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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. PMID:24142146

  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. Comparison of clinical features and polysomnographic findings between men and women with sleep apnea

    PubMed Central

    Kasai, Takatoshi; Tomita, Yasuhiro; Takaya, Hisashi; Kasagi, Satoshi; Kawabata, Masateru; Narui, Koji; Setoguchi, Yasuhiro

    2016-01-01

    Background There is a scarcity of reports comparing gender differences in polysomnographic findings among Asian patients with sleep apnea (SA). In this study, we elucidated gender differences in the clinical features and polysomnographic findings of SA patients in Japan. Methods We conducted a case-matched control study to compare the gender differences. A total of 4,714 patients (4,127 men; 587 women) were matched for age, apnea-hypopnea index (AHI), and body mass index (BMI). The criteria used for sex matching were (I) age ±4 years, (II) AHI ± 4 h of sleep, and (III) BMI ±2 kg/m2. This facilitated the comparison of polysomnography sleep variables in 296 men and 296 women with SA. Results Compared with their male counterparts, female SA patients had a significantly higher rapid eye movement AHI [men: 27.7 (IQR, 14.3-45.2); women: 43.3 (IQR, 25.5-56.6); P<0.001], lower supine AHI [men: 29.7 (IQR, 16.8-49.5); women: 25.0 (IQR, 14.7-39.3); P=0.004], longer total sleep time (TST), and non-rapid eye movement (NREM) sleep stage 3 (N3), %TST [TST in men: 356.3 (IQR, 319.5-392.3); women: 372.0 (IQR, 327.8-404.5); P=0.007; N3, %TST in men: 8.8 (IQR, 3.0-14.6); women: 14.4 (IQR, 8.3-20.4); P<0.001], and better sleep efficiency [men: 80.9 (IQR, 71.0-88.0); women: 83.2 (IQR, 74.5-90.0); P=0.011]. Conclusions This study revealed that women with SA had a significantly longer TST and N3, %TST, which represents deep sleep. Future prospective studies must be conducted together with polysomnography tests including electromyography of pharyngeal muscle expansion and electroencephalography. PMID:26904223

  5. The nosologic status of borderline personality: clinical and polysomnographic study.

    PubMed

    Akiskal, H S; Yerevanian, B I; Davis, G C; King, D; Lemmi, H

    1985-02-01

    The REM latencies of 24 nonschizotypal borderline outpatients--who were not in the midst of a major depressive episode--were in the range of those of 30 patients with primary major depression but were significantly shorter than those of 16 patients with nonborderline personality disorders and 14 nonpsychiatric controls. Also, more of the borderline subjects had lifetime diagnoses of affective disorder, such as dysthymic, cyclothymic, and bipolar II disorder, and of a spectrum of anxiety and somatization disorders. The authors conclude that contemporary operational criteria for borderline disorder identify a wide net of temperamental disorders with strong affective coloring rather than a unitary nosologic entity. PMID:3970243

  6. 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

  7. The Berlin questionnaire for sleep apnea in a sleep clinic population: relationship to polysomnographic measurement of respiratory disturbance.

    PubMed

    Ahmadi, Negar; Chung, Sharon A; Gibbs, Alison; Shapiro, Colin M

    2008-03-01

    The Berlin questionnaire (BQ) has been used to help identify patients at high risk of having sleep apnea in primary care and atrial fibrillation patients. The BQ may be a useful adjunct in sleep medicine and research, but it has never been validated in a sleep clinic population. The aim of the study is to determine the specificity and sensitivity of the BQ compared to the respiratory disturbance index (RDI) values obtained from two nights of polysomnographic recording in a sleep clinic population. This is a retrospective chart review study of 130 sleep clinic patients. Patients' demographics, BQ scores, RDI measurements, and sleep study parameters were extracted from the patients' chart. Of the 130 charts reviewed, the BQ identified 76 (58.5%) as being at high-risk of having sleep apnea, but overnight polysomnography found only 34 of the 130 patients (26.2%) had an RDI > 10. The BQ performed with 0.62 sensitivity and 0.43 specificity at the RDI > 10 level. Due to the low sensitivity and specificity as well as the large number of false negatives and positives, the Berlin questionnaire is not an appropriate instrument for identifying patients with sleep apnea in a sleep clinic population. PMID:17684781

  8. Correlates of Polysomnographic Sleep Changes in Cocaine Dependence: Self-administration and Clinical Outcomes*

    PubMed Central

    Angarita, Gustavo A.; Canavan, Sofija V.; Forselius, Erica; Bessette, Andrew; Morgan, Peter T.

    2014-01-01

    Background Abstinence from chronic cocaine use is associated with abnormal sleep architecture. As sleep abnormalities are associated with clinical outcome in alcohol dependence, we hypothesized a similar relationship in cocaine dependence. Methods We report data from a cocaine self-administration study (N=12) and the placebo arm of a randomized clinical trial (N=20). Self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay. Treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy. Measurements included polysomnography from early and late in abstinence during the inpatient stays. Clinical outcomes included amount of cocaine self-administered, urine tests, and self-reported use and withdrawal symptoms. Results Change in slow-wave sleep from early to late abstinence (ΔSWS; p=0.05), late abstinence rapid eye movement sleep (REM; p=0.002), and late abstinence total sleep time (p=0.02) were negatively correlated with the amount of cocaine self-administered. Early abstinence REM was positively correlated with withdrawal symptoms (p=0.02). Late abstinence REM was positively correlated with percent negative urines and maximum consecutive number of days abstinent (both p<0.001). ΔSWS was positively correlated with percent negative urines (p=0.03) and participants with increased SWS had greater percent negative urines (p=0.008) and maximum consecutive number of days abstinent (p=0.009). Conclusions Correlations between sleep deficits and amount of cocaine self-administered, clinical outcomes, and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence. PMID:25124303

  9. Polysomnographic characteristics in nonmalignant chronic pain populations: A review of controlled studies.

    PubMed

    Bjurstrom, Martin F; Irwin, Michael R

    2016-04-01

    Sleep and pain are critical homeostatic systems that interact in a bidirectional manner. Complaints of sleep disturbance are ubiquitous among patients with chronic pain disorders, and conversely, patients with persistent insomnia symptoms commonly report suffering from chronic pain. Sleep deprivation paradigms demonstrate that partial or complete sleep loss induce hyperalgesia, possibly due to shared mechanistic pathways including neuroanatomic and molecular substrates. Further, chronic pain conditions and sleep disturbances are intertwined through comorbidities, which together cause detrimental psychological and physical consequences. This critical review examines 29 polysomnography studies to evaluate whether nonmalignant chronic pain patients, as compared to controls, show differences in objective measures of sleep continuity and sleep architecture. Whereas these controlled studies did not reveal a consistent pattern of objective sleep disturbances, alterations of sleep continuity were commonly reported. Alterations of sleep architecture such as increases in light sleep or decreases in slow-wave sleep were less commonly reported and findings were mixed and also inconsistent. Methodological flaws were identified, which complicated interpretation and limited conclusions; hence, recommendations for future research are suggested. Knowledge of abnormalities in the sleep process has implications for understanding the pathophysiology of chronic pain conditions, which might also direct the development of novel intervention strategies. PMID:26140866

  10. Demographic, clinical, and polysomnographic features in patients with narcolepsy: an experience of 181 patients with narcolepsy from a Turkish sleep center.

    PubMed

    Erdem, Murat; Oz, Oguzhan; Balikci, Adem; Yucel, Mehmet; Alper, Mustafa; Akgun, Hakan; Ozgen, Fuat

    2012-06-01

    The present study was designed to describe the socio-demographic, clinical, and polysomnographic features of patients diagnosed with narcolepsy in our sleep center. This retrospective cross-sectional study was conducted on 181 patients diagnosed with narcolepsy based on the results of clinical evaluation, polysomnography (PSG), and multiple sleep latency test (MSLT) between 1993 and 2009. Approximately 70% of the patients had cataplexy, whereas 42% had hallucinations and 55.8% had sleep paralysis. Although sleep efficiency was higher (91.28 ± 5.89%) in patients with narcolepsy, they woke frequently during the night, and their percentages of deep sleep were low (stage 3, 5.12 ± 3.08%, stage 4, 9.60 ± 7.10%). Our study group was divided into two based on age: individuals aged <30 years (n = 152) and >30 years (n = 29). REM latency on PSG was shorter (t = 2.96, p = 0.004) and sleep onset REM (SOREM) on MSLT was higher (t = 2.56, p = 0.011) in the older group than in the younger group. Cataplexy is seen in most patients with narcolepsy. In older patients, REM latency on PSG is shorter and the number of SOREM on MSLT is higher. PMID:22426681

  11. 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

  12. A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-Day, Polysomnographic Study of Gabapentin in Transient Insomnia Induced by Sleep Phase Advance

    PubMed Central

    Furey, Sandy A.; Hull, Steven G.; Leibowitz, Mark T.; Jayawardena, Shyamalie; Roth, Thomas

    2014-01-01

    Study Objective: To evaluate multiple doses of gabapentin 250 mg on polysomnography (PSG) and participant-reported sleep assessments in a 5-h phase advance insomnia model. Methods: Adults reporting occasional disturbed sleep received gabapentin 250 mg (n = 128) or placebo (n = 128). On Days 1 and 28, participants received medication 30 min before bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, a post sleep questionnaire, and the Karolinska Sleep Diary. Next-day residual effects and tolerability were evaluated. On Days 2-27, participants took medication at home 30 min before their habitual bedtime. Results: Treatment-group demographics were comparable. Gabapentin resulted in significantly less PSG wake after sleep onset (WASO) compared with placebo on Day 1 (primary endpoint, mean: 107.0 versus 149.1 min, p ≤ 0.001) and Day 28 (113.6 versus 152.3 min, p = 0.002), and significantly greater total sleep time (TST; Day 1: 347.6 versus 283.9 min; Day 28: 335.3 versus 289.1 min) (p ≤ 0.001). Participant-reported WASO and TST also showed significant treatment effects on both days. Gabapentin was associated with less %stage1 on Day 1, and greater %REM on Day 28, versus placebo. During home use, gabapentin resulted in significantly less participant-reported WASO and higher ratings of sleep quality. Gabapentin was well tolerated (most common adverse events: headache, somnolence) with no evidence of next-day impairment. Conclusion: Gabapentin 250 mg resulted in greater PSG and participant-reported sleep duration following a 5-h phase advance on Day 1 and Day 28 of use without evidence of next-day impairment, and greater sleep duration during at-home use. Citation: Furey SA, Hull SG, Leibowitz MT, Jayawardena S, Roth T. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med 2014

  13. 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

  14. 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

  15. Polysomnographic Findings in Dementia With Lewy Bodies

    PubMed Central

    Pao, Winnie C.; Boeve, Bradley F.; Ferman, Tanis J.; Lin, Sioung-Chi; Smith, Glenn E.; Knopman, David S.; Graff-Radford, Neill R.; Petersen, Ronald C.; Parisi, Joseph E.; Dickson, Dennis W.; Silber, Michael H.

    2013-01-01

    Introduction The clinical features of dementia with Lewy bodies (DLB) during wakefulness are well known. Other than REM sleep behavior disorder (RBD), only limited data exists on other sleep disturbances and disorders in DLB. We sought to characterize the polysomnographic (PSG) findings in a series of DLB patients with sleep-related complaints. Methods Retrospective study of patients with DLB who underwent clinical PSG at Mayo Clinic Rochester or Mayo Clinic Jacksonville over an almost 11 year span for evaluation of dream enactment behavior, excessive nocturnal movements, sleep apnea, hypersomnolence, or insomnia. The following variables were analyzed: respiratory disturbance index (RDI) in disordered breathing events/hour, periodic limb movement arousal index (PLMAI), arousals for no apparent reason (AFNAR), total arousal index (TAI), presence of REM sleep without atonia (RSWA), and percent sleep efficiency (SE). Results Data on 78 patients (71M, 7F) were analyzed. The mean age was 71 ± 8 years. Seventy-five (96%) patients had histories of recurrent dream enactment during sleep with 83% showing confirmation of RSWA +/- dream enactment during PSG. Mean RDI = 11.9 ± 5.8, PLMAI = 5.9 ± 8.5, AFNARI = 10.7 ± 12.0, and TAI = 26.6 ± 17.4. SE was <80% in 72% of the sample, <70% in 49%, and <60% in 24%. In patients who did not show evidence of significant disordered breathing (23 with RDI<5), 62% of arousals were AFNARs. In those patients who had significant disordered breathing (55 with RDI ≥ 5), 36% of arousals were AFNARs. Six patients underwent evaluations with PSG plus MSLT. Two patients had mean initial sleep latencies less than five minutes, and both had RDI<5. No patient had any sleep onset rapid eye movement periods. Nineteen patients have undergone neuropathologic examination, and 18 have had limbic- or neocortical-predominant Lewy body pathology. One had progressive supranuclear palsy, but no REM sleep was recorded in prior PSG. Conclusions In patients

  16. Nonorganic insomnia in generalized anxiety disorder. 2. Comparative studies on sleep, awakening, daytime vigilance and anxiety under lorazepam plus diphenhydramine (Somnium) versus lorazepam alone, utilizing clinical, polysomnographic and EEG mapping methods.

    PubMed

    Saletu, B; Saletu-Zyhlarz, G; Anderer, P; Brandstätter, N; Frey, R; Gruber, G; Klösch, G; Mandl, M; Grünberger, J; Linzmayer, L

    1997-01-01

    Previous human pharmacological and toxicological studies demonstrated advantages of the combination drug Somnium [SOM, lorazepam (LOR) 1 mg plus diphenhydramine 25 mg] over 1 mg LOR alone, as it showed synergistic effects in hypnotic properties and antagonistic effects in regard to toxicity. In the present double-blind, parallel-group study, hypnotic and anxiolytic effects of SOM were studied in 44 patients with non-organic insomnia related to mild generalized anxiety disorder (GAD), as compared with LOR alone. After a placebo run-in phase of 1 week, they received active treatment (1 tablet SOM or LOR 1 mg) for 4 weeks and thereafter placebo again for 1 week. Clinical evaluations included the physician's general assessment of efficacy, tolerance and adverse effects, the Hamilton anxiety rating scale (HAMA), the Zung self-rating anxiety scale (SAS) and depression scale, the withdrawal symptom scale (WSS), hematology and blood chemistry. Sleep laboratory evaluations included objective and subjective sleep and awakening quality, measured by polysomnography, self-rating of sleep and awakening quality (SSA) and a psychometric test battery in the morning, as well as measurement of daytime brain function, objectivated by EEG mapping. Physicians' global evaluation of insomnia demonstrated no changes in the pre-drug placebo period, moderate improvement under both drugs, with a marginal advantage of SOM over LOR in the first 2 weeks, and a return to pre-drug values in the post-drug placebo period. Anxiety improved in observer ratings (HAMA) under both drugs, in self-rating (SAS) under the combination drug only, with the scores returning to pre-drug placebo values after post-drug placebo substitution. There were no significant findings in the self-rating depression scale and the WSS, with the exception of an improvement in the WSS score 4 weeks after SOM, as compared with pre-drug placebo. There were no rebound phenomena. Both drugs were well tolerated-in regard to both

  17. Effects of Botulinum Toxin on Jaw Motor Events during Sleep in Sleep Bruxism Patients: A Polysomnographic Evaluation

    PubMed Central

    Shim, Young Joo; Lee, Moon Kyu; Kato, Takafumi; Park, Hyung Uk; Heo, Kyoung; Kim, Seong Taek

    2014-01-01

    Study Objectives: To investigate the effects of botulinum toxin type A (BoNT-A) injection on jaw motor episodes during sleep in patients with or without orofacial pain who did not respond to oral splint treatment. Methods: Twenty subjects with a clinical diagnosis of SB completed this study. Ten subjects received bilateral BoNT-A injections (25 U per muscle) into the masseter muscles only (group A), and the other 10 received the injections into both the masseter and temporalis muscles (group B). Video-polysomnographic (vPSG) recordings were made before and at 4 weeks after injection. Rhythmic masticatory muscle activity (RMMA) and orofacial activity (OFA) were scored and analyzed for several parameters (e.g., frequency of episodes, bursts per episode, episode duration). The peak amplitude of electromyographic (EMG) activity in the two muscles was also measured. Results: BoNT-A injection did not reduce the frequency, number of bursts, or duration for RMMA episodes in the two groups. The injection decreased the peak amplitude of EMG burst of RMMA episodes in the injected muscles (p < 0.001, repeated measure ANOVA) in both groups. At 4 weeks after injection, 9 subjects self-reported reduction of tooth grinding and 18 subjects self-reported reduction of morning jaw stiffness. Conclusions: A single BoNT-A injection is an effective strategy for controlling SB for at least a month. It reduces the intensity rather than the generation of the contraction in jaw-closing muscles. Future investigations on the efficacy and safety in larger samples over a longer follow-up period are needed before establishing management strategies for SB with BoNT-A. Citation: Shim YJ; Lee MK; Kato T; Park HU; Heo K; Kim ST. Effects of botulinum toxin on jaw motor events during sleep in sleep bruxism patients: a polysomnographic evaluation. J Clin Sleep Med 2014;10(3):291-298. PMID:24634627

  18. 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

  19. [Polysomnographical studies of a patient with severe myoclonic epilepsy in infancy].

    PubMed

    Itoh, M; Tanuma, N; Shimohira, M; Suzuki, H; Iwakawa, Y

    1993-09-01

    In order to evaluate the brain function of a boy with severe myoclonic epilepsy, we performed serial polysomnographical studies. Although percent slow wave sleep and percent stage REM were normal in infancy, they were reduced with age after 1 year old. Concomitant existence of twitch movements and localized movements of mentalis muscle with REMs bursts, which decreased rapidly during infancy in healthy controls, were paradoxically increased with age in this patients. Since sleep parameters are thought to be controlled by the brainstem neural system, the present observations indicate that the brainstem function of this patient is deteriorated progressively at least during childhood. PMID:8398235

  20. Sensitivity and Specificity of Polysomnographic Criteria for Defining Insomnia

    PubMed Central

    Edinger, Jack D.; Ulmer, Christi S.; Means, Melanie K.

