from the 1000 mg MAD cohort was 6394 μg/g on day 5. Both cohorts were well tolerated with all adverse events reported as mild to moderate. Both SAD and MAD studies of surotomycin demonstrated minimal systemic exposure, with feces the primary route of elimination following oral administration; consistent with observations with similar compounds, such as fidaxomicin. Results of these phase 1 studies support the continued clinical development of surotomycin for the treatment of Clostridium difficile-associated diarrhea. NCT02835118 and NCT02835105 . Retrospectively registered, July 13 2016.

  19. Evaluation of the effect of quercetin treatment on CYP2C9 enzyme activity of diclofenac in healthy human volunteers.

    Science.gov (United States)

    Bedada, Satish Kumar; Neerati, Prasad

    2018-02-01

    The purpose of present study was to evaluate the effect of quercetin on pharmacokinetics of diclofenac sodium (DIC) in healthy volunteers. The open-label, 2 period, sequential study was conducted in 12 healthy volunteers. DIC 100 mg was administered during control and after quercetin phases. Quercetin 500 mg was administered twice daily for 10 days during quercetin phase. Treatment with quercetin significantly enhanced maximum plasma concentration (C max ) , area under the curve (AUC 0-∞ ), and half life, while significantly decreased elimination rate constant (k el ) and apparent oral clearance (CL/F) of DIC compared with control. On the other hand, C max and AUC 0-∞ of 4-hydroxydiclofenac (4-OHDIC) were decreased after quercetin treatment. In addition, geometric mean ratios and 90% confidence intervals for C max and AUC 0-∞ of DIC and 4-OHDIC were both out of the no-effect limits of 0.80-1.25, which indicates a significant pharmacokinetic interaction between quercetin and DIC. Furthermore, quercetin treatment significantly decreased metabolic ratios of C max and AUC 0-∞ suggesting that reduced formation of DIC to 4-OHDIC. The results suggest that quercetin might have inhibited CYP2C9-mediated metabolism of DIC. Accordingly, caution should be taken when quercetin is used in combination with therapeutic drugs metabolized by CYP2C9, and dose adjustment of CYP2C9 substrates may be necessary. Copyright © 2017 John Wiley & Sons, Ltd.

  20. Percutaneous absorption of diclofenac in healthy volunteers after single and repeated topical application of diclofenac Emulgel.

    Science.gov (United States)

    Sioufi, A; Pommier, F; Boschet, F; Godbillon, J; Lavoignat, D; Salliere, D

    1994-08-01

    The percutaneous absorption of diclofenac was studied in ten healthy volunteers treated with Emulgel containing 1.16% diclofenac diethylammonium for 8 d as follows: a single application of 5 g Emulgel on days 1 and 8, and two applications d-1 on days 2-7. Plasma concentration profiles of unchanged diclofenac and urinary concentrations of total diclofenac and metabolites (sum of free and conjugated) were determined. High inter-individual variations in plasma and urine data were recorded, due probably to the permeability and the hydration of the skin. Steady state was reached after 2 d of twice-daily administration. Plasma concentrations were low but remained in the range 10-50 nmol L-1 over the full day for most of the subjects, indicating prolonged absorption from the application site.

  1. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the CGRP Binding Monoclonal Antibody LY2951742 (Galcanezumab in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    David Monteith

    2017-10-01

    Full Text Available Background: Calcitonin gene-related peptide (CGRP is pivotal in the pathophysiology of migraine headaches and represents a promising target for migraine treatment. The humanized monoclonal antibody galcanezumab (LY2951742 binds to CGRP and may be effective in migraine prophylaxis.Objectives: The primary objective was to evaluate the safety and tolerability of single and multiple doses of galcanezumab in humans. Secondary objectives included assessing the pharmacokinetics and evaluating target engagement.Methods: A double-blind, randomized, placebo-controlled study (NCT 01337596 with single escalating and multiple subcutaneous (SC doses of galcanezumab was performed in healthy male volunteers. Single doses of 1, 5, 25, 75, 200, and 600 mg of galcanezumab (n = 7/dose or placebo (n = 2/dose were injected SC in six consecutive cohorts of nine subjects each. One cohort of nine subjects received multiple (4 150 mg doses of galcanezumab or placebo every other week. Target engagement was evaluated by measuring inhibition of capsaicin-induced increase in dermal blood flow (DBF.Findings: Sixty-three subjects were randomized and included in the safety analyses. Galcanezumab was well tolerated in single doses (1–600 mg SC and consecutive doses (150 mg SC. There was no dose-dependent difference in type or frequency of treatment-emergent adverse events, and no clinically meaningful difference when compared with placebo. Pharmacokinetics were linear. Galcanezumab induced a robust, dose-dependent, and durable inhibition of capsaicin-induced increase in DBF, supporting the continued clinical development of galcanezumab for prophylaxis in migraine patients.

  2. Renal effects of the non-ionic contrast medium iopentol after intravenous injection in healthy volunteers

    Energy Technology Data Exchange (ETDEWEB)

    Jakobsen, J.A.; Berg, K.J.; Waaler, A.; Andrew, E. (Rikshospitalet, Oslo (Norway). Dept. of Radiology Rikshospitalet, Oslo (Norway). Renal Section Nycomed A/S, Oslo (Norway). Dept. of Clinical Research and Development)

    1990-01-01

    Renal effects of the new non-ionic contrast medium iopentol in increasing doses were assessed and compared with the effects of physiologic saline. Twenty-four healthy male volunteers, allocated to three dose groups, were given iopentol intravenously in doses of 0.3, 0.6, and 1.2 g I/kg body weight, respectively. The highest dose group was also given physiologic saline separately as a control. The diuresis increased in all groups, most in the highest dose group, and with a concomitant fall of urine osmolality and increase in osmolar clearance. A slight decrease of serum osmolality, creatinine and urea occurred at 3 hours due to hemodilution. The glomerular filtration rate was unaffected by iopentol. The urinary excretion of albumin and {beta}{sub 2}-microglobulin was unchanged. However, urinary N-acetyl-{beta}-glucosaminidase and alkaline phosphatase increased significantly, most in the highest dose group. All changes were reversible. (orig.).

  3. Preventive effects of lansoprazole and famotidine on gastric mucosal injury induced by low-dose aspirin in Helicobacter pylori-negative healthy volunteers.

    Science.gov (United States)

    Nishino, Masafumi; Sugimoto, Mitsushige; Kodaira, Chise; Yamade, Mihoko; Uotani, Takahiro; Shirai, Naohito; Ikuma, Mutsuhiro; Tanaka, Tatsuo; Sugimura, Haruhiko; Hishida, Akira; Furuta, Takahisa

    2011-07-01

    The preventive effects of lansoprazole and famotidine on low-dose aspirin-induced gastric mucosal injury in relation to gastric acidity were compared in healthy Japanese volunteers. Fifteen Helicobacter pylori-negative volunteers with different CYP2C19 genotypes were randomly administered aspirin 100 mg, aspirin plus famotidine 20 mg twice daily, or aspirin plus lansoprazole 15 mg once daily for 7 days each in a crossover fashion. Gastroscopy for the evaluation of mucosal injury based on modified Lanza score (MLS) and 24-hour intragastric pH monitoring were performed on day 7 of each regimen. Aspirin induced gastric mucosal injury (median MLS = 3). Lansoprazole significantly decreased MLS to 0, which was significantly lower than that by famotidine (MLS = 1) (P lansoprazole regimen were significantly higher than those with famotidine (P lansoprazole appeared to be more protective than famotidine against low-dose aspirin-induced mucosal injury but a larger well-controlled study is necessary to establish a definitive clinical benefit.

  4. Volunteering is prospectively associated with health care use among older adults.

    Science.gov (United States)

    Kim, Eric S; Konrath, Sara H

    2016-01-01

    Although observational and experimental studies have shown that volunteering is linked with better mental health, physical health, and health behaviors, no studies have examined whether volunteering is associated with patterns of health care use. The purpose of this study was to prospectively examine whether volunteering was associated with a greater use of preventive health care services, but fewer doctor visits and nights spent in the hospital. Participants (n = 7168) were drawn from the 2006 wave of the Health and Retirement Study, a nationally representative panel study of American adults over the age of 51, and tracked for one wave (2 years). Logistic regression and generalized linear models were used for analyses. In analyses that adjusted for sociodemographic factors and baseline health, volunteers were 30% more likely to receive flu shots (OR = 1.30, 95% CI = 1.16-1.47), 47% more likely to receive cholesterol tests (OR = 1.47, 95% CI = 1.24-1.74); female volunteers were 53% more likely to receive mammograms/x-rays (OR = 1.53, 95% CI = 1.28-1.83) and 21% more likely to receive Pap smears (OR = 1.21, 95% CI = 1.03-1.41); male volunteers were 59% more likely to receive prostate exams (OR = 1.59, 95% CI = 1.29-1.95). In a model that adjusted for sociodemographic factors, volunteers spent 38% fewer nights in the hospital (RR = 0.62, 95% CI = 0.52-0.76), however volunteering was not associated with frequency of doctor visits (RR = 0.94, 95% CI = 0.87-1.02). The association between volunteering and number of nights spent in the hospital was minimally affected after adjusting for potential confounding (baseline health) and explanatory variables (health behaviors, social integration, stress, positive psychological factors, personality). This is the first known study to examine the association between volunteering and health care use. If future studies replicate these findings, the results may be used to inform the development of new

  5. Clinical pharmacology of sibutramine hydrochloride (BTS 54524), a new antidepressant, in healthy volunteers.

    Science.gov (United States)

    King, D J; Devaney, N

    1988-01-01

    The cardiovascular, anticholinergic and central effects of single doses of 30, 45 and 60 mg of sibutramine hydrochloride (BTS 54524), a new potential antidepressant, were compared with amitriptyline (50 mg) and placebo given at weekly intervals in a randomised design to six healthy male volunteers. Sibutramine was associated with increases in both supine heart rate and systolic blood pressure at 1, 2 and 6 h after 60 mg (P less than 0.05). Amitriptyline caused a significant 50-60% decrease in salivation compared with placebo at 2 and 6 h but there were no changes with sibutramine. No significant changes in pupil size were detected with either drug. Visual analogue rating scales (VARS) revealed significant drowsiness with amitriptyline but neither sedative nor stimulant effects with sibutramine. Impairments of simple auditory and visual reaction times, visual two-choice reaction time, finger tapping and trail making, measured using an automated test battery, occurred with amitriptyline compared with sibutramine. If sibutramine proves to be an effective antidepressant it should be devoid of anticholinergic or central depressant effects. Chronic dosage studies are indicated to evaluate the clinical significance of its cardiovascular effects. PMID:3207566

  6. Magnetic Resonance Elastography: Measurement of Hepatic Stiffness Using Different Direct Inverse Problem Reconstruction Methods in Healthy Volunteers and Patients with Liver Disease.

    Science.gov (United States)

    Saito, Shigeyoshi; Tanaka, Keiko; Hashido, Takashi

    2016-02-01

    The purpose of this study was to compare the mean hepatic stiffness values obtained by the application of two different direct inverse problem reconstruction methods to magnetic resonance elastography (MRE). Thirteen healthy men (23.2±2.1 years) and 16 patients with liver diseases (78.9±4.3 years; 12 men and 4 women) were examined for this study using a 3.0 T-MRI. The healthy volunteers underwent three consecutive scans, two 70-Hz waveform and a 50-Hz waveform scans. On the other hand, the patients with liver disease underwent scanning using the 70-Hz waveform only. The MRE data for each subject was processed twice for calculation of the mean hepatic stiffness (Pa), once using the multiscale direct inversion (MSDI) and once using the multimodel direct inversion (MMDI). There were no significant differences in the mean stiffness values among the scans obtained with two 70-Hz and different waveforms. However, the mean stiffness values obtained with the MSDI technique (with mask: 2895.3±255.8 Pa, without mask: 2940.6±265.4 Pa) were larger than those obtained with the MMDI technique (with mask: 2614.0±242.1 Pa, without mask: 2699.2±273.5 Pa). The reproducibility of measurements obtained using the two techniques was high for both the healthy volunteers [intraclass correlation coefficients (ICCs): 0.840-0.953] and the patients (ICC: 0.830-0.995). These results suggest that knowledge of the characteristics of different direct inversion algorithms is important for longitudinal liver stiffness assessments such as the comparison of different scanners and evaluation of the response to fibrosis therapy.

  7. Heart rate asymmetry follows the inspiration/expiration ratio in healthy volunteers

    International Nuclear Information System (INIS)

    Klintworth, Anne; Ajtay, Zénó; Paljunite, Alina; Szabados, Sándor; Hejjel, László

    2012-01-01

    Heart rate asymmetry (HRA) quantifies the uneven distribution of points above and below the identity-line in a Poincaré plot of RR-intervals. The authors investigated if HRA could be influenced by the inspiration/expiration ratio. Healthy volunteers (n = 18) were studied in the supine position at 4.5 s metronome breathing. ECG and breathing signals were recorded for 360 s at each breathing pattern: inspiration controlled, inspiration/expiration controlled (1:2, 1:1, 2:1 ratio), inspiration controlled again. Time domain, frequency domain and Poincaré plot heart rate variability (HRV) analysis with Porta's and Guzik's indices were performed on 300 s tachograms. There were no statistically significant differences in time domain, frequency domain and standard Poincaré plot parameters during the various breathing patterns, whereas Porta's and Guzik's indices significantly rose at 1:1 and 2:1 compared to physiological 1:2 breathing. There were no significant differences in the HRA parameters between the first and the last runs. In our population the inspiration/expiration ratio significantly influenced HRA, but not standard HRV parameters. Positive correlation of Guzik's and Porta's index reflects reciprocal changes of the number of points and their dispersion in the accelerating and decelerating sets of RR-intervals. HRA-analysis can be a promising method for investigating cardiovascular regulation/health particularly with further spreading of wearable monitors. (paper)

  8. Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers.

    Science.gov (United States)

    Padgaonkar, K A; Revankar, S N; Bhatt, A D; Vaz, J A; Desai, N D; D'Sa, S; Shah, V; Gandewar, K

    1999-07-01

    To assess the bioavailability of rifampicin (RMP) in three brands of combination formulations of anti-tuberculosis drugs. A three-way double-blind, cross-over bioavailability study of RMP and isoniazid (INH), consisting of a comparison of a two-drug combination of tablets of RMP and INH each separately (reference brand R) and a tablet of RMP + INH (brand N), and a capsule of RMP + INH (brand L) was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of RMP as well as INH and acetylisoniazid (ACINH) by two high performance liquid chromatography (HPLC) methods. The mean values of RMP in brand N (Cmax 6.49+/-0.52 microg/mL, Tmax 2.33+/-0.18 h, AUC(0-24h) 39.83+/-3.44 microg/mL.h) were comparable with those obtained with brand R (Cmax 5.22+/-0.59 microg/mL, Tmax 2.50+/-0.12 h, AUC(0-24h) 33.33+/-3.47 microg/mL.h). The mean values of RMP in brand L (Cmax 3.05+/-0.52 microg/ mL, Tmax 3.79+/-0.57 h and AUC(0-24h) 21.78+/-3.67 microg/ mL.h) were significantly different from those in brand R. Nevertheless, all of the pharmacokinetic parameters obtained for INH and ACINH in all three brands were comparable. Using brand R as a comparison, brand N was bioequivalent and brand L was not bioequivalent.

  9. The irradiation of human volunteer subjects in research

    International Nuclear Information System (INIS)

    Rosen, R.

    1980-01-01

    In medical research radiation is sometimes used to obtain data from healthy individuals. These subjects gain no specific benefit from the research. To safeguard their welfare, constraints are imposed on the dose to be received, on the selection of volunteer subjects, on ensuring their understanding of the procedures and risks, and on obtaining their free consent to participate. The research proposals are assessed by peer review prior to being approved by the host institution. The first example presented describes the use of diagnostic radiography to obtain in vivo data on the femur bone. Conservative dosimetry indicates an expected dose-equivalent per film of 0.5 mSv in bone and 0.18 mSv in bone marrow and gonad tissue. The critical organ total dose-equivalent is estimated to be 7% of the dose-equivalent limit for a volunteer. The second example involves the internal administration of radioactive tracers. Dosimetric calculations indicate an expected whole-body dose-equivalent of 0.5 mSv in the case of C-14 and 0.37 mSv in the case of H-3, these values bejng 10% and 7% of the relevant dose-equivalent limit. Both proposals were given conditional approval. In the generalized research use of volunteer human subjects the rights of the subject, the investigator and the institution need to be protected. At the University of New South Wales procedures have been introduced to govern all experjmental procedures involving human subjects. Some interesting problems which have arisen are discussed. (author)

  10. Relative bioavailability of two oral formulations of risperidone 2 mg: A single-dose, randomized-sequence, open-label, two-period crossover comparison in healthy Brazilian volunteers.

    Science.gov (United States)

    Belotto, Karisa Cristina Rodrigues; Raposo, Nádia Rezende Barbosa; Ferreira, Aline Siqueira; Gattaz, Wagner Farid

    2010-11-01

    Risperidone (RSP) is a benzisoxazole antipsychotic agent used to treat schizophrenia and other psychiatric illnesses in adults and children (including those with autism). After oral administration, RSP is completely absorbed from the gastrointestinal tract and undergoes hydroxylation to yield 9-hydroxyrisperidone (9-OH-RSP), an active metabolite that has a pharmacologic profile and potency similar to RSP. The aims of this study were to compare the relative bioavailability of a pharmaceutical-equivalent (test) formulation with a reference formulation of oral RSP 2 mg, both available commercially on the Brazilian pharmaceutical market, and to generate data regarding the oral bioavailability of the tested drug in healthy Brazilian volunteers. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in healthy Brazilian volunteers from August to December 2008. Subjects were randomly assigned to receive the test formulation followed by the reference formulation or vice versa, with a 30-day washout period between doses. Study drugs were administered after a 12-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.25, 0.5, 1, 1.5, 3, 5, 8, 12, 24, 48, 72, 96, and 120 hours after administration. Plasma concentrations of RSP and 9-OH-RSP were determined using LC-MS/MS. The test and reference formulations were to be considered bioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125%, in accordance with the policies of the Brazilian Sanitary Surveillance Agency and the US Food and Drug Administration. Tolerability was determined using clinical assessments, monitoring of vital signs, analysis of laboratory test results, and subject interviews regarding adverse events. A total of 22 subjects were enrolled (11 men, 11 women; mean [SD] age, 32 [12] years [range, 1858 years]; weight, 70.4 [11.9] kg [range, 50-103 kg]; height, 1.67 [0.08] m

  11. Abdominopelvic 1.5-T and 3.0-T MR Imaging in Healthy Volunteers: Relationship to Formation of DNA Double-Strand Breaks.

    Science.gov (United States)

    Suntharalingam, Saravanabavaan; Mladenov, Emil; Sarabhai, Theresia; Wetter, Axel; Kraff, Oliver; Quick, Harald H; Forsting, Michael; Iliakis, Georg; Nassenstein, Kai

    2018-05-01

    Purpose To investigate the relationship between abdominopelvic magnetic resonance (MR) imaging and formation of DNA double-strand breaks (DSBs) in peripheral blood lymphocytes among a cohort of healthy volunteers. Materials and Methods Blood samples were obtained from 40 healthy volunteers (23 women and 17 men; mean age, 27.2 years [range, 21-37 years]) directly before and 5 and 30 minutes after abdominopelvic MR imaging performed at 1.5 T (n = 20) or 3.0 T (n = 20). The number of DNA DSBs in isolated blood lymphocytes was quantified after indirect immunofluorescent staining of a generally accepted DSB marker, γ-H2AX, by means of high-throughput automated microscopy. As a positive control of DSB induction, blood lymphocytes from six volunteers were irradiated in vitro with x-rays at a dose of 1 Gy (70-90 keV). Statistical analysis was performed by using a Friedman test. Results No significant alteration in the frequency of DNA DSB induction was observed after MR imaging (before imaging: 0.22 foci per cell, interquartile range [IQR] = 0.54 foci per cell; 5 minutes after MR imaging: 0.08 foci per cell, IQR = 0.39 foci per cell; 30 minutes after MR imaging: 0.09 foci per cell, IQR = 0.63 foci per cell; P = .057). In vitro radiation of lymphocytes with 1 Gy led to a significant increase in DSBs (0.22 vs 3.43 foci per cell; P = .0312). The frequency of DSBs did not differ between imaging at 1.5 T and at 3.0 T (5 minutes after MR imaging: 0.23 vs 0.06 foci per cell, respectively [P = .57]; 30 minutes after MR imaging: 0.12 vs 0.08 foci per cell [P = .76]). Conclusion Abdominopelvic MR imaging performed at 1.5 T or 3.0 T does not affect the formation of DNA DSBs in peripheral blood lymphocytes. © RSNA, 2018.

  12. Short echo time proton spectroscopy of the brain in healthy volunteers using an insert gradient head coil

    DEFF Research Database (Denmark)

    Gideon, P; Danielsen, E R; Schneider, M

    1995-01-01

    An insert gradient head coil with built-in X, Y, and Z gradients was used for localized proton spectroscopy in the brain of healthy volunteers, using short echo time stimulated echo acquisition mode (STEAM) sequences. Volume of interest size was 3.4 ml, repetition time was 6.0 s, and echo times...... were 10 and 20 ms, respectively. Good quality proton spectra with practically no eddy current artefacts were acquired allowing observation of strongly coupled compounds, and compounds with short T2 relaxation times. The gradient head coil thus permits further studies of compounds such as glutamine....../glutamate and myo-inositols. These compounds were more prominent within grey matter than within white matter. Rough estimations of metabolite concentrations using water as an internal standard were in good agreement with previous reports....

  13. 'To give is better than to receive?' Couples massage significantly benefits both partners' wellbeing.

    Science.gov (United States)

    Naruse, Sayuri M; Cornelissen, Piers L; Moss, Mark

    2018-03-01

    This experimental study evaluated the differential effects of 'giving' and 'receiving' massage on wellbeing in healthy but stressed couples. Forty-two volunteers started the study and of these, 38 (i.e. 19 couples) completed a 3-week massage course. Emotional stress and mental clarity were assessed before and after mutual massage between each pair of adults belonging to a couple at home. While massage benefitted both parties' wellbeing within a session, critically we found no differences in wellbeing between those 'giving' and 'receiving' massage. These novel findings suggest that home-based massage may be advocated to couples as a 'selves-care', health-promoting behaviour.

  14. Ocular dynamics of Garcinia cola (Heckel on healthy volunteers following bolus ingestion

    Directory of Open Access Journals (Sweden)

    S. A. Igwe

    2007-12-01

    Full Text Available Garcinia cola Heckel, an angiospermae belonging to the  family Guttiferae, is known in commerce as bitter cola. It is a plant found in the West African subregion, mostly in moist conditions, and often in association with Cola acuminata. The seeds are highly valued ingredients in African ethonomedicine. The seeds have several social uses and applications in folk medicine. These seeds are ordinarily chewed by the local people without prescription or restriction. In an in vivo case control study, the effects of Garcinia cola on some visual functions: pupil diameter, near point of convergence (NPC, amplitude of accommodation (AA, intraocular pressure (IOP, visual acuity (VA and habitual phoria; following bolus ingestion of 20 g was undertaken using healthy visually active volunteers. Results showed that bolus ingestion of Garcinia cola constricted the pupil by 68%, reduced the NPC by 28%, increased the AA by 17.8% at peak effect and decreased the intraocular pressure by 31% without affecting the distance and near VA. The lateral phoria at far and near tended towards esophoria. Possibly the miotic effect and reduction in IOP could be of benefit to patients with raised IOP where conventional drugs may not be effective. Also it is possible that the effects on phoria could be exploited in oculomotor function in combination with visual training.

  15. A first‐in‐human pharmacodynamic and pharmacokinetic study of a fully human anti‐glucagon receptor monoclonal antibody in normal healthy volunteers

    Science.gov (United States)

    Kostic, Ana; King, Thomas Alexander; Yang, Feng; Chan, Kuo‐Chen; Yancopoulos, George D.; Gromada, Jesper

    2017-01-01

    Aims Glucagon receptor (GCGR) blockers are being investigated as potential therapeutics for type 1 and type 2 diabetes. Here we report the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of REGN1193, a fully human glucagon receptor blocking monoclonal antibody from a first‐in‐human healthy volunteer randomized double‐blinded trial. Methods Healthy men and women received single ascending doses of REGN1193 ranging from 0.05 to 0.6 mg/kg (n = 42) or placebo (n = 14) intravenously. Safety, tolerability and PK were assessed over 106 days. The glucose‐lowering effect of REGN1193 was assessed after induction of hyperglycaemia by serial glucagon challenges. Results REGN1193 was generally well tolerated. There were small (50 mg/dL, and did not require treatment or medical assistance. Concentration‐time profiles suggest a 2‐compartment disposition and marked nonlinearity, consistent with target‐mediated clearance. REGN1193 inhibited the glucagon‐stimulated glucose increase in a dose‐dependent manner. The 0.6 mg/kg dose inhibited the glucagon‐induced glucose area under the curve for 0 to 90 minutes (AUC0‐90 minutes) by 80% to 90% on days 3 and 15, while blunting the increase in C‐peptide. REGN1193 dose‐dependently increased total GLP‐1, GLP‐2 and glucagon, with plasma levels returning to baseline by day 29 in all dose groups. Conclusion REGN1193, a GCGR‐blocking monoclonal antibody, produced a safety, tolerability and PK/PD profile suitable for further clinical development. The occurrence of transient elevations in serum hepatic aminotransferases observed here and reported with several small molecule glucagon receptor antagonists suggests an on‐target effect of glucagon receptor blockade. The underlying mechanism is unknown. PMID:28755409

  16. Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: a randomized, single-dose, two-period, two-sequence crossover study.

