Safety pharmacology of acute MDMA administration in healthy subjects.

Science.gov (United States)

Vizeli, Patrick; Liechti, Matthias E

2017-05-01

3,4-Methylenedioxymethamphetamine (MDMA; ecstasy) is being investigated in MDMA-assisted psychotherapy. The present study characterized the safety pharmacology of single-dose administrations of MDMA (75 or 125 mg) using data from nine double-blind, placebo-controlled, crossover studies performed in the same laboratory in a total of 166 healthy subjects. The duration of the subjective effects was 4.2 ± 1.3 h (range: 1.4-8.2 h). The 125 mg dose of MDMA produced greater 'good drug effect' ratings than 75 mg. MDMA produced moderate and transient 'bad drug effect' ratings, which were greater in women than in men. MDMA increased systolic blood pressure to >160 mmHg, heart rate >100 beats/min, and body temperature >38°C in 33%, 29% and 19% of the subjects, respectively. These proportions of subjects with hypertension (>160 mmHg), tachycardia, and body temperature >38°C were all significantly greater after 125 mg MDMA compared with the 75 mg dose. Acute and subacute adverse effects of MDMA as assessed by the List of Complaints were dose-dependent and more frequent in females. MDMA did not affect liver or kidney function at EOS 29 ± 22 days after use. No serious adverse events occurred. In conclusion, MDMA produced predominantly acute positive subjective drug effects. Bad subjective drug effects and other adverse effects were significantly more common in women. MDMA administration was overall safe in physically and psychiatrically healthy subjects and in a medical setting. However, the risks of MDMA are likely higher in patients with cardiovascular disease and remain to be investigated in patients with psychiatric disorders.

Ibrutinib does not prolong the corrected QT interval in healthy subjects: results from a thorough QT study.

Science.gov (United States)

de Jong, Jan; Hellemans, Peter; Jiao, James Juhui; Huang, Yuhan; Mesens, Sofie; Sukbuntherng, Juthamas; Ouellet, Daniele

2017-12-01

Ibrutinib is an orally administered, irreversible Bruton's tyrosine kinase inhibitor for treatment of B-cell malignancy. This study evaluated the effects of single-dose ibrutinib at therapeutic and supratherapeutic exposures on cardiac repolarization in healthy subjects. Part 1 used an open-label, two-period sequential design to assess the safety and pharmacokinetics of single doses of ibrutinib 840 and 1680 mg in eight subjects. Part 2 was a randomized, placebo- and positive (moxifloxacin)-controlled, double-blind, single dose, four-way cross-over study to assess the effect of ibrutinib (840 and 1680 mg) on QT/QTc interval. 64 healthy subjects were planned to be enrolled. Baseline-adjusted QT (QTc) intervals for ibrutinib and moxifloxacin (assay sensitivity) were compared to placebo using linear mixed-effect model. A concentration-QTc analysis was also conducted. No clinically relevant safety observations were noted in Part 1. During Part 2, one subject experienced Grade 4 ALT/AST elevations with ibrutinib 1680 mg, leading to study termination and limiting the enrollment to 20 subjects. Ibrutinib demonstrated dose-dependent increases in exposure. The upper bounds of the 90% CIs for the mean difference in change from baseline in QTc between ibrutinib and placebo were Ibrutinib caused a concentration-dependent mild shortening of QTc and mild PR prolongation, but these effects were not considered clinically meaningful. Therapeutic and supratherapeutic concentrations of ibrutinib do not prolong the QTc interval. CLINICALTRIALS.GOV: NCT02271438.

Electroretinography in healthy subjects in relation to systemic glucocorticoid intake

DEFF Research Database (Denmark)

Kappelgaard, Per; Hansen, Katrine B; Vilsbøll, Tina

2012-01-01

This study examined electroretinographic function in healthy subjects before and after prednisolone intake. To separate the effect of prednisolone on the retina from the potentially confounding hyperglycemia-inducing effect of prednisolone, electroretinography was made while fasting and at a pre-...

The Effect of Ramadan Fasting on Biochemical Parameters in Healthy Thai Subjects.

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Ongsara, Sara; Boonpol, Sakulrat; Prompalad, Nussaree; Jeenduang, Nutjaree

2017-09-01

Although, the effect of Ramadan fasting on the risks for Cardiovascular Disease (CVD) has been reported in several studies, the results were inconsistent. In addition, the effect of Ramadan fasting on biochemical parameters in Thai subjects has not been evaluated. The aim of this study was to investigate the effect of Ramadan fasting on anthropometry, blood pressure, Fasting Blood Glucose (FBG), lipid profiles, and body composition in healthy Thai subjects. A total of 65 healthy subjects (21 men and 44 women) aged between 19-24 years were randomly recruited. Anthropometry, blood pressure, FBG, Total Cholesterol (TC), Triglyceride (TG), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), and body composition were measured before Ramadan, end of Ramadan and after one month of Ramadan. There were no changes in anthropometry, blood pressure, lipid profiles and body composition in both genders before Ramadan, end of Ramadan and after one month of Ramadan. Nevertheless, FBG levels were significantly increased after one month of Ramadan compared with baseline (5.09±0.50 versus 4.83±0.38 mmol/L, p=0.016, respectively) in women. The Ramadan fasting did not affect the lipid, anthropometric and body composition in healthy Thai subjects. However, the increased FBG levels after one month of Ramadan were observed in women. To improve the favourable biochemical parameters after Ramadan fasting, the lifestyle modifications such as, increased intake of healthy diets and increased physical activity should be recommended.

Step-to-step reproducibility and asymmetry to study gait auto-optimization in healthy and cerebral palsied subjects.

Science.gov (United States)

Descatoire, A; Femery, V; Potdevin, F; Moretto, P

2009-05-01

The purpose of our study was to compare plantar pressure asymmetry and step-to-step reproducibility in both able-bodied persons and two groups of hemiplegics. The relevance of the research was to determine the efficiency of asymmetry and reproducibility as indexes for diagnosis and rehabilitation processes. This study comprised 31 healthy young subjects and 20 young subjects suffering from cerebral palsy hemiplegia assigned to two groups of 10 subjects according to the severity of their musculoskeletal disorders. The peaks of plantar pressure and the time to peak pressure were recorded with an in-shoe measurement system. The intra-individual coefficient of variability was calculated to indicate the consistency of plantar pressure during walking and to define gait stability. The effect size was computed to quantify the asymmetry and measurements were conducted at eight footprint locations. Results indicated few differences in step-to-step reproducibility between the healthy group and the less spastic group while the most affected group showed a more asymmetrical and unstable gait. From the concept of self-optimisation and depending on the neuromotor disorders the organism could make priorities based on pain, mobility, stability or energy expenditure to develop the best gait auto-optimisation.

Vibration Response Imaging: evaluation of rater agreement in healthy subjects and subjects with pneumonia

International Nuclear Information System (INIS)

Bartziokas, Konstantinos; Daenas, Christos; Preau, Sebastien; Zygoulis, Paris; Triantaris, Apostolos; Kerenidi, Theodora; Makris, Demosthenes; Gourgoulianis, Konstantinos I; Daniil, Zoe

2010-01-01

We evaluated pulmonologists variability in the interpretation of Vibration response imaging (VRI) obtained from healthy subjects and patients hospitalized for community acquired pneumonia. The present is a prospective study conducted in a tertiary university hospital. Twenty healthy subjects and twenty three pneumonia cases were included in this study. Six pulmonologists blindly analyzed images of normal subjects and pneumonia cases and evaluated different aspects of VRI images related to the quality of data aquisition, synchronization of the progression of breath sound distribution and agreement between the maximal energy frame (MEF) of VRI (which is the maximal geographical area of lung vibrations produced at maximal inspiration) and chest radiography. For qualitative assessment of VRI images, the raters' evaluations were analyzed by degree of consistency and agreement. The average value for overall identical evaluations of twelve features of the VRI image evaluation, ranged from 87% to 95% per rater (94% to 97% in control cases and from 79% to 93% per rater in pneumonia cases). Inter-rater median (IQR) agreement was 91% (82-96). The level of agreement according to VRI feature evaluated was in most cases over 80%; intra-class correlation (ICC) obtained by using a model of subject/rater for the averaged features was overall 0.86 (0.92 in normal and 0.73 in pneumonia cases). Our findings suggest good agreement in the interpretation of VRI data between different raters. In this respect, VRI might be helpful as a radiation free diagnostic tool for the management of pneumonia

Vibration Response Imaging: evaluation of rater agreement in healthy subjects and subjects with pneumonia

Directory of Open Access Journals (Sweden)

Makris Demosthenes

2010-03-01

Full Text Available Abstract Background We evaluated pulmonologists variability in the interpretation of Vibration response imaging (VRI obtained from healthy subjects and patients hospitalized for community acquired pneumonia. Methods The present is a prospective study conducted in a tertiary university hospital. Twenty healthy subjects and twenty three pneumonia cases were included in this study. Six pulmonologists blindly analyzed images of normal subjects and pneumonia cases and evaluated different aspects of VRI images related to the quality of data aquisition, synchronization of the progression of breath sound distribution and agreement between the maximal energy frame (MEF of VRI (which is the maximal geographical area of lung vibrations produced at maximal inspiration and chest radiography. For qualitative assessment of VRI images, the raters' evaluations were analyzed by degree of consistency and agreement. Results The average value for overall identical evaluations of twelve features of the VRI image evaluation, ranged from 87% to 95% per rater (94% to 97% in control cases and from 79% to 93% per rater in pneumonia cases. Inter-rater median (IQR agreement was 91% (82-96. The level of agreement according to VRI feature evaluated was in most cases over 80%; intra-class correlation (ICC obtained by using a model of subject/rater for the averaged features was overall 0.86 (0.92 in normal and 0.73 in pneumonia cases. Conclusions Our findings suggest good agreement in the interpretation of VRI data between different raters. In this respect, VRI might be helpful as a radiation free diagnostic tool for the management of pneumonia.

[Bristol Stool Chart: Prospective and monocentric study of "stools introspection" in healthy subjects].

Science.gov (United States)

Amarenco, G

2014-09-01

The Bristol Stool Chart (BSC) allows patients to identify their stool form using seven different images with accompanying written descriptors. Stool form was found to correlate better than stool frequency with whole-gut transit as measured by a radio-opaque marker study. This score is widely used in order to verify the presence of a constipation and to evaluate the therapeutic impact of various treatments. In our clinical practice, we was strongly surprised by the facility and the great precision of the patients to report their stool form, meaning that they usually and daily verify these stools. We wanted to precise the goals of a such attitude. Two questionnaires were proposed to healthy and voluntary subjects. Q1 was supposedly presented in order to verify the sensibility of a French version of BSC in a healthy population. Thus, Q1 precised the difficulties or not to understand pictures and written descriptors, asked about exhaustive analysis by means of BSC of stool form and bowel condition. All subjects with history of ano-rectal disorders or specific treatment for bowel dysfunction were excluded. After Q1 fulfilled, Q2 was proposed to the subjects. Q2 was designed to precise the goals of the patient when he look at his stool and the frequency of such an investigation. Finally a specific question concerning the subject opinion about this behavior in terms of bothersome, shame, or metaphysic interrogation. Eighty-five healthy subjects were recruited (42 female and 43 male). Mean age was 37.2 (sd = 15.7). Mean score of BCS was 2.07 (sd =1.05) (2.07 for female and 1.81 for male, P = 0.22). Number of categories of stool form was only 1 in 40%, 2 categories in 31%, 3 in 19%, 4 in 10%. Presence of a constipation defined by category 1 or 2 was found in 17% (23% in F, 12% in M, P = 0.075). Precision of BSC was noted as excellent in 68%, moderated in 18% and poor in 14%. BSC was considered as easy to use in 75%. Frequency of inspection of feces was systematic for 37%, 1

Cytokine and chemokine levels in tears from healthy subjects.

Science.gov (United States)

Carreño, Ester; Enríquez-de-Salamanca, Amalia; Tesón, Marisa; García-Vázquez, Carmen; Stern, Michael E; Whitcup, Scott M; Calonge, Margarita

2010-11-01

There is growing evidence for the existence of an 'immune tone' in normal tears. The aim of this study was to determine the levels of a large panel of cytokines and chemokines in tears obtained from healthy subjects. These levels can then serve as baseline values for comparison with patients suffering from ocular surface diseases. Nine healthy subjects participated in this study, and normal ocular surface health was documented by the results of a dry eye questionnaire, Schirmer strip wetting, and vital staining of the cornea. Four microliters of tears were collected from each eye and analysed separately with multiplex bead-based assays for the concentration of 30 cytokines and chemokines. Twenty-five cytokines/chemokines were detected. CCL11/Eotaxin1, GM-CSF, G-CSF, IFN-γ, IL-2, IL-3, IL-4, IL-5, IL-10, IL-13, IL-12p70, IL-15, CX3CL1/Fractalkine, TNF-α, epidermal growth factor, and CCL4/MIP-1β were present at 5-100 pg/ml. IL-1β, IL-6, IL-7A, CXCL8/IL-8, and CCL2/MCP-1 were present at 100-400 pg/ml. IL-1Ra, CXCL10/IP-10 and vascular endothelial growth factor were present at more than 1000 pg/ml. Multiplex bead-based assays are convenient for cytokine/chemokine detection in tears. Fracktalkine has been detected in human healthy tears for the first time. The knowledge of cytokine/chemokine concentrations in tears from normal subjects is an important reference for further comparison with patients suffering from ocular surface diseases. Variability in their levels can reflect a phenomenon of potential importance for the understanding of the ocular surface cytokine pattern. © 2010 The Authors. Journal compilation © 2010 Acta Ophthalmol.

Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects.

Science.gov (United States)

Fiori, Valentina; Coccia, Michela; Marinelli, Chiara V; Vecchi, Veronica; Bonifazi, Silvia; Ceravolo, M Gabriella; Provinciali, Leandro; Tomaiuolo, Francesco; Marangolo, Paola

2011-09-01

A number of studies have shown that modulating cortical activity by means of transcranial direct current stimulation (tDCS) affects performances of both healthy and brain-damaged subjects. In this study, we investigated the potential of tDCS to enhance associative verbal learning in 10 healthy individuals and to improve word retrieval deficits in three patients with stroke-induced aphasia. In healthy individuals, tDCS (20 min, 1 mA) was applied over Wernicke's area (position CP5 of the International 10-20 EEG System) while they learned 20 new "words" (legal nonwords arbitrarily assigned to 20 different pictures). The healthy subjects participated in a randomized counterbalanced double-blind procedure in which they were subjected to one session of anodic tDCS over left Wernicke's area, one sham session over this location and one session of anodic tDCS stimulating the right occipito-parietal area. Each experimental session was performed during a different week (over three consecutive weeks) with 6 days of intersession interval. Over 2 weeks, three aphasic subjects participated in a randomized double-blind experiment involving intensive language training for their anomic difficulties in two tDCS conditions. Each subject participated in five consecutive daily sessions of anodic tDCS (20 min, 1 mA) and sham stimulation over Wernicke's area while they performed a picture-naming task. By the end of each week, anodic tDCS had significantly improved their accuracy on the picture-naming task. Both normal subjects and aphasic patients also had shorter naming latencies during anodic tDCS than during sham condition. At two follow-ups (1 and 3 weeks after the end of treatment), performed only in two aphasic subjects, response accuracy and reaction times were still significantly better in the anodic than in the sham condition, suggesting a long-term effect on recovery of their anomic disturbances.

Correlation between the availability of dopamine transporter and olfactory function in healthy subjects

International Nuclear Information System (INIS)

Pak, Kyoungjune; Kim, Keunyoung; Kim, In Joo; Lee, Myung Jun; Lee, Jae Meen; Kim, Bum Soo; Kim, Seong-Jang

2018-01-01

Olfactory dysfunction in Parkinson's disease is usually prodromal to other symptoms. In this study, we aimed to explore the association of olfactory function with the availabilities of striatal dopamine transporter (DAT) in healthy subjects. Data used in the preparation of this article were obtained from Parkinson's Progression Markers Initiative database (www.ppmi-info.org/data). The study population consisted of healthy controls with screening 123 I-FP-CIT single photon emission tomography (SPECT). University of Pennsylvania Smell Identification Test (UPSIT) was assessed to evaluate the olfactory function. Totally, 181 healthy subjects (117 male, 64 female) with 123 I-FP-CIT SPECT data were included in this study. Specific binding ratios (SBRs) of the caudate nucleus (rho = -0.4217, p < 0.0001), putamen (rho = -0.2292, p = 0.0019), and striatum (rho=-0.3425, p < 0.0001) showed a reduction with ageing. SBRs of the caudate nucleus, putamen, and striatum were positively correlated with UPSIT (rho = 0.3716, p < 0.0001; rho = 0.3655, p < 0.0001; rho = 0.3880, p < 0.0001). After controlling for age by partial correlation, SBRs of the caudate nucleus, putamen, and striatum showed an influence on UPSIT (rho = 0.3288, p < 0.0001; rho = 0.3374, p < 0.0001; rho = 0.3511, p < 0.0001). Olfactory function is associated with the availability of striatal DAT independent of age in healthy subjects. (orig.)

Gastric emptying of solid radiopaque markers: studies in healthy subjects and diabetic patients

International Nuclear Information System (INIS)

Feldman, M.; Smith, H.J.; Simon, T.R.

1984-01-01

The purpose of these studies was to develop a radiologic method for assessing gastric emptying of an indigestible solid in humans and to apply this technique to the evaluation of patients with diabetes mellitus. Thirty healthy subjects ingested 10 solid radiopaque markers (small pieces of nasogastric tubing) together with a standard meal (donuts and 7-Up). Radiographs of the upper abdomen were obtained hourly for up to 6 h until all markers had emptied from the stomach. In some experiments, 99mTc-labeled scrambled eggs were added to the meal so that emptying of this digestible solid, assessed by scintigraphy, could be compared with emptying of liquids and solid radiopaque markers. In healthy subjects, the digestible solid emptied more slowly than the liquid (t 1/2 . 154 +/- 11 min vs. 30 +/- 3 min, p less than 0.001), but emptying of digestible solid was significantly faster than the emptying of the indigestible solid radiopaque markers. In diabetics, emptying rates for the digestible solid and liquid were close to normal (t 1/2 . 178 +/- 5 min and 40 +/- 3 min, respectively), whereas indigestible solid markers were retained in the stomach 6 h after the meal in 50% of the patients. Radiopaque markers proved to be a simple method for measuring gastric emptying of indigestible solids in humans. Using this technique, patients with insulin-dependent diabetes mellitus had a high incidence of abnormally slow gastric emptying of indigestible solids; the method may be a more sensitive indicator of gastric motor dysfunction than radionuclide scintigraphy

Gastric emptying of solid radiopaque markers: studies in healthy subjects and diabetic patients

Energy Technology Data Exchange (ETDEWEB)

Feldman, M.; Smith, H.J.; Simon, T.R.

1984-10-01

The purpose of these studies was to develop a radiologic method for assessing gastric emptying of an indigestible solid in humans and to apply this technique to the evaluation of patients with diabetes mellitus. Thirty healthy subjects ingested 10 solid radiopaque markers (small pieces of nasogastric tubing) together with a standard meal (donuts and 7-Up). Radiographs of the upper abdomen were obtained hourly for up to 6 h until all markers had emptied from the stomach. In some experiments, 99mTc-labeled scrambled eggs were added to the meal so that emptying of this digestible solid, assessed by scintigraphy, could be compared with emptying of liquids and solid radiopaque markers. In healthy subjects, the digestible solid emptied more slowly than the liquid (t 1/2 . 154 +/- 11 min vs. 30 +/- 3 min, p less than 0.001), but emptying of digestible solid was significantly faster than the emptying of the indigestible solid radiopaque markers. In diabetics, emptying rates for the digestible solid and liquid were close to normal (t 1/2 . 178 +/- 5 min and 40 +/- 3 min, respectively), whereas indigestible solid markers were retained in the stomach 6 h after the meal in 50% of the patients. Radiopaque markers proved to be a simple method for measuring gastric emptying of indigestible solids in humans. Using this technique, patients with insulin-dependent diabetes mellitus had a high incidence of abnormally slow gastric emptying of indigestible solids; the method may be a more sensitive indicator of gastric motor dysfunction than radionuclide scintigraphy.

Theta Burst Stimulation Enhances Connectivity of the Dorsal Attention Network in Young Healthy Subjects: An Exploratory Study

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Lubomira Anderkova

2018-01-01

Full Text Available We examined effects of theta burst stimulation (TBS applied over two distinct cortical areas (the right inferior frontal gyrus and the left superior parietal lobule on the Stroop task performance in 20 young healthy subjects. Neural underpinnings of the behavioral effect were tested using fMRI. A single session of intermittent TBS of the left superior parietal lobule induced certain cognitive speed enhancement and significantly increased resting-state connectivity of the dorsal attention network. This is an exploratory study that prompts further research with multiple-session TBS in subjects with cognitive impairment.

Induction of depressed and elated mood by music influences the perception of facial emotional expressions in healthy subjects

NARCIS (Netherlands)

Bouhuys, Antoinette L.; Bloem, Gerda M.; Groothuis, Ton G.G.

1995-01-01

The judgement of healthy subject rating the emotional expressions of a set of schematic drawn faces is validated (study 1) to examine the relationship between mood (depressed/elated) and judgement of emotional expressions of these faces (study 2). Study 1: 30 healthy subjects judged 12 faces with

Evaluation of vocal fold vibration with an assessment form for high-speed digital imaging: comparative study between healthy young and elderly subjects.

Science.gov (United States)

Yamauchi, Akihito; Imagawa, Hiroshi; Yokonishi, Hisayuki; Nito, Takaharu; Yamasoba, Tatsuya; Goto, Takao; Takano, Shingo; Sakakibara, Ken-Ichi; Tayama, Niro

2012-11-01

We conducted a prospective study with a subjective assessment form for high-speed digital imaging (HSDI) to elucidate the features of vocal fold vibrations in vocally healthy subjects and to clarify gender- and age-related differences. Healthy adult volunteers participated in this study. They were divided into young (aged 35 and younger) and elderly (aged 65 and older) groups, and the scores of an assessment form for HSDI characteristics elaborated at our institution were statistically analyzed. Twenty-six young subjects (males: 9, females: 17; mean age: 27 years) and 20 elderly subjects (males: 8, females: 12; mean age: 72 years) were assigned to our study. Posterior gap and posterior-to-anterior longitudinal phase difference were characteristic to young females, whereas in young males, mucosal wave, anterior-to-posterior longitudinal phase difference, and supraglottic hyperactivity were frequent. In elderly males, axis shift, asymmetry, supraglottic hyperactivity, increased mucosal wave, lateral phase difference, and anterior-to-posterior longitudinal phase difference were frequent; and in elderly females, high incidence of lateral phase difference, atrophic change, anterior gap, and asymmetry were observed. The results show that the behaviors of vocal fold vibrations were diverse even in healthy subjects with no vocal complaints or history of laryngeal diseases, and hence, the diversity of vocal fold vibrations in normal subjects must be taken into account in evaluating vocal fold vibrations. Copyright © 2012 The Voice Foundation. Published by Mosby, Inc. All rights reserved.

Sonoelastography of Plantar Fascia: Reproducibility and Pattern Description in Healthy Subjects and Symptomatic Subjects.

Science.gov (United States)

Ríos-Díaz, José; Martínez-Payá, Jacinto J; del Baño-Aledo, María Elena; de Groot-Ferrando, Ana; Botía-Castillo, Paloma; Fernández-Rodríguez, David

2015-10-01

The purpose of the work reported here was to describe the sonoelastographic appearance of the plantar fascia of healthy volunteers and patients with fasciitis. Twenty-three healthy subjects and 21 patients with plantar fasciitis were examined using B-mode and real-time sonoelastography (RTSR) scanning. B-Mode examination included fascia thickness and echotexture. Echogenicity and echovariation of the color histogram were analyzed. Fasciae were classified into type 1, blue (more elastic); type 2, blue/green (intermediate); or type 3, green (less elastic). RTSE revealed 72.7% of fasciae as type 2, with no significant association with fasciitis (χ(2) = 3.6, df = 2, p = 0.17). Quantitative analysis of the color histogram revealed a significantly greater intensity of green (mean = 77.8, 95% confidence interval [CI] = 71.9-83.6) and blue (mean = 74.2, 95% CI = 69.7-78.8) in healthy subjects. Echovariation of the color red was 33.4% higher in the fasciitis group than in the healthy group (95% CI = 16.7-50.1). Sonoelastography with quantitative analysis of echovariation can be a useful tool for evaluation of plantar fascia pathology. Copyright © 2015 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

Ambulatory blood pressure and urinary albumin excretion in clinically healthy subjects

DEFF Research Database (Denmark)

Clausen, Peter Vilhelm; Jensen, J S; Borch-Johnsen, K

1998-01-01

UAER. Because 24-hour ambulatory blood pressure is a superior predictor of hypertensive target organ involvement, we aimed to investigate blood pressure profile in clinically healthy subjects with elevated UAER. Ambulatory blood pressure monitoring was performed with a portable recorder in 27 subjects...... loss of albumin could not be solely related to the higher blood pressure. In conclusion, apparently healthy subjects with elevated UAER had slightly but significantly higher 24-hour systolic and diastolic blood pressure levels in addition to increased blood pressure loads but normal circadian variation...

Atherosclerotic risk factors are increased in clinically healthy subjects with microalbuminuria

DEFF Research Database (Denmark)

Jensen, J S; Borch-Johnsen, K; Jensen, G

1995-01-01

in clinically healthy subjects. All healthy 40-65 year-old participants with microalbuminuria, examined within the first 21 months of The Copenhagen City Heart Study, were invited, and 28 were studied. An age- and sex-matched group of 60 randomly chosen subjects with normoalbuminuria served as control....... Microalbuminuria was defined as a UAER of 6.6-150 micrograms/min, and normoalbuminuria as a UAER group, systolic and diastolic blood pressures were both elevated (mean (95% C.I.) 128 (123-134) vs. 119 (116-122) mmHg; P = 0.005, and 75 (71-78) vs. 69 (67-71) mm......Hg; P = 0.008, respectively), and serum apolipoprotein (apo) A-1 concentration was lower (1.30 (1.20-1.37) vs. 1.42 (1.36-1.47) milligrams; P = 0.02) in comparison with the normoalbuminuric group. Furthermore, serum HDL-cholesterol concentration tended to be lower, whereas body weight, body mass index...

Gender differences associated with orienting attentional networks in healthy subjects

Institute of Scientific and Technical Information of China (English)

LIU Gang; HU Pan-pan; FAN Jin; WANG Kai

2013-01-01

Background Selective attention is considered one of the main components of cognitive functioning.A number of studies have demonstrated gender differences in cognition.This study aimed to investigate the gender differences in selective attention in healthy subjects.Methods The present experiment examined the gender differences associated with the efficiency of three attentional networks:alerting,orienting,and executive control attention in 73 healthy subjects (38 males).All participants performed a modified version of the Attention Network Test (ANT).Results Females had higher orienting scores than males (t=2.172,P ＜0.05).Specifically,females were faster at covert orienting of attention to a spatially cued location.There were no gender differences between males and females in alerting (t=0.813,P ＞0.05) and executive control (t=0.945,P ＞0.05) attention networks.Conclusions There was a significant gender difference between males and females associated with the orienting network.Enhanced orienting attention in females may function to motivate females to direct their attention to a spatially cued location.

Effects of a visuotemporal cue on walking ability of independent ambulatory subjects with spinal cord injury as compared with healthy subjects.

Science.gov (United States)

Pramodhyakul, N; Amatachaya, P; Sooknuan, T; Arayawichanon, P; Amatachaya, S

2014-03-01

An experimental, cross-sectional study. To investigate effects of using a visuotemporal cue on the walking ability of independent ambulatory subjects with spinal cord injury (SCI) as compared with healthy subjects. A tertiary rehabilitation center, Thailand. Forty independent ambulatory subjects with SCI and healthy subjects participated in the study (20 subjects per group). All of them were assessed for their walking speed, stride length, cadence and percents of step symmetry under two conditions, including walking at their fastest speed with and without a visuotemporal cue along a 10 m walkway. When walking with a visuotemporal cue, walking speed, stride length and cadence of the subjects were significantly increased from the uncued condition (Pwalking speed and cadence, whereas, subjects with SCI demonstrated significantly higher improvement in stride length as compared with the other group (Pbenefits of using a visuotemporal cue to improve variables relating to walking ability in subjects with intact integrative capability of the brain but with different levels of sensorimotor deterioration. The findings suggest the use of a visuotemporal cue to improve the effectiveness of programs in sport and exercise sciences, and rehabilitation treatments.

Oxidative stress and inflammation in renal patients and healthy subjects.

Directory of Open Access Journals (Sweden)

Diana M Lee

Full Text Available The first goal of this study was to measure the oxidative stress (OS and relate it to lipoprotein variables in 35 renal patients before dialysis (CKD, 37 on hemodialysis (HD and 63 healthy subjects. The method for OS was based on the ratio of cholesteryl esters (CE containing C18/C16 fatty acids (R2 measured by gas chromatography (GC which is a simple, direct, rapid and reliable procedure. The second goal was to investigate and identify a triacylglycerol peak on GC, referred to as TG48 (48 represents the sum of the three fatty acids carbon chain lengths which was markedly increased in renal patients compared to healthy controls. We measured TG48 in patients and controls. Mass spectrometry (MS and MS twice in tandem were used to analyze the fatty acid composition of TG48. MS showed that TG48 was abundant in saturated fatty acids (SFAs that were known for their pro-inflammatory property. TG48 was significantly and inversely correlated with OS. Renal patients were characterized by higher OS and inflammation than healthy subjects. Inflammation correlated strongly with TG, VLDL-cholesterol, apolipoprotein (apo C-III and apoC-III bound to apoB-containing lipoproteins, but not with either total cholesterol or LDL-cholesterol.In conclusion, we have discovered a new inflammatory factor, TG48. It is characterized with TG rich in saturated fatty acids. Renal patients have increased TG48 than healthy controls.

Gait symmetry and hip strength in women with developmental dysplasia following hip arthroplasty compared to healthy subjects: A cross-sectional study.

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Ruud A Leijendekkers

Full Text Available Untreated unilateral developmental dysplasia of the hip (DDH results in asymmetry of gait and hip strength and may lead to early osteoarthritis, which is commonly treated with a total hip arthroplasty (THA. There is limited knowledge about the obtained symmetry of gait and hip strength after the THA. The objectives of this cross-sectional study were to: a identify asymmetries between the operated and non-operated side in kinematics, kinetics and hip strength, b analyze if increased walking speed changed the level of asymmetry in patients c compare these results with those of healthy subjects.Women (18-70 year with unilateral DDH who had undergone unilateral THA were eligible for inclusion. Vicon gait analysis system was used to collect frontal and sagittal plane kinematic and kinetic parameters of the hip joint, pelvis and trunk during walking at comfortable walking speed and increased walking speed. Furthermore, hip abductor and extensor muscle strength was measured.Six patients and eight healthy subjects were included. In the patients, modest asymmetries in lower limb kinematics and kinetics were present during gait, but trunk lateral flexion asymmetry was evident. Patients' trunk lateral flexion also differed compared to healthy subjects. Walking speed did not significantly influence the level of asymmetry. The hip abduction strength asymmetry of 23% was not statistically significant, but the muscle strength of both sides were significantly weaker than those of healthy subjects.In patients with a DDH treated with an IBG THA modest asymmetries in gait kinematics and kinetics were present, with the exception of a substantial asymmetry of the trunk lateral flexion. Increased walking speed did not result in increased asymmetries in gait kinematics and kinetics. Hip muscle strength was symmetrical in patients, but significantly weaker than in healthy subjects. Trunk kinematics should be included as an outcome measure to assess the biomechanical

Thermal and hemodynamic response to whole-body cryostimulation in healthy subjects.

Science.gov (United States)

Zalewski, Pawel; Klawe, Jacek J; Pawlak, Joanna; Tafil-Klawe, Malgorzata; Newton, Julia

2013-06-01

Whole-body cryotherapy (WBC) is an increasing applied cryotherapeutic method, that involves application of a cryotherapeutic factor to stimulate the body by the means of intense hypothermia of virtually the body's entire area. This method is still not well recognized in Western Europe. However in recent years it is becoming increasingly popular in sports medicine and also in clinical application. Cryotherapeutic agents used in WBC are considered to be a strong stress stimulus which is associated with a variety of changes in functional parameters, particularly of the cardiovascular and autonomic nervous systems. However, such strong influence upon the entire body could be associated with the risk of unexpected reactions which might be dangerous for homeostasis. The present study evaluated the complex hemodynamic physiological reactions in response to WBC exposure in healthy subjects. Thirty healthy male volunteers participated. Each subject was exposed to WBC (-120°C) for 3-min. None of the participants had been exposed to such conditions previously. The research was conducted with modern and reliable measurements techniques, which assessed complex hemodynamic reactions and skin temperature changes non-invasively. All measurements were performed four times (before WBC, after WBC, WBC+3h and WBC+6h) with a Task Force Monitor (TFM - CNSystems, Medizintechnik, Gratz, Austria). Body superficial temperature was measured by infrared thermographic techniques - infra-red camera Flir P640 (Flir Systems Inc., Sweden). Our results show a significant decrease in heart rate, cardiac output, and increase in stroke volume, total peripheral resistance and baroreceptors reflex sensitivity. These changes were observed just after WBC exposure. At stages WBC+3h and WBC+6h there was observed a significant drop in baroreceptors reflex sensitivity due to increased thermogenesis. In conclusion, the present findings suggest that WBC strongly stimulates the baroreceptor cardiac reflex in

Voluntary control of corticomuscular coherence through neurofeedback: a proof-of-principle study in healthy subjects.

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von Carlowitz-Ghori, K; Bayraktaroglu, Z; Waterstraat, G; Curio, G; Nikulin, V V

2015-04-02

Corticomuscular coherence (CMC) relates to synchronization between activity in the motor cortex and the muscle activity. The strength of CMC can be affected by motor behavior. In a proof-of-principle study, we examined whether independent of motor output parameters, healthy subjects are able to voluntarily modulate CMC in a neurofeedback paradigm. Subjects received visual online feedback of their instantaneous CMC strength, which was calculated between an optimized spatial projection of multichannel electroencephalography (EEG) and electromyography (EMG) in an individually defined target frequency range. The neurofeedback training consisted of either increasing or decreasing CMC strength using a self-chosen mental strategy while performing a simple motor task. Evaluation of instantaneous coherence showed that CMC strength was significantly larger when subjects had to increase than when to decrease CMC; this difference between the two task conditions did not depend on motor performance. The exclusion of confounding factors such as motor performance, attention and task complexity in study design provides evidence that subjects were able to voluntarily modify CMC independent of motor output parameters. Additional analysis further strengthened the assumption that the subjects' response was specifically shaped by the neurofeedback. In perspective, we suggest that CMC-based neurofeedback could provide a therapeutic approach in clinical conditions, such as motor stroke, where CMC is altered. Copyright © 2015 IBRO. Published by Elsevier Ltd. All rights reserved.

Quantitative Analysis of Swallowing Function Between Dysphagia Patients and Healthy Subjects Using High-Resolution Manometry

OpenAIRE

Park, Chul-Hyun; Kim, Don-Kyu; Lee, Yong-Taek; Yi, Youbin; Lee, Jung-Sang; Kim, Kunwoo; Park, Jung Ho; Yoon, Kyung Jae

2017-01-01

Objective To compare swallowing function between healthy subjects and patients with pharyngeal dysphagia using high resolution manometry (HRM) and to evaluate the usefulness of HRM for detecting pharyngeal dysphagia. Methods Seventy-five patients with dysphagia and 28 healthy subjects were included in this study. Diagnosis of dysphagia was confirmed by a videofluoroscopy. HRM was performed to measure pressure and timing information at the velopharynx (VP), tongue base (TB), and upper esophage...

Effect of fluoxetine on the pharmacokinetics of lansoprazole: a two-treatment period study in healthy male subjects.

Science.gov (United States)

Vlase, Laurian; Popa, Adina; Neag, Maria; Muntean, Dana; Leucuta, Sorin E

2011-10-01

Fluoxetine is an inhibitor of the main metabolizing enzymes of lansoprazole and could influence the pharmacokinetics of lansoprazole. The changes in lansoprazole pharmacokinetics could have clinical significance concerning the safety of the therapy. The aim of this study was to evaluate the pharmacokinetic interaction between fluoxetine and lansoprazole in healthy subjects. A dose of lansoprazole 30 mg, alone or in combination with fluoxetine 60 mg, was administered to 18 healthy male subjects in a two-treatment study design, separated by an 8-day period in which fluoxetine alone was administered as a single oral daily dose. Plasma concentrations of lansoprazole were determined during a 12-hour period following drug administration. Lansoprazole plasma concentrations were determined by a validated liquid chromatography-mass spectrometry method. The pharmacokinetic parameters of lansoprazole were calculated using non-compartmental analysis. In the two periods of treatment, the mean maximum plasma concentration (C(max)) values were 817 ng/mL (lansoprazole alone) and 1370 ng/mL (lansoprazole in combination with fluoxetine after pre-treatment with fluoxetine for 8 days) [p lansoprazole and suggest that the observed interaction may be clinically significant, although its clinical relevance has yet to be confirmed.

[Circadian rhythms of acid production and alkalization in the stomach of healthy subjects and duodenal ulcer patients].

Science.gov (United States)

Kolesnikova, I Iu; Beliaeva, G S; Leint'eva, V A; Smirnova, A A

2008-01-01

We studied 24-h rhythms of acid production and alkalization in 30 patients with duodenal ulcer (DU) and 30 healthy subjects using upper endoscopic examination and computer intragastric pH-metry. Gastric acid production was higher in DU patients and was more intensive in the daytime than at night. Healthy subjects had low and monotonous acid production. In DU decompensation of alkalization in the antral stomach and suppression of duodenogastric reflux is total. In healthy subjects antrum alkalization is more evident and intensive at night due to, among other causes, duodenogastric reflux.

Clinical applications of functional MRI at 1.0 T: motor and language studies in healthy subjects and patients

International Nuclear Information System (INIS)

Papke, K.; Hellmann, T.; Renger, B.; Schuierer, G.; Reimer, P.; Morgenroth, C.; Knecht, S.

1999-01-01

In this article we describe clinical applications of functional MRI (fMRI) at 1.0 T. All experiments were performed on a commercially available 1.0-T system (Magnetom Impact Expert, Siemens AG, Erlangen, Germany) using a blood oxygen level-dependent (BOLD)-sensitive multi-slice EPI technique (TE 66 ms, 4 mm slice thickness, 210 mm field of view, 64 x 64 acquisition matrix). Different paradigms for localization of the motor cortex and for language lateralization were tested in healthy subjects and patients. Methodological considerations concerning the development of the paradigms are also described. In all healthy subjects, motor activation elicited BOLD signal changes in the sensorimotor cortex, permitting identification of primary motor and sensory cortical areas. Furthermore, focal activation of different cortical areas by a language task was possible in 6 of 10 subjects. Nineteen motor studies were performed in 18 patients with supratentorial lesions, in most cases prior to neurosurgical procedures. In 14 studies, fMRI results demonstrated the localization of the motor hand areas relative to the lesion. The results proved valuable for preoperative planning and contributed to therapeutical decisions. We conclude that functional MRI for clinically relevant applications, such as localization of motor and language function, is feasible even at a field strength of 1.0 T without dedicated equipment. (orig.)

Gastric emptying of solid radiopaque markers: studies in healthy subjects and diabetic patients.

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Feldman, M; Smith, H J; Simon, T R

1984-10-01

The purpose of these studies was to develop a radiologic method for assessing gastric emptying of an indigestible solid in humans and to apply this technique to the evaluation of patients with diabetes mellitus. Thirty healthy subjects ingested 10 solid radiopaque markers (small pieces of nasogastric tubing) together with a standard meal (donuts and 7-Up). Radiographs of the upper abdomen were obtained hourly for up to 6 h until all markers had emptied from the stomach. Although most of the liquid component of the meal, labeled with 111In, emptied during the first hour (as assessed simultaneously by radionuclide scintigraphy), few radiopaque markers emptied from the stomach during the first 2 h after the meal. Most markers emptied during the fourth postprandial hour, and all 10 markers had emptied by 6 h in 45 of 46 experiments. In contrast, not all of the solid radiopaque markers emptied from the stomach by 6 h in 16 of 26 experiments in patients with diabetes mellitus (p less than 0.001 vs. healthy controls). In some experiments, 99mTc-labeled scrambled eggs were added to the meal so that emptying of this digestible solid, assessed by scintigraphy, could be compared with emptying of liquids and solid radiopaque markers. In healthy subjects, the digestible solid emptied more slowly than the liquid (t 1/2 = 154 +/- 11 min vs. 30 +/- 3 min, p less than 0.001), but emptying of digestible solid was significantly faster than the emptying of the indigestible solid radiopaque markers. In diabetics, emptying rates for the digestible solid and liquid were close to normal (t 1/2 = 178 +/- 5 min and 40 +/- 3 min, respectively), whereas indigestible solid markers were retained in the stomach 6 h after the meal in 50% of the patients. Radiopaque markers proved to be a simple method for measuring gastric emptying of indigestible solids in humans. Using this technique, patients with insulin-dependent diabetes mellitus had a high incidence of abnormally slow gastric emptying of

Patients with gout differ from healthy subjects in renal response to changes in serum uric acid.

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Liu, Sha; Perez-Ruiz, Fernando; Miner, Jeffrey N

2017-03-01

Our objectives were to determine whether a change in serum uric acid (sUA) resulted in a corresponding change in the fractional excretion of uric acid (FEUA) and whether the renal response was different in patients with gout versus healthy subjects. FEUA was calculated from previously published studies and four new phase I studies in healthy subjects and/or patients with gout before and after treatment to lower or raise sUA. Treatments included xanthine oxidase inhibitors to lower sUA as well as infusion of uric acid and provision of a high-purine diet to raise sUA. Plots were created of FEUA versus sUA before and after treatment. For the phase I studies, percent change in FEUA per mg/dL change in sUA was calculated separately for healthy subjects and patients with gout, and compared using Student's t test. Analysis of previously published data and the new phase I clinical data indicates that changing sUA by a non-renal mechanism leads to a change in FEUA. The magnitude of change is greater in subjects with higher baseline FEUA versus patients with gout. Healthy subjects excrete more urate than do patients with gout at physiological urate-filtered load; this difference disappears when the urate-filtered load is decreased to ∼5000mg/24hours. These observations are consistent with a less saturated urate reabsorption system in patients with gout versus healthy subjects, resulting in elevated retention of uric acid. Further investigation could lead to the discovery of mechanisms responsible for the etiology of hyperuricemia/gout. Copyright © 2016 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Is dietary pattern of schizophrenia patients different from healthy subjects?

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Amani Reza

2007-05-01

Full Text Available Abstract Background There are limited findings about dietary patterns and food preferences among patients suffering from schizophrenia. The main objective of this study was therefore to compare the nutritional pattern of schizophrenia patients with that of matched healthy subjects. Methods The dietary pattern of 30 hospitalized 16–67 years old schizophrenic patients (11 female was compared with that of 30 healthy age and sex matched individuals as control group. Subjects' anthropometric measurements including weight, height and body mass index (BMI, semi-quantitative food frequency (FFQ, medical and food history questionnaires were also collected and FFQs were then scored using Food Guide Pyramid to obtain the dietary scores. Percent body fat (%BF was measured using bioelectrical impedance analysis (BIA method. Results Female patients had more %BF and lower dietary pattern scores than that of their controls (32 ± 3.6 vs 27.7 ± 4.6 percent and 43.2 ± 11.9 vs 54.5 ± 10.7 points; respectively, p Conclusion Schizophrenia patients have poor nutritional patterns. In particular, female patients have more percent body fat and lower dietary pattern scores compared with their healthy controls. All patients used to consume more fats and sweet drinks frequently. The findings of this study suggest that schizophrenia patients need specific medical nutrition therapies through limiting dietary fats and sugars intakes and weight control. Whether obesity is the consequence of disease, dietary preference or medications used remains to be cleared.

IRANIAN DIABETICS MAY NOT BE VITAMIN D DEFICIENT MORE THAN HEALTHY SUBJECTS

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T. R. Neyestani

2008-08-01

Full Text Available "nThere are some reports of decreased serum levels of 25(OHD in the subjects with impaired glucose tolerance and type 2 diabetes mellitus (T2DM. To assess vitamin D status of the Iranian diabetics, a pilot study was conducted on 90 subjects with either type 1 diabetes mellitus (T1DM (n= 30, T2DM (n= 30, or apparently healthy subjects (n= 30 during fall and winter of 2005. Serum samples were analyzed for 25-hydroxycholecalciferol using three different methods: high-performance liquid chromatography (HPLC, competitive protein-binding assay (CPBA and radioimmunoassay (RIA. In this study serum levels of 25(OHD were categorized as follows: sufficient ≥ 37 nmol/L; 25 nmol/L ≤ mild deficiency < 37 nmol/L; 12.5 nmol/L ≤ moderate deficiency < 25 nmol/L; severe deficiency < 12.5 nmol/L. Results showed that the occurrence of vitamin D insufficiency was almost the same in patients with T1DM and healthy controls. Mean serum level of 25(OHD in patients with T2DM was significantly higher than in T1DM, as judged by HPLC (58.2 ± 8.5 vs. 35 ± 5 nmol/L, Mann Whitney U-Wilcoxon, P= 0.024. Moreover, both CPBA and RIA showed some over-estimation of serum 25(OHD, compared to HPLC. Our findings suggest that, at least in the cold seasons, vitamin D status of the healthy subjects may not be higher than that of T1DM patients.

Effects of neurofeedback therapy in healthy young subjects.

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Altan, Sümeyra; Berberoglu, Bercim; Canan, Sinan; Dane, Şenol

2016-12-01

Neurofeedback refers to a form of operant conditioning of electrical brain activity, in which desirable brain activity is rewarded and undesirable brain activity is inhibited. The research team aimed to examine the efficacy of neurofeedback therapy on electroencephalogram (EEG) for heart rate, electrocardiogram (ECG) and galvanic skin resistance (GSR) parameters in a healthy young male population. Forty healthy young male subjects aged between 18 to 30 years participated in this study. Neurofeedback application of one session was made with bipolar electrodes placed on T3 and T4 (temporal 3 and 4) regions and with reference electrode placed on PF1 (prefrontal 1). Electroencephalogram (EEG), electrocardiogram (ECG) and galvanic skin resistance (GSR) were assessed during Othmer neurofeedback application of one session to regulate slow wave activity for forty minutes thorough the session. Data assessed before neurofeedback application for 5 minutes and during neurofeedback application of 30 minutes and after neurofeedback application for 5 minutes throughout the session of 40 minutes. Means for each 5 minutes, that is to say, a total 8 data points for each subjects over 40 minutes, were assessed. Galvanic skin resistance increased and heart rate decreased after neurofeedback therapy. Beta activity in EEG increased and alfa activity decreased after neurofeedback therapy. These results suggest that neurofeedback can be used to restore sympathovagal imbalances. Also, it may be accepted as a preventive therapy for psychological and neurological problems.

[Stress and night eating syndrome: a comparison study between a sample of psychiatric outpatients and healthy subjects].

Science.gov (United States)

Pacitti, Francesca; Maraone, Annalisa; Zazzara, Francesca; Biondi, Massimo; Caredda, Maria

2011-01-01

The Night Eating Syndrome (NES) is a disorder characterized by the clinical features of morning anorexia, evening hyperphagia, and insomnia with awakenings followed by nocturnal food ingestion. The core clinical feature appears to be a delay in the circadian timing of food intake. The diagnosis and early treatment of NES may represent an important means of prevention for obesity. Aims. The aim of the present study was to determine the vulnerability to develop NES between a clinical sample of patients with psychiatric disorders and a non clinical sample. We investigated a possible relation between stress and a dysfunctional eating behaviors as NES. Methods. The Night Eating Questionnaire (NEQ) has been administered to 147 psychiatric outpatients and to 531 subjects attending the University of L'Aquila. The NEQ is a questionnaire used to evaluate the prevalence of NES. The sample has been also evaluated through the Stress-related Vulnerability Scale (SVS) to measure both perceived stress and social support. Results. The 8.2% of patients scored above the diagnostic cut-off of the NEQ, compared to the 2.1% in the sample of healthy subjects. The majority of patients who had shown NEQ>25 had a diagnosis of major depressive disorder (MDD). The total scores on the NEQ were strongly associated with the SVS total score and especially with the "lack of social support" subscale. Conclusions. This study shows the increased vulnerability of NES in the sample of psychiatric patients compared to the sample of healthy subjects. The study further confirms the strong association between perceived stress, social support, altered eating behaviors and obesity.

iPad-assisted measurements of duration estimation in psychiatric patients and healthy control subjects.

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Irene Preuschoff

Full Text Available Handheld devices with touchscreen controls have become widespread in the general population. In this study, we examined the duration estimates (explicit timing made by patients in a major general hospital and healthy control subjects using a custom iPad application. We methodically assessed duration estimates using this novel device. We found that both psychiatric and non-psychiatric patients significantly overestimated time periods compared with healthy control subjects, who estimated elapsed time very precisely. The use of touchscreen-based methodologies can provide valuable information about patients.

Glycemic indices of five varieties of dates in healthy and diabetic subjects

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Gariballa Salah

2011-05-01

Full Text Available Abstract Background This study was designed to determine the glycemic indices of five commonly used varieties of dates in healthy subjects and their effects on postprandial glucose excursions in individuals with type 2 diabetes mellitus. Methods Composition analysis was carried out for five types of dates (Tamer stage. The weights of the flesh of the dates equivalent to 50 g of available carbohydrates were calculated. The study subjects were thirteen healthy volunteers with a mean (± SD age of 40.2 ± 6.7 years and ten participants with type 2 diabetes mellitus (controlled on lifestyle measures and/or metformin with a mean HbA1c (± SD of 6.6 ± (0.7% and a mean age (± SD of 40.8 ± 5.7 years. Each subject was tested on eight separate days with 50 g of glucose (on 3 occasions and 50 g equivalent of available carbohydrates from the 5 varieties of date (each on one occasion. Capillary glucose was measured in the healthy subjects at 0, 15, 30, 45, 60, 90 and 120 min and for the diabetics at 0, 30, 60, 90, 120, 150 and 180 min. The glycemic indices were determined as ratios of the incremental areas under the response curves for the dates compared to glucose. Statistical analyses were performed using the Mann-Whitney U test and repeated measures analysis of variance. Results Mean glycemic indices ± SEM of the dates for the healthy individuals were 54.0 ± 6.1, 53.5 ± 8.6, 46.3 ± 7.1, 49.1 ± 3.6 and 55.1 ± 7.7 for Fara'd, Lulu, Bo ma'an, Dabbas and Khalas, respectively. Corresponding values for those with type 2 diabetes were very similar (46.1 ± 6.2, 43.8 ± 7.7, 51.8 ± 6.9, 50.2 ± 3.9 and 53.0 ± 6.0. There were no statistically significant differences in the GIs between the control and the diabetic groups for the five types of dates, nor were there statistically significant differences among the dates' GIs (df = 4, F = 0.365, p = 0.83. Conclusion The results show low glycemic indices for the five types of dates included in the study and

Nailfold capillary patterns in healthy subjects: a real issue in capillaroscopy.

Science.gov (United States)

Ingegnoli, Francesca; Gualtierotti, Roberta; Lubatti, Chiara; Bertolazzi, Chiara; Gutierrez, Marwin; Boracchi, Patrizia; Fornili, Marco; De Angelis, Rossella

2013-11-01

Nailfold capillaroscopy has been extensively applied in a broad spectrum of pathologic conditions, but very few data have been published in healthy individuals. The aim of this study was to describe the nailfold capillary findings on a large series of healthy subjects using the video-capillaroscopy technique. Nailfold capillaries were studied based on their morphology, dimensions and density. Then, to evaluate jointly the association between different capillary findings in groups of subjects which were homogeneous for their characteristics, cluster analysis was performed. The results (median) of capillary measurements were as follows: loop length 207μm, external diameter 39μm, internal diameter 17μm, apical diameter 17μm, and intercapillary distance 143μm. Based on the cluster analysis three major "normal" morphologic capillaroscopic patterns were depicted: 1) the "normal" pattern mainly with 2 to 5 U-shaped loops/mm and ≤2 tortuous loops/mm; 2) the "perfect normal" pattern with ≥5 U-shaped loops/mm and 3) the "unusual normal" with at least 1 meandering or bushy loop, or at least 1 microhemorrhage, or with >4 crossed loops/mm. Regarding the loop measurements, the majority of subjects had a median of 7capillaries/mm with a median length of 198μm. © 2013 Elsevier Inc. All rights reserved.

Is cerebral oxygenation negatively affected by infusion of norepinephrine in healthy subjects?

DEFF Research Database (Denmark)

Brassard, P.; Seifert, T.; Secher, Niels H.

2009-01-01

BACKGROUND: Vasopressor agents are commonly used to increase mean arterial pressure (MAP) in order to secure a pressure gradient to perfuse vital organs. The influence of norepinephrine on cerebral oxygenation is not clear. The aim of this study was to evaluate the impact of the infusion of norep......BACKGROUND: Vasopressor agents are commonly used to increase mean arterial pressure (MAP) in order to secure a pressure gradient to perfuse vital organs. The influence of norepinephrine on cerebral oxygenation is not clear. The aim of this study was to evaluate the impact of the infusion...... of norepinephrine on cerebral oxygenation in healthy subjects. METHODS: Three doses of norepinephrine (0.05, 0.1, and 0.15 microg kg(-1) min(-1) for 20 min each) were infused in nine healthy subjects [six males; 26 (6) yr, mean (SD)]. MAP, cerebral oxygenation characterized by frontal lobe oxygenation (Sc(O2...

Protein carbonyl: An oxidative stress marker in gingival crevicular fluid in healthy, gingivitis, and chronic periodontitis subjects

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Avani R Pradeep

2013-01-01

Full Text Available Background: A defined role for reactive oxygen species (ROS in the tissue destruction that characterizes periodontitis has been described. Protein carbonyl (PC is the most widely used biomarker for oxidative damage to proteins, and reflects cellular damage induced by multiple forms of ROS. The purpose of this study is to determine the presence of PC in gingival crevicular fluid (GCF in healthy, gingivitis, and chronic periodontitis (CP subjects and to find an association, if any. Materials and Methods: A total number of 75 subjects (38 males and 37 females were selected based on their clinical parameters into three groups: Group 1 (25 healthy subjects, Group 2 (25 gingivitis subjects, and Group 3 (25 CP subjects. GCF samples were collected to estimate the levels of PC. Results: The PC concentration in GCF was highest in subjects with CP as compared to gingivitis and healthy subjects and a significant association was observed between GCF PC levels and all periodontal parameters. Conclusion: There was an increase in PC levels in GCF as the disease process progressed from healthy to gingivitis and CP, suggesting a role for increased oxidative stress in CP.

Changes in six-minute walking distance during pulmonary rehabilitation in patients with COPD and in healthy subjects

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Imen Ben Cheikh Rejbi

2010-07-01

Full Text Available Imen Ben Cheikh Rejbi1, Yassine Trabelsi1, Afef Chouchene1, Wafa Ben Turkia1, Helmi Ben Saad1, Abdelkarim Zbidi1, Abdelhamid Kerken2, Zouhair Tabka11Department of Physiology and Lung Testing, Faculty of Medicine of Sousse, Tunisia; 2Department of Biophysics, Faculty of Medicine of Monastir, TunisiaBackground: The six-minute walking distance (6MWD test has demonstrated validity and reliability to assess changes in functional capacity following pulmonary rehabilitation in patients with chronic obstructive lung disease. However, no attempt has been made to establish an iterative measurement of 6MWD during the overall period of pulmonary rehabilitation. Therefore, the aim of this study was to evaluate the impact of a twelve-week rehabilitation program on the iterative weekly measurement of 6MWD in chronic obstructive pulmonary disease (COPD patients and healthy subjects.Methods: Twenty-six patients with COPD and nine age-matched healthy subjects were studied. Measurements were taken at baseline and after twelve weeks except for the 6MWD. The exercise measurements included a six-minute walking test (6MWT and an incremental exercise test. Oxygen saturation, heart rate, and dyspnea will be monitored during all these tests. Results: At baseline there were significant differences between groups, except in age, body mass index, and oxygen saturation. After 12 weeks, there was no significant change in lung function in patients with COPD and healthy subjects. The 6MWD, peak oxygen uptake VO2peak and anaerobic threshold increased significantly after training in both groups (P < 0.01. The averaged trace of the 6MWD of patients with COPD and healthy subjects was followed-up respectively by a logarithmic and linear fitting. 6MWD showed a plateau after eight weeks in patients with COPD, however, it increased continually overall in healthy subjects.Conclusion: Both patients with COPD and healthy subjects demonstrated functional responses to training but with

The Effect of Different Attentional Focus Instructions during Finger Movement Tasks in Healthy Subjects: An Exploratory Study

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Giacomo Rossettini

2017-01-01

Full Text Available External focus of attention (EFA and internal focus of attention (IFA represent commonly used strategies to instruct subjects during exercise. Several studies showed EFA to be more effective than IFA to improve motor performance and learning. To date the role of these strategies on motor performance during finger movement was less studied. The objective of the study was to investigate motor performance, patient’s preference induced by IFA and EFA, and the focus during control condition. Ten healthy right-handed participants performed a finger movement task in control, EFA, and IFA conditions (counterbalanced. Errors, patient’s preference, and type of attentional focus spontaneously adopted during the control condition were recorded. EFA determined less error (p<0.01 compared to control and IFA. Participants preferred EFA against IFA and control condition. In the control group 10% of subjects adopted a purely EFA, 70% of subjects adopted a purely IFA, and 20% of subjects adopted a mixture of the two foci. Our results confirm that EFA is more effective than IFA and control in finger movement task. Due its clinical relevance, the interaction between attention and finger movement should be further investigated.

A common optimization principle for motor execution in healthy subjects and parkinsonian patients.

Science.gov (United States)

Baraduc, Pierre; Thobois, Stéphane; Gan, Jing; Broussolle, Emmanuel; Desmurget, Michel

2013-01-09

Recent research on Parkinson's disease (PD) has emphasized that parkinsonian movement, although bradykinetic, shares many attributes with healthy behavior. This observation led to the suggestion that bradykinesia in PD could be due to a reduction in motor motivation. This hypothesis can be tested in the framework of optimal control theory, which accounts for many characteristics of healthy human movement while providing a link between the motor behavior and a cost/benefit trade-off. This approach offers the opportunity to interpret movement deficits of PD patients in the light of a computational theory of normal motor control. We studied 14 PD patients with bilateral subthalamic nucleus (STN) stimulation and 16 age-matched healthy controls, and tested whether reaching movements were governed by similar rules in these two groups. A single optimal control model accounted for the reaching movements of healthy subjects and PD patients, whatever the condition of STN stimulation (on or off). The choice of movement speed was explained in all subjects by the existence of a preset dynamic range for the motor signals. This range was idiosyncratic and applied to all movements regardless of their amplitude. In PD patients this dynamic range was abnormally narrow and correlated with bradykinesia. STN stimulation reduced bradykinesia and widened this range in all patients, but did not restore it to a normal value. These results, consistent with the motor motivation hypothesis, suggest that constrained optimization of motor effort is the main determinant of movement planning (choice of speed) and movement production, in both healthy and PD subjects.

Pharmacokinetic Effects of Antidrug Antibodies Occurring in Healthy Subjects After a Single Dose of Intravenous Infliximab.

Science.gov (United States)

Ehrenpreis, Eli D

2017-12-01

Infliximab pharmacokinetic studies have been performed in patients receiving chronic infliximab therapy. In these patients, infliximab antidrug antibodies (ADAs) increase infliximab clearance and decrease serum levels and drug efficacy. This study analyzed the pharmacokinetic effect of infliximab ADAs in healthy subjects receiving a single dose of intravenous infliximab. Data were obtained from a single-blind, parallel-group, single-dose study of healthy subjects receiving 5 mg/kg of intravenous SB2 (infliximab biosimilar), EU-sourced Remicade (EU-IFX) or US-sourced Remicade (US-IFX). Serum infliximab was measured at 1, 2, 3, 6, 12, 24, 48, and 72 h and at 5, 7, 14, 21, 28, 42, 56, and 70 days after administration. ADAs were measured pre-dose and at 29 and 71 days. Data from the first ten subjects randomized to each treatment arm were utilized for this study. A two-compartment model of the serum infliximab vs. time curve was developed using nonlinear regression. At 10 weeks, 11 subjects (37%) developed ADAs. ADAs were detected in four subjects after SB2, one subject after EU-IFX, and six subjects after US-IFX infusion. Of these, neutralizing antibodies occurred in one subject after SB2, in no subjects after EU-IFX, and in three subjects after US-IFX infusion. Infliximab clearance was increased in subjects with ADAs vs. those without ADAs (12.89 ± 2.69 vs. 9.90 ± 1.74 ml/h; p ADAs (282.4 ± 56.4 vs. 343.3 ± 61.9 h; p ADAs are common in healthy subjects after a single intravenous dose of infliximab and result in faster infliximab clearance, shorter elimination time, and lower serum infliximab levels. These data confirm that ADAs are common with biologic therapy and significantly impact the efficacy of these drugs.

A single-dose, crossover, placebo- and moxifloxacin-controlled study to assess the effects of neratinib (HKI-272) on cardiac repolarization in healthy adult subjects.

Science.gov (United States)

Hug, Bruce; Abbas, Richat; Leister, Cathie; Burns, Jaime; Sonnichsen, Daryl

2010-08-01

Neratinib is an orally administered, small-molecule, irreversible pan-ErbB inhibitor in development for the treatment of ErbB2-positive breast cancer. This study assessed the effects of therapeutic and supratherapeutic neratinib concentrations on cardiac repolarization, in accordance with current regulatory guidance. This was a two-part study in healthy subjects. In part 1, subjects were randomized to receive placebo, 400 mg moxifloxacin, or 240 mg neratinib (therapeutic dose) following a high-fat meal. In part 2, after a washout period, subjects received placebo plus 400 mg ketoconazole or 240 mg neratinib plus ketoconazole (supratherapeutic dose). ANOVA was used to compare the baseline-adjusted QTc interval for neratinib with that of placebo (reference), and for neratinib plus ketoconazole with that of placebo plus ketoconazole (reference). Pharmacokinetic/pharmacodynamic analyses and categorical summaries of interval data were done. Assay sensitivity was evaluated by the effect of moxifloxacin on QTc compared with placebo. Sixty healthy subjects were enrolled in this study. The upper bounds of the 90% confidence interval for baseline-adjusted QTcN (population-specific corrected QT) were neratinib. Pharmacokinetic/pharmacodynamic analysis revealed no relationship between neratinib concentrations and QTc interval. No subjects had QTcI, QTcF, or QTcN intervals >450 milliseconds or change from baseline >30 milliseconds. Moxifloxacin produced a significant increase in QTcN compared with placebo (P neratinib do not prolong the QTc interval in healthy subjects. (c) 2010 AACR.

Remote ischemic conditioning improves coronary microcirculation in healthy subjects and patients with heart failure

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Kono Y

2014-08-01

Full Text Available Yasushi Kono,1 Shota Fukuda,1 Akihisa Hanatani,2 Koki Nakanishi,2 Kenichiro Otsuka,2 Haruyuki Taguchi,1 Kenei Shimada2 1Department of Medicine, Osaka Ekisaikai Hospital, Osaka, Japan; 2Department of Internal Medicine and Cardiology, Osaka City University School of Medicine, Osaka, Japan Background: Remote ischemic conditioning (RIC is a treatment modality that suppresses inflammation and improves endothelial function, which are factors involved in the pathogenesis of heart failure (HF with reduced left ventricular ejection fraction. Coronary flow reserve (CFR is a physiological index of coronary microcirculation and is noninvasively measured by transthoracic Doppler echocardiography (TTDE. This study aimed to investigate the effects of RIC on CFR in healthy subjects and patients with HF, through the assessment by TTDE. Methods: Ten patients with HF with left ventricular ejection fraction of less than 40%, and ten healthy volunteers were enrolled in this study. RIC treatment was performed twice a day for 1 week. Our custom-made RIC device was programmed to automatically conduct 4 cycles of 5 minutes inflation and 5 minutes deflation of a blood pressure cuff to create intermittent arm ischemia. CFR measurements and laboratory tests were examined before, and after 1 week of RIC treatment. Results: One week of RIC treatment was well tolerated in both groups. RIC treatment increased CFR from 4.0±0.9 to 4.6±1.3 (mean ± standard deviation in healthy subjects (P=0.02, and from 1.9±0.4 to 2.3±0.7 in patients with HF (P=0.03, respectively. Systolic blood pressure in healthy subjects, and heart rate in HF patients decreased after RIC treatment (both P<0.01. Conclusion: This study demonstrated that a 1 week course of RIC treatment improved coronary microcirculation in healthy subjects and patients with HF associated with reduced left ventricular ejection fraction. Keyword: echocardiography, coronary flow reserve, heart failure, preconditioning

Does Mindfulness Improve After Heart Coherence Training in Patients With Chronic Musculoskeletal Pain and Healthy Subjects? A Pilot Study.