    2013-01-01

    Study Objectives: In recent years, polysomnography-based eligibility criteria have been increasingly used to identify candidates for insomnia research, and this has been particularly true of studies evaluating pharmacologic therapy for primary insomnia. However, the sensitivity and specificity of PSG for identifying individuals with insomnia is unknown, and there is no consensus on the criteria sets which should be used for participant selection. In the current study, an archival data set was used to test the sensitivity and specificity of PSG measures for identifying individuals with primary insomnia in both home and lab settings. We then evaluated the sensitivity and specificity of the eligibility criteria employed in a number of recent insomnia trials for identifying primary insomnia sufferers in our sample. Design: Archival data analysis. Settings: Study participants' homes and a clinical sleep laboratory. Participants: Adults: 76 with primary insomnia and 78 non-complaining normal sleepers. Measurements and Results: ROC and cross-tabs analyses were used to evaluate the sensitivity and specificity of PSG-derived total sleep time, latency to persistent sleep, wake after sleep onset, and sleep efficiency for discriminating adults with primary insomnia from normal sleepers. None of the individual criteria accurately discriminated PI from normal sleepers, and none of the criteria sets used in recent trials demonstrated acceptable sensitivity and specificity for identifying primary insomnia. Conclusions: The use of quantitative PSG-based selection criteria in insomnia research may exclude many who meet current diagnostic criteria for an insomnia disorder. Citation: Edinger JD; Ulmer CS; Means MK. Sensitivity and specificity of polysomnographic criteria for defining insomnia. J Clin Sleep Med 2013;9(5):481-491. PMID:23674940

  1. 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

  2. Mindfulness-Based Cognitive Therapy Improves Polysomnographic and Subjective Sleep Profiles in Antidepressant Users with Sleep Complaints

    PubMed Central

    Britton, Willoughby B.; Haynes, Patricia L.; Fridel, Keith W.; Bootzin, Richard R.

    2012-01-01

    Background Many antidepressant medications (ADM) are associated with disruptions in sleep continuity that can compromise medication adherence and impede successful treatment. The present study investigated whether mindfulness meditation training could improve self-reported and objectively-measured polysomnographic sleep profiles in depressed individuals who had achieved at least partial remission with ADM, but still had residual sleep complaints. Methods Twenty-three ADM users with sleep complaints were randomized into an 8-week Mindfulness-Based Cognitive Therapy (MBCT) course or a waitlist control condition. Pre-post measurements included polysomnographic sleep studies and subjectively reported sleep and residual depression symptoms. Results Compared to controls, the MBCT participants improved on both polysomnographic and subjective measures of sleep. They showed a pattern of decreased wake time and increased sleep efficiency. Sleep depth, as measured by stage 1 and SWS, did not change as a result of mindfulness training. Conclusions Mindfulness meditation is associated with increases in both objectively and subjectively-measured sleep continuity in ADM users. MM training may serve as more desirable and cost-effective alternative to discontinuation or supplementation with hypnotics, and may contribute to a more sustainable recovery from depression. PMID:22832540

  3. 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

  4. 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

  5. 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

  6. 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

  7. Perceived poor sleep quality in the absence of polysomnographic sleep disturbance in women with severe premenstrual syndrome.

    PubMed

    Baker, Fiona C; Sassoon, Stephanie A; Kahan, Tracey; Palaniappan, Latha; Nicholas, Christian L; Trinder, John; Colrain, Ian M

    2012-10-01

    Women with severe premenstrual syndrome report sleep-related complaints in the late-luteal phase, but few studies have characterized sleep disturbances prospectively. This study evaluated sleep quality subjectively and objectively using polysomnographic and quantitative electroencephalographic measures in women with severe premenstrual syndrome. Eighteen women with severe premenstrual syndrome (30.5 ± 7.6 years) and 18 women with minimal symptoms (controls, 29.2 ± 7.3 years) had polysomnographic recordings on one night in each of the follicular and late-luteal phases of the menstrual cycle. Women with premenstrual syndrome reported poorer subjective sleep quality when symptomatic in the late-luteal phase compared with the follicular phase (P < 0.05). However, there were no corresponding changes in objective sleep quality. Women with premenstrual syndrome had more slow-wave sleep and slow-wave activity than controls at both menstrual phases (P < 0.05). They also had higher trait-anxiety, depression, fatigue and perceived stress levels than controls at both phases (P < 0.05) and mood worsened in the late-luteal phase. Both groups showed similar menstrual-phase effects on sleep, with increased spindle frequency activity and shorter rapid eye movement sleep episodes in the late-luteal phase. In women with premenstrual syndrome, a poorer subjective sleep quality correlated with higher anxiety (r = -0.64, P = 0.005) and more perceived nighttime awakenings (r = -0.50, P = 0.03). Our findings show that women with premenstrual syndrome perceive their sleep quality to be poorer in the absence of polysomnographically defined poor sleep. Anxiety has a strong impact on sleep quality ratings, suggesting that better control of mood symptoms in women with severe premenstrual syndrome may lead to better subjective sleep quality. PMID:22417163

  8. Relationships between polysomnographic variables, parameters of glucose metabolism, and serum androgens in obese adolescents with polycystic ovarian syndrome.

    PubMed

    de Sousa, Gideon; Schlüter, Bernhard; Menke, Thomas; Trowitzsch, Eckardt; Andler, Werner; Reinehr, Thomas

    2011-09-01

    The aim of this study was to compare polysomnographic variables of obese adolescents with polycystic ovarian syndrome (PCOS) to those of healthy controls and to analyse whether polysomnographic variables correlate to parameters of body weight/body composition, to serum androgens and to parameters of glucose metabolism. Thirty-one obese adolescents with PCOS (15.0 years ± 1.0, body mass index 32.7 kg per m(2) ± 6.2) and 19 healthy obese adolescents without PCOS (15.2 years ± 1.1, body mass index 32.4 kg per m(2) ± 4.0) underwent polysomnography to compare apnoea index, hypopnoea index, apnoea-hypopnoea index, the absolute number of obstructive apnoeas, percentage sleep Stages 1, 2, 3 and 4 of non-rapid eye movement (NREM) sleep, percentage of REM sleep, TIB, total sleep time (TST), sleep-onset latency, total wake time (TWT), wakefulness after sleep onset (WASO) and sleep efficiency. Furthermore, we correlated polysomnographic variables to parameters of body weight/body composition, to serum androgens and to parameters of glucose metabolism. We found no differences between the two groups concerning the respiratory indices, percentage sleep Stages 2, 3 and 4 of NREM sleep, TIB and sleep-onset latency. The girls with PCOS differed significantly from the controls regarding TST, WASO, TWT, sleep efficiency, percentage Stage 1 of NREM sleep and percentage of REM sleep. We found a weak significant correlation between insulin resistance and apnoea index and between insulin resistance and apnoea-hypopnoea index. Concerning the respiratory variables, adolescents with PCOS do not seem to differ from healthy controls; however, there seem to be differences concerning sleep architecture. PMID:21199038

  9. 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

  10. [Quality control in clinical trials].

    PubMed

    Fukushima, M

    1996-01-01

    Quality control (QC) in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. This has been developed since 1970s in the US, by establishing various regulations which are now called GCP. From the viewpoint of total QC, it should be emphasized that rigorous review of protocol by the Institutional Review Board and obtaining Informed Consent are prerequisites for insuring the quality of the given trial at high scientific level. When pursuing a clinical trial, first of all, facilities of the institutions and the ability of investigators must be of high quality. For this reason, at each institution previous data related to trials should be thoroughly reviewed and analyzed prior to developing a protocol. Educational courses in QC in clinical practice are invaluable. QC of diagnosis means, for example, central pathology review and standardization of diagnostic procedures and process. Secondly, at each institution, data managers collect the data and submit them to the central office at the indicated time. In order to evolve clinical trial, continuous education for data managers and expansion of their job are encouraged. Thirdly, at the statistical center independent from the research group office, subject-specific data managers, the biostatistical staff, must check submitted forms for completeness, consistency and accuracy. Finally, at the data analysis, quality evaluation of the research should also be carried out. Throughout the trial, monitoring and audit are particularly important to assure quality. The sponsor has the responsibility of monitoring the trial and make rigorous onsite visits, and the individual study group also have a monitoring program, while the FDA and the NCI audit by themselves. The purpose of audit is not only to assure data reliability but also to check out patient compliance to drug, education as to regulations and rules of clinical

  11. Oral Appliance Treatment Response and Polysomnographic Phenotypes of Obstructive Sleep Apnea

    PubMed Central

    Sutherland, Kate; Takaya, Hisashi; Qian, Jin; Petocz, Peter; Ng, Andrew T.; Cistulli, Peter A.

    2015-01-01

    Study Objectives: Mandibular advancement splints (MAS) are an effective treatment for obstructive sleep apnea (OSA); however, therapeutic response is variable. Younger age, female gender, less obesity, and milder and supine-dependent OSA have variably been associated with treatment success in relatively small samples. Our objective was to utilize a large cohort of MAS treated patients (1) to compare efficacy across patients with different phenotypes of OSA and (2) to assess demographic, anthropometric, and polysomnography variables as treatment response predictors. Methods: Retrospective analysis of MAS-treated patients participating in clinical trials in sleep centers in Sydney, Australia between years 2000–2013. All studies used equivalent customized two-piece MAS devices and treatment protocols. Treatment response was defined as (1) apnea-hypopnea index (AHI) < 5/h, (2) AHI < 10/h and ≥ 50% reduction, and (3) ≥ 50% AHI reduction. Results: A total of 425 patients (109 female) were included (age 51.2 ± 10.9 years, BMI 29.2 ± 5.0 kg/m2). MAS reduced AHI by 50.3% ± 50.7% across the group. Supine-predominant OSA patients had lower treatment response rates than non-positional OSA (e.g., 36% vs. 59% for AHI < 10/h). REM-predominant OSA showed a lower response rate than either NREM or non-stage dependent OSA. In prediction modelling, age, baseline AHI, and anthropometric variables were predictive of MAS treatment outcome but not OSA phenotype. Gender was not associated with treatment outcome. Conclusions: Lower MAS treatment response rates were observed in supine and REM sleep. In a large sample, we confirm that demographic, anthropometric, and polysomnographic data only weakly inform about MAS efficacy, supporting the need for alternative objective prediction methods to reliably select patients for MAS treatment. Citation: Sutherland K, Takaya H, Qian J, Petocz P, Ng AT, Cistulli PA. Oral appliance treatment response and polysomnographic phenotypes of

  12. 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

  13. Lack of efficacy of music to improve sleep: a polysomnographic and quantitative EEG analysis.

    PubMed

    Lazic, Stanley E; Ogilvie, Robert D

    2007-03-01

    An increasing number of studies have been examining non-pharmacological methods to improve the quality of sleep, including the use of music and other types of auditory stimulation. While many of these studies have found significant results, they suffer from a combination of subjective self-report measures as the primary outcome, a lack of proper controls, often combine music with some type of relaxation therapy, or do not randomise subjects to control and treatment conditions. It is therefore difficult to assess the efficacy of music to induce or improve sleep. The present study therefore examined the effects of music using standard polysomnographic measures and quantitative analysis of the electroencephalogram, along with subjective ratings of sleep quality. In addition, a tones condition was used to compare any effects of music with the effects of general auditory stimulation. Using a counter-balanced within-subjects design, the music was not significantly better than the tones or control conditions in improving sleep onset latency, sleep efficiency, wake time after sleep onset, or percent slow wave sleep, as determined by objective physiological criteria. PMID:17123654

  14. Sleep Symptoms and Polysomnographic Patterns of Obstructive Sleep Apnea in Obese Children

    PubMed Central

    TAVASOLI, Azita; JALILOLGHADR, Shabnam; LOTFI, Shiva

    2016-01-01

    Objective This study was conducted to investigate the sleep symptoms and polysomnographic patterns of obstructive sleep apnea in overweight and obese children. Materials & Methods Overweight or obese children aging 6-18 yr old referred during 2010 to Endocrinology Clinic of Ghods Hospital in Ghazvin, central Iran were enrolled in the study. Polysomnography was done for the diagnosis of obstructive sleep apnea and the BEARS and Children’s Sleep Habits questionnaires were used to survey sleep behaviors. Results: We enrolled 30 children (14 males, 16 females). Twenty-one cases had body mass index (BMI) >95% and 9 had 85%

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

    PubMed

    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

  16. 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

  17. 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

  18. 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

  19. Severe sleep-disordered breathing in a patient with Brown-Vialetto-Van Laere syndrome: polysomnographic findings.

    PubMed

    Miao, Jianting; Li, Hongzeng; Lin, Hong; Su, Changjun; Liu, Yu; Lei, Gesheng; Yang, Ting; Li, Zhuyi

    2007-12-15

    Brown-Vialetto-Van Laere (BVVL) syndrome is a rare disorder with clinical features that include progressive bilateral sensorineural deafness and a variety of cranial nerve impairments. Respiratory compromise has been observed in most familial and sporadic cases; however, few studies have been published regarding sleep-disordered breathing in this syndrome. We report the unique case of a 16-year-old girl with the clinical features of BVVL syndrome who presented with bilateral sensorineural hearing loss and then progressively developed paralysis of the 7th and 9th-12th cranial nerves. More importantly, she presented with the unusual feature of severe sleep-disordered breathing. A polysomnographic study showed evidence of dominant central sleep apnea, and the majority of apneic episodes more likely occurred in stage 2 during NREM sleep. The central sleep apnea was associated with rapid respiratory deterioration and death. This report raises the fact that a patient with BVVL syndrome may present with severe sleep-disordered breathing as a life-threatening condition, which emphasizes the need for greater attention to the early detection of potential sleep-disordered breathing in these afflicted with the BVVL syndrome for optimal clinical management. PMID:17669429

  20. 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

  1. Swiss regulations for controlling clinical trials.

    PubMed

    Zanini, G M

    1998-04-01

    Switzerland has recently issued regulations designed to control all trials with drugs in human subjects, namely the 'Regolamento dell'Ufficio Intercantonale per il controllo dei medicamenti in fase di studio clinico' (Intercantonal Regulations Controlling Drugs used in Clinical Trials), which have been operating since 1st January 1995. These new regulations are generally consistent with other international regulations and have introduced the concept of good clinical practice (GCP) into Switzerland. There are other regulations in Switzerland, such as Federal regulations on immunobiological products, special rules governing the administration of radiolabelled drugs to humans, drugs of abuse and medical devices. Any gap in the central regulations must be filled by cantonal regulations, where they exist. This is a comprehensive review of the regulations governing clinical trials in Switzerland, with special attention being devoted to trials with therapeutic compounds and to compatibility between Swiss and international procedures. PMID:9634649

  2. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology...

  3. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology...

  4. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology...

  5. 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... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology...

  6. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology...

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

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

    PubMed Central

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

    2016-01-01

    ABSTRACT 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

  14. 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

  15. 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.

  16. Assuring Quality Control of Clinical Education in Multiple Clinical Affiliates.

    ERIC Educational Resources Information Center

    Davis, Judith A.

    A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules, a…

  17. 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

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

    PubMed Central

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

    2012-01-01

    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. PMID:23393417

  19. Poor Sleep in Multiple Sclerosis Correlates with Beck Depression Inventory Values, but Not with Polysomnographic Data

    PubMed Central

    Veauthier, Christian; Gaede, Gunnar; Radbruch, Helena; Wernecke, Klaus-Dieter; Paul, Friedemann

    2016-01-01

    Objectives. Pittsburgh Sleep Quality Index (PSQI) values correlate with depression, but studies investigating the relationship between PSQI values and polysomnographic (PSG) data showed inconsistent findings. Methods. Sixty-five consecutive patients with multiple sclerosis (MS) were retrospectively classified as “good sleepers” (GS) (PSQI ≤ 5) and “poor sleepers” (PS) (PSQI > 5). The PSG data and the values of the Visual Analog Scale (VAS) of fatigue, Modified Fatigue Impact Scale (MFIS), Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), and the Beck Depression Inventory (BDI) were compared. Results. No significant differences were found either for PSG data or for ESS, MFIS, and FSS values; but PS showed significantly increased BDI and VAS values. Conclusions. Poor sleep is associated with increased depression and fatigue scale values. PMID:26885399

  20. Applying Statistical Process Control to Clinical Data: An Illustration.

    ERIC Educational Resources Information Center

    Pfadt, Al; And Others

    1992-01-01

    Principles of statistical process control are applied to a clinical setting through the use of control charts to detect changes, as part of treatment planning and clinical decision-making processes. The logic of control chart analysis is derived from principles of statistical inference. Sample charts offer examples of evaluating baselines and…

  1. 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

  2. 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

  3. 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. PMID:16708935

  4. 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. PMID:27213008

  5. 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

  6. Clinical consequences of altered chemoreflex control

    PubMed Central

    Plataki, Maria; Sands, Scott A.; Malhotra, Atul

    2015-01-01

    Control of ventilation dictates various breathing patterns. The respiratory control system consists of a central pattern generator and several feedback mechanisms that act to maintain ventilation at optimal levels. The concept of loop gain has been employed to describe its stability and variability. Synthesizing all interactions under a general model that could account for every behavior has been challenging. Recent insight into the importance of these feedback systems may unveil therapeutic strategies for common ventilatory disturbances. In this review we will address the major mechanisms that have been proposed as mediators of some of the breathing patterns in health and disease that have raised controversies and discussion on ventilatory control over the years. PMID:23681082

  7. 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

  8. 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

  9. 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

  10. Noninvasive Ventilation Improves Sleep in Amyotrophic Lateral Sclerosis: A Prospective Polysomnographic Study

    PubMed Central

    Vrijsen, Bart; Buyse, Bertien; Belge, Catharina; Robberecht, Wim; Van Damme, Philip; Decramer, Marc; Testelmans, Dries

    2015-01-01

    Study Objective: To evaluate the effects of noninvasive ventilation (NIV) on sleep in patients with amyotrophic lateral sclerosis (ALS) after meticulous titration with polysomnography (PSG). Methods: In this prospective observational study, 24 ALS patients were admitted to the sleep laboratory during 4 nights for in-hospital NIV titration with PSG and nocturnal capnography. Questionnaires were used to assess subjective sleep quality and quality of life (QoL). Patients were readmitted after one month. Results: In the total group, slow wave sleep and REM sleep increased and the arousal-awakening index improved. The group without bulbar involvement (non-bulbar) showed the same improvements, together with an increase in sleep efficiency. Nocturnal oxygen and carbon dioxide levels improved in the total and non-bulbar group. Except for oxygen saturation during REM sleep, no improvement in respiratory function or sleep structure was found in bulbar patients. However, these patients showed less room for improvement. Patient-reported outcomes showed improvement in sleep quality and QoL for the total and non-bulbar group, while bulbar patients only reported improvements in very few subscores. Conclusions: This study shows an improvement of sleep architecture, carbon dioxide, and nocturnal oxygen saturation at the end of NIV titration and after one month of NIV in ALS patients. More studies are needed to identify the appropriate time to start NIV in bulbar patients. Our results suggest that accurate titration of NIV by PSG improves sleep quality. Commentary: A commentary on this article appears in this issue on page 511. Citation: Vrijsen B, Buyse B, Belge C, Robberecht W, Van Damme P, Decramer M, Testelmans D. Noninvasive ventilation improves sleep in amyotrophic lateral sclerosis: a prospective polysomnographic study. J Clin Sleep Med 2015;11(5):559–566. PMID:25766713