    Science.gov (United States)

    Srichaiya, Arunee; Longchoopol, Chaowanee; Oo-Puthinan, Sarawut; Sayasathid, Jarun; Sripalakit, Pattana; Viyoch, Jarupa

    2008-10-01

    Lamotrigine is an antiepileptic drug which has been used in the treatment of epilepsy and bipolar disorder. A search of the literature did not find previously published bioequivalence and pharmacokinetic evaluations of lamotrigine in healthy Thai male volunteers. The aim of this study was to compare the pharmacokinetic parameters between 2 brands of lamotrigine in healthy Thai male volunteers. A randomized, single-dose, 2-period, 2-sequence, crossover study design with a 2-week washout period was conducted in healthy Thai males. Subjects were randomized to receive either the test or reference formulation in the first period. All subjects were required to be nonsmokers and without a history of alcohol or drug abuse. Plasma samples were collected over a 120-hour period after 100-mg lamotrigine administration in each period. A validated high-performance liquid chromatography ultraviolet method was used to analyze lamotrigine concentration in plasma. Pharmacokinetic parameters were determined using a noncompartmental method. Bioequivalence between the test and reference products, as defined by the US Food and Drug Administration (FDA), is determined when the ratio for the 90% CIs of the difference in the means of the log-transformed AUC(0-t), AUC(0-infinity), and C(max) of the 2 products are within 0.80 and 1.25. Adverse events were determined by measuring vital signs after dosing. Subjects were also asked if they suffered from undesirable effects such as nausea, vomiting, dizziness, and headache. This bioequivalence study was performed in 24 healthy Thai males (mean [SD] age, 20.5 [1.3] years; range, 19-24 years; weight, 62.5 [7.4] kg; height, 172.8 [6.9] cm; body mass index, 20.9 [2.0] kg/m(2)). The mean (SD) C(max) and T(max) of the test formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.2 (0.9) hours, respectively. The mean (SD) C(max) and T(max) of the reference formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.4 (1.0) hours, respectively. The mean

  17. Measurement of blood flow in the superior sagittal sinus in healthy volunteers, and in patients with normal pressure hydrocephalus and idiopathic intracranial hypertension with phase-contrast cine MR imaging

    DEFF Research Database (Denmark)

    Gideon, P; Thomsen, C; Gjerris, F

    1996-01-01

    PURPOSE: To measure blood flow and velocity in the superior sagittal ++sinus. MATERIAL AND METHODS: MR velocity mapping was used to examine 14 healthy volunteers, 15 patients with normal pressure hydrocephalus (NPH), 3 patients with high pressure hydrocephalus (HPH), and 11 patients with idiopathic...

  18. The CGRP-antagonist, BIBN4096BS does not affect cerebral or systemic haemodynamics in healthy volunteers

    DEFF Research Database (Denmark)

    Petersen, K A; Birk, S; Lassen, L H

    2005-01-01

    CBF(MCA)) was measured by 133-Xenon inhalation SPECT. The diameter of the temporal and radial artery was measured by high-resolution ultrasound. Systemic haemodynamics and partial pressure of CO(2) (P(et)CO(2)), and adverse events were monitored regularly. BIBN4096BS had no influence on global or regional cerebral blood......BIBN4096BS is a CGRP-antagonist effective in the treatment of migraine. Blocking the receptor of a strong vasodilator involves a theoretical risk of causing cerebral vasoconstriction, a probability not previously investigated with BIBN4096BS. Seven healthy volunteers completed this double...... flow, or on the blood flow velocity in the middle cerebral artery. There was no effect on systemic haemodynamics and adverse events were minor. We conclude that there is no effect of CGRP-receptor blockade on the cerebral or systemic circulation in humans. Circulating CGRP is therefore not likely...

  19. Horse meat consumption affects iron status, lipid profile and fatty acid composition of red blood cells in healthy volunteers.

    Science.gov (United States)

    Del Bó, Cristian; Simonetti, Paolo; Gardana, Claudio; Riso, Patrizia; Lucchini, Giorgio; Ciappellano, Salvatore

    2013-03-01

    This study investigated the effect of moderate consumption of horse meat on iron status, lipid profile and fatty acid composition of red blood cells in healthy male volunteers. Fifty-two subjects were randomly assigned to two groups of 26 subjects each: a test group consuming two portions of 175 g/week of horse meat, and a control group that abstained from eating horse meat during the 90 days trial. Before and after 90 days, blood samples were collected for analysis. Horse meat consumption significantly (p ≤ 0.05) reduced serum levels of total and low-density lipoprotein cholesterol ( - 6.2% and - 9.1%, respectively) and transferrin ( - 4.6%). Total n - 3, long chain polyunsaturated fatty acids n - 3 and docosahexeanoic acid content in erythrocytes increased (p ≤ 0.05) by about 7.8%, 8% and 11%, respectively. In conclusion, the regular consumption of horse meat may contribute to the dietary intake of n - 3 polyunsaturated fatty acids and may improve lipid profile and iron status in healthy subjects.

  20. From neural signatures of emotional modulation to social cognition: individual differences in healthy volunteers and psychiatric participants

    Science.gov (United States)

    Aguado, Jaume; Baez, Sandra; Huepe, David; Lopez, Vladimir; Ortega, Rodrigo; Sigman, Mariano; Mikulan, Ezequiel; Lischinsky, Alicia; Torrente, Fernando; Cetkovich, Marcelo; Torralva, Teresa; Bekinschtein, Tristan; Manes, Facundo

    2014-01-01

    It is commonly assumed that early emotional signals provide relevant information for social cognition tasks. The goal of this study was to test the association between (a) cortical markers of face emotional processing and (b) social-cognitive measures, and also to build a model which can predict this association (a and b) in healthy volunteers as well as in different groups of psychiatric patients. Thus, we investigated the early cortical processing of emotional stimuli (N170, using a face and word valence task) and their relationship with the social-cognitive profiles (SCPs, indexed by measures of theory of mind, fluid intelligence, speed processing and executive functions). Group comparisons and individual differences were assessed among schizophrenia (SCZ) patients and their relatives, individuals with attention deficit hyperactivity disorder (ADHD), individuals with euthymic bipolar disorder (BD) and healthy participants (educational level, handedness, age and gender matched). Our results provide evidence of emotional N170 impairments in the affected groups (SCZ and relatives, ADHD and BD) as well as subtle group differences. Importantly, cortical processing of emotional stimuli predicted the SCP, as evidenced by a structural equation model analysis. This is the first study to report an association model of brain markers of emotional processing and SCP. PMID:23685775

  1. Whole-body magnetic resonance imaging of healthy volunteers. Pilot study results from the population-based SHIP study

    Energy Technology Data Exchange (ETDEWEB)

    Hegenscheid, K.; Kuehn, J.P.; Hosten, N.; Puls, R. [Inst. fuer Diagnostische Radiologie und Neuroradiologie, Universitaetsklinikum der Ernst-Moritz-Arndt-Univ. Greifswald (Germany); Voelzke, H. [Inst. fuer Community Medicine, Universitaetsklinikum der Ernst-Moritz-Arndt-Univ. Greifswald (Germany); Biffar, R. [Zentrum fuer Zahn-, Mund- und Kieferheilkunde, Universitaetsklinikum der Ernst-Moritz-Arndt-Univ. Greifswald (Germany)

    2009-08-15

    Purpose: Approximately 4000 volunteers will undergo whole-body magnetic resonance imaging (WB-MRI) within the next 3 years in the population-based Study of Health in Pomerania (SHIP). Here we present a pilot study conducted (a) to determine the feasibility of adding a WB-MRI protocol to a large-scale population-based study, (b) to evaluate the reliability of standardized MRI interpretation, and (c) to establish an approach for handling pathological findings. Materials and Methods: The institutional review board approved the study, and oral and written informed consent was obtained from each participant. Two hundred healthy volunteers (99 women, 101 men; mean age 48.3 years) underwent a standardized WB-MRI protocol. The protocol was supplemented by contrast-enhanced cardiac MR1 and magnetic resonance (MR) angiography in 61 men (60.4%) and cardiac MRI and MR mammography in 44 women (44.4%). MR scans were evaluated independently by two readers. Abnormalities were discussed by an advisory board and classified according to the need for further clinical work-up. Results: One hundred ninety-four (97.0%) WB-MRI examinations were successfully completed in a mean scan time per subject of 90 minutes. There were 431 pathological findings in 176 (88%) of the participants. Of those 45 (10.4%) required further clinical work-up and 386 (89.6%) characterized as benign lesions did not. The interobserver agreement for the detection of pathological findings was excellent (K = 0.799) (orig.)

  2. Whole-body magnetic resonance imaging of healthy volunteers. Pilot study results from the population-based SHIP study

    International Nuclear Information System (INIS)

    Hegenscheid, K.; Kuehn, J.P.; Hosten, N.; Puls, R.; Voelzke, H.; Biffar, R.

    2009-01-01

    Purpose: Approximately 4000 volunteers will undergo whole-body magnetic resonance imaging (WB-MRI) within the next 3 years in the population-based Study of Health in Pomerania (SHIP). Here we present a pilot study conducted (a) to determine the feasibility of adding a WB-MRI protocol to a large-scale population-based study, (b) to evaluate the reliability of standardized MRI interpretation, and (c) to establish an approach for handling pathological findings. Materials and Methods: The institutional review board approved the study, and oral and written informed consent was obtained from each participant. Two hundred healthy volunteers (99 women, 101 men; mean age 48.3 years) underwent a standardized WB-MRI protocol. The protocol was supplemented by contrast-enhanced cardiac MR1 and magnetic resonance (MR) angiography in 61 men (60.4%) and cardiac MRI and MR mammography in 44 women (44.4%). MR scans were evaluated independently by two readers. Abnormalities were discussed by an advisory board and classified according to the need for further clinical work-up. Results: One hundred ninety-four (97.0%) WB-MRI examinations were successfully completed in a mean scan time per subject of 90 minutes. There were 431 pathological findings in 176 (88%) of the participants. Of those 45 (10.4%) required further clinical work-up and 386 (89.6%) characterized as benign lesions did not. The interobserver agreement for the detection of pathological findings was excellent (K = 0.799) (orig.)

  3. 45 CFR 1232.9 - General prohibitions against employment and volunteer service discrimination.

    Science.gov (United States)

    2010-10-01

    ... activity under which volunteers are assigned to work in a number of work stations will assure that a... volunteer service discrimination. 1232.9 Section 1232.9 Public Welfare Regulations Relating to Public... IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Employment and Volunteer Service...

  4. Conditioning pain stimulation does not affect itch induced by intra-epidermal histamine pricks but aggravates neurogenic inflammation in healthy volunteers

    DEFF Research Database (Denmark)

    Andersen, Hjalte Holm; Imai, Yosuke; Petersen, Kristian Kjær

    2016-01-01

    This study investigated whether itch induced by intra-epidermal histamine is subjected to modulation by a standardized conditioned pain modulation (CPM) paradigm in 24 healthy volunteers. CPM was induced by computer-controlled cuff pressure algometry and histamine was introduced to the volar...... forearm by skin prick test punctures. Moreover, neurogenic inflammation and wheal reactions induced by histamine and autonomic nervous system responses (heart rate variability and skin conductance) were monitored. CPM did not modulate the intensity of histamine-induced itch suggesting that pruriceptive...... signaling is not inhibited by pain-recruited endogenous modulation, however, CPM was found to aggravate histamine-induced neurogenic inflammation, likely facilitated by efferent sympathetic fibers....

  5. [The participation of seniors in volunteer activities: a systematic review].

    Science.gov (United States)

    Godbout, Elisabeth; Filiatrault, Johanne; Plante, Michelle

    2012-02-01

    Volunteer work can be a very significant form of social participation for seniors. It can also provide seniors with important physical and psychological health benefits. This explains why occupational therapists and other health care professionals, as well as community workers who are concerned with healthy aging, appeal to seniors to volunteer in health promotion and community support However, the recruitment and ongoing involvement of seniors as volunteers is often challenging. A systematic review of the literature was undertaken to enlighten practitioners working in this domain. The objective was to identify factors that influence seniors' participation in volunteer work. Six bibliographic databases were searched using key words. A total of 27 relevant papers were retrieved and allowed an identification of a series of factors that could influence seniors' participation in volunteer work, namely personal factors, environmental factors, and occupational factors. This analysis leads to practical guidelines for facilitating the recruitment and maintenance of seniors' engagement in volunteer work.

  6. Effects of red grape juice consumption on high density lipoprotein-cholesterol, apolipoprotein AI, apolipoprotein B and homocysteine in healthy human volunteers.

    Science.gov (United States)

    Khadem-Ansari, Mohammad H; Rasmi, Yousef; Ramezani, Fatemeh

    2010-01-01

    It has suggested that grape juice consumption has lipid- lowering effect and it is associated with a decreased risk of heart disease. We aimed to evaluate the effects of red grape juice (RGj) consumption on high density lipoprotein-cholesterol (HDL-C), apolipoprotein AI (apoAI), apolipoprotein B (apoB) and homocysteine (Hcy) levels in healthy human volunteers. Twenty six healthy and nonsmoking males, aged between 25-60 years, who were under no medication asked to consume 150 ml of RGj twice per day for one month. Serum HDL-C, apoAI, apoB and plasma Hcy levels were measured before and after one month RGj consumption. HDL-C levels after RGj consumption were significantly higher than the corresponding levels before the RGj consumption (41.44 ± 4.50 and 44.37 ± 4.30 mg/dl; P0.05). Hcy levels were decreased after RGj consumption (7.70 ± 2.80 and 6.20 ± 2.30 µmol/l; P<0.001). The present study demonstrates that RGj consumption can significantly increase serum HDL-C levels and decrease Hcy levels. These findings may have important implications for the prevention of atherosclerosis in healthy individuals.

  7. Randomized, Double-Blind Clinical Trial to Assess the Acute Diuretic Effect of Equisetum arvense (Field Horsetail in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Danilo Maciel Carneiro

    2014-01-01

    Full Text Available In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n=12 that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day, placebo (corn starch, 900 mg/day, or hydrochlorothiazide (25 mg/day, separated by a 10-day washout period. Each volunteer served as his own control, and the groups’ results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers’ water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine.

  8. Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers.

    Directory of Open Access Journals (Sweden)

    Jose Muñoz

    2018-01-01

    Full Text Available Ivermectin is a pivotal drug for the control of onchocerciasis and lymphatic filariasis, which is increasingly identified as a useful drug for the control of other Neglected Tropical Diseases. Its role in the treatment of soil transmitted helminthiasis through improved efficacy against Trichuris trichiura in combination with other anthelmintics might accelerate the progress towards breaking transmission. Ivermectin is a derivative of Avermectin B1, and consists of an 80:20 mixture of the equipotent homologous 22,23 dehydro B1a and B1b. Pharmacokinetic characteristics and safety profile of ivermectin allow to explore innovative uses to further expand its utilization through mass drug administration campaigns to improve coverage rates. We conducted a phase I clinical trial with 54 healthy adult volunteers who sequentially received 2 experimental treatments using a new 18 mg ivermectin tablet in a fixed-dose strategy of 18 and 36 mg single dose regimens, compared to the standard, weight based 150–200 μg/kg, regimen. Volunteers were recruited in 3 groups based on body weight. Plasma concentrations of ivermectin were measured through HPLC up to 168 hours post treatment. Safety data showed no significant differences between groups and no serious adverse events: headache was the most frequent adverse event in all treatment groups, none of them severe. Pharmacokinetic parameters showed a half-life between 81 and 91 h in the different treatment groups. When comparing the systemic bioavailability (AUC0t and Cmax of the reference product (WA-ref with the other two study groups using fixed doses, we observed an overall increase in AUC0t and Cmax for the two experimental treatments of 18 mg and 36 mg. Body mass index (BMI and weight were associated with t1/2 and V/F, probably reflecting the high liposolubility of IVM with longer retention times proportional to the presence of more adipose tissue. Systemic exposure to ivermectin (AUC0t or Cmax was not

  9. Pharmacokinetic and bioequivalence studies of immediate release diclofenac potassium tablets (50mg) in healthy volunteers.

    Science.gov (United States)

    Ali, Huma; Shoaib, Muhammad Harris; Zafar, Farya; Hanif, Muhammad; Bushra, Rabia; Naz, Asia; Khursheed, Raheela

    2016-09-01

    This study was conducted with the aim to determine the pharmacokinetic and bioequivalence of diclofenac potassium 50 mg test (F4) tablet formulation with reference product (Caflam). Present study was single dose, randomized, two phase cross over design, conducted in 12 healthy Pakistani volunteers and planned in accordance with FDA guidelines. In this study a simple, selective, sensitive and reproducible HPLC procedure was developed and validated for the estimation of diclofenac potassium in plasma. The process was validated in the range of 50 - 0.05 µg.mL-1 and used in bioequivalence trial of two products. Multiple blood samples were collected at various time points (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 14 hr after treating volunteers with test (F4) and marketed reference brand. Plasma separation and deproteination were carried out with acetonitrile; samples (20µL) were injected using the validated HPLC method. Various pharmacokinetic parameters (compartmental and noncompartmental) were estimated using KineticaTM 4.4.1 (Thermo Electron Corp. USA). Bioequivalence among the products was established by calculating the 90% CI with log and non log transformed data for Cmaxcalc, Tmaxcalc, AUC0-∞, AUCtot and AUClast using two way ANOVA and Schirmann's Two one sided t- test. No significant difference was found between log and non-log data. The 90% confidence interval values using log transformed data for AUC0-∞ (0.997-1.024), AUCtot (1.004-1.031), AUClast (0.997 -1.024), Cmaxcalc (0.994-1.007) and Tmaxcalc (0.996-1.013) for the trial and reference products were found within the FDA acceptable limits of 0.8-1.25. Results were further verified by the Schirmann's one-sided t test. Results showed the bioequivalence of test and reference formulations. Both the products were well tolerated.

  10. Effect of fermented milk containing Lactobacillus rhamnosus SD11 on oral microbiota of healthy volunteers: A randomized clinical trial.

    Science.gov (United States)

    Rungsri, P; Akkarachaneeyakorn, N; Wongsuwanlert, M; Piwat, S; Nantarakchaikul, P; Teanpaisan, R

    2017-10-01

    The aims of this study were to evaluate whether short-term consumption of fermented milk containing Lactobacillus rhamnosus SD11 affected levels of oral microbiota in vivo and whether L. rhamnosus SD11 could colonize in the human mouth. We also monitored for potential side effects of the probiotic. The applicability of using L. rhamnosus SD11 compared with Lactobacillus bulgaricus as a starter culture for fermented milk was evaluated. After informed consent, 43 healthy young adults were recruited and randomly assigned to either the probiotic or control group and received fermented milk containing L. rhamnosus SD11 or L. bulgaricus, respectively, once daily for 4 wk. The numbers of mutans streptococci, lactobacilli, and total bacteria in saliva were counted at baseline and then after 4 and 8 wk. An oral examination was performed at baseline and after 8 wk. The persistence of L. rhamnosus SD11 was investigated by DNA fingerprinting using arbitrary primer-PCR. Results demonstrated that statistically significant reductions in mutans streptococci and total bacteria were observed in the probiotic group compared with the control group, and the number of lactobacilli was significantly increased in both groups after receiving fermented milks. Lactobacillus rhamnosus SD11 could be detected (in >80% of subjects) up to 4 wk following cessation of dosing among subjects in the probiotic group. No side effects were reported. Thus, L. rhamnosus SD11 could be used as a starter culture for fermented milk. Daily consumption of L. rhamnosus SD11-containing fermented milk for 4 wk may have beneficial effects on oral health by reducing salivary levels of mutans streptococci. The probiotic was apparently able to colonize the oral cavity for a longer time than previously reported. However, the potential benefits of probiotic L. rhamnosus SD11 on oral health require further evaluation with a larger group of volunteers in a longer-term study. Copyright © 2017 American Dairy Science

  11. Relations between transit time, fermentation products, and hydrogen consuming flora in healthy humans.

    OpenAIRE

    El Oufir, L; Flourié, B; Bruley des Varannes, S; Barry, J L; Cloarec, D; Bornet, F; Galmiche, J P

    1996-01-01

    BACKGROUND/AIMS: To investigate whether transit time could influence H2 consuming flora and certain indices of colonic bacterial fermentation. METHODS: Eight healthy volunteers (four methane excretors and four non-methane excretors) were studied for three, three week periods during which they received a controlled diet alone (control period), and then the same diet with cisapride or loperamide. At the end of each period, mean transit time (MTT) was estimated, an H2 lactulose breath test was p...

  12. Lack of interaction between a new antihistamine, mizolastine, and lorazepam on psychomotor performance and memory in healthy volunteers.

    Science.gov (United States)

    Patat, A; Perault, M C; Vandel, B; Ulliac, N; Zieleniuk, I; Rosenzweig, P

    1995-01-01

    1. The possible interaction between a new H1 antihistamine, mizolastine, and lorazepam was assessed in a randomised, double-blind, cross-over, placebo-controlled study involving 16 healthy young male volunteers who received mizolastine 10 mg or placebo once daily for 8 days with a 1 week wash-out interval. The interaction of mizolastine, at steady-state, with a single oral dose of lorazepam or placebo was assessed on days 6 or 8 of each treatment period. 2. Psychomotor performance and cognitive function were evaluated using objective tests (critical flicker fusion threshold, choice reaction time, tapping, arithmetic calculation, body sway) and self-ratings (visual analogue scale, ARCI) before and at 2, 4, 6 and 8 h after dosing. Short-term memory (Sternberg memory scanning immediate free recall of a word list) and long-term memory (delayed free recall and recognition of words and pictures) were assessed before and at 3 h after dosing. Pharmacodynamic interactions were evaluated by repeated measures ANOVA in a 2 x 2 factorial interaction model. 3. Mizolastine, 10 mg once daily, at steady-state, was devoid of sedation and detrimental effect on skilled performance and memory. 4. In contrast, a single 2 mg dose of lorazepam produced marked impairment of psychomotor performance, cognitive functions (significant reduction in flicker fusion threshold, tapping and arithmetic calculation and increase in reaction times and body sway) and subjective sedation from 2 to 8 h after dosing. In addition, lorazepam induced an anterograde amnesia, characterised by a decrease in delayed free recall and recognition, and a deficit in short term memory.(ABSTRACT TRUNCATED AT 250 WORDS)

  13. A randomized placebo-controlled phase Ia malaria vaccine trial of two virosome-formulated synthetic peptides in healthy adult volunteers.

    Directory of Open Access Journals (Sweden)

    Blaise Genton

    2007-10-01

    Full Text Available Influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. The aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides. The specific objective was to demonstrate the safety and immunogenicity of two virosome-formulated P. falciparum protein derived synthetic peptide antigens given in two different doses alone or in combination.The design was a single blind, randomized, placebo controlled, dose-escalating study involving 46 healthy Caucasian volunteers aged 18-45 years. Five groups of 8 subjects received virosomal formulations containing 10 microg or 50 microg of AMA 49-CPE, an apical membrane antigen-1 (AMA-1 derived synthetic phospatidylethanolamine (PE-peptide conjugate or 10 ug or 50 ug of UK39, a circumsporozoite protein (CSP derived synthetic PE-peptide conjugate or 50 ug of both antigens each. A control group of 6 subjects received unmodified virosomes. Virosomal formulations of the antigens (designated PEV301 and PEV302 for the AMA-1 and the CSP virosomal vaccine, respectively or unmodified virosomes were injected i. m. on days 0, 60 and 180. In terms of safety, no serious or severe adverse events (AEs related to the vaccine were observed. 11/46 study participants reported 16 vaccine related local AEs. Of these 16 events, all being pain, 4 occurred after the 1(st, 7 after the 2(nd and 5 after the 3(rd vaccination. 6 systemic AEs probably related to the study vaccine were reported after the 1(st injection, 10 after the 2(nd and 6 after the 3(rd. Generally, no difference in the distribution of the systemic AEs between either the doses applied (10 respectively 50 microg or the synthetic antigen vaccines (PEV301 and PEV302 used for immunization was found. In terms of immunogenicity, both PEV301 and PEV302 elicited already after two injections a synthetic peptide

  14. Effects of milk curd on saliva secretion in healthy volunteer compared to baseline, 2% pilocarpine and equivalent pH adjusted acetic acid solutions

    OpenAIRE

    Neda Babaee; Atefeh Gholizadehpasha; Samir Zahedpasha; Yasaman Moghadamnia; Shiva Zamaninejad; Ali Akbar Moghadamnia

    2011-01-01

    Background: Dry mouth is a common clinical problem, and different products have been proposed to improve it. In this investigation, the effects of "milk curd" on the amount of saliva secretion were studied. Materials and Methods: A total of 32 patients (aged 20-30) were selected from healthy volunteers. Milk curd concentrations of 0.5, 1, 2 and 4%, and 2% pilocarpine were prepared as drops. The impact of the drugs on the saliva weight was assessed after 1-5 min. To determine the effects o...

  15. A single-dose, randomized, two-way crossover study comparing two olanzapine tablet products in healthy adult male volunteers under fasting conditions.