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Soer, Remko; de Jong, Annemieke B; Hofstra, Bert L; Preuper, Henrica R Schiphorst; Reneman, Michiel F

2015-07-01

Mindfulness and heart coherence training (HCT) training are applied increasingly in the treatment of patients with chronic musculoskeletal pain (CMP). Questionnaires have been developed to assess changes in mindfulness but no gold standard is available. Explore the relationship between changes in mindfulness scores and changes in heart coherence after 3 sessions of HCT in patients with CMP and in healthy subjects. Ten patients with CMP and 15 healthy subjects were trained in self-regulation with the use of HCT following a standardized stress relief program developed by the HeartMath Institute. A heart coherence-score (HC-score) was constructed with scores ranging from 0-100 with higher scores reflecting more heart rate variability (HRV) coherency. Change scores, Spearman correlation coefficients, and Wilcoxon Signed Rank test were calculated to test relationships and differences between HC-score, the Mindfulness Attention and Awareness Scale (MAAS) and Five Facet Mindfulness Questionnaire (FFMQ). A new questionnaire was constructed to explore on which mindfulness-related domains patients with CMP report changes after HCT. Increases were present on HC-score in healthy subjects (Ppilot study, mindfulness as assessed by the MAAS and FFMQ does not appear to improve after HCT. HRV coherency, MAAS, and FFMQ measure different constructs and are weakly related. It is of great importance to choose and develop valid measures that reflect patients' states of mindfulness. Content and face validity of measures of mindfulness may be considered in the light of performance-based measures.

Overweight causes left ventricular diastolic asynchrony and diastolic dysfunction: a study based on speckle tracking echocardiography in healthy subjects.

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Nakabachi, Masahiro; Mikami, Taisei; Okada, Kazunori; Onozuka, Hisao; Kaga, Sanae; Inoue, Mamiko; Yokoyama, Shinobu; Nishida, Mutsumi; Shimizu, Chikara; Matsuno, Kazuhiko; Iwano, Hiroyuki; Yamada, Satoshi; Tsutsui, Hiroyuki

2012-09-01

Left ventricular (LV) diastolic dysfunction is often observed in healthy subjects and can be a cause of heart failure with preserved ejection fraction (EF). We aimed to investigate the role of LV diastolic asynchrony as a cause of diastolic dysfunction in healthy subjects. In 40 healthy subjects, two-dimensional speckle tracking imaging (2DSTI) was performed to measure the peak early diastolic longitudinal strain rates (Esr) of the apical, mid-ventricular, and basal segments of the septum and posterior wall. A mean value of the Esr of the 6 segments (mEsr) was calculated. The time from aortic valve closure to the Esr was measured for each segment, and the standard deviation (SDTEsr) was calculated. The peak global early diastolic strain rate (gEsr) was measured with a region of interest (ROI) on the whole LV myocardium. LV flow propagation velocity (FPV) was measured using conventional Doppler techniques. SDTEsr was not correlated with age, but was significantly correlated with body mass index (BMI) (r = 0.41, p < 0.01). Although no significant correlation was observed between mEsr and FPV, gEsr and SDTEsr significantly correlated with FPV (r = 0.41, p < 0.01; r = -0.54, p < 0.001). As a result of the multiple regression analysis, SDTEsr was the single determinant of FPV. Diastolic asynchrony, associated with overweight but not with aging, may contribute to diastolic dysfunction in healthy subjects.

Action-blindsight in healthy subjects after transcranial magnetic stimulation

DEFF Research Database (Denmark)

Christensen, Mark Schram; Kristiansen, Lasse; Rowe, James B.

2008-01-01

Clinical cases of blindsight have shown that visually guided movements can be accomplished without conscious visual perception. Here, we show that blindsight can be induced in healthy subjects by using transcranial magnetic stimulation over the visual cortex. Transcranial magnetic stimulation...

Pharmacokinetics of neratinib during coadministration with lansoprazole in healthy subjects.

Science.gov (United States)

Keyvanjah, Kiana; DiPrimeo, Daniel; Li, Ai; Obaidi, Mohammad; Swearingen, Dennis; Wong, Alvin

2017-03-01

To evaluate the effect of lansoprazole, a proton-pump inhibitor, on the absorption, pharmacokinetics, and safety of neratinib, a pan-HER tyrosine kinase inhibitor, in healthy subjects. This was an open-label, two-period, fixed-sequence study. Fifteen healthy adult subjects received a single oral dose of neratinib 240 mg (Period 1), followed by a washout period, then oral lansoprazole 30 mg once daily for 7 days and a single dose of neratinib 240 mg on Day 5 (Period 2). Pharmacokinetic sampling was performed for 72 h following each neratinib dose. Plasma neratinib concentration-time data were analysed using noncompartmental methods. Geometric mean ratios for AUC 0-t , AUC 0-inf , and peak plasma concentrations (C max ) for neratinib plus lansoprazole vs. neratinib were used to assess the magnitude of the drug-drug interaction if the 90% confidence intervals were outside 80.00-125.00%. Neratinib geometric least-squares mean (LSM) C max was reduced from 84.5 ng ml -1 with neratinib alone to 24.5 ng ml -1 with neratinib plus lansoprazole. The extent of exposure to neratinib was also decreased: geometric LSM AUC 0-t was 1478 ng ml -1  h with neratinib vs. 426 ng ml -1  h with neratinib plus lansoprazole, and geometric LSM AUC 0-inf was 1557 ng ml -1  h vs. 542 ng ml -1  h, respectively. Mean t ½ was similar with both treatments (approximately 14 h). Geometric mean ratios 90% confidence intervals for AUC 0-t , AUC 0-inf and C max fell outside the prespecified equivalence range (80.0-125.0%). Treatment-emergent adverse events, all mild, were reported by five (33%) subjects. Coadministration of lansoprazole with neratinib reduced the rate and extent of neratinib exposure in healthy subjects. © 2016 The British Pharmacological Society.

Is cerebral oxygenation negatively affected by infusion of norepinephrine in healthy subjects?

DEFF Research Database (Denmark)

Brassard, P.; Seifert, T.; Secher, Niels H.

2009-01-01

BACKGROUND: Vasopressor agents are commonly used to increase mean arterial pressure (MAP) in order to secure a pressure gradient to perfuse vital organs. The influence of norepinephrine on cerebral oxygenation is not clear. The aim of this study was to evaluate the impact of the infusion of norep......BACKGROUND: Vasopressor agents are commonly used to increase mean arterial pressure (MAP) in order to secure a pressure gradient to perfuse vital organs. The influence of norepinephrine on cerebral oxygenation is not clear. The aim of this study was to evaluate the impact of the infusion...... of norepinephrine on cerebral oxygenation in healthy subjects. METHODS: Three doses of norepinephrine (0.05, 0.1, and 0.15 microg kg(-1) min(-1) for 20 min each) were infused in nine healthy subjects [six males; 26 (6) yr, mean (SD)]. MAP, cerebral oxygenation characterized by frontal lobe oxygenation (Sc(O2...... infused at 0.1 microg kg(-1) min(-1) [Sc(O2): 78 (75-94) to 69 (61-83)%; P

Absence of diurnal variation of C-reactive protein concentrations in healthy human subjects

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Meier-Ewert, H. K.; Ridker, P. M.; Rifai, N.; Price, N.; Dinges, D. F.; Mullington, J. M.

2001-01-01

BACKGROUND: The concentration of C-reactive protein (CRP) in otherwise healthy subjects has been shown to predict future risk of myocardial infarction and stroke. CRP is synthesized by the liver in response to interleukin-6, the serum concentration of which is subject to diurnal variation. METHODS: To examine the existence of a time-of-day effect for baseline CRP values, we determined CRP concentrations in hourly blood samples drawn from healthy subjects (10 males, 3 females; age range, 21-35 years) during a baseline day in a controlled environment (8 h of nighttime sleep). RESULTS: Overall CRP concentrations were low, with only three subjects having CRP concentrations >2 mg/L. Comparison of raw data showed stability of CRP concentrations throughout the 24 h studied. When compared with cutoff values of CRP quintile derived from population-based studies, misclassification of greater than one quintile did not occur as a result of diurnal variation in any of the subjects studied. Nonparametric ANOVA comparing different time points showed no significant differences for both raw and z-transformed data. Analysis for rhythmic diurnal variation using a method fitting a cosine curve to the group data was negative. CONCLUSIONS: Our data show that baseline CRP concentrations are not subject to time-of-day variation and thus help to explain why CRP concentrations are a better predictor of vascular risk than interleukin-6. Determination of CRP for cardiovascular risk prediction may be performed without concern for diurnal variation.

Microalbuminuria reflects a generalized transvascular albumin leakiness in clinically healthy subjects

DEFF Research Database (Denmark)

Jensen, J S; Borch-Johnsen, K; Jensen, G

1995-01-01

1. In epidemiological studies microalbuminuria, i.e. slightly elevated urinary albumin excretion rate, predicts increased atherosclerotic vascular morbidity and mortality. This study aimed to test the hypothesis that microalbuminuria in clinically healthy subjects is associated with a systemic...... transvascular albumin leakiness. In animal experiments the outflux of albumin and lipids to the arterial wall are highly correlated, and both are elevated in atherosclerosis. 2. All participants were recruited at random from a population-based epidemiological study, where the upper decile of urinary albumin...... excretion rate was 6.6 micrograms/min. Twenty-seven patients with persistent microalbuminuria (urinary albumin excretion rate 6.6-150 micrograms/min), and 56 age- and sex-matched control subjects with persistent normoalbuminuria (UAER

Effect of food intake on pharmacokinetics of oral artemisinin in healthy Vietnamese subjects

NARCIS (Netherlands)

Dien, T. K.; de Vries, P. J.; Khanh, N. X.; Koopmans, R.; Binh, L. N.; Duc, D. D.; Kager, P. A.; van Boxtel, C. J.

1997-01-01

The influence of food intake on the pharmacokinetics of artemisinin was studied with six healthy Vietnamese male subjects. In a crossover study, artemisinin capsules (500 mg) were administered with and without food after an overnight fast. Plasma samples were obtained up to 24 h after intake of each

Aerobic exercise modulation of mental stress-induced responses in cultured endothelial progenitor cells from healthy and metabolic syndrome subjects.

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Rocha, Natalia G; Sales, Allan R K; Miranda, Renan L; Silva, Mayra S; Silva, Jemima F R; Silva, Bruno M; Santos, Aline A; Nóbrega, Antonio C L

2015-02-15

Numerous studies have demonstrated that exercise acutely prevents the reduction in flow-mediated dilation induced by mental stress in subjects with metabolic syndrome (MetS). However, it is unknown whether a similar effect occurs in endothelial progenitors cells (EPCs). This study investigated whether exercise protects from the deleterious effect of mental stress on cultured EPCs in healthy subjects and those with MetS. Ten healthy subjects (aged 31±2) and ten subjects with MetS (aged 36±2) were enrolled. Subjects underwent a mental stress test, followed immediately by either 40 min of leg cycling or rest across two randomized sessions: mental stress+non-exercise control (MS) and mental stress+exercise (MS+EXE). The Stroop Color-Word Test was used to elicit mental stress. Blood samples were drawn at baseline and following sessions to isolate mononuclear cells. These cells were cultured in fibronectin-coated plates for seven days, and EPCs were identified by immunofluorescence (acLDL(+)/ UEA-I Lectin(+)). All subjects presented similar increases in mean blood pressure and heart rate during the mental stress test (P0.05). The EPC response to MS and MS+EXE was increased in healthy subjects, whereas it was decreased in subjects with MetS (Pexercise session increased EPCs in healthy subjects but did not prevent the EPC reduction induced by mental stress among subjects with MetS. © 2015.

Characteristics of Vocal Fold Vibrations in Vocally Healthy Subjects: Analysis with Multi-Line Kymography

Science.gov (United States)

Yamauchi, Akihito; Imagawa, Hiroshi; Sakakibara, Ken-Ichi; Yokonishi, Hisayuki; Nito, Takaharu; Yamasoba, Tatsuya; Tayama, Niro

2014-01-01

Purpose: In this study, the authors aimed to analyze longitudinal data from high-speed digital images in normative subjects using multi-line kymography. Method: Vocally healthy subjects were divided into young (9 men and 17 women; M[subscript age] = 27 years) and older groups (8 men and 12 women; M[subscript age] = 73 years). From high-speed…

Effectiveness of a perceptual - proprioceptive training with virtual visual feedback in healthy subjects: a pilot study

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Stefano Vando

2013-06-01

Full Text Available Background: the aim of this pilot study was to evaluate whether proprioceptive-motor training using the Wii Balance Board (WBB might improve postural sway in healthy subjects.Methods: twenty-five healthy subjects were trained for six weeks (two sessions per week with 5 “video games”: Wii Fit Plus (WFP program. Before and after training: Basic Balance, Single-leg Balance, Agility, Stability and Motion (lower limb: right-left and both leg were measured using the Wii Balance Board.Results: the Wilcoxon Test showed improvements at the end of the training program compared to the baseline conditions. Basic Balance increased during the WFP (33.33% and was associated with a 19.92% decrease in center of pressure (COP lenght. The Single-leg Balance results incremented after the WFP (left 29.09% vs. right 47.92% and accompanied by a decrement in COP (left 28.71% vs. right 30.45%. The values for the Agility test increased both in WFP and COP (28.57% and 58.57%, respectively. The Stability test scores increased in the WFP (66.67% along with a consequent decrease in COP (10.53%. Finally, the Motion test values increased in the WFP (73.17%, whilst COP for this test decreased (12.02%. These results indicate that 6 weeks of virtual training produced a good adaptability. Younger participants (<20 years demonstrated to be more responsive to dynamic stimulation with respect to those >20 years.Conclusions: significant improvements in all participants were observed, indicating that virtual training can influence posture and balance in healthy people. Because of its characteristics of low cost and easy availability, a portable system for balance training for everyone offers the possibility to more readily measure motor skill and to gauge improvement.

Erotic stimulus processing under amisulpride and reboxetine: a placebo-controlled fMRI study in healthy subjects.

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Graf, Heiko; Wiegers, Maike; Metzger, Coraline D; Walter, Martin; Grön, Georg; Abler, Birgit

2014-10-31

Impaired sexual function is increasingly recognized as a side effect of psychopharmacological treatment. However, underlying mechanisms of action of the different drugs on sexual processing are still to be explored. Using functional magnetic resonance imaging, we previously investigated effects of serotonergic (paroxetine) and dopaminergic (bupropion) antidepressants on sexual functioning (Abler et al., 2011). Here, we studied the impact of noradrenergic and antidopaminergic medication on neural correlates of visual sexual stimulation in a new sample of subjects. Nineteen healthy heterosexual males (mean age 24 years, SD 3.1) under subchronic intake (7 days) of the noradrenergic agent reboxetine (4 mg/d), the antidopaminergic agent amisulpride (200mg/d), and placebo were included and studied with functional magnetic resonance imaging within a randomized, double-blind, placebo-controlled, within-subjects design during an established erotic video-clip task. Subjective sexual functioning was assessed using the Massachusetts General Hospital-Sexual Functioning Questionnaire. Relative to placebo, subjective sexual functioning was attenuated under reboxetine along with diminished neural activations within the caudate nucleus. Altered neural activations correlated with decreased sexual interest. Under amisulpride, neural activations and subjective sexual functioning remained unchanged. In line with previous interpretations of the role of the caudate nucleus in the context of primary reward processing, attenuated caudate activation may reflect detrimental effects on motivational aspects of erotic stimulus processing under noradrenergic agents. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Comparative Study on the Pulse Wave Variables and Sasang Constitution in Cerebral Infarction Patients and Healthy Subjects

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Ko KiDuk

2007-06-01

Full Text Available This study was performed to determine whether a pulse analyzer was useful 1 to characterize the variables of pulse wave of cerebral infarction patieno (CI, compared with those of healthy subjects, as well as 2 to determine Sasang Constitution in CI and healthy subjects. 1. Calibrated in Gwan, the amount of energy(Energy, height of main peak(H1, height of aorticvalley(H2, height of aortic peak(H3, total area of pulse wave(At, and area of main peak width(Aw of the CI group were higher than those of the healthy group. 2. Calibrated in Cheek, Energy, H1, H2, H3, height of valve valley(H4, At, Aw, and main peak angle(MPA of the CI group were higher than those of the healthy group. 3. Among the healthy (subjects group, Taeumin showed the highest contact pressure(CP and height of valve peak(H5 calibrated in Chon. The main peak width divided by whole time of pulse wave(MPW/T calibrated in Gwan and Cheok, was highest in Soyangin and was lowest in Taeumin. The H3 divided by H1(H3/H1 and the time to valve valley minus the time to main peak and divided by T[(T4-T1/T] calibrated in Cheek were highest in Soyangin. The time to main peak(T1 was longest in Soumin. 4. Among the CI group, At calibrated in Chon was widest in Taeumin and was narrowest in Soumin The time to aortic peak(T3 calibrated in Cheek was longest in Soumin and was shortest in Soyangin. The time to valve peak(T5 was shortest in Soyangin. 5. There were main effects of cerebral infarction in the area of systolic period(As and area of diastolic period(Ad calibrated in Chon, Energy calibrated in Cwan, and Energy, H1, H2, H3, (H4+H5/Hl, and MPA calibrated in Cheek. 6. There were main effects of Sasang Constitution in (T4-T1/T, area of systolic period(As, and Ad calibrated in Chon. 7. The interactions between the cerebral infarction and Sasang Constitution were observed in H5/H1 , T, At, As, Ad, and MPA calibrated in Chon, H4, T4, (T4-T1/T, As, and Ad calibrated in Cwan, and 74,75, and MPW calibrated

Effects of Curcuma longa (turmeric) on postprandial plasma glucose and insulin in healthy subjects.

Science.gov (United States)

Wickenberg, Jennie; Ingemansson, Sandra Lindstedt; Hlebowicz, Joanna

2010-10-12

Previous animal studies have shown that Curcuma (C.) longa lowers plasma glucose. C. longa may thus be a promising ingredient in functional foods aimed at preventing type 2 diabetes. The purpose of the study is to study the effect of C. longa on postprandial plasma glucose, insulin levels and glycemic index (GI) in healthy subjects. Fourteen healthy subjects were assessed in a crossover trial. A standard 75 g oral glucose tolerance test (OGTT) was administered together with capsules containing a placebo or C. longa. Finger-prick capillary and venous blood samples were collected before, and 15, 30, 45, 60, 90, and 120 min after the start of the OGTT to measure the glucose and insulin levels, respectively. The ingestion of 6 g C. longa had no significant effect on the glucose response. The change in insulin was significantly higher 30 min (P = 0.03) and 60 min (P = 0.041) after the OGTT including C. longa. The insulin AUCs were also significantly higher after the ingestion of C. longa, 15 (P = 0.048), 30 (P = 0.035), 90 (P = 0.03), and 120 (P = 0.02) minutes after the OGTT. The ingestion of 6 g C. longa increased postprandial serum insulin levels, but did not seem to affect plasma glucose levels or GI, in healthy subjects. The results indicate that C. longa may have an effect on insulin secretion.

Behavioural relevance of atypical language lateralization in healthy subjects.

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Knecht, S; Dräger, B; Flöel, A; Lohmann, H; Breitenstein, C; Deppe, M; Henningsen, H; Ringelstein, E B

2001-08-01

In most humans, language is lateralized to the left side of the brain. It has been speculated that this hemispheric specialization is a prerequisite for the full realization of linguistic potential. Using standardized questionnaires and performance measures, we attempted to determine if there are behavioural correlates of atypical, i.e. right-hemispheric and bilateral, language lateralization. The side and degree of language lateralization were determined by measuring the hemispheric perfusion differences by functional transcranial Doppler ultrasonography during a word generation task in healthy volunteers. Subjects with left (n = 264), bilateral (n = 31) or right (n = 31) hemisphere language representation did not differ significantly with respect to mastery of foreign languages, academic achievement, artistic talents, verbal fluency or (as assessed in a representative subgroup) in intelligence or speed of linguistic processing. These findings suggest that atypical hemispheric specialization for language, i.e. right-hemisphere or bilateral specialization, is not associated with major impairments of linguistic faculties in otherwise healthy subjects.

Total and regional deposition of inhaled aerosols in supine healthy subjects and subjects with mild-to-moderate COPD

Energy Technology Data Exchange (ETDEWEB)

Darquenne, Chantal; Lamm, Wayne J.; Fine, Janelle M.; Corley, Richard A.; Glenny, Robb W.

2016-09-01

Despite substantial development of sophisticated subject-specific computational models of aerosol transport and deposition in human lungs, experimental validation of predic- tions from these new models is sparse. We collected aerosol retention and exhalation profiles in seven healthy volunteers and six subjects with mild-to-moderate COPD (FEV1 ¼ 50–80%predicted) in the supine posture. Total deposition was measured during continuous breathing of 1 and 2.9 mm-diameter particles (tidal volume of 1 L, flow rate of 0.3 L/s and 0.75 L/s). Bolus inhalations of 1 mm particles were performed to penetration volumes of 200, 500 and 800 mL (flow rate of 0.5 L/s). Aerosol bolus dispersion (H), deposition, and mode shift (MS) were calculated from these data. There was no significant difference in total deposition between healthy subjects and those with COPD. Total deposition increased with increasing particle size and also with increasing flow rate. Similarly, there was no significant difference in aerosol bolus deposition between subject groups. Yet, the rate of increase in dispersion and of decrease in MS with increasing penetration volume was higher in subjects with COPD than in healthy volunteers (H: 0.79870.205 vs. 0.52770.122 mL/mL, p¼ 0.01; MS: - 0.27170.129 vs. - 0.145 70.076 mL/mL, p¼ 0.05) indicating larger ventilation inhomogeneities (based on H) and increased flow sequencing (based on MS) in the COPD than in the healthy group. In conclusion, in the supine posture, deposition appears to lack sensitivity for assessing the effect of lung morphology and/or ventilation distribution alteration induced by mild-to- moderate lung disease on the fate of inhaled aerosols. However, other parameters such as aerosol bolus dispersion and mode shift may be more sensitive parameters for evaluating models of lungs with moderate disease.

Mefloquine pharmacokinetics in healthy subjects and in peptic ulcer patients after cimetidine administration.

Science.gov (United States)

Kolawole, J A; Mustapha, A; Abudu-Aguye, I; Ochekpe, N

2000-01-01

The pharmacokinetics of orally administered mefloquine were determined in six healthy male subjects and in six ulcer patients before and after a 3-day course of cimetidine (400 mg morning and evening). Peak plasma concentrations Cmax and AUC0-infinity were similarly and significantly (P infinity was increased by 37.5% in healthy and peptic ulcer subjects respectively. The values of t1/2ab absorption and t1/2 beta elimination, total crearance CLT/F and volume of distribution were altered to varying levels after cimetidine treatment but the changes were not statistically significant in both healthy and peptic ulcer subjects. The established long t1/2 beta and this apparent interaction between mefloquine and cimetidine which resulted in increased mefloquine plasma concentration might be of clinical significant in patients with neurological/psychiatric history.

Abdominal acupuncture reduces laser-evoked potentials in healthy subjects

DEFF Research Database (Denmark)

Pazzaglia, C.; Liguori, S.; Minciotti, I.

2015-01-01

Objective: Acupuncture is known to reduce clinical pain, although the exact mechanism is unknown. The aim of the current study was to investigate the effect of acupuncture on laser-evoked potential amplitudes and laser pain perception. Methods: In order to evaluate whether abdominal acupuncture...... is able to modify pain perception, 10 healthy subjects underwent a protocol in which laser-evoked potentials (LEPs) and laser pain perception were collected before the test (baseline), during abdominal acupuncture, and 15. min after needle removal. The same subjects also underwent a similar protocol...... in which, however, sham acupuncture without any needle penetration was used. Results: During real acupuncture, both N1 and N2/P2 amplitudes were reduced, as compared to baseline (p . < 0.01). The reduction lasted up to 15. min after needle removal. Furthermore, laser pain perception was reduced during...

Significance of changes of serum osteocalcin levels in healthy subjects and patients with metabolic bone diseases

International Nuclear Information System (INIS)

Li Liren; Dai Yaozong; Liang Minwen

2002-01-01

Objective: To study the significance of serum osteocalcin changes in healthy subjects and pathological conditions. Methods: The levels of S-BGP were measured with RIA in 270 normal subjects of different age groups (every 10 yrs as an age group), 60 patients with carebrovascular disease (CVD) and 85 patients with metabolic bone disease. Results: (1) The mean value of S-BGP in umbilical blood was 19.3 +- 16.8 μg/L (n = 89), in 3 day sold newborn infant was 7.4 +- 2.3 μg/L (n = 22), in healthy subjects (from 11 to 60 yrs, average age 39 yrs) was 5.2 +- 1.35 μg/L (n = 100), 5.3 +- 1.4 μg/L (n = 47) in males and 5.1 +- 1.34 μg/L (n = 53) in females. In old healthy subjects the mean value was 3.9 +- 1.48 μg/L (n = 30). The level of S-BGP was negatively correlated with the age significantly (r = -0.383, P < 0.001). (2) The mean levels of S-BGP in 85 patients with metabolic bone disease were: 21.7 +- 20.46 μg/L in patients with hyperthyroidism (n = 55, age from 21 to 60 yrs, average 37 yrs), being significantly higher than in healthy subjects (P < 0.01); 2.6 +- 0.99 μg/L in patients with NIDDM (n 30, from 60 to 79 yrs, average age 69 yrs), being significantly higher than in the old healthy subjects (P < 0.01). (3) In 60 patients with CVD (from 60 to 80 yrs, average age 66 yrs) the mean valve was 2.2 +- 1.1 μg/L in cerebral infarction (n = 30) and 2.5 +- 1.2 μg/L in cerebral hemorrhage (n = 30), both significantly higher than in old healthy subjects (P < 0.01). Conclusion: RIA of S-BGP is an important means for detecting changes of bone metabolism in normal and pathological condition

Prevalence of autoantibodies in the course of Gaucher disease type 1: A multicenter study comparing Gaucher disease patients to healthy subjects.

Science.gov (United States)

Serratrice, Christine; Bensalah, Nesma; Penaranda, Guillaume; Bardin, Nathalie; Belmatoug, Nadia; Masseau, Agathe; Rose, Christian; Lidove, Olivier; Camou, Fabrice; Maillot, François; Leguy, Vanessa; Magy-Bertrand, Nadine; Marie, Isabelle; Cherin, Patrick; Bengherbia, Monia; Carballo, Sebastian; Boucraut, José; Serratrice, Jacques; Berger, Marc; Verrot, Denis

2018-01-01

Type 1 Gaucher disease may be related to the presence of autoantibodies. Their clinical significance is questioned. Primary endpoint was to compare the prevalence of autoantibodies in type 1 Gaucher disease patients with healthy subjects, seeking correlations with autoimmune characteristics. Secondary endpoints were to determine whether patients with autoantibodies reported autoimmunity-related symptoms and if genotype, splenectomy or treatment influenced autoantibodies presence. Type 1 Gaucher disease patients and healthy volunteers were included in this national multicenter exploratory study. Autoantibodies presence was compared in both groups and assessed regarding to genotype, splenectomy, Gaucher disease treatment and autoimmunity-related symptoms. Twenty healthy subjects and 40 type 1 Gaucher disease patients were included. Of the studied group: 15 patients undergone splenectomy, 37 were treated either with enzyme replacement therapy (34) or with substrate reduction therapy (3), 25 were homozygous/heterozygous for the N370S mutation. In type 1 Gaucher disease group (studied group), 52% had positive autoantibodies versus 26% in control group. Antiphospholipid antibodies were more frequent in the studied group (30% vs. 5%), but without correlation to thrombosis, osteonecrosis or bone infarcts. In the studied group, antinuclear antibodies were more frequent (25% vs. 16%). None of the patients with autoantibodies had clinical manifestations of autoimmune diseases. Autoantibodies were not correlated with treatment, genotype, or splenectomy, except for anticardiolipid, more frequent in splenectomized patients. In type 1 Gaucher disease, autoantibodies were more frequent compared to a healthy population. However, they were not associated with an increased prevalence of clinical active autoimmune diseases. Copyright © 2016 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Relationship between leukocyte telomere length and personality traits in healthy subjects.

Science.gov (United States)

Sadahiro, R; Suzuki, A; Enokido, M; Matsumoto, Y; Shibuya, N; Kamata, M; Goto, K; Otani, K

2015-02-01

It has been shown that certain personality traits are related to mortality and disease morbidity, but the biological mechanism linking them remains unclear. Telomeres are tandem repeat DNA sequences located at the ends of chromosomes, and shorter telomere length is a predictor of mortality and late-life disease morbidity. Thus, it is possible that personality traits influence telomere length. In the present study, we examined the relationship of leukocyte telomere length with personality traits in healthy subjects. The subjects were 209 unrelated healthy Japanese who were recruited from medical students at 4th-5th grade. Assessment of personality traits was performed by the Revised NEO Personality Inventory (NEO-PI-R) and the Temperament and Character Inventory (TCI). Leukocyte relative telomere length was determined by a quantitative real-time PCR method for a ratio of telomere/single copy gene. In the stepwise multiple regression analysis, shorter telomere length was related to lower scores of neuroticism (Ppersonality traits, and this association may be implicated in the relationship between personality traits and mortality. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Assessment of salivary calcium, phosphate, magnesium, pH, and flow rate in healthy subjects, periodontitis, and dental caries.

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Rajesh, K S; Zareena; Hegde, Shashikanth; Arun Kumar, M S

2015-01-01

This study was conducted to estimate and compare inorganic salivary calcium, phosphate, magnesium, salivary flow rate, and pH of unstimulated saliva and oral hygiene status of healthy subjects, subjects with periodontitis and dental caries, and to correlate salivary calcium level with number of intact teeth. The study population consisted of 48 systemically healthy subjects in the age group of 18-55 years, which was further divided into three groups: healthy, periodontitis, and dental caries. Oral hygiene index-simplified, probing pocket depth, clinical attachment level, the number of intact teeth, and active carious lesions were recorded. Estimation of inorganic salivary calcium, phosphate, and magnesium was performed spectrophotometrically using Vitros 5.1 FS. Statistical analysis was performed using the one-way analysis of variance test at 5% significance level. There was a statistically significant increase in inorganic salivary calcium, phosphate, pH, flow rate, and poor oral hygiene status in periodontitis group compared to dental caries and healthy group. Subjects with increased inorganic salivary calcium, phosphate, pH, flow rate, and poor oral hygiene are at a higher risk of developing periodontitis. Since there is increased remineralization potential, these subjects have more number of intact teeth compared to the dental caries group.

Assessment of salivary calcium, phosphate, magnesium, pH, and flow rate in healthy subjects, periodontitis, and dental caries

Directory of Open Access Journals (Sweden)

K S Rajesh

2015-01-01

Full Text Available Aim: This study was conducted to estimate and compare inorganic salivary calcium, phosphate, magnesium, salivary flow rate, and pH of unstimulated saliva and oral hygiene status of healthy subjects, subjects with periodontitis and dental caries, and to correlate salivary calcium level with number of intact teeth. Materials and Methods: The study population consisted of 48 systemically healthy subjects in the age group of 18-55 years, which was further divided into three groups: healthy, periodontitis, and dental caries. Oral hygiene index-simplified, probing pocket depth, clinical attachment level, the number of intact teeth, and active carious lesions were recorded. Estimation of inorganic salivary calcium, phosphate, and magnesium was performed spectrophotometrically using Vitros 5.1 FS. Statistical analysis was performed using the one-way analysis of variance test at 5% significance level. Results: There was a statistically significant increase in inorganic salivary calcium, phosphate, pH, flow rate, and poor oral hygiene status in periodontitis group compared to dental caries and healthy group. Conclusion: Subjects with increased inorganic salivary calcium, phosphate, pH, flow rate, and poor oral hygiene are at a higher risk of developing periodontitis. Since there is increased remineralization potential, these subjects have more number of intact teeth compared to the dental caries group.

Evaluation of BAG3 levels in healthy subjects, hypertensive patients, and hypertensive diabetic patients.

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Derosa, Giuseppe; Maffioli, Pamela; Rosati, Alessandra; M, De Marco; Basile, Anna; D'Angelo, Angela; Romano, Davide; Sahebkar, Amirhossein; Falco, Antonia; Turco, Maria C

2018-03-01

BAG3 is a member of human BAG (Bcl-2-associated athanogene) proteins and plays a role in apoptosis, cell adhesion, cytoskeleton remodeling, and autophagy. The aim of this study was to evaluate BAG3 levels in healthy subjects, hypertensive patients, and hypertensive diabetic patients. We enrolled 209 Caucasian adults, of both sex, 18-75 years of age, 77 were healthy controls, 62 were affected by hypertension, and 70 were affected by hypertension and type 2 diabetes. All patients underwent an assessment that included medical history, physical examination, vital signs, a 12-lead electrocardiogram, measurements of systolic (SBP), and diastolic blood pressure (DBP), heart rate (HR), fasting plasma glucose (FPG), glycated hemoglobin (HbA 1c ), triglycerides (TG), transaminases, high sensitivity C-reactive protein (Hs-CRP), and BAG3. We observed higher blood pressure values in hypertensive, and hypertensive diabetic patients compared to controls. As expected, FPG and HbA 1c were higher in diabetic hypertensive patients, compared to the other two groups. No Tg levels differences were recorded among the three groups. Hs-CRP was higher in diabetic hypertensive patients compared to healthy subjects. Finally, BAG3 levels were higher in hypertensives, and hypertensive diabetic patients compared to controls. We observed higher levels of BAG3 in hypertensive patients compared to healthy controls, and even higher levels in hypertensive diabetic patients compared to healthy subjects. This paper could be the first of a long way to identify potential involvement of deregulated BAG3 levels in cardiometabolic diseases. © 2017 Wiley Periodicals, Inc.

Effect of the stringency of conditions on caloric test results in healthy subjects.

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Krstulovic, Claudio; Tulsidas Mahtani, Bharti; Atrache Al Attrache, Nabil; Pérez-Garrigues, Herminio

The caloric test is widely used to assess vestibular function, but the conditions in which it is performed can vary. Caloric nystagmus obtained in 57 healthy subjects were compared: 24 subjects studied in ideal conditions and 33 subjects in non-ideal conditions. A statistically significant decrease in the slow phase velocity of the 4 irrigations performed on the subjects in non-ideal conditions was observed. This must be considered, especially in subjects with suspected bilateral involvement. Stringent conditions reduce the risk of misdiagnosis with bilateral deficit. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

The effect of metabolic alkalosis on the ventilatory response in healthy subjects.

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Oppersma, E; Doorduin, J; van der Hoeven, J G; Veltink, P H; van Hees, H W H; Heunks, L M A

2018-02-01

Patients with acute respiratory failure may develop respiratory acidosis. Metabolic compensation by bicarbonate production or retention results in posthypercapnic alkalosis with an increased arterial bicarbonate concentration. The hypothesis of this study was that elevated plasma bicarbonate levels decrease respiratory drive and minute ventilation. In an intervention study in 10 healthy subjects the ventilatory response using a hypercapnic ventilatory response (HCVR) test was assessed, before and after administration of high dose sodium bicarbonate. Total dose of sodiumbicarbonate was 1000 ml 8.4% in 3 days. Plasma bicarbonate increased from 25.2 ± 2.2 to 29.2 ± 1.9 mmol/L. With increasing inspiratory CO 2 pressure during the HCVR test, RR, V t , Pdi, EAdi and V E increased. The clinical ratio ΔV E /ΔP et CO 2 remained unchanged, but Pdi, EAdi and V E were significantly lower after bicarbonate administration for similar levels of inspired CO 2 . This study demonstrates that in healthy subjects metabolic alkalosis decreases the neural respiratory drive and minute ventilation, as a response to inspiratory CO 2 . Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

[Comparative effects of ginkgo biloba extracts on psychomotor performances and memory in healthy subjects].

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Warot, D; Lacomblez, L; Danjou, P; Weiller, E; Payan, C; Puech, A J

1991-01-01

The effect on psychomotor and mnesic performances of acute oral dose (600 mg) of 2 Ginkgo biloba extracts were evaluated in twelve healthy female in a dummy placebo-controlled double blind study. Tests were performed comprising: objective measures of vigilance [critical flicker frequency (CFF), choice reaction time (CRT)], memory tasks (pictures and Sternberg scanning tests) and self-rating evaluation (visual analogue scales). Tests session took place before and 1 hour post-dosing. No statistically significant changes from placebo were observed on CFF, CRT or subjective rating of drug effects. No differences between treatment were evidenced on Sternberg scanning test and pictures recognition. Comparing to baseline, free recall score, while decreasing under placebo and Ginkgo, remained the same under Tanakan. As the differences between treatment are localized on one test, it appears important to examine the reproductility in healthy subjects. In order to verify the clinical relevance of these results, they need to be replicated in older healthy volunteers with age-associated memory impairment.

A protective effect of the BDNF Met/Met genotype in obesity in healthy Caucasian subjects but not in patients with coronary heart disease.

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Sustar, A; Nikolac Perkovic, M; Nedic Erjavec, G; Svob Strac, D; Pivac, N

2016-08-01

Brain-derived neurotrophic factor (BDNF) is a neurotrophic factor with an important role in the regulation of body weight, body mass index (BMI) and obesity. Increased BMI that leads to obesity is a substantial risk factor for coronary heart disease (CHD). The functional BDNF Val66Met polymorphism (rs6265) has been associated with CHD, obesity and BMI. The aim of the study was to determine the association between BDNF rs6265 polymorphism and CHD and/or BMI in patients with CHD and healthy control subjects. The study included 704 Caucasian subjects: 206 subjects with CHD and 498 healthy control subjects. The BDNF rs6265 genotype frequency was similar in male and female subjects, and there were no differences in the frequency of the BDNF rs6265 genotypes in 206 patients with CHD and in 498 healthy subjects. When study participants were subdivided according to the BMI categories into normal weight, overweight and obese subjects, significantly different BDNF rs6265 genotype frequency was found within healthy subjects, but not within patients with CHD. Healthy subjects, but not patients with CHD, subdivided into carriers of the Met/Met, Met/Val and Val/Val genotype, had different BMI scores. The BDNF rs6265 genotype frequency was similar in male and female subjects, and there were no differences in the frequency of the BDNF rs6265 genotypes in 206 patients with CHD and in 498 healthy subjects. When study participants were subdivided according to the BMI categories into normal weight, overweight and obese subjects, significantly different BDNF rs6265 genotype frequency was found within healthy subjects, but not within patients with CHD. Healthy subjects, but not patients with CHD, subdivided into carriers of the Met/Met, Met/Val and Val/Val genotype, had different BMI scores. BDNF rs6265 polymorphism was not associated with a diagnosis of CHD or with BMI categories among patients with CHD. In contrast, healthy Caucasians, carriers of the BDNF Met/Met genotype, had more

Failure of activation of spinal motoneurones after muscle fatigue in healthy subjects studied by transcranial magnetic stimulation

DEFF Research Database (Denmark)

Andersen, Birgit; Westlund, Barbro; Krarup, Christian

2003-01-01

During a sustained maximal effort a progressive decline in the ability to drive motoneurones (MNs) develops. We used the recently developed triple stimulation technique (TST) to study corticospinal conduction after fatiguing exercise in healthy subjects. This method employs a collision technique....... This points to increased probability of repetitive spinal MN activation during fatigue even if some MNs in the pool failed to discharge. Silent period duration following cortical stimulation lengthened by an average of 55 ms after the contraction and recovered within a time course similar to that of the TST...

Effects of Curcuma longa (turmeric on postprandial plasma glucose and insulin in healthy subjects

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Ingemansson Sandra

2010-10-01

Full Text Available Abstract Background Previous animal studies have shown that Curcuma (C. longa lowers plasma glucose. C. longa may thus be a promising ingredient in functional foods aimed at preventing type 2 diabetes. The purpose of the study is to study the effect of C. longa on postprandial plasma glucose, insulin levels and glycemic index (GI in healthy subjects. Methods Fourteen healthy subjects were assessed in a crossover trial. A standard 75 g oral glucose tolerance test (OGTT was administered together with capsules containing a placebo or C. longa. Finger-prick capillary and venous blood samples were collected before, and 15, 30, 45, 60, 90, and 120 min after the start of the OGTT to measure the glucose and insulin levels, respectively. Results The ingestion of 6 g C. longa had no significant effect on the glucose response. The change in insulin was significantly higher 30 min (P = 0.03 and 60 min (P = 0.041 after the OGTT including C. longa. The insulin AUCs were also significantly higher after the ingestion of C. longa, 15 (P = 0.048, 30 (P = 0.035, 90 (P = 0.03, and 120 (P = 0.02 minutes after the OGTT. Conclusions The ingestion of 6 g C. longa increased postprandial serum insulin levels, but did not seem to affect plasma glucose levels or GI, in healthy subjects. The results indicate that C. longa may have an effect on insulin secretion. Trial registration number NCT01029327

Modulation of the platelet serotonin transporter by thermal balneotherapy: a study in healthy subjects.

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Baroni, S; Marazziti, D; Consoli, G; Picchetti, M; Catena-Dell'Osso, M; Galassi, A

2012-05-01

Although the beneficial effects of balneotherapy have been recognized since a long time, a few information is available on the biological mechanisms underlying them and the subjective feelings of increased well-being and mood. The links between the serotonin (5-HT) system and mood prompted us to investigate the 5-HT platelet transporter (SERT), which is considered a reliable, peripheral marker of the same structure present in presynaptic neurons, in 30 healthy volunteers before (t0) and 30 minutes after (t1) thermal balneotherapy with ozonized water, as compared with a similar group who underwent a bath in non-mineral water. MATERIALS AN METHODS: The SERT was evaluated by means of the specific binding of 3H-paroxetine (3H-Par) to platelet membranes. Equilibrium-saturation binding data, the maximal binding capacity (Bmax) and the dissociation constant (Kd), were obtained by means of the Scatchard analysis. The results showed that, while Bmax values did not change in both groups, the Kd values decreased significantly at t1 only in those subjects who bathed in ozonized water. The results of this study, while showing a decrease of the dissociation constant (Kd) which is the inverse of affinity constant, of 3H-Par binding to SERT in all subjects after balneotherapy and not in those bathing in normal water, suggest that SERT modifications may be related to a specific effect of ozonized water and, perhaps, also to the increased sense of well-being.

Circadian profile of cardiac autonomic nervous modulation in healthy subjects

DEFF Research Database (Denmark)

Bonnemeier, Hendrik; Richardt, Gert; Potratz, Jürgen

2003-01-01

UNLABELLED: Circadian Profile of Heart Rate Variability. INTRODUCTION: Although heart rate variability (HRV) has been established as a tool to study cardiac autonomic activity, almost no data are available on the circadian patterns of HRV in healthy subjects aged 20 to 70 years. METHODS AND RESULTS...... higher in men. Younger men also exhibited significantly higher values...... parasympathetic activity. The significant gender-related difference of HRV decreases with aging. These findings emphasize the need to determine age-, gender-, and nycthemeral-dependent normal ranges for HRV assessment....

Oxidised fish oil does not influence established markers of oxidative stress in healthy human subjects

DEFF Research Database (Denmark)

Ottestad, Inger; Vogt, Gjermund; Retterstøl, Kjetil

2012-01-01

markers of oxidative stress, lipid peroxidation and inflammation, and the level of plasma n-3 FA after intake of oxidised fish oil. In a double-blinded randomised controlled study, healthy subjects (aged 18–50 years, n 54) were assigned into one of three groups receiving capsules containing either 8 g...... difference was observed between the fish oil groups. No changes in a variety of in vivo markers of oxidative stress, lipid peroxidation or inflammation were observed after daily intake of oxidised fish oil for 3 or 7 weeks, indicating that intake of oxidised fish oil may not have unfavourable short......-term effects in healthy human subjects....

Clinical implications of gait analysis in the rehabilitation of adult patients with "Prader-Willi" Syndrome: a cross-sectional comparative study ("Prader-Willi" Syndrome vs matched obese patients and healthy subjects

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Baccalaro Gabriele

2007-05-01

Full Text Available Abstract Background Being severely overweight is a distinctive clinical feature of Prader-Willi Syndrome (PWS. PWS is a complex multisystem disorder, representing the most common form of genetic obesity. The aim of this study was the analysis of the gait pattern of adult subjects with PWS by using three-Dimensional Gait Analysis. The results were compared with those obtained in a group of obese patients and in a group of healthy subjects. Methods Cross-sectional, comparative study: 19 patients with PWS (11 males and 8 females, age: 18–40 years, BMI: 29.3–50.3 kg/m2; 14 obese matched patients (5 males and 9 females, age: 18–40 years, BMI: 34.3–45.2 kg/m2; 20 healthy subjects (10 males and 10 females, age: 21–41 years, BMI: 19.3–25.4 kg/m2. Kinematic and kinetic parameters during walking were assessed by an optoelectronic system and two force platforms. Results PWS adult patients walked slower, had a shorter stride length, a lower cadence and a longer stance phase compared with both matched obese, and healthy subjects. Obese matched patients showed spatio-temporal parameters significantly different from healthy subjects. Furthermore, Range Of Motion (ROM at knee and ankle, and plantaflexor activity of PWS patients were significantly different between obese and healthy subjects. Obese subjects revealed kinematic and kinetic data similar to healthy subjects. Conclusion PWS subjects had a gait pattern significantly different from obese patients. Despite that, both groups had a similar BMI. We suggest that PWS gait abnormalities may be related to abnormalities in the development of motor skills in childhood, due to precocious obesity. A tailored rehabilitation program in early childhood of PWS patients could prevent gait pattern changes.

Insight on AV-45 binding in white and grey matter from histogram analysis: a study on early Alzheimer's disease patients and healthy subjects

Science.gov (United States)

Nemmi, Federico; Saint-Aubert, Laure; Adel, Djilali; Salabert, Anne-Sophie; Pariente, Jérémie; Barbeau, Emmanuel; Payoux, Pierre; Péran, Patrice

2014-01-01

Purpose AV-45 amyloid biomarker is known to show uptake in white matter in patients with Alzheimer’s disease (AD) but also in healthy population. This binding; thought to be of a non-specific lipophilic nature has not yet been investigated. The aim of this study was to determine the differential pattern of AV-45 binding in healthy and pathological populations in white matter. Methods We recruited 24 patients presenting with AD at early stage and 17 matched, healthy subjects. We used an optimized PET-MRI registration method and an approach based on intensity histogram using several indexes. We compared the results of the intensity histogram analyses with a more canonical approach based on target-to-cerebellum Standard Uptake Value (SUVr) in white and grey matters using MANOVA and discriminant analyses. A cluster analysis on white and grey matter histograms was also performed. Results White matter histogram analysis revealed significant differences between AD and healthy subjects, which were not revealed by SUVr analysis. However, white matter histograms was not decisive to discriminate groups, and indexes based on grey matter only showed better discriminative power than SUVr. The cluster analysis divided our sample in two clusters, showing different uptakes in grey but also in white matter. Conclusion These results demonstrate that AV-45 binding in white matter conveys subtle information not detectable using SUVr approach. Although it is not better than standard SUVr to discriminate AD patients from healthy subjects, this information could reveal white matter modifications. PMID:24573658

Insight on AV-45 binding in white and grey matter from histogram analysis: a study on early Alzheimer's disease patients and healthy subjects

International Nuclear Information System (INIS)

Nemmi, Federico; Saint-Aubert, Laure; Peran, Patrice; Adel, Djilali; Salabert, Anne-Sophie; Payoux, Pierre; Pariente, Jeremie; Barbeau, Emmanuel J.

2014-01-01

AV-45 amyloid biomarker is known to show uptake in white matter in patients with Alzheimer's disease (AD), but also in the healthy population. This binding, thought to be of a non-specific lipophilic nature, has not yet been investigated. The aim of this study was to determine the differential pattern of AV-45 binding in white matter in healthy and pathological populations. We recruited 24 patients presenting with AD at an early stage and 17 matched, healthy subjects. We used an optimized positron emission tomography-magnetic resonance imaging (PET-MRI) registration method and an approach based on an intensity histogram using several indices. We compared the results of the intensity histogram analyses with a more canonical approach based on target-to-cerebellum Standard Uptake Value (SUVr) in white and grey matter using MANOVA and discriminant analyses. A cluster analysis on white and grey matter histograms was also performed. White matter histogram analysis revealed significant differences between AD and healthy subjects, which were not revealed by SUVr analysis. However, white matter histograms were not decisive to discriminate groups, and indices based on grey matter only showed better discriminative power than SUVr. The cluster analysis divided our sample into two clusters, showing different uptakes in grey, but also in white matter. These results demonstrate that AV-45 binding in white matter conveys subtle information not detectable using the SUVr approach. Although it is not more efficient than standard SUVr in discriminating AD patients from healthy subjects, this information could reveal white matter modifications. (orig.)

Knee bioelectric impedance assessment in healthy/with osteoarthritis subjects

International Nuclear Information System (INIS)

Neves, Eduardo Borba; Pino, Alexandre Visintainer; De Almeida, Renan Moritz Varnier Rodrigues; De Souza, Márcio Nogueira

2010-01-01

The present study analyzes parameters estimated by bioelectric impedance spectroscopy (BIS) in subjects with healthy and with osteoarthritis (OA) knees. Thirty-two male volunteers, members of the Parachute Military Infantry Brigade of Rio de Janeiro, Brazil, participated in the study (62 knee joints). Clinical specialists used the Dejour scale for OA classification and divided the subjects into a control (without OA) and a pathological group (with different degrees of OA). BIS data were obtained in a standing position using a BIS technique based on the current response to a step voltage excitation. Differences between groups were measured by means of a Wilcoxon–Mann–Whitney test. Results indicate that raw bioimpedance parameters seem to be sensitive to the physiological changes associated with OA. Thus, data indicate that extra-cellular resistance (Re) and reactance of the equivalent capacitance (Xcx) increase according to the disease intensity (p < 0.001). In conclusion, the BIS technique seems to be able to provide the objective and non-invasive basis for helping the diagnosis of knee OA

Morphology and Three-Dimensional Inhalation Flow in Human Airways in Healthy and Diseased Subjects

Science.gov (United States)

Van de Moortele, Tristan

We investigate experimentally the relation between anatomical structure and respiratory function in healthy and diseased airways. Computed Tomography (CT) scans of human lungs are analyzed from the data base of a large multi-institution clinical study on Chronic Obstructive Pulmonary Disease (COPD). Through segmentation, the 3D volumes of the airways are determined at total lung capacity. A geometric analysis provides data on the morphometry of the airways, including the length and diameter of branches, the child-to-parent diameter ratio, and branching angles. While several geometric parameters are confirmed to match past studies for healthy subjects, previously unreported trends are reported on the length of branches. Specifically, in most dichotomous airway bifurcation, the branch of smaller diameter tends to be significantly longer than the one of larger diameter. Additionally, the branch diameter tends to be smaller in diseased airways than in healthy airways up to the 7th generation of bronchial branching. 3D fractal analysis is also performed on the airway volume. Fractal dimensions of 1.89 and 1.83 are found for healthy non-smokers and declining COPD subjects, respectively, furthering the belief that COPD (and lung disease in general) significantly affects the morphometry of the airways already in early stages of the disease. To investigate the inspiratory flow, 3D flow models of the airways are generated using Computer Aided Design (CAD) software and 3D printed. Using Magnetic Resonance Velocimetry (MRV), 3-component 3D flow fields are acquired for steady inhalation at Reynolds number Re 2000 defined at the trachea. Analysis of the flow data reveals that diseased subjects may experience greater secondary flow strength in their conducting airways, especially in deeper generations.

MRI pattern of arthritis in systemic lupus erythematosus: a comparative study with rheumatoid arthritis and healthy subjects

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Tani, Chiara; Possemato, Niccolo; Delle Sedie, Andrea; Bombardieri, Stefano; Mosca, Marta [University of Pisa, Rheumatology Unit, Department of Clinical and Experimental Medicine, Pisa (Italy); D' aniello, Dario; Caramella, Davide [Radiology Unit, University of Pisa, Pisa (Italy)

2014-10-24

In this study we aimed to describe the magnetic resonance imaging (MRI) pattern of the distribution of bone marrow edema (BME) and joint erosion in hands and wrists of patients with systemic lupus erythematosus (SLE) with arthritis in comparison with rheumatoid arthritis (RA) and healthy subjects (H). SLE patients with arthritis (n = 50), patients with RA (n = 22), and H (n = 48) were enrolled. Every patient underwent a non-dominant hand (2nd-5th metacarpophalangeal joints) and wrist MRI without contrast injection with a low-field extremity dedicated 0.2-Tesla instrument. BME was observed in two SLE patients in the hand (4 %) and in 15 in the wrist (13 %) versus three (30 %), and 14 (63 %) RA patients. No BME was found in H. Erosions were observed in the hand in 24 SLE patients (48 %), 15 RA patients (68 %), and 9 H (18 %); in the wrist, in 41 (82 %) SLE, all RA and 47 (97 %) H. The cumulative erosive burden in SLE was significantly higher than in H (c = 0.002) but similar to RA patients. Joint involvement of the wrist in SLE is similar to RA and is not as rare as expected, as shown by the comparison with healthy subjects. On the contrary, the involvement of the hand in SLE is significantly lower compared to RA. (orig.)

MRI pattern of arthritis in systemic lupus erythematosus: a comparative study with rheumatoid arthritis and healthy subjects

International Nuclear Information System (INIS)

Tani, Chiara; Possemato, Niccolo; Delle Sedie, Andrea; Bombardieri, Stefano; Mosca, Marta; D'aniello, Dario; Caramella, Davide

2015-01-01

In this study we aimed to describe the magnetic resonance imaging (MRI) pattern of the distribution of bone marrow edema (BME) and joint erosion in hands and wrists of patients with systemic lupus erythematosus (SLE) with arthritis in comparison with rheumatoid arthritis (RA) and healthy subjects (H). SLE patients with arthritis (n = 50), patients with RA (n = 22), and H (n = 48) were enrolled. Every patient underwent a non-dominant hand (2nd-5th metacarpophalangeal joints) and wrist MRI without contrast injection with a low-field extremity dedicated 0.2-Tesla instrument. BME was observed in two SLE patients in the hand (4 %) and in 15 in the wrist (13 %) versus three (30 %), and 14 (63 %) RA patients. No BME was found in H. Erosions were observed in the hand in 24 SLE patients (48 %), 15 RA patients (68 %), and 9 H (18 %); in the wrist, in 41 (82 %) SLE, all RA and 47 (97 %) H. The cumulative erosive burden in SLE was significantly higher than in H (c = 0.002) but similar to RA patients. Joint involvement of the wrist in SLE is similar to RA and is not as rare as expected, as shown by the comparison with healthy subjects. On the contrary, the involvement of the hand in SLE is significantly lower compared to RA. (orig.)

Glucose uptake and pulsatile insulin infusion: euglycaemic clamp and [3-3H]glucose studies in healthy subjects

International Nuclear Information System (INIS)

Schmitz, O.; Arnfred, J.; Hother Nielsen, O.; Beck-Nielsen, H.; Oerskov, H.

1986-01-01

To test the hypothesis that insulin has a greater effect on glucose metabolism when given as pulsatile than as continuous infusion, a 354-min euglycaemic clamp study was carried out in 8 healthy subjects. At random order soluble insulin was given intravenously either at a constant rate of 0.45mU/kg · min or in identical amounts in pulses of 1 1 / 2 to 2 1 / 4 min followed by intervals of 10 1 / 2 to 9 3 / 4 min. Average serum insulin levels were similar during the two infusion protocols, but pulsatile administration induced oscillations ranging between 15 and 62 μU/ml. Glucose uptake expressed as metabolic clearance rate (MCR) for glucose was significantly increased during pulsatile insulin delivery as compared with continuous administration (270-294 min: 8.7±0.7 vs 6.8±0.9 ml/kg · min, P 3 H]glucose infusion technique was suppressed to insignificant values. Finally, the effect of insulin on endogenous insulin secretion and lipolysis as assessed by changes in serum C-peptide and serum FFA was uninfluenced by the infusion mode. In conclusion, insulin infusion resulting in physiological serum insulin levels enhances glucose uptake in peripheral tissues in healthy subjects to a higher degree when given in a pulsed pattern mimicking that of the normal endocrine pancreas than when given as a continuous infusion. (author)

Free and protein-bound cobalamin absorption in healthy middle-aged and older subjects.

Science.gov (United States)

van Asselt, D Z; van den Broek, W J; Lamers, C B; Corstens, F H; Hoefnagels, W H

1996-08-01

To study free- and protein-bound cobalamin absorption and the correlation with atrophic gastritis in healthy middle-aged and older subjects. A cross-sectional study. Fifty-two healthy subjects, aged 26 to 87 years, apparently free from conditions known to influence the cobalamin status. Middle-aged subjects were defined as those younger than 65 years of age (median age 57 years) and older subjects as those 65 years and older (median age 75 years). Protein-bound cobalamin absorption was assessed by 48-hour urinary excretion method following oral administration of scrambled egg yolk, labeled in vivo with 57 Co-cobalamin by injecting a hen with 57 Co-cyanocobalamin. The percentage of 57 Co-cobalamin bound to protein was 65%. Free cobalamin absorption was assessed by 48-hour urinary excretion method following oral administration of crystalline 57 Co-cyanocobalamin. Plasma cobalamin, folate and fasting plasma gastrin, and pepsinogen A and C concentrations were determined. The median urinary excretion of egg yolk 57 Co-cobalamin in middle-aged subjects was 12.3% (25th and 75th percentiles 10.5%-14.5%) compared with 11.7% (25th and 75th percentiles 9.8%-13.6%) in older subjects (P = .283). The median urinary excretion after administration of free 57 Co-cobalamin in middle-aged subjects was 25.7% (25th and 75th percentiles 20.6%-30.7%) compared with 27.9% (25th and 75th percentiles 21.4%-34.5%) in older subjects (P = .694). Neither egg yolk nor free 57 Co-cobalamin excretion correlated with age. A ratio of pepsinogen A to pepsinogen C less than 1.6, indicating atrophic gastritis, was found in 13 subjects. Within the atrophic gastritis group, 11 subjects had a pepsinogen A concentration greater than or equal to 17 micrograms/L, indicating mild to moderate atrophic gastritis, and two subjects had a pepsinogen A concentration less than 17 micrograms/L, indicating severe atrophic gastritis or gastric atrophy. All subjects had normal fasting plasma gastrin concentrations. Free

Incidental findings in healthy control research subjects using whole-body MRI

International Nuclear Information System (INIS)

Morin, S.H.X.; Cobbold, J.F.L.; Lim, A.K.P.; Eliahoo, J.; Thomas, E.L.; Mehta, S.R.; Durighel, G.; Fitzpatrick, J.; Bell, J.D.

2009-01-01

Aim: Magnetic resonance imaging (MRI) is a powerful clinical tool used increasingly in the research setting. We aimed to assess the prevalence of incidental findings in a sequential cohort of healthy volunteers undergoing whole-body MRI as part of a normal control database for imaging research studies. Materials and methods: 148 healthy volunteers (median age 36 years, range 21-69 years; 63.5% males, 36.5% females) were enrolled into a prospective observational study at a single hospital-based MRI research unit in London, UK. Individuals with a clinical illness, treated or under investigation were excluded from the study. Results: 43 (29.1%) scans were abnormal with a total of 49 abnormalities detected. Of these, 20 abnormalities in 19 patients (12.8%) were of clinical significance. The prevalence of incidental findings increased significantly with both increasing age and body mass index (BMI). Obese subjects had a fivefold greater risk of having an incidental abnormality on MRI (OR 5.4, CI 2.1-14.0). Conclusions: This study showed that more than one quarter of healthy volunteers have MR-demonstrable abnormalities. There was an increased risk of such findings in obese patients. This has ethical and financial implications for future imaging research, particularly with respect to informed consent and follow-up of those with abnormalities detected during the course of imaging studies.

Evaluation of the effects of the Arm Light Exoskeleton on movement execution and muscle activities: a pilot study on healthy subjects.

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Pirondini, Elvira; Coscia, Martina; Marcheschi, Simone; Roas, Gianluca; Salsedo, Fabio; Frisoli, Antonio; Bergamasco, Massimo; Micera, Silvestro

2016-01-23

Exoskeletons for lower and upper extremities have been introduced in neurorehabilitation because they can guide the patient's limb following its anatomy, covering many degrees of freedom and most of its natural workspace, and allowing the control of the articular joints. The aims of this study were to evaluate the possible use of a novel exoskeleton, the Arm Light Exoskeleton (ALEx), for robot-aided neurorehabilitation and to investigate the effects of some rehabilitative strategies adopted in robot-assisted training. We studied movement execution and muscle activities of 16 upper limb muscles in six healthy subjects, focusing on end-effector and joint kinematics, muscle synergies, and spinal maps. The subjects performed three dimensional point-to-point reaching movements, without and with the exoskeleton in different assistive modalities and control strategies. The results showed that ALEx supported the upper limb in all modalities and control strategies: it reduced the muscular activity of the shoulder's abductors and it increased the activity of the elbow flexors. The different assistive modalities favored kinematics and muscle coordination similar to natural movements, but the muscle activity during the movements assisted by the exoskeleton was reduced with respect to the movements actively performed by the subjects. Moreover, natural trajectories recorded from the movements actively performed by the subjects seemed to promote an activity of muscles and spinal circuitries more similar to the natural one. The preliminary analysis on healthy subjects supported the use of ALEx for post-stroke upper limb robotic assisted rehabilitation, and it provided clues on the effects of different rehabilitative strategies on movement and muscle coordination.

No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.

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Linares, Ila M P; Guimaraes, Francisco S; Eckeli, Alan; Crippa, Ana C S; Zuardi, Antonio W; Souza, Jose D S; Hallak, Jaime E; Crippa, José A S

2018-01-01

Cannabidiol (CBD) is a component of Cannabis sativa that has a broad spectrum of potential therapeutic effects in neuropsychiatric and other disorders. However, few studies have investigated the possible interference of CBD on the sleep-wake cycle. The aim of the present study was to evaluate the effect of a clinically anxiolytic dose of CBD on the sleep-wake cycle of healthy subjects in a crossover, double-blind design. Twenty-seven healthy volunteers that fulfilled the eligibility criteria were selected and allocated to receive either CBD (300 mg) or placebo in the first night in a double-blind randomized design (one volunteer withdrew from the study). In the second night, the same procedure was performed using the substance that had not been administered in the previous occasion. CBD or placebo were administered 30 min before the start of polysomnography recordings that lasted 8 h. Cognitive and subjective measures were performed immediately after polysomnography to assess possible residual effects of CBD. The drug did not induce any significant effect ( p > 0.05). Different from anxiolytic and antidepressant drugs such as benzodiazepines and selective serotonin reuptake inhibitors, acute administration of an anxiolytic dose of CBD does not seem to interfere with the sleep cycle of healthy volunteers. The present findings support the proposal that CBD do not alter normal sleep architecture. Future studies should address the effects of CBD on the sleep-wake cycle of patient populations as well as in clinical trials with larger samples and chronic use of different doses of CBD. Such studies are desirable and opportune.

No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Directory of Open Access Journals (Sweden)

Ila M. P. Linares

2018-04-01

Full Text Available Cannabidiol (CBD is a component of Cannabis sativa that has a broad spectrum of potential therapeutic effects in neuropsychiatric and other disorders. However, few studies have investigated the possible interference of CBD on the sleep-wake cycle. The aim of the present study was to evaluate the effect of a clinically anxiolytic dose of CBD on the sleep-wake cycle of healthy subjects in a crossover, double-blind design. Twenty-seven healthy volunteers that fulfilled the eligibility criteria were selected and allocated to receive either CBD (300 mg or placebo in the first night in a double-blind randomized design (one volunteer withdrew from the study. In the second night, the same procedure was performed using the substance that had not been administered in the previous occasion. CBD or placebo were administered 30 min before the start of polysomnography recordings that lasted 8 h. Cognitive and subjective measures were performed immediately after polysomnography to assess possible residual effects of CBD. The drug did not induce any significant effect (p > 0.05. Different from anxiolytic and antidepressant drugs such as benzodiazepines and selective serotonin reuptake inhibitors, acute administration of an anxiolytic dose of CBD does not seem to interfere with the sleep cycle of healthy volunteers. The present findings support the proposal that CBD do not alter normal sleep architecture. Future studies should address the effects of CBD on the sleep-wake cycle of patient populations as well as in clinical trials with larger samples and chronic use of different doses of CBD. Such studies are desirable and opportune.

