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Sample records for controlled clinical polysomnographic

  1. Clinical and polysomnographic course of childhood narcolepsy with cataplexy

    PubMed Central

    Pizza, Fabio; Franceschini, Christian; Peltola, Hanna; Vandi, Stefano; Finotti, Elena; Ingravallo, Francesca; Nobili, Lino; Bruni, Oliviero; Lin, Ling; Edwards, Mark J.; Partinen, Markku; Dauvilliers, Yves; Mignot, Emmanuel; Bhatia, Kailash P.

    2013-01-01

    Our aim was to investigate the natural evolution of cataplexy and polysomnographic features in untreated children with narcolepsy with cataplexy. To this end, clinical, polysomnographic, and cataplexy-video assessments were performed at diagnosis (mean age of 10 ± 3 and disease duration of 1 ± 1 years) and after a median follow-up of 3 years from symptom onset (mean age of 12 ± 4 years) in 21 children with narcolepsy with cataplexy and hypocretin 1 deficiency (tested in 19 subjects). Video assessment was also performed in two control groups matched for age and sex at first evaluation and follow-up and was blindly scored for presence of hypotonic (negative) and active movements. Patients’ data at diagnosis and at follow-up were contrasted, compared with controls, and related with age and disease duration. At diagnosis children with narcolepsy with cataplexy showed an increase of sleep time during the 24 h; at follow-up sleep time and nocturnal sleep latency shortened, in the absence of other polysomnographic or clinical (including body mass index) changes. Hypotonic phenomena and selected facial movements decreased over time and, tested against disease duration and age, appeared as age-dependent. At onset, childhood narcolepsy with cataplexy is characterized by an abrupt increase of total sleep over the 24 h, generalized hypotonia and motor overactivity. With time, the picture of cataplexy evolves into classic presentation (i.e. brief muscle weakness episodes triggered by emotions), whereas total sleep time across the 24 h decreases, returning to more age-appropriate levels. PMID:24142146

  2. Clinical and polysomnographic course of childhood narcolepsy with cataplexy.

    PubMed

    Pizza, Fabio; Franceschini, Christian; Peltola, Hanna; Vandi, Stefano; Finotti, Elena; Ingravallo, Francesca; Nobili, Lino; Bruni, Oliviero; Lin, Ling; Edwards, Mark J; Partinen, Markku; Dauvilliers, Yves; Mignot, Emmanuel; Bhatia, Kailash P; Plazzi, Giuseppe

    2013-12-01

    Our aim was to investigate the natural evolution of cataplexy and polysomnographic features in untreated children with narcolepsy with cataplexy. To this end, clinical, polysomnographic, and cataplexy-video assessments were performed at diagnosis (mean age of 10 ± 3 and disease duration of 1 ± 1 years) and after a median follow-up of 3 years from symptom onset (mean age of 12 ± 4 years) in 21 children with narcolepsy with cataplexy and hypocretin 1 deficiency (tested in 19 subjects). Video assessment was also performed in two control groups matched for age and sex at first evaluation and follow-up and was blindly scored for presence of hypotonic (negative) and active movements. Patients' data at diagnosis and at follow-up were contrasted, compared with controls, and related with age and disease duration. At diagnosis children with narcolepsy with cataplexy showed an increase of sleep time during the 24 h; at follow-up sleep time and nocturnal sleep latency shortened, in the absence of other polysomnographic or clinical (including body mass index) changes. Hypotonic phenomena and selected facial movements decreased over time and, tested against disease duration and age, appeared as age-dependent. At onset, childhood narcolepsy with cataplexy is characterized by an abrupt increase of total sleep over the 24 h, generalized hypotonia and motor overactivity. With time, the picture of cataplexy evolves into classic presentation (i.e., brief muscle weakness episodes triggered by emotions), whereas total sleep time across the 24 h decreases, returning to more age-appropriate levels.

  3. Polysomnographic Technology

    MedlinePlus

    ... ACCREDITATION MENTOR | TAKE THE SITE VISITOR QUIZ Polysomnographic Technology Occupational Description Polysomnographic technologists perform sleep tests and work with physicians to provide information needed ...

  4. Oxidative stress parameters and their correlation with clinical, metabolic and polysomnographic parameters in severe obstructive sleep apnea syndrome

    PubMed Central

    Asker, Selvi; Asker, Muntecep; Sarikaya, Eren; Sunnetcioglu, Aysel; Aslan, Mehmet; Demir, Halit

    2015-01-01

    The aim of the present study was to assess the levels of oxidative stress markers, catalase (CAT), glutathione peroxidase (GPX) and malondialdehyde (MDA) in severe OSAS and to investigate any correlation between oxidative stress markers and clinical, metabolic and polysomnographic parameters. A total of 30 patients with severe OSAS and 30 healthy controls were included in this cross-sectional, clinical study. Demographic data, polysomnographic, biochemical and clinical indices as well as serum levels of CAT, MDA and GPX were measured and compared in OSAS and control groups. Furthermore, OSAS patients with and without pulmonary hypertension (PHT) were evaluated in terms of levels of CAT, MDA and GPX. Patients with severe OSAS exhibited significantly lower serum levels of CAT (P<0.001) and GPX (P<0.001). Serum MDA levels were remarkably higher in OSAS group (P<0.001). Correlation analysis revealed that levels of CAT and GPX were correlated with apnea-hypopnea index and there was a correlation between serum levels of MDA and CRP. Severe OSAS patients with and without PHT did not reveal any differences for CAT (P=0.789), MDA (P=0.805) and GPX levels (P=0.281). Our results have shown that oxidative stress markers significantly changed in patients with severe OSAS. This information is noteworthy because documentation of the role of oxidative stress in OSAS may have important implications regarding diagnosis, monitoring, treatment and prognosis. PMID:26379962

  5. Polysomnographic Findings and Clinical Correlates in Huntington Disease: A Cross-Sectional Cohort Study

    PubMed Central

    Piano, Carla; Losurdo, Anna; Della Marca, Giacomo; Solito, Marcella; Calandra-Buonaura, Giovanna; Provini, Federica; Bentivoglio, Anna Rita; Cortelli, Pietro

    2015-01-01

    Study Objectives: To evaluate the sleep pattern and the motor activity during sleep in a cohort of patients affected by Huntington disease (HD). Design: Cross-sectional cohort study. Setting: Sleep laboratory. Patients: Thirty HD patients, 16 women and 14 men (mean age 57.3 ± 12.2 y); 30 matched healthy controls (mean age 56.5 ± 11.8 y). Interventions: Subjective sleep evaluation: Epworth Sleepiness Scale (ESS); Berlin's Questionnaire, interview for restless legs syndrome (RLS), questionnaire for REM sleep behavior disorder (RBD). Clinical evaluation: disease duration, clinical severity (unified Huntington disease motor rating scale [UHDMRS]), genetic tests. Laboratory-based full-night attended video-polysomnography (V-PSG). Measurements and Results: The duration of the disease was 9.4 ± 4.4 y, UHMDRS score was 55.5 ± 23.4, CAG repeats were 44.3 ± 4.1. Body mass index was 21.9 ± 4.0 kg/m2. No patients or caregivers reported poor sleep quality. Two patients reported symptoms of RLS. Eight patients had an ESS score ≥ 9. Eight patients had high risk of obstructive sleep apnea. At the RBD questionnaire, two patients had a pathological score. HD patients, compared to controls, showed shorter sleep, reduced sleep efficiency index, and increased arousals and awakenings. Four patients presented with sleep disordered breathing (SDB). Periodic limb movements (PLMs) during wake and sleep were observed in all patients. No episode of RBD was observed in the V-PSG recordings, and no patients showed rapid eye movement (REM) sleep without atonia. The disease duration correlated with ESS score (P < 0.02). UHMDRS correlated positively with the ESS score (P < 0.005), and negatively with the percentage of REM sleep. Conclusions: Patients with Huntington disease showed a severe sleep disruption and a high prevalence of periodic limb movements, but no evidence of sleep disordered breathing or REM sleep behavior disorder. Citation: Piano C, Losurdo A, Della Marca G, Solito M

  6. Answer to comment on "sleep quality, arousal and pain thresholds in migraineurs: a blinded controlled polysomnographic study".

    PubMed

    Engstrøm, Morten; Hagen, Knut; Bjørk, Marte; Sand, Trond

    2013-07-01

    We discuss the comments on our article "Sleep quality, arousal and pain thresholds in migraineurs. A blinded controlled polysomnographic study" published in JHP 2013 Feb 14;14(1):12. We hypothesize that migraineurs need more sleep than healthy controls and more sleep than they manage to achieve. Some migraineurs probably have a decreased ability to process incoming stimuli. Increased spontaneous pain may follow either sleep restriction or sleep disturbance. A comparison of migraineurs with attack onset related to sleep, migraineurs with attack onset not related to sleep and controls will be reported in another paper.

  7. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome.

    PubMed

    Saletu, Michael; Anderer, Peter; Saletu-Zyhlarz, Gerda Maria; Parapatics, Silvia; Gruber, Georg; Nia, Saba; Saletu, Bernd

    2010-04-01

    The aim of the present placebo-controlled sleep laboratory study was to compare the acute effects of gabapentin (GBT) and ropinirole (ROP) in restless legs syndrome (RLS). In a parallel-group design, 40 RLS patients received 300 mg GBT and another 40 patients 0.5 mg ROP as compared with placebo. Polysomnographic and psychometric measures were obtained in three sleep laboratory nights (screening/placebo/drug). Statistics included a Wilcoxon test for differences between drug and placebo and a U test for inter-group differences. Sleep efficiency and latency were found significantly improved after GBT, while they remained unchanged after ROP, with significant inter-drug differences. Sleep architecture showed oppositional changes after the two drugs: While GBT decreased S1, increased slow-wave sleep and SREM and shortened REM latency, ROP increased S2, decreased slow-wave sleep and SREM and increased REM latency. Periodic leg movements (PLM) showed a significantly greater decrease after ROP (-73%) than after GBT (-35%). Subjective sleep quality improved significantly only after GBT; mental performance improved after both drugs with no inter-drug differences. In conclusion, the dopamine agonist ROP showed acute therapeutic efficacy with regard to PLM measures only, whereas GBT had a less pronounced effect on these measures, but improved objective and subjective sleep and awakening quality as compared with both placebo and ROP. Differential acute drug effects may serve as prognostic indicators of therapeutic response of individual patients.

  8. Insomnia in generalized anxiety disorder: polysomnographic, psychometric and clinical investigations before, during and after therapy with a long- versus a short-half-life benzodiazepine (quazepam versus triazolam).

    PubMed

    Saletu, B; Anderer, P; Brandstätter, N; Frey, R; Grünberger, J; Klösch, G; Mandl, M; Wetter, T; Zeitlhofer, J

    1994-01-01

    Within a double-blind, comparative study on the effects of the long-half-life benzodiazepine (BDZ), quazepam, and the short-half-life BDZ, triazolam, on clinical symptomatology, sleep and anxiety of 45 patients with insomnia based on a mild to moderate generalized anxiety disorder (GAD) (ICD-9 code: 307.42-1, 300,0; ASDC-APSS-Code: A.2.a), we compared, in a first step at baseline, drug-free polysomnographic and psychometric data of 22 patients recorded in the laboratory (L-group) and 21 patients recorded by the Oxford Medilog 9000 system at home (H-group) with those of normal controls. Sleep efficiency, total sleep time, wake within total sleep period (middle insomnia) and wake before buzzer (late insomnia) were significantly deteriorated in both patient groups as compared with controls, while sleep induction time only differed significantly in home recordings. Regarding sleep architecture, stage (S)2 was reduced, S3 and S4 increased in the H-group only, while no intergroup differences were seen in S1, SREM and REM latency. Subjective sleep quality was reduced in both patient groups, but not awakening quality. Psychometric tests in the morning demonstrated for the noopsyche, only a significantly deteriorated psychomotor activity in both patient groups. In the thymopsyche, evening well-being and mood in the morning were reduced in both the L- and H-group, affectivity and morning well-being only in the H-group. The psychopharmacological part of the study was completed by 40 patients (there were 4 drop-outs in the triazolam, 1 in the quazepam group). They were treated after 1 week placebo with either 15-30 mg (median 15 mg) quazepam or 0.25-0.5 mg (median 0.25 mg) triazolam for 4 weeks, and thereafter for 2 weeks with placebo. Anxiety (rated by HAMA and SAS) improved significantly with both drugs and remained improved throughout 2 weeks post-drug placebo, with quazepam being slightly superior to triazolam. Polysomnography demonstrated a shortened sleep onset only

  9. A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin in Transient Insomnia Induced by Sleep Phase Advance

    PubMed Central

    Rosenberg, Russell P.; Hull, Steven G.; Lankford, D. Alan; Mayleben, David W.; Seiden, David J.; Furey, Sandy A.; Jayawardena, Shyamalie; Roth, Thomas

    2014-01-01

    Study Objectives: To evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic (PSG) and participant-reported sleep measures in a 5-h phase advance insomnia model. Methods: Adults reporting occasional disturbed sleep received gabapentin 500 mg (n = 125), 250 mg (n = 125), or placebo (n = 127) 30 min prior to bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, post-sleep questionnaire, and the Karolinska Sleep Diary (KSD). Next-day residual effects (Digit Symbol Substitution Test [DSST] and Stanford Sleepiness Scale [SSS]) and tolerability were assessed. Results: Demographics were comparable among groups. Among PSG endpoints, wake after sleep onset (primary endpoint) (135.7 [placebo], 100.7 [250 mg], and 73.2 [500 mg] min) was significantly lower and total sleep time (TST) (311.4, 356.5, and 378.7 min) significantly greater in both gabapentin groups versus placebo. Latency to persistent sleep was not significantly different among groups. Percent slow wave sleep (12.6%, 15.4%, and 17.0%, respectively) was significantly greater and percent stage 1 (15.1%, 11.8%, and 10.8%, respectively) significantly lower relative to placebo. Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo; no other reported outcomes were significant. Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS. Adverse events were infrequent (< 5%). Conclusion: Participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth (versus placebo) in response to a phase advance manipulation known to disrupt sleep maintenance. Citation: Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient

  10. Sleep changes following statin therapy: a systematic review and meta-analysis of randomized placebo-controlled polysomnographic trials

    PubMed Central

    Broncel, Marlena; Gorzelak-Pabiś, Paulina; Sahebkar, Amirhossein; Serejko, Katarzyna; Ursoniu, Sorin; Rysz, Jacek; Corina Serban, Maria; Możdżan, Monika

    2015-01-01

    Introduction Statin use might be associated with an increased risk of sleep disturbances including insomnia, but the evidence regarding sleep changes following statin therapy has not been conclusive. Therefore we assessed the impact of statin therapy on sleep changes through a systematic review and meta-analysis of available randomized controlled trials (RCTs). Material and methods We searched MEDLINE and SCOPUS up to October 1, 2014 to identify placebo-controlled RCTs investigating the effect of statin therapy on sleep changes. A meta-analysis was performed using either a fixed-effects or a random-effect model according to the I2 statistic. Effect size was expressed as weighted mean difference (WMD) and 95% confidence interval (CI). Results Overall, the impact of statin therapy on polysomnography (PSG) indices of sleep was reported in 5 trials comprising 9 treatment arms. Overall, statin therapy had no significant effect on total sleep duration (WMD: –7.75 min, 95% CI: –18.98, 3.48, p = 0.176), sleep efficiency (WMD: 0.09%, 95% CI: –2.27, 2.46, p = 0.940), entries to stage I (WMD: 0.36, 95% CI: –0.91, 1.63, p = 0.580), or latency to stage I (WMD: –1.92 min, 95% CI: –4.74, 0.89, p = 0.181). In contrast, statin therapy significantly reduced wake time (WMD: –4.43 min, 95% CI: –7.77, –0.88, p = 0.014) and number of awakenings (WMD: –0.40, 95% CI: –0.46, –0.33, p < 0.001). Meta-regression did not suggest any correlation between changes in wake time and awakening episodes with duration of treatment and LDL-lowering effect of statins. Conclusions The results indicated that statins have no significant adverse effect on sleep duration and efficiency, entry to stage I, or latency to stage I sleep, but significantly reduce wake time and number of awakenings. PMID:26528331

  11. Effect of Placebo Conditions on Polysomnographic Parameters in Primary Insomnia: A Meta-Analysis

    PubMed Central

    Winkler, Alexander; Rief, Winfried

    2015-01-01

    Study Objectives: Little is known about the role of placebo response in the pharmacotherapy of primary insomnia, especially about the effect of placebo intake on objectively assessed outcome variables. Our aim was therefore to conduct an effect-size analysis of placebo conditions in randomized controlled drug trials addressing primary insomnia also including polysomnography. Design: We conducted a comprehensive literature search using PubMed, PsycINFO, PSYNDEX, PQDT OPEN, OpenGREY, ISI Web of Knowledge, Cochrane Clinical Trials, and the World Health Organization International Clinical Trials Registry Platform. The meta-analysis used a random effects model and was based on 32 studies reporting 82 treatment conditions covering a total of 3,969 participants. Special emphasis was given to the comparison of objective and subjective outcomes and the proportion of the placebo response to the drug response. Measurements and Results: Effect sizes estimates (Hedges g) suggest that there is a small to moderate yet significant and robust placebo response reducing the symptoms of insomnia in terms of sleep onset latency (−0.35), total sleep time (0.42), wake after sleep onset (−0.29), sleep efficiency (0.31), subjective sleep onset latency (−0.29), subjective total sleep time (0.43), subjective wake after sleep onset (−0.32), subjective sleep efficiency (0.25) and sleep quality (0.31). Thus, the placebo response was also evident in objective, physiological (polysomnographic) variables. Our results indicate that 63.56% of the drug responses are achieved even in the placebo groups. Conclusions: In light of these strong placebo responses, future studies should investigate how to exploit placebo mechanisms in clinical practice. Citation: Winkler A, Rief W. Effect of placebo conditions on polysomnographic parameters in primary insomnia: a meta-analysis. SLEEP 2015;38(6):925–931. PMID:25515108

  12. Sleep changes in the disorder of insomnia: a meta-analysis of polysomnographic studies.

    PubMed

    Baglioni, Chiara; Regen, Wolfram; Teghen, Armand; Spiegelhalder, Kai; Feige, Bernd; Nissen, Christoph; Riemann, Dieter

    2014-06-01

    Insomnia is a highly prevalent health problem worldwide. Primary insomnia (PI), i.e., insomnia not due to another disorder or substance use, represents a model to elucidate the pathophysiology of sleep. However, prior research in patients with PI has failed to demonstrate consistent abnormalities in the state-of-the-art assessment of sleep (polysomnography). The aim of this meta-analysis was to clarify whether there are identifiable polysomnographic sleep changes that correspond to the subjective complaints of patients with PI. Medline and PsycInfo databases were searched from 1994 to 2012. Effects were calculated as standardized mean differences. Studies were pooled with the random-effects metaanalytic model. Twenty-three studies met inclusion criteria. In total, 582 patients with PI and 485 good sleeper controls (GSC) were evaluated. The results showed that patients with PI present a disruption of sleep continuity and a significant reduction of slow wave sleep (SWS) and rapid eye movement (REM) sleep compared to GSC. The observed changes in sleep architecture, i.e., reductions in SWS and REM sleep, hitherto did not count among the typical polysomnographic findings in patients with PI. An advanced knowledge of the polysomnographic changes in PI may add to foster the understanding of the pathophysiology of sleep and its bi-directional relationships with somatic and mental disorders.

  13. Motor Events during Healthy Sleep: A Quantitative Polysomnographic Study

    PubMed Central

    Frauscher, Birgit; Gabelia, David; Mitterling, Thomas; Biermayr, Marlene; Bregler, Deborah; Ehrmann, Laura; Ulmer, Hanno; Högl, Birgit

    2014-01-01

    sleep, the future use of normative values for both research and clinical routine is essential. Citation: Frauscher B; Gabelia D; Mitterling T; Biermayr M; Bregler D; Ehrmann L; Ulmer H; Högl B. Motor events during healthy sleep: a quantitative polysomnographic study. SLEEP 2014;37(4):763-773. PMID:24744455

  14. Polysomnographic and long-term video electroencephalographic evaluation of cases presenting with parasomnias.

    PubMed

    Yiş, Uluç; Kurul, Semra Hiz; Öztura, Ibrahim; Ecevit, Mustafa Cenk; Dirik, Eray

    2013-09-01

    The aim of this study is to evaluate the clinical, electroencephalographic and polysomnographic features of patients presenting with parasomnias. Cases who were admitted for differentiating parasomnias from epilepsy were included in the study. Clinical features of cases were recorded and routine sleep electroencephalography was obtained from all cases. Cases whose symptoms strongly suggested nocturnal seizure underwent all night video electroencephalography monitoring. Polysomnography was obtained to evaluate the quality of breathing from patients whose symptoms suggested obstructive sleep apnea. Twenty-three patients with no neurological disorder were included in the study. The mean age of the patients was 11.7 ± 2.8 [7-17] years. Twelve patients (52 %) presented with sleep terrors and 11 patients (48 %) presented with sleep walking. All of the patients underwent a routine sleep electroencephalographic study and 15 patients (65 %) whose symptoms strongly suggested nocturnal epilepsy underwent long-term video electroencephalographic evaluation. Ten patients (43 %) underwent polysomnographic study. Three patients (20 %) who underwent long-term video electroencephalographic evaluation were diagnosed to have nocturnal frontal lobe epilepsy and two patients (20 %) who underwent polysomnography had pathological sleep apnea. Eleven patients (48 %) had a psychiatric disorder like major depression, anxiety disorder, hyperactivity disorder and obsessive-compulsive disorder. Childhood cases presenting with parasomnias should be searched for nocturnal epileptic disorders, sleep disordered breathing and psychiatric disorders. PMID:23135782

  15. Polysomnographic Findings in a Cohort of Chronic Insomnia Patients with Benzodiazepine Abuse

    PubMed Central

    Mazza, Marianna; Losurdo, Anna; Testani, Elisa; Marano, Giuseppe; Di Nicola, Marco; Dittoni, Serena; Gnoni, Valentina; Di Blasi, Chiara; Giannantoni, Nadia Mariagrazia; Lapenta, Leonardo; Brunetti, Valerio; Bria, Pietro; Janiri, Luigi; Mazza, Salvatore; Della Marca, Giacomo

    2014-01-01

    Study Objectives: To evaluate sleep modifications induced by chronic benzodiazepine (BDZ) abuse. Methods: Cohort study, comparison of sleep measures between BDZs abusers and controls. Drug Addiction Unit (Institute of Psychiatry) and Unit of Sleep Disorders (Institute of Neurology) of the Catholic University in Rome. Six outpatients affected by chronic BDZ abuse were enrolled, (4 men, 2 women, mean age 53.3 ± 14.8, range: 34-70 years); 55 healthy controls were also enrolled (23 men, 32 women, mean age 54.2 ± 13.0, range: 27-76 years). All patients underwent clinical evaluation, psychometric measures, ambulatory polysomnography, scoring of sleep macrostructure and microstructure (power spectral fast-frequency EEG arousal, cyclic alternating pattern [CAP]), and heart rate variability. Results: BDZ abusers had relevant modification of sleep macrostructure and a marked reduction of fast-frequency EEG arousal in NREM (patients: 6.6 ± 3.7 events/h, controls 13.7 ± 4.9 events/h, U-test: 294, p = 0.002) and REM (patients: 8.4 ± 2.4 events/h, controls 13.3 ± 5.1 events/h, U-test: 264, p = 0.016), and of CAP rate (patients: 15.0 ± 8.6%, controls: 51.2% ± 12.1%, U-test: 325, p < 0.001). Discussion: BDZ abusers have reduction of arousals associated with increased number of nocturnal awakenings and severe impairment of sleep architecture. The effect of chronic BDZ abuse on sleep may be described as a severe impairment of arousal dynamics; the result is the inability to modulate levels of vigilance. Citation: Mazza M; Losurdo A; Testani E; Marano G; Di Nicola M; Dittoni S; Gnoni V; Di Blasi C; Giannantoni NM; Lapenta L; Brunetti V; Bria P; Janiri L; Mazza S; Della Marca G. Polysomnographic findings in a cohort of chronic insomnia patients with benzodiazepine abuse. J Clin Sleep Med 2014;10(1):35-42. PMID:24426818

  16. Polysomnographic Characteristics of Sleep in Stroke: A Systematic Review and Meta-Analysis

    PubMed Central

    Baglioni, Chiara; Nissen, Christoph; Schweinoch, Adrian; Riemann, Dieter; Spiegelhalder, Kai; Berger, Mathias; Weiller, Cornelius; Sterr, Annette

    2016-01-01

    Background Research on sleep after stroke has focused mainly on sleep disordered breathing. However, the extend to which sleep physiology is altered in stroke survivors, how these alterations compare to healthy volunteers, and how sleep changes might affect recovery as well as physical and mental health has yet to be fully researched. Motivated by the view that a deeper understanding of sleep in stroke is needed to account for its role in health and well-being as well as its relevance for recovery and rehabilitation, we conducted a systematic review and meta-analysis of polysomnographic studies comparing stroke to control populations. Method Medline and PsycInfo databases were searched using "stroke" and words capturing polysomnographic parameters as search terms. This yielded 1692 abstracts for screening, with 15 meeting the criteria for systematic review and 9 for meta-analysis. Prisma best practice guidelines were followed for the systematic review; the Comprehensive Meta-Analysis software was used for random effects modelling. Results The meta-analysis revealed that patients with stroke have poorer sleep than controls. Patients had lower sleep efficiency (mean 75% vs 84%), shorter total-sleep-time (309.4 vs 340.3 min) and more wake-after-sleep-onset (97.2 vs 53.8 min). Patients also spend more time in stage 1 (13% vs 10%) and less time in stage 2 sleep (36% vs 45%) and slow-wave-sleep (10% vs 12%). No group differences were identified for REM sleep. The systematic review revealed a strong bias towards studies in the early recovery phase of stroke, with no study reporting specifically on patients in the chronic state. Moreover, participants in the control groups included community samples as well as other patients groups. Conclusions These results indicate poorer sleep in patients with stroke than controls. While strongly suggestive in nature, the evidence base is limited and methodologically diverse, and hands a clear mandate for further research. A particular

  17. [Controlling in clinical management].

    PubMed

    Bähr, K; Ellinger, K

    1999-02-01

    Managers of industrial enterprises strive continually to improve the efficiency of production, distribution and service for their customers in order to be able to compete on the market. In socially orientated non-profit-organisations this is not universe practice. Relating to section 17 Abs. 1 KHG and section 13 BPfIV of German social legislation hospital charges are refunded only, if the hospital is working efficiently and economically. Controlling is a tool to achieve these goals. Controlling coordinates the flow of information for planning and evaluation. Strategic and operative controlling are closely interrelated: Strategic controlling is directed towards new and promising activities, operative controlling supports decision--making--including future-oriented aspects-by providing and condensing information. Controlling is definitely not intended to dictate or "command" any action. Its object is to serve as an instrument or tool supporting result-oriented planning, regulating and evaluation.

  18. REM sleep behavior disorder in Parkinson's disease: A case from India confirmed with polysomnographic data

    PubMed Central

    Gupta, Ravi; Goel, Deepak; Walker, Jim; Farney, Robert J

    2013-01-01

    Rapid eye movement (REM) sleep behavior disorder is a condition characterized by dream enactment. This condition may accompany neurodegenerative disorders. However, only a few reports from India are available, that too, without any polysomnographic evidence. We are reporting a case of REM sleep behavior disorder with polysomnographic evidence. PMID:24174810

  19. A parasomnia overlap disorder involving sleepwalking, sleep terrors, and REM sleep behavior disorder in 33 polysomnographically confirmed cases.

    PubMed

    Schenck, C H; Boyd, J L; Mahowald, M W

    1997-11-01

    A series of 33 patients with combined (injurious) sleepwalking, sleep terrors, and rapid eye movement (REM) sleep behavior disorder (viz. "parasomnia overlap disorder") was gathered over an 8-year period. Patients underwent clinical and polysomnographic evaluations. Mean age was 34 +/- 14 (SD) years; mean age of parasomnia onset was 15 +/- 16 years (range 1-66); 70% (n = 23) were males. An idiopathic subgroup (n = 22) had a significantly earlier mean age of parasomnia onset (9 +/- 7 years) than a symptomatic subgroup (n = 11) (27 +/- 23 years, p = 0.002), whose parasomnia began with either of the following: neurologic disorders, n = 6 [congenital Mobius syndrome, narcolepsy, multiple sclerosis, brain tumor (and treatment), brain trauma, indeterminate disorder (exaggerated startle response/atypical cataplexy)]; nocturnal paroxysmal atrial fibrillation, n = 1; posttraumatic stress disorder/major depression, n = 1; chronic ethanol/amphetamine abuse and withdrawal, n = 1; or mixed disorders (schizophrenia, brain trauma, substance abuse), n = 2. The rate of DSM-III-R (Diagnostic and Statistical Manual, 3rd edition, revised) Axis 1 psychiatric disorders was not elevated; group scores on various psychometric tests were not elevated. Forty-five percent (n = 15) had previously received psychologic or psychiatric therapy for their parasomnia, without benefit. Treatment outcome was available for n = 20 patients; 90% (n = 18) had substantial parasomnia control with bedtime clonazepam (n = 13), alprazolam and/or carbamazepine (n = 4), or self-hypnosis (n = 1). Thus, "parasomnia overlap disorder" is a treatable condition that emerges in various clinical settings and can be understood within the context of current knowledge on parasomnias and motor control/dyscontrol during sleep. PMID:9456462

  20. Birth Control in Clinical Trials

    PubMed Central

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  1. Polysomnographic findings in nights preceding a migraine attack.

    PubMed

    Göder, R; Fritzer, G; Kapsokalyvas, A; Kropp, P; Niederberger, U; Strenge, H; Gerber, W D; Aldenhoff, J B

    2001-02-01

    Sleep recordings were performed in eight patients to analyse sleep alterations preceding migraine attacks. Polysomnographic recordings from nights before an attack were compared with nights without following migraine. We analysed standard sleep parameters and electroencephalogram (EEG) power spectra. The main findings preceding migraine attacks were a significant decrease in the number of arousals, a decrease in rapid eye movement (REM) density, a significant decrease of beta power in the slow wave sleep, and a decrease of alpha power during the first REM period. The results suggest a decrease in cortical activation during sleep preceding migraine attacks. According to the models of sleep regulation, alterations in the function of aminergic or cholinergic brainstem nuclei have to be discussed. PMID:11298661

  2. Towards a Wireless Smart Polysomnograph Using Symbolic Fusion.

    PubMed

    Ugon, Adrien; Seroussi, Brigitte; Philippe, Carole; Ganascia, Jean-Gabriel; Garda, Patrick; Sedki, Karima; Bouaud, Jacques; Pinna, Andrea

    2016-01-01

    Polysomnography is the gold standard test for sleep disorders among which the Sleep Apnea Syndrome (SAS) is considered a public health issue because of the increase of the cardio-and cerebro-vascular risk it is associated with. However, the reliability of this test is questioned since sleep scoring is a time-consuming task performed by medical experts with a high inter- and intra-scorers variability, and because data are collected from 15 sensors distributed over a patient's body surface area, using a wired connection which may be a source of artefacts for the patient's sleep. We have used symbolic fusion to support the automated diagnosis of SAS on the basis of the international guidelines of the AASM for the scoring of sleep events. On a sample of 70 patients, and for the Apnea-Hypopnea Index, symbolic fusion performed at the level of sleep experts (97.1% of agreement). The next step is to confirm these preliminary results and move forward to a smart wireless polysomnograph. PMID:27071869

  3. Vibration from freight trains fragments sleep: A polysomnographic study

    PubMed Central

    Smith, Michael G.; Croy, Ilona; Hammar, Oscar; Persson Waye, Kerstin

    2016-01-01

    As the number of freight trains on railway networks increases, so does the potential for vibration exposure in dwellings nearby to freight railway lines. Nocturnal trains in particular are of particular importance since night-time exposure may interfere with sleep. The present work investigates the impact of vibration and noise from night-time freight trains on human sleep. In an experimental polysomnographic laboratory study, 24 young healthy volunteers with normal hearing were exposed to simulated freight pass-bys with vibration amplitudes of 0.7 and 1.4 mm/s either 20 or 36 times during the night. Stronger vibrations were associated with higher probabilities of event-related arousals and awakenings (p < 0.001), and sleep stage changes (p < 0.05). Sleep macrostructure was most affected in high vibration nights with 36 events, with increased wakefulness (p < 0.05), reduced continual slow wave sleep (p < 0.05), earlier awakenings (p < 0.05) and an overall increase in sleep stage changes (p < 0.05). Subjects reported sleep disturbance due to vibration (F(4,92) = 25.9, p < 0.001) and noise (F(4,92) = 25.9, p < 0.001), with the number of trains having an effect only for the 0.7 mm/s condition (p < 0.05). The findings show that combined vibration and noise from railway freight affects the natural rhythm of sleep, but extrapolation of significance for health outcomes should be approached with caution. PMID:27090401

  4. Polysomnographic correlates of inflammatory complement components in young healthy males.

    PubMed

    Hussain, M Ejaz; Golam Sarwar, Abu Hasnath M; Alam, Mohd Shoeb; Noohu, Majumi M; Zannat, Wassilatul; Pandi-Perumal, Seithikurippu R; Bahammam, Ahmed S; Manzar, Md Dilshad

    2016-01-01

    A growing body of evidence has delineated the predominant role of humoral mediators of inflammation in linking sleep with immunity. Nonetheless, characterization of the relationship between complement components with inflammatory functions and objective sleep measures has not been performed. In this study we investigated the relationships between objective measures of sleep and complement components with inflammatory functions. Thirty-six healthy male university students (age, 23.94±4.23 years; BMI, 23.44±2.67 kg/m(2)) completed the study. An RMS Quest 32 polysomnograph (PSG) was used for sleep recording. Non-fasting blood was collected before subjects went to bed on the second night in the sleep laboratory to estimate complement component 3 (C-3), complement component 4 (C-4), complement factor-H (Factor-H), C1-inhibitor (C1INH), complement factor I (CFI) and other inflammatory mediators, such as IL-6 and sICAM-1. Multiple linear regression analysis was used to assess the association between PSG sleep measures and inflammatory mediators. Higher values of C-3 and lower values of sICAM-1, C1INH, and CFI (adjusted model, R2=0.211, p<0.041) predicted longer sleep duration. Lower C-3 (adjusted model, R2=0.078, p<0.055) predicted higher N1 (%). Higher levels of C1INH and CFI and lower values of C-4 (model adjusted R2=0.269, p<0.008) predicted higher N3 (%). Higher C-3, higher C-4, lower IL-6, lower C1INH and lower CFI (model adjusted R2=0.296, p<0.007) predicted higher REM (%). Poor sleep measures were associated with increased levels of pro-inflammatory complement components and decreased anti-inflammatory complement components. PMID:27656278

  5. Polysomnographic Study of Sleep in Survivors of Breast Cancer

    PubMed Central

    Reinsel, Ruth A.; Starr, Tatiana D.; O'Sullivan, Barbara; Passik, Steven D.; Kavey, Neil B.

    2015-01-01

    Study Objective: Insomnia is a frequent complaint in breast cancer patients during and after treatment. Breast cancer survivors, 1–10 years posttreatment, underwent in-lab polysomnography (PSG) to objectively define the insomnia in those patients with such a complaint. Methods: Twenty-six breast cancer survivors (aged 39–80, mean 54.0 months posttreatment) spent 2 nights in the sleep laboratory. Sleep on Night 2 was scored for sleep stages, sleep onset latency, REM sleep onset latency, wake time, apneas and hypopneas, periodic limb movements and arousals. Subjects were allocated into 2 groups by their scores on the Pittsburgh Sleep Quality Index (PSQI): no/ mild sleep disturbance (PSQI score ≤ 9, n = 15) or moderate/ severe sleep disturbance (PSQI ≥ 10, n = 11). Results: Standard PSG/EEG parameters failed to differentiate insomniacs from non-insomniacs. The single variable that distinguished the insomnia group was periodic limb movements in sleep (PLMS). PLMS were significantly correlated (r ≅ 0.7, p < 0.02) with subjective report of insomnia on PSQI and insomnia severity index. Log[Number of PLMS] was higher in the moderate/severe insomnia group (p = 0.008). Five of 11 patients in the moderate/severe insomnia group had a PLMS index ≥ 15, compared to only one of 15 patients in the none/mild insomnia group (p = 0.02). Menopausal symptoms and use of caffeine, hypnotics, and antidepressants were unrelated to insomnia severity or PLMS. Conclusions: PLMS was the sole PSG variable that separated breast cancer survivors with moderate/severe insomnia from those with no/mild sleep disturbance. Further study of the incidence and significance of PLMS in breast cancer survivors with the complaint of insomnia is merited. Citation: Reinsel RA, Starr TD, O'Sullivan B, Passik SD, Kavey NB. Polysomnographic study of sleep in survivors of breast cancer. J Clin Sleep Med 2015;11(12):1361–1370. PMID:26194735

  6. Subjective sleep complaints indicate objective sleep problems in psychosomatic patients: a prospective polysomnographic study

    PubMed Central

    Linden, Michael; Dietz, Marie; Veauthier, Christian; Fietze, Ingo

    2016-01-01

    Objective To elucidate the relationship between subjective complaints and polysomnographical parameters in psychosomatic patients. Method A convenience sample of patients from a psychosomatic inpatient unit were classified according to the Pittsburgh Sleep Quality Index (PSQI) as very poor sleepers (PSQI >10, n=80) and good sleepers (PSQI <6, n=19). They then underwent a polysomnography and in the morning rated their previous night’s sleep using a published protocol (Deutschen Gesellschaft für Schlafforschung und Schlafmedizin morning protocol [MP]). Results In the polysomnography, significant differences were found between very poor and good sleepers according to the PSQI with respect to sleep efficiency and time awake after sleep onset. When comparing objective PSG and subjective MP, the polysomnographical sleep onset latency was significantly positively correlated with the corresponding parameters of the MP: the subjective sleep onset latency in minutes and the subjective evaluation of sleep onset latency (very short, short, normal, long, very long) were positively correlated with the sleep latency measured by polysomnography. The polysomnographical time awake after sleep onset (in minutes) was positively correlated with the subjective time awake after sleep onset (in minutes), evaluation of time awake after sleep onset (seldom, normal often), and subjective restfulness. The polysomnographical total sleep time (TST) was positively correlated with the subjective TST. Conversely, the polysomnographical TST was negatively correlated with the evaluation of TST (high polysomnographical TST was correlated with the subjective evaluation of having slept short or normal and vice versa). The polysomnographical sleep efficiency was positively correlated with subjective feeling of current well-being in the morning and subjective TST and negatively with subjective restfulness, subjective sleep onset latency, subjective evaluation of sleep onset latency, and evaluation of

  7. Motor disturbances during non-REM and REM sleep in narcolepsy-cataplexy: a video-polysomnographic analysis.

    PubMed

    Frauscher, Birgit; Gschliesser, Viola; Brandauer, Elisabeth; Schönwald, Suzana V; Falkenstetter, Tina; Ehrmann, Laura; Tokmak, Ismail; Poewe, Werner; Högl, Birgit

    2011-12-01

    Motor events during sleep can be frequently observed in patients with narcolepsy-cataplexy. We hypothesized that increased motor events and related arousals contribute to sleep fragmentation in this disease. We aimed to perform a detailed whole-night video-polysomnographic analysis of all motor events during non-rapid eye movement and rapid eye movement sleep in a group of narcolepsy-cataplexy patients and matched controls, and to assess the association with arousals. Video-polysomnographic registrations of six narcolepsy-cataplexy patients and six sex- and age-matched controls were analysed. Each motor event in the video was classified according to topography, number of involved body parts, duration and its association with arousals. The mean motor activity index was 59.9 ± 23.0 h(-1) in patients with narcolepsy-cataplexy compared with 15.4 ± 9.2 h(-1) in controls (P = 0.004). Distribution of motor events was similar in non-rapid eye movement and rapid eye movement sleep in the patient group (P = 0.219). In narcolepsy-cataplexy, motor events involved significantly more body parts (≥ 2 body regions: 38.2 ± 15.6 versus 14.9 ± 10.0; P = 0.011). In addition, the proportion of motor events lasting longer than 1 s was higher in patients than controls (88% versus 44.4%; P < 0.001). Both total and motor activity-related arousal indices were increased in narcolepsy-cataplexy (total arousal index: 21.6 ± 9.0 versus 8.7 ± 3.5; P = 0.004; motor activity-related arousal index: 17.6 ± 9.8 versus 5.9 ± 2.3; P = 0.002). Motor activity and motor activity-related arousal indices are increased in both non-rapid eye movement and rapid eye movement sleep in narcolepsy-cataplexy compared with controls. This supports the concept of a general sleep motor dysregulation in narcolepsy-cataplexy, which potentially contributes to or even underlies sleep fragmentation in this disease.

  8. Blind source separation methods applied to synthesized polysomnographic recordings: a comparative study

    PubMed Central

    Kachenoura, Amar; Albera, Laurent; Senhadji, Lotfi

    2007-01-01

    Blind Source Separation (BSS) problems, under the assumption of static mixture, were extensively explored from the theoretical point of view. Powerful algorithms are now at hand to deal with many concrete BSS applications. Nevertheless, the performances of BSS methods, for a given biomedical application, are rarely investigated. The aim of this paper is to perform quantitative comparisons between various well-known BSS techniques. To do so, synthetic data, reproducing real polysomnographic recordings, are considered. PMID:18002843

  9. Polysomnographic study of sleeplessness and oneiricisms in the alcohol withdrawal syndrome.

    PubMed

    Plazzi, Giuseppe; Montagna, Pasquale; Meletti, Stefano; Lugaresi, Elio

    2002-05-01

    We describe a polysomnographic observation of the acute phase of the alcohol withdrawal syndrome, characterized by an alteration of the sleep-wake cycle and by the absence of non-rapid eye movement sleep. An atypical transitional state between rapid eye movement sleep and wake with hallucinations and enacting-dream behaviors represented the sole sleep pattern. Analogies of alcohol withdrawal syndrome with fatal familial insomnia and Morvan's fibrillary chorea suggest a common pathophysiological mechanism in these conditions. PMID:14592220

  10. Sleep Disturbances in Essential Tremor and Parkinson Disease: A Polysomnographic Study

    PubMed Central

    Barut, Banu Ozen; Tascilar, Nida; Varo, Armagan

    2015-01-01

    Objective: Sleep problems are a common non-motor complication of Parkinson disease (PD), and patients with essential tremor (ET) share a number of motor and non-motor features of PD. To clarify the relationship between these disorders, we evaluated the sleep problems in patients with ET and PD using assessment scales and objective polysomnographic (PSG) testing. Method: Twenty-one consecutive patients with PD, 16 with ET, and 14 healthy subjects participated in this study and were compared in terms of sleep related complaints, final sleep related diagnosis, and polysomnographic features. Results: The results of our study have shown that patients with PD were more likely than were those with ET to have a history of REM sleep behavior disorders (RBD) (p = 0.001) and excessive daytime sleepiness (p ≤ 0.05). Additionally, PSG data revealed that ET patients had lower mean SpO2 values (p ≤ 0.05) and REM without atonia (RWA) (p = 0.032) than did patients with PD. Conclusion: This is the first study to use PSG to evaluate sleep problems both in ET and PD patients. The results point out different sleep problems in these two common movement disorders which should be investigated in further studies. Citation: Barut BO, Tascilar N, Varo A. Sleep disturbances in essential tremor and Parkinson disease: a polysomnographic study. J Clin Sleep Med 2015;11(6):655–662. PMID:25700875

  11. A Prospective Video-Polysomnographic Analysis of Movements during Physiological Sleep in 100 Healthy Sleepers

    PubMed Central

    Stefani, Ambra; Gabelia, David; Mitterling, Thomas; Poewe, Werner; Högl, Birgit; Frauscher, Birgit

    2015-01-01

    and shorter than NREM movements, indicating different influences on motor control during both sleep states. Citation: Stefani A, Gabelia D, Mitterling T, Poewe W, Högl B, Frauscher B. A prospective video-polysomnographic analysis of movements during physiological sleep in 100 healthy sleepers. SLEEP 2015;38(9):1479–1487. PMID:25669176

  12. QT Interval Variability Index and QT Interval Duration in Different Sleep Stages: Analysis of Polysomnographic Recordings in Nonapneic Male Patients

    PubMed Central

    Viigimae, Moonika; Karai, Deniss; Pirn, Peeter; Pilt, Kristjan; Meigas, Kalju; Kaik, Jyri

    2015-01-01

    The aim of the study was to determine whether different sleep stages, especially REM sleep, affect QT interval duration and variability in male patients without obstructive sleep apnea (OSA). Polysomnographic recordings of 30 patients were analyzed. Beat-to-beat QT interval variability was calculated using QTV index (QTVI) formula. For QTc interval calculation, in addition to Bazett's formula, linear and parabolic heart rate correction formulas with two separate α values were used. QTVI and QTc values were calculated as means of 2 awake, 3 NREM, and 3 REM sleep episodes; the duration of each episode was 300 sec. Mean QTVI values were not statistically different between sleep stages. Therefore, elevated QTVI values found in patients with OSA cannot be interpreted as physiological sympathetic impact during REM sleep and should be considered as a risk factor for potentially life-threatening ventricular arrhythmias. The absence of difference of the mean QTc interval values between NREM and REM stages seems to confirm our conclusion that sympathetic surges during REM stage do not induce repolarization variability. In patients without notable structural and electrical remodeling of myocardium, physiological elevation in sympathetic activity during REM sleep remains subthreshold concerning clinically significant increase of myocardial electrical instability. PMID:26693490

  13. A polysomnographic study of sleep disturbance in community elderly with self-reported environmental chemical odor intolerance.

    PubMed

    Bell, I R; Bootzin, R R; Ritenbaugh, C; Wyatt, J K; DeGiovanni, G; Kulinovich, T; Anthony, J L; Kuo, T F; Rider, S P; Peterson, J M; Schwartz, G E; Johnson, K A

    1996-07-15

    Subjective sleep complaints and food intolerances, especially to milk products, are frequent symptoms of individuals who also report intolerance for low-level odors of various environmental chemicals. The purpose of the present study was to evaluate the objective nature of nocturnal sleep patterns during different diets, using polysomnography in community older adults with self-reported illness from chemical odors. Those high in chemical odor intolerance (n = 15) exhibited significantly lower sleep efficiency (p = .005) and lower rapid-eye-movement (REM) sleep percent (p = .04), with a trend toward longer latency to REM sleep (p = .07), than did those low in chemical intolerance (n = 15), especially on dairy-containing as compared with nondairy (soy) diets. The arousal pattern of the chemical odor intolerant group differed from the polysomnographic features of major depression, classical organophosphate toxicity, and subjective insomnia without objective findings. The findings suggest that community elderly with moderate chemical odor intolerance and minimal sleep complaints exhibit objectively poorer sleep than do their normal peers. Individual differences in underlying brain function may help generate these observations. The data support the need for similar studies in clinical populations with chemical odor intolerance, such as multiple chemical sensitivity patients and perhaps certain veterans with "Persian Gulf Syndrome." PMID:8793044

  14. QT Interval Variability Index and QT Interval Duration in Different Sleep Stages: Analysis of Polysomnographic Recordings in Nonapneic Male Patients.

    PubMed

    Viigimae, Moonika; Karai, Deniss; Pirn, Peeter; Pilt, Kristjan; Meigas, Kalju; Kaik, Jyri

    2015-01-01

    The aim of the study was to determine whether different sleep stages, especially REM sleep, affect QT interval duration and variability in male patients without obstructive sleep apnea (OSA). Polysomnographic recordings of 30 patients were analyzed. Beat-to-beat QT interval variability was calculated using QTV index (QTVI) formula. For QTc interval calculation, in addition to Bazett's formula, linear and parabolic heart rate correction formulas with two separate α values were used. QTVI and QTc values were calculated as means of 2 awake, 3 NREM, and 3 REM sleep episodes; the duration of each episode was 300 sec. Mean QTVI values were not statistically different between sleep stages. Therefore, elevated QTVI values found in patients with OSA cannot be interpreted as physiological sympathetic impact during REM sleep and should be considered as a risk factor for potentially life-threatening ventricular arrhythmias. The absence of difference of the mean QTc interval values between NREM and REM stages seems to confirm our conclusion that sympathetic surges during REM stage do not induce repolarization variability. In patients without notable structural and electrical remodeling of myocardium, physiological elevation in sympathetic activity during REM sleep remains subthreshold concerning clinically significant increase of myocardial electrical instability. PMID:26693490

  15. Polysomnographic parameters during non-rapid eye movement sleep predict continuous positive airway pressure adherence.

    PubMed

    Hoshino, Tetsurou; Sasanabe, Ryujiro; Murotani, Kenta; Arimoto, Mariko; Inagawa, Shuntaro; Tanigawa, Tohru; Uchida, Yasue; Ogawa, Tetsuya; Ueda, Hiromi; Shiomi, Toshiaki

    2016-05-01

    The aim of this study was to investigate the potential polysomnographic predictors of CPAP adherence using polysomnographic parameters at the time of obstructive sleep apnea diagnosis that distinguished between REM and NREM sleep. This was a retrospective cross-sectional study of 173 patients. Patients who used CPAP for more than 4 hours per night for at least 70% of nights over a 6-month period were considered to have good adherence. The poor adherence group included those who had used CPAP for 6 months from initiation, but did not fulfill the definition of good adherence or gave up the treatment within 6 months of treatment initiation. Of the 173 participants, 44 patients had good CPAP adherence and 129 patients had poor adherence. Univariate analysis showed that patients with good adherence had significantly higher apnea-hypopnea index during NREM sleep (p = 0.043), oxygen desaturation index during NREM sleep (p = 0.011), and cumulative percentage of time spent at saturations below 90% (CT90) during NREM sleep (p < .001). In multiple logistic regression analysis including all variables, CT90 during NREM sleep was the only factor independently associated with CPAP adherence (odds ratio, 0.693; 95% confidence interval, 0.582-0.824; p <.0001). The area under the receiver-operating characteristic curve of CT90 during NREM sleep was 0.823 (95% confidence interval, 0.745-0.901).Evaluating NREM sleep is important in reliably predicting CPAP adherence using polysomnographic parameters. CT90 during NREM sleep was the best predictor of CPAP adherence. PMID:27303106

  16. A Polysomnographic Study of Parkinson's Disease Sleep Architecture.

    PubMed

    Martinez-Ramirez, Daniel; De Jesus, Sol; Walz, Roger; Cervantes-Arriaga, Amin; Peng-Chen, Zhongxing; Okun, Michael S; Alatriste-Booth, Vanessa; Rodríguez-Violante, Mayela

    2015-01-01

    Sleep disturbance is a common nonmotor phenomenon in Parkinson's disease (PD) affecting patient's quality of life. In this study, we examined the association between clinical characteristics with sleep disorders and sleep architecture patterns in a PD cohort. Patients underwent a standardized polysomnography study (PSG) in their "on medication" state. We observed that male gender and disease duration were independently associated with obstructive sleep apnea (OSA). Only lower levodopa equivalent dose (LED) was associated with periodic limb movement disorders (PLMD). REM sleep behavior disorder (RBD) was more common among older patients, with higher MDS-UPDRS III scores, and LED. None of the investigated variables were associated with the awakenings/arousals (A/A). Sleep efficiency was predicted by amantadine usage and age, while sleep stage 1 was predicted by dopamine agonists and Hoehn & Yahr severity. The use of MAO-B inhibitors and MDS-UPDRS part III were predictors of sleep stages 2 and 3. Age was the only predictor of REM sleep stage and gender for total sleep time. We conclude that sleep disorders and architecture are poorly predictable by clinical PD characteristics and other disease related factors must also be contributing to these sleep disturbances. PMID:26504612

  17. A Polysomnographic Study of Parkinson's Disease Sleep Architecture

    PubMed Central

    Martinez-Ramirez, Daniel; De Jesus, Sol; Walz, Roger; Cervantes-Arriaga, Amin; Peng-Chen, Zhongxing; Okun, Michael S.; Alatriste-Booth, Vanessa; Rodríguez-Violante, Mayela

    2015-01-01

    Sleep disturbance is a common nonmotor phenomenon in Parkinson's disease (PD) affecting patient's quality of life. In this study, we examined the association between clinical characteristics with sleep disorders and sleep architecture patterns in a PD cohort. Patients underwent a standardized polysomnography study (PSG) in their “on medication” state. We observed that male gender and disease duration were independently associated with obstructive sleep apnea (OSA). Only lower levodopa equivalent dose (LED) was associated with periodic limb movement disorders (PLMD). REM sleep behavior disorder (RBD) was more common among older patients, with higher MDS-UPDRS III scores, and LED. None of the investigated variables were associated with the awakenings/arousals (A/A). Sleep efficiency was predicted by amantadine usage and age, while sleep stage 1 was predicted by dopamine agonists and Hoehn & Yahr severity. The use of MAO-B inhibitors and MDS-UPDRS part III were predictors of sleep stages 2 and 3. Age was the only predictor of REM sleep stage and gender for total sleep time. We conclude that sleep disorders and architecture are poorly predictable by clinical PD characteristics and other disease related factors must also be contributing to these sleep disturbances. PMID:26504612

  18. Polysomnographic Markers in Children With Cystic Fibrosis Lung Disease

    PubMed Central

    McGinley, Brian M.; Braun, Andrew T.; Schneider, Hartmut

    2015-01-01

    BACKGROUND AND OBJECTIVES: Children with cystic fibrosis (CF) often report poor sleep, increased daytime sleepiness, and fatigue. The purpose of this study was to identify respiratory patterns over the spectrum of disease severity in children with CF. The overall hypothesis for the current study is that children with CF compared with snoring control subjects demonstrate gas exchange abnormalities and increased respiratory loads during sleep that are not reported or recognized by conventional polysomnography (PSG). METHODS: Analysis of breathing patterns and gas exchange on PSG was performed in children with CF and healthy controls matched by age and BMI. For all CF and control subjects, the indication for PSG was evaluation for obstructive sleep apnea based on a history of snoring. RESULTS: Children with CF, compared with age- and BMI-matched snoring controls, demonstrated lower oxyhemoglobin saturation (95% ± 1.6% vs 98% ± 0.6%, P = .005), higher respiratory rate (19.5 ± 4.9 vs 16.5 ± 1.2 breaths per minute, P = .03), and a higher proportion of inspiratory flow limitation (44.1% ± 24.7% vs 12.1% ± 13.5%, P = .007) during non–rapid eye movement sleep. The respiratory disturbance index did not differ between CF and snoring control groups (1.5 ± 2.7 vs 0.6 ± 0.6 events per hour, P = .11). CONCLUSIONS: Children with CF exhibited abnormalities in gas exchange and increased respiratory load during sleep compared with normal age- and BMI-matched snoring controls. Because these abnormalities were independent of weight and lung function, sleep state may serve as an opportunity for early detection of breathing abnormalities and possibly CF lung disease progression. PMID:26482667

  19. Comparing the Effects of Reflexology and Footbath on Sleep Quality in the Elderly: A Controlled Clinical Trial

    PubMed Central

    Valizadeh, Leila; Seyyedrasooli, Alehe; Zamanazadeh, Vahid; Nasiri, Khadijeh

    2015-01-01

    Background: Sleep disorders are common mental disorders reported among the elderly in all countries, and with nonpharmacological interventions, they could be helped to improve their sleep quality. Objectives: The aim of this study was to compare the effects of two interventions, foot reflexology and foot bath, on sleep quality in elderly people. Patients and Methods: This three-group randomized clinical trial (two experimental groups and a control group) was conducted on 69 elderly men. The two experimental groups had reflexology (n = 23) and foot bath (n = 23) interventions for 6 weeks. The reflexology intervention was done in the mornings, once a week for ten minutes on each foot. The participants in the foot bath group were asked to soak their feet in 41°C to 42°C water one hour before sleeping. The pittsburgh sleep quality index (PSQI) was completed before and after the intervention through an interview process. Results: The results showed that the PSQI scores after intervention compared to before it in the reflexology and foot bath groups were statistically significant (P = 0.01 , P = 0.001); however, in the control group did not show a statistically significant difference (P = 0.14). In addition, the total score changes among the three groups were statistically significant (P = 0.01). Comparing the score changes of quality of sleep between the reflexology and foot bath groups showed that there was no significant difference in none of the components and the total score (P = 0.09). The two interventions had the same impact on the quality of sleep. Conclusions: It is suggested that the training of nonpharmacological methods to improve sleep quality such as reflexology and foot bath be included in the elderly health programs. In addition, it is recommended that the impact of these interventions on subjective sleep quality using polysomnographic recordings be explored in future research. PMID:26734475

  20. Is polysomnographic examination necessary for subjects with diaphragm pathologies?

    PubMed Central

    Oruc, Ozlem; Sarac, Sema; Afsar, Gulgun Cetintas; Topcuoglu, Ozgur Bilgin; Kanbur, Serda; Yalcinkaya, Irfan; Tepetam, Fatma Merve; Kirbas, Gokhan

    2016-01-01

    OBJECTIVES: While respiratory distress is accepted as the only indication for diaphragmatic plication surgery, sleep disorders have been underestimated. In this study, we aimed to detect the sleep disorders that accompany diaphragm pathologies. Specifically, the association of obstructive sleep apnea syndrome with diaphragm eventration and diaphragm paralysis was evaluated. METHODS: This study was performed in Süreyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital between 2014–2016. All patients had symptoms of obstructive sleep apnea (snoring and/or cessation of breath during sleep and/or daytime sleepiness) and underwent diaphragmatic plication via video-assisted mini-thoracotomy. Additionally, all patients underwent pre- and postoperative full-night polysomnography. Pre- and postoperative clinical findings, polysomnography results, Epworth sleepiness scale scores and pulmonary function test results were compared. RESULTS: Twelve patients (7 males) with a mean age of 48 (range, 27-60) years and a mean body mass index of 25 (range, 20-30) kg/m2 were included in the study. Preoperative polysomnography showed obstructive sleep apnea syndrome in 9 of the 12 patients (75%), while 3 of the patients (25%) were regarded as normal. Postoperatively, patient complaints, apnea hypopnea indices, Epworth sleepiness scale scores and pulmonary function test results all demonstrated remarkable improvement. CONCLUSION: All patients suffering from diaphragm pathologies with symptoms should undergo polysomnography, and patients diagnosed with obstructive sleep apnea syndrome should be operated on. In this way, long-term comorbidities of sleep disorders may be prevented.

  1. Is polysomnographic examination necessary for subjects with diaphragm pathologies?

    PubMed Central

    Oruc, Ozlem; Sarac, Sema; Afsar, Gulgun Cetintas; Topcuoglu, Ozgur Bilgin; Kanbur, Serda; Yalcinkaya, Irfan; Tepetam, Fatma Merve; Kirbas, Gokhan

    2016-01-01

    OBJECTIVES: While respiratory distress is accepted as the only indication for diaphragmatic plication surgery, sleep disorders have been underestimated. In this study, we aimed to detect the sleep disorders that accompany diaphragm pathologies. Specifically, the association of obstructive sleep apnea syndrome with diaphragm eventration and diaphragm paralysis was evaluated. METHODS: This study was performed in Süreyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital between 2014–2016. All patients had symptoms of obstructive sleep apnea (snoring and/or cessation of breath during sleep and/or daytime sleepiness) and underwent diaphragmatic plication via video-assisted mini-thoracotomy. Additionally, all patients underwent pre- and postoperative full-night polysomnography. Pre- and postoperative clinical findings, polysomnography results, Epworth sleepiness scale scores and pulmonary function test results were compared. RESULTS: Twelve patients (7 males) with a mean age of 48 (range, 27-60) years and a mean body mass index of 25 (range, 20-30) kg/m2 were included in the study. Preoperative polysomnography showed obstructive sleep apnea syndrome in 9 of the 12 patients (75%), while 3 of the patients (25%) were regarded as normal. Postoperatively, patient complaints, apnea hypopnea indices, Epworth sleepiness scale scores and pulmonary function test results all demonstrated remarkable improvement. CONCLUSION: All patients suffering from diaphragm pathologies with symptoms should undergo polysomnography, and patients diagnosed with obstructive sleep apnea syndrome should be operated on. In this way, long-term comorbidities of sleep disorders may be prevented. PMID:27652831

  2. Cognitive, Psychomotor, and Polysomnographic Effects of Trazodone in Primary Insomniacs

    PubMed Central

    Roth, Alicia J.; McCall, W. Vaughn; Liguori, Anthony

    2011-01-01

    Summary Trazodone is widely prescribed as a sleep aid, although it is indicated for depression, not insomnia. Its daytime cognitive and psychomotor effects have not been systematically investigated in insomniacs. The primary goal of this study was to quantify, in primary insomniacs, the hypnotic efficacy of trazodone and subsequent daytime impairments. Sixteen primary insomniacs (mean age 44 years) participated, with insomnia confirmed by overnight polysomnography (sleep efficiency ≤ 85%). Trazodone 50 mg was administered to participants 30 minutes before bedtime for seven days, in a three-week, within-subjects, randomized, double-blind, placebo-controlled design. Subjective effects, equilibrium (anterior/posterior body sway), short-term memory, verbal learning, simulated driving, and muscle endurance were assessed the morning after Days 1 and 7 of drug administration. Sleep was evaluated with overnight polysomnography and modified Multiple Sleep Latency Tests (MSLT) on Days 1 and 7. Trazodone produced small but significant impairments of short-term memory, verbal learning, equilibrium, and arm muscle endurance across time points. Relative to placebo across test days, trazodone was associated with fewer nighttime awakenings, minutes of Stage 1 sleep, and self-reports of difficulty sleeping. On Day 7 only, slow wave sleep was greater and objective measures of daytime sleepiness lower with trazodone than with placebo. Although trazodone is efficacious for sleep maintenance difficulties, its associated cognitive and motor impairments may provide a modest caveat to healthcare providers. PMID:21623982

  3. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control.... Class I (general controls). Except when used in donor screening, unassayed material is exempt from...

  4. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  5. The Effect of Psychosocial Stress on Sleep: A Review of Polysomnographic Evidence

    PubMed Central

    Kim, Eui-Joong; Dimsdale, Joel E.

    2014-01-01

    This systematic review examines the effect of diverse psychosocial stressors on polysomnographic measures of sleep. Sixty-three articles were located and categorized in terms of the types of stressors imposed. Experimental stress resulted in fairly consistent changes: decreases in slow wave sleep, REM sleep, and sleep efficiency (SE), as well as increases in awakenings. Data were limited in terms of response to non-experimental stressors, except for the case of post-traumatic stress disorder (PTSD) on sleep, where a number of reports suggest that PTSD patients have increased awakenings and decreased SE. Future research needs to define stress more precisely in terms of duration and severity and to measure its impacts on sleep in populations that differ in terms of age, comorbid illness, gender, and so forth. Without such fine-grained analyses, it is difficult to draw definitive conclusions about this important area. PMID:17937582

  6. Polysomnographic evaluation of sleep quality and quantitative variables in women as a function of mood, reproductive status, and age.

    PubMed

    Orff, Henry J; Meliska, Charles J; Lopez, Ana; Martinez, Fernando; Sorenson, Diane; Parry, Barbara L

    2012-12-01

    This archival cross-sectional investigation examined the impact of mood, reproductive status (RS), and age on polysomnographic (PSG) measures in women. PSG was performed on 73 normal controls (NC) and 64 depressed patients (DP), in the course of studies in menstruating, pregnant, postpartum, and peri- and postmenopausal women. A two-factor, between-subjects multivariate analysis of variance (MANOVA) was used to test the main effects of reproductive status (RS: menstrual vs pregnant vs postpartum vs menopausal) and diagnosis (NC vs DP), and their interaction, on PSG measures. To further refine the analyses, a two-factor, between subjects MANOVA was used to test the main effects of age (19 to 27 vs 28 to 36 vs 37 to 45 vs 46+ years) and diagnosis on the PSG data. Analyses revealed that in DP women, rapid eye movement (REM) sleep percentage was significantly elevated relative to NC across both RS and age. Significant differences in sleep efficiency, Stage 1%, and REM density were associated with RS; differences in total sleep time, Stage 2 percentage, and Stage 4 percentage were associated with differences in age. Both RS and age were related to differences in sleep latency, Stage 3 percentage, and Delta percentage. Finally, wake after sleep onset time, REM percentage, and REM latency did not vary with respect to RS or age. Overall, this investigation examined three major variables (mood, RS, and age) that are known to impact sleep in women. Of the variables, age appeared to have the greatest impact on PSG sleep measures, reflecting changes occurring across the lifespan.

  7. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical toxicology control material. 862.3280... Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and...

  8. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem. PMID:24165457

  9. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  10. [Oral candidiasis: clinical features and control].