  11. 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

  12. 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

  13. 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

  14. 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

  15. Recommendations for conducting controlled clinical studies of dental restorative materials.

    PubMed

    Hickel, R; Roulet, J-F; Bayne, S; Heintze, S D; Mjör, I A; Peters, M; Rousson, V; Randall, R; Schmalz, G; Tyas, M; Vanherle, G

    2007-03-01

    About 35 years ago, Ryge provided a practical approach to evaluation of clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and non-standard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to meaningfully interpret. In many cases, the insensitivity of the original Ryge methods is misinterpreted as good clinical performance. While there are many good features of the original system, it is now time to move to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial

  16. 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

  17. [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. PMID:21229708

  18. Sleep and Respiration in 100 Healthy Caucasian Sleepers—A Polysomnographic Study According to American Academy of Sleep Medicine Standards

    PubMed Central

    Mitterling, Thomas; Högl, Birgit; Schönwald, Suzana Veiga; Hackner, Heinz; Gabelia, David; Biermayr, Marlene; Frauscher, Birgit

    2015-01-01

    Study Objectives: Despite differences between American Academy of Sleep Medicine (AASM) and Rechtschaffen and Kales scoring criteria, normative values following the current AASM criteria are lacking. We investigated sleep and respiratory variables in healthy adults over the lifespan, and established polysomnographic normative values according to current standards. Design: Prospective polysomnographic investigation. Setting: Academic referral hospital sleep laboratory. Participants: One hundred healthy sleepers aged 19–77 y were selected from a representative population sample by a two-step screening. Interventions: N/A. Measurements and Results: All subjects underwent one full-night polysomnography. Sleep and arousals were scored according to AASM standards. Respiration was scored according to AASM 2007 and 2012 criteria in order to compare both methods. Percentile curves showed age-related differences in sleep architecture: a decrease was found for sleep efficiency [≤ 30 y: 87.0 (71.9–94.1)% versus > 60 y: 79.7 (44.5–90.9)%], total sleep time [≤ 30 y: 413.5 (345.6–451.9) min versus > 60 y: 378.3 (216.0–440.0) min], the percentages of N3 [≤ 30 y 20.7 (15.2–37.5)% versus > 60 y: 14.9 (2.4–35.6)%] and rapid eye movement sleep [≤ 30 y 15.5 (7.5–23.6)% versus. > 60 y: 10.3 (1.9–21.9)%], whereas the percentage of wake time after sleep onset increased with age [≤ 30 y 6.0 (1.9–22.8)% versus > 60 y: 15.2 (6.3–48.7)%]. The apnea-hypopnea index (AHI) was higher when applying the AASM 2012 criteria [AHI AASM 2007 0.7 (0.0–21.5)/h versus 2012: 1.7 (0.0–25)/h; P < 0.001]. Eight percent of subjects had an AHI > 15/h. Conclusions: This study provides normative data on sleep macrostructure, microstructure, and respiration in adults following AASM standards. Furthermore, we demonstrated that respiration scoring according to AASM 2012 results in higher AHIs, and challenge the use of age-independent respiratory cutoff values. Citation: Mitterling

  19. 77 FR 72409 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services..., 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made... controlled substance for analytical research and clinical trials. The import of the above listed basic...

  20. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... FR 60143, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services... registration of Fisher Clinical Services, Inc., to import the basic class of controlled substance is...

  1. 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

  2. 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

  3. Development of a current-controlled defibrillator for clinical tests.

    PubMed

    Fischer, M; Schönegg, M; Schöchlin, J; Bolz, A

    2002-01-01

    The work presented here is only a part of the development for a new current-controlled defibrillator. In the diploma thesis "Development and construction of a current-controlled defibrillator for clinical tests" the most important part was the control and safety of the defibrillator. To ensure a safe circuit design, a risk-analysis and a Failure Mode and Effects Analysis (FMEA) were necessary. Another major part was the programming of a microcontroller in embedded C and a programmable logic device in Very High Speed Integrated Circuit Description Language (VHDL). The circuit had to be constructed, and the defibrillator was optically decoupled from the laptop for safety reasons. The waveform-data can be transmitted to the microcontroller from the laptop, and the logged data is then transmitted back. PMID:12465307

  4. Controlled clinical comparison of three commercial blood culture systems.

    PubMed

    Frank, U; Malkotsis, D; Mlangeni, D; Daschner, F D

    1999-04-01

    In a controlled clinical comparison, three commercial blood culture systems--the standard aerobic BacT/Alert bottle (STD), the aerobic BacT/Alert FAN bottle (FAN) and the Isolator system (ISO; Wampole Laboratories, USA) were compared for their ability to detect aerobic and facultatively anaerobic microorganisms. A total of 945 BacT/Alert (STD and FAN) blood culture sets were compared. Of these, 110 blood culture sets (11.6%) yielded growth of 116 clinically significant bacterial and fungal isolates. Microorganisms were recovered from 10.7% (101/945) of the FAN bottles compared to 8.9% (84/945) of the STD bottles. Of the significant isolates, 78 (67.2%) were recovered by both bottles, 29 (25%) by the FAN bottle only and nine (7.8%) by the STD bottle only (P<0.01). Along with 56.1% (530/945) of BacT/Alert blood culture sets, a concomitant ISO tube was obtained. Of the triple (STD + FAN + ISO) blood culture sets, 54 (10.2%) yielded growth of 59 clinically relevant isolates. Microorganisms were detected in 9.1% (48/530) of the FAN bottles, 8.3% (44/530) of the STD bottles and 4% (21/530) of the ISO tubes (P<0.001). Overall, the BacT/Alert system detected more clinically significant microorganisms than the ISO tube; the STD and the FAN bottle each recovered significantly more staphylococci (P<0.01 and P<0.001, respectively) and gram-negative rods (P<0.01, both). In conclusion, the BacT/Alert FAN bottle performed better than the BacT/Alert STD bottle; both BacT/Alert bottles, however, were superior to the ISO tube in terms of recovery of clinically significant microorganisms, including gram-positive and gram-negative bacteria. PMID:10385012

  5. 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

  6. 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

  7. Statistical models for the control phase of clinical monitoring.

    PubMed

    Stevens, Richard J; Oke, Jason; Perera, Rafael

    2010-08-01

    The rise in the prevalence of chronic conditions means that these are now the leading causes of death and disability worldwide, accounting for almost 60% of all deaths and 43% of the global burden of disease. Management of chronic conditions requires both effective treatment and ongoing monitoring. Although costs related to monitoring are substantial, there is relatively little evidence on its effectiveness. Monitoring is inherently different to diagnosis in its use of regularly repeated tests, and increasing frequency can result in poorer rather than better statistical properties because of multiple testing in the presence of high variability. We present here a general framework for modelling the control phase of a monitoring programme, and for the estimation of quantities of potential clinical interest such as the ratio of false to true positive tests. We show how four recent clinical studies of monitoring cardiovascular disease, hypertension, diabetes and HIV infection can be thought as special cases of this framework; as well as using this framework to clarify the choice of estimation and calculation methods available. Noticeably, in each of the presented examples over-frequent monitoring appears to be a greater problem than under-frequent monitoring. We also present recalculations of results under alternative conditions, illustrating conceptual decisions about modelling the true or observed value of a clinical measure. PMID:20442195

  8. 78 FR 59064 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services... 21, 2013, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made... for clinical trials, analytical research and testing. The import of the above listed basic classes...

  9. 77 FR 60143 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services..., Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made application by... substance for analytical research and clinical trials. The import of the above listed basic class...

  10. Randomized controlled trial of atorvastatin in clinically isolated syndrome

    PubMed Central

    Waubant, E.; Pelletier, D.; Mass, M.; Cohen, J.A.; Kita, M.; Cross, A.; Bar-Or, A.; Vollmer, T.; Racke, M.; Stüve, O.; Schwid, S.; Goodman, A.; Kachuck, N.; Preiningerova, J.; Weinstock-Guttman, B.; Calabresi, P.A.; Miller, A.; Mokhtarani, M.; Iklé, D.; Murphy, S.; Kopetskie, H.; Ding, L.; Rosenberg, E.; Spencer, C.; Zamvil, S.S.; Waubant, E.; Pelletier, D.; Mass, M.; Bourdette, D.; Egan, R.; Cohen, J.; Stone, L.; Kita, M.; Elliott, M.; Cross, A.; Parks, B.J.; Bar-Or, A.; Vollmer, T.; Campagnolo, D.; Racke, M.; Stüve, O.; Frohman, E.; Schwid, S.; Goodman, A.; Segal, B.; Kachuck, N.; Weiner, L.; Preiningerova, J.; Carrithers, M.; Weinstock-Guttman, B.; Calabresi, P.; Kerr, D.; Miller, A.; Lublin, F.; Sayre, Peter; Hayes, Deborah; Rosenberg, Ellen; Gao, Wendy; Ding, Linna; Adah, Steven; Mokhtarani, Masoud; Neuenburg, Jutta; Bromstead, Carolyn; Olinger, Lynn; Mullen, Blair; Jamison, Ross; Speth, Kelly; Saljooqi, Kerensa; Phan, Peter; Phippard, Deborah; Seyfert-Margolis, Vicki; Bourcier, Katarzyna; Debnam, Tracia; Romaine, Jennifer; Wolin, Stephanie; O'Dale, Brittany; Iklé, David; Murphy, Stacey; Kopetskie, Heather

    2012-01-01

    Objective: To test efficacy and safety of atorvastatin in subjects with clinically isolated syndrome (CIS). Methods: Subjects with CIS were enrolled in a phase II, double-blind, placebo-controlled, 14-center randomized trial testing 80 mg atorvastatin on clinical and brain MRI activity. Brain MRIs were performed quarterly. The primary endpoint (PEP) was development of ≥3 new T2 lesions, or one clinical relapse within 12 months. Subjects meeting the PEP were offered additional weekly interferon β-1a (IFNβ-1a). Results: Due to slow recruitment, enrollment was discontinued after 81 of 152 planned subjects with CIS were randomized and initiated study drug. Median (interquartile range) numbers of T2 and gadolinium-enhancing (Gd) lesions were 15.0 (22.0) and 0.0 (0.0) at baseline. A total of 53.1% of atorvastatin recipients (n = 26/49) met PEP compared to 56.3% of placebo recipients (n = 18/32) (p = 0.82). Eleven atorvastatin subjects (22.4%) and 7 placebo subjects (21.9%) met the PEP by clinical criteria. Proportion of subjects who did not develop new T2 lesions up to month 12 or to starting IFNβ-1a was 55.3% in the atorvastatin and 27.6% in the placebo group (p = 0.03). Likelihood of remaining free of new T2 lesions was significantly greater in the atorvastatin group compared with placebo (odds ratio [OR] = 4.34, p = 0.01). Likelihood of remaining free of Gd lesions tended to be higher in the atorvastatin group (OR = 2.72, p = 0.11). Overall, atorvastatin was well tolerated. No clear antagonistic effect of atorvastatin plus IFNβ-1a was observed on MRI measures. Conclusion: Atorvastatin treatment significantly decreased development of new brain MRI T2 lesion activity, although it did not achieve the composite clinical and imaging PEP. Classification of Evidence: This study provided Class II evidence that atorvastatin did not reduce the proportion of patients with CIS meeting imaging and clinical criteria for starting immunomodulating therapy after 12 months

  11. Efficacy and tolerability of almotriptan in controlled clinical trials.

    PubMed

    Mathew, Ninan T

    2005-01-01

    Seven triptans are now available for the acute treatment of migraine. While all of these agents have been shown to be safe and more or less well tolerated, they differ in ways that are clinically relevant to individual patients. Almotriptan has been investigated in approximately 3,500 patients enrolled in short-term clinical trials and 1,500 patients enrolled in long-term open-label trials. In a meta-analysis of placebo-controlled almotriptan trials (n = 2,294), treatment with almotriptan 12.5 mg results in a 2-hour pain-relief rate of 63.7% and a 2-hour pain-free rate of 36.4%. Almotriptan is associated with a rapid onset of action, with 30-min pain-relief and pain-free rates significantly better than placebo (p < 0.05). Direct comparator studies show the efficacy of almotriptan 12.5 mg to be comparable to that of sumatriptan but almotriptan is associated with superior tolerability. Trials assessing the efficacy of almotriptan over multiple attacks show that this agent is associated with a consistent and persistent response, not differing from the first to the last attack, an important property for a medication used to treat a chronic condition such as migraine. Early intervention with almotriptan enhances the activity of this agent. Treatment of mild pain with almotriptan has resulted in 2-hour pain-free rates of 84 and 77% and a sustained pain-free rate of 67%. Early treatment (within 1 h) of moderate to severe headaches with almotriptan also improves outcomes. In conclusion, clinical trials and post hoc analyses of such trials have shown almotriptan to be effective and well tolerated for the acute treatment of migraine. Its placebo-like tolerability makes it a good choice for early intervention, a strategy associated with better patient outcomes. PMID:15920335

  12. Reviewing birth control methods for new clinic patients.

    PubMed

    1980-01-01

    The DHEW guidelines governing funding for family planning services specify that each new patient be educated about the commonly used birth control methods on the first visit. Pills, IUDs, the diaphragm, condoms, foam, natural family planning, and sterilization plus any additional methods offered by the clinic should be explained in terms of how it is used, effectiveness, contraindications, and side effects. Patients need to be able to compare effectiveness rates for the the methods. The 2 rates should include the level of effectiveness to be expected if you used the method right all the time and the level of effectiveness if you make the average number of mistakes. Suggestions for setting the tone of a group discussion are minimimize interruptions; maximize physical comfort; watch body language; encourage questions and reading. A patient who has made up her mind to a method and finds she has a contraindication to a method may be upset and have difficulty choosing another method. Other first visit topics which should be explained either in discussion or literature are why family planning is important; reproductive anatomy and physiology; locations for emergency medical care; clinic procedures, including fees; vaginities and sexually transmitted infections; pregnancy options; and, list of services available. PMID:12336138

  13. Clinical spectrum of impulse control disorders in Parkinson's disease.

    PubMed

    Weintraub, Daniel; David, Anthony S; Evans, Andrew H; Grant, Jon E; Stacy, Mark

    2015-02-01

    Impulse control disorders (ICDs), including compulsive gambling, buying, sexual behavior, and eating, are a serious and increasingly recognized psychiatric complication in Parkinson's disease (PD). Other impulsive-compulsive behaviors (ICBs) have been described in PD, including punding (stereotyped, repetitive, purposeless behaviors) and dopamine dysregulation syndrome (DDS; compulsive PD medication overuse). ICDs have been most closely related to the use of dopamine agonists (DAs), perhaps more so at higher doses; in contrast, DDS is primarily associated with shorter-acting, higher-potency dopaminergic medications, such as apomorphine and levodopa. Possible risk factors for ICDs include male sex, younger age and younger age at PD onset, a pre-PD history of ICDs, and a personal or family history of substance abuse, bipolar disorder, or gambling problems. Given the paucity of treatment options and potentially serious consequences, it is critical for PD patients to be monitored closely for development of ICDs as part of routine clinical care. PMID:25370355

  14. Fundamental and clinical studies on tumor control by TBI

    SciTech Connect

    Sakamoto, Kiyohiko; Myojin, Miyako

    1996-12-31

    Total body irradiation (TBI) has been considered to bring about immunosuppressive effects on organisms. The conclusion is derived from data obtained by sublethal doses of TBI, but there are no data on how low doses of TBI act on organisms. On the other hand, it is known that low doses of TBI are effective on some malignant lymphoma or chronic myelogenous leukemia. However, the effect of low doses of TBI is rarely investigated radiobiologically. For 15 yr, the authors have studied the effects of low doses of TBI on normal or tumor-bearing mice and its immunological background. In this paper, they show the results of fundamental and clinical studies on tumor control by low doses of TBI.

  15. Pulmonary rehabilitation in lymphangioleiomyomatosis: a controlled clinical trial.

    PubMed

    Araujo, Mariana S; Baldi, Bruno G; Freitas, Carolina S G; Albuquerque, André L P; Marques da Silva, Cibele C B; Kairalla, Ronaldo A; Carvalho, Celso R F; Carvalho, Carlos R R

    2016-05-01

    Lymphangioleiomyomatosis (LAM) is a cystic lung disease frequently associated with reduced exercise capacity. The aim of this study was to assess safety and efficacy of pulmonary rehabilitation in LAM.This controlled clinical trial included 40 patients with LAM and a low physical activity level. The pulmonary rehabilitation programme comprised 24 aerobic and muscle strength training sessions and education. The primary outcome was exercise capacity (endurance time during a constant work rate exercise test). Secondary outcomes included health-related quality of life (St George's Respiratory Questionnaire (SGRQ)), 6-min walking distance (6MWD), dyspnoea, peak oxygen consumption (V'O2 ), daily physical activity (pedometer), symptoms of anxiety and depression, lung function and peripheral muscle strength (one-repetition maximum).The baseline characteristics were well balanced between the groups. The pulmonary rehabilitation group exhibited improvements in the following outcomes versus controls: endurance time (median (interquartile range) 169 (2-303) s versus -33 (-129-39) s; p=0.001), SGRQ (median (interquartile range) -8 (-16-2) versus 2 (-4-5); p=0.002) and 6MWD (median (interquartile range) 59 (13-81) m versus 20 (-12-30) m; p=0.002). Dyspnoea, peak V'O2 , daily physical activity and muscle strength also improved significantly. No serious adverse events were observed.Pulmonary rehabilitation is a safe intervention and improves exercise capacity, dyspnoea, daily physical activity, quality of life and muscle strength in LAM. PMID:26917604

  16. 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

  17. Polysomnographic Sleep Characteristics of Generally-Anxious and Healthy Children Assessed in the Home Environment

    PubMed Central

    Patriquin, Michelle A.; Mellman, Thomas A.; Glaze, Daniel G.; Alfano, Candice A.

    2014-01-01

    Background Using laboratory-based polysomnography (PSG) we recently provided evidence of significantly prolonged sleep onset latency (SOL) and reduced latency to rapid eye movement (REM) sleep among non-depressed children with generalized anxiety disorder (GAD) compared to healthy age-matched controls. In the current study we conducted unattended ambulatory PSG in a new sample of children with GAD and controls in order to examine sleeping characteristics in the home environment. Method Thirty-two children (ages of 7–11 years) including 16 children with primary GAD and 16 controls receiving no psychotropic medications were studied. The anxious group had a primary diagnosis of GAD without secondary mood disorders and controls were free of any medical or psychiatric diagnoses. All participants underwent structured diagnostic assessments and completed one night of home-based polysomnography (PSG). Results Children with GAD exhibited significantly higher sleep efficiency (SE) and fewer rapid eye movement (REM) sleep periods compared to controls. Self-reported somatic arousal during the pre-sleep period was negatively correlated with the percentage of total REM sleep among controls, but positively correlated with REM sleep percentage in the GAD group. Limitations A small sample size and one night of PSG only. Conclusions Home-based PSG recording do not provide evidence of disrupted sleep patterns in children with GAD. Contextual factors that better elucidate differences between laboratory and home-based sleep findings are suggested as important directions for future research. PMID:24751311

  18. Effects of Homeopathic Medicines on Polysomnographic Sleep of Young Adults with Histories of Coffee-Related Insomnia

    PubMed Central

    Bell, Iris R.; Howerter, Amy; Jackson, Nicholas; Aickin, Mikel; Baldwin, Carol M.; Bootzin, Richard R.