Switching from rivaroxaban to warfarin: an open label pharmacodynamic study in healthy subjects

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Moore, Kenneth Todd; Byra, William; Vaidyanathan, Seema; Natarajan, Jaya; Ariyawansa, Jay; Salih, Hiba; Turner, Kenneth C

2015-01-01

Aims The primary objective was to explore the pharmacodynamic changes during transition from rivaroxaban to warfarin in healthy subjects. Safety, tolerability and pharmacokinetics were assessed as secondary objectives. Methods An open label, non-randomized, sequential two period study. In treatment period 1 (TP1), subjects received rivaroxaban 20 mg once daily (5 days), followed by co-administration with a warfarin loading dose regimen of 5 or 10 mg (for the 10 mg regimen, the dose could be uptitrated to attain target international normalized ratio [INR] ≥2.0) once daily (2–4 days). When trough INR values ≥2.0 were attained, rivaroxaban was discontinued and warfarin treatment continued as monotherapy (INR 2.0–3.0). During treatment period 2, subjects received the same warfarin regimen as in TP1, but without rivaroxaban. Results During co-administration, maximum INR and prothrombin time (PT) values were higher than with rivaroxaban or warfarin monotherapy. The mean maximum effect (Emax) for INR after co-administration was 2.79–4.15 (mean PT Emax 41.0–62.7 s), compared with 1.41–1.74 (mean PT Emax 20.1–25.2 s) for warfarin alone. However, rivaroxaban had the smallest effect on INR at trough rivaroxaban concentrations. Neither rivaroxaban nor warfarin significantly affected maximum plasma concentrations of the other drug. Conclusions The combined pharmacodynamic effects during co-administration of rivaroxaban and warfarin were greater than additive, but the pharmacokinetics of both drugs were unaffected. Co-administration was well tolerated. When transitioning from rivaroxaban to warfarin, INR monitoring during co-administration should be performed at the trough rivaroxaban concentration to minimize the effect of rivaroxaban on INR. PMID:25475601

The effect of baclofen and diazepam on motor skill acquisition in healthy subjects

DEFF Research Database (Denmark)

Willerslev-Olsen, Maria; Lundbye-Jensen, Jesper; Petersen, Tue Hvass

2011-01-01

investigated the influence of baclofen and diazepam on acquisition of a visuomotor skill. The study was designed as a semi-randomized, double-blinded, placebo-controlled, crossover study in 16 healthy human subjects. The motor skill task required the subjects to match a given force trajectory by increasing...... that diazepam and baclofen interfere with the acquisition of a motor skill by disrupting some of the neuroplastic changes that are involved in improved motor performance. This suggests that antispastic treatment should be used with caution in subjects receiving concomitant physiotherapy.......Antispastic medication is often used in the clinic together with physiotherapy. However, some of the antispastic drugs, e.g., baclofen and diazepam, may influence the plastic mechanisms that are necessary for motor learning and hence efficient physiotherapy. In the present study, we consequently...

Effect of kinesiotaping, non-elastic taping and bracing on segmental foot kinematics during drop landing in healthy subjects and subjects with chronic ankle instability.

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Kuni, B; Mussler, J; Kalkum, E; Schmitt, H; Wolf, S I

2016-09-01

To evaluate the effects of kinesiotape, non-elastic tape, and soft brace on segmental foot kinematics during drop landing in subjects with chronic ankle instability and healthy subjects. Controlled study with repeated measurements. Three-dimensional motion analysis laboratory. Twenty participants with chronic ankle instability and 20 healthy subjects. The subjects performed drop landings with 17 retroreflective markers on the foot and lower leg in four conditions: barefoot, with kinesiotape, with non-elastic tape and with a soft brace. Ranges of motion of foot segments using a foot measurement method. In participants with chronic ankle instability, midfoot movement in the frontal plane (inclination of the medial arch) was reduced significantly by non-elastic taping, but kinesiotaping and bracing had no effect. In healthy subjects, both non-elastic taping and bracing reduced that movement. In both groups, non-elastic taping and bracing reduced rearfoot excursion in inversion/eversion significantly, which indicates a stabilisation effect. No such effect was found with kinesiotaping. All three methods reduced maximum plantar flexion significantly. Non-elastic taping stabilised the midfoot best in patients with chronic ankle instability, while kinesiotaping did not influence foot kinematics other than to stabilise the rearfoot in the sagittal plane. ClinicalTrials.gov NCT01810471. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Induction of depressed and elated mood by music influences the perception of facial emotional expressions in healthy subjects.

Science.gov (United States)

Bouhuys, A L; Bloem, G M; Groothuis, T G

1995-04-04

The judgement of healthy subject rating the emotional expressions of a set of schematic drawn faces is validated (study 1) to examine the relationship between mood (depressed/elated) and judgement of emotional expressions of these faces (study 2). Study 1: 30 healthy subjects judged 12 faces with respect to the emotions they express (fear, happiness, anger, sadness, disgust, surprise, rejection and invitation). It was found that a particular face could reflect various emotions. All eight emotions were reflected in the set of faces and the emotions were consensually judged. Moreover, gender differences in judgement could be established. Study 2: In a cross-over design, 24 healthy subjects judged the faces after listening to depressing or elating music. The faces were subdivided in six 'ambiguous' faces (i.e., expressing similar amounts of positive and negative emotions) and six 'clear' faces (i.e., faces showing a preponderance of positive or negative emotions). In addition, these two types of faces were distinguished with respect to the intensity of emotions they express. 11 subjects who showed substantial differences in experienced depression after listening to the music were selected for further analysis. It was found that, when feeling more depressed, the subjects perceived more rejection/sadness in ambiguous faces (displaying less intensive emotions) and less invitation/happiness in clear faces. In addition, subjects saw more fear in clear faces that express less intensive emotions. Hence, results show a depression-related negative bias in the perception of facial displays.

Differentiation of schizophrenia patients from healthy subjects by mismatch negativity and neuropsychological tests.

Directory of Open Access Journals (Sweden)

Yi-Ting Lin

Full Text Available BACKGROUND: Schizophrenia is a heterogeneous disorder with diverse presentations. The current and the proposed DSM-V diagnostic system remains phenomenologically based, despite the fact that several neurobiological and neuropsychological markers have been identified. A multivariate approach has better diagnostic utility than a single marker method. In this study, the mismatch negativity (MMN deficit of schizophrenia was first replicated in a Han Chinese population, and then the MMN was combined with several neuropsychological measurements to differentiate schizophrenia patients from healthy subjects. METHODOLOGY/PRINCIPAL FINDINGS: 120 schizophrenia patients and 76 healthy controls were recruited. Each subject received examinations for duration MMN, Continuous Performance Test, Wisconsin Card Sorting Test, and Wechsler Adult Intelligence Scale Third Edition (WAIS-III. The MMN was compared between cases and controls, and important covariates were investigated. Schizophrenia patients had significantly reduced MMN amplitudes, and MMN decreased with increasing age in both patient and control groups. None of the neuropsychological indices correlated with MMN. Predictive multivariate logistic regression models using the MMN and neuropsychological measurements as predictors were developed. Four predictors, including MMN at electrode FCz and three scores from the WAIS-III (Arithmetic, Block Design, and Performance IQ were retained in the final predictive model. The model performed well in differentiating patients from healthy subjects (percentage of concordant pairs: 90.5%. CONCLUSIONS/SIGNIFICANCE: MMN deficits were found in Han Chinese schizophrenia patients. The multivariate approach combining biomarkers from different modalities such as electrophysiology and neuropsychology had a better diagnostic utility.

Tolerability, pharmacokinetics and pharmacodynamics of TA-8995, a selective cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects

NARCIS (Netherlands)

Ford, John; Lawson, Matt; Fowler, David; Maruyama, Nobuko; Mito, Seiji; Tomiyasu, Koichi; Kinoshita, Shuji; Suzuki, Chisa; Kawaguchi, Atsuhiro; Round, Patrick; Boyce, Malcolm; Warrington, Steve; Weber, Werner; van Deventer, Sander; Kastelein, John J. P.

2014-01-01

Two double-blind, randomized studies were conducted to assess the tolerability, pharmacokinetics and pharmacodynamics of oral TA-8995, a new cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects. Study 1: Subjects received single doses of TA-8995 or placebo (fasted). Doses were 5,

Quantitative tissue parameters of Achilles tendon and plantar fascia in healthy subjects using a handheld myotonometer.

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Orner, Sarah; Kratzer, Wolfgang; Schmidberger, Julian; Grüner, Beate

2018-01-01

The aim of the study was to examine the quantitative tissue properties of the Achilles tendon and plantar fascia using a handheld, non-invasive MyotonPRO device, in order to generate normal values and examine the biomechanical relationship of both structures. Prospective study of a large, healthy sample population. The study sample included 207 healthy subjects (87 males and 120 females) for the Achilles tendon and 176 healthy subjects (73 males and 103 females) for the plantar fascia. For the correlations of the tissue parameters of the Achilles tendon and plantar fascia an intersection of both groups was formed which included 150 healthy subjects (65 males and 85 females). All participants were measured in a prone position. Consecutive measurements of the Achilles tendon and plantar fascia were performed by MyotonPRO device at defined sites. For the left and right Achilles tendons and plantar fasciae all five MyotonPRO parameters (Frequency [Hz], Decrement, Stiffness [N/m], Creep and Relaxation Time [ms]) were calculated of healthy males and females. The correlation of the tissue parameters of the Achilles tendon and plantar fascia showed a significant positive correlation of all parameters on the left as well as on the right side. The MyotonPRO is a feasible device for easy measurement of passive tissue properties of the Achilles tendon and plantar fascia in a clinical setting. The generated normal values of the Achilles tendon and plantar fascia are important for detecting abnormalities in patients with Achilles tendinopathy or plantar fasciitis in the future. Biomechanically, both structures are positively correlated. This may provide new aspects in the diagnostics and therapy of plantar fasciitis and Achilles tendinopathy. Copyright © 2017 Elsevier Ltd. All rights reserved.

Serum 25-hydroxyvitamin D is associated with both arterial and ventricular stiffness in healthy subjects.

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Şeker, Taner; Gür, Mustafa; Kuloğlu, Osman; Kalkan, Gülhan Yüksel; Şahin, Durmuş Yıldıray; Türkoğlu, Caner; Elbasan, Zafer; Baykan, Ahmet Oytun; Gözübüyük, Gökhan; Çaylı, Murat

2013-12-01

Vitamin D regulates the renin-angiotensin system, suppresses proliferation of vascular smooth muscle and improves endothelial cell dependent vasodilatation. These mechanisms may play a role on pathogenesis of arterial and left ventricular stiffness. We aimed to investigate the association between serum 25-hydroxyvitamin D with arterial and left ventricular stiffness in healthy subjects. We studied 125 healthy subjects without known cardiovascular risk factors or overt heart disease (mean age: 60.2 ± 11.9 years). Serum 25-hydroxyvitamin D was measured using a direct competitive chemiluminescent immunoassay. The subjects were divided into two groups according to the serum vitamin D level; vitamin D sufficient (≥ 20 ng/ml, n = 56) and vitamin D deficient (stiffness such as E/A and E/E' were measured. Pulse wave velocity (PWV), which reflects arterial stiffness, was calculated using the single-point method via the Mobil-O-Graph(®) ARC solver algorithm. Systolic blood pressure, level of serum calcium, PWV and E/E' values were higher and E/A values were lower in vitamin D deficient group compared with vitamin D sufficient group. Multiple linear regression analysis showed that vitamin D level was independently associated with E/E' (β = -0.364, pstiffness as well as systolic blood pressure in healthy subjects. Copyright © 2013 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Immediate effects of acupuncture on biceps brachii muscle function in healthy and post-stroke subjects

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Fragoso Ana

2012-03-01

Full Text Available Abstract Background The effects of acupuncture on muscle function in healthy subjects are contradictory and cannot be extrapolated to post-stroke patients. This study evaluated the immediate effects of manual acupuncture on myoelectric activity and isometric force in healthy and post-stroke patients. Methods A randomized clinical trial, with parallel groups, single-blinded study design, was conducted with 32 healthy subjects and 15 post-stroke patients with chronic hemiparesis. Surface electromyography from biceps brachii during maximal isometric voluntary tests was performed before and after 20-min intermittent, and manual stimulation of acupoints Quchi (LI11 or Tianquan (PC2. Pattern differentiation was performed by an automated method based on logistic regression equations. Results Healthy subjects showed a decrease in the root mean-squared (RMS values after the stimulation of LI11 (pre: 1.392 ± 0.826 V; post: 0.612 ± 0.0.320 V; P = 0.002 and PC2 (pre: 1.494 ± 0.826 V; post: 0.623 ± 0.320 V; P = 0.001. Elbow flexion maximal isometric voluntary contraction (MIVC was not significantly different after acupuncture stimulation of LI11 (pre: 22.2 ± 10.7 kg; post: 21.7 ± 9.5 kg; P = 0.288 or PC2 (pre: 18.8 ± 4.6 kg; post: 18.7 ± 6.0 kg; P = 0.468. Post-stroke patients did not exhibit any significant decrease in the RMS values after the stimulation of LI11 (pre: 0.627 ± 0.335 V; post: 0.530 ± 0.272 V; P = 0.187 and PC2 (pre: 0.601 ± 0.258 V; post: 0.591 ± 0.326 V; P = 0.398. Also, no significant decrease in the MIVC value was observed after the stimulation of LI11 (pre: 9.6 ± 3.9 kg; post: 9.6 ± 4.7 kg; P = 0.499 or PC2 (pre: 10.7 ± 5.6 kg; post: 10.2 ± 5.3 kg; P = 0.251. Different frequency of patterns was observed among healthy subjects and post-stroke patients groups (χ2 = 9.759; P = 0.021. Conclusion Manual acupuncture provides sufficient neuromuscular stimuli to promote immediate changes in motor unit gross recruitment without

Clinical pharmacokinetics of Icotinib, an anti-cancer drug: evaluation of dose proportionality, food effect, and tolerability in healthy subjects.

Science.gov (United States)

Liu, Dongyang; Jiang, Ji; Zhang, Li; Tan, Fenlai; Wang, Yingxiang; Zhang, Don; Hu, Pei

2014-04-01

Icotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, has proved effectiveness in xenografted nude mice. Purpose of the present studies was to investigate tolerability and pharmacokinetics of Icotinib in healthy subjects for the first time, including dose proportionality, food effect, and tolerability. Two studies were conducted in total of 22 healthy subjects: a randomized, two-Latin-square crossover, dose proportional study (n = 12) and a randomized two-way crossover food-effect study (n = 10). Plasma concentration of Icotinib reached peak at a median Tmax of 0.75-3.5 h after single dose and then declined with a mean t1/2β of 6.02-7.83 h. Over the dose range of 100-600 mg, AUC values were proportional to dose and Cmax showed a slight saturation when dose increases. Only 0.2 % of the dose was excreted through kidney in unchanged Icotinib. After dosing 400 mg of Icotinib with high-fat and high-calorie meal, mean Cmax and AUC were significantly increased by 59 and 79 %, respectively. Three subjects experienced four adverse events (rash, increase in AST and ALT, and external injury). Rash and increased levels of AST and ALT were considered as drug-related. No serious adverse events were reported. The current work demonstrated that Icotinib was well tolerated in healthy male subjects (n = 22) over the dose range of 100-600 mg with or without food. Icotinib exposure, expressed in AUC, was proportionally increased with dose over the above dose range. Food intake significantly increased the absorption and exposure of Icotinib in healthy subjects.

Effects of growth and aging on the reference values of pulmonary nitric oxide dynamics in healthy subjects.

Science.gov (United States)

Högman, M; Thornadtsson, A; Liv, P; Hua-Huy, T; Dinh-Xuan, A T; Tufvesson, E; Dressel, H; Janson, C; Koskela, K; Oksa, P; Sauni, R; Uitti, J; Moilanen, E; Lehtimäki, L

2017-09-13

The lung just like all other organs is affected by age. The lung matures by the age of 20 and age-related changes start around middle age, at 40-50 years. Exhaled nitric oxide (F E NO) has been shown to be age, height and gender dependent. We hypothesize that the nitric oxide (NO) parameters alveolar NO (C A NO), airway flux (J aw NO), airway diffusing capacity (D aw NO) and airway wall content (C aw NO) will also demonstrate this dependence. Data from healthy subjects were gathered by the current authors from their earlier publications in which healthy individuals were included as control subjects. Healthy subjects (n = 433) ranged in age from 7 to 78 years. Age-stratified reference values of the NO parameters were significantly different. Gender differences were only observed in the 20-49 age group. The results from the multiple regression models in subjects older than 20 years revealed that age, height and gender interaction together explained 6% of variation in F E NO at 50 ml s -1 (F E NO 50 ), 4% in J aw NO, 16% in C aw NO, 8% in D aw NO and 12% in C A NO. In conclusion, in this study we have generated reference values for NO parameters from an extended NO analysis of healthy subjects. This is important in order to be able to use these parameters in clinical practice.

Pomegranate juice does not affect the disposition of simvastatin in healthy subjects.

Science.gov (United States)

Park, Soo-Jin; Yeo, Chang-Woo; Shim, Eon-Jeong; Kim, Hyunmi; Liu, Kwang-Hyeon; Shin, Jae-Gook; Shon, Ji-Hong

2016-08-01

Previous in vitro and in vivo investigations reported controversial results for the inhibitory potential of pomegranate on Cytochrome P450 (CYP) 3A activity. This study evaluated the effect of pomegranate juice on the disposition of simvastatin, a CYP3A4 substrate, and simvastatin acid, its active metabolite, compared with grapefruit juice in healthy subjects. A single oral pharmacokinetic study of 40 mg simvastatin was conducted as a three-way crossover (control, pomegranate, and grapefruit juices) in 12 healthy male subjects. The subjects took pomegranate or grapefruit juice three times per day for 3 days (900 mL/day) and on the third day, the pharmacokinetic study was executed. Blood samples were collected to 24 h post-dose and the pharmacokinetic parameters of simvastatin and simvastatin acid were compared among the study periods. In the period of grapefruit juice, the mean C max and AUCinf of simvastatin [the geometric mean ratio (90 % CI) 15.6 (11.6-21.0) and 9.1 (6.0-13.7)] were increased significantly when compared with the control period, whereas they were not significantly different in the period of pomegranate juice [C max and AUCinf 1.20 (0.89-1.62) and 1.29 (0.85-1.94)]. The mean C max and AUCinf of simvastatin acid were increased significantly after intake of grapefruit juice, but not pomegranate juice. These results suggest that pomegranate juice affects little on the disposition of simvastatin in humans. Pomegranate juice does not seem to have a clinically relevant inhibitory potential on CYP3A4 activity.

Diamine oxidase determination in serum - Low assay reproducibility and misclassification of healthy subjects

DEFF Research Database (Denmark)

Schnoor, Heidi Julius; Mosbech, Holger Fausbøll; Skov, Per Stahl

2013-01-01

Summary Background: Impaired histamine degradation based on reduced diamine oxidase (DAO) activity has been suggested to cause symptoms mimicking an allergic reaction. Aim: To test whether patients presenting with possible histamine-induced symptoms have a low serum activity of DAO compared...... in the test kit was 86 %. Only 11 out of the 31 subjects were uniformly classified in all three runs. Among the healthy subjects, 9–12 out of 18 showed reduced or highly reduced activities; in the patient group, 0–5 out of 11 showed reduced or highly reduced activities in the three measurements...... normal range caused misclassification in more than half of the cases. Using a commercial immunoassay, it was not possible to distinguish healthy subjects from patients showing potentially histamine-induced symptoms....

Pharmacokinetics of rilmenidine in healthy subjects

International Nuclear Information System (INIS)

Genissel, P.; Bromet, N.; Fourtillan, J.B.; Mignot, A.; Albin, H.

1988-01-01

Rilmenidine is a novel alpha 2-adrenoceptor agonist, used in the treatment of mild or moderate hypertension at the oral dose of 1 mg once or twice daily. The pharmacokinetic parameters were investigated after single or repeated administration in healthy subjects, using labeled and unlabeled compounds. Rilmenidine was rapidly and extensively absorbed, with an absolute bioavailability factor close to 1 and a maximal plasma concentration achieved within 2 hours. Rilmenidine was not subject to presystemic metabolism. Distribution was independent of the free fraction because rilmenidine was weakly bound to plasma proteins (less than 10%). The volume of distribution was approximately 5 l.kg-1 (315 liters). Elimination was rapid with a total body plasma clearance of approximately 450 ml.min-1 and an elimination half-life of approximately 8 hours. Renal excretion was the major elimination process (two-thirds of the total clearance). Metabolism was very poor, with a renal elimination of rilmenidine as the parent drug (urinary fraction of rilmenidine was about 65% and no metabolite plasma levels were detected). Linear pharmacokinetics were demonstrated for rilmenidine from 0.5 to 2 mg but, at 3 mg, a slight deviation from linearity was observed. In repeated administration, the linear disposition of rilmenidine with dose was confirmed

Gene expression patterns in CD4+ peripheral blood cells in healthy subjects and stage IV melanoma patients.

Science.gov (United States)

Felts, Sara J; Van Keulen, Virginia P; Scheid, Adam D; Allen, Kathleen S; Bradshaw, Renee K; Jen, Jin; Peikert, Tobias; Middha, Sumit; Zhang, Yuji; Block, Matthew S; Markovic, Svetomir N; Pease, Larry R

2015-11-01

Melanoma patients exhibit changes in immune responsiveness in the local tumor environment, draining lymph nodes, and peripheral blood. Immune-targeting therapies are revolutionizing melanoma patient care increasingly, and studies show that patients derive clinical benefit from these newer agents. Nonetheless, predicting which patients will benefit from these costly therapies remains a challenge. In an effort to capture individual differences in immune responsiveness, we are analyzing patterns of gene expression in human peripheral blood cells using RNAseq. Focusing on CD4+ peripheral blood cells, we describe multiple categories of immune regulating genes, which are expressed in highly ordered patterns shared by cohorts of healthy subjects and stage IV melanoma patients. Despite displaying conservation in overall transcriptome structure, CD4+ peripheral blood cells from melanoma patients differ quantitatively from healthy subjects in the expression of more than 2000 genes. Moreover, 1300 differentially expressed genes are found in transcript response patterns following activation of CD4+ cells ex vivo, suggesting that widespread functional discrepancies differentiate the immune systems of healthy subjects and melanoma patients. While our analysis reveals that the transcriptome architecture characteristic of healthy subjects is maintained in cancer patients, the genes expressed differentially among individuals and across cohorts provide opportunities for understanding variable immune states as well as response potentials, thus establishing a foundation for predicting individual responses to stimuli such as immunotherapeutic agents.

Potassium and magnesium distribution, ECG changes, and ventricular ectopic beats during beta 2-adrenergic stimulation with terbutaline in healthy subjects

DEFF Research Database (Denmark)

Tveskov, C; Djurhuus, M S; Klitgaard, N A

1994-01-01

OBJECTIVE: To study the effect of intravenous (i.v.) terbutaline on potassium (K) and magnesium (Mg) distribution, ECG changes, and prevalence of ventricular ectopic beats in healthy subjects. DESIGN: Randomized double-blind, placebo-controlled crossover. Subjects received either placebo or terbu......OBJECTIVE: To study the effect of intravenous (i.v.) terbutaline on potassium (K) and magnesium (Mg) distribution, ECG changes, and prevalence of ventricular ectopic beats in healthy subjects. DESIGN: Randomized double-blind, placebo-controlled crossover. Subjects received either placebo......-potassium pump number. Urinary excretion of potassium and magnesium. ECG changes (T-wave and QTC interval) and the number of ventricular ectopic beats. MAIN RESULTS: Terbutaline produced an immediate decrease in serum potassium level from 4.17 (4.04 to 4.30) mmol/L to a nadir of 3.32 (3.06 to 3.58) mmol/L (p ... of sodium-potassium pumps. Furthermore, terbutaline induced changes in ECG with a highly significant lengthening of the QTc interval but with an unchanged number of ventricular ectopic beats in healthy subjects....

T1rho, T{sub 2} and focal knee cartilage abnormalities in physically active and sedentary healthy subjects versus early OA patients - a 3.0-Tesla MRI study

Energy Technology Data Exchange (ETDEWEB)

Stahl, Robert [University of California, San Francisco, Musculoskeletal and Quantitative Imaging Group, Department of Radiology, San Francisco, CA (United States); University Hospitals-Campus Grosshadern, Ludwig Maximilians University of Munich, Department of Clinical Radiology, Munich (Germany); Luke, Anthony; Ma, C.B. [University of California, San Francisco, Department of Orthopedic Surgery, San Francisco, CA (United States); Li, Xiaojuan; Carballido-Gamio, Julio; Majumdar, Sharmila; Link, Thomas M. [University of California, San Francisco, Musculoskeletal and Quantitative Imaging Group, Department of Radiology, San Francisco, CA (United States)

2009-01-15

(1) To assess the degree of focal cartilage abnormalities in physically active and sedentary healthy subjects as well as in patients with early osteoarthritis (OA). (2) To determine the diagnostic value of T2 and T1rho measurements in identifying asymptomatic physically active subjects with focal cartilage lesions. Thirteen asymptomatic physically active subjects, 7 asymptomatic sedentary subjects, and 17 patients with mild OA underwent 3.0-T MRI of the knee joint. T1rho and T2 values, cartilage volume and thickness, as well as the WORMS scores were obtained. Nine out of 13 active healthy subjects had focal cartilage abnormalities. T1rho and T2 values in active subjects with and without focal cartilage abnormalities differed significantly (p<0.05). T1rho and T2 values were significantly higher (p<0.05) in early OA patients compared to healthy subjects. T1rho measurements were superior to T2 in differentiating OA patients from healthy subjects, yet T1rho was moderately age-dependent. (1) Active subjects showed a high prevalence of focal cartilage abnormalities and (2) active subjects with and without focal cartilage abnormalities had different T1rho and T2 composition of cartilage. Thus, T1rho and T2 could be a parameter suited to identify active healthy subjects at higher risk for developing cartilage pathology. (orig.)

Modulation of protein fermentation does not affect fecal water toxicity: a randomized cross-over study in healthy subjects.

Directory of Open Access Journals (Sweden)

Karen Windey

Full Text Available Protein fermentation results in production of metabolites such as ammonia, amines and indolic, phenolic and sulfur-containing compounds. In vitro studies suggest that these metabolites might be toxic. However, human and animal studies do not consistently support these findings. We modified protein fermentation in healthy subjects to assess the effects on colonic metabolism and parameters of gut health, and to identify metabolites associated with toxicity.After a 2-week run-in period with normal protein intake (NP, 20 healthy subjects followed an isocaloric high protein (HP and low protein (LP diet for 2 weeks in a cross-over design. Protein fermentation was estimated from urinary p-cresol excretion. Fecal metabolite profiles were analyzed using GC-MS and compared using cluster analysis. DGGE was used to analyze microbiota composition. Fecal water genotoxicity and cytotoxicity were determined using the Comet assay and the WST-1-assay, respectively, and were related to the metabolite profiles.Dietary protein intake was significantly higher during the HP diet compared to the NP and LP diet. Urinary p-cresol excretion correlated positively with protein intake. Fecal water cytotoxicity correlated negatively with protein fermentation, while fecal water genotoxicity was not correlated with protein fermentation. Heptanal, 3-methyl-2-butanone, dimethyl disulfide and 2-propenyl ester of acetic acid are associated with genotoxicity and indole, 1-octanol, heptanal, 2,4-dithiapentane, allyl-isothiocyanate, 1-methyl-4-(1-methylethenyl-benzene, propionic acid, octanoic acid, nonanoic acid and decanoic acid with cytotoxicity.This study does not support a role of protein fermentation in gut toxicity. The identified metabolites can provide new insight into colonic health.ClinicalTrial.gov NCT01280513.

Effects of the "affectionless control" parenting style on personality traits in healthy subjects.

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Otani, Koichi; Suzuki, Akihito; Oshino, Shingo; Ishii, Genki; Matsumoto, Yoshihiko

2009-01-30

The effects of the affectionless control (AC) parenting style on personality traits were studied in 414 Japanese healthy subjects. Perceived parental rearing was assessed by the Parental Bonding Instrument, which comprises care and protection factors, and personality traits were assessed by the Temperament and Character Inventory, which has seven dimensions. Parental rearing was classified into four types, i.e., optimal parenting (high care/low protection), affectionate constraint (high care/high protection), neglectful parenting (low care/low protection), and AC (low care/high protection). Males with maternal AC showed significantly higher harm avoidance (HA) scores and lower scores of persistence and cooperativeness than those with maternal optimal parenting. Females with maternal AC showed significantly higher HA scores and lower self-directedness scores than those with maternal optimal parenting. Paternal AC was not significantly related to any personality score. In females, the interaction between paternal rearing and maternal rearing was significant; the effect of maternal AC on HA scores was strongest when combined with paternal neglectful parenting. The present study suggests that the AC type parenting by mothers is associated with specific personality traits, especially high HA, in healthy subjects.

Pharmacokinetic comparison of controlled-release and immediate-release oral formulations of simvastatin in healthy Korean subjects: a randomized, open-label, parallel-group, single- and multiple-dose study.

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Jang, Seong Bok; Lee, Yoon Jung; Lim, Lay Ahyoung; Park, Kyung-Mi; Kwon, Bong-Ju; Woo, Jong Soo; Kim, Yong-Il; Park, Min Soo; Kim, Kyung Hwan; Park, Kyungsoo

2010-01-01

A controlled-release (CR) formulation of simvastatin was recently developed in Korea. The formulation is expected to yield a lower C(max) and similar AUC values compared with the immediate-release (IR) formulation. The goal of this study was to compare the pharmacokinetics of the new CR formulation and an IR formulation of simvastatin after single- and multiple-dose administration in healthy Korean subjects. This study was developed as part of a product development project at the request of the Korean regulatory agency. This was a randomized, open-label, parallelgroup, 2-part study. Eligible subjects were healthy male or female volunteers between the ages of 19 and 55 years and within 20% of their ideal weight. In part I, each subject received a single dose of the CR or IR formulation of simvastatin 40 mg orally (20 mg x 2 tablets) after fasting. In part II, each subject received the same dose of the CR or IR formulation for 8 consecutive days. Blood samples were obtained for 48 hours after the dose in part I and after the first and the last dose in part II. Pharmacokinetic parameters were determined for both simvastatin (the inactive prodrug) and simvastatin acid (the active moiety). An adverse event (AE) was defined as any unfavorable sign (including an abnormal laboratory finding) or symptom, regardless of whether it had a causal relationship with the study medication. Serious AEs were defined as any events that are considered life threatening, require hospitalization or prolongation of existing hospitalization, cause persistent or significant disability or incapacity, or result in congenital abnormality, birth defect, or death. AEs were determined based on patient interviews and physical examinations. Twenty-four healthy subjects (17 men, 7 women; mean [SD] age, 29 [7] years; age range, 22-50 years) were enrolled in part I, and 29 subjects (17 men, 12 women; mean age, 33 [9] years; age range, 19-55 years) were enrolled in part II. For simvastatin acid, C

Arterial stiffness estimation in healthy subjects: a validation of oscillometric (Arteriograph) and tonometric (SphygmoCor) techniques.

Science.gov (United States)

Ring, Margareta; Eriksson, Maria Jolanta; Zierath, Juleen Rae; Caidahl, Kenneth

2014-11-01

Arterial stiffness is an important cardiovascular risk marker, which can be measured noninvasively with different techniques. To validate such techniques in healthy subjects, we compared the recently introduced oscillometric Arteriograph (AG) technique with the tonometric SphygmoCor (SC) method and their associations with carotid ultrasound measures and traditional risk indicators. Sixty-three healthy subjects aged 20-69 (mean 48 ± 15) years were included. We measured aortic pulse wave velocity (PWVao) and augmentation index (AIx) by AG and SC, and with SC also the PWVao standardized to 80% of the direct distance between carotid and femoral sites (St-PWVaoSC). The carotid strain, stiffness index and intima-media thickness (cIMTmean) were evaluated by ultrasound. PWVaoAG (8.00 ± 2.16 m s(-1)) was higher (Pstiffness indices by AG and SC correlate with vascular risk markers in healthy subjects. AIxao results by AG and SC are closely interrelated, but higher values are obtained by AG. In the lower range, PWVao values by AG and SC are similar, but differ for higher values. Our results imply the necessity to apply one and the same technique for repeated studies.

Insight on AV-45 binding in white and grey matter from histogram analysis: a study on early Alzheimer's disease patients and healthy subjects

Energy Technology Data Exchange (ETDEWEB)

Nemmi, Federico; Saint-Aubert, Laure; Peran, Patrice [Inserm, Imagerie Cerebrale et Handicaps Neurologiques UMR 825, Centre Hospitalier Universitaire de Toulouse (France); Universite de Toulouse, UPS, Imagerie Cerebrale et Handicaps Neurologiques UMR 825, Centre Hospitalier Universitaire de Toulouse, Toulouse (France); Adel, Djilali; Salabert, Anne-Sophie; Payoux, Pierre [Inserm, Imagerie Cerebrale et Handicaps Neurologiques UMR 825, Centre Hospitalier Universitaire de Toulouse (France); Universite de Toulouse, UPS, Imagerie Cerebrale et Handicaps Neurologiques UMR 825, Centre Hospitalier Universitaire de Toulouse, Toulouse (France); Centre Hospitalier Universitaire de Toulouse, Service de Medecine Nucleaire, Pole Imagerie, Toulouse (France); Pariente, Jeremie [Inserm, Imagerie Cerebrale et Handicaps Neurologiques UMR 825, Centre Hospitalier Universitaire de Toulouse (France); Universite de Toulouse, UPS, Imagerie Cerebrale et Handicaps Neurologiques UMR 825, Centre Hospitalier Universitaire de Toulouse, Toulouse (France); Centre Hospitalier Universitaire de Toulouse, Service de Neurologie, Pole Neurosciences, Toulouse (France); Barbeau, Emmanuel J. [Centre Hospitalier Universitaire de Toulouse, Service de Neurologie, Pole Neurosciences, Toulouse (France); Universite de Toulouse, UPS, Centre de Recherche Cerveau et Cognition, CNRS, CerCo, Toulouse (France)

2014-07-15

AV-45 amyloid biomarker is known to show uptake in white matter in patients with Alzheimer's disease (AD), but also in the healthy population. This binding, thought to be of a non-specific lipophilic nature, has not yet been investigated. The aim of this study was to determine the differential pattern of AV-45 binding in white matter in healthy and pathological populations. We recruited 24 patients presenting with AD at an early stage and 17 matched, healthy subjects. We used an optimized positron emission tomography-magnetic resonance imaging (PET-MRI) registration method and an approach based on an intensity histogram using several indices. We compared the results of the intensity histogram analyses with a more canonical approach based on target-to-cerebellum Standard Uptake Value (SUVr) in white and grey matter using MANOVA and discriminant analyses. A cluster analysis on white and grey matter histograms was also performed. White matter histogram analysis revealed significant differences between AD and healthy subjects, which were not revealed by SUVr analysis. However, white matter histograms were not decisive to discriminate groups, and indices based on grey matter only showed better discriminative power than SUVr. The cluster analysis divided our sample into two clusters, showing different uptakes in grey, but also in white matter. These results demonstrate that AV-45 binding in white matter conveys subtle information not detectable using the SUVr approach. Although it is not more efficient than standard SUVr in discriminating AD patients from healthy subjects, this information could reveal white matter modifications. (orig.)

Pharyngeal chemosensitivity in patients with obstructive sleep apnea and healthy subjects.

Science.gov (United States)

Heiser, Clemens; Zimmermann, Ingo; Sommer, J Ulrich; Hörmann, Karl; Herr, Raphael M; Stuck, Boris A

2013-09-01

Signs of pharyngeal neurodegeneration have been detected in patients with obstructive sleep apnea (OSA). Along with this neurodegeneration, a decreased pharyngeal sensitivity to mechanical stimulation has been described. The decreased sensitivity may play a role in the pathophysiology of this disease. The aim of the study was to investigate the chemosensitivity of the pharyngeal mucosa in patients with OSA compared with controls. Healthy controls and patients with OSA (age: 30-60 years) were included. Testing of oropharyngeal chemosensitivity was performed with subjective intensity ratings of capsaicin (SIR, visual analogue scale 0-10), air puffs (presented with an olfactometer), and stimulation with CO2 at the posterior pharyngeal wall. A 2-point discrimination test at the soft palate, an intensity rating of capsaicin at the tongue, and a nasal lateralization test were performed. Twenty-six patients with OSA and 18 healthy controls were included. No differences were detected in the SIR of capsaicin at the tongue or in the nasal lateralization test. At the pharynx, a decreased sensitivity to capsaicin (OSA: 6.8 ± 2.3; healthy control: 8.6 ± 1.3), air puffs (OSA: 2.8 ± 1.9; healthy control: 4.2 ± 1.6), and stimulation with CO2 (OSA: 1.5 ± 1.7; healthy control: 2.8 ± 1.8) were demonstrated in patients with OSA (all P < 0.05). Two-point discrimination at the soft palate was reduced with statistical significance in the OSA group (OSA: 11.5 ± 5.4 mm; healthy control: 5.0 ± 2.4 mm). The results suggest reduced pharyngeal chemosensitivity in OSA patients in addition to the reduced mechanical pharyngeal sensitivity shown with 2-point discrimination. This demonstrates peripheral neurodegeneration in the context of this disease.

Low-frequency dynamics of autonomic regulation of circulatory system in healthy subjects

Science.gov (United States)

Skazkina, V. V.; Borovkova, E. I.; Galushko, T. A.; Khorev, V. S.; Kiselev, A. R.

2018-04-01

The paper is devoted to the analysis of dynamic of interactions between signals of autonomic circulatory regulation. We investigated two-hour experimental records of 30 healthy people. Phase synchronization was studied using the signals of the electrocardiogram and the photoplethysmogram of vessels. We found the presence of long synchronous intervals in some subjects. For analysis of the dynamic we calculated autocorrelation functions. The analysis made it possible to reveal indirect signs of the influence of the humoral regulation system.

Relationship between ocular surface temperature and peripheral vasoconstriction in healthy subjects: a thermographic study.

Science.gov (United States)

Vannetti, Federica; Matteoli, Sara; Finocchio, Lucia; Lacarbonara, Francesco; Sodi, Andrea; Menchini, Ugo; Corvi, Andrea

2014-03-01

An impairment of ocular blood flow regulation is commonly considered one of the main pathogenetic mechanisms involved in the development of several eye diseases, like glaucoma. The aim of this study was to investigate whether an alteration of ocular blood supply induced by peripheral vasoconstriction might be detected by measuring the ocular surface temperature. The ocular surface temperature was evaluated in a group of 38 healthy young subjects (28 males and 10 females; mean age: 25.4 ± 4.1 years) by infrared thermography. For each subject, the experimental procedure consisted of two thermographic acquisitions both lasting 10 s, recorded before and during the immersion of both hands in a mixture of ice and water (1.6 °C ± 0.4 °C). Specifically, the second acquisition began 20 s after the hand immersion. Analysis of variance was used to compare the ocular surface temperature of the two profiles. The analysis of infrared images was carried out every 2 s: at the eye opening (t(0)) until 10 s (t(5)), for both profiles. Data showed that ocular surface temperature increased significantly (p-value temperature at t(0) for P(1) = 0.12 °C ± 0.13 °C). Therefore, these results suggest a response of the ocular hemodynamic to the peripheral vasoconstriction. The ocular surface temperature may represent a cheap, non-invasive and non-time-consuming test to evaluate ocular vaso-regulation.

Short and long-term effects of sham-controlled prefrontal EEG-neurofeedback training in healthy subjects.

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Engelbregt, H J; Keeser, D; van Eijk, L; Suiker, E M; Eichhorn, D; Karch, S; Deijen, J B; Pogarell, O

2016-04-01

In this study we evaluated long-term effects of frontal beta EEG-neurofeedback training (E-NFT) on healthy subjects. We hypothesized that E-NFT can change frontal beta activity in the long-term and that changes in frontal beta EEG activity are accompanied by altered cognitive performance. 25 healthy subjects were included and randomly assigned to active or sham E-NFT. On average the subjects underwent 15 E-NFT training sessions with a training duration of 45 min. Resting-state EEG was recorded prior to E-NFT training (t1) and in a 3-year follow-up (t3). Compared to sham E-NFT, which was used for the control group, real E-NFT increased beta activity in a predictable way. This increase was maintained over a period of three years post training. However, E-NFT did not result in significantly improved cognitive performance. Based on our results, we conclude that EEG-NFT can selectively modify EEG beta activity both in short and long-term. This is a sham controlled EEG neurofeedback study demonstrating long-term effects in resting state EEG. Copyright © 2016 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Brain-heart linear and nonlinear dynamics during visual emotional elicitation in healthy subjects.

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Valenza, G; Greco, A; Gentili, C; Lanata, A; Toschi, N; Barbieri, R; Sebastiani, L; Menicucci, D; Gemignani, A; Scilingo, E P

2016-08-01

This study investigates brain-heart dynamics during visual emotional elicitation in healthy subjects through linear and nonlinear coupling measures of EEG spectrogram and instantaneous heart rate estimates. To this extent, affective pictures including different combinations of arousal and valence levels, gathered from the International Affective Picture System, were administered to twenty-two healthy subjects. Time-varying maps of cortical activation were obtained through EEG spectral analysis, whereas the associated instantaneous heartbeat dynamics was estimated using inhomogeneous point-process linear models. Brain-Heart linear and nonlinear coupling was estimated through the Maximal Information Coefficient (MIC), considering EEG time-varying spectra and point-process estimates defined in the time and frequency domains. As a proof of concept, we here show preliminary results considering EEG oscillations in the θ band (4-8 Hz). This band, indeed, is known in the literature to be involved in emotional processes. MIC highlighted significant arousal-dependent changes, mediated by the prefrontal cortex interplay especially occurring at intermediate arousing levels. Furthermore, lower and higher arousing elicitations were associated to not significant brain-heart coupling changes in response to pleasant/unpleasant elicitations.

The pharmacokinetics of artemisinin after administration of two different suppositories to healthy Vietnamese subjects

NARCIS (Netherlands)

Koopmans, R.; Ha, L. D.; Duc, D. D.; Dien, T. K.; Kager, P. A.; Khanh, N. X.; van Boxtel, C. J.; de Vries, P. J.

1999-01-01

Eight healthy Vietnamese male subjects received 400 mg artemisinin formulated into fatty suppositories (FS), and six different subjects received 500 mg of artemisinin formulated in polyethylene glycol suppositories (PEGS). Plasma concentrations were measured by high-performance liquid chromatography

Acute effects of LSD on amygdala activity during processing of fearful stimuli in healthy subjects

OpenAIRE

Mueller, F.; Lenz, C.; Dolder, P. C.; Harder, S.; Schmid, Y.; Lang, U. E.; Liechti, M. E.; Borgwardt, S.

2017-01-01

Lysergic acid diethylamide (LSD) induces profound changes in various mental domains, including perception, self-awareness and emotions. We used functional magnetic resonance imaging (fMRI) to investigate the acute effects of LSD on the neural substrate of emotional processing in humans. Using a double-blind, randomised, cross-over study design, placebo or 100 μg LSD were orally administered to 20 healthy subjects before the fMRI scan, taking into account the subjective and pharmacological pea...

Clinical studies of cerebral arteriosclerosis in diabetic subjects. Analysis with brain MRI study

International Nuclear Information System (INIS)

Ohashi, Makoto; Tanahashi, Hideo; Nomura, Makoto; Yamada, Yoshio; Abe, Hiroshi.

1994-01-01

In order to investigate the clinical characteristics of cerebral arteriosclerosis in diabetic subjects, brain MRI studies were conducted in diabetic patients and healthy subjects. The subjects were 93 diabetic patients without symptoms and signs of cerebral infarction (49 males and 44 females) with a mean age of 59 years and 73 healthy subjects (43 males and 30 females) with a mean age of 57 years. The MRI studies were performed on a General Electric 1.5-T signa system. The spin-echo technique (T2-weighted image) was used with a pulse repetition time (TR) of 2,500 msec and echo time (TE) of 80 msec. The quantitative evaluation of cerebral infarction was assessed using personal computer and image-scanner. By MRI, the incidence of cerebral infarction in diabetic patients was significantly higher than that in healthy subjects (30.1% vs. 13.7%, respectively, p<0.05). The mean age of the diabetic patients with cerebral infarctions was higher than that of those without cerebral infarctions. Hypertension and diabetic nephropathy were present more frequently in the subjects with cerebral infarctions. These data suggest that it is important to delay the onset and slow the progression of cerebral infarction in diabetic patients by strict blood glucose control and management of blood pressure. (author)

Sensory Over-Responsiveness among Healthy Subjects is Associated with a Pronociceptive State.

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Weissman-Fogel, Irit; Granovsky, Yelena; Bar-Shalita, Tami

2018-04-01

Chronic pain patients show hypersensitivity to sensory nonpainful stimuli. Sensory over-responsiveness (SOR) to innocuous daily stimuli, experienced as painful, is prevalent in 10% of the healthy population. This altered sensory processing may be an expression of overfacilitation, or a less efficient pain-inhibitory process in the pain pathways. We therefore aimed to investigate specifically the pain-inhibitory system of subjects with SOR who are otherwise healthy, not studied as of yet. Thirty healthy subjects, divided into an SOR group (n = 14) and a non-SOR group (n = 16) based on responses to the Sensory Responsiveness Questionnaire, were psychophysically tested in order to evaluate (1) hyperalgesic responses; (2) adaptation/sensitization to 14 phasic heat stimuli; (3) habituation; (4) 6-minute after-sensations; and (5) conditioned pain modulation (CPM) (ie, phasic heat stimuli applied with and without hand immersion in a hot water bath). The SOR group differed from the non-SOR group in (1) a steeper escalation in NPS ratings to temperature increase (P = 0.003), indicating hyperalgesia; (2) increased sensitization (P < 0.001); (3) habituation responses (P < 0.001); (4) enhanced pain ratings during the after-sensation (P = 0.006); and (5) no group difference was found in CPM. SOR is associated with a pronociceptive state, expressed by amplification of experimental pain, yet with sufficient inhibitory processes. Our results support previous findings of enhanced facilitation of pain-transmitting pathways but also reveal preserved inhibitory mechanisms, although they were slower to react. © 2017 World Institute of Pain.

Intra-individual biological variation in sweat chloride concentrations in CF, CFTR dysfunction, and healthy pediatric subjects.

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Cirilli, Natalia; Raia, Valeria; Rocco, Ilaria; De Gregorio, Fabiola; Tosco, Antonella; Salvadori, Laura; Sepe, Angela Ornella; Buzzetti, Roberto; Minicuci, Nadia; Castaldo, Giuseppe

2018-04-02

The sweat test is one of the main diagnostic tools used in newborn screening programs and as a confirmatory test, in case of suspect of Cystic Fibrosis (CF). Since sweat chloride (Cl) concentration is also considered an appropriate parameter to explore the efficacy of CFTR modulators in clinical trials, it is crucial to evaluate the biological variability of this test in healthy and pathological conditions. The aim of this pilot study was to determine the intra-individual biological variability of sweat Cl, both in healthy individuals and CF patients and to assess its correlation with diet, season, and menstrual cycle. Thirty-five out of 36 selected subjects (6-18 years) were enrolled by 2 CF care centers and assigned to 3 cohorts: CF, CFTR-related disorder (CFTR-RD) and healthy volunteers. Each participant was subjected to eight sweat tests in different conditions and time of the year. Data were analyzed using linear mixed effects models for repeated measures, taking also into account intra-individual correlations. We observed a high intra-individual variability of sweat Cl, with the lowest mean CV% values among CF patients (20.21 in CF, 29.74 in CFTR-RD, and 31.15 in healthy subjects). Gender and diet had no influence on sweat Cl variability, nor had pubertal age and menstrual phase. Results of this pilot study confirmed that sweat Cl variability is high in CF patients, although non-CF individuals displayed even higher mean CV% values. Season significantly influenced sweat test values only in CF patients, likely due to changes in their hydration status. © 2018 Wiley Periodicals, Inc.

Enhancing memory for lists by grouped presentation and rehearsal: a pilot study in healthy subjects with unexpected results.

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Hoppe, Christian; Stojanovic, Jelena; Elger, Christian E

2009-12-01

List learning is probably the most established paradigm for the psychometric evaluation of episodic memory deficits in different neuropsychiatric conditions including epilepsy. Strategies which are capable of increasing the test performance might be promising candidates for a therapeutic improvement of daily memory performance. Based on the classical 'temporal grouping effect' we wanted to evaluate the memory-enhancing potential of disentangling perceiving, rehearsing and encoding by temporally grouped presentation and group-wise reproduction during acquisition. According to the ethical principle of subsidiary the study was performed in healthy adolescents (N=126) before setting-up a patient study. Subjects had to learn a list of 12 semantically unrelated nouns and a list of 12 figures during two acquisition trials under one of four experimental conditions defined by the size of presented item groups (GS): GS=1 (single items, i.e., 12 x 1 item), GS=3 (4 x 3 items), GS=6 (2 x 6 items), and GS=12 (standard presentation mode, i.e., 1 x 12 items). Repeated measures MANOVA confirmed a positive effect of smaller GS on acquisition performance but the grouping condition obtained no effect on immediate and delayed free recall or on yes/no recognition. For verbal retention, GS=12 even showed a tendency toward an advantage as compared to GS=3. Although appearing reasonable and promising, facilitating acquisition during list learning by temporal grouping and grouped overt rehearsal turned out to be ineffective with regard to long-term memory encoding and retrieval. A strategy however which fails in healthy subjects is unlikely to obtain a therapeutic potential in patients with memory deficits.

Acute Consumption of Resistant Starch Reduces Food Intake but Has No Effect on Appetite Ratings in Healthy Subjects.

Science.gov (United States)

Ble-Castillo, Jorge L; Juárez-Rojop, Isela E; Tovilla-Zárate, Carlos A; García-Vázquez, Carlos; Servin-Cruz, Magda Z; Rodríguez-Hernández, Arturo; Araiza-Saldaña, Claudia I; Nolasco-Coleman, Ana M; Díaz-Zagoya, Juan C

2017-07-04

Previous studies have shown the benefits of native banana starch (NBS) supplementation in improving glucose metabolism and reducing body weight (BW) in humans. However, the effect of this starch on appetite regulation is unknown. The aim of this study was to examine the effects of NBS rich resistant starch on subjective measurements of appetite, energy intake, and appetite hormones in healthy subjects. Postprandial glucose and insulin responses were also assessed. In a randomized, single-blind, crossover study, 28 healthy young subjects consumed a beverage containing either 40 g of NBS or 40 g of digestible corn starch (DCS) on two separate occasions. Effects on appetite were estimated using visual analogue scales (VAS) and satiety hormone responses. At the end of the intervention, participants were provided with a pre-weighed ad libitum homogeneous test meal. After a washout period of 1 week, subjects received the alternative treatment. NBS supplementation induced a reduction in food intake, glucose area under the curve (AUC)-180 min, and insulin AUC-180 min. However, there was no associated effect on the subjective appetite ratings or gut hormones. NBS supplementation may help to reduce meal size and control BW.

Single-dose FTY720 pharmacokinetics, food effect, and pharmacological responses in healthy subjects

Science.gov (United States)

Kovarik, John M; Schmouder, Robert; Barilla, Denise; Wang, Yibin; Kraus, Gerolf

2004-01-01

Aims FTY720 is a sphingosine-1-phosphate receptor agonist that redirects lymphocytes from the circulation to lymph nodes without impairing lymphocyte function. It is being developed as an immunomodulator for the prevention of acute rejection after organ transplantation. This study was performed to provide guidance on administration with respect to meals and to measure pharmacologic responses in healthy subjects. Methods In this randomized, two-period, crossover study, 14 healthy subjects received placebo on day −1 of each period with baseline circadian measurements of lymphocyte count and heart rate. Subjects subsequently received a single 1 mg oral dose of FTY720 on day 1 under fasting conditions and after a high fat meal. Blood FTY720 concentrations, lymphocyte count, and supine heart rate were assessed over an 8 day period after each FTY720 dose. The effect of food on FTY720 pharmacokinetics was assessed by standard bioequivalence testing. Results Both the peak concentration (0.65 ± 0.17 vs 0.64 ± 0.18 ng ml−1) and total exposure (AUC 149 ± 65 vs 139 ± 43 ng ml−1 h) did not differ significantly between fasting and fed states, respectively. The corresponding fed/fasting ratios and 90% confidence intervals were 1.00 (0.86, 1.17) for Cmax and 0.98 (0.86, 1.11) for AUC. Under both treatment conditions peripheral blood lymphocyte count decreased from baseline by 38 ± 9% over the first 2 days postdose and then increased towards predose values over the subsequent week. Whereas a circadian rhythm in supine heart rate was preserved in the presence of FTY720, the heart rate vs time curve was shifted downwards by 10% over the first day postdose and then recovered to prestudy values by days 3–5 postdose. These changes were asymptomatic. Conclusions Single 1 mg doses of FTY720 were well tolerated in healthy subjects and elicited a moderate decrease in peripheral blood lymphocyte count and a transient decrease in heart rate consistent with its pharmacological

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....

Neurofeedback-Based Enhancement of Single Trial Auditory Evoked Potentials: Feasibility in Healthy Subjects.

Science.gov (United States)

Rieger, Kathryn; Rarra, Marie-Helene; Moor, Nicolas; Diaz Hernandez, Laura; Baenninger, Anja; Razavi, Nadja; Dierks, Thomas; Hubl, Daniela; Koenig, Thomas

2018-03-01

Previous studies showed a global reduction of the event-related potential component N100 in patients with schizophrenia, a phenomenon that is even more pronounced during auditory verbal hallucinations. This reduction assumingly results from dysfunctional activation of the primary auditory cortex by inner speech, which reduces its responsiveness to external stimuli. With this study, we tested the feasibility of enhancing the responsiveness of the primary auditory cortex to external stimuli with an upregulation of the event-related potential component N100 in healthy control subjects. A total of 15 healthy subjects performed 8 double-sessions of EEG-neurofeedback training over 2 weeks. The results of the used linear mixed effect model showed a significant active learning effect within sessions ( t = 5.99, P < .001) against an unspecific habituation effect that lowered the N100 amplitude over time. Across sessions, a significant increase in the passive condition ( t = 2.42, P = .03), named as carry-over effect, was observed. Given that the carry-over effect is one of the ultimate aims of neurofeedback, it seems reasonable to apply this neurofeedback training protocol to influence the N100 amplitude in patients with schizophrenia. This intervention could provide an alternative treatment option for auditory verbal hallucinations in these patients.

Suppressive effect of cellulose on osmotic diarrhea caused by maltitol in healthy female subjects.

Science.gov (United States)

Oku, Tsuneyuki; Hongo, Ryoko; Nakamura, Sadako

2008-08-01

Using a single-group time-series design, we determined that osmotic diarrhea caused by maltitol ingestion was suppressed by the addition of not only soluble but also insoluble dietary fiber in healthy humans. We then clarified that cellulose delayed gastric emptying in rats. Twenty-seven healthy volunteers ingested maltitol step-wise at doses of 15, 20, 25, 30, 35, 40 and 45 g from small to large amounts. Within that range of ingested amounts, 22 out of 27 subjects experienced osmotic diarrhea from maltitol ingestion, and the minimal dose level of maltitol that induced osmotic diarrhea (MMD) was established for each subject. When 5 g of cellulose was added to the MMD, osmotic diarrhea was suppressed in 13 out of 19 subjects (68.4%), while partially hydrolyzed alginate-Na (PHA-Na), a soluble dietary fiber, suppressed osmotic diarrhea in 10 out of 20 subjects (50.0%). When a mixed solution of cellulose and maltitol was administered to rats, the gastric emptying of maltitol was significantly delayed at 30 and 60 min after administration (p=0.019, p=0.013), respectively. PHA-Na also significantly delayed gastric emptying at 30 min (p=0.013). In conclusion, cellulose can suppress the osmotic diarrhea caused by maltitol ingestion in humans and delay the gastric emptying of maltitol in rats. A new physiological property of cellulose was clarified in this study.

Pharmacokinetics, Safety and Tolerability of Sacubitril/Valsartan (LCZ696) After Single-Dose Administration in Healthy Chinese Subjects.

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Han, Yi; Ayalasomayajula, Surya; Pan, Wei; Yang, Fan; Yuan, Yaozong; Langenickel, Thomas; Hinder, Markus; Kalluri, Sampath; Pal, Parasar; Sunkara, Gangadhar

2017-02-01

Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor (ARNI) and has been recently approved in several countries for the treatment of patients with heart failure and reduced ejection fraction. This was the first study conducted to characterise the pharmacokinetics of LCZ696 analytes (pro-drug sacubitril, active neprilysin inhibitor LBQ657 and valsartan) after single-dose administration of LCZ696 in healthy Chinese subjects. In this open-label, randomised, parallel-group study, following screening and baseline evaluation, eligible healthy subjects received single oral doses of LCZ696 50, 100, 200 or 400 mg. The pharmacokinetics, safety and tolerability of LCZ696 were assessed up to 72 h after dosing. A total of 40 healthy male subjects were enrolled, and all completed the study. Following oral administration, LCZ696 delivered systemic exposure to sacubitril, LBQ657 and valsartan with a median time to reach maximum plasma concentration (T max ) ranging from 0.50 to 1.25, 2.00 to 3.00 and 1.50 to 2.50 h, respectively, over the investigated dose range. The mean terminal elimination half-life (T 1/2 ) ranged from 0.89 to 1.35, 8.57 to 9.24 and 5.33 to 7.91 h for sacubitril, LBQ657 and valsartan, respectively. The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last ), and maximum plasma concentration (C max ) for LBQ657 increased dose proportionally over the entire dose range. Dose linear increase in the exposure was observed across the dose range for sacubitril and valsartan. LCZ696 was safe and well tolerated at all doses in this study. Adverse events of only mild intensity, which required no treatment, were reported in 6 (15 %) subjects. The pharmacokinetic profiles of LCZ696 analytes in Chinese subjects are similar to those reported previously in Caucasian subjects.

Effect of chewing speed on energy expenditure in healthy subjects.

Science.gov (United States)

Paphangkorakit, Jarin; Leelayuwat, Naruemon; Boonyawat, Nattawat; Parniangtong, Auddamar; Sripratoom, Jindamanee

2014-08-01

The aim of the study was to investigate the effect of rate of chewing on energy expenditure in human subjects. Fourteen healthy subjects (aged 18-24 years) within the normal range of BMI participated in a cross-over experiment consisting of two 6-min sessions of gum chewing, slow (∼60 cycles/min) and fast (∼120 cycles/min) chewing. The resting energy expenditure (REE) and during gum chewing was measured using a ventilated hood connected to a gas analyzer system. The normality of data was explored using the Shapiro-Wilk test. The energy expenditure rate during chewing and the energy expenditure per chewing cycle were compared between the two chewing speeds using Wilcoxon signed ranks tests. The energy expenditure per chewing cycle during slow chewing (median 1.4, range 5.2 cal; mean 2.1±1.6 cal) was significantly higher than that during fast chewing (median 0.9, range 2.2 cal; mean 1.0±0.7 cal) (p chewing speeds (p > 0.05). The results of this study suggest that chewing at a slower speed could increase the energy expenditure per cycle and might affect the total daily energy expenditure.

The Impact of the Level of the Intestinal Short Chain Fatty Acids in Inflammatory Bowel Disease Patients Versus Healthy Subjects

Science.gov (United States)

Huda-Faujan, N.; Abdulamir, A.S.; Fatimah, A.B.; Anas, O. Muhammad; Shuhaimi, M.; Yazid, A.M.; Loong, Y.Y.

2010-01-01

The aim of this study was to determine the changes of short chain fatty acids (SCFAs) in faeces of inflammatory bowel disease (IBD) patients compared to healthy subjects. SCFAs such as pyruvic, lactic, formic, acetic, propionic, isobutyric and butyric acids were analyzed by using high performance liquid chromatography (HPLC). This study showed that the level of acetic, 162.0 µmol/g wet faeces, butyric, 86.9 µmol/g wet faeces, and propionic acids, 65.6 µmol/g wet faeces, decreased remarkably in IBD faecal samples when compared with that of healthy individuals, 209.7, 176.0, and 93.3 µmol/g wet faeces respectively. On the contrary, lactic and pyruvic acids showed higher levels in faecal samples of IBD than in healthy subjects. In the context of butyric acid level, this study also found that the molar ratio of butyric acid was higher than propionic acid in both faecal samples. This might be due to the high intake of starch from rice among Malaysian population. It was concluded that the level of SCFAs differ remarkably between faecal samples in healthy subjects and that in IBD patients providing evidence that SCFAs more likely play an important role in the pathogenesis of IBD. PMID:20563285

The effects of Pilates breathing trainings on trunk muscle activation in healthy female subjects: a prospective study.

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Kim, Sung-Tae; Lee, Joon-Hee

2017-02-01

[Purpose] To investigate the effects of Pilates breathing on trunk muscle activation. [Subjects and Methods] Twenty-eight healthy female adults were selected for this study. Participants' trunk muscle activations were measured while they performed curl-ups, chest-head lifts, and lifting tasks. Pilates breathing trainings were performed for 60 minutes per each session, 3 times per week for 2 weeks. Post-training muscle activations were measured by the same methods used for the pre-training muscle activations. [Results] All trunk muscles measured in this study had increased activities after Pilates breathing trainings. All activities of the transversus abdominis/internal abdominal oblique, and multifidus significantly increased. [Conclusion] Pilates breathing increased activities of the trunk stabilizer muscles. Activation of the trunk muscle indicates that practicing Pilates breathing while performing lifting tasks will reduce the risk of trunk injuries.

Age Effects on Upper Limb Kinematics Assessed by the REAplan Robot in Healthy Subjects Aged 3 to 93 Years.

Science.gov (United States)

Gilliaux, Maxime; Lejeune, Thierry M; Sapin, Julien; Dehez, Bruno; Stoquart, Gaëtan; Detrembleur, Christine

2016-04-01

Kinematics is recommended for the quantitative assessment of upper limb movements. The aims of this study were to determine the age effects on upper limb kinematics and establish normative values in healthy subjects. Three hundred and seventy healthy subjects, aged 3-93 years, participated in the study. They performed two unidirectional and two geometrical tasks ten consecutive times with the REAplan, a distal effector robotic device that allows upper limb displacements in the horizontal plane. Twenty-six kinematic indices were computed for the four tasks. For the four tasks, nineteen of the computed kinematic indices showed an age effect. Seventeen indices (the accuracy, speed and smoothness indices and the reproducibility of the accuracy, speed and smoothness) improved in young subjects aged 3-30 years, showed stabilization in adults aged 30-60 years and declined in elderly subjects aged 60-93 years. Additionally, for both geometrical tasks, the speed index exhibited a decrease throughout life. Finally, a principal component analysis provided the relations between the kinematic indices, tasks and subjects' age. This study is the first to assess age effects on upper limb kinematics and establish normative values in subjects aged 3-93 years.

Voxel-based analysis of whole-brain effects of age and gender on dopamine transporter SPECT imaging in healthy subjects

International Nuclear Information System (INIS)

Eusebio, Alexandre; Azulay, Jean-Philippe; Ceccaldi, Mathieu; Girard, Nadine; Mundler, Olivier; Guedj, Eric

2012-01-01

Several studies have shown age- and gender-related differences in striatal dopamine transporter (DaT) binding. These studies were based on a striatal region on interest approach that may have underestimated these effects and could not evaluate extrastriatal regions. Our aim was to determine the effects at the voxel level of age and gender on whole-brain DaT distribution using [ 123 I]FP-CIT SPECT in healthy subjects. We performed a whole-brain [ 123 I]FP-CIT SPECT voxel-based analysis using SPM8 and a standardized normalization template (p < 0.05, corrected using the false discovery rate method) in 51 healthy subjects aged from 21 to 79 years. We found an age-related DaT binding decrease in the striatum, anterior cingulate/medial frontal cortices and insulo-opercular cortices. Also DaT binding ratios were higher in women than men in the striatum and opercular cortices. This study showed both striatal and extrastriatal age-related and gender-related differences in DaT binding in healthy subjects using a whole-brain voxel-based non-a priori approach. These differences highlight the need for careful age and gender matching in DaT analyses of neuropsychiatric disorders. (orig.)