    Science.gov (United States)

    Elshafeey, Ahmed H; Elsherbiny, Mohamed A; Fathallah, Mohsen M

    2009-03-01

    Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. The aim of this study was to assess the bioequivalence of 2 commercial 10-mg tablet formulations of olanzapine by statistical analysis of the pharmacokinetic parameters C(max), AUC from 0 to 72 hours after dosing (AUC(0-72)), and AUC(0-infinity) as required by the Egyptian health authority for the marketing of a generic product. This bioequivalence study was carried out in healthy male volunteers using a single-dose, randomized, 2-way crossover design under fasting conditions. Statistical analysis of the pharmacokinetic parameters C(max), AUC(0-72), and AUC(0-infinity) was conducted to determine bioequivalence (after log-transformation of data using analysis of variance and 90% CIs) and to gain marketing approval in Egypt. The formulations were considered to be bioequivalent if the log-transformed ratios of the 3 pharmacokinetic parameters were within the predetermined bioequivalence range (ie, 80%-125%), as established by the US Food and Drug Administration (FDA). Both the test product (Trademark: Integrol((R)) [Global Napi Pharmaceuticals, Cairo, Egypt]) and the reference product (Trademark: Zyprexa((R)) [Eli Lilly and Company, Basingstoke, Hampshire, United Kingdom]) were administered as 10-mg tablets with 240 mL of water after an overnight fast on 2 treatment days, separated by a 2-week washout period. After dosing, serial blood samples were collected for 72 hours. Plasma samples were analyzed using a sensitive, reproducible, and accurate liquid chromatography-tandem mass spectrometry method capable of quantitating olanzapine in the range of 0.167 to 16.7 ng/mL, with a lower limit of quantitation of 0.167 ng/mL. Adverse events were reported by the volunteers as instructed or observed by the resident physician, and were recorded, tabulated, and evaluated. Twenty-four healthy adult male volunteers participated in this study. Their mean (SD) age was 24.7 (6.2) years (range, 19

  16. MORPHOMETRICAL PARAMETERS OF GUT MICROFLORA IN HUMAN VOLUNTEERS

    NARCIS (Netherlands)

    Wilkinson, M.H.F.; Meijer, B.C

    1991-01-01

    The morphology of faecal microflora of nine healthy human volunteers was studied by digital image analysis of microscopic slides. Weekly specimens were collected during an 8-week period. Seven morphometrical parameters were derived: the means and medians of components 1, 2 and 3, and morphometrical

  17. Physiologic effects of intravenous fluid administration in healthy volunteers

    DEFF Research Database (Denmark)

    Holte, Kathrine; Jensen, Peter; Kehlet, Henrik

    2003-01-01

    , infusion of the fluid over 3 h in the morning, and additionally 24-h hospitalization under standardized conditions. Primary outcome assessments were pulmonary function (spirometry), exercise capacity (submaximal treadmill test), balance function (BalanceMaster), and weight. Infusion of 40 mL/kg of lactated...... by fluid administration. These findings may serve as a basis for clinical studies applying the same type of fluid in different amounts to determine the optimal amount of perioperative fluid in various surgical procedures. IMPLICATIONS: Infusion of 40 mL/kg of lactated Ringer's solution in volunteers led...

  18. Effects of oral lycopene supplementation on vascular function in patients with cardiovascular disease and healthy volunteers: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Parag R Gajendragadkar

    Full Text Available AIMS: The mechanisms by which a 'Mediterranean diet' reduces cardiovascular disease (CVD burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV. METHODS AND RESULTS: We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV, sodium nitroprusside (endothelium-independent vasodilatation; EIDV, and NG-monomethyl-L-arginine (basal nitric oxide (NO synthase activity were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: -45% to -10%, P = 0.008, despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: -1.6 to -0.9 mmol/L, P<0.001. Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: -30% to +30%, P = 0.85, also suggesting lycopene improved endothelial function. CONCLUSIONS: Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01100385.

  19. A Phase I clinical trial of lodenafil carbonate, a new phosphodiesterase Type 5 (PDE5) inhibitor, in healthy male volunteers.

    Science.gov (United States)

    Mendes, Gustavo D; dos Santos Filho, Hilton Oliveira; dos Santos Pereira, Alberto; Mendes, Fabiana D; Ilha, Jaime O; Alkharfy, Khalid M; De Nucci, Gilberto

    2012-12-01

    Lodenafil carbonate is a new phosphodiesterase Type 5 (PDE5) inhibitor used in treatment of erectile dysfunction. The present study was conducted to evaluate the safety, tolerability, and pharmacokinetics of lodenafil carbonate after administering ascending (1 - 100 mg) single oral doses to healthy male volunteers (n = 33). The study was an open label, dose-escalation, Phase I clinical trial involving the administration of single oral doses of lodenafil carbonate. Lodenafil carbonate was administered sequentially, escalating in single doses of 1 mg - 100 mg with a washout period of at least 1 week between each dose. The progression to the next dose was allowed after clinical and laboratory exams, Ambulatory Monitoring of Arterial Pressure (AMAP) without relevant clinical modifications and adverse events without clinical relevancy. Blood samples were collected at pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 14, 16, 20 and 24 h post-dosing. Plasma samples for measurement of lodenafil carbonate and lodenafil were analyzed by liquid chromatography coupled to tandem mass spectrometry. No serious adverse events were observed, and none of the subjects discontinued the study due to intolerance. The AMAP measurements, clinical and laboratory exams and ECG revealed no significant changes even at higher doses. Lodenafil carbonate was not detected in any samples, indicating that it acts as a prodrug. The mean lodenafil pharmacokinetic parameters for tmax and t1/2 were 1.6 ( ± 0.4) h and 3.3 ( ± 1.1) h, respectively. This study demonstrated that lodenafil carbonate was well tolerated and showed a good safety profile in healthy male volunteers.

  20. Effects of Oral Lycopene Supplementation on Vascular Function in Patients with Cardiovascular Disease and Healthy Volunteers: A Randomised Controlled Trial

    Science.gov (United States)

    Gajendragadkar, Parag R.; Hubsch, Annette; Mäki-Petäjä, Kaisa M.; Serg, Martin; Wilkinson, Ian B.; Cheriyan, Joseph

    2014-01-01

    Aims The mechanisms by which a ‘Mediterranean diet’ reduces cardiovascular disease (CVD) burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV). Methods and Results We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV), sodium nitroprusside (endothelium-independent vasodilatation; EIDV), and NG-monomethyl-L-arginine (basal nitric oxide (NO) synthase activity) were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo) without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: −45% to −10%, P = 0.008), despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: −1.6 to −0.9 mmol/L, Plycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: −30% to +30%, P = 0.85), also suggesting lycopene improved endothelial function. Conclusions Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. Trial Registration ClinicalTrials.gov NCT01100385 PMID:24911964

  1. Comparison of the Effects of Acarbose and TZQ-F, a New Kind of Traditional Chinese Medicine to Treat Diabetes, Chinese Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Huang Yuhong

    2014-01-01

    Full Text Available Ethnopharmacological Relevance. TZQ-F has been traditionally used in Traditional Chinese Medicine as a formula for the treatment of diabetes. Aim of the Study. This study aims to compare the pharmacologic effects and gastrointestinal adverse events between TZQ-F and acarbose. Methods. The double-blind randomized placebo-controlled fivefold crossover study was performed in 20 healthy male volunteers. Plasma glucose, plasma IRI, and plasma C-peptide were measured to assess the pharmacologic effects. Flatus and bowel activity were measured to assess the adverse event of gastrointestinal effect. Results. 3 and 4 tablets of TZQ decreased the Cmax of plasma glucose compared with that of the previous day and with placebo. 3 tablets also decreased Cmax of plasma C-peptide compared with placebo. 4 tablets increased Cmax of plasma insulin after breakfast and the AUC of plasma C-peptide after breakfast and dinner. 2 tablets did not decrease plasma glucose and elevated the Cmax and AUC of C-peptide after breakfast and dinner, respectively. Acarbose 50 mg decreased the Cmax of plasma insulin and C-peptide after breakfast and the Cmax of plasma glucose and C-peptide after dinner. The subjects who received TZQ did not report any abdominal adverse events. Conclusions. 3 tablets of TZQ have the same effects as the acarbose.

  2. An anatomical study of the parasacral block using magnetic resonance imaging of healthy volunteers.

    LENUS (Irish Health Repository)

    O'Connor, Maeve

    2012-01-31

    BACKGROUND: The parasacral approach to sciatic blockade is reported to be easy to learn and perform, with a high success rate and few complications. METHODS: Using magnetic resonance imaging, we evaluated the accuracy of a simulated needle (perpendicular to skin) in contacting the sacral plexus with this approach in 10 volunteers. Intrapelvic structures encountered during the simulated parasacral blocks were also recorded. RESULTS: The sacral plexus was contacted by the simulated needle in 4 of the 10 volunteers, and the sciatic nerve itself in one volunteer. The plexus was accurately located adjacent to a variety of visceral structures, including small bowel, blood vessels, and ovary. In the remaining five volunteers (in whom the plexus was not contacted on first needle pass), small bowel, rectum, blood vessels, seminal vesicles, and bony structures were encountered. Historically, when plexus is not encountered, readjustment of the needle insertion point more caudally has been recommended. We found that such an adjustment resulted in simulated perforation of intrapelvic organs or the perianal fossa. CONCLUSIONS: These findings question the reliability of the anatomical landmarks of the parasacral block and raise the possibility of frequent visceral puncture using this technique.

  3. Volunteering and health benefits in general adults: cumulative effects and forms.

    Science.gov (United States)

    Yeung, Jerf W K; Zhang, Zhuoni; Kim, Tae Yeun

    2017-07-11

    Although the health benefits of volunteering have been well documented, no research has examined its cumulative effects according to other-oriented and self-oriented volunteering on multiple health outcomes in the general adult public. This study examined other-oriented and self-oriented volunteering in cumulative contribution to health outcomes (mental and physical health, life satisfaction, social well-being and depression). Data were drawn from the Survey of Texas Adults 2004, which contains a statewide population-based sample of adults (n = 1504). Multivariate linear regression and Wald test of parameters equivalence constraint were used to test the relationships. Both forms of volunteering were significantly related to better health outcomes (odds ratios = 3.66% to 11.11%), except the effect of self-oriented volunteering on depression. Other-oriented volunteering was found to have better health benefits than did self-volunteering. Volunteering should be promoted by public health, education and policy practitioners as a kind of healthy lifestyle, especially for the social subgroups of elders, ethnic minorities, those with little education, single people, and unemployed people, who generally have poorer health and less participation in volunteering.

  4. An evoked auditory response fMRI study of the effects of rTMS on putative AVH pathways in healthy volunteers.

    LENUS (Irish Health Repository)

    Tracy, D K

    2010-01-01

    Auditory verbal hallucinations (AVH) are the most prevalent symptom in schizophrenia. They are associated with increased activation within the temporoparietal cortices and are refractory to pharmacological and psychological treatment in approximately 25% of patients. Low frequency repetitive transcranial magnetic stimulation (rTMS) over the temporoparietal cortex has been demonstrated to be effective in reducing AVH in some patients, although results have varied. The cortical mechanism by which rTMS exerts its effects remain unknown, although data from the motor system is suggestive of a local cortical inhibitory effect. We explored neuroimaging differences in healthy volunteers between application of a clinically utilized rTMS protocol and a sham rTMS equivalent when undertaking a prosodic auditory task.

  5. Seroprevalence of Hepatitis B and C Infections among Healthy Volunteer Blood Donors in the Central California Valley.

    Science.gov (United States)

    Sheikh, Muhammad Y; Atla, Pradeep R; Ameer, Adnan; Sadiq, Humaira; Sadler, Patrick C

    2013-01-01

    The Central California Valley has a diverse population with significant proportions of Hispanics and Asians. This cross-sectional study was conducted to evaluate the prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in healthy blood donors in the Valley. A total of 217,738 voluntary blood donors were identified between 2006 and 2010 (36,795 first-time donors; 180,943 repeat donors). Among the first-time donors, the HBV and HCV prevalence was 0.28% and 0.52%, respectively. Higher HBV prevalence seen in Asians (3%) followed by Caucasians (0.05%), African Americans (0.15%), and Hispanics (0.05%). Hmong had a HBV prevalence of 7.63% with a peak prevalence of 8.76% among the 16- to 35-year-old age group. Highest HCV prevalence in Native Americans (2.8) followed by Caucasians (0.59%), Hispanics (0.45%), African Americans (0.38%), and Asians (0.2%). Ethnic disparities persist with regard to the prevalence of HBV and HCV in the Central California Valley. The reported prevalence may be an underestimate because our study enrolled healthy volunteer blood donors only. The development of aggressive public health measures to evaluate the true prevalence of HBV and HCV and to identify those in need of HBV and HCV prevention measures and therapy is critically important.

  6. From neural signatures of emotional modulation to social cognition: individual differences in healthy volunteers and psychiatric participants.

    Science.gov (United States)

    Ibáñez, Agustín; Aguado, Jaume; Baez, Sandra; Huepe, David; Lopez, Vladimir; Ortega, Rodrigo; Sigman, Mariano; Mikulan, Ezequiel; Lischinsky, Alicia; Torrente, Fernando; Cetkovich, Marcelo; Torralva, Teresa; Bekinschtein, Tristan; Manes, Facundo

    2014-07-01

    It is commonly assumed that early emotional signals provide relevant information for social cognition tasks. The goal of this study was to test the association between (a) cortical markers of face emotional processing and (b) social-cognitive measures, and also to build a model which can predict this association (a and b) in healthy volunteers as well as in different groups of psychiatric patients. Thus, we investigated the early cortical processing of emotional stimuli (N170, using a face and word valence task) and their relationship with the social-cognitive profiles (SCPs, indexed by measures of theory of mind, fluid intelligence, speed processing and executive functions). Group comparisons and individual differences were assessed among schizophrenia (SCZ) patients and their relatives, individuals with attention deficit hyperactivity disorder (ADHD), individuals with euthymic bipolar disorder (BD) and healthy participants (educational level, handedness, age and gender matched). Our results provide evidence of emotional N170 impairments in the affected groups (SCZ and relatives, ADHD and BD) as well as subtle group differences. Importantly, cortical processing of emotional stimuli predicted the SCP, as evidenced by a structural equation model analysis. This is the first study to report an association model of brain markers of emotional processing and SCP. © The Author (2013). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

  7. Understanding paratyphoid infection: study protocol for the development of a human model of Salmonella enterica serovar Paratyphi A challenge in healthy adult volunteers.

    Science.gov (United States)

    McCullagh, David; Dobinson, Hazel C; Darton, Thomas; Campbell, Danielle; Jones, Claire; Snape, Matthew; Stevens, Zoe; Plested, Emma; Voysey, Merryn; Kerridge, Simon; Martin, Laura B; Angus, Brian; Pollard, Andrew J

    2015-06-16

    This study will develop the first human challenge model of paratyphoid infection which may then be taken forward to evaluate paratyphoid vaccine candidates. Salmonella Paratyphi A is believed to cause a quarter of the estimated 20 million cases of enteric fever annually. Epidemiological evidence also suggests that an increasing proportion of the enteric fever burden is attributable to S. Paratyphi infection meriting further attention and interest in vaccine development. Assessment of paratyphoid vaccine efficacy in preclinical studies is complicated by the lack of a small animal model and the human-restricted nature of the infection. The use of experimental human infection in healthy volunteers provides an opportunity to address these problems in a cost-effective manner. Volunteers will ingest virulent S. Paratyphi A bacteria (NVGH308 strain) with a bicarbonate buffer solution to establish the infectious dose resulting in an 'attack rate' of 60-75%. Using an a priori decision-making algorithm, the challenge dose will be escalated or de-escalated to achieve the target attack rate, with the aim of reaching the study end point while exposing as few individuals as possible to infection. The attack rate will be determined by the proportion of paratyphoid infection in groups of 20 healthy adult volunteers, with infection being defined by one or more positive blood cultures (microbiological end point) and/or fever, defined as an oral temperature exceeding 38 °C sustained for at least 12 h (clinical end point); 20-80 participants will be required. Challenge participants will start a 2-week course of an oral antibiotic on diagnosis of infection, or after 14 days follow-up. The strict eligibility criterion aims to minimise risk to participants and their close contacts. Ethical approval has been obtained. The results will be disseminated in a peer-reviewed journal and presented at international congresses. NCT02100397. Published by the BMJ Publishing Group Limited. For

  8. Computed tomographic findings in normal elderly volunteers and demented patients

    International Nuclear Information System (INIS)

    Nishino, Hideo; Ide, Hiroshi; Kurihara, Norimitsu; Tanno, Munehiko; Yamada, Hideo; Chiba, Kazuo; Kasahara, Isao; Karasawa, Akihide; Hasegawa, Kazuo.

    1988-01-01

    CT findings of demented patients with CVD (49 cases) and without CVD (51 cases) were compared with those of healthy age matched volunteers with CVD (29 cases) and without CVD (110 cases). The results were as follows. 1) About 20 % of healthy volunteers had CVD (silent stroke) and these cases should never be regarded as real healthy aged peoples. 2) In aged healthy peoples, size of lateral ventricles, sulci and Sylvian fissure were increased with aging. The degree of PVL and size of third ventricle were not increased with age. 3) Incidence of PVL was closely related with presence of CVD. In demented patients without CVD, however, PVL increased with aging. 4) In dementia the size of lateral ventricle, sulci, Sylvian fissure and third ventricle showed no correlation with aging. In general, enlargement of the lateral ventricle and Sylvian fissure were more prominent in demented peoples without CVD. 5) Atrophy in the medial temporal lobe were observed most frequently in demented peoples without CVD aged 50 to 59 years. In demented patients over 60, no difference was observed in finding of the area between those with and without CVD. (author)

  9. The administration of psilocybin to healthy, hallucinogen-experienced volunteers in a mock-functional magnetic resonance imaging environment: a preliminary investigation of tolerability.

    Science.gov (United States)

    Carhart-Harris, Robin L; Williams, Tim M; Sessa, Ben; Tyacke, Robin J; Rich, Ann S; Feilding, Amanda; Nutt, David J

    2011-11-01

    This study sought to assess the tolerability of intravenously administered psilocybin in healthy, hallucinogen-experienced volunteers in a mock-magnetic resonance imaging environment as a preliminary stage to a controlled investigation using functional magnetic resonance imaging to explore the effects of psilocybin on cerebral blood flow and activity. The present pilot study demonstrated that up to 2 mg of psilocybin delivered as a slow intravenous injection produces short-lived but typical drug effects that are psychologically and physiologically well tolerated. With appropriate care, this study supports the viability of functional magnetic resonance imaging work with psilocybin.

  10. Interferência da coloração de esmaltes de unha e do tempo na oximetria de pulso em voluntários sadios Interference of nail polish colors and time on pulse oximetry in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Mara Harumi Miyake

    2003-12-01

    Full Text Available INTRODUÇÃO: A oximetria de pulso é um método não invasivo de mensuração da saturação periférica da oxiemoglobina (SpO2. É freqüentemente utilizado em unidades de emergência, de terapia intensiva e em centro cirúrgico. A leitura da oximetria de pulso tem acurácia limitada na presença de metaemoglobina, carboxiemoglobina, anemia, vasoconstrição periférica, esmalte de unha, luz fluorescente e movimentação. OBJETIVO: Avaliar a interferência da coloração de esmalte de unha e do tempo sobre a SpO2 em indivíduos sadios. MÉTODO: Participaram do estudo 61 voluntárias sadias, com idades entre 18 e 32 anos. Foi avaliada SpO2 nas seguintes colorações de esmaltes: base (dedo mínimo, rosa claro (dedo anular, rosa claro com cintilante (dedo médio e vermelha (polegar. O indicador não recebeu esmalte. Foi analisado o tempo para cada coloração de esmalte, a cada minuto até completar cinco minutos. RESULTADOS: Quando comparadas as medidas da SpO2 com o controle, as colorações base (p = 0,56, rosa claro (p = 0,56 e rosa claro com cintilante (p = 0,37 não apresentaram diferença estatisticamente significante. A SpO2 apresentou variação significante na cor vermelha (p BACKGROUND: Pulse oximetry is a noninvasive method to measure the saturation of peripheral oxyhaemoglobin (SpO2. It's usually used in emergency, intensive care and operating room units. Pulse oximeter readings have limited accuracy in the presence of methemoglobin, carboxyhemoglobin, anaemia, peripheral vasoconstriction, nail polish, fluorescent light, and motion. OBJECTIVES: To evaluate the interferences of the color of nail polishes and time on SpO2 in healthy individuals. METHODS: Sixty-one healthy female volunteers, ages ranging from 18 to 32 years. The nail polish colors used to evaluate SpO2 were: base coat on the little finger, light pink on the ring finger, sparkling light pink on the medium finger and red on the thumb. The index finger was used as control

  11. Platelet inhibitory effects of juices from Pachyrhizus erosus L. root and Psidium guajava L. fruit: a randomized controlled trial in healthy volunteers.

    Science.gov (United States)

    Thaptimthong, Thitiporn; Kasemsuk, Thitima; Sibmooh, Nathawut; Unchern, Supeenun

    2016-08-03

    The purpose of this study is to investigate cardiovascular benefits of juices obtained from two commonly consumed fruits in Thailand, Pachyrhizus erosus, L. (yam bean) and Psidium guajava, L. (guava), by examining their acute cardiovascular effects in healthy volunteers. Possible involvements of the dietary nitrate on their effects were investigated as well. Thirty healthy volunteers were randomly divided into three groups of 10 subjects per group and each group was allocated to drink 500 ml of freshly prepared yam bean root juice, guava fruit juice, or water. Systemic nitrate and nitrite concentrations, heart rate, systolic and diastolic blood pressure, serum K(+) concentrations, ex vivo platelet aggregation, and plasma cGMP concentrations were monitored at the baseline and at various time points after the intake of juices or water. Data were compared by repeated measures ANOVA. Following the ingestion of both yam bean root juice and guava fruit juice, collagen-induced but not ADP-induced platelet aggregation was attenuated. Ingestion of yam bean root juice increased systemic nitrate and nitrite concentrations whereby elevated nitrite concentrations correlated with the extent of inhibiting collagen-induced platelet aggregation. In addition, positive correlation between systemic nitrite and plasma cGMP concentrations and negative correlation between plasma cGMP concentrations and the extent of collagen-induced platelet aggregation were revealed. Nevertheless, yam bean root juice reduced only diastolic blood pressure while guava fruit juice reduced heart rate, systolic and diastolic blood pressure. The present study has illustrated, for the first time, acute inhibitory effects of yam bean root juice and guava fruit juice on ex vivo collagen-induced platelet aggregation in healthy subjects. Dietary nitrate was shown to underlie the effect of yam bean root juice but not that of guava fruit juice. Following yam bean root juice ingestion, systemic nitrate apparently

  12. Fate and effects of Camembert cheese micro-organisms in the human colonic microbiota of healthy volunteers after regular Camembert consumption.

    Science.gov (United States)

    Firmesse, Olivier; Alvaro, Elise; Mogenet, Agnès; Bresson, Jean-Louis; Lemée, Riwanon; Le Ruyet, Pascale; Bonhomme, Cécile; Lambert, Denis; Andrieux, Claude; Doré, Joël; Corthier, Gérard; Furet, Jean-Pierre; Rigottier-Gois, Lionel

    2008-07-15

    The objective of this study was to determine i) if Camembert cheese micro-organisms could be detected in fecal samples after regular consumption by human subjects and ii) the consequence of this consumption on global metabolic activities of the host colonic microbiota. An open human protocol was designed where 12 healthy volunteers were included: a 2-week period of fermented products exclusion followed by a 4-weeks Camembert ingestion period where 2x40 g/day of Camembert cheese was consumed. Stools were collected from the volunteers before consumption, twice during the ingestion period (2nd and 4th week) and once after a wash out period of 2 weeks. During the consumption of Camembert cheese, high levels of Lactococcus lactis and Leuconostoc mesenteroides were measured in fecal samples using real-time quantitative PCR, reaching median values of 8.2 and 7.5 Log(10) genome equivalents/g of stool. For Ln. mesenteroides, persistence was observed 15 days after the end of Camembert consumption. The survival of Geotrichum candidum was also assessed and the fecal concentration reached a median level of 7.1 Log(10) CFU/g in stools. Except a decreasing trend of the nitrate reductase activity, no significant modification was shown in the metabolic activities during this study.

  13. Is overseas volunteering beneficial to the NHS? The analysis of volunteers' responses to a feedback questionnaire following experiences in low-income and middle-income countries.

    Science.gov (United States)

    Yeomans, Daniel; Le, Grace; Pandit, Hemant; Lavy, Chris

    2017-10-16

    Locally requested and planned overseas volunteering in low-income and middle-income countries by National Health Service (NHS) staff can have benefits for the host or receiving nation, but its impact on the professional development of NHS staff is not proven. The Knowledge and Skills Framework (KSF) and Leadership Framework (LF) are two tools used by employers as a measure of individuals' development. We have used dimensions from both tools as a method of evaluating the benefit to NHS doctors who volunteer overseas. 88 NHS volunteers participating with local colleagues in Primary Trauma Care and orthopaedic surgical training courses in sub-Saharan Africa were asked to complete an online self-assessment questionnaire 6 months following their return to the UK. The survey consisted of questions based on qualities outlined in both the KSF and LF. 85 completed responses to the questionnaire were received. In every KSF domain assessed, the majority of volunteers agreed that their overseas volunteering experience improved their practice within the NHS. Self-assessed pre-course and post-course scores evaluating the LF also saw a universal increase, notably in the 'working with others' domain. There is a growing body of literature outlining the positive impact of overseas volunteering on NHS staff. Despite increasing evidence that such experiences can develop volunteers' essential skills, individuals often find it difficult to gain support of their employers. Our study, in line with the current literature, shows that overseas volunteering by NHS staff can provide an opportunity to enhance professional and personal development. Skills gained from volunteering within international links match many of the qualities outlined in both KSF and LF, directly contributing to volunteers' continued professional development. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless

  14. Characteristics of volunteers and non-volunteers for voluntary counseling and HIV testing among unmarried male undergraduates.

    Science.gov (United States)

    Adewole, D A; Lawoyin, T O

    2004-06-01

    The 2001 HIV sero-prevalence survey in Nigeria revealed a rate of 5.8 percent with those under the age of 25 years having the highest prevalence rate. Most University students fall within this age group. This study is part of a larger study on the sexual behavior of youths and young adults and was designed to compare the characteristics of volunteers and non-volunteers for voluntary confidential counseling and HIV testing (VCT) among males. Six hundred and nine male undergraduate students were randomly selected and enrolled for the study. Data were collected using a pre-tested questionnaire. Of the 609, 51 (8.3%) volunteered to have their blood screened for HIV. All volunteers who received pre-test counseling went for the HIV test. Volunteers were significantly older than the non-volunteers (Pmarriage pattern of their parents with regard to polygyny was similar, and fewer volunteers had fathers in the higher socio-economic class and mothers who had completed secondary education (Pcounseling. One of the three was positive for HIV. Of those who tested positive, 3 (37.5%) reported not using the condom at all, while the rest were using it only occasionally. VCT among the youths is possible however, small numbers encountered in the study is a limitation and there is a need to replicate this study using larger numbers. Tertiary institutions should provide VCT services for the students where they can be counseled appropriately and continuously throughout their stay in the institution. This hopefully will reduce the number of new HIV cases seen.