    PubMed

    Yamamoto, Tetsuya

    2010-10-01

    Candidiasis is the most commonly encountered fungal infection, and oral candidiasis is often observed as a local opportunistic infection. Oral candidiasis is clinically divided into three types: acute forms, chronic forms, and Candida-associated lesions. Candida adhesion and multiplication are largely regulated by the local and systemic factors of the host. The local factors include impairment of the oral mucosal integrity, which is usually impaired by hyposalivation, anticancer drugs/radiation for head and neck cancers, denture wearing, a decrease in the oral bacterial population, and poor oral hygiene. Among Candida species, oral candidiasis is mostly caused by Candida albicans (C. albicans), C. glabrata, or C. tropicalis. Oral Candida induces a variety of symptoms, such as oral mucosal inflammation manifesting as an uncomfortable feeling, pain, erythema, erosion, taste abnormalities, and hyperplasia of the oral mucosa. Candida overgrowth in the oral cavity may disseminate to distant organs. Therefore, in order to avoid the sequelae of systemic candidiasis, oral candidiasis should be rapidly controlled. Oral candidiasis is usually treated by the local application of antifungal drugs. However, oral candidiasis occasionally escapes the control of such local treatment due to the development of multi-drug resistant Candida strains and species or due to the suppression of salivation or cellular immune activity. When drug-resistant strains are suspected as the pathogens and when the host is generally compromised, the oral administration of combinations of antifungal drugs, enhancement of cellular immune activity, and improvement of the nutritional condition are recommended.

  11. The course and character of sleepwalking in adulthood: a clinical and polysomnographic study.

    PubMed

    Bušková, Jitka; Piško, Juraj; Pastorek, Lukáš; Šonka, Karel

    2015-01-01

    To describe characteristics of adult sleepwalking (potential triggers and correlates with polysomnography), 52 patients were interviewed regarding their sleepwalking episodes and underwent video-polysomnography on two consecutive nights. Sleepwalking history averaged 12 years and frequent episodes (more than once per week) occurred in 62%. Higher frequency was associated with earlier onset of sleepwalking (p < 0.005) and 53.8% reported dangerous sleepwalking behavior. The most common self-reported triggers were sleep deprivation and stressful events, while no specific trigger was reported in 37% of patients. More awakening from slow-wave sleep was associated with a higher frequency of sleepwalking episodes (p < 0.001). A longer history of sleepwalking was associated with more sleepwalking episodes, even without the presence of sleep comorbidities or other known precipitating factors. PMID:24597508

  12. The course and character of sleepwalking in adulthood: a clinical and polysomnographic study.

    PubMed

    Bušková, Jitka; Piško, Juraj; Pastorek, Lukáš; Šonka, Karel

    2015-01-01

    To describe characteristics of adult sleepwalking (potential triggers and correlates with polysomnography), 52 patients were interviewed regarding their sleepwalking episodes and underwent video-polysomnography on two consecutive nights. Sleepwalking history averaged 12 years and frequent episodes (more than once per week) occurred in 62%. Higher frequency was associated with earlier onset of sleepwalking (p < 0.005) and 53.8% reported dangerous sleepwalking behavior. The most common self-reported triggers were sleep deprivation and stressful events, while no specific trigger was reported in 37% of patients. More awakening from slow-wave sleep was associated with a higher frequency of sleepwalking episodes (p < 0.001). A longer history of sleepwalking was associated with more sleepwalking episodes, even without the presence of sleep comorbidities or other known precipitating factors.

  13. Detection of Periodic Leg Movements by Machine Learning Methods Using Polysomnographic Parameters Other Than Leg Electromyography

    PubMed Central

    Umut, İlhan; Çentik, Güven

    2016-01-01

    The number of channels used for polysomnographic recording frequently causes difficulties for patients because of the many cables connected. Also, it increases the risk of having troubles during recording process and increases the storage volume. In this study, it is intended to detect periodic leg movement (PLM) in sleep with the use of the channels except leg electromyography (EMG) by analysing polysomnography (PSG) data with digital signal processing (DSP) and machine learning methods. PSG records of 153 patients of different ages and genders with PLM disorder diagnosis were examined retrospectively. A novel software was developed for the analysis of PSG records. The software utilizes the machine learning algorithms, statistical methods, and DSP methods. In order to classify PLM, popular machine learning methods (multilayer perceptron, K-nearest neighbour, and random forests) and logistic regression were used. Comparison of classified results showed that while K-nearest neighbour classification algorithm had higher average classification rate (91.87%) and lower average classification error value (RMSE = 0.2850), multilayer perceptron algorithm had the lowest average classification rate (83.29%) and the highest average classification error value (RMSE = 0.3705). Results showed that PLM can be classified with high accuracy (91.87%) without leg EMG record being present. PMID:27213008

  14. Aircraft noise effects on sleep: application of the results of a large polysomnographic field study.

    PubMed

    Basner, Mathias; Samel, Alexander; Isermann, Ullrich

    2006-05-01

    The Institute of Aerospace Medicine at the German Aerospace Center (DLR) investigated the influence of nocturnal aircraft noise on sleep in polysomnographic laboratory and field studies between 1999 and 2004. The results of the field studies were used by the Regional Council of Leipzig (Germany) for the establishment of a noise protection plan in the official approval process for the expansion of Leipzig/Halle airport. Methods and results of the DLR field study are described in detail. Special attention is given to the dose-response relationship between the maximum sound pressure level of an aircraft noise event and the probability to wake up, which was used to establish noise protection zones directly related to the effects of noise on sleep. These protection zones differ qualitatively and quantitatively from zones that are solely based on acoustical criteria. The noise protection plan for Leipzig/Halle airport is presented and substantiated: (1) on average, there should be less than one additional awakening induced by aircraft noise, (2) awakenings recalled in the morning should be avoided as much as possible, and (3) aircraft noise should interfere as little as possible with the process of falling asleep again. Issues concerned with the representativeness of the study sample are discussed.

  15. Detection of Periodic Leg Movements by Machine Learning Methods Using Polysomnographic Parameters Other Than Leg Electromyography.

    PubMed

    Umut, İlhan; Çentik, Güven

    2016-01-01

    The number of channels used for polysomnographic recording frequently causes difficulties for patients because of the many cables connected. Also, it increases the risk of having troubles during recording process and increases the storage volume. In this study, it is intended to detect periodic leg movement (PLM) in sleep with the use of the channels except leg electromyography (EMG) by analysing polysomnography (PSG) data with digital signal processing (DSP) and machine learning methods. PSG records of 153 patients of different ages and genders with PLM disorder diagnosis were examined retrospectively. A novel software was developed for the analysis of PSG records. The software utilizes the machine learning algorithms, statistical methods, and DSP methods. In order to classify PLM, popular machine learning methods (multilayer perceptron, K-nearest neighbour, and random forests) and logistic regression were used. Comparison of classified results showed that while K-nearest neighbour classification algorithm had higher average classification rate (91.87%) and lower average classification error value (RMSE = 0.2850), multilayer perceptron algorithm had the lowest average classification rate (83.29%) and the highest average classification error value (RMSE = 0.3705). Results showed that PLM can be classified with high accuracy (91.87%) without leg EMG record being present.

  16. Sleep in the spider monkey (Ateles geoffroyi): A semi-restrictive, non-invasive, polysomnographic study.

    PubMed

    Cruz-Aguilar, Manuel Alejandro; Ayala-Guerrero, Fructuoso; Jiménez-Anguiano, Anabel; Santillán-Doherty, Ana María; García-Orduña, Francisco; Velázquez-Moctezuma, Javier

    2015-02-01

    The normal sleep patterns of the spider monkey (Ateles geoffroyi) have not been described yet. The objective of this study was to characterize the electrophysiological patterns, sleeping postures, and sleep-wake cycle in semi-restricted spider monkeys. Continuous 24-hr polysomnographic (PSG) recordings, involving simultaneous recording of non-invasive electroencephalographic (EEG), electro-oculographic (EOG), and electromyographic (EMG) activities, were carried out in captive monkeys living in outdoor rainforest enclosures. Electrode placement was done according to the human international 10-20 system. Specific behaviors displayed by monkeys during the sleep-wake cycles were correlated with the PSG recordings. The nycthemeral distribution of the sleep-wake cycle was also calculated. The results show that electrophysiological N-REM sleep patterns in spider monkeys are similar to those observed in other primates, including human beings. Furthermore, a vertical semi-fetal posture was observed during N-REM and REM sleep phases. The amount of nocturnal sleep was significantly higher than that of the diurnal period, showing that the spider monkey is a diurnal primate. An outstanding finding was the absence of muscular atonia during the spider monkey's REM sleep, which suggests that arboreal primates have developed a neuromuscular mechanism specialized for sleeping in a vertical posture.

  17. Do periodic arm movements during sleep exist in healthy subjects? A polysomnographic study

    PubMed Central

    Gabelia, David; Mitterling, Thomas; Högl, Birgit; Wenning, Gregor K.; Frauscher, Birgit

    2014-01-01

    Background Despite several polysomnographic studies on periodic leg movements (PLM) in healthy sleep, data on the prevalence and characteristics of periodic arm movements (PAM) in normal subjects are lacking. We aimed to investigate PAM and their association with PLM during wakefulness and sleep in healthy subjects. Methods Ninety-one participants underwent video-polysomnography according to American Academy of Sleep Medicine 2007 criteria. In addition to standard electromyographic registration, data for both flexor digitorum superficialis muscles were recorded. Results Sixty-two subjects (68.1%) had a PAM index during wakefulness >5/h (median PAM index during wakefulness, 8.8/h; range, 0–77). Seven subjects (7.7%) had a PAM index >5/h during sleep (median PAM index during sleep, 0.7/h; range, 0–47.4). In 14% of cases, PAM during wakefulness were coincident with PLM during wakefulness. During sleep, this coincidence was not evident. The correlation between PAM and PLM was weak to moderate (during wakefulness: Spearman's ρ = 0.576, P < 0.001; during sleep: Spearman's ρ = 0.222, P = 0.036). Conclusion In healthy subjects, PAM occur predominantly during wakefulness with no apparent true periodicity. In contrast to classical PLM, some PAM may not present a true periodic phenomenon, but rather random voluntary movements meeting the wide range of periodicity criteria for PLM. PMID:25037838

  18. Clinical Research Methodology 3: Randomized Controlled Trials.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  19. Selecting control interventions for clinical outcome studies.

    PubMed

    Barkauskas, Violet H; Lusk, Sally L; Eakin, Brenda L

    2005-04-01

    In the current research environment the design and management of control groups is becoming more complex. The selection of a control group design is dependent on study goals, presence and quality of existing interventions, urgency of the problem or issue being addressed by the intervention, and factors related to the study site. The purpose of the presentation is to identify various approaches to the design of control groups in experimental studies and to identify their strengths, limitations, and applications. A case study exemplifies the issues associated with control group selection and design.

  20. Sleep Irregularity in the Previous Week Influences the First-Night Effect in Polysomnographic Studies

    PubMed Central

    Lee, Da-Hye; Cho, Chul-Hyun; Han, Changsu; Bok, Ki-Nam; Moon, Jung Ho; Lee, Eunil; Kim, Leen

    2016-01-01

    Objective The first-night effect is a well-known phenomenon resulting from an individual's maladaptation to the unfamiliar environment of a sleep laboratory. However, there have been no direct reports of the effect of previous sleep patterns on the first-night effect. We aimed to investigate the effect the previous week's sleep pattern on the first-night effect. Methods Twenty-four young, healthy, male participants completed the study procedure. During one week prior to study, the participants kept sleep diaries and wore actigraphs to identify sleep-wake pattern. Two consecutive nights of polysomnography were conducted after that. Wilcoxon signed-rank tests were applied to compare sleep variables of the two nights. Variance (standard deviation) of sleep onset time during the previous week was used as an index of irregularity. A Kendall's ranked correlation analysis and a linear regression test were applied to detect correlation between sleep irregularity and the first-night effect measured by polysomnography. Results There were significant differences in the values of sleep efficiency (p=0.011) and wake after sleep onset (WASO) (p=0.006) between the two nights. Sleep efficiency was lower and WASO was higher on the first night as compared to the second night. Sleep irregularity in the previous week was negatively correlated with sleep efficiency (p<0.001) of the first night, but was not significantly correlated with any other sleep parameters. Conclusion We replicated the existence of the first-night effect commonly observed in sleep studies. Sleep irregularity in the previous week may influence the first-night effect in polysomnographic studies. PMID:27081381

  1. Clinical governance and infection control in the United Kingdom.

    PubMed

    Masterson, R G; Teare, E L

    2001-01-01

    The recent organizational changes in the NHS have at their core the concept of clinical governance. Although initially poorly defined and understood this term has now taken on a clear identity, placing quality alongside fiscal probity and corporate governance at the top of NHS priorities. Integral to clinical governance are the basic elements of clear national standards for services and treatments that are to be locally delivered through assured, monitored, high quality healthcare. It is within this framework that workers in infection control must develop their own methods of applying clinical governance. This review explores the implications that the strategy of clinical governance holds for the speciality of infection control, emphasizing the benefits its active adoption can bring and highlighting the key relevance of clinical risk management in this setting. It illustrates clinical governance as a tool to engage colleagues on a multi-disciplinary front, most particularly the crucial link to senior Trust management. PMID:11281117

  2. Clinical governance and infection control in the United Kingdom.

    PubMed

    Masterson, R G; Teare, E L

    2001-01-01

    The recent organizational changes in the NHS have at their core the concept of clinical governance. Although initially poorly defined and understood this term has now taken on a clear identity, placing quality alongside fiscal probity and corporate governance at the top of NHS priorities. Integral to clinical governance are the basic elements of clear national standards for services and treatments that are to be locally delivered through assured, monitored, high quality healthcare. It is within this framework that workers in infection control must develop their own methods of applying clinical governance. This review explores the implications that the strategy of clinical governance holds for the speciality of infection control, emphasizing the benefits its active adoption can bring and highlighting the key relevance of clinical risk management in this setting. It illustrates clinical governance as a tool to engage colleagues on a multi-disciplinary front, most particularly the crucial link to senior Trust management.

  3. Polysomnographic measures of sleep in cocaine dependence and alcohol dependence: Implications for age‐related loss of slow wave, stage 3 sleep

    PubMed Central

    Bjurstrom, Martin F.; Olmstead, Richard

    2016-01-01

    Abstract Background and aims Sleep disturbance is a prominent complaint in cocaine and alcohol dependence. This controlled study evaluated differences of polysomnographic (PSG) sleep in cocaine‐ and alcohol‐dependent subjects, and examined whether substance dependence interacts with age to alter slow wave sleep and rapid eye movement (REM) sleep. Design Cross‐sectional comparison. Setting Los Angeles and San Diego, CA, USA. Participants Abstinent cocaine‐dependent subjects (n = 32), abstinent alcohol‐dependent subjects (n = 73) and controls (n = 108); mean age 40.3 years recruited 2005–12. Measurements PSG measures of sleep continuity and sleep architecture primary outcomes of Stage 3 sleep and REM sleep. Covariates included age, ethnicity, education, smoking, body mass index and depressive symptoms. Findings Compared with controls, both groups of substance dependent subjects showed loss of Stage 3 sleep (P < 0.001). A substance dependence × age interaction was found in which both cocaine‐ and alcohol‐dependent groups showed loss of Stage 3 sleep at an earlier age than controls (P < 0.05 for all), and cocaine‐dependent subjects showed loss of Stage 3 sleep at an earlier age than alcoholics (P < 0.05). Compared with controls, REM sleep was increased in both substance‐dependent groups (P < 0.001), and cocaine and alcohol dependence were associated with earlier age‐related increase in REM sleep (P < 0.05 for all). Conclusions Cocaine and alcohol dependence appear to be associated with marked disturbances of sleep architecture, including increased rapid eye movement sleep and accelerated age‐related loss of slow wave, Stage 3 sleep. PMID:26749502

  4. Bed Bugs: Clinical Relevance and Control Options

    PubMed Central

    Dwyer, Dominic E.; Peñas, Pablo F.; Russell, Richard C.

    2012-01-01

    Summary: Since the late 1990s, bed bugs of the species Cimex lectularius and Cimex hemipterus have undergone a worldwide resurgence. These bed bugs are blood-sucking insects that readily bite humans. Cutaneous reactions may occur and can start out as small macular lesions that can develop into distinctive wheals of around 5 cm in diameter, which are accompanied by intense itching. Occasionally, bullous eruptions may result. If bed bugs are numerous, the patient can present with widespread urticaria or eythematous rashes. Often, bites occur in lines along the limbs. Over 40 pathogens have been detected in bed bugs, but there is no definitive evidence that they transmit any disease-causing organisms to humans. Anemia may result when bed bugs are numerous, and their allergens can trigger asthmatic reactions. The misuse of chemicals and other technologies for controlling bed bugs has the potential to have a deleterious impact on human health, while the insect itself can be the cause of significant psychological trauma. The control of bed bugs is challenging and should encompass a multidisciplinary approach utilizing nonchemical means of control and the judicious use of insecticides. For accommodation providers, risk management procedures should be implemented to reduce the potential of bed bug infestations. PMID:22232375

  5. Comparison of metabolic control among diabetic subjects at two clinics.

    PubMed Central

    O'Connor, P J; Fragneto, R; Coulehan, J; Crabtree, B F

    1989-01-01

    A cross-sectional study was conducted to investigate whether glucose control in 20 non-insulin-dependent diabetic subjects seen at a remote rural clinic was comparable to control achieved in 66 diabetic subjects seen at the regional hospital clinic. Sampling was done to assure that study subjects were representative of all care-seeking, diagnosed diabetics in a well-defined Navajo community. The two groups of patients were comparable in terms of age, sex, and duration of diabetes from time of diagnosis. Compliance with care, hospitalization rates, and complication rates were similar in each group. Results showed no significant differences in glycemic control between the rural clinic (mean fasting plasma glucose = 177, mean random plasma glucose = 227) and the regional hospital clinic (mean fasting plasma glucose = 187, mean random plasma glucose = 249). The percentages of diabetics under "acceptable" control by American Diabetes Association guidelines was 40 percent at the rural clinic and 29 percent at the hospital clinic (P greater than .05). The authors conclude that adequacy of glycemic control in diabetics is not compromised by providing care at a remote rural clinic. PMID:2508176

  6. Clinical translation of controlled protein delivery systems for tissue engineering

    PubMed Central

    Spiller, Kara L.; Vunjak-Novakovic, Gordana

    2013-01-01

    Strategies that utilize controlled release of drugs and proteins for tissue engineering have enormous potential to regenerate damaged organs and tissues. The multiple advantages of controlled release strategies merit overcoming the significant challenges to translation, including high costs and long, difficult regulatory pathways. This review highlights the potential of controlled release of proteins for tissue engineering and regenerative medicine. We specifically discuss treatment modalities that have reached preclinical and clinical trials, with emphasis on controlled release systems for bone tissue engineering, the most advanced application with several products already in clinic. Possible strategies to address translational and regulatory concerns are also discussed. PMID:25787736

  7. Assessment Of Noise-induced Sleep Fragility In Two Age Ranges By Means Of Polysomnographic Microstructure

    NASA Astrophysics Data System (ADS)

    Terzano, M. G.; Parrino, L.; Spaggiari, M. C.; Buccino, G. P.; Fioriti, G.; Depoortere, H.

    1993-04-01

    The microstructure of sleep, which translates the short-lived fluctuations of the arousal level, is a commonly neglected feature in polysomnographic studies. Specifically arranged microstructural EEG events may provide important information on the dynamic characteristics of the sleep process. CAP (cyclic alternating pattern) and non-CAP are complementary modalities in which arousal-related "phasic" EEG phenomena are organized in non-REM sleep, and they correspond to opposite conditions of unstable and stable sleep depth, respectively. Thus, arousal instability can be measured by the CAP rate, the percentage ratio of total CAP time to total non-REM sleep time. The CAP rate, an age-related physiological variable that increases in several pathological conditions, is highly sensitive to acoustic perturbation. In the present study, two groups of healthy subjects without complaints about sleep, belonging to different age ranges (six young adults, three males and three females, between 20 and 30 years, and six middle-aged individuals, three males and three females, between 40 and 55 years) slept, after adaptation to the sleep laboratory, in a random sequence for two non-consecutive nights either under silent baseline (27·3 dB(A) Lcq) or noise-disturbed (continuous 55 dB(A) white noise) conditions. Age-related and noise-related effects on traditional sleep parameters and on the CAP rate were statistically evaluated by a split-plot test. Compared to young adults, the middle-aged individuals showed a significant reduction of total sleep time, stage 2 and REM sleep and significantly higher values of nocturnal awakenings and the CAP rate. The noisy nights were characterized by similar alterations. The disruptive effects of acoustic perturbation were greater on the more fragile sleep architecture of the older group. The increased fragility of sleep associated with aging probably reflects the decreased capacity of the sleeping brain to maintain steady states of vigilance. Total

  8. Clinical infection control in gene therapy: a multidisciplinary conference.

    PubMed

    Evans, M E; Jordan, C T; Chang, S M; Conrad, C; Gerberding, J L; Kaufman, H L; Mayhall, C G; Nolta, J A; Pilaro, A M; Sullivan, S; Weber, D J; Wivel, N A

    2000-10-01

    Gene therapy is being studied for the treatment of a variety of acquired and inherited disorders. Retroviruses, adenoviruses, poxviruses, adeno-associated viruses, herpesviruses, and others are being engineered to transfer genes into humans. Treatment protocols using recombinant viruses are being introduced into clinical settings. Infection control professionals will be involved in reviewing the safety of these agents in their clinics and hospitals. To date, only a limited number of articles have been written on infection control in gene therapy, and no widely available recommendations exist from federal or private organizations to guide infection control professionals. The goals of the conference were to provide a forum where gene therapy experts could share their perspectives and experience with infection control in gene therapy and to provide an opportunity for newcomers to the field to learn about issues specific to infection control in gene therapy. Recommendations for infection control in gene therapy were proposed.

  9. Cognitive control in alcohol use disorder: deficits and clinical relevance

    PubMed Central

    Wilcox, Claire E.; Dekonenko, Charlene J.; Mayer, Andrew R.; Bogenschutz, Michael P.; Turner, Jessica A.

    2014-01-01

    Cognitive control refers to the internal representation, maintenance, and updating of context information in the service of exerting control over thoughts and behavior. Deficits in cognitive control likely contribute to difficulty in maintaining abstinence in individuals with alcohol use disorders (AUD). In this article, we define three cognitive control processes in detail (response inhibition, distractor interference control, and working memory), review the tasks measuring performance in these areas, and summarize the brain networks involved in carrying out these processes. Next, we review evidence of deficits in these processes in AUD, including both metrics of task performance and functional neuroimaging. Finally, we explore the clinical relevance of these deficits by identifying predictors of clinical outcome and markers that appear to change (improve) with treatment. We observe that individuals with AUD experience deficits in some, but not all, metrics of cognitive control. Deficits in cognitive control may predict clinical outcome in AUD, but more work is necessary to replicate findings. It is likely that performance on tasks requiring cognitive control improves with abstinence, and with some psychosocial and medication treatments. Future work should clarify which aspects of cognitive control are most important to target during treatment of AUD. PMID:24361772

  10. A clinical data repository enhances hospital infection control.

    PubMed Central

    Samore, M.; Lichtenberg, D.; Saubermann, L.; Kawachi, C.; Carmeli, Y.

    1997-01-01

    We describe the benefits of a relational database of hospital clinical data (Clinical Data Repository; CDR) for an infection control program. The CDR consists of > 40 Sybase tables, and is directly accessible for ad hoc queries by members of the infection control unit who have been granted privileges for access by the Information Systems Department. The data elements and functional requirements most useful for surveillance of nosocomial infections, antibiotic use, and resistant organisms are characterized. Specific applications of the CDR are presented, including the use of automated definitions of nosocomial infection, graphical monitoring of resistant organisms with quality control limits, and prospective detection of inappropriate antibiotic use. Hospital surveillance and quality improvement activities are significantly benefited by the availability of a querable set of tables containing diverse clinical data. PMID:9357588

  11. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial. PMID:16144669

  12. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial.

  13. [Critical role of clinical laboratories in hospital infection control].

    PubMed

    Yagi, Tetsuya

    2010-11-01

    The hospital infection control and prevention is recognized to be more and more important according to the advances in modern medical treatment and care. Clinical microbiology laboratory play critical roles in the hospital infection control as a member of infection control team (ICT). They are the first in a hospital to identify outbreak of MRSA in NICU and molecular epidemiological analysis of the isolates lead proper intervention of ICT to the concerned ward. From a viewpoint of infectious disease specialist, rapid and precise microbiological information is essential for the appropriate diagnosis and treatment of infectious diseases. Each medical technologist need to make efforts to understand the characteristics of the examinations for infectious diseases and send out information useful for clinical practices. In our hospital, with the participation of all members of medical technologists, rapid reporting system was developed for blood culture examinations, which greatly contribute to the appropriate treatment of bloodstream infections. Collaborations of clinical microbiology laboratory with other members of ICT realize high quality hospital infection control. They also need to be aware of themselves as good practitioners of infection control measures to prevent hospital infections.

  14. Clinical applications of biomedical microdevices for controlled drug delivery.

    PubMed

    Gurman, Pablo; Miranda, Oscar R; Clayton, Kevin; Rosen, Yitzhak; Elman, Noel M

    2015-01-01

    Miniaturization of devices to micrometer and nanometer scales, combined with the use of biocompatible and functional materials, has created new opportunities for the implementation of drug delivery systems. Advances in biomedical microdevices for controlled drug delivery platforms promise a new generation of capabilities for the treatment of acute conditions and chronic illnesses, which require high adherence to treatment, in which temporal control over the pharmacokinetic profiles is critical. In addition, clinical conditions that require a combination of drugs with specific pharmacodynamic profiles and local delivery will benefit from drug delivery microdevices. This review provides a summary of various clinical applications for state-of-the-art controlled drug delivery microdevices, including cancer, endocrine and ocular disorders, and acute conditions such as hemorrhagic shock. Regulatory considerations for clinical translation of drug delivery microdevices are also discussed. Drug delivery microdevices promise a remarkable gain in clinical outcomes and a substantial social impact. A review of articles covering the field of microdevices for drug delivery was performed between January 1, 1990, and January 1, 2014, using PubMed as a search engine.

  15. Comparison Study of Polysomnographic Features in Multiple System Atrophy-cerebellar Types Combined with and without Rapid Eye Movement Sleep Behavior Disorder

    PubMed Central

    Ding, Yan; Hu, Yue-Qing; Zhan, Shu-Qin; Li, Cun-Jiang; Wang, Hong-Xing; Wang, Yu-Ping

    2016-01-01

    Background: The brain stem is found to be impaired in multiple system atrophy-cerebellar types (MSA-C). Rapid eye movement (REM) sleep behavior disorder (RBD) is reported as a marker of progressive brain stem dysfunction. Few systematic studies about the sleep disturbances in MSA-C patients combined with or without RBD were reported. This study aimed to explore the polysomnographic (PSG) features of sleep disturbances between MSA-C patients with and without RBD. Methods: Totally, 46 MSA-C patients (23 with RBD, and 23 without RBD) were enrolled in this study. All patients underwent a structured interview for their demographic data, history of sleep pattern, and movement disorders; and then, overnight video-PSG was performed in each patient. All the records were evaluated by specialists at the Sleep Medicine Clinic for RBD and the Movement Disorder Clinic for MSA-C. The Student's t-test, Mann-Whitney U-test for continuous variables, and the Chi-square test for categorical variables were used in this study. Results: MSA-C patients with RBD had younger visiting age (52.6 ± 7.4 vs. 56.7 ± 6.0 years, P = 0.046) and shorter duration of the disease (12.0 [12.0, 24.0] vs. 24.0 [14.0, 36.0] months, P = 0.009) than MSA-C patients without RBD. MSA-C with RBD had shorter REM sleep latency (111.7 ± 48.2 vs. 157.0 ± 68.8 min, P = 0.042), higher percentage of REM sleep (14.9% ±4.0% vs. 10.0% ± 3.2%, P = 0.019), and lower Stage I (9.5% ±7.2% vs. 15.9% ±8.0%, P = 0.027) than MSA-C without RBD. Moreover, MSA-C patients with RBD had more decreased sleep efficiency (52.4% ±12.6% vs. 65.8% ±15.9%, P = 0.029) than that without RBD. Conclusions: In addition to the RBD, MSA-C patients with RBD had other more severe sleep disturbances than those without RBD. The sleep disorders of MSA patients might be associated with the progress of the disease. PMID:27625088

  16. Ethical considerations in placebo-controlled randomised clinical trials

    PubMed Central

    2015-01-01

    Summary Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to maximise understanding and minimise therapeutic misconception. This editorial expands on themes raised by Chen et al’s article ‘Disclosing the Potential Impact of Placebo Controls in Antidepressant Trials’ and serves as an invitation for further submissions to BJPsych Open on ethics, research design and informed consent. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  17. Repurposing historical control clinical trial data to provide safety context.

    PubMed

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. PMID:26523771

  18. Unhealthy Weight Control Practices: Culprits and Clinical Recommendations

    PubMed Central

    Ferraro, Zachary Michael; Patterson, Sean; Chaput, Jean-Philippe

    2015-01-01

    Preoccupation with weight status and a desire to lose weight appears common. Many individuals seek “magic bullet” approaches to weight loss and waive the risks of using these products. In this paper, we review the challenges of weight maintenance, highlight some unhealthy weight control practices, and discuss the futility and potential danger of unregulated weight control agents. Novel clinical strategies are discussed that health care providers may use to triage patients with obesity in an attempt to make ethical and personalized treatment decisions. PMID:25733947

  19. Repurposing historical control clinical trial data to provide safety context.

    PubMed

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety.

  20. A sequential procedure for monitoring clinical trials against historical controls.

    PubMed

    Xiong, Xiaoping; Tan, Ming; Boyett, James

    2007-03-30

    In this paper, we develop a sequential procedure to monitor clinical trials against historical controls. When there is a strong ethical concern about randomizing patients to existing treatment because biological and medical evidence suggests that the new treatment is potentially superior to the existing one, or when the enrollment is too limited for randomization of subjects into experimental and control groups, one can monitor the trial sequentially against historical controls if the historical data with required quality and sample size are available to form a valid reference for the trial. This design of trial is sometimes the only alternative to a randomized phase III trial design that is intended but not feasible in situations such as above. Monitoring this type of clinical trial leads to a statistical problem of comparing two population means in a situation in which data from one population are sequentially collected and compared with all data from the other population at each interim look. The proposed sequential procedures is based on the sequential conditional probability ratio test (SCPRT) by which the conclusion of the sequential test would be virtually the same as that arrived at by a non-sequential test based on all data at the planned end of the trial. We develop the sequential procedure by proposing a Brownian motion that emulates the test statistic, and then proposing an SCPRT that is adapted to the special properties of the trial. PMID:16900551

  1. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  2. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    PubMed

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect. PMID:26149004

  3. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    PubMed

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.

  4. Clinical situations associated with difficult-to-control hypertension.

    PubMed

    Oliveras, Anna; Schmieder, Roland E

    2013-03-01

    There is no doubt that patients with high blood pressure (BP) are at higher cardiovascular and death risk than those subjects whose BP levels are below the admitted normal threshold. However, most of the epidemiological surveys show that BP is uncontrolled in more than fifty percent of hypertensive subjects. There are several reasons that can justify this lack of hypertension control, some of them depending on the patient, such as therapeutic adherence, or some related to the doctor, due to therapeutic inertia or reluctance to increment the number and doses of antihypertensive drugs. Sometimes the efficacy or adverse effects related to the antihypertensive drugs underlie the uncontrolled hypertension. And, finally, there are some clinical conditions that are associated with difficult-to-control hypertension. Among them, comorbidities such as diabetes, obesity, obstructive sleep apnoea syndrome or chronic kidney disease, but also drug-related hypertension or resistant hypertension. In this article we review the epidemiology and the conditions which are related to poorly controlled hypertension and that can explain why hypertension may become difficult-to-treat. PMID:23389084

  5. [Sleep in anorexia nervosa, bulimia nervosa and depressive diseases: a polysomnographic comparative study].

    PubMed

    Lauer, C; Krieg, J C; Zulley, J; Riemann, D; Berger, M

    1989-10-01

    All-night EEG sleep in 20 anorexics, 10 bulimics, 10 endogenous depressives, and in 10 healthy subjects (all age matched) was compared. In addition, the REM sleep-induction-test was performed in 12 patients with an eating disorder, 7 depressives, and 12 controls by application of the cholinergic agent RS 86. During baseline night, EEG-sleep parameters, especially REM latency, did not differ between the patients and the controls, except for the phasic components of REM sleep (REM density) that were increased in the depressive patients. The frequency of shortened REM latencies, however, was significantly higher in the depressed patients. These observations indicate that in some of the young depressives the disturbance of the REM sleep regulating transmitter system is already present to a similar degree as it is assumed in elderly depressives. After the application of RS 86, REM latency was shortened in all groups under investigation. However, the REM sleep inducing effect of RS 86 was significantly more pronounced in the depressives when compared with both the eating disorder patients and the controls. In the latter two samples, the shortening of REM latency was similar. Furthermore, the eating disorder patients with a concomitant major depression reacted similar to RS 86 as the non-depressed eating disorder patients and the control subjects. Whereas baseline EEG-sleep did not differ significantly among eating disorder patients, young depressives, and healthy subjects, the REM sleep inducing effect of the cholinergic agent RS 86 clearly distinguished between the depressives and both the patients suffering from eating disorders and the controls.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. Clinical Use of Cannabinoids for Symptom Control in Multiple Sclerosis.

    PubMed

    Notcutt, William G

    2015-10-01

    The endocannabinoid system was discovered in 1988 but has received little attention for its potential therapeutic possibilities. That has started to change, and since 2000, a significant number of clinical trials of cannabinoids, principally for the control of spasticity in multiple sclerosis, have been undertaken. These studies have been difficult because of the nature of the disease and have involved patients for whom other therapies have failed or proved inadequate. This paper outlines the background to the use of cannabinoids available and discusses the principles of practice associated with their safe use. The focus has been on nabiximols, being the most studied and the only cannabinoid that has been both adequately researched for use in multiple sclerosis and granted a license by the regulators. However, what has emerged is that the effect for many patients can be much wider than just control of spasticity. Within and outside of neurology there seems to be an expanding range of possibilities for the therapeutic use of cannabinoids.

  7. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  8. Modelling of polysomnographic respiratory measurements for artefact detection and signal restoration.

    PubMed

    Rathnayake, S I; Abeyratne, U R; Hukins, C; Duce, B

    2008-09-01

    Polysomnography (PSG), which incorporates measures of sleep with measures of EEG arousal, air flow, respiratory movement and oxygenation, is universally regarded as the reference standard in diagnosing sleep-related respiratory diseases such as obstructive sleep apnoea syndrome. Over 15 channels of physiological signals are measured from a subject undergoing a typical overnight PSG session. The signals often suffer from data losses, interferences and artefacts. In a typical sleep scoring session, artefact-corrupted signal segments are visually detected and removed from further consideration. This is a highly time-consuming process, and subjective judgement is required for the job. During typical sleep scoring sessions, the target is the detection of segments of diagnostic interest, and signal restoration is not utilized for distorted segments. In this paper, we propose a novel framework for artefact detection and signal restoration based on the redundancy among respiratory flow signals. We focus on the air flow (thermistor sensors) and nasal pressure signals which are clinically significant in detecting respiratory disturbances. The method treats the respiratory system and other organs that provide respiratory-related inputs/outputs to it (e.g., cardiovascular, brain) as a possibly nonlinear coupled-dynamical system, and uses the celebrated Takens embedding theorem as the theoretical basis for signal prediction. Nonlinear prediction across time (self-prediction) and signals (cross-prediction) provides us with a mechanism to detect artefacts as unexplained deviations. In addition to detection, the proposed method carries the potential to correct certain classes of artefacts and restore the signal. In this study, we categorize commonly occurring artefacts and distortions in air flow and nasal pressure measurements into several groups and explore the efficacy of the proposed technique in detecting/recovering them. The results we obtained from a database of clinical

  9. Migraine, arousal and sleep deprivation: comment on: "sleep quality, arousal and pain thresholds in migraineurs: a blinded controlled polysomnographic study".

    PubMed

    Vollono, Catello; Testani, Elisa; Losurdo, Anna; Mazza, Salvatore; Della Marca, Giacomo

    2013-06-10

    We discuss the hypothesis proposed by Engstrom and coworkers that Migraineurs have a relative sleep deprivation, which lowers the pain threshold and predispose to attacks. Previous data indicate that Migraineurs have a reduction of Cyclic Alternating Pattern (CAP), an essential mechanism of NREM sleep regulation which allows to dump the effect of incoming disruptive stimuli, and to protect sleep. The modifications of CAP observed in Migraineurs are similar to those observed in patients with impaired arousal (narcolepsy) and after sleep deprivation. The impairment of this mechanism makes Migraineurs more vulnerable to stimuli triggering attacks during sleep, and represents part of a more general vulnerability to incoming stimuli.

  10. Sleep and dreaming in patients with borderline personality disorder: a polysomnographic study.

    PubMed

    Schredl, Michael; Paul, Franc; Reinhard, Iris; Ebner-Priemer, Ulrich Walter; Schmahl, Christian; Bohus, Martin

    2012-12-30

    Previous research has demonstrated disturbances in sleep continuity in subjects with borderline personality disorders (BPD). Moreover, depression-like sleep abnormalities like reduced REM latency have been found in BPD subjects, even without comorbid major depression disorder. Yet it is still unknown what the effect is of co-morbid posttraumatic stress disorder on sleep continuity and dream content in BPD patients group. The present study compared 27 unmedicated female BPD subjects and healthy controls. The patients exhibited increased sleep fragmentation, increased REM density, and reduced REM latency. The findings were independent from co-morbid posttraumatic stress response (PTSD), which was present in 33% of the patient sample. Negatively toned dreams obtained by REM awakenings and nightmares were also reported more often by the patients-also irrespective of co-morbid PTSD-whereas dreams of specific BPD behavior, like self-mutilation, were rare. Taking these finding into account, one might productively investigate whether the sleep abnormalities improve during successful treatment of BPD and whether efficient methods for treating nightmares can be beneficial for this patient group.

  11. Sleep in healthy elderly subjects: a 24-hour ambulatory polysomnographic study.

    PubMed

    Gigli, G L; Placidi, F; Diomedi, M; Maschio, M; Silvestri, G; Scalise, A; Marciani, M G

    1996-04-01

    It is still debated whether the deterioration of the sleep pattern, frequently reported by elderly subjects, is due only to aging per se. Other factors associated with aging or modifications of biological rhythms could also be involved. Elderly subjects frequently complain of daytime sleepiness, but it is not clear whether this actually represents a return to a polyphasic structure of sleep, or only a consequence of a disturbed night sleep. Ten healthy, independent and active elderly subjects (age > 72 years) were elevated by means of 24-hour ambulatory polysomnography. Findings of nocturnal sleep were compared with sleep of the same group in the 24-hour period and with sleep of young healthy controls. We observed a fragmentation of nocturnal sleep, but a fairly good representation of stages and a preservation of cyclicity. Except for three cases, with early or late times of sleep onset and wake-up, sleep disruption did not seem to be related to modification of circadian rhythms. Only three subjects presented undesired daytime naps, whereas the others either did not show daytime sleep at all, or were used to having their siesta after lunch since their young adulthood. In normal aging, daytime sleep does not constitute a social problem. Ambulatory polysomnography is a valid alternative to laboratory recordings in the identification of daytime sleep. PMID:8734563

  12. Polysomnographic study of nocturnal sleep in idiopathic hypersomnia without long sleep time.

    PubMed

    Pizza, Fabio; Ferri, Raffaele; Poli, Francesca; Vandi, Stefano; Cosentino, Filomena I I; Plazzi, Giuseppe

    2013-04-01

    We investigated nocturnal sleep abnormalities in 19 patients with idiopathic hypersomnia without long sleep time (IH) in comparison with two age- and sex- matched control groups of 13 normal subjects (C) and of 17 patients with narcolepsy with cataplexy (NC), the latter considered as the extreme of excessive daytime sleepiness (EDS). Sleep macro- and micro- (i.e. cyclic alternating pattern, CAP) structure as well as quantitative analysis of EEG, of periodic leg movements during sleep (PLMS), and of muscle tone during REM sleep were compared across groups. IH and NC patients slept more than C subjects, but IH showed the highest levels of sleep fragmentation (e.g. awakenings), associated with a CAP rate higher than NC during lighter sleep stages and lower than C during slow wave sleep respectively, and with the highest relative amount of A3 and the lowest of A1 subtypes. IH showed a delta power in between C and NC groups, whereas muscle tone and PLMS had normal characteristics. A peculiar profile of microstructural sleep abnormalities may contribute to sleep fragmentation and, possibly, EDS in IH.

  13. Remotely Controlled Mandibular Protrusion during Sleep Predicts Therapeutic Success with Oral Appliances in Patients with Obstructive Sleep Apnea

    PubMed Central

    Remmers, John; Charkhandeh, Shouresh; Grosse, Joshua; Topor, Zbigniew; Brant, Rollin; Santosham, Peter; Bruehlmann, Sabina

    2013-01-01

    Study Objectives: The present study addresses the need for a validated tool that prospectively identifies favorable candidates for oral appliance therapy in treatment of obstructive sleep apnea. The objective of the study was to evaluate the ability of a mandibular titration study, performed with a remotely controlled mandibular positioner (RCMP), to predict treatment outcome with a mandibular repositioning appliance (MRA) and to predict an effective target protrusive position (ETPP). Design: A prospective, blinded, outcome study. Setting: Standard clinical care with tests performed in the polysomnographic laboratory. Participants: Consecutive patients (n = 67) recruited from a sleep center or a dental practice using broad inclusion criteria (age 21-80 years; AHI > 10/h; BMI < 40 kg/m2). Interventions: Therapeutic outcome with a mandibular protruding oral appliance was predicted following a mandibular protrusive titration study in the polysomnographic laboratory using a remotely controlled positioner and prospectively established predictive rules. An ETPP was also prospectively determined for participants predicted to be therapeutically successful with MRA therapy. All participants were blindly treated with a MRA, at either the predicted ETPP or a sham position, and therapeutic outcome was compared against prediction. Measurements and Results: At the final protrusive position, standard predictive parameters (sensitivity, specificity, positive and negative predictive values) showed statistically significant predictive accuracy (P < 0.05) in the range of 83% to 94%. The predicted ETPP provided an efficacious protrusive position in 87% of participants predicted to be therapeutically successful with MRA therapy (P < 0.05). Conclusions: Using prospectively established rules for interpreting the polysomnographic data, the mandibular titration study predicted mandibular repositioning appliance therapeutic outcome with significant accuracy, particularly with regard to

  14. Is severe obesity a form of addiction? Rationale, clinical approach, and controlled clinical trial.

    PubMed

    Riva, Giuseppe; Bacchetta, Monica; Cesa, Gianluca; Conti, Sara; Castelnuovo, Gianluca; Mantovani, Fabrizia; Molinari, Enrico

    2006-08-01

    For many, obesity is just a problem of energy input and expenditure: more energy input than expenditure. However, the clinical practice and epidemiological data clearly show that weight control is more complex than expected by this simple equation. This is particularly true in morbid obesity, a form of severe obesity in which a person's Body Mass Index (BMI, kg/m(2)) is over 40. If we compare the definitions and diagnostic criteria for "dependence" and "addiction" with the situation of many severe obese subjects, it is apparent that they match very well. Further, different neurological studies confirm this similarity: both addiction and obesity patients have a deficiency of dopamine receptors. Nevertheless, when we compare many of the actual obesity treatments with the ones used in the area of addictions it is possible to find relevant differences: obesity treatments neither consider different levels of type and intensity of care, nor a multidimensional approach. To overcome these limitations, in this paper we propose a bio-psychosocial approach in which the genetic influence (lack of dopamine receptors) is matched by psychosocial issues (pressure for thinness and diet as main body image dissatisfaction treatment). Further, the paper outlines how this approach may influence the treatment options, by focusing both on the lessons coming from actual addiction treatment and the opportunities offered by virtual reality. Finally, the paper presents and discusses the outcome of a controlled trial, based on the proposed approach, including a 6-month follow-up (211 morbid obese females with a BMI of >40 and a documented history of failures.

  15. Clinical significance of sleep EEG abnormalities in chronic schizophrenia.

    PubMed

    Yang, Changkook; Winkelman, John W

    2006-02-28

    This study aimed to investigate the relationship between measures of clinical symptom severity and sleep EEG parameters in a relatively diagnostically homogeneous group of patients with schizophrenia. We obtained sleep EEG data in 15 drug-free inpatients who met DSM-IV-R criteria for schizophrenia, undifferentiated type, with 15 age- and sex-matched normal controls over two consecutive night polysomnographic recordings. Clinical symptoms were assessed by the Positive and Negative Symptom Scale (PANSS) and Hamilton Rating Scale for Depression. Characteristic features of sleep disturbance were seen in patients with schizophrenia: profound difficulties in sleep initiation and maintenance, poor sleep efficiency, a slow wave sleep (SWS) deficit, and an increased REM density. SWS was inversely correlated with cognitive symptoms. REM density was inversely correlated with positive, cognitive, and emotional discomfort symptoms as well as PANSS total score. Our data demonstrate that drug-free patients with chronic undifferentiated type schizophrenia suffer from profound disturbances in sleep continuity and sleep architecture. Both the SWS deficit and cognitive impairment found in schizophrenics in this study may relate to similar underlying structural brain abnormalities.

  16. 77 FR 38084 - Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ... FR 24984, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Clinical Supplies... U.S.C. 823(a) and 952(a) and determined that the registration of Clinical Supplies Management,...

  17. Empathy in Boys with Gender Identity Disorder: A Comparison to Externalizing Clinical Control Boys and Community Control Boys and Girls

    ERIC Educational Resources Information Center

    Owen-Anderson, Allison F. H.; Jenkins, Jennifer M.; Bradley, Susan J.; Zucker, Kenneth J.

    2008-01-01

    Objective: The construct of empathy was examined in 20 boys with gender identity disorder (GID), 20 clinical control boys with externalizing disorders (ECC), 20 community control boys (NCB), and 20 community control girls (NCG). The mean age of the children was 6.86 years (range = 4-8 years). It was hypothesized that boys with GID would show…

  18. Clinical Characteristics of Impaired Trunk Control in Children with Spastic Cerebral Palsy

    ERIC Educational Resources Information Center

    Heyrman, Lieve; Desloovere, Kaat; Molenaers, Guy; Verheyden, Geert; Klingels, Katrijn; Monbaliu, Elegast; Feys, Hilde

    2013-01-01

    This study aimed to identify clinical characteristics of impaired trunk control in hundred children with spastic CP (mean age 11.4 [plus or minus] 2.1 years, range 8-15 years). Assessment of trunk control was performed with the Trunk Control Measurement Scale (TCMS). Trunk control was clearly impaired, indicated by a median total TCMS score of…

  19. Development of a clinical data warehouse for hospital infection control.

    PubMed

    Wisniewski, Mary F; Kieszkowski, Piotr; Zagorski, Brandon M; Trick, William E; Sommers, Michael; Weinstein, Robert A

    2003-01-01

    Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse.

  20. When the FRAX® test is applied to controlled clinical trials

    PubMed Central

    Fiore, Carmelo Erio; Gaudio, Agostino

    2012-01-01

    Summary FRAX® is a computer-based algorithm developed by the World Health Organization Collaborating Centre for Metabolic Bone Diseases in Sheffield (UK). This algorithm calculates fracture probability from easily obtained clinical risk factors in men and women: age, sex, body mass index and dichotomized variables comprising prior fragility fracture, parental history of hip fracture, current tobacco smoking, use of long-term oral glucocorticoid, rheumatoid arthritis, other causes of secondary osteoporosis and high alcohol consumption (femoral neck bone mineral density can be optionally input to enhance fracture risk prediction). The output of FRAX® is the 10-year probability of a major osteoporotic fracture (hip, clinical spine, humerus or wrist fracture) and the 10-year probability of hip fracture. Recently various Authors have re-evaluated the effectiveness of drugs approved for postmenopausal osteoporosis to test whether they are more effective in women with higher FRAX® probabilities. PMID:23289024

  1. Development of a Clinical Data Warehouse for Hospital Infection Control

    PubMed Central

    Wisniewski, Mary F.; Kieszkowski, Piotr; Zagorski, Brandon M.; Trick, William E.; Sommers, Michael; Weinstein, Robert A.

    2003-01-01

    Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse. PMID:12807807

  2. [Controlling methods of clinical research on acu-moxibustion commonly used of abroad].

    PubMed

    Wang, Xin-juan; Zhao, Bai-xiao

    2006-06-01

    With the application of scientific studying methods, the level of clinical study has been improved greatly, and people has been paid more attention to scientific evaluation of the clinical effect of Chinese medicine and acu-moxibustion. Formerly, because of lack in acceptance and application of modern scientific studying methods in Chinese clinical acu-moxibustion researchers, their achievements weren't approved by the international academy for the faulty model of study. Randomized Control Trial (RCT) is the golden standard method widely accepted at present, so it is of great importance for clinical acu-moxibustion researchers to exert control methods correctly and effectively. The commonly used controlling methods of overseas clinical acu-moxibustion studies were discussed in this article in order to give some suggestion and benifits to the internal acu-moxibustion clinical researchers. PMID:16841681

  3. [Controlling methods of clinical research on acu-moxibustion commonly used of abroad].

    PubMed

    Wang, Xin-juan; Zhao, Bai-xiao

    2006-06-01

    With the application of scientific studying methods, the level of clinical study has been improved greatly, and people has been paid more attention to scientific evaluation of the clinical effect of Chinese medicine and acu-moxibustion. Formerly, because of lack in acceptance and application of modern scientific studying methods in Chinese clinical acu-moxibustion researchers, their achievements weren't approved by the international academy for the faulty model of study. Randomized Control Trial (RCT) is the golden standard method widely accepted at present, so it is of great importance for clinical acu-moxibustion researchers to exert control methods correctly and effectively. The commonly used controlling methods of overseas clinical acu-moxibustion studies were discussed in this article in order to give some suggestion and benifits to the internal acu-moxibustion clinical researchers.

  4. Computer AIDS for Clinical Research Management and Control: General Analysis and Design

    PubMed Central

    Willard, Christopher G.; Gatewood, Laël C.; Ellis, Lynda B. M.

    1979-01-01

    Clinical research projects involve concurrent management of subjects, protocol, analysis and study. This complicated management problem could be aided by the use of computerized data systems. For most effective aid, such a system should consider all aspects of clinical research. We have analyzed clinical research tasks involving data collection, communication, and management and have used this task analysis to develop a system model for clinical research data management and control. The model deals with data control, study monitoring, user interfaces, report and analysis libraries, and study subject and support data bases. It may be used as a basis for computerized data system study and development. The model also indicates that the role of computerized systems in clinical research could be expanded into such areas as automatic report generation and control, process control aids, quality assurance monitoring, and study documentation.

  5. Clinical Effects of Subgingivally Delivered Spirulina Gel in Chronic Periodontitis Cases: A Placebo Controlled Clinical Trial

    PubMed Central

    Mahendra, Jaideep; Mahendra, Little; Muthu, Jananni; John, Libby; Romanos, Georgios E.

    2013-01-01

    Aims and Objectives: The aim of this study was to assess the clinical effects of Spirulina in-situ gel as an adjunct to Scaling And Root Planning (SRP) in the treatment of chronic periodontitis subjects. Material and Methods: 64 sites were selected with probing pocket depth of ≥5mm and they were divided into 2 groups; 33 sites were treated with SRP along with spirulina gel (Group A) and 31 sites were treated with SRP alone (Group B). Clinical parameters were recorded at baseline before SRP and at 120th day after the treatment therapy. The parameters included Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL). Results: Both the groups showed significant improvement in the parameters. However, Group A (SRP along with spirulina) showed statistically significant decrease in mean probing pocket depth and gain in the clinical attachment level after 120 days as compared to Group B SRP alone. Conclusion: Locally delivered spirulina gel, along with scaling and root planning, has been shown to cause a beneficial impact. The efficacy of the product as a local drug delivery system in the non-surgical treatment of periodontitis without any side effects has been proved. Spirulina appears to be promising. It exerts strong anti-inflammatory effects which are closely connected with its antioxidative activity. This study can have a significant impact on the treatment procedures of periodontitis, with the use of blue green algae in the future. PMID:24298522

  6. Subjective Sleep Complaints in Pediatric Depression: A Controlled Study and Comparison with EEG Measures of Sleep and Waking

    ERIC Educational Resources Information Center

    Bertocci, Michele A.; Dahl, Ronald E.; Williamson, Douglas E.; Iosif, Ana-Maria; Birmaher, Boris; Axelson, David; Ryan, Neal D.

    2005-01-01

    Objective: Children with major depressive disorder (MDD) often complain of sleep disturbances; however, polysomnographic studies have failed to find objective evidence of these disturbances. This article examines subjective sleep reports of children with MDD and healthy controls focusing on comparing subjective and objective sleep measures.…

  7. [Ancient literature on the heat control of umbilicus fumigation method and the modern clinical research].

    PubMed

    Zhang, Xiaoning; Guo, Xin; Yu, Baoluo; Zhang, Na; Ma, Yuxia

    2016-01-01

    In order to improve the clinical efficacy of the umbilicus fumigation method, the ancient literature with the heat control of umbilicus fumigation method involved is collected extensively and analyzed systematically, and the heat control, precautions and contraindications of this method are discussed. In association with the cases and the present clinical experience, the main factors to the heat control are introduced, such as preparation of doughnuts, filling quantity, size of moxa cone and numbers of moxa cones so that the clinical application of the umbilicus fumigation method can be promoted and enhanced.

  8. Maternal Control and Adolescent Depression: Ethnic Differences among Clinically Referred Girls.

    ERIC Educational Resources Information Center

    Finkelstein, Jo-Ann S.; Donenberg, Geri R.; Martinovich, Zoran

    2001-01-01

    Examined the relationship between perceived maternal control and depression for 11 urban adolescent girls seeking psychological services at an outpatient clinic. No relation between control and depression was found for Caucasian and Latina girls, but high control was linked to less depression among African American girls. Findings highlight the…

  9. 77 FR 14805 - Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention: Notice of Charter Renewal This gives notice under the... Improvement Advisory Committee, Centers for Disease Control and Prevention (CDC), Department of Health...

  10. Creation and implementation of a historical controls database from randomized clinical trials

    PubMed Central

    Desai, Jigar R; Bowen, Edward A; Danielson, Mark M; Allam, Rajasekhar R; Cantor, Michael N

    2013-01-01

    Background Ethical concerns about randomly assigning patients to suboptimal or placebo arms and the paucity of willing participants for randomization into control and experimental groups have renewed focus on the use of historical controls in clinical trials. Although databases of historical controls have been advocated, no published reports have described the technical and informatics issues involved in their creation. Objective To create a historical controls database by leveraging internal clinical trial data at Pfizer, focusing on patients who received only placebo in randomized controlled trials. Methods We transformed disparate clinical data sources by indexing, developing, and integrating clinical data within internal databases and archives. We focused primarily on trials mapped into a consistent standard and trials in the pain therapeutic area as a pilot. Results Of the more than 20 000 internal Pfizer clinical trials, 2404 completed placebo controlled studies with a parallel design were identified. Due to challenges with informed consent and data standards used in older clinical trials, studies completed before 2000 were excluded, yielding 1134 studies from which placebo subjects and associated clinical data were extracted. Conclusions It is technically feasible to pool portions of placebo populations through a stratification and segmentation approach for a historical placebo group database. A sufficiently large placebo controls database would enable previous distribution calculations on representative populations to supplement, not eliminate, the placebo arm of future clinical trials. Creation of an industry-wide placebo controls database, utilizing a universal standard, beyond the borders of Pfizer would add significant efficiencies to the clinical trial and drug development process. PMID:23449762

  11. Clinical significance of sleep bruxism on several occlusal and functional parameters.

    PubMed

    Ommerborn, Michelle A; Giraki, Maria; Schneider, Christine; Fuck, Lars Michael; Zimmer, Stefan; Franz, Matthias; Raab, Wolfgang Hans-michael; Schaefer, Ralf

    2010-10-01

    The aim of this study was to evaluate the association between various functional and occlusal parameters and sleep bruxism. Thirty-nine (39) sleep bruxism patients and 30 controls participated in this investigation. The assessment of sleep bruxism was performed using the Bruxcore Bruxism-Monitoring Device (BBMD) combined with a new computer-based analyzing method. Sixteen functional and/or occlusal parameters were recorded. With a mean slide of 0.95 mm in the sleep bruxism group and a mean slide of 0.42 mm in the control group (Mann Whitney U test; p<0.003), results solely demonstrated a significant group difference regarding the length of a slide from centric occlusion to maximum intercuspation. The results suggest that the slightly pronounced slide could be of clinical importance in the development of increased wear facets in patients with current sleep bruxism activity. Following further evaluation including polysomnographic recordings, the BBMD combined with this new analyzing technique seems to be a clinically feasible instrument that allows the practitioner to quantify abrasion over a short period. PMID:21032978

  12. Participants’ perception of pharmaceutical clinical research: a cross-sectional controlled study

    PubMed Central

    González-Saldivar, Gerardo; Rodríguez-Gutiérrez, René; Viramontes-Madrid, José Luis; Salcido-Montenegro, Alejandro; Carlos-Reyna, Kevin Erick Gabriel; Treviño-Alvarez, Andrés Marcelo; Álvarez-Villalobos, Neri Alejandro; González-González, José Gerardo

    2016-01-01

    Background There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. Methods To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. Results Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. Conclusion Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions. PMID:27199549

  13. 78 FR 54913 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... notice published in the Federal Register on September 23, 1975, 40 FR 43745-46, all applicants for... Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies..., 2013, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103,...

  14. 77 FR 47109 - Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... Federal Register on September 23, 1975, 40 FR 43745-46, all applicants for registration to import a basic... Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies..., 2012, Clinical Supplies ] Management Inc., 342 42nd Street South, Fargo, North Dakota 58103,...

  15. 77 FR 24984 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... the Federal Register on September 23, 1975, 40 FR 43745-46, all applicants for registration to import... Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies.... Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on November 13, 2011, Clinical...

  16. Controlling Rater Stringency Error in Clinical Performance Rating: Further Validation of a Performance Rating Theory.

    ERIC Educational Resources Information Center

    Cason, Gerald J.; And Others

    Prior research in a single clinical training setting has shown Cason and Cason's (1981) simplified model of their performance rating theory can improve rating reliability and validity through statistical control of rater stringency error. Here, the model was applied to clinical performance ratings of 14 cohorts (about 250 students and 200 raters)…

  17. 78 FR 39339 - Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ..., 77 FR 50162, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103... importer of the basic classes of controlled substances: Drug Schedule Methylphenidate (1724) II...

  18. 'Simple schizophrenia': a controlled MRI and clinical/neuropsychological study.

    PubMed

    Galderisi, S; Bucci, P; Mucci, A; D'Amato, A C; Conforti, R; Maj, M

    1999-10-11

    The present study explored the frequency of neuromorphological, neurological and neuropsychological abnormalities in 13 patients with an ICD-8/9 diagnosis of simple schizophrenia, also fulfilling DSM-IV criteria for 'simple deteriorative disorder', and in 13 matched patients with an ICD-8/9 diagnosis of a subtype of schizophrenia other than simple schizophrenia, fulfilling DSM-IV criteria for schizophrenia. The frequency of neuromorphological abnormalities in the two patient groups was also compared with that observed in 13 neurological control subjects. Both patients with simple schizophrenia and those with other schizophrenia subtypes showed a higher frequency of brain developmental abnormalities and greater ventricular and subarachnoid space volumes than controls. There was no significant difference between the two groups of patients with respect to neuromorphological variables. Two patients with simple schizophrenia (vs. none of those with other schizophrenia subtypes) had gross brain abnormalities; they were the most deteriorated subjects in the whole sample. Patients with simple schizophrenia, as compared to those with other schizophrenia subtypes, presented a higher frequency of soft neurological signs and a greater impairment of social relationships.

  19. Peripherally acting opioids and clinical implications for pain control.

    PubMed

    Sehgal, Nalini; Smith, Howard S; Manchikanti, Laxmaiah

    2011-01-01

    Opioid receptors are widely expressed in the central and peripheral nervous system and in the non-neuronal tissues. Data from animal and human clinical studies support the involvement of peripheral opioid receptors in analgesia, especially in the presence of inflammation. Inflammation has been shown to increase the synthesis of opioid receptors in the dorsal root ganglion neurons and enhance transport and accumulation of opioid receptors in the peripheral terminals of sensory neurons. Under the influence of chemokines and adhesion molecules, opioid peptide-containing immune cells extravasate and accumulate in the injured tissues. Stress, chemokines, cytokines, and other releasing factors in inflamed tissues stimulate these granulocytes to release opioid peptides. Once secreted, opioid peptides bind to and activate peripheral opioid receptors on sensory nerve fibers and produce analgesia by decreasing the excitability of sensory nerves and/or inhibiting release of pro-inflammatory neuropeptides. Research has revealed that local application of exogenous opioid agonists produces a potent analgesic effect by activating peripheral opioid receptors in inflamed tissues. The analgesic activity occurs without activation of opioid receptors in the central nervous system (CNS), and therefore centrally mediated side effects, such as respiratory depression, mental clouding, altered consciousness, or addiction, are not associated with peripheral opioid activity. This discovery has stimulated research on developing peripherally restricted opioid agonists that lack CNS effects. In addition, it has been recognized that opioid receptors modulate inflammation, and that opioids have anti-inflammatory effects. The anti-inflammatory actions of opioids are not well known or understood. Conflicting reports on mu-opioids suggest both anti-inflammatory and pro-inflammatory effects. This article will present the basis for peripheral opioid analgesia and describe current research directed at

  20. Preoperative whole body disinfection--a controlled clinical study.

    PubMed

    Hayek, L J; Emerson, J M

    1988-04-01

    Preoperative whole body washing with chlorhexidine scrub was compared with soap for its effect on prevention of wound infection in clean surgery. Two thousand and fifteen patients were studied using chlorhexidine scrub, placebo or plain soap. The overall infection rate in the control and placebo groups was 12.8% (p less than 0.05) and 11.7% as opposed to 9% (p less than 0.05) in the treated group. Three per cent fewer infections were found in treated 'clean surgery' patients, and the incidence of Staphylococcus aureus infections was reduced from 6% (bar soap) to 3% (chlorhexidine). The saving in bed occupancy from prevention of infection is a significant cost-saving.

  1. A Pragmatic Guide on How Physicians Can Take Over Financial Control of Their Clinical Practice

    PubMed Central

    Fischer, Thorsten

    2012-01-01

    Control of clinical cost is becoming increasingly important in health care worldwide. Physicians should accept the limitation of resources and take responsibility to improve their clinical cost-reimbursement ratio. To achieve this, they will need basic education in clinic management to control and adjust costs and reimbursement, without impacting professional quality of care. Rational use of diagnostics and therapy should be implemented and frequently verified. Physicians are the only professionals that are able to integrate economics with health care. This is in the best interest of patients and will improve a physician's position, influence, and professional freedom levels within our hospitals. PMID:23484576

  2. Advances in clinical NK cell studies: Donor selection, manufacturing and quality control

    PubMed Central

    Koehl, U.; Kalberer, C.; Spanholtz, J.; Lee, D. A.; Miller, J. S.; Cooley, S.; Lowdell, M.; Uharek, L.; Klingemann, H.; Curti, A.; Leung, W.; Alici, E.