Voxel-based analysis of whole-brain effects of age and gender on dopamine transporter SPECT imaging in healthy subjects

Energy Technology Data Exchange (ETDEWEB)

Eusebio, Alexandre; Azulay, Jean-Philippe [APHM, Hopital de la Timone, Service de Neurologie et Pathologie du Mouvement, Marseille (France); CNRS, Aix-Marseille Univ, Institut de Neurosciences de la Timone, Marseille (France); Ceccaldi, Mathieu [APHM, Hopital de la Timone, Service de Neurologie et de Neuropsychologie, Marseille (France); Aix-Marseille Univ, UMR Inserm 1106, Institut de Neurosciences des Systemes, Marseille (France); Girard, Nadine [APHM, Hopital de la Timone, Service de Neuroradiologie diagnostique et interventionnelle, Marseille (France); Mundler, Olivier [APHM, Hopital de la Timone, Service Central de Biophysique et Medecine Nucleaire, Marseille (France); Aix-Marseille Univ, CERIMED, Marseille (France); Guedj, Eric [CNRS, Aix-Marseille Univ, Institut de Neurosciences de la Timone, Marseille (France); APHM, Hopital de la Timone, Service Central de Biophysique et Medecine Nucleaire, Marseille (France); Aix-Marseille Univ, CERIMED, Marseille (France)

2012-11-15

Several studies have shown age- and gender-related differences in striatal dopamine transporter (DaT) binding. These studies were based on a striatal region on interest approach that may have underestimated these effects and could not evaluate extrastriatal regions. Our aim was to determine the effects at the voxel level of age and gender on whole-brain DaT distribution using [{sup 123}I]FP-CIT SPECT in healthy subjects. We performed a whole-brain [{sup 123}I]FP-CIT SPECT voxel-based analysis using SPM8 and a standardized normalization template (p < 0.05, corrected using the false discovery rate method) in 51 healthy subjects aged from 21 to 79 years. We found an age-related DaT binding decrease in the striatum, anterior cingulate/medial frontal cortices and insulo-opercular cortices. Also DaT binding ratios were higher in women than men in the striatum and opercular cortices. This study showed both striatal and extrastriatal age-related and gender-related differences in DaT binding in healthy subjects using a whole-brain voxel-based non-a priori approach. These differences highlight the need for careful age and gender matching in DaT analyses of neuropsychiatric disorders. (orig.)

Test-Retest Reproducibility of the Microperimeter MP3 With Fundus Image Tracking in Healthy Subjects and Patients With Macular Disease.

Science.gov (United States)

Palkovits, Stefan; Hirnschall, Nino; Georgiev, Stefan; Leisser, Christoph; Findl, Oliver

2018-02-01

To evaluate the test-retest reproducibility of a novel microperimeter with fundus image tracking (MP3, Nidek Co, Japan) in healthy subjects and patients with macular disease. Ten healthy subjects and 20 patients suffering from range of macular diseases were included. After training measurements, two additional microperimetry measurements were scheduled. Test-retest reproducibility was assessed for mean retinal sensitivity, pointwise sensitivity, and deep scotoma size using the coefficient of repeatability and Bland-Altman diagrams. In addition, in a subgroup of patients microperimetry was compared with conventional perimetry. Average differences in mean retinal sensitivity between the two study measurements were 0.26 ± 1.7 dB (median 0 dB; interquartile range [IQR] -1 to 1) for the healthy and 0.36 ± 2.5 dB (median 0 dB; IQR -1 to 2) for the macular patient group. Coefficients of repeatability for mean retinal sensitivity and pointwise retinal sensitivity were 1.2 and 3.3 dB for the healthy subjects and 1.6 and 5.0 dB for the macular disease patients, respectively. Absolute agreement in deep scotoma size between both study days was found in 79.9% of the test loci. The microperimeter MP3 shows an adequate test-retest reproducibility for mean retinal sensitivity, pointwise retinal sensitivity, and deep scotoma size in healthy subjects and patients suffering from macular disease. Furthermore, reproducibility of microperimetry is higher than conventional perimetry. Reproducibility is an important measure for each diagnostic device. Especially in a clinical setting high reproducibility set the basis to achieve reliable results using the specific device. Therefore, assessment of the reproducibility is of eminent importance to interpret the findings of future studies.

Serial position effects in patients with mild cognitive impairment and early and moderate Alzheimer's disease compared with healthy comparison subjects.

Science.gov (United States)

Moser, B; Deisenhammer, E A; Marksteiner, J; Papousek, I; Fink, A; Weiss, E M

2014-01-01

This study aimed to investigate whether the serial position effects in memory can differentiate patients with different subtypes of mild cognitive impairment (MCI) from healthy controls and patients with different stages of Alzheimer's disease (AD). The serial position effects was tested with the CERAD word list task in 184 persons (39 healthy control subjects, 15 amnestic MCI single domain subjects, 23 amnestic MCI multiple domain subjects, 31 nonamnestic MCI subjects, 45 early or mild AD patients, and 31 moderate AD patients). With progression of dementia, memory deficits increased and the impairment in the primacy effect during the learning trials advanced, whereas the recall of recent items was less impaired. The serial position profile of nonamnestic MCI patients resembled that of healthy control subjects, whereas amnestic MCI patients showed poorer performance in all 3 positions but no significant difference as a function of serial word position. Analyses of the serial position effect may be a useful complement to clinical neuropsychological measures for distinguishing amnestic MCI patients from normal aging and patients with different stages of dementia. © 2013 S. Karger AG, Basel.

DEFB1 polymorphisms and salivary hBD-1 concentration in Oral Lichen Planus patients and healthy subjects.

Science.gov (United States)

Polesello, Vania; Zupin, Luisa; Di Lenarda, Roberto; Biasotto, Matteo; Pozzato, Gabriele; Ottaviani, Giulia; Gobbo, Margherita; Crovella, Sergio; Segat, Ludovica

2017-01-01

The aetiology of Oral Lichen Planus (OLP), a chronic inflammatory disease of oral mucosa, is not yet well understood. Since innate immunity may be hypothesized as involved in the susceptibility to OLP, we studied human beta defensin 1 (hBD-1) an antimicrobial peptide constitutively expressed in the saliva, looking at functional genetic variants possibly able to diminish hBD-1 production an consequently conferring major susceptibility to OLP. We analysed three DEFB1 polymorphisms at 5' UTR, -52G>A (rs1799946), -44C>G (rs1800972), -20G>A (rs11362) and two DEFB1 polymorphisms at 3'UTR, c*5G>A (rs1047031), c*87A>G (rs1800971), with the aim of correlating these genetic variants and hBD-1 salivary level in a group of OLP patients and in healthy subjects. We also evaluated hBD-1 salivary concentrations, using ELISA, in OLP and healthy controls. We compared hBD-1 concentrations in OLP and healthy subjects: hBD-1 concentration was significantly higher in OLP patients respect to control. When considering the correlation between DEFB1 polymorphisms genotypes and hBD-1 expression levels, significant results were obtained for SNPs -52G>A (p=0.03 both in OLP patients and healthy individuals) and -44C>G (p=0.02 in OLP patients). hBD-1 production was different between OLP and healthy subjects (not age-matched with OLP). DEFB1 gene polymorphisms, -52G>A and -44C>G, correlated with hBD-1 salivary concentrations. Copyright © 2016 Elsevier Ltd. All rights reserved.

Heart rate variability analysis in healthy subjects, patients suffering from congestive heart failure and heart transplanted patients

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Argentina Leite

2013-12-01

Full Text Available This study aimed to find parameters to characterize heart rate variability (HRV and discriminate healthy subjects and patients with heart diseases. The parameters used for discrimination characterize the different components of HRV memory (short and long and are extracted from HRV recordings using parametric as well as non parametric methods. Thus, the parameters are: spectral components at low frequencies (LH and high frequencies (HF which are associated with the short memory of HRV and the long memory parameter (d obtained from autoregressive fractionally integrated moving average (ARFIMA models. In the non parametric context, short memory (α1 and long memory (α2 parameters are obtained from detrended fluctuation analysis (DFA. The sample used in this study contains 24-hour Holter HRV recordings of 30 subjects: 10 healthy individuals, 10 patients suffering from congestive heart failure and 10 heart transplanted patients from the Noltisalis database. It was found that short memory parameters present higher values for the healthy individuals whereas long memory parameters present higher values for the diseased individuals. Moreover, there is evidence that ARFIMA modeling allows the discrimination between the 3 groups under study, being advantageous over DFA.

Blood flow in the forearm in patients with Rheumatoid arthritis and healthy subjects under local thermotherapy

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C. Mucha

2002-02-01

Full Text Available Objectives: Muscle blood flow in the forearm of patients with rheuma-toid arthritis and healthy volunteers following treatment with temperature increasingarm baths, mudpacks and short- or decimeter-wave diathermy was studied in thisinvestigation. The aim of the study was to find out the difference of reactive hyperemia between the different temperature methods as well as the influence on theconsensual reaction. Subjects: Eighty patients with rheumatoid arthritis, stage 3 according toSteinbrocker, as well as 80 healthy human subjects had been assigned numerically in the four therapy- and controlgroups. Patients with diseases influencing the peripheral blood flow were excluded. Design: Blood flow was measured by venous occlusion plethysmography in both forearms with the subjects lyingsupine. The application of the local heat therapies had been excluded on the left forearm. The forearm blood flow wasmonitored before heat therapy, directly after as well as in two further 10 minutes intervals. An analysis of variancewas used to determine the influence on blood flow of the response to the heat therapies in patients with rheumatoidarthritis and healthy subjects.Results: Under homogeneous starting conditions and a statistically uniformed high blood flow in rest the reactive values of blood flow on the left-hand side of application and the right consensual side showed high significant differencesbetween all methods of therapy. Differences between the patients and the healthy subjects only showed tendencies withpartially lower reactions, concerning the patients with rheumatoid arthritis. All methods of heat therapy caused a statistically provable consensual reaction that turned out smaller after diathermic methods. Here the post therapeuticreaction of the blood flow on the side of application was also lower or rather shorter. Conclusion: Greater differences of the blood flow in rest between the patients with rheumatoid arthritis and healthysubjects

Quantitative Analysis of Swallowing Function Between Dysphagia Patients and Healthy Subjects Using High-Resolution Manometry

Science.gov (United States)

2017-01-01

Objective To compare swallowing function between healthy subjects and patients with pharyngeal dysphagia using high resolution manometry (HRM) and to evaluate the usefulness of HRM for detecting pharyngeal dysphagia. Methods Seventy-five patients with dysphagia and 28 healthy subjects were included in this study. Diagnosis of dysphagia was confirmed by a videofluoroscopy. HRM was performed to measure pressure and timing information at the velopharynx (VP), tongue base (TB), and upper esophageal sphincter (UES). HRM parameters were compared between dysphagia and healthy groups. Optimal threshold values of significant HRM parameters for dysphagia were determined. Results VP maximal pressure, TB maximal pressure, UES relaxation duration, and UES resting pressure were lower in the dysphagia group than those in healthy group. UES minimal pressure was higher in dysphagia group than in the healthy group. Receiver operating characteristic (ROC) analyses were conducted to validate optimal threshold values for significant HRM parameters to identify patients with pharyngeal dysphagia. With maximal VP pressure at a threshold value of 144.0 mmHg, dysphagia was identified with 96.4% sensitivity and 74.7% specificity. With maximal TB pressure at a threshold value of 158.0 mmHg, dysphagia was identified with 96.4% sensitivity and 77.3% specificity. At a threshold value of 2.0 mmHg for UES minimal pressure, dysphagia was diagnosed at 74.7% sensitivity and 60.7% specificity. Lastly, UES relaxation duration of dysphagia. Conclusion We present evidence that HRM could be a useful evaluation tool for detecting pharyngeal dysphagia. PMID:29201816

Objective assessment of mastication predominance in healthy dentate subjects and patients with unilateral posterior missing teeth.

Science.gov (United States)

Yamasaki, Y; Kuwatsuru, R; Tsukiyama, Y; Oki, K; Koyano, K

2016-08-01

We aimed to investigate mastication predominance in healthy dentate individuals and patients with unilateral posterior missing teeth using objective and subjective methods. The sample comprised 50 healthy dentate individuals (healthy dentate group) and 30 patients with unilateral posterior missing teeth (partially edentulous group). Subjects were asked to freely chew three kinds of test foods (peanuts, beef jerky and chewing gum). Electromyographic activity of the bilateral masseter muscles was recorded. The chewing side (right side or left side) was judged by the level of root mean square electromyographic amplitude. Mastication predominance was then objectively assessed using the mastication predominant score and the mastication predominant index. Self-awareness of mastication predominance was evaluated using a modified visual analogue scale. Mastication predominance scores of the healthy dentate and partially edentulous groups for each test food were analysed. There was a significant difference in the distribution of the mastication predominant index between the two groups (P mastication predominant score was weakly correlated with self-awareness of mastication predominance in the healthy dentate group, whereas strong correlation was observed in the partially edentulous group (P mastication predominance and were more aware of mastication predominance than healthy dentate individuals. Our findings suggest that an objective evaluation of mastication predominance is more precise than a subjective method. © 2016 John Wiley & Sons Ltd.

The relationship between serum 25-hydroxy vitamin D concentration and obesity in type 2 diabetic patients and healthy subjects

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Taheri Ehsaneh

2012-09-01

Full Text Available Abstract Background Both obesity and type 2 diabetes are associated with hypovitaminosis D. The aims of this study were to investigate the association of serum 25-hydroxy vitamin D (25(OH D and parathyroid hormone (PTH concentration with body mass index (BMI in type 2 diabetic patients compared to control subjects and their predicting role in obesity. Methods This cross-sectional study was conducted on 200 subjects (100 type 2 diabetics and 100 healthy controls. Concentration of 25(OH D, calcium, phosphorous, parathyroid hormone (PTH, fasting blood glucose, HbA1c, serum insulin, homeostasis model assessment of insulin resistance (HOMA-IR was determined in the fasting samples. Anthropometric measurements including body mass index (BMI were also measured. Results Eighty-five percent of type 2 diabetics and 79% of healthy subjects were suffering from vitamin D deficiency or insufficiency. Serum concentration of 25(OH D (22.08 ± 15.20 ng/ml (r = −0.11, P = 0.04 and calcium (8.94 ± 0.59 mg/dl (r = −2.25, P = 0.04 has significant statistically with BMI in type 2 diabetic patients. Serum concentration of PTH has non-significantly associated with BMI in diabetic patients and healthy subjects. Conclusion Serum levels of vitamin D inversely and PTH positively are associated with BMI after adjusted for age, gender and serum calcium in both type 2 diabetic patients and healthy subjects. These associations were statistically significant for serum concentration of vitamin D and calcium only in diabetic patients. So the status of vitamin D is considered as an important factor in type 2 diabetic patients.

Ocular Blood Flow Measurements in Healthy White Subjects Using Laser Speckle Flowgraphy.

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Nikolaus Luft

Full Text Available To assess the feasibility and reliability of Laser Speckle Flowgraphy (LSFG to measure ocular perfusion in a sample of healthy white subjects and to elucidate the age-dependence of the parameters obtained.This cross-sectional study included 80 eyes of 80 healthy, non-smoking white subjects of Western European descent between 19 and 79 years of age. A commercial LSFG instrument was applied to measure ocular blood flow at the optic nerve head (ONH three successive times before and after pharmacological pupil dilation. The mean blur rate (MBR, a measure of relative blood flow velocity, was obtained for different regions of the ONH. Eight parameters of ocular perfusion derived from the pulse-waveform analysis of MBR including blowout time (BOT and falling rate (FR were also recorded.Artifact-free LSFG images meeting the quality criteria for automated image analysis were obtainable in 93.8% without pupil dilation and in 98.8% with pharmacological pupil dilation. Measurements of MBR showed excellent repeatability with intraclass correlation coefficients ≥ 0.937 and were barely affected by pupil dilation. The majority of pulse-waveform derived variables exhibited equally high repeatability. MBR-related blood flow indices exhibited significant age dependence (p<0.001. FR (r = 0.747, p<0.001 and BOT (r = -0.714, p<0.001 most strongly correlated with age.LSFG represents a reliable method for the quantitative assessment of ocular blood flow in white subjects. Our data affirms that the LSFG-derived variables FR and BOT may be useful biomarkers for age-related changes in ocular perfusion.

Effects of kinesthetic haptic feedback on standing stability of young healthy subjects and stroke patients.

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Afzal, Muhammad Raheel; Byun, Ha-Young; Oh, Min-Kyun; Yoon, Jungwon

2015-03-13

Haptic control is a useful therapeutic option in rehabilitation featuring virtual reality interaction. As with visual and vibrotactile biofeedback, kinesthetic haptic feedback may assist in postural control, and can achieve balance control. Kinesthetic haptic feedback in terms of body sway can be delivered via a commercially available haptic device and can enhance the balance stability of both young healthy subjects and stroke patients. Our system features a waist-attached smartphone, software running on a computer (PC), and a dedicated Phantom Omni® device. Young healthy participants performed balance tasks after assumption of each of four distinct postures for 30 s (one foot on the ground; the Tandem Romberg stance; one foot on foam; and the Tandem Romberg stance on foam) with eyes closed. Patient eyes were not closed and assumption of the Romberg stance (only) was tested during a balance task 25 s in duration. An Android application running continuously on the smartphone sent mediolateral (ML) and anteroposterior (AP) tilt angles to a PC, which generated kinesthetic haptic feedback via Phantom Omni®. A total of 16 subjects, 8 of whom were young healthy and 8 of whom had suffered stroke, participated in the study. Post-experiment data analysis was performed using MATLAB®. Mean Velocity Displacement (MVD), Planar Deviation (PD), Mediolateral Trajectory (MLT) and Anteroposterior Trajectory (APT) parameters were analyzed to measure reduction in body sway. Our kinesthetic haptic feedback system was effective to reduce postural sway in young healthy subjects regardless of posture and the condition of the substrate (the ground) and to improve MVD and PD in stroke patients who assumed the Romberg stance. Analysis of Variance (ANOVA) revealed that kinesthetic haptic feedback significantly reduced body sway in both categories of subjects. Kinesthetic haptic feedback can be implemented using a commercial haptic device and a smartphone. Intuitive balance cues were

Doppler-echocardiographic assessment of valvular regurgitation in healthy young subjects

International Nuclear Information System (INIS)

Filcheva, K.; Gochev, D.; Petrovski, P.; Kotsev, P.

1995-01-01

The study covers 300 clinically healthy, randomly selected young subjects, aged 17 to 21 years. The incidence and characteristic features of the valvular regurgitations are assayed by means of pulsed and continuous transthoracic Doppler echocardiography. Valvular insufficiency is registered in total of 198 cases (66%). Regurgitation of single valve is observed in 122 cases (61%), regurgitation of two valves - in 70 (36%) and three valves - in six (3%). Right-sided regurgitations (tricuspid, pulmonic and a combination of both) are detected in 156 subjects, and left-sided (mitral and/or aortic) in twenty-six of which only one regurgitation of the aortic valve. There is a definite tendency of the first two to prevail at a ratio 6:1. A constellation of various anatomical and physiological factors are considered as a likely underlying cause. Whenever atrio-ventricular valves are examined (the mitral one in particular), it is necessary that the regurgitation jet involves over 50% of systole in order to avoid hyperdiagnostics and the so-called 'Doppler's disease'. 14 refs., 1 tab., 2 figs. (author)

Association between Asian Dust-Borne Air Pollutants and Daily Symptoms on Healthy Subjects: A Web-Based Pilot Study in Yonago, Japan

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Abir Majbauddin

2016-01-01

Full Text Available During the spring, Asian dust (AD repeatedly makes its way to Japan, originating from drylands. We evaluated the association between AD-borne air pollutants and daily reported subjective symptoms in healthy subjects. We constructed an Internet questionnaire on daily ocular, nasal, respiratory, and skin symptoms. Forty-two healthy volunteers residents of Yonago (mean age, 33.57 were selected from the self-reporting web-based survey and recorded their symptoms between 1 and 31 of March 2013. We also collected information on levels of suspended particulate matter (SPM, particulate matter < 2.5 µm (PM2.5, sulfur dioxide (SO2, and nitrogen oxide (NOx per hour on each of those days. SPM and PM2.5 were the dominant pollutants recorded throughout the month. A positive correlation was observed between SPM and ocular (r=0.475, p<0.01, nasal (r=0.614, p<0.001, and skin (r=0.445, p<0.05 symptoms. PM2.5 correlations were significant for ocular (r=0.428, p<0.05, nasal (r=0.560, p<0.01, and skin (r=0.437, p<0.05 symptoms. Our findings provide introductory evidence of AD-borne air pollutants and their association with several bodily symptoms in healthy subjects with the implementation of a self-administrated web-based survey application.

Effect of intravenous N-acetylcysteine infusion on haemostatic parameters in healthy subjects

DEFF Research Database (Denmark)

Knudsen, TT; Thorsen, S; Jensen, SA

2005-01-01

BACKGROUND AND AIMS: N-acetylcysteine is used to treat paracetamol overdose but depresses the activity of plasma coagulation factors II, VII, and X, which are often used to assess liver injury. The aim of this study was to investigate the effect of N-acetylcysteine on haemostasis in normal...... volunteers. METHODS: Haemostatic parameters in 10 healthy subjects were analysed before and following intravenous infusion of therapeutic doses of N-acetylcysteine, as well as in vitro. RESULTS: N-acetylcysteine induced significant decreases in plasma levels of vitamin K dependent haemostatic proteins...... activity, and free protein S reactivity, respectively. These data suggest that N-acetylcysteine induces protein modifications affecting activity. Five subjects developed an adverse reaction to infusion of N-acetylcysteine and these were associated with a rapid increase in levels of factor VIII and its...

Modulating Memory Performance in Healthy Subjects with Transcranial Direct Current Stimulation Over the Right Dorsolateral Prefrontal Cortex.

Science.gov (United States)

Smirni, Daniela; Turriziani, Patrizia; Mangano, Giuseppa Renata; Cipolotti, Lisa; Oliveri, Massimiliano

2015-01-01

The role of the Dorsolateral Prefrontal Cortex (DLPFC) in recognition memory has been well documented in lesion, neuroimaging and repetitive Transcranial Magnetic Stimulation (rTMS) studies. The aim of the present study was to investigate the effects of transcranial Direct Current Stimulation (tDCS) over the left and the right DLPFC during the delay interval of a non-verbal recognition memory task. 36 right-handed young healthy subjects participated in the study. The experimental task was an Italian version of Recognition Memory Test for unknown faces. Study included two experiments: in a first experiment, each subject underwent one session of sham tDCS and one session of left or right cathodal tDCS; in a second experiment each subject underwent one session of sham tDCS and one session of left or right anodal tDCS. Cathodal tDCS over the right DLPFC significantly improved non verbal recognition memory performance, while cathodal tDCS over the left DLPFC had no effect. Anodal tDCS of both the left and right DLPFC did not modify non verbal recognition memory performance. Complementing the majority of previous studies, reporting long term memory facilitations following left prefrontal anodal tDCS, the present findings show that cathodal tDCS of the right DLPFC can also improve recognition memory in healthy subjects.

Dietary Interventions and Changes in Cardio-Metabolic Parameters in Metabolically Healthy Obese Subjects: A Systematic Review with Meta-Analysis

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Marta Stelmach-Mardas

2016-07-01

Full Text Available The aim of this systematic review was to assess the effect of diet on changes in parameters describing the body size phenotype of metabolically healthy obese subjects. The databases Medline, Scopus, Web of Knowledge and Embase were searched for clinical studies carried out between 1958 and June 2016 that reported the effect of dietary intervention on BMI, blood pressure, concentration of fasting triglyceride (TG, high density lipoprotein cholesterol (HDL-C, fasting glucose level, the homoeostatic model assessment of insulin resistance (HOMA-IR and high sensitivity C-Reactive Protein (hsCRP in metabolically healthy, obese subjects. Twelve clinical studies met inclusion criteria. The combined analyzed population consists of 1827 subjects aged 34.4 to 61.1 with a BMI > 30 kg/m2. Time of intervention ranged from eight to 104 weeks. The baseline characteristics related to lipid profile were more favorable for metabolically healthy obese than for metabolically unhealthy obese. The meta-analyses revealed a significant associations between restricted energy diet and BMI (95% confidence interval (CI: −0.88, −0.19, blood pressure (systolic blood pressure (SBP: −4.73 mmHg; 95% CI: −7.12, −2.33; and diastolic blood pressure (DBP: −2.75 mmHg; 95% CI: −4.30, −1.21 and TG (−0.11 mmol/l; 95% CI: −0.16, −0.06. Changes in fasting glucose, HOMA-IR and hsCRP did not show significant changes. Sufficient evidence was not found to support the use of specific diets in metabolically healthy obese subjects. This analysis suggests that the effect of caloric restriction exerts its effects through a reduction in BMI, blood pressure and triglycerides in metabolically healthy obese (MHO patients.

Assessment of colorectal length using the electromagnetic capsule tracking system: a comparative validation study in healthy subjects.

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Mark, E B; Poulsen, J L; Haase, A M; Frøkjaer, J B; Schlageter, V; Scott, S M; Krogh, K; Drewes, A M

2017-09-01

We aimed to determine colorectal length with the 3D-Transit system by describing a 'centreline' of capsule movement and comparing it with known anatomy, as determined by magnetic resonance imaging (MRI). Further, we aimed to test the day-to-day variation of colorectal length assessed with the system. The 3D-Transit system consists of electromagnetic capsules that can be tracked as they traverse the gastrointestinal tract. Twenty-five healthy subjects were examined with both 3D-Transit and MRI. Another 21 healthy subjects were examined with 3D-Transit on two consecutive days. Computation of colorectal length from capsule passage was possible for 60 of the 67 3D-Transit recordings. The length of the colorectum measured with MRI and 3D-Transit was 95 (75-153) cm and 99 (77-147) cm, respectively (P = 0.15). The coefficient of variation (CV) between MRI and 3D-Transit was 7.8%. Apart from the caecum/ascending colon being 26% (P = 0.002) shorter on MRI, there were no other differences in total or segmental colorectal lengths between methods (all P > 0.05). The length of the colorectum measured with 3D-Transit on two consecutive days was 102 (73-119) cm and 103 (75-123) cm (P = 0.67). The CV between days was 7.3%. The 3D-Transit system allows accurate and reliable determination of colorectal length compared with MRI-derived colorectal length and between days. Antegrade or retrograde capsule movement relative to this centreline, as well as the length and speed of movements, may be determined by future studies to allow better classification and treatment in patients with dysmotility. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Inverse Effects of Oxytocin on Attributing Mental Activity to Others in Depressed and Healthy Subjects: A Double-Blind Placebo Controlled fMRI Study.

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David Pincus

2010-10-01

Full Text Available Background: Oxytocin is a stress-attenuating and pro-social neuropeptide. To date, no study has looked at the effects of oxytocin in modulating brain activity in depressed individuals nor attempted to correlate this activity with attribution of mental activity in others. Method: We enrolled 10 unmedicated depressed adults and 10 matched healthy controls in a crossover, double blind placebo controlled fmri 40 i.u. intra-nasal oxytocin study (20 i.u. per nostril. Each subject performed Reading the Mind in the Eyes task (RMET before and after inhalation of oxytocin or placebo control for a total of 80 scans. Results: Before oxytocin administration, RMET engaged medial and lateral prefrontal cortex, amygdala, insula and associative areas. Depressed subjects showed increased anterior ventral activation for the RMET minus gender identification contrast whereas matched controls showed increased dorsal and frontal activity. Compared to placebo, oxytocin in depressed subjects showed increased activity in the superior middle frontal gyrus and insula, while controls exhibited more activity in ventral regions. Oxytocin also led to inverse effects in reaction times on attribution task between groups, with controls getting faster and depressed individuals slower to respond. Conclusion: Depression is associated with increased paralimbic activity during emotional mental attribution of others, appearing to be distinctly modulated by oxytocin when compared to healthy controls. Further studies are needed to explore long-term exposure to pro-social neuropeptides on mood in depressed populations and assess their clinical relevance.

Reaching in reality and virtual reality: a comparison of movement kinematics in healthy subjects and in adults with hemiparesis

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Feldman Anatol G

2004-12-01

Full Text Available Abstract Background Virtual reality (VR is an innovative tool for sensorimotor rehabilitation increasingly being employed in clinical and community settings. Despite the growing interest in VR, few studies have determined the validity of movements made in VR environments with respect to real physical environments. The goal of this study was to compare movements done in physical and virtual environments in adults with motor deficits to those in healthy individuals. Methods The participants were 8 healthy adults and 7 adults with mild left hemiparesis due to stroke. Kinematics of functional arm movements involving reaching, grasping and releasing made in physical and virtual environments were analyzed in two phases: 1 reaching and grasping the ball and 2 ball transport and release. The virtual environment included interaction with an object on a 2D computer screen and haptic force feedback from a virtual ball. Temporal and spatial parameters of reaching and grasping were determined for each phase. Results Individuals in both groups were able to reach, grasp, transport, place and release the virtual and real ball using similar movement strategies. In healthy subjects, reaching and grasping movements in both environments were similar but these subjects used less wrist extension and more elbow extension to place the ball on the virtual vertical surface. Participants with hemiparesis made slower movements in both environments compared to healthy subjects and during transport and placing of the ball, trajectories were more curved and interjoint coordination was altered. Despite these differences, patients with hemiparesis also tended to use less wrist extension during the whole movement and more elbow extension at the end of the placing phase. Conclusion Differences in movements made by healthy subjects in the two environments may be explained by the use of a 2D instead of a 3D virtual environment and the absence of haptic feedback from the VR target

Test–Retest Reproducibility of the Microperimeter MP3 With Fundus Image Tracking in Healthy Subjects and Patients With Macular Disease

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Palkovits, Stefan; Hirnschall, Nino; Georgiev, Stefan; Leisser, Christoph

2018-01-01

Purpose To evaluate the test–retest reproducibility of a novel microperimeter with fundus image tracking (MP3, Nidek Co, Japan) in healthy subjects and patients with macular disease. Methods Ten healthy subjects and 20 patients suffering from range of macular diseases were included. After training measurements, two additional microperimetry measurements were scheduled. Test–retest reproducibility was assessed for mean retinal sensitivity, pointwise sensitivity, and deep scotoma size using the coefficient of repeatability and Bland-Altman diagrams. In addition, in a subgroup of patients microperimetry was compared with conventional perimetry. Results Average differences in mean retinal sensitivity between the two study measurements were 0.26 ± 1.7 dB (median 0 dB; interquartile range [IQR] −1 to 1) for the healthy and 0.36 ± 2.5 dB (median 0 dB; IQR −1 to 2) for the macular patient group. Coefficients of repeatability for mean retinal sensitivity and pointwise retinal sensitivity were 1.2 and 3.3 dB for the healthy subjects and 1.6 and 5.0 dB for the macular disease patients, respectively. Absolute agreement in deep scotoma size between both study days was found in 79.9% of the test loci. Conclusion The microperimeter MP3 shows an adequate test–retest reproducibility for mean retinal sensitivity, pointwise retinal sensitivity, and deep scotoma size in healthy subjects and patients suffering from macular disease. Furthermore, reproducibility of microperimetry is higher than conventional perimetry. Translational Relevance Reproducibility is an important measure for each diagnostic device. Especially in a clinical setting high reproducibility set the basis to achieve reliable results using the specific device. Therefore, assessment of the reproducibility is of eminent importance to interpret the findings of future studies. PMID:29430338

Clinical Parameters following Multiple Oral Dose Administration of a Standardized Andrographis paniculata Capsule in Healthy Thai Subjects.

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Suriyo, Tawit; Pholphana, Nanthanit; Ungtrakul, Teerapat; Rangkadilok, Nuchanart; Panomvana, Duangchit; Thiantanawat, Apinya; Pongpun, Wanwisa; Satayavivad, Jutamaad

2017-06-01

Andrographis paniculata has been widely used in Scandinavian and Asian counties for the treatment of the common cold, fever, and noninfectious diarrhea. The present study was carried out to investigate the physiological effects of short-term multiple dose administration of a standardized A. paniculata capsule used for treatment of the common cold and uncomplicated upper respiratory tract infections, including blood pressure, electrocardiogram, blood chemistry, hematological profiles, urinalysis, and blood coagulation in healthy Thai subjects. Twenty healthy subjects (10 males and 10 females) received 12 capsules per day orally of 4.2 g of a standardized A. paniculata crude powder (4 capsules of 1.4 g of A. paniculata , 3 times per day, 8 h intervals) for 3 consecutive days. The results showed that all of the measured clinical parameters were found to be within normal ranges for a healthy person. However, modulation of some parameters was observed after the third day of treatment, for example, inductions of white blood cells and absolute neutrophil count in the blood, a reduction of plasma alkaline phosphatase, and an induction of urine pH. A rapid and transient reduction in blood pressure was observed at 30 min after capsule administration, resulting in a significant reduction of mean systolic blood pressure. There were no serious adverse events observed in the subjects during the treatment period. In conclusion, this study suggests that multiple oral dosing of A. paniculata at the normal therapeutic dose for the common cold and uncomplicated upper respiratory tract infections modulates various clinical parameters within normal ranges for a healthy person. Georg Thieme Verlag KG Stuttgart · New York.

Phase I clinical studies of the advanced glycation end-product (AGE)-breaker TRC4186: safety, tolerability and pharmacokinetics in healthy subjects.

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Chandra, Kumar P; Shiwalkar, Ajay; Kotecha, Jignesh; Thakkar, Purav; Srivastava, Ambrish; Chauthaiwale, Vijay; Sharma, Sanjay K; Cross, Maurice R; Dutt, Chaitanya

2009-01-01

Advanced glycation end-products (AGEs) have been implicated in the pathogenesis of diabetic complications through a variety of mechanisms including endothelial dysfunction and structural abnormalities in the vasculature and myocardium. Reducing the AGEs burden and their ensuing pro-inflammatory, pro-oxidative and pro-coagulant effect with associated dysfunctional proteins in various target tissues may retard the progression of and even reverse diabetic macro- and microvascular complications. Pyridinium, 3-[[2-(methylsulfonyl) hydrazino] carbonyl]-1-[2-oxo-2-2-thienyl) ethyl]-chloride (TRC4186) has demonstrated AGE-breaking activities in in vitro experiments and improvement in the endothelial and myocardial function in animal models of diabetes mellitus with reduction of AGEs accumulation in tissues over time. The safety of TRC4186 has been established in in vitro and in vivo preclinical studies. Thus, this drug is being developed for the treatment of complications associated with diabetes. This investigation set out to evaluate the safety, tolerability and pharmacokinetics of TRC4186 in healthy human subjects after single and multiple ascending doses, fixed doses in elderly male and female subjects, and with food and different formulations of the compound. Four studies were conducted during phase I clinical development of TRC4186. These were: (i) a randomized, double-blind, placebo-controlled, single-dose, dose-ascending study in healthy male subjects with doses of TRC4186 ranging from 250 to 2500 mg administered as an oral solution (total six doses); (ii) a randomized, double-blind, placebo-controlled, multiple-dose, dose-ascending study in healthy male subjects with three doses of TRC4186 ranging from 500 to 2000 mg twice daily for 6 days with a final single dose on day 7; (iii) a randomized, open-label, three-way crossover study to assess the effect of food (fasted vs fed) and formulation (solution vs tablet) with TRC4186 500 mg; (iv) a randomized, double

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

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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.

Evaluating fMRI methods for assessing hemispheric language dominance in healthy subjects.

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Baciu, Monica; Juphard, Alexandra; Cousin, Emilie; Bas, Jean François Le

2005-08-01

We evaluated two methods for quantifying the hemispheric language dominance in healthy subjects, by using a rhyme detection (deciding whether couple of words rhyme) and a word fluency (generating words starting with a given letter) task. One of methods called "flip method" (FM) was based on the direct statistical comparison between hemispheres' activity. The second one, the classical lateralization indices method (LIM), was based on calculating lateralization indices by taking into account the number of activated pixels within hemispheres. The main difference between methods is the statistical assessment of the inter-hemispheric difference: while FM shows if the difference between hemispheres' activity is statistically significant, LIM shows only that if there is a difference between hemispheres. The robustness of LIM and FM was assessed by calculating correlation coefficients between LIs obtained with each of these methods and manual lateralization indices MLI obtained with Edinburgh inventory. Our results showed significant correlation between LIs provided by each method and the MIL, suggesting that both methods are robust for quantifying hemispheric dominance for language in healthy subjects. In the present study we also evaluated the effect of spatial normalization, smoothing and "clustering" (NSC) on the intra-hemispheric location of activated regions and inter-hemispheric asymmetry of the activation. Our results have shown that NSC did not affect the hemispheric specialization but increased the value of the inter-hemispheric difference.

Evaluating fMRI methods for assessing hemispheric language dominance in healthy subjects

International Nuclear Information System (INIS)

Baciu, Monica; Juphard, Alexandra; Cousin, Emilie; Bas, Jean Francois Le

2005-01-01

We evaluated two methods for quantifying the hemispheric language dominance in healthy subjects, by using a rhyme detection (deciding whether couple of words rhyme) and a word fluency (generating words starting with a given letter) task. One of methods called 'flip method' (FM) was based on the direct statistical comparison between hemispheres' activity. The second one, the classical lateralization indices method (LIM), was based on calculating lateralization indices by taking into account the number of activated pixels within hemispheres. The main difference between methods is the statistical assessment of the inter-hemispheric difference: while FM shows if the difference between hemispheres' activity is statistically significant, LIM shows only that if there is a difference between hemispheres. The robustness of LIM and FM was assessed by calculating correlation coefficients between LIs obtained with each of these methods and manual lateralization indices MLI obtained with Edinburgh inventory. Our results showed significant correlation between LIs provided by each method and the MIL, suggesting that both methods are robust for quantifying hemispheric dominance for language in healthy subjects. In the present study we also evaluated the effect of spatial normalization, smoothing and 'clustering' (NSC) on the intra-hemispheric location of activated regions and inter-hemispheric asymmetry of the activation. Our results have shown that NSC did not affect the hemispheric specialization but increased the value of the inter-hemispheric difference

Striatal μ-opioid receptor availability predicts cold pressor pain threshold in healthy human subjects

DEFF Research Database (Denmark)

Hagelberg, Nora; Aalto, Sargo; Tuominen, Lauri

2012-01-01

the potential associations between μ-opioid receptor BP(ND) and psychophysical measures. The results show that striatal μ-opioid receptor BP(ND) predicts cold pressor pain threshold, but not cold pressor pain tolerance or tactile sensitivity. This finding suggests that striatal μ-opioid receptor density......Previous PET studies in healthy humans have shown that brain μ-opioid receptor activation during experimental pain is associated with reductions in the sensory and affective ratings of the individual pain experience. The aim of this study was to find out whether brain μ-opioid receptor binding...... at the resting state, in absence of painful stimulation, can be a long-term predictor of experimental pain sensitivity. We measured μ-opioid receptor binding potential (BP(ND)) with μ-opioid receptor selective radiotracer [(11)C]carfentanil and positron emission tomography (PET) in 12 healthy male subjects...

Left ventricular synchrony assessed by phase analysis of gated myocardial perfusion SPECT imaging in healthy subjects

International Nuclear Information System (INIS)

Wang Yuetao; Wang Jianfeng; Yang Minfu; Niu Rong

2013-01-01

Objective: To investigate the value of Cedars-Sinai quantitative gated SPECT (QGS) phase analysis for left ventricular synchrony assessment in healthy subjects. Methods: Seventy-four healthy subjects (41 males, 33 females,average age: (60±13) years) underwent both rest and exercise 99 Tc m -MIBI G-MPI. QGS software was used to analyze the reconstructed rest gated SPECT images automatically, and then the parameters of left ventricular synchrony including phase bandwidth (BW) and phase standard deviation (SD) were obtained. The influences of gender and age (age<60 years, n=36; age ≥ 60 years, n=38) on left ventricular systolic synchronicity were analyzed. The phase angle for original segmental contraction was measured to determine the onset of the ventricular contraction using 17-segment model. Forty healthy subjects were selected by simple random sampling method to evaluate the intra-observer and interobserver repeatability of QGS phase analysis software. Two-sample t test and linear correlation analysis were used to analyze the data. Results: The BW and SD of left ventricular in healthy subjects were (37.22 ±11.71)°, (11.84±5.39)° respectively. Comparisons between male and female for BW and SD yielded no statistical significance (BW: (36.00±9.70)°, (38.73±13.84)°; SD: (11.88±5.56)°, (11.79±5.26)°; t=0.96 and-0.07, both P>0.05); whereas the older subjects (age≥60 years) had larger BW than the others (age<60 years ; (39.95± 12.65)°, (34.33± 10.00)°; t=-2.11, P<0.05) and no statistical significance was shown for SD between the two age groups ((11.18±4.31)°, (12.54±6.33)°; t=1.08, P>0.05). Of the 74 subjects, the mechanical activation started from the ventricular base to apex in 54 subjects (73%), and from apex to base in only 20 subjects (27%). High repeatability of phase analysis was observed for both intra-observer and inter-observer (r=0.867-0.906, all P<0.001). Conclusions: Good left ventricular segmental synchrony is shown in healthy

Breakfast high in whey protein or carbohydrates improves coping with workload in healthy subjects.

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Sihvola, Nora; Korpela, Riitta; Henelius, Andreas; Holm, Anu; Huotilainen, Minna; Müller, Kiti; Poussa, Tuija; Pettersson, Kati; Turpeinen, Anu; Peuhkuri, Katri

2013-11-14

Dietary components may affect brain function and influence behaviour by inducing the synthesis of neurotransmitters. The aim of the present study was to examine the influence of consumption of a whey protein-containing breakfast drink v. a carbohydrate drink v. control on subjective and physiological responses to mental workload in simulated work. In a randomised cross-over design, ten healthy subjects (seven women, median age 26 years, median BMI 23 kg/m(2)) participated in a single-blinded, placebo-controlled study. The subjects performed demanding work-like tasks after having a breakfast drink high in protein (HP) or high in carbohydrate (HC) or a control drink on separate sessions. Subjective states were assessed using the NASA Task Load Index (NASA-TLX), the Karolinska sleepiness scale (KSS) and the modified Profile of Mood States. Heart rate was recorded during task performance. The ratio of plasma tryptophan (Trp) to the sum of the other large neutral amino acids (LNAA) and salivary cortisol were also analysed. The plasma Trp:LNAA ratio was 30 % higher after the test drinks HP (median 0·13 (μmol/l)/(μmol/l)) and HC (median 0·13 (μmol/l)/(μmol/l)) than after the control drink (median 0·10 (μmol/l)/(μmol/l)). The increase in heart rate was smaller after the HP (median 2·7 beats/min) and HC (median 1·9 beats/min) drinks when compared with the control drink (median 7·2 beats/min) during task performance. Subjective sleepiness was reduced more after the HC drink (median KSS - 1·5) than after the control drink (median KSS - 0·5). There were no significant differences between the breakfast types in the NASA-TLX index, cortisol levels or task performance. We conclude that a breakfast drink high in whey protein or carbohydrates may improve coping with mental tasks in healthy subjects.

Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects

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Cui Y

2013-12-01

Full Text Available Yimin Cui,1 Yan Song,2 Jessie Wang,2 Zhigang Yu,2 Alan Schuster,2 Yu Chen Barrett,2 Charles Frost2 1Peking University First Hospital, Beijing, People's Republic of China; 2Bristol-Myers Squibb, Princeton, NJ, USA Background: The pharmacokinetics (PK, pharmacodynamics (PD, and safety of apixaban were assessed in healthy Chinese subjects in this randomized, placebo-controlled, double-blind, single-sequence, single- and multiple-dose study. Subjects and methods: Eighteen subjects 18–45 years of age were randomly assigned (2:1 ratio to receive apixaban or matched placebo. Subjects received a single 10 mg dose of apixaban or placebo on day 1, followed by 10 mg apixaban or placebo twice daily for 6 days (days 4–9. The PK and PD of apixaban were assessed by collecting plasma samples for 72 hours following the dose on day 1 and the morning dose on day 9, and measuring apixaban concentration and anti-Xa activity. Safety was assessed via physical examinations, vital sign measurements, electrocardiograms, and clinical laboratory evaluations. Results: PK analysis showed similar characteristics of apixaban after single and multiple doses, including a median time to maximum concentration of ~3 hours, mean elimination half-life of ~11 hours, and renal clearance of ~1.2 L/hour. The accumulation index was 1.7, consistent with twice-daily dosing and the observed elimination half-life. Single-dose data predict multiple-dose PK, therefore apixaban PK are time-independent. The relationship between anti-Xa activity and plasma apixaban concentrations appears to be linear. Apixaban was safe and well tolerated, with no bleeding-related adverse events reported. Conclusion: Apixaban was safe and well tolerated in healthy Chinese subjects. Apixaban PK and PD were predictable and consistent with findings from previous studies in Asian and non-Asian subjects. The administration of apixaban does not require any dose modification based on race. Keywords: apixaban, oral

Effect of Recumbent Body Positions on Dynamic Lung Function Parameters in Healthy Young Subjects.

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Pal, Arvind Kumar; Tiwari, Sunita; Verma, Dileep Kumar

2017-05-01

The change in body position can alter pulmonary functions parameters, therefore it is important to understand the physiological basis of these alteration. Ideally, spirometry is done in sitting position until the subject is unable to do so. Hospitalized patients often assume recumbent body positions irrespective of underlying pathology. Hence, need arises to find out best recumbent body positions for the benefit of these patients to make breathing comfortable for them. The aim of this study was to find out whether the change from the supine position to crook lying and Fowler's position (45° dorsal elevation) causes change in spirometric parameters. The present work was carried out at Department of Physiology, King George's Medical University, Lucknow. A total 131 apparently healthy individuals were enrolled in this cross-sectional study. Lung function was assessed using a PC-based spirometer according to American Thoracic Society guideline in the supine, crook lying and Fowler's position (45° dorsal elevation). The study consisted of 131 subjects (male 66%, female 34%), with mean age of 20.15±2.71 years and BMI 21.20±3.28 Kg/m 2 . Repeated measures ANOVA with post hoc Bonferroni test was used to compare the mean values between each body position. Compared with the other two positions, Fowler's position showed significantly (p<0.05) higher values for FVC, FEV 1 , PEF, FEF 25-75% . Recumbent body position influences spirometric parameters in young healthy subjects. We demonstrated that spirometric values are higher in the Fowler's position than in the supine or crook lying position. The results of this study will help in the selection of the best alternative position for the spirometry in bed ridden patients.

Alteration patterns of brain glucose metabolism: comparisons of healthy controls, subjective memory impairment and mild cognitive impairment.

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Song, In-Uk; Choi, Eun Kyoung; Oh, Jin Kyoung; Chung, Yong-An; Chung, Sung-Woo

2016-01-01

Some groups have focused on the detection and management of subjective memory impairment (SMI) as the stage that precedes mild cognitive impairment (MCI). However, there have been few clinical studies that have examined biomarkers of SMI to date. To investigate the differences in glucose metabolism as a prodromal marker of dementia in patients with SMI, MCI, and healthy controls using brain F-18 fluoro-2-deoxyglucose positron emission tomography (FDG-PET). Sixty-eight consecutive patients with SMI, 47 patients with MCI, and 42 age-matched healthy subjects were recruited. All subjects underwent FDG-PET and detailed neuropsychological testing. FDG-PET images were analyzed using the statistical parametric mapping (SPM) program. FDG-PET analysis showed glucose hypometabolism in the periventricular regions of patients with SMI and in the parietal, precentral frontal, and periventricular regions of patients with MCI compared with healthy controls. Interestingly, hypometabolism on FDG-PET was noted in the parietal and precentral frontal regions in MCI patients compared to SMI patients. The results suggest that hypometabolism in the periventricular regions as seen on FDG-PET may play a role as a predictive biomarker of pre-dementia, and the extension of reduced glucose metabolism into parietal regions likely reflects progression of cognitive deterioration. © The Foundation Acta Radiologica 2014.

Assessment of torque-steadiness reliability at the ankle level in healthy young subjects: implications for cerebral palsy

DEFF Research Database (Denmark)

Bandholm, Thomas; Rose, Martin Høyer; Sonne-Holm, Stig

2008-01-01

It was the primary objective of this study to investigate whether quantifying fluctuations in dorsi and plantarflexor torque during submaximal isometric contractions is a reliable measurement in young healthy subjects. A secondary objective was to investigate the reliability of the associated mus...

What is healthy food? Objective nutrient profile scores and subjective lay evaluations in comparison.

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Bucher, T; Müller, B; Siegrist, M

2015-12-01

To date, it is unclear how consumers evaluate the healthiness of individual foods and meals and how consumers' perceptions are related to expert opinions. This knowledge is essential for efficient communication of nutrition information with the goal of promoting healthy eating. This study used the fake food buffet method to investigate health perceptions of selected meals and of 54 individual foods and beverages. Lay consumers' subjective healthiness evaluations of meals and foods were compared to objective nutrient profile scores, which were previously shown to correlate highly with expert opinions. The results show that nutrition profile scores and lay evaluations were highly correlated, which indicates that lay people used similar criteria as experts to evaluate the healthiness of foods. However, lay consumers tended to neglect the amount of saturated fat, protein and sodium for their judgments. Also, it was found that while lay consumers were quite able to evaluate single food products, they had difficulties in evaluating entire meals. Future interventions should focus particularly on educating the consumer about the negative effects of diets high in salt and saturated fat and they should improve the consumer's abilities to evaluate entire meals. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effect of dilute baby shampoo on nasal mucociliary clearance in healthy subjects.

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Isaacs, Seth; Fakhri, Samer; Luong, Amber; Whited, Chad; Citardi, Martin J

2011-01-01

Biofilm formation has been implicated as an etiologic factor in the development of chronic rhinosinusitis (CRS). Nasal irrigation with surfactants including dilute baby shampoo have been proposed as an antibiofilm treatment for CRS patients. The effect of dilute baby shampoo on normal sinonasal mucosal function is unknown. Mucociliary clearance time (MCT), as measured by the time in minutes for a subject to detect a sweet taste after the application of a saccharin granules at the anterior part of the inferior turbinate, was performed before and shortly after nasal irrigation with 50 ml of 1% baby shampoo (Johnson & Johnson, New Brunswick, NJ) in 27 healthy volunteers. Mean MCTs before and after irrigation were 12.09 (±4.83 minutes) and 15.45 (±7.71 minutes) minutes, respectively. The mean difference, 3.37 minutes, was statistically significant (p = 0.031). Pre- and post-MCTs for each subject were not correlated (r = 0.324; p = 0.100). Nasal irrigations with dilute baby shampoo increase MCTs in healthy subjects. The impact of such interventions in CRS patients warrants additional investigation.

Lack of association between systolic blood pressure and blood viscosity in normotensive healthy subjects.

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Irace, Concetta; Carallo, Claudio; Scavelli, Faustina; Loprete, Antonio; Merante, Valentina; Gnasso, Agostino

2012-01-01

A direct relationship between blood pressure and viscosity has frequently been reported, although clear data are not available. To better understand the relationship between these two variables, we evaluated blood viscosity and blood pressure in a group of healthy subjects without cardiovascular risk factors. Healthy subjects were selected from participants in a campaign of prevention of cardiovascular disease (n = 103). They underwent blood sampling for measurement of plasma and blood viscosity, haematocrit, blood lipids and glucose. The quantity and distribution of body fat was assessed by body mass index and waist/hip ratio, respectively. Systolic blood pressure (SBP) correlated significantly with age (r = 0.222) and waist/hip ratio (r = 0.374). Diastolic blood pressure (DBP) correlated significantly with waist/hip ratio (r = 0.216), haematocrit (r = 0.333) and blood viscosity (r = 0.258). Multiple linear regression analyses demonstrated that the only variable significantly associated with SBP was age, while haematocrit was the only variable significantly associated with DBP. Blood viscosity was closely related to waist/hip ratio. These findings show that SBP, in healthy subjects, is not influenced by haematocrit and blood viscosity. In contrast, DBP is related to the values of haematocrit. Among classical cardiovascular risk factors, waist/hip ratio is closely related to blood viscosity.

Evaluation of the antioxidant effect of a new functional food enriched with Sideritis euboea in healthy subjects.

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Skouroliakou, Maria; Kastanidou, Olympia; Stathopoulou, Maria; Vourli, Georgia

2009-10-01

Sideritis euboea is a Greek plant that is traditionally consumed as a beverage (mountain tea). From in vitro studies, its extract has shown antioxidant and estrogenic activities. In our study we used S. euboea as an enriching food factor in order to produce a new functional food, a jelly dessert, in order to explore its antioxidant effects if consumed on a daily basis by healthy subjects. In this placebo-controlled clinical trial, 63 subjects were recruited for a 1-month nutritional intervention. Twelve subjects were excluded. The remaining 51 subjects were randomly classified in the intervention group (daily consumption of the jelly containing 0.3 g of S. euboea extract) or the placebo group (daily consumption of the same jelly without the enrichment). Vitamins C, A, and E, glutathione, coenzyme Q10, total nitrites, nitrates, total nitrogen oxide, nitrites/nitrates ratio, and total antioxidant status were measured in blood samples before and after the intervention. After the intervention, free glutathione and coenzyme Q10 increased, and nitrites decreased significantly in both groups. The other antioxidant markers were not altered. No statistical significant differences were observed between the two groups. The daily consumption of the functional food, for 30 days, had no effects on the antioxidant status of healthy volunteers.

Comparison of childhood sexual histories in subjects with pedophilia or opiate addiction and healthy controls: is childhood sexual abuse a risk factor for addictions?

Science.gov (United States)

Cohen, Lisa J; Forman, Howard; Steinfeld, Matthew; Fradkin, Yuli; Frenda, Steven; Galynker, Igor

2010-11-01

Given the recent interest in the concept of sexual addictions, it is instructive to study subjects with pedophilia alongside chemically addicted individuals and non-addicted controls in order to help identify which factors may determine the objects of people's respective addictions, as well as any factors that may predispose people to developing an addictive disorder. In this study, we considered whether childhood sexual abuse (CSA) is a specific risk factor for pedophilia as opposed to other types of addictive disorders by comparing the childhood sexual histories of 48 pedophilic sex offenders, 25 subjects with opiate addiction in remission, and 61 healthy controls. CSA was assessed with The Sexual History Questionnaire and the Child Trauma Questionnaire (CTQ). Compared with both opiate addicted subjects and healthy controls, subjects with pedophilia were more likely to report experiencing adult sexual advances when they were children and a first sexual contact by age 13 with a partner at least 5 years older. Although both subjects with pedophilia and those with opiate addiction first had sex at a younger age than healthy controls, opiate addicted subjects, compared with healthy controls, reported neither increased reception of sexual advances as children nor increased rates of first sexual contact before age 13 with a partner at least 5 years older. Further, subjects with pedophilia but not those with opiate addiction scored significantly higher than healthy controls on the CTQ. Sexual abuse in childhood may be a specific risk factor for sexual addictions such as pedophilia but may not be a specific risk factor for chemical addictions.

The hypertriglyceridemic clamp technique. Studies using long-chain and structured triglyceride emulsions in healthy subjects.

Science.gov (United States)

Nordenström, Jörgen; Thörne, Anders; Aberg, Wiveca; Carneheim, Claes; Olivecrona, Thomas

2006-11-01

In a randomized crossover study, plasma kinetics of 2 different types of fat emulsions were studied in 8 healthy volunteers by using a hypertriglyceridemic clamp technique. The method involves the stabilization of serum triglyceride (TG) concentration during 180 minutes at a predetermined level (4 mmol/L) by adjustment of TG infusion rate by repeated online measurements of serum TG concentration. The fat emulsions under study were a long-chain fatty acid triglyceride (LCT) emulsion (Intralipid 20%, Fresenius Kabi, Sweden) and a structured triglyceride (STG) emulsion (Structolipid 20%, Fresenius Kabi) where medium- and long-chain fatty acids have been interesterified within a TG molecule. The hypertriglyceridemic clamp was found to have acceptable reproducibility when tested in 3 healthy individuals on 2 different occasions, as similar steady-state TG levels were obtained by infusing similar amounts of fat. The average (+/-SEM) TG concentration during the 180-minute clamp was similar for STGs and LCTs (4.0 +/- 0.1 vs 3.9 +/- 0.1 mmol/L; not significant), but the amount of fat that had to be infused was significantly higher during STG than during LCT clamping (0.31 +/- 0.04 vs 0.21 +/- 0.02 g TG per minute; P < .05). Higher serum levels of free fatty acids (1.80 +/- 0.13 vs 0.96 +/- 0.09 mmol/L; P < .05), free glycerol (1.30 +/- 0.07 vs 0.76 +/- 0.08 mmol/L; P < .001), and beta-OH butyrate (1.61 +/- 0.44 vs 1.17 +/- 0.23 mmol/L; not significant) were obtained at the end of the clamp during infusion of STGs compared with LCTs. During infusion of STGs the medium-chain fatty acids octanoic (C:8) and decanoic acid (C:10) constituted approximately half of circulating fatty acids that correspond to the compositional ratio of the emulsion. Plasma lipoprotein lipase (LPL) concentration was higher during STG than during LCT clamping (6.06 +/- 0.62 vs 3.15 +/- 0.40 mU/mL; P < .05), and there was a positive correlation between the mean LPL concentration and the amount of

Bradykinin or acetylcholine as vasodilators to test endothelial venous function in healthy subjects

Directory of Open Access Journals (Sweden)

Eneida R. Rabelo

2008-01-01

Full Text Available INTRODUCTION: The evaluation of endothelial function has been performed in the arterial bed, but recently evaluation within the venous system has also been explored. Endothelial function studies employ different drugs that act as endothelium-dependent vasodilatory response inductors. OBJECTIVES: The aim of this study is to compare the endothelium-dependent venous vasodilator response mediated by either acetylcholine or bradykinin in healthy volunteers. METHODS AND RESULTS: Changes in vein diameter after phenylephrine-induced venoconstriction were measured to compare venodilation induced by acetylcholine or bradykinin (linear variable differential transformer dorsal hand vein technique. We studied 23 healthy volunteers; 31% were male, and the subject had a mean age of 33 ± 8 years and a mean body mass index of 23 ± 2 kg/m². The maximum endothelium-dependent venodilation was similar for both drugs (p = 0.13, as well as the mean responses for each dose of both drugs (r = 0.96. The maximum responses to acetylcholine and bradykinin also had good agreement. CONCLUSION: There were no differences between acetylcholine and bradykinin as venodilators in this endothelial venous function investigation.

In vivo measurement of GABA transmission in healthy subjects and schizophrenia patients.

Science.gov (United States)

Frankle, W Gordon; Cho, Raymond Y; Prasad, Konasale M; Mason, N Scott; Paris, Jennifer; Himes, Michael L; Walker, Christopher; Lewis, David A; Narendran, Rajesh

2015-11-01

Postmortem studies in schizophrenia reveal alterations in gene products that regulate the release and extracellular persistence of GABA. However, results of in vivo studies of schizophrenia measuring total tissue GABA with magnetic resonance spectroscopy (MRS) have been inconsistent. Neither the postmortem nor the MRS studies directly address the physiological properties of GABA neurotransmission. The present study addresses this question through an innovative positron emission tomography (PET) paradigm. The binding of [(11)C]flumazenil, a benzodiazepine-specific PET radiotracer, was measured before and after administration of tiagabine (0.2 mg/kg of body weight), a GABA membrane transporter (GAT1) blocker, in 17 off-medication patients with schizophrenia and 22 healthy comparison subjects. Increased extracellular GABA, through GAT1 blockade, enhances the affinity of GABAA receptors for benzodiazepine ligands, detected as an increase in [(11)C]flumazenil tissue distribution volume (VT). [(11)C]Flumazenil VT was significantly increased across all cortical brain regions in the healthy comparison group but not in the schizophrenia group. This lack of effect was most prominent in the antipsychotic-naive schizophrenia group. In this subgroup, [(11)C]flumazenil ΔVT in the medial temporal lobe was correlated with positive symptoms, and baseline [(11)C]flumazenil VT in the medial temporal lobe was negatively correlated with visual learning. In the healthy comparison group but not the schizophrenia group, [(11)C]flumazenil ΔVT was positively associated with gamma-band oscillation power. This study demonstrates, for the first time, an in vivo impairment in GABA transmission in schizophrenia, most prominent in antipsychotic-naive individuals. The impairment in GABA transmission appears to be linked to clinical symptoms, disturbances in cortical oscillations, and cognition.

Molecular Monitoring of the Fecal Microbiota of Healthy Human Subjects during Administration of Lactulose and Saccharomyces boulardii

Science.gov (United States)

Vanhoutte, Tom; De Preter, Vicky; De Brandt, Evie; Verbeke, Kristin; Swings, Jean; Huys, Geert

2006-01-01

Diet is a major factor in maintaining a healthy human gastrointestinal tract, and this has triggered the development of functional foods containing a probiotic and/or prebiotic component intended to improve the host's health via modulation of the intestinal microbiota. In this study, a long-term placebo-controlled crossover feeding study in which each subject received several treatments was performed to monitor the effect of a prebiotic substrate (i.e., lactulose), a probiotic organism (i.e., Saccharomyces boulardii), and their synbiotic combination on the fecal microbiota of three groups of 10 healthy human subjects differing in prebiotic dose and/or intake of placebo versus synbiotic. For this purpose, denaturing gradient gel electrophoresis (DGGE) analysis of 16S rRNA gene amplicons was used to detect possible changes in the overall bacterial composition using the universal V3 primer and to detect possible changes at the subpopulation level using group-specific primers targeting the Bacteroides fragilis subgroup, the genus Bifidobacterium, the Clostridium lituseburense group (cluster XI), and the Clostridium coccoides-Eubacterium rectale group (cluster XIVa). Although these populations remained fairly stable based on DGGE profiling, one pronounced change was observed in the universal fingerprint profiles after lactulose ingestion. Band position analysis and band sequencing revealed that a band appearing or intensifying following lactulose administration could be assigned to the species Bifidobacterium adolescentis. Subsequent analysis with real-time PCR (RT-PCR) indicated a statistically significant increase (P < 0.05) in total bifidobacteria in one of the three subject groups after lactulose administration, whereas a similar but nonsignificant trend was observed in the other two groups. Combined RT-PCR results from two subject groups indicated a borderline significant increase (P = 0.074) of B. adolescentis following lactulose intake. The probiotic yeast S

Effect of Guava in Blood Glucose and Lipid Profile in Healthy Human Subjects: A Randomized Controlled Study

Science.gov (United States)

Rakavi, R; Mangaraj, Manaswini

2016-01-01

Introduction The fruit of Psidium guajava (P.guajava) is known to contain free sugars yet the fruit juice showed hypoglycaemic effect. Hypoglycaemic activity of guava leaves has been well documented but not for guava fruit. Aim So we aimed to evaluate the effect of ripe guava (with peel and without peel) fruit supplementation on blood glucose and lipid profile in healthy human subjects. Materials and Methods Randomized Controlled study undertaken in: 1) Baseline; 2) 6 weeks supplementation phase. Forty five healthy MBBS students were included and randomly enrolled into Group A, Group B and Group C. In Baseline phase: Fasting Plasma Glucose (FPG) and serum lipid profile was done in all 3 groups. Group A were supplemented with 400g of ripe guava with peel and group B without peel, for 6 weeks. Rest 15 treated as control i.e., Group C. Result Supplementation of ripe guava fruit with peel reduced BMI as well as blood pressure (pguava pulp supplementation was not significant. Serum Total cholesterol, Triglycerides and Low Density Lipoprotein Cholesterol (LDLc) levels decreased significantly (pguava pulp without peel may have a favourable effect on lipid levels and blood sugar as well. Conclusion Guava fruit without peel is more effective in lowering blood sugar as well as serum total cholesterol, triglycerides and LDLc. It increases HDLc levels also. PMID:27790420

Failure of activation of spinal motoneurones after muscle fatigue in healthy subjects studied by transcranial magnetic stimulation

DEFF Research Database (Denmark)

Andersen, Birgit; Westlund, Barbro; Krarup, Christian

2003-01-01

. This points to increased probability of repetitive spinal MN activation during fatigue even if some MNs in the pool failed to discharge. Silent period duration following cortical stimulation lengthened by an average of 55 ms after the contraction and recovered within a time course similar to that of the TST......During a sustained maximal effort a progressive decline in the ability to drive motoneurones (MNs) develops. We used the recently developed triple stimulation technique (TST) to study corticospinal conduction after fatiguing exercise in healthy subjects. This method employs a collision technique...... conventional transcranial magnetic stimulation (TMS) and responses to peripheral nerve stimulation were recorded following the same fatigue protocol. The size of both the MEPs and the peripheral responses increased after the contraction and were in direct contrast to the decrease in size of the TST response...

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

Science.gov (United States)

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

2017-02-01

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

Pupillographic assessment of sleepiness in sleep-deprived healthy subjects.