  15. Kinetic Modeling of the Tau PET Tracer 18F-AV-1451 in Human Healthy Volunteers and Alzheimer Disease Subjects.

    Science.gov (United States)

    Barret, Olivier; Alagille, David; Sanabria, Sandra; Comley, Robert A; Weimer, Robby M; Borroni, Edilio; Mintun, Mark; Seneca, Nicholas; Papin, Caroline; Morley, Thomas; Marek, Ken; Seibyl, John P; Tamagnan, Gilles D; Jennings, Danna

    2017-07-01

    18 F-AV-1451 is currently the most widely used of several experimental tau PET tracers. The objective of this study was to evaluate 18 F-AV-1451 binding with full kinetic analysis using a metabolite-corrected arterial input function and to compare parameters derived from kinetic analysis with SUV ratio (SUVR) calculated over different imaging time intervals. Methods: 18 F-AV-1451 PET brain imaging was completed in 16 subjects: 4 young healthy volunteers (YHV), 4 aged healthy volunteers (AHV), and 8 Alzheimer disease (AD) subjects. Subjects were imaged for 3.5 h, with arterial blood samples obtained throughout. PET data were analyzed using plasma and reference tissue-based methods to estimate the distribution volume, binding potential (BP ND ), and SUVR. BP ND and SUVR were calculated using the cerebellar cortex as a reference region and were compared across the different methods and across the 3 groups (YHV, AHV, and AD). Results: AD demonstrated increased 18 F-AV-1451 retention compared with YHV and AHV based on both invasive and noninvasive analyses in cortical regions in which paired helical filament tau accumulation is expected in AD. A correlation of R 2 > 0.93 was found between BP ND (130 min) and SUVR-1 at all time intervals. Cortical SUVR curves reached a relative plateau around 1.0-1.2 for YHV and AHV by approximately 50 min, but increased in AD by up to approximately 20% at 110-130 min and approximately 30% at 160-180 min relative to 80-100 min. Distribution volume (130 min) was lower by 30%-35% in the YHV than AHV. Conclusion: Our data suggest that although 18 F-AV-1451 SUVR curves do not reach a plateau and are still increasing in AD, an SUVR calculated over an imaging window of 80-100 min (as currently used in clinical studies) provides estimates of paired helical filament tau burden in good correlation with BP ND , whereas SUVR sensitivity to regional cerebral blood changes needs further investigation. © 2017 by the Society of Nuclear Medicine and

  16. Comparative fasting bioavailability of 2 bepotastine formulations in healthy male Chinese volunteers: an open-label, randomized, single-dose, 2-way crossover study.

    Science.gov (United States)

    Shentu, Jianzhong; Zhou, Huili; Hu, Xingjiang; Wu, Guolan; Wu, Lihua; Zhu, Meixiang; Zhai, You; Zheng, Yunliang; Liu, Jian

    2014-04-01

    Bepotastine is a second-generation histamine1 receptor antagonist that is used in the treatment of allergic rhinitis, urticaria, and pruritus associated with skin disease. A new generic formulation of bepotastine has been developed in China, and information concerning bioavailability and pharmacokinetic properties in the Chinese population has not been reported. The aim of the present study was to compare the bioavailability and pharmacokinetic properties of 2 tablet formulations of bepotastine, the 10-mg generic formulation (test) and a branded formulation (reference), in healthy male Chinese volunteers to obtain registration approval of the test formulation. A single-center, open-label, randomized, 2-way crossover study with a 1-week washout period was conducted in 24 healthy male volunteers. Blood samples were collected for 16 hours after a single dose of the 10-mg bepotastine test formulation or the reference formulation. Plasma bepotastine concentrations were determined using a validated LC-MS/MS method. Cmax, Tmax, AUC₀-t, AUC₀-∞, and t½ were determined using noncompartmental analysis. The formulations were considered bioequivalent if the 90% CIs for the log-transformed Cmax and AUC values were within the predetermined interval of 75% to 133% and 80% to 125%, respectively, according to the guidelines of the China Food and Drug Administration. No significant differences were found in mean (SD) pharmacokinetic parameters between the test and reference drugs, including Cmax (74.81 [9.91] ng/mL vs 78.60 [29.58] ng/mL), AUC₀-t (295.55[115.29] ng·h/mL vs 299.17[109.29] ng·h/mL), and AUC0-∞ (305.28 [118.50] ng·h/mL vs 310.90 [112.20] ng·h/mL). The mean (SD) t½ values of the test and reference formulations were 2.53 (0.50) hours and 2.62 (0.41) hours, respectively. The 90% CIs of the treatment ratios for the logarithmic transformed values of Cmax, AUC₀-t, and AUC₀-∞ were 86.96% to 101.80%, 93.22% to 104.13%, and 92.66% to 103.30%, respectively

  17. Scintigraphic evaluation of floating, gastroretentive formulation of clarithramycin in healthy human volunteers

    International Nuclear Information System (INIS)

    Ali, Raisuddin; Aji Alex, M.R.; Dutta, M.; Singh, Thakuri; Bhatnagar, A.; Bajaj, M.; Singla, Y.P.; Ahmad, F.J.; Khar, R.K.

    2010-01-01

    Full text: Objective of the present study concerns formulation and evaluation of oral buoyant effervescent tablets of clarithromycin for prolongation of gastric residence time (GRT) and to enhance eradication of Helicobacter pylori (H. pylori) for longer period of time. Materials and Methods: Clarithromycin (CLA) a macrolide antibiotic was chosen as the candidate drug for its immense potential as an Anti H. pylori agent. HPMC and/or xanthan gum were used as release-retarding polymer(s) whereas sodium bicarbonate (NaHCO 3 ) was utilized as a gas former. The tablets were prepared by wet granulation method. Formulations were evaluated for physicochemical properties, in vitro drug release as well as drug release kinetics and stability studies. In vivo gamma scintigraphic studies were assessed for the optimized buoyant gastroretentive tablets in six healthy human volunteers to study influence of nature of the dosage form i.e. conventional or sustained release gastroretentive tablets and the presence of food in the stomach on intragastric performance of gastroretentive tablets. Result: The fabricated tablets showed acceptable physiochemical properties. Non-fickian release transport was confirmed as the drug release mechanism from the prepared tablets. Optimized tablets composed of HPMC K15M, xanthan gum, and NaHCO 3 were promising systems exhibiting excellent floating properties. The overall performance was found to be highly sustained. Scintigraphic imaging revealed GRT of 320 min or more in fed state on the other hand GRT of 180 min or less in case of unfed state. Conclusion: The developed gastroretentive system has potential to increase efficacy of the therapy and improve patient

  18. How stable are quantitative sensory testing measurements over time? Report on 10-week reliability and agreement of results in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Nothnagel H

    2017-08-01

    Full Text Available Helen Nothnagel,1,2,* Christian Puta,1,3,* Thomas Lehmann,4 Philipp Baumbach,5 Martha B Menard,6,7 Brunhild Gabriel,1 Holger H W Gabriel,1 Thomas Weiss,8 Frauke Musial2 1Department of Sports Medicine and Health Promotion, Friedrich Schiller University, Jena, Germany; 2Department of Community Medicine, National Research Center in Complementary and Alternative Medicine, UiT, The Arctic University of Norway, Tromsø, Norway; 3Center for Interdisciplinary Prevention of Diseases Related to Professional Activities, 4Department of Medical Statistics, Computer Sciences and Documentation, Friedrich Schiller University, 5Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena, Germany; 6Crocker Institute, Kiawah Island, SC, 7School of Integrative Medicine and Health Sciences, Saybrook University, Oakland, CA, USA; 8Department of Biological and Clinical Psychology, Friedrich Schiller University, Jena, Germany *These authors contributed equally to this work Background: Quantitative sensory testing (QST is a diagnostic tool for the assessment of the somatosensory system. To establish QST as an outcome measure for clinical trials, the question of how similar the measurements are over time is crucial. Therefore, long-term reliability and limits of agreement of the standardized QST protocol of the German Research Network on Neuropathic Pain were tested. Methods: QST on the lower back and hand dorsum (dominant hand were assessed twice in 22 healthy volunteers (10 males and 12 females; mean age: 46.6±13.0 years, with sessions separated by 10.0±2.9 weeks. All measurements were performed by one investigator. To investigate long-term reliability and agreement of QST, differences between the two measurements, correlation coefficients, intraclass correlation coefficients (ICCs, Bland–Altman plots (limits of agreement, and standard error of measurement were used. Results: Most parameters of the QST were reliable over 10 weeks in

  19. A survey of family members' satisfaction with the services provided by hospice palliative care volunteers.

    Science.gov (United States)

    Claxton-Oldfield, Stephen; Gosselin, Natasha; Schmidt-Chamberlain, Kirsten; Claxton-Oldfield, Jane

    2010-05-01

    A total of 22 family members, whose deceased loved ones had used the services of a hospice palliative care volunteer, responded to a brief survey designed to assess the importance of the different kinds of support offered to them (family members) by the volunteer, their impressions of the volunteers' personal qualities/characteristics, their general experiences with the volunteer, and their overall satisfaction with the volunteer services. The kind of support that received the highest importance rating from family members was the opportunity to take a much-needed break from the demands of caring for their loved one, closely followed by emotional support, the volunteer spending time with them, and the volunteer providing them with information. Family members rated volunteers highly on a list of qualities/characteristics that exemplify individuals who are effective in this role. In all, 85% of the family members felt that their volunteer was well trained and 95% did not feel that their or their loved one's privacy had been invaded by having a volunteer. Overall, family members were very satisfied with the volunteer support they received. Some limitations of the study are discussed.

  20. Coronative antibody tires in sera of healthy adults and experimentally infected volunteers.

    Science.gov (United States)

    Bradburne, A F; Somerset, B A

    1972-06-01

    Six coronaviruses isolated in the U.S.A. have been inoculated into volunteers and all produced colds. Between 10 and 20% of infected volunteers developed heterologous antibody responses after these and other experimental infections with coronaviruses. The haemagglutination-inhibition test with the OC43 virus strain was found to detect antibody rises after infection with a variety of strains.Studies on normal adult sera taken between 1965 and 1970 revealed a high frequency of neutralizing antibody to one strain (229 E) and a frequency of HI antibody to strain OC43 which fluctuated from year to year. Complement-fixing antibodies to these two viruses were also found, revealing an apparent increase in the activity of coronaviruses in the general population of the U.K., during the winter of 1968-9.

  1. Whole-brain in-vivo measurements of the axonal g-ratio in a group of 37 healthy volunteers

    Directory of Open Access Journals (Sweden)

    Siawoosh eMohammadi

    2015-11-01

    Full Text Available The g-ratio, quantifying the ratio between the inner and outer diameters of a fiber, is an important microstructural characteristic of fiber pathways and is functionally related to conduction velocity. We introduce a novel method for estimating the MR g-ratio non-invasively across the whole brain using high-fidelity magnetization transfer (MT imaging and single-shell diffusion MRI. These methods enabled us to map the MR g-ratio in vivo across the brain’s prominent fiber pathways in a group of 37 healthy volunteers and to estimate the inter-subject variability. Effective correction of susceptibility-related distortion artifacts was essential before combining the MT and diffusion data, in order to reduce partial volume and edge artifacts. The MR g-ratio is in good qualitative agreement with histological findings despite the different resolution and spatial coverage of MRI and histology. The MR g-ratio holds promise as an important non-invasive biomarker due to its microstructural and functional relevance in neurodegeneration.

  2. Sex differences in itch perception and modulation by distraction--an FMRI pilot study in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Astrid Stumpf

    Full Text Available BACKGROUND: Even though itch is a common syndrome of many diseases there is only little knowledge about sex and gender differences in pruritus, especially in central itch perception and modulation. To our knowledge, this is the first fMRI study examining sex differences in perception and its modulation by distraction. METHODS: Experimental itch was induced by application of histamine (0.1 mM via microdialysis fibers twice at the left forearm and twice at the left lower leg in 33 healthy volunteers (17 females, 16 males. The brain activation patterns were assessed by fMRI during itch without and with distraction (Stroop task. Between the various conditions, subjects were asked to rate itch intensity, desire to scratch and pain intensity. In a second experiment in 10 of the 33 volunteers histamine was replaced by saline solution to serve as control for the 'Stroop' condition. RESULTS: Women generally presented higher itch intensities compared to men during itch over the course of the experiment. A more specific analysis revealed higher itch intensities and desire to scratch in women during experimental induced itch that can be reduced by distraction at the lower legs when itch is followed by 'Stroop'. In contrast, men depicted significant reduction of 'itch' by 'Stroop' at the forearms. Women depicted higher brain activation of structures responsible for integration of sensory, affective information and motor integration/planning during 'itch' and 'Stroop' condition when compared to men. No sex differences were seen in the saline control condition. CONCLUSION: Women and men exhibited localisation dependent differences in their itch perception with women presenting higher itch intensities and desire to scratch. Our findings parallel clinical observations of women reporting higher itch intensities depending on itch localisation and suffering more from itch as compared to men.

  3. Electromyographic activity of the diaphragm during neostigmine or sugammadex-enhanced recovery after neuromuscular blockade with rocuronium: a randomised controlled study in healthy volunteers.

    Science.gov (United States)

    Schepens, Tom; Cammu, Guy; Saldien, Vera; De Neve, Nikolaas; Jorens, Philippe G; Foubert, Luc; Vercauteren, Marcel

    2015-01-01

    The use of neuromuscular blocking agents has been associated with severe postoperative respiratory morbidity. Complications can be attributed to inadequate reversal, and reversal agents may themselves have adverse effects. To compare the electromyographic activity of the diaphragm (EMGdi) during recovery from neuromuscular blockade using neostigmine and sugammadex. The hypothesis was that there would be better neuromuscular coupling of the diaphragm when sugammadex was used. A randomised, controlled, parallel-group, single-centre, double-blinded study. District general hospital in Belgium. Twelve healthy male volunteers. Individuals were anaesthetised with propofol and remifentanil. After rocuronium 0.6 mg kg, a transoesophageal electromyography (EMG) recorder was inserted. For reversal of neuromuscular blockade, volunteers received sugammadex 2 mg kg (n = 6) or neostigmine 70 μg kg (n = 6). EMGdi, airway pressure and flow were continuously measured during weaning from the ventilator until tracheal extubation. Arterial blood gas samples were obtained for PaO2 and PaCO2 analysis at the first spontaneous breathing attempt and after tracheal extubation. During weaning, 560 breaths were retained for analysis. The median (95% CI) peak EMGdi was 1.1 (0.9 to 1.5) μV in the neostigmine group and 1.6 (1.3 to 1.9) μV in the sugammadex group (P sugammadex group (P = 0.008). The median (95% CI) tidal volume was 287 (256 to 335) ml after neostigmine and 359 (313 to 398) ml after sugammadex (P = 0.013). The median (95% CI) PaO2 immediately after extubation was 30.5 (22.8 to 37.1) kPa after sugammadex vs. 20.7 (12.9 to 27.5) kPa after neostigmine (P = 0.03). EMGdi, tidal volume and PaO2 following tracheal extubation were increased after sugammadex compared with neostigmine, reflecting diaphragm-driven inspiration after sugammadex administration. Sugammadex may free more diaphragmatic acetylcholine receptors than neostigmine, which has an

  4. 7 Tesla quantitative hip MRI: T1, T2 and T2* mapping of hip cartilage in healthy volunteers

    Energy Technology Data Exchange (ETDEWEB)

    Lazik, Andrea; Theysohn, Jens M.; Geis, Christina [University Hospital Essen, Department of Diagnostic and Interventional Radiology and Neuroradiology, Essen (Germany); Johst, Soeren; Kraff, Oliver [University of Duisburg-Essen, Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen (Germany); Ladd, Mark E. [University Hospital Essen, Department of Diagnostic and Interventional Radiology and Neuroradiology, Essen (Germany); University of Duisburg-Essen, Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen (Germany); German Cancer Research Center (DKFZ), Medical Physics in Radiology, Heidelberg (Germany); Quick, Harald H. [University of Duisburg-Essen, Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen (Germany); University Hospital Essen, High Field and Hybrid MR Imaging, Essen (Germany)

    2016-05-15

    To evaluate the technical feasibility and applicability of quantitative MR techniques (delayed gadolinium-enhanced MRI of cartilage (dGEMRIC), T2 mapping, T2* mapping) at 7 T MRI for assessing hip cartilage. Hips of 11 healthy volunteers were examined at 7 T MRI with an 8-channel radiofrequency transmit/receive body coil using multi-echo sequences for T2 and T2* mapping and a dual flip angle gradient-echo sequence before (T1{sub 0}) and after intravenous contrast agent administration (T1{sub Gd}; 0.2 mmol/kg Gd-DTPA{sup 2-} followed by 0.5 h of walking and 0.5 h of rest) for dGEMRIC. Relaxation times of cartilage were measured manually in 10 regions of interest. Pearson's correlations between R1{sub delta} = 1/T1{sub Gd} - 1/T1{sub 0} and T1{sub Gd} and between T2 and T2* were calculated. Image quality and the delineation of acetabular and femoral cartilage in the relaxation time maps were evaluated using discrete rating scales. High correlations were found between R1{sub delta} and T1{sub Gd} and between T2 and T2* relaxation times (all p < 0.01). All techniques delivered diagnostic image quality, with best delineation of femoral and acetabular cartilage in the T2* maps (mean 3.2 out of a maximum of 4 points). T1, T2 and T2* mapping of hip cartilage with diagnostic image quality is feasible at 7 T. To perform dGEMRIC at 7 T, pre-contrast T1 mapping can be omitted. (orig.)

  5. A dark brown roast coffee blend is less effective at stimulating gastric acid secretion in healthy volunteers compared to a medium roast market blend.

    Science.gov (United States)

    Rubach, Malte; Lang, Roman; Bytof, Gerhard; Stiebitz, Herbert; Lantz, Ingo; Hofmann, Thomas; Somoza, Veronika

    2014-06-01

    Coffee consumption sometimes is associated with symptoms of stomach discomfort. This work aimed to elucidate whether two coffee beverages, containing similar amounts of caffeine, but differing in their concentrations of (β) N-alkanoyl-5-hydroxytryptamides (C5HTs), chlorogenic acids (CGAs), trigonelline, and N-methylpyridinium (N-MP) have different effects on gastric acid secretion in healthy volunteers. The intragastric pH after administration of bicarbonate with/without 200 mL of a coffee beverage prepared from a market blend or dark roast blend was analyzed in nine healthy volunteers. Coffee beverages were analyzed for their contents of C5HT, N-MP, trigonelline, CGAs, and caffeine using HPLC-DAD and HPLC-MS/MS. Chemical analysis revealed higher concentrations of N-MP for the dark brown blend (87 mg/L) compared to the market blend coffee (29 mg/L), whereas concentrations of C5HT (0.012 versus 0.343 mg/L), CGAs (323 versus 1126 mg/L), and trigonelline (119 versus 343 mg/L) were lower, and caffeine concentrations were similar (607 versus 674 mg/mL). Gastric acid secretion was less effectively stimulated after administration of the dark roast blend coffee compared to the market blend. Future studies are warranted to verify whether a high ratio of N-MP to C5HT and CGAs is beneficial for reducing coffee-associated gastric acid secretion. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  6. Motivations of German Hospice Volunteers: How Do They Compare to Nonhospice Volunteers and US Hospice Volunteers?

    Science.gov (United States)

    Stelzer, Eva-Maria; Lang, Frieder R

    2016-03-01

    We examined reasons of volunteering for hospice and nonhospice organizations in a study with 125 volunteers (22-93 years) from the United States and Germany. Motives of US and German hospice volunteers revealed similarities and few differences. Hospice volunteers are involved because they seek to help others, seek new learning experiences, seek social contacts, or seek personal growth. The US hospice volunteers reported motives related to altruistic concerns, enhancement, and social influence as more influential, while German hospice volunteers rated career expectations as being more important. Comparison of German hospice with nonhospice volunteers revealed stronger differences: German hospice volunteers scored higher on altruistic motives, while German nonhospice volunteers yielded higher scores on self-serving motives. Findings contribute to improved understanding of volunteering motivation and of activating or retaining hospice volunteers. © The Author(s) 2014.

  7. Ketamine-induced deficits in auditory and visual context-dependent processing in healthy volunteers: implications for models of cognitive deficits in schizophrenia.

    Science.gov (United States)

    Umbricht, D; Schmid, L; Koller, R; Vollenweider, F X; Hell, D; Javitt, D C

    2000-12-01

    In patients with schizophrenia, deficient generation of mismatch negativity (MMN)-an event-related potential (ERP) indexing auditory sensory ("echoic") memory-and a selective increase of "context dependent" ("BX") errors in the "A-X" version of the Continuous Performance Test (AX-CPT) indicate an impaired ability to form and use transient memory traces. Animal and human studies implicate deficient N-methyl-D-aspartate receptor (NMDAR) functioning in such abnormalities. In this study, effects of the NMDAR antagonists ketamine on MMN generation and AX-CPT performance were investigated in healthy volunteers to test the hypothesis that NMDARs are critically involved in human MMN generation, and to assess the nature of ketamine-induced deficits in AX-CPT performance. In a single-blind placebo-controlled study, 20 healthy volunteers underwent an infusion with subanesthetic doses of ketamine. The MMN-to-pitch and MMN-to-duration deviants were obtained while subjects performed an AX-CPT. Ketamine significantly decreased the peak amplitudes of the MMN-to-pitch and MMN-to-duration deviants by 27% and 21%, respectively. It induced performance deficits in the AX-CPT characterized by decreased hit rates and specific increases of errors (BX errors), reflecting a failure to form and use transient memory traces of task relevant information. The NMDARs are critically involved in human MMN generation. Deficient MMN in schizophrenia thus suggests deficits in NMDAR-related neurotransmission. N-methyl-D-aspartate receptor dysfunction may also contribute to the impairment of patients with schizophrenia in forming and using transient memory traces in more complex tasks, such as the AX-CPT. Thus, NMDAR-related dysfunction may underlie deficits in transient memory at different levels of information processing in schizophrenia. Arch Gen Psychiatry. 2000;57:1139-1147.

  8. Bioequivalence and pharmacokinetic evaluation of two formulations of risperidone 2 mg : an open-label, single-dose, fasting, randomized-sequence, two-way crossover study in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Yun; Zhang, Meng-qi; Jia, Jing-ying; Liu, Yan-mei; Liu, Gang-yi; Li, Shui-jun; Wang, Wei; Weng, Li-ping; Yu, Chen

    2013-03-01

    Risperidone is a benzisoxazole derivate and is effective in the treatment of schizophrenia and other psychiatric illnesses in adults and children. Although there are a few reports in the literature regarding the pharmacokinetic characteristics of risperidone, insufficient data on its pharmacokinetic properties in a Chinese population are available. To meet the requirements for marketing a new generic product, this study was designed to compare the pharmacokinetic properties and bioequivalence of two 2 mg tablet formulations of risperidone: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult male Chinese volunteers. A single-dose, open-label, randomized-sequence, 2 × 2 crossover study was conducted in fasted healthy male Chinese volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 1 tablet (2 mg each) of the test formulation (Risperidone tablet; Dr. Reddy's Laboratories Ltd., Hyderabad, India) or the reference formulation (Risperdal(®) tablet; Xian-Janssen Pharmaceutical Ltd., Xi-an, China), followed by a 2-week washout period and subsequent administration of the alternate formulation. The study drugs were administered after a 10-hour overnight fast. Plasma samples were collected over 96 hours. Plasma concentrations of the parent drug, risperidone, and its active metabolite, 9-hydroxy-risperidone, were analyzed by a liquid chromatography-tandem mass spectrometry method. The formulations would be considered bioequivalent if the 90% confidence intervals (CIs) of the natural log-transformed values were within the predetermined 80-125% equivalence range for the maximum plasma drug concentration (Cmax) and the area under the plasma concentration-time curve (AUC), in accordance with guidelines issued by the US Food and Drug Administration. Assessment of tolerability was based on recording of adverse events (AEs), monitoring of vital signs, electrocardiograms, and laboratory tests at baseline

  9. Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Cecile Berteau

    2010-09-01

    Full Text Available Cecile Berteau1, Florence Schwarzenbach1, Yves Donazzolo2, Mathilde Latreille2, Julie Berube3, Herve Abry1, Joël Cotten1, Celine Feger1, Philippe E Laurent11BD Medical Pharmaceutical Systems, Le-Pont-de-Claix, 2Eurofins Optimed Clinical Research, Gières, France; 3Statistics, BD Corporate, Franklin Lakes, NJ, USAObjective: A disposable autoinjector was developed for subcutaneous (SC self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe.Methods: This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects’ preferred system for a final study injection or future treatment.Results: A total of 960 injections (480 with autoinjector, 480 with syringe were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the autoinjector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment.Conclusion: This study indicated that the autoinjector used by

  10. Palatability, digestibility and emotional pattern in 60 healthy volunteers after ingestion of an iced dessert presented in four different flavours: a subjective evaluation.