    2016-01-01

    ABSTRACT Natural killer (NK) cells are increasingly used in clinical studies in order to treat patients with various malignancies. The following review summarizes platform lectures and 2013–2015 consortium meetings on manufacturing and clinical use of NK cells in Europe and United States. A broad overview of recent pre-clinical and clinical results in NK cell therapies is provided based on unstimulated, cytokine-activated, as well as genetically engineered NK cells using chimeric antigen receptors (CAR). Differences in donor selection, manufacturing and quality control of NK cells for cancer immunotherapies are described and basic recommendations are outlined for harmonization in future NK cell studies. PMID:27141397

  3. Complement analysis 2016: Clinical indications, laboratory diagnostics and quality control.

    PubMed

    Prohászka, Zoltán; Nilsson, Bo; Frazer-Abel, Ashley; Kirschfink, Michael

    2016-11-01

    In recent years, complement analysis of body fluids and biopsies, going far beyond C3 and C4, has significantly enhanced our understanding of the disease process. Such expanded complement analysis allows for a more precise differential diagnosis and for critical monitoring of complement-targeted therapy. These changes are a result of the growing understanding of the involvement of complement in a diverse set of disorders. To appreciate the importance of proper complement analysis, it is important to understand the role it plays in disease. Historically, it was the absence of complement as manifested in severe infection that was noted. Since then complement has been connected to a variety of inflammatory disorders, such as autoimmune diseases and hereditary angioedema. While the role of complement in the rejection of renal grafts has been known longer, the significant impact of complement. In certain nephropathies has now led to the reclassification of some rare kidney diseases and an increased role for complement analysis in diagnosis. Even more unexpected is that complement has also been implicated in neural, ophtalmological and dermatological disorders. With this level of involvement in some varied and impactful health issues proper complement testing is clearly important; however, analysis of the complement system varies widely among laboratories. Except for a few proteins, such as C3 and C4, there are neither well-characterized standard preparations nor calibrated assays available. This is especially true for the inter-laboratory variation of tests which assess classical, alternative, or lectin pathway function. In addition, there is a need for the standardization of the measurement of complement activation products that are so critical in determining whether clinically relevant complement activation has occurred in vivo. Finally, autoantibodies to complement proteins (e.g. anti-C1q), C3 and C4 convertases (C3 and C4 nephritic factor) or to regulatory proteins

  4. Complement analysis 2016: Clinical indications, laboratory diagnostics and quality control.

    PubMed

    Prohászka, Zoltán; Nilsson, Bo; Frazer-Abel, Ashley; Kirschfink, Michael

    2016-11-01

    In recent years, complement analysis of body fluids and biopsies, going far beyond C3 and C4, has significantly enhanced our understanding of the disease process. Such expanded complement analysis allows for a more precise differential diagnosis and for critical monitoring of complement-targeted therapy. These changes are a result of the growing understanding of the involvement of complement in a diverse set of disorders. To appreciate the importance of proper complement analysis, it is important to understand the role it plays in disease. Historically, it was the absence of complement as manifested in severe infection that was noted. Since then complement has been connected to a variety of inflammatory disorders, such as autoimmune diseases and hereditary angioedema. While the role of complement in the rejection of renal grafts has been known longer, the significant impact of complement. In certain nephropathies has now led to the reclassification of some rare kidney diseases and an increased role for complement analysis in diagnosis. Even more unexpected is that complement has also been implicated in neural, ophtalmological and dermatological disorders. With this level of involvement in some varied and impactful health issues proper complement testing is clearly important; however, analysis of the complement system varies widely among laboratories. Except for a few proteins, such as C3 and C4, there are neither well-characterized standard preparations nor calibrated assays available. This is especially true for the inter-laboratory variation of tests which assess classical, alternative, or lectin pathway function. In addition, there is a need for the standardization of the measurement of complement activation products that are so critical in determining whether clinically relevant complement activation has occurred in vivo. Finally, autoantibodies to complement proteins (e.g. anti-C1q), C3 and C4 convertases (C3 and C4 nephritic factor) or to regulatory proteins

  5. Family Physician Clinical Inertia in Glycemic Control among Patients with Type 2 Diabetes

    PubMed Central

    Lang, Valerija Bralić; Marković, Biserka Bergman; Kranjčević, Ksenija

    2015-01-01

    Background Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. Material/Methods This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15–25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. Results A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Conclusions Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control. PMID:25652941

  6. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    PubMed Central

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  7. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  8. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  9. Frontiers in Microcirculation: Control Processes and Clinical Applications

    PubMed Central

    Segal, Steven S.

    2010-01-01

    This edition of Microcirculation presents five current and emerging perspectives of the microcirculation in development, health and disease. The onset of blood flow and pressure are central to cardiovascular development. These hemodynamic forces are explored in light of underlying molecular signaling pathways that affect vascular and cardiac cell shape and proliferation. Shear-induced strain exerted on the plasma membrane and cytoskeleton is transmitted to cell nuclei and thereby affects gene activation through mechanotransduction. Altered stiffness or disturbed surfaces of aberrant vascular cells may affect an array of vasculopathies through altered gene expression. The endothelium is both a site and source for inflammatory responses triggered by cardiovascular risk factors often mediated through reactive oxygen species and angiotensin II. Tumor microenvironments are disturbed with abnormal growth and remodeling of blood and lymphatic vessels. More effective targeting strategies for delivering anti-angiogenic and cytotoxic agents are being developed through advances in intravital imaging. Blood flow control requires both vasodilation and vasoconstriction to be coordinated along and among arterioles and feed arteries. Evolving insights into signaling pathways between smooth muscle cells and endothelial cells illuminate how such processes can be affected in vasculopathies. These timely reviews provide a novel reference for advancing research frontiers in microcirculation. PMID:20374480

  10. Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes

    PubMed Central

    2011-01-01

    Objective To characterize the types of control procedures used in controlled clinical trials of cervical spine manipulation and to evaluate the outcomes obtained by subjects in control groups so as to improve the quality of future clinical trials Methods A search of relevant clinical trials was performed in PubMed 1966-May 2010 with the following key words: "Chiropractic"[Mesh] OR "Manipulation, Spinal"[Mesh]) AND "Clinical Trial "[Publication Type]. Reference lists from these trials were searched for any additional trials. The reference lists of two prior studies, one review and one original study were also searched. Accepted reports were then rated for quality by 2 reviewers using the PEDro scale. Studies achieving a score of >50% were included for data extraction and analysis. Intra-group change scores on pain outcomes were obtained. For determining clinically important outcomes, a threshold of 20% improvement was used where continuous data were available; otherwise, an effect size of 0.30 was employed Results The PubMed search yielded 753 citations of which 13 were selected. Eight (8) other studies were identified by reviewing two systematic reviews and through reference searches. All studies scored >50% on the PEDro scale. There were 9 multi-session studies and 12 single-session studies. The most commonly used control procedure was "manual contact/no thrust". Four (4) studies used a placebo-control (patient blinded). For two of these studies with VAS data, the average change reported was 4.5 mm. For the other control procedures, variable results were obtained. No clinically important changes were reported in 57% of the paired comparisons, while, in 43% of these, changes which would be considered clinically important were obtained in the control groups. Only 15% of trials reported on post-intervention group registration. Conclusions Most control procedures in cervical manipulation trials result in small clinical changes, although larger changes are observed in

  11. Non-participation in a randomized controlled trial: the effect on clinical and non-clinical variables.

    PubMed

    Vermaire, J H; van Loveren, C; Poorterman, J H G; Hoogstraten, J

    2011-01-01

    Studies reporting clinical and non-clinical parameters of participants and non-participants of clinical trials are scarce. In the available studies non-participants were likely to show less favourable outcomes than participants on both socioeconomic parameters as well as on caries experience. However, the impact of non-participation on the total sample of the research population is not established. In the present study, as part of baseline data collection for a randomized controlled trial on caries-preventive strategies, 346 parents of children 6.0 years (± 3 months) of age were approached to let their child participate. Sixty parents refused, but 56 of them were willing to fill out the same set of questionnaires and to allow their child to be clinically examined once. Parents from participating children had higher socioeconomic status, were more often of autochthonous origin and scored better on knowledge questions than parents of non-participating children. Furthermore, parents of participating children reported a higher willingness to invest, were more likely to hold on to regular meals and their child had lower levels of plaque compared to non-participating children. Surprisingly, the participating children had higher dmfs scores than the non-participating children. Their care index (fs/ds + fs) was higher than that of non-participating children. Based on the findings of this study, the presumption that non-participating children will show less favourable clinical outcomes cannot be supported. Although participants differed from non-participants, they did not differ from the total population. It is suggested that the external validity of a randomized controlled trial on caries-preventive strategies is not necessarily affected by non-participation bias. PMID:21576959

  12. Functional MRI in human motor control studies and clinical applications.

    PubMed

    Toma, Keiichiro; Nakai, Toshiharu

    2002-07-01

    Functional magnetic resonance imaging (fMRI) has been a useful tool for the noninvasive mapping of brain function associated with various motor and cognitive tasks. Because fMRI is based on the blood oxygenation level dependent (BOLD) effect, it does not directly record neural activity. With the fMRI technique, distinguishing BOLD signals created by cortical projection neurons from those created by intracortical neurons appears to be difficult. Two major experimental designs are used in fMRI studies: block designs and event-related designs. Block-designed fMRI presupposes the steady state of regional cerebral blood flow and has been applied to examinations of brain activation caused by tasks requiring sustained or repetitive movements. By contrast, the more recently developed event-related fMRI with time resolution of a few seconds allows the mapping of brain activation associated with a single movement according to the transient aspects of the hemodynamic response. Increasing evidence suggests that multiple motor areas are engaged in a networked manner to execute various motor acts. In order to understand functional brain maps, it is important that one understands sequential and parallel organizations of anatomical connections between multiple motor areas. In fMRI studies of complex motor tasks, elementary parameters such as movement length, force, velocity, acceleration and frequency should be controlled, because inconsistency in those parameters may alter the extent and intensity of motor cortical activation, confounding interpretation of the findings obtained. In addition to initiation of movements, termination of movements plays an important role in the successful achievement of complex movements. Brain areas exclusively related to the termination of movements have been, for the first time, uncovered with an event-related fMRI technique. We propose the application of fMRI to the elucidation of the pathophysiology of movement disorders, particularly dystonia

  13. Disciplined Decision Making in an Interdisciplinary Environment: Some Implications for Clinical Applications of Statistical Process Control.

    ERIC Educational Resources Information Center

    Hantula, Donald A.

    1995-01-01

    Clinical applications of statistical process control (SPC) in human service organizations are considered. SPC is seen as providing a standard set of criteria that serves as a common interface for data-based decision making, which may bring decision making under the control of established contingencies rather than the immediate contingencies of…

  14. Nutritional screening; control of clinical undernutrition with analytical parameters.

    PubMed

    de Ulíbarri Pérez, José Ignacio; Fernández, Guillermo; Rodríguez Salvanés, Francisco; Díaz López, Ana María

    2014-01-13

    Objetivo: Actualizar el cribado nutricional. La alta prevalencia del desequilibrio nutricional que genera la Desnutrición Clínica (DC), especialmente en hospitales y residencias asistidas, obliga al uso de herramientas de cribado y a controlar su evolución para combatirla sobre la marcha. La DC deriva menos de la carencia nutricional que de los efectos de la enfermedad y sus tratamientos, pero los actuales sistemas de cribado buscan más la desnutrición ya establecida que el riesgo nutricional existente. Las alteraciones metabólicas del equilibrio nutricional que constituyen la trofopatía se pueden captar en el plasma sin demoras, automáticamente, permitiendo rectificar actitudes terapéuticas demasiado agresivas o complementarlas con el adecuado soporte nutricional. Con los sistemas manuales de cribado, solo pasados días o semanas se evidenciarán, tardíamente, los cambios somáticos expresivos de esa desnutrición. La concentración de la albúmina plasmática es un parámetro muy valioso en el control nutricional. Su disminución, cualquiera que sea la causa, expresa un posible déficit pero también el riesgo nutricional a que se ve sometida la célula, antes de que la desnutrición se manifieste somáticamente. La precocidad de la detección del riesgo nutricional, anticipándose a la desnutrición y su gran capacidad pronóstica hacen de las herramientas basadas en parámetros analíticos, el procedimiento más útil, ergonómico, seguro y eficiente para el cribado y pronóstico nutricional en el entorno clínico. Conclusión: es hora de actualizar conceptos, deshacer mitos y optar por sistemas modernos de cribado eficientes, única manera de alcanzar el sueño de controlar la DC en nuestras poblaciones enfermas y frágiles.

  15. [Planning and data analysis in prospective controlled clinical trials (author's transl)].

    PubMed

    Barth, H

    1978-11-01

    Planning of prospective controlled clinical trials in surgery requires the use of test and control groups, sufficiently frequent repetition of experiments, random allocation of patients to the groups (example), and balancing. The descriptive data analysis should be performed in a stepwise manner (list of new data, rank list, range, median, quartiles, histogram, mean value standard deviation). The advantages of the median-quartile-system and the prerequisites for application of various significance tests are pointed out. In the conduct of controlled clinical trials, the consultative role of experimental surgeons is proposed.

  16. Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

    PubMed

    Sennerby, L; Gottlow, J

    2008-06-01

    Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3). PMID:18498589

  17. The Clinical Value of Huangqi Injection in the Treatment of Leucopenia: A Meta-Analysis of Clinical Controlled Trials

    PubMed Central

    Zhou, Xifa; Dong, Chunlei; Luo, Judong; Liu, Yongping

    2013-01-01

    Background Huangqi injection is derived from Astragalus membranaceus root. In China, recent reports of Huangqi injection for the treatment of leucopenia have emerged. However, a systematic review of these reports has not been performed. Thus, we conducted a meta-analysis of clinical controlled trials to assess the clinical value of Huangqi injection in the treatment of leucopenia. Methods We searched the Chinese Biomedical Literature Database (CBM), Wanfang Database, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Full-text Database (VIP), as well as PubMed and EMBASE to collect the data about trials of Huangqi injection for treating leucopenia. A meta-analysis was performed using RevMan 5.2 software. Results A total of 13 studies involving 841 patients were included in this study. The overall study quality was lower according to the Jadad scale. The meta-analysis showed that experimentally treated patients experienced greater therapeutic efficacy and lower white blood cell counts than control groups treated with Western medicine (P < 0.05). No publication bias was evident, according to Egger’s test. Conclusions The validity of this meta-analysis was limited by the overall poor quality of the included studies. Huangqi injection may have potential clinical value in the treatment of leucopenia, but confirmation with rigorously well-designed multi-center trials is needed. PMID:24349444

  18. Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

    PubMed Central

    Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

    2013-01-01

    Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

  19. Clinical implementation of a computer controlled milling machine for compensating filter production.

    PubMed

    Partridge, M; Donovan, E; Fenton, N; Reise, S; Blane, S

    1999-11-01

    The procedures required for the clinical implementation of a computer controlled milling machine for producing compensators for breast radiotherapy are described. Moulds are cut in a rigid polymer foam block and filled with stainless-steel granulate. Quality assurance procedures are described for ensuring that the compensators produced are consistent and accurate. Relative and absolute dosimetric measurements are presented showing that the compensators are accurate to better than 1% and demonstrate the technique to be clinically acceptable.

  20. [A trial approach to the ideal control-management and systematization of clinical laboratory].

    PubMed

    Tadano, J

    1993-04-01

    Clinical laboratory examinations have continued to expand with the increase in demand for medical care. However, recent high-technology, medical care has made introduction of a new system of quality control in the clinical laboratory indispensable. First, regarding personnel (clinical laboratory technicians), reducing staff hours led to a drop in the employment of newcomers and subsequent aging of the staff. Next, introducing a system to save labor is extremely expensive, making the cost effectiveness very poor and consequently making it difficult to introduce such a system in many laboratories. This symposium was initiated to assist the search for ways in which the present clinical laboratory can survive despite rising personnel expenses and reagent costs, while reducing medical expenses. And at the same time developing a guide to establishing our ideal for the clinical laboratory of the 21st century.

  1. An Artificial Neural Network Estimation of Gait Balance Control in the Elderly Using Clinical Evaluations

    PubMed Central

    Lugade, Vipul; Lin, Victor; Farley, Arthur; Chou, Li-Shan

    2014-01-01

    The use of motion analysis to assess balance is essential for determining the underlying mechanisms of falls during dynamic activities. Clinicians evaluate patients using clinical examinations of static balance control, gait performance, cognition, and neuromuscular ability. Mapping these data to measures of dynamic balance control, and the subsequent categorization and identification of community dwelling elderly fallers at risk of falls in a quick and inexpensive manner is needed. The purpose of this study was to demonstrate that given clinical measures, an artificial neural network (ANN) could determine dynamic balance control, as defined by the interaction of the center of mass (CoM) with the base of support (BoS), during gait. Fifty-six elderly adults were included in this study. Using a feed-forward neural network with back propagation, combinations of five functional domains, the number of hidden layers and error goals were evaluated to determine the best parameters to assess dynamic balance control. Functional domain input parameters included subject characteristics, clinical examinations, cognitive performance, muscle strength, and clinical balance performance. The use of these functional domains demonstrated the ability to quickly converge to a solution, with the network learning the mapping within 5 epochs, when using up to 30 hidden nodes and an error goal of 0.001. The ability to correctly identify the interaction of the CoM with BoS demonstrated correlation values up to 0.89 (P<.001). On average, using all clinical measures, the ANN was able to estimate the dynamic CoM to BoS distance to within 1 cm and BoS area to within 75 cm2. Our results demonstrated that an ANN could be trained to map clinical variables to biomechanical measures of gait balance control. A neural network could provide physicians and patients with a cost effective means to identify dynamic balance issues and possible risk of falls from routinely collected clinical examinations

  2. Overview: clinical and physiological comparison of meditation with other self-control strategies.

    PubMed

    Shapiro, D H

    1982-03-01

    In 1977 the American Psychiatric Association called for a critical examination of the clinical effectiveness of meditation. The author provides a review of the literature bearing on clinical and physiological comparisons of meditation with other self-control strategies. He begins by providing a definition of mediation and then cites the literature comparing mediation with such self-regulation strategies as biofeedback, hypnosis, and progressive relaxation. He pays particular attention to the "uniqueness" of mediation as a clinical intervention strategy a well as the adverse effects of meditation. Finally, he offers suggestions and guidelines for future research.

  3. Wireless remote control clinical image workflow: utilizing a PDA for offsite distribution

    NASA Astrophysics Data System (ADS)

    Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

    2004-04-01

    Last year we presented in RSNA an application to perform wireless remote control of PACS image distribution utilizing a handheld device such as a Personal Digital Assistant (PDA). This paper describes the clinical experiences including workflow scenarios of implementing the PDA application to route exams from the clinical PACS archive server to various locations for offsite distribution of clinical PACS exams. By utilizing this remote control application, radiologists can manage image workflow distribution with a single wireless handheld device without impacting their clinical workflow on diagnostic PACS workstations. A PDA application was designed and developed to perform DICOM Query and C-Move requests by a physician from a clinical PACS Archive to a CD-burning device for automatic burning of PACS data for the distribution to offsite. In addition, it was also used for convenient routing of historical PACS exams to the local web server, local workstations, and teleradiology systems. The application was evaluated by radiologists as well as other clinical staff who need to distribute PACS exams to offsite referring physician"s offices and offsite radiologists. An application for image workflow management utilizing wireless technology was implemented in a clinical environment and evaluated. A PDA application was successfully utilized to perform DICOM Query and C-Move requests from the clinical PACS archive to various offsite exam distribution devices. Clinical staff can utilize the PDA to manage image workflow and PACS exam distribution conveniently for offsite consultations by referring physicians and radiologists. This solution allows the radiologist to expand their effectiveness in health care delivery both within the radiology department as well as offisite by improving their clinical workflow.

  4. Design control for clinical translation of 3D printed modular scaffolds.

    PubMed

    Hollister, Scott J; Flanagan, Colleen L; Zopf, David A; Morrison, Robert J; Nasser, Hassan; Patel, Janki J; Ebramzadeh, Edward; Sangiorgio, Sophia N; Wheeler, Matthew B; Green, Glenn E

    2015-03-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  5. Design Control for Clinical Translation of 3D Printed Modular Scaffolds

    PubMed Central

    Hollister, Scott J.; Flanagan, Colleen L.; Zopf, David A.; Morrison, Robert J.; Nasser, Hassan; Patel, Janki J.; Ebramzadeh, Edward; Sangiorgio, Sophia N.; Wheeler, Matthew B.; Green, Glenn E.

    2015-01-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  6. Design control for clinical translation of 3D printed modular scaffolds.

    PubMed

    Hollister, Scott J; Flanagan, Colleen L; Zopf, David A; Morrison, Robert J; Nasser, Hassan; Patel, Janki J; Ebramzadeh, Edward; Sangiorgio, Sophia N; Wheeler, Matthew B; Green, Glenn E

    2015-03-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  7. Utilizing measure-based feedback in control-mastery theory: A clinical error.

    PubMed

    Snyder, John; Aafjes-van Doorn, Katie

    2016-09-01

    Clinical errors and ruptures are an inevitable part of clinical practice. Often times, therapists are unaware that a clinical error or rupture has occurred, leaving no space for repair, and potentially leading to patient dropout and/or less effective treatment. One way to overcome our blind spots is by frequently and systematically collecting measure-based feedback from the patient. Patient feedback measures that focus on the process of psychotherapy such as the Patient's Experience of Attunement and Responsiveness scale (PEAR) can be used in conjunction with treatment outcome measures such as the Outcome Questionnaire 45.2 (OQ-45.2) to monitor the patient's therapeutic experience and progress. The regular use of these types of measures can aid clinicians in the identification of clinical errors and the associated patient deterioration that might otherwise go unnoticed and unaddressed. The current case study describes an instance of clinical error that occurred during the 2-year treatment of a highly traumatized young woman. The clinical error was identified using measure-based feedback and subsequently understood and addressed from the theoretical standpoint of the control-mastery theory of psychotherapy. An alternative hypothetical response is also presented and explained using control-mastery theory. (PsycINFO Database Record PMID:27631857

  8. Clinical Hypnosis in the Treatment of Post-Menopausal Hot Flashes: A Randomized Controlled Trial

    PubMed Central

    Elkins, Gary R.; Fisher, William I.; Johnson, Aimee K.; Carpenter, Janet S.; Keith, Timothy Z.

    2012-01-01

    Objective The use of estrogen and progesterone to manage vasomotor symptoms (i.e., hot flashes, night sweats) has declined due to concerns over their risks and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized, controlled trial of clinical hypnosis in treating vasomotor symptoms among post-menopausal women. Methods Randomized, single-blind, controlled, clinical trial involving 187 post-menopausal women reporting a minimum of seven hot flashes per day, or at least 50 hot flashes a week at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries at weeks 2–6, and 12. Secondary outcomes included measures of hot flash related daily interference, sleep quality and treatment satisfaction. Results In a modified intent-to-treat analysis that included all randomized participants that provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 hot flashes for the clinical hypnosis intervention (74.16%), versus a 12.89 hot flash reduction (17.13%) for the control (p<.001, 95% CI, 36.15–49.67). Mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared to 3.53 (15.38%) for the control (p<.001, 95% CI, 12.60–17.54). At 12 week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and .88 (9.94%) for the control (p<.001, 95% CI, 2.00–5.46). Secondary outcomes were significantly improved compared to control at 12 week follow-up in hot flash related interference (p<.001, 95% CI, 2.74–4.02), sleep quality (p<.001, 95% CI, 3.65–5.84), and treatment satisfaction (p<.001, 95% CI, 7.79–8.59). Conclusion Compared

  9. Evaluation of the Clinical and Cost Effectiveness of Intermediate Care Clinics for Diabetes (ICCD): A Multicentre Cluster Randomised Controlled Trial

    PubMed Central

    Hardy, Ainsley; Raymond, Neil; Szczepura, Ala; Crossman, Ric; Baines, Darrin; Khunti, Kamlesh; Kumar, Sudhesh; Saravanan, Ponnusamy

    2014-01-01

    Background Configuring high quality care for the rapidly increasing number of people with type 2 diabetes (T2D) is a major challenge worldwide for both providers and commissioners. In the UK, about two thirds of people with T2D are managed entirely in primary care, with wide variation in management strategies and achievement of targets. Pay for performance, introduced in 2004, initially resulted in improvements but disparities exist in ethnic minorities and the improvements are levelling off. Community based, intermediate care clinics for diabetes (ICCDs) were considered one solution and are functioning across the UK. However, there is no randomised trial evidence for the effectiveness of such clinics. Trial Design, Methods and Findings This is a cluster-randomised trial, involving 3 primary care trusts, with 49 general practices randomised to usual care (n = 25) or intervention (ICCDs; n = 24). All eligible adult patients with T2D were invited; 1997 were recruited and 1280 followed-up after 18-months intervention. Primary outcome: achievement of all three of the NICE targets [(HbA1c≤7.0%/53 mmol/mol; Blood Pressure <140/80 mmHg; cholesterol <154 mg/dl (4 mmol/l)]. Primary outcome was achieved in 14.3% in the intervention arm vs. 9.3% in the control arm (p = 0.059 after adjustment for covariates). The odds ratio (95% CI) for achieving primary outcome in the intervention group was 1.56 (0.98, 2.49). Primary care and community clinic costs were significantly higher in the intervention group, but there were no significant differences in hospital costs or overall healthcare costs. An incremental cost-effectiveness ratio (ICER) of +£7,778 per QALY gained, indicated ICCD was marginally more expensive at producing health gain. Conclusions Intermediate care clinics can contribute to improving target achievement in patients with diabetes. Further work is needed to investigate the optimal scale and organisational structure of ICCD services and whether, over

  10. Prenatal Pregnancy Complications and Psychiatric Symptoms: Children with ASD versus Clinic Controls

    ERIC Educational Resources Information Center

    Tudor, Megan E.; DeVincent, Carla J.; Gadow, Kenneth D.

    2012-01-01

    The current study examined the association between prenatal pregnancy complications (PPC) and childhood psychiatric symptoms in children with an autism spectrum disorder (ASD) and non-ASD children who were referred to a psychiatric clinic (Controls). Parents completed a "DSM-IV"-referenced rating scale and developmental history questionnaire.…

  11. 77 FR 50162 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc. Correction In notice document 2012-19197 appearing on pages 47109-47110 in the issue...

  12. Development of Automatic Controller of Brain Temperature Based on the Conditions of Clinical Use

    NASA Astrophysics Data System (ADS)

    Utsuki, Tomohiko; Wakamatsu, Hidetoshi

    A new automatic controller of brain temperature was developed based on the inevitable conditions of its clinical use from the viewpoint of various kinds of feasibility, in particular, electric power consumption of less than 1,500W in ICU. The adaptive algorithm was employed to cope with individual time-varying characteristic change of patients. The controller under water-surface cooling hypothermia requires much power for the frequent regulation of the water temperature of cooling blankets. Thus, in this study, the power consumption of the controller was checked by several kinds of examinations involving the control simulation of brain temperature using a mannequin with thermal characteristics similar to that of adult patients. The required accuracy of therapeutic brain hypothermia, i.e. control deviation within ±0.1C was experimentally confirmed using “root mean square of the control error”, despite the present controller consumes less energy comparing with the one in the case of our conventional controller, where it can still keeps remaining power margin more than 300W even in the full operation. Thereby, the clinically required water temperature was also confirmed within the limit of power supply, thus its practical application is highly expected with less physical burden of medical staff inclusive of more usability and more medical cost performance.

  13. Klebsiella pneumoniae liver abscess in diabetic patients: association of glycemic control with the clinical characteristics

    PubMed Central

    2013-01-01

    Background Klebsiella pneumoniae liver abscess (KPLA) has been reported with increasing frequency in East Asian countries in the past 3 decades, especially in Taiwan and Korea. Diabetes is a well-known risk factor for KPLA and highly associated with septic metastatic complications from KPLA. We investigated the association of glycemic control in diabetic patients with the clinical characteristics of KPLA in Taiwan. Methods Adult diabetic patients with KPLA were identified retrospectively in a medical center from January 2007 to January 2012. Clinical characteristics were compared among patients with different levels of current hemoglobin A1c (HbA1c). Risk factors for metastatic infection from KPLA were analyzed. Results Patients with uncontrolled glycemia (HbA1c ≥ 7%) were significantly younger than those with controlled glycemia (HbA1c < 7%). Patients with uncontrolled glycemia had the trend to have a higher rate of gas-forming liver abscess, cryptogenic liver abscess, and metastatic infection than those with controlled glycemia. Cryptogenic liver abscess and metastatic infection were more common in the poor glycemic control group (HbA1c value >; 10%) after adjustment with age. HbA1c level and abscess < 5 cm were independent risk factors for metastatic complications from KPLA. Conclusions Glycemic control in diabetic patients played an essential role in the clinical characteristics of KPLA, especially in metastatic complications from KPLA. PMID:23363608

  14. Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

    PubMed

    Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

    2011-11-01

    This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

  15. Electroacupuncture in the treatment of chronic lameness in horses and ponies: a controlled clinical trial.

    PubMed Central

    Steiss, J E; White, N A; Bowen, J M

    1989-01-01

    Electroacupuncture was used to treat lameness in horses and ponies with chronic laminitis (n = 10) or navicular disease (n = 10). A clinical trial was conducted with random allocation of equal numbers of animals to control and treatment groups. Acupuncture was performed three times per week for four consecutive weeks. The degree of lameness was assessed by 1) a grading scheme, 2) measurement of stride lengths and 3) analysis of weight distribution using a force plate. Although seven out of ten animals with chronic laminitis improved clinically during the trial, there were no statistically significant differences between treatment and control groups. Six out of ten horses with navicular disease improved, but there were no significant differences between treatment and control groups. PMID:2653599

  16. Riposte to Guest Commentaries on 'Problems associated with randomized controlled clinical trials in breast cancer.

    PubMed

    Johnson, A E

    1998-08-01

    This paper addresses the objections of Professor M. Baum and Mr W. J. Cunliffe to my thesis that the randomized controlled clinical trial is a poor tool for the investigation of the treatment of breast cancer, argued in a discussion paper entitled 'Problems associated with randomized controlled clinical trials in breast cancer' (A.E. Johnson, 1998, Journal of Evaluation in Clinical Practice 4, 119-126). The objections range from those that have a philosophical basis, through those founded on differing concepts of the classification of primary tumours and the nature of the metastatic tumour, to those that question the reliability and usefulness of the clinical evaluation of response to treatment in terms of histological grade and rate of tumour shrinkage. An alternative approach to research through primary systemic therapy with selection of treatment according to predicted tumour behaviour was severely criticized, both on the preceding grounds and because it was assumed that the alternative to randomization is management by anecdote. These objections are examined and evidence in support of reliable and useful clinical measurement of response is presented in some detail. The problems associated with randomization as a technique for the evaluation of treatments, when the intrinsic variability of tumours is very large without the intervention of treatment, remain unsolved.

  17. Intrasession reliability and influence of breathing during clinical assessment of lumbar spine postural control.

    PubMed

    Lafond, Danik; Dimmock, Mathilde; Champagne, Annick; Descarreaux, Martin

    2009-04-01

    The aims of this study were to evaluate the influence of breathing when measuring lumbar postural control during a clinical progressive lumbar stabilization test (LST) and to estimate the intrasession reliability of the LST. The lumbar postural control index was calculated by using a biofeedback pressure unit. The LST was performed in two different positions (crook lying and upright) and two respiratory conditions (apnea and breathing) by 20 healthy individuals. The intrasession reliability of the lumbar postural control index of one trial was estimated with intraclass correlation coefficient (ICC) based on an Anova model. The results showed that the lumbar postural control index is similar between testing positions. There is an increase of the lumbar postural control index during breathing compared to the apnea. The reliability of the lumbar postural control index was fair to good (ICC 0.28-0.58). We also found that for the apnea, three trials had to be averaged to attain an ICC of 0.80 for both positions. The results of the present study indicate that the progressive LST can be similarly conducted in either supine or upright posture. Clinicians should be aware of the influence of breathing during LST. However, breathing could also serve as a clinical strategy to challenge lumbar spine postural control and stability during bracing therapeutic exercises. PMID:19384740

  18. Clinical and radiographic assessment of the efficacy of calcium silicate indirect pulp capping: a randomized controlled clinical trial.

    PubMed

    Hashem, D; Mannocci, F; Patel, S; Manoharan, A; Brown, J E; Watson, T F; Banerjee, A

    2015-04-01

    The aims of this study were to assess the effectiveness of calcium silicate cement (Biodentine) versus glass ionomer cement (GIC; control group) as indirect pulp capping materials in patients with reversible pulpitis and to compare the effectiveness of cone beam computed tomography (CBCT) versus periapical (PA) radiographs in detecting PA changes at baseline (T0) and at 12 mo (T12) postoperatively. Seventy-two restorations (36 Biodentine, 36 Fuji IX) were placed randomly in 53 patients. CBCT/PA radiographs were taken at T0 and T12. Two calibrated examiners assessed the presence/absence and increase/decrease in the size of existing PA radiolucencies under standardized conditions. The Kappa coefficient evaluated statistically the effectiveness of CBCT versus PA radiographs in detecting PA changes. Chi-square/Mann-Whitney tests were used to evaluate the association between PA changes in CBCT with various clinical measures. Significance was predetermined at α = 0.05. Clinical success rates for Biodentine and Fuji IX GIC were 83.3%. CBCT was significantly more effective in detecting PA radiolucencies compared with radiographs (P = 0.0069). Of the teeth, 65.4% and 90.4% were deemed healthy using CBCT and PA radiographs, respectively, at T12. Healing/healed rates were 17.3%/0%, while new/progressed radiolucency were 30.8%/9.6% with CBCT/PA radiographs, respectively. Seventy-one percent of healed lesions had received Biodentine; 88% of new/progressed lesions received Fuji IX GIC. Teeth presenting with an initial CBCT PA lesion had a failure rate of 63%, whereas teeth with no initial lesion had a failure rate of 16%. Although no statistically significant difference was detected in the clinical efficacy of Biodentine/Fuji IX when used as indirect pulp capping materials in patients with reversible pulpitis, CBCT showed a significant difference in that most healed CBCT lesions had received Biodentine while most that did not heal received Fuji IX. Longer-term follow-up is

  19. High-dose intravenous immunoglobulin in inflammatory myopathies: experience based on controlled clinical trials.

    PubMed

    Dalakas, M C

    2003-10-01

    Controlled clinical trials with high-dose intravenous immunoglobulin (IVIg) have been conducted in patients with DM and IBM, but not PM. A double-blind placebo-controlled study in DM patients, resistant or partially responsive to conventional therapies, showed that IVIg is very effective in improving both the muscle strength and the skin rash. The clinical benefit, which was impressive in patients with early disease, was associated with improvement in the muscle cytoarchitecture. Quantitative histological studies in repeated muscle biopsies showed a statistically significant increased in the size of muscle fibers and the number of capillaries with normalization of the capillary diameter. Resolution of the aberrant immunopathological parameters including interception of complement activation products and downregulation of T cells, ICAM-I, VCAM, TGF-beta and MHC-I molecules was also noted. In IBM, IVIg showed marginal, and non statistically significant, improvements in muscle strength. Up to 20% of patients however, demonstrated clinical improvement with increased activities of daily living while certain muscle groups, such as the muscles of swallowing, showed significant improvements compared to placebo implying mild regional benefits. In PM, small uncontrolled series have shown improvements in muscle strength in up to 70% of the IVIg-treated patients. Because PM, as a stand-alone clinical entity, is a very rare disease, completion of controlled trials will be very difficult.

  20. [Construction and implementation of quality control index for clinical safety of Chinese medicine injection].

    PubMed

    Jiang, Jun-jie; Xie, Yan-ming

    2015-12-01

    In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference. PMID:27245020

  1. Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories.

    PubMed

    Chen, Ming-Shu; Wu, Ming-Hsun; Lin, Chih-Ming

    2014-04-30

    The traditional criteria for acceptability of analytic quality may not be objective in clinical laboratories. To establish quality control procedures intended to enhance Westgard multi-rules for improving the quality of clinical biochemistry tests, we applied the Cp and Cpk quality-control indices to monitor tolerance fitting and systematic variation of clinical biochemistry test results. Daily quality-control data of a large Taiwanese hospital in 2009 were analyzed. The test items were selected based on an Olympus biochemistry machine and included serum albumin, aspartate aminotransferase, cholesterol, glucose and potassium levels. Cp and Cpk values were calculated for normal and abnormal levels, respectively. The tolerance range was estimated with data from 50 laboratories using the same instruments and reagents. The results showed a monthly trend of variation for the five items under investigation. The index values of glucose were lower than those of the other items, and their values were usually <2. In contrast to the Cp value for cholesterol, Cpk of cholesterol was lower than 2, indicating a systematic error that should be further investigated. This finding suggests a degree of variation or failure to meet specifications that should be corrected. The study indicated that Cp and Cpk could be applied not only for monitoring variations in quality control, but also for revealing inter-laboratory qualitycontrol capability differences.

  2. Age-Matched, Case-Controlled Comparison of Clinical Indicators for Development of Entropion and Ectropion

    PubMed Central

    Michels, Kevin S.; Czyz, Craig N.; Cahill, Kenneth V.; Foster, Jill A.; Burns, John A.; Everman, Kelly R.

    2014-01-01

    Purpose. To analyze the clinical findings associated with involutional entropion and ectropion and compare them to each other and to age-matched controls. Methods. Prospective, age-matched cohort study involving 30 lids with involutional entropion, 30 lids with involutional ectropion, and 52 age-matched control lids. Results. The statistically significant differences associated with both the entropion and ectropion groups compared to the control group were presence of a retractor dehiscence, presence of a “white line,” occurrence of orbital fat prolapse in the cul-de-sac, decreased lower lid excursion, increased lid laxity by the snapback test, and an increased lower lid distraction. Entropion also differed from the control group with an increased lid crease height and decreased lateral canthal excursion. Statistically significant differences associated with entropion compared to ectropion were presence of a retractor dehiscence, decreased lateral canthal excursion, and less laxity in the snapback test. Conclusion. Entropic and ectropic lids demonstrate clinically and statistically significant anatomical and functional differences from normal, age-matched lids. Many clinical findings associated with entropion are also present in ectropion. Entropion is more likely to develop with a pronounced retractor deficiency. Ectropion is more likely to develop with diminished elasticity as measured by the snapback test. PMID:24734167

  3. Compliance with infection control practices in an university hospital dental clinic

    PubMed Central

    Mutters, Nico T.; Hägele, Ulrike; Hagenfeld, Daniel; Hellwig, Elmar; Frank, Uwe

    2014-01-01

    Aim: Compliance with infection control practices is the key to quality care and excellence in dentistry. Infection control remains one of the most cost-beneficial interventions available. However, implementing control procedures requires full compliance of the whole dental team. The aim of our study was to measure the compliance in daily clinical practice. Methods: The compliance with infection control practices in dentistry by dental health care personnel (DHCP) in a German university dental clinic was observed during clinical work. In addition, a survey was conducted to assess the individual knowledge about infection control procedures. Contamination of the workplace during invasive dental procedures was tested, as well. Results: A total of 58 invasive dental treatments implying close contacts between HCWs and patients were scrutinized. All HCWs (100%) wore gloves during dental work, but in some cases (female dentists: 14.3%; dental assistants: 28.6%) gloves were neither changed nor hands were disinfected between different activities or patient contacts (female dentists: 68.6%; male dentists: 60.9%; dental assistants: 93%). Only 31.4% of female and 39.1% of male dentists carried out adequate hygienic hand disinfection after removing gloves. Male dentists wore significantly more often (100%) protective eyewear compared to 77.1% of female dentists (p<0.05). In addition, most of female dentists (62.9%) and dental assistants (80.7%) wore jewelry during dental procedures. Conclusion: Despite the knowledge of distinct hygiene procedures only a small percentage of dental staff performs hygiene practices according to recommended guidelines. Strict audit is clearly needed in the dental setting to ensure compliance with infection control guidelines to prevent transmission of pathogens. Our results provide insights for the development of a targeted education and training strategy to enhance compliance of dental staff especially of dental assistants with infection control

  4. Parenting clinically anxious versus healthy control children aged 4-12 years.

    PubMed

    van der Sluis, C M; van Steensel, F J A; Bögels, S M

    2015-05-01

    This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to assess parenting behaviors in for children hypothetically anxious situations. Results showed that parents of clinically anxious children reported more anxiety-enhancing parenting (reinforcement of dependency and punishment) as well as more positive parenting (positive reinforcement). For the clinical sample, fathers reported using more modeling/reassurance than mothers, and parents reported using more force with their 4-7-year-olds than with their 8-12-year-olds. No interaction effects were found for child gender with child anxiety status on parenting. Results indicate that for intervention, it is important to measure parenting behaviors, and to take into account father and mother differences and the age of the child. PMID:25819172

  5. Parenting clinically anxious versus healthy control children aged 4-12 years.

    PubMed

    van der Sluis, C M; van Steensel, F J A; Bögels, S M

    2015-05-01

    This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to assess parenting behaviors in for children hypothetically anxious situations. Results showed that parents of clinically anxious children reported more anxiety-enhancing parenting (reinforcement of dependency and punishment) as well as more positive parenting (positive reinforcement). For the clinical sample, fathers reported using more modeling/reassurance than mothers, and parents reported using more force with their 4-7-year-olds than with their 8-12-year-olds. No interaction effects were found for child gender with child anxiety status on parenting. Results indicate that for intervention, it is important to measure parenting behaviors, and to take into account father and mother differences and the age of the child.

  6. Clinical comparison of two tartar control dentifrices: a twelve-week study.

    PubMed

    Sowinski, J; Petrone, D M; Battista, G; Petrone, M E; DeVizio, W; Volpe, A R

    1998-01-01

    The objective of this double-blind clinical study was to investigate the anticalculus efficacy of a new improved tartar control dentifrice formulation containing tetrasodium pyrophosphate, sodium tripolyphosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals) as the test dentifrice, compared to a previously marketed, American Dental Association-accepted, tartar control dentifrice formulation containing tetrasodium pyrophosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals), as the positive control dentifrice. Adult male and female subjects were entered into the study based on a pre-test (baseline) Volpe-Manhold calculus index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for the formation of supragingival dental calculus were performed after twelve-weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol and completed the entire study. At the 12-week examination, the test dentifrice group exhibited a statistically significant (p < 0.0008) 44.1% reduction in the mean Volpe-Manhold calculus index score compared to the mean calculus scores of the previously marketed, positive control dentifrice group. Thus, the results of this clinical study support the conclusion that the New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals is more efficacious in controlling the development of supragingival calculus formation than the previously marketed Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals.

  7. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    PubMed Central

    Venekamp, Roderick P.; Bonten, Marc J.M.; Rovers, Maroeska M.; Verheij, Theo J.M.; Sachs, Alfred P.E.

    2012-01-01

    Background: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic corticosteroid monotherapy for clinically diagnosed, uncomplicated acute rhinosinusitis. Methods: We conducted a block-randomized, double-blind, placebo-controlled clinical trial at 54 primary care practices (68 family physicians) in the Netherlands between Dec. 30, 2008, and Apr. 28, 2011. Adult patients with clinically diagnosed acute rhinosinusitis were randomly assigned to receive either prednisolone 30 mg/d or placebo for 7 days and asked to complete a symptom diary for 14 days. The primary outcome measure was the proportion of patients with resolution of facial pain or pressure on day 7. Results: Of the 185 patients included in the trial (93 in the treatment group, 92 in the placebo group), 2 withdrew from the study and 9 were excluded from the primary analysis because of incomplete symptom reporting. The remaining 174 patients (88 in the treatment group, 86 in the placebo group) were included in the intention-to-treat analysis. The proportions of patients with resolution of facial pain or pressure on day 7 were 62.5% (55/88) in the prednisolone group and 55.8% (48/86) in the placebo group (absolute risk difference 6.7%, 95% confidence interval −7.9% to 21.2%). The groups were similar with regard to the decrease over time in the proportion of patients with total symptoms (combined symptoms of runny nose, postnasal discharge, nasal congestion, cough and facial pain) and health-related quality of life. Adverse events were mild and did not differ significantly between the groups. Interpretation: Systemic corticosteroid monotherapy had no clinically relevant beneficial effects among patients with clinically diagnosed acute rhinosinusitis. Netherlands Trial Register

  8. Lipid-lowering therapies, glucose control and incident diabetes: evidence, mechanisms and clinical implications.

    PubMed

    Zafrir, Barak; Jain, Mohit

    2014-08-01

    Lipid-lowering therapies constitute an essential part in the treatment and prevention of cardiovascular diseases and are consistently shown to reduce adverse cardiovascular outcomes in wide-scale populations. Recently, there is increased awareness of the possibility that lipid-lowering drugs may affect glucose control and insulin resistance. This phenomenon is reported in all classes of lipid-modifying agents, with differential effects of distinct drugs. Since the prevalence of metabolic syndrome and diabetes is rising, and lipid-modifying therapies are widely used to reduce the cardiovascular burden in these populations, it is of importance to examine the relationship between lipid-lowering drugs, glycemic control and incident diabetes. In the current review we discuss the evidence, ranging from experimental studies to randomized controlled clinical trials and meta-analyses, of how lipid-modifying therapies affect glycemic control and insulin sensitivity. Cumulative data suggest that both statins and niacin are associated with increased risk of impaired glucose control and development of new-onset diabetes, as opposed to bile-acid sequestrants which display concomitant moderate lipid and glucose lowering effects, and fibrates (particularly the pan-PPAR agonist bezafibrate) which may produce beneficial effects on glucose metabolism and insulin sensitivity. Ezetimibe is implied to ameliorate metabolic markers such as hepatic steatosis and insulin resistance, with yet little support from clinical trials, while fish oils which in experimental studies produce favorable effects on insulin sensitivity, although studied extensively, continue to show inconclusive effects on glucose homeostasis in patients with diabetes. Suggested mechanisms of how lipid-modifying agents affect glucose control and their clinical implications in this context, are summarized. PMID:24952127

  9. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Meta-Analyses of Randomized Controlled Clinical Trials (RCTs... constructive discussion and information-sharing about best practices in meta-analyses of clinical trial data... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled...

  10. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly.

    PubMed

    Christofides, Elena A

    2016-01-01

    In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

  11. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly

    PubMed Central

    Christofides, Elena A

    2016-01-01

    In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

  12. Obstructive sleep apnea related to rapid-eye-movement or non-rapid-eye-movement sleep: comparison of demographic, anthropometric, and polysomnographic features

    PubMed Central

    Sunnetcioglu, Aysel; Sertogullarından, Bunyamin; Ozbay, Bulent; Gunbatar, Hulya; Ekin, Selami

    2016-01-01

    Objective : To determine whether there are significant differences between rapid-eye-movement (REM)-related obstructive sleep apnea (OSA) and non-REM (NREM)-related OSA, in terms of the demographic, anthropometric, and polysomnographic characteristics of the subjects. Methods : This was a retrospective study of 110 patients (75 males) with either REM-related OSA (n = 58) or NREM-related OSA (n = 52). To define REM-related and NREM-related OSA, we used a previously established criterion, based on the apnea-hypopnea index (AHI): AHI-REM/AHI-NREM ratio > 2 and ≤ 2, respectively. Results : The mean age of the patients with REM-related OSA was 49.5 ± 11.9 years, whereas that of the patients with NREM-related OSA was 49.2 ± 12.6 years. The overall mean AHI (all sleep stages combined) was significantly higher in the NREM-related OSA group than in the REM-related OSA group (38.6 ± 28.2 vs. 14.8 ± 9.2; p < 0.05). The mean AHI in the supine position (s-AHI) was also significantly higher in the NREM-related OSA group than in the REM-related OSA group (49.0 ± 34.3 vs. 18.8 ± 14.9; p < 0.0001). In the NREM-related OSA group, the s-AHI was higher among the men. In both groups, oxygen desaturation was more severe among the women. We found that REM-related OSA was more common among the patients with mild-to-moderate OSA, whereas NREM-related OSA was more common among those with severe OSA. Conclusions : We found that the severity of NREM-related OSA was associated mainly with s-AHI. Our findings suggest that the s-AHI has a more significant effect on the severity of OSA than does the AHI-REM. When interpreting OSA severity and choosing among treatment modalities, physicians should take into consideration the sleep stage and the sleep posture. PMID:26982041

  13. Sleep-related eating disorder in a 29 year-old man: a case report with diagnostic polysomnographic findings.

    PubMed

    Yeh, Shih-Bin; Schenck, Carlos H

    2007-06-01

    This is a case of a 29-year-old man with a 6 year history of sleep-related eating disorder (SRED) that occurred with partial consciousness on a nightly basis. His family or wife witnessed up to 5 episodes every night, with each eating episode lasting 8-16 minutes. Polysomnography documented 4 episodes of sleep-related eating arising from stage 2 Non-REM sleep, when he consumed cookies that he had brought to the sleep lab that night. While eating, his EEG remained in stage 2 sleep or else was a wakeful EEG, and the eating episodes lasted for a mean 13.3 minutes. There was no epileptiform EEG activity during the polysomnogrphic study with a seizure montage and fast paper speed. Therapy with clonazepam, 0.5 mg bedtime, did not control the nocturnal eating. The patient tried to limit access to food in his home before bedtime, and this had modest benefit. This case of SRED has both typical and atypical features, which are discussed.

  14. Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review

    PubMed Central

    Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

    2015-01-01

    While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and

  15. Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

    PubMed

    Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

    2015-01-01

    While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and

  16. Case-control studies in clinical research: mechanism and prevention of selection bias.

    PubMed

    Morabia, A

    1997-01-01

    The mechanism by which selection bias occurs in case-control studies is explained to an audience of clinicians using a simple conceptual framework and a graphical presentation. A case-control study consists in comparing the frequency of exposure in a group of subjects having the studied disease (the cases) relative to another group free of that disease (the controls). Cases and controls can be thought of as arising from a hypothetical cohort study. Thus, enrolled cases are a fraction F1 of the exposed who developed the disease plus a fraction F3 of the unexposed who developed the disease during a given period. Similarly, enrolled controls are a fraction F2 of the exposed who did not develop disease plus a fraction F4 of the unexposed who did not develop the disease. A selection process is inherent to the design of case-control studies but it leads to selection bias only when the ratio of F1 x F4/F2 x F3 is not equal to unity. Examples demonstrate the implication of sampling fractions for designing and interpreting case-control studies performed in clinical settings.

  17. Biological rationales and clinical applications of temperature controlled hyperthermia--implications for multimodal cancer treatments.

    PubMed

    Schildkopf, P; Ott, O J; Frey, B; Wadepohl, M; Sauer, R; Fietkau, R; Gaipl, U S

    2010-01-01

    Hyperthermia (HT)--heating the tumor in the range of 40.0- 44.0 °C--combined with radiation (RT) and/or chemotherapy (CT) is a well proven treatment for malignant tumors. The improvement of the techniques for monitoring and adapting of the desired temperatures even in deep seated tumors has led to a renaissance of, now quality-controlled, HT in multimodal tumor therapy approaches. Randomized clinical trials have shown improved disease-free survival and local tumor control without an increase in toxicity for the combined treatment. In this review, we will focus on biological rationales of HT comprising direct cytotoxicity, systemic effects, chemosensitization, radiosensitization, and immune modulation. The latter is a prerequisite for the control of recurrent tumors and micrometastases. Immunogenic tumor cell death forms induced by HT will be introduced. Modulations of the cytotoxic properties of chemotherapeutic agents by HT as well as synergistic effects of HT with RT will be presented in the context of the main aims of anti-tumor therapy. Furthermore, modern techniques for thermal mapping like magnet resonance imaging will be outlined. The effectiveness of HT will be demonstrated by reviewing recent clinical trials applying HT in addition to CT and/or RT. We conclude that hyperthermia is a very potent radio- as well as chemosensitizer, which fosters the induction of immunogenic dead tumor cells leading to local and in special cases also to systemic tumor control.

  18. Group sequential control of overall toxicity incidents in clinical trials - non-Bayesian and Bayesian approaches.

    PubMed

    Yu, Jihnhee; Hutson, Alan D; Siddiqui, Adnan H; Kedron, Mary A

    2016-02-01

    In some small clinical trials, toxicity is not a primary endpoint; however, it often has dire effects on patients' quality of life and is even life-threatening. For such clinical trials, rigorous control of the overall incidence of adverse events is desirable, while simultaneously collecting safety information. In this article, we propose group sequential toxicity monitoring strategies to control overall toxicity incidents below a certain level as opposed to performing hypothesis testing, which can be incorporated into an existing study design based on the primary endpoint. We consider two sequential methods: a non-Bayesian approach in which stopping rules are obtained based on the 'future' probability of an excessive toxicity rate; and a Bayesian adaptation modifying the proposed non-Bayesian approach, which can use the information obtained at interim analyses. Through an extensive Monte Carlo study, we show that the Bayesian approach often provides better control of the overall toxicity rate than the non-Bayesian approach. We also investigate adequate toxicity estimation after the studies. We demonstrate the applicability of our proposed methods in controlling the symptomatic intracranial hemorrhage rate for treating acute ischemic stroke patients.

  19. Optimal design of clinical trials comparing several treatments with a control.

    PubMed

    Marschner, Ian C

    2007-01-01

    Clinical trials are often designed to compare several treatments with a common control arm in pairwise fashion. In this paper we study optimal designs for such studies, based on minimizing the total number of patients required to achieve a given level of power. A common approach when designing studies to compare several treatments with a control is to achieve the desired power for each individual pairwise treatment comparison. However, it is often more appropriate to characterize power in terms of the family of null hypotheses being tested, and to control the probability of rejecting all, or alternatively any, of these individual hypotheses. While all approaches lead to unbalanced designs with more patients allocated to the control arm, it is found that the optimal design and required number of patients can vary substantially depending on the chosen characterization of power. The methods make allowance for both continuous and binary outcomes and are illustrated with reference to two clinical trials, one involving multiple doses compared to placebo and the other involving combination therapy compared to mono-therapies. In one example a 55% reduction in sample size is achieved through an optimal design combined with the appropriate characterization of power. PMID:17323312

  20. Informed Conditioning on Clinical Covariates Increases Power in Case-Control Association Studies

    PubMed Central

    Zaitlen, Noah; Lindström, Sara; Pasaniuc, Bogdan; Cornelis, Marilyn; Genovese, Giulio; Pollack, Samuela; Barton, Anne; Bickeböller, Heike; Bowden, Donald W.; Eyre, Steve; Freedman, Barry I.; Friedman, David J.; Field, John K.; Groop, Leif; Haugen, Aage; Heinrich, Joachim; Henderson, Brian E.; Hicks, Pamela J.; Hocking, Lynne J.; Kolonel, Laurence N.; Landi, Maria Teresa; Langefeld, Carl D.; Le Marchand, Loic; Meister, Michael; Morgan, Ann W.; Raji, Olaide Y.; Risch, Angela; Rosenberger, Albert; Scherf, David; Steer, Sophia; Walshaw, Martin; Waters, Kevin M.; Wilson, Anthony G.; Wordsworth, Paul; Zienolddiny, Shanbeh; Tchetgen, Eric Tchetgen; Haiman, Christopher; Hunter, David J.; Plenge, Robert M.; Worthington, Jane; Christiani, David C.; Schaumberg, Debra A.; Chasman, Daniel I.; Altshuler, David; Voight, Benjamin; Kraft, Peter; Patterson, Nick; Price, Alkes L.

    2012-01-01

    Genetic case-control association studies often include data on clinical covariates, such as body mass index (BMI), smoking status, or age, that may modify the underlying genetic risk of case or control samples. For example, in type 2 diabetes, odds ratios for established variants estimated from low–BMI cases are larger than those estimated from high–BMI cases. An unanswered question is how to use this information to maximize statistical power in case-control studies that ascertain individuals on the basis of phenotype (case-control ascertainment) or phenotype and clinical covariates (case-control-covariate ascertainment). While current approaches improve power in studies with random ascertainment, they often lose power under case-control ascertainment and fail to capture available power increases under case-control-covariate ascertainment. We show that an informed conditioning approach, based on the liability threshold model with parameters informed by external epidemiological information, fully accounts for disease prevalence and non-random ascertainment of phenotype as well as covariates and provides a substantial increase in power while maintaining a properly controlled false-positive rate. Our method outperforms standard case-control association tests with or without covariates, tests of gene x covariate interaction, and previously proposed tests for dealing with covariates in ascertained data, with especially large improvements in the case of case-control-covariate ascertainment. We investigate empirical case-control studies of type 2 diabetes, prostate cancer, lung cancer, breast cancer, rheumatoid arthritis, age-related macular degeneration, and end-stage kidney disease over a total of 89,726 samples. In these datasets, informed conditioning outperforms logistic regression for 115 of the 157 known associated variants investigated (P-value = 1×10−9). The improvement varied across diseases with a 16% median increase in χ2 test statistics and a

  1. Statistical process control for referrals by general practitioner at Health Insurance Organization clinics in Alexandria.

    PubMed

    Abdel Wahab, Moataza M; Nofal, Laila M; Guirguis, Wafaa W; Mahdy, Nehad H

    2004-01-01

    Quality control is the application of statistical techniques to a process in an effort to identify and minimize both random and non-random sources of variation. The present study aimed at the application of Statistical Process Control (SPC) to analyze the referrals by General Practitioners (GP) at Health Insurance Organization (HIO) clinics in Alexandria. Retrospective analysis of records and cross sectional interview to 180 GPs were done. Using the control charts (p chart), the present study confirmed the presence of substantial variation in referral rates from GPs to specialists; more than 60% of variation was of the special cause, which revealed that the process of referral in Alexandria (HIO) was completely out of statistical control. Control charts for referrals by GPs classified by different GP characteristics or organizational factors revealed much variation, which suggested that the variation was at the level of individual GPs. Furthermore, the p chart for each GP separately; which yielded a fewer number of points out of control (outliers), with an average of 4 points. For 26 GPs, there was no points out of control, those GPs were slightly older than those having points out of control. Otherwise, there was no significant difference between them. The revised p chart for those 26 GPs together yielded a centerline of 9.7%, upper control limit of 12.0% and lower control limit of 7.4%. Those limits were in good agreement with the limits specified by HIO; they can be suggested to be the new specification limits after some training programs. PMID:17265609

  2. Clinical effect of a gel containing Lippia sidoides on plaque and gingivitis control

    PubMed Central

    Pereira, Sérgio Luis da Silva; Praxedes, Yuri Carvalho Machado; Bastos, Thiago Catunda; Alencar, Phillipe Nogueira Barbosa; da Costa, Flávio Nogueira

    2013-01-01

    Objective: This parallel controlled clinical trial evaluated the effect of a gel containing Lippia sidoides essential oil on plaque and gingivitis control. Methods: Thirty patients (n=30) were randomly selected and allocated into three groups: Lippia sidoides (LS, n=10), chlorhexidine (CLX, n=10) or placebo (control, n=10). Plaque and bleeding index were recorded at baseline and after three months. All volunteers were instructed to brush with the gel three times a day throughout the experiment period. Results: There was a significant reduction on plaque and gingivitis in the test groups (P<.05), but no statistically significant difference was observed between them (P>.05). Conclusion: A gel preparation containing 10% Lippia sidoides essential oil was an efficient herbal antiplaque and antigingivitis agent. PMID:23408652

  3. Assessment of hypertension control and clinical course of patients excluded from the SYMPLICITY HTN-3 trial.

    PubMed

    Yerasi, Charan; Baker, Nevin C; Jonnalagadda, Anil K; Torguson, Rebecca; Singh, Suman; Vies, Judith; Waksman, Ron

    2015-12-01

    The screening of patients referred for the Symplicity Renal-Denervation Catheter Therapy on Resistant Hypertension (SYMPLICITY HTN-3) trial was rigorous, with many found not eligible to participate. We investigate patients who were not included in the trial and evaluate their current hypertensive (HTN) therapy, control and clinical status. A retrospective review and telephone interview was performed 8-10 months postscreening on 45 patients and their referring providers who were ultimately not included. Patients were grouped into 4 categories: (1) noninterest; (2) excluded (not meeting inclusion criteria); (3) screen failure (excluded during screening visits due to adequate blood pressure control guided by HTN specialist); or (4) referred after enrollment closure. Primary outcomes evaluated included current anti-HTN management and clinical outcomes. This population consisted of 42% males, mean age 65 ± 5 years, 78% African American, 64% diabetic, and 21% chronic kidney disease. Primary referral basis included cardiology (44%), nephrology (30%), and primary care (26%). At time of follow-up, 20% had continued resistant HTN while most of the patients had controlled HTN (60%); with highest success rates among the screen failure group (88%) who also had the lowest average systolic blood pressure (137 ± 11 mm of Hg) when compared to other groups (P = .04). Average number of medications was lowest in the screen failure group (2.8 ± 1.6, P = .07). Resistant and/or uncontrolled HTN was most prevalent in the noninterest or excluded groups, as were hospitalization for cardiovascular and HTN urgency/emergency. This study highlights the disparity of HTN control and treatment in daily practice compared with clinical trials, and confirms a need for vigilant screening of those considered candidates for renal denervation.

  4. Molecular analysis of sarcoidosis lymph nodes for microorganisms: a case–control study with clinical correlates

    PubMed Central

    Robinson, Lary A; Smith, Prudence; SenGupta, Dhruba J; Prentice, Jennifer L; Sandin, Ramon L

    2013-01-01

    Introduction Sarcoidosis is an incurable, chronic granulomatous disease primarily involving the lungs and lymph nodes of unknown aetiology, treated with non-specific anti-inflammatory/immunosuppressive drugs. Persistently symptomatic patients worsen with a disabling, potentially fatal clinical course. To determine a possible infectious cause, we correlated in a case-control study the clinical information with the presence of bacterial DNA in sarcoidosis mediastinal lymph nodes compared with control lymph nodes resected during cancer surgery. Methods We retrospectively studied formalin-fixed, paraffin-embedded, mediastinal lymph nodes from 30 patients with sarcoidosis and 30 control patients with lung cancer. Nucleic acids were extracted from nodes, evaluated by ribosomal RNA PCR for bacterial 16S ribosomal DNA and the results were sequenced and compared with a bacterial sequence library. Clinical information was correlated. Results 11/30 (36.7%) of lymph nodes from patients with sarcoidosis had detectable bacterial DNA, significantly more than control patient lymph nodes (2/30, 6.7%), p=0.00516. At presentation, 19/30 (63.3%) patients with sarcoidosis were symptomatic including all patients with detectable bacterial DNA. Radiographically, there were 18 stage I and 12 stage II patients. All stage II patients were symptomatic and 75% had PCR-detectable bacteria. After a mean follow-up of 52.8±32.8 months, all patients with PCR-detectable bacteria in this series were persistently symptomatic requiring treatment. Discussion 36.6% of patients with sarcoidosis had detectable bacterial DNA on presentation, all of these patients were quite symptomatic and most were radiographically advanced stage II. These findings suggest that bacterial DNA-positive, symptomatic patients have more aggressive sarcoidosis that persists long term and might benefit from antimicrobial treatment directed against this presumed chronic granulomatous infection. PMID:24366580

  5. Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.

    PubMed

    Castiello, Luciano; Sabatino, Marianna; Zhao, Yingdong; Tumaini, Barbara; Ren, Jiaqiang; Ping, Jin; Wang, Ena; Wood, Lauren V; Marincola, Francesco M; Puri, Raj K; Stroncek, David F

    2013-02-01

    Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra- and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

  6. Effect of clinical parameters on the control of myoelectric robotic prosthetic hands.

    PubMed

    Atzori, Manfredo; Gijsberts, Arjan; Castellini, Claudio; Caputo, Barbara; Hager, Anne-Gabrielle Mittaz; Elsig, Simone; Giatsidis, Giorgio; Bassetto, Franco; Müller, Henning

    2016-01-01

    Improving the functionality of prosthetic hands with noninvasive techniques is still a challenge. Surface electromyography (sEMG) currently gives limited control capabilities; however, the application of machine learning to the analysis of sEMG signals is promising and has recently been applied in practice, but many questions still remain. In this study, we recorded the sEMG activity of the forearm of 11 male subjects with transradial amputation who were mentally performing 40 hand and wrist movements. The classification performance and the number of independent movements (defined as the subset of movements that could be distinguished with >90% accuracy) were studied in relationship to clinical parameters related to the amputation. The analysis showed that classification accuracy and the number of independent movements increased significantly with phantom limb sensation intensity, remaining forearm percentage, and temporal distance to the amputation. The classification results suggest the possibility of naturally controlling up to 11 movements of a robotic prosthetic hand with almost no training. Knowledge of the relationship between classification accuracy and clinical parameters adds new information regarding the nature of phantom limb pain as well as other clinical parameters, and it can lay the foundations for future "functional amputation" procedures in surgery. PMID:27272750

  7. Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials.

    PubMed

    Stanworth, S J; Brunskill, S J; Hyde, C J; McClelland, D B L; Murphy, M F

    2004-07-01

    Summary Randomized controlled trials of good quality are a recognized means to robustly assess the efficacy of interventions in clinical practice. A systematic identification and appraisal of all randomized trials involving fresh frozen plasma (FFP) has been undertaken in parallel to the drafting of the updated British Committee for Standards in Haematology guidelines on the use of FFP. A total of 57 trials met the criteria for inclusion in the review. Most clinical uses of FFP, currently recommended by practice guidelines, are not supported by evidence from randomized trials. In particular, there is little evidence for the effectiveness of the prophylactic use of FFP. Many published trials on the use of FFP have enrolled small numbers of patients, and provided inadequate information on the ability of the trial to detect meaningful differences in outcomes between the two patient groups. Other concerns about the design of the trials include the dose of FFP used, and the potential for bias. No studies have taken adequate account of the extent to which adverse effects might negate the clinical benefits of treatment with FFP. There is a need to consider how best to develop new trials to determine the efficacy of FFP in different clinical scenarios to provide the evidence base to support national guidelines for transfusion practice. Trials of modified FFP (e.g. pathogen inactivated) are of questionable value when there is little evidence that the standard product is an effective treatment. PMID:15198745

  8. Pharmacogenetics of controlled ovarian hyperstimulation: time to corroborate the clinical utility of FSH receptor genetic markers.