Science.gov (United States)

Wilhelm, B; Wilhelm, H; Lüdtke, H; Streicher, P; Adler, M

1998-05-01

Spontaneous pupillary-behavior in darkness provides information about a subject's level of sleepiness. In the present work, pupil measurements in complete darkness and quiet have been recorded continuously over 11-minute period with infrared video pupillography at 25 Hz. The data have been analyzed to yield three parameters describing pupil behavior; the power of diameter variation at frequencies below 0.8 Hz (slow changes in pupil size), the pupillary unrest index, and the average pupil size. To investigate the changes of these parameters in sleep deprivation, spontaneous pupillary behavior in darkness was recorded every 2 hours in 13 healthy subjects from 19:00 to 07:00 during forced wakefulness. On each occasion, comparative subjective sleepiness was assessed with a self-rating scale (Stanford Sleepiness Scale, SSS). The power of slow pupillary oscillations (< or = 0.8 Hz) increased significantly and so did the values of SSS, while basic pupil diameter decreased significantly. Slow pupillary oscillations and SSS did not correlate well in general but high values of pupil parameters were always associated with high values in subjective rating. Our results demonstrate a strong relationship between ongoing sleep deprivation and typical changes in the frequency profiles of spontaneous pupillary oscillations and the tendency to instability in pupil size in normals. These findings suggest that the results of pupil data analysis permit an objective measurement of sleepiness.

[Proteinase activity in Candida albicans strains isolated from the oral cavity of immunocompromised patients, with oral candidiasis and in healthy subjects].

Science.gov (United States)

Hernández-Solís, Sandra E; Rueda-Gordillo, Florencio; Rojas-Herrera, Rafael A

2014-01-01

Candida albicans has a variety of virulence factors, including secreted aspartyl proteases, which are determinant factors in the pathogenesis of this yeast in immunocompromised patients. Proteinase activity was identified in C. albicans strains isolated from the oral cavity of immunocompromised patients with cancer, diabetes and HIV+, with oral candidiasis and in healthy subjects. Two hundred and fifty C. albicans strains were analyzed, distributed in 5 different groups: patients with cancer, diabetes, HIV+, with oral candidiasis and healthy subjects. Proteolytic activity was identified in 46% of the strains from cancer patients, 54% from HIV+ patients, 60% from diabetics, 70% from oral candidiasis patients, and 42% from healthy subjects. Activity was higher in strains from immunocompromised and oral candidiasis patients than in healthy subjects. Differences were observed between the candidiasis-healthy, candidiasis-HIV+, and diabetic-healthy groups. No differences were observed between the oral candidiasis, diabetes and cancer patients, between the diabetes and HIV+ patients, or between the cancer patients, HIV+ patients and healthy subjects. The present results suggest that although secreted aspartyl proteases are important in the pathogenesis of C. albicans, their activity depends on host conditions. Copyright © 2012 Revista Iberoamericana de Micología. Published by Elsevier Espana. All rights reserved.

Stereoselective pharmacokinetics of moguisteine metabolites in healthy subjects.

Science.gov (United States)

Bernareggi, A; Crema, A; Carlesi, R M; Castoldi, D; Ratti, E; Renoldi, M I; Ratti, D; Ceserani, R; Tognella, S

1995-01-01

We studied the pharmacokinetics of moguisteine, a racemic non-narcotic peripheral antitussive drug, in 12 healthy male subjects after a single oral administration of 200 mg. The unchanged drug was absent in plasma and urine of all subjects. Moguisteine was immediately and completely hydrolyzed to its main active metabolite, the free carboxylic acid M1. Therefore, we evaluated the kinetic profiles of M1, of its enantiomers R(+)-M1 and S(-)-M1, and of M1 sulfoxide optical isomers M2/I and M2/II by conventional and stereospecific HPLC. Maximum plasma concentrations for M1 (2.83 mg/l), M2/I (0.26 mg/l) and M2/II (0.40 mg/l), were respectively reached at 1.3, 1.6 and 1.5 h after moguisteine administration. Plasma concentrations declined after the peak with mean apparent terminal half-lives of 0.65 h (M1), 0.88 h (M2/I) and 0.84 h (M2/II). Most of the administered dose was recovered in urine within 6 h from moguisteine treatment. The systemic and renal clearance values indicated high renal extraction ratio for all moguisteine metabolites, and particularly for M1 sulfoxide optical isomers. Plasma concentration-time profiles and urinary excretion patterns for M1 enantiomers R(+)-M1 and S(-)-M1 were quite similar. Thus, for later moguisteine pharmacokinetic evaluations the investigation of the plasma concentration-time curve and the urinary excretion of the sole racemic M1 through non-stereospecific analytical methods may suffice in most cases.

Changes in ventilatory mechanics caused by variations in PEEP and pressure support: study in healthy subjects under non-invasive mechanical ventilation

Directory of Open Access Journals (Sweden)

Isabel Cristina Muñoz

2017-04-01

Conclusions: The proposed technique allowed to find compliance and resistance values consistent with those set in the mechanical simulator, which, in turn, coincide with those reported in the literature for healthy subjects. This information is useful for decision-making in intensive care units..

Acute effects of LSD on amygdala activity during processing of fearful stimuli in healthy subjects.

Science.gov (United States)

Mueller, F; Lenz, C; Dolder, P C; Harder, S; Schmid, Y; Lang, U E; Liechti, M E; Borgwardt, S

2017-04-04

Lysergic acid diethylamide (LSD) induces profound changes in various mental domains, including perception, self-awareness and emotions. We used functional magnetic resonance imaging (fMRI) to investigate the acute effects of LSD on the neural substrate of emotional processing in humans. Using a double-blind, randomised, cross-over study design, placebo or 100 μg LSD were orally administered to 20 healthy subjects before the fMRI scan, taking into account the subjective and pharmacological peak effects of LSD. The plasma levels of LSD were determined immediately before and after the scan. The study (including the a priori-defined study end point) was registered at ClinicalTrials.gov before study start (NCT02308969). The administration of LSD reduced reactivity of the left amygdala and the right medial prefrontal cortex relative to placebo during the presentation of fearful faces (PLSD-induced amygdala response to fearful stimuli and the LSD-induced subjective drug effects (PLSD modulates the engagement of brain regions that mediate emotional processing.

Similar to adiponectin, serum levels of osteoprotegerin are associated with obesity in healthy subjects.

LENUS (Irish Health Repository)

Ashley, David T

2011-07-01

An increase in serum osteoprotegerin (OPG) is associated with type 2 diabetes mellitus, the severity of vascular calcification, and coronary artery disease. Obesity is a risk factor for diabetes and cardiovascular disease, but little is known about the relationship between OPG and obesity. The purpose of this study was to determine if changes in body mass index (BMI) and insulin sensitivity influence circulating OPG in healthy subjects. A total of 100 subjects (36 lean, 41 overweight, and 23 obese) with normal glucose tolerance, blood pressure, and electrocardiogram stress test result volunteered for this study. Insulin sensitivity was estimated using a 2-hour oral glucose tolerance test with oral glucose insulin sensitivity analysis. Osteoprotegerin, tumor necrosis factor-related apoptosis-inducing ligand (TRAIL),soluble receptor activator of nuclear factor-κβ ligand (sRANKL), and adiponectin were analyzed using commercially available enzyme-linked immunosorbent assays. Osteoprotegerin (P < .01) and adiponectin (P < .001) were significantly decreased in the obese compared with lean subjects. There was no significant difference between BMI categories for TRAIL or sRANKL. Controlling for age and sex, there was a significant correlation between OPG and adiponectin (r = 0.391, P < .001), BMI (r = -0.331, P < .001), waist circumference (r = -0.268, P < .01), homeostasis model assessment of insulin resistance (r = -0.222, P < .05), and oral glucose insulin sensitivity (r = 0.221, P < .05). Both OPG and adiponectin were negatively correlated with body weight, BMI, waist circumference, and fasting plasma insulin while being positively correlated with insulin sensitivity (P < .05). Controlling for age, sex, and BMI, TRAIL was positively related to fat mass (r = 0.373, P < .001) and waist circumference (r = 0.257, P < .05). In contrast to patients with type 2 diabetes mellitus, circulating OPG is lower in obese, but otherwise healthy subjects and is positively correlated

Simulated Prism Therapy in Virtual Reality produces larger after-effects than standard prism exposure in normal healthy subject - Implications for Neglect Therapy

DEFF Research Database (Denmark)

Wilms, Inge Linda

2018-01-01

BACKGROUND: Virtual reality is an important area of exploration within computer-based cognitive rehabilitation of visual neglect. Virtual reality will allow for closer monitoring of patient behaviour during prism adaptation therapy and perhaps change the way we induce prismatic after......-effects. OBJECTIVE: This study compares the effect of two different prism simulation conditions in virtual reality to a standard exposure to prism goggles after one session of Prism Adaptation Therapy in healthy subjects. METHOD: 20 healthy subjects were subjected to one session of prism adaptation therapy under...... training for rehabilitation of hemi spatial attentional deficits such as visual neglect....

Gait variability measurements in lumbar spinal stenosis patients: part A. Comparison with healthy subjects

International Nuclear Information System (INIS)

Papadakis, N C; Christakis, D G; Tzagarakis, G N; Chlouverakis, G I; Kampanis, N A; Stergiopoulos, K N; Katonis, P G

2009-01-01

The objective of this study is to compare the gait variability of patients with lumbar spinal stenosis (experimental group) with healthy individuals (control group). The hypothesis is that the preoperative gait variability of the experimental group is higher than the control group. The experimental group consisted of 35 adults (18 males, 17 females). The subjects of the experimental group suffered exclusively from spinal stenosis. The patients were determined by MRI scans. A tri-axial accelerometer sensor was used for the gait measurement, and differential entropy algorithm was used to quantify the gait acceleration signal. The Oswestry Low Back Pain Questionnaire was used to determine the condition on the day of the measurement. Receiver operating characteristic (ROC) was utilized to assess the diagnostic value of the method and determine a cut-off value. There is a statistically significant difference between gait variability in the control group and the experimental group. ROC analysis determines a cut-off differential entropy value. The cut-off value has a 97.6% probability of separating patients with spinal stenosis from healthy subjects. The Oswestry Low Back Questionnaire is well correlated with the spectral differential entropy values

Pharmacokinetics and pharmacogenetics of the MEK1/2 inhibitor, selumetinib, in Asian and Western healthy subjects: a pooled analysis.

Science.gov (United States)

Dymond, Angela W; Elks, Cathy; Martin, Paul; Carlile, David J; Mariani, Gabriella; Lovick, Susan; Huang, Yifan; Lorch, Ulrike; Brown, Helen; So, Karen

2017-06-01

Emerging data on selumetinib, a MEK1/2 inhibitor in clinical development, suggest a possible difference in pharmacokinetics (PK) between Japanese and Western patients. This pooled analysis sought to assess the effect of ethnicity on selumetinib exposure in healthy Western and Asian subjects, and to identify any association between genetic variants in the UGT1A1, CYP2C19 and ABCG2 genes and observed differences in selumetinib PK. A pooled analysis of data from ten Phase I studies, one in Asian subjects (encompassing Japanese, non-Japanese Asian and Indian Asian subjects) and nine in Western subjects, was conducted. Key findings were derived from the collective exposure data across doses of 25, 35, 50 and 75 mg selumetinib; primary variables were dose-normalized AUC and C max . PK data from 308 subjects (10 studies) were available for the pooled analysis; genetic data from 87 subjects (3 studies) were available for the pharmacogenetic analysis. Dose-normalized AUC and C max were 35% (95% CI: 25-47%) and 39% (95% CI: 24-56%) higher in the pooled Asian group, respectively, compared with Western subjects. PK exposure parameters were similar between the Japanese, non-Japanese Asian and Indian groups. There was no evidence that the polymorphisms assessed in the genes UGT1A1, CYP2C19 and ABCG2 account for observed PK differences. Selumetinib exposure was higher in healthy Asian subjects compared with Western subjects, and these data provide valuable insight for clinicians to consider when treating patients of Asian ethnicity with selumetinib.

Acute effects of 3,4-methylenedioxymethamphetamine and methylphenidate on circulating steroid levels in healthy subjects.

OpenAIRE

Seibert Julia; Hysek Cédric M; Penno Carlos A; Schmid Yasmin; Kratschmar Denise V; Liechti Matthias E; Odermatt Alex

2014-01-01

3,4-Methylenedioxymethamphetamine (MDMA, 'ecstasy') and methylphenidate are widely used psychoactive substances. MDMA primarily enhances serotonergic neurotransmission, and methylphenidate increases dopamine but has no serotonergic effects. Both drugs also increase norepinephrine, resulting in sympathomimetic properties. Here we studied the effects of MDMA and methylphenidate on 24-h plasma steroid profiles. Sixteen healthy subjects (eight men, eight women) were treated with single doses of M...

Evaluating fMRI methods for assessing hemispheric language dominance in healthy subjects

Energy Technology Data Exchange (ETDEWEB)

Baciu, Monica [Laboratoire de Psychologie et NeuroCognition, UMR 5105 CNRS, Universite Pierre Mendes-France, F38040 Grenoble Cedex 09 (France)]. E-mail: mbaciu@upmf-grenoble.fr; Juphard, Alexandra [Laboratoire de Psychologie et NeuroCognition, UMR 5105 CNRS, Universite Pierre Mendes-France, F38040 Grenoble Cedex 09 (France); Cousin, Emilie [Laboratoire de Psychologie et NeuroCognition, UMR 5105 CNRS, Universite Pierre Mendes-France, F38040 Grenoble Cedex 09 (France); Bas, Jean Francois Le [Unite IRM, CHU Grenoble (France)

2005-08-01

We evaluated two methods for quantifying the hemispheric language dominance in healthy subjects, by using a rhyme detection (deciding whether couple of words rhyme) and a word fluency (generating words starting with a given letter) task. One of methods called 'flip method' (FM) was based on the direct statistical comparison between hemispheres' activity. The second one, the classical lateralization indices method (LIM), was based on calculating lateralization indices by taking into account the number of activated pixels within hemispheres. The main difference between methods is the statistical assessment of the inter-hemispheric difference: while FM shows if the difference between hemispheres' activity is statistically significant, LIM shows only that if there is a difference between hemispheres. The robustness of LIM and FM was assessed by calculating correlation coefficients between LIs obtained with each of these methods and manual lateralization indices MLI obtained with Edinburgh inventory. Our results showed significant correlation between LIs provided by each method and the MIL, suggesting that both methods are robust for quantifying hemispheric dominance for language in healthy subjects. In the present study we also evaluated the effect of spatial normalization, smoothing and 'clustering' (NSC) on the intra-hemispheric location of activated regions and inter-hemispheric asymmetry of the activation. Our results have shown that NSC did not affect the hemispheric specialization but increased the value of the inter-hemispheric difference.

Retinal Oxygen Delivery and Metabolism in Healthy and Sickle Cell Retinopathy Subjects.

Science.gov (United States)

Shahidi, Mahnaz; Felder, Anthony E; Tan, Ou; Blair, Norman P; Huang, David

2018-04-01

Reduction in inner retinal oxygen delivery (DO2) can cause retinal hypoxia and impair inner retinal oxygen metabolism (MO2), leading to vision loss. The purpose of the current study was to establish measurements of DO2 and MO2 in healthy subjects and test the hypothesis that DO2 and MO2 are reduced in sickle cell retinopathy (SCR) subjects. Dual wavelength retinal oximetry and Doppler optical coherence tomography were performed in 12 healthy control and 12 SCR subjects. Images were analyzed to measure retinal arterial and venous oxygen content (O2A and O2V), venous diameter (DV), and total retinal blood flow (TRBF). Retinal arteriovenous oxygen content difference (O2AV), DO2, MO2, and oxygen extraction fraction (OEF) were calculated according to the following equations: O2AV = O2A - O2V; DO2 = TRBF * O2A; MO2 = TRBF * O2AV; OEF = MO2/DO2. Retinal DV and TRBF were higher in the SCR group as compared to the control group, whereas, O2A, O2V, and O2AV were lower in SCR group as compared to the control group. DO2, MO2, and OEF were not significantly different between control and SCR groups. MO2 and DO2 were linearly related, such that higher MO2 was associated with higher DO2. There was an inverse relationship between TRBF and OEF, such that lower TRBF was associated with higher OEF. Increased blood flow compensated for decreased oxygen content, thereby maintaining DO2, MO2, and OEF at predominately lower stages of SCR. Quantitative assessment of these parameters has the potential to advance knowledge and improve diagnostic evaluation of retinal ischemic conditions.

Flow rates in the head and neck lymphatics after food stimulation in healthy subjects

Energy Technology Data Exchange (ETDEWEB)

Thommesen, P.; Buhl, J.; Jansen, K.; Funch-Jensen, P.

1981-02-01

In 22 healthy subjects lymph transport flow rates was studied in the head lymphatics after food stimulation, mastication (chewing) and taste. After food stimulation there was a significantly higher transport rate (0.67 meter/hour) than after taste (0.57 meter/hour) and mastication (0.55 meter/hour). The calculation of transport flow rate was independent of quantitative distribution of radioactivity in the head and neck lymphatics, and it could therefore perhaps be of clinical value.

Flow rates in the head and neck lymphatics after food stimulation in healthy subjects

International Nuclear Information System (INIS)

Thommesen, P.; Buhl, J.; Jansen, K.; Funch-Jensen, P.; Central Hospital Randers; Municipal Hospital Aarhus

1981-01-01

In 22 healthy subjects lymph transport flow rates was studied in the head lymphatics after food stimulation, mastication (chewing) and taste. After food stimulation there was a significantly higher transport rate (0.67 meter/hour) than after taste (0.57 meter/hour) and mastication (0.55 meter/hour). The calculation of transport flow rate was independent of quantitative distribution of radioactivity in the head and neck lymphatics, and it could therefore perhaps be of clinical value. (orig.) [de

Estimation and correlation of salivary thiocyanate levels in periodontally healthy subjects, smokers, nonsmokers, and gutka-chewers with chronic periodontitis.

Science.gov (United States)

Hegde, Shashikanth; Chatterjee, Elashri; Rajesh, K S; Kumar, M S Arun

2016-01-01

This study was conducted to estimate and correlate salivary thiocyanate (SCN) levels in periodontally healthy subjects, smokers, nonsmokers, and gutka-chewers with chronic periodontitis. The study population consisted of 40 systemically healthy subjects in the age group of 18-55 years that was further divided into four groups: Control, smokers, nonsmokers, and gutka-chewers with chronic periodontitis. Gingival index (GI) (Loe and Silness-1963), probing depth (PD), clinical attachment loss was assessed. Estimation of SCN was performed by ultraviolet spectrophotometer at 447 nm wavelength. Statistical analysis was performed using the one-way ANOVAs Welch test and Pearson's correlation test using SPSS version 17 software. Results showed statistically significant increase in SCN levels in smokers as compared to gutka-chewers with chronic periodontitis, control, and nonsmokers with chronic periodontitis subjects. Significantly higher PD and loss of attachment were seen in smokers group compared with other groups. A negative correlation observed between the GI and thiocyanate levels. The present study revealed a significant increase in SCN levels in smokers with periodontitis as compared to nonsmokers.

Normative perceptual estimates for 91 healthy subjects age 60-75

DEFF Research Database (Denmark)

Wilms, Inge Linda; Nielsen, Simon

2014-01-01

Visual perception serves as the basis for much of the higher level cognitive processing as well as human activity in general. Here we present normative estimates for the following components of visual perception: the visual perceptual threshold, the visual short-term memory capacity and the visual...... perceptual encoding/decoding speed (processing speed) of visual short-term memory based on an assessment of 91 healthy subjects aged 60-75. The estimates are presented at total sample level as well as at gender level. The estimates were modelled from input from a whole-report assessment based on A Theory...... speed of Visual Short-term Memory (VTSM) but not the capacity of VSTM nor the visual threshold. The estimates will be useful for future studies into the effects of various types of intervention and training on cognition in general and visual attention in particular....

Exhaled nitric oxide - circadian variations in healthy subjects

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Antosova M

2009-12-01

Full Text Available Abstract Objective Exhaled nitric oxide (eNO has been suggested as a marker of airway inflammatory diseases. The level of eNO is influenced by many various factor including age, sex, menstrual cycle, exercise, food, drugs, etc. The aim of our study was to investigate a potential influence of circadian variation on eNO level in healthy subjects. Methods Measurements were performed in 44 women and 10 men, non-smokers, without respiratory tract infection in last 2 weeks. The eNO was detected at 4-hour intervals from 6 a.m. to 10 p.m. using an NIOX analyzer. We followed the ATS/ERS guidelines for eNO measurement and analysis. Results Peak of eNO levels were observed at 10 a.m. (11.1 ± 7.2 ppb, the lowest value was detected at 10 p.m. (10.0 ± 5.8 ppb. The difference was statistically significant (paired t-test, P Conclusions The daily variations in eNO, with the peak in the morning hours, could be of importance in clinical practice regarding the choice of optimal time for monitoring eNO in patients with respiratory disease.

Tissue Factor and Toll Like Receptor (TLR)4 in Hyperglycemia-Hyperinsulinemia: Effects in Healthy Subjects, and Type 1 and Type 2 Diabetes Mellitus

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Singh, Anamika; Boden, Guenther; Rao, A. Koneti

2015-01-01

SUMMARY Background Diabetes mellitus (DM) patients have increased cardiovascular events. Blood tissue factor-procoagulant activity (TF-PCA), the initiating mechanism for blood coagulation, is elevated in DM. We have shown that hyperglycemia (HG), hyperinsulinemia (HI) and combined HG+HI (induced using 24 hr infusion clamps) increases TF-PCA in healthy and T2DM subjects, but not in T1DM subjects. The mechanisms for this are unknown. DM patients have elevated plasma lipopolysaccharide (LPS), a toll-like receptor (TLR) 4 ligand. We postulated that TLR4 plays a role in modulating TF levels. Objectives and Methods We studied the effect of HG+HI on TLR4 and TF-PCA in vivo during 24 hr HG+HI infusion clamps in healthy subjects, and T1DM and T2DM subjects, and in vitro in blood. Results In vivo, in healthy subjects, 24 hr HG + HI infusion increased TLR4 6-fold, which correlated with TF-PCA (r= 0.91, p<0.0001). T2DM patients showed smaller increases in both. In T1DM subjects, TLR4 declined (50%, p<0.05) and correlated with TF-PCA (r=0.55; p<0.05). In vitro, HG (200 mg/dl added glucose) and HI (1-100 nM added insulin) increased TF-PCA in healthy subjects (~2-fold, 2-4 hr). Insulin inhibited by ~30% LPS-induced increase in TF-PCA and high glucose reversed it. TLR4 levels paralleled TF-PCA (r=0.71, p<0.0001); HG and HI increased TLR4 and insulin inhibited LPS-induced TLR4 increase. Conclusions This is first evidence that even in healthy subjects, HG of short duration increases TLR4 and TF-PCA, key players in inflammation and thrombosis. TLR4-TF interplay is strikingly different in non-diabetic, T1DM and T2DM subjects. PMID:25653143

[Motor skills and safety of patients with bi- or trimalleolar ankle injury : Comparison with healthy, active, age-matched control subjects].

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Loudovici-Krug, Dana; Benkenstein, Monique; Derlien, Steffen; Best, Norman

2018-06-01

Do patients with bi- or trimalleolar ankle injury show differences in motor skills and safety in comparison with healthy, active, age-matched control subjects? Prospective controlled cross-sectional study. Inclusion of 17 patients with bi- or trimalleolar ankle injury (mean 1.5 years postsurgery) and 23 healthy, active subjects of comparable age (fitness studio). Measurement instruments: motor test procedures and questionnaires. Comparison of patients and control subjects by routine daily motor function: patients  0.05), fear of falling: patients > controls (p = 0.003) and physical activity: patients motor deficits in activities of daily life between the patients and controls, only tendencies; however, the patients showed definite limitations with an increased fear of falling and a reduced physical activity compared with the healthy control group. The resulting differences should be positively influenced by appropriate enhancement of training or participation in sports courses. The aim is to achieve a similar quality of life by a perception of safety and trust in one's own motor skills.

Effects of simulated altitude (normobaric hypoxia on cardiorespiratory parameters and circulating endothelial precursors in healthy subjects

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Pierini Alberto

2007-08-01

Full Text Available Abstract Background Circulating Endothelial Precursors (PB-EPCs are involved in the maintenance of the endothelial compartment being promptly mobilized after injuries of the vascular endothelium, but the effects of a brief normobaric hypoxia on PB-EPCs in healthy subjects are scarcely studied. Methods Clinical and molecular parameters were investigated in healthy subjects (n = 8 in basal conditions (T0 and after 1 h of normobaric hypoxia (T1, with Inspiratory Fraction of Oxygen set at 11.2% simulating 4850 mt of altitude. Blood samples were obtained at T0 and T1, as well as 7 days after hypoxia (T2. Results In all studied subjects we observed a prompt and significant increase in PB-EPCs, with a return to basal value at T2. The induction of hypoxia was confirmed by Alveolar Oxygen Partial Pressure (PAO2 and Spot Oxygen Saturation decreases. Heart rate increased, but arterial pressure and respiratory response were unaffected. The change in PB-EPCs percent from T0 to T1 was inversely related to PAO2 at T1. Rapid (T1 increases in serum levels of hepatocyte growth factor and erythropoietin, as well as in cellular PB-EPCs-expression of Hypoxia Inducible Factor-1α were observed. Conclusion In conclusion, the endothelial compartment seems quite responsive to standardized brief hypoxia, possibly important for PB-EPCs activation and recruitment.

Assessment of macrovascular endothelial function using pulse wave analysis and its association with microvascular reactivity in healthy subjects.

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Ibrahim, N N I N; Rasool, A H G

2017-08-01

Pulse wave analysis (PWA) and laser Doppler fluximetry (LDF) are non-invasive methods of assessing macrovascular endothelial function and microvascular reactivity respectively. The aim of this study was to assess the correlation between macrovascular endothelial function assessed by PWA and microvascular reactivity assessed by LDF. 297 healthy and non-smoking subjects (159 females, mean age (±SD) 23.56 ± 4.54 years) underwent microvascular reactivity assessment using LDF followed by macrovascular endothelial function assessments using PWA. Pearson's correlation showed no correlation between macrovascular endothelial function and microvascular reactivity (r = -0.10, P = 0.12). There was no significant correlation between macrovascular endothelial function assessed by PWA and microvascular reactivity assessed by LDF in healthy subjects. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Functional analyses of the skin surface of the areola mammae: comparison between healthy adult male and female subjects and between healthy individuals and patients with atopic dermatitis.

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Kikuchi, K; Tagami, H; Akaraphanth, R; Aiba, S

2011-01-01

Although the nipple and areola of the breast constitute a unique and prominent area on the chest, so far no study has been done on the functional properties of their skin surfaces. To study the stratum corneum (SC) covering the areola using noninvasive methods. Eighteen adult healthy subjects comprising nine men and nine women and 18 age- and sex-matched patients with atopic dermatitis (AD), none of whom had visible skin lesions, participated in the study. Transepidermal water loss (TEWL), skin surface hydration and skin surface lipid levels were measured on the areola and adjacent breast skin. The size of the skin surface corneocytes of these skin regions was assessed. All the healthy subjects showed significantly higher TEWL accompanied by smaller sized corneocytes on the areola than on the adjacent breast skin. Only female subjects revealed a significantly higher skin surface hydration state together with significantly increased skin surface lipid levels on the areola than on the adjacent breast skin. These sex differences were observed even in patients with AD. Comparison between healthy individuals and the patients with AD demonstrated higher TEWL, decreased skin surface hydration state and lower skin surface lipid levels associated with smaller sized corneocytes in the areola in the patients with AD, especially in male patients. In adults, the SC barrier function and SC water-binding capacity of the areola were functionally poorer than in the adjacent skin, being covered by smaller sized corneocytes and lower amounts of skin surface lipids, especially in men and in patients with AD. © 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011.

Motor performance during and following acute alcohol intoxication in healthy non-alcoholic subjects

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Poulsen, Mette Buch; Jakobsen, Johannes Klitgaard; Andersen, Henning

2007-01-01

Chronic alcohol abuse has adverse effects on skeletal muscle, and reduced muscle strength is frequently seen in chronic alcoholics. In this study the acute effects of moderate alcohol intoxication on motor performance was evaluated in 19 non-alcoholic healthy subjects (10 women, 9 men......). A randomised double-blinded placebo controlled design was applied to subjects receiving alcohol in juice and pure juice at two separate test periods. Isokinetic and isometric muscle strength and endurance were determined before, during, 24 and 48 h after the ingestion of alcohol in juice and juice (placebo......). To detect a reduced activation of the central motor pathways superimposed external electrical stimulations during voluntary contractions were applied. Creatine kinase (CK) was measured to detect any alcohol-induced changes in sarcolemmal integrity. No change was seen in isokinetic as well as in isometric...

Linear and nonlinear analysis of heart rate variability in healthy subjects and after acute myocardial infarction in patients

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V.C. Kunz

2012-05-01

Full Text Available The objectives of this study were to evaluate and compare the use of linear and nonlinear methods for analysis of heart rate variability (HRV in healthy subjects and in patients after acute myocardial infarction (AMI. Heart rate (HR was recorded for 15 min in the supine position in 10 patients with AMI taking β-blockers (aged 57 ± 9 years and in 11 healthy subjects (aged 53 ± 4 years. HRV was analyzed in the time domain (RMSSD and RMSM, the frequency domain using low- and high-frequency bands in normalized units (nu; LFnu and HFnu and the LF/HF ratio and approximate entropy (ApEn were determined. There was a correlation (P < 0.05 of RMSSD, RMSM, LFnu, HFnu, and the LF/HF ratio index with the ApEn of the AMI group on the 2nd (r = 0.87, 0.65, 0.72, 0.72, and 0.64 and 7th day (r = 0.88, 0.70, 0.69, 0.69, and 0.87 and of the healthy group (r = 0.63, 0.71, 0.63, 0.63, and 0.74, respectively. The median HRV indexes of the AMI group on the 2nd and 7th day differed from the healthy group (P < 0.05: RMSSD = 10.37, 19.95, 24.81; RMSM = 23.47, 31.96, 43.79; LFnu = 0.79, 0.79, 0.62; HFnu = 0.20, 0.20, 0.37; LF/HF ratio = 3.87, 3.94, 1.65; ApEn = 1.01, 1.24, 1.31, respectively. There was agreement between the methods, suggesting that these have the same power to evaluate autonomic modulation of HR in both AMI patients and healthy subjects. AMI contributed to a reduction in cardiac signal irregularity, higher sympathetic modulation and lower vagal modulation.

Correlation between Very Short and Short-Term Blood Pressure Variability in Diabetic-Hypertensive and Healthy Subjects.

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Casali, Karina R; Schaan, Beatriz D; Montano, Nicola; Massierer, Daniela; M F Neto, Flávio; Teló, Gabriela H; Ledur, Priscila S; Reinheimer, Marilia; Sbruzzi, Graciele; Gus, Miguel

2018-02-01

Blood pressure (BP) variability can be evaluated by 24-hour ambulatory BP monitoring (24h-ABPM), but its concordance with results from finger BP measurement (FBPM) has not been established yet. The aim of this study was to compare parameters of short-term (24h-ABPM) with very short-term BP variability (FBPM) in healthy (C) and diabetic-hypertensive (DH) subjects. Cross-sectional study with 51 DH subjects and 12 C subjects who underwent 24h-ABPM [extracting time-rate, standard deviation (SD), coefficient of variation (CV)] and short-term beat-to-beat recording at rest and after standing-up maneuvers [FBPM, extracting BP and heart rate (HR) variability parameters in the frequency domain, autoregressive spectral analysis]. Spearman correlation coefficient was used to correlate BP and HR variability parameters obtained from both FBPM and 24h-ABPM (divided into daytime, nighttime, and total). Statistical significance was set at p ABPM) and LF component of short-term variability (FBPM, total, R = 0.591, p = 0.043); standard deviation (24h-ABPM) with LF component BPV (FBPM, total, R = 0.608, p = 0.036), coefficient of variation (24h-ABPM) with total BPV (FBPM, daytime, -0.585, p = 0.046) and alpha index (FBPM, daytime, -0.592, p = 0.043), time rate (24h-ABPM) and delta LF/HF (FBPM, total, R = 0.636, p = 0.026; daytime R = 0,857, p ABPM (total, daytime) reflect BP and HR variability evaluated by FBPM in healthy individuals. This does not apply for DH subjects.

Cancer survivors exhibit a different relationship between muscle strength and health-related quality of life/fatigue compared to healthy subjects.

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Morishita, S; Tsubaki, A; Fu, J B; Mitobe, Y; Onishi, H; Tsuji, T

2018-05-16

We investigated the difference in relationship between muscle strength and quality of life (QOL)/fatigue in long-term cancer survivors and healthy subjects. Thirty-six cancer survivors and 29 healthy subjects were assessed for body composition and bone status at the calcaneus using the Osteo Sono Assessment Index. Muscle strength was evaluated via handgrip and knee extensor strength. Health-related QOL was assessed using the Medical Outcome Study 36-item Short-Form Health Survey. Fatigue was measured using the brief fatigue inventory. Cancer survivors exhibited lower QOL scores in the physical functioning, physical role function, bodily pain and general health domains (p < .05). Grip and knee extension muscle strength in cancer survivors was positively correlated with the physical function and bodily pain of QOL (p < .05). The usual fatigue subscale score was only significantly higher in cancer survivors than in healthy subjects (p < .05). However, there were no correlations between muscle strength and fatigue in cancer survivors. Our results showed that muscle strength was an important factor for improving QOL in cancer survivors. We believe that the findings of this study will be relevant in the context of planning rehabilitation for cancer survivors. © 2018 John Wiley & Sons Ltd.

Similar elimination rates of glucagon-like peptide-1 in obese type 2 diabetic patients and healthy subjects

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Vilsbøll, Tina; Agersø, H; Krarup, T

2003-01-01

of this study was to examine the pharmacokinetics of GLP-1 in healthy subjects and type 2 diabetic patients after iv bolus doses ranging from 2.5-25 nmol/subject. Bolus injections iv of 2.5, 5, 15, and 25 nmol of GLP-1 and a meal test were performed in six type 2 diabetic patients [age, mean (range): 56 (48...... response seen after ingestion of a standard breakfast meal must therefore be caused by a decreased secretion of GLP-1 in type 2 diabetic patients....

Effects of diazepam and levodopa single doses on motor cortex plasticity modulation in healthy human subjects: A TMS study

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Ilić Nela V.

2012-01-01

Full Text Available Introduction. Administration of pharmacological agents with specific actions on neurotransmitter systems is a powerful driver of functional cortical reorganization. Plastic reorganization of the motor cortex in humans studies by the use of non-invasive stimulation protocols, which mimic the Hebbian model of associative plasticity. Objective. Aiming to explore pharmacological modulation on human motor cortex plasticity, we tested healthy subjects after each dosage of diazepam, levodopa i placebo administration, using paired associative stimulation protocol (PAS that induce fenomena similar to a long-term potentiation and depression, as defined on the synaptic level. Methods. We analyzed effects of benzodiazepines (10 mg, levodopa (200 mg and placebo on PAS protocol in 14 healthy volunteers, using a double-blind placebo-controlled study design. PAS consisted of electrical stimuli pairs at n.medianus and magnetic pulses over the scalp (transcranial magnetic stimulation in precisely defined intervals (ISI was 10 and 25 ms for a total of about 15 minutes (200 pairs. MEP amplitudes before and after (0, 10, 20 and 30 minutes later interventional protocols were compared. Results. When protocols were applied with placebo depending on ISI (10 ms - inhibitory, 25 ms - facilitatory effects, MEP amplitudes decreased or increased, while values in the postinterventional period (0, 10, 20 and 30 min were compared with initial values before the use of SAS. The use of benzodiazepines caused the occlusion of LTP-like effect, in contrast to amplification effects recorded after the administration of levodopa. With respect to the LTD-like protocol, the reverse was true (ANOVA for repeat measurements p<0.001. Conclusion. Administration of GABA-ergic agonist diazepam interferes with the induction of associative plasticity in the motor cortex of healthy individuals, as opposed to the use of levodopa, which stimulates these processes. The observed effects point at a

Pharmacokinetics and Safety of Intravenous Murepavadin Infusion in Healthy Adult Subjects Administered Single and Multiple Ascending Doses.

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Wach, Achim; Dembowsky, Klaus; Dale, Glenn E

2018-04-01

Murepavadin is the first in class of the outer membrane protein-targeting antibiotics (OMPTA) and a pathogen-specific peptidomimetic antibacterial with a novel, nonlytic mechanism of action targeting Pseudomonas aeruginosa Murepavadin is being developed for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The pharmacokinetics (PK) and safety of single and multiple doses of murepavadin were investigated in healthy male subjects. Part A of the study was a double-blind, randomized, placebo-controlled, single-ascending-dose investigation in 10 sequential cohorts where each cohort comprised 6 healthy male subjects; 4 subjects were randomized to murepavadin, and 2 subjects were randomized to placebo. Part B was a double-blind, randomized, placebo-controlled, multiple-ascending-dose investigation in 3 sequential cohorts. After a single dose of murepavadin, the geometric mean half-life (2.52 to 5.30 h), the total clearance (80.1 to 114 ml/h/kg), and the volume of distribution (415 to 724 ml/kg) were consistent across dose levels. The pharmacokinetics of the dosing regimens evaluated were dose proportional and linear. Murepavadin was well tolerated, adverse events were transient and generally mild, and no dose-limiting toxicity was identified. Copyright © 2018 American Society for Microbiology.

Characterization of LDL-receptors of freshly isolated mononuclear cells of healthy subjects and of FH-patients

International Nuclear Information System (INIS)

Banyai, M.

1991-05-01

The central role of the LDL (=low density lipoproteins) receptor in artherosclerosis was first appreciated when it was shown that its absence was responsible for FH (familial hypercholesterolemia). To determine the high affinity cell surface binding activity in circulating human mononuclear cells (MNCs), these cells were incubated with low concentrations (1-50 μg protein/ml) of 123 I-LDL or 111 In-LDL either in the presence or absence of an excess of unlabeled LDL at 4 deg C for 45 minutes. MNCs of healthy subjects and of heterozygous FH-patients were found to possess high affinity LDL receptors immediately after they were isolated from the blood stream. The results indicate that the FH-patients enclosed in this study possess a reduced number of the same high affinity binding sites as healthy subjects confirming the diagnosis of heterozygous FH. In this study 123 I-LDL binding and 111 In-LDL binding to MNCs has been shown to saturable, reversible and displaceable and time-dependent. 123 I-LDL and 111 In-LDL as well can be recommended for the in-vitro determination of LDL-receptor binding activity as both binding processes show approximately the same characteristics. (author)

Diquafosol Tetrasodium Increases the Concentration of Mucin-like Substances in Tears of Healthy Human Subjects.

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Shigeyasu, Chika; Hirano, Shinichiro; Akune, Yoko; Yamada, Masakazu

2015-09-01

This study was undertaken to determine the effect of topical application of diquafosol tetrasodium on proteins and mucin-like substances from tears of clinically healthy subjects. Tears were collected from both the eyes of 10 healthy volunteers. Diquafosol tetrasodium solution (3%) was applied once to the right eye and 0.9% sodium chloride solution (saline) once to the left eye. Tear samples were collected by Schirmer test strips before application and 5, 15, 30 and 60 min after application. Sialic acid, a marker of mucin-like substances, and major tear proteins including secretory IgA, lactoferrin, lipocalin-1, and lysozyme were measured by high performance liquid chromatography. Levels of total protein, sIgA and lysozyme were transiently decreased in both groups but returned to baseline levels within 15 min after application. The concentration of lactoferrin and lipocalin-1 did not change significantly in both groups. Sialic acid in tears was significantly decreased 5 min after saline application, but significantly increased 5 min after diquafosol application. No significant difference in sialic acid was seen after 15 min in both groups. Topical application of saline and diquafosol resulted in transient decrease of tear proteins possibly due to wash out or dilution effects. In contrast, diquafosol application significantly increased sialic acid, although the effect was transient. This suggests diquafosol stimulates the secretion of mucins from ocular tissues of healthy human subjects.

Exercises focusing on rotator cuff and scapular muscles do not improve shoulder joint position sense in healthy subjects.

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Lin, Yin-Liang; Karduna, Andrew

2016-10-01

Proprioception is essential for shoulder neuromuscular control and shoulder stability. Exercise of the rotator cuff and scapulothoracic muscles is an important part of shoulder rehabilitation. The purpose of this study was to investigate the effect of rotator cuff and scapulothoracic muscle exercises on shoulder joint position sense. Thirty-six healthy subjects were recruited and randomly assigned into either a control or training group. The subjects in the training group received closed-chain and open-chain exercises focusing on rotator cuff and scapulothoracic muscles for four weeks. Shoulder joint position sense errors in elevation, including the humerothoracic, glenohumeral and scapulothoracic joints, was measured. After four weeks of exercise training, strength increased overall in the training group, which demonstrated the effect of exercise on the muscular system. However, the changes in shoulder joint position sense errors in any individual joint of the subjects in the training group were not different from those of the control subjects. Therefore, exercises specifically targeting individual muscles with low intensity may not be sufficient to improve shoulder joint position sense in healthy subjects. Future work is needed to further investigate which types of exercise are more effective in improving joint position sense, and the mechanisms associated with those changes. Copyright © 2016 Elsevier B.V. All rights reserved.

Safety, Tolerability and Pharmacokinetics of the Serotonin 5-HT6 Receptor Antagonist, SUVN-502, in Healthy Young Adults and Elderly Subjects.

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Nirogi, Ramakrishna; Mudigonda, Koteshwara; Bhyrapuneni, Gopinadh; Muddana, Nageswara Rao; Goyal, Vinod Kumar; Pandey, Santosh Kumar; Palacharla, Raghava Choudary

2018-05-01

SUVN-502, a selective 5-HT6 receptor antagonist, was found to be active in preclinical models of cognitive deterioration suggesting a potential role in the treatment of dementia related to Alzheimer's disease. The objective of this study was to characterize the safety, tolerability and pharmacokinetics of SUVN-502 in healthy young adults and elderly subjects following single and multiple oral doses. Single doses (5, 15, 50, 100 and 200 mg SUVN-502) and multiple doses (50, 100 and 130 mg SUVN-502 once daily for 7 days) were evaluated in healthy young adults and multiple doses (50 and 100 mg SUVN-502 once daily for 14 days) were evaluated in elderly subjects using randomized, double-blind, placebo-controlled, dose-escalating study designs. The effect of food, gender and age on SUVN-502 pharmacokinetics (100 mg single dose) was evaluated using an open-label, two-period, randomized, fed and fasted in a crossover design. SUVN-502 and M1 (major metabolite of SUVN-502) were monitored using validated analytical methods. SUVN-502 is safe and well tolerated up to the highest tested single dose of 200 mg in healthy young adults and multiple doses up to 130 mg for 7 days and 100 mg for 14 days in healthy young adults and elderly subjects, respectively. Exposures of SUVN-502 and M1 were more than dose-proportional over the evaluated dose range. Food and gender did not have a clinically meaningful effect on SUVN-502 exposure. The mean SUVN-502 total (AUC 0-∞ , and AUC 0-last ) and peak exposures (C max ) were 2.9- and 2.2-fold higher, respectively, in elderly subjects compared to young subjects. Steady-state was achieved for SUVN-502 and M1 within 7 days after once-daily dosing of SUVN-502. SUVN-502 exhibited an acceptable safety, tolerability and pharmacokinetic profile in healthy young adults and elderly subjects. Based on the above results, 50 and 100 mg once-daily doses of SUVN-502 were advanced to Phase 2 evaluation in patients with moderate AD.

Lack of Correlation Between Vasodilatation and Pharmacologically Induced Immediate Headache in Healthy Subjects

DEFF Research Database (Denmark)

Ashina, Messoud; Tfelt-Hansen, Peer; Dalgaard, Peter

2011-01-01

these experiments were vasodilators we examined a possible correlation between headache scores and increases in arterial diameter. Methods: We identified nine studies and retrieved raw data in 89 healthy subjects (46 females, 43 males), mean age 27 years (range 18–59 years). The following variables were collected...... intensity. Results: The scatter plots show no relationship between maximal headache score and the relative changes in VmeanMCA and diameter of the STA. The main analyses of covariance showed a significant effect only of heart rate on headache (p = .014). The interaction tests were insignificant for all...

Comparison of pharmacokinetics of newly discovered aromatase inhibitors by a cassette microdosing approach in healthy Japanese subjects.

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Kusuhara, Hiroyuki; Takashima, Tadayuki; Fujii, Hisako; Takashima, Tsutomu; Tanaka, Masaaki; Ishii, Akira; Tazawa, Shusaku; Takahashi, Kazuhiro; Takahashi, Kayo; Tokai, Hidekichi; Yano, Tsuneo; Kataoka, Makoto; Inano, Akihiro; Yoshida, Suguru; Hosoya, Takamitsu; Sugiyama, Yuichi; Yamashita, Shinji; Hojo, Taisuke; Watanabe, Yasuyoshi

2017-12-01

The aim of the present study is to investigate the pharmacokinetics of our newly developed aromatase inhibitors (cetrozole and TMD-322) in healthy subjects by a cassette microdose strategy. A cocktail of cetrozole and TMD-322 was administered intravenously or orally (1.98 μg for each drug) to six healthy volunteers in a crossover fashion. Anastrozole (1.98 μg) was also included in the oral cocktail. Total body clearance and bioavailability were 12.1 ± 7.1 mL/min/kg and 34.9 ± 32.3% for cetrozole, and 16.8 ± 3.5 mL/min/kg and 18.4 ± 12.2% for TMD-322, respectively. The area under the plasma concentration-time curves of cetrozole and TMD-322 after oral administration was markedly lower than that of anastrozole because of their high hepatic clearance. Two subjects out of six exhibited 4- and 17-fold larger exposure of cetrozole than the others following intravenous and oral administration, respectively. Such variation was not observed for TMD-322 and anastrozole. Extensive metabolism of cetrozole and TMD-322 was observed in the CYP2C19 expression system among the test CYP isoforms (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4). We report the first clinical investigation of our aromatase inhibitors by a cassette microdose strategy in healthy Japanese subjects. This strategy offers an optional approach for candidate selection as a phase zero study in drug development. Copyright © 2017. Published by Elsevier Ltd.

Prediction of Neurocognitive Deficits by Parkinsonian Motor Impairment in Schizophrenia: A Study in Neuroleptic-Naïve Subjects, Unaffected First-Degree Relatives and Healthy Controls From an Indigenous Population.

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Molina, Juan L; González Alemán, Gabriela; Florenzano, Néstor; Padilla, Eduardo; Calvó, María; Guerrero, Gonzalo; Kamis, Danielle; Stratton, Lee; Toranzo, Juan; Molina Rangeon, Beatriz; Hernández Cuervo, Helena; Bourdieu, Mercedes; Sedó, Manuel; Strejilevich, Sergio; Cloninger, Claude Robert; Escobar, Javier I; de Erausquin, Gabriel A

2016-11-01

Neurocognitive deficits are among the most debilitating and pervasive symptoms of schizophrenia, and are present also in unaffected first-degree relatives. Also, multiple reports reveal parkisonian motor deficits in untreated subjects with schizophrenia and in first-degree relatives of affected subjects. Yet, the relation between motor and cognitive impairment and its value as a classifier of endophenotypes has not been studied. To test the efficacy of midbrain hyperechogenicity (MHE) and parkinsonian motor impairment (PKM) as predictors of neurocognitive impairment in subjects with or at risk for schizophrenia, that could be used to segregate them from first-degree relatives and healthy controls. Seventy-six subjects with chronic schizophrenia never exposed to antipsychotic medication, 106 unaffected first-degree relatives, and 62 healthy controls were blindly assessed for cognitive and motor function, and transcranial ultrasound. Executive function, fluid intelligence, motor planning, and hand coordination showed group differences. PKM and MHE were significantly higher in untreated schizophrenia and unaffected relatives. Unaffected relatives showed milder impairment, but were different from controls. PKM and MHE predict cognitive impairment in neuroleptic-naive patients with schizophrenia and their unaffected first-degree relatives and may be used to segregate them from first-degree relatives and healthy controls. © The Author 2016. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Effect of food on the pharmacokinetic properties of the oral sarpogrelate hydrochloride controlled-release tablet in healthy male Korean subjects.

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Jung, Jin Ah; Kim, Jung-Ryul; Kim, Tae-Eun; Lee, Soo-Youn; Huh, Wooseong; Lee, Jae Won; Jun, Hun; Ko, Jae-Wook

2013-07-01

A new controlled-release formulation of sarpogrelate, a 5-hydroxytryptamine receptor subtype 2 antagonist that blocks serotonin-induced platelet aggregation, has been developed for once-daily administration. This study evaluated the effect of food on the pharmacokinetic properties of controlled-release sarpogrelate (sarpogrelate CR) in healthy volunteers. A randomized, open-label, two-period, two-treatment crossover study was performed in healthy male Korean subjects. Following an overnight fast, a single dose of sarpogrelate CR 300 mg was administered either in the fasted condition or immediately after a high-fat breakfast. Pharmacokinetic parameters were calculated using a noncompartmental analysis. Tolerability was determined using clinical laboratory testing and physical examination, including vital sign measurements, electrocardiography, and interviews with the volunteers regarding adverse events (AEs). A total of 24 healthy subjects were enrolled, 23 of whom completed the study (mean [range] age, 26 years [21-45]; weight, 68.1 kg [56.0-79.9]; body mass index, 22.1 kg/m(2) [18.8-25.0]). Sarpogrelate C(max) and AUC(last) were decreased In the fed condition compared with those in the fasted condition, with geometric mean ratios (90% CI) of 0.4868 (0.4041-0.5864) and 0.7394 (0.6809-0.8028), respectively. T(max) was delayed from 0.75 to 4.0 hours after a high-fat meal, but the fed condition exhibited a similar elimination profile to that of the fasted condition. The most commonly reported AE was headache (n = 2), and other AEs were reported in 1 subject each. All of the AEs were considered mild in intensity, and the participants recovered without treatment. Compared with the administration of sarpogrelate CR 300 mg in the fasted condition, administration with food was associated with a decreased rate and extent of absorption, as assessed by C(max) and AUC(last), respectively. The drug was well-tolerated by the healthy subjects in this study. Copyright © 2013

Are there healthy obese?

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Griera Borrás, José Luis; Contreras Gilbert, José

2014-01-01

It is currently postulated that not all obese individuals have to be considered as pathological subjects. From 10% to 20% of obese people studied do not show the metabolic changes common in obese patients. The term "healthy obese" has been coined to refer to these patients and differentiate them from the larger and more common group of pathological obese subjects. However, the definition of "healthy obese" is not clear. Use of "healthy obese" as a synonym for obese without metabolic complications is risky. Clinical markers such as insulin resistance are used to identify this pathology. It is not clear that healthy obese subjects have lower morbidity and mortality than pathologically obese patients. According to some authors, healthy obese would represent an early stage in evolution towards pathological obesity. There is no agreement as to the need to treat healthy obese subjects. Copyright © 2012 SEEN. Published by Elsevier Espana. All rights reserved.

Analysis of prototypical narratives produced by aphasic individuals and cognitively healthy subjects

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Gabriela Silveira

Full Text Available Aphasia can globally or selectively affect comprehension and production of verbal and written language. Discourse analysis can aid language assessment and diagnosis.Objective:[1] To explore narratives that produce a number of valid indicators for diagnosing aphasia in speakers of Brazilian Portuguese. [2] To analyze the macrostructural aspects of the discourse of normal individuals. [3] To analyze the macrostructural aspects of the discourse of aphasic individuals.Methods:The macrostructural aspects of three narratives produced by aphasic individuals and cognitively healthy subjects were analyzed.Results:A total of 30 volunteers were examined comprising 10 aphasic individuals (AG and 20 healthy controls (CG. The CG included 5 males. The CG had a mean age of 38.9 years (SD=15.61 and mean schooling of 13 years (SD=2.67 whereas the AG had a mean age of 51.7 years (SD=17.3 and mean schooling of 9.1 years (SD=3.69. Participants were asked to narrate three fairy tales as a basis for analyzing the macrostructure of discourse. Comparison of the three narratives revealed no statistically significant difference in number of propositions produced by the groups. A significant negative correlation was found between age and number of propositions produced. Also, statistically significant differences were observed in the number of propositions produced by the individuals in the CG and the AG for the three tales.Conclusion:It was concluded that the three tales are applicable for discourse assessment, containing a similar number of propositions and differentiating aphasic individuals and cognitively healthy subjects based on analysis of the macrostructure of discourse.

Similar and contrasting dimensions of social cognition in schizophrenia and healthy subjects.

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Mehta, Urvakhsh Meherwan; Thirthalli, Jagadisha; Bhagyavathi, H D; Keshav Kumar, J; Subbakrishna, D K; Gangadhar, Bangalore N; Eack, Shaun M; Keshavan, Matcheri S

2014-08-01

Schizophrenia patients experience substantial impairments in social cognition (SC) and these deficits are associated with their poor functional outcome. Though SC is consistently shown to emerge as a cognitive dimension distinct from neurocognition, the dimensionality of SC is poorly understood. Moreover, comparing the components of SC between schizophrenia patients and healthy comparison subjects would provide specific insights on the construct validity of SC. We conducted principal component analyses of eight SC test scores (representing four domains of SC, namely, theory of mind, emotion processing, social perception and attributional bias) independently in 170 remitted schizophrenia patients and 111 matched healthy comparison subjects. We also conducted regression analyses to evaluate the relative contribution of individual SC components to other symptom dimensions, which are important clinical determinants of functional outcome (i.e., neurocognition, negative symptoms, motivational deficits and insight) in schizophrenia. A three-factor solution representing socio-emotional processing, social-inferential ability and external attribution components emerged in the patient group that accounted for 64.43% of the variance. In contrast, a two-factor solution representing socio-emotional processing and social-inferential ability was derived in the healthy comparison group that explained 56.5% of the variance. In the patient group, the social-inferential component predicted negative symptoms and motivational deficits. Our results suggest the presence of a multidimensional SC construct. The dimensionality of SC observed across the two groups, though not identical, displayed important parallels. Individual components also demonstrated distinct patterns of association with other symptom dimensions, thus supporting their external validity. Copyright © 2014 Elsevier B.V. All rights reserved.

ST-segment deviation during 24-hour ambulatory electrocardiographic monitoring and exercise stress test in healthy male subjects 51 to 75 years of age: the Copenhagen City Heart Study

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Vaage-Nilsen, M; Rasmussen, Verner; Sørum, C

1999-01-01

or descending ST-segment depression of >/=0.15 mV during Holter monitoring or at the exercise test, respectively. Furthermore, the specificity was 0.95 when a horizontal or downsloping ST-segment depression of 0.1 mV was displayed in both the Holter and exercise electrocardiographic recording system......BACKGROUND: Although ST-segment deviation has been evaluated and used during many years both on continuous electrocardiographic Holter monitoring and during exercise stress testing, considerable controversy still remains concerning the prevalence and diagnostic significance of fortuitously...... discovered ST-segment deviation in asymptomatic healthy persons. METHODS AND RESULTS: The occurrence of ST-segment deviation was studied in a population of 63 clinically healthy male subjects 51 to 75 years of age, with the use of 24-hour Holter monitoring and exercise stress testing. The subjects were...

Variability of insulin-stimulated myocardial glucose uptake in healthy elderly subjects

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Kofoed, Klaus F; Hove, Jens D; Freiberg, Jacob

2002-01-01

The aim of this study was to assess regional and global variability of insulin-stimulated myocardial glucose uptake in healthy elderly subjects and to evaluate potentially responsible factors. Twenty men with a mean age of 64 years, no history of cardiovascular disease, and normal blood pressure...... rest and hyperaemic blood flow during dipyridamole infusion were measured with nitrogen-13 ammonia and positron emission tomography in 16 left ventricular myocardial segments. Intra-individual and inter-individual variability of insulin-stimulated myocardial glucose uptake [relative dispersion...... = (standard deviation/mean)] was 13% and 29% respectively. Although inter-individual variability of glucose uptake and blood flow at rest was of the same magnitude, no correlation was found between these measures. Regional and global insulin-stimulated myocardial glucose uptake correlated linearly with whole...

Comparative gut microbiota and resistome profiling of intensive care patients receiving selective digestive tract decontamination and healthy subjects.

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Buelow, Elena; Bello González, Teresita D J; Fuentes, Susana; de Steenhuijsen Piters, Wouter A A; Lahti, Leo; Bayjanov, Jumamurat R; Majoor, Eline A M; Braat, Johanna C; van Mourik, Maaike S M; Oostdijk, Evelien A N; Willems, Rob J L; Bonten, Marc J M; van Passel, Mark W J; Smidt, Hauke; van Schaik, Willem

2017-08-14

The gut microbiota is a reservoir of opportunistic pathogens that can cause life-threatening infections in critically ill patients during their stay in an intensive care unit (ICU). To suppress gut colonization with opportunistic pathogens, a prophylactic antibiotic regimen, termed "selective decontamination of the digestive tract" (SDD), is used in some countries where it improves clinical outcome in ICU patients. Yet, the impact of ICU hospitalization and SDD on the gut microbiota remains largely unknown. Here, we characterize the composition of the gut microbiota and its antimicrobial resistance genes ("the resistome") of ICU patients during SDD and of healthy subjects. From ten patients that were acutely admitted to the ICU, 30 fecal samples were collected during ICU stay. Additionally, feces were collected from five of these patients after transfer to a medium-care ward and cessation of SDD. Feces from ten healthy subjects were collected twice, with a 1-year interval. Gut microbiota and resistome composition were determined using 16S rRNA gene phylogenetic profiling and nanolitre-scale quantitative PCRs. The microbiota of the ICU patients differed from the microbiota of healthy subjects and was characterized by lower microbial diversity, decreased levels of Escherichia coli and of anaerobic Gram-positive, butyrate-producing bacteria of the Clostridium clusters IV and XIVa, and an increased abundance of Bacteroidetes and enterococci. Four resistance genes (aac(6')-Ii, ermC, qacA, tetQ), providing resistance to aminoglycosides, macrolides, disinfectants, and tetracyclines, respectively, were significantly more abundant among ICU patients than in healthy subjects, while a chloramphenicol resistance gene (catA) and a tetracycline resistance gene (tetW) were more abundant in healthy subjects. The gut microbiota of SDD-treated ICU patients deviated strongly from the gut microbiota of healthy subjects. The negative effects on the resistome were limited to selection

Pulmonary function studies in healthy Filipino adults residing in the United States.

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Lin, F L; Kelso, J M

1999-08-01

Differences in lung volumes among various ethnic groups are known to occur; however, this has not been studied in Filipinos. We sought to assess pulmonary function in healthy, nonsmoking Filipinos residing in the United States compared with standards for white subjects. Healthy adult Filipinos, age 18 years or greater, were recruited. All subjects were screened with health questionnaires to exclude those with cardiopulmonary disease. Pulmonary function tests were performed by using forced expiratory maneuvers. Values for FEV(1 ), forced vital capacity (FVC), FEV(1 )/FVC, forced expiratory flow from 25% to 75% of FVC, and peak expiratory flow rate were compared with predicted values for white subjects (ie, without a racial adjustment). Two hundred twenty-four healthy subjects (121 men and 103 women) completed the study. The group means (as a percentage of the predicted standard for white subjects) were as follows: FEV(1 ), 86%; FVC, 84%; FEV(1 )/FVC, 103%; forced expiratory flow from 25% to 75% of FVC, 96%; and peak expiratory flow rate, 107%. These findings are very similar to those for African Americans and other Asians. We conclude that it is appropriate to use an 85% racial adjustment for FEV(1 ) and FVC when interpreting pulmonary function test results in Filipinos.

Using functional Magnetic Resonance Imaging to differentiate between healthy aging subjects, Mild Cognitive Impairment, and Alzheimer′s patients

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Mohammad Ali Oghabian

2010-01-01

Full Text Available Background: Alzheimer′s disease is the most common form of dementia which is still difficult to be differentiated from other types of brain disorders. Moreover, Mild Cognitive Impairment refers to the presence of cognitive impairments that is not severe enough to meet the criteria of Alzheimer′s, and its diagnosis in early stages is so critical. There is currently no distinct method available for diagnosing Alzheimer′s or Mild Cognitive Impairment, and their diagnosis needs a combination of different methods and assessments. Methods: The aim of this study was to evaluate the effectiveness of functional Magnetic Resonance Imaging (fMRI in differentiating between Alzheimer′s, Mild Cognitive Impairment (MCI and healthy aging. To prove fMRI′s ability, resting-state brain activation patterns between these three groups of subjects were compared using Independent Component Analysis (ICA algorithm. Forty age- and sex-matched subjects, 15 elderly, 11 MCI and 14 Alzheimer′s subjects were examined. Results: The results showed that during a certain resting-state session, healthy aging brain benefits from larger area and greater intensity of activation (compared with MCI and Alzheimer′s group in Posterior Cingulate Cortex (PCC region of the brain, as part of Default Mode Network. Conclusions: This difference in activation pattern can be used as a diagnostic criterion in using fMRI for differentiating between Alzheimer′s Disease (AD, MCI and healthy aging.

Pituitary gland volume in patients with schizophrenia, subjects at ultra high-risk of developing psychosis and healthy controls: a systematic review and meta-analysis.

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Nordholm, Dorte; Krogh, Jesper; Mondelli, Valeria; Dazzan, Paola; Pariante, Carmine; Nordentoft, Merete

2013-11-01

A larger pituitary size is thought to reflect a greater activation of the hypothalamic-pituitary-adrenal (HPA) axis, which may be related to an increase in the number and size of corticotroph cells. Some studies, but not all, indicate that pituitary volume increases before or at the onset of psychosis. There is a need for at critical appraisal of the literature on this topic accompanied by a meta-analytical evaluation of the data. We included studies comparing the volume of the pituitary gland in healthy controls and patients with schizophrenia, first episode of psychosis (FEP), schizotypal disorder or ultra high-risk (UHR) subjects. We defined three groups of subjects for the analyses: healthy controls; UHR and schizotypal patients; and patients diagnosed with first episode of psychosis, schizophrenia or schizoaffective disorder. Ten studies were included in the meta-analysis. We found a trend of a larger pituitary volume in both UHR subject who had transition to psychosis (p=0.05) and in FEP subjects (p=0.09) compared to healthy controls. There was no difference in pituitary volume between patients with schizophrenia combined with FEP versus healthy controls (p=0.52) or between UHR (with and without transition) and healthy controls (p=0.24). In a regression analysis, we demonstrated that the number of subjects receiving antipsychotics and pituitary volume were positively correlated. As previously reported in other samples, gender also had an impact on pituitary volume with females presenting with a larger mean volume. Results from this meta-analysis suggest that the pituitary gland could be increasing before the onset of psychosis. Both gender and use of antipsychotics have a major impact on the pituitary volume. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effect of Sacroiliac Joint Manipulation on Selected Gait Parameters in Healthy Subjects.

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Wójtowicz, Sebastian; Sajko, Igor; Hadamus, Anna; Mosiołek, Anna; Białoszewski, Dariusz

2017-08-31

The sacroiliac joints have complicated biomechanics. While the movements in the joints are small, they exert a significant effect on gait. This study aimed to assess how sacroiliac joint manipulation influences selected gait parameters. The study enrolled 57 healthy subjects. The experimental group consisted of 26 participants diagnosed with dysfunction of one sacroiliac joint. The control group was composed of 31 persons. All subjects from the experimental group underwent sacroiliac joint manipulation. The experimental group showed significant lengthening of the step on both sides and the stride length in this group increased as well. Moreover, the duration of the stride increased (p=0.000826). The maximum midfoot pressure was higher and maximum heel pressure decreased. The differences were statistically significant. 1. Subclinical dysfunctions of the sacroiliac joints may cause functional gait disturbance. 2. Manipulation of the iliosacral joint exerts a significant effect on gait parameters, which may lead to improved gait economy and effec-tiveness. 3. Following manipulation of one iliosacral joint, altered gait parameters are noted on both the manipulated side and the contralateral side, which may translate into improved quality of locomotion.

Correlation between spirometry values and pulmonary artery pressure in young healthy subjects.