    Science.gov (United States)

    Garzaro, M; Raimondo, L; Pecorari, G; Riva, G; Sensini, M; Naqe, N; Giordano, C

    2012-01-01

    Several variables lead to changes in human and animal eating behaviour and food choices. A pivotal role is played by food palatability, represented by food, smell, taste, texture, appearance and temperature. The aim of our study is to assess the potential differences in palatability and digestibility of four different flavoured iced desserts, consumed at the end of a standardized meal, and their impact on the emotional status of 60 healthy volunteers. Sixty healthy volunteers, after ENT and psychological assessment, were asked to fill out a Psycho-Emotional Questionnaire (PEQ) to assess their basal emotional pattern before the consumption of an iced dessert at the end of a standard meal, after which they completed an Organoleptic-Sensory Questionnaire (OSQ), a Dynamic Digestibility Questionnaire (DDQ) and again the PEQ. Four different flavors (lemon, tangerine, pineapple and chocolate) were tested on 4 consecutive days on the same subjects. Most of the 60 subjects, by means of OSQ, found taste, aspect, texture and smell of the 4 flavours pleasant, lemon and tangerine were the freshest and lightest. The DDQ identified pineapple and chocolate dessert as those less digestible. By means of PEQ we recorded an improvement in joy, mood and activation, associated with good data of digestibility and palatability after the consumption of all flavors. Our data showed that all flavors improve joy, mood and activation, after their consumption, without statistically significant differences. However, among the tested flavours, lemon and tangerine appear to be the most pleasant and those which facilitate the digestive process.

  11. Dexamethasone prolongs local analgesia after subcutaneous infiltration of bupivacaine microcapsules in human volunteers

    DEFF Research Database (Denmark)

    Holte, Kathrine; Werner, Mads U; Lacouture, Peter G

    2002-01-01

    BACKGROUND: The addition of small amounts of dexamethasone to extended-release formulations of bupivacaine in microcapsules has been found to prolong local analgesia in experimental studies, but no clinical data are available. METHODS: In a double-blinded study, 12 healthy male volunteers were...... randomized to receive simultaneous subcutaneous injections of bupivacaine microcapsules with dexamethasone and bupivacaine microcapsules without dexamethasone in each calf. Local analgesia was assessed with a validated human pain model; main parameters evaluated were thermal, mechanical, and pain detection...... curve [AUC]) were considered best estimate of analgesia. Safety evaluations were performed daily for the first week and at 2 weeks, 6 weeks, and 6 months after injection. RESULTS: The addition of dexamethasone significantly prolonged local analgesia of bupivacaine microcapsules without influence...

  12. Blood glucose control in healthy subject and patients receiving intravenous glucose infusion or total parenteral nutrition using glucagon-like peptide 1

    DEFF Research Database (Denmark)

    Nauck, Michael A; Walberg, Jörg; Vethacke, Arndt

    2004-01-01

    It was the aim of the study to examine whether the insulinotropic gut hormone GLP-1 is able to control or even normalise glycaemia in healthy subjects receiving intravenous glucose infusions and in severely ill patients hyperglycaemic during total parenteral nutrition.......It was the aim of the study to examine whether the insulinotropic gut hormone GLP-1 is able to control or even normalise glycaemia in healthy subjects receiving intravenous glucose infusions and in severely ill patients hyperglycaemic during total parenteral nutrition....

  13. Health effects of a subway environment in mild asthmatic volunteers.

    Science.gov (United States)

    Klepczyńska-Nyström, Anna; Larsson, Britt-Marie; Grunewald, Johan; Pousette, Charlotte; Lundin, Anders; Eklund, Anders; Svartengren, Magnus

    2012-01-01

    Particle exposure is known to have negative health effects. In Stockholm the environment in the subway has been reported to have higher particle exposure levels, measured as PM(2.5) and PM(10), than roads with intense traffic in the inner city area. We have recently shown that healthy volunteers exposed to subway environment had statistically significant increase of fibrinogen and CD4 cells expressing regulatory T-cell marker CD25(bright)/FOXP3 in blood. The aim of the present study was to find out whether a more vulnerable population, asthmatics, would demonstrate similar or other changes in the lungs or in the peripheral blood. Sixteen mild asthmatics were exposed to a subway and a control environment for 2 h while being monitored by measurements of lung function, and inflammatory response in the lower airways evaluated by bronchoscopy and in peripheral blood. An attempt to standardize the exposures was done, by letting the volunteers alternate 15 min intervals of moderate exercise on a bicycle ergometer with 15 min of rest. We found a statistically significant increased frequency of CD4 cells expressing T-cell activation marker CD25 in bronchoalveolar lavage fluid, but no significant increase of regulatory T-cells in blood as was found in healthy volunteers. Our study shows that airway inflammatory responses after exposure in subway environment differ between asthmatic and healthy humans. Copyright © 2011 Elsevier Ltd. All rights reserved.

  14. Cutaneous Respirometry as Novel Technique to Monitor Mitochondrial Function: A Feasibility Study in Healthy Volunteers

    Science.gov (United States)

    Stolker, Robert Jan; Mik, Egbert

    2016-01-01

    Background The protoporphyrin IX-triplet state lifetime technique (PpIX-TSLT) is proposed as a potential clinical non-invasive tool to monitor mitochondrial function. This technique has been evaluated in several animal studies. Mitochondrial respirometry allows measurement in vivo of mitochondrial oxygen tension (mitoPO2) and mitochondrial oxygen consumption (mitoVO2) in skin. This study describes the first use of a clinical prototype in skin of humans. Methods The clinical prototype was tested in 30 healthy volunteers. A self-adhesive patch containing 2 mg 5-aminolevulinic acid (ALA) was applied on the skin of the anterior chest wall (sternal) for induction of mitochondrial protoporphyrin IX and was protected from light for 5 h. MitoPO2 was measured by means of oxygen-dependent delayed fluorescence of protoporphyrin IX. MitoVO2 was determined by dynamic mitoPO2 measurements on the primed skin, while locally blocking oxygen supply by applying local pressure with the measurement probe. MitoPO2 was recorded before and during a 60-s period of compression of the microcirculation, at an interval of 1 Hz. Oxygen consumption (i.e. the local oxygen disappearance rate) was calculated from the decay of the mitoPO2 slope. Results Oxygen-dependent delayed fluorescence measurements were successfully performed in the skin of 27 volunteers. The average value (± SD) of mitoPO2 was 44 ± 17 mmHg and mean mitoVO2 values were 5.8 ± 2.3 and 6.1 ± 1.6 mmHg s-1 at a skin temperature of 34°C and 40°C, respectively. No major discomfort during measurement and no long-term dermatological abnormalities were reported in a survey performed 1 month after measurements. Conclusion These results show that the clinical prototype allows measurement of mitochondrial oxygenation and oxygen consumption in humans. The development of this clinically applicable device offers opportunities for further evaluation of the technique in humans and the start of first clinical studies. PMID:27455073

  15. Healthy Kids; Healthy World - Take Your Child to Work Day 2016

    Science.gov (United States)

    On April 28th CGH joined several NCI offices at the Shady Grove campus to celebrate Take Your Child to Work Day 2016. Volunteers hosted three activity stations, each offering creative fun with a message: With healthy kids, we can create a healthier world.

  16. What do women gain from volunteering? The experience of lay Arab and Jewish women volunteers in the Women for Women's Health programme in Israel.

    Science.gov (United States)

    Daoud, Nihaya; Shtarkshall, Ronny; Laufer, Neri; Verbov, Gina; Bar-El, Hagar; Abu-Gosh, Nasreen; Mor-Yosef, Shlomo

    2010-03-01

    Ambiguous feelings regarding women engaging in formal volunteering and concerns about their exploitation might explain the dearth of studies regarding the volunteering benefits specifically experienced by low socioeconomic status women. The current study examined benefits of volunteering among women participating in Women for Women's Health (WWH), a lay health volunteers (LHV) programme implemented in Jewish and Arab communities in Israel, and aiming at empowering such women to become active volunteers and promote health activities in their communities. Two years after the introduction of WWH in each community, all 45 Jewish and 25 Arab volunteers were contacted by phone and invited to participate in the focus group discussions. Five focus group discussions were conducted with 25/42 Jewish volunteers in 2003 and four with 20/25 Arab volunteers in 2005. The other volunteers could not attend the scheduled meetings or became inactive for personal reasons. Four benefit categories were identified in both ethnic groups: 1. Personal benefits of having increased knowledge, feeling self-satisfaction, mastering new skills and performing healthy behaviours; 2. Group-social benefits of social support and sense of cohesion; 3. Purposive benefits of achieving the WWH mission and goals; 4. Sociopolitical benefits of learning to accept the other and experiencing increased solidarity. However, the relatively less privileged Arab volunteers enumerated more benefits within the personal and purposive categories. They also identified the unique sociocultural category of improving women's status in the community by creating a legitimate space for women by public sphere involvement, traditionally solely a male domain. We conclude that volunteering in community-based health promotion programmes can be an empowering experience for lay women without being exploitative. Positive volunteering benefits will be even more discernable among underprivileged women who enjoy fewer opportunities in

  17. Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers

    DEFF Research Database (Denmark)

    Bagi, Per; Hannibalsen, Jane; Permild, Rikke

    2011-01-01

    in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p catheter; it was preferred by nurses for 20 of 23......Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice...... with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference...

  18. A single dose, randomized, open-label, cross-over bioequivalence study of sildenafil citrate tablets in healthy Chinese volunteers
.

    Science.gov (United States)

    Li, Dai; Wang, Yu-Lu; Xu, Su-Mei; Li, Dan; Li, Xiao-Min; Pan, Jing; Xu, Ping-Sheng

    2017-02-01

    The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period. Plasma sildenafil concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Tolerability was assessed during the entire study period. 32 healthy volunteers (aged 19 - 30) were enrolled in the study; 31 volunteers completed the fasting study, while 32 volunteers completed the postprandial study. The test formulation was bioequivalent to the marketed formulation as the 90% CIs for the ratio of geometric means of Cmax (fasting: 98.79 - 119.61%; fed: 94.47 - 119.65%), AUClast (fasting: 98.70 - 109.71%; fed: 96.39 - 112.89%), and AUC∞ (fasting: 98.45 - 108.87%; fed: 96.36 - 112.74%) were within equivalence limits (80 - 125%) under both fasting and postprandial conditions. When sildenafil was given with high-fat meals, mean Cmax was reduced by 23%, and median tmax ranged from 0.75 to 1.50 hours (p ≤ 0.05). However, both AUClast and AUC∞ were comparable between fasting and postprandial conditions. No serious adverse events were found among the subjects. This study confirmed that test and reference sildenafil citrate tablets were bioequivalent under fasting and postprandial conditions.
.

  19. Volunteering and Volunteers: Benefit-Cost Analyses

    Science.gov (United States)

    Handy, Femida; Mook, Laurie

    2011-01-01

    This article examines the phenomenon of volunteering from a benefit-cost perspective. Both the individual making a decision to volunteer and the organization making a decision to use volunteer labor face benefits and costs of their actions, yet these costs and benefits almost always remain unarticulated, perhaps because the common perception of…

  20. The feasibility of susceptibility weighted imaging for assessing renal difference of healthy volunteers after water loading

    International Nuclear Information System (INIS)

    Ding Jiule; Xing Wei; Chen Jie; Yu Shengnan; Qiu Jianguo; Xing Shijun; Sun Jun

    2013-01-01

    Objective: To probe the feasibility of susceptibility weighted imaging (SWI) for evaluation of renal blood oxygenation level of healthy volunteers after water loading. Methods: SWI of 11 healthy volunteers, acquired before (group 1) and after water loading (group 2), were assessed retrospectively by two radiologists with more than 10 years abdominal work experience independently. In those images of the same section plane derived from two groups, the phase values in cortex (φ cor ) and medulla (φ med ), difference between the same vein and surrounding tissue on phase map (△ φ ) were measured using SPIN software package, and the oxygen extraction fraction changes (△OEF) was calculated. The φ cor , φ med and △ φ between two groups were compared by paired t test. And the intraclass correlation coefficient (ICC) was used to evaluate the consistency between two radiologists. Results: For the radiologist 1, the φ cor , φ med and △ φ were (0.046 ± 0.019), (-0.014 ± 0.003) and (1.3 ± 0.4) rad in group 1, and were (0.047 ± 0.014), (-0.012 ± 0.005) and (1.1 ± 0.4) rad in group 2 respectively, and no significant change was found in φ cor and φ med after water loading (t = -0.589 and-0.206, P > 0.05 in all), except of in △ φ (t = 2.400, P < 0.01). For the radiologist 2, the φ cor , φ med and △ φ were (0.049 ± 0.011), (-0.012 ± 0.004) and (1.5 ±0.4) rad in Group 1, and were (0.046 ± 0.017), (-0.011 ± 0.003) and (1.3 ± 0.2) rad in group 2 respectively, there was no significant change in φ cor and φ med after water loading (t = 0.590 and -0.974, P > 0.05 in all), except of in △ φ (t = 2.760, P < 0.05). Between two radiologists, the ICC of φ cor , φ med and △ φ were 0.623, 0.472 and 0.328 in group 1 and 0.599, 0.442 and 0.445 in group 2 respectively. △OEF decreased about (-4.2 ± 2.3)% and (-4.3 ± 2.8)% measured by two radiologists respectively, and the consistency is good between two radiologists (ICC = 0.784). Conclusion: SWI

  1. Volunteer work in the church among older Mexican Americans.

    Science.gov (United States)

    Krause, Neal; Hayward, R David

    2012-07-01

    The purpose of this study is to identify the factors that influence the amount of volunteer work that older Mexican Americans perform in the place where they worship. The relationship between religion and volunteering is viewed from a social identity perspective. Data from a nationally representative sample of older Mexican Americans suggest that Evangelical/Pentecostal church members spend more time performing volunteer work at church than older Mexican Americans who affiliate with other denominations. Moreover, the findings indicate that the difference in the amount of volunteering between the two groups can largely be explained by differences in the nature of the spiritual support that Evangelical/Pentecostal receive from their fellow church members as well as depth of their commitment to their faith.

  2. Effects of experimental insoles on body posture, mandibular kinematics and masticatory muscles activity. A pilot study in healthy volunteers.

    Science.gov (United States)

    Marini, Ida; Alessandri Bonetti, Giulio; Bortolotti, Francesco; Bartolucci, Maria Lavinia; Gatto, Maria Rosaria; Michelotti, Ambra

    2015-06-01

    It has been hypothesized that different plantar sensory inputs could influence the whole body posture and dental occlusion but there is a lack of evidence on this possible association. To investigate the effects of experimental insoles redistributing plantar pressure on body posture, mandibular kinematics and electromyographic (EMG) activity of masticatory muscles on healthy subjects. A pilot study was conducted on 19 healthy volunteers that wore custom-made insoles normalizing the plantar pressure distribution for 2 weeks. Body posture parameters were measured by means of an optoelectronic stereophotogrammetric analysis; mandibular kinematics was analyzed by means of gothic arch tracings; superficial EMG activity of head and neck muscles was performed. Measurements were carried out 10 days before the insertion of the insoles, immediately before the insertion, the day after, 7 and 14 days after, in four different exteroceptive conditions. The outcomes of the present study show that insoles do not modify significantly over time the parameters of body posture, SEMG activity of head and neck muscles and mandibular kinematics. In this pilot study the experimental insoles did not significantly influence the body posture, the mandibular kinematics and the activity of masticatory muscles during a 14-day follow up period. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Motives for volunteering are associated with mortality risk in older adults.

    Science.gov (United States)

    Konrath, Sara; Fuhrel-Forbis, Andrea; Lou, Alina; Brown, Stephanie

    2012-01-01

    The purpose of this study is to examine the effects of motives for volunteering on respondents' mortality risk 4 years later. Logistic regression analysis was used to examine whether motives for volunteering predicted later mortality risk, above and beyond volunteering itself, in older adults from the Wisconsin Longitudinal Study. Covariates included age, gender, socioeconomic variables, physical, mental, and cognitive health, health risk behaviors, personality traits, received social support, and actual volunteering behavior. Replicating prior work, respondents who volunteered were at lower risk for mortality 4 years later, especially those who volunteered more regularly and frequently. However, volunteering behavior was not always beneficially related to mortality risk: Those who volunteered for self-oriented reasons had a mortality risk similar to nonvolunteers. Those who volunteered for other-oriented reasons had a decreased mortality risk, even in adjusted models. This study adds to the existing literature on the powerful effects of social interactions on health and is the first study to our knowledge to examine the effect of motives on volunteers' subsequent mortality. Volunteers live longer than nonvolunteers, but this is only true if they volunteer for other-oriented reasons.

  4. Reproducibility of the serum lipid response to coffee oil in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Katan Martijn B

    2003-10-01

    Full Text Available Abstract Background Humans and animals show a certain consistency in the response of their serum lipids to fat-modified diets. This may indicate a genetic basis underlying this response. Coffee oil might be used as a model substance to investigate which genes determine differences in the serum lipid response. Before carrying out such studies our objective was to investigate to what extent the effect of coffee oil on serum lipid concentrations is reproducible within subjects. Methods The serum lipid response of 32 healthy volunteers was measured twice in separate five-week periods in which coffee oil was administered (69 mg cafestol / day. Results Total cholesterol levels increased by 24% in period 1 (range:0;52% and 18% in period 2 (1;48%, LDL cholesterol by 29 % (-9;71% and 20% (-12;57%, triglycerides by 66% (16;175% and 58% (-13;202%, and HDL cholesterol did not change significantly: The range of the HDL response was -19;25% in period 1 and -20;33% in period 2. The correlation between the two responses was 0.20 (95%CI -0.16, 0.51 for total cholesterol, 0.16 (95%CI -0.20, 0.48 for LDL, 0.67 (95%CI 0.42, 0.83 for HDL, and 0.77 (95%CI 0.56, 0.88 for triglycerides. Conclusions The responses of total and LDL cholesterol to coffee oil were poorly reproducible within subjects. The responses of HDL and triglycerides, however, appeared to be highly reproducible. Therefore, investigating the genetic sources of the variation in the serum-lipid response to coffee oil is more promising for HDL and triglycerides.

  5. Bilateral ce-MR angiography of the hands at 3.0 T and 1.5 T: intraindividual comparison of quantitative and qualitative image parameters in healthy volunteers

    International Nuclear Information System (INIS)

    Winterer, Jan T.; Markl, Michael; Frydrychowicz, Alexander; Bley, Thorsten A.; Langer, Mathias; Moske-Eick, Olaf

    2008-01-01

    The purpose of this study was to determine the benefit of bilateral contrast-enhanced MR angiography (ce-MRA) of the hands at 3.0 Tesla (T) compared with an established 1.5-T technique in healthy volunteers. Intraindividual bilateral ce-MRA of the hands was performed at 1.5 T and 3.0 T in 14 healthy volunteers using a timed ultra-fast GRE sequence featuring parallel acquisition. The evaluation comprised measurement of the vessel signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), rating of the image quality and the assessment of artefacts and venous contamination. At 3.0 T, SNR improved up to 95% and CNR up to 129%. The image quality of the larger inflow arteries, the palm arches and common digital arteries was good or sufficient at either magnetic field strengths. However, 3.0-T MRA was clearly superior in the depiction of the digital arteries. Ce-MRA of the hand clearly profits from the use of 3.0 T. Compared with 1.5 T, a substantial increase of CNR is found resulting in a significantly better delineation of the small digital arteries. Saturation affects more the SNR of the perivascular tissue than the contrast-enhanced blood, and thus leads to a marked increase of CNR at 3.0. (orig.)

  6. Assessment of the short-term safety and tolerability of a quantified 80 % ethanol extract from the stem bark of Nauclea pobeguinii (PR 259 CT1) in healthy volunteers: a clinical phase I study.

    Science.gov (United States)

    Mesia, Kahunu; Cimanga, Kanyanga; Tona, Lutete; Mampunza, Ma Miezi; Ntamabyaliro, Nsengi; Muanda, Tsobo; Muyembe, Tamfum; Totté, Jozef; Mets, Tony; Pieters, Luc; Vlietinck, Arnold

    2011-01-01

    The aim of this study was to evaluate the short-term safety and tolerability of an antimalarial herbal medicinal product (PR 259 CT1) consisting of a quantified 80 % ethanol extract from the stem bark of Nauclea pobeguinii when given orally to healthy adult male volunteers. The amount of the major alkaloid strictosamide in the extract was determined by a validated HPLC method and was shown to be 5.6 %. The herbal preparation was formulated in a gelatine capsule form containing 500 mg of PCR 259 CT1. A sample of 15 healthy male volunteers, selected using the Lot Quality Assurance of Sampling (LQAS) method, was eligible for inclusion after fulfillment of the inclusion criteria and clinical examination by a physician. The volunteers were treated in an outpatient clinic with a drug regimen of two 500 mg capsules three times daily (each eight hours) for seven days, during meals. Safety and tolerability were monitored clinically, haematologically, biochemically and by electrocardiographic (ECG) examination at days 0, 1, 3, 7 and 14. Adverse effects were recorded by self-reporting of the participants or by detection of abnormalities in clinical examinations by a physician. The oral administration of PR 259 CT1 at high doses of 2 × 500 mg/capsule/day for 7 days was found to induce no significant changes in the concentration levels of all investigated haematological, biochemical, electrocardiogram and vital sign parameters and physical characteristics after 14 days of treatment compared to those seen in the baseline data. The concentration levels of all evaluated parameters were within the normal limits as reported in the literature. All adverse events noted were mild and self-resolving including increase of appetite (33 %), headache (20 %) and nausea (20 %). Other minor side effects were insomnia, somnolence and asthenia (7 %). Thus, PR 259 CT1 presented a significant safety and tolerability in healthy volunteers to allow its further development by starting a phase II

  7. Pharmacokinetic comparison and bioequivalence evaluation of losartan/ hydrochlorothiazide tablet between Asian Indian and Japanese volunteers.

    Science.gov (United States)

    Kumar, Sudershan; Monif, Tausif; Khuroo, Arshad; Reyar, Simrit; Jain, Rakesh; Singla, Ajay K; Kurachi, Kazuya

    2014-01-01

    To demonstrate the bioequivalence between the test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablet and evaluate the effect of ethnicity on pharmacokinetics properties of losartan, losartan carboxylic acid and hydrochlorothiazide on healthy Asian Indian and Japanese volunteers. Randomized, open-label, crossover, bioavailability studies were conducted separately in healthy Asian Indian and Japanese volunteers. One tablet either of test or of reference product was administered after 10 hours of overnight fasting. After dosing, serial blood samples were collected for a period of 48 hours for both the studies. Plasma samples were analyzed for losartan, losartan carboxylic acid and hydrochlorothiazide by a validated liquid chromatographic and mass spectrometric method (LC-MS/MS). The pharmacokinetic parameters AUC0-t, AUC0-∞, Cmax, tmax, and other pharmacokinetics parameters were determined from plasma concentration-time profiles for both test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablets. Statistical evaluations were done to evaluate bioequivalence between generic test formulation (EPR0001) and Japanese reference product (Preminent®). Losartan, losartan carboxylic acid and hydrochlorothiazide were well tolerated by subjects in all periods of each study under fasted conditions. No serious adverse events were observed. The ratios of least square means for AUC0-t and Cmax and the affiliated 90% confidence intervals were within acceptance range recommended by PMDA. Marginal differences were observed in pharmacokinetic values of Asian Indian and Japanese volunteers. The results of these bioavailability studies indicate that the test formulation of losartan/hydrochlorothiazide 50 + 12.5 mg (EPR0001) tablets is bioequivalent to marketed Preminent® reference formulation in Asian Indian and Japanese volunteers, when administered under fasting conditions. Both test and reference formulations were well tolerated

  8. A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 suppositories for 14 days.

    Science.gov (United States)

    Bell, D; Duffin, A; Jacobs, A; Pediconi, C; Gruss, H J

    2014-03-01

    The 1R,2S stereoisomer of methoxamine hydrochloride, NRL001, is a highly selective α1-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone. This study investigated the steady state pharmacokinetics (PK) and safety of 2 g rectal suppositories containing NRL001 in different strengths (7.5, 10, 12.5 or 15 mg). Healthy volunteers aged 18-45 years received 14 daily doses of NRL001 2 g suppositories or matching placebo. In each dose group nine participants received NRL001 and three received placebo. Blood samples to determine NRL001 concentrations were taken on Days 1, 7 and 14. Cardiovascular parameters were collected via electrocardiograms, Holter monitoring (three lead Holter monitor) and vital signs. Forty-eight volunteers were enrolled; 43 completed the study and were included in the PK analysis population. AUC and Cmax broadly increased with increasing dose, Tmax generally occurred between 4.0 and 5.0 h. Although the data did not appear strongly dose proportional, dose proportionality analysis did not provide evidence against dose proportionality as the log(dose) coefficients were not significantly < 1. NRL001 did not accumulate over time for any dose. Increasing NRL001 concentrations were related to changes in vital sign variables, most notably decreased heart rate. The most commonly reported adverse events (AEs) in the active treatment groups were paraesthesia and piloerection. Treatment with NRL001 was generally well tolerated over 14 days once daily dosing and plasma NRL001 did not accumulate over time. Treatment was associated with changes in vital sign variables, most notably decreased heart rate. AEs commonly reported with NRL001 treatment were events indicative of a systemic α-adrenergic effect. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  9. Three-dimensional patterns of speech-induced cerebral and cerebellar activation in healthy volunteers and in aphasic stroke patients studied by positron emission tomography of 2(18F)-fluorodeoxyglucose

    International Nuclear Information System (INIS)

    Pawlik, G.; Heiss, W.D.; Beil, C.; Gruenewald, G.; Herholz, K.; Wienhard, K.; Wagner, R.

    1987-01-01

    Eight healthy male volunteers and eight moderately aphasic patients with a single cerebral infarctions in the postacute stage, were studied by dynamic positron emission tomography (PET) using the 2(18F)-fluoro-2-deoxy-D-glucose method and a 7-slice positron camera. Because hemispheric speech dominance is commonly thought to be closely related to handedness, subjects were tested by the Oldfield and Bryden questionnaires; the volunteers also had a tracking and pin-sort test. PET studies were performed in random order, both at rest and during spontaneous speech of rather abstract and some biographic content, with a time interval of 2 to 7 days between measurements of the same individual. Data was analyzed by means of weighted, repeated measures of analysis of variance (ANOVA). 11 refs.; 2 figs

  10. Relative bioavailability of generic and branded 250-mg and 500-mg oral chlorphenesin carbamate tablets in healthy Korean volunteers: a single-dose, randomized-sequence, open-label, two-period crossover trial.