    PubMed

    Morón, Francisco Jesús; Ruiz, Agustín

    2010-11-01

    Several studies have shown high variability in clinical outcome among women undergoing follicle-stimulating hormone treatment. Pharmacogenetic studies have revealed a series of genetic markers involved in controlled ovarian hyperstimulation (COH) response. FSHR gene-associated SNPs, including the N680S missense variant, are the most promising genetic markers available to date. In this paper the state of the art pharmacogenetic analysis of COH outcome is reviewed and a meta-analysis is conducted with available data that confirms that the N680S marker is associated with poor response during COH. Thus, we propose that by pooling together available information, it is possible to go one step further with this biomarker to definitively validate its utility in the clinical field. We propose to conduct clinical trials, to look for algorithms integrating the N680S genotype and to test if such clinical protocols can optimize recombinant follicle-stimulating hormone dose and detect women at risk of a poor response during a COH cycle.

  9. Effect of posture-control insoles on function in children with cerebral palsy: Randomized controlled clinical trial

    PubMed Central

    2012-01-01

    Introduction Cerebral palsy (CP) is a posture and movement disorder and different therapeutic modalities, such as the use of braces, have sought to favor selective motor control and muscle coordination in such patients. The aim of the proposed study is to determine the effect of the combination of posture-control insoles and ankle-foot orthoses (AFOs) improving functional limitation in children with CP. Methods/Design The sample will be composed of 24 children with CP between four and 12 years of age. After the signing of the statement of informed consent, the children will be randomly allocated to two groups: a control group using AFOs alone and an experimental group using both posture-control insoles and AFOs. Evaluations will be performed on five occasions: without any accessory (insoles or AFOs), immediately after, one month after, six months after and one year after AFOs or insole and AFOs use. The evaluation will involve the analysis of gait, static and functional balance, mobility and hypertonia. The three-dimensional assessment of gait will involve the eight-camera SMART-D SMART-D 140® system (BTS Engineering), two Kistler force plates (model 9286BA) and an eight-channel, wireless FREEEMG® electromyography (BTS Engineering). Static balance will be assessed using a Kistler force plate (model 9286BA). Clinical functional balance and mobility will be assessed using the Berg Balance Scale, Timed Up-and-Go Test and Six-Minute Walk Test. The posture-control insoles will be made of ethylene vinyl acetate, with thermal molding for fixation. The fixed orthoses will be made of polypropylene and attached to the ankle region (AFO). The results will be analyzed statistically, with the level significance set to 5% (p < 0.05). Trial Registration Trial Registration Number: RBR6d342s (http://www.ensaiosclinicos.gov.br/news/) PMID:23033863

  10. Developing a quality control protocol for diffusion imaging on a clinical MRI system.

    PubMed

    Delakis, Ioannis; Moore, Elizabeth M; Leach, Martin O; De Wilde, Janet P

    2004-04-21

    This work describes the development of a quality control protocol, which can be implemented to assess the accuracy, precision and reproducibility of the apparent diffusion coefficient (ADC) measurement on a clinical magnetic resonance imaging (MRI) system. The precision and accuracy of the ADC measurement are analysed with regard to MRI system noise, signal reproducibility and differences between nominal and effective b values. Two aqueous test-solutions of CuSO4 and sucrose are prepared for the quality control protocol. ADC measurement with the CuSO4 solution is more sensitive to differences between nominal and effective b values, on account of the solution's high ADC. ADC measurement with the sucrose solution is more sensitive to signal reproducibility due to the solution's low baseline signal intensity. The ADC of the test-solutions is measured on an MRI system at our centre with a sequence used for clinical studies using diffusion imaging. Two parameters, Q and R, are defined for the analysis of the quality control ADC values. The Q parameter is the ratio of the standard deviation of the quality control mean ADC values over time to the optimal standard deviation, as derived from the effect of thermal noise on the ADC measurement uncertainty. Analysis with the Q parameter indicates that signal reproducibility errors contribute to ADC variations on our MRI system when imaging with high b values (b > 500 mm s(-2)), whereas differences between nominal and effective b values have a greater impact on the ADC measurement when imaging with low b values (b < 500 mm s(-2)). The R parameter is defined as the ratio of the directional variation of the ADC quality control values to the uncertainty of the ADC measurement. Analysis with the R parameter shows that the effect of directional variation of the ADC measurement on our MRI system is more pronounced when imaging with low b values. The quality control protocol identified a systematic error, which introduced a small

  11. The default network and self-generated thought: component processes, dynamic control, and clinical relevance

    PubMed Central

    Andrews-Hanna, Jessica R.; Smallwood, Jonathan; Spreng, R. Nathan

    2014-01-01

    Though only a decade has elapsed since the default network was first emphasized as being a large-scale brain system, recent years have brought great insight into the network’s adaptive functions. A growing theme highlights the default network as playing a key role in internally-directed—or self-generated—thought. Here, we synthesize recent findings from cognitive science, neuroscience, and clinical psychology to focus attention on two emerging topics as current and future directions surrounding the default network. First, we present evidence that self-generated thought is a multi-faceted construct whose component processes are supported by different subsystems within the network. Second, we highlight the dynamic nature of the default network, emphasizing its interaction with executive control systems when regulating aspects of internal thought. We conclude by discussing clinical implications of disruptions to the integrity of the network, and consider disorders when thought content becomes polarized or network interactions become disrupted or imbalanced. PMID:24502540

  12. Controlled clinical evaluations of chlorine dioxide, chlorite and chlorate in man.

    PubMed Central

    Lubbers, J R; Chauan, S; Bianchine, J R

    1982-01-01

    To assess the relative safety of chronically administered chlorine water disinfectants in man, a controlled study was undertaken. The clinical evaluation was conducted in the three phases common to investigational drug studies. Phase I, a rising dose tolerance investigation, examined the acute effects of progressively increasing single doses of chlorine disinfectants to normal healthy adult male volunteers. Phase II considered the impact on normal subjects of daily ingestion of the disinfectants at a concentration of 5 mg/l. for twelve consecutive weeks. Persons with a low level of glucose-6-phosphate dehydrogenase may be expected to be especially susceptible to oxidative stress; therefore, in Phase III, chlorite at a concentration of 5 mg/l. was administered daily for twelve consecutive weeks to a small group of potentially at-risk glucose-6-phosphate dehydrogenase-deficient subjects. Physiological impact was assessed by evaluation of a battery of qualitative and quantitative tests. The three phases of this controlled double-blind clinical evaluation of chlorine dioxide and its potential metabolites in human male volunteer subjects were completed uneventfully. There were no obvious undesirable clinical sequellae noted by any of the participating subjects or by the observing medical team. In several cases, statistically significant trends in certain biochemical or physiological parameters were associated with treatment; however, none of these trends was judged to have physiological consequence. One cannot rule out the possibility that, over a longer treatment period, these trends might indeed achieve proportions of clinical importance. However, by the absence of detrimental physiological responses within the limits of the study, the relative safety of oral ingestion of chlorine dioxide and its metabolites, chlorite and chlorate, was demonstrated. PMID:6961033

  13. Clinical and Immunological Changes of Immunotherapy in Patients with Atopic Dermatitis: Randomized Controlled Trial

    PubMed Central

    Sánchez Caraballo, Jorge Mario; Cardona Villa, Ricardo

    2012-01-01

    Background. Immunotherapy has proven to be an useful tool in the management of allergic respiratory diseases; however, little has been studied in atopic dermatitis. Objective. To evaluate the clinical and immunological impact of immunotherapy with mites allergen extracts in atopic dermatitis. Methods. Patients with atopic dermatitis were assigned with computer-generated randomization to either of the following groups: (a) controls received only topical treatment with steroids and/or tacrolimus and (b) actively treated patients received topical treatment plus immunotherapy. Levels of serum total IgE, mites-specific IgE and IgG4 were assessed at study start and after one year of immunotherapy. Results. 31 patients in the active group and 29 in the control group completed the study. Symptoms and medication scores were significantly reduced in the active group after six months. Three patients in the control group showed new sensitizations to mites, while 3 patients in the active group showed neosensitization to shrimp with negative oral food challenge. We observed significant increase of mites-specific IgG4 levels in active group. Conclusion. Specific allergen immunotherapy induced a tolerogenic IgG4 response to mite allergens associated with favorable clinical effects in atopic dermatitis patients. PMID:23724240

  14. [From Nebuchadnezzar to the randomized controlled trial--milestones in the development of clinical research].

    PubMed

    Oberbaum, Menachem; Lysy, Joseph; Gropp, Cornelius

    2011-08-01

    The first clinical experiment is described in the bible: The prophet Daniel is reported being nourished during ten days by seeds and water only, in order to check if his physical state would deteriorate as a result of this minimal nutrition. In the 15th century, French surgeon Ambroise Parí experimented with a mixture of turpentine, egg protein and rose oil to treat combat wounds, which is thought to be the first clinical study to be reported. In the 19th century British scientist James Lind designed the first controlled prospective study with parallel groups, proving that ingesting citrus fruit prevents scurvy. A short time afterwards British scientist John Haygarth was the first to use a placebo drug in a clinical study. Important work on placebo was conducted by the American scientists Austin Flint and later by Henry K. Beecher, who showed that placebo itself has biological properties. The importance of comparative studies was first understood by French psychologist CLaude Bernard. He is considered the founder of the modern scientific method based on observation, analysis of data and examination of hypotheses. Bernard's work was based on the work of fellow Frenchman Pierre Charles Alexandre Louis, who is justly considered a founding father of modern epidemiology, and who was the first to use statistics in clinical experiments. Random distributions in clinical studies were reported even before this time, for instance in the work of the Flemish physician Johannes Baptista van Helmont. Danish Nobel prize winner Johannes Fibiger pioneered the use of selection bias in his work with diphtheria serum. PMID:21939122

  15. [From Nebuchadnezzar to the randomized controlled trial--milestones in the development of clinical research].

    PubMed

    Oberbaum, Menachem; Lysy, Joseph; Gropp, Cornelius

    2011-08-01

    The first clinical experiment is described in the bible: The prophet Daniel is reported being nourished during ten days by seeds and water only, in order to check if his physical state would deteriorate as a result of this minimal nutrition. In the 15th century, French surgeon Ambroise Parí experimented with a mixture of turpentine, egg protein and rose oil to treat combat wounds, which is thought to be the first clinical study to be reported. In the 19th century British scientist James Lind designed the first controlled prospective study with parallel groups, proving that ingesting citrus fruit prevents scurvy. A short time afterwards British scientist John Haygarth was the first to use a placebo drug in a clinical study. Important work on placebo was conducted by the American scientists Austin Flint and later by Henry K. Beecher, who showed that placebo itself has biological properties. The importance of comparative studies was first understood by French psychologist CLaude Bernard. He is considered the founder of the modern scientific method based on observation, analysis of data and examination of hypotheses. Bernard's work was based on the work of fellow Frenchman Pierre Charles Alexandre Louis, who is justly considered a founding father of modern epidemiology, and who was the first to use statistics in clinical experiments. Random distributions in clinical studies were reported even before this time, for instance in the work of the Flemish physician Johannes Baptista van Helmont. Danish Nobel prize winner Johannes Fibiger pioneered the use of selection bias in his work with diphtheria serum.

  16. Design of clinical trials of antidepressants: should a placebo control arm be included?

    PubMed

    Fritze, J; Möller, H J

    2001-01-01

    There is no doubt that available antidepressants are efficacious and effective. Nevertheless, more effective drugs with improved tolerability are needed. With this need in mind, some protagonists claim that future antidepressants should be proved superior to, or at least as effective as, established antidepressants, making placebo control methodologically dispensable in clinical trials. Moreover, the use of placebo control is criticised as unethical because it might result in effective treatment being withheld. There are, however, a number of methodological reasons why placebo control is indispensable for the proof of efficacy of antidepressants. Comparing investigational antidepressants only with standard antidepressants and not placebo yields ambiguous results that are difficult to interpret, be it in superiority or equivalence testing, and this method of assessment requires larger sample sizes than those required with the use of placebo control. Experimental methodology not adhering to the optimal study design is ethically questionable. Restricting the testing of investigational antidepressants only to superiority over standard antidepressants is an obstacle to therapeutic progress in terms of tolerability and the detection of innovative mechanisms of action from which certain subgroups of future patients might benefit. The use of a methodology that requires larger samples for testing of superiority or equivalence is also ethically questionable. In view of the high placebo response rates in trials of antidepressants, placebo treatment does not mean withholding effective treatment. Accepting the necessity of the clinical evaluation of new, potentially ineffective antidepressants implicitly means accepting placebo control as ethically justified. Three- or multi-arm comparisons including placebo and an active reference represent the optimal study design. PMID:11602002

  17. Controlled clinical trial of oral and topical diethylcarbamazine in treatment of onchocerciasis.

    PubMed

    Taylor, H R; Greene, B M; Langham, M E

    1980-05-01

    In a double-blind controlled clinical trial comparing the safety and efficacy of oral diethylcarbamazine citrate (DEC) with topical DEC for the treatment of onchocerciasis twenty men with moderate skin-snip microfilarial counts received daily therapy for 1 week, then weekly therapy for the rest of 6 months. The number of microfilariae per skin snip dropped quickly to 2% of initial levels and remained at low levels in those receiving oral DEC, and to 20% of initial levels in patients treated with DEC lotion. Side-effects in both groups included lymphadenopathy, fever, pruritus, rash, proteinuria, and chorioretinitis; they were commoner with topical DEC.

  18. Quality control of software in dissimilar systems using a common clinical data base

    SciTech Connect

    Erickson, J. J.; Price, R. R.; Touya, J. J.; Kronenberg, M. W.; Pederson, R.; Rollo, F. D.

    1980-01-01

    For a long time there has been widespread interest in the quality control of diagnostic instrumentation. The increasing dependence on computational systems for clinical results makes it imperative that methods for quality control of diagnostic software be developed. This paper proposes a method based on the use of a collection of patient studies for which the results have been corroborated by independent methods. The data set will be distributed in a format requiring no special handling by the system being tested and will appear identical to studies actually collected by the host system. An example of the use of a preliminary version of the data set for comparison of two systems is shown. The comparison shows that analyses performed on the two systems agree very well and can be reliably compared for follow-up studies of a patient.

  19. EMD in periodontal regenerative surgery modulates cytokine profiles: A randomised controlled clinical trial

    PubMed Central

    Villa, Oscar; Wohlfahrt, Johan C.; Koldsland, Odd Carsten; Brookes, Steven J.; Lyngstadaas, Staale P.; Aass, Anne M.; Reseland, Janne E.

    2016-01-01

    The enamel matrix derivative (EMD) contains hundreds of peptides in different levels of proteolytic processing that may provide a range of biological effects of importance in wound healing. The aim of the present study was to compare the effect of EMD and its fractions on the cytokine profiles from human gingival fibroblasts in vitro and in gingival crevicular fluid (GCF) in a randomized controlled split-mouth clinical study (n = 12). Levels of cytokines in cell culture medium and in GCF were measured by Luminex over a 2-week period. In the clinical study, levels of pro-inflammatory cytokines and chemokines were increased, whereas the levels of transforming growth factor-α (TGF-α) and platelet-derived growth factor-BB (PDGF-BB) were reduced. The in vitro study showed that EMD and its high and low molecular weight fractions reduced the secretion of pro-inflammatory cytokines and chemokines compared to untreated cells. EMD had an effect on levels of cytokines related to fibroplasia, angiogenesis, inflammation and chemotaxis both in vitro and in vivo, however, the anti-inflammatory effect induced by EMD observed in the in vitro study could not be confirmed clinically. PMID:26976446

  20. Randomized controlled trials of maternal-fetal surgery: a challenge to clinical equipoise.

    PubMed

    Rodrigues, H C M L; van den Berg, P P

    2014-10-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable.

  1. Two phase randomised controlled clinical trial of postoperative oral dietary supplements in surgical patients.

    PubMed Central

    Keele, A M; Bray, M J; Emery, P W; Duncan, H D; Silk, D B

    1997-01-01

    BACKGROUND: Previous work has shown that the administration of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinically significant short term benefits. AIMS: This study aimed firstly to re-evaluate these short term effects, and secondly to establish whether there are any long term benefits. SUBJECTS: One hundred patients admitted for elective moderate or major gastrointestinal surgery. METHODS: In the inpatient phase, patients were randomised to receive a normal ward diet postoperatively, or the same diet supplemented with an oral dietary supplement. In the outpatient phase, patients were further randomised to receive their home diet, or their home diet supplemented with the oral dietary supplement for four months. RESULTS: During the inpatient phase, patients treated with oral supplements had a significantly improved nutritional intake and lost less weight (2.2, 95% confidence interval (95% CI) 0.9 kg) compared with control patients (4.2 (0.78) kg, p < 0.001). Supplemented patients maintained their hand grip strength whereas control patients showed a significant reduction in grip strength (p < 0.01). Subjective levels of fatigue increased significantly above preoperative levels in control patients (p < 0.01) but not in the supplemented group. Twelve patients in the control group developed complications compared with four in the supplemented group (p < 0.05). In the outpatient phase, supplemented patients had improved nutrient intakes but there were no significant differences in indices of nutritional status or wellbeing between the groups. CONCLUSIONS: The prescription of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinically significant benefits. These benefits, however, are restricted to the inpatient phase. PMID:9135531

  2. Clinically Apparent Internal Mammary Nodal Metastasis in Patients With Advanced Breast Cancer: Incidence and Local Control

    SciTech Connect

    Zhang Yujing; Oh, Julia L.; Whitman, Gary J.

    2010-07-15

    Purpose: To investigate the incidence and local control of internal mammary lymph node metastases (IMN+) in patients with clinical N2 or N3 locally advanced breast cancer. Methods and Materials: We retrospectively reviewed the records of 809 breast cancer patients diagnosed with advanced nodal disease (clinical N2-3) who received radiation treatment at our institution from January 2000 December 2006. Patients were considered IMN+ on the basis of imaging studies. Results: We identified 112 of 809 patients who presented with IMN+ disease (13.8%) detected on ultrasound, computed tomography (CT), positron emission tomography/CT (PET/CT), and/or magnetic resonance imaging (MRI) studies. All 112 patients with IMN+ disease received anthracycline and taxane-based chemotherapy. Neoadjuvant chemotherapy (NCT) resulted in a complete response (CR) on imaging studies of IMN disease in 72.1% of patients. Excluding 16 patients with progressive disease, 96 patients received adjuvant radiation to the breast or the chest wall and the regional lymphatics including the IMN chain with a median dose of 60 Gy if the internal mammary lymph nodes normalized after chemotherapy and 66 Gy if they did not. The median follow-up of surviving patients was 41 months (8-118 months). For the 96 patients able to complete curative therapy, the actuarial 5-year IMN control rate, locoregional control, overall survival, and disease-free survival were 89%, 80%, 76%, and 56%. Conclusion: Over ten percent of patients with advanced nodal disease will have IMN metastases on imaging studies. Multimodality therapy including IMN irradiation achieves excellent rates of control in the IMN region and a DFS of more than 50% after curative treatment.

  3. Comparison of clinical effectiveness of laser acupuncture and amitriptyline in diabetic peripheral neuropathy (DPN): a sham controlled randomized clinical trial

    NASA Astrophysics Data System (ADS)

    Hassan Khan, Imran; Anwar, Shahzad; Hanif, Asif; Ayub, Muhammad; Jamil Raja, Arsalan

    2014-02-01

    Background: Painful neuropathy is a very common complication in diabetic patients. Various treatment strategies like manual therapies, conservative management, drug therapy and exercise have been opted for this problem. Studies have shown clinical effectiveness of laser acupuncture as well. On the other hand, Amitryptaline is also a commonly used treatment for this disease. We aim to compare the efficacy of both treatments. Objective: To assess the effect of laser acupuncture in patients suffering from painful diabetic neuropathy and its comparison with standard of care. Patients and Method: This study was conducted in Diabetic and Endocrine Management Center (DEMC) Lahore General Hospital, Lahore, Pakistan. A randomized control trial (RCT) was opted and a total of 164 patients were chosen using Non-probability purposive sampling technique. Pain was graded by using a patient friendly Visual Analogue Score (VAS), scoring from 0 to 10. Treatment was done involving organized fortnightly follow ups. Data of all patients was recorded on Performa and was entered and analyzed for descriptive statistics in PASW 18 (IBM®. SPSS). Results: A total of 164 subjects were included in the study who were subdivided into three groups labeled as A, B and C for laser therapy treatment, amitryptaline treatment and controls respectively. The mean age of subjects was 51.54+/-10.46 in Group A, 49.38+/-10.56 in Group B and 51.70+/-11.43 in Group C. The difference of mean ages in all study groups was statistically insignificant (p-value= 0.469). The average pain score in patients who received laser therapy was 5.95+/-0.91 before treatment, whereas after treatment it was 4.31+/-0.98. The mean pain score in subjects having Amitryptaline before starting the treatment was 6.87+/-0.71 and after treatment, it was 6.23+/-0.98. The mean score for daily life activities in subjects who received laser therapy was 9.562.37 before treatment, while after treatment it was 7.56+/-1.54. The average score

  4. Bacterial colonization of the ovarian bursa in dogs with clinically suspected pyometra and in controls.

    PubMed

    Rubio, Alejandro; Boyen, Filip; Tas, Olaf; Kitshoff, Adriaan; Polis, Ingeborgh; Van Goethem, Bart; de Rooster, Hilde

    2014-10-15

    Septic peritonitis occurs relatively commonly in dogs. Secondary septic peritonitis is usually associated with perforation of intestines or infected viscera, such as the uterus in pyometra cases. The aim of this study was to evaluate the bacterial flora in the ovarian bursae of intact bitches as a potential source of contamination. One hundred forty dogs, clinically suspected of pyometra, were prospectively enrolled. The control group consisted of 26 dogs that underwent elective ovariohysterectomies and 18 dogs with mammary gland tumors that were neutered at the time of mastectomy. Bacteriology samples were taken aseptically at the time of surgery from the bursae and the uterus in all dogs. Twenty-two dogs that were clinically suspected of pyometra had sterile uterine content ("mucometra" cases); the remaining 118 had positive uterine cultures ("pyometra" cases) and septic peritoneal fluid was present in 10% of these cases. Of the 118 pyometra cases, 9 had unilateral and 15 had bilateral bacterial colonization of their ovarian bursae. However, the bacteria from the ovarian bursa were similar to those recovered from the uterine pus in only half of the cases. Furthermore, positive bursae were also seen in one mucometra dog (unilateral) and in four control dogs (two unilateral and two bilateral). The data illustrate that the canine ovarian bursa can harbor bacteria. The biological importance of these isolations remains unclear.

  5. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

    PubMed

    Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

    2013-01-15

    Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

  6. Bacterial colonization of the ovarian bursa in dogs with clinically suspected pyometra and in controls.

    PubMed

    Rubio, Alejandro; Boyen, Filip; Tas, Olaf; Kitshoff, Adriaan; Polis, Ingeborgh; Van Goethem, Bart; de Rooster, Hilde

    2014-10-15

    Septic peritonitis occurs relatively commonly in dogs. Secondary septic peritonitis is usually associated with perforation of intestines or infected viscera, such as the uterus in pyometra cases. The aim of this study was to evaluate the bacterial flora in the ovarian bursae of intact bitches as a potential source of contamination. One hundred forty dogs, clinically suspected of pyometra, were prospectively enrolled. The control group consisted of 26 dogs that underwent elective ovariohysterectomies and 18 dogs with mammary gland tumors that were neutered at the time of mastectomy. Bacteriology samples were taken aseptically at the time of surgery from the bursae and the uterus in all dogs. Twenty-two dogs that were clinically suspected of pyometra had sterile uterine content ("mucometra" cases); the remaining 118 had positive uterine cultures ("pyometra" cases) and septic peritoneal fluid was present in 10% of these cases. Of the 118 pyometra cases, 9 had unilateral and 15 had bilateral bacterial colonization of their ovarian bursae. However, the bacteria from the ovarian bursa were similar to those recovered from the uterine pus in only half of the cases. Furthermore, positive bursae were also seen in one mucometra dog (unilateral) and in four control dogs (two unilateral and two bilateral). The data illustrate that the canine ovarian bursa can harbor bacteria. The biological importance of these isolations remains unclear. PMID:25127745

  7. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    ERIC Educational Resources Information Center

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  8. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  9. Clinical results of renal artery embolization to control postoperative hemorrhage after partial nephrectomy

    PubMed Central

    Jeon, Chang Ho; Yoon, Chang Jin; Byun, Seok-Soo; Lee, Sang Eun

    2016-01-01

    Background With the wider application of nephron-sparing surgery, there has been an increase in the occurrence of postoperative hemorrhage. However, despite such an increase, there are only a limited number of reports regarding renal artery embolization (RAE) for the management of postoperative bleeding after nephron-sparing surgery, especially after robot-assisted laparoscopic partial nephrectomy (RALPN). Purpose To evaluate the safety and clinical efficacy of transcatheter RAE for postoperative hemorrhage after open partial nephrectomy (OPN) and RALPN. Material and Methods A total of 29 patients (17 men, 12 women; age range, 31–70 years) who were referred to our hospital for postoperative hemorrhage after partial nephrectomy, between December 2003 and December 2014, were selected. We retrospectively reviewed patients’ clinical data, angiographic findings, embolization details, and clinical outcomes. Results Embolization was performed in patients who underwent OPN (25/29) and RALPN (4/29). The angiographic findings were as follows: renal artery pseudoaneurysm (n = 18), contrast extravasation (n = 8), and arteriovenous fistula (n = 3). Fiber-coated microcoil and n-butyl-2-cyanoacrylate (NBCA) was administered to the targeted bleeding renal arteries in 12 and 11 patients, respectively. In six patients, fiber-coated microcoil and NBCA were used concurrently. Technical and clinical successes were achieved in all patients (100%). Bleeding cessation was achieved in all patients, and no further relevant surgeries or interventions were required for hemorrhage control. There were no episodes of hemorrhagic recurrence during the follow-up period (median, 20 days; range, 7–108 days). Conclusion Angiography and RAE identified the origin of bleeding and could successfully preserve the residual renal function. PMID:27570638

  10. Adaptive control of drug dosage regimens: basic foundations, relevant issues, and clinical examples.

    PubMed

    Jelliffe, R W; Maire, P; Sattler, F; Gomis, P; Tahani, B

    1994-06-01

    In this paper we examine several of the fundamental foundations and relevant clinical issues in adaptive control of drug dosage regimens for patients. Truly individualized therapy with drugs having narrow margins of safety first requires a practical pharmacokinetic/dynamic model of the behavior of a drug. Past experience with a drug is stored in the form of a population model. Next, using the information in such a model and its relationship to the incidence of adverse reactions, a specific, explicit therapeutic goal must be selected by the responsible clinician, based on the patient's need for the drug and the risk of adverse reactions felt to be justified by each patient's need, small, moderate, or great. Individualized drug therapy thus begins with the selection of individualized therapeutic goals (low, moderate, or high) for each patient. Using subsequent feedback from the patient's serum drug levels, and using Bayesian fitting, the model is then linked to each patient as a patient-specific model. Control of the model by the dosage regimen increasingly controls the patient, to better obtain the desired explicit therapeutic goals. This process is essentially similar to that of a flight control or missile guidance system.

  11. Clinical efficacy of trivalent oral poliomyelitis vaccine: a case-control study.

    PubMed Central

    Deivanayagam, N.; Nedunchelian, K.; Ahamed, S. S.; Rathnam, S. R.

    1993-01-01

    A case-control study was carried out between May 1988 and May 1989 to assess the effectiveness of three doses of trivalent oral poliomyelitis vaccine (TOPV3) in children aged 6-35 months in Madras city. All the cases were patients with acute paralytic poliomyelitis who were residing in Madras city and were hospitalized in the Institute of Child Health; they represented 95% of such cases in the city. The diagnosis was based on clinical grounds and confirmed by stool culture which was positive in 60%. Age- and sex-matched controls, all residing in the city of Madras, were recruited concurrently from the Institute's outpatient department. There were 78 cases and 315 controls. Vaccine efficacy observed for TOPV3 was 81% (95% CI, 58-91%) for the 6-35-month age group and 86% (95% CI, 67-94%) for the 6-23-month age group. Vaccine efficacy, after controlling for age using the Mantel-Haenszel method, was 83% (95% CI, 67-91%). An unimmunized child was at 5 times greater risk of developing acute paralytic poliomyelitis than a fully immunized child. PMID:8324848

  12. Using historical control information for the design and analysis of clinical trials with overdispersed count data.

    PubMed

    Gsteiger, Sandro; Neuenschwander, Beat; Mercier, Francois; Schmidli, Heinz

    2013-09-20

    Results from clinical trials are never interpreted in isolation. Previous studies in a similar setting provide valuable information for designing a new trial. For the analysis, however, the use of trial-external information is challenging and therefore controversial, although it seems attractive from an ethical or efficiency perspective. Here, we consider the formal use of historical control data on lesion counts in a multiple sclerosis trial. The approach to incorporating historical data is Bayesian, in that historical information is captured in a prior that accounts for between-trial variability and hence leads to discounting of historical data. We extend the meta-analytic-predictive approach, a random-effects meta-analysis of historical data combined with the prediction of the parameter in the new trial, from normal to overdispersed count data of individual-patient or aggregate-trial format. We discuss the prior derivation for the lesion mean count in the control group of the new trial for two populations. For the general population (without baseline enrichment), with 1936 control patients from nine historical trials, between-trial variability was moderate to substantial, leading to a prior effective sample size of about 45 control patients. For the more homogenous population (with enrichment), with 412 control patients from five historical trials, the prior effective sample size was approximately 63 patients. Although these numbers are small relative to the historical data, they are fairly typical in settings where between-trial heterogeneity is moderate. For phase II, reducing the number of control patients by 45 or by 63 may be an attractive option in many multiple sclerosis trials.

  13. Do sleep hygiene measures and progressive muscle relaxation influence sleep bruxism? Report of a randomised controlled trial.

    PubMed

    Valiente López, M; van Selms, M K A; van der Zaag, J; Hamburger, H L; Lobbezoo, F

    2015-04-01

    The aim of this study was to assess the effects of sleep hygiene measures combined with relaxation techniques in the management of sleep bruxism (SB) in a double-blind, parallel, controlled, randomised clinical trial design. Sixteen participants (mean ± s.d. age = 39·9 ± 10·8 years) were randomly assigned to a control group (n = 8) or to the experimental treatment group (n = 8). Participants belonging to the latter group were instructed to perform sleep hygiene measures and progressive muscle relaxation techniques for a 4-week period. Two polysomnographic recordings, including bilateral masseter electromyographic activity, were made: one prior to the treatment and the other after the treatment period. The number of bruxism episodes per hour, the number of burst per hour and the bruxism time index (i.e. the percentage of total sleep time spent bruxing) were established as outcome variables. No significant differences could be observed between the outcome measures obtained before and after the 4-week period, neither for the sleep bruxism variables nor for the sleep variables. Within the limitations of this study, it was concluded that there is no effect of sleep hygiene measures together with progressive relaxation techniques on sleep bruxism or sleep over a 4-week observation period.

  14. [Hospital infection control in 21st century, the importance of networking with each division and clinical laboratory in the hospital. 1. From the aspect of clinical laboratory division].

    PubMed

    Mitsuda, T

    2001-08-01

    Clinical laboratory division plays an important roll for the management of nosocomial infection. Staff from clinical laboratory division including technologist and/or medical doctor can work as a part of infection control team. Since the bacterial surveillance data from clinically isolated strains accumulates in the clinical laboratory division, these staff have a chance to notice outbreak in hospital at first time. While handling information from each strain, we need to feedback these data with additional information for physicians. From June, 2000, a national project started. That was a surveillance program for drag-resistant bacteria. We can compare information from local isolates and nation-wide isolates by this project. Genotypic methods especially pulsed-field gel electrophoresis(PFGE) is suitable for the identification of infection route in the hospital environment. And PFGE analysis for pathogenic strains works effective in our hospital.

  15. Clinical significance of determining plasma homocysteine: case-control study on arterial and venous thrombotic patients

    PubMed Central

    Vučković, Biljana A.; Čabarkapa, Velibor S.; Ilić, Tatjana A.; Salatić, Iva R.; Lozanov-Crvenković, Zagorka S.; Mitić, Gorana P.

    2013-01-01

    Aim To determine the differences in plasma homocysteine levels between three MTHFR 677 genotype subgroups in patients with thrombosis and in controls, as well as between patients with thrombosis and controls with the same MTHFR 677 genotype. Methods This case-control study was conducted in Clinical Center of Vojvodina, Novi Sad, from June to December 2011. We included 65 patients with either arterial or venous thrombosis (mean age, 40.97 ± 11.38 years) and 65 controls with no history or clinical evidence of any thrombotic event (mean age, 41.23 ± 11.12 years). Patients and controls were age- and sex-matched. Results In comparison with controls, thrombotic patients had significantly higher homocysteine levels (12.81 ± 4.94 µmol/L vs 9.82 ± 3.68 µmol/L; P < 0.001) and significantly higher incidence of hyperhomocysteinemia (55% vs 22%; P < 0.001; odds ratio [OR] = 4.521). There were no significant differences in homocysteine levels between homozygous carriers, heterozygous carriers, and non-carriers of the MTHFR 677 mutation in either thrombotic patients (12.97 ± 5.40 µmol/L vs 12.55 ± 5.71 µmol/L vs 13.27 ± 1.71 µmol/L; P = 0.100) or controls (10.07 ± 2.50 µmol/L vs 10.25 ± 4.84 µmol/L vs 9.20 ± 2.44 µmol/L; P = 0.651). However, in comparison with controls, homozygous carriers in thrombotic patient group did not have significantly higher levels of homocysteine (12.97 ± 5.40 µmol/L vs 10.07 ± 2.50 µmol/L; P = 0.072), but heterozygous carriers (12.55 ± 5.71 µmol/L vs 10.25 ± 4.84 µmol/L; P = 0.020) and non-carriers (13.27 ± 1.71 µmol/L vs 9.20 ± 2.44 µmol/L; P < 0.001) did. There was no significant difference in homocysteine levels between patients with arterial and venous thrombosis (12.76 ± 3.60 µmol/L vs 12.86 ± 5.51 µmol/L; P = 0.990) and between patients with one thrombotic event and those with recurrent thrombotic events

  16. Metabolic Correction in the Management of Diabetic Peripheral Neuropathy: Improving Clinical Results Beyond Symptom Control

    PubMed Central

    Miranda-Massari, Jorge R.; Gonzalez, Michael J.; Jimenez, Francisco J.; Allende-Vigo, Myriam Z.; Duconge, Jorge

    2013-01-01

    Current Clinical Management Guidelines of Diabetic Peripheral Neuropathy (DPN) are based on adequate glucose control and symptomatic pain relief. However, meticulous glycemic control could delay the onset or slow the progression of diabetic neuropathy in patients with DM type 2, but it does not completely prevent the progression of the disease. Complications of DPN as it continues its natural course, produce increasing pain and discomfort, loss of sensation, ulcers, infections, amputations and even death. In addition to the increased suffering, disability and loss of productivity, there is a very significant economic impact related to the treatment of DPN and its complications. In USA alone, it has been estimated that there are more than 5,000,000 patients suffering from DPN and the total annual cost of treating the disease and its complications is over $10,000 million dollars. In order to be able to reduce complications of DPN, it is crucial to improve or correct the metabolic conditions that lead to the pathology present in this condition. Pathophysiologic mechanisms implicated in diabetic neuropathy include: increased polyol pathway with accumulation of sorbitol and reduced Na+/K+-ATPase activity, microvascular damage and hypoxia due to nitric oxide deficit and increased oxygen free radical activity. Moreover, there is a decrease in glutathione and increase in homocysteine. Clinical trials in the last two decades have demonstrated that the use of specific nutrients can correct some of these metabolic derangements, improving symptom control and providing further benefits such as improved sensorium, blood flow and nerve regeneration. We will discuss the evidence on lipoic acid, acetyi-L-carnitine, benfotiamine and the combination of active B vitamins L-methylfolate, methylcobalamin and piridoxal-6-phosphate. In addition, we discuss the role of metforrnin, an important drug in the management of diabetes, and the presence of specific polymorphic genes, in the risk

  17. A twelve-week clinical comparison of two tartar control dentifrices.

    PubMed

    Sowinski, J; Battista, G; Petrone, D M; Petrone, M E; DeVizio, W; Volpe, A R; Proskin, H M

    2000-01-01

    The objective of this double-blind clinical study, conducted using the Volpe-Manhold evaluation method for dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after twelve weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol, and completed the entire study. At the twelve-week examination, the Test Dentifrice group exhibited a statistically significant 43.5% reduction in mean Volpe-Manhold Calculus Index scores compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice, containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base, is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base.

  18. Impaired fetal thymic growth precedes clinical preeclampsia: a case-control study.

    PubMed

    Eviston, David P; Quinton, Ann E; Benzie, Ron J; Peek, Michael J; Martin, Andrew; Nanan, Ralph K

    2012-06-01

    In preeclampsia the maternal adaptive immune system undergoes specific changes, which are different from the physiological processes associated with healthy pregnancy. Whether preeclampsia also affects the fetal immune system is difficult to investigate, due to limited access to the fetus. We hypothesized that if preeclampsia affects the fetal adaptive immune system this might be associated with early changes in thymic growth. In this case-control study, 53 preeclamptic and 120 healthy control pregnancies were matched for maternal age, gestational age and smoking. Fetal thymus diameter was measured as the greatest width perpendicular to a line connecting sternum and spine based on ultrasound images taken at 17-21 weeks gestation. Independent of fetal and maternal anthropometric measures, thymuses were found to be smaller in preeclamptic pregnancies than healthy controls (16.2 mm versus 18.3 mm, respectively, mean difference=2.1 mm, 95% CI: 0.8-3.3, p<0.001), and the odds of developing preeclampsia was estimated to be 0.72 (95% CI: 0.60-0.86, p<0.001) lower for each 1 mm increase in thymus diameter. There was no correlation between the onset of preeclampsia and fetal thymus size. This is the first study to suggest that fetal thymus growth is reduced before the clinical onset of preeclampsia and precedes any described fetal anomalies or maternal immunological changes associated with preeclampsia. We propose that the fetal adaptive immune system is either passively affected by maternal processes preceding clinical preeclampsia or is actively involved in initiating preeclampsia in later pregnancy.

  19. The Reduction of Distress Using Therapeutic Geothermal Water Procedures in a Randomized Controlled Clinical Trial

    PubMed Central

    Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

    2015-01-01

    Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis. Results. A significant positive effect on distress (P < 0.001) was established after 2 weeks of treatment: the number of stress symptoms declined by 60%, while the intensity of stress symptoms reduced by 41%, and the control improved by 32%. Health risks caused by distress were reduced, and resources increased, whereas the probability of general health risk decreased by 18% (P = 0.01). Conclusion. Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine. PMID:25866680

  20. Neuroimaging in clinical studies of craving: importance of reward and control networks.

    PubMed

    Thayer, Rachel E; Hutchison, Kent E

    2013-06-01

    Research on neurobiological mechanisms, especially the function of networks that underlie reward and cognitive control, may offer an opportunity to explore how existing treatments work and provide means for developing new treatments for substance use disorders. In this respect, the special issue of Psychology of Addictive Behaviors highlights efforts to integrate translational neuroimaging with clinical research by actively linking neuroimaging measures with psychosocial treatment mechanisms. Based on several of the articles in this special issue, mindfulness-based approaches appear poised to make rapid progress in terms of integrating neuroimaging with research on mechanisms that mediate treatment success. This commentary briefly discusses research on incentive salience and cognitive control networks in the context of addiction, followed by a discussion of specific studies within this special issue that address the integration of neuroimaging assessments in the context of mindfulness approaches. Future work may be able to leverage measures of changes in networks and regions that underlie reward processing and cognitive control to better understand how treatments work, especially for mindfulness-based approaches. PMID:23815450

  1. [An outpatient clinic measure and control system for anticoagulation levels, CoaguChek XS].

    PubMed

    Romero Guardeño, Araceli; Pérez Lucena, Dolores Amalia

    2009-03-01

    A significant increase during recent years in the number of patients who need Oral Anticoagulant Treatment has meant a greater role for nurses, especially in Primary Health Care Centers, since nurses, along with doctors, are the professionals responsible for treating those patients. This control is carried out by measuring the levels of anticoagulants in the blood, regulating the anticoagulant medicine doses, and providing patients with the essential health education so patients participate in the treatment of their illness. To a large degree, the preponderance of Primary Health Care Centers in the aforementioned control has developed hand-in-hand with the availability of portable, simple and low cost coagulation measuring systems which permit a direct reading of a patient's anticoagulation level with one drop of capillary blood. The objective of this article is introduce the reader to a measuring system appropriate for outpatient clinic control of anticoagulant levels in blood by mans of the CoaguChek XS System, which is described. The authors specify the sample extraction procedure, how to measure coagulant levels, and recommendations to keep in mind while carrying out this procedure. The authors sketch the importance of health education and finally, they describe some advantages and inconveniences this system has.

  2. The reduction of distress using therapeutic geothermal water procedures in a randomized controlled clinical trial.

    PubMed

    Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

    2015-01-01

    Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis. Results. A significant positive effect on distress (P < 0.001) was established after 2 weeks of treatment: the number of stress symptoms declined by 60%, while the intensity of stress symptoms reduced by 41%, and the control improved by 32%. Health risks caused by distress were reduced, and resources increased, whereas the probability of general health risk decreased by 18% (P = 0.01). Conclusion. Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine.

  3. [Rethinking clinical research in surgical oncology. From comic opera to quality control].

    PubMed

    Evrard, Serge

    2016-01-01

    The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation.

  4. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

    PubMed

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

    2016-01-01

    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

  5. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    PubMed Central

    Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu

    2011-01-01

    A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50). Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe. PMID:20953383

  6. Traditional endodontic surgery versus modern technique: a 5-year controlled clinical trial.

    PubMed

    Tortorici, Silvia; Difalco, Paolo; Caradonna, Luigi; Tetè, Stefano

    2014-05-01

    In this study, we compared outcomes of traditional apicoectomy versus modern apicoectomy, by means of a controlled clinical trial with a 5-year follow-up. The study investigated 938 teeth in 843 patients. On the basis of the procedure performed, the teeth were grouped in 3 groups. Differences between the groups were the method of osteotomy (type of instruments used), type of preparation of retrograde cavity (different apicoectomy angles and instruments used for root-end preparation), and root-end filling material used (gray mineral trioxide aggregate or silver amalgam). Outcome (tooth healing) was estimated after 1 and 5 years, postoperatively. Clinical success rates after 1 year were 67% (306 teeth), 90% (186 teeth), and 94% (256 teeth) according to traditional apicoectomy (group 1), modern microsurgical apicoectomy using burns for osteotomy (group 2) or using piezo-osteotomy (group 3), respectively. After 1 year, group comparison results were statistically significant (P < 0.0001). Linear trend test was also statistically significant (P < 0.0001), pointing out larger healing from group 1 to group 3. After 5 years, teeth were classified into 2 groups on the basis of root-end filling material used. Clinical success was 90.8% (197 teeth) in the silver amalgam group versus 96% (309 teeth) in the mineral trioxide aggregate group (P < 0.00214). Multiple logistic regression analysis found that surgical technique was independently associated to tooth healing. In conclusion, modern apicoectomy resulted in a probability of success more than 5 times higher (odds ratio, 5.20 [95% confidence interval, 3.94-6.92]; P < 0.001) compared with the traditional technique. PMID:24469371

  7. Nonsurgical treatment of moderate and advanced periimplantitis lesions: a controlled clinical study.

    PubMed

    Schwarz, Frank; Bieling, Katrin; Bonsmann, Martin; Latz, Thilo; Becker, Jürgen

    2006-12-01

    The aim of this controlled, parallel design clinical study was to evaluate the effectiveness of an Er:YAG (erbium-doped:yttrium, aluminum, and garnet) laser for nonsurgical treatment of periimplantitis lesions. Twenty patients, each of whom displayed at least one implant with (a) moderate and (b) advanced periimplantitis (n=40 implants; IMZ, ITI, Spline Twist, ZL-Duraplant, Camlog), were randomly instrumented nonsurgically using either (1) an Er:YAG laser (100 mJ/pulse, 10 Hz) device (LAS) or (2) mechanical debridement using plastic curettes and antiseptic therapy with chlorhexidine digluconate (0.2%) (C). The following clinical parameters were measured at baseline, 3, 6, and 12 months after treatment: plaque index, bleeding on probing (BOP), probing depth, gingival recession, and clinical attachment level (CAL). Mean BOP improved significantly in both groups at 3, 6, and 12 months (a- lesions: P<0.001 and b- lesions: P<0.01, respectively). After 3 and 6 months, the mean reduction of BOP was significantly higher in the LAS group when compared to the C group (a- and b- lesions: P<0.01 and P<0.05, respectively). At 3 and 6 months, both groups revealed significant CAL gains at a- and b- lesions (P<0.01, respectively). In both groups, however, the mean CAL at a- and b- lesions was not significantly different from the respective baseline values at 12 months (P>0.05, respectively). Although treatment of periimplantitis lesions with LAS resulted in a significantly higher BOP reduction than C, its effectiveness seemed to be limited to a period of 6 months, particularly at b- lesions.

  8. Blood pressure control in treated hypertensive patients: clinical performance of general practitioners.

    PubMed Central

    Frijling, B D; Spies, T H; Lobo, C M; Hulscher, M E; van Drenth, B B; Braspenning, J C; Prins, A; van der Wouden, J C; Grol, R P

    2001-01-01

    BACKGROUND: The blood pressure of many treated hypertensive patients remains above recommended target levels. This discrepancy may be related to general practitioners' (GPs') actions. AIM: To assess clinical performance of GPs in blood pressure control in treated hypertensive patients and to explore the influence of patient and GP characteristics on clinical performance. DESIGN OF STUDY: Cross-sectional study conducted on 195 GPs with invitations to participate made via bulletins and by letter. SETTING: One hundred and thirty-two practices in the southern half of The Netherlands from November 1996 to April 1997. METHOD: Performance criteria were selected from Dutch national hypertension guidelines for general practice. GPs completed self-report forms immediately after follow-up visits of hypertensive patients treated with antihypertensive medication. RESULTS: The GPs recorded 3526 follow-up visits. In 63% of these consultations the diastolic blood pressure (DBP) was 90 mmHg or above. The median performance rates of the GPs were less than 51% for most of the recommended actions, even at a DBP of > or = 100 mmHg. Performance of non-pharmacological actions increased gradually with increasing DBP; prescribing an increase in antihypertensive medication and making a follow-up appointment scheduled within six weeks rose steeply at a DBP of > or = 100 mmHg. Patient and GP characteristics contributed little to clinical performance. Action performance rates varied considerably between GPs. CONCLUSION: GPs seem to target their actions at a DBP of below 100 mmHg, whereas guidelines recommend targeting at a DBP of below 90 mmHg. PMID:11271892

  9. An audit of blood pressure control in clinical practice in Thailand.

    PubMed

    Buranakitjaroen, Peera

    2006-11-01

    To gain "real life" data on the BP control of hypertensive patients in clinical practice in Thailand, a multi-centre cross-sectional study was carried out. Demographic data, cardiovascular risk factors, and antihypertensive regimens were collected. A total of 1,259 patients were enrolled between October 2003 and December 2003, 924 cases from 6 regions of different levels of health care and 335 cases from 4 medical training centres and a tertiary care hospital in Bangkok. Eighty one percent of the patients, age ranged from 45 to 75 years (61.2 +/- 11.6). Forty four percent of patients in audit had a BP < 140/90 mm Hg and only 12.3% of DM patients had attained a JNC 7 recommended BP target of 130/80 mm Hg. Hypercholesterolaemia (65.3%) was the most prevalent risk followed by DM (27. 7%). Antihypertensive drug used at the initial visit compared with the last visit were ARB (0.9% vs 6.1%), ACE Inhibitors (30.1% vs 40.0%), beta-blockers (27.3% vs 46. 7%), CCBs (23.2% vs 37.7%), and diuretics (46.0% vs 53.5%). In addition, the numbers of antihypertensive drugs used at the initial visit compared with the last clinic visit were one drug (62.0% vs 33.0%), two drugs (29.7% vs 45.8%), three drugs or more (3.7% vs 20.4%), with an average of 1.3 +/- 0.6 vs 1.9 +/- 0.8 drugs per patient. Two thirds of patients (66.2%) were on 2 or more antihypertensive drugs. Among the type 2 DM, 5% had records of microalbuminuria, and 50.6% and 9.8% were receiving ACE Inhibitors and ARBs, respectively at the last clinic visit. PMID:17718243

  10. Temperature-controlled laser-soldering system and its clinical application for bonding skin incisions.

    PubMed

    Simhon, David; Gabay, Ilan; Shpolyansky, Gregory; Vasilyev, Tamar; Nur, Israel; Meidler, Roberto; Hatoum, Ossama Abu; Katzir, Abraham; Hashmonai, Moshe; Kopelman, Doron

    2015-01-01

    Laser tissue soldering is a method of repairing incisions. It involves the application of a biological solder to the approximated edges of the incision and heating it with a laser beam. A pilot clinical study was carried out on 10 patients who underwent laparoscopic cholecystectomy. Of the four abdominal incisions in each patient, two were sutured and two were laser soldered. Cicatrization, esthetical appearance, degree of pain, and pruritus in the incisions were examined on postoperative days 1, 7, and 30. The soldered wounds were watertight and healed well, with no discharge from these wounds or infection. The total closure time was equal in both methods, but the net soldering time was much shorter than suturing. There was no difference between the two types of wound closure with respect to the pain and pruritus on a follow-up of one month. Esthetically, the soldered incisions were estimated as good as the sutured ones. The present study confirmed that temperature-controlled laser soldering of human skin incisions is clinically feasible, and the results obtained were at least equivalent to those of standard suturing. PMID:26720882

  11. Temperature-controlled laser-soldering system and its clinical application for bonding skin incisions

    NASA Astrophysics Data System (ADS)

    Simhon, David; Gabay, Ilan; Shpolyansky, Gregory; Vasilyev, Tamar; Nur, Israel; Meidler, Roberto; Hatoum, Ossama Abu; Katzir, Abraham; Hashmonai, Moshe; Kopelman, Doron

    2015-12-01

    Laser tissue soldering is a method of repairing incisions. It involves the application of a biological solder to the approximated edges of the incision and heating it with a laser beam. A pilot clinical study was carried out on 10 patients who underwent laparoscopic cholecystectomy. Of the four abdominal incisions in each patient, two were sutured and two were laser soldered. Cicatrization, esthetical appearance, degree of pain, and pruritus in the incisions were examined on postoperative days 1, 7, and 30. The soldered wounds were watertight and healed well, with no discharge from these wounds or infection. The total closure time was equal in both methods, but the net soldering time was much shorter than suturing. There was no difference between the two types of wound closure with respect to the pain and pruritus on a follow-up of one month. Esthetically, the soldered incisions were estimated as good as the sutured ones. The present study confirmed that temperature-controlled laser soldering of human skin incisions is clinically feasible, and the results obtained were at least equivalent to those of standard suturing.

  12. Endoscopic shuffling, infection control, and the clinical practice of push enteroscopy.

    PubMed

    Muscarella, Lawrence F

    2007-01-01

    Failure to identify and diagnose the site and cause of obscure bleeding or some other gastrointestinal disorder may be an indication for push enteroscopy. During this procedure, a long, narrow, flexible gastrointestinal endoscope, known as a push enteroscope, is advanced into the upper gastrointestinal tract to examine and evaluate the proximal section (first one third) of the small bowel. Because of limited funding and inadequate instrument availability, some gastrointestinal endoscopy units may perform this procedure using a colonoscope instead of a push enteroscope. Although not specifically designed for push enteroscopy, colonoscopes are less expensive than push enteroscopes and readily available for clinical use in virtually every gastrointestinal endoscopy unit. The use of a colonoscope or other lower gastrointestinal endoscope to perform push enteroscopy or another upper gastrointestinal procedure (or the use of an upper gastrointestinal endoscope to perform a lower gastrointestinal procedure) is defined in this article as endoscopic shuffling. Although it is arguably efficient and cost effective (and in some instances may improve clinical outcomes), endoscopic shuffling raises a number of economic, legal, medical, and ethical questions and concerns, several of which are discussed in this article, with a particular focus on infection control. PMID:17440313

  13. Control of ACTH secretion by excitatory amino acids: functional significance and clinical implications.

    PubMed

    Jezova, Daniela

    2005-12-01

    The involvement of excitatory amino acids in the control of ACTH release is well established. Activation of ionotropic glutamate receptors has a stimulatory effect on ACTH release, while the role of metabotropic receptors is not yet understood in detail. Glutamatergic regulation of ACTH release has a clear significance for the stress response and neuroendocrine functions during development. A dysregulation of the hypothalamic-pituitary-adrenocortical (HPA) axis has been reported in several psychiatric and neurological disorders. So far, only fractional indices on the clinical importance of the interaction between glutamate and ACTH secretion have been obtained in both preclinical and clinical studies. Some antidepressant drugs, such as tianeptine, which were found to modulate ACTH release, appear to interfere with brain glutamatergic system. Changes in ACTH and cortisol release may be of importance for mood stabilizing effects of antiepileptic drugs modulating glutamate release, such as lamotrigine. Brain glutamate and HPA axis interaction seems to be of importance in alcohol and drug abuse. Little information is available on ACTH release in response to glutamate-modulating drugs used in the treatment of schizophrenia and Alzheimer disease. Nevertheless, pharmacological interventions influencing interaction between glutamate and the HPA axis are promising treatment possibilities in psychiatry and neurology.

  14. An empirical evaluation of devolving administrative control to Costa Rican hospital and clinic directors.

    PubMed

    Lee, Theodore; McKee, Douglas

    2015-01-01

    In the early 2000s, Costa Rica implemented comprehensive reforms of its health care system, including devolving administrative power from the central government to some providers that remain part of the national system. In this article, we evaluate how this aspect of the reform affected clinic efficiency and population health by analyzing administrative data on regional providers and mortality rates in local areas. We compare changes in outcomes across time between areas that signed performance contracts with the central government and received limited budgetary control to those that continued to be managed directly by the central government. We believe the reform created opportunities for providers to become more efficient and effective. Our results suggest that the reform significantly decreased costs without adversely affecting quality of care or population health.

  15. Chemotherapy of onchocerciasis: a controlled clinical trial of topical diethylcarbamazine (DEC) in Guatemala.

    PubMed

    Taylor, H R; Langham, M E; de Stahl, E M; Figueroa, L N; Beltranena, F

    1980-09-01

    A double-masked, controlled clinical trial was conducted in Guatemala to assess the safety and efficacy of diethylcarbamazine (DEC) lotion as compared to placebo lotion in the treatment of onchocerciasis. One hundred eighty-seven people were enrolled in this study and were followed for two months. Lotion was applied daily for seven days, then weekly for seven weeks. The decrease in mean microfilarial counts per skin snip was significantly greater in those receiving DEC lotion than for those receiving placebo lotion. The proportionate reduction in microfilarial counts was similar for people with light, moderate, or heavy microfilarial loads. Side effects were mainly related to skin changes, fever, and malaise, and occurred in nearly one-third of the people receiving DEC lotion. These reactions occurred almost as commonly in those people who were lightly infected as in those who had moderate or heavy infections.

  16. The case for randomized controlled trials to assess the impact of clinical information systems

    PubMed Central

    Wyatt, Jeremy C

    2011-01-01

    There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

  17. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

    PubMed Central

    Wiljer, David; Cafazzo, Joseph A

    2016-01-01

    Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study

  18. An empirical evaluation of devolving administrative control to Costa Rican hospital and clinic directors.

    PubMed

    Lee, Theodore; McKee, Douglas

    2015-01-01

    In the early 2000s, Costa Rica implemented comprehensive reforms of its health care system, including devolving administrative power from the central government to some providers that remain part of the national system. In this article, we evaluate how this aspect of the reform affected clinic efficiency and population health by analyzing administrative data on regional providers and mortality rates in local areas. We compare changes in outcomes across time between areas that signed performance contracts with the central government and received limited budgetary control to those that continued to be managed directly by the central government. We believe the reform created opportunities for providers to become more efficient and effective. Our results suggest that the reform significantly decreased costs without adversely affecting quality of care or population health. PMID:25813506

  19. People v. Stockton Pregnancy Control Medical Clinic, Inc., 28 July 1988.

    PubMed

    1988-01-01

    The defendants, a pregnancy control clinic and physicians, appealed a decision enjoining them from violating a California statute that required them to report as child abuse instances where minors under the age of 14 were diagnosed as being pregnant, as having a sexually transmitted disease, or as suffering from the complications of an abortion. The Court reversed part of the lower court decision and held that the defendants did not have to report voluntary sexual contact where the parties are of similar age. However, it also ruled that where the parties were of disparate age, such a reporting requirement did not violate the constitutional right to privacy of minors and served the compelling state interest of preventing child abuse. PMID:12289577

  20. Nutraceuticals and Blood Pressure Control: Results from Clinical Trials and Meta-Analyses.

    PubMed

    Cicero, Arrigo F G; Colletti, Alessandro

    2015-09-01

    Beyond the well-known effects on blood pressure (BP) of the dietary approaches to stop hypertension (DASH) and the Mediterranean diets, a large number of studies has investigated the possible BP lowering effect of different dietary supplements and nutraceuticals, the most part of them being antioxidant agents with a high tolerability and safety profile. In particular relatively large body of evidence support the use of potassium, L-arginine, vitamin C, cocoa flavonoids, beetroot juice, coenzyme Q10, controlled-release melatonin, and aged garlic extract. However there is a need for data about the long-term safety of a large part of the above discussed products. Moreover further clinical research is advisable to identify between the available active nutraceuticals those with the best cost-effectiveness and risk-benefit ratio for a large use in general population with low-added cardiovascular risk related to uncomplicated hypertension. PMID:25788027

  1. Risk factors and clinical features of ovarian pregnancy: a case–control study

    PubMed Central

    Zhu, Qian; Li, Cheng; Zhao, Wei-Hong; Yuan, Jiang-Jing; Yan, Ming-Xing; Qin, Guo-Juan; Zhang, Jian

    2014-01-01

    Objective To identify risk factors for ovarian pregnancy (OP) and compare clinical features between OP and tubal pregnancy (TP) patients. Design Case–control study. Setting University hospital. Participants A case–control study was conducted from January 2005 to May 2014. Women diagnosed with OP were recruited as the case group (n=71), 145 women with TP and 146 with intrauterine pregnancy (IUP) were matched as controls at a ratio of 1:2:2. Women who refused interviews or provided incomplete information were excluded. Results OP risk was lower than TP risk in women with serological evidence of Chlamydia trachomatis infection (adjusted OR1 0.17, 95% CI 0.06 to 0.52), previous adnexal surgery (adjusted OR1 0.25, 95% CI 0.07 to 0.95), and current levonorgestrel emergency contraceptive use (adjusted OR1 0.24, 95% CI 0.07 to 0.78). In vitro fertilisation-embryo transfer (IVF-ET) carried a higher risk of OP (adjusted OR1 12.18, 95% CI 2.23 to 66.58) than natural conception. When Controlled by IUP women, current users of intrauterine devices (IUDs) carried a higher risk of OP than non-users of any contraceptives (adjusted OR2 9.60, 95% CI 1.76 to 42.20). β-Human chorionic gonadotropin (hCG) levels on the day of surgery were higher in OP patients than in TP patients (p<0.01). Women with OP were less likely to initially present with vaginal bleeding than those with TP (p=0.02). Moreover, shock (p=0.02), rupture (p<0.01), haemoperitoneum (p<0.01) and emergency laparotomy (p<0.01) were more common in the OP group than in the TP group. Conclusions IVF-ET and IUD use may be risk factors for OP, and OP patients tend to have high β-hCG levels and a poor clinical outcome (shock, rupture, haemoperitoneum and need for emergency laparotomy). Our findings may contribute to the prevention and early diagnosis of OP. PMID:25472658

  2. Promising New Wart Treatment: A Randomized, Placebo-Controlled, Clinical Trial

    PubMed Central

    Zandi, Shokrollah; Ahmad Zadeh, Razyeh; Yousefi, Sayedeh Reyhaneh; Gharibi, Fardin

    2016-01-01

    Background Warts are common dermatological lesion caused by skin epithelial cells’ infection with human Papillomavirus (HPV). Objectives This study aimed to assess the efficacy of a new method for the treatment of dermal warts. Patients and Methods In this clinical trial study, 60 patients (older than 10 years) with dermal warts living in Baneh city, west of Iran, were allocated into the intervention and control groups using the block randomized method in 2012. In the intervention group, outer layers of the dermal wart carved using scalpel and HD tablet set on it and covered with adhesive. In the second and third days, it was repeated again. All stages in the intervention group were similar to the placebo group. Placebo was prepared by a pharmacologist, which was similar to the HD tablet. In both groups, patients were examined one week and one month after taking the last tablet by the physician in terms of improvement or lack of improvement. Data were analyzed by SPSS software version 18 using chi-square test, Fisher’s exact test, Mann-Whitney test and ANOVA for repeated measures. Results In the first week after the intervention, warts were changed in 93.3% of the cases; however, no changes were recorded in the control group. One month after follow-up, the mean was 0.4 ± 0.7 in the intervention group and 5.5 ± 4.9 in the control group (P = 0.0001). Based on ANOVA for repeated measures and t-test, the average number of warts, before, one week and one month after the intervention was statistically significant for both intervention (P = 0.009) and control groups (P = 0.0001). Conclusions This method is recommended for the treatment of dermal warts, owing to the effectiveness, short duration of treatment, and low cost of topical treatment for dermal warts using HD tablets. PMID:27761268

  3. A new framework for interpreting the outcomes of imperfectly blinded controlled clinical trials.

    PubMed

    Arandjelović, Ognjen

    2012-01-01

    It is well known that the outcome of an intervention is affected both by the inherent effects of the intervention and the patient's expectations. For this reason in comparative clinical trials an effort is made to conceal the nature of the administered intervention from the participants in the trial i.e. to blind the trial. Yet, in practice perfect blinding is impossible to ensure or even verify post hoc. The current clinical standard is to follow up the trial with an auxiliary questionnaire, which allows trial participants to express in closed form their belief concerning the intervention, i.e. trial group assignment (treatment or control). Auxiliary questionnaire responses are then used to compute the extent of blinding in the trial in the form of a blinding index. If the estimated extent of blinding exceeds a particular threshold the trial is deemed sufficiently blinded; otherwise, the strength of evidence of the trial is brought into question. This may necessitate that the trial is repeated. In this paper we make several contributions. Firstly, we identify a series of problems of the aforesaid clinical practice and discuss them in context of the most commonly used blinding indexes. Secondly, we formulate a novel approach for handling imperfectly blinded trials. We adopt a feedback questionnaire of the same form as that which is currently in use, but interpret the collected data using a novel statistical method, significantly different from that proposed in the previous work. Unlike the previously proposed approaches, our method is void of any ad hoc free parameters and robust to small changes in the participants' feedback responses. Our method also does not discard any data and is not predicated on any strong assumptions used to interpret participants' feedback. The key idea behind the present method is that it is meaningful to compare only the corresponding treatment and control participant sub-groups, that is, sub-groups matched by their auxiliary responses

  4. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

    PubMed

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-03-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

  5. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

    PubMed Central

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-01-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

  6. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

    PubMed

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-03-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

  7. Virtual Reality for Enhanced Ecological Validity and Experimental Control in the Clinical, Affective and Social Neurosciences.

    PubMed

    Parsons, Thomas D

    2015-01-01

    An essential tension can be found between researchers interested in ecological validity and those concerned with maintaining experimental control. Research in the human neurosciences often involves the use of simple and static stimuli lacking many of the potentially important aspects of real world activities and interactions. While this research is valuable, there is a growing interest in the human neurosciences to use cues about target states in the real world via multimodal scenarios that involve visual, semantic, and prosodic information. These scenarios should include dynamic stimuli presented concurrently or serially in a manner that allows researchers to assess the integrative processes carried out by perceivers over time. Furthermore, there is growing interest in contextually embedded stimuli that can constrain participant interpretations of cues about a target's internal states. Virtual reality environments proffer assessment paradigms that combine the experimental control of laboratory measures with emotionally engaging background narratives to enhance affective experience and social interactions. The present review highlights the potential of virtual reality environments for enhanced ecological validity in the clinical, affective, and social neurosciences.

  8. Clinical consultations in an aboriginal community-controlled health service: a comparison with general practice.

    PubMed

    Thomas, D P; Heller, R F; Hunt, J M

    1998-02-01

    Clinical consultation at Danila Dilba, an Aboriginal community-controlled health service in Darwin, were compared with consultations in Australian general practice. We described 583 consultations, using a questionnaire based on the International Classification of Primary Care. The methods were similar to those of the Australian Morbidity and Treatment Survey (AMTS) of consultations in Australian general practice undertaken by the University of Sydney Family Medicine Research Unit. Compared with Australian general practice consultations, consultations with Danila Dilba were more complex: more young patients, more new patients, more home visits, more problems managed, more new problems and more consultations leading to emergency hospital admission. Skin infections, diabetes mellitus, chronic alcohol abuse, rheumatic heart disease (or rheumatic fever) and chronic suppurative otitis media were much more commonly managed at study consultations at Danila Dilba than at consultations with general practitioners in the AMTS. Nearly all patients saw an Aboriginal health worker first, and nearly half the consultations were with Aboriginal health workers alone. The results suggest possible limitations of fee-for-item Medicare funding of Aboriginal community-controlled health services compared with existing block grant funding. PMID:9599858

  9. Virtual Reality for Enhanced Ecological Validity and Experimental Control in the Clinical, Affective and Social Neurosciences

    PubMed Central

    Parsons, Thomas D.