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Grossman, Alon; Benderly, Michal; Prokupetz, Alex; Gordon, Barak; Kalter-Leibovici, Ofra

2014-03-01

Pulmonary hypertension is frequently associated with parenchymal lung disease. We evaluated the association between spirometry values and pulmonary artery systolic pressure (PASP) in young subjects without lung disease : We studied applicants to the Israeli Air Force, who undergo routine evaluation that includes resting spirometry and echocardiography. Applicants with overt lung disease were excluded. All echocardiographic studies performed in the years 1994 through 2010 (n = 6,598) were screened, and files that included PASP and spirometry values were analyzed for the association between PASP and FVC, FEV1, FEV1/FVC, peak expiratory flow, and forced expiratory flow during the middle half of the FVC maneuver. Of the 647 air force applicants who underwent echocardiography in which PASP was measurable and had spirometry data, 607 (94%) were male, and their average age was 18.16 ± 0.73 years. Mean PASP was 26.4 ± 5.2 mm Hg (range 10-41 mm Hg). None of the spirometry values significantly correlated with PASP. PASP in young healthy subjects is not significantly associated with spirometry values. Lung mechanics probably do not contribute significantly to PASP in this population.

Effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of racemic warfarin in healthy subjects

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Lilja, Jari J; Backman, Janne T; Neuvonen, Pertti J

2005-01-01

Aims Case reports suggest that gemfobrozil can increase the anticoagulant effect of warfarin. Because gemfibrozil inhibits CYP2C9 in vitro, we studied its effects on the pharmacokinetics and pharmacodynamics of racemic warfarin. Methods In a randomized cross-over study, 10 healthy subjects ingested 600 mg gemfibrozil or placebo twice daily for 8 days. On day 3, they were administered a single dose of 10 mg racemic R-S-warfarin orally. The concentrations of R- and S-warfarin in plasma and thromboplastin time were monitored up to 168 h. Results Gemfibrozil decreased the mean (±SD) area under the plasma concentration-time curve [AUC(0–∞)] of S-warfarin by 11%, from 19.9 ± 5.2 mg l−1 h to 17.6 ± 4.7 mg l−1 h (95% CI on the difference −3.7, −0.78; P gemfibrozil phase to 29.5 ± 6.9 mg l−1 h during the placebo phase (95% CI −3.3, −0.33; P Gemfibrozil did not alter the anticoagulant effect of warfarin. Conclusion Unexpectedly, gemfibrozil slightly decreased the plasma concentrations of R- and S-warfarin. Displacement of warfarin from plasma albumin by gemfibrozil or its interference with the absorption of warfarin could explain the present findings. Usual therapeutic doses of gemfibrozil seem to have limited effects on the pharmacokinetics and pharmacodynamics of single dose warfarin in healthy subjects. PMID:15801938

Quantitative Molecular Detection of Putative Periodontal Pathogens in Clinically Healthy and Periodontally Diseased Subjects

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Göhler, André; Hetzer, Adrian; Holtfreter, Birte; Geisel, Marie Henrike; Schmidt, Carsten Oliver; Steinmetz, Ivo; Kocher, Thomas

2014-01-01

Periodontitis is a multi-microbial oral infection with high prevalence among adults. Putative oral pathogens are commonly found in periodontally diseased individuals. However, these organisms can be also detected in the oral cavity of healthy subjects. This leads to the hypothesis, that alterations in the proportion of these organisms relative to the total amount of oral microorganisms, namely their abundance, rather than their simple presence might be important in the transition from health to disease. Therefore, we developed a quantitative molecular method to determine the abundance of various oral microorganisms and the portion of bacterial and archaeal nucleic acid relative to the total nucleic acid extracted from individual samples. We applied quantitative real-time PCRs targeting single-copy genes of periodontal bacteria and 16S-rRNA genes of Bacteria and Archaea. Testing tongue scrapings of 88 matched pairs of periodontally diseased and healthy subjects revealed a significantly higher abundance of P. gingivalis and a higher total bacterial abundance in diseased subjects. In fully adjusted models the risk of being periodontally diseased was significantly higher in subjects with high P. gingivalis and total bacterial abundance. Interestingly, we found that moderate abundances of A. actinomycetemcomitans were associated with reduced risk for periodontal disease compared to subjects with low abundances, whereas for high abundances, this protective effect leveled off. Moderate archaeal abundances were health associated compared to subjects with low abundances. In conclusion, our methodological approach unraveled associations of the oral flora with periodontal disease, which would have gone undetected if only qualitative data had been determined. PMID:25029268

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

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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.

Reliability and Reproducibility of Advanced ECG Parameters in Month-to-Month and Year-to-Year Recordings in Healthy Subjects

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Starc, Vito; Abughazaleh, Ahmed S.; Schlegel, Todd T.

2014-01-01

Advanced resting ECG parameters such the spatial mean QRS-T angle and the QT variability index (QTVI) have important diagnostic and prognostic utility, but their reliability and reproducibility (R&R) are not well characterized. We hypothesized that the spatial QRS-T angle would have relatively higher R&R than parameters such as QTVI that are more responsive to transient changes in the autonomic nervous system. The R&R of several conventional and advanced ECG para-meters were studied via intraclass correlation coefficients (ICCs) and coefficients of variation (CVs) in: (1) 15 supine healthy subjects from month-to-month; (2) 27 supine healthy subjects from year-to-year; and (3) 25 subjects after transition from the supine to the seated posture. As hypothesized, for the spatial mean QRS-T angle and many conventional ECG parameters, ICCs we-re higher, and CVs lower than QTVI, suggesting that the former parameters are more reliable and reproducible.

Effects of supplementation with n-3 polyunsaturated fatty acids on cognitive performance and cardiometabolic risk markers in healthy 51 to 72 years old subjects: a randomized controlled cross-over study

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Nilsson Anne

2012-11-01

Full Text Available Abstract Background Higher plasma n-3 polyunsaturated fatty acids (PUFA have been associated with a lower risk of age related cognitive decline, and to beneficially affect cardiometabolic risk factors. A relation exists between metabolic disorders such as diabetes type 2 and cognitive decline. Results regarding the potential effects of n-3 PUFA on risk factors in healthy subjects are divergent, and studies regarding the possible relation between cardiometabolic parameters and cognitive performance are scarce. The objective was to evaluate the effects of five weeks intake of long chain n-3 PUFA on cognitive performance in healthy individuals, and to exploit the possible relation between outcomes in cognitive tests to cardiometabolic risk parameters. Methods Fish oil n-3 PUFA (3g daily were consumed during 5weeks separated by a 5 week washout period in a cross-over placebo controlled study, including 40 healthy middle aged to elderly subjects. Cognitive performance was determined by tests measuring working memory (WM and selective attention. Results Supplementation with n-3 PUFA resulted in better performance in the WM-test compared with placebo (p p p p = 0.05, and s-TNF-α (p = 0.05, were inversely related to the performance in cognitive tests. Conclusions Intake of n-3 PUFA improved cognitive performance in healthy subjects after five weeks compared with placebo. In addition, inverse relations were obtained between cardiometabolic risk factors and cognitive performance, indicating a potential of dietary prevention strategies to delay onset of metabolic disorders and associated cognitive decline.

Pharmacokinetics and tolerability of the new second-generation nonnucleoside reverse- transcriptase inhibitor KM-023 in healthy subjects

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Cha YJ

2014-09-01

Full Text Available Yu-Jung Cha,1,* Kyoung Soo Lim,2,* Min-Kyu Park,1 Stephen Schneider,3 Brian Bray,3 Myung-Chol Kang,3 Jae-Yong Chung,1 Seo Hyun Yoon,1 Joo-Youn Cho,1 Kyung-Sang Yu11Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea; 2Department of Clinical Pharmacology and Therapeutics, CHA University School of Medicine and CHA Bundang Medical Center, Seongnam, South Korea; 3Kainos Medicine USA Inc., Morrisville, NC, USA *These authors contributed equally to this workBackground: KM-023 is a new second-generation nonnucleoside reverse-transcriptase inhibitor that is under development for the treatment of human immunodeficiency virus (HIV type 1 infection. Objective: This study determined KM-023 tolerability and pharmacokinetic characteristics in healthy subjects. Materials and methods: A randomized, double-blinded, placebo-controlled, dose-escalation study was conducted in 80 healthy South Korean male volunteers. The subjects were allocated to single- or multiple-dose (once daily for 7 days groups that received 75, 150, 300, or 600 mg drug or placebo in a 4:1 ratio. Safety and pharmacokinetic assessments were performed during the study. Plasma and urine concentrations were quantified using liquid chromatography–tandem mass spectrometry. Results: The average maximum concentration (Cmax and area under the concentration–time curve from time 0 to infinity (AUC∞ values of KM-023 for the 75–600 mg doses in the single-dose study ranged from 440.2 ng/mL to 1,245.4 ng/mL and 11,142.4 ng • h/mL to 33,705.6 ng • h/mL, respectively. Values of the mean Cmax at a steady state and AUC within the dosing interval ranged from 385.1 ng/mL to 1,096.7 ng/mL and 3,698.9 ng • h/mL to 10,232.6 ng • h/mL, respectively, following 75–600 mg doses in the multiple-dose study. Dose proportionality was not observed for KM-023. KM-023 showed a 0.6-fold accumulation after multiple doses in the 600

Tract-specific analysis of white matter pathways in healthy subjects: a pilot study using diffusion tensor MRI

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Yasmin, Hasina; Abe, Osamu; Nakata, Yasuhiro; Hayashi, Naoto; Masutani, Yoshitaka; Goto, Masami; Ohtomo, Kuni [University of Tokyo, Department of Radiology, Bunkyo-ku, Tokyo (Japan); Aoki, Shigeki [Juntendo University, Department of Radiology, Bunkyo-ku, Tokyo (Japan)

2009-12-15

To date, very scant data is available regarding normal diffusion properties of white matter (WM) fibers. The present study aimed to initiate the establishment of a database of normal diffusion tensor metrics of cerebral WM fibers, including the uncinate fasciculus (UF), posterior cingulum (PC), fornix, and corticospinal tract (CST) for healthy adults using tract-specific analysis by diffusion tensor tractography (DTT). We also attempted to clarify whether age and laterality exerted any effects on this study group. DTT of WM fibers were generated for 100 healthy subjects, then mean diffusivity (MD) and fractional anisotropy (FA) of the tracts were measured. Pearson correlation analysis was used to evaluate age relationships. Paired t testing was used to compare hemispheric asymmetry. Interobserver correlation tests were also performed. Our results showed FA values for UF (right, 0.42 {+-} 0.03; left, 0.40{+-}0.03), PC (0.51 {+-} 0.06, 0.52 {+-} 0.06), fornix (0.37 {+-} 0.06, 0.38 {+-} 0.06), CST (0.70 {+-} 0.06, 0.69 {+-} 0.07), and MD values for UF (0.81 {+-} 0.03, 0.82 {+-} 0.04), PC (0.72 {+-} 0.03, 0.72 {+-} 0.04), fornix (1.86 {+-} 0.32, 1.94 {+-} 0.37), and CST (0.72 {+-} 0.03, 0.74 {+-} 0.04). We identified a significant positive correlation between age and MD in the right UF and bilateral fornices, and a negative correlation between age and FA in bilateral fornices. Hemispheric asymmetry was observed in FA of UF (right > left) and MD of CST (left > right). The results constitute a normative dataset for diffusion parameters of four WM tracts that can be used to identify, characterize, and establish the significance of changes in diseases affecting specific tracts. (orig.)

Effects of befloxatone, a reversible selective monoamine oxidase-A inhibitor, on psychomotor function and memory in healthy subjects.

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Warot, D; Berlin, I; Patat, A; Durrieu, G; Zieleniuk, I; Puech, A J

1996-10-01

Befloxatone is a new reversible and selective monoamine oxidase (MAO-A) inhibitor that has been shown to have antidepressant activity in various animal models. To assess the effects of single oral doses of befloxatone (5, 10, and 20 mg) on psychomotor performance and memory, a randomized, double-blind, five-way, crossover study with both placebo and amitriptyline (50 mg) was carried out in 15 healthy male volunteers. Psychomotor and cognitive functions were evaluated using both objective measures, including Critical Flicker Frequency (CFF), Choice Reaction Time (CRT), Digit Symbol Substitution Test (DSST), and a picture memory test and subjective measures, including Visual Analog Scales (VAS) and Addiction Research Center Inventory (ARCI), before and 2, 4, and 8 hours after administration. Pupil diameter was recorded by videopupillography. Single doses of befloxatone from 5 to 20 mg did not result in any detrimental effects on skilled performance and memory. In contrast, amitriptyline significantly impaired arousal (CFF), speed of reaction (CRT), information processing (DSST) and long-term memory (delayed free recall of pictures) and produced subjective sedation from 2 to 8 hours after administration. At the doses studied amitriptyline induced miosis but befloxatone did not modify pupil diameter. There was no evidence in this study to suggest that befloxatone, at the doses studied, has any sedative or amnesic effects in healthy subjects.

Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial.

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Jörg Täubel

Full Text Available Rupatadine is a marketed second generation antihistamine, with anti-PAF activity, indicated for symptomatic treatment of allergic rhinitis and urticaria. This study was conducted to evaluate the pharmacokinetics (PK, pharmacodynamics (PD, safety and tolerability of rupatadine in healthy Japanese subjects after single and multiple oral doses.In this randomised, double-blind, placebo-controlled study, 27 male and female healthy Japanese subjects were administered single and multiple escalating rupatadine dose of 10, 20 and 40 mg or placebo. Blood samples were collected at different time points for PK measurements and subjects were assessed for safety and tolerability. The effect of rupatadine on cognitive functioning was evaluated by means of computerized cognitive tests: rapid visual information processing (RVP, reaction time (RT, spatial working memory (SWM and visual analogue scales (VAS.Exposure to rupatadine as measured by Cmax and AUC was found to increase in a dose dependent manner over the dose range of 10-40 mg for both single and multiple dose administration. The safety assessments showed that all treatment related side effects were of mild intensity and there were no serious adverse events (SAEs or withdrawals due to treatment-emergent adverse events (TEAEs in this study. The therapeutic dose of rupatadine did not show any CNS impairment in any of the cognitive tests.This study demonstrated that rupatadine is safe and well tolerated by Japanese healthy subjects. The PK-PD profile confirmed previous experience with rupatadine.

A double blind parallel group placebo controlled comparison of sedative and mnesic effects of etifoxine and lorazepam in healthy subjects [corrected].

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Micallef, J; Soubrouillard, C; Guet, F; Le Guern, M E; Alquier, C; Bruguerolle, B; Blin, O

2001-06-01

This paper describes the psychomotor and mnesic effects of single oral doses of etifoxine (50 and 100 mg) and lorazepam (2 mg) in healthy subjects. Forty-eight healthy subjects were included in this randomized double blind, placebo controlled parallel group study [corrected]. The effects of drugs were assessed by using a battery of subjective and objective tests that explored mood and vigilance (Visual Analog Scale), attention (Barrage test), psychomotor performance (Choice Reaction Time) and memory (digit span, immediate and delayed free recall of a word list). Whereas vigilance, psychomotor performance and free recall were significantly impaired by lorazepam, neither dosage of etifoxine (50 and 100 mg) produced such effects. These results suggest that 50 and 100 mg single dose of etifoxine do not induce amnesia and sedation as compared to lorazepam.

Some hematological parameters and the prognostic values of CD4, CD8 and total lymphocyte counts and CD4/CD8 cell count ratio in healthy HIV sero-negative, healthy HIV sero-positive and AIDS subjects in Port Harcourt, Nigeria

Directory of Open Access Journals (Sweden)

Blessing Didia

2008-12-01

Full Text Available OBJECTIVE: The present study attempts to determine normal values of CD4, CD8, CD4/CD8 ratio, total WBC and differential counts, hematocrit and total lymphocyte count (TLC in healthy HIV sero-negative and sero-positive subjects, and to assess the prognostic significance of these parameters in these subjects as compared to AIDS subjects.METHODS: A total of 300 subjects (147 M, 153 F aged between 17 and 71 years were recruited into the study. Subjects were separated according to sex and divided into three groups: Group A: healthy HIV sero-negative subjects; Group B: healthy HIV sero-positive newly diagnosed ART-naïve subjects; and Group C: AIDS subjects. CD4 and CD8 counts were determined by flow cytometry; hematocrit was determined using Hawksley micro-capillary tubes; total WBC and differential counts were determined manually with the improved Neubauer counting chamber; and TLC was obtained by multiplying the percentage of lymphocytes by the total WBC count.RESULTS: For male subjects, significant differences were found in CD4 count, CD4/CD8 count ratio, hematocrit, total WBC and TLC, whereas for female subjects, significant differences were found only in CD4 and CD4/CD8 count ratio in the three groups of subjects. In both sexes, however, these parameters were found to be highest in healthy HIV sero-negative subjects and lowest in AIDS subjects, with HIV sero-positive subjects having intermediate values. CONCLUSION: The results confirm previous reports that the CD4 count and CD4/CD8 count ratio are fairly reliable indicators of the progression of HIV infection. In addition, the results also apparently suggest that the prognostic value of CD8 count is limited and that of TLC possibly sex-dependent. The results could be of importance in our environment since previous reports have been relatively scarce.

A pharmacokinetic and pharmacodynamic drug interaction between rosuvastatin and valsartan in healthy subjects.

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Jung, Jin Ah; Lee, Soo-Yun; Kim, Jung-Ryul; Ko, Jae-Wook; Jang, Seong Bok; Nam, Su Youn; Huh, Wooseong

2015-01-01

Valsartan, an angiotensin-receptor blocker, and rosuvastatin, a competitive inhibitor of the 3-hydroxy-3-methylglutaryl coenzyme A reductase, are frequently coadministered to treat patients with hypertension and dyslipidemia. The study reported here sought to evaluate the pharmacokinetic and pharmacodynamic interactions between rosuvastatin and valsartan in healthy Korean subjects. Thirty healthy male Korean subjects were administered with rosuvastatin (20 mg/day), valsartan (160 mg/day), and both drugs concomitantly for 4 days in a randomized, open-label, multiple-dose, three-treatment, three-period crossover study. Plasma concentrations of rosuvastatin, N-desmethyl rosuvastatin, and valsartan were determined using validated high-performance liquid chromatography with tandem mass spectrometry. Lipid profiles and vital signs (systolic and diastolic blood pressure and pulse rate) were measured for the pharmacodynamic assessment. For rosuvastatin, the geometric mean ratios (90% confidence intervals [CIs]) of coadministration to mono-administration were 0.8809 (0.7873-0.9857) for maximum plasma concentration at steady state and 0.9151 (0.8632-0.9701) for area under the concentration-time curve (AUC) over a dosing interval at steady state. For valsartan, the geometric mean ratios (90% CIs) of those were 0.9300 (0.7946-1.0884) and 1.0072 (0.8893-1.1406), respectively. There were no significant differences in the metabolic ratio of N-desmethyl rosuvastatin AUC to rosuvastatin AUC between coadministration and rosuvastatin alone. No interaction was found in terms of systolic or diastolic blood pressure or lipid profiles. Combined treatment with valsartan and rosuvastatin was generally well tolerated without serious adverse events. The pharmacokinetic profiles of rosuvastatin and valsartan in combination were comparable with those of rosuvastatin and valsartan administered individually, suggesting that their individual pharmacokinetics were not affected by their

Hidden truth of circulating neutrophils (polymorphonuclear neutrophil function in periodontally healthy smoker subjects

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Chitra Agarwal

2016-01-01

Full Text Available Context: Tobacco smoking is considered to be a major risk factor associated with periodontal disease. Smoking exerts a major effect on the protective elements of the immune response, resulting in an increase in the extent and severity of periodontal destruction. Aims: The aim of the present study was to assess viability and phagocytic function of neutrophils in circulating blood of the smokers and nonsmokers who are periodontally healthy. Settings and Design: Two hundred subjects in the mean range of 20–30 years of age were included in the study population. It was a retrospective study carried out for 6 months. Materials and Methods: Two hundred subjects were divided into four groups: 50 nonsmokers, 50 light smokers (15 cigarettes/day. Full mouth plaque index, sulcus bleeding index, and probing depths were measured. Percentage viability of circulating neutrophils and average number of phagocytosed Candida albicans were recorded. Statistical Analysis Used: Means and standard deviations were calculated from data obtained within the groups. Comparison between the smokers and nonsmokers was performed by Kruskal–Wallis ANOVA analysis. Comparison between smoker groups was performed using Mann–Whitney–Wilcoxon test. Results: Percentage viability of neutrophils was significantly less in heavy smokers (66.9 ± 4.0, moderate (76.6 ± 4.2, light smokers (83.1 ± 2.5 as compared to nonsmokers (92.3 ± 2.6 (P < 0.01. The ability of neutrophils to phagocytose, i.e., mean particle number was significantly less in light smokers (3.5 ± 0.5, moderate smokers (2.3 ± 0.5, and heavy smokers (1.4 ± 0.5 compared to nonsmokers (4.9 ± 0.7 (P < 0.01 with evidence of dose-response effect. Conclusions: Smoking significantly affects neutrophils viability and phagocytic function in periodontally healthy population.

A comprehensive compartmental model of blood glucose regulation for healthy and type 2 diabetic subjects

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Vahidi, O; Kwok, K E; Gopaluni, R B

2016-01-01

We have expanded a former compartmental model of blood glucose regulation for healthy and type 2 diabetic subjects. The former model was a detailed physiological model which considered the interactions of three substances, glucose, insulin and glucagon on regulating the blood sugar. The main...... variations of blood glucose concentrations following an oral glucose intake. Another model representing the incretins production in the gastrointestinal tract along with their hormonal effects on boosting pancreatic insulin production is also added to the former model. We have used two sets of clinical data...... obtained during oral glucose tolerance test and isoglycemic intravenous glucose infusion test from both type 2 diabetic and healthy subjects to estimate the model parameters and to validate the model results. The estimation of model parameters is accomplished through solving a nonlinear optimization...

Subjective memory complaints, cognitive performance, and psychological factors in healthy older adults.

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Steinberg, Susanne I; Negash, Selamawit; Sammel, Mary D; Bogner, Hillary; Harel, Brian T; Livney, Melissa G; McCoubrey, Hannah; Wolk, David A; Kling, Mitchel A; Arnold, Steven E

2013-12-01

To determine whether subjective memory complaints (SMCs) are associated with performance on objective cognitive measures and psychological factors in healthy, community-dwelling older adults. The cohort was composed of adults, 65 years and older with no clinical evidence of cognitive impairment (n = 125). Participants were administered: CogState computerized neurocognitive battery, Prospective Retrospective Memory Questionnaire, personality and meaning-in-life measures. SMCs were associated with poorer performance on measures of executive function (p = 0.001). SMCs were also associated with impaired delayed recall (p = 0.006) but this did not remain significant after statistical adjustment for multiple comparisons. SMCs were inversely associated with conscientiousness (p = 0.004) and directly associated with neuroticism (p cognitive changes and are associated with personality traits and meaning-in-life in healthy, older adults.

Intake of St John's wort improves the glucose tolerance in healthy subjects who ingest metformin compared with metformin alone

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Stage, Tore Bjerregaard; Pedersen, Rasmus Steen; Damkier, Per

2015-01-01

AIMS: Our objective was to investigate the steady-state pharmacokinetic and pharmacodynamic interaction between the antidepressive herbal medicine St John's wort and the antidiabetic drug metformin. METHODS: We performed an open cross-over study in 20 healthy male subjects, who received 1 g...

Difference in F-18 FDG uptake after esophago gastroduodenoscopy and colonoscopy in healthy sedated subjects

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Oh, Jong Ryool; Chang, Woo Jin; Bae, Seung Il; Song, In Wook; Bong, Jin Gu; Jeong, Hye Yeon; Park, So Young; Bae, Jeong Yup; Yoon, Hyun Dae [Raphael Hospital, Daegu (Korea, Republic of); Seo, Ji Hyoung [Dept. of Nuclear MedicineFatima Hospital, Daegu (Korea, Republic of)

2017-09-15

We aimed to evaluate the difference in fluorodeoxyglucose (FDG) uptake in sedated healthy subjects after they underwent esophagogastroduodenoscopy (EGD) and colonoscopy procedures. The endoscopy group (n = 29) included healthy subjects who underwent screening via F-18 FDG positron emission tomography/computed tomography (PET/CT) after an EGD and/or colonoscopy under sedation on the same day. The control group (n = 35) included healthy subjects who underwent screening via PET/CT only. FDG uptake in the tongue, uvula, epiglottis, vocal cords, esophagus, stomach, duodenum, liver, cecum, colon, anus, and muscle were compared between the two groups. Maximum standardized uptake value (SUVmax) in the tongue, pharynx, larynx, and esophagus did not significantly differ between the endoscopy and control groups. In contrast, mean SUVmax in the whole stomach was 18 % higher in the endoscopy group than in the control group (SUVmax: 2.96 vs. 2.51, P = 0.010). In the lower gastrointestinal track, SUVmax from the cecum to the rectum was not significantly different between the two groups, whereas SUVmax in the anus was 20 % higher in the endoscopy group than in the control group (SUVmax: 4.21 vs. 3.50, P = 0.002). SUVmax in the liver and muscle was not significantly different between the two groups. Mean volume of the stomach and mean cross section of the colon was significantly higher in the endoscopy group than in the control group (stomach: 313.28 cm{sup 3} vs. 209.93 cm{sup 3}, P < 0.001, colon: 8.82 cm{sup 2} vs. 5.98 cm{sup 2}, P = 0.001). EGD and colonoscopy under sedation does not lead to significant differences in SUVmax in most parts of the body. Only gastric FDG uptake in the EGD subjects and anal FDG uptake in the colonoscopy subjects was higher than uptake in those regions in the control subjects.

Sleep spindles are related to schizotypal personality traits and thalamic glutamine/glutamate in healthy subjects.

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Lustenberger, Caroline; O'Gorman, Ruth L; Pugin, Fiona; Tüshaus, Laura; Wehrle, Flavia; Achermann, Peter; Huber, Reto

2015-03-01

Schizophrenia is a severe mental disorder affecting approximately 1% of the worldwide population. Yet, schizophrenia-like experiences (schizotypy) are very common in the healthy population, indicating a continuum between normal mental functioning and the psychosis found in schizophrenic patients. A continuum between schizotypy and schizophrenia would be supported if they share the same neurobiological origin. Two such neurobiological markers of schizophrenia are: (1) a reduction of sleep spindles (12-15 Hz oscillations during nonrapid eye movement sleep), likely reflecting deficits in thalamo-cortical circuits and (2) increased glutamine and glutamate (Glx) levels in the thalamus. Thus, this study aimed to investigate whether sleep spindles and Glx levels are related to schizotypal personality traits in healthy subjects. Twenty young male subjects underwent 2 all-night sleep electroencephalography recordings (128 electrodes). Sleep spindles were detected automatically. After those 2 nights, thalamic Glx levels were measured by magnetic resonance spectroscopy. Subjects completed a magical ideation scale to assess schizotypy. Sleep spindle density was negatively correlated with magical ideation (r = -.64, P .1). The common relationship of sleep spindle density with schizotypy and thalamic Glx levels indicates a neurobiological overlap between nonclinical schizotypy and schizophrenia. Thus, sleep spindle density and magical ideation may reflect the anatomy and efficiency of the thalamo-cortical system that shows pronounced impairment in patients with schizophrenia. © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Correlation of Serum Ascorbic Acid with Serum Lipids in Healthy Subjects

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藤野, 武彦; 村田, 晃; 金谷, 庄蔵; 森田, ケイ; 宇都宮, 弘子; 本多, 理恵

1985-01-01

The serum levels of ascorbic acid (ASA), total cholesterol, HDL cholesterol and triglyceride were estimated in 82 healthy persons who consisted of 41 men aged 18 to 69 and 41 women aged 32 to 69. None of fasting lipid profils correlated with the serum level of ASA in total subjects. In young men aged 18 to 23, however, there was significant negative correlation between ASA and total cholesterol. These findings suggest that ASA may be one of effective drug to decrease the level of cholesterol.

Reduced mRNA expression of PTGDS in peripheral blood mononuclear cells of rapid-cycling bipolar disorder patients compared with healthy control subjects

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Munkholm, Klaus; Peijs, Lone; Kessing, Lars Vedel

2015-01-01

was measured in 37 rapid-cycling bipolar disorder patients and 40 age- and gender-matched healthy control subjects using reverse transcription quantitative real-time polymerase chain reaction. Repeated measurements of PTGDS and AKR1C3 mRNA expression were obtained in various affective states during 6-12 months...... and compared with repeated measurements in healthy control subjects. RESULTS: Adjusted for age and gender, PTGDS mRNA expression was down-regulated in rapid-cycling bipolar disorder patients in a euthymic, depressive, and manic/hypomanic state compared with healthy control subjects. No difference in PTGDS m...

Assessment of Blood Glucose Regulation and Safety of Resistant Starch Formula-Based Diet in Healthy Normal and Subjects With Type 2 Diabetes.

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Lin, Chia-Hung; Chang, Daw-Ming; Wu, Da-Jen; Peng, Hui-Yu; Chuang, Lee-Ming

2015-08-01

To evaluate the effects of the new resistant starch (RS) formula, PPB-R-203, on glucose homeostasis in healthy subjects and subjects with type 2 diabetes.A cohort consisting of 40 healthy participants received test and control diets and was checked for up to 3 hours post-meal. A randomized, 2-regimen, cross-over, comparative study was conducted in 44 subjects with type 2 diabetes and glycemic control was assessed with a continuous glucose monitoring system.In healthy participants, serum glucose values and incremental areas under the glucose curves (AUC) were significantly lower in the PPB-R-203 than the control group (P blood glucose concentrations for subjects on the control regimen were higher than those for subjects on the PPB-R-203-based regimen (7.9 ± 1.7, 95% confidence interval [CI] 7.4-8.4 vs 7.4 ± 1.6, 95% CI 6.9-7.9 mmol/L, respectively; P = 0.023). AUCs for total blood glucose and hyperglycemia (glucose >10 mmol/L) were also reduced for subjects on the PPB-R-203-based regimen as compared with those on control regimen (total blood glucose: 16.2 ± 4.0, 95% CI 14.9-17.4 vs 18.7 ± 4.0, 95% CI 17.6-20.1, P AUC measurements for hypoglycemia (glucose glucose excursion.

Orlistat accelerates gastric emptying and attenuates GIP release in healthy subjects

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Enç, Feruze Yilmaz; Ones, Tunç; Akin, H Levent

2008-01-01

Orlistat, an inhibitor of digestive lipases, is widely used for the treatment of obesity. Previous reports on the effect of orally ingested orlistat together with a meal on gastric emptying and secretion of gut peptides that modulate postprandial responses are controversial. We investigated...... the effect of ingested orlistat on gastric emptying and plasma responses of gut peptides in response to a solid mixed meal with a moderate energy load. In healthy subjects, gastric emptying was determined using scintigraphy and studies were performed without and with 120 mg of orlistat in pellet form......, implying that inhibition of fat absorption modifies determinants of gastric emptying of a meal. Orlistat administered similar to its use in obesity treatment accelerates gastric emptying of a solid mixed meal with a moderate energy load and profoundly attenuates release of GIP without appreciably altering...

Microheterogeneity of alpha 1-acid glycoprotein in healthy elderly subjects: patterns obtained by crossed affino-immunoelectrophoresis.

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Kawerk, N; Succari-Aderschlag, M; Foglietti, M J

1991-10-14

Total serum alpha 1-acid glycoprotein (AGP) concentration and concanavalin A-dependent microheterogeneity were studied in 31 healthy elderly subjects (18 men, 13 women, 71 to 76 yr old). Crossed affino-immunoelectrophoresis (CAIE) revealed three microheterogeneity variants of AGP: non-reactive, weakly reactive and strongly reactive with ConA. Two patterns were found in both elderly men and women, i.e. a normal pattern and one with an increase in the non-reactive form. Mean serum AGP levels in the elderly subjects with slightly higher than in a reference group of younger subjects. The Con A non-reactive form of AGP was increased in 42% of the elderly population. An increase in the non-reactive form of AGP in CAIE should be considered as general expression of chronic inflammation which is of no clinical relevance.

The Gut Microbiota of Healthy Chilean Subjects Reveals a High Abundance of the Phylum Verrucomicrobia

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Fujio-Vejar, Sayaka; Vasquez, Yessenia; Morales, Pamela; Magne, Fabien; Vera-Wolf, Patricia; Ugalde, Juan A.; Navarrete, Paola; Gotteland, Martin

2017-01-01

The gut microbiota is currently recognized as an important factor regulating the homeostasis of the gastrointestinal tract and influencing the energetic metabolism of the host as well as its immune and central nervous systems. Determining the gut microbiota composition of healthy subjects is therefore necessary to establish a baseline allowing the detection of microbiota alterations in pathologic conditions. Accordingly, the aim of this study was to characterize the gut microbiota of healthy Chilean subjects using 16S rRNA gene sequencing. Fecal samples were collected from 41 young, asymptomatic, normal weight volunteers (age: 25 ± 4 years; ♀:48.8%; BMI: 22.5 ± 1.6 kg/m2) with low levels of plasma (IL6 and hsCRP) and colonic (fecal calprotectin) inflammatory markers. The V3-V4 region of the 16S rRNA gene of bacterial DNA was amplified and sequenced using MiSeq Illumina system. 109,180 ± 13,148 sequences/sample were obtained, with an α-diversity of 3.86 ± 0.37. The dominant phyla were Firmicutes (43.6 ± 9.2%) and Bacteroidetes (41.6 ± 13.1%), followed by Verrucomicrobia (8.5 ± 10.4%), Proteobacteria (2.8 ± 4.8%), Actinobacteria (1.8 ± 3.9%) and Euryarchaeota (1.4 ± 2.7%). The core microbiota representing the genera present in all the subjects included Bacteroides, Prevotella, Parabacteroides (phylum Bacteroidetes), Phascolarctobacterium, Faecalibacterium, Ruminococcus, Lachnospira, Oscillospira, Blautia, Dorea, Roseburia, Coprococcus, Clostridium, Streptococcus (phylum Firmicutes), Akkermansia (phylum Verrucomicrobia), and Collinsella (phylum Actinobacteria). Butyrate-producing genera including Faecalibacterium, Roseburia, Coprococcus, and Oscillospira were detected. The family Methanobacteriaceae was reported in 83% of the subjects and Desulfovibrio, the most representative sulfate-reducing genus, in 76%. The microbiota of the Chilean individuals significantly differed from those of Papua New Guinea and the Matses ethnic group and was closer to that of

The Gut Microbiota of Healthy Chilean Subjects Reveals a High Abundance of the Phylum Verrucomicrobia

Directory of Open Access Journals (Sweden)

Sayaka Fujio-Vejar

2017-06-01

Full Text Available The gut microbiota is currently recognized as an important factor regulating the homeostasis of the gastrointestinal tract and influencing the energetic metabolism of the host as well as its immune and central nervous systems. Determining the gut microbiota composition of healthy subjects is therefore necessary to establish a baseline allowing the detection of microbiota alterations in pathologic conditions. Accordingly, the aim of this study was to characterize the gut microbiota of healthy Chilean subjects using 16S rRNA gene sequencing. Fecal samples were collected from 41 young, asymptomatic, normal weight volunteers (age: 25 ± 4 years; ♀:48.8%; BMI: 22.5 ± 1.6 kg/m2 with low levels of plasma (IL6 and hsCRP and colonic (fecal calprotectin inflammatory markers. The V3-V4 region of the 16S rRNA gene of bacterial DNA was amplified and sequenced using MiSeq Illumina system. 109,180 ± 13,148 sequences/sample were obtained, with an α-diversity of 3.86 ± 0.37. The dominant phyla were Firmicutes (43.6 ± 9.2% and Bacteroidetes (41.6 ± 13.1%, followed by Verrucomicrobia (8.5 ± 10.4%, Proteobacteria (2.8 ± 4.8%, Actinobacteria (1.8 ± 3.9% and Euryarchaeota (1.4 ± 2.7%. The core microbiota representing the genera present in all the subjects included Bacteroides, Prevotella, Parabacteroides (phylum Bacteroidetes, Phascolarctobacterium, Faecalibacterium, Ruminococcus, Lachnospira, Oscillospira, Blautia, Dorea, Roseburia, Coprococcus, Clostridium, Streptococcus (phylum Firmicutes, Akkermansia (phylum Verrucomicrobia, and Collinsella (phylum Actinobacteria. Butyrate-producing genera including Faecalibacterium, Roseburia, Coprococcus, and Oscillospira were detected. The family Methanobacteriaceae was reported in 83% of the subjects and Desulfovibrio, the most representative sulfate-reducing genus, in 76%. The microbiota of the Chilean individuals significantly differed from those of Papua New Guinea and the Matses ethnic group and was closer to

Effects of intermittent theta-burst stimulation on practice-related changes in fast finger movements in healthy subjects.

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Agostino, Rocco; Iezzi, Ennio; Dinapoli, Loredana; Suppa, Antonio; Conte, Antonella; Berardelli, Alfredo

2008-08-01

In this paper we investigated the effects of intermittent theta-burst stimulation (iTBS) applied to the primary motor cortex on practice-related changes in motor performance. Seventeen healthy subjects underwent two experimental sessions, one testing real iTBS and the other testing sham iTBS. Before and after both iTBS sessions, the subjects practiced fast right index-finger abductions for a few minutes. As measures of cortical excitability we calculated resting motor threshold and motor-evoked potential amplitude. As measures of practice-related changes we evaluated the mean movement amplitude, peak velocity and peak acceleration values for each block. When subjects practiced the movement task, the three variables measuring practice-related changes improved to a similar extent during real and sham iTBS whereas cortical excitability increased only during real iTBS. In a further group of five healthy subjects we investigated the effect of real and sham iTBS on changes in motor performance after a longer task practice and found no significant changes in motor performance and retention after real and sham iTBS. From our results overall we conclude that in healthy subjects iTBS applied to the primary motor cortex leaves practice-related changes in an index finger abduction task unaffected. We suggest that iTBS delivered over the primary motor cortex is insufficient to alter motor performance because early motor learning probably engages a wide cortical and subcortical network.

Left temporal and temporoparietal brain activity depends on depth of word encoding: a magnetoencephalographic study in healthy young subjects.

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Walla, P; Hufnagl, B; Lindinger, G; Imhof, H; Deecke, L; Lang, W

2001-03-01

Using a 143-channel whole-head magnetoencephalograph (MEG) we recorded the temporal changes of brain activity from 26 healthy young subjects (14 females) related to shallow perceptual and deep semantic word encoding. During subsequent recognition tests, the subjects had to recognize the previously encoded words which were interspersed with new words. The resulting mean memory performances across all subjects clearly mirrored the different levels of encoding. The grand averaged event-related fields (ERFs) associated with perceptual and semantic word encoding differed significantly between 200 and 550 ms after stimulus onset mainly over left superior temporal and left superior parietal sensors. Semantic encoding elicited higher brain activity than perceptual encoding. Source localization procedures revealed that neural populations of the left temporal and temporoparietal brain areas showed different activity strengths across the whole group of subjects depending on depth of word encoding. We suggest that the higher brain activity associated with deep encoding as compared to shallow encoding was due to the involvement of more neural systems during the processing of visually presented words. Deep encoding required more energy than shallow encoding but for all that led to a better memory performance. Copyright 2001 Academic Press.

Who is healthy? Aspects to consider when including healthy volunteers in QST-based studies- a consensus statement by the EUROPAIN and NEUROPAIN consortia

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Gierthmühlen, Janne; Enax-Krumova, Elena K; Attal, Nadine

2015-01-01

studies, so that results are less likely to be false negative or false positive due to subject related factors.The EUROPAIN and NEUROPAIN consortia aimed to define factors influencing the variability in selection of healthy subjects in QST-based studies before the start of both projects and to give...

A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects.

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Hanes, Vladimir; Chow, Vincent; Zhang, Nan; Markus, Richard

2017-05-01

This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 980 and trastuzumab in healthy males. In this single-blind study, 157 healthy males were randomized 1:1:1 to a single 6 mg/kg intravenous infusion of ABP 980, FDA-licensed trastuzumab [trastuzumab (US)], or EU-authorized trastuzumab [trastuzumab (EU)]. Primary endpoints were area under the serum concentration-time curve from time 0 to infinity (AUC inf ) and maximum observed serum concentration (C max ). To establish equivalence, the geometric mean ratio (GMR) and 90% confidence interval (CI) for C max and AUC inf had to be within the equivalence criteria of 0.80-1.25. The GMRs and 90% CIs for C max and AUC inf , respectively, were: 1.04 (0.99-1.08) and 1.06 (1.00-1.12) for ABP 980 versus trastuzumab (US); 0.99 (0.95-1.03) and 1.00 (0.95-1.06) for ABP 980 versus trastuzumab (EU); and 0.96 (0.92-1.00) and 0.95 (0.90-1.01) for trastuzumab (US) versus trastuzumab (EU). All comparisons were within the equivalence criteria of 0.80-1.25. Treatment-emergent adverse events (TEAEs) were reported in 84.0, 75.0, and 78.2 of subjects in the ABP 980, trastuzumab (US), and trastuzumab (EU) groups, respectively. There were no deaths or TEAEs leading to study discontinuation and no binding or neutralizing anti-drug anti-bodies were detected. This study demonstrated the PK similarity of ABP 980 to both trastuzumab (US) and trastuzumab (EU), and of trastuzumab (US) to trastuzumab (EU). No differences in safety and tolerability between treatments were noted; no subject tested positive for binding anti-bodies.

Serum carotenoids and macular pigment optical density in patients with intestinal resections and healthy subjects: an exploratory study

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Eriksen, Jane Nygaard; Prahm, August P; Falk, Mads Krüger

2018-01-01

Reduced absorption capacity in patients with intestinal resections (IR) could result in malabsorption of fat-soluble components like carotenoids, which are of clinical interest in relation to visual health. In this case cohort, we investigated the association between IR and serum lutein, zeaxanthin......·0001) in the group with IR. Serum lutein, zeaxanthin, β-carotene and macular pigment optical density were >15 % lower in the patient group compared with healthy controls (P carotenoids. Results suggest...... that for a test of macular carotenoid supplementation, subjects with a potentially clinically significant carotenoid deficit could be recruited among patients with IR....

A clinical study to examine the potential effect of lansoprazole on the pharmacokinetics of bosutinib when administered concomitantly to healthy subjects.

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Abbas, Richat; Leister, Cathie; Sonnichsen, Daryl

2013-08-01

Bosutinib is an orally bioavailable, dual Src and Abl tyrosine kinase inhibitor approved in the USA for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia following development of resistance or intolerance to prior therapy. In vitro studies demonstrated that bosutinib displays pH-dependent aqueous solubility, suggesting that concomitant administration of agents that alter gastric pH could affect bosutinib absorption. The objectives of this study were to evaluate the effect of lansoprazole, a gastric proton pump inhibitor, on the pharmacokinetics and safety of bosutinib. This open-label, non-randomized, phase I study involved inpatients and outpatients at a single site. The study participants were healthy men or women of non-childbearing potential aged 18-50 years. Each subject received bosutinib 400 mg on Day 1, lansoprazole 60 mg on Day 14, and bosutinib 400 mg co-administered with lansoprazole 60 mg on Day 15 under fasting conditions. The main outcome measure was the effect of multiple doses of lansoprazole on the pharmacokinetic profile of a single oral dose of bosutinib. A total of 24 healthy male subjects were enrolled. Co-administration with lansoprazole decreased the mean maximum plasma concentration (C(max)) of bosutinib from 70.2 to 42.9 ng/mL, and the total area under the plasma concentration-time curve (AUC) from 1,940 to 1,470 ng·h/mL. Log-transformed bosutinib pharmacokinetic parameters indicated significant between-treatment differences; the least squares geometric mean ratio for C(max) was 54 % (95 % CI 42-70) and for AUC was 74 % (95 % CI 60-90). Mean apparent total body clearance from plasma after oral administration increased from 237 to 330 L/h, and the median time to reach Cmax increased from 5 to 6 h, although this change may be related to decreased bosutinib absorption when combined with lansoprazole. When co-administered with lansoprazole, bosutinib maintained an acceptable safety profile, which was primarily

Effect of commercial rye whole-meal bread on postprandial blood glucose and gastric emptying in healthy subjects

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Darwich Gassan

2009-06-01

Full Text Available Abstract Background The intake of dietary fibre has been shown to reduce the risk of developing diabetes mellitus. The aim of this study was to compare the effects of commercial rye whole-meal bread containing whole kernels and white wheat bread on the rate of gastric emptying and postprandial glucose response in healthy subjects. Methods Ten healthy subjects took part in a blinded crossover trial. Blood glucose level and gastric emptying rate (GER were determined after the ingestion of 150 g white wheat bread or 150 g whole-meal rye bread on two different occasions after fasting overnight. The GER was measured using real-time ultrasonography, and was calculated as the percentage change in antral cross-sectional area 15 and 90 minutes after completing the meal. Results No statistically significant difference was found between the GER values or the blood glucose levels following the two meals when evaluated with the Wilcoxon signed rank sum test. Conclusion The present study revealed no difference in postprandial blood glucose response or gastric emptying after the ingestion of rye whole-meal bread compared with white wheat bread. Trial registration NCT00779298

Optimizing visualization in enhanced depth imaging OCT in healthy subjects and patients with retinal pigment epithelial detachment

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Kampik A

2012-11-01

Full Text Available Lukas Reznicek, Efstathios Vounotrypidis, Florian Seidensticker, Karsten Kortuem, Anselm Kampik, Aljoscha S Neubauer, Armin WolfDepartment of Ophthalmology, Ludwig Maximilians University Muenchen, Munich, GermanyBackground: This study’s objective was to optimize the visualization of three different spectral-domain optical coherence tomography (SD-OCT display modalities and evaluate enhanced depth imaging (EDI by comparing the maximum depth of assessment in conventional versus inverted cross-sectional OCT images in healthy subjects and in patients with retinal pigment epithelial detachment (PED.Methods: Cross-sectional SD-OCT conventional and inverted images were obtained with the HRA2 (Heidelberg Retina Angiograph II, Heidelberg Engineering, Heidelberg, Germany. Horizontal as well as vertical sections in three different display modes were blinded for evaluation by three independent, experienced graders for maximal imaging depth of the deep ocular fundus layers.Results: The mean imaging depth as measured from the inner segment/outer segment (IS/OS to the outer choroid of all 14 healthy subjects was 197 ± 44 µm vs 263 ± 56 µm for conventional vs EDI scans: in black/white mode, it was significantly lower (P < 0.001 than in white/black mode (249 ± 42 µm vs 337 ± 71 µm and color/heat mode (254 ± 48 µm vs 354 ± 73 µm. The mean imaging depth of all 14 study eyes with PED was 240 ± 78 µm vs 345 ± 100 µm for conventional vs EDI scans in black/white mode, and was significantly lower (P < 0.001 than in white/black mode (393 ± 104 µm vs 464 ± 126 µm and in color/heat mode (373 ± 106 µm vs 453 ± 114 µm. In each display modality of healthy subjects and of patients with PED, EDI scans showed a significantly higher imaging depth than the corresponding conventional scans.Conclusion: White/black and color/heat modes allow increased imaging depth, compared to black/white mode using both conventional or EDI OCT scans in healthy subjects or

Study of Subjective Life Quality in Young People with Disabilities

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Kurtanova Yu.E.,

2014-08-01

Full Text Available We present a study of subjective life quality in young people with disabilities compared with their healthy peers. The study sample comprised 62 women aged 14 to 18 years. The experimental study group consisted of 30 students of grades VIII-XI of Secondary School of home-based learning № 1673 "Support". The control group included 32 student of grades VIII-XI of School № 1222 with in-depth study of the German language. The methods used were: Medical Outcomes Study 36 Item Short Form Health Survey (SF-36, M. Kuhn test "Who am I" (M. Kuhn, T. McPartland; modification by T.V. Rumjantseva, Method and diagnosis of health, activity and mood, projective technique "Picture of the actual self" and "Picture of the desired self" with questions. We formulated conclusions about the features of the subjective assessment of the quality of life in young people with disabilities compared with their healthy peers.

Effect of Graded Unilateral Sanding Exercise on Metabolic and Cardiopulmonary Function in the Healthy and the Hemiparetic Elderly Subjects

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Muraki, Toshiaki

1997-01-01

The purpose of this study was to investigate how 18 elderly subjects with cerebral vascular accident (CVA) (14 men and 4 women) and 19 healthy elderly subjects (6 men and 13 women) would respond to a five-step graded unilateral sanding activity. Three indicators of pulmonary function such as expiratory tidal volume, respiratory rate, and expiratory volume and four indicators of cardiometabolic function such as metabolic equivalents (METS), systolic blood pressure, heart rate, and pressure rat...

Effect of changes of serum IGF-II and CT contents on bone metabolism in healthy subjects

International Nuclear Information System (INIS)

Xie Rongxing; Chen Wenhan; Chen Shaozhu

2005-01-01

Objective: To explore the effect of changes of serum insulin like growth factor II (IGF-II) and calcitonin (CT) on bone metabolism in both male and female healthy subjects of different age groups. Methods: Serum IGF-II and CT contents were determined with RIA in 180 healthy subjects of both sexes in 5 age groups (27-39, 40-49, 50-59, 60-69 and over 70). Results: The serum contents of IGF-II and CT decreased gradually as the age increased. The IGF-II contents in subjects above 70 were significantly lower than those in all other subjects (P<0.01); the values in subjects of the age group 27-39 were also significantly higher than those in the 60-69 group (P<0.05). Again, the serum CT contents in subjects over 50 were significantly lower than those in subjects below 50 (P<0.05, P<0.01). There were little differences among the levels in both sexes, with the exception of a slight but not significant lower value in the females above 50. Conclusion: In older subjects, the decreased contents of serum IGF-II would exert less modulation on osteoblastic activity while the decreased contents of CT would exert less inhibition on osteolytic activity. The contents in older females were even lower due to the decreased estrogen level. Combination of these two factors would lead to the initiation and development of osteoporosis. (authors)

Specific Antibodies Reacting with SV40 Large T Antigen Mimotopes in Serum Samples of Healthy Subjects.

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Mauro Tognon

Full Text Available Simian Virus 40, experimentally assayed in vitro in different animal and human cells and in vivo in rodents, was classified as a small DNA tumor virus. In previous studies, many groups identified Simian Virus 40 sequences in healthy individuals and cancer patients using PCR techniques, whereas others failed to detect the viral sequences in human specimens. These conflicting results prompted us to develop a novel indirect ELISA with synthetic peptides, mimicking Simian Virus 40 capsid viral protein antigens, named mimotopes. This immunologic assay allowed us to investigate the presence of serum antibodies against Simian Virus 40 and to verify whether Simian Virus 40 is circulating in humans. In this investigation two mimotopes from Simian Virus 40 large T antigen, the viral replication protein and oncoprotein, were employed to analyze for specific reactions to human sera antibodies. This indirect ELISA with synthetic peptides from Simian Virus 40 large T antigen was used to assay a new collection of serum samples from healthy subjects. This novel assay revealed that serum antibodies against Simian Virus 40 large T antigen mimotopes are detectable, at low titer, in healthy subjects aged from 18-65 years old. The overall prevalence of reactivity with the two Simian Virus 40 large T antigen peptides was 20%. This new ELISA with two mimotopes of the early viral regions is able to detect in a specific manner Simian Virus 40 large T antigen-antibody responses.

Lung morphometry using hyperpolarized 129 Xe multi-b diffusion MRI with compressed sensing in healthy subjects and patients with COPD.

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Zhang, Huiting; Xie, Junshuai; Xiao, Sa; Zhao, Xiuchao; Zhang, Ming; Shi, Lei; Wang, Ke; Wu, Guangyao; Sun, Xianping; Ye, Chaohui; Zhou, Xin

2018-05-04

FS acquisitions were 1.0%, 2.6%, -0.03%, 1.5%, and -5.5%, respectively. Good agreement between measurements with the CS and FS acquisitions was also observed during the single breath-hold experiments. Furthermore, there were significant differences between the morphometric parameters for the healthy and COPD subjects (P < 0.05). Our study has shown that HP 129 Xe multi-b diffusion MRI with CS could be beneficial in lung microstructural assessments by acquiring less data while maintaining the consistent results with the FS acquisitions. © 2018 American Association of Physicists in Medicine.

A comprehensive compartmental model of blood glucose regulation for healthy and type 2 diabetic subjects.

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Vahidi, O; Kwok, K E; Gopaluni, R B; Knop, F K

2016-09-01

We have expanded a former compartmental model of blood glucose regulation for healthy and type 2 diabetic subjects. The former model was a detailed physiological model which considered the interactions of three substances, glucose, insulin and glucagon on regulating the blood sugar. The main drawback of the former model was its restriction on the route of glucose entrance to the body which was limited to the intravenous glucose injection. To handle the oral glucose intake, we have added a model of glucose absorption in the gastrointestinal tract to the former model to address the resultant variations of blood glucose concentrations following an oral glucose intake. Another model representing the incretins production in the gastrointestinal tract along with their hormonal effects on boosting pancreatic insulin production is also added to the former model. We have used two sets of clinical data obtained during oral glucose tolerance test and isoglycemic intravenous glucose infusion test from both type 2 diabetic and healthy subjects to estimate the model parameters and to validate the model results. The estimation of model parameters is accomplished through solving a nonlinear optimization problem. The results show acceptable precision of the estimated model parameters and demonstrate the capability of the model in accurate prediction of the body response during the clinical studies.

Echocardiographic assessment of right ventricular functions in healthy subjects who migrated from the sea level to a moderate altitude.

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Arısoy, Arif; Topçu, Selim; Demirelli, Selami; Altunkaş, Fatih; Karayakalı, Metin; Çelik, Ataç; Tanboğa, İbrahim Halil; Aksakal, Enbiya; Sevimli, Serdar; Gürlertop, Hanefi Yekta

2015-11-25

The aim of this study was to evaluate right ventricle (RV) functions using echocardiography in healthy subjects who migrated from the sea level to moderate altitude (1890 m). The prospective observational in this study population consisted of 33 healthy subjects (23 men; mean age 20.4±3.2 years) who migrated from the sea level to a moderate altitude (Erzurum city centre, 1890 m above sea level) for long-term stay. Subjects underwent echocardiographic evaluation within the first 48 h of exposure to the moderate altitude and at the sixth month of arrival. Conventional echocardiographic parameters such as RV sizes and areas, systolic, and diastolic functional indices [fractional area change (FAC), tricuspid flow velocities, myocardial performance index (MPI), and tricuspid annular plane systolic excursion (TAPSE)] were obtained. Systolic (S) and diastolic (E', A') velocities were acquired from the apical fourchamber view using tissue Doppler imaging. Kolmogorov-Smirnov test, student's t-test, Wilcoxon test, and chi-square test were used in this study. There were no significant changes in RV size, FAC, MPI, TAPSE, inferior inspiratory vena cava collapse, tricuspid E velocity, and tricuspid annulus E' velocity. Compared with the baseline, there was a significant increase in mean pulmonary artery pressure (p=0.001); RV end systolic area (p=0.014); right atrial end diastolic area (p=0.021); tricuspid A velocity (p=0.013); tricuspid annulus S and A' velocity (p=0.031 and p=0.006, respectively); and RV free wall S, E', and A' velocity (p=0.007, pa significant decrease in tricuspid E/A ratio (1.61±0.3 vs. 1.45±0.2, p=0.038) and tricuspid annulus E'/A' ratio (1.52±0.5 vs. 1.23±0.4, p=0.002) at the sixth month. Our study revealed that right ventricular diastolic function was altered while the systolic function was preserved in healthy subjects who migrated from the sea level to a moderate altitude.

Electroacupuncture effect at the LI 4 Hegu point on the plasma β-endorphin level of healthy subjects

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Setiawardhani, A. L.; Srilestari, A.; Simadibrata, C.

2017-08-01

As a therapy modality, acupuncture is becoming popular for treating diseases. Nevertheless, the acupuncture mechanism of action remains unclear until now. Some studies suggest that acupuncture works by stimulating the β-endorphin release, whereas other studies show the opposite. This study aims to determine whether electro acupuncture at the LI 4 Hegu point could increase the plasma β-endorphin level as a basic of acupuncture mechanism of action. Thirty-six healthy subjects were involved and divided randomly into two groups, namely, intervention (n=18) and control (n=18). In the intervention group, electroacupuncture was applied at the LI 4 Hegu point with a low frequency for 30 min. In the control group, sham electroacupuncture was applied at a non-acupoint for 30 min. The plasma β-endorphin was examined before and after intervention using the ELISA method. A significant difference was found between the intervention and control groups in increasing the plasma β-endorphin level (9(50%) vs. 1(5.6%); p = 0.009). A significant difference was also observed in the plasma β-endorphin level after intervention between the two groups (35.1±3.4 vs. 10.3±1.8 p=0.003). Electroacupuncture at the LI 4 Hegu point was found to increase the plasma β-endorphin level in healthy subjects.

Randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of beta-1,3/1,6 glucan on stress associated with daily lifestyle in healthy subjects

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Yoshihiko Ojiri

2015-04-01

Full Text Available Background: Fatigue is attributable to physical and psychological stress. Fatigue is also a common symptom which occurs in both sick and healthy individuals. Although its mechanism of cause is complex, fatigue from stress is known to affect the existing equilibrium of the immune system. However, nutrition, such as beta-1,3/1,6 glucan, has been reported to play an important role in regulating stress and fatigue states, via modulating a weakened immune system. In this study, a popular and healthy beverage in Okinawa, Japan, containing a soluble baker’s yeast in black koji vinegar (Moromisu, was provided to healthy subjects with a non-strenuous daily lifestyle. Results: By performing statistical analysis on the results of the Profile of Mood States (POMS survey, we observed that overall study results (n=14 demonstrated significant differences in fatigue and confusion in the POMS factors. Conclusions: In this study we confirmed that beta-1,3/1,6 glucan improved some of the factors related to stress and fatigue, as indicated by evaluation of POMS survey results.

Effect of psychological intervention in the form of relaxation and guided imagery on cellular immune function in normal healthy subjects. An overview

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Zachariae, R; Kristensen, J S; Hokland, P

1991-01-01

The present study measured the effects of relaxation and guided imagery on cellular immune function. During a period of 10 days 10 healthy subjects were given one 1-hour relaxation procedure and one combined relaxation and guided imagery procedure, instructing the subjects to imagine their immune...... on the immune defense and could form the basis of further studies on psychological intervention and immunological status. Udgivelsesdato: 1990-null...

Incretin and islet hormone responses to meals of increasing size in healthy subjects.

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Alsalim, Wathik; Omar, Bilal; Pacini, Giovanni; Bizzotto, Roberto; Mari, Andrea; Ahrén, Bo

2015-02-01

Postprandial glucose homeostasis is regulated through the secretion of glucagon-like peptide 1 (GLP-1) through the stimulation of insulin secretion and inhibition of glucagon secretion. However, how these processes dynamically adapt to demands created by caloric challenges achieved during daily life is not known. The objective of the study was to explore the adaptation of incretin and islet hormones after mixed meals of increasing size in healthy subjects. Twenty-four healthy lean subjects ingested a standard breakfast after an overnight fast followed, after 4 hours, by a lunch of a different size (511, 743, and 1034 kcal) but with identical nutrient composition together with 1.5 g paracetamol. Glucose, insulin, C-peptide, glucagon, intact GLP-1, and glucose-dependent insulinotropic polypeptide (GIP) and paracetamol were measured after the meals. Area under the 180-minute curve (AUC) for insulin, C-peptide, glucagon, GLP-1, and GIP and model-derived β-cell function and paracetamol appearance were calculated. Glucose profiles were similar after the two larger meals, whereas after the smaller meal, there was a postpeak reduction below baseline to a nadir of 3.8 ± 0.1 mmol/L after 75 minutes (P lunch meals of increasing size elicit a caloric-dependent insulin response due to increased β-cell secretion achieved by increased GIP and GLP-1 levels. The adaptation at larger meals results in identical glucose excursions, whereas after a lower caloric lunch, the insulin response is high, resulting in a postpeak suppression of glucose below baseline.

Influence of nopal intake upon fasting glycemia in type II diabetics and healthy subjects.

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Frati, A C; Gordillo, B E; Altamirano, P; Ariza, C R; Cortés-Franco, R; Chávez-Negrete, A; Islas-Andrade, S

1991-01-01

To assess if the acute hypoglycemic effect of nopal which occurs in diabetic patients also appears in healthy individuals, 500 g of nopal stems (O. streptacantha Lem.) were given orally to 14 healthy volunteers and to 14 patients with NIDDM. Serum glucose and insulin levels were measured at 0, 60, 120 and 180 minutes after nopal ingestion. A control test was performed with the intake of 400 ml of water. The intake of nopal by the NIDDM group was followed by a significant reduction of serum glucose and insulin concentration reaching 40.8 + 4.6 mg/dl (n = 14) (mean+SEM) and 7.8 + 1.5 uU/ml (n = 7) less than basal value, respectively, at 180 minutes. (P less than 0.001 vs control test). No significant changes were noticed in the healthy group as compared with the control test (P greater than 0.05). Acute hypoglycemic effect of nopal was observed in patients with NIDDM but not in healthy subjects, thus the mechanisms of this effect differs from current hypoglycemic agents.

Cervical flexion-rotation test and physiological range of motion - A comparative study of patients with myogenic temporomandibular disorder versus healthy subjects.

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Greenbaum, Tzvika; Dvir, Zeevi; Reiter, Shoshana; Winocur, Ephraim

2017-02-01

Temporomandibular Disorders (TMD) refer to several common clinical disorders which involve the masticatory muscles, the temporomandibular joint (TMJ) and the adjacent structures. Although neck signs and symptoms are found with higher prevalence in TMD patients compared to the overall population, whether limitation of cervical mobility is an additional positive finding in this cohort is still an open question. To compare the physiological cervical range of motion (CROM) and the extent of rotation during cervical flexion (flexion-rotation test, FRT) in people with TMD (muscular origin) and healthy control subjects. The range of motion of the neck and FRT was measured in 20 women with myogenic TMD and 20 age matched healthy controls. Women with myogenic TMD had significantly lower FRT scores compared to their matched healthy women. No difference was found between groups in CROM in any of the planes of movement. The FRT was positive (less than 32°) in 90% of the TMD participants versus 5% in the healthy control but the findings were not correlated with TMD severity. The results point out a potential involvement of the upper cervical joints (c1-c2) in women with myogenic TMD. Copyright © 2016 Elsevier Ltd. All rights reserved.

Metabolic impact of certain dietary proteins and/or amino acids - Glycaemic and hormonal responses to carbohydrate meals in healthy subject

OpenAIRE

Gunnerud, Ulrika

2013-01-01

Re-occurring hyperglycaemic episodes promote subclinical low-grade inflammation and CVD in type 2 diabetes, emphasising the therapeutic role of tight blood glucose regulation. A tight blood glucose regulation is probably beneficial also in healthy subjects and mild elevations in postprandial glycaemia and triglycerides are associated with impaired flow-mediated dilation and increased markers of oxidative stress in young healthy subjects. Certain dietary proteins and amino acids (AA) have insu...

Radiologically defining horizontal gaze using EOS imaging-a prospective study of healthy subjects and a retrospective audit.

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Hey, Hwee Weng Dennis; Tan, Kimberly-Anne; Ho, Vivienne Chien-Lin; Azhar, Syifa Bte; Lim, Joel-Louis; Liu, Gabriel Ka-Po; Wong, Hee-Kit

2018-06-01

As sagittal alignment of the cervical spine is important for maintaining horizontal gaze, it is important to determine the former for surgical correction. However, horizontal gaze remains poorly-defined from a radiological point of view. The objective of this study was to establish radiological criteria to define horizontal gaze. This study was conducted at a tertiary health-care institution over a 1-month period. A prospective cohort of healthy patients was used to determine the best radiological criteria for defining horizontal gaze. A retrospective cohort of patients without rigid spinal deformities was used to audit the incidence of horizontal gaze. Two categories of radiological parameters for determining horizontal gaze were tested: (1) the vertical offset distances of key identifiable structures from the horizontal gaze axis and (2) imaginary lines convergent with the horizontal gaze axis. Sixty-seven healthy subjects underwent whole-body EOS radiographs taken in a directed standing posture. Horizontal gaze was radiologically defined using each parameter, as represented by their means, 95% confidence intervals (CIs), and associated 2 standard deviations (SDs). Subsequently, applying the radiological criteria, we conducted a retrospective audit of such radiographs (before the implementation of a strict radioimaging standardization). The mean age of our prospective cohort was 46.8 years, whereas that of our retrospective cohort was 37.2 years. Gender was evenly distributed across both cohorts. The four parameters with the lowest 95% CI and 2 SD were the distance offsets of the midpoint of the hard palate (A) and the base of the sella turcica (B), the horizontal convergents formed by the tangential line to the hard palate (C), and the line joining the center of the orbital orifice with the internal occipital protuberance (D). In the prospective cohort, good sensitivity (>98%) was attained when two or more parameters were used. Audit using Criterion B

Gut-targeted immunonutrition boosting natural killer cell activity using Saccharomyces boulardii lysates in immuno-compromised healthy elderly subjects.