    Science.gov (United States)

    Yu, Ji-young; Song, Hyun Ho; Kim, Bo Gyeom; Park, Hyeon Ju; Choi, Kwang Sik; Kwon, Young Ee

    2009-11-01

    Chlorphenesin carbamate is a skeletal muscle relaxant approved in Korea for use in the treatment of pain and discomfort related to skeletal muscle trauma and inflammation. The aim of this study was to assess the bioequivalence of a generic formulation of chlorphenesin carbamate at doses of 250 and 500 mg and 2 branded formulations of the same doses in healthy Korean adults. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in healthy Korean male and female volunteers. Subjects were assigned to receive, in a randomized sequence, a single dose of the generic (test) and branded (reference) formulations of chlorphenesin carbamate at a dose of 250 or 500 mg. Blood samples were drawn at 0, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 9, 12, and 15 hours after administration. Pharmacokinetic properties (C(max), T(max), AUC(0-t) AUC(0-infinity), t(1/2), and ke) were determined using HPLC. The formulations were to be considered bioequivalent if the 90% CIs of the treatment ratios of the geometric means of C(max) and AUC(0-t) were within a predetermined range of log 0.80 to log 1.25 based on regulatory criteria. Tolerability was assessed by monitoring for adverse events (AEs) on physical examination and/or e-mail and personal interview at the beginning and end of each study period. Twenty-eight subjects (22 men, 6 women) received chlorphenesin carbamate at the 250-mg dose, and 24 male subjects received the 500-mg dose. The mean (SD) ages of the subjects were 24.0 (2.6) and 24.0 (1.9) years in the 250- and 500-mg groups, respectively. No significant differences were found between the test and reference formulations (90% CIs: C(max), 1.0048-1.1153 with the 250-mg dose and 0.9630-1.1189 with the 500-mg dose; AUC(0-t), 0.9882-1.0546 and 0.9842-1.0578, respectively). No clinically significant AEs (upper gastric pain, abdominal bloating, pyrexia, edema, nausea, heartburn, constipation, headache, dizziness, drowsiness, or fatigue) were reported throughout

  11. Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.

    Science.gov (United States)

    Yoshita, Tomohiro; Uchida, Shinya; Namiki, Noriyuki

    2013-01-01

    Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; pdisintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

  12. Effects of acute hypoventilation and hyperventilation on exhaled carbon monoxide measurement in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Di Donato Michele

    2009-12-01

    Full Text Available Abstract Background High levels of exhaled carbon monoxide (eCO are a marker of airway or lung inflammation. We investigated whether hypo- or hyperventilation can affect measured values. Methods Ten healthy volunteers were trained to achieve sustained end-tidal CO2 (etCO2 concentrations of 30 (hyperventilation, 40 (normoventilation, and 50 mmHg (hypoventilation. As soon as target etCO2 values were achieved for 120 sec, exhaled breath was analyzed for eCO with a photoacoustic spectrometer. At etCO2 values of 30 and 40 mmHg exhaled breath was sampled both after a deep inspiration and after a normal one. All measurements were performed in two different environmental conditions: A ambient CO concentration = 0.8 ppm and B ambient CO concentration = 1.7 ppm. Results During normoventilation, eCO mean (standard deviation was 11.5 (0.8 ppm; it decreased to 10.3 (0.8 ppm during hyperventilation (p 2 changes (hyperventilation: 10% Vs 25% decrease; hypoventilation 3% Vs 25% increase. Taking a deep inspiration before breath sampling was associated with lower eCO values (p Conclusions eCO measurements should not be performed during marked acute hyperventilation, like that induced in this study, but the influence of less pronounced hyperventilation or of hypoventilation is probably negligible in clinical practice

  13. Novel ultrasound-guided inter-semispinal plane block: a comparative pilot study in healthy volunteers.

    Science.gov (United States)

    Ohgoshi, Yuichi; Nishizakura, Ryo; Takahashi, Yuki; Takeda, Keisuke; Nakayama, Hirosuke; Kawamata, Mariko; Kurahashi, Kiyoyasu

    2018-02-01

    We previously reported that a novel multifidus cervicis plane (MCP) block could anesthetize the dorsal rami of the cervical spinal nerves. While MCP sonoanatomy is easily detectable in most patients, it is sometimes difficult to recognize the MCP injection plane, especially in elderly patients. Thus, we proposed the inter-semispinal plane (ISP) block as an alternative for the MCP block. The aim of this study was to evaluate the utility of the ISP block by evaluating the area and duration of anesthesia, compared with that of the MCP block in eight healthy volunteers. Each participant underwent unilateral ultrasound-guided MCP block and ISP block. For each block, 20 ml of ropivacaine 0.2% was injected, and the area of anesthesia was determined using the pinprick test. The anesthetic area ranged from C4 to T2 (3/8; 37.5%), T3 (2/8; 25%), or T4 (3/8; 37.5%) in the MCP block, and from C4 to T1 (1/8; 12.5%), T2 (3/8; 37.5%), T3 (2/8; 25%), or T4 (1/8; 12.5%) in the ISP block. The mean (standard deviation) duration of sensory loss following MCP and ISP blocks was 329 (77) min and 349 (70) min, respectively. Thus, the ISP block may be a reliable alternative to the MCP block.

  14. The effect of sodium nitroprusside on cerebral hemodynamics and headache in healthy subjects

    DEFF Research Database (Denmark)

    Guo, Song; Ashina, Messoud; Olesen, Jes

    2013-01-01

    InvestigationSodium nitroprusside (SNP) is a powerful vasodilatory agent that, similarly to glyceryl trinitrate (GTN), releases nitric oxide (NO) but in contrast does not pass the blood-brain barrier. Nevertheless, it has already been used in animal models without any knowledge of its headache......-inducing potential. We hypothesized that SNP would induce headache and vasodilation of cephalic and radial but not cerebral arteries.MethodsFive healthy volunteers received intravenous infusions of SNP in a non-randomized dose-titration (1-5 µg/kg/min) study. We recorded headache intensity (verbal rating scale from...

  15. Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers.

    Science.gov (United States)

    Doshi, Maulik S; Naik, Anuja A; Mehta, Mohit R; Gogtay, Nithya J; Thatte, Urmila M; Menon, Mala D

    2013-10-01

    To compare the bioavailability of two brands of phenytoin sodium tablets available in the Indian market using Eptoin™ as the reference. A randomized, assessor-blind, three-way crossover design study was carried out over a period of 6 months after approval from the Institutional Review Board (IRB). Twenty-two healthy male participants received a single oral 300 mg oral tablet of either of the formulations with a 2-week washout. Blood samples were collected predose and at regular intervals postdose. Plasma phenytoin levels were estimated by high-performance liquid chromatography. Calculation of Cmax, AUC0-t, and AUC0-∞ was done by the linear trapezoidal rule and 90-110% margin (90% confidence interval (CI)) was used to assess bioequivalence. Twenty volunteers completed the study. It was seen that the log-transformed values of Cmax, AUC0-t, and AUC0-∞ of the test formulations were not within the specified limits. Bioinequivalence of available phenytoin brands indicates that switching brands could lead to variations in blood concentrations and thus impact safety and efficacy. If a brand switch is done for any reason, stringent drug-level monitoring is advised.

  16. [Application of Fourier amplitude sensitivity test in Chinese healthy volunteer population pharmacokinetic model of tacrolimus].

    Science.gov (United States)

    Guan, Zheng; Zhang, Guan-min; Ma, Ping; Liu, Li-hong; Zhou, Tian-yan; Lu, Wei

    2010-07-01

    In this study, we evaluated the influence of different variance from each of the parameters on the output of tacrolimus population pharmacokinetic (PopPK) model in Chinese healthy volunteers, using Fourier amplitude sensitivity test (FAST). Besides, we estimated the index of sensitivity within whole course of blood sampling, designed different sampling times, and evaluated the quality of parameters' and the efficiency of prediction. It was observed that besides CL1/F, the index of sensitivity for all of the other four parameters (V1/F, V2/F, CL2/F and k(a)) in tacrolimus PopPK model showed relatively high level and changed fast with the time passing. With the increase of the variance of k(a), its indices of sensitivity increased obviously, associated with significant decrease in sensitivity index for the other parameters, and obvious change in peak time as well. According to the simulation of NONMEM and the comparison among different fitting results, we found that the sampling time points designed according to FAST surpassed the other time points. It suggests that FAST can access the sensitivities of model parameters effectively, and assist the design of clinical sampling times and the construction of PopPK model.

  17. Reproducibility of current perception threshold with the Neurometer(®) vs the Stimpod NMS450 peripheral nerve stimulator in healthy volunteers: an observational study.

    Science.gov (United States)

    Tsui, Ban C H; Shakespeare, Timothy J; Leung, Danika H; Tsui, Jeremy H; Corry, Gareth N

    2013-08-01

    Current methods of assessing nerve blocks, such as loss of perception to cold sensation, are subjective at best. Transcutaneous nerve stimulation is an alternative method that has previously been used to measure the current perception threshold (CPT) in individuals with neuropathic conditions, and various devices to measure CPT are commercially available. Nevertheless, the device must provide reproducible results to be used as an objective tool for assessing nerve blocks. We recruited ten healthy volunteers to examine CPT reproducibility using the Neurometer(®) and the Stimpod NMS450 peripheral nerve stimulator. Each subject's CPT was determined for the median (second digit) and ulnar (fifth digit) nerve sensory distributions on both hands - with the Neurometer at 5 Hz, 250 Hz, and 2000 Hz and with the Stimpod at pulse widths of 0.1 msec, 0.3 msec, 0.5 msec, and 1.0 msec, both at 5 Hz and 2 Hz. Intraclass correlation coefficients (ICC) were also calculated to assess reproducibility; acceptable ICCs were defined as ≥ 0.4. The ICC values for the Stimpod ranged from 0.425-0.79, depending on pulse width, digit, and stimulation; ICCs for the Neurometer were 0.615 and 0.735 at 250 and 2,000 Hz, respectively. These values were considered acceptable; however, the Neurometer performed less efficiently at 5 Hz (ICCs for the second and fifth digits were 0.292 and 0.318, respectively). Overall, the Stimpod device displayed good to excellent reproducibility in measuring CPT in healthy volunteers. The Neurometer displayed poor reproducibility at low frequency (5 Hz). These results suggest that peripheral nerve stimulators may be potential devices for measuring CPT to assess nerve blocks.

  18. Volunteer recruitment: the role of organizational support and anticipated respect in non-volunteers' attraction to charitable volunteer organizations.

    Science.gov (United States)

    Boezeman, Edwin J; Ellemers, Naomi

    2008-09-01

    In 3 experiments the authors examined how specific characteristics of charitable volunteer organizations contribute to the recruitment of new volunteers. In line with predictions, Study 1 revealed that providing non-volunteers with information about organizational support induced anticipated feelings of respect, which subsequently enhanced their attraction to the volunteer organization. However, information about the current success of the volunteer organization did not affect anticipated pride (as among those who seek paid employment) and in fact caused potential volunteers to perceive the organization as being in less need for additional volunteers. Study 2 further showed that information about support from the volunteer organization is a more relevant source of anticipated respect and organizational attraction than support from co-volunteers. Study 3 finally showed that information about task and emotional support for volunteers contributes to anticipated respect and organizational attractiveness and that this increases the actual willingness of non-volunteers to participate in the volunteer organization. Interventions aimed at attracting volunteers and avenues for further research are discussed.

  19. Whole-body distribution and radiation dosimetry of the dopamine transporter radioligand [11C]PE2I in healthy volunteers

    International Nuclear Information System (INIS)

    Ribeiro, Maria-Joao; Ricard, Marcel; Lievre, Marie-Angele; Bourgeois, Sandrine; Emond, Patrick; Gervais, Philippe; Dolle, Frederic; Syrota, Andre

    2007-01-01

    Introduction: This study reports on the biodistribution and radiation dosimetry of a cocaine analog, the (E)-N-(3-iodoprop-2-enyl)-2β-carbomethoxy-3β-(4'-tolyl)nortropane (PE2I), labeled with carbon 11 ([ 11 C]PE2I). [ 11 C]PE2I is used in positron emission tomography (PET) for examination of the dopamine neuronal transporter (DAT). DAT radioligands are often used to evaluate the progression of Parkinson's disease or the efficiency of neuroprotective therapeutics, and, typically, these studies required several successive PET scans. Methods: In three healthy male volunteers, whole-body scans were performed up to 2 h following intravenous injection of 321±6 MBq of [ 11 C]PE2I. For each subject, regions of interest were defined over all visible organs to generate time-activity curves and calculate the percentage of injected activity. Time-activity data were fitted to a monoexponential model, as an uptake phase followed by a mono-exponential washout, or bi-exponential model to obtain residence times. With the use of the MIRD method, several source organs were considered in estimating residence time and mean effective radiation absorbed doses. Results: Blood pressure and ECG findings remained unchanged after radioligand injection. The primary route of clearance was renal. Ten minutes after injection, high activities were observed in the kidneys, urinary-bladder, stomach, liver, salivary glands and brain. The urine bladder wall, stomach and liver received the highest absorbed doses. The average effective dose of [ 11 C]PE2I was estimated to be 6.4±0.6 μSv/MBq. Conclusion: The amount of [ 11 C]PE2I required for adequate DAT PET imaging results in an acceptable effective dose equivalent permitting two or three repeated cerebral PET studies, with the injection of 222 MBq for each study

  20. Acute fluoxetine modulates emotional processing in young adult volunteers.

    Science.gov (United States)

    Capitão, L P; Murphy, S E; Browning, M; Cowen, P J; Harmer, C J

    2015-08-01

    Fluoxetine is generally regarded as the first-line pharmacological treatment for young people, as it is believed to show a more favourable benefit:risk ratio than other antidepressants. However, the mechanisms through which fluoxetine influences symptoms in youth have been little investigated. This study examined whether acute administration of fluoxetine in a sample of young healthy adults altered the processing of affective information, including positive, sad and anger cues. A total of 35 male and female volunteers aged between 18 and 21 years old were randomized to receive a single 20 mg dose of fluoxetine or placebo. At 6 h after administration, participants completed a facial expression recognition task, an emotion-potentiated startle task, an attentional dot-probe task and the Rapid Serial Visual Presentation. Subjective ratings of mood, anxiety and side effects were also taken pre- and post-fluoxetine/placebo administration. Relative to placebo-treated participants, participants receiving fluoxetine were less accurate at identifying anger and sadness and did not show the emotion-potentiated startle effect. There were no overall significant effects of fluoxetine on subjective ratings of mood. Fluoxetine can modulate emotional processing after a single dose in young adults. This pattern of effects suggests a potential cognitive mechanism for the greater benefit:risk ratio of fluoxetine in adolescent patients.

  1. Volunteer Income Tax Assistance Programs and Taxpayer Actions to Improve Personal Finances

    Science.gov (United States)

    Bobbitt, Erica; Bowen, Cathy F.; Kuleck, Robin L.; Taverno, Ronald

    2012-01-01

    The income tax-filing process creates teachable moments for learning about taxes and other financial matters. Educators and volunteers from Penn State Cooperative Extension helped taxpayers file 2008 returns under Volunteer Income Tax Assistance Program (VITA). Nearly 600 filers (588) completed and simultaneously received educational information…

  2. Effect of oral D-tagatose on liver volume and hepatic glycogen accumulation in healthy male volunteers.

    Science.gov (United States)

    Boesch, C; Ith, M; Jung, B; Bruegger, K; Erban, S; Diamantis, I; Kreis, R; Bär, A

    2001-04-01

    Standard toxicity tests with high levels of D-tagatose showed a reversible enlargement of the liver in Sprague-Dawley rats without increase of liver enzymes. The present study tests the hypotheses that partial substitution of dietary sucrose by D-tagatose for 28 days increases the volume of human liver and the concentration of liver glycogen. Twelve healthy, male volunteers were studied in a double-blind crossover study with ingestion of D-tagatose (3x15 g daily) and placebo (sucrose, 3x15 g daily) for periods of 28 days each. Liver volume and glycogen concentration have been determined by magnetic resonance (MR) imaging and spectroscopy, which were accompanied by routine medical examinations. MR examinations before and after the treatments revealed no effects (P>0.05) of treatment, period, or subject for changes in liver volume or glycogen concentration. A steady increase of liver volumes, independent of the D-tagatose or placebo intake, has been observed over the study in parallel with a slight increase in body weight. The treatment with D-tagatose was not associated with clinically relevant changes of the examined clinico-chemical and hematological parameters, including liver enzymes and uric acid. Copyright 2001 Academic Press.

  3. Monoamine related functional gene variants and relationships to monoamine metabolite concentrations in CSF of healthy volunteers

    Directory of Open Access Journals (Sweden)

    Propping Peter

    2004-03-01

    Full Text Available Abstract Background Concentrations of monoamine metabolites in human cerebrospinal fluid (CSF have been used extensively as indirect estimates of monoamine turnover in the brain. CSF monoamine metabolite concentrations are partly determined by genetic influences. Methods We investigated possible relationships between DNA polymorphisms in the serotonin 2C receptor (HTR2C, the serotonin 3A receptor (HTR3A, the dopamine D4 receptor (DRD4, and the dopamine β-hydroxylase (DBH genes and CSF concentrations of 5-hydroxyindolacetic acid (5-HIAA, homovanillic acid (HVA, and 3-methoxy-4-hydroxyphenylglycol (MHPG in healthy volunteers (n = 90. Results The HTR3A 178 C/T variant was associated with 5-HIAA levels (p = 0.02. The DBH-1021 heterozygote genotype was associated with 5-HIAA (p = 0.0005 and HVA (p = 0.009 concentrations. Neither the HTR2C Cys23Ser variant, nor the DRD4 -521 C/T variant were significantly associated with any of the monoamine metabolites. Conclusions The present results suggest that the HTR3A and DBH genes may participate in the regulation of dopamine and serotonin turnover rates in the central nervous system.

  4. Association between Municipal Health Promotion Volunteers' Health Literacy and Their Level of Outreach Activities in Japan.

    Science.gov (United States)

    Taguchi, Atsuko; Murayama, Hiroshi; Murashima, Sachiyo

    2016-01-01

    To explore the association between health literacy and levels of three types of core activities among health promotion volunteers (developing a healthy lifestyle, outreach to family, and outreach to community members). A cross-sectional, anonymous, self-administered postal survey of registered health promotion volunteers in the Konan area in Shiga Prefecture in Japan, conducted in January 2010. The study sample was 575 registered health promotion volunteers. The survey collected data on health literacy, gender, age, education, self-rated health, perceptions about the volunteer organization, and perceptions of recognition in the community. The level of engagement in health promotion activities was measured by the extent to which the participants engaged in seven healthy behaviors and promoted them to family members and the community. The authors compared the health literacy level and other characteristics of the participants by core health promotion activities, using a chi-squared test, to examine the associations between demographic and other variables and the three core activities (healthy lifestyle, outreach to family, and outreach to community).Logistic regression analysis was conducted to examine the association between the degree to which the volunteers engaged in core activities ("healthy lifestyle," "outreach to family," "outreach to community") and the levels of health literacy (low, medium, high) among health promotion volunteers, controlling for the effects of age, gender, health condition, education which may also have an impact on volunteers' outreach activities. Four hundred and fifty-four questionnaires were returned, a 79.0% response rate. Excluding 16 cases with missing values on health literacy or the degree of health promotion activities, 438 research subjects were included in the analysis (valid response rate: 76.2%). Health literacy and a few demographic and other characteristics of the volunteers were associated with the three core health

  5. Association between Municipal Health Promotion Volunteers' Health Literacy and Their Level of Outreach Activities in Japan.

    Directory of Open Access Journals (Sweden)

    Atsuko Taguchi

    Full Text Available To explore the association between health literacy and levels of three types of core activities among health promotion volunteers (developing a healthy lifestyle, outreach to family, and outreach to community members.A cross-sectional, anonymous, self-administered postal survey of registered health promotion volunteers in the Konan area in Shiga Prefecture in Japan, conducted in January 2010. The study sample was 575 registered health promotion volunteers.The survey collected data on health literacy, gender, age, education, self-rated health, perceptions about the volunteer organization, and perceptions of recognition in the community. The level of engagement in health promotion activities was measured by the extent to which the participants engaged in seven healthy behaviors and promoted them to family members and the community. The authors compared the health literacy level and other characteristics of the participants by core health promotion activities, using a chi-squared test, to examine the associations between demographic and other variables and the three core activities (healthy lifestyle, outreach to family, and outreach to community.Logistic regression analysis was conducted to examine the association between the degree to which the volunteers engaged in core activities ("healthy lifestyle," "outreach to family," "outreach to community" and the levels of health literacy (low, medium, high among health promotion volunteers, controlling for the effects of age, gender, health condition, education which may also have an impact on volunteers' outreach activities.Four hundred and fifty-four questionnaires were returned, a 79.0% response rate. Excluding 16 cases with missing values on health literacy or the degree of health promotion activities, 438 research subjects were included in the analysis (valid response rate: 76.2%. Health literacy and a few demographic and other characteristics of the volunteers were associated with the three core

  6. Is volunteering in later life impeded or stimulated by other activities?

    Science.gov (United States)

    Dury, Sarah; De Donder, Liesbeth; De Witte, Nico; Brosens, Dorien; Smetcoren, An-Sofie; Van Regenmortel, Sofie; Verté, Dominique

    2016-01-01

    Volunteering among older adults has received increasing attention from researchers, policy makers, and associations. However, there remains a lack of knowledge in how volunteering is impacted by other activities in the lives of older adults. In order to understand activity engagement in later life, insights into the extent to which activities compete with or complement each other are necessary. Data for the present research were derived from the Belgian Aging Studies (N = 23,768). The main objective is to uncover the activities that impede or stimulate actual volunteering and/or the likeliness to volunteer at an older age. Structural equation models indicate a strong positive correlation between altruistic types of activities and actual volunteering. Furthermore, older adults active in personal leisure activities are more drawn to be potential volunteers. The article demonstrates that the activity level of older people is not sufficient to understand volunteering, that is, a distinction between the types of activities is essential. © The Author(s) 2015.

  7. Why Volunteer? Understanding Motivations for Student Volunteering

    Science.gov (United States)

    Holdsworth, Clare

    2010-01-01

    The profile of volunteering in English Higher Education (HE) has been enhanced in recent years through various initiatives that have not only funded activities, but have sought to expand the range of volunteering opportunities available to students and recognise the contribution that volunteering can make to students' employability. This expansion…

  8. Effects of temperature on bleeding time and clotting time in normal male and female volunteers.

    Science.gov (United States)

    Valeri, C R; MacGregor, H; Cassidy, G; Tinney, R; Pompei, F

    1995-04-01

    This study was done to assess the effects of temperature on bleeding time and clotting time in normal male and female volunteers. Open study utilizing normal volunteers. University research laboratory. Fifty-four healthy male and female volunteers, ranging in age from 19 to 35 yrs, who were not receiving medications. The study was done and the samples of venous blood and shed blood collected at the template bleeding time site were obtained at a convenient time for each volunteer. Skin temperature was changed from +20 degrees to +38 degrees C and blood samples were obtained from the antecubital vein of each volunteer. The effect of local skin temperature ranging from +20 degrees to +38 degrees C on bleeding time was evaluated in 38 normal volunteers (19 male and 19 female). Skin temperature was maintained at +20 degrees to +38 degrees C by cooling or warming the forearm. At each temperature, measurements were made of complete blood count, bleeding time, and thromboxane B2 concentrations in shed blood collected at the template bleeding time site and in serum and plasma isolated from blood collected from the antecubital vein. Clotting time studies were measured in 16 normal volunteers (eight male and eight female) at temperatures ranging from +22 degrees to +37 degrees C. At +32 degrees C, the bleeding time was longer and hematocrit was lower in female than in male volunteers. However, at local skin temperatures of < +32 degrees C, both the males and females exhibited significantly increased bleeding times, which were associated with a reduction in shed blood thromboxane B2. Each 1 degree C decrease in temperature was associated with a 15% decrease in the shed blood thromboxane B2 concentration. Clotting times were three times longer at +22 degrees C than at +37 degrees C. Each 1 degree C reduction in the temperature of the clotted blood was associated with a 15% reduction in the serum thromboxane B2 concentration. Our data indicate that during surgical procedures, it

  9. College Students' Volunteering: Factors Related to Current Volunteering, Volunteer Settings, and Motives for Volunteering

    Science.gov (United States)

    Moore, Erin W.; Warta, Samantha; Erichsen, Kristen

    2014-01-01

    Research has not explored the types of settings that college students prefer to volunteer for and how these settings might be influenced by personal factors (e.g., demographic, academic major, volunteering motivation, religiosity). Students from a Midwestern university (N = 406, 71.9% female) completed a survey that inquired about their…

  10. The effects of smoking on levels of endothelial progenitor cells and microparticles in the blood of healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Fariborz Mobarrez

    Full Text Available BACKGROUND: Cigarette smoking, both active and passive, is one of the leading causes of morbidity and mortality in cardiovascular disease. To assess the impact of brief smoking on the vasculature, we determined levels of circulating endothelial progenitor cells (EPCs and circulating microparticles (MPs following the smoking of one cigarette by young, healthy intermittent smokers. MATERIALS AND METHODS: 12 healthy volunteers were randomized to either smoking or not smoking in a crossover fashion. Blood sampling was performed at baseline, 1, 4 and 24 hours following smoking/not smoking. The numbers of EPCs and MPs were determined by flow cytometry. MPs were measured from platelets, leukocytes and endothelial cells. Moreover, MPs were also labelled with anti-HMGB1 and SYTO 13 to assess the content of nuclear molecules. RESULTS: Active smoking of one cigarette caused an immediate and significant increase in the numbers of circulating EPCs and MPs of platelet-, endothelial- and leukocyte origin. Levels of MPs containing nuclear molecules were increased, of which the majority were positive for CD41 and CD45 (platelet- and leukocyte origin. CD144 (VE-cadherin or HMGB1 release did not significantly change during active smoking. CONCLUSION: Brief active smoking of one cigarette generated an acute release of EPC and MPs, of which the latter contained nuclear matter. Together, these results demonstrate acute effects of cigarette smoke on endothelial, platelet and leukocyte function as well as injury to the vascular wall.