    2010-01-01

    Background Homeopathy, a common form of alternative medicine worldwide, relies on subjective patient reports for diagnosis and treatment. Polysomnography offers a modern methodology for evaluating the objective effects of taking homeopathic remedies that clinicians claim exert effects on sleep quality in susceptible individuals. Animal studies have previously shown changes in non rapid eye movement sleep with certain homeopathic remedies. Methods Young adults of both sexes (ages 18–31) with above-average scores on standardized personality scales for either cynical hostility or anxiety sensitivity (but not both), and a history of coffee-induced insomnia, participated in the month-long study. At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of eight recordings (nights 1, 2, 8, 9, 15, 16, 22, 23). Subjects (N=54) received placebo pellets on night 8 (single-blind) and verum pellets on night 22 (double-blind) in 30c doses of one of two homeopathic remedies, Nux Vomica or Coffea Cruda. Subjects completed daily morning sleep diaries and weekly Pittsburgh Sleep Quality Index scales, as well as Profile of Mood States Scales at bedtime on polysomnography nights. Results Verum remedies significantly increased PSG total sleep time and NREM, as well as awakenings and stage changes. Changes in actigraphic and self-rated scale effects were not significant. Conclusions The study demonstrated the feasibility of using in-home all-night sleep recordings to study homeopathic remedy effects. Findings are similar though not identical to those reported in animals with the same remedies. Possible mechanisms include initial disruption of the nonlinear dynamics of sleep patterns by the verum remedies. PMID:20673648

  19. Headache secondary to sleep-related bruxism: A case with polysomnographic findings

    PubMed Central

    Das, Sourav; Gupta, Ravi; Dhyani, Mohan; Goel, Deepak

    2015-01-01

    Sleep-related bruxism may present with headache. However, in clinical practice it may be difficult to differentiate from other causes of headache, especially in subjects with substance abuse. We are presenting a case of sleep-related bruxism that presented with headache and sleep-related symptoms in the presence of substance abuse. Polysomnography was used to ascertain cause of headache. How the other possible causes of headache ruled out is also discussed in report. In short, Sleep-related bruxism can cause headache that is worse in the morning. It is associated with poor quality sleep. PMID:25883492

  20. Adult Attachment Interview differentiates adolescents with Childhood Sexual Abuse from those with clinical depression and non-clinical controls.

    PubMed

    van Hoof, Marie-José; van Lang, Natasja D J; Speekenbrink, Sandra; van IJzendoorn, Marinus H; Vermeiren, Robert R J M

    2015-01-01

    Although attachment representation is considered to be disturbed in traumatized adolescents, it is not known whether this is specific for trauma, as comparative studies with other clinical groups are lacking. Therefore, attachment representation was studied by means of the Adult Attachment Interview in adolescents with Childhood Sexual Abuse (CSA) (N = 21), clinical depression (N = 28) and non-clinical controls (N = 28). Coherence of mind and unresolved loss or trauma, as well as the disorganized attachment classification differentiated the CSA group from the clinical depression group and controls, over and above age, IQ, and psychiatric symptomatology. In the current era of sustained criticism on criteria-based classification, this may well carry substantial clinical relevance. If attachment is a general risk or vulnerability factor underlying specific psychopathology, this may guide diagnostic assessment as well as treatment. PMID:26047034

  1. Letter: Kilopascals. Control of oral contraceptive clinical trails.

    PubMed

    Mitchell, G D

    1975-02-01

    To deal with the confusion surrounding clinical acceptability of specific oral contraceptive preparations, a single set of forms for use in clinical research, together with a set of definitions, was recommended. Senior representatives of major pharmaceutical companies engaging in clinical trials in the United Kingdom were invited to cooperate. The Family Planning Research Unit of the University of Exeter was requested to provide facilities for meetings which began in 1972. An agreed set of forms has been designed and set of definitions has been developed to make the collection and interpretation of data more efficient. Organizations carrying out oral contraceptive clinical trials are invited to contact this unit. Forms, definitions, and further information will be provided on request. PMID:1089453

  2. 78 FR 23958 - Importer of Controlled Substances: Notice of Registration; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ... FR 72409, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made... Enforcement Administration Importer of Controlled Substances: Notice of Registration; Fisher Clinical Services... effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc., to ensure that the...

  3. Polysomnographic Assessment of Sleep Comorbidities in Drug-Naïve Narcolepsy-Spectrum Disorders--A Japanese Cross-Sectional Study.

    PubMed

    Sasai-Sakuma, Taeko; Kinoshita, Akihiko; Inoue, Yuichi

    2015-01-01

    This is a large cross-sectional study which aimed to investigate comorbidity rate, degree of sleep-related breathing disorder, polysomnigraphically diagnosible rapid eye movement sleep behavior disorder/rapid eye movement sleep without atonia and periodic limb movements during sleep in Japanese drug-naïve patients with narcolepsy-spectrum disorders. A total of 158 consecutive drug naïve patients with narcolepsy with cataplexy, 295 patients with narcolepsy without cataplexy and 395 patients with idiopathic hypersomnia without long sleep time were enrolled. From retrospectively analyzed data of nocturnal polysomnography and multiple sleep latency test, higher rates of periodic limb movements during sleep (> = 15 h(-1)) (10.2%) and polysomnographically diagnosable rapid eye movement sleep behavior disorder (1.9%) were found in patients with narcolepsy with cataplexy. They had more severe periodic limb movements during sleep especially during rapid eye movement sleep and higher percentages of rapid eye movement sleep without atonia than the other two patient groups. In the present large sample study, Japanese drug naïve patients with narcolepsy with cataplexy showed the highest comorbidity rates of periodic limb movements during sleep, polysomnographically diagnosable rapid eye movement sleep behavior disorder and rapid eye movement sleep without atonia among those with the other narcolepsy-spectrum disorders; the rates were lower than those for Western patients. PMID:26322978

  4. Polysomnographic Assessment of Sleep Comorbidities in Drug-Naïve Narcolepsy-Spectrum Disorders—A Japanese Cross-Sectional Study

    PubMed Central

    2015-01-01

    This is a large cross-sectional study which aimed to investigate comorbidity rate, degree of sleep-related breathing disorder, polysomnigraphically diagnosible rapid eye movement sleep behavior disorder/rapid eye movement sleep without atonia and periodic limb movements during sleep in Japanese drug-naïve patients with narcolepsy-spectrum disorders. A total of 158 consecutive drug naïve patients with narcolepsy with cataplexy, 295 patients with narcolepsy without cataplexy and 395 patients with idiopathic hypersomnia without long sleep time were enrolled. From retrospectively analyzed data of nocturnal polysomnography and multiple sleep latency test, higher rates of periodic limb movements during sleep (> = 15 h-1) (10.2%) and polysomnographically diagnosable rapid eye movement sleep behavior disorder (1.9%) were found in patients with narcolepsy with cataplexy. They had more severe periodic limb movements during sleep especially during rapid eye movement sleep and higher percentages of rapid eye movement sleep without atonia than the other two patient groups. In the present large sample study, Japanese drug naïve patients with narcolepsy with cataplexy showed the highest comorbidity rates of periodic limb movements during sleep, polysomnographically diagnosable rapid eye movement sleep behavior disorder and rapid eye movement sleep without atonia among those with the other narcolepsy-spectrum disorders; the rates were lower than those for Western patients. PMID:26322978

  5. 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

  6. Sleep in conduct-disordered adolescents--a polysomnographic and spectral power analysis study.

    PubMed

    Lindberg, Nina; Tani, Pekka; Sailas, Eila; Virkkala, Jussi; Urrila, Anna-Sofia; Virkkunen, Matti

    2008-06-30

    The aim of the present study was to characterize sleep in conduct-disordered adolescents using polysomnography and spectral power analysis. The two hypotheses were that conduct disorder would be associated with objective sleep problems, and that conduct disorder--as a precursor of adult antisocial personality disorder--would be associated with the same kind of abnormal sleep architecture, with both increased deep sleep and delta power, as previously reported in antisocial personality disorder. The patients consisted of 15 adolescents (age range 13-17 years, mean age 14.7 years) with histories of antisocial behavior so functionally impairing that they were ordered by child welfare to undergo a psychosocial evaluation in a closed social services ward. The healthy age-matched controls comprised 20 volunteers recruited with a newspaper advertisement. Opposite to earlier subjective sleep studies among conduct-disordered children, no significant differences in sleep parameters were observed between the two groups. The adolescents with conduct disorder slept a little bit longer, but the percentage amount of different sleep stages did not differ significantly between the two groups. Relative spectral power of sleep, delta power in particular, was similar in both groups, assessed in total sleep time as well as in first half of it. Different alternative explanations for these findings are discussed. PMID:18462804

  7. 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. PMID:23061443

  8. 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…

  9. 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…

  10. 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

  11. [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

  12. 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

  13. 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

  14. 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

  15. Clinical requirements for closed-loop control systems.

    PubMed

    Clarke, William L; Renard, Eric

    2012-03-01

    Closed-loop (CL) therapy systems should be safe, efficacious, and easily manageable for type 1 diabetes mellitus patient use. For the first two clinical requirements, noninferiority and superiority criteria must be determined based on current conventional and intensive therapy outcomes. Current frequencies of hypoglycemia and diabetic ketoacidosis are reviewed and safety expectations for CL therapy systems are proposed. Glycosylated hemoglobin levels lower than current American Diabetes Association recommendations for different age groups are proposed as superiority criteria. Measures of glycemic variability are described and the recording of blood glucose levels as percentages within, above, and below a target range are suggested as reasonable alternatives to sophisticated statistical analyses. It is also suggested that Diabetes Quality of Life and Fear of Hypoglycemia surveys should be used to track psychobehavioral outcomes. Manageability requirements for safe and effective clinical management of CL systems are worth being underscored. The weakest part of the infusion system remains the catheter, which is exposed to variable and under-delivery incidents. Detection methods are needed to warn both the system and the patient about altered insulin delivery, including internal pressure and flow alarms. Glucose monitor sensor accuracy is another requirement; it includes the definition of conditions that lead to capillary glucose measurement, eventually followed by sensor recalibration or replacement. The crucial clinical requirement will be a thorough definition of the situations when the patient needs to move from CL to manual management of insulin delivery, or inversely can switch back to CL after a requested interruption. Instructions about these actions will constitute a major part of the education process of the patients before using CL systems and contribute to the manageability of these systems. PMID:22538159

  16. [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. PMID:26946743

  17. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    PubMed

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia. PMID:21461716

  18. 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…

  19. 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...

  20. Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan

    PubMed Central

    Sugawara, Norio; Ishioka, Masamichi; Tsuchimine, Shoko; Tsuruga, Koji; Sato, Yasushi; Furukori, Hanako; Kudo, Shuhei; Tomita, Tetsu; Nakagami, Taku; Yasui-Furukori, Norio

    2015-01-01

    Background Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs. Aims The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan. Method Using a cross-sectional design, we recruited patients (n = 251) aged 47.7±13.2 (mean±SD) with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials. Results The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation. Conclusions Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias. PMID:26600382

  1. 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

  2. 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

  3. Integrated control of lower urinary tract – clinical perspective

    PubMed Central

    Fowler, Clare J

    2006-01-01

    The neural mechanisms that determine social bladder control are reviewed, with a particular emphasis on the role played by sensation in the process. Much has been learnt about the neural control of the bladder from studying patients with neurological disease and those disorders that are known to disrupt bladder storage are described. Possible approaches to treatment of the resulting incontinence are reviewed and it is acknowledged that in the future, the optimal treatment for incontinence may be determined by its precise underlying pathophysiology in each instance, for example, suprapontine causes requiring different medication to spinal causes. Although the main emphasis of urological research and development so far has been the treatment of incontinence, effective therapy for other bladder disorders such an impaired emptying or bladder pain could have an important impact on the bladder symptoms of many patients. PMID:16465178

  4. Azathioprine with prednisone for polymyositis. A controlled, clinical trial.

    PubMed

    Bunch, T W; Worthington, J W; Combs, J J; Ilstrup, D M; Engel, A G

    1980-03-01

    A controlled, prospective, double-blind, therapeutic trial of azathioprine was conducted in the initial therapy of polymyositis. Sixteen patients received 60 mg prednisone per day plus either azathioprine (2 mg/kg of body weight per day) or placebo for a period of 3 months. Creatine phosphokinase (CPK) levels fell to normal slightly sooner in the placebo group, but not significantly so. The azathioprine group did not become significantly stronger (P = 0.58) and did not manifest significantly greater improvement of histopathologic features of muscle (P = 0.80) than the placebo group. Initial CPK elevations were significantly related to the degree of muscle inflammation (P = 0.037), but this was not the case at 3 months (P greater than 0.05). Normalization of the CPK could not be equated with disease control. Type II fiber atrophy, attributed to steroid therapy, was more marked in women than in men (P less than 0.03). PMID:6986827

  5. 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...

  6. CONTROLLED CLINICAL EVALUATIONS OF CHLORINE DIOXIDE, CHLORITE AND CHLORATE IN MAN

    EPA Science Inventory

    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 does tolerance investigation, exam...

  7. 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...

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.…

  15. 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…

  16. Clinical Features of Obstructive Sleep Apnea That Determine Its High Prevalence in Resistant Hypertension

    PubMed Central

    Min, Hyun Jin; Cho, Yang-Je; Kim, Chang-Hoon; Kim, Da Hee; Kim, Ha Yan; Choi, Ji In; Lee, Jeung-Gweon

    2015-01-01

    Purpose Resistant hypertension (HTN) occurs in 15-20% of treated hypertensive patients, and 70-80% of resistant hypertensive patients have obstructive sleep apnea (OSA). The characteristics of resistant HTN that predispose patients to OSA have not been reported. Therefore, we aimed to determine the clinical, laboratory, and polysomnographic features of resistant HTN that are significantly associated with OSA. Materials and Methods Hypertensive patients (n=475) who underwent portable polysomnography were enrolled. The patients were categorized into controlled (n=410) and resistant HTN (n=65) groups. The risk factors for the occurrence of OSA in controlled and resistant hypertensive patients were compared, and independent risk factors that are associated with OSA were analyzed. Results Out of 475 patients, 359 (75.6%) were diagnosed with OSA. The prevalence of OSA in resistant HTN was 87.7%, which was significantly higher than that in controlled HTN (73.7%). Age, body mass index, neck circumference, waist circumference, and hip circumference were significantly higher in OSA. However, stepwise multivariate analyses revealed that resistant HTN was not an independent risk factor of OSA. Conclusion The higher prevalence and severity of OSA in resistant HTN may be due to the association of risk factors that are common to both conditions. PMID:26256968

  17. 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

  18. 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.

  19. Antibiotics and the social history of the controlled clinical trial, 1950-1970.

    PubMed

    Podolsky, Scott H

    2010-07-01

    The histories of antibiotics, controlled clinical trials, and attempts by academics to inculcate an explicitly rational therapeutics among clinicians in the United States were linked during a formative period from 1950 to 1970. Maxwell Finland and Harry Dowling would serve at the epicenter of such efforts in the context of first the broad-spectrum antibiotics, and then, and still more critically, the since-forgotten influx of "fixed-dose combination" antibiotics. With their attention focused less upon individual clinicians than upon pharmaceutical marketers, clinical investigators, the American Medical Association, and the federal government, Finland, Dowling and their supporters would wield the "controlled clinical trial" against the pharmaceutical "testimonial" as a means of ensuring a rational therapeutics. In doing so, they would play an important role in the direction the subsequent Kefauver hearings (1959-1962) would take toward mandating proof of drug efficacy via controlled clinical trials prior to new drug approval. Understanding such a trajectory allows us to better appreciate not only the social history of the controlled clinical trial and the priorities of leaders in infectious disease in the United States during this time, but the consequences of their efforts as well. PMID:20215414

  20. 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

  1. 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

  2. METHODOLOGY IN MEDICAL RESEARCH—The Need for Controlled Clinical Studies

    PubMed Central

    Hall, Robert A.

    1955-01-01

    Too many medical researchers vitiate their work by ignoring the problem of uncontrolled variables. They therefore publish clinical impressions “dressed up” in scientifically meaningless numbers. A prototypical example of this practice is contrasted with a controlled study, each employing the same (small) number of patients. It is shown how the use of controls can convert a meaningless experiment into one that has assessable scientific significance. A survey of current literature revealed that in only 21 of 100 articles studied were adequately controlled experimental conditions employed. Since they usually deal with very complex systems, it is urged that medical researchers exercise more scientific rigor with regard to control problems. PMID:14379057

  3. 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.…

  4. 78 FR 23594 - Importer of Controlled Substances, Notice of Application, Almac Clinical Services, Inc., (ACSI)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous...(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: April 10... controlled substances will be granted only for analytical testing and clinical trials. This...

  5. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    PubMed Central

    Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

  6. 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.

  7. 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

  8. Computerized Management of Patient Care in a Complex, Controlled Clinical Trial in the Intensive Care Unit

    PubMed Central

    Sittig, Dean F.

    1987-01-01

    Acute Respiratory Distress Syndrome (ARDS) is often not responsive to conventional supportive therapy and the mortality rate may exceed 90%. A new form of supportive care, Extracorporeal Carbon Dioxide Removal (ECCO2R), has shown a dramatic increase in survival (48%). A controlled clinical trial of the new ECCO2R therapy versus conventional Continuous Positive Pressure Ventilation (CPPV) is being initiated. Detailed care protocols have been developed by “expert” critical care physicians for the management of patients. Using a blackboard control architecture, the protocols have been implemented on an existing hospital information system and will direct patient care and help manage the controlled clinical trial. Therapeutic instructions are automatically generated by the computer from data input by physicians, nurses, respiratory therapists, and the laboratory. Preliminary results show that the computerized protocol system can direct therapy for acutely ill patients.