    2015-01-01

    An essential tension can be found between researchers interested in ecological validity and those concerned with maintaining experimental control. Research in the human neurosciences often involves the use of simple and static stimuli lacking many of the potentially important aspects of real world activities and interactions. While this research is valuable, there is a growing interest in the human neurosciences to use cues about target states in the real world via multimodal scenarios that involve visual, semantic, and prosodic information. These scenarios should include dynamic stimuli presented concurrently or serially in a manner that allows researchers to assess the integrative processes carried out by perceivers over time. Furthermore, there is growing interest in contextually embedded stimuli that can constrain participant interpretations of cues about a target’s internal states. Virtual reality environments proffer assessment paradigms that combine the experimental control of laboratory measures with emotionally engaging background narratives to enhance affective experience and social interactions. The present review highlights the potential of virtual reality environments for enhanced ecological validity in the clinical, affective, and social neurosciences. PMID:26696869

  10. Alpha lipoic acid efficacy in burning mouth syndrome. A controlled clinical trial

    PubMed Central

    Palacios-Sánchez, Begoña; Cerero-Lapiedra, Rocío; Llamas-Martínez, Silvia; Esparza-Gómez, Germán

    2015-01-01

    Background A double-blind placebo-controlled trial was conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease. Material and Methods 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with follow up of 2 months. Results 64% of ALA patients reported some level of improvement, with a level of maintenance of 68.75% one month after treatment. 27.6% of the placebo group also demonstrated some reduction in BMS symptoms. Conclusions Long-term evolution and the intensity of symptoms are variables that reduce the probability of improvement with ALA treatment. Key words: Burning mouth syndrome, neuropathy, alpha lipoic acid. PMID:26034927

  11. Clinical study of yoga techniques in university students with asthma: a controlled study.

    PubMed

    Vedanthan, P K; Kesavalu, L N; Murthy, K C; Duvall, K; Hall, M J; Baker, S; Nagarathna, S

    1998-01-01

    Adult asthmatics, ranging from 19 to 52 years from an asthma and allergy clinic in a university setting volunteered to participate in the study. The 17 students were randomly divided into yoga (9 subjects) and nonyoga control (8 subjects) groups. The yoga group was taught a set of breathing and relaxation techniques including breath slowing exercises (pranayama), physical postures (yogasanas), and meditation. Yoga techniques were taught at the university health center, three times a week for 16 weeks. All the subjects in both groups maintained daily symptom and medication diaries, collected A.M. and P.M. peak flow readings, and completed weekly questionnaires. Spirometry was performed on each subject every week. Analysis of the data showed that the subjects in the yoga group reported a significant degree of relaxation, positive attitude, and better yoga exercise tolerance. There was also a tendency toward lesser usage of beta adrenergic inhalers. The pulmonary functions did not vary significantly between yoga and control groups. Yoga techniques seem beneficial as an adjunct to the medical management of asthma.

  12. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial

    PubMed Central

    Ferreira, Luciano Ambrosio; Grossmann, Eduardo; Januzzi, Eduardo; Gonçalves, Rafael Tardin Rosa Ferraz; Mares, Fernando Antonio Guedes; de Paula, Marcos Vinicius Queiroz; Carvalho, Antonio Carlos Pires

    2015-01-01

    Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study) and the use of the occlusal splint plate alone (control). We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p < 0.05). However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p < 0.05) already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term. PMID:26351510

  13. Clinical and social determinants of diarrhoeal disease in a rural HIV/AIDS clinic, South Africa: a case-control study.

    PubMed

    Moshabela, M; MacPherson, P; Ezard, N; Frean, E; Mashimbye, L; Elliott, J H; Oldenburg, B

    2012-05-01

    Diarrhoeal diseases are a common cause of morbidity and are associated with mortality in HIV-infected populations. Little is known about the contribution of clinical and socio-environmental factors to the risk of diarrhoea in these populations in rural sub-Saharan Africa. We conducted a case-control study of people attending a rural HIV clinic with an episode of diarrhoea in Bushbuckridge, South Africa. Cases were defined as HIV-positive adults with symptoms of diarrhoea before or after initiation of antiretroviral therapy (ART). Controls without diarrhoea were randomly selected from clinic attendees. Structured questionnaires and case-file reviews were undertaken to describe clinical and socioenvironmental risk factors. We recruited 103 cases of diarrhoea from 121 patients meeting case definitions. Cases were more likely to be women (P = 0.013), aged over 45 years (P = 0.002), divorced or separated (P = 0.006), have limited formal education (P = 0.003), have inadequate access to sanitation facilities (P = 0.045), have water access limited to less than three days per week (P = 0.032) and not yet initiated on ART (P < 0.001). In multivariate analysis, diarrhoea remained associated with female gender (adjusted odds ratio [aOR]: 2.02, 95% CI 1.10-3.73), older age (aOR: 6.31, 95% CI 1.50-26.50), limited access to water (aOR: 2.66, 95% CI 1.32-5.35) and pre-ART status (aOR: 5.87, 95% CI 3.05-11.27). Clinical and socio-environmental factors are associated with occurrence of diarrhoeal disease among rural HIV patients in South Africa. Further intervention research is urgently needed, combining community- and clinic-based approaches, to improve access to water, sanitation and ART for rural areas with high HIV prevalence, along with structural interventions to address gender inequities.

  14. Clinical Evaluation of the Use of a Multifunctional Remotely Controlled Insulin Pump

    PubMed Central

    Pinget, Michel; Lachgar, Karim; Parkin, Christopher G.; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-01-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system’s advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. PMID:25107708

  15. Aloe Vera Gel and Cesarean Wound Healing; A Randomized Controlled Clinical Trial

    PubMed Central

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2015-01-01

    Background: Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. Methods: This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. Results: The participants’ mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. Conclusion: According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel. PMID:25560349

  16. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial.

    PubMed

    El-Gammal, Mona Y; Salem, Ahmed S; Anees, Mohamed M; Tawfik, Mohamed A

    2016-04-01

    Immediate loading of dental implants in situations where low bone density exist, such as the posterior maxillary region, became possible recently after the introduction of biomimetic agents. This 1-year preliminary clinical trial was carried out to clinically and radiographically evaluate immediate-loaded 1-piece implants with local application of melatonin in the osteotomy site as a biomimetic material. 14 patients with missing maxillary premolars were randomized to receive 14 implants of 1-piece type that were subjected to immediate loading after 2 weeks of initial placement. Group I included 7 implants with acid-etched surface while group II included 7 implants with acid-etched surface combined with local application of melatonin gel at the osteotomy site. Patients were recalled for follow up at 1, 3, 6, and 12 months after loading. All implants were considered successful after 12 months of follow-up. Significant difference (P < 0.05) was found between both groups at 1 month of implant loading when considering the implant stability. At 1 and 3 months there were significant differences in the marginal bone level between the 2 groups. These results suggest that the local application of melatonin at the osteotomy site is associated with good stability and minimal bone resorption. However, more studies for longer follow-up periods are required to confirm the effect of melatonin hormone on osseointegration of dental implants.

  17. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial

    PubMed Central

    Miceli, Giovanni; Marino, Natale; Sciortino, Davide; Bagnato, Gian Filippo

    2016-01-01

    Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Results. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of −0.73 (95% CI − 1.24 to − 0.19) was seen in VAS score, while the effect size was −0.34 (95% CI − 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. Conclusion. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278 PMID:26705327

  18. Randomized controlled clinical trial of 2 types of hydroxyapatite-coated implants on moderate periodontitis patients

    PubMed Central

    2016-01-01

    Purpose The aim of this study was to compare and analyze the peri-implant tissue conditions and prospective clinical outcomes associated with 2 types of hydroxyapatite (HA)-coated implants: (1) fully HA-coated implants and (2) partially HA-coated implants with resorbable blast medium on the coronal portion of the threads. Methods Forty-four partially edentulous patients were randomly assigned to undergo the placement of 62 HA-coated implants, and were classified as the control group (partially HA-coated, n=30) and the test group (fully HA-coated, n=32). All patients had chronic periodontitis with moderate crestal bone loss around the edentulous area. The stability and clinical outcomes of the implants were evaluated using the primary and secondary implant stability quotient (ISQ), as well as radiographic, mobility, and peri-implant soft tissue assessments around the implants. The Wilcoxon signed-rank test and the Mann-Whitney test were used to evaluate differences between and within the 2 groups, with P values <0.05 considered to indicate statistical significance. Results The fully HA-coated implants displayed good retention of crestal bone, and insignificant differences were found in annual marginal bone loss between the 2 types of HA-coated implants (P>0.05). No significant differences were found in the survival rate (group I, 100%; group II, 100%) or the success rate (group I, 93.3%; group II, 93.8%). The fully HA-coated implants also did not significantly increase the risk of peri-implantitis (P>0.05). Conclusions The fully HA-coated implants did not lead to an increased risk of peri-implantitis and showed good retention of the crestal bone, as well as good survival and success rates. Our study suggests that fully HA-coated implants could become a reliable treatment alternative for edentulous posterior sites and are capable of providing good retention of the crestal bone. PMID:27800216

  19. Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Methods for ATMP Release.

    PubMed

    Radrizzani, Marina; Soncin, Sabrina; Lo Cicero, Viviana; Andriolo, Gabriella; Bolis, Sara; Turchetto, Lucia

    2016-01-01

    Mesenchymal stromal/stem cells (MSC) are promising candidates for the development of cell-based therapies for various diseases and are currently being evaluated in a number of clinical trials (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014). MSC for therapeutic applications are classified as advanced therapy medicinal products (ATMP) (Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004) and must be prepared according to good manufacturing practices ( http://ec.europa.eu/health/documents/eudralex/vol-4 ). They may be derived from different starting materials (mainly bone marrow (BM), adipose tissue, or cord blood) and applied as fresh or cryopreserved products, in the autologous as well as an allogeneic context (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014; Sensebé and Bourin, Transplantation 87(9 Suppl):S49-S53, 2009). In any case, they require an approved and well-defined panel of assays in order to be released for clinical use.This chapter describes analytical methods implemented and performed in our cell factory as part of the release strategy for an ATMP consisting of frozen autologous BM-derived MSC. Such methods are designed to assess the safety (sterility, endotoxin, and mycoplasma assays) and identity/potency (cell count and viability, immunophenotype and clonogenic assay) of the final product. Some assays are also applied to the biological starting material (sterility) or carried out as in-process controls (sterility, cell count and viability, immunophenotype, clonogenic assay).The validation strategy for each analytical method is described in the accompanying Chapter 20 .

  20. Hyperproteic hypocaloric enteral nutrition in the critically ill patient: A randomized controlled clinical trial

    PubMed Central

    Rugeles, Saúl-Javier; Rueda, Juan-David; Díaz, Carlos-Eduardo; Rosselli, Diego

    2013-01-01

    Introduction: Our aim was to evaluate the impact of hyperproteic hypocaloric enteral feeding on clinical outcomes in critically ill patients, particularly on severity of organic failure measured with the Sequential Organ Failure Assessment (SOFA). Materials and Methods: In a double blind clinical trial, 80 critically ill adult patients were randomized to hyperproteic hypocaloric or to isocaloric enteral nutrition; all patients completed follow-up of at least 4 days. Prescribed caloric intake was: Hyperproteic hypocaloric enteral nutrition (15 kcal/kg with 1.7 g/kg of protein) or isocaloric enteral nutrition (25 kcal/kg with 20% of the calories as protein). The main outcome was the differences in delta SOFA at 48 h. Secondary outcomes were intensive care unit (ICU) length of stay, days on ventilator, hyperglycemic events, and insulin requirements. Results: There were no differences in SOFA score at baseline (7.5 (standard deviation (SD) 2.9) vs 6.7 (SD 2.5) P = 0.17). The total amount of calories delivered was similarly low in both groups (12 kcal/kg in intervention group vs 14 kcal/kg in controls), but proteic delivery was significantly different (1.4 vs 0.76 g/kg, respectively P ≤ 0.0001). The intervention group showed an improvement in SOFA score at 48 h (delta SOFA 1.7 (SD 1.9) vs 0.7 (SD 2.8) P = 0.04) and less hyperglycemic episodes per day (1.0 (SD 1.3) vs 1.7 (SD 2.5) P = 0.017). Discussion: Enteral hyperproteic hypocaloric nutrition therapy could be associated with a decrease in multiple organ failure measured with SOFA score. We also found decreased hyperglycemia and a trend towards less mechanical ventilation days and ICU length of stay. PMID:24501485

  1. Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Methods for ATMP Release.

    PubMed

    Radrizzani, Marina; Soncin, Sabrina; Lo Cicero, Viviana; Andriolo, Gabriella; Bolis, Sara; Turchetto, Lucia

    2016-01-01

    Mesenchymal stromal/stem cells (MSC) are promising candidates for the development of cell-based therapies for various diseases and are currently being evaluated in a number of clinical trials (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014). MSC for therapeutic applications are classified as advanced therapy medicinal products (ATMP) (Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004) and must be prepared according to good manufacturing practices ( http://ec.europa.eu/health/documents/eudralex/vol-4 ). They may be derived from different starting materials (mainly bone marrow (BM), adipose tissue, or cord blood) and applied as fresh or cryopreserved products, in the autologous as well as an allogeneic context (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014; Sensebé and Bourin, Transplantation 87(9 Suppl):S49-S53, 2009). In any case, they require an approved and well-defined panel of assays in order to be released for clinical use.This chapter describes analytical methods implemented and performed in our cell factory as part of the release strategy for an ATMP consisting of frozen autologous BM-derived MSC. Such methods are designed to assess the safety (sterility, endotoxin, and mycoplasma assays) and identity/potency (cell count and viability, immunophenotype and clonogenic assay) of the final product. Some assays are also applied to the biological starting material (sterility) or carried out as in-process controls (sterility, cell count and viability, immunophenotype, clonogenic assay).The validation strategy for each analytical method is described in the accompanying Chapter 20 . PMID:27236681

  2. Hypnosis and self-hypnosis, administered and taught by nurses, for the reduction of chronic pain: a controlled clinical trial.

    PubMed

    Buchser, E; Burnand, B; Sprunger, A L; Clémence, A; Lepage, C; Martin, Y; Chédel, D; Guex, P; Sloutskis, D; Rumley, R

    1994-01-01

    Hypnosis is a technique whereby an individual can reach a particular state, quite unrelated to sleep, characterized by aroused, attentive and focused concentration. Although there are numerous clinical applications of hypnosis, there are virtually no controlled clinical trials to support its effectiveness. We propose a controlled randomized clinical trial comparing a "control" group of chronic pain patients treated by a programme including conventional oral medication combined with various nerve blocks and/or spinal administration of drugs, with a "treatment" group having a similar treatment programme plus hypnosis carried out by nurses. Outcome measurements include mainly the variation of pain intensity, the amount of analgesic drug consumption, spontaneous physical activity, and the change in health-related quality of life. The assessment of the outcome variable is done at the initial workup, weekly for the first 3 weeks, and at 6 and 12 weeks. A follow-up survey is conducted at 6 months. PMID:8073244

  3. Hypnosis and self-hypnosis, administered and taught by nurses, for the reduction of chronic pain: a controlled clinical trial.

    PubMed

    Buchser, E; Burnand, B; Sprunger, A L; Clémence, A; Lepage, C; Martin, Y; Chédel, D; Guex, P; Sloutskis, D; Rumley, R

    1994-01-01

    Hypnosis is a technique whereby an individual can reach a particular state, quite unrelated to sleep, characterized by aroused, attentive and focused concentration. Although there are numerous clinical applications of hypnosis, there are virtually no controlled clinical trials to support its effectiveness. We propose a controlled randomized clinical trial comparing a "control" group of chronic pain patients treated by a programme including conventional oral medication combined with various nerve blocks and/or spinal administration of drugs, with a "treatment" group having a similar treatment programme plus hypnosis carried out by nurses. Outcome measurements include mainly the variation of pain intensity, the amount of analgesic drug consumption, spontaneous physical activity, and the change in health-related quality of life. The assessment of the outcome variable is done at the initial workup, weekly for the first 3 weeks, and at 6 and 12 weeks. A follow-up survey is conducted at 6 months.

  4. Neuroendocrine Regulation and Metabolism of Glucose and Lipids in Primary Chronic Insomnia: A Prospective Case-Control Study

    PubMed Central

    Seelig, Eleonora; Keller, Ulrich; Klarhöfer, Markus; Scheffler, Klaus; Brand, Serge; Holsboer-Trachsler, Edith; Hatzinger, Martin; Bilz, Stefan

    2013-01-01

    Objectives To investigate the relation between primary chronic insomnia and insulin sensitivity, visceral adiposity, non alcoholic fatty liver disease and neuroendocrine hormones. Materials and Methods In a case-controlled, prospective clinical trial 13 women with primary chronic insomnia according to DSM-IV criteria were compared to 12 healthy controls matched for age, sex, BMI, body composition and menopausal status. All participants had a sleep assessment including polysomnographic studies and neuropsychiatric evaluation. Insulin sensitivity was evaluated using the euglycaemic hyperinsulinemic clamp. Hepatic fat content, visceral adipose tissue and intramyocellular lipid accumulation were assessed using magnetic resonance imaging and spectroscopy. The hormonal stress axis was evaluated by measurements of midnight and early morning salivary cortisol, urinary catecholamines and plasma metanephrines. Body composition was determined using body impedance analysis and indirect calorimetry. Results Although the diagnosis of primary chronic insomnia was made by established clinical criteria, standard polysomongraphic studies failed to identify altered sleep continuity and architecture when compared to matched controls. However, women with primary chronic insomnia showed significantly higher midnight salivary cortisol concentrations (1.46 vs. 0.76 nmol/l, p = 0.02), indicating dysregulation of the hypothalamo-pituitary-adrenal (HPA) axis. Plasma glucose and lipid concentrations, insulin sensitivity, hepatic and intramyocellular fat content, visceral adipose tissue mass and body composition did not differ between the two groups. Conclusion Healthy women with clinically diagnosed primary chronic insomnia demonstrate a dysregulation of circadian cortisol secretion despite normal sleep continuity and architecture. Increased midnight cortisol levels, however, were not associated with impaired metabolism of glucose and lipids. PMID:23593497

  5. The Use of Wet Cupping for Persistent Nonspecific Low Back Pain: Randomized Controlled Clinical Trial

    PubMed Central

    AlBedah, Abdullah; Elolemy, Ahmed; Hussein, Asim A.; AlQaed, Meshari; Al Mudaiheem, Abdullah; Abutalib, Raid A.; Bazaid, Faisal Mohamed; Bafail, Ahmad Saeed; Essa, AboBakr; Bakrain, Mohammed Yahia

    2015-01-01

    Abstract Objectives: To evaluate the effectiveness and safety of wet cupping therapy as a single treatment for persistent nonspecific low back pain (PNSLBP). Design: Randomized controlled trial comparing wet cupping versus no treatment in PNSLBP. Setting: Outpatient clinic in three secondary care hospitals in Saudi Arabia. Patients: Eighty eligible participants with PNSLBP for at least 3 months were randomly allocated to an intervention group (n=40) or to a control group (n=40). Interventions: Six wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points among BL23, BL24, and BL25. Only acetaminophen was allowed as a rescue treatment in both groups. Outcome measures: The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded. Results: At the end of the intervention, statistically significant differences in the three outcome measures favoring the wet cupping group compared with the control group were seen: NRS score, 29.2 (95% confidence interval [CI], 24.6–33.8) versus 57.9 (95% CI, 53.3–62.6), respectively; PPI score, 1.17 (95% CI, 0.96–1.4) versus 2.3 (95% CI, 2.1– 2.7); and ODQ score, 19.6 (95% CI, 16.5–22.7) versus 35.4 (95% CI, 32.3–38.5) (p=0.0001). This improvement continued for another 2 weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported. Conclusions: Wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed. PMID:26069973

  6. Silymarin for the Prevention of Contrast-Induced Nephropathy: A Placebo-Controlled Clinical Trial

    PubMed Central

    Sedighifard, Zohreh; Roghani, Farshad; Bidram, Peyman; Harandi, Samaneh Aalami; Molavi, Safieh

    2016-01-01

    Background: Silymarin is a flavonoid complex with nephro-protective properties. We evaluated the efficacy of silymarin in the prevention of contrast-induced nephropathy (CIN). Methods: This placebo-controlled clinical trial was conducted on 143 patients with chronic stable angina referring for elective coronary angiography. Patients with low to moderate risk for CIN were included and were randomized to receive silymarin (280 mg) or placebo 2 h before administration of the contrast material. A nonionic, iso-osmolar contrast material was used. Serum creatinine was measured before and 48 h after injection of the contrast material. CIN was defined as an increase in creatinine of ≥0.5 mg/dL or ≥25% from the baseline. Results: Serum creatinine was increased by 0.02 ± 0.07 mg/dL (P = 0.004) with silymarin and by 0.04 ± 0.15 mg/dL (P = 0.008) with placebo after contrast material injection (between group difference = 0.01 ± 0.02 mg/dL, P = 0.881). CIN was occurred less frequently, though statistically nonsignificant, with silymarin compared with placebo (2.9% vs. 10.8%, Odds ratio [OR] [95% confidence interval (CI)] = 0.246 [0.050–1.203], P = 0.099). In the logistic regression analysis controlling for patients characteristics and baseline creatinine level, silymarin was nonsignificantly associated with lower frequency of CIN (OR [95% CI] = 0.203 [0.037–1.117], P = 0.067). Conclusions: We found a trend toward the efficacy of silymarin in preventing contrast-induced renal dysfunction. Further trials with larger sample size and in patients with higher risk of CIN are warranted. PMID:26941924

  7. Clinical aspects of the control of plasma volume at microgravity and during return to one gravity

    NASA Technical Reports Server (NTRS)

    Convertino, V. A.

    1996-01-01

    Plasma volume is reduced by 10-20% within 24-48 h of exposure to simulated or actual microgravity. The clinical importance of microgravity induced hypovolemia is manifested by its relationship with orthostatic intolerance and reduced maximal oxygen uptake (VO2max) after return to one gravity (1G). Since there is no evidence to suggest that plasma volume reduction during microgravity is associated with thirst or renal dysfunctions, a diuresis induced by an immediate blood volume shift to the central circulation appears responsible for microgravity-induced hypovolemia. Since most astronauts choose to restrict their fluid intake before a space mission, absence of increased urine output during actual space flight may be explained by low central venous pressure (CVP) which accompanies dehydration. Compelling evidence suggests that prolonged reduction in CVP during exposure to microgravity reflects a "resetting" to a lower operating point, which acts to limit plasma volume expansion during attempts to increase fluid intake. In ground based and space flight experiments, successful restoration and maintenance of plasma volume prior to returning to an upright posture may depend upon development of treatments that can return CVP to its baseline IG operating point. Fluid-loading and lower body negative pressure (LBNP) have not proved completely effective in restoring plasma volume, suggesting that they may not provide the stimulus to elevate the CVP operating point. On the other hand, exercise, which can chronically increase CVP, has been effective in expanding plasma volume when combined with adequate dietary intake of fluid and electrolytes. The success of designing experiments to understand the physiological mechanisms of and development of effective counter measures for the control of plasma volume in microgravity and during return to IG will depend upon testing that can be conducted under standardized controlled baseline conditions during both ground-based and space

  8. The basis of clinical tribalism, hierarchy and stereotyping: a laboratory-controlled teamwork experiment

    PubMed Central

    Braithwaite, Jeffrey; Clay-Williams, Robyn; Vecellio, Elia; Marks, Danielle; Hooper, Tamara; Westbrook, Mary; Westbrook, Johanna; Blakely, Brette; Ludlow, Kristiana

    2016-01-01

    Objectives To examine the basis of multidisciplinary teamwork. In real-world healthcare settings, clinicians often cluster in profession-based tribal silos, form hierarchies and exhibit stereotypical behaviours. It is not clear whether these social structures are more a product of inherent characteristics of the individuals or groups comprising the professions, or attributable to a greater extent to workplace factors. Setting Controlled laboratory environment with well-appointed, quiet rooms and video and audio equipment. Participants Clinical professionals (n=133) divided into 35 groups of doctors, nurses and allied health professions, or mixed professions. Interventions Participants engaged in one of three team tasks, and their performance was video-recorded and assessed. Primary and secondary measures Primary: teamwork performance. Secondary, pre-experimental: a bank of personality questionnaires designed to assess participants’ individual differences. Postexperimental: the 16-item Mayo High Performance Teamwork Scale (MHPTS) to measure teamwork skills; this was self-assessed by participants and also by external raters. In addition, external, arm's length blinded observations of the videotapes were conducted. Results At baseline, there were few significant differences between the professions in collective orientation, most of the personality factors, Machiavellianism and conservatism. Teams generally functioned well, with effective relationships, and exhibited little by way of discernible tribal or hierarchical behaviours, and no obvious differences between groups (F (3, 31)=0.94, p=0.43). Conclusions Once clinicians are taken out of the workplace and put in controlled settings, tribalism, hierarchical and stereotype behaviours largely dissolve. It is unwise therefore to attribute these factors to fundamental sociological or psychological differences between individuals in the professions, or aggregated group differences. Workplace cultures are more likely to

  9. Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting. Methods and design An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS) as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique) or the control group (usual care without this tape technique). In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test) and pain severity (11-point numerical rating scale). The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up. Discussion This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS. Trial registration Trial registration number: NTR2575 PMID:21849055

  10. Internal Amplification Control for a Cryptosporidium Diagnostic PCR: Construction and Clinical Evaluation.

    PubMed

    Hawash, Yousry; Ghonaim, M M; Al-Hazmi, Ayman S

    2015-04-01

    Various constituents in clinical specimens, particularly feces, can inhibit the PCR assay and lead to false-negative results. To ensure that negative results of a diagnostic PCR assay are true, it should be properly monitored by an inhibition control. In this study, a cloning vector harboring a modified target DNA sequence (≈375 bp) was constructed to be used as a competitive internal amplification control (IAC) for a conventional PCR assay that detects ≈550 bp of the Cryptosporidium oocyst wall protein (COWP) gene sequence in human feces. Modification of the native PCR target was carried out using a new approach comprising inverse PCR and restriction digestion techniques. IAC was included in the assay, with the estimated optimum concentration of 1 fg per reaction, as duplex PCR. When applied on fecal samples spiked with variable oocysts counts, ≈2 oocysts were theoretically enough for detection. When applied on 25 Cryptosporidium-positive fecal samples of various infection intensities, both targets were clearly detected with minimal competition noticed in 2-3 samples. Importantly, both the analytical and the diagnostic sensitivities of the PCR assay were not altered with integration of IAC into the reactions. When tried on 180 randomly collected fecal samples, 159 were Cryptosporidium-negatives. Although the native target DNA was absent, the IAC amplicon was obviously detected on gel of all the Cryptosporidium-negative samples. These results imply that running of the diagnostic PCR, inspired with the previously developed DNA extraction protocol and the constructed IAC, represents a useful tool for Cryptosporidium detection in human feces.

  11. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

  12. Clinical Aspects of the Control of Plasma Volume at Microgravity and During Return to One Gravity

    NASA Technical Reports Server (NTRS)

    Convertino, Victor A.

    1995-01-01

    Plasma volume is reduced by 10%-20% within 24 to 48 h of exposure to simulated or actual microgravity. The clinical importance of microgravity-induced hypovolemia is manifested by its relationship with orthostatic intolerance and reduced VO2max after return to one gravity (1G). Since there is no evidence to suggest plasma volume reduction during microgravity is associated with thirst or renal dysfunctions, a diuresis induced by an immediate blood volume shift to the central circulation appears responsible for microgravity-induced hypovolemia. Since most astronauts choose to restrict their fluid intake before a space mission, absence of increased urine output during actual spaceflight may be explained by low central venous pressure (CVP) which accompanies dehydration. Compelling evidence suggests that prolonged reduction in CVP during exposure to microgravity reflects a 'resetting' to a lower operating point which acts to limit plasma volume expansion during attempts to increase fluid intake. In groudbase and spaceflight experiments, successful restoration and maintenance of plasma volume prior to returning to an upright posture may depend upon development of treatments that can return CVP to its baseline 10 operating point. Fluid-loading and LBNP have not proved completely effective in restoring plasma volume, suggesting that they may not provide the stimulus to elevate the CVP operating point. On the other, exercise, which can chronically increase CVP, has been effective in expanding plasma volume when combined with adequate dietary intake of fluid and electrolytes. The success of designing experiments to understand the physiological mechanisms of and development of effective countermeasures for the control of plasma volume in microgravity and during return to one gravity will depend upon testing that can be conducted under standardized controlled baseline condi

  13. Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial

    PubMed Central

    Pleșea Condratovici, Cătălin; Bacarea, Vladimir; Piqué, Núria

    2016-01-01

    Background. Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the antidiarrheal effect of xyloglucan were assessed in children with acute gastroenteritis receiving oral rehydration solution (ORS). Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months–12 years) with acute gastroenteritis of infectious origin. Children were randomized to xyloglucan and ORS, or ORS only, for 5 days. Diarrheal symptoms, including stool number/characteristics, and safety were assessed at baseline and after 2 and 5 days and by fulfillment of a parent diary card. Results. Thirty-six patients (58.33% girls) were included (n = 18/group). Patients receiving xyloglucan and ORS had better symptom evolution than ORS-only recipients, with a faster onset of action. At 6 hours, xyloglucan produced a significantly greater decrease in the number of type 7 stools (0.11 versus 0.44; P = 0.027). At days 3 and 5, xyloglucan also produced a significantly greater reduction in types 6 and 7 stools compared with ORS alone. Xyloglucan plus ORS was safe and well tolerated. Conclusions. Xyloglucan is an efficacious and safe option for the treatment of acute gastroenteritis in children, with a rapid onset of action in reducing diarrheal symptoms. This study is registered with ISRCTN number 65893282. PMID:27212943

  14. The Role of Serotonin (5-HT) in Behavioral Control: Findings from Animal Research and Clinical Implications.

    PubMed

    Sanchez, C L; Biskup, C S; Herpertz, S; Gaber, T J; Kuhn, C M; Hood, S H; Zepf, F D

    2015-05-19

    The neurotransmitters serotonin and dopamine both have a critical role in the underlying neurobiology of different behaviors. With focus on the interplay between dopamine and serotonin, it has been proposed that dopamine biases behavior towards habitual responding, and with serotonin offsetting this phenomenon and directing the balance toward more flexible, goal-directed responding. The present focus paper stands in close relationship to the publication by Worbe et al. (2015), which deals with the effects of acute tryptophan depletion, a neurodietary physiological method to decrease central nervous serotonin synthesis in humans for a short period of time, on the balance between hypothetical goal-directed and habitual systems. In that research, acute tryptophan depletion challenge administration and a following short-term reduction in central nervous serotonin synthesis were associated with a shift of behavioral performance towards habitual responding, providing further evidence that central nervous serotonin function modulates the balance between goal-directed and stimulus-response habitual systems of behavioral control. In the present focus paper, we discuss the findings by Worbe and colleagues in light of animal experiments as well as clinical implications and discuss potential future avenues for related research.

  15. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial

    PubMed Central

    Imamura, Marta; Imamura, Satiko Tomikawa; Targino, Rosa Alves; Morales-Quezada, León; Onoda Tomikawa, Luis C.; Onoda Tomikawa, Luis G.; Alfieri, Fabio M.; Filippo, Thais R.; da Rocha, Ivan D.; Neto, Raul Bolliger; Fregni, Felipe; Battistella, Linamara Rizzo

    2016-01-01

    In this large, sham-controlled, randomized trial, we examined the efficacy of the combination of standard treatment and paraspinous lidocaine injection compared with standard therapy alone in subjects with chronic low back pain. There is little research-based evidence for the routine clinical use of paraspinous lidocaine injection for low back pain. A total of 378 subjects with nonspecific chronic low back pain were randomized to 3 groups: paraspinous lidocaine injection, analgesics, and exercises (group 1, LID-INJ); sham paraspinous lidocaine injection, analgesics, and exercises (group 2, SH-INJ); and analgesics and exercises (group 3, STD-TTR). A blinded rater assessed the study outcomes at 3 time points: baseline, after treatment, and after 3 months of follow-up. There were increased frequency of pain responses and better low back functional scores in the LID-INJ group compared with the SH-INJ and STD-TTR groups. These effects remained at the 3-month follow-up but differed between all 3 groups. There were significant changes in pain threshold immediately after treatment, supporting the effects of this intervention in reducing central sensitization. Paraspinous lidocaine injection therapy is not associated with a higher risk of adverse effects compared with conventional treatment and sham injection. Its effects on hyperalgesia might correlate with changes in central sensitization. PMID:26828801

  16. A Pre-Clinical Framework for Neural Control of a Therapeutic Upper-Limb Exoskeleton.

    PubMed

    Blank, Amy; O'Malley, Marcia K; Francisco, Gerard E; Contreras-Vidal, Jose L

    2013-01-01

    In this paper, we summarize a novel approach to robotic rehabilitation that capitalizes on the benefits of patient intent and real-time assessment of impairment. Specifically, an upper-limb, physical human-robot interface (the MAHI EXO-II robotic exoskeleton) is augmented with a non-invasive brain-machine interface (BMI) to include the patient in the control loop, thereby making the therapy 'active' and engaging patients across a broad spectrum of impairment severity in the rehabilitation tasks. Robotic measures of motor impairment are derived from real-time sensor data from the MAHI EXO-II and the BMI. These measures can be validated through correlation with widely used clinical measures and used to drive patient-specific therapy sessions adapted to the capabilities of the individual, with the MAHI EXO-II providing assistance or challenging the participant as appropriate to maximize rehabilitation outcomes. This approach to robotic rehabilitation takes a step towards the seamless integration of BMIs and intelligent exoskeletons to create systems that can monitor and interface with brain activity and movement. Such systems will enable more focused study of various issues in development of devices and rehabilitation strategies, including interpretation of measurement data from a variety of sources, exploration of hypotheses regarding large scale brain function during robotic rehabilitation, and optimization of device design and training programs for restoring upper limb function after stroke.

  17. Towards human-centric visual access control for clinical data management.

    PubMed

    Fahl, Sascha; Harbach, Marian; Smith, Matthew

    2012-01-01

    We propose a novel human-centric, visual, and context-aware access control (AC) system for distributed clinical data management and health information systems. Human-centricity in this context means that medical staff should be able to configure AC rules, both in a timesaving and reliable manner. Since medical data often includes (meta-) information about a patient, it is essential that an AC system includes the patient into the AC process. To cater for the strong security needs in the medical domain, both the AC policy creation by medical staff as well as the patient-interaction feature need to be taken into account. While traditional AC systems offer sufficient security in theory, they lack in comfort and flexibility and as a result find no widespread acceptance with non tech-savvy users. Distributed medical institutions could enormously benefit from the opportunity of dynamic AC configuration at an end-user level while adhering to legal, ethical or other privacy requirements. Hence, this paper presents a human-centric visual AC model for medical data, addressing usability, information security and patient interaction. PMID:22874293

  18. Development of compression-controlled low-level laser probe system: towards clinical application

    PubMed Central

    Yeo, Changmin; Son, Taeyoon; Park, Junghwan; Lee, Young-Heum; Kwon, Kiwoon; Nelson, J. Stuart

    2011-01-01

    Various physico-chemical tissue optical clearing (TOC) methods have been suggested to maximize photon density in tissue. In order to enhance photon density, a compression-controlled low-level laser probe (CCLLP) system was developed by utilizing the principle of mechanical tissue compression. Negative compression (NC) was applied to the laser probes built in various diameters and simultaneously the laser was irradiated into ex-vivo porcine skin samples. Laser photon density (LPD) was evaluated as a function of NC and probe diameter by analyzing 2D diffusion images of the laser exposures. The CCLLP system resulted in a concentrated laser beam profile, which means enhancement of the LPD. As indicators of LPD, the laser peak intensity increased and the full width at half maximum (FWHM) decreased as a function of NC. The peak intensity at −–30 kPa increased 2.74, 3.22, and 3.64 fold at laser probe diameters of 20, 30, and 40 mm, respectively. In addition, sample temperature was measured with a thermal camera and increased 0.4 K at −30 kPa after 60 s of laser irradiation as a result of enhanced LPD. The CCLLP system effectively demonstrated enhancement of the LPD in tissue and potentially its clinical feasibility. PMID:20393768

  19. The Role of Serotonin (5-HT) in Behavioral Control: Findings from Animal Research and Clinical Implications

    PubMed Central

    Sanchez, CL; Biskup, CS; Herpertz, S; Gaber, TJ; Kuhn, CM; Hood, SH

    2015-01-01

    The neurotransmitters serotonin and dopamine both have a critical role in the underlying neurobiology of different behaviors. With focus on the interplay between dopamine and serotonin, it has been proposed that dopamine biases behavior towards habitual responding, and with serotonin offsetting this phenomenon and directing the balance toward more flexible, goal-directed responding. The present focus paper stands in close relationship to the publication by Worbe et al. (2015), which deals with the effects of acute tryptophan depletion, a neurodietary physiological method to decrease central nervous serotonin synthesis in humans for a short period of time, on the balance between hypothetical goal-directed and habitual systems. In that research, acute tryptophan depletion challenge administration and a following short-term reduction in central nervous serotonin synthesis were associated with a shift of behavioral performance towards habitual responding, providing further evidence that central nervous serotonin function modulates the balance between goal-directed and stimulus-response habitual systems of behavioral control. In the present focus paper, we discuss the findings by Worbe and colleagues in light of animal experiments as well as clinical implications and discuss potential future avenues for related research. PMID:25991656

  20. In vivo assessment of Ectoin: a randomized, vehicle-controlled clinical trial.

    PubMed

    Heinrich, U; Garbe, B; Tronnier, H

    2007-01-01

    The aim of the study was to assess an Ectoin formulation with regard to the antiageing properties. The study was designed as a monocentric, randomized, double-blind application test, in order to ensure the compatibility and the efficacy of Ectoin in comparison to a vehicle emulsion. A total of 104 voluntary healthy female test subjects were included in the study. Moisturizing properties as well as other parameters of skin ageing, like skin surface structure and skin elasticity, were determined for treatment A (vehicle) and treatment B (with 2% Ectoin) versus an untreated control. Statistical evaluations according to the Wilcoxon rank-sum test indicate a general preference for the Ectoin treatment by the test subjects in both the application and the efficacy tests. None of the participating test subjects had any side effects throughout the study. In terms of antiageing properties, previous in vitro studies could be confirmed by this clinical trial, clarifying that the natural cell protection concept of Ectoin is transferable to skin care with manifold benefits.

  1. A Pre-Clinical Framework for Neural Control of a Therapeutic Upper-Limb Exoskeleton.

    PubMed

    Blank, Amy; O'Malley, Marcia K; Francisco, Gerard E; Contreras-Vidal, Jose L

    2013-01-01

    In this paper, we summarize a novel approach to robotic rehabilitation that capitalizes on the benefits of patient intent and real-time assessment of impairment. Specifically, an upper-limb, physical human-robot interface (the MAHI EXO-II robotic exoskeleton) is augmented with a non-invasive brain-machine interface (BMI) to include the patient in the control loop, thereby making the therapy 'active' and engaging patients across a broad spectrum of impairment severity in the rehabilitation tasks. Robotic measures of motor impairment are derived from real-time sensor data from the MAHI EXO-II and the BMI. These measures can be validated through correlation with widely used clinical measures and used to drive patient-specific therapy sessions adapted to the capabilities of the individual, with the MAHI EXO-II providing assistance or challenging the participant as appropriate to maximize rehabilitation outcomes. This approach to robotic rehabilitation takes a step towards the seamless integration of BMIs and intelligent exoskeletons to create systems that can monitor and interface with brain activity and movement. Such systems will enable more focused study of various issues in development of devices and rehabilitation strategies, including interpretation of measurement data from a variety of sources, exploration of hypotheses regarding large scale brain function during robotic rehabilitation, and optimization of device design and training programs for restoring upper limb function after stroke. PMID:24887296

  2. Pulsed electromagnetic fields on postmenopausal osteoporosis in Southwest China: a randomized, active-controlled clinical trial.

    PubMed

    Liu, Hui-Fang; Yang, Lin; He, Hong-Chen; Zhou, Jun; Liu, Ying; Wang, Chun-Yan; Wu, Yuan-Chao; He, Cheng-Qi

    2013-05-01

    A randomized, active-controlled clinical trial was conducted to examine the effect of pulsed electromagnetic fields (PEMFs) on women with postmenopausal osteoporosis (PMO) in southwest China. Forty-four participants were randomly assigned to receive alendronate or one course of PEMFs treatment. The primary endpoint was the mean percentage change in bone mineral density of the lumbar spine (BMDL), and secondary endpoints were the mean percentage changes in left proximal femur bone mineral density (BMDF), serum 25OH vitamin D3 (25(OH)D) concentrations, total lower-extremity manual muscle test (LE MMT) score, and Berg Balance Scale (BBS) score. The BMDL, BMDF, total LE MMT score and BBS score were recorded at baseline, 5, 12, and 24 weeks. Serum concentrations of 25(OH)D were measured at baseline and 5 weeks. Using a mixed linear model, there was no significant treatment difference between the two groups in the BMDL, BMDF, total LE MMT score, and BBS score (P ≥ 0.05). For 25(OH)D concentrations, the effects were also comparable between the two groups (P ≥ 0.05) with the Mann-Whitney's U-test. These results suggested that a course of PEMFs treatment with specific parameters was as effective as alendronate in treating PMO within 24 weeks.

  3. Control of Scar Tissue Formation in the Cornea: Strategies in Clinical and Corneal Tissue Engineering

    PubMed Central

    Wilson, Samantha L.; El Haj, Alicia J.; Yang, Ying

    2012-01-01

    Corneal structure is highly organized and unified in architecture with structural and functional integration which mediates transparency and vision. Disease and injury are the second most common cause of blindness affecting over 10 million people worldwide. Ninety percent of blindness is permanent due to scarring and vascularization. Scarring caused via fibrotic cellular responses, heals the tissue, but fails to restore transparency. Controlling keratocyte activation and differentiation are key for the inhibition and prevention of fibrosis. Ophthalmic surgery techniques are continually developing to preserve and restore vision but corneal regression and scarring are often detrimental side effects and long term continuous follow up studies are lacking or discouraging. Appropriate corneal models may lead to a reduced need for corneal transplantation as presently there are insufficient numbers or suitable tissue to meet demand. Synthetic optical materials are under development for keratoprothesis although clinical use is limited due to implantation complications and high rejection rates. Tissue engineered corneas offer an alternative which more closely mimic the morphological, physiological and biomechanical properties of native corneas. However, replication of the native collagen fiber organization and retaining the phenotype of stromal cells which prevent scar-like tissue formation remains a challenge. Careful manipulation of culture environments are under investigation to determine a suitable environment that simulates native ECM organization and stimulates keratocyte migration and generation. PMID:24955637

  4. Pre-clinical and clinical walking kinematics in female breeding pigs with lameness: A nested case-control cohort study.

    PubMed

    Stavrakakis, S; Guy, J H; Syranidis, I; Johnson, G R; Edwards, S A

    2015-07-01

    Gait profiles were investigated in a cohort of female pigs experiencing a lameness period prevalence of 29% over 17 months. Gait alterations before and during visually diagnosed lameness were evaluated to identify the best quantitative clinical lameness indicators and early predictors for lameness. Pre-breeding gilts (n= 84) were recruited to the study over a period of 6 months, underwent motion capture every 5 weeks and, depending on their age at entry to the study, were followed for up to three successive gestations. Animals were subject to motion capture in each parity at 8 weeks of gestation and on the day of weaning (28 days postpartum). During kinematic motion capture, the pigs walked on the same concrete walkway and an array of infra-red cameras was used to collect three dimensional coordinate data of reflective skin markers attached to the head, trunk and limb anatomical landmarks. Of 24 pigs diagnosed with lameness, 19 had preclinical gait records, whilst 18 had a motion capture while lame. Depending on availability, data from one or two preclinical motion capture 1-11 months prior to lameness and on the day of lameness were analysed. Lameness was best detected and evaluated using relative spatiotemporal gait parameters, especially vertical head displacement and asymmetric stride phase timing. Irregularity in the step-to-stride length ratio was elevated (deviation  ≥ 0.03) in young pigs which presented lameness in later life (odds ratio 7.2-10.8). PMID:25986130

  5. Blood pressure control among hypertensive patients with and without diabetes mellitus in six public primary care clinics in Malaysia.

    PubMed

    Cheong, Ai Theng; Tong, Seng Fah; Sazlina, Sharrif G; Azah, Abdul Samad; Salmiah, Md Sharif

    2015-03-01

    Hypertension is a common comorbidity among diabetic patients. This study aimed to determine blood pressure (BP) control among hypertensive patients with and without diabetes. This was a cross-sectional study in 6 public primary care clinics in Wilayah Persekutuan, Malaysia. Hypertensive patients aged ≥18 years and attending the clinics were selected via systematic random sampling. The BP control target was defined as <130/80 mm Hg for diabetic patients and <140/90 mm Hg for nondiabetic patients. A total of 1107 hypertensive patients participated in this study and 540 (48.7%) had diabetes. About one fourth (24.3%) of the hypertensive patients with diabetes achieved BP control target, compared with 60.1% patients without diabetes (P < .001). Being diabetic and on ≥2 antihypertensive treatments were associated with poor BP control. Attention needs to be given to these groups of patients when managing patients with hypertension.

  6. Purified fibronectin administration to patients with severe abdominal infections. A controlled clinical trial.

    PubMed Central

    Lundsgaard-Hansen, P; Doran, J E; Rubli, E; Papp, E; Morgenthaler, J J; Späth, P

    1985-01-01

    Subnormal plasma fibronectin (Fn) levels are found in patients with severe abdominal infections (SAI). The repletion of Fn has been postulated to have therapeutic benefit by virtue of its opsonic, reticuloendothelial system (RES) stimulating effects. A controlled, prospective trial of Fn administration was performed in patients with SAI to assess its use as an adjunct to standard procedures of intensive care. Thirty-three SAI patients were given daily doses of 0.8 g of purified Fn on days 1-5 following admission to the ICU, whereas 34 control patients received no Fn. All patients received the clinical care, antibiotics, and pharmacologic agents appropriate to their individual needs. The admission status and laboratory profiles of the two patient groups (+ and -Fn) were comparable on admission to the study. No side effects of the Fn preparation were observed. As judged by subgroup averages, the Fn replacement regimen was effective in elevating Fn levels to within normal range from day 2 onwards, as measured by immunological and functional assays. The estimated intravascular recovery of Fn averaged 82% in those patients who survived, yet only 52% in the nonsurvivors. Ultimate hospital mortality was 9/33 (27.3%) in the +Fn group versus 13/34 (38.2%) in the -Fn group (p = 0.244, Fisher's exact test). Although ultimate mortality was not significantly changed by the administration of Fn, the Fn treated patients appeared to survive longer than did the control patients. This trend was confirmed through the analysis of expected survival curves (D = 3.12, 0.1 greater than p greater than 0.05). When compared to the survivors, the ultimate nonsurvivors entered the study with statistically higher group averages of bilirubin and creatinine concomitant with lower averages of Fn, antithrombin III, C4, C3, C3b-INH, and transferrin. These differences persisted throughout the 11-day monitoring period; differences between survivors and nonsurvivors with respect to platelets

  7. Clinical and radiographic evaluation of intra-bony defects in localized aggressive periodontitis patients with platelet rich plasma/hydroxyapatite graft: A comparative controlled clinical trial

    PubMed Central

    Gupta, Geeti

    2014-01-01

    Background: Aggressive periodontitis is a characterized by rapid attachment loss, bone destruction and familial aggregation. Platelet-rich plasma (PRP) has been proposed to promote regeneration of the lost periodontal tissues. The aim of this study was to evaluate and compare the efficacy of PRP combined with hydroxyapatite (HA) graft in the treatment of intra-bony defects in localized aggressive periodontitis (L-AgP) patients. Materials and Methods: Ten L-AgP patients having bilateral intra-bony defect ≥2 mm and probing depth (PD) ≥6 mm were randomly treated either with the PRP/HA graft or HA graft alone. The clinical (plaque control record, bleeding on probing index, PD, and relative attachment level [RAL]), and radiographic parameters (size of the bone defect) were recorded pre- and post-operatively at 3, 6, and 12 months. Results: After 12 months, for both maxillary and mandibular arches, the mean PD decrease was significantly more (P < 0.05) for the test group than the control group (3.2 mm vs. 1.9 mm and 3.6 mm vs. 1.9 mm, respectively). Furthermore, the mean RAL decrease in both maxillary and mandibular arches was significantly more (P < 0.05) for the test group than the control group (3.0 mm vs. 1.2 mm and 3.1 mm vs. 1.4 mm, respectively). Radiographically, the test group showed significantly more defect fill as compared with the control group. Conclusion: Both treatments provided significant improvements in clinical and radiographic parameters in a 12-month postoperative period. PRP/HA group presented superior results regarding PD reduction, clinical attachment gain and radiographic bone fill than HA group. PMID:25395757

  8. Assessment of asthma control using asthma control test in chest clinics in Cameroon: a cross-sectional study

    PubMed Central

    Hugo, Mbatchou Ngahane Bertrand; Walter, Pefura-Yone Eric; Maïmouna, Mama; Malea, Nganda Motto; Ubald, Olinga; Adeline, Wandji; Bruno, Tengang; Emmanuel, Nyankiyé; Emmanuel, Afane Ze; Christopher, Kuaban

    2016-01-01

    Introduction The goal of asthma treatment is to obtain and maintain a good control of symptoms. Investigating factors associated with inadequately control asthma could help in strategies to improve asthma control. This study aimed to determine the prevalence and factors associated with inadequately controlled asthma in asthma patients under chest specialist care. Methods A cross-sectional study was conducted from November 2012 to May 2013. Physician-diagnosed asthma patients aged 12 years and above were included. A questionnaire was used to collect demographic data, comorbidities, and medical history of asthma. Asthma control was assessed using the Asthma Control Test (ACT), with a score less than 20 for inadequately controlled asthma and a score greater or equal to 20 for controlled asthma. A multivariate analysis was used to identify factors associated with inadequately controlled asthma. Results Overall, 243 patients were included in this study. Asthma was controlled in 141 patients (58%) and inadequately controlled in 102 (42%). The mean duration of asthma was 8 years with an interquartile range of 4 and 18 years. Forty-three participants (17.7%) were not under any controller medication while the mean ACT score was 19.3 ± 4.6. Independent associations were found between inadequately controlled asthma and female gender (OR 1.91; 95% CI 1.06-3.47) and obesity (OR 1.81; 1.01-3.27). Conclusion Asthma remains poorly controlled in a large proportion of asthma patients under specialist care in Cameroon. Educational programs for asthma patients targeting women and based on weight loss for obese patients may help in improving the control of asthma. PMID:27217894

  9. Clinical review: Consensus recommendations on measurement of blood glucose and reporting glycemic control in critically ill adults

    PubMed Central

    2013-01-01

    The management reporting and assessment of glycemic control lacks standardization. The use of different methods to measure the blood glucose concentration and to report the performance of insulin treatment yields major disparities and complicates the interpretation and comparison of clinical trials. We convened a meeting of 16 experts plus invited observers from industry to discuss and where possible reach consensus on the most appropriate methods to measure and monitor blood glucose in critically ill patients and on how glycemic control should be assessed and reported. Where consensus could not be reached, recommendations on further research and data needed to reach consensus in the future were suggested. Recognizing their clear conflict of interest, industry observers played no role in developing the consensus or recommendations from the meeting. Consensus recommendations were agreed for the measurement and reporting of glycemic control in clinical trials and for the measurement of blood glucose in clinical practice. Recommendations covered the following areas: How should we measure and report glucose control when intermittent blood glucose measurements are used? What are the appropriate performance standards for intermittent blood glucose monitors in the ICU? Continuous or automated intermittent glucose monitoring - methods and technology: can we use the same measures for assessment of glucose control with continuous and intermittent monitoring? What is acceptable performance for continuous glucose monitoring systems? If implemented, these recommendations have the potential to minimize the discrepancies in the conduct and reporting of clinical trials and to improve glucose control in clinical practice. Furthermore, to be fit for use, glucose meters and continuous monitoring systems must match their performance to fit the needs of patients and clinicians in the intensive care setting. See related commentary by Soto-Rivera and Agus, http://ccforum.com/content/17

  10. Evaluation of the efficacy of an hyaluronic acid-based biogel on periodontal clinical parameters. A randomized-controlled clinical pilot study

    PubMed Central

    Pilloni, Andrea; Annibali, Susanna; Dominici, Francesco; Di Paolo, Carlo; Papa, Marco; Cassini, Maria Antonietta; Polimeni, Antonella

    2012-01-01

    Summary Hyaluronic acid (HA) is an ubiquitous form of non-sulphated glycosaminoglycan of the extracellular matrix of all mammalian connective tissues. It is mainly present during tissue’s formation or during most of initial tissue’s repair processess. Cell migration, adhesion and differentiation are only part of several unique biological characteristics of HA which have been under investigation in the past decades. Aim of the study Evaluate the possible positive effect of an esterified form of HA on gingival tissues in mild chronic periodontitis patients, seeking for the reduction of all the periodontal disease clinical parameters PLI (Plaque Index), BOP (Bleeding on Probing), PPD (Probing Pocket Depth), GI (Gingival Index), PAL (Probing Attachment Level). Materials and methods The study is an open, intra-patient, controlled, single center pilot clinical trial including 19 adult patients with mild chronic periodontitis and shallow pockets (< 4 mm) in at least two different quadrants. One quadrant was treated with HA gel after regular toothbrushing (test), the other without (control). Results Although oral hygiene itself had a similar positive influence on the improvement of all the clinical indexes for test and control, the treatment with HA gel showed a greater effect almost always statistically significant. BOP in the HA gel treated areas had a decrease of 92.7% and GI of 96.5%, whereas controls 75.8% and 79.0% respectively. The difference of PPD in both areas was statistically significant (p<0.01) in favour of the HA gel treated zone. Also PAL and Pl were reduced more with gel than with oral hygiene alone, although this did not reach a statistical significant difference. Conclusion It appears that an esterified gel form of HA has shown an effect in reducing the gingival inflammation when used as an adjunct to mechanical home plaque control and that it could be successfully used to improve the periodontal clinical indexes. This pilot study will gain

  11. Clinical effects of undershirts coated with borage oil on children with atopic dermatitis: a double-blind, placebo-controlled clinical trial.

    PubMed

    Kanehara, Shoko; Ohtani, Toshio; Uede, Koji; Furukawa, Fukumi

    2007-12-01

    It has been reported that gamma-linolenic acid contained in borage oil is effective against atopic dermatitis. The clinical effects of undershirts coated with borage oil rich in gamma-linolenic acid on atopic dermatitis were evaluated. Thirty-two children, aged 1-10 years, were involved in the clinical control study. Sixteen had worn undershirts coated with borage oil everyday for 2 weeks, and 16 had worn non-coated undershirts as a placebo. Their symptoms were assessed on a 4-point scale. Those children who had worn undershirts coated with borage oil for 2 weeks showed improvements in their erythema and itch, which were statistically significant. Transepidermal water loss from the back was decreased. In the placebo group, there were no statistically significant differences. The undershirts coated with borage oil were found to be statistically effective, and had no side-effects on children with mild atopic dermatitis. PMID:18078406

  12. Clinical effects of undershirts coated with borage oil on children with atopic dermatitis: a double-blind, placebo-controlled clinical trial.

    PubMed

    Kanehara, Shoko; Ohtani, Toshio; Uede, Koji; Furukawa, Fukumi

    2007-12-01

    It has been reported that gamma-linolenic acid contained in borage oil is effective against atopic dermatitis. The clinical effects of undershirts coated with borage oil rich in gamma-linolenic acid on atopic dermatitis were evaluated. Thirty-two children, aged 1-10 years, were involved in the clinical control study. Sixteen had worn undershirts coated with borage oil everyday for 2 weeks, and 16 had worn non-coated undershirts as a placebo. Their symptoms were assessed on a 4-point scale. Those children who had worn undershirts coated with borage oil for 2 weeks showed improvements in their erythema and itch, which were statistically significant. Transepidermal water loss from the back was decreased. In the placebo group, there were no statistically significant differences. The undershirts coated with borage oil were found to be statistically effective, and had no side-effects on children with mild atopic dermatitis.

  13. ASSOCIATION BETWEEN URINARY MUTAGENICITY AND RISK OF COLORECTAL ADENOMAS IN A CLINIC-BASED CASE-CONTROL STUDY

    EPA Science Inventory

    ASSOCIATION BETWEEN URINARY MUTAGENICITY AND RISK OF COLORECTAL ADENOMAS IN A CLINIC-BASED CASE-CONTROL STUDY

    Humans are exposed to a variety of mutagens from diet, smoking, or occupation. To explore if exposure to mutagens was related to the risk of colorectal adenomas i...

  14. Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

    ERIC Educational Resources Information Center

    Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

    2016-01-01

    Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

  15. A Brief Experimental Analysis of Reinforcer and Response Dimensions Related to Self-Control in an Outpatient Clinic

    ERIC Educational Resources Information Center

    Falcomata, Terry S.; Cooper-Brown, Linda J.; Wacker, David P.; Gardner, Andrew W.; Boelter, Eric W.

    2010-01-01

    We conducted an assessment of self-control and impulsivity with 9 children referred to an outpatient clinic for impulsive, inattentive, and hyperactive behaviors. Each condition of the assessment consisted of a choice between 2 concurrently presented math or writing tasks, with 1 alternative reflecting impulsive responding and 1 alternative…

  16. Physician and patient characteristics associated with clinical inertia in blood pressure control.

    PubMed

    Harle, Christopher A; Harman, Jeffrey S; Yang, Shuo

    2013-11-01

    Clinical inertia, the failure to adjust antihypertensive medications during patient visits with uncontrolled hypertension, is thought to be a common problem. This retrospective study used 5 years of electronic medical records from a multispecialty group practice to examine the association between physician and patient characteristics and clinical inertia. Hierarchical linear models (HLMs) were used to examine (1) differences in physician and patient characteristics among patients with and without clinical inertia, and (2) the association between clinical inertia and future uncontrolled hypertension. Overall, 66% of patients experienced clinical inertia. Clinical inertia was associated with one physician characteristic, patient volume (odds ratio [OR]=0.998). However, clinical inertia was associated with multiple patient characteristics, including patient age (OR=1.021), commercial insurance (OR=0.804), and obesity (OR=1.805). Finally, patients with clinical inertia had 2.9 times the odds of uncontrolled hypertension at their final visit in the study period. These findings may aid the design of interventions to reduce clinical inertia.

  17. A comparative evaluation of the efficacy of probiotic and chlorhexidine mouthrinses on clinical inflammatory parameters of gingivitis: A randomized controlled clinical study

    PubMed Central

    Nadkerny, Purnima Vidyesh; Ravishankar, Potluri Leela; Pramod, Virupapuram; Agarwal, Lavanya Abhay; Bhandari, Saurabh

    2015-01-01

    Background: The aim of our clinical trial was to assess and compare the antiplaque and anti-inflammatory potential of a probiotic mouthwash with 0.2% chlorhexidine and saline. Materials and Methods: A randomized parallel group study was designed for a period of 4 weeks on 45 systemically healthy subjects between 20 and 30 years having chronic gingivitis. The study population was divided into three groups. Group A - 15 subjects were advised experimental (probiotic) mouthwash. Group B - 15 subjects were advised positive control (chlorhexidine) mouthwash and Group C - 15 subjects into a negative control group (normal saline). Oral prophylaxis was done for all groups at baseline. After the proper oral hygiene instructions, all the three groups were instructed to rinse their mouth with 10 ml of their respective mouthrinse, undiluted for 1 min twice daily, 30 min after brushing. Clinical parameters such as plaque index (PI), gingival index (GI), and oral hygiene index simplified (OHI-S) were assessed at baseline, 2 weeks and 4 weeks, respectively. Results: At day 28, the PI, GI, and OHI-S were significantly reduced by all treatment modalities ranking probiotic and chlorhexidine is greater than saline. Conclusion: The probiotic mouthrinses tested was effectively used as an adjunct to mechanical plaque control in the prevention of plaque and gingivitis. Thus, the probiotic mouthrinse has a great therapeutic potential. PMID:26941513

  18. Treatment of clinical endometritis in dairy cows by previously used controlled internal drug release devices.

    PubMed

    Eslami, Mohsen; Bolourchi, Mahmoud; Seifi, Hesam A; Asadi, Farzad; Akbari, Rahmat

    2015-08-01

    Postpartum endometritis is considered as one of the diseases that lead to a potential profit reduction in dairy cows. The aims of the present study were to promote follicle growth by a previously used controlled internal drug release (CIDR) device and to evaluate its effect on the likelihood of recovery and the reproductive performance of clinical endometritis (CE) cows. Endometritis was diagnosed using ultrasonographic examination at 31 ± 3 (Day 0 of the experiment) days in milk, and CE cows were included in one of the three experimental groups according to the presence of a CL on their ovaries. Cows without CL on their ovaries received a reused CIDR device, which was previously used for 14 days (CIDR-14, n = 108), or PGF2α (PG-1, n = 112) on Day 0. In the third group, those with CL on their ovaries received PGF2α (PG-2, n = 107) at the same time. Ovarian structures, serum estradiol and progesterone concentrations were measured on Days 0, 7, and 14. Controlled internal drug release devices were removed, and response to treatment was evaluated in all treated cows on Day 14. Diameters of ovarian follicles were 11.61 ± 0.50, 12.46 ± 0.25, and 18.36 ± 0.60 mm on Day 7 and 11.63 ± 0.58, 14.35 ± 0.40, and 21.96 ± 0.77 mm on Day 14 in PG-1, PG-2, and CIDR-14 cows, respectively (P < 0.05). Serum estradiol concentrations were higher in CIDR-14 cows (141.17 ± 1.04 pg/mL) than in PG-1 (116.85 ± 1.05 pg/mL) and PG-2 (119.10 ± 1.05 pg/mL) cows on Day 7 (P < 0.05). Higher progesterone concentrations were observed in PG-2 cows than in PG-1 and CIDR-14 cows on Days 0, 7, and 14 (P < 0.001). The likelihood of clinical cure was 54.46%, 62.61%, and 64.81% in PG-1, PG-2, and CIDR-14 cows, respectively (P = 0.11). First-service conception risk, days to the first service, calving to conception interval, proportion of cows bred and pregnant by 120 days in milk did not differ among the treated groups (P > 0.05). The cumulative pregnancy risk was lower in PG-1 (77.67%) cows

  19. Albumin in Burn Shock Resuscitation: A Meta-Analysis of Controlled Clinical Studies

    PubMed Central

    Greenhalgh, David G.; Wilkes, Mahlon M.