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Naito, Yasuhiro; Marotta, Francesco; Kantah, Makoto K; Zerbinati, Nicola; Kushugulova, Almagul; Zhumadilov, Zhaxybay; Illuzzi, Nicola; Sapienza, Chiara; Takadanohara, Hiroshi; Kobayashi, Riyichi; Catanzaro, Roberto

2014-04-01

The aim of this study was to assess the immunomodulatory effect of KC-1317 (a symbiotic mixture containing Saccharomyces boulardii lysate in a cranberry, colostrum-derived lactoferrin, fragaria, and lactose mixture) supplementation in immune-compromised but otherwise healthy elderly subjects. A liquid formulation of KC-1317 was administered in a randomized controlled trial (RCT) fashion to healthy volunteers (65-79 years) previously selected for low natural killer (NK) cell activity, and this parameter was checked at the completion of the study. A significant improvement in NK cell activity of KC-1317 consumers was observed as compared to placebo at the end of 2 months. Although preliminary, these beneficial immune-modulatory effects of KC-1317 in aged individuals might indicate its employment within a wider age-management strategy.

Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects

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Patrick C. Dolder

2017-09-01

Full Text Available Rationale: Lisdexamfetamine is a prodrug of D-amphetamine used for the treatment of attention-deficit/hyperactivity disorder (ADHD. Lisdexamfetamine is thought to have a prolonged pharmacokinetic profile compared with oral D-amphetamine, possibly associated with lower drug liking and a lower risk of oral misuse. However, differences in the pharmacokinetics and pharmacodynamics of lisdexamfetamine and D-amphetamine have not been directly compared.Methods: Equimolar doses of D-amphetamine (40 mg and lisdexamfetamine (100 mg, and placebo were administered in 24 healthy subjects in a randomized, double-blind, placebo-controlled, cross-over study. Plasma concentrations of amphetamine, subjective effects, and vital signs were repeatedly assessed. The pharmacokinetic parameters were determined using compartmental modeling.Results: The increase in plasma concentrations of amphetamine had a 0.6 ± 0.6 h (mean ± SD longer lag time and reached peak levels 1.1 ± 1.5 h later after lisdexamfetamine administration compared with D-amphetamine administration, but no differences in maximal concentrations or total exposure (AUC were found between the two treatments. Consistent with the pharmacokinetics, the subjective and cardiovascular stimulant effects of lisdexamfetamine also occurred later compared with D-amphetamine. However, no differences in peak ratings of potentially abuse-related subjective drug effects (e.g., drug liking, drug high, stimulation, happy, well-being, and self-confidence were observed after lisdexamfetamine administration compared with D-amphetamine administration. Lisdexamfetamine and D-amphetamine also produced similar peak increases in mean arterial blood pressure, heart rate, body temperature, pupil size, and adverse effects.Conclusion: The pharmacokinetics and pharmacodynamics of lisdexamfetamine are similar to D-amphetamine administered 1h later. Lisdexamfetamine is likely associated with a similar risk of oral abuse as D

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

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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

Colour Doppler ultrasonography evaluation of vascularization in the wrist and finger joints in rheumatoid arthritis patients and healthy subjects

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Carotti, M. [Department of Radiology, Poliytechnic University of Marche, Ancona (Italy); Salaffi, F., E-mail: fsalaff@tin.it [Department of Rheumatology, Poliytechnic University of Marche, Ospedale A. Murri - Via dei Colli 52, 60035 Jesi, Ancona (Italy); Morbiducci, J. [Department of Radiology, Poliytechnic University of Marche, Ancona (Italy); Ciapetti, A., E-mail: ciapetti.a@libero.it [Department of Rheumatology, Poliytechnic University of Marche, Ospedale A. Murri - Via dei Colli 52, 60035 Jesi, Ancona (Italy); Bartolucci, L. [Department of Radiology, Poliytechnic University of Marche, Ancona (Italy); Gasparini, S. [Department of Rheumatology, Poliytechnic University of Marche, Ospedale A. Murri - Via dei Colli 52, 60035 Jesi, Ancona (Italy); Ferraccioli, G. [Division of Rheumatology, Catholic University of the Sacred Heart, Rome (Italy); Giuseppetti, G.M. [Department of Radiology, Poliytechnic University of Marche, Ancona (Italy); Grassi, W. [Department of Rheumatology, Poliytechnic University of Marche, Ospedale A. Murri - Via dei Colli 52, 60035 Jesi, Ancona (Italy)

2012-08-15

Objectives: To evaluate the presence of blood flow by colour Doppler ultrasonography (CDUS) in the wrist and finger joints of rheumatoid arthritis (RA) patients and healthy subjects and to define a cut-off value of CDUS resistive index (RI). Methods: Forty-three patients with RA and 43 healthy controls were examined by CDUS. The wrists, second and third metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints were evaluated in each patient and healthy subject. Spectral Doppler analysis was performed in order to characterize the type of flow and a mean RI was measured to define a cut-off level. The area under receiver operating characteristic curve was used to evaluate the screening method's performance. Results: Flow was detected in 219 of the 430 total joints (50.9%) of RA patients (111 in the wrists, 49 in the MCP and 30 in the PIP joints). Healthy subjects had a quantifiable flow in 45 of the 430 joints (10.5%) and, in particular, 39 (86.4%) in the wrist, 5 (11.14%) in the MCP and 1 (2.2%) in the PIP joints. The intra- and inter-reader agreements for the detection of Doppler signal were very good (kappa 0.82 and 0.89, respectively). Mean RI values were 0.72 {+-} 0.06 in RA patients and 0.86 {+-} 0.06 in healthy subjects (p < 0.01). At cut-off point of RI < 0.79 the sensitivity was 89.6% and the specificity was 78.8% (positive likelihood ratio 4.22). Conclusion: DUS is a useful tool for the detection of abnormal blood flow in inflammatory joints of RA patients.

Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.

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Chae, Dong Woo; Son, Mijeong; Kim, Yukyung; Son, Hankil; Jang, Seong Bok; Seo, Jeong Min; Nam, Su Youn; Park, Kyungsoo

2015-10-01

As hypertension and dyslipidemia are frequent comorbidities, antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment. Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia. A combination formulation of these two drugs would improve patient compliance due to ease of dosing. The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination (FDC) tablet containing telmisartan/rosuvastatin 80/20 mg (test treatment) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet (reference treatment) in healthy Korean male volunteers. This was a single-dose, randomized, open-label, 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2. Each subject received a single dose of the reference and test treatments with a 14-day washout period. Blood sampling was performed at prespecified intervals for up to 72 hours after dosing. Primary pharmacokinetic parameters were Cmax, AUClast, and AUC0-∞ of telmisartan, rosuvastatin, and N-desmethyl rosuvastatin. Bioequivalence was assessed by determining whether the 90% confidence intervals (CIs) of the geometric mean ratios (test treatment/reference treatment) of these parameters were within the standard range of 80% to 125%. Adverse events were monitored via regular interviews with the subjects and by physical examinations. 60 subjects were enrolled and 55 completed the study. The 90% CIs of the geometric mean ratios of Cmax, AUClast, and AUC00-∞ were 0.9262-1.1498, 0.9294-1.0313, and 0.9312-1.0320 for telmisartan, 0.9041-1.0428, 0.9262-1.0085, and 0.9307-1.0094 for rosuvastatin, and 0.8718-1.0022, 0.8901-0.9904, and 0.8872-0.9767 for N-desmethyl rosuvastatin, respectively. There was no statistical difference in the incidence of adverse events (AEs) (all of which were mild or moderate) between the reference and test

5D.07: THE IMPACT OF FLAVONOL-RICH DARK CHOCOLATE ON BLOOD PRESSURE AND VASCULAR FUNCTION IN HEALTHY SUBJECTS.

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Heuten, H; Van Ackeren, K; Hoymans, V; Wouters, K; Goovaerts, I; Conraads, V; Vrints, C

2015-06-01

Flavanoids may have a beneficial effect on blood pressure (BP) and endothelial function. There is however, limited data on this effect during a longer period (8 weeks) and no data on the effect on EPC (endothelial progenitor cells) in healthy subjects. Healthy, non-smoking, male and female volunteers aged 35-65 year with no history of diabetes or cardiovascular disease and with normal or mild hypertensive blood pressure (chocolate (High-DC). Group 2 (n = 26): daily consuming 20 gram of low-flavanol dark chocolate (Low-DC). At week 0,4,6,7 and 8 blood pressure was assessed in all subjects, and endothelial function (FMD, flow mediated dilation) in a subgroup. A blood sample was taken in each subject at week 0 and 8 for measuring glucose, lipids and EPC. Baseline characteristics were comparable between both groups. There was a decrease in systolic and diastolic blood pressure over time in both groups, however at 8 weeks there was no statistically significant difference between groups (delta SBP -2.17  + /-8.53 mmHg in gr 1 versus -4.06 + /-8.05 mmHg in gr 2, p = 0.4; delta DBP -3.97  + /-7.1 mmHg in gr 1 versus -4.67  + /-5.99 mmHg in gr 2, p = 0.7).FMD was performed in 9 subjects from each group, no significant difference was noted between both groups over time (delta FMD gr 1: -3.50  + /- 6.00 % versus gr 2: + 0.12  + /- 2.51 %, p = 0.06). EPC values did not differ between groups at baseline (T0) and at the end of the study (T8) (ISHAGE count (T8-T0): gr1: 3.23 (-68.01 - 41.71) versus gr 2: -9.23 (-57.59 - 17.28), p = 0.4). Glucose and lipids were comparable between both groups at baseline and at the end of the study (p = ns). In this study, no beneficial effect was noticed in favour of the consumption of flavanol-rich dark chocolate during 8 weeks on blood pressure or vascular function, in healthy subjects.

Reliability of the standard goniometry and diagrammatic recording of finger joint angles: a comparative study with healthy subjects and non-professional raters.

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Macionis, Valdas

2013-01-09

Diagrammatic recording of finger joint angles by using two criss-crossed paper strips can be a quick substitute to the standard goniometry. As a preliminary step toward clinical validation of the diagrammatic technique, the current study employed healthy subjects and non-professional raters to explore whether reliability estimates of the diagrammatic goniometry are comparable with those of the standard procedure. The study included two procedurally different parts, which were replicated by assigning 24 medical students to act interchangeably as 12 subjects and 12 raters. A larger component of the study was designed to compare goniometers side-by-side in measurement of finger joint angles varying from subject to subject. In the rest of the study, the instruments were compared by parallel evaluations of joint angles similar for all subjects in a situation of simulated change of joint range of motion over time. The subjects used special guides to position the joints of their left ring finger at varying angles of flexion and extension. The obtained diagrams of joint angles were converted to numerical values by computerized measurements. The statistical approaches included calculation of appropriate intraclass correlation coefficients, standard errors of measurements, proportions of measurement differences of 5 or less degrees, and significant differences between paired observations. Reliability estimates were similar for both goniometers. Intra-rater and inter-rater intraclass correlation coefficients ranged from 0.69 to 0.93. The corresponding standard errors of measurements ranged from 2.4 to 4.9 degrees. Repeated measurements of a considerable number of raters fell within clinically non-meaningful 5 degrees of each other in proportions comparable with a criterion value of 0.95. Data collected with both instruments could be similarly interpreted in a simulated situation of change of joint range of motion over time. The paper goniometer and the standard goniometer can

A longitudinal study of gene expression in healthy individuals

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Tessier Michel

2009-06-01

Full Text Available Abstract Background The use of gene expression in venous blood either as a pharmacodynamic marker in clinical trials of drugs or as a diagnostic test requires knowledge of the variability in expression over time in healthy volunteers. Here we defined a normal range of gene expression over 6 months in the blood of four cohorts of healthy men and women who were stratified by age (22–55 years and > 55 years and gender. Methods Eleven immunomodulatory genes likely to play important roles in inflammatory conditions such as rheumatoid arthritis and infection in addition to four genes typically used as reference genes were examined by quantitative reverse transcription-polymerase chain reaction (qRT-PCR, as well as the full genome as represented by Affymetrix HG U133 Plus 2.0 microarrays. Results Gene expression levels as assessed by qRT-PCR and microarray were relatively stable over time with ~2% of genes as measured by microarray showing intra-subject differences over time periods longer than one month. Fifteen genes varied by gender. The eleven genes examined by qRT-PCR remained within a limited dynamic range for all individuals. Specifically, for the seven most stably expressed genes (CXCL1, HMOX1, IL1RN, IL1B, IL6R, PTGS2, and TNF, 95% of all samples profiled fell within 1.5–2.5 Ct, the equivalent of a 4- to 6-fold dynamic range. Two subjects who experienced severe adverse events of cancer and anemia, had microarray gene expression profiles that were distinct from normal while subjects who experienced an infection had only slightly elevated levels of inflammatory markers. Conclusion This study defines the range and variability of gene expression in healthy men and women over a six-month period. These parameters can be used to estimate the number of subjects needed to observe significant differences from normal gene expression in clinical studies. A set of genes that varied by gender was also identified as were a set of genes with elevated

Narrow cervical canal in 1211 asymptomatic healthy subjects: the relationship with spinal cord compression on MRI.

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Nakashima, Hiroaki; Yukawa, Yasutsugu; Suda, Kota; Yamagata, Masatsune; Ueta, Takayoshi; Kato, Fumihiko

2016-07-01

Narrow cervical canal (NCC) has been a suspected risk factor for later development of cervical myelopathy. However, few studies have evaluated the prevalence in asymptomatic subjects. The purpose of this study was to investigate the prevalence of NCC in a large cohort of asymptomatic volunteers. This study was a cross-sectional study of 1211 asymptomatic volunteers. Approximately 100 men and 100 women representing each decade of life from the 20s to the 70s were included in this study. Cervical canal anteroposterior diameters at C5 midvertebral level on X-rays, and the prevalence of spinal cord compression (SCC) and increased signal intensity (ISI) changes on MRI were evaluated. Receiver operating characteristic analysis was performed to determine the cut-off value of the severity of canal stenosis resulting in SCC. NCC (<14 mm) was observed in 123 (10.2 %) subjects. SCC and ISI were found in 64 (5.3 %) and 28 (2.3 %) subjects, respectively. The prevalence of NCC was significantly higher in females and older subjects, but the occurrence of severe NCC (<12 mm) did not increase with age. The canal size in subjects with SCC or ISI was significantly smaller than in those without SCC (p < 0.0001). The cut-off values of cervical canal stenosis resulting in SCC were 14.8 and 13.9 mm in males and females, respectively. The prevalence of NCC was considerably lower among asymptomatic healthy volunteers; the cervical canal diameter in subjects with SCC or ISI was significantly smaller than in asymptomatic subjects; NCC is a risk factor for SCC.

Prefrontal Activity and Connectivity with the Basal Ganglia during Performance of Complex Cognitive Tasks Is Associated with Apathy in Healthy Subjects.

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Fazio, Leonardo; Logroscino, Giancarlo; Taurisano, Paolo; Amico, Graziella; Quarto, Tiziana; Antonucci, Linda Antonella; Barulli, Maria Rosaria; Mancini, Marina; Gelao, Barbara; Ferranti, Laura; Popolizio, Teresa; Bertolino, Alessandro; Blasi, Giuseppe

2016-01-01

Convergent evidence indicates that apathy affects cognitive behavior in different neurological and psychiatric conditions. Studies of clinical populations have also suggested the primary involvement of the prefrontal cortex and the basal ganglia in apathy. These brain regions are interconnected at both the structural and functional levels and are deeply involved in cognitive processes, such as working memory and attention. However, it is unclear how apathy modulates brain processing during cognition and whether such a modulation occurs in healthy young subjects. To address this issue, we investigated the link between apathy and prefrontal and basal ganglia function in healthy young individuals. We hypothesized that apathy may be related to sub-optimal activity and connectivity in these brain regions. Three hundred eleven healthy subjects completed an apathy assessment using the Starkstein's Apathy Scale and underwent fMRI during working memory and attentional performance tasks. Using an ROI approach, we investigated the association of apathy with activity and connectivity in the DLPFC and the basal ganglia. Apathy scores correlated positively with prefrontal activity and negatively with prefrontal-basal ganglia connectivity during both working memory and attention tasks. Furthermore, prefrontal activity was inversely related to attentional behavior. These results suggest that in healthy young subjects, apathy is a trait associated with inefficient cognitive-related prefrontal activity, i.e., it increases the need for prefrontal resources to process cognitive stimuli. Furthermore, apathy may alter the functional relationship between the prefrontal cortex and the basal ganglia during cognition.

Prefrontal Activity and Connectivity with the Basal Ganglia during Performance of Complex Cognitive Tasks Is Associated with Apathy in Healthy Subjects.

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Leonardo Fazio

Full Text Available Convergent evidence indicates that apathy affects cognitive behavior in different neurological and psychiatric conditions. Studies of clinical populations have also suggested the primary involvement of the prefrontal cortex and the basal ganglia in apathy. These brain regions are interconnected at both the structural and functional levels and are deeply involved in cognitive processes, such as working memory and attention. However, it is unclear how apathy modulates brain processing during cognition and whether such a modulation occurs in healthy young subjects. To address this issue, we investigated the link between apathy and prefrontal and basal ganglia function in healthy young individuals. We hypothesized that apathy may be related to sub-optimal activity and connectivity in these brain regions.Three hundred eleven healthy subjects completed an apathy assessment using the Starkstein's Apathy Scale and underwent fMRI during working memory and attentional performance tasks. Using an ROI approach, we investigated the association of apathy with activity and connectivity in the DLPFC and the basal ganglia.Apathy scores correlated positively with prefrontal activity and negatively with prefrontal-basal ganglia connectivity during both working memory and attention tasks. Furthermore, prefrontal activity was inversely related to attentional behavior.These results suggest that in healthy young subjects, apathy is a trait associated with inefficient cognitive-related prefrontal activity, i.e., it increases the need for prefrontal resources to process cognitive stimuli. Furthermore, apathy may alter the functional relationship between the prefrontal cortex and the basal ganglia during cognition.

Intraocular pressure following 18 hours of systemic dehydration in ocular normotensive healthy subjects

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Faustina K. Idu

2015-07-01

Full Text Available Aim: To investigate the effect of dehydration on intraocular pressure (IOP. Subjects: The study population comprised 50 subjects (27 men and 23 women with a mean age of 42.84 ± 2.64 years. Method: The subjects dehydrated for 18 hours. IOP was assessed in both eyes using the Perkins handheld applanation tonometer. Baseline measurement of IOP was taken before the subjects dehydrated for 18 hours and repeated after dehydration. Blood samples were taken before and after dehydration for the determination of plasma osmolality and plasma antidiuretic hormone (ADH concentrations. Results: A statistically significant (p < 0.001 reduction in the mean weight of subjects occurred after dehydration. There was a significant reduction in IOP from 16.68 mmHg ± 0.32 mmHg to 13.08 mmHg ± 0.31 mmHg after dehydration (p < 0.001. Mean plasma osmolality showed a statistically significant increase (p < 0.05 from baseline of 290.02 mOsmol/kg ± 1.25 mOsmol/kg to 294.96 mOsmol/kg ± 1.33 mOsmol/kg after dehydration. There was also a significant increase (p < 0.05 in mean plasma ADH concentration from 5.36 pg/mL ± 0.21 pg/mL to 6.40 pg/mL ± 0.20 pg/mL after dehydration. There were no significant differences in both systolic and diastolic blood pressures before and after dehydration. Conclusion: Dehydration decreases IOP in healthy humans; this decrease probably results from an increase in plasma osmolality and plasma ADH concentrations.

Deep pain thresholds in the distal limbs of healthy human subjects.

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Rolke, R; Andrews Campbell, K; Magerl, W; Treede, R-D

2005-02-01

Pressure pain thresholds (PPTs) in distal limbs have been under-investigated despite their potential clinical importance. Therefore, we compared PPTs over nail bed, bony prominences, and muscle in distal parts of upper and lower limbs. We investigated 12 healthy subjects using three handheld devices: a spring-loaded, analogue pressure threshold meter (PTM) with two operating ranges, and an electronic Algometer. PPTs were determined with three series of ascending stimulus intensities with a ramp of about 50 kPa/s. PPTs were normally distributed in logarithmic space. PPTs over different tissues varied significantly (ANOVA, pAlgometer than with PTMs (ANOVA, ptesting over muscle. There was no significant right-left difference (ANOVA, p=0.33). In spite of considerable variability across subjects, reproducibility within subjects was high (correlation coefficients>0.90). For within-subject comparisons, threshold elevations beyond 33-43% would be abnormal (95% confidence intervals), whereas only deviations from the group mean by at least a factor of two would be abnormal with respect to absolute normative values. PPTs over distal muscles were comparable to published values on proximal limb and trunk muscles. These findings suggest that pressure pain testing over distal muscles may be a sensitive test for deep pain sensitivity and that the simple and less expensive devices are sufficient for testing this tissue type. Intra-individual site-to-site comparisons will be more sensitive than absolute normative values.

Spectral components of laser Doppler flowmetry signals recorded in healthy and type 1 diabetic subjects at rest and during a local and progressive cutaneous pressure application: scalogram analyses

International Nuclear Information System (INIS)

Humeau, Anne; Koitka, Audrey; Abraham, Pierre; Saumet, Jean-Louis; L'Huillier, Jean-Pierre

2004-01-01

A significant transient increase in laser Doppler flowmetry (LDF) signals is observed in response to a local and progressive cutaneous pressure application in healthy subjects. This reflex may be impaired in diabetic patients. The work presents a signal processing providing the clarification of this phenomenon. Scalogram analyses of LDF signals recorded at rest and during a local and progressive cutaneous pressure application are performed on healthy and type 1 diabetic subjects. Three frequency bands, corresponding to myogenic, neurogenic and endothelial related metabolic activities, are studied. The results show that, at rest, the scalogram energy of each frequency band is significantly lower for diabetic patients than for healthy subjects, but the scalogram relative energies do not show any statistical difference between the two groups. Moreover, the neurogenic and endothelial related metabolic activities are significantly higher during the progressive pressure than at rest, in healthy and diabetic subjects. However, the relative contribution of the endothelial related metabolic activity is significantly higher during the progressive pressure than at rest, in the interval 200-400 s following the beginning of the pressure application, but only for healthy subjects. These results may improve knowledge on cutaneous microvascular responses to injuries or local pressures initiating diabetic complications

Spectral components of laser Doppler flowmetry signals recorded in healthy and type 1 diabetic subjects at rest and during a local and progressive cutaneous pressure application: scalogram analyses

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Humeau, Anne [Groupe ISAIP-ESAIP, 18 rue du 8 mai 1945, BP 80022, 49180 Saint Barthelemy d' Anjou cedex (France); Koitka, Audrey [Laboratoire de Physiologie et d' Explorations Vasculaires, Centre Hospitalier Universitaire d' Angers, 49033 Angers cedex 01 (France); Abraham, Pierre [Laboratoire de Physiologie et d' Explorations Vasculaires, Centre Hospitalier Universitaire d' Angers, 49033 Angers cedex 01 (France); Saumet, Jean-Louis [Laboratoire de Physiologie et d' Explorations Vasculaires, Centre Hospitalier Universitaire d' Angers, 49033 Angers cedex 01 (France); L' Huillier, Jean-Pierre [Ecole Nationale Superieure d' Arts et Metiers (ENSAM), Laboratoire Procedes-Materiaux-Instrumentation (LPMI), 2 boulevard du Ronceray, BP 3525, 49035 Angers cedex (France)

2004-09-07

A significant transient increase in laser Doppler flowmetry (LDF) signals is observed in response to a local and progressive cutaneous pressure application in healthy subjects. This reflex may be impaired in diabetic patients. The work presents a signal processing providing the clarification of this phenomenon. Scalogram analyses of LDF signals recorded at rest and during a local and progressive cutaneous pressure application are performed on healthy and type 1 diabetic subjects. Three frequency bands, corresponding to myogenic, neurogenic and endothelial related metabolic activities, are studied. The results show that, at rest, the scalogram energy of each frequency band is significantly lower for diabetic patients than for healthy subjects, but the scalogram relative energies do not show any statistical difference between the two groups. Moreover, the neurogenic and endothelial related metabolic activities are significantly higher during the progressive pressure than at rest, in healthy and diabetic subjects. However, the relative contribution of the endothelial related metabolic activity is significantly higher during the progressive pressure than at rest, in the interval 200-400 s following the beginning of the pressure application, but only for healthy subjects. These results may improve knowledge on cutaneous microvascular responses to injuries or local pressures initiating diabetic complications.

The Effects of the Disturbance of the Vestibular System on the Dynamic Balance of Idiopathic Scoliotic Subjects with and Without Exercise Therapy Compared to Healthy Subjects

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N. Farahpour

2004-01-01

Full Text Available The mechanism of the neuromuscular system’s disorders in Adolescent Idiopathic Scoliosis (AIS are not well known. The objectives of this study were to assess the dynamic balance of the AIS patients and the influence of exercise therapy on patients' dynamic balance. Eleven teenager scoliotic subjects after three months exercise therapy, nine similar patients without therapy and 13 healthy age matched subjects as control group were studied. Using dynamic stability platform, the deviation of COG of subjects in different positions, including up right standing, standing with head flexion and standing with head hyper extension were measured. The tests were repeated in both lose and stable condition of the foot platform. Results showed that the stability of the foot platform resulted in COG's deviation by 1.13 0.08 in all subjects. Dynamic balance of scoliotic patients without treatment was similar to that of the normal subjects. While, exercised patients had less COG deviation than the other groups. The change in head position increased the COG deviation by 2.5 times in control and non-exercised patients and 1.5 times in exercised patients. The dynamic balance in scoliosis was not affected. Exercise improved the dynamic balance in scoliotic subjects. Exercise therapy is recommended to improve the proprioceptives function.

Population pharmacokinetics of artesunate and dihydroartemisinin following single- and multiple-dosing of oral artesunate in healthy subjects

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Kirsch Lee E

2009-12-01

Full Text Available Abstract Background The population pharmacokinetics of artesunate (AS and its active metabolite dihydroartemisinin (DHA were studied in healthy subjects receiving single- or multiple-dosing of AS orally either in combination with pyronaridine (PYR or as a monotherapy with or without food. Methods Data from 118 concentration-time profiles arising from 91 healthy Korean subjects were pooled from four Phase I clinical studies. Subjects received 2-5 mg/kg of single- and multiple-dosing of oral AS either in combination with PYR or as a monotherapy with or without food. Plasma AS and DHA were measured simultaneously using a validated liquid chromatography- mass spectrometric method with a lower limit of quantification of 1 ng/mL for both AS and DHA. Nonlinear mixed-effect modelling was used to obtain the pharmacokinetic and variability (inter-individual and residual variability parameter estimates. Results A novel parent-metabolite pharmacokinetic model consisting of a dosing compartment, a central compartment for AS, a central compartment and a peripheral compartment for DHA was developed. AS and DHA data were modelled simultaneously assuming stoichiometric conversion to DHA. AS was rapidly absorbed with a population estimate of absorption rate constant (Ka of 3.85 h-1. The population estimates of apparent clearance (CL/F and volume of distribution (V2/F for AS were 1190 L/h with 36.2% inter-individual variability (IIV and 1210 L with 57.4% IIV, respectively. For DHA, the population estimates of apparent clearance (CLM/F and central volume of distribution (V3/F were 93.7 L/h with 28% IIV and 97.1 L with 30% IIV, respectively. The population estimates of apparent inter-compartmental clearance (Q/F and peripheral volume of distribution (V4/F for DHA were 5.74 L/h and 18.5 L, respectively. Intake of high-fat and high-caloric meal prior to the drug administration resulted in 84% reduction in Ka. Body weight impacted CLM/F, such that a unit change in

Pharmacokinetic and bioavailability studies of commercially available simvastatin tablets in healthy and moderately hyperlipidaemic human subjects

International Nuclear Information System (INIS)

Ahmed, M.; Qamar-uz-Zaman, M.; Madni, A.; Usman, M.; Atif, M.; Akhtar, N.; Murtaza, G.

2011-01-01

Simvastatin, an analogue of Lovostatin, is a HMG.CoA reductase inhibitor. It is widely used in the treatment of hyperlipidaemia and coronary heart disease (CHD) with low incidence of myopathy and rhabdomyolysis. As these diseases may alter the pharmacokinetics of drugs, the present study was aimed to elaborate the variation in the pharmacokinetics and bioavailability of simvastatin in local healthy and moderately hyperlipidaemic population. Open, single dose and parallel design was applied to study. A total of 36 male volunteers were used for healthy and moderately hyperlipidaemic groups (n 18 for each) in this study on the basis of screening procedures, body chemistry and physical examination. Simvastatin 40 mg tablets (Saista 40, Bosch, Pakistan) were administered to over-night fasted volunteers. Blood samples were collected before dosing (zero time) and at regular intervals of time. The plasma samples were processed through a liquid-liquid extraction procedure and assayed by using HPLC consisting reversed phase C/sub 18/ column (ZORBAX, 4.6 x 150 mm, 5 mu m), UV detector set at 238 nm. The mobile phase consisted of the mixture of 0.025 M sodium dihydrogen phosphate (pH 4.5): acetonitrile (35: 65, v/v) which was pumped at a flow rate of 1.5 mL.min/sup -1/. The retention time of simvastatin was 7.5 minutes. The plasma drug concentration-time profiles of both groups were found significantly (P 0.05) difference between the values of following pharmacokinetic parameters in healthy and hyperlipidaemic volunteers i.e. C/sub max/, t/sub max/, AUC/sub 0-fi), AUMC/sub 0-enfinity), MRT, t/sub 1/2/, Cl/sub t /and K/sub e/. This study confirmed no significant (P > 0.05) difference in pharmacokinetics and bioavailability parameters after the administration of a single oral dose of 40 mg simvastatin (cholesterol lowering drug) to healthy and moderately hyperlipidaemic volunteers. (author)

A pharmacokinetic and pharmacodynamic drug interaction between rosuvastatin and valsartan in healthy subjects

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Jung JA

2015-03-01

Full Text Available Jin Ah Jung,1 Soo-Yun Lee,2 Jung-Ryul Kim,1 Jae-Wook Ko,1,2 Seong Bok Jang,3 Su Youn Nam,3 Wooseong Huh1,41Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, 2Department of Health Sciences and Technology, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, 3Yuhan Research Institute, Yuhan Corporation, 4Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaPurpose: Valsartan, an angiotensin-receptor blocker, and rosuvastatin, a competitive inhibitor of the 3-hydroxy-3-methylglutaryl coenzyme A reductase, are frequently coadministered to treat patients with hypertension and dyslipidemia. The study reported here sought to evaluate the pharmacokinetic and pharmacodynamic interactions between rosuvastatin and valsartan in healthy Korean subjects. Subjects and methods: Thirty healthy male Korean subjects were administered with rosuvastatin (20 mg/day, valsartan (160 mg/day, and both drugs concomitantly for 4 days in a randomized, open-label, multiple-dose, three-treatment, three-period crossover study. Plasma concentrations of rosuvastatin, N-desmethyl rosuvastatin, and valsartan were determined using validated high-performance liquid chromatography with tandem mass spectrometry. Lipid profiles and vital signs (systolic and diastolic blood pressure and pulse rate were measured for the pharmacodynamic assessment.Results: For rosuvastatin, the geometric mean ratios (90% confidence intervals [CIs] of coadministration to mono-administration were 0.8809 (0.7873-0.9857 for maximum plasma concentration at steady state and 0.9151 (0.8632-0.9701 for area under the concentration–time curve (AUC over a dosing interval at steady state. For valsartan, the geometric mean ratios (90% CIs of those were 0.9300 (0.7946-1.0884 and 1.0072 (0.8893-1.1406, respectively. There were no significant differences in the metabolic ratio of N

Small intestinal bacterial overgrowth prevalence in celiac disease patients is similar in healthy subjects and lower in irritable bowel syndrome patients.

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Lasa, J S; Zubiaurre, I; Fanjul, I; Olivera, P; Soifer, L

2015-01-01

Untreated celiac disease has traditionally been linked to a greater risk for small intestinal bacterial overgrowth, but the existing evidence is inconclusive. To compare the prevalence of small intestinal bacterial overgrowth in subjects with celiac disease compared with control subjects and patients with irritable bowel syndrome. The study included 15 untreated celiac disease patients, 15 subjects with irritable bowel syndrome, and 15 healthy controls. All enrolled patients underwent a lactulose breath test measuring hydrogen and methane. Small intestinal bacterial overgrowth was defined according to previously published criteria. No differences were found in relation to age or sex. The prevalence of small intestinal bacterial overgrowth was similar between the celiac disease patients and the controls (20 vs. 13.33%, P=NS), whereas it was higher in patients with irritable bowel syndrome (66.66%, Pintestinal bacterial overgrowth between the untreated celiac disease patients and healthy controls. Copyright © 2015 Asociación Mexicana de Gastroenterología. Published by Masson Doyma México S.A. All rights reserved.

Study on Yang-Xu Using Body Constitution Questionnaire and Blood Variables in Healthy Volunteers

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Hong-Jhang Chen

2016-01-01

Full Text Available Traditional Chinese medicine (TCM formulates treatment according to body constitution (BC differentiation. Different constitutions have specific metabolic characteristics and different susceptibility to certain diseases. This study aimed to assess the Yang-Xu constitution using a body constitution questionnaire (BCQ and clinical blood variables. A BCQ was employed to assess the clinical manifestation of Yang-Xu. The logistic regression model was conducted to explore the relationship between BC scores and biomarkers. Leave-one-out cross-validation (LOOCV and K-fold cross-validation were performed to evaluate the accuracy of a predictive model in practice. Decision trees (DTs were conducted to determine the possible relationships between blood biomarkers and BC scores. According to the BCQ analysis, 49% participants without any BC were classified as healthy subjects. Among them, 130 samples were selected for further analysis and divided into two groups. One group comprised healthy subjects without any BC (68%, while subjects of the other group, named as the sub-healthy group, had three BCs (32%. Six biomarkers, CRE, TSH, HB, MONO, RBC, and LH, were found to have the greatest impact on BCQ outcomes in Yang-Xu subjects. This study indicated significant biochemical differences in Yang-Xu subjects, which may provide a connection between blood variables and the Yang-Xu BC.

Effect of repeated gaboxadol administration on night sleep and next-day performance in healthy elderly subjects.

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Mathias, Stefan; Zihl, Josef; Steiger, Axel; Lancel, Marike

2005-04-01

Aging is associated with dramatic reductions in sleep continuity and sleep intensity. Since gaboxadol, a selective GABA(A) receptor agonist, has been demonstrated to improve sleep consolidation and promote deep sleep, it may be an effective hypnotic, particularly for elderly patients with insomnia. In the present study, we investigated the effects of subchronic gaboxadol administration on nocturnal sleep and its residual effects during the next days in elderly subjects. This was a randomized, double-blind, placebo-controlled, balanced crossover study in 10 healthy elderly subjects without sleep complaints. The subjects were administered either placebo or 15 mg gaboxadol hydrochloride at bedtime on three consecutive nights. Sleep was recorded during each night from 2300 to 0700 h and tests assessing attention (target detection, stroop test) and memory function (visual form recognition, immediate word recall, digit span) were applied at 0900, 1400, and 1700 h during the following days. Compared with placebo, gaboxadol significantly shortened subjective sleep onset latency and increased self-rated sleep intensity and quality. Polysomnographic recordings showed that it significantly decreased the number of awakenings, the amount of intermittent wakefulness, and stage 1, and increased slow wave sleep and stage 2. These effects were stable over the three nights. None of the subjects reported side effects. Next-day cognitive performance was not affected by gaboxadol. Gaboxadol persistently improved subjective and objective sleep quality and was devoid of residual effects. Thus, at the employed dose, it seems an effective hypnotic in elderly subjects.

Frontolimbic serotonin 2A receptor binding in healthy subjects is associated with personality risk factors for affective disorder

DEFF Research Database (Denmark)

Frokjaer, Vibe G.; Mortensen, Erik L.; Nielsen, Finn Årup

2008-01-01

Background: Serotonergic dysfunction has been associated with affective disorders. High trait neuroticism, as measured on personality inventories, is a risk factor for major depression. In this study we investigated whether neuroticism is associated with serotonin 2A receptor binding in brain...... regions of relevance for affective disorders. Methods: Eighty-three healthy volunteers completed the standardized personality questionnaire NEO-PI-R (Revised NEO Personality Inventory) and underwent [F-18]altanserin positron emission tomography imaging for assessment of serotonin 2A receptor binding...... remained significant after correction for multiple comparisons (r = .35, p = .009). Conclusions: In healthy subjects the personality dimension neuroticism and particularly its constituent trait, vulnerability, are positively associated with frontolimbic serotonin 2A binding. Our findings point...

Thermal balneotherapy induces changes of the platelet serotonin transporter in healthy subjects.

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Marazziti, Donatella; Baroni, Stefano; Giannaccini, Gino; Catena Dell'Osso, Mario; Consoli, Giorgio; Picchetti, Michela; Carlini, Marina; Massimetti, Gabriele; Provenzano, Serafina; Galassi, Antonio

2007-10-01

Although the beneficial effects of balneotherapy have been recognized since a long time, a few information is available on the biological mechanisms underlying them and the subjective feelings of increased well-being and mood. The links between the serotonin (5-HT) system and mood prompted us to investigate the 5-HT platelet transporter (SERT), which is considered a reliable, peripheral marker of the same structure present in presynaptic neurons, in 20 healthy volunteers before (t0) and 30 min after (t1) thermal balneotherapy with ozonized water of Montecatini spa, as compared with a similar group who underwent a bath in non-mineral water. The SERT was evaluated by means of the specific binding of (3)H-paroxetine ((3)H-Par) to platelet membranes. Equilibrium-saturation binding data, the maximal binding capacity (Bmax) and the dissociation constant (Kd), were obtained by means of the Scatchard analysis. The results showed that, while Bmax values did not change in both groups, the Kd values decreased significantly at t1 only in those subjects who bathed in ozonized water. The results of this study, while showing a decrease of the dissociation constant (Kd) which is the inverse of affinity constant, of (3)H-Par binding to SERT in all subjects after balneotherapy and not in those bathing in normal water, suggest that SERT modifications may be related to a specific effect of ozonized water and, perhaps, also to the increased sense of well-being.

Malassezia intra-specific diversity and potentially new species in the skin microbiota from Brazilian healthy subjects and seborrheic dermatitis patients.

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Renan Cardoso Soares

Full Text Available Malassezia yeasts are part of the resident cutaneous microbiota, and are also associated with skin diseases such as seborrheic dermatitis (SD. The role these fungi play in skin diseases and why they are pathogenic for only some individuals remain unclear. This study aimed to characterize Malassezia microbiota from different body sites in healthy and SD subjects from Brazil. Scalp and forehead samples from healthy, mild SD and severe SD subjects were collected. Non-scalp lesions from severe SD patients were also sampled. 5.8S rDNA/ITS2 amplicons from Malassezia sp. were analyzed by RFLP and sequencing. Results indicate that Malassezia microbiota did not group according to health condition or body area. Phylogenetic analysis revealed that three groups of sequences did not cluster together with any formally described species, suggesting that they might belong to potential new species. One of them was found in high proportions in scalp samples. A large variety of Malassezia subtypes were detected, indicating intra-specific diversity. Higher M. globosa proportions were found in non-scalp lesions from severe SD subjects compared with other areas, suggesting closer association of this species with SD lesions from areas other than scalp. Our results show the first panorama of Malassezia microbiota in Brazilian subjects using molecular techniques and provide new perspectives for further studies to elucidate the association between Malassezia microbiota and skin diseases.

The Effect of Isomaltulose Together with Green Tea on Glycemic Response and Antioxidant Capacity: A Single-Blind, Crossover Study in Healthy Subjects.

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Suraphad, Passakorn; Suklaew, Phim On; Ngamukote, Sathaporn; Adisakwattana, Sirichai; Mäkynen, Kittana

2017-05-06

Isomaltulose, a naturally-occurring isomer of sucrose, is commonly used as an alternative sweetener in foods and beverages. The goal of this study was to determine the effect of isomaltulose together with green tea on postprandial plasma glucose and insulin concentration, as well as antioxidant capacity in healthy subjects. In a randomized, single-blind, crossover study, 15 healthy subjects (eight women and seven men; ages 23.5 ± 0.7 years; with body mass index of 22.6 ± 0.4 kg/m²) consumed five beverages: (1) 50 g sucrose in 400 mL water; (2) 50 g isomaltulose in 400 mL of water; (3) 400 mL of green tea; (4) 50 g sucrose in 400 mL of green tea; and (5) 50 g isomaltulose in 400 mL of green tea. Incremental area under postprandial plasma glucose, insulin, ferric reducing ability of plasma (FRAP) and malondialdehyde (MDA) concentration were determined during 120 min of administration. Following the consumption of isomaltulose, the incremental 2-h area under the curve (AUC 0-2 h ) indicated a higher reduction of postprandial glucose (43.4%) and insulin concentration (42.0%) than the consumption of sucrose. The addition of green tea to isomaltulose produced a greater suppression of postprandial plasma glucose (20.9%) and insulin concentration (37.7%). In accordance with antioxidant capacity, consumption of sucrose (40.0%) and isomaltulose (28.7%) caused the reduction of green tea-induced postprandial increases in FRAP. A reduction in postprandial MDA after drinking green tea was attenuated when consumed with sucrose (34.7%) and isomaltulose (17.2%). In conclusion, green tea could enhance the reduction of postprandial glucose and insulin concentration when consumed with isomaltulose. In comparison with sucrose, isomaltulose demonstrated less alteration of plasma antioxidant capacity after being consumed with green tea.

Pharmacokinetics of lansoprazole and its main metabolites after single intravenous doses in healthy Chinese subjects.

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Zhang, Dan; Yang, Man; Liu, Man; Zhang, Yanan; Wang, Xiaolin; Xiao, Xue; Liu, Huichen

2012-11-01

The aim of the study was to evaluate the pharmacokinetics (PK) of lansoprazole (LPZ) and its main metabolites 5'-hydroxy lansoprazole (HLPZ) and lansoprazole sulphone (LPZS) after single intravenous (i.v.) doses of LPZ in healthy Chinese subjects, and the relationship between the cytochrome P450 (CYP) 2C19 phenotypes and the plasma concentrations of LPZS at the time-points in the elimination phase of LPZ. Twelve subjects were given lansoprazole by i.v. infusion. Blood samples were collected at designated time points up to 24 h. Plasma concentrations of LPZ, HLPZ and LPZS were quantified by a selective and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) method. After single i.v. doses of 15, 30 and 60 mg LPZ, C(max) and area under the plasma concentration-time curve (AUC(0-t)) of LPZ were 725 ± 151, 1480 ± 190, 3130 ± 480 µg · L(-1) and 1690 ± 1210, 3630 ± 2530, 8080 ± 4550 µg · h · L(-1), respectively. LPZ was generally well tolerated in healthy Chinese subjects, and displayed linear PK in the range of 15-60 mg. There were significant differences in the elimination of LPZ and the formation of LPZS between the single CYP2C19 poor metabolizer (PM) and the CYP2C19 extensive metabolizers (EM). The concentration of LPZS at the time-points in the elimination phase of LPZ could be monitored for CYP2C19 phenotyping. As a probe drug for CYP2C19 phenotyping, LPZ for injection might be more suitable than LPZ oral formulations.

Effect of fosamprenavir-ritonavir on the pharmacokinetics of dolutegravir in healthy subjects.

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Song, Ivy; Borland, Julie; Chen, Shuguang; Peppercorn, Amanda; Wajima, Toshihiro; Piscitelli, Stephen C

2014-11-01

Dolutegravir (DTG) is an HIV integrase inhibitor (INI) with demonstrated activity in INI-naive and INI-resistant patients. The objective of this open-label, 2-period, single-sequence study was to evaluate the effect of fosamprenavir-ritonavir (FPV-RTV) on the steady-state plasma pharmacokinetics of DTG. Twelve healthy subjects received 50 mg DTG once daily for 5 days (period 1), followed by 10 days of 50 mg DTG once daily in combination with 700/100 mg FPV-RTV every 12 h (period 2). All doses were administered in the fasting state. Serial pharmacokinetic samples for DTG and amprenavir and safety assessments were obtained throughout the study. Noncompartmental pharmacokinetic analysis was performed, and geometric least-squares mean ratios and 90% confidence intervals were generated for within-subject treatment comparison. Fosamprenavir-ritonavir decreased the DTG area under the concentration-time curve, maximum concentration in plasma, and concentration in plasma at the end of the dosing interval by 35%, 24%, and 49%, respectively. Both DTG and DTG with FPV-RTV were well tolerated; no subject withdrew because of adverse events. The most frequently reported drug-related adverse events were rash, abnormal dreams, and nasopharyngitis. The modest decrease in DTG exposure when it was coadministered with FPV-RTV is not considered clinically significant, and DTG dose adjustment is not required with coadministration of FPV-RTV in INI-naive patient populations on the basis of established "no-effect" boundaries of DTG. In the INI-resistant population, as a cautionary measure, alternative combinations that do not include FPV-RTV should be considered. (This study has been registered at ClinicalTrials.gov under identifier NCT01209065.). Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Methodologic Considerations for Quantitative 18F-FDG PET/CT Studies of Hepatic Glucose Metabolism in Healthy Subjects.

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Trägårdh, Malene; Møller, Niels; Sørensen, Michael

2015-09-01

PET with the glucose analog (18)F-FDG is used to measure regional tissue metabolism of glucose. However, (18)F-FDG may have affinities different from those of glucose for plasma membrane transporters and intracellular enzymes; the lumped constant (LC) can be used to correct these differences kinetically. The aims of this study were to investigate the feasibility of measuring human hepatic glucose metabolism with dynamic (18)F-FDG PET/CT and to determine an operational LC for (18)F-FDG by comparison with (3)H-glucose measurements. Eight healthy human subjects were included. In all studies, (18)F-FDG and (3)H-glucose were mixed in saline and coadministered. A 60-min dynamic PET recording of the liver was performed for 180 min with blood sampling from catheters in a hepatic vein and a radial artery (concentrations of (18)F-FDG and (3)H-glucose in blood). Hepatic blood flow was determined by indocyanine green infusion. First, 3 subjects underwent studies comparing bolus administration and constant-infusion administration of tracers during hyperinsulinemic-euglycemic clamping. Next, 5 subjects underwent studies comparing fasting and hyperinsulinemic-euglycemic clamping with tracer infusions. Splanchnic extraction fractions of (18)F-FDG (E*) and (3)H-glucose (E) were calculated from concentrations in blood, and the LC was calculated as ln(1 - E*)/ln(1 - E). Volumes of interest were drawn in the liver tissue, and hepatic metabolic clearance of (18)F-FDG (mL of blood/100 mL of liver tissue/min) was estimated. For bolus versus infusion, E* values were always negative when (18)F-FDG was administered as a bolus and were always positive when it was administered as an infusion. For fasting versus clamping, E* values were positive in 4 of 5 studies during fasting and were always positive during clamping. Negative extraction fractions were ascribed to the tracer distribution in the large volume of distribution in the prehepatic splanchnic bed. The LC ranged from 0.43 to 2

Recapitulation of Clinical Individual Susceptibility to Drug-Induced QT Prolongation in Healthy Subjects Using iPSC-Derived Cardiomyocytes

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Tadahiro Shinozawa

2017-02-01

Full Text Available To predict drug-induced serious adverse events (SAE in clinical trials, a model using a panel of cells derived from human induced pluripotent stem cells (hiPSCs of individuals with different susceptibilities could facilitate major advancements in translational research in terms of safety and pharmaco-economics. However, it is unclear whether hiPSC-derived cells can recapitulate interindividual differences in drug-induced SAE susceptibility in populations not having genetic disorders such as healthy subjects. Here, we evaluated individual differences in SAE susceptibility based on an in vitro model using hiPSC-derived cardiomyocytes (hiPSC-CMs as a pilot study. hiPSCs were generated from blood samples of ten healthy volunteers with different susceptibilities to moxifloxacin (Mox-induced QT prolongation. Different Mox-induced field potential duration (FPD prolongation values were observed in the hiPSC-CMs from each individual. Interestingly, the QT interval was significantly positively correlated with FPD at clinically relevant concentrations (r > 0.66 in multiple analyses including concentration-QT analysis. Genomic analysis showed no interindividual significant differences in known target-binding sites for Mox and other drugs such as the hERG channel subunit, and baseline QT ranges were normal. The results suggest that hiPSC-CMs from healthy subjects recapitulate susceptibility to Mox-induced QT prolongation and provide proof of concept for in vitro preclinical trials.

A pharmacokinetic and bioequivalence study of Contiflo ICON 400 µg tablets in healthy Indian subjects.

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Monif, T; Arora, V; Madan, S; Arora, R; Balaji, A; Jha, D; Thudi, N R

2010-12-01

Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in human prostate. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of benign prostatic hypertrophy. A new formulation Contiflo ICON 400 µg has been developed by Ranbaxy Laboratories Limited, India similar to Flomaxtra XL 400 µg of Astellas Pharma Limited, United Kingdom. This product is specifically designed to achieve a more consistent plasma concentration over a period of 24-h, a lower maximum plasma concentration (Cmax) and an independence of pharmacokinetics (PKs) on food intake. The objective of the present study was to evaluate the pharmacokinetics and bioequivalence of the new formulation Contiflo ICON 400 µg of Ranbaxy Laboratories Limited, India and Flomaxtra XL 400 µg prolonged release tablets (containing tamsulosin hydrochloride prolonged release 400 µg) of Astellas Pharma Limited, United Kingdom. Study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single-dose bioequivalence study in 32 adult male human subjects under fed conditions. The mean (range) age, weight and height of the study subjects were 27.03 years (19 - 40 years), 57.19 kg (48 - 72 kg) and 166.81 cm (154 - 181 cm) respectively. Blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 20, 24, 36, 48, 72, and 96 h post dose in each period. Plasma samples were analyzed for tamsulosin by using validated liquid chromatographic mass spectrometry (LC-MS/MS) method. The Mean ± SD of pharmacokinetic parameters tmax, Cmax, AUC24, AUClast and AUCinf for Tamsulosin were 11.741 ± 4.7201 and 12.155 ± 6.3077 h, 10.7614 ± 4.76709 and 10.4954 ± 5.08979 ng/ml, 171.4674 ± 77.39695 and 160.6738 ± 77.98628 ng.h/ml, 262.7771 ± 150.21432 and 250.6854 ± 156.75581 ng

Population pharmacokinetics of nalmefene in healthy subjects and its relation to μ-opioid receptor occupancy.

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Kyhl, Lars-Erik Broksoe; Li, Shen; Faerch, Kirstine Ullitz; Soegaard, Birgitte; Larsen, Frank; Areberg, Johan

2016-02-01

The aims of this study were to develop a population pharmacokinetic (PK) model to describe the PK of nalmefene in healthy subjects and to relate the exposure of nalmefene to the μ-opioid receptor occupancy by simulations in the target population. Data from nine phase I studies (243 subjects) with extensive blood sampling were pooled and used for the population PK model building. Data from four other phase I studies (85 subjects) were pooled and used as an external validation dataset. Eight subjects from an imaging study contributed occupancy data and the pharmacokinetic/pharmacodynamic (PK/PD) relationship was modelled. Combining the population PK model and the PK/PD relationship enabled simulations to predict μ-opioid occupancy. A two compartment model with first order absorption best described the nalmefene PK data. The typical subject in the population was estimated to have a systemic clearance of 60.4 l h(-1) and a central volume of distribution of 266 l. Absolute oral bioavailability was estimated to 41% without food intake and with food about 53%. Simulation of the μ-opioid receptor occupancy shows that the 95% confidence bound is within or above 60-90% occupancy for up to 22-24 h after a single dose of 20 mg nalmefene. A robust population PK model for nalmefene was developed. Based on the concentration-occupancy model the μ-opioid receptor occupancy after a single 20 mg dose of nalmefene is predicted to be above the target therapeutic occupancy for about 24 h in about 95% of the target population. © 2015 The British Pharmacological Society.

Using functional Magnetic Resonance Imaging to differentiate between Healthy Aging subjects, Mild Cognitive Impairment, and Alzheimer’s Patients

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Mohammad Ali Oghabian

2010-01-01

Full Text Available

Back ground: Alzheimer's disease is the most common form of dementia which is still difficult to be differentiated from other types of brain disorders. Moreover, Mild Cognitive Impairment refers to the presence of cognitive impairments that is not severe enough to meet the criteria of dementia, and its diagnosis in early stages is so critical. There is currently no distinct method available for diagnosing Alzheimer's or Mild Cognitive Impairment, and their diagnosis needs a combination of different methods and assessments.

Methods: Our goal in this study was to evaluate the effectiveness of fMRI imaging in differentiating between Alzheimer's, Mild Cognitive Impairment (MCI and Healthy Aging. To prove fMRI's ability, we compared resting-state brain activation patterns between these three groups of subjects using Independent Component Algorithm (ICA. We examined 40 age- and sex-matched subjects, 15 elderly, 11 MCI and 14 Alzheimer's subjects.

Results: The results show that during a certain resting-state session, healthy aging brain benefits from larger area and greater intensity of activation (compared with MCI and Alzheimer's group in Posterior Cingulate Cortex (PCC region of the brain, as part of Default Mode Network.

Conclusion: This difference in activation pattern can be used as a diagnostic criterion in using fMRI for differentiating between Alzheimer's disease (AD, MCI and Healthy Aging.

Keywords: fMRI, Default Mode Network, Alzheimer's, Mild Cognitive Impairment, Resting-State

[Microflora of the upper part of the small bowel in healthy Peruvian subjects].

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Vidal-Neira, L; Yi-Chu, A; León Barúa, R

1983-01-01

In 20 healthy Peruvians aerobic cultures were done of upper small bowel contents, obtained following the method of the string capsule or Enterotest, and of faringeal material, obtained doing gargles with sterilized water. In 15 (75%) of the 20 subjects cultures of small bowel contents either were sterile (in 5 subjects, or 25% of the total) or revealed only diverse aerobic germs (in 10 subjects, or 50% of the total), the germs more frequently found being: negative coagulase staphylococcus albus (in 7 subjects, or 35% of the total), alpha hemolytic streptococcus (in 4 subjects, or 20% of the total) and Neisseria catarrhalis (in 4 subjects, or 20% of the total). In 5 (25%) of the 20 subjects, coliform bacteria were found in the upper small bowel (Klebsiella pneumonia in 2, and Escherichia coli in the remaining 3). Of those 5 subjects, only 2 (10% or the total of 20) had the microorganisms exclusively in the bowel, and in both the concentration of germs was 10(4)/ml. On the contrary, the 3 remaining subjects (15% of the total) had coliforms also in the pharynx; in 2 of the 3 subjects the concentration of germs found in the bowel was 10(3)/ml, and, in the remaining one, 10/ml; only one of the 3 subjects presented germs in the pharynx in a greater concentration than in the bowel, while another presented germs in the same concentration in both localizations, and the remaining one presented germs in the bowel in a concentration lower than in the pharynx.(ABSTRACT TRUNCATED AT 250 WORDS)

Study of GABA in healthy volunteers: pharmacokinetics and pharmacodynamics

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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.

Magnetic resonance imaging of ligaments and membranes in the craniocervical junction in whiplash-associated injury and in healthy control subjects

International Nuclear Information System (INIS)

Dullerud, Reidar; Gjertsen, Oeivind; Server, Andres

2010-01-01

Background: The pathogenesis and imaging findings in whiplash-associated injury (WAD) are poorly understood and remain debatable. Purpose: To assess the ligaments and membranes in the craniocervical junction with magnetic resonance imaging (MRI) in patients with WAD and to compare them with healthy control subjects. Material and Methods: Twenty-eight patients with WAD were selected at random from a total number of 180 examined with MRI using 2-mm proton density (PD)-weighted images in three orthogonal planes at 1.5T. The patients were compared with 27 healthy control subjects without neck trauma. Results: High signal intensity of the alar and transverse ligaments was quite common and was reported at an average of about 50% both among patients and control subjects. The incidence of abnormalities of the tectorial and posterior atlanto-occipital membranes was low in both groups. No statistically significant difference between control subjects and patients with WAD was revealed for any of the structures assessed. Additional fat-suppressed images seemed to reduce the number of reported anomalies. Conclusion: Due to lack of significant differences between patients with WAD and healthy control subjects, it is not recommended that MRI with the current technique and classification system be used in the routine workup of patients with WAD

Magnetic resonance imaging of ligaments and membranes in the craniocervical junction in whiplash-associated injury and in healthy control subjects

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Dullerud, Reidar; Gjertsen, Oeivind; Server, Andres (Dept. of Neuroradiology, Ullevaal Univ. Hospital, Oslo (Norway)), e-mail: redu@lds.no

2010-03-15

Background: The pathogenesis and imaging findings in whiplash-associated injury (WAD) are poorly understood and remain debatable. Purpose: To assess the ligaments and membranes in the craniocervical junction with magnetic resonance imaging (MRI) in patients with WAD and to compare them with healthy control subjects. Material and Methods: Twenty-eight patients with WAD were selected at random from a total number of 180 examined with MRI using 2-mm proton density (PD)-weighted images in three orthogonal planes at 1.5T. The patients were compared with 27 healthy control subjects without neck trauma. Results: High signal intensity of the alar and transverse ligaments was quite common and was reported at an average of about 50% both among patients and control subjects. The incidence of abnormalities of the tectorial and posterior atlanto-occipital membranes was low in both groups. No statistically significant difference between control subjects and patients with WAD was revealed for any of the structures assessed. Additional fat-suppressed images seemed to reduce the number of reported anomalies. Conclusion: Due to lack of significant differences between patients with WAD and healthy control subjects, it is not recommended that MRI with the current technique and classification system be used in the routine workup of patients with WAD

Fast-food-based hyper-alimentation can induce rapid and profound elevation of serum alanine aminotransferase in healthy subjects.

Science.gov (United States)

Kechagias, S; Ernersson, A; Dahlqvist, O; Lundberg, P; Lindström, T; Nystrom, F H

2008-05-01

To study the effect of fast-food-based hyper-alimentation on liver enzymes and hepatic triglyceride content (HTGC). Prospective interventional study with parallel control group. University Hospital of Linköping, Sweden. 12 healthy men and six healthy women with a mean (SD) age of 26 (6.6) years and a matched control group. Subjects in the intervention group aimed for a body weight increase of 5-15% by eating at least two fast-food-based meals a day with the goal to double the regular caloric intake in combination with adoption of a sedentary lifestyle for 4 weeks. Weekly changes of serum aminotransferases and HTGC measured by proton nuclear magnetic resonance spectroscopy at baseline and after the intervention. Subjects in the intervention group increased from 67.6 (9.1) kg to 74.0 (11) kg in weight (p19 U/l, men >30 U/l) during the intervention. Sugar (mono- and disaccharides) intake during week 3 correlated with the maximal ALT/baseline ALT ratio (r = 0.62, p = 0.006). HTGC increased from 1.1 (1.9)% to 2.8 (4.8)%, although this was not related to the increase in ALT levels. ALT levels were unchanged in controls. Hyper-alimentation per se can induce profound ALT elevations in less than 4 weeks. Our study clearly shows that in the evaluation of subjects with elevated ALT the medical history should include not only questions about alcohol intake but also explore whether recent excessive food intake has occurred.

A Study on Pharmacokinetics of Bosentan with Systems Modeling, Part 2: Prospectively Predicting Systemic and Liver Exposure in Healthy Subjects.

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Li, Rui; Kimoto, Emi; Niosi, Mark; Tess, David A; Lin, Jian; Tremaine, Larry M; Di, Li

2018-04-01

Predicting human pharmacokinetics of novel compounds is a critical step in drug discovery and clinical study design but continues to be a challenging task for hepatic transporter substrates, particularly in predicting their liver exposures. In this study, using bosentan as an example, we prospectively predicted systemic exposure and the (pseudo) steady-state unbound liver-to-unbound plasma ratio ( K p uu ) in healthy subjects using 1) a mechanistic approach solely based on in vitro hepatocyte assays and 2) an approach based on hepatic process rates from monkey in vivo data but Michaelis-Menten constants from in vitro data. Both methods reasonably match the observed human systemic time course data, but the second method leads to better prediction accuracy. In addition, the second method can predict a human K p uu value that is close to the value deduced using clinical data. We also generated rat and monkey liver K p uu values in terminal studies. However, these directly measured animal values are different from the deduced human value. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Elevated urinary albumin excretion is not linked to the angiotensin I-converting enzyme gene polymorphism in clinically healthy subjects

DEFF Research Database (Denmark)

Clausen, P; Jensen, J S; Borch-Johnsen, K

2000-01-01

An elevated urinary albumin excretion (UAE) in non-diabetic subjects without renal or cardiovascular disease has been shown to be predictive of ischaemic heart disease. An insertion (I)/deletion (D) polymorphism in the angiotensin I-converting enzyme (ACE) gene has been identified and the D allele...... control group (n = 46). Elevated UAE in clinically healthy subjects is not linked to the ACE gene polymorphism....... aged 40-65 years with elevated UAE in a dipstick negative urinary sample (n = 27) from The Copenhagen City Heart Study. Neither the ACE genotype distribution (p = 0.12) nor the D and I allele frequencies (p = 0.69) differed significantly between subjects with elevated UAE and a matched normoalbuminuric...

Retinal nerve fiber layer measurements by scanning laser polarimetry with enhanced corneal compensation in healthy subjects.

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Rao, Harsha L; Venkatesh, Chirravuri R; Vidyasagar, Kelli; Yadav, Ravi K; Addepalli, Uday K; Jude, Aarthi; Senthil, Sirisha; Garudadri, Chandra S

2014-12-01

To evaluate the (i) effects of biological (age and axial length) and instrument-related [typical scan score (TSS) and corneal birefringence] parameters on the retinal nerve fiber layer (RNFL) measurements and (ii) repeatability of RNFL measurements with the enhanced corneal compensation (ECC) protocol of scanning laser polarimetry (SLP) in healthy subjects. In a cross-sectional study, 140 eyes of 73 healthy subjects underwent RNFL imaging with the ECC protocol of SLP. Linear mixed modeling methods were used to evaluate the effects of age, axial length, TSS, and corneal birefringence on RNFL measurements. One randomly selected eye of 48 subjects from the cohort underwent 3 serial scans during the same session to determine the repeatability. Age significantly influenced all RNFL measurements. RNFL measurements decreased by 1 µm for every decade increase in age. TSS affected the overall average RNFL measurement (β=-0.62, P=0.003), whereas residual anterior segment retardance affected the superior quadrant measurement (β=1.14, P=0.01). Axial length and corneal birefringence measurements did not influence RNFL measurements. Repeatability, as assessed by the coefficient of variation, ranged between 1.7% for the overall average RNFL measurement and 11.4% for th nerve fiber indicator. Age significantly affected all RNFL measurements with the ECC protocol of SLP, whereas TSS and residual anterior segment retardance affected the overall average and the superior average RNFL measurements, respectively. Axial length and corneal birefringence measurements did not influence any RNFL measurements. RNFL measurements had good intrasession repeatability. These results are important while evaluating the change in structural measurements over time in glaucoma patients.

Intermittent fasting during Ramadan attenuates proinflammatory cytokines and immune cells in healthy subjects.

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Faris, Mo'ez Al-Islam E; Kacimi, Safia; Al-Kurd, Ref'at A; Fararjeh, Mohammad A; Bustanji, Yasser K; Mohammad, Mohammad K; Salem, Mohammad L

2012-12-01

Intermittent fasting and caloric restriction have been shown to extend life expectancy and reduce inflammation and cancer promotion in animal models. It was hypothesized that intermittent prolonged fasting practiced during the month of Ramadan (RIF) could positively affect the inflammatory state. To investigate this hypothesis, a cross-sectional study was designed to investigate the impact of RIF on selected inflammatory cytokines and immune biomarkers in healthy subjects. Fifty (21 men and 29 women) healthy volunteers who practiced Ramadan fasting were recruited for the investigation of circulating proinflammatory cytokines (interleukin [IL]-1β, IL-6, and tumor necrosis factor α), immune cells (total leukocytes, monocytes, granulocytes, and lymphocytes), and anthropometric and dietary assessments. The investigations were conducted 1 week before Ramadan fasting, at the end of the third week of Ramadan, and 1 month after the cessation of Ramadan month. The proinflammatory cytokines IL-1β, IL-6, and tumor necrosis factor α; systolic and diastolic blood pressures; body weight; and body fat percentage were significantly lower (P fasting. Immune cells significantly decreased during Ramadan but still remained within the reference ranges. These results indicate that RIF attenuates inflammatory status of the body by suppressing proinflammatory cytokine expression and decreasing body fat and circulating levels of leukocytes. Copyright © 2012 Elsevier Inc. All rights reserved.