  11. Doppler ultrasonography measurement of hepatic hemodynamics during Valsalva maneuver: healthy volunteer study

    Directory of Open Access Journals (Sweden)

    Dong-Ho Bang

    2015-01-01

    Full Text Available Purpose: The aim of our study was to assess the hemodynamic change of liver during the Valsalva maneuver using Doppler ultrasonography. Methods: Thirty healthy men volunteers were enrolled (mean age, 25.5±3.64 years. The diameter, minimal and maximal velocities, and volume flow of intrahepatic inferior vena cava (IVC, middle hepatic vein (MHV, and right main portal vein (RMPV was measured during both rest and Valsalva maneuver. These changes were compared using paired t-test. Results: The mean diameters (cm of the intrahepatic IVC at rest and Valsalva maneuver were 1.94±0.40 versus 0.56±0.66 (P<0.001. The mean diameter (cm, minimal velocity (cm/sec, maximal velocity (cm/sec, and volume flow (mL/min of MHV at rest and Valsalva maneuver were 0.60±0.15 versus 0.38±0.20 (P<0.001, -7.98±5.47 versus 25.74±13.13 (P<0.001, 21.34±6.89 versus 35.12±19.95 (P=0.002, and 106.94±97.65 versus 153.90±151.80 (P=0.014, respectively. Those of RMPV at rest and Valsalva maneuver were 0.78±0.21 versus 0.76±0.20 (P=0.485, 20.21±8.22 versus 18.73±7.43 (P=0.351, 26.79±8.85 versus 24.93±9.91 (P=0.275, and 391.52±265.63 versus 378.43±239.36 (P=0.315, respectively. Conclusion: The blood flow velocity and volume flow of MHV increased significantly during Valsalva maneuver. These findings suggest that hepatic vein might play an important role to maintain venous return to the heart during the maneuver.

  12. Doppler ultrasonography measuement of hepatic hemodynamics during Valsalva maneuver: healthy volunteers study

    Energy Technology Data Exchange (ETDEWEB)

    Bang, Dong Ho; Son, Young Jin; Lee, Young Hwan; Yoon, Kwon Ha [Dept. of Radiology, Wonkwang University School of Medicine, Iksan (Korea, Republic of)

    2015-01-15

    The aim of our study was to assess the hemodynamic change of liver during the Valsalva maneuver using Doppler ultrasonography. Thirty healthy men volunteers were enrolled (mean age, 25.5±3.64 years). The diameter, minimal and maximal velocities, and volume flow of intrahepatic inferior vena cava (IVC), middle hepatic vein (MHV), and right main portal vein (RMPV) was measured during both rest and Valsalva maneuver. These changes were compared using paired t-test. The mean diameters (cm) of the intrahepatic IVC at rest and Valsalva maneuver were 1.94±0.40 versus 0.56±0.66 (P<0.001). The mean diameter (cm), minimal velocity (cm/sec), maximal velocity (cm/sec), and volume flow (mL/min) of MHV at rest and Valsalva maneuver were 0.60±0.15 versus 0.38±0.20 (P<0.001), -7.98±5.47 versus 25.74±13.13 (P<0.001), 21.34±6.89 versus 35.12±19.95 (P=0.002), and 106.94±97.65 versus 153.90±151.80 (P=0.014), respectively. Those of RMPV at rest and Valsalva maneuver were 0.78±0.21 versus 0.76±0.20 (P=0.485), 20.21±8.22 versus 18.73±7.43 (P=0.351), 26.79±8.85 versus 24.93±9.91 (P=0.275), and 391.52±265.63 versus 378.43±239.36 (P=0.315), respectively. The blood flow velocity and volume flow of MHV increased significantly during Valsalva maneuver. These findings suggest that hepatic vein might play an important role to maintain venous return to the heart during the maneuver.

  13. The Data Reliability of Volunteered Geographic Information with Using Traffic Accident Data

    Science.gov (United States)

    Sevinç, H. K.; Karaş, I. R.

    2017-11-01

    The development of mobile technologies is important in the lives of humans. Mobile devices constitute a great part of the daily lives of people. It has come to such a point that when people first wake up, they check their smart phones for the first thing. Users may share their positions with the GNSS sensors in mobile devices or they can add information about their positions in mobile applications. Users contribute to Geographical Information System with this sharing. These users consist of native (citizens) living in that geographical position not of the CBS specialists. Creating, collecting, sharing and disseminating the geographical data provided by voluntary individuals constitute the Volunteered Geographic Information System. The data in the Volunteered Geographic Information System are received from amateur users. "How reliable will the data received from amateur users instead of specialists of the field be in scientific terms?" In this study, the reliability between the data received from the voluntary users through Volunteered Geographic Information System and real data is investigated. The real data consist of the traffic accident coordinates. The data that will be received from users will be received through the speed values in the relevant coordinates and the marking of the users for possible accident points on the map.

  14. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  15. NRPB volunteer study: deposition and clearance of inhaled particles

    International Nuclear Information System (INIS)

    Etherington, G.; Smith, J.

    1996-01-01

    At the Board Meeting of the National Radiological Protection Board held on 15 February 1996, approval was given for an experimental study of the deposition and clearance of inhaled particles in the human nasal passage. This is the latest in a series of volunteer biokinetic studies that have been conducted at NRPB since its formation. This article explains the purpose of the study, how ethical approval was obtained, how the study will be performed, what volunteers will be asked to do, and what doses they will receive. Doses will of course be carefully controlled, and will be well below the annual limits set for such experiments. The success of the study is of course crucially dependent on recruitment of a sufficient number of volunteers. The aim of this article is to provide information to anyone who might be interested in volunteering. (UK)

  16. Transverse plane tendon and median nerve motion in the carpal tunnel: ultrasound comparison of carpal tunnel syndrome patients and healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Margriet H M van Doesburg

    Full Text Available The median nerve and flexor tendons are known to translate transversely in the carpal tunnel. The purpose of this study was to investigate these motions in differential finger motion using ultrasound, and to compare them in healthy people and carpal tunnel syndrome patients.Transverse ultrasounds clips were taken during fist, index finger, middle finger and thumb flexion in 29 healthy normal subjects and 29 CTS patients. Displacement in palmar-dorsal and radial-ulnar direction was calculated using Analyze software. Additionally, the distance between the median nerve and the tendons was calculated.We found a changed motion pattern of the median nerve in middle finger, index finger and thumb motion between normal subjects and CTS patients (p<0.05. Also, we found a changed motion direction in CTS patients of the FDS III tendon in fist and middle finger motion, and of the FDS II and flexor pollicis longus tendon in index finger and thumb motion, respectively (p<0.05. The distance between the median nerve and the FDS II or FPL tendon is significantly greater in patients than in healthy volunteers for index finger and thumb motion, respectively (p<0.05.Our results suggest a changed motion pattern of the median nerve and several tendons in carpal tunnel syndrome patients compared to normal subjects. Such motion patterns may be useful in distinguishing affected from unaffected individuals, and in studies of the pathomechanics of carpal tunnel syndrome.

  17. Targeted and Untargeted Metabolomics to Explore the Bioavailability of the Secoiridoids from a Seed/Fruit Extract (Fraxinus angustifolia Vahl in Human Healthy Volunteers: A Preliminary Study

    Directory of Open Access Journals (Sweden)

    Rocío García-Villalba

    2015-12-01

    Full Text Available The bark, seeds, fruits and leaves of the genus Fraxinus (Oleaceae which contain a wide range of phytochemicals, mostly secoiridoid glucosides, have been widely used in folk medicine against a number of ailments, yet little is known about the metabolism and uptake of the major Fraxinus components. The aim of this work was to advance in the knowledge on the bioavailability of the secoiridoids present in a Fraxinus angustifolia Vahl seed/fruit extract using both targeted and untargeted metabolomic analyses. Plasma and urine samples from nine healthy volunteers were taken at specific time intervals following the intake of the extract and analyzed by UPLC-ESI-QTOF. Predicted metabolites such as tyrosol and ligstroside-aglycone glucuronides and sulfates were detected at low intensity. These compounds reached peak plasma levels 2 h after the intake and exhibited high variability among the participants. The ligstroside-aglycone conjugates may be considered as potential biomarkers of the Fraxinus secoiridoids intake. Using the untargeted approach we additionally detected phenolic conjugates identified as ferulic acid and caffeic acid sulfates, as well as hydroxybenzyl and hydroxyphenylacetaldehyde sulfate derivatives which support further metabolism of the secoiridoids by phase I and (or microbial enzymes. Overall, the results of this study suggest low uptake of intact secoiridoids from a Fraxinus angustifolia Vahl extract in healthy human volunteers and metabolic conversion by esterases, glycosidases, and phase II sulfo- and glucuronosyl transferases to form smaller conjugated derivatives.

  18. Effect of Misoprostol on the Pharmacokinetics of Sustained Release Diclofenac in Myanmar Healthy Male Volunteers

    Directory of Open Access Journals (Sweden)

    Htet Htet Aung

    2017-03-01

    Full Text Available Background: Sustained release diclofenac (diclofenac SR is the commonly used non-steroidal anti-inflammatory drug for chronic inflammatory conditions such as rheumatoid arthritis. Misoprostol, prostaglandin analogue, is the agent that enhances gastrointestinal mucosal defense. Concomitant administration of misoprostol with diclofenac SR can prevent the gastrointestinal side effects of diclofenac SR. Objective: The purpose of the study was to explore the effect of misoprostol on the pharmacokinetics of diclofenac SR in healthy volunteers. Methods: Crossover study was evaluated in 14 male volunteers. Single oral dose of 100 mg diclofenac SR was concomitantly administered with 200 μg misoprostol with one-week wash out period. Plasma concentrations at 0, 0.5, 1, 1.5, 2, 3, 6 and 10 hrs were determined by high performance liquid chromatography (HPLC. Pharmacokinetic parameters such as area under concentration-time curve (AUC0-α, peak plasma concentration (Cmax, time to achieve peak plasma concentration (Tmax, absorption half-life (T½(ab, elimination half-life (T1/2(el, absorption rate constant (Kab, and elimination rate constant (Kel were determined. Results: With misoprostol, the mean AUC0-α of diclofenac SR was significantly reduced from 12.11±5.25μg/ mL×hr to 4.17±2.72μg/mL×hr (p0.05. The mean T½(ab was decreased from 0.56±0.23hr to 0.54±0.19hr (p>0.05. The mean Kab were almost the same 1.43±0.54hr-1 and 1.43±0.48hr-1. The mean T1/2(el was decreased from 3.68±1.64hr to 3.03±1.08hr (p>0.05. The mean Kel was increased from 0.21±0.09hr-1 to 0.25±0.09hr-1 (p>0.05. Conclusion: There was a significant reduction in the extent of absorption of diclofenac SR when concomitantly administered with misoprostol. Therefore, the dose of diclofenac SR may need to be increased to avoid therapeutic failure of diclofenac SR or concurrent use with misoprostol may need to be changed to other gastroprotective agents.

  19. Challenges in volunteering from cancer care volunteers perspectives.

    Science.gov (United States)

    Kamaludin, Kauthar Mohamad; Muhammad, Mazanah; Wahat, Nor Wahiza Abdul; Ibrahim, Rahimah

    2013-01-01

    The involvement of non-government organizations (NGOs) and support groups has helped strengthen public health services in addressing cancer care burden. Owing to the contribution of volunteers in cancer care, this article documents a qualitative study that examined challenges in attracting and retaining cancer care volunteers as part of the effort to develop a volunteer recruitment model. Data were collected through three focus group discussions involving 19 cancer support group members in Malaysia. Findings of the study revealed that mobility and locality appeared to be significant in Malaysian context, while the need for financial support and time flexibility are challenges faced by cancer support groups to attract and retain volunteers. The findings imply that cancer care initiatives can benefit from more local volunteers but at the same time these volunteers require flexibility and financial support to sustain their engagement.

  20. Reference intervals for putative biomarkers of drug-induced liver injury and liver regeneration in healthy human volunteers.

    Science.gov (United States)

    Francis, Ben; Clarke, Joanna I; Walker, Lauren E; Brillant, Nathalie; Jorgensen, Andrea L; Park, B Kevin; Pirmohamed, Munir; Antoine, Daniel J

    2018-05-02

    The potential of mechanistic biomarkers to improve the prediction of drug-induced liver injury (DILI) and hepatic regeneration is widely acknowledged. We sought to determine reference intervals for new biomarkers of DILI and regeneration as well as to characterize their natural variability and impact of diurnal variation. Serum samples from 200 healthy volunteers were recruited as part of a cross sectional study; of these, 50 subjects had weekly serial sampling over 3 weeks, while 24 had intensive blood sampling over a 24h period. Alanine aminotransferase (ALT), MicroRNA-122 (miR-122), high mobility group box-1 (HMGB1), total keratin-18 (FL-K18), caspase cleaved keratin-18 (cc-K18), glutamate dehydrogenase (GLDH) and colony stimulating factor-1 (CSF-1) were assessed by validated assays. Reference intervals were established for each biomarker based on the 97.5% quantile (90% CI) following the assessment of fixed effects in univariate and multivariable models (ALT 50 (41-50) U/l, miR-122 3548 (2912-4321) copies/µl, HMGB1 2.3 (2.2-2.4) ng/ml, FL-K18 475 (456-488) U/l, cc-K18 272 (256-291) U/l, GLDH 27 (26-30) U/l and CSF-1 2.4 (2.3-2.9) ng/ml). There was a small but significant intra-individual time random effect detected but no significant impact of diurnal variation was observed, with the exception of GLDH. Reference intervals for novel DILI biomarkers have been described for the first time. An upper limit of a reference range might represent the most appropriate method to utilize these data. Regulatory authorities have published letters of support encouraging further qualification of leading candidate biomarkers. These data can now be used to interpret data from exploratory clinical DILI studies and to assist their further qualification. Drug-induced liver injury (DILI) has a big impact on patient health and the development of new medicines. Unfortunately, currently used blood-based tests to assess liver injury and recovery suffer from insufficiencies. Newer blood

  1. Photoplethysmographic signals and blood oxygen saturation values during artificial hypothermia in healthy volunteers

    International Nuclear Information System (INIS)

    Shafique, M; Kyriacou, P A

    2012-01-01

    Pulse oximetry utilizes the technique of photoplethysmography to estimate arterial oxygen saturation (SpO 2 ) values. During hypothermia, the amplitude of the photoplethysmograph (PPG) is compromised which can lead to inaccurate estimation of SpO 2 . A new mutlimode PPG/pulse oximeter sensor was developed to investigate the behaviour of PPGs during conditions of induced hypothermia (hand immersed in an ice bath). PPG measurements from 20 volunteers were conducted and SpO 2 values were estimated at all stages of the experiment. Good quality PPG signals were observed from the majority of the volunteers at almost all hand temperatures. At low temperature ranges, from 13 to 21 °C, the failure rate to estimate SpO 2 values from the multimode transreflectance PPG sensor was 2.4% as compared to the commercial pulse oximeter with a failure rate of 70%. (paper)

  2. Psychopharmacology of theobromine in healthy volunteers.

    Science.gov (United States)

    Baggott, Matthew J; Childs, Emma; Hart, Amy B; de Bruin, Eveline; Palmer, Abraham A; Wilkinson, Joy E; de Wit, Harriet

    2013-07-01

    Theobromine, a methylxanthine related to caffeine and present in high levels in cocoa, may contribute to the appeal of chocolate. However, current evidence for this is limited. We conducted a within-subjects placebo-controlled study of a wide range of oral theobromine doses (250, 500, and 1,000 mg) using an active control dose of caffeine (200 mg) in 80 healthy participants. Caffeine had the expected effects on mood including feelings of alertness and cardiovascular parameters. Theobromine responses differed according to dose; it showed limited subjective effects at 250 mg and negative mood effects at higher doses. It also dose-dependently increased heart rate. In secondary analyses, we also examined individual differences in the drug's effects in relation to genes related to their target receptors, but few associations were detected. This study represents the highest dose of theobromine studied in humans. We conclude that theobromine at normal intake ranges may contribute to the positive effects of chocolate, but at higher intakes, effects become negative.

  3. Metabolic responses of healthy or prediabetic adults to bovine whey protein and sodium caseinate do not differ.

    Science.gov (United States)

    Hoefle, Anja S; Bangert, Adina M; Stamfort, Adelmar; Gedrich, Kurt; Rist, Manuela J; Lee, Yu-Mi; Skurk, Thomas; Daniel, Hannelore

    2015-03-01

    Casein is considered a slowly digestible protein compared with whey protein, and this may cause differences in hormone responses and the kinetics of delivering amino acids into the circulation. We investigated whether postprandial plasma hormone and metabolite responses were different when bovine casein or whey protein was co-administered with carbohydrates in healthy and prediabetic adults. White healthy male adults (n = 15) and white, well-defined male and female prediabetic adults (n = 15) received test drinks randomly on 3 different occasions at least 2 d apart which contained 50 g of maltodextrin19 (MD19) alone or in combination with 50 g of whey protein isolate (WPI) or 50 g of sodium caseinate (SC). Blood samples were collected over a 240-min time period and were analyzed for hormone profiles and defined metabolites. No evidence was found that gastric emptying was different between the 2 protein drinks. Both proteins increased peak plasma insulin concentrations in prediabetic persons by 96% compared with MD19 (each, P < 0.05), which was accompanied by a reduction of peak venous blood glucose by 21% (each, P < 0.0001) without a difference between the 2 proteins. Peak plasma glucagon concentrations increased by 101% in both groups after the protein drinks (P < 0.05). The WPI drink also increased peak plasma glucose-dependent insulinotropic polypeptide concentrations in healthy volunteers by 56% (P < 0.01). Differences in plasma metabolite concentrations in volunteers could be attributed exclusively to the differences in the amino acid composition of the 2 proteins ingested. The WPI and the SC drinks similarly reduced postprandial glucose excursions when ingested with carbohydrates in healthy and prediabetic volunteers. Under our experimental conditions, however, no evidence was found that gastrointestinal processing of the 2 protein varieties differed substantially. This trial was registered at clinicaltrials.gov as DRKS00005682. © 2015 American Society for

  4. Bioavailability of everolimus administered as a single 5 mg tablet versus five 1 mg tablets: a randomized, open-label, two-way crossover study of healthy volunteers.

    Science.gov (United States)

    Thudium, Karen; Gallo, Jorge; Bouillaud, Emmanuel; Sachs, Carolin; Eddy, Simantini; Cheung, Wing

    2015-01-01

    The mammalian target of rapamycin (mTOR) inhibitor everolimus has a well-established pharmacokinetics profile. We conducted a randomized, single-center, open-label, two-sequence, two-period crossover study of healthy volunteers to assess the relative bioavailability of everolimus administered as one 5 mg tablet or five 1 mg tablets. Subjects were randomized 1:1 to receive everolimus dosed as one 5 mg tablet or as five 1 mg tablets on day 1, followed by a washout period on days 8-14 and then the opposite formulation on day 15. Blood sampling for pharmacokinetic evaluation was performed at prespecified time points, with 17 samples taken for each treatment period. Primary variables for evaluation of relative bioavailability were area under the concentration-time curve from time zero to infinity (AUCinf) and maximum blood concentration (Cmax). Safety was assessed by reporting the incidence of adverse events (AEs). Twenty-two participants received everolimus as one 5 mg tablet followed by five 1 mg tablets (n=11) or the opposite sequence (n=11). The Cmax of five 1 mg tablets was 48% higher than that of one 5 mg tablet (geometric mean ratio, 1.48; 90% confidence interval [CI], 1.35-1.62). AUCinf was similar (geometric mean ratio, 1.08; 90% CI, 1.02-1.16), as were the extent of absorption and the distribution and elimination kinetics. AEs, all grade 1 or 2, were observed in 54.5% of subjects. Although the extent of absorption was similar, the Cmax of five 1 mg tablets was higher than that of one 5 mg tablet, suggesting these formulations lead to different peak blood concentrations and are not interchangeable at the dose tested.

  5. Effect of sildenafil on gastric emptying and postprandial frequency of antral contractions in healthy humans

    DEFF Research Database (Denmark)

    Madsen, J L; Søndergaard, S B; Fuglsang, S

    2004-01-01

    BACKGROUND: Sildenafil is known to block phosphodiesterase type 5, which degrades nitric oxide-stimulated cyclic guanosine monophosphate, thereby relaxing smooth muscle cells in various organs. The effect of sildenafil on gastric motor function after a meal was investigated in healthy humans....... METHODS: Ten healthy male volunteers (21-28 years) participated in a placebo-controlled, double-blind, cross-over study. In random order and on two separate days each volunteer ingested either 50 mg sildenafil (Viagra, Pfizer, New York, N.Y., USA) or placebo. A gamma camera technique was used to measure......: A single dose of 50 mg sildenafil does not change gastric emptying or postprandial frequency of antral contractions in healthy volunteers....

  6. Evaluation of two over-the-counter natural thyroid hormone preparations in human volunteers.

    Science.gov (United States)

    Csako, G; Corso, D M; Kestner, J; Bokser, A D; Kennedy, P E; Pucino, F

    1992-04-01

    To determine the pharmacologic activity of over-the-counter (OTC) thyroid preparations. In vitro analysis and a prospective, crossover study in vivo. Tertiary care center. Two healthy adult volunteers. Three OTC preparations (Thyrotrophin PMG [bovine thyroid PMG extract], Thyro Forte [thyroid lymphogland concentrate with synergistic complex], and Thyro Complex [thyroid lyophilized gland concentrate with synergistic complex]) were analyzed in vitro. Volunteers were administered two times the manufacturer's maximum recommended daily dose of either Thyrotrophin PMG or Thyro Forte for one week, washed out for four to five weeks, and crossed over to receive the opposite tablet preparation for an additional week. The triiodothyronine (T3) and thyroxine (T4) contents of OTC preparations were measured by HPLC. Vital signs, serum total and free T4, total T3, thyroid stimulating hormone, thyroxine binding globulin, thyroglobulin, and general chemistry tests (including glucose and cholesterol) were monitored before, during, and between administration of the products. HPLC analysis of the three OTC preparations showed no T4 but did show possible T3 in two of these products. We found no definite clinical or laboratory evidence of thyroid hormone excess with either product. Healthcare professionals should advise against the use of these scientifically unsound and relatively expensive OTC thyroid preparations, of which the therapeutic efficacy is unknown.

  7. Intravenous Bolus versus Continuous Infusion of Famotidine or Ranitidine on 24 H Intragastric Acidity in Fasting Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    ABR Thomson

    1995-01-01

    Full Text Available Infusions of H2-receptor antagonists may be clinically indicated to maintain intragastric pH above 4 to reduce acute gastric mucosal lesions or to treat patients with bleeding peptic ulcers. Eight fasting healthy volunteers were randomly assigned to receive ranitidine infusion alone (150 mg/day, ranitidine infusion plus 50 mg bolus injection of ranitidine (total of 200 mg/day, famotidine infusion alone (40 mg/day or famotidine infusion plus 40 mg bolus injection of famotidine (total of 80 mg/day. Gastric fluid contents were aspirated for 24 h and collected as half-hourly samples in which pH measurements were made. Measures analyzed were mean and median pH, percentage pH at or below 3, 4 or 5 for the 24 h period, daytime, evening and nighttime. The data for each of the variables were analyzed as a Latin square crossover design of variance therapy; base pH before treatment administration in each crossover phase was employed as the covariant. Significant differential treatment means were tested by Newman-Keul’s multiple range test at the 5% level of significance. The mean and median evening pH were higher after famotidine than after ranitidine infusion, but all other pH readings were similar when using these doses. The addition of an initial loading bolus of 50 mg ranitidine to the ranitidine infusion did not result in any added differences in pH, whereas the addition of an initial loading bolus of 40 mg famotidine to the famotidine infusion resulted in a higher 24 h median pH, as well as a lower percentage of pH values of 4 or below, 16.6% versus 28.5%, P<0.05. However, the loading doses of ranitidine and famotidine were not equivalent in potency, and studies are needed to compare the potency of equivalent doses of ranitidine and famotidine when given by bolus plus infusion. Also the clinical relevance of these findings needs to be explored further in the type of individuals potentially requiring intravenous H2-receptor antagonists.

  8. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Vance L Albaugh

    Full Text Available Atypical antipsychotics exhibit metabolic side effects including diabetes mellitus and obesity. The adverse events are preceded by acute worsening of oral glucose tolerance (oGTT along with reduced plasma free fatty acids (FFA and leptin in animal models. It is unclear whether the same acute effects occur in humans.A double blind, randomized, placebo-controlled crossover trial was conducted to examine the potential metabolic effects of olanzapine in healthy volunteers. Participants included male (8 and female (7 subjects [18-30 years old, BMI 18.5-25]. Subjects received placebo or olanzapine (10 mg/day for three days prior to oGTT testing. Primary endpoints included measurement of plasma leptin, oral glucose tolerance, and plasma free fatty acids (FFA. Secondary metabolic endpoints included: triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol, heart rate, blood pressure, body weight and BMI. Olanzapine increased glucose Area Under the Curve (AUC by 42% (2808±474 vs. 3984±444 mg/dl·min; P = 0.0105 during an oGTT. Fasting plasma leptin and triglycerides were elevated 24% (Leptin: 6.8±1.3 vs. 8.4±1.7 ng/ml; P = 0.0203 and 22% (Triglycerides: 88.9±10.1 vs. 108.2±11.6 mg/dl; P = 0.0170, whereas FFA and HDL declined by 32% (FFA: 0.38±0.06 vs. 0.26±0.04 mM; P = 0.0166 and 11% (54.2±4.7 vs. 48.9±4.3 mg/dl; P = 0.0184, respectively after olanzapine. Other measures were unchanged.Olanzapine exerts some but not all of the early endocrine/metabolic changes observed in rodent models of the metabolic side effects, and this suggest that antipsychotic effects are not limited to perturbations in glucose metabolism alone. Future prospective clinical studies should focus on identifying which reliable metabolic alterations might be useful as potential screening tools in assessing patient susceptibility to weight gain and diabetes caused by atypical antipsychotics.ClinicalTrials.gov NCT00741026.