    2016-01-01

    Critical appraisal of outcomes after burn shock resuscitation with albumin has previously been restricted to small relatively old randomized trials, some with high risk of bias. Extensive recent data from nonrandomized studies assessing the use of albumin can potentially reduce bias and add precision. The objective of this meta-analysis was to determine the effect of burn shock resuscitation with albumin on mortality and morbidity in adult patients. Randomized and nonrandomized controlled clinical studies evaluating mortality and morbidity in adult patients receiving albumin for burn shock resuscitation were identified by multiple methods, including computer database searches and examination of journal contents and reference lists. Extracted data were quantitatively combined by random-effects meta-analysis. Four randomized and four nonrandomized studies with 688 total adult patients were included. Treatment effects did not differ significantly between the included randomized and nonrandomized studies. Albumin infusion during the first 24 hours showed no significant overall effect on mortality. However, significant statistical heterogeneity was present, which could be abolished by excluding two studies at high risk of bias. After those exclusions, albumin infusion was associated with reduced mortality. The pooled odds ratio was 0.34 with a 95% confidence interval of 0.19 to 0.58 (P < .001). Albumin administration was also accompanied by decreased occurrence of compartment syndrome (pooled odds ratio, 0.19; 95% confidence interval, 0.07–0.50; P < .001). This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited, and additional trials are needed. PMID:25426807

  20. Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial

    PubMed Central

    Ang, Dennis C.; Hilligoss, Janna; Stump, Timothy

    2014-01-01

    Objectives Compared to healthy controls, patients with fibromyalgia (FM) have more mast cells in the skin. Whether mast cells are involved in the pathogenesis of FM is unclear. We sought to determine the effects of a mast cell stabilizer (ketotifen) on FM symptoms. Methods Fifty-one FM subjects were randomized to daily oral ketotifen 2 mg BID (n=24) for 8 weeks or placebo (N=27). Mean age of subjects was 51.2 years (standard deviation/SD 8.4); 88% were female and 88% were white; 22% were taking concomitant opiates; and mean pressure pain sensitivity (range 0-20) was 10.0 (0.4). At study entry, the weekly average pain intensity was 6.4 (1.1) and the mean score on the Revised Fibromyalgia Impact Questionnaire (FIQR) was 66.8 (14.0). Results We found no statistically significant treatment group differences from baseline in either group for the two primary measures: weekly average pain intensity [ketotifen −1.3 (1.9) vs. placebo −1.5 (1.9), p=0.7]; and FIQR score [−12.1 (19.5) vs. −12.2 (18.1), p=0.9]. No secondary outcome measures (BPI pain intensity, and pressure pain sensitivity) reached statistical significance; results did not differ in the intent-to-treat and completer analyses. Other than transient sedation [6 (28.6%) vs. 1 (4.0%)], ketotifen was well tolerated. Discussion The study results question whether skin mast cells play a major role in the pathogenesis of FM. However, given the role of mast cells in peripheral and central nociception, and the minimal side effects of ketotifen, a randomized clinical trial using increasing doses of ketotifen may be warranted. PMID:25370135

  1. Clinical significance of hyperhomocysteinemia in infective endocarditis: A case-control study.

    PubMed

    Iossa, Domenico; Molaro, Rosa; Andini, Roberto; Parrella, Antonio; Ursi, Maria Paola; Mattucci, Irene; De Vincentiis, Lucia; Dialetto, Giovanni; Utili, Riccardo; Durante-Mangoni, Emanuele

    2016-09-01

    Blood coagulation plays a key role in the pathogenesis of infective endocarditis (IE). Conditions associated with thrombophilia could enhance IE vegetation formation and promote embolic complications.In this study, we assessed prevalence, correlates, and clinical consequences of hyper-homocysteinemia (h-Hcy) in IE.Homocysteine (Hcy) plasma levels were studied in 246 IE patients and 258 valvular heart disease (VHD) patients, as well as in 106 healthy controls.IE patients showed Hcy levels comparable to VHD patients (14.9 [3-81] vs 16 [5-50] μmol/L, respectively; P = 0.08). H-Hcy was observed in 48.8% of IE patients and 55.8% of VHD (P = 0.13). Vegetation size and major embolic complications were not related to Hcy levels. IE patients with h-Hcy had a higher prevalence of chronic kidney disease and a higher 1-year mortality (19.6% vs 9.9% in those without h-Hcy; OR 2.21 [1.00-4.89], P = 0.05). However, at logistic regression analysis, h-Hcy was not an independent predictor of 1-year mortality (OR 1.87 [95% CI 0.8-4.2]; P = 0.13).Our data suggest h-Hcy in IE is common, is related to a worse renal function, and may be a marker of cardiac dysfunction rather than infection. H-Hcy does not appear to favor IE vegetation formation or its symptomatic embolic complications. PMID:27684846

  2. Efficacy of Thermotherapy to Treat Cutaneous Leishmaniasis: A Meta-Analysis of Controlled Clinical Trials

    PubMed Central

    2015-01-01

    Introduction The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power. Objective To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis. Methods A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality. The reproducibility and completeness were guaranteed in the information search and extraction. Heterogeneity, sensitivity and publication bias were assessed by graphical methods (Galbraith, L'Abblé, funnel plot, Egger plot, and influence plot) and analytical methods (DerSimonian-Laird, Begg and Egger). Random-effects forest plots were constructed, and a cumulative meta-analysis was performed. Results Eight studies were included with 622 patients who underwent thermotherapy, with an efficacy of 73.2% (95% confidence interval (CI) = 69.6-76.7%), and with 667 patients who underwent systemic treatment, with an efficacy of 70.6% (95% CI=67.1-74.1%). Heterogeneity between studies, good sensitivity for the combined measure, and no publication bias were observed. The relative risk for comparison of the efficacy of treatment was 1.02 (95%CI=0.91, 1.15), showing that the effectiveness of thermotherapy is equal to that of pentavalent antimonial drugs. Conclusion Due to its efficacy, greater safety and lower cost, thermotherapy should be the first treatment option for cutaneous leishmaniasis in areas where the prevalence of the mucocutaneous form is low and in patients with contraindications to systemic treatment, such as kidney, liver and heart diseases, as well as in pregnant women, infants, and patients with human immunodeficiency virus infection/acquired immune deficiency syndrome. PMID:26009885

  3. An evaluation of the infection control potential of a UV clinical podiatry unit

    PubMed Central

    2014-01-01

    Background Infection control is a key issue in podiatry as it is in all forms of clinical practice. Airborne contamination may be particularly important in podiatry due to the generation of particulates during treatment. Consequently, technologies that prevent contamination in podiatry settings may have a useful role. The aims of this investigation were twofold, firstly to determine the ability of a UV cabinet to protect instruments from airborne contamination and secondly to determine its ability to remove microbes from contaminated surfaces and instruments. Method A UV instrument cabinet was installed in a University podiatry suite. Impact samplers and standard microbiological techniques were used to determine the nature and extent of microbial airborne contamination. Sterile filters were used to determine the ability of the UV cabinet to protect exposed surfaces. Artificially contaminated instruments were used to determine the ability of the cabinet to remove microbial contamination. Results Airborne bacterial contamination was dominated by Gram positive cocci including Staphylococcus aureus. Airborne fungal levels were much lower than those observed for bacteria. The UV cabinet significantly reduced (p < 0.05) the observed levels of airborne contamination. When challenged with contaminated instruments the cabinet was able to reduce microbial levels by between 60% to 100% with more complex instruments e.g. clippers, remaining contaminated. Conclusions Bacterial airborne contamination is a potential infection risk in podiatry settings due to the presence of S. aureus. The use of a UV instrument cabinet can reduce the risk of contamination by airborne microbes. The UV cabinet tested was unable to decontaminate instruments and as such could pose an infection risk if misused. PMID:24576315

  4. A Promising Approach to Effectively Reduce Cramp Susceptibility in Human Muscles: A Randomized, Controlled Clinical Trial

    PubMed Central

    Behringer, Michael; Moser, Markus; McCourt, Molly; Montag, Johannes; Mester, Joachim

    2014-01-01

    Background To investigate if the cramp threshold frequency (CTF) can be altered by electrical muscle stimulation in a shortened position. Methods A total of 15 healthy male sport students were randomly allocated to an intervention (IG, n = 10) and a non-treatment control group (CG, n = 5). Calf muscles of both legs in the IG were stimulated equally twice a week over 6 weeks. The protocol was 3×5 s on, 10 s off, 150 µs impulse width, 30 Hz above the individual CTF, and was at 85% of the maximal tolerated stimulation energy. One leg was stimulated in a shortened position, inducing muscle cramps (CT), while the opposite leg was fixated in a neutral position at the ankle, hindering muscle cramps (nCT). CTF tests were performed prior to the first and 96 h after the 6th (3 w) and 12th (6 w) training session. Results After 3 w, the CTF had significantly (p<0.001) increased in CT calves from 23.3±5.7 Hz to 33.3±6.9 Hz, while it remained unchanged in nCT (pre: 23.6±5.7 Hz, mid: 22.3±3.5 Hz) and in both legs of the CG (pre: 21.8±3.2 Hz, mid: 22.0±2.7 Hz). Only CT saw further insignificant increases in the CTF. The applied stimulation energy (mA2 • µs) positively correlated with the effect on the CTF (r = 0.92; p<0.001). Conclusions The present study may be useful for developing new non-pharmacological strategies to reduce cramp susceptibility. Trial Registry German Clinical Trials Register DRKS00005312 PMID:24727897

  5. A systematic review of controlled clinical trials on the prevention of back pain in industry.

    PubMed Central

    van Poppel, M N; Koes, B W; Smid, T; Bouter, L M

    1997-01-01

    OBJECTIVE: To assess the effectiveness of lumbar supports, education, and exercise in the prevention of back pain in industry. METHODS: A computerised search for controlled clinical trials was conducted. A criteria list was used to assess the methodological quality of the studies. The available evidence for the effectiveness of the interventions was graded with a rating system for the level of evidence. Effect sizes of individual studies were combined if the studies were sufficiently similar. RESULTS: 11 studies were identified for the review. The methodological quality of all studies was low, with a maximum score of three out of seven for internal validity. There was no evidence for the effectiveness of lumbar supports due to contradictory outcomes of the studies. Five of the six studies on education reported no effect. Thus there is limited evidence that education does not help to prevent back pain. All three studies on exercise reported a positive result, indicating limited evidence for the effectiveness of exercise. The combined effect size for exercise was 0.53, which is a medium sized effect. CONCLUSIONS: Although widely used, there is little evaluative research on the preventive measures studied here. The review showed that there is limited evidence that exercise has some effect in the prevention of back pain and that education is not effective. No conclusive evidence was found for or against the effectiveness of lumbar supports. Research of higher methodological quality is needed before firm conclusions on the effectiveness of lumbar supports, education, and exercise in the prevention of back pain in industry can be drawn. PMID:9470890

  6. Experience-Based Quality Control of Clinical Intensity-Modulated Radiotherapy Planning

    SciTech Connect

    Moore, Kevin L.; Brame, R. Scott; Low, Daniel A.; Mutic, Sasa

    2011-10-01

    Purpose: To incorporate a quality control tool, according to previous planning experience and patient-specific anatomic information, into the intensity-modulated radiotherapy (IMRT) plan generation process and to determine whether the tool improved treatment plan quality. Methods and Materials: A retrospective study of 42 IMRT plans demonstrated a correlation between the fraction of organs at risk (OARs) overlapping the planning target volume and the mean dose. This yielded a model, predicted dose = prescription dose (0.2 + 0.8 [1 - exp(-3 overlapping planning target volume/volume of OAR)]), that predicted the achievable mean doses according to the planning target volume overlap/volume of OAR and the prescription dose. The model was incorporated into the planning process by way of a user-executable script that reported the predicted dose for any OAR. The script was introduced to clinicians engaged in IMRT planning and deployed thereafter. The script's effect was evaluated by tracking {delta} = (mean dose-predicted dose)/predicted dose, the fraction by which the mean dose exceeded the model. Results: All OARs under investigation (rectum and bladder in prostate cancer; parotid glands, esophagus, and larynx in head-and-neck cancer) exhibited both smaller {delta} and reduced variability after script implementation. These effects were substantial for the parotid glands, for which the previous {delta} = 0.28 {+-} 0.24 was reduced to {delta} = 0.13 {+-} 0.10. The clinical relevance was most evident in the subset of cases in which the parotid glands were potentially salvageable (predicted dose <30 Gy). Before script implementation, an average of 30.1 Gy was delivered to the salvageable cases, with an average predicted dose of 20.3 Gy. After implementation, an average of 18.7 Gy was delivered to salvageable cases, with an average predicted dose of 17.2 Gy. In the prostate cases, the rectum model excess was reduced from {delta} = 0.28 {+-} 0.20 to {delta} = 0.07 {+-} 0

  7. A Randomized Controlled Trial of Online versus Clinic-Based CBT for Adolescent Anxiety

    ERIC Educational Resources Information Center

    Spence, Susan H.; Donovan, Caroline L.; March, Sonja; Gamble, Amanda; Anderson, Renee E.; Prosser, Samantha; Kenardy, Justin

    2011-01-01

    Objective: The study examined the relative efficacy of online (NET) versus clinic (CLIN) delivery of cognitive behavior therapy (CBT) in the treatment of anxiety disorders in adolescents. Method: Participants included 115 clinically anxious adolescents aged 12 to 18 years and their parent(s). Adolescents were randomly assigned to NET, CLIN, or…

  8. Sleep deprivation impairs inhibitory control during wakefulness in adult sleepwalkers.

    PubMed

    Labelle, Marc-Antoine; Dang-Vu, Thien Thanh; Petit, Dominique; Desautels, Alex; Montplaisir, Jacques; Zadra, Antonio

    2015-12-01

    Sleepwalkers often complain of excessive daytime somnolence. Although excessive daytime somnolence has been associated with cognitive impairment in several sleep disorders, very few data exist concerning sleepwalking. This study aimed to investigate daytime cognitive functioning in adults diagnosed with idiopathic sleepwalking. Fifteen sleepwalkers and 15 matched controls were administered the Continuous Performance Test and Stroop Colour-Word Test in the morning after an overnight polysomnographic assessment. Participants were tested a week later on the same neuropsychological battery, but after 25 h of sleep deprivation, a procedure known to precipitate sleepwalking episodes during subsequent recovery sleep. There were no significant differences between sleepwalkers and controls on any of the cognitive tests administered under normal waking conditions. Testing following sleep deprivation revealed significant impairment in sleepwalkers' executive functions related to inhibitory control, as they made more errors than controls on the Stroop Colour-Word Test and more commission errors on the Continuous Performance Test. Sleepwalkers' scores on measures of executive functions were not associated with self-reported sleepiness or indices of sleep fragmentation from baseline polysomnographic recordings. The results support the idea that sleepwalking involves daytime consequences and suggest that these may also include cognitive impairments in the form of disrupted inhibitory control following sleep deprivation. These disruptions may represent a daytime expression of sleepwalking's pathophysiological mechanisms. PMID:26087833

  9. Sleep deprivation impairs inhibitory control during wakefulness in adult sleepwalkers.

    PubMed

    Labelle, Marc-Antoine; Dang-Vu, Thien Thanh; Petit, Dominique; Desautels, Alex; Montplaisir, Jacques; Zadra, Antonio

    2015-12-01

    Sleepwalkers often complain of excessive daytime somnolence. Although excessive daytime somnolence has been associated with cognitive impairment in several sleep disorders, very few data exist concerning sleepwalking. This study aimed to investigate daytime cognitive functioning in adults diagnosed with idiopathic sleepwalking. Fifteen sleepwalkers and 15 matched controls were administered the Continuous Performance Test and Stroop Colour-Word Test in the morning after an overnight polysomnographic assessment. Participants were tested a week later on the same neuropsychological battery, but after 25 h of sleep deprivation, a procedure known to precipitate sleepwalking episodes during subsequent recovery sleep. There were no significant differences between sleepwalkers and controls on any of the cognitive tests administered under normal waking conditions. Testing following sleep deprivation revealed significant impairment in sleepwalkers' executive functions related to inhibitory control, as they made more errors than controls on the Stroop Colour-Word Test and more commission errors on the Continuous Performance Test. Sleepwalkers' scores on measures of executive functions were not associated with self-reported sleepiness or indices of sleep fragmentation from baseline polysomnographic recordings. The results support the idea that sleepwalking involves daytime consequences and suggest that these may also include cognitive impairments in the form of disrupted inhibitory control following sleep deprivation. These disruptions may represent a daytime expression of sleepwalking's pathophysiological mechanisms.

  10. ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

    PubMed

    Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

    2012-03-01

    In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts.

  11. Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy

    PubMed Central

    FERES, Magda; GURSKY, Lauren Christine; FAVERI, Marcelo; TSUZUKI, Claudia Ota; FIGUEIREDO, Luciene Cristina

    2009-01-01

    Aim To compare the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with mechanical (professional plaque control - PPC) or chemical (chlorhexidine rinsing - CHX) control of supragingival plaque in the treatment of chronic periodontitis. Methods Sixty subjects were randomly assigned to receive SRP alone or combined with PPC (twice a week) or with CHX rinsing (twice a day). The adjunctive treatments began with SRP and continued for 42 days. Clinical and microbiological examinations were performed at baseline, 2 and 6 months post-therapy. Subgingival plaque samples were analyzed for 38 bacterial species by checkerboard DNA-DNA hybridization. Results The two test treatments were more effective in improving probing depth and clinical attachment level (CAL) than SRP alone, even in intermediate and deep sites. CAL gain was better maintained in the CHX group. The most beneficial microbiological changes were observed in CHX-treated subjects, who showed a significant reduction in the proportions of red and orange complexes, as well as an increase in the proportions of the host-compatible bacterial species. Conclusion Strict plaque control performed during and after SRP improves periodontal treatment outcomes. The greatest microbiological and clinical benefits were observed with the use of CHX rinsing. PMID:19703236

  12. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study

    PubMed Central

    Teughels, Wim; Durukan, Andaç; Ozcelik, Onur; Pauwels, Martine; Quirynen, Marc; Haytac, Mehmet Cenk

    2013-01-01

    Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol 2013; 40: 1025–1035. doi: 10.1111/jcpe.12155. AimThe aim of this randomized placebo-controlled clinical trial was to evaluate the effects of Lactobacillus reuteri-containing probiotic lozenges as an adjunct to scaling and root planing (SRP). Material and MethodsThirty chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, 3, 6, 9 and 12 weeks after therapy. All patients received one-stage full-mouth disinfection and randomly assigned over a test (SRP + probiotic, n = 15) or control (SRP + placebo, n = 15) group. The lozenges were used two times a day for 12 weeks. ResultsAt week 12, all clinical parameters were significantly reduced in both groups, while there was significantly more pocket depth reduction (p < 0.05) and attachment gain (p < 0.05) in moderate and deep pockets; more Porphyromonas gingivalis reduction was observed in the SRP + probiotic group. ConclusionsThe results indicate that oral administration of L. reuteri lozenges could be a useful adjunct to SRP in chronic periodontitis. PMID:24164569

  13. Environmental risk factors for clinical malaria: a case-control study in the Grau region of Peru.

    PubMed

    Guthmann, J P; Hall, A J; Jaffar, S; Palacios, A; Lines, J; Llanos-Cuentas, A

    2001-01-01

    The role of environmental risk factors in clinical malaria has been studied mainly in Africa and Asia, few investigations have been carried out in Latin America. Field observations in northern coastal Peru, where the prevalence of malaria is high during the agricultural season, suggested that the risk of disease varied according to the characteristics of the house and the house environment. Environmental determinants of the risk of clinical malaria were therefore investigated through a case-control study: 323 clinical cases of malaria, recruited through community-based active case-finding, and 969 age-, sex- and village-matched controls were recruited into the study over a period of 12 months ending June 1997. Residual spraying of houses in the previous 6 months, living more than 100 m from a canal, a level of education equal to primary school or above and working in agriculture conferred significant protection from the risk of developing clinical malaria. The presence of spaces between the wall and roof in the subject's bedroom (eaves) and a house aged > 4 years statistically significantly increased the risk of disease. Based on these results we discuss possible control measures for malaria in this area of the country.

  14. The clinical effects of red blood cell transfusions: an overview of the randomized controlled trials evidence base.

    PubMed

    Wilkinson, Kirstin L; Brunskill, Susan J; Dorée, Carolyn; Hopewell, Sally; Stanworth, Simon; Murphy, Mike F; Hyde, Chris

    2011-04-01

    No up-to-date overview of randomized controlled trials (RCTs) in red blood cell (RBC) transfusion exists. This systematic review examines the quantity and quality of the evidence for the clinical effects of RBC transfusion. One hundred forty-two eligible RCTs were identified through searches of The Cochrane Library (issue 4, 2009), MEDLINE (1950 to November 2009), EMBASE (1974 to November 2009), and other relevant sources. After data extraction and methodological quality assessment, trials were grouped by clinical specialty and type of RBC transfusion. Data analysis was predominantly descriptive. The 142 RCTs covered 11 specialties and 10 types of RBC transfusion. The number of included patients varied widely across the RCTs (median, 57; IQ range, 27-167). Most trials were single center comparing 2 parallel study arms. Overall, the reporting of methodological assessment was poor, although it improved markedly from 2001. Clinical areas with few trials are highlighted. Comparison with a study of RBC use in clinical practice highlighted a lack of correlation between the size of the evidence base for a given clinical specialty and the proportion of total RBC use by that clinical specialty. The gaps in the evidence base and the poor methodology of trials particularly in the past do not provide a strong evidence base for the use of RBC transfusions, but they indicate important targets for future research. PMID:21345644

  15. Clinical and antimicrobial efficacy of a controlled-release device containing chlorhexidine in the treatment of chronic periodontitis.

    PubMed

    Pattnaik, S; Anand, N; Chandrasekaran, S C; Chandrashekar, L; Mahalakshmi, K; Satpathy, A

    2015-10-01

    A controlled-release device (CRD) containing chlorhexidine gluconate, such as PerioCol(™)CG (Eucare Pharmaceuticals Pvt. Ltd,, Chennai, India), for subgingival application has little reported data with clinical as well as antimicrobial efficacy. This study evaluated clinical and subgingival microbial changes on using indigenously developed PerioCol™CG as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis. Forty posterior first molar sites having probing pocket depth ≥ 5 mm were selected and divided into two groups, with 20 sites in each group, in a split-mouth design. Group A (test site) was treated with SRP and PerioCol(™)CG, while group B (control site) was treated with SRP alone. Subgingival microbial samples were collected at baseline and 1 month after the initial SRP, while probing depth (PD), clinical attachment level (CAL) and gingival index (GI) were recorded at baseline, after 1 month and after 3 months. Microbial detection of Porphyromonas gingivalis (P. gingivalis) and Tannerella forsythia (T. forsythia) was done by means of polymerase chain reaction (PCR). A significant improvement was observed in all clinical measures in sites treated with PerioCol(™)CG as compared to the control sites during the study period. Also, there was a statistically significant reduction in the proportion of occurrence of P. gingivalis and T. forsythia after intervention in test sites as compared to control sites. Our data suggest that SRP combined with subgingival administration of PerioCol™CG has a significantly better and prolonged effect compared to SRP alone on the PD, clinical attachment loss and elimination of periodontopathogens.

  16. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    PubMed Central

    Stegink-Jansen, Caroline W.

    2015-01-01

    Introduction. Patients with chronic lateral elbow (LE) tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1) to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE) for patients with chronic LE tendinopathy, and (2) to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment. Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities. Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows) were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows) or EE treatment (56 elbows). Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments. Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047) and in maximum grip strength (p = 0.008) than EE subjects. Astym therapy also resolved 20/21 (95.7%) of the EE non-responders, who showed improvements in DASH scores (p < 0.005), pain with activity (p = 0.002), and function (p = 0.004) following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported. Conclusion. This study

  17. The effect of student self-video of performance on clinical skill competency: a randomised controlled trial.

    PubMed

    Maloney, Stephen; Storr, Michael; Morgan, Prue; Ilic, Dragan

    2013-03-01

    Emerging technologies and student information technology literacy are enabling new methods of teaching and learning for clinical skill performance. Facilitating experiential practice and reflection on performance through student self-video, and exposure to peer benchmarks, may promote greater levels of skill competency. This study examines the impact of student self-video on the attainment of clinical skills. A total of 60 Physiotherapy students (100%) consented to participate in the randomised controlled trial. One group (50%) was taught a complex clinical skill with regular practical tutoring, whilst the other group (50%) supplemented the tutoring with a self-video task aimed at promoting reflection on performance. Student skill performance was measured in an objective structured clinical examination (OSCE). Students also completed an anonymous questionnaire, which explored their perception of their learning experiences. Students received significantly higher scores in the OSCE when the examined clinical skill had been supplemented with a self-video of performance task (P = 0.048). Descriptive analysis of the questionnaires relating to student perceptions on the teaching methods identified that the self-video of performance task utilised contributed to improvement in their clinical performance and their confidence for future clinical practice. Students identified a number of aspects of the submission process that contributed to this perception of educational value. The novel results of this study demonstrate that greater clinical skill competency is achieved when traditional tutoring methods are supplemented with student self-video of performance tasks. Additional benefits included the ability of staff and students to monitor longitudinal performance, and an increase in feedback opportunities.

  18. Dose escalation with overdose control using a quasi-continuous toxicity score in cancer Phase I clinical trials.

    PubMed

    Chen, Zhengjia; Tighiouart, Mourad; Kowalski, Jeanne

    2012-09-01

    Escalation with overdose control (EWOC) is a Bayesian adaptive design for selecting dose levels in cancer Phase I clinical trials while controlling the posterior probability of exceeding the maximum tolerated dose (MTD). EWOC has been used by clinicians to design many cancer Phase I clinical trials, see e.g. [1-4]. However, this design treats the toxicity response as a binary indicator of dose limiting toxicity (DLT) and does not account for the number and specific grades of toxicities experienced by patients during the trial. Chen et al. (2010) proposed a novel toxicity score system to fully utilize all toxicity information using a normalized equivalent toxicity score (NETS). In this paper, we propose to incorporate NETS into EWOC using a quasi-Bernoulli likelihood approach to design cancer Phase I clinical trials. We call the design escalation with overdose control using normalized equivalent toxicity score (EWOC-NETS). Simulation results show that this design has good operating characteristics and improves the accuracy of MTD, trial efficiency, therapeutic effect, and overdose control relative to EWOC which is used as a representative of designs treating toxicity response as a binary indicator of DLT. We illustrate the performance of this design using real trial data in identifying the Phase II dose. PMID:22561391

  19. Dual Release Paracetamol in Osteoarthritis of Knee: A Randomized Controlled Clinical Trial

    PubMed Central

    Raj, D. Gokul; Sharma, Ateet B.; Swami B., Mallikarjun; Batra, Sumit; Acharya, Apurv; Maroo, Sanjaykumar H.; Patel, Ketan R.; Prajapati, Vipul

    2014-01-01

    Background: Paracetamol is recommended as first line agent for pain management in osteoarthritis (OA) by various guidelines. The main problem associated with management of osteoarthritis is long term patient compliance to paracetamol due to its frequent dosing. Objective: To evaluate the efficacy and safety of Paracetamol 650 mg dual release tablet twice daily (PCM 650 dual release) compared to paracetamol 500mg immediate release tablet thrice daily (PCM 500 IR) in the treatment of Knee OA. Materials and Methods: In this randomized, open label, parallel, active controlled clinical study, 250 patients of OA knee meeting inclusion criteria were randomized to receive either PCM 650 dual release two times daily or PCM 500 IR three times daily for 6 weeks. Patients were assessed at baseline, 2, 4 and 6 weeks. Primary efficacy measures were severity of pain (Visual Analogue Scale) and Knee injury and osteoarthritis outcome score (KOOS) subscale for pain at week 2, 4 and 6. Other KOOS subscales (symptoms other than pain, function in daily living, function in sport and recreation, quality of life) and patient’s and physicians global assessment of therapy were included as secondary endpoints. Results: Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving PCM 650 dual release showed significant improvement of pain in both primary endpoints at each study visit compared to patients receiving PCM 500 IR (p<0.001). PCM 650 dual release was significantly superior to PCM 500 IR for improvement in all KOOS subscales at each study visit (p<0.01). Less number of patients required additional rescue analgesics in PCM 650 dual release group (16% patients vs 26%, PCM 500 IR; p>0.05). Adverse effects were significantly less in PCM 650 dual release group (6% vs. 14% in PCM 500 IR; p<0.05). Patient’s and physician’s global assessment of therapy favoured PCM 650 dual release than PCM 500 IR (p<0.001). Conclusion: Patients with

  20. The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs.

    PubMed

    Vray, Muriel; Hamelin, Bernard; Jaillon, Patrice

    2005-01-01

    The respective roles of controlled clinical trials and observational studies (cohort or case-control studies) in evaluating the efficacy, safety and usefulness of a drug were analysed. A randomised, controlled, double-blind study is the best method of estimating the efficacy of a treatment. It provides the least biased and most robust estimate of the causal relationship. In certain situations and on the basis of certain criteria, observational studies can have a proof-of-efficacy value. Randomised, controlled, pre- and postmarketing authorisation (MA) clinical studies identify the rarer adverse effects and compare them with those resulting from the reference treatment. Before the MA, the pooled safety data from different controlled trials can provide an estimation of relatively frequent adverse events and subjects at risk. However, an observational study is the most appropriate method of evaluating the safety of a drug in the currently used conditions. By definition, a drug influences the health of a population if it directly or indirectly improves its health. A drug would have a major role in public health if it reduced mortality or morbidity related to a particular disease or if it improved the quality of life of patients with this disease. Prior to marketing a product, modelling is the approach of choice to quantify the expected effect. Pragmatic, postmarketing trials and observational studies are the reference methods used to define the population affected, the efficacy and safety of the drug in a real situation and its usefulness for public health. In conclusion, randomised clinical trials remain the reference approach for evaluating efficacy, while observational studies have a confirmatory value. Observational studies are the most appropriate way of evaluating safety in the currently used conditions, as the clinical trial has limited indications. In the interests of public health, modelling is the pre-marketing approach of choice, while pragmatic trials and

  1. Two-year clinical evaluation of resin composite in posterior teeth: A randomized controlled study

    PubMed Central

    Gianordoli-Neto, Ranulfo; Padovani, Gislaine Cristina; Mondelli, José; de Lima Navarro, Maria Fidela; Mendonça, Juliano Sartori; Santiago, Sérgio Lima

    2016-01-01

    Background: Clinical evaluations as fundamental method to prove the efficiency of restorative materials. Aim: This study evaluated the clinical performance of restorative systems during 2 years of clinical service. Materials and Methods: This study assessed the clinical performance of restorative systems (Filtek Z250 and P60), during 2 years of clinical service, using the US Public Health Service system. The randomized and double-blind study comprising thirty volunteers. The restorations were evaluated at baseline, 6, 12, and 24 months. It was used the following criteria: marginal discoloration (MD), marginal integrity (MI), superficial texture (ST), wear (W), postoperative sensitivity (PS) and recurrent caries (RC). Results: Statistic analysis was performed using Fisher's and McNemar's exact tests and Pearsons's Chi-square in a significance level of 5%. The results at baseline and 24 months for Group I were: MD – 100, 100%; MI – 100, 88.6%; ST – 100, 94.3%; W – 100, 94.3%; PS – 100, 100%; RC – 100, 100%, of alpha scores; Group II: MD – 100, 97.1%; MI – 100, 91.4%; ST – 100, 94.3%; W – 100, 91.4%; PS – 100, 100%; RC – 100, 100%, of alpha scores. It was observed no statistical difference in the evaluated criteria and period. Conclusions: After 24 months of evaluation, both restorative systems exhibited acceptable clinical performance. PMID:27563176

  2. Building a web-based tool to support clinical decisions in the control of Chlamydia trachomatis and Neisseria gonorrhoeae infections.

    PubMed

    Zhao, Kun; Qiu, Fasheng; Chen, Guantao

    2013-12-20

    Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the agents of two common, sexually transmitted diseases afflicting women in the United States (http://www.cdc.gov). We designed a novel web-based application that offers simple recommendations to help optimize medical outcomes with CT and GC prevention and control programs. This application takes population groups, prevalence rates, parameters for available screening assays and treatment regimens (costs, sensitivity, and specificity), as well as budget limits as inputs. Its output suggests optimal screening and treatment strategies for selected at-risk groups, commensurate with the clinic's budget allocation. Development of this tool illustrates how a clinical informatics application based on rigorous mathematics might have a significant impact on real-world clinical issues. PMID:24564848

  3. Established rheumatoid arthritis: rationale for best practice: physicians' perspective of how to realise tight control in clinical practice.

    PubMed

    Horton, S C; Walsh, C A E; Emery, P

    2011-08-01

    Developments in the understanding of the pathogenesis of rheumatoid arthritis (RA) and the introduction of targeted biologic therapies have greatly advanced the management of RA in clinical practice. The management of RA is now aimed at achieving remission, to prevent joint damage and disability. In particular, a critical period early in disease is recognised, in which early aggressive treatment with disease-modifying therapy is advocated. Although a state of remission is the ideal, this chapter discusses the difficulties which may arise in achieving this goal in patients with established disease. The evidence for best management, aimed at achieving clinical remission in established disease, is reviewed. The consequences of incomplete control of chronic inflammation in established disease, including pain, disability and co-morbidities (such as cardiovascular disease and osteoporosis), also pose a significant clinical challenge. The rationale for a multidisciplinary team approach in reducing the associated morbidity and mortality of the disease are examined.

  4. Validity of self-reported sleep bruxism among myofascial temporomandibular disorder patients and controls.

    PubMed

    Raphael, K G; Janal, M N; Sirois, D A; Dubrovsky, B; Klausner, J J; Krieger, A C; Lavigne, G J

    2015-10-01

    Sleep bruxism (SB), primarily involving rhythmic grinding of the teeth during sleep, has been advanced as a causal or maintenance factor for a variety of oro-facial problems, including temporomandibular disorders (TMD). As laboratory polysomnographic (PSG) assessment is extremely expensive and time-consuming, most research testing this belief has relied on patient self-report of SB. The current case-control study examined the accuracy of those self-reports relative to laboratory-based PSG assessment of SB in a large sample of women suffering from chronic myofascial TMD (n = 124) and a demographically matched control group without TMD (n = 46). A clinical research coordinator administered a structured questionnaire to assess self-reported SB. Participants then spent two consecutive nights in a sleep laboratory. Audiovisual and electromyographic data from the second night were scored to assess whether participants met criteria for the presence of 2 or more (2+) rhythmic masticatory muscle activity episodes accompanied by grinding sounds, moderate SB, or severe SB, using previously validated research scoring standards. Contingency tables were constructed to assess positive and negative predictive values, sensitivity and specificity, and 95% confidence intervals surrounding the point estimates. Results showed that self-report significantly predicted 2+ grinding sounds during sleep for TMD cases. However, self-reported SB failed to significantly predict the presence or absence of either moderate or severe SB as assessed by PSG, for both cases and controls. These data show that self-report of tooth grinding awareness is highly unlikely to be a valid indicator of true SB. Studies relying on self-report to assess SB must be viewed with extreme caution.

  5. Randomized controlled clinical trial of long-term chemo-mechanical caries removal using PapacarieTM gel

    PubMed Central

    MOTTA, Lara Jansiski; BUSSADORI, Sandra Kalil; CAMPANELLI, Ana Paula; da SILVA, André Luis; ALFAYA, Thays Almeida; de GODOY, Camila Haddad Leal; NAVARRO, Maria Fidela de Lima

    2014-01-01

    Objectives Compare the effectiveness of PapacarieTM gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings. Material and Methods A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with PapacarieTM and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations. Results No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment. Conclusion PapacarieTM is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia. PMID:25141203

  6. Clinical efficacy and safety of Chinese herbal medicine for Wilson's disease: a systematic review of 9 randomized controlled trials.

    PubMed

    Wang, Yan; Xie, Cheng-long; Fu, Deng-lei; Lu, Lin; Lin, Yan; Dong, Qi-qian; Wang, Xiao-tong; Zheng, Guo-qing

    2012-06-01

    Wilson's disease is an autosomal recessive disorder of copper metabolism. Despite being treatable, there is no universally accepted treatment regimen. Currently, various Chinese herbal medicines (CHMs) are widely used in the treatment of Wilson's disease in China, but there is a lack of reliable scientific evidence for the effectiveness of such therapies. The objective of this systematic review is to assess the clinical efficacy and safety of CHM as an alternative or/and adjuvant therapy for Wilson's disease. A systematic literature search in different medical databases was performed to identify randomized controlled trials comparing CHM as monotherapy or CHM as adjuvant therapy with western conventional medical therapy in the treatment of Wilson's disease. A total of 687 participants were included in nine eligible studies. The main findings are that CHM as monotherapy or adjuvant therapy for Wilson's disease may be able to improve the clinical symptoms, to promote the urinary copper excretion, to ameliorate liver function and/or liver cirrhosis, and has fewer adverse effects in comparison with western conventional medication. Furthermore, CHM generally appeared to be safe and well tolerated in patients with Wilson's disease. However, the evidence presented in this review are insufficient to warrant a clinical recommendation due to the generally low methodological quality of the included studies. In conclusion, CHM seems to be beneficial and safe for Wilson's disease, but high-quality evidences are still needed to further evaluate this therapy. Therefore, additional well-designed, randomized, placebo-controlled clinical trials are needed.

  7. A Clinical Tool to Measure Trunk Control in Children with Cerebral Palsy: The Trunk Control Measurement Scale

    ERIC Educational Resources Information Center

    Heyrman, Lieve; Molenaers, Guy; Desloovere, Kaat; Verheyden, Geert; De Cat, Jos; Monbaliu, Elegast; Feys, Hilde

    2011-01-01

    In this study the psychometric properties of the Trunk Control Measurement Scale (TCMS) in children with cerebral palsy (CP) were examined. Twenty-six children with spastic CP (mean age 11 years 3 months, range 8-15 years; Gross Motor Function Classification System level I n = 11, level II n = 5, level III n = 10) were included in this study. To…

  8. How to Respond to a Paranoid Thought: A Comparison of Patients With Clinically Relevant Delusions and Healthy Controls in Chile.

    PubMed

    Wüsten, Caroline; Lincoln, Tania M

    2015-09-01

    Although paranoid thoughts occur frequently in the population, most people do not develop clinically relevant delusions. The main purpose of the study was to explore whether participants without a mental disorder will respond in a more functional way to paranoid thoughts and be more flexible in their cognitive processes than patients with clinically relevant delusions. The Responses to Paranoid Thoughts Scale was translated into Spanish and was completed by patients (n = 36) and healthy controls (n = 39) in Chile (South America). The Beck Cognitive Insight Scale was used to assess cognitive insight. The patients responded in a more depressive, physical, and concealing way to paranoid thoughts than the healthy controls. Moreover, they showed significantly less cognitive insight and self-reflectiveness. Higher cognitive insight and self-reflectiveness were associated with more normalizing and communicative responses to paranoid thoughts.

  9. Ant colony method to control variance reduction techniques in the Monte Carlo simulation of clinical electron linear accelerators

    NASA Astrophysics Data System (ADS)

    García-Pareja, S.; Vilches, M.; Lallena, A. M.

    2007-09-01

    The ant colony method is used to control the application of variance reduction techniques to the simulation of clinical electron linear accelerators of use in cancer therapy. In particular, splitting and Russian roulette, two standard variance reduction methods, are considered. The approach can be applied to any accelerator in a straightforward way and permits, in addition, to investigate the "hot" regions of the accelerator, an information which is basic to develop a source model for this therapy tool.

  10. Clinical signs and household characteristics associated with human fascioliasis among rural population in Egypt: a case-control study.

    PubMed

    Curtale, F; Mas-Coma, S; Hassanein, Y A El Wahab; Barduagni, P; Pezzotti, P; Savioli, L

    2003-03-01

    The symptomatology associated with human fascioliasis has been studied mostly in hospitalised subjects. Very little is known about clinical signs and symptoms associated with infections in human endemic zones, as well as on possible new ways of transmission which might be responsible for the increased number of human cases reported in recent years. This information is of great importance to facilitate diagnosis and plan effective control measures. With the objective to identify clinical signs, blood tests, household characteristics and hygienic habits associated with human fascioliasis, a cross-sectional case-control study was implemented among the rural population of three endemic foci in the Nile Delta, Egypt. Clinical history was collected from 53 cases of fascioliasis and the same number of individually matched controls. They received a complete clinical examination and a range of blood tests was performed on them. Information on socio-economic conditions, dietary and hygienic habits was also collected. The most important complaints, associated with the infection, were right abdominal pain (Odds Ratio 20, P = 0.005), epigastric burning (o.r. 16, P = 0.007) and nausea (o.r. 8, P = 0.05). Blood analyses reported a marked increase in blood eosinophils (o.r 1.3, P = 0.001) among cases. The presence of cows (o.r 3.2), buffaloes (o.r 3.0) and goats (o.r 2.6) in the household was closely associated with the infection together with the habit to bring those animals to the canal for bathing and/or drinking (o.r. 3.2). Among dietary habits investigated, eating raw seeds was more common in cases than controls (o.r. 9, P = 0.03) and emerged as a possible new way of infection.

  11. Relations of Anxiety Sensitivity, Control Beliefs, and Maternal Over-Control to Fears in Clinic-Referred Children with Specific Phobia

    PubMed Central

    Kane, Elisabeth J; Braunstein, Kara; Ollendick, Thomas H.; Muris, Peter

    2014-01-01

    The relations of fear to anxiety sensitivity, control beliefs, and maternal overprotection were examined in 126 7- to 13-year-old clinically referred children with specific phobias. Results indicated that anxiety sensitivity and control beliefs were significant predictors of children’s fear levels, accounting for approximately 48% of the total variance. Unexpectedly, age, gender, and maternal overprotection did not emerge as significant predictors of fear in the overall sample. In subsequent analyses, anxiety sensitivity was found to be a consistent, significant predictor for both girls and boys, for both younger and older children, and for children with and without an additional anxiety disorder diagnosis. Control beliefs were only a significant predictor for girls, younger children, and children with an additional anxiety diagnosis. Maternal overprotection was not a significant predictor for any group. Children with an additional anxiety disorder diagnosis had higher levels of fear, anxiety sensitivity, and maternal overprotection, as well as lower levels of control beliefs than the non-additional anxiety disorder subgroup. Future directions and clinical implications are explored. PMID:26273182

  12. Control of Clinical Pathogens by the Haemolymph of Paratelphusa hydrodromous, a Freshwater Crab

    PubMed Central

    Arul Prakash, A.; Balasubramanian, S.; Gunasekaran, G.; Prakash, M.; Senthil Raja, P.

    2011-01-01

    In the present study, effort has been made to find the antimicrobial activity of haemolymph collected from freshwater crab, Paratelphusa hydrodromous. The haemolymph collected was tested for antimicrobial assay by disc diffusion method against clinical pathogens. Five bacterial species, namely, Escherichia coli, Klebsiella pneumonia, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus, and five fungal strains, namely and Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, Rhizopus sp., and Mucor sp., were selected for the study. The result shows a strong response of haemolymph against the clinical pathogens which confirms the immune mechanism of the freshwater crab. PMID:22084719

  13. A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL evidence -based medicine course

    PubMed Central

    2010-01-01

    Background and objectives Evidence-based health care requires clinicians to engage with use of evidence in decision-making at the workplace. A learner-centred, problem-based course that integrates e-learning in the clinical setting has been developed for application in obstetrics and gynaecology units. The course content uses the WHO reproductive health library (RHL) as the resource for systematic reviews. This project aims to evaluate a clinically integrated teaching programme for incorporation of evidence provided through the WHO RHL. The hypothesis is that the RHL-EBM (clinically integrated e-learning) course will improve participants' knowledge, skills and attitudes, as well as institutional practice and educational environment, as compared to the use of standard postgraduate educational resources for EBM teaching that are not clinically integrated. Methods The study will be a multicentre, cluster randomized controlled trial, carried out in seven countries (Argentina, Brazil, Democratic Republic of Congo, India, Philippines, South Africa, Thailand), involving 50-60 obstetrics and gynaecology teaching units. The trial will be carried out on postgraduate trainees in the first two years of their training. In the intervention group, trainees will receive the RHL-EBM course. The course consists of five modules, each comprising self-directed e-learning components and clinically related activities, assignments and assessments, coordinated between the facilitator and the postgraduate trainee. The course will take about 12 weeks, with assessments taking place pre-course and 4 weeks post-course. In the control group, trainees will receive electronic, self-directed EBM-teaching materials. All data collection will be online. The primary outcome measures are gain in EBM knowledge, change in attitudes towards EBM and competencies in EBM measured by multiple choice questions (MCQs) and a skills-assessing questionniare administered eletronically. These questions have been

  14. Out of control little-used clinical assets are draining healthcare budgets.

    PubMed

    Horblyuk, Ruslan; Kaneta, Kristopher; McMillen, Gary L; Mullins, Christopher; O'Brien, Thomas M; Roy, Ankita

    2012-07-01

    To improve utilization and reduce the cost of maintaining mobile clinical equipment, healthcare organization leaders should do the following: Select an initial asset group to target. Conduct a physical inventory. Evaluate the organization's asset "ecosystem." Optimize workflow processes. Phase in new processes, and phase out inventory. Devote time to change management. Develop a replacement strategy.

  15. [Examination of the knee joint. The value of clinical findings in arthroscopic control].

    PubMed

    Steinbrück, K; Wiehmann, J C

    1988-01-01

    Purely clinical examination of the knee joint can, at best, only be regarded as a "screening procedure". Diagnosis with the aid of apparatus (sonography, arthrography, CT, NMR) produces better results. However, arthroscopy performed by an experienced examiner confirms the diagnosis in cases of suspected meniscus injury or isolated lesions of the cruciate ligaments and leads to early and therefore optimal therapy. In a retrospective study 300 arthroscopies performed in 1985 were selected and evaluated. In 1986/87, a further 300 patients were clinically examined prospectively, according to the same criteria, and findings were compared with the arthroscopy performed the following day. Clinically, in 287 patients with multiple diagnoses, internal meniscus lesions were diagnosed in 162 cases (54%), external meniscus lesions in 38 (13%), chondropathia patellae in 54 (18%), and old ruptures of the cruciate ligaments in 46 (15%). In 13 patients no diagnosis could be established. Arthroscopically, pathology of the internal meniscus was found in 98 (33%) of the 300 patients, of the external meniscus in 40 (13%), cartilage damage in 103 (34%), old cruciate ligament ruptures in 51 (17%), and recent anterior cruciate ligament ruptures in 156 (52%); in 40 cases findings were normal. At 78%, the highest positive predictive value (proportion of tentative clinical diagnoses confirmed by arthroscopy) was found in cases of old ruptures of the anterior cruciate ligament, followed by external meniscus lesions (61%) and internal meniscus lesions (55%); i.e., only 55 out of 100 clinically suspected internal meniscus lesions are diagnosed by arthroscopy.(ABSTRACT TRUNCATED AT 250 WORDS)

  16. Clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (acronym CLARITY): a multicentre phase IIb randomised active-controlled clinical trial

    PubMed Central

    Sivaprasad, Sobha; Prevost, A Toby; Bainbridge, James; Edwards, Rhiannon Tudor; Hopkins, David; Kelly, Joanna; Luthert, Phil; Murphy, Caroline; Ramu, Jayashree; Sarafraz-Shekary, Negin; Vasconcelos, Joana; White-Alao, Beverley; Hykin, Philip

    2015-01-01

    Introduction Proliferative diabetic retinopathy (PDR) is the main cause of severe visual loss in people with diabetes mellitus. The standard treatment for this condition is panretinal photocoagulation (PRP). This laser treatment is inherently destructive, with predictable adverse effects on visual function, and a safer alternative is required. Intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors can induce short-term regression of retinal neovascularisation. The aim of this randomised controlled trial is to determine the efficacy, safety and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and placental growth factor (PLGF), in PDR, and to investigate the impact on local oxygenation. Methods and analysis This is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of PDR. 220 participants with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or PRP for a period of 52 weeks. The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks. Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness. Ocular and non-ocular adverse events will also be reported over 52 weeks. Ethics and dissemination The study has been approved by the National Research Ethics Service (NRES) committee with respect to scientific content and compliance with applicable research and human subjects’ regulations. Findings will be reported through scientific publications and research conferences. The results of this study will provide clinical evidence for the feasibility, efficacy safety and cost-effectiveness of intravitreal aflibercept for PDR. Trial registration number ISRCTN 32207582. PMID:26369798

  17. Wormwood (Artemisia absinthium) suppresses tumour necrosis factor alpha and accelerates healing in patients with Crohn's disease - A controlled clinical trial.

    PubMed

    Krebs, Simone; Omer, Talib N; Omer, Bilal

    2010-04-01

    Suppression of tumour necrosis factor alpha (TNF-alpha) and other interleukins by wormwood (Artemisia absinthium) extracts were reported recently in in vitro studies. The aim of the present study was to find out if this effect can be also be observed in Crohn's Disease (CD) patients where TNF-alpha appears to play an important role. In a controlled trial, 10 randomly selected patients suffering from CD were given in addition to their basic CD therapy 3x750mg dried powdered wormwood for 6 weeks. Ten patients, also randomly selected who met the inclusion criteria served as control group. Minimum score of 200 on Crohn's Disease Activity Index (CDAI) was required at baseline for inclusion in each group. Patients who received infliximab or similar were excluded from the trial. TNF-alpha level in serum were measured at baseline, and after three and six weeks. During this period all concomitant CD medications was maintained at the baseline dose levels. Average serum TNF-alpha level fell from 24.5+/-3.5pg/ml at baseline to 8.0+/-2.5pg/ml after six weeks. The corresponding levels in the control group were 25.7+/-4.6 (week 0), and 21.1+/-3.2 (week 6). On the clinical side, CDAI scores fell from 275+/-15 to below 175+/-12 in wormwood group with remission of symptoms in eight patients (CDAI score below 170 or reduction by 70 points), compared to only two in the placebo group (CDAI of placebo group 282+/-11 at baseline and 230+/-14 on week 6). IBDQ also reflected accelerated clinical response with wormwood. Of clinical significance were the findings that wormwood also improved mood of the CD patients, as reflected in Hamilton's Depression Scale. These findings provide a base to test wormwood in clinical conditions thought to be mediated by increased production of pro-inflammatory cytokines such as TNF-alpha.

  18. Psychological Distress and Emotional Pain Among Adult Attendees of a Dental Clinic: A Case-Control Study.

    PubMed

    Erinfolami, Adebayo Rasheed; Olagunju, Andrew Toyin; Oshodi, Yewande Olufunmilayo; Akinbode, Abiola Adelphine; Fadipe, Babatunde; Adeyemo, Wasiu Lanre

    2016-05-18

    We set out to carry out a case-control evaluation of psychological distress and emotional pain among adult attendees of a Nigerian dental clinic. A total of 201 subjects, made up of 101 dental patients (test group) matched with age and sex with 100 normal subjects (controls), was recruited into the study. All participants completed a designed socio-demographic questionnaire. General Health Question naire and Psyche ache Assessment Schedule were also administered to assess psychological distress based on cut-off scores ≥3 and emotional pain based on cut-off scores ≥28 respectively. The mean ages of study and control group were 33 (±12) and 36 (±13) years respectively, and both study and control groups were not significantly different in all the assessed socio-demographic parameters. Overall, 21.8% (n=22) of the subjects had psychological distress, while only 7% of the control group had psychological distress. This difference was statistically significant (P=0.003). Similarly, there was significant difference in the experience of psyche ache (unbearable psychological pain) as over a third of the dental patients (37.6%, n=38) had emotional pain, while only 13% of the controls experienced psych ache (P<0.001). In this study, the burden of psychological distress and emotional pain was many-fold in dental patients when compared with the controls. PMID:27403272

  19. Psychological Distress and Emotional Pain Among Adult Attendees of a Dental Clinic: A Case-Control Study

    PubMed Central

    Erinfolami, Adebayo Rasheed; Olagunju, Andrew Toyin; Oshodi, Yewande Olufunmilayo; Akinbode, Abiola Adelphine; Fadipe, Babatunde; Adeyemo, Wasiu Lanre

    2016-01-01

    We set out to carry out a case-control evaluation of psychological distress and emotional pain among adult attendees of a Nigerian dental clinic. A total of 201 subjects, made up of 101 dental patients (test group) matched with age and sex with 100 normal subjects (controls), was recruited into the study. All participants completed a designed socio-demographic questionnaire. General Health Question naire and Psyche ache Assessment Schedule were also administered to assess psychological distress based on cut-off scores ≥3 and emotional pain based on cut-off scores ≥28 respectively. The mean ages of study and control group were 33 (±12) and 36 (±13) years respectively, and both study and control groups were not significantly different in all the assessed socio-demographic parameters. Overall, 21.8% (n=22) of the subjects had psychological distress, while only 7% of the control group had psychological distress. This difference was statistically significant (P=0.003). Similarly, there was significant difference in the experience of psyche ache (unbearable psychological pain) as over a third of the dental patients (37.6%, n=38) had emotional pain, while only 13% of the controls experienced psych ache (P<0.001). In this study, the burden of psychological distress and emotional pain was many-fold in dental patients when compared with the controls. PMID:27403272

  20. Using Statistical Process Control to Make Data-Based Clinical Decisions.

    ERIC Educational Resources Information Center

    Pfadt, Al; Wheeler, Donald J.

    1995-01-01

    Statistical process control (SPC), which employs simple statistical tools and problem-solving techniques such as histograms, control charts, flow charts, and Pareto charts to implement continual product improvement procedures, can be incorporated into human service organizations. Examples illustrate use of SPC procedures to analyze behavioral data…

  1. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    PubMed

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.

  2. Effects of Family-Center Empowerment Model on the Lifestyle of Heart Failure Patients: A Randomized Controlled Clinical Trial

    PubMed Central

    Rakhshan, Mahnaz; Kordshooli, Khadijeh Rahimi; Ghadakpoor, Soraya

    2015-01-01

    Background: Cardiovascular diseases are the most prevalent disorders in developed countries and heart failure is the major one among them. This disease is caused by numerous factors and one of the most considerable risk factors is unhealthy lifestyle. So the aim of this research was to study the effect of family-center empowerment model on the lifestyle of heart failure patients. Methods: This is a randomized controlled clinical trial on 70 heart failure patients referring to Hazrate Fatemeh heart clinic in Shiraz. After convenience sampling the patients were divided into two control and intervention groups using block randomization Method. The intervention based on family-center empowerment model was performed during 5 sessions. Research tools are lifestyle and demographic information questionnaires. Results: Both intervention and control groups were similar regarding their demographic information (P>0.001). Before the intervention on lifestyle, all measures of the two groups were equal (P>0.001) but after the intervention; statistically significant differences were reported in all dimensions of lifestyle, the total lifestyle score in the intervention group was 70.09±16.38 and in the control group -6.03±16.36 (P<0.001). Conclusion: Performing the family-center empowerment model for heart failure patients is practically possible, leading to improvement or refinement of their and their families’ lifestyle. Trial Registration Number: IRCT 2014072018468N3 PMID:26448952

  3. Bacillary angiomatosis and bacillary peliosis in patients infected with human immunodeficiency virus: clinical characteristics in a case-control study.

    PubMed

    Mohle-Boetani, J C; Koehler, J E; Berger, T G; LeBoit, P E; Kemper, C A; Reingold, A L; Plikaytis, B D; Wenger, J D; Tappero, J W

    1996-05-01

    Clinical characteristics associated with bacillary angiomatosis and bacillary peliosis (BAP) in patients with human immunodeficiency virus (HIV) infection were evaluated in a case-control study; 42 case-patients and 84 controls were matched by clinical care institution. Case-patients presented with fever (temperature, > 37.8 degrees C; 93%), a median CD4 lymphocyte count of 21/mm3, cutaneous or subcutaneous vascular lesions (55%), lymphadenopathy (21%), and/or abdominal symptoms (24%). Many case-patients experienced long delays between medical evaluation and diagnosis of BAP (median, 4 weeks; range, 1 day to 24 months). Case-patients were more likely than controls to have fever, lymphadenopathy, hepatomegaly, splenomegaly, a low CD4 lymphocyte count, anemia, or an elevated serum level of alkaline phosphatase (AP) (P < .001). In multivariate analysis, a CD4 lymphocyte count of < 200/mm3 (matched odds ratio [OR], 9.9; P < .09), anemia reflected by a hematocrit value of < 0.36 (OR, 19.7; P < .04), and an elevated AP level of > or = 2.6 mukat/L (OR, 23.9; P < .05) remained associated with disease after therapy with zidovudine was controlled for. BAP should be considered an AIDS-defining opportunistic infection and should be included in the differential diagnosis for febrile, HIV-infected patients with cutaneous or osteolytic lesions, lymphadenopathy, abdominal symptoms, anemia, or an elevated serum level of AP.

  4. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    PubMed

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach. PMID:26132048

  5. EFFECT OF A DENTIFRICE CONTAINING ALOE VERA ON PLAQUE AND GINGIVITIS CONTROL. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

    PubMed Central

    de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

    2008-01-01

    The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) – dentifrice containing Aloe vera - or the control group (n=15) – fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice. PMID:19089263

  6. Effect of Massage Therapy on Vital Signs and GCS Scores of ICU Patients: A Randomized Controlled Clinical Trial

    PubMed Central

    Vahedian-Azimi, Amir; Ebadi, Abbas; Asghari Jafarabadi, Mohammad; Saadat, Soheil; Ahmadi, Fazlollah

    2014-01-01

    Background: Unalleviated complications related to hospitalization, including stress, anxiety, and pain, can easily influence different structures, like the neural system, by enhancing the stimulation of sympathetic nervous pathways and causing unstable vital signs and deterioration in the level of consciousness. Objectives: The purpose of this study was to determine the effects of massage therapy by family members on vital signs and Glasgow Coma Scale Score (GCS) of patients hospitalized in the Intensive Care Unit (ICU). Patients and Methods: This randomized controlled clinical trial was conducted at the ICU of the Shariati Hospital during 2012; 45 ICU patients and 45 family members in the experimental group and the same number of patients and family members in the control group were consecutively selected . The data collection instrument consisted of two parts. The first part included demographic data (age, marital status and Body Mass Index) and the second part included a checklist to record the patient’s vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR)) and GCS. All measurements were done at the same time in both groups before the intervention (full body massage therapy), and 1 hour, 2 hours, 3 hours, and 4 hours after intervention. The patients were provided with a 60-minute full body massage The massage protocol included static, surface tension, stretching, superficial lymph unload, transverse friction, and myofacial releasing techniques. Results: Significant differences were observed between experimental and control groups in the SBP at 1 hour, SBP 2 hours, and SBP 3 hours, and also in GCS at 1 hour to GCS at 4 hours (P < 0.05). Multivariate analysis revealed a significant difference between experimental and control groups in SBP at all time points (P < 0.05). Conclusions: Massage via family members had several positive effects on the patients’ clinical conditions, and therefore, it should

  7. Effectiveness of a clinical intervention in improving pain control in outpatients with cancer treated by radiation therapy

    SciTech Connect

    Vallieres, Isabelle . E-mail: isabelle.vallieres@mail.chuq.qc.ca; Aubin, Michele; Blondeau, Lucie; Simard, Serge; Giguere, Anik

    2006-09-01

    Purpose: To determine the effectiveness of a multicomponent clinical intervention to reduce pain in outpatients with cancer. Methods and Materials: Sixty-four patients were randomly assigned to receive either a clinical intervention including an information session, the use of a pain diary, and the possibility to contact a physician to adjust the pain medication, or the usual treatment of pain by the staff radiation oncologist. All patients reported their average and worst pain levels at baseline and 2 and 3 weeks after the start of the intervention. Results: The study groups were similar with respect to their baseline characteristics and pain levels at randomization. After 3 weeks, the average and worst pain experienced by patients randomized to the clinical intervention group was significantly inferior to the average pain experienced by patients in the control group (2.9/10 vs. 4.4/10 and 4.2/10 vs. 5.5/10, respectively). Results showed that the experimental group patients decreased their pain levels more than the control group patients did over time. Conclusion: An intervention including patient education, a pain diary, and defining a procedure for therapeutic adjustments can be effective to improve pain relief in outpatients with cancer.

  8. Effectiveness of Mini Implants in Three-Dimensional Control During Retraction - A Clinical Study

    PubMed Central

    Victor, Deepak; Prabhakar, Ramchandra; Karthikeyan, M.K.; Saravanan, R.; Vanathi, P.; Vikram, N. Raj; Reddy, P. Adarsh; Sudeepthi, M.

    2014-01-01

    Introduction: Three-dimensional control throughout the orthodontic treatment is essential for uncompromised results. Mini screws introduced for orthodontic anchorage has given the clinician an option of absolute three dimensional control. The purpose of this study was to compare and measure the vertical control and torque control of incisors and molar during enmass retraction with titanium microimplants and conventional molar anchorage. Material and Methods: Twenty patients were selected with extraction of all first premolars and bonded with 0.022″ slot MBT system. After aligning and leveling, all subjects were placed with 0.019″ X 0.025″ posted SS wire with standardized torquing curve. The 20 subjects were randomly divided into 2 groups consisting of 10 each (Group A & Group B). Group A subjects, implants were placed and Group B formed the control group. Retraction was carried out using NiTi closed coil springs. The assessment of the vertical and torque control of incisors and tipping and vertical control of molars was done by radiographic method using lateral cephalogram taken before and after retraction. Results: The torque control of incisors, P11 value in group A and B indicated no significant difference. The molar tip, P12 value in group A indicated that there was distal tipping of molars while the P12 in group B indicated mesial tipping. On vertical plane P21, P22 and P23 values in Group A indicated that there was intrusion of incisors and molars while value in Group B indicated extrusion of incisors and molars. Conclusion: Three dimensional control is better in the implant group compared to the non implant group. Therefore the implant group definitely has citied advantages over conventional method. PMID:24701541

  9. Oral Zinc Sulfate as Adjuvant Treatment in Children With Nephrolithiasis: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Yousefichaijan, Parsa; Cyrus, Ali; Dorreh, Fatemeh; Rafeie, Mohammad; Sharafkhah, Mojtaba; Frohar, Faryar; Safi, Fatemeh

    2015-01-01

    Background: Nephrolithiasis in children is associated with a high rate of complications and recurrence. Objectives: Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. Patients and Methods: This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups). Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day) oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment) assessing size and number of stones in the kidneys. Results: Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84) (P = 0.001) and size (cm) (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39) (P = 0.001) of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P < 0.0001) in a way that the decrease in the intervention group showed no difference with the control group. Conclusions: Adjuvant treatment with zinc is not more effective than consecutive treatment in children with nephrolithiasis. However, further studies are recommended due to the lack of clinical evidence in this field. PMID:26635934

  10. Clinical experiences utilizing wireless remote control and an ASP model backup archive for a disaster recovery event

    NASA Astrophysics Data System (ADS)

    Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

    2004-04-01

    tested. Radiologists were able to successfully query PACS images utilizing a wireless handheld device from the ASP backup archive at IPIL and route the PACS images directly to a second clinical site at UCLA where they and the patients are located at that time. In a disaster scenario, using a wireless device, radiologists at the disaster health care center can route PACS data from an ASP backup archive server to be reviewed in a live clinical PACS environment at a secondary site. This solution allows Radiologists to use a wireless handheld device to control the image workflow and to review PACS images during a major disaster event where patients must be moved to a secondary site.

  11. Field trial of a Caryospora species vaccine for controlling clinical coccidiosis in falcons.

    PubMed

    Forbes, N A; Fox, M T

    2005-01-29

    A Caryospora species vaccine was prepared and used in an attempt to prevent infection and associated morbidity in falcons. A blind field trial was conducted, involving a vaccinated group of 20 birds and two control groups of seven and four birds, which were subsequently challenged with a live mixed-species vaccine. There was a statistically significant reduction in morbidity and shedding of oocysts in the vaccinated group compared with the control groups.

  12. Plasmid-Based Materials as Multiplex Quality Controls and Calibrators for Clinical Next-Generation Sequencing Assays.

    PubMed

    Sims, David J; Harrington, Robin D; Polley, Eric C; Forbes, Thomas D; Mehaffey, Michele G; McGregor, Paul M; Camalier, Corinne E; Harper, Kneshay N; Bouk, Courtney H; Das, Biswajit; Conley, Barbara A; Doroshow, James H; Williams, P Mickey; Lih, Chih-Jian

    2016-05-01

    Although next-generation sequencing technologies have been widely adapted for clinical diagnostic applications, an urgent need exists for multianalyte calibrator materials and controls to evaluate the performance of these assays. Control materials will also play a major role in the assessment, development, and selection of appropriate alignment and variant calling pipelines. We report an approach to provide effective multianalyte controls for next-generation sequencing assays, referred to as the control plasmid spiked-in genome (CPSG). Control plasmids that contain approximately 1000 bases of human genomic sequence with a specific mutation of interest positioned near the middle of the insert and a nearby 6-bp molecular barcode were synthesized, linearized, quantitated, and spiked into genomic DNA derived from formalin-fixed, paraffin-embedded-prepared hapmap cell lines at defined copy number ratios. Serial titration experiments demonstrated the CPSGs performed with similar efficiency of variant detection as formalin-fixed, paraffin-embedded cell line genomic DNA. Repetitive analyses of one lot of CPSGs 90 times during 18 months revealed that the reagents were stable with consistent detection of each of the plasmids at similar variant allele frequencies. CPSGs are designed to work across most next-generation sequencing methods, platforms, and data analysis pipelines. CPSGs are robust controls and can be used to evaluate the performance of different next-generation sequencing diagnostic assays, assess data analysis pipelines, and ensure robust assay performance metrics. PMID:27105923

  13. Inulin controls inflammation and metabolic endotoxemia in women with type 2 diabetes mellitus: a randomized-controlled clinical trial.

    PubMed

    Dehghan, Parvin; Gargari, Bahram Pourghassem; Jafar-Abadi, Mohammad Asghari; Aliasgharzadeh, Akbar

    2014-02-01

    There is limited evidence on the effects of prebiotics on inflammation. Therefore, the aim of this study was to evaluate the effects of inulin supplementation on inflammatory indices and metabolic endotoxemia in patients with type 2 diabetes mellitus. The participants included diabetic females (n = 49). They were divided into an intervention group (n = 24) as well as a control group (n = 25) and received 10 g/d inulin or maltodextrin for 8 weeks, respectively. Fasting blood sugar (FBS), HbA1c, insulin, high-sensitive C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), interleukin-10 (IL-10), and plasma lipopolysaccharide (LPS) were measured pre and post intervention. Inulin-supplemented patients exhibited a significant decrease in FBS (8.5%), HbA1c (10.4%), fasting insulin (34.3%), homeostasis model assessment of insulin resistance (HOMA-IR) (39.5%), hs-CRP (35.6%), TNF-α (23.1%), and LPS (27.9%) compared with the maltodextrin group (p < 0.05). Increase in IL-10 was not significant in inulin compared with the maltodextrin group. It can be concluded that inulin supplementation seems to be able to modulate inflammation and metabolic endotoxemia in women with type 2 diabetes.