  9. Informed conditioning on clinical covariates increases power in case-control association studies.

    PubMed

    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 χ(2) test statistics and a

  10. Randomized clinical trial comparing ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows.

    PubMed

    Cortinhas, Cristina Simões; Tomazi, Tiago; Zoni, Mário Sérgio Ferreira; Moro, Elio; Veiga Dos Santos, Marcos

    2016-07-01

    The objective of this study was to compare ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows. A total of 264 clinical mastitis cases on 11 commercial dairy farms were treated with intramammary infusions, once a day for 4 d using 1 of 2 treatments: (1) ceftiofur hydrochloride 125mg; or (2) control: tetracycline 200mg + neomycin 250mg + bacitracin 28mg + prednisolone 10mg. Streptococcus agalactiae was the most frequently isolated gram-positive pathogen from clinical mastitis, followed by Staphylococcus aureus. Klebsiella spp. and Escherichia coli were the most isolated gram-negative bacteria from clinical mastitis. No significant differences were observed between treatments regarding the overall clinical cure, bacteriological cure, and new infection. No effect of treatment regimen was observed when the bacterial group (gram-positive vs. gram-negative) was evaluated. The overall clinical cure was 0.79 for ceftiofur-treated cows and 0.74 for control-treated cows, whereas the overall bacteriological cure was 0.79 for ceftiofur-treated cows and 0.76 for control-treated cows. Furthermore, the new intramammary infection was 0.10 for cows treated with ceftiofur and 0.11 for cows treated with control. In conclusion, the use of intramammary ceftiofur hydrochloride for treatment of nonsevere clinical mastitis has similar efficacy as a treatment regimen with a combination of antimicrobial agents (tetracycline + neomycin + bacitracin). PMID:27157576

  11. Oestrus control and the incidence of mammary nodules in bitches, a clinical study with two progestogens.

    PubMed

    van Os, J L; van Laar, P H; Oldenkamp, E P; Verschoor, J S

    1981-01-01

    The incidence, size and location of mammary nodules were established in 10 practices in The Netherlands by the clinical examination of bitches in which oestrus was controlled with proligestone (P), 331 animals, or medroxyprogesterone acetate (MAP), 341 animals and in 339 animals never medicated with such compounds. In comparison with the unmedicated control and the P-medicated animals of comparable age the incidence of mammary nodules of all sizes was significantly increased in the MAP-medicated animals. There was no significant difference in nodule incidence between the P-medicated animals and the control animals. Based on the assumption that nodules above a certain size are most likely tumours, these results indicate that oestrus control with MAP stimulates tumour development even in animals medicated for less than four years. The practical value of the reported differences, especially in relation to the subsequent requirement for surgical removal of tumours in bitches, medicated for oestrus control, is discussed. PMID:6451952

  12. [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

  13. Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials?*

    PubMed Central

    2009-01-01

    In Europe many cancer patients use complementary therapies, particularly mistletoe. Only a few controlled clinical trials have been performed with the mistletoe preparation Iscador as a complementary treatment for cancer, many of them with medium to low quality due to methodological shortcomings. Reasons for some quality concerns, particularly discontinuation of treatment and/or participation and premature termination are analyzed. Analysis is based on controlled clinical trials dealing with Iscador. Data stem from the archive of published and ongoing research of the «Verein für Krebsforschung» (Society for Cancer Research) in Arlesheim, Switzerland. Controlled clinical studies with cancer patients that were started after 01.01.1990 or were not completed by then have been evaluated. Fifty-six controlled studies are documented, 24 of them randomized and 32 non-randomized. Nine of the randomized studies were done by matched-pair design, the others by conventional parallel group design; six of the last were terminated prematurely primarily for slow recruitment due to patient preferences and compliance of physicians. Patient and physician preference seem to be important factors limiting recruitment for randomized trials and hence implementation. This adds to the overall unwillingness of participation by patients with serious diseases. A well-balanced mix of designs using different research methods and outcomes is suggested combined with analyses, in countries where mistletoe therapy in general or Iscador in particular is unknown or not available. PMID:18955241

  14. Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials?

    PubMed

    Ziegler, Renatus

    2009-03-01

    In Europe many cancer patients use complementary therapies, particularly mistletoe. Only a few controlled clinical trials have been performed with the mistletoe preparation Iscador as a complementary treatment for cancer, many of them with medium to low quality due to methodological shortcomings. Reasons for some quality concerns, particularly discontinuation of treatment and/or participation and premature termination are analyzed. Analysis is based on controlled clinical trials dealing with Iscador. Data stem from the archive of published and ongoing research of the (Society for Cancer Research) in Arlesheim, Switzerland. Controlled clinical studies with cancer patients that were started after 01.01.1990 or were not completed by then have been evaluated. Fifty-six controlled studies are documented, 24 of them randomized and 32 non-randomized. Nine of the randomized studies were done by matched-pair design, the others by conventional parallel group design; six of the last were terminated prematurely primarily for slow recruitment due to patient preferences and compliance of physicians. Patient and physician preference seem to be important factors limiting recruitment for randomized trials and hence implementation. This adds to the overall unwillingness of participation by patients with serious diseases. A well-balanced mix of designs using different research methods and outcomes is suggested combined with analyses, in countries where mistletoe therapy in general or Iscador in particular is unknown or not available. PMID:18955241

  15. Clinical prediction of the need for interventions for the control of myopia.

    PubMed

    McMonnies, Charles W

    2015-11-01

    The prevalence of myopia is increasing in Western populations but in East Asian countries, it is increasing to epidemic levels, where there are also markedly increased rates of progression to pathological myopia. Measures to more effectively control the development and progression of myopia are urgently needed. Notwithstanding a large volume of research, especially regarding the different mechanisms for the development of myopia and the efficacy of particular methods of intervention, there is still a great need and scope for improvements in clinical efforts to prevent and/or control myopic progression. Too often clinical efforts may involve only one method of intervention; however, the heterogenous nature of myopia suggests that clinical intervention may be more successful when interventions are employed in combination. The decision to prescribe interventions for the control of myopia in children, especially prior to onset, may be better framed by a comprehensive estimation of the degree of risk for the development and/or progression of myopia. For example, rather than ascribing equal weight to any degree of parental myopia, more accurate estimates may be obtained, if risk is judged to increase with the degree of parental myopia and the extent of any associated degenerative pathology. Risk estimates may be limited to broad mild, moderate and severe classifications due to lack of accurate weighting of risk factors. Nevertheless, comprehensive assessment of risk factors appears likely to better inform a prognosis and discussions with parents. Consideration of numerous environmental influences, for example, such as continuity and intensity of near work and time spent outdoors, may contribute to better risk estimation. Family-based practice appears to be ideally suited for risk estimation and the clinical application of approaches to control myopia. A proactive approach to estimating risk of developing myopia prior to its onset may be beneficial. Earlier implementation

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled clinical... others from the general public, about the use of meta-analyses of randomized trials as a tool for...

  1. Aggression control therapy for violent forensic psychiatric patients: method and clinical practice.

    PubMed

    Hornsveld, Ruud H J; Nijman, Henk L I; Hollin, Clive R; Kraaimaat, Floor W

    2008-04-01

    Aggression control therapy is based on Goldstein, Gibbs, and Glick's aggression replacement training and was developed for violent forensic psychiatric in- and outpatients (adolescents and adults) with a (oppositional-defiant) conduct disorder or an antisocial personality disorder. First, the conditions for promoting "treatment integrity" are examined. Then, target groups, framework, and procedure are described in detail, followed by the most important clinical findings during the period 2002 to 2006. Finally, new programme developments are mentioned, with aggression control therapy as a starting point. PMID:17636205

  2. 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

  3. The Role of Clinical and Instrumented Outcome Measures in Balance Control of Individuals with Multiple Sclerosis

    PubMed Central

    Kanekar, Neeta; Aruin, Alexander S.

    2013-01-01

    Purpose. The aim of the study was to investigate differences in balance control between individuals with multiple sclerosis (MS) and healthy control subjects using clinical scales and instrumented measures of balance and determine relationships between balance measures, fatigue, and disability levels in individuals with MS with and without a history of falls. Method. Twelve individuals with MS and twelve healthy controls were evaluated using the Berg Balance and Activities-specific Balance Confidence Scales, Modified Clinical Test of Sensory Interaction on Balance, and Limits of Stability Tests as well as Fatigue Severity Scale and Barthel Index. Results. Mildly affected individuals with MS had significant balance performance deficits and poor balance confidence levels (P < 0.05). MS group had higher sway velocities and diminished stability limits (P < 0.05), significant sensory impairments, high fatigue and disability levels (P < 0.05). Sway velocity was a significant predictor of balance performance and the ability to move towards stability limits for the MS group. For the MS-fallers group, those with lower disability levels had faster movement velocities and better balance performance. Conclusion. Implementation of both clinical and instrumented tests of balance is important for the planning and evaluation of treatment outcomes in balance rehabilitation of people with MS. PMID:23766907

  4. Inter- and intra-observer reliability of clinical movement-control tests for marines

    PubMed Central

    2012-01-01

    Background Musculoskeletal disorders particularly in the back and lower extremities are common among marines. Here, movement-control tests are considered clinically useful for screening and follow-up evaluation. However, few studies have addressed the reliability of clinical tests, and no such published data exists for marines. The present aim was therefore to determine the inter- and intra-observer reliability of clinically convenient tests emphasizing movement control of the back and hip among marines. A secondary aim was to investigate the sensitivity and specificity of these clinical tests for discriminating musculoskeletal pain disorders in this group of military personnel. Methods This inter- and intra-observer reliability study used a test-retest approach with six standardized clinical tests focusing on movement control for back and hip. Thirty-three marines (age 28.7 yrs, SD 5.9) on active duty volunteered and were recruited. They followed an in-vivo observation test procedure that covered both low- and high-load (threshold) tasks relevant for marines on operational duty. Two independent observers simultaneously rated performance as “correct” or “incorrect” following a standardized assessment protocol. Re-testing followed 7–10 days thereafter. Reliability was analysed using kappa (κ) coefficients, while discriminative power of the best-fitting tests for back- and lower-extremity pain was assessed using a multiple-variable regression model. Results Inter-observer reliability for the six tests was moderate to almost perfect with κ-coefficients ranging between 0.56-0.95. Three tests reached almost perfect inter-observer reliability with mean κ-coefficients > 0.81. However, intra-observer reliability was fair-to-moderate with mean κ-coefficients between 0.22-0.58. Three tests achieved moderate intra-observer reliability with κ-coefficients > 0.41. Combinations of one low- and one high-threshold test best discriminated prior back pain, but results

  5. 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

  6. 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

  7. Use of historical control data for assessing treatment effects in clinical trials

    PubMed Central

    Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G.; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

    2014-01-01

    Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study’s control arm. There is obvious appeal in using (i.e., ‘borrowing’) this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of ‘dynamic’ (versus ‘static’) borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. PMID:23913901

  8. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    PubMed

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs. PMID:26591543

  9. Psychosocial and Cardiac Outcomes of Yoga for ICD Patients: A Randomized Clinical Control Trial

    PubMed Central

    Toise, Stefanie C.F.; Sears, Samuel F.; Schoenfeld, Mark H.; Blitzer, Mark L.; Marieb, Mark A.; Drury, John H.; Slade, Martin D.; Donohue, Thomas J.

    2013-01-01

    Background Because as many as 46% of implantable cardioverter defibrillator (ICD) patients experience clinical symptoms of shock anxiety, this randomized controlled study evaluated the efficacy of adapted yoga (vs. usual care) in reducing clinical psychosocial risks shown to impact morbidity and mortality in ICD recipients. Methods Forty-six participants were randomized to a control group or an 8-week adapted yoga group that followed a standardized protocol with weekly classes and home practice. Medical and psychosocial data were collected at baseline and follow-up, then compared and analyzed. Results Total shock anxiety decreased for the yoga group and increased for the control group, t(4.43, 36), p < 0.0001, with significant differences between these changes. Similarly, consequential anxiety decreased for the yoga group but increased for the control group t(2.86,36) p = 0.007. Compared to the control, the yoga group had greater overall self-compassion, t(–2.84,37), p = 0.007, and greater mindfulness, t(–2.10,37) p = 0.04, at the end of the study. Exploratory analyses utilizing a linear model (R2 = .98) ofobserved device-treated ventricular (DTV) events revealed that the expected number of DTV events in the yoga group was significantly lower than in the control group (p<.0001). Compared to the control, the yoga group had a 32% lower risk of experiencing device-related firings at end of follow-up. Conclusions Our study demonstrated psychosocial benefits from a program of adapted yoga (vs. usual care) for ICD recipients. This data supports continued research to better understand the role of complementary medicine to address ICD-specific stress in cardiac outcomes. PMID:23981048

  10. The effectiveness of the "Clean-Area-System" for infection control in the dental clinic.

    PubMed

    Noro, A; Suyama, Y; Takahashi, E; Chattin, B R; Hirai, Y; Takahashi, K; Ishikawa, T

    1998-02-01

    The use of effective infection control procedures and universal precautions in dental clinics, prevents cross contamination that could extend to dental health care workers and patients. The present study was initiated to investigate airborne environmental contamination in the dental clinic by viable cell count of oral streptococci grown on Mitis-Salivarius and blood agar plates. The reduction of the contamination by the "Clean-Area-System" was evaluated. "Andersen-Microbe-Sampler-Apparatus" and "Laser-Particle-Counter-System" were used for sampling and counting the bacterial cells and airborne dust, respectively. Numbers of viable cells counted as total colony forming units (CFUs) in the dental clinic were found to be significantly higher than those in the waiting room and the research laboratory. We found that the "Clean-Area-System" significantly reduced the CFUs grown on blood agar plates (p < 0.05), and that using the "Clean-Area-System" combined with the "Extra-Oral-Vacuum-Aspirator" is desirable in dental procedures such as cavity preparation. The "Extra-Oral-Vacuum-Aspirator" reduced airborne environmental contamination during tooth cutting and ultrasonic scaling procedures. In non-grinding procedures, this system proved to be very useful for infection control in the operative area. The authors concluded that the combined use of "Clean-Area-System" (dust collection ablation) and "Extra-Oral-Vacuum-Aspirator" (absorb dust ablation) was effective to reduce airborne environmental contamination in the dental clinic. We also fully confirmed that oral streptococci were an adequate indicator in the assessment for infection control in dental institutions. PMID:9663027

  11. 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. PMID:22407172

  12. 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

  13. 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

  14. Randomized controlled clinical trial on the efficacy of fosfomycin trometamol for uncomplicated gonococcal urethritis in men.

    PubMed

    Yuan, Z; He, C; Yan, S; Ke, Y; Tang, W

    2016-06-01

    We assessed the efficacy of fosfomycin trometamol in treating uncomplicated gonococcal urethritis in men. We conducted an open randomized controlled trial in 152 consecutive men with any main complaints suggestive of uncomplicated gonococcal urethritis in Dujiangyan Medical Center between 1 September 2013 and 31 August 2015. In total, 126 patients completed all aspects of this study. Sixty were provided therapy with fosfomycin trometamol 3 g orally on days 1, 3 and 5 in the intervention group; the other 61 were provided ceftriaxone 250 mg intramuscularly plus azithromycin 1 g orally simultaneously as a single dose in the control group. The primary outcomes involved clinical and microbiologic cure on days 7 and 14 after receipt of all the study medications. At the day 7 follow-up visit, all the 121 participants had complete resolution of clinical symptoms and signs. In addition, five patients (two in the intervention group and three in the control group) discontinued intervention because of unsuccessful treatment. After receipt of all the study medications, these five patients still had urethral purulent discharge and were switched to other unknown treatment regimens by other doctors. The bacterial smears and cultures of urethral or urine specimens in the 121 patients who completed all aspects of the study were negative on a test-of-cure visit. In the per-protocol analysis, both clinical and microbiologic cure were experienced by 96.8% (60/62 patients) in the intervention group and 95.3% (61/64 patients) in the control group. There were no recurrences at the day 14 test-of-cure visit. This trial indicates that fosfomycin trometamol exhibits excellent efficacy for treatment of uncomplicated gonococcal urethritis in men. Serious adverse effects are rare. PMID:27064136

  15. 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

  16. Quality Controls in Cellular Immunotherapies: Rapid Assessment of Clinical Grade Dendritic Cells by Gene Expression Profiling

    PubMed Central

    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

    2013-01-01

    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. PMID:23147403

  17. Educating the clinical trainer: professional gain for the trainee? A controlled intervention study in general practice.

    PubMed

    Jochemsen-van der Leeuw, H G A Ria; van Dijk, Nynke; de Jong, Wilfried; Wieringa-de Waard, Margreet

    2014-12-01

    The aim of this study was to establish whether a 'teach-the-trainer' course leads to improvements in, firstly, the knowledge and attitude of clinical trainers and their trainees, and, secondly, the role model behaviour of the clinical trainers. A controlled intervention study was performed with GP trainers and GP trainees from four training institutes in the Netherlands. Clinical trainers in the two intervention institutes received two 3-h training sessions on weight management, focusing on knowledge and attitudes towards obesity, and on conveying the correct professional competency as a positive role model for trainees. This was measured using questionnaires on knowledge, attitude, and role model behaviour (the role model apperception tool; RoMAT). GP trainers showed an increase in knowledge and several characteristics could be identified as being related to positive role model behaviour. A small correlation was found between the trainer's score on the RoMAT and the attitude of the trainee. A teach-the-trainer course in which knowledge, attitudes, and role modelling are integrated proved to be a first step toward improving the knowledge of clinical trainers, but did not result in a measurably better professional outcome for the trainee, maybe due to a more objective level of assessment. PMID:25338922

  18. 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

  19. The Stimulation Effect of Auricular Magnetic Press Pellets on Older Female Adults with Sleep Disturbance Undergoing Polysomnographic Evaluation

    PubMed Central

    Lo, Chyi; Liao, Wen-Chun; Liaw, Jen-Jiuan; Hang, Liang-Wen; Lin, Jaung-Geng

    2013-01-01

    Study Objectives. To examine the stimulation effect of auricular magnetic press pellet therapy on older female adults with sleep disturbance as determined by polysomnography (PSG). Design. Randomized, single-blind, experimental-controlled, parallel-group. Setting. Community. Participants. Twenty-seven older female adults with sleep disturbance according to the Pittsburgh Sleep Quality Index (PSQI) >5 for at least 3 months were recruited. Participants were screened by both the Hospital Anxiety and Depression Scale (HADS) and the Mini-Mental State Examination (MMSE), as well as polysomnography prior to randomization. Interventions. All eligible participants were randomly allocated into the experimental or control group. Both groups were taped with magnetic press pellet on auricular points for 3 weeks. The experimental group was treated by applying pressure on the magnetic press pellets 3 times per day while no stimulation was applied on the control group. Measurements and Results. Both groups were measured by PSG and PSQI at the beginning of the study and 3 weeks after the study. Both groups showed improvements on PSQI scores compared to the baseline. One-way analysis of covariance adjusted for baseline scores showed that significant improvements of PSG-derived sleep parameters, such as sleep efficiency, were found in the experimental group. However, no significant differences between groups were observed in the proportion of sleep stages with the exception of Stage 2. Conclusions. Auricular therapy using magnetic pellets and stimulation by pressing was more effective in improving the sleep quality compared to auricular therapy without any stimulation. PMID:23573133