Myoelectric manifestations of jaw elevator muscle fatigue and recovery in healthy and TMD subjects.

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Castroflorio, T; Falla, D; Tartaglia, G M; Sforza, C; Deregibus, A

2012-09-01

The effects of muscle pain and fatigue on the control of jaw elevator muscles are not well known. Furthermore, the myoelectric manifestations of fatigue and recovery from fatigue in the masticatory muscles are not reported in literature. The main aims of this study were (i) to evaluate the possible use of surface electromyography (sEMG) as an objective measure of fatigue of the jaw elevator muscles, (ii) to compare the myoelectric manifestations of fatigue in the temporalis anterior and masseter muscles bilaterally, (iii) to assess recovery of the investigated muscles after an endurance test and (iv) to compare fatigue and recovery of the jaw elevator muscles in healthy subjects and patients with muscle-related temporomandibular disorders (TMD). The study was performed on twenty healthy volunteers and eighteen patients with muscle-related TMD. An intra-oral compressive-force sensor was used to measure the voluntary contraction forces close to the intercuspal position and to provide visual feedback of submaximal forces to the subject. Surface EMG signals were recorded with linear electrode arrays during isometric contractions at 20%, 40%, 60% and 80% of the maximum voluntary contraction force, during an endurance test and during the recovery phase. The results showed that (i) the slope of the mean power spectral frequency (MNF) and the initial average rectified value (ARV) could be used to monitor fatigue of the jaw elevators, (ii) the temporalis anterior and masseter muscle show the same myoelectric manifestations of fatigue and recovery and (iii) the initial values of MNF and ARV were lower in patients with muscle-related TMD. The assessment of myoelectric manifestations of fatigue in the masticatory muscles may assist in the clinical assessment of TMDs. © 2012 Blackwell Publishing Ltd.

Defining guilt in depression: a comparison of subjects with major depression, chronic medical illness and healthy controls.

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Ghatavi, Kayhan; Nicolson, Rob; MacDonald, Cathy; Osher, Sue; Levitt, Anthony

2002-04-01

Although guilt is a widely accepted feature of depression, there is limited and inconsistent data defining the nature of this symptom. The purpose of the current study was to examine the specificity and nature of guilt in subjects with major depression as compared to patients with another chronic medical illness and healthy controls. Outpatients with current major depressive episode (MDE; n=34), past-MDE (n=22), chronic cardiac illness (n=20) and healthy controls (n=59) were administered the following measures: The Guilt Inventory (GI), State Shame and Guilt Scale (SSGS), 17-item Hamilton Rating Scale for Depression (Ham-D) and the Structured Clinical Interview for DSM-IV. Overall multivariate analysis of covariance comparing mean scores for the six guilt subscales [state-guilt, trait-guilt, moral standards (from the GI); state-guilt, -pride, and -shame (from the SSGS)] across the four groups was significant (F=9.1, df=6:121, pguilt (GI), current-MDE>past-MDE>cardiac=healthy controls; for trait-guilt (GI), current-MDE=past-MDE>cardiac=healthy controls; for state-shame, -guilt and -pride (SSGS), current-MDE>past-MDE, past-MDE=cardiac, past-MDE>healthy, cardiac=healthy controls. Among depressed patients, there was significant correlation between Ham-D score and all guilt sub-scales (pguilt, shame and low pride distinguish acutely depressed from all other groups, and are highly influenced by severity of depression. Trait-guilt does not differentiate acute from past depressed. Data suggests guilt may represent both an enduring and fluctuating feature of depressive illness over its longitudinal course.

Efficacy of a 3-month lifestyle intervention program using a Japanese-style healthy plate on body weight in overweight and obese diabetic Japanese subjects: a randomized controlled trial.

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Yamauchi, Keiko; Katayama, Tomomi; Yamauchi, Takahiro; Kotani, Kazuhiko; Tsuzaki, Kokoro; Takahashi, Kaoru; Sakane, Naoki

2014-11-24

The portion size of food is a determinant of energy intake, linking with obese traits. A healthy plate for portion control has recently been made in a Japanese style. The aim of the current study was to assess the efficacy of a lifestyle intervention program using the Japanese-style healthy plate on weight reduction in overweight and obese diabetic Japanese subjects. We randomized overweight and obese diabetic subjects (n = 19, 10 women) into an intervention group including educational classes on lifestyle modification incorporating the healthy plate (n = 10) or a waiting-list control group (n = 9). The intervention period was three months, and the educational classes using the healthy plate were conducted monthly in a group session for the intervention group. The body weight, blood glycemic and metabolic measures, and psychosocial variables were measured at the baseline and after the 3-month intervention in both groups. The impression of the intervention was interviewed using a structured questionnaire. There was one drop-out in the control group. No adverse events were reported in the groups. Subjects in the intervention group had a greater weight change from baseline to the end of the 3-month intervention period (-3.7 +/- 2.5 [SD] kg in the intervention group vs. -0.1 +/- 1.4 kg in the control group, P = 0.002). Most subjects recorded that the use of a healthy plate could be recommended to other people. The lifestyle intervention program using the Japanese-style healthy plate, which was developed for portion control, may effectively reduce body weight in overweight and obese diabetic subjects in Japan. Further studies are needed to establish the efficacy of this methodology on weight management.

Anterior lamina cribrosa insertion in primary open-angle glaucoma patients and healthy subjects.

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Kyoung Min Lee

Full Text Available To determine using swept-source optical coherence tomography (SS-OCT whether there are differences in the location of the anterior lamina cribrosa insertion (ALI in primary open-angle glaucoma (POAG patients and healthy subjects.Fifty three eyes from 53 patients with POAG, and 53 eyes from 53 age-matched healthy subjects were included prospectively in Seoul National University Bundang Hospital. Twelve radial line B-scans centered on the optic disc in every half-clock-hour meridian were acquired using SS-OCT. The ALI position was assessed by measuring two parameters: (1 ALI distance (ALID--the distance from the anterior scleral canal opening (ASCO to the ALI; and (2 marginal anterior lamina cribrosa surface depth (mALCSD--the perpendicular distance from the ASCO plane to the anterior lamina cribrosa surface. These parameters were compared between the two groups for each meridian.Both ALID (256 ± 54 vs. 209 ± 37 µm, mean ± SD, p < 0.001 and mALCSD (232 ± 63 vs. 187 ± 40 µm, p < 0.001 were significantly greater in the POAG group than in the normal group. The largest difference was observed at the 6.5 o'clock and 11.5 o'clock meridians for both ALID and mALCSD. Multiple regression analysis revealed a negative correlation between age and both ALID and mALCSD in the control group, and a negative correlation between mean deviation of the visual field test and both ALID and mALCSD in the POAG group.The ALI was displaced posteriorly in eyes with POAG compared to those of healthy controls. This finding suggests that the posteriorly located lamina cribrosa insertion is an important component of glaucomatous optic nerve excavation.

EEG spectral coherence data distinguish chronic fatigue syndrome patients from healthy controls and depressed patients--a case control study.

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Duffy, Frank H; McAnulty, Gloria B; McCreary, Michelle C; Cuchural, George J; Komaroff, Anthony L

2011-07-01

Previous studies suggest central nervous system involvement in chronic fatigue syndrome (CFS), yet there are no established diagnostic criteria. CFS may be difficult to differentiate from clinical depression. The study's objective was to determine if spectral coherence, a computational derivative of spectral analysis of the electroencephalogram (EEG), could distinguish patients with CFS from healthy control subjects and not erroneously classify depressed patients as having CFS. This is a study, conducted in an academic medical center electroencephalography laboratory, of 632 subjects: 390 healthy normal controls, 70 patients with carefully defined CFS, 24 with major depression, and 148 with general fatigue. Aside from fatigue, all patients were medically healthy by history and examination. EEGs were obtained and spectral coherences calculated after extensive artifact removal. Principal Components Analysis identified coherence factors and corresponding factor loading patterns. Discriminant analysis determined whether spectral coherence factors could reliably discriminate CFS patients from healthy control subjects without misclassifying depression as CFS. Analysis of EEG coherence data from a large sample (n = 632) of patients and healthy controls identified 40 factors explaining 55.6% total variance. Factors showed highly significant group differentiation (p EEG spectral coherence analysis identified unmedicated patients with CFS and healthy control subjects without misclassifying depressed patients as CFS, providing evidence that CFS patients demonstrate brain physiology that is not observed in healthy normals or patients with major depression. Studies of new CFS patients and comparison groups are required to determine the possible clinical utility of this test. The results concur with other studies finding neurological abnormalities in CFS, and implicate temporal lobe involvement in CFS pathophysiology.

Evaluation of T1ρ as a potential MR biomarker for liver cirrhosis: Comparison of healthy control subjects and patients with liver cirrhosis

International Nuclear Information System (INIS)

Rauscher, Isabel; Eiber, Matthias; Ganter, Carl; Martirosian, Petros; Safi, Wajima; Umgelter, Andreas; Rummeny, Ernst J.; Holzapfel, Konstantin

2014-01-01

Objectives: The purpose of this study was to compare mean liver T 1ρ values in patients with liver cirrhosis and healthy control subjects in order to evaluate T 1ρ as a potential MR biomarker for liver cirrhosis. Materials and methods: Ten healthy control subjects (mean age 42.7 years; 6 female, 4 male) and 21 patients with clinically diagnosed liver cirrhosis (mean age 56.5 years; 5 female, 16 male) were examined at 1.5 T (Magnetom Avanto, Siemens). T 1ρ -weighted images were acquired using a 2D TurboFLASH sequence (TR/TE 3/1.31 ms, FA 8°, FoV 309 × 380 mm, resolution 2 × 2 × 6 mm, acquisition time 15 s, slice thickness 6 mm) with spin-lock preparation. T 1ρ maps were calculated from five breath-hold measurements, performed with different spin-lock times (4, 8, 16, 32 and 48 ms). Mean liver T 1ρ values of healthy control subjects and patients with liver cirrhosis were calculated and compared using Student t-test. In addition, a receiver operating characteristic (ROC) curve analysis was performed to evaluate the utility of mean liver T 1ρ values for the prediction of liver cirrhosis. Results: Mean liver T 1ρ values in patients with liver cirrhosis (57.4 ± 7.4 ms) were significantly higher than those of healthy subjects (47.8 ± 4.2 ms; p = 0.0007). According to the ROC analysis at a threshold value of 50.1 ms the sensitivity and specificity of mean liver T 1ρ in predicting liver cirrhosis were 90.5% and 90%, respectively. The area under the ROC curve was 0.90. Conclusion: Mean liver T 1ρ values in patients with liver cirrhosis were significantly higher than those in healthy subjects suggesting a potential role of liver T 1ρ as a MR biomarker for liver cirrhosis

A comparative study of simple auditory reaction time in blind (congenitally) and sighted subjects.

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Gandhi, Pritesh Hariprasad; Gokhale, Pradnya A; Mehta, H B; Shah, C J

2013-07-01

Reaction time is the time interval between the application of a stimulus and the appearance of appropriate voluntary response by a subject. It involves stimulus processing, decision making, and response programming. Reaction time study has been popular due to their implication in sports physiology. Reaction time has been widely studied as its practical implications may be of great consequence e.g., a slower than normal reaction time while driving can have grave results. To study simple auditory reaction time in congenitally blind subjects and in age sex matched sighted subjects. To compare the simple auditory reaction time between congenitally blind subjects and healthy control subjects. STUDY HAD BEEN CARRIED OUT IN TWO GROUPS: The 1(st) of 50 congenitally blind subjects and 2(nd) group comprises of 50 healthy controls. It was carried out on Multiple Choice Reaction Time Apparatus, Inco Ambala Ltd. (Accuracy±0.001 s) in a sitting position at Government Medical College and Hospital, Bhavnagar and at a Blind School, PNR campus, Bhavnagar, Gujarat, India. Simple auditory reaction time response with four different type of sound (horn, bell, ring, and whistle) was recorded in both groups. According to our study, there is no significant different in reaction time between congenital blind and normal healthy persons. Blind individuals commonly utilize tactual and auditory cues for information and orientation and they reliance on touch and audition, together with more practice in using these modalities to guide behavior, is often reflected in better performance of blind relative to sighted participants in tactile or auditory discrimination tasks, but there is not any difference in reaction time between congenitally blind and sighted people.

Effect of mental stress on plasma homovanillic acid in healthy human subjects.

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Sumiyoshi, T; Yotsutsuji, T; Kurachi, M; Itoh, H; Kurokawa, K; Saitoh, O

1998-07-01

Plasma levels of homovanillic acid (pHVA) have been suggested to provide a measure of dopaminergic activity in the central nervous system. The present study investigated the effect of mental stress by the Kraepelin test, a test of continuous arithmetic addition of single-digit figures for 30 min, on pHVA levels in 13 male psychiatrically normal healthy volunteers. Following an overnight fast and restricted physical activity, plasma samples were collected immediately before and after the administration of the Kraepelin test. Plasma HVA levels following the administration of the Kraepelin test were significantly lower than the pretest pHVA levels. The percent change in pHVA levels by the Kraepelin test positively correlated with pretest pHVA levels. The observed reduction in pHVA levels by mental stress in normal subjects may reflect some aspects of a dopamine-dependent restitutive system in the brain.

Relationship between Corrected-QT Intervals and Other ECG Characteristics with Methadone Dose in Methadone Maintenance Treatment (MMT Patients and Healthy Subjects: A Case- Control Study

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Mina Akbari Rad

2017-05-01

Full Text Available Background In this study we assessed the relationship between corrected-QT intervals and other ECG characteristics with methadone dose and other parameters in MMT patients and healthy subjects. Methods This was a case-control study which was carried out on patients underwent MMT and healthy control group who had been referred to Ebne-Sina academic hospital, Mashhad during 2014 - 2015. At the time of the study, 40 patients who received MMT therapy for at least 6 months and 40 voluntary healthy subjects who matched on age and sex enrolled in the study. 12-lead ECG was performed for all the patients. Mean QT interval, PR interval and QRS duration in every 12 leads were documented for each patient in maximum. Results To evaluate the patients, we divided 80 patients into two groups: 40 patients under treatment with Methadone and 40 voluntary participants as control group. There were 20 males and 20 females in each group. Duration of addiction was 214.80 ± 126.99 months in MMT group. Significant differences were observed in PRi between the patient and control groups (P = 0.007, and also between methadone dose and PRi (r = 0.468, P = 0.038 in males. QTc prolongation was reported in 4 patients of addicted group (10%. All of the QTc prolongation patients were female (P = 0.037. There was significant relationship between PRi and weight (P = 0.015, addiction period (P = 0.011, methadone treatment period (P = 0.018 as well as methadone dosage (P = 0.14. Methadone cut off point of 65 mg had a significant relationship with systolic blood pressure (P = 0.002, diastolic blood pressure (P = 0.013, QTCi (P = 0.016 and QRS (P = 0.044; however, no significant relationship was reported with PRi (P = 0.451. Conclusions We found that there is no exact dosage of methadone in which the side effects such as TdP (Torsade de pointes or QTc prolongation can be predicted. Female gender and methadone dosage ≥ 65 mg were risk factors of our study for QTc prolongation which

Antidopaminergic medication in healthy subjects provokes subjective and objective mental impairments tightly correlated with perturbation of biogenic monoamine metabolism and prolactin secretion

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Veselinović T

2018-04-01

Full Text Available Tanja Veselinović,1,2 Ingo Vernaleken,1,2 Paul Cumming,3,4 Uwe Henning,5 Lina Winkler,1,2 Peter Kaleta,1,2 Michael Paulzen,1,2 Christian Luckhaus,6 Gerhard Gründer1,2,7 1Department of Psychiatry, Psychotherapy, and Psychosomatics, Faculty of Medicine, RWTH Aachen University, Aachen, 2Translational Brain Medicine, Jülich Aachen Research Alliance (JARA, Jülich, Germany; 3IHBI, School of Psychology and Counselling, Queensland University of Technology, 4QIMR Berghofer Institute, Brisbane, Australia; 5Neurobiochemical Research Unit, Department of Psychiatry, Heinrich Heine University, Düsseldorf, 6LWL University Hospital Bochum, Department of Psychiatry, Division of Cognitive Neuropsychiatry and Psychiatric Preventive Medicine, Ruhr University Bochum, Bochum, 7Department of Molecular Neuroimaging, Central Institute of Mental Health, Mannheim, Germany Objectives: Off-label prescription of antipsychotics to patients without psychotic symptoms has become a routine matter for many psychiatrists and also some general practitioners. Nonetheless, little is known about the possibly detrimental effects of antidopaminergic medications on general psychopathology, subjective mental state, or a possible association with physiological parameters in nonpsychotic individuals.Methods: In this randomized, single-blinded study, groups of healthy volunteers (n=18 received low doses of reserpine, aripiprazole, haloperidol, or placebo on 7 successive days. Relevant physiological parameters (plasma prolactin, concentrations of catecholamine metabolites in plasma, and 24-hour urine and each subject’s mental state (Positive and Negative Syndrome Scale, Hamilton Rating Scale for Depression, visual analogue scale, Beck Depression Inventory II were assessed at the start and end of the trial.Results: Of the three active treatments, only reserpine caused a significant increase in some plasma- and urine-catecholamine metabolites, but all three medications evoked objective

Dietary quality, lifestyle factors and healthy ageing in Europe: the SENECA study

NARCIS (Netherlands)

Haveman-Nies, A.; Groot, de C.P.G.M.; Staveren, van W.A.

2003-01-01

Objective: to identify dietary and lifestyle factors that contribute to healthy ageing. Subjects: for the analyses, data of the longitudinal SENECA study were used. The study population consisted of 1091 men and 1109 women aged 70-75 years from Belgium, France, Denmark, Italy, The Netherlands,

Mechanism of Cerebralcare Granule® for Improving Cognitive Function in Resting-State Brain Functional Networks of Sub-healthy Subjects

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Jing Li

2017-07-01

Full Text Available Cerebralcare Granule® (CG, a Chinese herbal medicine, has been used to ameliorate cognitive impairment induced by ischemia or mental disorders. The ability of CG to improve health status and cognitive function has drawn researchers' attention, but the relevant brain circuits that underlie the ameliorative effects of CG remain unclear. The present study aimed to explore the underlying neurobiological mechanisms of CG in ameliorating cognitive function in sub-healthy subjects using resting-state functional magnetic resonance imaging (fMRI. Thirty sub-healthy participants were instructed to take one 2.5-g package of CG three times a day for 3 months. Clinical cognitive functions were assessed with the Chinese Revised Wechsler Adult Intelligence Scale (WAIS-RC and Wechsler Memory Scale (WMS, and fMRI scans were performed at baseline and the end of intervention. Functional brain network data were analyzed by conventional network metrics (CNM and frequent subgraph mining (FSM. Then 21 other sub-healthy participants were enrolled as a blank control group of cognitive functional. We found that administrating CG can improve the full scale of intelligence quotient (FIQ and Memory Quotient (MQ scores. At the same time, following CG treatment, in CG group, the topological properties of functional brain networks were altered in various frontal, temporal, occipital cortex regions, and several subcortical brain regions, including essential components of the executive attention network, the salience network, and the sensory-motor network. The nodes involved in the FSM results were largely consistent with the CNM findings, and the changes in nodal metrics correlated with improved cognitive function. These findings indicate that CG can improve sub-healthy subjects' cognitive function through altering brain functional networks. These results provide a foundation for future studies of the potential physiological mechanism of CG.

Subjective experience of coercion in psychiatric care: a study comparing the attitudes of patients and healthy volunteers towards coercive methods and their justification.

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Mielau, J; Altunbay, J; Gallinat, J; Heinz, A; Bermpohl, F; Lehmann, A; Montag, C

2016-06-01

Under certain conditions, coercive interventions in psychotic patients can help to regain insight and alleviate symptoms, but can also traumatize subjects. This study explored attitudes towards psychiatric coercive interventions in healthy individuals and persons suffering from schizophrenia, schizoaffective or bipolar disorder. The impact of personal history of coercive treatment on preferences concerning clinical management of patients unable to consent was investigated. Six case vignettes depicting scenarios of ethical dilemmas and demanding decisions in favour of or against coercive interventions were presented to 60 healthy volunteers and 90 patients. Structured interviews focusing on experienced coercion were performed in conjunction with the Coercion Experience Scale and the Admission Experience Survey. Symptom severity, psychosocial functioning and insight into illness were assessed as influencing variables. Student's t tests compared patients' and controls' judgments, followed by regression analyses to define the predictive value of symptoms and measures of coercion on judgments regarding the total patient sample and patients with experience of fixation. Patients and non-psychiatric controls showed no significant difference in their attitudes towards involuntary admission and forced medication. Conversely, patients more than controls significantly disapproved of mechanical restraint. Subjective experience of coercive interventions played an important role for the justification of treatment against an individual's "natural will". Factors influencing judgments on coercion were overall functioning and personal experience of treatment effectiveness and fairness. Qualitative and quantitative aspects of perceived coercion, in addition to insight into illness, predicted judgments of previously fixated patients. Results underline the importance of the quality of practical implementation and care, if coercive interventions cannot be avoided.

Quantitative performance of E-Scribe warehouse in detecting quality issues with digital annotated ECG data from healthy subjects.

Science.gov (United States)

Sarapa, Nenad; Mortara, Justin L; Brown, Barry D; Isola, Lamberto; Badilini, Fabio

2008-05-01

The US Food and Drug Administration recommends submission of digital electrocardiograms in the standard HL7 XML format into the electrocardiogram warehouse to support preapproval review of new drug applications. The Food and Drug Administration scrutinizes electrocardiogram quality by viewing the annotated waveforms and scoring electrocardiogram quality by the warehouse algorithms. Part of the Food and Drug Administration warehouse is commercially available to sponsors as the E-Scribe Warehouse. The authors tested the performance of E-Scribe Warehouse algorithms by quantifying electrocardiogram acquisition quality, adherence to QT annotation protocol, and T-wave signal strength in 2 data sets: "reference" (104 digital electrocardiograms from a phase I study with sotalol in 26 healthy subjects with QT annotations by computer-assisted manual adjustment) and "test" (the same electrocardiograms with an intentionally introduced predefined number of quality issues). The E-Scribe Warehouse correctly detected differences between the 2 sets expected from the number and pattern of errors in the "test" set (except for 1 subject with QT misannotated in different leads of serial electrocardiograms) and confirmed the absence of differences where none was expected. E-Scribe Warehouse scores below the threshold value identified individual electrocardiograms with questionable T-wave signal strength. The E-Scribe Warehouse showed satisfactory performance in detecting electrocardiogram quality issues that may impair reliability of QTc assessment in clinical trials in healthy subjects.

Influence of chemoreflexes on respiratory variability in healthy subjects

NARCIS (Netherlands)

van den Aardweg, Joost G.; Karemaker, John M.

2002-01-01

The background of this study was the hypothesis that respiratory variability is influenced by chemoreflex regulation, In search for periodicities in the variability due to instability of the respiratory control system, spectral analysis was applied to breath-to-breath variables in 19 healthy

Hypertension and white matter lesions are independently associated with apathetic behavior in healthy elderly subjects. The Sefuri brain MRI study

International Nuclear Information System (INIS)

Yao, Hiroshi; Takashima, Yuki; Mori, Takahiro; Hashimoto, Manabu; Yuzuriha, Takefumi; Uchino, Akira; Miwa, Yoshikazu; Sasaguri, Toshiyuki

2009-01-01

Apathy is defined as a syndrome of primary loss of motivation not attributable to emotional distress, intellectual impairment or consciousness disturbance. The aim of our study was to investigate the effects of vascular risk factors and silent ischemic brain lesions on apathetic behavior of community-dwelling elderly subjects. Brain MRI and other medical examinations were performed on 222 non-demented community-dwelling elderly subjects (96 men and 126 women, average age 70.1 years). The apathy group was defined as the most apathetic quintile determined by Starkstein's apathy scale. Silent infarction, deep white matter lesions (DWMLs) and periventricular hyperintensities were detected in 12.2, 39.2 and 22.5%, respectively. Linear regression analysis (Pearson) revealed that the scores on the apathy scale correlated slightly but significantly with logarithmically transformed scores of the Modified Stroop Test (r=0.135, P=0.045), but not with the Mini-Mental State Examination. The apathy group tended to have more high blood pressure (141.6/82.6 vs. 136.1/79.6 mmHg), less prevalent hyperlipidemia (18 vs. 35%) and lower serum albumin. Multivariate analysis (the forward stepwise method of logistic analysis) revealed an independent correlation between the apathy and grade of DWMLs (odds ratio 1.826, 95% confidence interval (CI) 1.129-2.953 per grade) or diastolic blood pressure (DBP) (odds ratio 1.055, 95% CI 1.0 14-1.098 per mmHg) after adjusting for possible confounders. The mean apathy scale score in the DBP≥90 mmHg group was significantly lower (more apathetic) than that in the DBP<80 group (P=0.011, analysis of covariance). This study showed that hypertension and DWMLs are independently associated with apathy in healthy elderly subjects. (author)

Impaired basal glucose effectiveness but unaltered fasting glucose release and gluconeogenesis during short-term hypercortisolemia in healthy subjects

DEFF Research Database (Denmark)

Nielsen, Michael F; Caumo, Andrea; Chandramouli, Visvanathan

2004-01-01

Excess cortisol has been demonstrated to impair hepatic and extrahepatic insulin action. To determine whether glucose effectiveness and, in terms of endogenous glucose release (EGR), gluconeogenesis, also are altered by hypercortisolemia, eight healthy subjects were studied after overnight infusion...... resistance. Postabsorptive glucose production (P = 0.64) and the fractional....... Hepatic GE was lower during cortisol than during saline infusion (2.39 +/- 0.24 vs. 3.82 +/- 0.51 ml.kg-1.min-1; P

Effects of Twenty Days of the Ketogenic Diet on Metabolic and Respiratory Parameters in Healthy Subjects.

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Rubini, Alessandro; Bosco, Gerardo; Lodi, Alessandra; Cenci, Lorenzo; Parmagnani, Andrea; Grimaldi, Keith; Zhongjin, Yang; Paoli, Antonio

2015-12-01

The effects of the ketogenic diet (KD) on weight loss, metabolic, and respiratory parameters were investigated in healthy subjects. Thirty-two healthy subjects were randomized into two groups. The KD group followed a ketogenic diet for 20 days (KD t 0-t 20), then switched to a low-carbohydrate, no-ketogenic diet for 20 days (KD t 20-t 40), and finally was on a Mediterranean diet (MD) for 2 more months (KD t 40-t 2m). The MD group followed a MD for 20 days (MD t 0-t 20), then followed a MD of 1400 kcal over the next 20 days (MD t 20-t 40), and completed the study with the MD for 2 months (MD t 40-t 2m). Body weight, body fat, respiratory rate, and respiratory gas parameters (including respiratory exchange ratio (RER) and carbon dioxide end-tidal partial pressure (PETCO2), oxygen uptake (VO2), carbon dioxide production (VCO2), and resting energy expenditure (REE)) were measured at each point. A significant decrease (p diets significantly decreased body fat mass, the KD diet overall proved to have a higher percentage of fat loss versus the MD diet. The KD may significantly decrease carbon dioxide body stores, which may theoretically be beneficial for patients with increased carbon dioxide arterial partial pressure due to respiratory insufficiency or failure.

The functional magnetic resonance imaging (fMRI) procedure as experienced by healthy participants and stroke patients – A pilot study

International Nuclear Information System (INIS)

Szameitat, André J; Shen, Shan; Sterr, Annette

2009-01-01

An important aspect in functional imaging research employing magnetic resonance imaging (MRI) is how participants perceive the MRI scanning itself. For instance, the knowledge of how (un)comfortable MRI scanning is perceived may help institutional review boards (IRBs) or ethics committees to decide on the approval of a study, or researchers to design their experiments. We provide empirical data from our lab gained from 70 neurologically healthy mainly student subjects and from 22 mainly elderly patients suffering from motor deficits after brain damage. All participants took part in various basic research fMRI studies using a 3T MRI scanner. Directly after the scanning, all participants completed a questionnaire assessing their experience with the fMRI procedure. 87.2% of the healthy subjects and 77.3% of the patients rated the MRI procedure as acceptable to comfortable. In healthy subjects, males found the procedure more comfortable, while the opposite was true for patients. 12.1% of healthy subjects considered scanning durations between 30 and 60 min as too long, while no patient considered their 30 min scanning interval as too long. 93.4% of the healthy subjects would like to participate in an fMRI study again, with a significantly lower rate for the subjects who considered the scanning as too long. Further factors, such as inclusion of a diffusion tensor imaging (DTI) scan, age, and study duration had no effect on the questionnaire responses. Of the few negative comments, the main issues were noise, the restriction to keep still for the whole time, and occasional feelings of dizziness. MRI scanning in the basic research setting is an acceptable procedure for elderly and patient participants as well as young healthy subjects

Fibrinolytic response to tumor necrosis factor in healthy subjects

NARCIS (Netherlands)

van der Poll, T.; Levi, M. [=Marcel M.; Büller, H. R.; van Deventer, S. J.; de Boer, J. P.; Hack, C. E.; ten Cate, J. W.

1991-01-01

Tumor necrosis factor (TNF) may be involved in the disturbance of the procoagulant-fibrinolytic balance in septicemia, leading to microvascular thrombosis. To assess the dynamics of the fibrinolytic response to TNF in humans, we performed a crossover saline-controlled study in six healthy men,

Effect of mushroom diet on pharmacokinetics of gabapentin in healthy Chinese subjects.

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Toh, Dorothy Su Lin; Limenta, Lie Michael George; Yee, Jie Yin; Wang, Ling-Zhi; Goh, Boon-Cher; Murray, Michael; Lee, Edmund Jon Deoon

2014-07-01

This study evaluated the pharmacokinetics of gabapentin in Chinese subjects who received a diet rich in shiitake mushrooms. Shiitake mushrooms have been shown to contain high amount of ergothioneine. In vitro studies have shown that OCTN1-mediated secretion of gabapentin is trans-stimulated by ergothioneine. This study also investigated the concentrations of ergothioneine in plasma at baseline and following mushroom consumption. Ten healthy male subjects were recruited and received a diet containing no mushrooms (treatment A) or a high mushroom diet (treatment B; after at least a 7 day washout period) 1 day prior to administration of a single oral dose of gabapentin 600 mg. Ingestion of shiitake mushrooms produced significant increases in plasma ergothioneine concentrations that were sustained for more than 48 h. A statistically significant but modest increase in the renal clearance (CLR ) of gabapentin occurred after intake of the mushroom diet (91.1 ± 25.1 vs. 76.9 ± 20.6 ml min(-1) , P = 0.031). No significant changes in AUC(0,tlast ) of gabapentin were observed (P = 0.726). Creatinine clearance did not correlate with CLR of gabapentin at baseline (treatment A). After ingestion of the mushroom diet, creatinine clearance accounted for 65.3% of the variance in CLR of gabapentin. These data suggest that diet-drug pharmacokinetic interactions may occur during co-exposure to gabapentin and mushroom constituents. However, as it does not affect the AUC(0,tlast ) of gabapentin, it may not have clinically important consequences. Shiitake mushrooms can also be used as a source of ergothioneine for future clinical studies. © 2013 The British Pharmacological Society.

Urinary elimination of molybdenum by healthy subjects as determined by inductively coupled plasma mass spectrometry.

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Allain, P; Berre, S; Prémel-Cabic, A; Mauras, Y; Cledes, A; Cournot, A

The concentration of molybdenum was measured by inductively coupled plasma mass spectrometry (ICPMS) in the urines of two groups of healthy people living in two areas of France, Brest and Paris, about 500 km away. The concentration of Mo in the 24-hour urines of 10 healthy subjects from the Brest region was 25 +/- 10 micrograms/l, 38 +/- 20 micrograms/24 h and 21 +/- 9 micrograms/g creatinine. The concentration of Mo in the morning urines of 23 healthy men of the Paris region was 41 +/- 34 micrograms/l and 21 +/- 15 micrograms/g creatinine. Thus the mean elimination of Mo per gram of creatinine was the same in the two groups (21 +/- 9 and 21 +/- 15). Since the three main isotopes of Mo m/z = 95, 96 and 98, corresponding to an abundance percentage of 16, 17 and 24.5, respectively, were simultaneously analyzed in each sample and led to similar results, the ICPMS method seems reliable.

Healthy Dental Pulp Oxygen Saturation Rates in Subjects with Homozygous Sickle Cell Anemia: A Cross-Sectional Study Nested in a Cohort.

Science.gov (United States)

Souza, Soraia de Fátima Carvalho; Thomaz, Erika Bárbara Abreu Fonseca; Costa, Cyrene Piazera Silva

2017-12-01

To compare the percentage of arterial oxygen saturation (SpO 2 ) in healthy teeth with confirmed pulp vitality between individuals with sickle cell anemia (HbSS) and normal hemoglobin A (HbAA). This is a cross-sectional study nested within a cohort. Samples (n = 2543) comprised teeth with intact crowns and pulp vitality confirmed by thermal sensitivity tests and no history of caries, periodontal disease, or dental trauma. A total of 728 teeth of 113 individuals with HbSS and 1815 teeth of 246 individuals with HbAA were evaluated. Data analysis was performed using the χ 2 and Mann-Whitney tests and Spearman correlation analysis (α = 0.05). The study groups were comparable in terms of age, race, and sex (P > .05). Subjects with HbSS exhibited lower median SpO 2 levels in the body and upper teeth, excluding canines, than subjects with HbAA (P  .05). Compared with individuals with HbAA, those with HbSS exhibited lower SpO 2 in maxillary teeth with confirmed pulp vitality, except in the canines. There was no correlation between SpO 2 levels of the body and dental pulp in individuals with HbSS or HbAA. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Effects of Force Load, Muscle Fatigue, and Magnetic Stimulation on Surface Electromyography during Side Arm Lateral Raise Task: A Preliminary Study with Healthy Subjects.

Science.gov (United States)

Cao, Liu; Wang, Ying; Hao, Dongmei; Rong, Yao; Yang, Lin; Zhang, Song; Zheng, Dingchang

2017-01-01

The aim of this study was to quantitatively investigate the effects of force load, muscle fatigue, and extremely low-frequency (ELF) magnetic stimulation on surface electromyography (SEMG) signal features during side arm lateral raise task. SEMG signals were recorded from 18 healthy subjects on the anterior deltoid using a BIOSEMI ActiveTwo system during side lateral raise task (with the right arm 90 degrees away from the body) with three different loads on the forearm (0 kg, 1 kg, and 3 kg; their order was randomized between subjects). The arm maintained the loads until the subject felt exhausted. The first 10 s recording for each load was regarded as nonfatigue status and the last 10 s before the subject was exhausted was regarded as fatigue status. The subject was then given a five-minute resting between different loads. Two days later, the same experiment was repeated on every subject, and this time the ELF magnetic stimulation was applied to the subject's deltoid muscle during the five-minute rest period. Three commonly used SEMG features, root mean square (RMS), median frequency (MDF), and sample entropy (SampEn), were analyzed and compared between different loads, nonfatigue/fatigue status, and ELF stimulation and no stimulation. Variance analysis results showed that the effect of force load on RMS was significant ( p 0.05). In comparison with nonfatigue status, for all the different force loads with and without ELF stimulation, RMS was significantly larger at fatigue (all p < 0.001) and MDF and SampEn were significantly smaller (all p < 0.001).

Simple artificial training device for respiratory muscle strength and lung volumes in healthy young male and female subjects: A pilot study.

Science.gov (United States)

Leelarungrayub, Jirakrit; Pinkaew, Decha; Yankai, Araya; Chautrakoon, Busaba; Kuntain, Rungtiwa

2017-10-01

The aim of this study was to evaluate the efficiency of a simple artificial device for respiratory muscle strength training and lung volumes using either combined or non-combined exercise with elastic bands in healthy young participants. Forty healthy young participants (20 male and 20 female) aged 19-24 years old were randomized into two main experiments with four sub-groups; (1) artificial device (n = 10) & standard device (n = 10) training, and (2) artificial device training combined with elastic band (EB) exercise (n = 10) & standard device training combined with EB (n = 10) exercise. Respiratory muscle strength with maximal peak inspiratory pressure (PImax), and lung volumes; tidal volume (TV), inspiratory reserve volume (IRV), expiratory reserve volume (ERV) and vital capacity (VC) were evaluated before and after training once daily for 3 weeks. Moreover, the peak dyspnea score and vital sign parameters were compared between the experimental groups after final training. All parameters had no statistical differences (p > 0.5) between the training devices alone and those combined with EB exercise prior to any experiments. Results from the first experiment showed that training with an artificial device increased all parameters (PImax, VC, IRV, ERV) significantly (p artificial device training combined with EB exercise showed a significant increase in all parameters, except for TV, and they were the same as the increased results in training with the standard device combined with EB exercise. There was no significant difference of data between these groups after the training period. Finally, the results of peak dyspnea score and all vital sign parameters from using the artificial device, with or without EB exercise, showed no statistical difference when compared to use of the standard device. This study proposed that a simple artificial device can be used to train the respiratory muscle with or without elastic band exercise in healthy young subjects

Incretin secretion in relation to meal size and body weight in healthy subjects and people with type 1 and type 2 diabetes mellitus

DEFF Research Database (Denmark)

Vilsbøll, T; Krarup, T; Sonne, J

2003-01-01

in patients with diabetes mellitus. The aim of the present investigation was to investigate incretin secretion, in obesity and type 1 and type 2 diabetes mellitus, and its dependence on the magnitude of the meal stimulus. Plasma concentrations of incretin hormones (total, reflecting secretion and intact...... subjects (22% P = 0.04) during the large meal, compared with the small meal, perhaps reflecting the increased incretin response. We conclude: 1) that a decreased GLP-1 secretion may contribute to impaired insulin secretion in type 2 diabetes mellitus, whereas GIP and GLP-1 secretion is normal in type 1......, reflecting potential action) were measured during two meal tests (260 kcal and 520 kcal) in eight type 1 diabetic patients, eight lean healthy subjects, eight obese type 2 diabetic patients, and eight obese healthy subjects. Both in diabetic patients and in healthy subjects, significant increases in GLP-1...

Creatine metabolism: detection of creatine and guanidinoacetate in saliva of healthy subjects.

Science.gov (United States)

Martínez, Lidia D; Bezard, Miriam; Brunotto, Mabel; Dodelson de Kremer, Raquel

2016-04-01

Creatine (Cr) plays an important role in storage and transmission of phosphate-bound energy. Cerebral creatine deficiency syndromes comprise three inherited defects in Cr biosynthesis and transport. The aim of this study was to investigate whether Cr and Guanidinoacetate (GAA) can be detected in saliva of healthy subjects and to establish the relationship between salivary and plasma levels of these molecules. An adapted gas chromatography (GC) method is described for the quantification of Cr and GAA biomarkers in saliva. Reference values were established for GAA and Cr in saliva. These values were age dependent (p= 0.001). No difference between genders was observed. We detected a difference between GAA and Cr concentrations in saliva and in plasma. The GC method for simultaneous determination of GAA and Cr in human saliva is fast, reliable, sensitive, non-invasive and precise to use as a biochemical approach in early detection of cerebral creatine deficiency syndromes. Sociedad Argentina de Investigación Odontológica.

Measurements of exhaled nitric oxide in healthy subjects age 4 to 17 years

DEFF Research Database (Denmark)

Buchvald, Frederik; Baraldi, Eugenio; Carraro, Silvia

2005-01-01

to almost 100% from the age of 10 years. The repeatability of 3 approved measurements was 1.6 ppb (95% CI, 1.49-1.64 ppb). CONCLUSION: FE NO in healthy children is below 15 to 25 ppb depending on age and self-reported atopy. Measurement of FE NO by NIOX is simple and safe and has a good repeatability...... NO was measured in healthy subjects of 4 to 17 years according to American Thoracic Society guidelines (single breath online, exhalation flow 50 mL/s) with a chemiluminescence analyzer (NIOX Exhaled Nitric Oxide Monitoring System, Aerocrine, Sweden) in 3 European and 2 US centers. Each child performed 3...... NO in 405 children was 9.7 ppb, and the upper 95% confidence limit was 25.2 ppb. FE NO increased significantly with age, and higher FE NO was seen in children with self-reported rhinitis/conjunctivitis or hay fever. The success rate was age-dependent and improved from 40% in the children 4 years old...

Effect of consumption of micronutrient enriched wheat steamed bread on postprandial plasma glucose in healthy and type 2 diabetic subjects.

Science.gov (United States)

Su-Que, Lan; Ya-Ning, Meng; Xing-Pu, Li; Ye-Lun, Zhang; Guang-Yao, Song; Hui-Juan, Ma

2013-05-17

Steamed wheat bread have previously been shown to induce comparatively high postprandial plasma glucose responses, on the contrary, buckwheat products induced lower postprandial plasma glucose. The present study was to assess the effects of micronutrient enriched bread wheat variety Jizi439 and buckwheat on postprandial plasma glucose in healthy and diabetic subjects comparing with buckwheat and other bread wheat varieties. Two experiments were conducted to study the effects of bread wheat variety Jizi439 on the postprandial plasma glucose levels of the randomly selected subjects. The first experiment involved three types of steamed bread with equivalent of 50 g available carbohydrate fed to 10 normal weight young healthy subjects. Two types of steamed bread were made from two purple-grain bread wheat varieties, Jizi439 and Chu20, respectively, and the third type was made from the mixture of different white grain wheat varieties. Plasma glucose levels of each subject were measured at 15, 30, 45, 60, 120 min after eating. Glucose was used as a reference, the total area under curve (AUC) and glycemic index (GI) was calculated for test meal. The second experiment was performed among ten type 2 diabetics who were served equivalent of 50 g available carbohydrate of steamed bread made from Jizi 439, the mixture of white grain bread wheat and buckwheat, respectively. The plasma glucose increment was determined two hours thereafter. In the first experiment, consumption of the steamed bread made from Jizi439 resulted in the least increase in plasma glucose and the GI was significantly lower than that of Chu20 and the mixture. In the second experiment, the average of postprandial 2 h plasma glucose increment of Jizi439 was 2.46 mmol/L which was significantly lower than that of the mixture of white wheat but was not significantly different from buckwheat. The results indicated that consumption of Jizi439 steamed bread resulted in significantly lower plasma glucose in

A mixed diet supplemented with l-arabinose does not alter glycaemic or insulinaemic responses in healthy human subjects

DEFF Research Database (Denmark)

Halschou-Jensen, Kia; Knudsen, Knud E Bach; Nielsen, Soren

2015-01-01

of the present study showed that the peak plasma concentration, time to reach peak plasma concentration or AUC values of glucose, insulin and C-peptide were not altered after consumption of the test meals. Overall, it was not possible to reproduce the beneficial effects of L-arabinose added to sucrose drinks...... effects on postprandial blood glucose, insulin and C-peptide responses in humans. However, the effects of adding L-arabinose to mixed meals on the indices of glucose control are unknown. The purpose of the present study was to investigate whether the positive effects of L-arabinose added to a sugar drink...... could be reproduced in subjects consuming a mixed meal containing sucrose and/or starch from wheat flour. A total of seventeen healthy men participated in study 1, a randomised, double-blind, cross-over trial. In this study, the subjects consumed two different breakfast meals containing sucrose...

Lactobacillus reuteri supplements do not affect salivary IgA or cytokine levels in healthy subjects: A randomized, double-blind, placebo-controlled, cross-over trial.

Science.gov (United States)

Jørgensen, Mette Rose; Keller, Mette Kirstine; Kragelund, Camilla; Hamberg, Kristina; Ericson, Dan; Nielsen, Claus Henrik; Twetman, Svante

2016-07-01

To evaluate the effect of daily ingestion of probiotic lactobacilli on the levels of secretory IgA (sIgA) and selected cytokines in whole saliva of healthy young adults. The study group consisted of 47 healthy adults (18-32 years) who volunteered for a randomized, double-blind, placebo-controlled, cross-over trial after informed consent. During intervention, the subjects ingested two lozenges per day containing two strains of the probiotic bacterium Lactobacillus reuteri (DSM 17938 and ATCC PTA 5289) or placebo lozenges. The intervention and wash-out periods were 3 weeks. Saliva samples were collected at baseline, immediately after each intervention period and 3 weeks post-intervention. ELISA was used to measure sIgA and luminex technology was used to measure the interleukins (IL)-1β, IL-6, IL-8 and IL-10. For statistical analyses a mixed ANOVA model was employed to calculate changes in the salivary outcome variables. Forty-one subjects completed the study and reported a good compliance. No significant differences in the concentrations of salivary sIgA or cytokines were recorded between the L. reuteri and placebo interventions or between baseline and 3 weeks post-intervention levels. No side- or adverse effects were reported. Supplementation with two strains of the probiotic L. reuteri did not affect sIgA or cytokine levels in whole saliva in healthy young adults. The results thereby indicate that daily oral supplementation with L. reuteri do not seem to modulate the salivary oral immune response in healthy young subjects (ClinicalTrials.gov NCT02017886).

The efficiency of simultaneous binaural ocular vestibular evoked myogenic potentials: a comparative study with monaural acoustic stimulation in healthy subjects.

Science.gov (United States)

Kim, Min-Beom; Ban, Jae Ho

2012-12-01

To evaluate the test-retest reliability and convenience of simultaneous binaural acoustic-evoked ocular vestibular evoked myogenic potentials (oVEMP). Thirteen healthy subjects with no history of ear diseases participated in this study. All subjects underwent oVEMP test with both separated monaural acoustic stimulation and simultaneous binaural acoustic stimulation. For evaluating test-retest reliability, three repetitive sessions were performed in each ear for calculating the intraclass correlation coefficient (ICC) for both monaural and binaural tests. We analyzed data from the biphasic n1-p1 complex, such as latency of peak, inter-peak amplitude, and asymmetric ratio of amplitude in both ears. Finally, we checked the total time required to complete each test for evaluating test convenience. No significant difference was observed in amplitude and asymmetric ratio in comparison between monaural and binaural oVEMP. However, latency was slightly delayed in binaural oVEMP. In test-retest reliability analysis, binaural oVEMP showed excellent ICC values ranging from 0.68 to 0.98 in latency, asymmetric ratio, and inter-peak amplitude. Additionally, the test time was shorter in binaural than monaural oVEMP. oVEMP elicited from binaural acoustic stimulation yields similar satisfactory results as monaural stimulation. Further, excellent test-retest reliability and shorter test time were achieved in binaural than in monaural oVEMP.

Repeatability, interocular correlation and agreement of quantitative swept-source optical coherence tomography angiography macular metrics in healthy subjects.

Science.gov (United States)

Fang, Danqi; Tang, Fang Yao; Huang, Haifan; Cheung, Carol Y; Chen, Haoyu

2018-05-29

To investigate the repeatability, interocular correlation and agreement of quantitative swept-source optical coherence tomography angiography (SS-OCTA) metrics in healthy subjects. Thirty-three healthy normal subjects were enrolled. The macula was scanned four times by an SS-OCTA system using the 3 mm×3 mm mode. The superficial capillary map images were analysed using a MATLAB program. A series of parameters were measured: foveal avascular zone (FAZ) area, FAZ perimeter, FAZ circularity, parafoveal vessel density, fractal dimension and vessel diameter index (VDI). The repeatability of four scans was determined by intraclass correlation coefficient (ICC). Then the averaged results were analysed for intereye difference, correlation and agreement using paired t-test, Pearson's correlation coefficient (r), ICC and Bland-Altman plot. The repeatability assessment of the macular metrics exported high ICC values (ranged from 0.853 to 0.996). There is no statistically significant difference in the OCTA metrics between the two eyes. FAZ area (ICC=0.961, r=0.929) and FAZ perimeter (ICC=0.884, r=0.802) showed excellent binocular correlation. Fractal dimension (ICC=0.732, r=0.578) and VDI (ICC=0.707, r=0.547) showed moderate binocular correlation, while parafoveal vessel density had poor binocular correlation. Bland-Altman plots showed the range of agreement was from -0.0763 to 0.0954 mm 2 for FAZ area and from -0.0491 to 0.1136 for parafoveal vessel density. The macular metrics obtained using SS-OCTA showed excellent repeatability in healthy subjects. We showed high intereye correlation in FAZ area and perimeter, moderate correlation in fractal dimension and VDI, while vessel density had poor correlation in normal healthy subjects. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pharmacokinetics and Safety of DW1029M, a Botanical Drug for the Treatment of Diabetic Nephropathy, Following Single Doses in Healthy Subjects.

Science.gov (United States)

Kim, Yunjeong; Jeon, Ji-Young; Kim, Eun-Young; Lim, Cheol-Hee; Jang, Hwan Bong; Kim, Min-Gul

2017-09-01

DW1029M is a botanical extract of Morus albalinne root bark and Puerariae radix that is used for the treatment of diabetic nephropathy. This study evaluated the safety and pharmacokinetics of DW1029M following its administration in healthy Korean subjects. We conducted a randomized, open-label, single-dose, crossover phase 1 clinical study. During each period, subjects received 300, 600, or 1200 mg oral doses of DW1029M. Plasma concentrations of puerarin, daidzin, and daidzein were analyzed using a liquid chromatography-tandem mass spectrometry. Six healthy male subjects completed the study. The maximum concentration of the drug in the plasma (C max ) and area under the plasma drug concentration-time curve to the last measurable concentration (AUC last ) for puerarin, daidzin, and daidzein were assessed after oral administration of DW1029M. No serious adverse events or clinically or statistically significant adverse events associated with any of the drug levels were observed. The results of the measurement of vital signs, electrocardiogram, laboratory tests, and physical examinations indicated that no clinically significant changes occurred during this study. The DW1029M tablet was safe and well tolerated over a single dose range of 300-1200 mg. This pharmacokinetic study of a botanical drug may aid in the development of DW1029M. © 2017, The American College of Clinical Pharmacology.

The effects of various sources of dietary fibre on cholesterol metabolism and colonic function in healthy subjects

NARCIS (Netherlands)

Stasse-Wolthuis, M.

1980-01-01

This thesis deals with the influence of several types of dietary fibre on cholesterol metabolism and colonic function in young healthy subjects. Dietary fibre has been defined as those plant polysaccharides (cellulose, hemicelluloses, pectic substances) and lignin which are resistant to hydrolysis

Exposure of healthy subjects with emissions from a gas metal arc welding process: part 3--biological effect markers and lung function.

Science.gov (United States)

Brand, P; Bischof, K; Siry, L; Bertram, J; Schettgen, T; Reisgen, U; Kraus, T; Gube, M

2013-01-01

Metal active gas welding (MAG) is a widely-used welding technique resulting in high emissions of welding fume particles. This study investigated whether short-term exposure to these fume particles results in changes in lung function and early stages of inflammatory reactions. Twelve healthy, young male subjects were exposed to MAG fumes for 6 h with three different exposure concentrations in a three-fold cross-over study design. Exposure was performed in the "Aachen Workplace Simulation Laboratory" under controlled conditions with constant fume concentration. Fume concentrations were 0, 1, and 2.5 mg m(-3) in randomized order. Before and after each exposure, spirometry, and impulse oscillometry were performed and breath condensate samples were collected in order to quantify inflammatory markers like Nitrate, Nitrite, Nitrotyrosine, Hydroxyprolin and Malondialdehyde. A significant dependency on the exposure concentration could not be established for any of the endpoint parameters. In healthy, young subjects neither changes in spirometry nor changes in inflammatory markers measured in exhaled breath condensate could be detected after short-term exposure.

Neuroticism and serotonin 5-HT_1A receptors in healthy subjects

DEFF Research Database (Denmark)

Hirvonen, Jussi; Tuominen, Lauri; Någren, Kjell

2015-01-01

subjects is unclear. We measured brain serotonin 5-HT1A receptor in 34 healthy subjects in vivo using positron emission tomography (PET) and [carbonyl-(11)C]WAY-100635. Binding potential (BPP) was determined using the golden standard of kinetic compartmental modeling using arterial blood samples...... and radiometabolite determination. Personality traits were assessed using the Karolinska Scales of Personality. We found a strong negative association between serotonin 5-HT1A receptor BPP and neuroticism. That is, individuals with high neuroticism tended to have lower 5-HT1A receptor binding than individuals...... with low neuroticism. This finding was confirmed with an independent voxel-based whole-brain analysis. Other personality traits did not correlate with 5-HT1A receptor BPP. Previous observations have reported lower serotonin 5-HT1A receptor density in major depression. This neurobiological finding may...

Pharmacokinetics and pharmacodynamics of the cathepsin S inhibitor, LY3000328, in healthy subjects.

Science.gov (United States)

Payne, Christopher D; Deeg, Mark A; Chan, Melanie; Tan, Lai Hock; LaBell, Elizabeth Smith; Shen, Tong; DeBrota, David J

2014-12-01

The aim of this study was to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LY3000328 when administered as single escalating doses to healthy volunteers. This was a phase 1, placebo-controlled, dose escalation study with LY3000328 in 21 healthy male volunteers. Subjects were administered escalating LY3000328 doses up to 300 mg with food in this single dose study. Blood samples were collected at set times post-dose for the assessment of LY3000328 pharmacokinetics and the measurement of cathepsin S (CatS) activity, CatS mass and calculated CatS specific activity. All doses of LY3000328 were well tolerated, with linear pharmacokinetics up to the 300 mg dose. The pharmacodynamic activity of LY3000328 was measured ex vivo showing a biphasic response to LY3000328, where CatS activity declines, then returns to baseline, and then increases to a level above baseline. CatS mass was also assessed post-dose which increased in a dose-dependent manner, and continued to increase after LY3000328 had been cleared from the body. CatS specific activity was additionally calculated to normalize CatS activity for changes in CatS mass. This demonstrated the increase in CatS activity was attributable to the increase in CatS mass detected in plasma. A specific inhibitor of CatS which is cleared quickly from plasma may produce a transient decrease in plasma CatS activity which is followed by a more prolonged increase in plasma CatS mass which may have implications for the future clinical development of inhibitors of CatS. © 2014 The British Pharmacological Society.

113Insup(m) radiocardiographic measurements of cardiopulmonary parameters in healthy subjects and in cardiac patients

International Nuclear Information System (INIS)

Kuikka, Jyrki.

1976-05-01

Single detector arrangements are used to measure heart radioactivity curves in healthy subjects and in patients with various heart failures. A method is developed from a modified gamma function to determine the cardiopulmonary parameters from the radiocardiograms: systemic flow, pulmonary flow, right to left shunting flow, left to right shunting flow, regurgitant fractions, stroke volume, atrial blood volumes, ventricular end-diastolic volumes, pulmonary blood volume and ejection fractions. The method is well suited to clinical routine and requires only a desk calculator or a mini-computer for data handling. The cardiopulmonary parameters were measured from 70 healthy subjects with following results: cardiac index 3.46+-0.72 l/min/m 2 , stroke index 49+-9 ml/b/m 2 , right atrial blood volume 35+-13 ml/m 2 , right ventricular end-diastolic volume 76+-15 ml/m 2 , pulmonary blood volume 250+-51 ml/m 2 , left atrial blood volume 41+-15 ml/m 2 , left ventricular end-diastolic volume 75+-15 ml/m 2 , right heart ejection fraction 0.64+-0.11, left heart ejection fraction 0.66+-0.12. These values agree closely with the data accumulated from more elaborate methods. (author)

Intra-rater reliability of cervical sensory motor function and cervical reconstruction test in healthy subjects

Directory of Open Access Journals (Sweden)

Hatamvand S

2016-07-01

Full Text Available Impairment of cervicocephalic and head joint position sense has an important role in the recurrent and chronic of cervicocephalic pain. The various tools are suggested for evaluating the cervicocephalic joint position sense. Although reconstruction of cervical angle is a clinical criterion for measuring the cervicocephalic proprioception, the reliability of this method has not been completely accepted. The purpose of this study was to evaluate intra-rater reliability of cervical sensory motor function and cervical reconstruction test in healthy subjects. twenty four healthy subjects (25.70±6.08 y through simple non-probability sampling participated in this single-group repeatedmeasures reliability study. Participants were asked to relocate the neck, as accurately as possible, after full active cervical flexion, extension and rotation to the left and right sides. Five trials were performed for each movement. Laser pointer was used in head of patient. The distance between zero spot and joint position which patient had been reconstructed, was measured by centimeter. Intra-class correlation Coefficient (ICCs and Pearson's correlation coefficient test was used to determine intra-rater reliability of variables. The results showed that intra-class correlation Coefficient (ICCs values with 95% confidence interval (CI and the standard error of the measurement (SEM were good to excellent agreement for a single investigator between measurement occasions. Intra-class correlation Coefficient (ICCs values were obtained for flexion movement (ICCs:0.75, good, extension movement (ICCs:0.81, very good, right rotation (ICCs:0.64, good and left rotation (ICCs:0.64, good. The cervicocephalic relocation test to neutral head position by laser pointer is a reliable method to measure cervical sensory motor function. Therefore, it can be used for evaluating cervicocephalic proprioception of patient with cervicocephalic pain.

Lost in translation? The potential psychobiotic Lactobacillus rhamnosus (JB-1) fails to modulate stress or cognitive performance in healthy male subjects.

Science.gov (United States)

Kelly, John R; Allen, Andrew P; Temko, Andriy; Hutch, William; Kennedy, Paul J; Farid, Niloufar; Murphy, Eileen; Boylan, Geraldine; Bienenstock, John; Cryan, John F; Clarke, Gerard; Dinan, Timothy G

2017-03-01

Preclinical studies have identified certain probiotics as psychobiotics - live microorganisms with a potential mental health benefit. Lactobacillus rhamnosus (JB-1) has been shown to reduce stress-related behaviour, corticosterone release and alter central expression of GABA receptors in an anxious mouse strain. However, it is unclear if this single putative psychobiotic strain has psychotropic activity in humans. Consequently, we aimed to examine if these promising preclinical findings could be translated to healthy human volunteers. To determine the impact of L. rhamnosus on stress-related behaviours, physiology, inflammatory response, cognitive performance and brain activity patterns in healthy male participants. An 8week, randomized, placebo-controlled, cross-over design was employed. Twenty-nine healthy male volunteers participated. Participants completed self-report stress measures, cognitive assessments and resting electroencephalography (EEG). Plasma IL10, IL1β, IL6, IL8 and TNFα levels and whole blood Toll-like 4 (TLR-4) agonist-induced cytokine release were determined by multiplex ELISA. Salivary cortisol was determined by ELISA and subjective stress measures were assessed before, during and after a socially evaluated cold pressor test (SECPT). There was no overall effect of probiotic treatment on measures of mood, anxiety, stress or sleep quality and no significant effect of probiotic over placebo on subjective stress measures, or the HPA response to the SECPT. Visuospatial memory performance, attention switching, rapid visual information processing, emotion recognition and associated EEG measures did not show improvement over placebo. No significant anti-inflammatory effects were seen as assessed by basal and stimulated cytokine levels. L. rhamnosus was not superior to placebo in modifying stress-related measures, HPA response, inflammation or cognitive performance in healthy male participants. These findings highlight the challenges associated with

A novel noninvasive method for measuring fatigability of the quadriceps muscle in noncooperating healthy subjects

DEFF Research Database (Denmark)

Poulsen, Jesper Brøndum; Rose, Martin Høyer; Møller, Kirsten

2015-01-01

days, nonvoluntary isometric contractions (twitch and tetanic) of the quadriceps femoris muscle evoked by transcutaneous electrical muscle stimulation were recorded in twelve healthy adults. For tetanic contractions, the Fatigue Index (ratio of peak torque values) and the slope of the regression line...... of peak torque values were primary outcome measures. For twitch contractions, maximum peak torque and rise time were calculated. Relative (intraclass correlation, ICC3.1) and absolute (standard error of measurement, SEM) reliability were assessed and minimum detectable change was calculated using a 95...... fatigability of the quadriceps muscle produces reliable results in healthy subjects and may provide valuable data on quantitative changes in muscle working capacity and treatment effects in patients who are incapable of producing voluntary muscle contractions....

Gender differences in brain regional homogeneity of healthy subjects after normal sleep and after sleep deprivation: a resting-state fMRI study.

Science.gov (United States)

Dai, Xi-Jian; Gong, Hong-Han; Wang, Yi-Xiang; Zhou, Fu-Qing; Min, You-Jiang; Zhao, Feng; Wang, Si-Yong; Liu, Bi-Xia; Xiao, Xiang-Zuo

2012-06-01

To explore the gender differences of brain regional homogeneity (ReHo) in healthy subjects during the resting-state, after normal sleep, and after sleep deprivation (SD) using functional magnetic resonance imaging (fMRI) and the ReHo method. Sixteen healthy subjects (eight males and eight females) each underwent the resting-state fMRI exams twice, i.e., once after normal sleep and again after 24h's SD. According to the gender and sleep, 16 subjects were all measured twice and divided into four groups: the male control group (MC), female control group (FC), male SD group (MSD), and female SD group (FSD). The ReHo method was used to calculate and analyze the data, SPM5 software was used to perform a two-sample T-test and a two-pair T-test with a P value right paracentral lobule (BA3/6), but in no obviously lower regions. Compared with the FC, the FSD showed significantly higher ReHo in bilateral parietal lobes (BA2/3), bilateral vision-related regions of occipital lobes (BA17/18/19), right frontal lobe (BA4/6), and lower ReHo in the right frontal lobe. Compared with the FC, the MC showed significantly higher ReHo in the left occipital lobe (BA18/19), and left temporal lobe (BA21), left frontal lobe, and lower ReHo in the right insula and in the left parietal lobe. Compared with the FSD, the MSD showed significantly higher ReHo in the left cerebellum posterior lobe (uvula/declive of vermis), left parietal lobe, and bilateral frontal lobes, and lower ReHo in the right occipital lobe (BA17) and right frontal lobe (BA4). The differences of brain activity in the resting state can be widely found not only between the control and SD group in a same gender group, but also between the male group and female group. Thus, we should take the gender differences into consideration in future fMRI studies, especially the treatment of brain-related diseases (e.g., depression). Copyright © 2012 Elsevier B.V. All rights reserved.

The impact of the CACNA1C risk allele on limbic structures and facial emotions recognition in bipolar disorder subjects and healthy controls.

Science.gov (United States)

Soeiro-de-Souza, Márcio Gerhardt; Otaduy, Maria Concepción Garcia; Dias, Carolina Zadres; Bio, Danielle S; Machado-Vieira, Rodrigo; Moreno, Ricardo Alberto

2012-12-01

Impairments in facial emotion recognition (FER) have been reported in bipolar disorder (BD) during all mood states. FER has been the focus of functional magnetic resonance imaging studies evaluating differential activation of limbic regions. Recently, the α1-C subunit of the L-type voltage-gated calcium channel (CACNA1C) gene has been described as a risk gene for BD and its Met allele found to increase CACNA1C mRNA expression. In healthy controls, the CACNA1C risk (Met) allele has been reported to increase limbic system activation during emotional stimuli and also to impact on cognitive function. The aim of this study was to investigate the impact of CACNA1C genotype on FER scores and limbic system morphology in subjects with BD and healthy controls. Thirty-nine euthymic BD I subjects and 40 healthy controls were submitted to a FER recognition test battery and genotyped for CACNA1C. Subjects were also examined with a 3D 3-Tesla structural imaging protocol. The CACNA1C risk allele for BD was associated to FER impairment in BD, while in controls nothing was observed. The CACNA1C genotype did not impact on amygdala or hippocampus volume neither in BD nor controls. Sample size. The present findings suggest that a polymorphism in calcium channels interferes FER phenotype exclusively in BD and doesn't interfere on limbic structures morphology. Copyright © 2012 Elsevier B.V. All rights reserved.

A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group clinical trial to assess the effects of teduglutide on gastric emptying of liquids in healthy subjects.

Science.gov (United States)

Berg, Jolene Kay; Kim, Eric H; Li, Benjamin; Joelsson, Bo; Youssef, Nader N

2014-02-12

Teduglutide, a recombinant analog of human glucagon-like peptide (GLP)-2, is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support. Previous studies assessing the effect of GLP-2 on gastric emptying in humans have yielded inconsistent results, with some studies showing no effect and others documenting a GLP-2-dependent delay in gastric emptying. The primary objective of this study was to assess the effect of teduglutide on gastric emptying of liquids in healthy subjects, as measured by the pharmacokinetics of acetaminophen. This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning. Gastric emptying of a mixed nutrient liquid meal was assessed by measuring acetaminophen levels predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, and 14 hours after administration of 1000 mg acetaminophen on Days 0 and 10. The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo. No significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo. There were no serious adverse events (AEs), deaths, or discontinuations due to an AE reported during the study. Teduglutide 4 mg/day for 10 days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics. No unexpected safety signals were observed. This study was registered at ClinicalTrials.gov, identifier NCT01209351.