  14. Application of sigma metrics for the assessment of quality control in clinical chemistry laboratory in Ghana: A pilot study

    PubMed Central

    Afrifa, Justice; Gyekye, Seth A.; Owiredu, William K. B. A.; Ephraim, Richard K. D.; Essien-Baidoo, Samuel; Amoah, Samuel; Simpong, David L.; Arthur, Aaron R.

    2015-01-01

    Background: Sigma metrics provide a uniquely defined scale with which we can assess the performance of a laboratory. The objective of this study was to assess the internal quality control (QC) in the clinical chemistry laboratory of the University of Cape Cost Hospital (UCC) using the six sigma metrics application. Materials and Methods: We used commercial control serum [normal (L1) and pathological (L2)] for validation of quality control. Metabolites (glucose, urea, and creatinine), lipids [triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C)], enzymes [alkaline phosphatase (ALP), alanine aminotransferase (AST)], electrolytes (sodium, potassium, chloride) and total protein were assessed. Between-day imprecision (CVs), inaccuracy (Bias) and sigma values were calculated for each control level. Results: Apart from sodium (2.40%, 3.83%), chloride (2.52% and 2.51%) for both L1 and L2 respectively, and glucose (4.82%), cholesterol (4.86%) for L2, CVs for all other parameters (both L1 and L2) were >5%. Four parameters (HDL-C, urea, creatinine and potassium) achieved sigma levels >1 for both controls. Chloride and sodium achieved sigma levels >1 for L1 but <1 for L2. In contrast, cholesterol, total protein and AST achieved sigma levels <1 for L1 but >1 for L2. Glucose and ALP achieved a sigma level >1 for both control levels whereas TG achieved a sigma level >2 for both control levels. Conclusion: Unsatisfactory sigma levels (<3) where achieved for all parameters using both control levels, this shows instability and low consistency of results. There is the need for detailed assessment of the analytical procedures and the strengthening of the laboratory control systems in order to achieve effective six sigma levels for the laboratory. PMID:25657495

  15. Rapid progression of intracranial melanoma metastases controlled with combined BRAF/MEK inhibition after discontinuation of therapy: a clinical challenge.

    PubMed

    N Cagney, Daniel; Alexander, Brian M; Hodi, F Stephen; Buchbinder, Elizabeth I; Ott, Patrick A; Aizer, Ayal A

    2016-09-01

    Novel systemic therapies with anti-tumor activity in the brain including small molecules targeting BRAF and MEK, and immune checkpoint inhibition, offer the possibility of improved control of intracranial disease. A number of prospective trials support the judicious use of modern systemic therapies in patients with melanoma and limited brain metastases .The intracranial clinical course of patients who progress extracranially on BRAF/MEK inhibition remains poorly described in the literature. In this report, we highlight a series of clinical cases, with rapid progression of intracranial disease following discontinuation of dabrafenib/trametinib for extracranial disease progression or toxicity, a previously unreported finding in the medical literature with significant implications for patient care.

  16. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study

    PubMed Central

    Rodrigues, Beverly T.; Vangaveti, Venkat N.

    2016-01-01

    Objective. The aim of the study was to evaluate the prevalence of and risk factors for lower limb amputation in a specialist foot clinic-based setting. Methods. A retrospective quantitative study was conducted, using clinical and biochemical profiles of diabetic foot patients attending the High Risk Foot Clinic at The Townsville Hospital, Australia, between January 1, 2011, and December 31, 2013. Results. The total study sample included 129 subjects, comprising 81 males and 48 females with M : F ratio of 1.7 : 1. Twenty-three subjects were Indigenous Australians, representing 17.8% of the study population. The average age of the cohort was 63.4 years ± 14.1 years [CI 90.98–65.89]. Lower limb amputation was identified as a common and significant outcome (n = 44), occurring in 34.1%, more commonly amongst the Indigenous Australians (56.5% versus 29.2%; p = 0.94, OR 0.94). Risk factors most closely associated with amputation included diabetic retinopathy (p = 0.00, OR 4.4), coronary artery bypass graft (CABG) surgery (p = 0.01, OR 4.1), Charcot's arthropathy (p = 0.01, OR 2.9), and Indigenous ethnicity (p = 0.01, OR 3.4). Although average serum creatinine, corrected calcium, and glycosylated haemoglobin A1c (Hba1c) levels were higher amongst amputees they were statistically insignificant. Conclusions. Lower limb amputation is a common outcome and linked to ethnicity and neurovascular diabetic complications amongst subjects with diabetic foot ulcer. Further research is needed to identify why risk of lower limb amputation seems to differ according to ethnicity. PMID:27446962

  17. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study.

    PubMed

    Rodrigues, Beverly T; Vangaveti, Venkat N; Malabu, Usman H

    2016-01-01

    Objective. The aim of the study was to evaluate the prevalence of and risk factors for lower limb amputation in a specialist foot clinic-based setting. Methods. A retrospective quantitative study was conducted, using clinical and biochemical profiles of diabetic foot patients attending the High Risk Foot Clinic at The Townsville Hospital, Australia, between January 1, 2011, and December 31, 2013. Results. The total study sample included 129 subjects, comprising 81 males and 48 females with M : F ratio of 1.7 : 1. Twenty-three subjects were Indigenous Australians, representing 17.8% of the study population. The average age of the cohort was 63.4 years ± 14.1 years [CI 90.98-65.89]. Lower limb amputation was identified as a common and significant outcome (n = 44), occurring in 34.1%, more commonly amongst the Indigenous Australians (56.5% versus 29.2%; p = 0.94, OR 0.94). Risk factors most closely associated with amputation included diabetic retinopathy (p = 0.00, OR 4.4), coronary artery bypass graft (CABG) surgery (p = 0.01, OR 4.1), Charcot's arthropathy (p = 0.01, OR 2.9), and Indigenous ethnicity (p = 0.01, OR 3.4). Although average serum creatinine, corrected calcium, and glycosylated haemoglobin A1c (Hba1c) levels were higher amongst amputees they were statistically insignificant. Conclusions. Lower limb amputation is a common outcome and linked to ethnicity and neurovascular diabetic complications amongst subjects with diabetic foot ulcer. Further research is needed to identify why risk of lower limb amputation seems to differ according to ethnicity. PMID:27446962

  18. Clinical impact of evaluation of cardiovascular control by novel methods of heart rate dynamics.

    PubMed

    Huikuri, Heikki V; Perkiömäki, Juha S; Maestri, Roberto; Pinna, Gian Domenico

    2009-04-13

    Heart rate variability (HRV) has been conventionally analysed with time- and frequency-domain methods, which measure the overall magnitude of RR interval fluctuations around its mean value or the magnitude of fluctuations in some predetermined frequencies. Analysis of heart rate dynamics by novel methods, such as heart rate turbulence after ventricular premature beats, deceleration capacity of heart rate and methods based on chaos theory and nonlinear system theory, have gained recent interest. Recent observational studies have suggested that some indices describing nonlinear heart rate dynamics, such as fractal scaling exponents, heart rate turbulence and deceleration capacity, may provide useful prognostic information in various clinical settings and their reproducibility may be better than that of traditional indices. For example, the short-term fractal scaling exponent measured by the detrended fluctuation analysis method has been shown to predict fatal cardiovascular events in various populations. Similarly, heart rate turbulence and deceleration capacity have performed better than traditional HRV measures in predicting mortality in post-infarction patients. Approximate entropy, a nonlinear index of heart rate dynamics, which describes the complexity of RR interval behaviour, has provided information on the vulnerability to atrial fibrillation. There are many other nonlinear indices which also give information on the characteristics of heart rate dynamics, but their clinical usefulness is not as well established. Although the concepts of nonlinear dynamics, fractal mathematics and complexity measures of heart rate behaviour, heart rate turbulence, deceleration capacity in relation to cardiovascular physiology or various cardiovascular events are still far away from clinical medicine, they are a fruitful area for research to expand our knowledge concerning the behaviour of cardiovascular oscillations in normal healthy conditions as well as in disease states.

  19. Ayurvedic treatment of obesity: a randomised double-blind, placebo-controlled clinical trial.

    PubMed

    Paranjpe, P; Patki, P; Patwardhan, B

    1990-04-01

    Seventy obese subjects were randomised into four groups. Ayurvedic drug treatments were given for three months while one group received a placebo. Physical, clinical and pathological investigations were carried out at regular intervals. A significant weight loss was observed in drug therapy groups when compared with the placebo. Body measurements such as skin fold thickness and hip and waist circumferences were significantly decreased. Decreases in serum cholesterol and triglyceride levels were observed. No side effects of any kind were observed during the treatment period. PMID:2278549

  20. Clinical strategies for complete denture rehabilitation in a patient with Parkinson disease and reduced neuromuscular control.

    PubMed

    Haralur, Satheesh B

    2015-01-01

    The dentist has a large role in geriatric health care for the ever increasing elder population with associated physical and neurological disorders. The Parkinson disease is progressive neurological disorder with resting tremor, bradykinesia, akinesia, and postural instability. The psychological components of disease include depression, anxiety, and cognitive deficiency. Poor oral hygiene, increased susceptibility for dental caries, and periodontal diseases predispose them to early edentulism. The number of Parkinson affected patients visiting dental clinic seeking complete denture is growing. This case report explains the steps involved in the complete denture rehabilitation of Parkinson patient. The effective prosthesis will help in alleviating functional, aesthetic, and psychological disabilities of the patient.

  1. The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

    PubMed

    Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

    2016-06-01

    Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p < 0.001). Pain severity decreased significantly in treatment group after eight weeks of treatment. There was a significant difference in pain intensity between the two groups after eight weeks of treatment and one month after the end of treatment (p < 0.001 for both). A weekly high dose (50 000 IU) oral vit D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.

  2. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

    PubMed

    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  3. NeuroControl of movement: system identification approach for clinical benefit

    PubMed Central

    Meskers, Carel G. M.; de Groot, Jurriaan H.; de Vlugt, Erwin; Schouten, Alfred C.

    2015-01-01

    Progress in diagnosis and treatment of movement disorders after neurological diseases like stroke, cerebral palsy (CP), dystonia and at old age requires understanding of the altered capacity to adequately respond to physical obstacles in the environment. With posture and movement disorders, the control of muscles is hampered, resulting in aberrant force generation and improper impedance regulation. Understanding of this improper regulation not only requires the understanding of the role of the neural controller, but also attention for: (1) the interaction between the neural controller and the “plant”, comprising the biomechanical properties of the musculaskeletal system including the viscoelastic properties of the contractile (muscle) and non-contractile (connective) tissues: neuromechanics; and (2) the closed loop nature of neural controller and biomechanical system in which cause and effect interact and are hence difficult to separate. Properties of the neural controller and the biomechanical system need to be addressed synchronously by the combination of haptic robotics, (closed loop) system identification (SI), and neuro-mechanical modeling. In this paper, we argue that assessment of neuromechanics in response to well defined environmental conditions and tasks may provide for key parameters to understand posture and movement disorders in neurological diseases and for biomarkers to increase accuracy of prediction models for functional outcome and effects of intervention. PMID:26441563

  4. Neutrophil-to-lymphocyte ratio in patients with peripheral vertigo: a prospective controlled clinical study.

    PubMed

    Ozbay, Isa; Kahraman, Cuneyt; Balikci, Hasan Huseyin; Kucur, Cuneyt; Kahraman, Nilufer Kuzeyli; Ozkaya, Derya Pınar; Oghan, Fatih

    2014-01-01

    We aimed to investigate the relationship between peripheral vertigo and inflammation by using the neutrophil-to-lymphocyte ratio (NLR) as an inflammatory marker. We recruited 103 patients with peripheral vertigo (71 women, 32 men; mean age, 39.8 ± 14.7 years) who presented to the Otolaryngology Department of Dumlupinar University Hospital. Vertigo patients with systemic diseases, neurological disorders, malignancy or any inflammatory disease that could alter the NLR were excluded from the study. We also enrolled 103 age- and sex-matched healthy subjects (controls; 82 women, 21 men; mean age, 36.7 ± 13.5 years) who underwent routine checkups in our hospital. The vertigo patients underwent full otolaryngologic and neurologic examinations and audiometric tests to rule out any other pathology causing the peripheral vertigo. NLR was calculated in all subjects and was compared between the patient and control groups. There were no significant differences between the study and control groups in terms of lipid profiles, liver-function tests, white blood cell (WBC) count, hemoglobin level, mean platelet volume, and vitamin B12 and folate levels. The mean NLR was significantly higher in the patients than in the controls (P<0.05). In conclusion, this study, which was the first to investigate the relationship between the NLR and peripheral vertigo, found that the NLR is significantly higher among peripheral vertigo patients than among healthy controls. This result suggests that the NLR is a novel potential marker of stress in peripheral vertigo patients.

  5. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 3: Design considerations.

    PubMed

    Ball, Greg; Silverman, Michael H

    2011-09-01

    Ongoing safety monitoring of clinical trials of investigational treatments must operate at levels that range from the minute and detailed - namely, mathematical treatment of trial data - to the philosophical and societal - namely, ethical concerns for individuals and populations. Between those two poles lies a realm of environmental and pragmatic considerations that reflect the goals, biases, risk-tolerance, and constraints of study sponsors and organizers. These factors, while more difficult to quantify or, at times, to justify, also have a meaningful impact on the approach to safety monitoring and the resulting actions and outcomes. This paper considers the influence and interaction of two such factors, study design and statistical framework, on continuous safety monitoring procedures. Group sequential designs have been generally preferred for clinical trials over continuous sequential designs because of practical considerations. The group means and greater time for deliberation when using a group sequential procedure, as opposed to a continuous sequential procedure, can improve the quality of the analyses with minimal loss in sensitivity. However, undertaking any sequential analysis within a frequentist framework provokes considerable theoretical and practical difficulties. Continuous monitoring with a likelihood based method, on the other hand, has the advantages that all available information, including new data, can be used; sample sizes need not be fixed; and decisions can be made at any time without statistical penalty, irrespective of trial design. Such responsive statistical rules are needed to provide guidance to the human beings charged with trial monitoring.

  6. Cellular reprogramming for pancreatic β-cell regeneration: clinical potential of small molecule control.

    PubMed

    Pandian, Ganesh N; Taniguchi, Junichi; Sugiyama, Hiroshi

    2014-03-27

    Recent scientific breakthroughs in stem cell biology suggest that a sustainable treatment approach to cure diabetes mellitus (DM) can be achieved in the near future. However, the transplantation complexities and the difficulty in obtaining the stem cells from adult cells of pancreas, liver, bone morrow and other cells is a major concern. The epoch-making strategy of transcription-factor based cellular reprogramming suggest that these barriers could be overcome, and it is possible to reprogram any cells into functional β cells. Contemporary biological and analytical techniques help us to predict the key transcription factors needed for β-cell regeneration. These β cell-specific transcription factors could be modulated with diverse reprogramming protocols. Among cellular reprogramming strategies, small molecule approach gets proclaimed to have better clinical prospects because it does not involve genetic manipulation. Several small molecules targeting certain epigenetic enzymes and/or signaling pathways have been successful in helping to induce pancreatic β-cell specification. Recently, a synthetic DNA-based small molecule triggered targeted transcriptional activation of pancreas-related genes to suggest the possibility of achieving desired cellular phenotype in a precise mode. Here, we give a brief overview of treating DM by regenerating pancreatic β-cells from various cell sources. Through a comprehensive overview of the available transcription factors, small molecules and reprogramming strategies available for pancreatic β-cell regeneration, this review compiles the current progress made towards the generation of clinically relevant insulin-producing β-cells.

  7. Limitations of student-driven formative assessment in a clinical clerkship. A randomised controlled trial

    PubMed Central

    Palmer, Edward J; Devitt, Peter G

    2008-01-01

    Background Teachers strive to motivate their students to be self-directed learners. One of the methods used is to provide online formative assessment material. The concept of formative assessment and use of these processes is heavily promoted, despite limited evidence as to their efficacy. Methods Fourth year medical students, in their first year of clinical work were divided into four groups. In addition to the usual clinical material, three of the groups were provided with some form of supplementary learning material. For two groups, this was provided as online formative assessment. The amount of time students spent on the supplementary material was measured, their opinion on learning methods was surveyed, and their performance in summative exams at the end of their surgical attachments was measured. Results The performance of students was independent of any educational intervention imposed by this study. Despite its ready availability and promotion, student use of the online formative tools was poor. Conclusion Formative learning is an ideal not necessarily embraced by students. If formative assessment is to work students need to be encouraged to participate, probably by implementing some form of summative assessment. PMID:18471324

  8. Video- or text-based e-learning when teaching clinical procedures? A randomized controlled trial

    PubMed Central

    Buch, Steen Vigh; Treschow, Frederik Philip; Svendsen, Jesper Brink; Worm, Bjarne Skjødt

    2014-01-01

    Background and aims This study investigated the effectiveness of two different levels of e-learning when teaching clinical skills to medical students. Materials and methods Sixty medical students were included and randomized into two comparable groups. The groups were given either a video- or text/picture-based e-learning module and subsequently underwent both theoretical and practical examination. A follow-up test was performed 1 month later. Results The students in the video group performed better than the illustrated text-based group in the practical examination, both in the primary test (P<0.001) and in the follow-up test (P<0.01). Regarding theoretical knowledge, no differences were found between the groups on the primary test, though the video group performed better on the follow-up test (P=0.04). Conclusion Video-based e-learning is superior to illustrated text-based e-learning when teaching certain practical clinical skills. PMID:25152638

  9. Correlation of Clinical Neuromusculoskeletal and Central Somatosensory Performance: Variability in Controls and Patients With Severe and Mild Focal Hand Dystonia

    PubMed Central

    Byl, Nancy N.; Nagarajan, Srikantan S.; Merzenich, Michael M.; Roberts, Tim; McKenzie, Alison

    2002-01-01

    Focal hand dystonia (FHd) is a recalcitrant, disabling movement disorder, characterized by involuntary co-contractions of agonists and antagonists, that can develop in patients who overuse or misuse their hands. The aim of this study was to document clinical neuromusculoskeletal performance and somatosensory responses (magnetoencephalography) in healthy controls and in FHd subjects with mild versus severe hand dystonia. The performance of healthy subjects (n = 17) was significantly better than that of FHd subjects (n = 17) on all clinical parameters. Those with mild dystonia (n = 10) demonstrated better musculoskeletal skills, task-specific motor performance, and sensory discrimination, but the performance of sensory and fine motor tasks was slower than that of patients with severe dystonia. In terms of somatosensory evoked field responses (SEFs), FHd subjects demonstrated a significant difference in the location of the hand representation on the x and y axes, lower amplitude of SEFs integrated across latency, and a higher ratio of mean SEF amplitude to latency than the controls. Bilaterally,. those with FHd (mild and severe) lacked progressive sequencing of the digits from inferior to superior. On the affected digits, subjects with severe dystonia had a significantly higher ratio of SEF amplitude to latency and a significantly smaller mean volume of the cortical hand representation than those with mild dystonia. Severity of dystonia positively correlated with the ratio of SEF mean amplitude to latency (0.9029 affected, 0.8477 unaffected; p<0.01). The results of the present study strengthen the evidence that patients with FHd demonstrate signs of somatosensory degradation of the hand that correlates with clinical sensorimotor dysfunction, with characteristics of the dedifferentiation varying by the severity of hand dystonia. If these findings represent aberrant learning, then effective rehabilitation must incorporate the principles of neuroplasticity. Training must

  10. Comparative clinicoradiographical evaluation of effect of aminobisphosphonate (sodium alendronate) on peri-implant bone status: Controlled clinical trial

    PubMed Central

    Aggarwal, Rajni; Babaji, Prashant; Nathan, S. Senthil; Attokaran, George; Santosh Kumar, S. M.; Sathnoorkar, Sharanpriya

    2016-01-01

    Aim: The present study aims to compare the peri-implant bone status around immediately loaded dental implants treated with aminobisphosphonate solution and untreated control implants in terms of clinical and radiographical parameters. Materials and Methods: A total of 24 patients were randomly divided equally into two groups. This study was conducted in accordance to the Helsinki's declaration of 1975, revised in 2000, and with the approval of the institutional ethical committee. In the control group after preparation, osteotomy sites were irrigated with normal saline solution, whereas in the test group osteotomy sites were irrigated with modified bisphosphonate solution and then TRX-OP, Hi-Tec dental implants were inserted. Clinical parameters, such as modified plaque and gingival index, probing depth, mobility, and radiographic parameters were recorded at baseline (0), 3, 6, and 9 months. Data analysis was performed using the Statistical Package for the Social Sciences version 17 for windows, and the statistical techniques employed were repeated measures analysis of variance, independent sample t-test, and paired sample t-test. Results: Reduction in mean radiographic bone levels (height) was observed on the mesial and distal aspect of the control group in comparison to its baseline at all intervals. In the test group, there was reduction in mean radiographic bone levels on mesial and distal aspect of the implant site in comparison to its baseline till 6-month follow up, however, at 9 month, there was gain in bone level on both mesial and distal aspect of implant. This represents the effectiveness of sodium alendronate in enhancing the bone formation. On comparison, between both groups on mesial and distal aspect of implants, statistically significant differences were observed at 3 and 9 months on mesial and distal aspect, respectively, without any clinical evidence of mobility in the test group. Conclusion: Implant site treated with aminobisphosphonate solution

  11. Ebola infection control in Sierra Leonean health clinics: A large cross-agency cooperative project.

    PubMed

    Levy, Benjamin; Rao, Carol Y; Miller, Laura; Kennedy, Ngozi; Adams, Monica; Davis, Rosemary; Hastings, Laura; Kabano, Augustin; Bennett, Sarah D; Sesay, Momodu

    2015-07-01

    The Ebola virus disease outbreak occurring in West Africa has resulted in at least 199 cases of Ebola in Sierra Leonean health care workers, many as a result of transmission occurring in health facilities. The Ministry of Health and Sanitation of Sierra Leone recognized that improvements in infection prevention and control (IPC) were necessary at all levels of health care delivery. To this end, the U.S. Centers for Disease Control and Prevention, United Nations Children's Fund, and multiple nongovernmental organizations implemented a national IPC training program in 1,200 peripheral health units (PHUs) in Sierra Leone. A tiered training of trainers program was used. Trainers conducted multiday trainings at PHUs and coordinated the delivery of personal protective equipment (gloves, gowns, masks, boots) and infection control supplies (chlorine, buckets, disposable rags, etc) to all PHU staff. Under the ongoing project, 4,264 health workers have already been trained, and 98% of PHUs have received their first shipment of supplies.

  12. Randomized, controlled clinical study to evaluate efficacy of novel indigenously designed controlled release flurbiprofen gel system for management of periodontal diseases

    PubMed Central

    Deshpande, Neeraj C.; Bhat, K. M.; Bhat, G. S.; Deshpande, Anshula N.

    2013-01-01

    Background: This randomized, controlled clinical study was planned to evaluate the use of anti-inflammatory drug flurbiprofen in the form of locally delivered controlled release gel in the treatment of periodontal disease. Materials and Methods: The flurbiprofen gel was indigenously prepared in the concentration of 0.3%. The 30 patients with localized periodontal pockets measuring ≥5 mm were randomly divided into three groups. The groups received flurbiprofen gel, flurbiprofen gel after prophylaxis, and placebo gel after oral prophylaxis, respectively. The clinical parameters for plaque and gingival inflammation were evaluated at baseline, 7th day, and 14th day. Results: The results of the study suggested the statistically significant (P < 0.05) improvement in the gingival status of the patients with the use of flurbiprofen gel as an adjunct to scaling and root planing as compared to oral prophylaxis or gel alone. Conclusion: The data demonstrated that the additional use of local drug delivery of flurbiprofen through gel media enhances the positive effects of scaling and root planing and helps in faster resolution of the inflammation. PMID:23853449

  13. Early filiform needle acupuncture for poststroke depression: a meta-analysis of 17 randomized controlled clinical trials

    PubMed Central

    Zhang, Jiping; Chen, Jing; Chen, Junqi; Li, Xiaohui; Lai, Xueyan; Zhang, Shaoqun; Wang, Shengxu

    2014-01-01

    OBJECTIVE: To evaluate the effectiveness and safety of filiform needle acupuncture for poststroke depression, and to compare acupuncture with the therapeutic efficacy of antidepressant drugs. DATA RETRIEVAL: We retrieved data from the Chinese National Knowledge Infrastructure (1979–2012), Wanfang (1980–2012), VIP (1989–2012), Chinese Biomedical Literature (1975–2012), PubMed (1966–2012), Ovid Lww (–2012), and Cochrane Library (–2012) Database using the internet. SELECTION CRITERIA: Randomized controlled trials on filiform needle acupuncture versus antidepressant drugs for treatment of poststroke depression were included. Moreover, the included articles scored at least 4 points on the Jadad scale. Exclusion criteria: other acupuncture therapies as treatment group, not stroke-induced depression patients, score < 4 points, non-randomized controlled trials, or animal trials. MAIN OUTCOME MEASURES: These were the Hamilton Depression Scale scores, clinical effective rate, Self-Rating Depression Scale scores, Side Effect Rating Scale scores, and incidence of adverse reaction and events. RESULTS: A total of 17 randomized controlled clinical trials were included. Meta-analysis results displayed that after 4 weeks of treatment, clinical effective rate was better in patients treated with filiform needle acupuncture than those treated with simple antidepressant drugs [relative risk = 1.11, 95% confidence interval (CI): 1.03–1.21, P = 0.01]. At 6 weeks, clinical effective rate was similar between filiform needle acupuncture and antidepressant drug groups. At 2 weeks after filiform needle acupuncture, Hamilton Depression Scale (17 items) scores were lower than in the antidepressant drug group (mean difference = −2.34, 95%CI: −3.46 to −1.22, P < 0.000,1). At 4 weeks, Hamilton Depression Scale (24 items) scores were similar between filiform needle acupuncture and antidepressant drug groups. Self-Rating Depression Scale scores were lower in filiform needle

  14. Treatment of chronic heart failure with β adrenergic blockade beyond controlled clinical trials: the BRING-UP experience

    PubMed Central

    Maggioni, A P; Sinagra, G; Opasich, C; Geraci, E; Gorini, M; Gronda, E; Lucci, D; Tognoni, G; Balli, E; Tavazzi, L

    2003-01-01

    Background: Several large controlled trials have shown that β blockers given to patients with heart failure (New York Heart Association functional class II–IV) reduce morbidity and mortality. Despite these impressive results, implementing the use of β blockade in clinical practice appears slow and difficult. The BRING-UP study was designed to tackle this problem. Objectives: To accelerate the adoption of β blockade in clinical practice; to provide an epidemiological estimate of the proportion of patients with heart failure suitable for this treatment in general cardiology care; and to assess effectiveness of these drugs outside the setting of clinical trials. Methods: The design of the study and recommendations derived from available evidence on the use of β blockers were discussed with cardiologists during regional meetings. All consecutive heart failure patients in a one month period, whether treated or not with β blockers, were eligible for the study. In each patient, the decision to prescribe a β blocker was a free choice for the participating physicians. All centres were provided with carvedilol, metoprolol, and bisoprolol at appropriate doses; the choice of the drug and dosage was left to the responsible clinician. All patients were followed for one year. Results: 197 cardiological centres enrolled 3091 patients, 24.9% of whom were already on β blocker treatment at baseline. β Blockers were newly prescribed in 32.7% of cases, more often in younger and less severely ill patients. The mean daily dose of the drugs used at one year corresponded to about 70% of the maximum dose used in clinical trials. Starting treatment with β blockers did not affect the prescription or dosage of other recommended drugs. The overall rate of β blocker treatment increased over the year of the study from 24.9% to 49.7%. During the 12 month period, 351 deaths occurred (11.8%). In multivariate analysis, the use of β blockers was independently associated with a better

  15. Somatostatin plus isosorbide 5-mononitrate versus somatostatin in the control of acute gastro-oesophageal variceal bleeding: a double blind, randomised, placebo controlled clinical trial

    PubMed Central

    Junquera, F; Lopez-Talavera, J; Mearin, F; Saperas, E; Videla, S; Armengol, J; Esteban, R; Malagelada, J

    2000-01-01

    BACKGROUND—Variceal bleeding is a severe complication of portal hypertension. Somatostatin reduces portal pressure by decreasing splanchnic blood flow, and nitrates by diminishing intrahepatic resistance. Experimental studies have shown that the combination of somatostatin and nitrates has an additive effect in decreasing portal pressure.
AIM—To compare the therapeutic efficacy of either intravenous infusion of somatostatin plus oral isosorbide 5-mononitrate or somatostatin alone in gastro-oesophageal variceal bleeding associated with liver cirrhosis.
METHODS—A unicentre, double blind, placebo controlled, clinical trial was conducted. Sixty patients bleeding from oesophageal or gastric varices were randomised to receive intravenous infusion of somatostatin (250 µg/hour) plus oral isosorbide 5-mononitrate (40 mg/12 hours) (group I) or somatostatin infusion plus placebo (group II) for 72 hours.
RESULTS—The two groups of patients had similar clinical, endoscopic, and haematological characteristics. Control of bleeding was achieved in 18 out of 30 patients (60%) in group I and 26 out of 30 patients (87%) in group II (p<0.05). There was no significant difference in mean transfusion requirements between the two groups: 2.6 (2.2) v 1.8 (1.6) respectively; means (SD). Mortality and side effects were similar in the two groups, but development of ascites was higher in group I (30%) than in group II (7%) (p<0.05).
CONCLUSION—In cirrhotic patients with acute gastro-oesophageal variceal bleeding, addition of isosorbide 5-mononitrate to somatostatin does not improve therapeutic efficacy, induces more adverse effects, and should not be used.


Keywords: gastro-oesophageal bleeding; haemorrhage; portal hypertension; clinical trial; isosorbide 5-mononitrate; somatostatin PMID:10601068

  16. A Controlled Clinical Trial for Stuttering in Persons Aged 9 to 14 Years.

    ERIC Educational Resources Information Center

    Craig, Ashley; And Others

    1996-01-01

    This paper presents results of a controlled trial of 3 child stuttering treatment strategies in 97 subjects. All 3 treatments (electromyography feedback, intensive smooth speech, and home-based smooth speech) were very successful in the long term for 70% of the group, with electromyography and home-based treatment appearing to be especially…

  17. Glycemic Control in a Clinic-Based Sample of Diabetics in M'Bour Senegal

    ERIC Educational Resources Information Center

    BeLue, Rhonda; Ndiaye, Khadidiatou; NDao, Fatou; Ba, Fatou Niass Niang; Diaw, Mor

    2016-01-01

    Background: Sub-Saharan Africa (SSA) including Senegal is faced with a significant and increasing burden of type 2 diabetes. However, little information is available about diabetes management among Senegalese diabetics. Purpose: The current study aims to describe the level of glycemic control among a convenience sample of diabetics who receive…

  18. Is Neurofeedback an Efficacious Treatment for ADHD? A Randomised Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Gevensleben, Holger; Holl, Birgit; Albrecht, Bjorn; Vogel, Claudia; Schlamp, Dieter; Kratz, Oliver; Studer, Petra; Rothenberger, Aribert; Moll, Gunther H.; Heinrich, Hartmut

    2009-01-01

    Background: For children with attention deficit/hyperactivity disorder (ADHD), a reduction of inattention, impulsivity and hyperactivity by neurofeedback (NF) has been reported in several studies. But so far, unspecific training effects have not been adequately controlled for andor studies do not provide sufficient statistical power. To overcome…

  19. The Empirical Status of Empirically Supported Psychotherapies: Assumptions, Findings, and Reporting in Controlled Clinical Trials

    ERIC Educational Resources Information Center

    Westen, Drew; Novotny, Catherine M.; Thompson-Brenner, Heather

    2004-01-01

    This article provides a critical review of the assumptions and findings of studies used to establish psychotherapies as empirically supported. The attempt to identify empirically supported therapies (ESTs) imposes particular assumptions on the use of randomized controlled trial (RCT) methodology that appear to be valid for some disorders and…

  20. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial

    PubMed Central

    Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2010-01-01

    Objective To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Methods Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. Results For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of ‘late’ DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of ‘late’ DSTs (p=0.57) compared with the control. Conclusions Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting. PMID:21113076

  1. Supportive Nursing Care and Satisfaction of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    PubMed Central

    Navidian, Ali; Ebrahimi, Hossein; Keykha, Roghaieh

    2015-01-01

    Background: Patient satisfaction is the most important criterion in evaluating the quality of care. Besides, its assessment in patients with severe mental disorder treated by electroconvulsive therapy (ECT) is highly appropriate. The ECT is accompanied by lower satisfaction and may exacerbate the patients’ condition. Objectives: The current study aimed to determine the effect of supportive nursing care on the satisfaction of patients receiving ECT. Patients and Methods: This randomized controlled trial was conducted in the education center of Baharan psychiatric hospital, Zahedan, Iran. Seventy hospitalized patients receiving ECT were randomly divided into two groups of control (n = 35) and intervention (n = 35).The socio-personal and Webster Satisfaction Questionnaire were used as data collection tools. The intervention group received supportive nursing care by nurses trained in informational, emotional, and physical aspects. The control group received only regular nursing care. The levels of satisfaction were measured and compared between groups, before and after the intervention. Data were analyzed using the SPSS software, and Chi-square, independent and paired t tests, as well as covariance analysis were performed. Results: The results showed similarities in socio-personal characteristics of both groups. However, there was a significant difference (P < 0.001) between the means of satisfaction in the groups, predominantly for the intervention group. In other words, a significant difference (P < 0.001) was observed between the means of satisfaction of the intervention (54.71 ± 5.27) and control (36.28 ± 7.00) groups after intervention by controlling the effect of socio-personal variables. Conclusions: Results of the current study confirmed the effect of supportive nursing care on increasing the level of satisfaction in ECT receiving patients, recommending the use of this therapeutic method. PMID:26473077

  2. Importance/performance analysis: a tool for service quality control by clinical laboratories.

    PubMed

    Scammon, D L; Weiss, R

    1991-01-01

    A study of customer satisfaction with clinical laboratory service is used as the basis for identifying potential improvements in service and more effectively targeting marketing activities to enhance customer satisfaction. Data on customer satisfaction are used to determine the aspects of service most critical to customers, how well the organization is doing in delivery of service, and how consistent service delivery is. Importance-performance analysis is used to highlight areas for future resource reallocation and strategic emphasis. Suggestions include the establishment of performance guidelines for customer contact personnel, the enhancement of timely delivery of reports via electronic transmission (computer and fax), and the development of standardized graphics for request and report forms to facilitate identification of appropriate request forms and guide clients to key items of information on reports.

  3. Statistical examination of laser therapy effects in controlled double-blind clinical trial

    NASA Astrophysics Data System (ADS)

    Boerner, Ewa; Podbielska, Halina

    2001-10-01

    For the evaluation of the therapy effects the double-blind clinical trial followed by statistical analysis was performed. After statistical calculations it was stated that laser therapy with IR radiation has a significant influence on the decrease of the level of pain in the examined group of patients suffering from various locomotive diseases. The level of pain of patients undergoing laser therapy was statistically lower than the level of pain of patients undergoing placebo therapy. It means that laser therapy had statistically significant influence on the decrease of the level of pain. The same tests were performed for evaluation of movement range. Although placebo therapy contributes to the increase of the range of movement, the statistically significant influence was stated in case of the therapeutic group treated by laser.

  4. Preclinical Rationale and Clinical Considerations for Radiotherapy Plus Immunotherapy: Going Beyond Local Control.

    PubMed

    Schoenhals, Jonathan E; Seyedin, Steven N; Tang, Chad; Cortez, Maria A; Niknam, Sharareh; Tsouko, Efrosini; Chang, Joe Y; Hahn, Stephen M; Welsh, James W

    2016-01-01

    The use of radiation for cancer therapy has expanded and sparked interest in possible synergistic effects by combining it with current immunotherapies. In this review, we present a case of a patient who responded to programmed cell death 1 (PD1) blockade and radiation therapy and discuss possible mechanisms. We provide background on the blockade of the cytotoxic T-lymphocyte antigen 4 (CTLA-4) and PD1 checkpoints and highlight future immune-based therapies that may synergize with radiation, including cytosine-phosphate-guanine vaccines, OX40 agonists, CD40 agonists, regulatory T-cell depletion, and metabolic "rewiring" of cancer cells. Clinical considerations are noted for combining radiation with immunotherapies to extend the benefit of immunotherapy to more patients. New trials are needed to appropriately investigate the best sequencing and radiation dose to prime an immune response and to identify predictive biomarkers of such responses. PMID:27111909

  5. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial.

    PubMed

    dos Santos, Gisele Munhoes; Bento, Ricardo Ferreira; de Medeiros, Italo Roberto Torres; Oiticcica, Jeanne; da Silva, Eleonora Csipai; Penteado, Silvio

    2014-07-23

    Hearing aids with an integrated sound generator have been used to enhance the treatment of tinnitus. The main aim of this study was to verify whether the combined use of amplification and sound generator is more effective than conventional amplification alone in reducing tinnitus annoyance by means of the use of a new hearing aid with an integrated sound generator. A total of 49 patients underwent a blind randomized clinical trial. Tinnitus annoyance was measured by Tinnitus Handicap Inventory and numerical scales, and psychoacoustic measures of tinnitus were also performed. The sound generator was set at the lowest intensity capable of providing relief from tinnitus. Results showed that 62.5% of the patients presented a reduction in tinnitus annoyance in the combined fitting group and in the group with amplification alone, 78% showed a reduction. This difference between the groups was not statistically significant.

  6. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial.

    PubMed

    Kazemipoor, Mahnaz; Radzi, Che Wan Jasimah Bt Wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377. PMID:24319489

  7. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial.

    PubMed

    Kazemipoor, Mahnaz; Radzi, Che Wan Jasimah Bt Wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377.

  8. Cognitive Behavioral Therapy for Early Adolescents with Autism Spectrum Disorders and Clinical Anxiety: A Randomized, Controlled Trial

    PubMed Central

    Wood, Jeffrey J.; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C.; De Nadai, Alessandro S.; Arnold, Elysse; Lewin, Adam B.; Murphy, Tanya K.; Storch, Eric A.

    2014-01-01

    Background Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009), was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Method Thirty-three adolescents (11–15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and post-treatment/post-waitlist. Results In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators’ ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. Conclusions The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  9. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed.

  10. Autologous mesenchymal stem cell therapy for progressive supranuclear palsy: translation into a phase I controlled, randomized clinical study

    PubMed Central

    2014-01-01

    Background Progressive Supranuclear Palsy (PSP) is a sporadic and progressive neurodegenerative disease which belongs to the family of tauopathies and involves both cortical and subcortical structures. No effective therapy is to date available. Methods/design Autologous bone marrow (BM) mesenchymal stem cells (MSC) from patients affected by different type of parkinsonisms have shown their ability to improve the dopaminergic function in preclinical and clinical models. It is also possible to isolate and expand MSC from the BM of PSP patients with the same proliferation rate and immuphenotypic profile as MSC from healthy donors. BM MSC can be efficiently delivered to the affected brain regions of PSP patients where they can exert their beneficial effects through different mechanisms including the secretion of neurotrophic factors. Here we propose a randomized, placebo-controlled, double-blind phase I clinical trial in patients affected by PSP with MSC delivered via intra-arterial injection. Discussion To our knowledge, this is the first clinical trial to be applied in a no-option parkinsonism that aims to test the safety and to exploit the properties of autologous mesenchymal stem cells in reducing disease progression. The study has been designed to test the safety of this “first-in-man” approach and to preliminarily explore its efficacy by excluding the placebo effect. Trial registration NCT01824121 PMID:24438512

  11. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  12. Antiobesity Effect of Caraway Extract on Overweight and Obese Women: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Radzi, Che Wan Jasimah Bt wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A.

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377. PMID:24319489

  13. A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee.

    PubMed

    Vishal, Amar A; Mishra, Artatrana; Raychaudhuri, Siba P

    2011-01-01

    Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin(®) and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin(®) in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin(®) or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA. PMID:22022214

  14. A study of characteristics of vasectomy acceptors at the Fertility Control Clinic, U.P. PGH Medical Center.

    PubMed

    Patacsil, G R

    1978-01-01

    The clinical records of 166 available vasectomy patients at the Fertility Control Clinic of the University of the Philippines, Philippines Medical Center were examined and in-depth interviews using the case study method were conducted with 10 vasectomy acceptors in an attempt to obtain the characteristics of vasectomy acceptors and to determine the persons most influential in the decision to accept vasectomy as well as the fears and problems relating to vasectomy. The demographic characteristics of age, educational achievement, occupation, residence, race, religion, marital status, total live births, and contraceptives used before vasectomy were gathered. The most probable acceptors of vasectomy are men in the 30-39 year age bracket, with high school education, an unskilled job, married, Catholic, father of 3-4 children, and wives who have used oral contraception. For 64% of the acceptors the reason for vasectomy was socioeconomic, according to clinic records. The in-depth interviews indicated the reasons for acceptance to be contraceptive failure and convenience. The mass media and "significant others" (such as friends; neighbors; associates; and the husband's manager) played a major role in the dissemination of vasectomy information. Husbands were the decision-makers in the family, particularly with regard to the choice of vasectomy. The nature of preoperative fears was related to possible side effects and the uncertain outcome of the procedure. The sexual relationship remained unchanged in regard to coital frequency, coital attitude, and behavior.

  15. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics.

    PubMed

    Chien, Wai-Tong; Bressington, Daniel

    2015-09-30

    This study aimed to test the effectiveness of a nurse-led structured psychosocial intervention program in Chinese patients with first-onset mental illness. A single-blind, parallel group, randomized controlled trial design was used. The study involved 180 participants with mild to moderate-severe symptoms of psychotic or mood disorders who were newly referred to two psychiatric outpatient clinics in Hong Kong. Patients were randomly assigned to either an eight-session nurse-led psychosocial intervention program (plus usual care) or usual psychiatric outpatient care (both n=90). The primary outcome was psychiatric symptoms. Outcomes were measured at recruitment, one week and 12 months post-intervention. Patients in the psychosocial intervention group reported statistically significant improvements in symptoms compared to treatment as usual. There were also significant improvements in illness insight and perceived quality of life and reduction in length of re-hospitalizations over the 12-month follow-up. The findings provide evidence that the nurse-led psychosocial intervention program resulted in improved health outcomes in Chinese patients with first-onset mental illness.

  16. Developing treatment and control conditions in a clinical trial of massage therapy for advanced cancer.

    PubMed

    Smith, Marlaine; Kutner, Jean; Hemphill, Linnea; Yamashita, Traci; Felton, Susanne

    2007-01-01

    The purpose of this article is to describe the challenges faced by a research team in developing treatment and control conditions in a study of the efficacy of massage therapy for advanced cancer. Five design considerations were addressed related to developing a massage therapy protocol: (1) dosage, that is, the number, spacing and length of treatments; (2) type of massage therapy; (3) degree to which the protocol for the treatment is standardized; (4) qualifications of the persons providing the treatment; and (5) conditions under which the treatment is provided. Five criteria for structuring the control condition of the study are elaborated: (1) equivalency of contact; (2) similarity of form; (3) minimum adverse or negative effects; (4) expectancy of therapeutic benefit; and (5) minimum therapeutic benefit.

  17. Attitudes towards smoking and tobacco control among pre-clinical medical students in Malaysia.

    PubMed

    Tee, G H; Hairi, N N; Hairi, F

    2012-08-01

    Physicians should play a leading role in combatting smoking; information on attitudes of future physicians towards tobacco control measures in a middle-income developing country is limited. Of 310 future physicians surveyed in a medical school in Malaysia, 50% disagreed that it was a doctor's duty to advise smokers to stop smoking; 76.8% agreed that physicians should not smoke before advising others not to smoke; and 75% agreed to the ideas of restricting the sale of cigarettes to minors, making all public places smoke-free and banning advertising of tobacco-related merchandise. Future physicians had positive attitudes towards tobacco regulations but had not grasped their responsibilities in tobacco control measures.

  18. Disciplined decision making in an interdisciplinary environment: some implications for clinical applications of statistical process control.

    PubMed Central

    Hantula, D A

    1995-01-01

    This paper explores some of the implications the statistical process control (SPC) methodology described by Pfadt and Wheeler (1995) may have for analyzing more complex performances and contingencies in human services or health care environments at an organizational level. Service delivery usually occurs in an organizational system that is characterized by functional structures, high levels of professionalism, subunit optimization, and organizational suboptimization. By providing a standard set of criteria and decision rules, SPC may provide a common interface for data-based decision making, may bring decision making under the control of the contigencies that are established by these rules rather than the immediate contingencies of data fluctuation, and may attenuate escalation of failing treatments. SPC is culturally consistent with behavior analysis, sharing an emphasis on data-based decisions, measurement over time, and graphic analysis of data, as well as a systemic view of organizations. PMID:7592155

  19. Novel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical Trial

    PubMed Central

    Anyanwu, Juliana N; Williams, Olatundun; Sautter, Casey L; Kasirye, Phillip; Hume, Heather; Opoka, Robert O; Latham, Teresa; Ndugwa, Christopher; Ware, Russell E

    2016-01-01

    Background Sickle cell anemia (SCA), one of most prevalent monogenic diseases worldwide, is caused by a glutamic acid to valine substitution on the beta globin protein of hemoglobin, which leads to hemolytic anemia. Hydroxyurea, the only disease-modifying therapy approved by the Food and Drug Administration for SCA, has proven to be a viable therapeutic option for SCA patients in resource-rich settings, given clinical improvements experienced while taking the medication and its once-daily oral dosing. Significant studies have demonstrated its safety and clinical efficacy among children and adults in developed countries. In Sub-Saharan Africa, however, the risk of malaria, hematologic toxicities, and safety of hydroxyurea in children with SCA living in malaria-endemic areas are unknown. Objectives Study objectives include determining the incidence of malaria in SCA patients taking hydroxyurea versus placebo; establishing the frequency of hematologic toxicities and adverse events (AEs) in children with SCA treated with hydroxyurea versus placebo; and defining the relationships between hydroxyurea treatment and fetal hemoglobin, soluble intracellular adhesion molecule-1, and nitric oxide levels, and between levels of these factors and risk of subsequent malaria. Methods Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM, NCT01976416) is a prospective, randomized, placebo-controlled, double-blinded phase III trial to compare risk of malaria with oral hydroxyurea versus placebo. Children will be recruited from the Mulago Hospital Sickle Cell Clinic in Kampala, Uganda. Results Two hundred Ugandan children aged between 1.00 and 3.99 years with confirmed SCA will be randomized into treatment groups by order of entry in the study, based on a predetermined blinded randomization list. The primary outcome of the trial is malaria incidence in the 2 study groups, defined as episodes of clinical malaria occurring over the 1-year randomized study treatment period

  20. Neuro-hormonal control of food intake: basic mechanisms and clinical implications.

    PubMed

    Konturek, P C; Konturek, J W; Cześnikiewicz-Guzik, M; Brzozowski, T; Sito, E; Konturek, S J

    2005-12-01

    Obesity is one of the most common metabolic diseases and the greatest threats of the health because of possibility of numerous complications. In order to design effective drugs or apply the helpful surgical procedure it is essential to understand physiology of appetite control and pathophysiology of obesity. According to the first law of thermodynamics, the energy input in the form of food, equals energy expenditure through exercise, basal metabolism, thermogenesis and fat biosynthesis. The control of body weight actually concerns the control of adipose tissue with the key role of hypothalamus, possessing several neuronal centers such as that in lateral hypothalamic nuclei considered to be "hunger" center and in ventromedial nuclei serving as the "satiety" center. In addition, paraventricular and arcuate hypothalamic nuclei (ARC) are the sites where multiple hormones, released from the gut and adipose tissue, converge to regulate food intake and energy expenditure. There are two distinct types of neurons in ARC that are important in control of food intake; (1) preopiomelanocortin (POMC) neurons activated by an orexigenic hormones and releasing alpha-melanocyte-stimulating hormone (alpha-MSH) in satiety center and (2) neurons activated by orexigenic peptides such as ghrelin that release the substances including neuropeptide Y (NPY) and Agouti-Related Peptide (AgRP) in hunger center. ARC integrates neural (mostly vagal) and humoral inputs such as enteropeptides including orexigenic (ghrelin and orexins) and an orexigenic peptides (cholecystokinin, polypeptide YY, glucagon-like peptide-1, oxyntomodulin, leptin and others) that exert a physiological role in regulating appetite and satiety. The peripherally (gut, adipose tissue) and centrally expressed modulators of appetitive behavior act through specific receptors in the afferent (mostly vagal) nerves and hypothalamic neurons implicated in adiposity signaling and regulation of food intake.

  1. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    PubMed

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  2. Routine Quality Control of Clinical Nuclear Medicine Instrumentation: A Brief Review*

    PubMed Central

    Zanzonico, Pat

    2009-01-01

    This article reviews routine quality-control (QC) procedures for current nuclear medicine instrumentation, including the survey meter, dose calibrator, well counter, intraoperative probe, organ (“thyroid”) uptake probe, γ-camera, SPECT and SPECT/CT scanner, and PET and PET/CT scanner. It should be particularly useful for residents, fellows, and other trainees in nuclear medicine, nuclear cardiology, and radiology. The procedures described and their respective frequencies are presented only as general guidelines. PMID:18587088

  3. A polysomnographically documented case of adult somnambulism with long-distance automobile driving and frequent nocturnal violence: parasomnia with continuing danger as a noninsane automatism?

    PubMed

    Schenck, C H; Mahowald, M W

    1995-11-01

    A case of childhood-onset somnambulism is reported in which a 43-year-old man presented with repeated sleep-related injuries incurred during violent nocturnal activity, which included frenzied running, throwing punches and wielding knives. He had also driven an automobile a long distance during a presumed somnambulistic state. His wife had been repeatedly injured, and she felt that her life was threatened by his nocturnal violence 2-3 times yearly. Polysomnography (PSG) documented multiple episodes of complex and violent behaviors arising exclusively from stage 3/4 sleep, thus confirming the diagnosis of somnambulism. Other causes of sleep-related violence were excluded. The patient responded promptly to treatment with bedtime clonazepam, and benefit was maintained at 5-year follow-up. Although this strictly clinical case did not have any legal repercussions, it does carry forensic implications, particularly when placed in the context of the published medical literature on PSG-documented parasomnias (somnambulism, rapid eye movement sleep behavior disorder) containing explicit examples of recurrent violence, at times life-threatening, directed toward the bed partner and others. Thus, a new medical-legal concept is proposed, consisting of "parasomnia with continuing danger" as a noninsane automatism. Treatment guidelines, within the context of forensic medicine, are presented. PMID:8638069

  4. Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?

    PubMed Central

    Luo, Jian; Liu, Dan; Liu, Chun-Tao

    2015-01-01

    Abstract Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics. From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV1, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots. Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV1 (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001). Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25

  5. Determinants of Tuberculosis Infection among Adult HIV Positives Attending Clinical Care in Western Ethiopia: A Case-Control Study

    PubMed Central

    Melkamu, Hatoluf; Seyoum, Berhanu; Dessie, Yadeta

    2013-01-01

    There has been a drastic rise of tuberculosis (TB) infection across the world associated with the pandemic occurrence of HIV/AIDS. There are various determinants factors that increase the chance of TB infection among HIV positives (TB/HIV confection) that varies contextually. This study aimed to assess the determinants of TB/HIV coinfection among adult HIV positives attending clinical care at two public health facilities in Nekemte, western Ethiopia. Unmatched case-control study was conducted from December 26, 2011, to February 29, 2012. Cases were 123 TB infected HIV positives, and controls were 246 non-TB infected HIV positives. Being divorced/widowed AOR = 3.02, 95% CI (1.70, 7.88), not attending formal education AOR = 4.32, 95% CI (2.20, 14.15), being underweight (BMI < 18.5 kg/m2) AOR = 3.87, 95% CI (2.18, 6.87), having history of diabetic mellitus AOR = 3.63, 95% CI (1.33, 9.94), and being in advanced WHO HIV/AIDS clinical staging AOR = 2.29, 95% CI (1.32, 3.98), were determinant factors associated with TB/HIV co-infection. Having a separate kitchen AOR = 0.48, 95% CI (0.28, 0.81) showed protective role. For most of these determinants interventions can be made at individual and institutional levels, whereas, factors like education and nutrition need societal level integrations. PMID:24222846

  6. Clinical Significance of Serum Interleukin-31 and Interleukin-33 Levels in Patients of Endometrial Cancer: A Case Control Study

    PubMed Central

    Zeng, Xi; Zhang, Zhu; Gao, Qian-Qian; Wang, Yan-Yun; Yu, Xiu-Zhang; Zhou, Bin; Xi, Ming-Rong

    2016-01-01

    Aims. Previous evidence has proved that interleukin-31 (IL-31) and interleukin-33 (IL-33) can be potential markers in some cancers' formulation. We aimed to determine the potential role of IL-31 and IL-33 in prognosis of endometrial cancer patients. Methods. Serum samples were collected from 160 patients with endometrial cancer and 160 healthy controls. The ELISA kits (Raybio® Systems) specific for human IL-31 and human IL-33 were used. Serum levels of tumor markers (CEA, CA-125, and CA19-9) were measured by chemiluminescence immunoassay. A two-side P value < 0.05 was indicated to be significant. Results. Serum levels of IL-31 and IL-33 in patients were significantly elevated compared to those of healthy controls. The interleukin levels were also related to clinical characteristics, including tumor stages, depth of invasion, and existence of node metastases and distant metastases. The sensitivity and specificity of IL-31 and IL-33 were higher than the counterparts of tumor markers, both separately and in combination of IL-31, IL-33, and the clinical markers. Conclusions. This report is the first one mentioning the possible association between serum IL-31 and IL-33 and endometrial cancer. With their sensitivity and specificity, the interleukins may be useful biomarkers for endometrial cancer's prognosis. PMID:27340318

  7. Clinical Decision Support and Closed-Loop Control for Cardiopulmonary Management and Intensive Care Unit Sedation Using Expert Systems.

    PubMed

    Gholami, Behnood; Bailey, James M; Haddad, Wassim M; Tannenbaum, Allen R

    2012-03-01

    Patients in the intensive care unit (ICU) who require mechanical ventilation due to acute respiratory failure also frequently require the administration of sedative agents. The need for sedation arises both from patient anxiety due to the loss of personal control and the unfamiliar and intrusive environment of the ICU, and also due to pain or other variants of noxious stimuli. While physicians select the agent(s) used for sedation and cardiovascular function, the actual administration of these agents is the responsibility of the nursing staff. If clinical decision support systems and closed-loop control systems could be developed for critical care monitoring and lifesaving interventions as well as the administration of sedation and cardiopulmonary management, the ICU nurse could be released from the intense monitoring of sedation, allowing her/him to focus on other critical tasks. One particularly attractive strategy is to utilize the knowledge and experience of skilled clinicians, capturing explicitly the rules expert clinicians use to decide on how to titrate drug doses depending on the level of sedation. In this paper, we extend the deterministic rule-based expert system for cardiopulmonary management and ICU sedation framework presented in [1] to a stochastic setting by using probability theory to quantify uncertainty and hence deal with more realistic clinical situations.

  8. Clinical Significance of Serum Interleukin-31 and Interleukin-33 Levels in Patients of Endometrial Cancer: A Case Control Study.

    PubMed

    Zeng, Xi; Zhang, Zhu; Gao, Qian-Qian; Wang, Yan-Yun; Yu, Xiu-Zhang; Zhou, Bin; Xi, Ming-Rong

    2016-01-01

    Aims. Previous evidence has proved that interleukin-31 (IL-31) and interleukin-33 (IL-33) can be potential markers in some cancers' formulation. We aimed to determine the potential role of IL-31 and IL-33 in prognosis of endometrial cancer patients. Methods. Serum samples were collected from 160 patients with endometrial cancer and 160 healthy controls. The ELISA kits (Raybio® Systems) specific for human IL-31 and human IL-33 were used. Serum levels of tumor markers (CEA, CA-125, and CA19-9) were measured by chemiluminescence immunoassay. A two-side P value < 0.05 was indicated to be significant. Results. Serum levels of IL-31 and IL-33 in patients were significantly elevated compared to those of healthy controls. The interleukin levels were also related to clinical characteristics, including tumor stages, depth of invasion, and existence of node metastases and distant metastases. The sensitivity and specificity of IL-31 and IL-33 were higher than the counterparts of tumor markers, both separately and in combination of IL-31, IL-33, and the clinical markers. Conclusions. This report is the first one mentioning the possible association between serum IL-31 and IL-33 and endometrial cancer. With their sensitivity and specificity, the interleukins may be useful biomarkers for endometrial cancer's prognosis. PMID:27340318

  9. Efficacy of Acupuncture in Itch: A Systematic Review and Meta-Analysis of Clinical Randomized Controlled Trials

    PubMed Central

    Yu, Chi; Lv, Zheng-Tao; Li, Jing-Jing; Wu, Cai-Hua; Gao, Fang; Yuan, Xiao-Cui; Zhang, Jing; He, Wei; Jing, Xiang-Hong

    2015-01-01

    Background. Itch (pruritus) is a sensitive state that provokes the desire to scratch. It is not only a common symptom of skin diseases but it also occurs in some systemic diseases. Clinical studies on the efficacy of the acupuncture therapy in alleviating itch are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This systematic review aims to assess the effectiveness of acupuncture therapy for itch. Materials and Methods. A comprehensive literature search of eight databases was performed up to June 2014, and randomized controlled trials which compared acupuncture therapy and placebo acupuncture or no treatment group were identified. Accordingly, a meta-analysis was conducted. Results. This review included three articles of randomized controlled trials (RCTs) from a total of 2530 articles. The results of Meta-analysis showed that acupuncture therapy was effective to alleviate itch compared with placebo acupuncture and no treatment group. Conclusion. Based on the findings of this systematic review, we cautiously suggest that acupuncture therapy could improve the clinical efficacy of itch. However, this conclusion needs more studies on various ethnic samples to confirm our final conclusion. PMID:26064156

  10. Coronally Advanced Flap with Different Designs in the Treatment of Gingival Recession: A Comparative Controlled Randomized Clinical Trial.

    PubMed

    Zucchelli, Giovanni; Stefanini, M; Ganz, S; Mazzotti, Claudio; Mounssif, Ilham; Marzadori, Matteo

    2016-01-01

    The aim of this parallel double-blind randomized controlled clinical trial was to describe a modified approach using the coronally advanced flap (CAF) with triangular design and to compare its efficacy, in terms of root coverage and esthetics, with a trapezoidal type of CAF. A sample of 50 isolated Miller Class I and II gingival recessions with at least 1 mm of keratinized tissue apical to the defects were treated with CAF. Of these recessions, 25 were randomly treated with trapezoidal CAF (control group) while the other 25 (test group) were treated with a modified triangular CAF. The clinical and esthetic evaluations, made by the patient and an independent periodontist, were performed 3 months, 6 months, and 1 year after the surgery. No statistically significant difference was demonstrated between the two CAF groups in terms of recession reduction, complete root coverage, or 6-month and 1-year patient esthetic scores. Better 3-month patient esthetic evaluations and better periodontist root coverage, color match, and contiguity assessments were reported after triangular CAF. Trapezoidal CAF was associated with greater incidence of keloid formation. Single-type gingival recessions can be successfully covered with both types of CAF. The triangular CAF should be preferred for esthetically demanding patients. PMID:27100801

  11. Favorable effect of rehabilitation on balance in ankylosing spondylitis: a quasi-randomized controlled clinical trial.

    PubMed

    Demontis, Alessandra; Trainito, Sabina; Del Felice, Alessandra; Masiero, Stefano

    2016-03-01

    Balance impairment is a frequent and undertreated manifestation in ankylosing spondylitis, leading to increased risk of falls and lower quality of life. Our aim was to assess supervised training and home-based rehabilitation efficacy on balance improvement in ankylosing spondylitis subjects on biologic agents. This was a single-blinded, quasi-randomized parallel study in a single outpatient Rehabilitation Clinic of a tertiary referral center. Subjects with ankylosing spondylitis on biologic agents were assigned either to supervised training and home-based rehabilitation program (rehabilitation group) plus educational-behavioral therapy, or to educational-behavioral therapy alone (educational groups). The same therapist provided therapy. Outcome measures were assessed at baseline (T0), end of treatment (T1) and at 7-month follow-up (T2). Rheumatologic outcomes were Bath Ankylosing Spondylitis Metrology Index, Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index. Balance parameters (anterior-posterior oscillation, latero-lateral oscillation, sway area, sway density and sway path) were evaluated by stabilometry in a condition of open and closed eyes. Forty-six subjects (36 M, 10 F) were enrolled. Demographic data and clinical status at baseline were comparable between the two groups (22 rehabilitation group, 20 educational group). Primary outcome was sway density that improved both at T1 (SDy: open eyes p = 0.003, closed eyes p = 0.004) and at T2 (SDx: open eyes p = 0.0015, closed eyes p = 0.032). A trend toward improvement in the rehabilitation group rather than in the educational group emerged for balance parameters, especially those measured with closed eyes (0.004 < p < 0.048 at T1 and 0.004 < p < 0.036 at T2). Supervised training and home exercise lead to balance improvement in people with ankylosing spondylitis. Eyes-closed trials show a more marked trend toward improvement, and this may suggest a

  12. The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Axillary lymph node dissection (ALND) in patients with breast cancer has the potential to induce side-effects, including upper-limb lymphedema. Axillary reverse mapping (ARM) is a technique that enables discrimination of the lymphatic drainage of the breast from that of the upper limb in the axillary lymph node (LN) basin. If lymphedema is caused by removing these lymphatics and nodes in the upper limb, the possibility of identifying these lymphatics would enable surgeons to preserve them. The aim of this study is to determine the clinical relevance of selective axillary LN and lymphatic preservation by means of ARM. To minimize the risk of overlooking tumor-positive ARM nodes and the associated risk of undertreatment, we will only include patients with a tumor-positive sentinel lymph node (SLN). Patients who are candidates for ALND because of a proven positive axillary LN at clinical examination can be included in a registration study. Methods/design The study will enroll 280 patients diagnosed with SLN biopsy-proven metastasis of invasive breast cancer with an indication for a completion ALND. Patients will be randomized to undergo standard ALND or an ALND in which the ARM nodes and their corresponding lymphatics will be left in situ. Primary outcome is the presence of axillary surgery-related lymphedema at 6, 12, and 24 months post-operatively, measured by the water-displacement method. Secondary outcome measures include pain, paresthesia, numbness, and loss of shoulder mobility, quality of life, and axillary recurrence risk. Discussion The benefit of ALND in patients with a positive SLN is a subject of debate. For many patients, an ALND will remain the treatment of choice. This multicenter randomized trial will provide evidence of whether or not axillary LN preservation by means of ARM decreases the side-effects of an ALND. Enrolment of patients will start in April 2013 in five breast-cancer centers in the Netherlands, and is expected to conclude by

  13. Amiloride Clinical Trial In Optic Neuritis (ACTION) protocol: a randomised, double blind, placebo controlled trial

    PubMed Central

    McKee, Justin B; Elston, John; Evangelou, Nikos; Gerry, Stephen; Fugger, Lars; Kennard, Christopher; Kong, Yazhuo; Palace, Jacqueline; Craner, Matthew

    2015-01-01

    Introduction Neurodegeneration is a widely accepted contributor to the development of long-term disability in multiple sclerosis (MS). While current therapies in MS predominantly target inflammation and reduce relapse rate they have been less effective at preventing long-term disability. The identification and evaluation of effective neuroprotective therapies within a trial paradigm are key unmet needs. Emerging evidence supports amiloride, a licenced diuretic, as a neuroprotective agent in MS through acid sensing ion channel blockade. Optic neuritis (ON) is a common manifestation of MS with correlates of inflammation and neurodegeneration measurable within the visual pathways. Amiloride Clinical Trial In Optic Neuritis (ACTION) will utilise a multimodal approach to assess the neuroprotective efficacy of amiloride in acute ON. Methods and analysis 46 patients will be recruited within 28 days from onset of ON visual symptoms and randomised on a 1:1 basis to placebo or amiloride 10 mg daily. Double-blinded treatment groups will be balanced for age, sex and visual loss severity by a random-deterministic minimisation algorithm. The primary objective is to demonstrate that amiloride is neuroprotective in ON as assessed by scanning laser polarimetry of the peripapillary retinal nerve fibre layer (RNFL) thickness at 6 months in the affected eye compared to the unaffected eye at baseline. RNFL in combination with further retinal measures will also be assessed by optical coherence tomography. Secondary outcome measures on brain MRI will include cortical volume, diffusion-weighted imaging, resting state functional MRI, MR spectroscopy and magnetisation transfer ratio. In addition, high and low contrast visual acuity, visual fields, colour vision and electrophysiology will be assessed alongside quality of life measures. Ethics and dissemination Ethical approval was given by the south central Oxford B research ethics committee (REC reference: 13/SC/0022). The findings

  14. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

    PubMed Central

    Münch, Andreas; Bohr, Johan; Miehlke, Stephan; Benoni, Cecilia; Olesen, Martin; Öst, Åke; Strandberg, Lars; Hellström, Per M; Hertervig, Erik; Armerding, Peter; Stehlik, Jiri; Lindberg, Greger; Björk, Jan; Lapidus, Annika; Löfberg, Robert; Bonderup, Ole; Avnström, Sören; Rössle, Martin; Dilger, Karin; Mueller, Ralph; Greinwald, Roland; Tysk, Curt; Ström, Magnus

    2016-01-01

    Objective This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis. Design A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase. Results Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious. Conclusions Budesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation. Trial registration numbers http://www.clinicaltrials.gov (NCT01278082) and http

  15. Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya

    PubMed Central

    Lowther, Keira; Harding, Richard; Ahmed, Aabid; Gikaara, Nancy; Ali, Zippy; Kariuki, Hellen; Sherr, Lorraine; Simms, Victoria; Selman, Lucy

    2016-01-01

    ABSTRACT Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care. The implications of study participation on outcome data in such populations have been discussed theoretically, but rarely empirically examined. We aimed to explore the effects of participating in a randomised controlled trial conducted in an HIV clinic in Mombasa, Kenya. We report qualitative data from the Treatment Outcomes in Palliative Care trial, which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to standard care. Participants in both arms attended five monthly quantitative data collection appointments. Post-trial exit, 10 control and 20 intervention patients participated in semi-structured qualitative interviews, analysed using thematic analysis. We found benefit attributed to the compassion of the research team, social support, communication, completion of patient reported outcome measures (PROMs) and material support (transport reimbursement). Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team, which improved mental health and well-being. Open and non-judgmental communication made participants feel accepted. Participants described how repeated completion of the PROMs was a prompt for reflection, through which they began to help themselves and self-care. Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities, enhancing self-worth. These findings emphasise the importance of compassion, support and effective communication in the clinical encounter, particularly in stigmatised and isolated populations, and the potential of the integration of simple PROMs to improve patient outcomes. Participation in research has unexpected positive benefits for participants, which

  16. Disc replacement using Pro-Disc C versus fusion: a prospective randomised and controlled radiographic and clinical study

    PubMed Central

    Ahlhelm, F.; Pitzen, T.; Steudel, W. I.; Jung, J.; Shariat, K.; Steimer, O.; Bachelier, F.; Pape, D.