  20. Neural Dysfunction in Cognitive Control Circuits in Persons at Clinical High-Risk for Psychosis.

    PubMed

    Colibazzi, Tiziano; Horga, Guillermo; Wang, Zhishun; Huo, Yuankai; Corcoran, Cheryl; Klahr, Kristin; Brucato, Gary; Girgis, Ragy; Gill, Kelly; Abi-Dargham, Anissa; Peterson, Bradley S

    2016-04-01

    Cognitive control, a set of functions that develop throughout adolescence, is important in the pathogenesis of psychotic disorders. Whether cognitive control has a role in conferring vulnerability for the development of psychotic illness is still unknown. The aim of this study was to investigate the neural systems supporting cognitive control in individuals deemed to be potentially prodromal for psychotic illness. We recruited 56 participants at clinical high-risk (CHR) for psychosis based on the Structured Interview for Psychosis-Risk Syndromes (SIPS) and 49 healthy controls. Twelve of the CHR participants eventually developed psychosis. We compared functional magnetic resonance imaging (fMRI) BOLD signal during the performance of the Simon task. We tested for differences between CHR individuals and controls in conflict-related functional activity. In the CHR group when compared with controls, we detected smaller conflict-related activations in several cortical areas, including the Dorsolateral Prefrontal Cortex (DLPFC). Furthermore, conflict-related activations in the DLPFC of those CHR individuals who ultimately developed psychosis (CHR converters) were smaller than in non-converters (CHR non-converters). Higher levels of conflict-related activation were associated with better social and role outcome. Risk for psychosis was associated at the neural level with reduced conflict-related brain activity. This neural phenotype appears correlated within the DLPFC with the development of psychosis and with functional outcome. PMID:26354046

  1. 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

  2. A randomised controlled trial of cognitive-behaviour therapy for clinical perfectionism: A preliminary study

    PubMed Central

    Riley, Caroline; Lee, Michelle; Cooper, Zafra; Fairburn, Christopher G.; Shafran, Roz

    2007-01-01

    Perfectionism can be a problem in its own right and it can impede the progress of treatment of Axis I disorders. This study reports on a preliminary randomised controlled trial of cognitive-behaviour therapy (CBT) for “clinical perfectionism”. Twenty participants were randomly assigned to either immediate treatment (IT) (n=10) or a waitlist (NL) (n=10). Treatment consisted of ten sessions of CBT over eight weeks. Two participants did not complete the follow-up assessments (10%). Fifteen of the original 20 participants (75%) were clinically significantly improved after treatment and the effect size was large (1.8). Treatment gains were maintained at 8-week and 16-week follow-up. PMID:17275781

  3. Placebo preparation for the proper clinical trial of herbal medicine--requirements, verification and quality control.

    PubMed

    Fai, Cheng K; Qi, Guan De; Wei, Ding A; Chung, Leung P

    2011-05-01

    Randomized controlled trials (RCT) have been recognized as the gold standard for interventional clinical trials. In many clinical trials of herbal medicine, it is very difficult to create a quality placebo. To achieve the purpose of blinding, the characteristics of the real drug and placebo should be identical in color, appearance, smell and taste. The quality placebo should be identical to the real drug in physical form, sensory perception, packaging, and labeling, and it should have no pharmaceutical activity. The aim of this study was to evaluate a placebo capsule and its matching herbal medicine D&G capsule in physical form, chemical nature, appearance, packaging and labeling. The assessment results suggested that the placebo was satisfactory in these aspects. The results demonstrated that a placebo could be created for a RCT involving herbal medicine. This report also discusses the means to acquire patent. PMID:21457134

  4. 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

  5. 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

  6. Using statistical process control to make data-based clinical decisions.

    PubMed Central

    Pfadt, A; Wheeler, D J

    1995-01-01

    Applied behavior analysis is based on an investigation of variability due to interrelationships among antecedents, behavior, and consequences. This permits testable hypotheses about the causes of behavior as well as for the course of treatment to be evaluated empirically. Such information provides corrective feedback for making data-based clinical decisions. This paper considers how a different approach to the analysis of variability based on the writings of Walter Shewart and W. Edwards Deming in the area of industrial quality control helps to achieve similar objectives. Statistical process control (SPC) was developed to implement a process of continual product improvement while achieving compliance with production standards and other requirements for promoting customer satisfaction. SPC involves the use of simple statistical tools, such as histograms and control charts, as well as problem-solving techniques, such as flow charts, cause-and-effect diagrams, and Pareto charts, to implement Deming's management philosophy. These data-analytic procedures can be incorporated into a human service organization to help to achieve its stated objectives in a manner that leads to continuous improvement in the functioning of the clients who are its customers. Examples are provided to illustrate how SPC procedures can be used to analyze behavioral data. Issues related to the application of these tools for making data-based clinical decisions and for creating an organizational climate that promotes their routine use in applied settings are also considered. PMID:7592154

  7. Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study

    PubMed Central

    Nowbar, Alexandra N; Mielewczik, Michael; Shun-Shin, Matthew J; Francis, Darrel P

    2015-01-01

    Objectives To compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal. Design Blinded case-control study. Setting Journals in PubMed. Population 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis. Main outcome measure Total number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report. Results Of 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); P<0.001). Papers with a discrepancy were significantly more likely to be retracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); P<0.001). In particular, three types of discrepancy arose significantly more frequently in retracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result. Conclusions Discrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist

  8. [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

  9. Clinical Decision Support Tools for Osteoporosis Disease Management: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Straus, Sharon E.

    2008-01-01

    BACKGROUND Studies indicate a gap between evidence and clinical practice in osteoporosis management. Tools that facilitate clinical decision making at the point of care are promising strategies for closing these practice gaps. OBJECTIVE To systematically review the literature to identify and describe the effectiveness of tools that support clinical decision making in osteoporosis disease management. DATA SOURCES Medline, EMBASE, CINAHL, and EBM Reviews (CDSR, DARE, CCTR, and ACP J Club), and contact with experts in the field. REVIEW METHODS Randomized controlled trials (RCTs) in any language from 1966 to July 2006 investigating disease management interventions in patients at risk for osteoporosis. Outcomes included fractures and bone mineral density (BMD) testing. Two investigators independently assessed articles for relevance and study quality, and extracted data using standardized forms. RESULTS Of 1,246 citations that were screened for relevance, 13 RCTs met the inclusion criteria. Reported study quality was generally poor. Meta-analysis was not done because of methodological and clinical heterogeneity; 77% of studies included a reminder or education as a component of their intervention. Three studies of reminders plus education targeted to physicians and patients showed increased BMD testing (RR range 1.43 to 8.67) and osteoporosis medication use (RR range 1.60 to 8.67). A physician reminder plus a patient risk assessment strategy found reduced fractures [RR 0.58, 95% confidence interval (CI) 0.37 to 0.90] and increased osteoporosis therapy (RR 2.44, CI 1.43 to 4.17). CONCLUSION Multi-component tools that are targeted to physicians and patients may be effective for supporting clinical decision making in osteoporosis disease management. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0812-9) contains supplementary material, which is available to authorized users. PMID:18836782

  10. Glycemic Control in a Clinic-Based Sample of Diabetics in M'Bour Senegal.

    PubMed

    BeLue, Rhonda; Ndiaye, Khadidiatou; NDao, Fatou; Ba, Fatou Niass Niang; Diaw, Mor

    2016-04-01

    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 care at the M'Bour Hospital in M'Bour, Senegal.Methods A total of 106 type 2 diabetic patients were recruited at the hospital complex of M'Bour, Senegal. Linear regression was employed to assess the relationship between clinical and sociodemographic factors and Hba1c.Results Only 24.8% of the sample had glycemic control, according to an Hba1c test. Participants who were diagnosed earlier were less likely to have diabetes control (mean = 7.8 years) compared with those who were diagnosed more recently (mean = 6.5 years);p< .05.Conclusions We found that glycemic control in our sample was suboptimal. Length of time with diabetes was one of the key factors related to glycemic control. Length of time with diabetes is negatively associated with glycemic control. Early diagnosis and early glycemic control are essential to long-term glycemic control screening, and early detection for diabetes is uncommon given the general lack of health insurance and most people paying out of pocket for medical care. In the absence of universal health insurance, public health programs that provide blood sugar screenings for high-risk individuals would provide preliminary indication of abnormal glucose; however, subsequent diagnostic testing and follow-up may still be cost prohibitive. PMID:27037142

  11. Impulse Control Disorders: Updated Review of Clinical Characteristics and Pharmacological Management

    PubMed Central

    Schreiber, Liana; Odlaug, Brian L.; Grant, Jon E.

    2011-01-01

    Impulse control disorders (ICDs) are characterized by urges and behaviors that are excessive and/or harmful to oneself or others and cause significant impairment in social and occupational functioning, as well as legal and financial difficulties. ICDs are relatively common psychiatric conditions, yet are poorly understood by the general public, clinicians, and individuals struggling with the disorder. Although ICD treatment research is limited, studies have shown ICDs may respond well to pharmacological treatment. This article presents a brief overview about the clinical characteristics of ICDs and pharmacological treatment options for individuals with ICDs. PMID:21556272

  12. Ethics of placebo-controlled clinical trials in multiple sclerosis: a reassessment.

    PubMed

    Polman, C H; Reingold, S C; Barkhof, F; Calabresi, P A; Clanet, M; Cohen, J A; Cutter, G R; Freedman, M S; Kappos, L; Lublin, F D; McFarland, H F; Metz, L M; Miller, A E; Montalban, X; O'Connor, P W; Panitch, H; Richert, J R; Petkau, J; Schwid, S R; Sormani, M P; Thompson, A J; Weinshenker, B G; Wolinsky, J S

    2008-03-25

    The increasing number of established effective therapies for relapsing multiple sclerosis (MS) and emerging consensus for early treatment raise practical concerns and ethical dilemmas for placebo-controlled clinical trials in this disease. An international group of clinicians, ethicists, statisticians, regulators, and representatives from the pharmaceutical industry convened to reconsider prior recommendations regarding the ethics of placebo-controlled trials in MS. The group concluded that placebo-controlled trials can still be done ethically, with restrictions. For patients with relapsing MS for which established effective therapies exist, placebo-controlled trials should only be offered with rigorous informed consent if the subjects refuse to use these treatments, have not responded to them, or if these treatments are not available to them for other reasons (e.g., economics). Suggestions are provided to protect subject autonomy and improve informed consent procedures. Recommendations are tighter than previously suggested for placebo-controlled trials in "resource-restricted" environments where established therapies may not be available. Guidance is also provided on the ethics of alternative trial designs and the balance between study subject burden and risk, scientific rationale and interpretability of trial outcomes. PMID:18362273

  13. A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results.

    PubMed

    Saccà, Francesco; Quarantelli, Mario; Rinaldi, Carlo; Tucci, Tecla; Piro, Raffaele; Perrotta, Gaetano; Carotenuto, Barbara; Marsili, Angela; Palma, Vincenzo; De Michele, Giuseppe; Brunetti, Arturo; Brescia Morra, Vincenzo; Filla, Alessandro; Salvatore, Marco

    2012-01-01

    Amyotrophic lateral sclerosis (ALS) is a fatal neurological disease with motor neuron degeneration. Riluzole is the only available treatment. Two-thirds of ALS patients present with growth hormone (GH) deficiency. The aim of this study is to determine if add-on of GH to riluzole, with an individually regulated dose based on Insulin-like growth factor 1 (IGF-I) production, was able to reduce neuronal loss in the motor cortex, reduce mortality, and improve motor function of ALS patients. Patients with definite/probable ALS, in treatment with riluzole, aged 40-85 years, and with disease duration ≤3 years were enrolled. The study was randomized, placebo controlled, and double blind. Before treatment, patients were tested with a GH releasing hormone (GHRH) + arginine test. The initial dose of GH was 2 IU s.c. every other day, and was progressively increased to a maximum of 8 IU. Primary endpoint was N-acetylaspartate/(creatine + choline) (NAA/Cre + Cho) ratio in motor cortex assessed by magnetic resonance spectroscopy performed at months 0, 6, and 12. Secondary endpoints were mortality and ALS functional rating scale revised (ALSFRS-R). The NAA/(Cre + Cho) ratio decreased in all patients who completed the trial. No significant difference was noted between treated and placebo group. At baseline, although IGF-I levels were within the normal range, 73% of patients had GH deficiency, being severe in half of them. Compared with bulbar onset, spinal-onset patients showed more depressed GH response to the GHRH + arginine stimulation test (10.4 ± 7.0 versus 15.5 ± 8.1 ng/mL; p < 0.05). Insulin resistance [homeostasis model assessment of insulin resistance (HOMA-IR)] increased from 2.1 ± 1.0 at baseline to 4.6 ± 1.9 at 12 months (p < 0.001). Insulin-like growth factor (IGF) binding protein 3 (IGFBP-3) decreased from 8,435 ± 4,477 ng/mL at baseline to 3,250 ± 1,780 ng/mL at 12 months (p < 0.001). The results show that GH exerted no effect on cerebral NAA or clinical

  14. 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.

  15. 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

  16. 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

  17. Sleep misperception, EEG characteristics and autonomic nervous system activity in primary insomnia: a retrospective study on polysomnographic data.

    PubMed

    Maes, J; Verbraecken, J; Willemen, M; De Volder, I; van Gastel, A; Michiels, N; Verbeek, I; Vandekerckhove, M; Wuyts, J; Haex, B; Willemen, T; Exadaktylos, V; Bulckaert, A; Cluydts, R

    2014-03-01

    Misperception of Sleep Onset Latency, often found in Primary Insomnia, has been cited to be influenced by hyperarousal, reflected in EEG- and ECG-related indices. The aim of this retrospective study was to examine the association between Central Nervous System (i.e. EEG) and Autonomic Nervous System activity in the Sleep Onset Period and the first NREM sleep cycle in Primary Insomnia (n=17) and healthy controls (n=11). Furthermore, the study examined the influence of elevated EEG and Autonomic Nervous System activity on Stage2 sleep-protective mechanisms (K-complexes and sleep spindles). Confirming previous findings, the Primary Insomnia-group overestimated Sleep Onset Latency and this overestimation was correlated with elevated EEG activity. A higher amount of beta EEG activity during the Sleep Onset Period was correlated with the appearance of K-complexes immediately followed by a sleep spindle in the Primary Insomnia-group. This can be interpreted as an extra attempt to protect sleep continuity or as a failure of the sleep-protective role of the K-complex by fast EEG frequencies following within one second. The strong association found between K-alpha (K-complex within one second followed by 8-12 Hz EEG activity) in Stage2 sleep and a lower parasympathetic Autonomic Nervous System dominance (less high frequency HR) in Slow-wave sleep, further assumes a state of hyperarousal continuing through sleep in Primary Insomnia. PMID:24177246

  18. Craniosacral therapy for migraine: Protocol development for an exploratory controlled clinical trial

    PubMed Central

    Mann, John D; Faurot, Keturah R; Wilkinson, Laurel; Curtis, Peter; Coeytaux, Remy R; Suchindran, Chirayath; Gaylord, Susan A

    2008-01-01

    Background Migraine affects approximately 20% of the population. Conventional care for migraine is suboptimal; overuse of medications for the treatment of episodic migraines is a risk factor for developing chronic daily headache. The study of non-pharmaceutical approaches for prevention of migraine headaches is therefore warranted. Craniosacral therapy (CST) is a popular non-pharmacological approach to the treatment or prevention of migraine headaches for which there is limited evidence of safety and efficacy. In this paper, we describe an ongoing feasibility study to assess the safety and efficacy of CST in the treatment of migraine, using a rigorous and innovative randomized controlled study design involving low-strength static magnets (LSSM) as an attention control intervention. Methods The trial is designed to test the hypothesis that, compared to those receiving usual care plus a treatment with low-strength static magnets (attention-control complementary therapy), subjects receiving usual medical care plus CST will demonstrate significant improvement in: quality-of-life as measured by the Headache Impact Test (HIT-6); reduced frequency of migraine; and a perception of clinical benefit. Criteria for inclusion are either gender, age > 11, English or Spanish speaking, meeting the International Classification of Headache Disorders (ICHD) criteria for migraine with or without aura, a headache frequency of 5 to 15 per month over at least two years. After an 8 week baseline phase, eligible subjects are randomized to either CST or an attention control intervention, low strength static magnets (LSSM). To evaluate possible therapist bias, videotaped encounters are analyzed to assess for any systematic group differences in interactions with subjects. Results 169 individuals have been screened for eligibility, of which 109 were eligible for the study. Five did not qualify during the baseline phase because of inadequate headache frequency. Nineteen have withdrawn from the

  19. CLECOS_P: clinical evolution control system on Parkinsonian patients undergoing neural transplantation.

    PubMed

    Morales, F; Molina, H; Cruz, N; Valladares, P; Muñoz, J; Ortega, I; Torres, O; Leon, M

    1995-01-01

    The CLECOS_P system was conceived for registering and automating the processing of clinical evaluations performed on patients with Parkinson's disease who undergo functional neurosurgery and/or neural transplant. CLECOS_P represents the first time a computerized system is able to offer--with high precision and considerable time-savings--an integral analysis of the evolutive behavior of the universe in integrated variables at the core assessment program for intracerebral transplantations (CAPIT). CAPIT is used internationally for the evaluation and follow-up of patients with this pathology who have undergone neural transplant. We used the so-called MEDSAC methodology for the preparation of this system. The methodology that was used for the design of an intelligent system aimed at medical decision-making was based on the quantitative analysis of the clinical evolution. At the present moment, there are 20 patients controlled by this system: 11 bilaterally transplanted, 9 unilaterally (registered in ranks of 3 months before operation up to 1, 2, 3, 6, 9, 12, 18, and 24 months after operation). The application of CLECOS_P to these patients permitted the evaluation of 400 clinical variables, where a better evolutive characterization of the patients was obtained, thus getting most favorable results with personalized therapeutic methods aimed at raising their quality of life. CLECOS_P is used in a multi-user environment on a local area network running Novell Netware version 3.11. PMID:8591284

  20. 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

  1. 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.