  9. Whole-body distribution and radiation dosimetry of the dopamine transporter radioligand [{sup 11}C]PE2I in healthy volunteers

    Energy Technology Data Exchange (ETDEWEB)

    Ribeiro, Maria-Joao [Service Hospitalier Frederic Joliot, Institut d' Imagerie Biomedicale, Direction des Sciences du Vivant, Commissariat a l' Energie Atomique, F-91406 Orsay (France)]. E-mail: maria-joao.ribeiro@cea.fr; Ricard, Marcel [Service de Physique, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif (France); Lievre, Marie-Angele [Service Hospitalier Frederic Joliot, Institut d' Imagerie Biomedicale, Direction des Sciences du Vivant, Commissariat a l' Energie Atomique, F-91406 Orsay (France); Bourgeois, Sandrine [Service Hospitalier Frederic Joliot, Institut d' Imagerie Biomedicale, Direction des Sciences du Vivant, Commissariat a l' Energie Atomique, F-91406 Orsay (France); Emond, Patrick [INSERM U316, Laboratoire de Biophysique medicale et pharmaceutique, UFR des Sciences Pharmaceutiques, 37200 Tours (France); Gervais, Philippe [Service Hospitalier Frederic Joliot, Institut d' Imagerie Biomedicale, Direction des Sciences du Vivant, Commissariat a l' Energie Atomique, F-91406 Orsay (France); Dolle, Frederic [Service Hospitalier Frederic Joliot, Institut d' Imagerie Biomedicale, Direction des Sciences du Vivant, Commissariat a l' Energie Atomique, F-91406 Orsay (France); Syrota, Andre [Service Hospitalier Frederic Joliot, Institut d' Imagerie Biomedicale, Direction des Sciences du Vivant, Commissariat a l' Energie Atomique, F-91406 Orsay (France)

    2007-05-15

    Introduction: This study reports on the biodistribution and radiation dosimetry of a cocaine analog, the (E)-N-(3-iodoprop-2-enyl)-2{beta}-carbomethoxy-3{beta}-(4'-tolyl)nortropane (PE2I), labeled with carbon 11 ([{sup 11}C]PE2I). [{sup 11}C]PE2I is used in positron emission tomography (PET) for examination of the dopamine neuronal transporter (DAT). DAT radioligands are often used to evaluate the progression of Parkinson's disease or the efficiency of neuroprotective therapeutics, and, typically, these studies required several successive PET scans. Methods: In three healthy male volunteers, whole-body scans were performed up to 2 h following intravenous injection of 321{+-}6 MBq of [{sup 11}C]PE2I. For each subject, regions of interest were defined over all visible organs to generate time-activity curves and calculate the percentage of injected activity. Time-activity data were fitted to a monoexponential model, as an uptake phase followed by a mono-exponential washout, or bi-exponential model to obtain residence times. With the use of the MIRD method, several source organs were considered in estimating residence time and mean effective radiation absorbed doses. Results: Blood pressure and ECG findings remained unchanged after radioligand injection. The primary route of clearance was renal. Ten minutes after injection, high activities were observed in the kidneys, urinary-bladder, stomach, liver, salivary glands and brain. The urine bladder wall, stomach and liver received the highest absorbed doses. The average effective dose of [{sup 11}C]PE2I was estimated to be 6.4{+-}0.6 {mu}Sv/MBq. Conclusion: The amount of [{sup 11}C]PE2I required for adequate DAT PET imaging results in an acceptable effective dose equivalent permitting two or three repeated cerebral PET studies, with the injection of 222 MBq for each study.

  10. Guanidinoacetic acid loading affects plasma γ-aminobutyric acid in healthy men.

    Science.gov (United States)

    Ostojic, Sergej M; Stojanovic, Marko

    2015-08-01

    Guanidinoacetic acid (GAA), a precursor of creatine and an innovative dietary agent, activates γ-amino butyric acid (GABA) receptors yet clinical effects of dietary GAA on GABA metabolism are currently unknown. The main aim of this pilot research was to investigate whether GAA loading affected peripheral GABA homeostasis in healthy humans. Eight healthy male volunteers aged 22-25 years were randomized in a double-blind design to receive either GAA (three grams daily) or placebo by oral administration for 3 weeks. At baseline and after 3 weeks participants provided fasting blood samples for free plasma levels of GABA, GAA, creatine and glutamine. Following 3 weeks of intervention, plasma GABA level dropped significantly in participants receiving 3 g of GAA per day as compared to the placebo (P = 0.03). GAA loading significantly decreased plasma GABA by 88.8 nmol/L (95% confidence interval; 5.4-172.1) after 3 weeks of intervention as compared to the baseline (P = 0.03). GAA intervention positively affected both plasma GAA and creatine (P GABA metabolism, and potentially down-regulates GABA synthesis in peripheral tissues. Possible GABAergic action of dietary GAA adds to the safety profile of this novel dietary supplement.

  11. Intake of whole apples or clear apple juice has contrasting effects on plasma lipids in healthy volunteers.

    Science.gov (United States)

    Ravn-Haren, Gitte; Dragsted, Lars O; Buch-Andersen, Tine; Jensen, Eva N; Jensen, Runa I; Németh-Balogh, Mária; Paulovicsová, Brigita; Bergström, Anders; Wilcks, Andrea; Licht, Tine R; Markowski, Jarosław; Bügel, Susanne

    2013-12-01

    Fruit consumption is associated with a decreased risk of CVD in cohort studies and is therefore endorsed by health authorities as part of the '5 or more a day' campaigns. A glass of fruit juice is generally counted as one serving. Fruit may cause protection by affecting common risk factors of CVD. Apples are among the most commonly consumed fruits and were chosen for a comprehensive 5 × 4 weeks dietary crossover study to assess the effects of whole apples (550 g/day), apple pomace (22 g/day), clear and cloudy apple juices (500 ml/day), or no supplement on lipoproteins and blood pressure in a group of 23 healthy volunteers. The intervention significantly affected serum total and LDL-cholesterol. Trends towards a lower serum LDL-concentration were observed after whole apple (6.7%), pomace (7.9%) and cloudy juice (2.2%) intake. On the other hand, LDL-cholesterol concentrations increased by 6.9% with clear juice compared to whole apples and pomace. There was no effect on HDL-cholesterol, TAG, weight, waist-to-hip ratio, blood pressure, inflammation (hs-CRP), composition of the gut microbiota or markers of glucose metabolism (insulin, IGF1 and IGFBP3). Apples are rich in polyphenols and pectin, two potentially bioactive constituents; however, these constituents segregate differently during processing into juice products and clear juice is free of pectin and other cell wall components. We conclude that the fibre component is necessary for the cholesterol-lowering effect of apples in healthy humans and that clear apple juice may not be a suitable surrogate for the whole fruit in nutritional recommendations.

  12. Are Volunteer Satisfaction and Enjoyment Related to Cessation of Volunteering by Older Adults?

    Science.gov (United States)

    Okun, Morris; Infurna, Frank J; Hutchinson, Ianeta

    2016-05-01

    Previous research indicates that volunteer satisfaction and enjoyment do not exert direct effects on the cessation of volunteering by older adults. This study examined whether satisfaction with and enjoyment of volunteering indirectly affect volunteer cessation via hours volunteered. Our sample consisted of participants in the Americans' Changing Lives study (N = 380) who were 65 years old and older and who volunteered at Wave 1. Volunteer satisfaction, volunteer enjoyment, hours volunteered, and several covariates were assessed at Wave 1, and volunteer cessation was assessed 3 years later at Wave 2. Volunteer satisfaction and volunteer enjoyment were positively associated with hours volunteered, and more hours volunteered was associated with decreased likelihood of volunteer cessation. The indirect effects of volunteer satisfaction and volunteer enjoyment on volunteer cessation via hours volunteered were -.023 (p = .059) and -.036 (p = .015), respectively. The dynamics of volunteer cessation are important because a volunteer shortage is forecasted and because the benefits of volunteering may attenuate when volunteering stops. Future research should test the proposed causal sequence using longitudinal data with at least 3 waves. © The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  13. Volunteering with Newcomers: The Perspectives of Canadian- and Foreign-born Volunteers

    Directory of Open Access Journals (Sweden)

    Behnam Behnia

    2012-12-01

    Full Text Available Canadian- and foreign-born volunteers have contributed to the settlement of newcomers into Canadian society. Despite their important contribution, little has been reported about the experiences and perspectives of these volunteers. Using the information collected from face-to-face interviews with 60 Canadian- and foreign-born volunteers who support newcomers, this article discusses factors that motivate people to volunteer with newcomers. The study results revealed among other findings that (1 to become a volunteer, one not only needs to be motivated but also needs to believe that volunteering will produce the expected positive results and to have confidence in one’s ability to complete the assigned tasks, (2 once people become volunteers, the experience of volunteering tests their perceived self-efficacy and their belief about the effectiveness of their volunteer work. Success or failure in their expectations influences their decision tocontinue or discontinue their volunteer work.

  14. Closed and open breathing circuit function in healthy volunteers during exercise at Mount Everest base camp (5300 m).

    LENUS (Irish Health Repository)

    McMorrow, R C N

    2012-08-01

    We present a randomised, controlled, crossover trial of the Caudwell Xtreme Everest (CXE) closed circuit breathing system vs an open circuit and ambient air control in six healthy, hypoxic volunteers at rest and exercise at Everest Base Camp, at 5300 m. Compared with control, arterial oxygen saturations were improved at rest with both circuits. There was no difference in the magnitude of this improvement as both circuits restored median (IQR [range]) saturation from 75%, (69.5-78.9 [68-80]%) to > 99.8% (p = 0.028). During exercise, the CXE closed circuit improved median (IQR [range]) saturation from a baseline of 70.8% (63.8-74.5 [57-76]%) to 98.8% (96.5-100 [95-100]%) vs the open circuit improvement to 87.5%, (84.1-88.6 [82-89]%; p = 0.028). These data demonstrate the inverse relationship between supply and demand with open circuits and suggest that ambulatory closed circuits may offer twin advantages of supplying higher inspired oxygen concentrations and\\/or economy of gas use for exercising hypoxic adults.

  15. Evaluation of the ease of taking mini-tablets compared with other tablet formulations in healthy volunteers.

    Science.gov (United States)

    Hayakawa, Yoshiyuki; Uchida, Shinya; Namiki, Noriyuki

    2016-03-10

    "Mini-tablets" (MTs) are tablets of diameter≤3mm and have been widely studied and developed. However, reports comparing MTs with other tablet formulations are few. We wished to evaluate the ease of taking a MT quantitatively in comparison with an orally disintegrating mini-tablet (ODMT), conventional tablet (CT) and conventional orally disintegrating tablet (ODT). Four types of tablets were prepared. We prepared tablets of two diameters (3mm for MTs and ODMTs vs. 8mm for CTs and ODTs) and two formulations (MTs and CTs vs. ODMTs and ODTs). Our randomized crossover trial in 18 healthy volunteers (8 men and 10 women; mean age, 22.5years) indicated that the visual analog scale (VAS) score for the ease and amount of water required for intake of MTs was significantly lower than those of CTs. An ODMT required the least amount of water and smallest VAS score for the ease of taking a tablet. Our results showed that the advantage of MTs with regard to the ease of taking and decreased amount of water required was exerted for a unit of dosing comprising tablets. These data suggested the usefulness of MTs and the importance of the number of MTs for comfortable consumption by patients. Copyright © 2015. Published by Elsevier B.V.

  16. Plasma homovanillic acid correlates inversely with history of learning problems in healthy volunteer and personality disordered subjects.

    Science.gov (United States)

    Coccaro, Emil F; Hirsch, Sharon L; Stein, Mark A

    2007-01-15

    Central dopaminergic activity is critical to the functioning of both motor and cognitive systems. Based on the therapeutic action of dopaminergic agents in treating attention deficit hyperactivity disorder (ADHD), ADHD symptoms may be related to a reduction in central dopaminergic activity. We tested the hypothesis that dopaminergic activity, as reflected by plasma homovanillic acid (pHVA), may be related to dimensional aspects of ADHD in adults. Subjects were 30 healthy volunteer and 39 personality disordered subjects, in whom morning basal pHVA concentration and a dimensional measure of childhood ADHD symptoms (Wender Utah Rating Scale: WURS) were obtained. A significant inverse correlation was found between WURS Total score and pHVA concentration in the total sample. Among WURS factor scores, a significant inverse relationship was noted between pHVA and history of "childhood learning problems". Consistent with the dopaminergic dysfunction hypothesis of ADHD and of cognitive function, pHVA concentrations were correlated with childhood history of ADHD symptoms in general and with history of "learning problems" in non-ADHD psychiatric patients and controls. Replication is needed in treated and untreated ADHD samples to confirm these initial results.

  17. Risk and Emotion Among Healthy Volunteers in Clinical Trials

    NARCIS (Netherlands)

    Cottingham, M.D.; Fisher, J.A.

    2016-01-01

    Theorized as objective or constructed, risk is recognized as unequally distributed across social hierarchies. Yet the process by which social forces shape risk and risk emotions remains unknown. The pharmaceutical industry depends on healthy individuals to voluntarily test early-stage,

  18. Psychological effects of ketamine in healthy volunteers - Phenomenological study

    NARCIS (Netherlands)

    Pomarol-Clotet, E.; Honey, G. D.; Murray, G. K.; Corlett, P. R.; Absalom, A. R.; Lee, M.; McKenna, P. J.; Bullmore, E. T.; Fletcher, P. C.

    Background: The psychosis-inducing effect of ketamine is important evidence supporting the glutamate hypothesis of schizophrenia. However, the symptoms the drug produces have not been described systematically. Aim: To examine the effects of ketamine in healthy people using a structured psychiatric

  19. Healthy bread initiative: methods, findings, and theories--Isfahan Healthy Heart Program.

    Science.gov (United States)

    Talaei, Mohammad; Mohammadifard, Noushin; Khaje, Mohammad-Reza; Sarrafzadegan, Nizal; Sajjadi, Firoozeh; Alikhasi, Hasan; Maghroun, Maryam; Iraji, Farhad; Ehteshami, Shahram

    2013-03-01

    The scientific evidences show that the content, baking methods, and types of bread can make health impacts. Bread, as a major part of Iranian diet, demonstrates a significant potential to be targeted as health promotion subject. Healthy Food for Healthy Communities (HFHC) was a project of Isfahan Healthy Heart Program (IHHP), consisting of a wide variety of strategies, like Healthy Bread (HB) Initiative. The HB Initiative was designed to improve the behaviour of both producers and consumers, mainly aiming at making high-fibre, low-salt bread, eliminating the use of baking soda, providing enough rest time for dough before baking (at least one hour), and enough baking time (at least one minute in oven). A workshop was held for volunteer bakers, and a baker-to-baker training protocol under direct supervision was designed for future volunteers. Cereal Organization was persuaded to provide less refined flour that contained more bran. Health messages in support of new breads were disseminated by media and at bakeries by health professionals. Evaluation of the HB Initiative was done using before-after assessments and population surveys. While HB was baked in 1 (0.01%) bakery at baseline, 402 (41%) bakeries in the intervention area joined the HB Initiative in 2009. Soda was completely eliminated and fibre significantly increased from 4 +/- 0.4 g% before study to 12 +/- 0.6 g% after the intervention (p bread decreased from 13 +/- 1.8 g% to 2 +/- 0.5 g% and was expressed as the most important advantage of this initiative by consumers. People who lived in Isfahan city consumed whole bread 6 times more than those who lived in reference area Arak (p breads as a healthy choice that were compatible with local dishes and made a model to solve the longstanding problems of bread. It used various health promotion approaches but was best consistent with Beattie's model.

  20. Effect of royal jelly ingestion for six months on healthy volunteers

    Directory of Open Access Journals (Sweden)

    Morita Hiroyuki

    2012-09-01

    Full Text Available Abstract Background Royal jelly is a widely ingested supplement for health, but its effects on humans are not well known. The objective was to evaluate the effects of long-term royal jelly ingestion on humans. Methods We conducted a randomized placebo-controlled, double-blind trial. A total of 61 healthy volunteers aged 42-83 years were enrolled and were randomly divided into a royal jelly group (n = 31 and a control group (n = 30. Three thousand mg of royal jelly (RJ or a placebo in 100 ml liquid/day were ingested for 6 months. The primary outcomes were changes in anthropometric measurements and biochemical indexes from baseline to 6 months after intervention. Results Thirty subjects in the RJ group and 26 in the control group were included in the analysis of endpoints. In an adjusted mean change of the variables from the baseline, significant differences between the two groups could be found in red blood cell counts (+0.16x106 /μL for the RJ group vs. -0.01x106 /μL for the control group, P = 0.0134, hematocrit (+0.9% vs. -0.8%, P = 0.0251, log (fasting plasma glucose (+0.01 ± 0.01 log mg/dL vs. +0.05 ± 0.01 log mg/dL, P = 0.0297, log (insulinogenic index (+0.25 vs. -0.13, P = 0.0319, log dehydroepiandrosterone sulfate (DHEA-S (+0.08 log μg/dL vs. +0.20 log μg/dL, P = 0.0483, log testosterone (T (+0.12 ± 0.04 log ng/mL vs. -0.02 ± 0.05 log ng/mL, P = 0.0416, log T/DHEA-S ratio (+0.05 ± 0.05 vs. -0.23 ± 0.59, P = 0.0015, and in one of the SF-36 subscale scores, mental health (MH (+4 vs. -7, P = 0.0276. Conclusions Six-month ingestion of RJ in humans improved erythropoiesis, glucose tolerance and mental health. Acceleration of conversion from DHEA-S to T by RJ may have been observed among these favorable effects.

  1. Comparison of Anti-Saccharomyces Cerevisiae Antibodies (ASCA in Behcet’s Disease Patients with Three Groups of Oral Aphthosis, other Rheumatologic Diseases and Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Saeed Kerdari

    2015-07-01

    Full Text Available Introduction: Behcet’s Disease (BD is a general and progressive vasculitis and involves various organs. Its main etiology is not yet understood; however, immunologic and infectious causes and genetic predisposition have been proposed. Saccharomyces Cerevisiae is a type of yeast which is used in the bread and wine industries. Antibodies against this yeast have a well-proven role in inflammatory bowel diseases. The aim of the present study was to assess the frequency of Anti-Saccharomyces Cerevisiae Antibody (ASCA and its relation to clinical symptoms and disease activity index in patients afflicted by BD. Materials and Methods: Serum ASCA levels, determined by ELISA, were Studied in Behcet’s disease along with oral aphthosis, other rheumatologic diseases and healthy volunteers (n=30 in each group. In the BD group the disease activity index and different clinical symptoms were recorded during the study course. Results:Serum level of ASCA in the four studied groups of BD, oral aphthosis, other rheumatologic disease and healthy volunteers was 9.18±9.69, 10.90±10.40, 11.29±17.96 and 8.86±5.31IU/ml, respectively;  indicating no meaningful difference (p=0.811. The ASCA titer was not related to Behcet’s disease severity (p=0.399. Serum level of ASCA in BD patients with oral aphthosis or with gastrointestinal symptoms was significantly higher than the other Behcet’s Disease patients (p=0.012, p=0.014. Conclusion: ASCS is not a valuable test for distinguishing BD from recurrent oral aphthosis or other connective tissue disorders. It also cannot be used for determining disease severity. However, it has a higher level in BD patients with oral aphthous ulcers and gastrointestinal symptoms.

  2. Sjoegren's syndrome of the parotid gland: value of diffusion-weighted echo-planar MRI for diagnosis at an early stage based on MR sialography grading in comparison with healthy volunteers

    International Nuclear Information System (INIS)

    Regier, Marc; Ries, T.; Arndt, C.; Cramer, M.C.; Adam, G.; Habermann, C.R.; Graessner, J.; Reitmeier, F.; Jaehne, M.

    2009-01-01

    To investigate the value of diffusion-weighted echo-planar imaging (DW-EPI) for quantifying functional changes of the parotid gland in Sjoegren's disease and to evaluate whether ADC mapping allows for early diagnosis based on MR sialography grading. Using a DW-EPI sequence at 1.5T (b-factors: 0, 500 and 1000 sec/mm 2 ), the parotid glands of 52 healthy volunteers and 13 patients with histologically verified affection of Sjoegren's disease were examined. All scans were performed prior to and following gustatory stimulation with 5 ml of lemon juice. ADC maps were evaluated by placing an inordinate region-of-interest (ROI) enclosing the entire parotid gland. Sjoegren's disease was graded based on MR sialography findings using a 4-point grading-scale. Statistics included student t-test and kappa-analysis. In healthy volunteers mean ADCs of 1.14 x 10 -3 mm 2 /sec before and 1.2 x 10 -3 mm 2 /sec after stimulation were observed. Higher ADCs were determined for early-stage Sjoegren's disease, averaging 1.22 x 10 -3 mm 2 /sec before and 1.29 x 10 -3 mm 2 /sec after stimulation. Advanced disease revealed significantly lower ADCs (0.97 x 10 -3 mm 2 /sec (p = 0.002) before and 1.01 x 10 -3 mm 2 /sec (p < 0.001) after stimulation). (orig.)

  3. Effect of alcohol consumption on whole-body protein turnover in healthy adults.

    Science.gov (United States)

    Wutzke, Klaus D; Krentz, Helga; Bruns, Gerrit

    2011-03-01

    The aim of the study was to investigate the whole-body protein turnover, either before or after continuous, moderate ethanol-induced oxidative stress by red wine consumption over a relatively short period in healthy volunteers. Ten healthy adults received an individual regular diet over 20 days. After 10 days, the subjects consumed 0.4 ml ethanol kg(-1) day(-1) as red wine together with dinner over a 10-day period. After 8 and 18 days, respectively, a (15)N-labelled yeast protein was administered in a dosage of 4.2 mg kg(-1) body weight. Urine and faeces were collected over 48 h, respectively. The (15)N-enrichment was measured by isotope ratio mass spectrometry, whereas the protein flux rates were calculated by a three-compartment model. The whole-body protein turnover without/with red wine consumption amounted to 3.73±0.6 and 3.49±0.6 g kg(-1) day(-1) (not significant), respectively. Moderate alcohol consumption does not induce significant short-term changes in the whole-body protein turnover of healthy adults.

  4. Daytime Ayahuasca administration modulates REM and slow-wave sleep in healthy volunteers.

    Science.gov (United States)

    Barbanoj, Manel J; Riba, Jordi; Clos, S; Giménez, S; Grasa, E; Romero, S

    2008-02-01

    Ayahuasca is a traditional South American psychoactive beverage and the central sacrament of Brazilian-based religious groups, with followers in Europe and the United States. The tea contains the psychedelic indole N,N-dimethyltryptamine (DMT) and beta-carboline alkaloids with monoamine oxidase-inhibiting properties that render DMT orally active. DMT interacts with serotonergic neurotransmission acting as a partial agonist at 5-HT(1A) and 5-HT(2A/2C) receptor sites. Given the role played by serotonin in the regulation of the sleep/wake cycle, we investigated the effects of daytime ayahuasca consumption in sleep parameters. Subjective sleep quality, polysomnography (PSG), and spectral analysis were assessed in a group of 22 healthy male volunteers after the administration of a placebo, an ayahuasca dose equivalent to 1 mg DMT kg(-1) body weight, and 20 mg d-amphetamine, a proaminergic drug, as a positive control. Results show that ayahuasca did not induce any subjectively perceived deterioration of sleep quality or PSG-measured disruptions of sleep initiation or maintenance, in contrast with d-amphetamine, which delayed sleep initiation, disrupted sleep maintenance, induced a predominance of 'light' vs 'deep' sleep and significantly impaired subjective sleep quality. PSG analysis also showed that similarly to d-amphetamine, ayahuasca inhibits rapid eye movement (REM) sleep, decreasing its duration, both in absolute values and as a percentage of total sleep time, and shows a trend increase in its onset latency. Spectral analysis showed that d-amphetamine and ayahuasca increased power in the high frequency range, mainly during stage 2. Remarkably, whereas slow-wave sleep (SWS) power in the first night cycle, an indicator of sleep pressure, was decreased by d-amphetamine, ayahuasca enhanced power in this frequency band. Results show that daytime serotonergic psychedelic drug administration leads to measurable changes in PSG and sleep power spectrum and suggest an

  5. The effect of volunteer management professionalization level on volunteer work satisfaction

    OpenAIRE

    Peychlová, Štěpánka

    2013-01-01

    This text concentrates on volunteering in volunteer organizations. It examines the connection between volunteer management professionalization level and volunteer work satisfaction in these organizations. In the theoretical part is defined the concepts of volunteering, professionalization and satisfaction are defined and their particular aspects associated with the focus of the thesis are highlighted. The empirical part describes the construction of the research method and presents the analys...

  6. South African volunteers' experiences of volunteering at the 2010 ...

    African Journals Online (AJOL)

    The purpose of this research was to study the phenomenon of volunteering through South African volunteers' experiences of volunteering at the 2010 FIFA World Cup, specifically in the City of Tshwane (COT) in the Tshwane Metropolitan Area (TMA). A qualitative research design was employed, with specific reference to ...

  7. Volunteering, driving status, and mortality in U.S. retirees.

    Science.gov (United States)

    Lee, Sei J; Steinman, Michael A; Tan, Erwi