    2006-01-01

    Anterior cervical discectomy and fusion (ACDF) may be considered to be the gold standard for treatment of symptomatic degenerative disc disease within the cervical spine. However, fusion of the segment may result in progressive degeneration of the adjacent segments. Therefore, dynamic stabilization procedures have been introduced. Among these, artificial disc replacement by disc prosthesis seems to be promising. However, to be so, segmental motion must be preserved. This, again, is very difficult to judge and has not yet been proven. The aim of the current study was to first analyse the segmental motion following artificial disc replacement using a disc prosthesis. A second aim was to compare both segmental motion as well as clinical result to the current gold standard (ACDF). This is a prospective controlled study. Twenty-five patients with cervical disc herniation were enrolled and assigned to either study group (receiving a disc prosthesis) or control group (receiving ACDF, using a cage with bone graft and an anterior plate.) Radiostereometric analysis was used to quantify intervertebral motion immediately as well as 3, 6, 12 and 24 weeks postoperatively. Further, clinical results were judged using visual analogue scale and neuro-examination. Cervical spine segmental motion decreased over time in the presence of disc prosthesis or ACDF. However, the loss of segmental motion is significantly higher in the ACDF group, when looked at 3, 6, 12 and 24 weeks after surgery. We observed significant pain reduction in neck and arm postoperatively, without significant difference between both groups (P > 0.05). Cervical spine disc prosthesis preserves cervical spine segmental motion within the first 6 months after surgery. The clinical results are the same when compared to the early results following ACDF. PMID:17106665

  17. Clinical relevance of surgical site infection as defined by the criteria of the Centers for Disease Control and Prevention.

    PubMed

    Henriksen, N A; Meyhoff, C S; Wetterslev, J; Wille-Jørgensen, P; Rasmussen, L S; Jorgensen, L N

    2010-07-01

    Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant (CRSSI) and whether there is agreement between evaluations according to the CDC criteria, the ASEPSIS score (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of Stay) and CRSSI. We included 54 patients diagnosed with SSI and a matched control group (N=46) without SSI according to the CDC criteria after laparotomy. Two blinded experienced surgeons evaluated the hospital records and determined whether patients had CRSSI, based on the following criteria: antibiotic treatment, surgical intervention, prolonged hospital stay or referral to an intensive care unit for SSI. The rate of CRSSI was 38 of 54 (70%) in patients with CDC-diagnosed SSI and none in patients without a CDC-diagnosed SSI. Sixty-one percent of the CDC-diagnosed SSIs were superficial, of which 48% were considered clinically relevant. There was substantial agreement between the CDC criteria and CRSSI [kappa=0.69; 95% confidence interval (CI): 0.55-0.83] and fair agreement between the ASEPSIS score and the CDC criteria (kappa=0.23; 95% CI: 0-0.49) and between the ASEPSIS score and CRSSI (kappa=0.39; 95% CI: 0.17-0.61). The CDC criteria represent a suitable standard definition for monitoring and identifying SSI, even if some cases of less clinically significant superficial SSI are included.

  18. Controlled clinical comparison of Isolator and BACTEC 9240 Aerobic/F resin bottle for detection of bloodstream infections.

    PubMed Central

    Pohlman, J K; Kirkley, B A; Easley, K A; Washington, J A

    1995-01-01

    A controlled clinical comparison was carried out with the BACTEC 9240 Aerobic/F resin bottle and the Isolator system with adult patients suspected of having bloodstream infections. A total of 10,500 paired specimens were collected, of which 1,122 from 520 patients were positive. There were 68 false-positive BACTEC bottles; 259 positive cultures that were excluded from analysis because the bottle, the Isolator, or both failed to meet the minimum volume criterion of 8 ml of blood; and 207 positive cultures that were excluded because the isolates were found to be clinically insignificant or of indeterminate clinical significance on the basis of patient assessment. A total of 656 positive cultures from 258 patients formed the basis of the analysis. Significantly more Staphylococcus aureus isolates (P = 0.03), Staphylococcus epidermidis isolates (P = 0.03), members of the family Enterobacteriaceae (P = 0.03), and Pseudomonas aeruginosa isolates (P = 0.04) were recovered from the resin bottle, and there was no category of organism that was recovered significantly more frequently from the Isolator system. With patients receiving antibiotics at the time of blood culture, S. aureus, S. epidermidis, and gram-negative bacilli were recovered significantly more frequently from the resin bottle. No significant differences between systems were found with cultures from patients not receiving antibiotics at the time of blood culture. Only 12 clinically significant organisms were recovered from the bottle on terminal subcultures, and only 1 of these had not been previously isolated from another blood culture set (10 of the 12) or from the companion Isolator (1 of 12).(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8567877

  19. A randomised controlled crossover trial of nurse practitioner versus doctor led outpatient care in a bronchiectasis clinic

    PubMed Central

    Sharples, L; Edmunds, J; Bilton, D; Hollingworth, W; Caine, N; Keogan, M; Exley, A

    2002-01-01

    Background: With the decrease in junior doctor hours, the advent of specialist registrars, and the availability of highly trained and experienced nursing personnel, the service needs of patients with chronic respiratory diseases attending routine outpatient clinics may be better provided by appropriately trained nurse practitioners. Methods: A randomised controlled crossover trial was used to compare nurse practitioner led care with doctor led care in a bronchiectasis outpatient clinic. Eighty patients were recruited and randomised to receive 1 year of nurse led care and 1 year of doctor led care in random order. Patients were followed up for 2 years to ensure patient safety and acceptability and to assess differences in lung function. Outcome measures were forced expiratory volume in 1 second (FEV1), 12 minute walk test, health related quality of life, and resource use. Results: The mean difference in FEV1 was 0.2% predicted (95% confidence interval –1.6 to 2.0%, p=0.83). There were no significant differences in the other clinical or health related quality of life measures. Nurse led care resulted in significantly increased resource use compared with doctor led care (mean difference £1497, 95% confidence interval £688 to £2674, p<0.001), a large part of which resulted from the number and duration of hospital admissions. The mean difference in resource use was greater in the first year (£2625) than in the second year (£411). Conclusions: Nurse practitioner led care for stable patients within a chronic chest clinic is safe and is as effective as doctor led care, but may use more resources. PMID:12149523

  20. Case-control approach application for finding a relationship between candidate genes and clinical mastitis in Holstein dairy cattle.

    PubMed

    Bagheri, Masoumeh; Moradi-Sharhrbabak, M; Miraie-Ashtiani, R; Safdari-Shahroudi, M; Abdollahi-Arpanahi, R

    2016-02-01

    Mastitis is a major source of economic loss in dairy herds. The objective of this research was to evaluate the association between genotypes within SLC11A1 and CXCR1 candidate genes and clinical mastitis in Holstein dairy cattle using the selective genotyping method. The data set contained clinical mastitis records of 3,823 Holstein cows from two Holstein dairy herds located in two different regions in Iran. Data included the number of cases of clinical mastitis per lactation. Selective genotyping was based on extreme values for clinical mastitis residuals (CMR) from mixed model analyses. Two extreme groups consisting of 135 cows were formed (as cases and controls), and genotyped for the two candidate genes, namely, SLC11A1 and CXCR1, using polymerase chain reaction-single strand conformation polymorphism (PCR-SSCP) and polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP), respectively. Associations between single nucleotide polymorphism (SNP) genotypes with CMR and breeding values for milk and protein yield were carried out by applying logistic regression analyses, i.e. estimating the probability of the heterogeneous genotype in the dependency of values for CMR and breeding values (BVs). The sequencing results revealed a novel mutation in 1139 bp of exon 11 of the SLC11A1 gene and this SNP had a significant association with CMR (P < 0.05). PCR-RFLP analysis leads to three banding patterns for CXCR1c.735C>G and these genotypes had significant relationships with CMR. Overall, the results showed that SLC11A1 and CXCR1 are valuable candidate genes for the improvement of mastitis resistance as well as production traits in dairy cattle populations.

  1. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial

    PubMed Central

    2011-01-01

    Background High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD). Methods Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second. Results Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes. Conclusions HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population. Trial Registration ClinicalTrials.gov: NCT00181285 PMID:21906390

  2. Clinical utility of far-infrared therapy for improvement of vascular access blood flow and pain control in hemodialysis patients

    PubMed Central

    Choi, Soo Jeong; Cho, Eun Hee; Jo, Hye Min; Min, Changwook; Ji, Young Sok; Park, Moo Yong; Kim, Jin Kuk; Hwang, Seung Duk

    2015-01-01

    Background Maintenance of a well-functioning vascular access and minimal needling pain are important goals for achieving adequate dialysis and improving the quality of life in hemodialysis (HD) patients. Far-infrared (FIR) therapy may improve endothelial function and increase access blood flow (Qa) and patency in HD patients. The aim of this study was to evaluate effects of FIR therapy on Qa and patency, and needling pain in HD patients. Methods This prospective clinical trial enrolled 25 outpatients who maintained HD with arteriovenous fistula. The other 25 patients were matched as control with age, sex, and diabetes. FIR therapy was administered for 40 minutes during HD 3 times/wk and continued for 12 months. The Qa was measured by the ultrasound dilution method, whereas pain was measured by a numeric rating scale at baseline, then once per month. Results One patient was transferred to another facility, and 7 patients stopped FIR therapy because of an increased body temperature and discomfort. FIR therapy improved the needling pain score from 4 to 2 after 1 year. FIR therapy increased the Qa by 3 months and maintained this change until 1 year, whereas control patients showed the decrease in Qa. The 1-year unassisted patency with FIR therapy was not significantly different from control. Conclusion FIR therapy improved needling pain. Although FIR therapy improved Qa, the unassisted patency was not different compared with the control. A larger and multicenter study is needed to evaluate the effect of FIR therapy. PMID:27069856

  3. Effects of Safflower Yellow on the Treatment of Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial.

    PubMed

    Li, Xiao-Jin; Wang, Ru-Rong; Kang, Yan; Liu, Jin; Zuo, Yun-Xia; Zeng, Xue-Feng; Cheng, Gong

    2016-01-01

    Objective. To evaluate the clinical effect of safflower yellow on the treatment of severe sepsis and septic shock. Methods. 85 patients with severe sepsis and septic shock were randomly selected to receive either therapy according to the international guidelines for management of severe sepsis and septic shock (Surviving Sepsis Campaign 2012) (control group, n = 45) or conventional therapy plus safflower yellow (study group, n = 40). The 28-day mortality and 28-day Kaplan-Meier survival curves were compared as primary outcomes. Results. The 28-day mortality from all causes and in-hospital mortality were significantly lower in the study group (50%, 17.5%) as compared to the control group (78.58%, 54.76%) (P = 0.007, all causes, P < 0.001, in-hospital), and the 28-day Kaplan-Meier survival curve was higher in the study group than in the control group (P = 0.008, all causes, P < 0.001, in-hospital, Log Rank). 72 hours after treatment, secondary outcomes including heart rate, leukocyte counts, lactate levels, and platelet counts of patients in the study group were ameliorated significantly as compared with the control group. Conclusion. This study offers a potential new strategy employing safflower yellow to more effectively treat patients with severe sepsis and septic shock. This trial is registered with identifier ChiCTR-TRC-14005196. PMID:26989426

  4. Study protocol: a randomised placebo-controlled clinical trial to study the effect of vitamin D supplementation on glycaemic control in type 2 Diabetes Mellitus SUNNY trial

    PubMed Central

    2014-01-01

    Background Besides the classical role of vitamin D on calcium and bone homeostasis, vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus. However, it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus. There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control. The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus. Methods/design In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D3 at monthly intervals. The primary outcome measure is the change in glycated haemoglobin level between baseline and six months. Secondary outcome measures include blood pressure, anthropometric parameters, lipid profile, insulin resistance, quality of life, advanced glycation end products and safety profiles. Quality of life will be measured by The Short Form (SF-36) Health Survey questionnaire. Advanced glycation end products are measured by an AGE-reader. Discussion This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus. Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus. Trial registration The Netherlands trial register: NTR3154 PMID:25033925

  5. Quality control of radiation therapy in multi-institutional randomized clinical trial for localized prostate cancer

    SciTech Connect

    Hafermann, M.D.; Gibbons, R.P.; Murphy, G.P.

    1988-02-01

    The National Prostatic Cancer Project (NPCP) from 1978 through 1985 compared definitive radiation therapy for Stages B2, C, D1 lesions in those who received only radiation treatment to those who received two years of additional cyclophosphamide (Cytoxan) or estramustine phosphate (Emcyt) chemotherapy. Two hundred fifty-four patients were entered and 229 evaluated for compliance of the spatial localization of the prostate through review of the simulation and port films. In 78 per cent this was satisfactory, whereas in 12 per cent it was unsatisfactory, and another 10 per cent were not evaluable. The principle cause of an unsatisfactory rating was failure to adequately cover the prostatic target volume, especially the apex which was found to be variable in location. Routine use of retrograde urethrocystography is urged as part of the localization method in patients to receive definitive external beam radiation therapy for prostate cancer. The role and impact of quality assurance programs for radiotherapy in cooperative clinical study groups is reviewed and discussed.

  6. Asymptomatic Bacteriuria in Clinical Urological Practice: Preoperative Control of Bacteriuria and Management of Recurrent UTI.

    PubMed

    Cai, Tommaso; Mazzoli, Sandra; Lanzafame, Paolo; Caciagli, Patrizio; Malossini, Gianni; Nesi, Gabriella; Wagenlehner, Florian M E; Köves, Bela; Pickard, Robert; Grabe, Magnus; Bjerklund Johansen, Truls E; Bartoletti, Riccardo

    2016-01-01

    Asymptomatic bacteriuria (ABU) is a common clinical condition that often leads to unnecessary antimicrobial use. The reduction of antibiotic overuse for ABU is consequently an important issue for antimicrobial stewardship and to reduce the emergence of multidrug resistant strains. There are two issues in everyday urological practice that require special attention: the role of ABU in pre-operative prophylaxis and in women affected by recurrent urinary tract infections (rUTIs). Nowadays, this is the time to think over our practice and change our way of thinking. Here, we aimed to summarize the current literature knowledge in terms of ABU management in patients undergoing urological surgery and in patients with rUTIs. In the last years, the approach to patient with ABU has changed totally. Prior to all surgical procedures that do not enter the urinary tract, ABU is generally not considered as a risk factor, and screening and treatment are not considered necessary. On the other hand, in the case of all procedures entering the urinary tract, ABU should be treated in line with the results of a urine culture obtained before the procedure. In patients affected by rUTIs, ABU can even have a protective role in preventing symptomatic recurrence, particularly when Enterococcus faecalis (E. faecalis) has been isolated. PMID:26742080

  7. Inhaled beclomethasone dipropionate administered through a new spacer device: a controlled clinical study.

    PubMed

    Vecchiet, L; Pieralisi, G; Ambrosi, L; Di Lorenzo, L; Cantini, L

    1996-01-01

    This 4-week, randomized, parallel-group study compared the efficacy and safety of a metered-dose inhaler equipped with a new spacer device (Jet spacer) with those of a standard actuator in the administration of inhaled beclomethasone dipropionate (0.5 mg twice daily) in 66 adults with chronic obstructive pulmonary disease (COPD) who were responsive to beta 2-agonists. Lung function values, symptom scores, and daily consumption of a beta 2-agonist determined efficacy. At baseline and after treatment, levels of morning serum and 24-hour urinary cortisol were measured in half of the patients (one center). Ease of use of the two devices was expressed by patients at the final visit. Lung function values and clinical symptoms improved in both groups (P < .01 at the final visit); the Jet group reported a better outcome (P < .05 between groups) than the standard-actuator group for predicted normal values of forced expiratory volume in 1 second, forced vital capacity, and bronchial noises. Salbutamol consumption decreased in both groups. One patient in the Jet group and 5 patients in the standard-actuator group reported adverse reactions. No significant between-group differences were found in plasma and urinary cortisol levels. The Jet device was judged easier to use (P < .05 between groups) than the standard actuator. In conclusion, the jet device was more effective than a standard actuator in reducing local adverse reactions to inhaled beclomethasone dipropionate in adults with COPD, with a better efficacy profile.

  8. Physical Activity, Weight Control, and Breast Cancer Risk and Survival: Clinical Trial Rationale and Design Considerations

    PubMed Central

    Hunsberger, Sally; Alciati, Marianne H.; Blair, Steven N.; Goodwin, Pamela J.; McTiernan, Anne; Wing, Rena; Schatzkin, Arthur

    2009-01-01

    Substantial observational epidemiological evidence exists that physical activity and weight control are associated with decreased risk of postmenopausal breast cancer. Uncertainty remains regarding several aspects of these associations, including the effect of possible confounding factors on these associations. We present the rationale and design for two randomized controlled trials that can help resolve this uncertainty. In a 5-year prevention trial conducted among women at high risk of breast cancer, the primary endpoint would be breast cancer incidence. For a comparable survivorship trial, the primary endpoint would be the disease-free interval and secondary endpoints would be breast cancer recurrence–free interval, second primary breast cancer, and total invasive plus in situ breast cancer. A set of inclusion and exclusion criteria is proposed for both trials. Intervention goals are the same for both trials. Goals for the weight control intervention would be, for women whose body mass index (BMI) is greater than 25 kg/m2, to lose 10% of body weight and, for women whose BMI is less than or equal to 25 kg/m2, to avoid weight gain. The goal for the physical activity intervention would be to achieve and maintain regular participation in a moderate-intensity physical activity program for a total of 150–225 minutes over at least 5 days per week. Sample size calculations are based on alternative assumptions about hazard ratio, adherence, follow-up duration, and power and are presented for the primary prevention and survivorship trials. Although both studies could enhance our understanding of breast cancer etiology and benefit public health, practical considerations, including smaller sample size, ease of recruitment, and reduced likelihood of early termination, favor the survivorship trial at this time. PMID:19401543

  9. Probiotic for irritable bowel syndrome in pediatric patients: a randomized controlled clinical trial

    PubMed Central

    Kianifar, Hamidreza; Jafari, Seyed Ali; Kiani, Mohammadali; Ahanchian, Hamid; Ghasemi, Seyed Vahid; Grover, Zubin; Mahmoodi, Leili Zarif; Bagherian, Rita; Khalesi, Maryam

    2015-01-01

    Background: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder in children. Recently, probiotics have been suggested as a treatment option for gastrointestinal disorders. The most effective species and the most appropriate doses are still unknown. Objective: The aim of this study was to assess the effects of Lactobacillus GG (LGG) for treating IBS in pediatric patients. Methods: In a controlled, double blind, randomized trial, patients with IBS diagnosed by Rome III criteria from August 2012 to September 2012 at Dr. Sheikh Hospital, Mashhad University of Medical Sciences, Iran, were assigned to one of two groups, i.e., intervention and control groups. For four weeks, the intervention group received a probiotic in capsule form that contained LGG at a concentration of 1×1010 cfu/ml bacteria. For the same period, the control group received a placebo capsule that had the same shape and color but only contained inulin, which also was present in the LGG capsules. The primary outcome was any change in the severity of the patients’ pain, and we used a five-point Likert scale to evaluate the severity of their pain. Secondary outcomes were ghanges of the functional scale, stool patterns, and associated problems. Results: Fifty-two patients participated in the study, and 26 patients were assigned randomly to each of the two groups. The severity of the patients’ pain decreased significantly in the intervention group after one, two, three, and four weeks of treatment, as indicated by P-values of 0.01, 0.00, 0.00, and 0.00, respectively. Also, there was significant improvement in the functional scale after two weeks of treatment (P-value ≤ 0.00). Conclusion: Lactobacillus GG at a concentration of 1×1010 cfu/ml for a period of four weeks can lessen the severity of the patients’ pain and improve the functional scale in patients with irritable bowel syndrome. Probiotics can have therapeutic effects for IBS patients. PMID:26435825

  10. Local bupivacaine for postoperative pain management in thyroidectomized patients: A prospective and controlled clinical study

    PubMed Central

    Dumlu, Ersin Gürkan; Tokaç, Mehmet; Öcal, Haydar; Durak, Doğukan; Kara, Halil; Kılıç, Mehmet; Yalçın, Abdussamed

    2016-01-01

    Objective We aimed to evaluate the effect of bupivacaine and to compare the routes of administration of bupivacaine in the management of postoperative incision site pain after thyroidectomy. Material and Methods Consecutive patients who were planned for thyroidectomy surgery were randomized into three groups of 30 patients each: Group 1 (control group): standard thyroidectomy surgery without additional intervention; Group 2 (paratracheal infiltration with bupivacaine): following thyroidectomy, 0.25% bupivacaine was applied on the surgical area; Group 3 (subcutaneous infiltration with bupivacaine): following thyroidectomy, 0.25% bupivacaine was injected into the cutaneous, subcutaneous region and fascia of the surgical area. Postoperative pain was evaluated by a visual analog scale (VAS) at 1st, 4th, and 12th hours after thyroidectomy. Total daily requirement for additional analgesia was recorded. Results The mean age of 90 patients was 44.37±13.42 years, and the female:male ratio was 62:28. There was no difference between study groups in terms of age, thyroid volume, TSH and T4 levels. VAS score of patients in paratracheal infiltration with bupivacaine group was significantly lower than control group patients at 1st, 4th and 12th hours following thyroidectomy (p=0.030, p=0.033, p=0.039, respectively). The need for analgesics was significantly lower in both paratracheal infiltration and subcutaneous infiltration groups than the control group (86.7%, 83.0%, and 73.3%, respectively, p=0.049). Conclusions Intraoperative local bupivacaine application is effective in decreasing postoperative pain in patients with thyroidectomy. PMID:27528810

  11. A randomized controlled clinical trial of SPA -- the Seattle Protocol for Activity in older adults

    PubMed Central

    Teri, Linda; McCurry, Susan M.; Logsdon, Rebecca G.; Gibbons, Laura E.; Buchner, David M.; Larson, Eric B.

    2012-01-01

    OBJECTIVES Evaluate the efficacy of a physical activity program (Seattle Protocol for Activity: SPA) for low-exercising older adults, compared to educational health promotion program (HP), combination treatment (SPA+HP), and routine medical care control conditions (RMC). DESIGN Single-blinded, randomized controlled trial with 2 × 2 factorial design. SETTING: November 2001 to September 2004, in community centers in King County, Washington. PARTICIPANTS 273 community-residing, cognitively intact older adults (mean age, 79.2 y; 62% women). INTERVENTIONS SPA (in-class exercises with assistance setting weekly home exercise goals), and HP (information about age-appropriate topics relevant to enhancing health), with randomization to four conditions: SPA only (n = 69), HP only (n = 73), SPA+HP (n = 67), and RMC control (n = 64). Active treatment participants attended nine group classes over three months, followed by five booster sessions over one year. MAIN OUTCOME MEASURES Self-rated health (SF-36) and depression (GDS). Secondary ratings of physical performance, treatment adherence, and self-rated health and affective function were also collected. RESULTS At 3-months, participants in SPA exercised more and had significantly better self-reported health, strength, and general well-being (p<.05) than participants in HP or RMC. Over 18 months, SPA participants maintained health and physical function benefits, and had continued to exercise more than non-SPA participants. SPA+HP was not significantly better than SPA alone. Better adherence was associated with better outcomes. CONCLUSION Older adults participating in low levels of regular exercise can establish and maintain a home-based exercise program that yields immediate and long-term physical and affective benefits. PMID:21718259

  12. Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial

    PubMed Central

    Rosen, Sydney; Maskew, Mhairi; Fox, Matthew P.; Nyoni, Cynthia; Mongwenyana, Constance; Sanne, Ian; Sauls, Celeste; Long, Lawrence

    2016-01-01

    Background High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit. Methods and Findings RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (≥18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study (“rapid arm”) received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study (“standard arm”) followed standard clinic procedures (three to five additional clinic visits over 2–4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis

  13. [Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    PubMed

    Ruiz de Gopegui Bordes, Enrique; Serrano, M del Remedio Guna; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Cardona, Concepción Gimeno

    2011-12-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons of the 2010 controls. As a whole, the results obtained in 2010 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls to ensure maximal quality of microbiological tests(1).

  14. Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background The prevalence of type 2 diabetes is rising worldwide, as has been the global mean fasting plasma glucose level. This study aimed to evaluate the effectiveness of a structured individual-based lifestyle education (SILE) program to reduce the hemoglobin A1c (HbA1c) level in type 2 diabetes patients delivered by registered dietitians in primary care clinical settings. Methods This was a 6-month prospective cluster randomized controlled trial in a primary care setting with randomization at the practice level. Twenty general practitioners in 20 clinics in Kanagawa prefecture, Japan, were involved. 193 adults (51% men, mean age 61.3 years) with type 2 diabetes and HbA1c ≥6.5% who received treatment in medical clinics were the participants. A SILE program was implemented through 4 sessions with trained registered dietitians during the 6-month study period. Results were compared with those of a control group who received usual care. The primary endpoint was the change in HbA1c levels at 6 months from baseline. Secondary endpoints were the changes at 6 months from baseline in fasting plasma glucose, lipid profile, blood pressure, BMI, energy, and nutrient intakes (whole day and each meal). Intention-to-treat analysis was conducted. Mixed-effects linear models were used to examine the effects of the treatment. Results The mean change at 6 months from baseline in HbA1c was a 0.7% decrease in the intervention group (n = 100) and a 0.2% decrease in the control group (n = 93) (difference −0.5%, 95%CI: -0.2% to −0.8%, p = 0.004). After adjusting for baseline values and other factors, the difference was still significant (p = 0.003 ~ 0.011). The intervention group had a significantly greater decrease in mean energy intake at dinner compared with the control group and a greater increase in mean vegetable intake for the whole day, breakfast, and lunch as shown in crude and adjusted models. A tendency toward improvement was observed in the other

  15. Toward comprehensive management tailored to prognostic factors of patients with clinical stages I and II in Hodgkin's disease. The EORTC Lymphoma Group controlled clinical trials: 1964-1987.

    PubMed

    Tubiana, M; Henry-Amar, M; Carde, P; Burgers, J M; Hayat, M; Van der Schueren, E; Noordijk, E M; Tanguy, A; Meerwaldt, J H; Thomas, J

    1989-01-01

    From 1964 to 1987, the EORTC Lymphoma Group conducted four consecutive controlled clinical trials on clinical stages I and II Hodgkin's disease in which 1,579 patients were entered. From the onset the main aim of these trials was to identify the subsets of patients who could be treated safely by regional radiotherapy (RT). Therefore, several prognostic indicators were prospectively registered and progressively used in the trial protocols for the delineation of the favorable and unfavorable subgroups as soon as they were recognized of high predictive value. In the H2 trial (1972 to 1976), the histologic subtype was the only variable taken into account for the therapeutic strategy and the staging laparotomy findings were found to be of prognostic value only in patients with favorable prognostic indicators. In the H5 trial (1977 to 1982), patients were subdivided into two subgroups according to six prognostic indicators. Patients with favorable features were submitted to a staging laparotomy (lap); lap negative patients were randomized between mantle field RT and mantle field plus paraaortic RT. Disease free survival (DFS) and total survival (S) were similar in the two arms. Among patients with unfavorable features, DFS and S were significantly higher in the arm treated by combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT than in the arm treated by total nodal irradiation. Nevertheless, in patients below the age of 40, the overall survival rates were equivalent in the two arms. In the H6 trial, the delineation of the favorable subgroup was based on (a) absence of systemic symptoms and elevated ESR, (b) no more than one or two lymph node areas involved. The aim of the study was to assess the impact on survival of a therapeutic strategy including staging laparotomy. At a 4-year follow-up, no difference in survival was evidenced. In patients with unfavorable prognostic indicators, 3 MOPP-RT-3 MOPP were compared with 3

  16. Clinical Significance of Auditive Involvement in Rheumatoid Arthritis: A Case-Control Study

    PubMed Central

    Alonso, Laura; Gutierrez-Farfan, Ileana; Peña-Ayala, Angelica; Perez-Bastidas, Maria-Esther; Espinosa, Rolando

    2011-01-01

    Introduction. Rheumatoid arthritis (RA) can involve the incudomalleolar or incudostapedial articulations. Objective. To know the punctual prevalence of audiological alterations in patients with RA. Patients and Methods. RA patients and their controls (Cs), were evaluated by Tonal Audiometry (AU); if there were alterations in the air conduction (AC), bone conduction (BC), Logoaudiometry (LG), and Tympanometry (T) were performed. Results. 45 RA patients and 45 Cs were evaluated. RA patients had 40% of bilateral and 17.8% unilateral alteration versus Cs with 22.2% bilateral and 4.4% unilateral alteration versus Cs with 22.2% bilateral and 4.4% unilateral in AC audiometry. In conventional T (CT) As-type curves in patients with RA, there were 22 LE (48.8%) and 26 RE (57.7%) versus Cs, there were16 RE (35.5%) and 20 LE (44.4%). In High-frequency T (HFT): the 3B1G pattern in RA more frequent versus Controls (Cs) in RE (P = .002 and LE (P = .01). There were no differences according to RA activity or RA disease evolution. Conclusions. There is a greater tendency of auditive loss of As curves in CT (rigidity in ossicular chain) and of the 3B1G pattern in HFT in RA. PMID:22482066

  17. A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia

    PubMed Central

    Gomar, Jesús J.; Valls, Elia; Radua, Joaquim; Mareca, Celia; Tristany, Josep; del Olmo, Francisco; Rebolleda-Gil, Carlos; Jañez-Álvarez, María; de Álvaro, Francisco J.; Ovejero, María R.; Llorente, Ana; Teixidó, Cristina; Donaire, Ana M.; García-Laredo, Eduardo; Lazcanoiturburu, Andrea; Granell, Luis; Mozo, Cristina de Pablo; Pérez-Hernández, Mónica; Moreno-Alcázar, Ana; Pomarol-Clotet, Edith; McKenna, Peter J.

    2015-01-01

    The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results. PMID:26006264

  18. Effect of ozonated oil and chlorhexidine gel on plaque induced gingivitis: A randomized control clinical trial

    PubMed Central

    Indurkar, Maya Sanjeev; Verma, Renu

    2016-01-01

    Background: Several chemotherapeutic agents have been developed to prevent gingivitis and its progression into periodontitis. In this present study, the efficacy of ozonated oil and chlorhexidine gel was assessed and compared on plaque induced gingivitis. Aim: To evaluate the effect of ozonated oil on plaque induced gingivitis and to compare its efficacy with chlorhexidine gel. Materials and Methods: A total of 20 subjects, aged from 18 to 65 years, with plaque-induced gingivitis were selected from the outpatient Department of Periodontology, Government Dental College and Hospital, Aurangabad, for this study. They were divided randomly into the test or ozonated oil group (Group I) and the control or chlorhexidine gel group (Group II) with 10 subjects in each group. Subjects were randomly assigned to massage their gingiva thrice a day for 3 weeks with ozonated oil (test), and chlorhexidine gel (control). Plaque index and gingival index scores were recorded for the 20 subjects at baseline and after 3 weeks. Results: Ozonated oil (Group I) and chlorhexidine gel (Group II) groups showed statistically significant differences with respect to plaque index and gingival index, from the baseline to 3 weeks (P < 0.001 in both). But the difference between Group I and Group II, at the end of the study period, was not statistically significant with respect to the plaque index and gingival index. Conclusions: The ozonated oil and chlorhexidine gel, both can be used as an effective agent in maintaining and improving gingival health. PMID:27041835

  19. Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial

    PubMed Central

    Pauné, Jaime; Morales, Hari; Armengol, Jesús; Quevedo, Lluisa; Faria-Ribeiro, Miguel; González-Méijome, José M.

    2015-01-01

    Objective. To evaluate the degree of axial elongation with soft radial refractive gradient (SRRG) contact lenses, orthokeratology (OK), and single vision (SV) spectacle lenses (control) during a period of 1 year before treatment and 2 years after treatment. Methods. This was a prospective, longitudinal, nonrandomized study. The study groups consisted of 30, 29, and 41 children, respectively. The axial length (AL) was measured during 2 years after recruitment and lens fitting. Results. The baseline refractive sphere was correlated significantly (Spearman's Rho (ρ) correlation = 0.542; P < 0.0001) with the amount of myopia progression before baseline. After 2 years, the mean myopia progression values for the SRRG, OK, and SV groups were −0.56 ± 0.51, −0.32 ± 0.53, and −0.98 ± 0.58 diopter, respectively. The results represent reductions in myopic progression of 43% and 67% for the SRRG and OK groups, respectively, compared to the SV group. The AL increased 27% and 38% less in the SRRG and OK groups, respectively compared with the SV group at the 2-year visit (P < 0.05). Axial elongation was not significantly different between SRRG and OK (P = 0.430). Conclusion. The SRRG lens significantly decreased AL elongation compared to the SV control group. The SRRG lens was similarly effective to OK in preventing myopia progression in myopic children and adolescent. PMID:26605331

  20. Periodontal treatment during pregnancy decreases the rate of adverse pregnancy outcome: a controlled clinical trial

    PubMed Central

    SANT’ANA, Adriana Campos Passanezi; de CAMPOS, Marinele R.; PASSANEZI, Selma Campos; de REZENDE, Maria Lúcia Rubo; GREGHI, Sebastião Luiz Aguiar; PASSANEZI, Euloir

    2011-01-01

    Objectives The aim of this study was to evaluate the effects of non-surgical treatment of periodontal disease during the second trimester of gestation on adverse pregnancy outcomes. Material and Methods Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center were divided into 2 groups: NIG – "no intervention" (n=17) or IG- "intervention" (n=16). IG patients were submitted to a non-surgical periodontal treatment performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). NIG received PROPH and OHI during pregnancy and were referred for treatment after delivery. Periodontal evaluation was performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes were preterm birth (<37 weeks), low birth weight (<2.5 kg), late abortion (14-24 weeks) or abortion (<14 weeks). The results obtained were statistically evaluated according to OR, unpaired t test and paired t test at 5% significance level. Results No significant differences were observed between groups at baseline examination. Periodontal treatment resulted in stabilization of CAL and PI (p>0.05) at IG and worsening of all periodontal parameters at NIG (p<0.0001), except for PI. Significant differences in periodontal conditions of IG and NIG were observed at 2nd examination (p<0.001). The rate of adverse pregnancy outcomes was 47.05% in NIG and 6.25% in IG. Periodontal treatment during pregnancy was associated to a decreased risk of developing adverse pregnancy outcomes [OR=13.50; CI: 1.47-123.45; p=0.02]. Conclusions Periodontal treatment during the second trimester of gestation contributes to decrease adverse pregnancy outcomes. PMID:21552714

  1. A quality control program within a clinical trial Consortium for PCR protocols to detect Plasmodium species.

    PubMed

    Taylor, Steve M; Mayor, Alfredo; Mombo-Ngoma, Ghyslain; Kenguele, Hilaire M; Ouédraogo, Smaïla; Ndam, Nicaise Tuikue; Mkali, Happy; Mwangoka, Grace; Valecha, Neena; Singh, Jai Prakash Narayan; Clark, Martha A; Verweij, Jaco J; Adegnika, Ayola Akim; Severini, Carlo; Menegon, Michela; Macete, Eusebio; Menendez, Clara; Cisteró, Pau; Njie, Fanta; Affara, Muna; Otieno, Kephas; Kariuki, Simon; ter Kuile, Feiko O; Meshnick, Steven R

    2014-06-01

    Malaria parasite infections that are only detectable by molecular methods are highly prevalent and represent a potential transmission reservoir. The methods used to detect these infections are not standardized, and their operating characteristics are often unknown. We designed a proficiency panel of Plasmodium spp. in order to compare the accuracy of parasite detection of molecular protocols used by labs in a clinical trial consortium. Ten dried blood spots (DBSs) were assembled that contained P. falciparum, P. vivax, P. malariae, and P. ovale; DBSs contained either a single species or a species mixed with P. falciparum. DBS panels were tested in 9 participating laboratories in a masked fashion. Of 90 tests, 68 (75.6%) were correct; there were 20 false-negative results and 2 false positives. The detection rate was 77.8% (49/63) for P. falciparum, 91.7% (11/12) for P. vivax, 83.3% (10/12) for P. malariae, and 70% (7/10) for P. ovale. Most false-negative P. falciparum results were from samples with an estimated ≤ 5 parasites per μl of blood. Between labs, accuracy ranged from 100% to 50%. In one lab, the inability to detect species in mixed-species infections prompted a redesign and improvement of the assay. Most PCR-based protocols were able to detect P. falciparum and P. vivax at higher densities, but these assays may not reliably detect parasites in samples with low P. falciparum densities. Accordingly, formal quality assurance for PCR should be employed whenever this method is used for diagnosis or surveillance. Such efforts will be important if PCR is to be widely employed to assist malaria elimination efforts.

  2. Metformin in Amnestic Mild Cognitive Impairment: Results of a Pilot Randomized Placebo Controlled Clinical Trial.

    PubMed

    Luchsinger, José A; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Davangere P; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (aMCI) with the goal of collecting preliminary data on feasibility, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with aMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake in the posterior cingulate-precuneus in brain fluorodeoxyglucose positron emission tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty percent of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7±8.5 versus 5.3±8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD. PMID:26890736

  3. Garlic powder intake and cardiovascular risk factors: a meta-analysis of randomized controlled clinical trials

    PubMed Central

    Kwak, Jin Sook; Kim, Ji Yeon; Paek, Ju Eun; Lee, You Jin; Kim, Haeng-Ran; Park, Dong-Sik

    2014-01-01

    BACKGROUND/OBJECTIVES Although preclinical studies suggest that garlic has potential preventive effects on cardiovascular disease (CVD) risk factors, clinical trials and reports from systematic reviews or meta-analyses present inconsistent results. The contradiction might be attributed to variations in the manufacturing process that can markedly influence the composition of garlic products. To investigate this issue further, we performed a meta-analysis of the effects of garlic powder on CVD risk factors. MATERIALS/METHODS We searched PubMed, Cochrane, Science Direct and EMBASE through May 2014. A random-effects meta-analysis was performed on 22 trials reporting total cholesterol (TC), 17 trials reporting LDL cholesterol (LDL-C), 18 trials reporting HDL cholesterol (HDL-C), 4 trials reporting fasting blood glucose (FBG), 9 trials reporting systolic blood pressure (SBP) and 10 trials reporting diastolic blood pressure (DBP). RESULTS The overall garlic powder intake significantly reduced blood TC and LDL-C by -0.41 mmol/L (95% confidence interval [CI], -0.69, -0.12) (-15.83 mg/dL [95% CI, -26.64, -4.63]) and -0.21 mmol/L (95% CI, -0.40, -0.03) (-8.11 mg/dL [95% CI, -15.44, -1.16]), respectively. The mean difference in the reduction of FBG levels was -0.96 mmol/L (95% CI, -1.91, -0.01) (-17.30 mg/dL [95% CI, -34.41, -0.18]). Evidence for SBP and DBP reduction in the garlic supplementation group was also demonstrated by decreases of -4.34 mmHg (95% CI, -8.38, -0.29) and -2.36 mmHg (95% CI, -4.56, -0.15), respectively. CONCLUSIONS This meta-analysis provides consistent evidence that garlic powder intake reduces the CVD risk factors of TC, LDL-C, FBG and BP. PMID:25489404

  4. Metformin in Amnestic Mild Cognitive Impairment: results of a pilot randomized placebo controlled clinical trial

    PubMed Central

    Luchsinger, José A.; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Devangere P.; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (AMCI) with the goal of collecting preliminary data on feasiblity, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with AMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake (rCMRgl) in the posterior cingulate-precuneus in brain Fluorodeoxyglucose Positron Emission Tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty % of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7 ± 8.5 vs. 5.3 ± 8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD. PMID:26890736

  5. Internet-delivered Treatment for Substance Abuse: A Multi-site Randomized Controlled Clinical Trial

    PubMed Central

    Campbell, Aimee N. C.; Nunes, Edward V.; Matthews, Abigail G.; Stitzer, Maxine; Miele, Gloria M.; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A.; Kyle, Tiffany L.; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E.

    2014-01-01

    Objective Drug and alcohol abuse constitutes a major public health problem. Computer-delivered interventions have potential to improve access to quality care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System, an internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Method Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to 12-weeks of treatment-as-usual (n=252) or treatment-as-usual + Therapeutic Education System, whereby the intervention substituted for 2 hours of standard care per week (n=255). Therapeutic Education System consists of 62 computer-interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment-as-usual consisted of individual and group counseling at the participating programs. Primary outcomes were (1) abstinence from drugs and heavy drinking measured by twice weekly urine drug screens and self-report, and (2) time to drop-out from treatment. Results Compared to treatment-as-usual, those receiving Therapeutic Education System reduced dropout from treatment (Hazard Ratio=0.72 [95% CI, 0.57-0.92], P=.010), and increased abstinence (Odds Ratio=1.62 [95% CI: 1.12-2.35], P=.010), an effect that was more pronounced among patients with a positive urine drug and/or breath alcohol screen at the point of study entry (n=228) (Odds Ratio=2.18 [95% CI: 1.30-3.68], P=.003). Conclusion Internet-delivered interventions, such as Therapeutic Education System, have the potential to expand access and improve addiction treatment outcomes; additional research is needed to assess effectiveness in non-specialty clinical systems and to differentiate the effect of Community Reinforcement Approach and Contingency Management. PMID:24700332

  6. Chiropractic spinal manipulative therapy for migraine: a study protocol of a single-blinded placebo-controlled randomised clinical trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Tuchin, Peter J; Russell, Michael Bjørn

    2015-01-01

    Introduction Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT). Method and analysis According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs. Ethics and dissemination The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals. Trial registration number NCT01741714. PMID:26586317

  7. The Effect of Melatonin on Climacteric Symptoms in Menopausal Women; A Double-Blind, Randomized Controlled, Clinical Trial

    PubMed Central

    PARANDAVAR, Nehleh; ABDALI, Khadijeh; KESHTGAR, Sara; EMAMGHOREISHI, Maasoumeh; AMOOEE, Seddegheh

    2014-01-01

    Abstract Background Menopause is one of the most critical periods of woman’s life. With reducing of ovarian estrogen; women are more prone to psychological and physical symptoms. The present study aimed to investigate the effect of melatonin on the climacteric symptoms. Methods The present double blind, placebo randomized controlled clinical trial was conducted on 240 menopausal women (40 - 60 years old) referring to the gynecology clinics of Shiraz University of Medical Sciences (January - November 2012). The participants were randomly divided into two groups through sortition. Demographic characteristics, Goldberg’s general health questionnaire (GHQ), Greene Climacteric Scale and level of Follicle Stimulating Hormone (FSH) were determined for both groups before the intervention. The intervention group received one 3mg melatonin tablet each night for 3 months and the control group received the placebo in the same period. Changes of climacteric symptoms and drug complications were measured 1, 2 and 3 months after the intervention Results We analyzed the data of 99 postmenopausal women in the intervention group and 101 postmenopausal women in the control group. In the melatonin group, the climacteric symptoms score decreased from 35.73+11.6 to 17.09+10.22 during the 3-month study period and regardless of time, a significant difference was observed between the two groups (P<0.001). In addition, a significant difference was found between the two groups regarding various dimensions of the climacteric symptoms over time (P<0.001). No significant difference was found regarding side effects between the two groups (P= 0.135). Conclusion The study findings showed that using melatonin improved the climacteric symptoms. PMID:26060703

  8. Innovative techniques in radiation oncology. Clinical research programs to improve local and regional control in cancer

    SciTech Connect

    Brady, L.W.; Markoe, A.M.; Micaily, B.; Fisher, S.A.; Lamm, F.R. )

    1990-02-01

    There is a growing importance in failure analysis in cancer management. In these analyses locoregional failure as the cause of death emerges as a significant problem in many tumor sites, e.g., head and neck cancer, gynecologic cancer, genitourinary cancer. Because of these data, the radiation oncology community has attributed high priority to research efforts to improve locoregional control. These efforts include the following: (1) brachytherapy alone or with external beam radiation therapy or surgery; (2) intraoperative radiation therapy; (3) hyperthermia with radiation therapy; (4) particle irradiation (protons, neutrons, stripped nuclei, and pions); and (5) routes of administration of the treatment, including infusional (intravenous) chemotherapy with radiation therapy, intraarterial monoclonal antibodies with radionuclides, and intraarterial chemotherapy with radiation therapy. Each area of investigation is discussed.

  9. Sorafenib for Hepatocellular Carcinoma: From Randomized Controlled Trials to Clinical Practice.

    PubMed

    Cabibbo, Giuseppe; Petta, Salvatore; Maida, Marcello; Cammà, Calogero

    2015-09-01

    Hepatocellular carcinoma is a challenging malignancy of global importance. It is the sixth most common solid malignancy and the third leading cause of cancer-related death, worldwide. Curative treatments at early stages include liver transplantation, resection and percutaneous ablation, while transarterial chemoembolization can improve survival in patients with intermediate tumor stage. Patients with mild, related symptoms and/or macrovascular invasion or extrahepatic spread are classified under the advanced stage. The standard of care in this group is sorafenib, an inhibitor of Raf kinase and vascular endothelial growth factor receptor, whose effectiveness has been proven by 2 recent randomized controlled trials (RCTs). The aim of this brief review is to highlight the main concerns and pitfalls and to analyze the recent data of literature regarding the efficacy and the management of sorafenib therapy from RCTs to real practice. PMID:26398633

  10. [Ultrasonic aspirator with controllable suction system--variable action suction adapter and clinical experience with it].

    PubMed

    Nagasawa, S; Shimano, H; Kuroiwa, T

    2000-12-01

    While the ultrasonic aspirator (UA) has been widely used as one of the indispensable tools in the field of neurosurgery, a potential risk when using the present UA is injury to the neurovascular structures due to ultrasonic pulverization and constant forceful suction power. We have devised a small variable action suction adapter that can be used in a similar manner to conventional surgical suction tubes. The UA control unit and the handpiece used in this study were the Sonopet UST-2000 and HA-01, respectively (M & M Corporation Tokyo, Japan). The handpiece is slim, with the mid-portion diameter of 13 mm, and it weighs 100 grams. A variable action suction adapter was made from polycarbonate of 15 x 12 x 13 mm in size. The adapter was connected to the suction tube using a Y-shaped connector (Fig. 2 A), which was integrated into the handpiece. The suction power is regulated by variably closing the oval-shaped hole. The adapter can be variously placed on and rotated around the handpiece (Fig. 2 B and C) so that either the right or left hand handles it in a similar fashion to conventional suction tubes. We used this UA in surgery for 8 patients with large brain tumors (meningioma in 5 cases, metastatic brain tumor in 2 cases and glioma in one case). It reduced the risk of suction-related injury to the neurovascular structures and was handled in a similar manner to conventional suction tubes. This adapter ensures the complete control of suction power, which will reduce the risk of suction injury.

  11. Neurofeedback intervention in fibromyalgia syndrome; a randomized, controlled, rater blind clinical trial.

    PubMed

    Kayiran, Sadi; Dursun, Erbil; Dursun, Nigar; Ermutlu, Numan; Karamürsel, Sacit

    2010-12-01

    We designed a randomized, rater blind study to assess the efficacy of EEG Biofeedback (Neurofeedback-NFB) in patients with fibromyalgia syndrome (FMS). Eighteen patients received twenty sessions of NFB-sensory motor rhythm (SMR) treatment (NFB group) during 4 weeks, and eighteen patients were given 10 mg per day escitalopram treatment (control group) for 8 weeks. Visual Analog Scales for pain and fatigue, Hamilton and Beck Depression and Anxiety Inventory Scales, Fibromyalgia Impact Questionnaire and Short Form 36 were used as outcome measures which were applied at baseline and 2nd, 4th, 8th, 16th, 24th weeks. Mean amplitudes of EEG rhythms (delta, theta, alpha, SMR, beta1 and beta2) and theta/SMR ratio were also measured in NFB group. All post-treatment measurements showed significant improvements in both of the groups (for all parameters p < 0.05). NFB group displayed greater benefits than controls (for all parameters p < 0.05). Therapeutic efficacy of NFB was found to begin at 2nd week and reached to a maximum effect at 4th week. On the other hand, the improvements in SSRI treatment were also detected to begin at 2nd week but reached to a maximum effect at 8th week. No statistically significant changes were noted regarding mean amplitudes of EEG rhythms (p > 0.05 for all). However, theta/SMR ratio showed a significant decrease at 4th week compared to baseline in the NFB group (p < 0.05). These data support the efficacy of NFB as a treatment for pain, psychological symptoms and impaired quality of life associated with fibromyalgia. PMID:20614235

  12. Photodynamic therapy as adjunct to non-surgical periodontal treatment in patients on periodontal maintenance: a randomized controlled clinical trial.

    PubMed

    Chondros, Panos; Nikolidakis, Dimitris; Christodoulides, Nicos; Rössler, Ralf; Gutknecht, Norbert; Sculean, Anton

    2009-09-01

    Recent preclinical and clinical data have suggested the potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, currently, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of the present study was to evaluate the clinical and microbiological effects of the adjunctive use of PDT in non-surgical periodontal treatment in patients receiving supportive periodontal therapy. Twenty-four patients receiving regularly supportive periodontal therapy were randomly treated with either subgingival scaling and root planing followed by a single episode of PDT (test) or subgingival scaling and root planing alone (control). The following parameters were evaluated at baseline and at 3 months and 6 months after therapy: full mouth plaque score (FMPS), full mouth bleeding score (FMBS), bleeding on probing (BOP) at experimental sites, probing pocket depth (PPD), gingival recession (REC), and clinical attachment level (CAL). Primary outcome variables were changes in PPD and CAL. Microbiological evaluation of Aggregatibacter actinomycetemcomitans (A.a.), Porphyromonas gingivalis (P.g.), Prevotella intermedia (P.i.), Tannerella forsythensis (T.f.), Treponema denticola (T.d.), Peptostreptococcus micros (P.m.), Fusobacterium nucleatum (F.n.), Campylobacter rectus (C.r.), Eubacterium nodatum (E.n.), Eikenella corrodens (E.c.), and Capnocytophaga species (C.s.) was also performed at baseline and at 3 months and 6 months after therapy, using a commercially available polymerase chain reaction test. No differences in any of the investigated parameters were observed at baseline between the two groups. At 3 months and 6 months after treatment, there were no statistically significant differences between the groups in terms of PPD, CAL and FMPS. At 3 months and 6 months, a statistically significantly higher improvement of BOP was found in the test group. At 3 months after therapy

  13. Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial

    PubMed Central

    Hartmann, Andreas; Müllner, Julia; Meier, Niklaus; Hesekamp, Helke; van Meerbeeck, Priscilla; Habert, Marie-Odile; Kas, Aurélie; Tanguy, Marie-Laure; Mazmanian, Merry; Oya, Hervé; Abuaf, Nissen; Gaouar, Hafida; Salhi, Sabrina; Charbonnier-Beaupel, Fanny; Fievet, Marie-Hélène; Galanaud, Damien; Arguillere, Sophie; Roze, Emmanuel; Degos, Bertrand; Grabli, David; Lacomblez, Lucette; Hubsch, Cécile; Vidailhet, Marie; Bonnet, Anne-Marie

    2016-01-01

    ClinicalTrials.gov NCT01341431 PMID:27403743

  14. A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial

    PubMed Central

    Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

    2015-01-01

    Background/Aims: Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). Methods: This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial’s sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. Results: We included 142 of 231 protocols in the final analysis (concept = 78; ad hoc = 64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10–0.58)) than in the concept arm (0.27 (0.06–0.50)), but the difference was not significant (p = 0.67). Limitations: The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. Conclusion: A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines

  15. Neuro Emotional Technique for the treatment of trigger point sensitivity in chronic neck pain sufferers: A controlled clinical trial

    PubMed Central

    Bablis, Peter; Pollard, Henry; Bonello, Rod

    2008-01-01

    Background Trigger points have been shown to be active in many myofascial pain syndromes. Treatment of trigger point pain and dysfunction may be explained through the mechanisms of central and peripheral paradigms. This study aimed to investigate whether the mind/body treatment of Neuro Emotional Technique (NET) could significantly relieve pain sensitivity of trigger points presenting in a cohort of chronic neck pain sufferers. Methods Sixty participants presenting to a private chiropractic clinic with chronic cervical pain as their primary complaint were sequentially allocated into treatment and control groups. Participants in the treatment group received a short course of Neuro Emotional Technique that consists of muscle testing, general semantics and Traditional Chinese Medicine. The control group received a sham NET protocol. Outcome measurements included pain assessment utilizing a visual analog scale and a pressure gauge algometer. Pain sensitivity was measured at four trigger point locations: suboccipital region (S); levator scapulae region (LS); sternocleidomastoid region (SCM) and temporomandibular region (TMJ). For each outcome measurement and each trigger point, we calculated the change in measurement between pre- and post- treatment. We then examined the relationships between these measurement changes and six independent variables (i.e. treatment group and the above five additional participant variables) using forward stepwise General Linear Model. Results The visual analog scale (0 to 10) had an improvement of 7.6 at S, 7.2 at LS, 7.5 at SCM and 7.1 at the TMJ in the treatment group compared with no improvement of at S, and an improvement of 0.04 at LS, 0.1 at SCM and 0.1 at the TMJ point in the control group, (P < 0.001). Conclusion After a short course of NET treatment, measurements of visual analog scale and pressure algometer recordings of four trigger point locations in a cohort of chronic neck pain sufferers were significantly improved when

  16. Efficacy of clonidine, guanfacine and methadone in the rapid detoxification of heroin addicts: a controlled clinical trial.

    PubMed

    San, L; Camí, J; Peri, J M; Mata, R; Porta, M

    1990-01-01

    The efficacy of clonidine, methadone, and guanfacine in rapid detoxification of heroin inpatients was assessed in a randomized controlled clinical trial. Signs and symptoms of abstinence and of side effects were analysed in 90 heroin addicts successfully completing a 12-day inpatient trial. All patients fit DSM-III criteria for opioid dependence, the age range being 18 to 36 years. All three drugs were effective in controlling abstinence; however, the course of abstinence was different in the methadone group as compared to the adrenergic agonists, the latter showing limitations in their ability to suppress withdrawal manifestations. While mean number of withdrawal signs and symptoms was significantly lower during days 2 to 5 in the methadone group (p less than 0.01), adrenergic agonists were slightly more effective at the end of the trial. Incidence of side effects was closely related to the dose administered. Hypotensive action of adrenergic agonists was more marked in orthostatic position. The present results suggest that methadone is superior to adrenergic agonists. Between these drugs clonidine appears to be less effective than guanfacine in controlling some withdrawal manifestations, and causes more side effects, mainly of cardiovascular nature.

  17. Effects of Gentle Human Touch and Field Massage on Urine Cortisol Level in Premature Infants: A Randomized, Controlled Clinical Trial

    PubMed Central

    Asadollahi, Malihe; Jabraeili, Mahnaz; Mahallei, Majid; Asgari Jafarabadi, Mohammad; Ebrahimi, Sakine

    2016-01-01

    Introduction: Hospitalization in neonatal intensive care unit may leads to many stresses for premature infants. Since premature infants cannot properly process stressors, identifying interventions that reduce the stress level for them is seems necessary. The aim of present study was to compare the effects of Field massage and Gentle Human Touch (GHT) techniques on the urine level of cortisol, as an indicator of stress in preterm infants. Methods: This randomized, controlled clinical trial was carried out in Al-Zahra hospital, Tabriz. A total of 84 premature infants were randomly assigned into three groups. First groups were touched by their mothers three times a day (15 minutes in each session) for 5 days by GHT technique. The second group was received 15 minutes Field massage with sunflower oil three times a day by their mothers for 5 days. The third group received routine care. In all groups, 24-hours urine samples were collected in the first and sixth day after the intervention and analyzed for cortisol level. Data were analyzed by SPSS software. Results: There were significant differences between mean of changes in cortisol level between GHT and control groups and Field massage and control groups (0.026). Conclusion: Although the massage with Field technique resulted in a significant reduction in blood cortisol level, but the GHT technique have also a similar effect. So, both methods are recommended for decreasing of stress in preterm infants. PMID:27752484

  18. Effect of breviscapine injection on clinical parameters in diabetic nephropathy: A meta-analysis of randomized controlled trials

    PubMed Central

    Liu, Xiaodan; Yao, Li; Sun, Da; Zhu, Xinwang; Liu, Qiang; Xu, Tianhua; Wang, Lining

    2016-01-01

    Diabetic nephropathy (DN) is currently a major public health problem worldwide. The objective of the present study was to evaluate the clinical effect of breviscapine injections in patients with DN. A meta-analysis was performed using the following databases to obtain published reports in any language: PubMed/MEDLINE, Embase, China National Knowledge Infrastructure, Chinese Evidence-Based Medicine, Wanfang Digital Periodicals, Chinese Academic Journals Full-text Database, Chinese Biological and Medical Database, China Doctoral and Masters Dissertations Full-text Database and the Chinese Proceedings of Conference Full-text Database. Two assessors independently reviewed each trial. A total of 35 randomized controlled trials, which performed studies on a total of 2,320 patients (1,188 in treatment groups and 1,132 in control groups), were included in the present meta-analysis. Data were analyzed using Stata version 11.0 for Windows. The results from the analysis demonstrated that breviscapine injections have greater therapeutic effects in patients with DN in comparison with the control group, including renal protective effects (reducing urine protein, serum creatinine and blood urea nitrogen) and adjustment for dyslipidemia (affecting levels of cholesterol, triglycerides and high density lipoproteins). These effects indicate that breviscapine injections are beneficial to patients with DN. Further studies are required to determine the mechanisms underlying the therapeutic effects of breviscapine. PMID:27588060

  19. The Effectiveness and Cost of Clinical Supervision for Motivational Interviewing: A Randomized Controlled Trial.

    PubMed

    Martino, Steve; Paris, Manuel; Añez, Luis; Nich, Charla; Canning-Ball, Monica; Hunkele, Karen; Olmstead, Todd A; Carroll, Kathleen M

    2016-09-01

    The effectiveness of a competency-based supervision approach called Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP) was compared to supervision-as-usual (SAU) for increasing clinicians' motivational interviewing (MI) adherence and competence and client retention and primary substance abstinence in a multisite hybrid type 2 effectiveness-implementation randomized controlled trial. Participants were 66 clinicians and 450 clients within one of eleven outpatient substance abuse programs. An independent evaluation of audio recorded supervision sessions indicated that MIA: STEP and SAU were highly and comparably discriminable across sites. While clinicians in both supervision conditions improved their MI performance, clinician supervised with MIA: STEP, compared to those in SAU, showed significantly greater increases in the competency in which they used fundamental and advanced MI strategies when using MI across seven intakes through a 16-week follow-up. There were no retention or substance use differences among the clients seen by clinicians in MIA: STEP or SAU. MIA: STEP was substantially more expensive to deliver than SAU. Innovative alternatives to resource-intensive competency-based supervision approaches such as MIA: STEP are needed to promote the implementation of evidence-based practices.

  20. Abdominal acupuncture for insomnia in women: a randomized controlled clinical trial.

    PubMed

    Wang, Xiao-Yun; Yuan, Song-Hun; Yang, Hong-Yan; Sun, Yan-Mei; Cheng, Fang-Ping; Zhang, Chun-Ling; Huang, Xu-Chun

    2008-01-01

    A randomized single-blind trial was conducted to evaluate the efficacy of short-term abdominal acupuncture as a novel treatment for insomnia in Chinese women. Forty-four patients between the ages of 22 and 56 were randomly assigned to an acupuncture (n = 23) and a medication group (n = 21). The acupuncture group received abdominal acupuncture once a day for the first three days and once every three days for the remaining 11 days. In addition, every subject in acupuncture group also received a placebo pill once daily. Abdominal acupuncture was administered according to a standardized protocol involving four master and four adjunctive acupoints: Zhongwan (CV 12), Xiawan (CV 10), Guanyuan (CV 4), and Qihai (CV 6); bilateral Shangqu (KI 17), Huaroumen (ST 24), Xiafengshidian, and Qipang. Subjects in the medication group were treated with sham acupuncture at the same time as the acupuncture group and received estazolam once a day. The outcome measure was the Leeds Sleep Evaluation Questionnaire (LSEQ), administered before and after the trial. Subjects who received abdominal acupuncture lowered their LSEQ scores by an average of 26.32 points (95% CI: 37.34, 15.30). After controlling for potential confounding factors, the effect of abdominal acupuncture in relieving insomnia was still statistically significant. Results indicate that short-term abdominal acupuncture is more effective than pharmacological treatment for relieving insomnia in adult women and has few adverse effects. PMID:18672743

  1. Impulse Control Disorders Following Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease: Clinical Aspects

    PubMed Central

    Demetriades, Polyvios; Rickards, Hugh; Cavanna, Andrea Eugenio

    2011-01-01

    Parkinson's disease (PD) has been associated with the development of impulse control disorders (ICDs), possibly due to overstimulation of the mesolimbic system by dopaminergic medication. Preliminary reports have suggested that deep brain stimulation (DBS), a neurosurgical procedure offered to patients with treatment-resistant PD, affects ICD in a twofold way. Firstly, DBS allows a decrease in dopaminergic medication and hence causes an improvement in ICDs. Secondly, some studies have proposed that specific ICDs may develop after DBS. This paper addresses the effects of DBS on ICDs in patients with PD. A literature search identified four original studies examining a total of 182 patients for ICDs and nine case reports of 39 patients that underwent DBS and developed ICDs at some point. Data analysis from the original studies did not identify a significant difference in ICDs between patients receiving dopaminergic medication and patients on DBS, whilst the case reports showed that 56% of patients undergoing DBS had poor outcome with regards to ICDs. We discuss these ambivalent findings in the light of proposed pathogenetic mechanisms. Longitudinal, prospective studies with larger number of patients are required in order to fully understand the role of DBS on ICDs in patients with PD. PMID:21403902

  2. Power of univariate and multivariate analyses of repeated measurements in controlled clinical trials.

    PubMed

    Overall, J E; Atlas, R S

    1999-04-01

    The power of univariate and multivariate tests of significance is compared in relation to linear and nonlinear patterns of treatment effects in a repeated measurement design. Bonferroni correction was used to control the experiment-wise error rate in combining results from univariate tests of significance accomplished separately on average level, linear, quadratic, and cubic trend components. Multivariate tests on these same components of the overall treatment effect, as well as a multivariate test for between-groups difference on the original repeated measurements, were also evaluated for power against the same representative patterns of treatment effects. Results emphasize the advantage of parsimony that is achieved by transforming multiple repeated measurements into a reduced set of mean ngful composite variables representing average levels and rates of change. The Bonferroni correction applied to