  2. 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)…

  3. Escalation with Overdose Control Using Time to Toxicity for Cancer Phase I Clinical Trials

    PubMed Central

    Tighiouart, Mourad; Liu, Yuan; Rogatko, André

    2014-01-01

    Escalation with overdose control (EWOC) is a Bayesian adaptive phase I clinical trial design that produces consistent sequences of doses while controlling the probability that patients are overdosed. However, this design does not take explicitly into account the time it takes for a patient to exhibit dose limiting toxicity (DLT) since the occurrence of DLT is ascertained within a predetermined window of time. Models to estimate the Maximum Tolerated Dose (MTD) that use the exact time when the DLT occurs are expected to be more precise than those where the variable of interest is categorized as presence or absence of DLT, given that information is lost in the process of categorization of the variable. We develop a class of parametric models for time to toxicity data in order to estimate the MTD efficiently, and present extensive simulations showing that the method has good design operating characteristics relative to the original EWOC and a version of time to event EWOC (TITE-EWOC) which allocates weights to account for the time it takes for a patient to exhibit DLT. The methodology is exemplified by a cancer phase I clinical trial we designed in order to estimate the MTD of Veliparib (ABT-888) in combination with fixed doses of gemcitabine and intensity modulated radiation therapy in patients with locally advanced, un-resectable pancreatic cancer. PMID:24663812

  4. Dopamine cell transplantation for Parkinson's disease: the importance of controlled clinical trials.

    PubMed

    Freed, Curt R; Zhou, Wenbo; Breeze, Robert E

    2011-10-01

    Transplantation of human fetal dopamine neurons into the brain of Parkinson's disease patients started in the late 1980s, less than 10 years after experiments in rats showed that embryonic dopamine neurons from a narrow window of development are suitable for transplantation. For human transplantation, the critical stage of development is 6 to 8 weeks after conception. Because putamen is the basal ganglia structure most depleted of dopamine in Parkinson's disease and because it is the structure most closely mapped to the motor cortex, it has been the primary target for neurotransplantation. The double blind trial conducted at the University of Colorado, Columbia University, and North Shore University is the first controlled surgical trial performed in the field of neurosurgery. Results have shown that transplants of fetal dopamine neurons can survive transplantation without immunosuppression and without regard to the age of the patients. Transplants improved objective signs of Parkinson's disease to the best effects of L-DOPA seen preoperatively. Placebo surgery produced no clinical changes. In subjects in whom transplants replaced the need for L-DOPA, the implants replicated the preoperative effects of L-DOPA, including dyskinesias in susceptible patients. Our trial has provided the first controlled evidence that dopamine cell transplants can improve the clinical state of patients with Parkinson's disease. PMID:21997523

  5. Skin-impedance in Fabry Disease: A prospective, controlled, non-randomized clinical study

    PubMed Central

    Gupta, Surya N; Ries, Markus; Murray, Gary J; Quirk, Jane M; Brady, Roscoe O; Lidicker, Jeffrey R; Schiffmann, Raphael; Moore, David F

    2008-01-01

    Background We previously demonstrated improved sweating after enzyme replacement therapy (ERT) in Fabry disease using the thermo-regularity sweat and quantitative sudomotor axon reflex tests. Skin-impedance, a measure skin-moisture (sweating), has been used in the clinical evaluation of burns and pressure ulcers using the portable dynamic dermal impedance monitor (DDIM) system. Methods We compared skin impedance measurements in hemizygous patients with Fabry disease (22 post 3-years of bi-weekly ERT and 5 ERT naive) and 22 healthy controls. Force compensated skin-moisture values were used for statistical analysis. Outcome measures included 1) moisture reading of the 100th repetitive reading, 2) rate of change, 3) average of 60–110th reading and 4) overall average of all readings. Results All outcome measures showed a significant difference in skin-moisture between Fabry patients and control subjects (p < 0.0001). There was no difference between Fabry patients on ERT and patients naïve to ERT. Increased skin-impedance values for the four skin-impedance outcome measures were found in a small number of dermatome test-sites two days post-enzyme infusions. Conclusion The instrument portability, ease of its use, a relatively short time required for the assessment, and the fact that DDIM system was able to detect the difference in skin-moisture renders the instrument a useful clinical tool. PMID:18990229

  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. [Clinical application and experimental studies of the pulsed inhaled nitric oxide flow controlling instrument].

    PubMed

    Mo, Xu-ming; Zhao, En-chun; Wang, Min-sheng; Gu, Xinglin; Wang, Zhenxi; Wang, Chunsheng

    2002-01-01

    A flow controlling system for pulsed inhaled nitric oxide has been developed and tested, and here its features and initial animal experiments and clinical applications are described. The physical characteristic test indicates that the practical released dose of NO gas is very close to the theoretical flow of NO gas at variant pressures. Animal experiments demonstrate that inhaled NO gas concentration is lower than the concentration of theoretical inhalation, but the variance is not remarkable (p>0.05). When sixteen cases with CHD and PH were chosen to inhale NO gas (15 ppm, 15 min) PAP and PVR of all cases were reduced after inhalation of NO gas from 617 +/-51.3 dyn x s x cm(-5), 54.4+/-13.1 mmHg to 417+/-36.9 dym x s x cm(-5), 33.8+/-12.3 mmHg (PVR, p<0.01; PAP, p<0.01) respectively. When gas inhalation was stopped, these values returned to their base lines after a short period of time. All these show that the pulsed inhaled NO flow controlling instrument in accordance with the requirements of the designing, can be widely used in clinical diagnoses and treatments and will be a new tool offered for the treatments of the patients with PH. PMID:16104155

  8. Randomized, Controlled Clinical Trial of Bilayer Ceramic and Metal-Ceramic Crown Performance

    PubMed Central

    Esquivel-Upshaw, Josephine; Rose, William; Oliveira, Erica; Yang, Mark; Clark, Arthur E.; Anusavice, Kenneth

    2013-01-01

    Purpose Analyzing the clinical performance of restorative materials is important, as there is an expectation that these materials and procedures will restore teeth and do no harm. The objective of this research study was to characterize the clinical performance of metal-ceramic crowns, core ceramic crowns, and core ceramic/veneer ceramic crowns based on 11 clinical criteria. Materials and Methods An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study. The following three types of full crowns were fabricated: (1) metal-ceramic crown (MC) made from a Pd-Au-Ag-Sn-In alloy (Argedent 62) and a glass-ceramic veneer (IPS d.SIGN veneer); (2) non-veneered (glazed) lithium disilicate glass-ceramic crown (LDC) (IPS e.max Press core and e.max Ceram Glaze); and (3) veneered lithia disilicate glass-ceramic crown (LDC/V) with glass-ceramic veneer (IPS Empress 2 core and IPS Eris). Single-unit crowns were randomly assigned. Patients were recalled for each of 3 years and were evaluated by two calibrated clinicians. Thirty-six crowns were placed in 31 patients. A total of 12 crowns of each of the three crown types were studied. Eleven criteria were evaluated: tissue health, marginal integrity, secondary caries, proximal contact, anatomic contour, occlusion, surface texture, cracks/chips (fractures), color match, tooth sensitivity, and wear (of crowns and opposing enamel). Numerical rankings ranged from 1 to 4, with 4 being excellent, and 1 indicating a need for immediate replacement. Statistical analysis of the numerical rankings was performed using a Fisher’s exact test. Results There was no statistically significant difference between performance of the core ceramic crowns and the two veneered crowns at year 1 and year 2 (p > 0.05). All crowns were rated either as excellent or good for each of the clinical criteria; however, between years 2 and 3, gradual roughening of the occlusal surface occurred in some of the ceramic-ceramic crowns

  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. Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial

    PubMed Central

    Wang, Xiaohui; Zhang, Xiaoke; Zong, Zhiyong; Yu, Rujia; Lv, Xiaoju; Xin, Jianbao; Tong, Chaohui; Hao, Qinglin; Qin, Zhiqiang; Xiong, Ying; Liu, Hong; Ding, Guohua; Hu, Chengping

    2013-01-01

    Background & objectives: Biapenem is a newly developed carbapenem to treat moderate and severe bacterial infections. This multicenter, randomized, parallel-controlled clinical trial was conducted to compare the clinical efficacy, bacterial eradication rates and safety of biapenem and meropenem in the treatment of bacterial lower respiratory tract infections and urinary tract infections (UTIs) at nine centres in China. Methods: Patients diagnosed with bacterial lower respiratory tract infections or UTIs were randomly assigned to receive either biapenem (300 mg every 12 h) or meropenem (500 mg every 8 h) by intravenous infusion for 7 to 14 days according to their disease severity. The overall clinical efficacy, bacterial eradication rates and drug-related adverse reactions of biapenem and meropenem were analyzed. Results: A total of 272 enrolled cases were included in the intent-to-treat (ITT) analysis and safety analysis. There were no differences in demographics and baseline medical characteristics between biapenem group and meropenem group. The overall clinical efficacies of biapenem and meropenem were not significantly different, 94.70 per cent (125/132) vs. 93.94 per cent (124/132). The overall bacterial eradication rates of biapenem and meropenem showed no significant difference, 96.39 per cent (80/83) vs. 93.75 per cent (75/80). Drug-related adverse reactions were comparable in biapenem and meropenem groups with the incidence of 11.76 per cent (16/136) and 15.44 per cent (21/136), respectively. The most common symptoms of biapenem-related adverse reactions were rash (2.2%) and gastrointestinal distress (1.5%). Interpretation & conclusions: Biapenem was non-inferior to meropenem and was well-tolerated in the treatment of moderate and severe lower respiratory tract infections and UTIs. PMID:24521647

  11. Risk Factors for Pancreatic Neuroendocrine Tumors (PNETs): A Clinic-Based Case-Control study

    PubMed Central

    Halfdanarson, Thorvardur R.; Bamlet, William R.; McWilliams, Robert R; Hobday, Timothy J.; Burch, Patrick A.; Rabe, Kari G.; Petersen, Gloria M.

    2014-01-01

    Objectives Pancreatic neuroendocrine tumors (PNETs) are uncommon, and little is known about their risk factors and association with other cancers. We evaluated whether risk factors known to be associated with pancreatic adenocarcinoma are also associated with PNETs: smoking, alcohol use, family history of PNET and other cancers, and personal history of diabetes as potential risk factors. Methods Patients with PNETs seen at Mayo Clinic Rochester between 2000 and 2011 were compared to controls seen for a general medical evaluation. Patients and controls completed the same questionnaires. After excluding insulinoma and high-grade PNETs, 355 cases were evaluated, and 309 were matched to 602 controls (2:1) on age, sex, and region of residence. Results Personal smoking history was not associated with PNETs. Alcohol use was less common among cases (54% vs. 67%, p<0.001). Cases were more likely to report a family member with sarcoma (p=0.02), PNET (p=0.02), gall bladder cancer (p=0.02), ovarian cancer (p=0.04) and gastric cancer (p=0.01). There was no association with other cancers in family members. Diabetes was more commonly reported by cases than controls (19% vs. 11%, p<0.001). Conclusions With the exception of diabetes, risk factors that are associated with pancreatic adenocarcinoma are not risk factors for PNETs. PMID:25291526

  12. A systematic review of measures used to assess chronic musculoskeletal pain in clinical and randomized controlled clinical trials

    PubMed Central

    Litcher-Kelly, Leighann; Martino, Sharon A.; Broderick, Joan E.; Stone, Arthur A.

    2009-01-01

    There are many types of pain assessments available to researchers conducting clinical trials, ranging from simple, single-item Visual Analog Scale (VAS) questions through extensive, multidimensional inventories. The primary question addressed in this survey of top-tier medical journals was: Which pain assessments are most commonly used in trials? Articles addressing chronic musculoskeletal pain in clinical trials were identified in seven major medical journals for the year 2003. A total of 50 studies (total original research articles reviewed: 1,476) met selection criteria, and from these we identified 28 types of pain assessments. Selected studies were classified according to the dimensions of pain assessed, the type of scale and descriptors/anchors used, and the reporting period specified. The most frequently used assessments were the single-item VAS scale and the Numeric Rating Scale (NRS); multidimensional inventories were used infrequently. There was considerable variability in the instructions patients received about the period to consider when evaluating their pain, and many studies provided only cursory information about their assessments in the methods. Overall, it appears that clinical trials utilize simple measures of pain and that there is no widely accepted standard for clinical pain assessment that would facilitate comparison of outcomes across trials. Perspective This review highlights the heterogeneity of pain outcome measures used and the abundance of single-item measures in clinical trials. While there are many pain outcome measures available to clinical researchers, more consistency in the field should be encouraged so that results between studies can be compared. PMID:17690014

  13. 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. PMID:11460609

  14. Metabolic correction in the management of diabetic peripheral neuropathy: improving clinical results beyond symptom control.

    PubMed

    Miranda-Massari, J R; Gonzalez, M J; Jimenez, F J; Allende-Vigo, M Z; Duconge, J

    2011-11-01

    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, acetyl-L-carnitine, benfotiamine and the combination of active B vitamins L-methylfolate, methylcobalamin and piridoxal-6-phosphate. In addition, we discuss the role of metformin, an important drug in the management of diabetes, and the presence of specific polymorphic genes, in the risk of

  15. Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial

    PubMed Central

    Gaylord, Susan A; Whitehead, William E; Coble, Rebecca S; Faurot, Keturah R; Palsson, Olafur S; Garland, Eric L; Frey, William; Mann, John Douglas

    2009-01-01

    Background Irritable bowel syndrome (IBS), a functional bowel disorder with symptoms of abdominal pain and disturbed defecation experienced by 10% of U.S. adults, results in significant disability, impaired quality of life, and health-care burden. Conventional medical care focusing on pharmacological approaches, diet, and lifestyle management has been partially effective in controlling symptoms. Behavioral treatments, such as cognitive-behavioral therapy and hypnosis, are promising. This paper describes an on-going feasibility study to assess the efficacy of mindfulness training, a behavioral treatment involving directing and sustaining attention to present-moment experience, for the treatment of IBS. Methods/Design The study design involves randomization of adult women with IBS according to Rome II criteria, to either an eight-week mindfulness training group (based on a Mindfulness-based Stress Reduction [MBSR] format) or a previously validated IBS social-support group as an attention-control condition. The primary hypothesis is that, compared to Support Group participants, those in the Mindfulness Program will demonstrate significant improvement in IBS symptoms as measured by the IBS Symptom Severity Scale [1]. Discussion 214 individuals have been screened for eligibility, of whom 148 were eligible for the study. Of those, 87 were enrolled, with 21 withdrawing after having given consent. 66 have completed or are in the process of completing the interventions. It is feasible to undertake a rigorous randomized clinical trial of mindfulness training for people with IBS, using a standardized MBSR protocol adapted for those experiencing IBS, compared to a control social-support group previously utilized in IBS studies. Trial Registration Clinical Trials.gov Identifier: NCT00680693 PMID:19638214

  16. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

    PubMed Central

    Barnes, Thomas Re; Leeson, Verity C; Paton, Carol; Costelloe, Céire; Simon, Judit; Kiss, Noemi; Osborn, David; Killaspy, Helen; Craig, Tom Kj; Lewis, Shôn; Keown, Patrick; Ismail, Shajahan; Crawford, Mike; Baldwin, David; Lewis, Glyn; Geddes, John; Kumar, Manoj; Pathak, Rudresh; Taylor, Simon

    2016-01-01

    BACKGROUND Negative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions. OBJECTIVE To establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia. DESIGN A multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up. SETTING Adult psychiatric services, treating people with schizophrenia. PARTICIPANTS Inpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity. INTERVENTIONS Eligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study. MAIN OUTCOME MEASURES The primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich's Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale. RESULTS No therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference -1.3, 95% confidence interval -2.5 to -0.09). There

  17. Clinical characteristics of patients with motor disability due to conversion disorder: a prospective control group study

    PubMed Central

    Binzer, M.; Andersen, P.; Kullgren, G.

    1997-01-01

    OBJECTIVES—Previous studies have suggested associations between conversion and many different clinical characteristics. This study investigates these findings in a prospective design including a control group.
METHODS—Thirty consecutive patients with a recent onset of motor disability due to a conversion disorder were compared with a control group of patients with corresponding motor symptoms due to a definite organic lesion. Both groups had a similar duration of symptoms and a comparable age and sex profile and were assessed on a prospective basis. Background information about previous somatic and psychiatric disease was collected and all patients were assessed by means of a structured clinical interview linked to the diagnostic system DSM III-R, the Hamilton rating depression scale, and a special life events inventory.
RESULTS—The conversion group had a higher degree of psychopathology with 33% of the patients fulfilling the criteria for psychiatric syndromes according to DSM-III-R axis I, whereas 50% had axis II personality disorders compared with 10% and 17% respectively in the control group. Conversion patients also had significantly higher scores according to the Hamilton rating depression scale. Although patients with known neurological disease were not included in the conversion group, a concomitant somatic disorder was found in 33% of the patients and 50% complained of benign pain. The educational background in conversion patients was poor with only 13% having dropped out of high school compared with 67% in the control group. Self reported global assessment of functioning according to the axis V on DSM IV was significantly lower in conversion patients, who also registered significantly more negative life events before the onset of symptoms than controls. Logistic regression analysis showed that low education, presence of a personality disorder, and high Hamilton depression score were significantly associated with conversion disorder

  18. Improving Motor Control in Walking: A Randomized Clinical Trial in Older Adults with Subclinical Walking Difficulty

    PubMed Central

    Brach, Jennifer S.; Lowry, Kristin; Perera, Subashan; Hornyak, Victoria; Wert, David; Studenski, Stephanie A.; VanSwearingen, Jessie M.

    2016-01-01

    Objective The objective was to test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait. Design Single blinded randomized clinical trial. Setting University research laboratory. Participants Forty older adults 65 years of age and older, with gait speed >1.0 m/s and impaired motor skill (Figure of 8 walk time > 8 secs). Interventions The two interventions included a task-oriented motor learning and a standard exercise program. Both interventions lasted 12 weeks, with twice weekly one hour physical therapist supervised sessions. Main Outcome Measures Two measure of the motor control of gait, gait variability and smoothness of walking, were assessed pre and post intervention by assessors masked to treatment arm. Results Of 40 randomized subjects; 38 completed the trial (mean age 77.1±6.0 years). Motor control group improved more than standard group in double support time variability (0.13 vs. 0.05 m/s; adjusted difference, AD=0.006, p=0.03). Smoothness of walking in the anterior/posterior direction improved more in motor control than standard for all conditions (usual: AD=0.53, p=0.05; narrow: AD=0.56, p=0.01; dual task: AD=0.57, p=0.04). Conclusions Among older adults with subclinical walking difficulty, there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking, while standard exercise does not. Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults, and needs to be evaluated in a definitive larger trial. PMID:25448244

  19. Training Mentors of Clinical and Translational Research Scholars: A Randomized Controlled Trial

    PubMed Central

    Pfund, Christine; House, Stephanie C.; Asquith, Pamela; Fleming, Michael F.; Buhr, Kevin A.; Burnham, Ellen L.; Gilmore, Julie M. Eichenberger; Huskins, W. Charles; McGee, Richard; Schurr, Kathryn; Shapiro, Eugene D.; Spencer, Kimberly C.; Sorkness, Christine A.

    2014-01-01

    Purpose To determine whether a structured mentoring curriculum improves research mentoring skills. Method The authors conducted a randomized controlled trial (RCT) at 16 academic health centers (June 2010 to July 2011). Faculty mentors of trainees who were conducting clinical/translational research ≥50% of the time were eligible. The intervention was an eight-hour, case-based curriculum focused on six mentoring competencies. The primary outcome was the change in mentors’ self-reported pretest to posttest composite scores on the Mentoring Competency Assessment (MCA). Secondary outcomes included changes in the following: mentors’ awareness as measured by their self-reported retrospective change in MCA scores, mentees’ ratings of their mentors’ competency as measured by MCA scores, and mentoring behaviors as reported by mentors and their mentees. Results A total of 283 mentor–mentee pairs were enrolled: 144 mentors were randomized to the intervention; 139 to the control condition. Self-reported pre-/posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls (P < .001). Retrospective changes in MCA composite scores between the two groups were even greater, and extended to all six subscale scores (P < .001). More intervention-group mentors reported changes in their mentoring practices than control mentors (P < .001). Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre-/posttest scores (P = .003) and more changes in their mentors’ behavior (P = .002) than those paired with control mentors. Conclusions This RCT demonstrates that a competency-based research mentor training program can improve mentors’ skills. PMID:24667509

  20. 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. PMID:25866680

  1. [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. PMID:26610367

  2. [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. PMID:19462604

  3. 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

  4. 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

  5. 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

  6. 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

  7. Neuronal LR11 expression does not differentiate between clinically-defined Alzheimer's disease and control brains.

    PubMed

    Sager, Kristen L; Wuu, Joanne; Herskowitz, Jeremy H; Mufson, Elliott J; Levey, Allan I; Lah, James J

    2012-01-01

    Alzheimer's disease (AD) is the leading cause of dementia in the elderly. Because the pathological changes underlying this disease can begin decades prior to the onset of cognitive impairment, identifying the earliest events in the AD pathological cascade has critical implications for both the diagnosis and treatment of this disease. We previously reported that compared to autopsy confirmed healthy control brain, expression of LR11 (or SorLA) is markedly reduced in AD brain as well as in a subset of people with mild cognitive impairment (MCI), a prodromal clinical stage of AD. Recent studies of the LR11 gene SORL1 have suggested that the association between SORL1 single nucleotide polymorphisms (SNPs) and AD risk may not be universal. Therefore, we sought to confirm our earlier findings in a population chosen solely based on clinical criteria, as in most genetic studies. Quantitative immunohistochemistry was used to measure LR11 expression in 43 cases from the Religious Orders Study that were chosen based on a final pre-mortem clinical diagnosis of MCI, mild/moderate AD or no cognitive impairment (NCI). LR11 expression was highly variable in all three diagnostic groups, with no significant group differences. Low LR11 cases were identified using the lowest tertile of LR11 expression observed across all cases as a threshold. Contrary to previous reports, low LR11 expression was found in only 29% of AD cases. A similar proportion of both the MCI and NCI cases also displayed low LR11 expression. AD-associated lesions were present in the majority of cases regardless of diagnostic group, although we found no association between LR11 levels and pathological variables. These findings suggest that the relationship between LR11 expression and the development of AD may be more complicated than originally believed. PMID:22927900

  8. Two randomized controlled clinical trials to study the effectiveness of prednisolone treatment in preventing and restoring clinical nerve function loss in leprosy: the TENLEP study protocols

    PubMed Central

    2012-01-01

    Background Nerve damage in leprosy often causes disabilities and deformities. Prednisolone is used to treat nerve function impairment (NFI). However, optimal dose and duration of prednisolone treatment has not been established yet. Besides treating existing NFI it would be desirable to prevent NFI. Studies show that before NFI is clinically detectable, nerves often show subclinical damage. Within the ‘Treatment of Early Neuropathy in LEProsy’ (TENLEP) study two double blind randomized controlled trials (RCT) will be carried out: a trial to establish whether prednisolone treatment of 32 weeks duration is more effective than 20 weeks in restoring nerve function in leprosy patients with clinical NFI (Clinical trial) and a trial to determine whether prednisolone treatment of early sub-clinical NFI can prevent clinical NFI (Subclinical trial). Methods Two RCTs with a follow up of 18 months will be conducted in six centers in Asia. In the Clinical trial leprosy patients with recent (< 6 months) clinical NFI, as determined by Monofilament Test and Voluntary Muscle Test, are included. The primary outcomes are the proportion of patients with restored or improved nerve function. In the Subclinical trial leprosy patients with subclinical neuropathy, as determined by Nerve Conduction Studies (NCS) and/or Warm Detection Threshold (WDT), and without any clinical signs of NFI are randomly allocated to a placebo group or treatment group receiving 20 weeks prednisolone. The primary outcome is the proportion of patients developing clinical NFI. Reliability and normative studies are carried out before the start of the trial. Discussion This study is the first RCT testing a prednisolone regimen with a duration longer than 24 weeks. Also it is the first RCT assessing the effect of prednisolone in the prevention of clinical NFI in patients with established subclinical neuropathy. The TENLEP study will add to the current understanding of neuropathy due to leprosy and provide insight

  9. Trichophyton tonsurans infection in Japan: epidemiology, clinical features, diagnosis and infection control.

    PubMed

    Hiruma, Junichiro; Ogawa, Yumi; Hiruma, Masataro

    2015-03-01

    In this review, we summarize the status of Trichophyton tonsurans infection in Japan in terms of epidemiology, clinical features, diagnosis and infection control. Since approximately 2000, outbreaks of T. tonsurans infections among combat sports club members have been reported frequently, with the infection then spreading to their friends and family members. The most common clinical features of T. tonsurans infection are tinea corporis, which is difficult to differentiate from eczema, and tinea capitis. Tinea capitis is classified as the seborrheic form, kerion celsi form or "black dot" form, although 90% or more of patients are asymptomatic carriers. The diagnosis of symptomatic T. tonsurans infection is established by potassium hydroxide examination and fungal culture. However, because there are many asymptomatic carriers of T. tonsurans infection, tests using the hairbrush culture method are necessary. An increase in asymptomatic carriers of T. tonsurans makes assessment of the current prevalence of the infection challenging and underscores the importance of educational efforts and public awareness campaigns to prevent T. tonsurans epidemics. PMID:25736317

  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. Optimal control-based bayesian detection of clinical and behavioral state transitions.

    PubMed

    Santaniello, Sabato; Sherman, David L; Thakor, Nitish V; Eskandar, Emad N; Sarma, Sridevi V

    2012-09-01

    Accurately detecting hidden clinical or behavioral states from sequential measurements is an emerging topic in neuroscience and medicine, which may dramatically impact neural prosthetics, brain-computer interface and drug delivery. For example, early detection of an epileptic seizure from sequential electroencephalographic (EEG) measurements would allow timely administration of anticonvulsant drugs or neurostimulation, thus reducing physical impairment and risks of overtreatment. We develop a Bayesian paradigm for state transition detection that combines optimal control and Markov processes. We define a hidden Markov model of the state evolution and develop a detection policy that minimizes a loss function of both probability of false positives and accuracy (i.e., lag between estimated and actual transition time). Our strategy automatically adapts to each newly acquired measurement based on the state evolution model and the relative loss for false positives and accuracy, thus resulting in a time varying threshold policy. The paradigm was used in two applications: 1) detection of movement onset (behavioral state) from subthalamic single unit recordings in Parkinson's disease patients performing a motor task; 2) early detection of an approaching seizure (clinical state) from multichannel intracranial EEG recordings in rodents treated with pentylenetetrazol chemoconvulsant. Our paradigm performs significantly better than chance and improves over widely used detection algorithms. PMID:22893447

  12. 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.

  13. 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

  14. Phytopharmaceutical treatment of anxiety, depression, and dementia in the elderly: evidence from randomized, controlled clinical trials.

    PubMed

    Kasper, Siegfried

    2015-06-01

    Based on subgroup analyses of randomized, controlled clinical trials, we review the efficacy of three phytopharmaceutical drugs, respectively of the corresponding active substances silexan® (WS® 1265, lavender oil) in anxiety disorders, WS® 5570 (Hypericum extract) in major depression, and EGb 761® (Ginkgo biloba extract) in Alzheimer, vascular, or mixed type dementia, in elderly patients aged ≥ 60 years. Four trials were eligible in each indication. Meta-analyses and analyses based on pooled raw data showed that the three drugs were significantly superior to placebo in the elderly subset, and that their treatment effects reflected in the main outcome measures (Hamilton Anxiety scale, Hamilton Depression scale, Neuropsychiatric Inventory) were comparable with those observed in the original trials without age restrictions. The results confirm the efficacy of the three herbal active substances in elderly patients of ≥ 60 years of age. In anxiety, depression, and dementia, they thus represent efficacious and well-tolerated alternatives to synthetic drugs. PMID:26092515

  15. 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

  16. 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

  17. 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

  18. Clinical manifestations of primary hyperparathyroidism before and after parathyroidectomy. A case-control study.

    PubMed Central

    Chan, A K; Duh, Q Y; Katz, M H; Siperstein, A E; Clark, O H

    1995-01-01

    BACKGROUND: There has been an National Institutes of Health consensus meeting concerning the management of patients with "asymptomatic" primary hyperparathyroidism, yet there is no clear definition of this condition. The authors, therefore, documented the clinical manifestations and frequencies of these manifestations in unselected patients with primary hyperparathyroidism and determined whether these clinical manifestations resolved after parathyroidectomy. METHOD: The authors studied 152 unselected consecutive patients with primary hyperparathyroidism and 132 control patients with nontoxic thyroid disorders who were treated by parathyroidectomy or thyroidectomy, respectively, between January 1986 and June 1991. All patients received a questionnaire during their initial office visits and the same questionnaire again after their operations. Patients were also questioned about their perception of the success of the operation. Eighty percent of the parathyroid patients and 70.5% of the thyroid patients completed the questionnaires, and the mean follow-up time was 20 months. RESULTS: Only 7 (4.6%) patients with primary hyperparathyroidism had no symptoms, and 26 (17.1%) had no associated conditions despite 74.3% of these patients having serum calcium levels less than 12 mg/dL. Symptoms including fatigue, exhaustion, weakness, polydipsia, polyuria, nocturia, joint pain, bone pain, constipation, depression, anorexia, nausea, heartburn, and associated conditions, including nephrolithiasis, and hematuria occurred more often in patients with primary hyperparathyroidism than in the thyroid control patients (p < 0.05). After parathyroidectomy, only eight (5.3%) patients failed to have any improvement in symptoms or associated conditions. Fifty-seven percent of the parathyroid patients versus 30% of the thyroid patients felt better overall after the operation, strength subjectively improved in 29% of parathyroid patients versus 13% in thyroid patients; thirty-seven percent of

  19. Statistical Versus Clinical Significance for Infants with Brain Injury: Reanalysis of Outcome Data from a Randomized Controlled Study

    PubMed Central

    Badr, Lina Kurdahi

    2009-01-01

    By adopting more appropriate statistical methods to appraise data from a previously published randomized controlled trial (RCT), we evaluated the statistical and clinical significance of an intervention on the 18 month neurodevelopmental outcome of infants with suspected brain injury. The intervention group (n =32) received extensive, individualized cognitive/sensorimotor stimulation by public health nurses (PHNs) while the control group (n = 30) received standard follow-up care. At 18 months 43 infants remained in the study (22 = intervention, 21 = control). The results indicate that there was a significant statistical change within groups and a clinical significance whereby more infants in the intervention group improved in mental, motor and neurological functioning at 18 months compared to the control group. The benefits of looking at clinical significance from a meaningful aspect for practitioners are emphasized. PMID:19276403

  20. Level of control among patients with type 2 diabetes mellitus attending diabetic clinic under family medicine compared to diabetic clinic under endocrinology

    PubMed Central

    AlHabdan, Mohammed A; AlAteeq, Mohammed A; AlJurbou, Fiasal I

    2016-01-01

    Objectives To assess and compare level of control among patients with type 2 diabetes mellitus attending diabetic clinic under family medicine service and patients attending diabetic clinics under endocrinology service, and to explore the effect of different variables on the level of control in both groups. Methods Retrospective cross-sectional study by reviewing medical records of patients with type 2 diabetes mellitus and laboratory studies from Hospital Information System at King Abdul-Aziz Medical City, National Guard, Riyadh – Saudi Arabia using predesigned sheet for data collection. Results Among 352 patients enrolled in the study, 176 (50%) patients were from the family medicine setting and 176 (50%) patients were from the hospital setting. The mean glycosylated hemoglobin for the whole study population was 8.97±1.87. There was no significant difference between the two groups in regard to level of control (9.01±1.75 in the family medicine setting compared to 8.93±1.98 in the hospital setting). No significant correlation was found between level of control and age, duration of disease and number of follow-up visits in both settings. Conclusion Patients with type 2 diabetes mellitus in this study were found to be poorly controlled in both the settings, diabetic clinic under family medicine and diabetic clinic under endocrinology. More research should be done to explore quality of care in a family medicine setting for patients with type 2 diabetes mellitus, as such a setting is expected to be more accessible, more convenient, and more cost effective to patients. PMID:27143944

  1. [Clinical randomized controlled trials of acupoint catgut-embedding for simple obesity: a meta-analysis].

    PubMed

    Liao, Jian-Qiong; Song, Xiang; Chen, Ying; Liang, Li-Chang; Wang, Sheng-Xu

    2014-06-01

    The clinical therapeutic effect of acupoint catgut-embedding for simple obesity was systemically analyzed to provide reference and assistance for its clinical treatment and research. By searching in the CBM, CNKI, VIP, Wanfang, Pubmed, Springer and Medline databases, clinical randomized controlled trials (RCT) of acupoint catgut-embedding for simple obesity published from Jan, 2009 to July, 2013 were collected while Revman 5. 2 software was applied to perform the Meta-analysis. Totally 19 articles were acquired with 1 658 cases involved. The effective rate was selected as primary outcome measure in 19 articles. The Meta-analysis was performed among homogeneous researches. The results indicated that compared with other therapies, pooled OR of acupoint catgut-embedding was 2.45 with 95% CI [1.81, 3.32]; in the test for overall effect, Z = 5.81, implying the efficacy difference of two therapies was significant in the treatment of simple obesity (P < 0.01). In subgroups analysis, in the event of treatment session with more than 3 months, compared with other therapies, pooled OR of acupoint catgut-embedding was 2.61 with 95% CI [1.53, 4.46]; in test for overall effect, Z = 3.51, implying the efficacy difference of two therapies was significant in the treatment of simple obesity (P < 0.01); in the event of treatment session with less than 3 months, compared with other therapies, pooled OR of acupoint catgut-embedding was 2.38 with 95% CI [1.65, 3.44]; in test for overall effect, Z = 4.46, implying in the treatment of simple obesity the efficacy difference of two therapies was significant (P < 0.01). Compared with electroacupuncture, OR of acupoint catgut-embedding was 1.79, 95% CI [1.08, 2.95] (P = 0.02). Compared with acupuncture, OR of acupoint catgut-embedding was 1.89, 95% CI [1.16, 3.09] (P = 0.01), which explained that compared with electroacupuncture and acupuncture, the efficacy of acupoint catgut-embedding was significantly different. In a word, the clinical

  2. 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

  3. 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

  4. The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

    PubMed Central

    2010-01-01

    Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601 PMID:20487567

  5. Effect of olive oil massage on weight gain in preterm infants: A randomized controlled clinical trial

    PubMed Central

    Jabraeile, Mahnaz; Rasooly, Alehe Seyyed; Farshi, Mahni Rahkar; Malakouti, Jamileh

    2016-01-01

    Background: Despite the fact that effect of massage with or without oil on the baby's weight gain is not clear, but recent studies have shown that massage with essential oils make lipid absorption through the skin. The aim of this study was to evaluate the effect of olive oil massage on weight gain in preterm infants. Materials and Methods: This study was a single-blind, randomized controlled clinical trial. In this study, infants who met inclusion criteria for the study were divided into two groups by using random numbers table. Newborns in intervention group were under massage for 10 days and 3 times for 15 min daily; the mother of these newborns had been trained already using olive oil. Moreover, the infants of the control group were under massaging without oil same as the above-mentioned method. Researchers weighed babies daily during 10 days and recorded it at the checklist. Data from the study were reviewed and analyzed by descriptive statistics and repeated measure test using the statistical software SPSS/13. Results: This study showed that the neonatal weight gain in the infants with the oil massage was 21 g daily in average, whereas the increase in infant massage without oil was 7 g. This difference was statistically significant (P < 0.001). Conclusion: Considering the positive effect of infant massage on weight gain in premature infants with olive oil, it is recommended that nurses use oil in infant massage in the neonatal units. PMID:27397955

  6. 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

  7. Physical and psychological sequelae to torture. A controlled clinical study of exiled asylum applicants.

    PubMed

    Hougen, H P

    1988-10-01

    The study comprised 24 male Lebanese refugees living in Denmark. Twelve of them alleged having been tortured in Lebanon during the period 1981-85. The remaining twelve had neither been imprisoned nor tortured and thus acted as control persons. All the testimonies were found to be valid according to a method previously used by the author. The most common forms of torture were blows against the head, body and foot soles, suspension and asphyxiation. Threats and solitary confinement were frequent, and sexual violations were also reported. At the time of examination (March-November 1986), the main complaints were headaches, various cardiopulmonary symptoms, sleep disturbances with nightmares, impaired concentration and memory, and emotional lability. Suicide attempts were reported. Prior to the torture all the probands had been healthy except for several cases of gunshot wounds. The clinical examination revealed different scars possibly related to torture in nearly all the cases. Missing or fractured teeth, peripheral nerve damage and mental depression were also found. The 12 controls had several mental and physical complaints, but significantly fewer than the probands. Almost all of them had scars from gunshot wounds. The present study clearly indicates that torture plus exilation has a more deteriorating effect on the health status than exilation alone. PMID:3209147

  8. 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

  9. Comparison of Ondansetron and Meperidine for Treatment of Postoperative Shivering: A Randomized Controlled Clinical Trial

    PubMed Central

    Mahoori, Alireza; Noroozinia, Heydar; Hasani, Ebrahim; Soltanahmadi, Maryam

    2014-01-01

    Background: The involved neurotransmitter pathways in the postoperative shivering (POS) are poorly understood. Recently, 5-hydroxytryptamine 3 (5-HT3) receptor antagonists have been reported to prevent POS. We investigated the effect of ondansetron, a 5-HT3 antagonist that is used to treat postoperative nausea and vomiting, on shivering. Objectives: This study aimed to compare the efficacy of ondansetron and meperidine in the treatment of shivering after general anesthesia. Patients and Methods: In this double-blinded randomized clinical trial, 83 patients (age range, 18-60 years) who had shivering after general anesthesia were randomly allocated to any of these three groups: Group A, (number = 27) received 4 mg of intravenous ondansetron, Group B, (number = 27) received 8 mg of intravenous ondansetron, and Group C, (number = 29) received 0.4 mg/kg of intravenous meperidine at recovery room. The surface temperatures and the incidence as well as intensity of shivering were recorded. Results: Shivering was controlled in 16 patients (59%) in Group A, 22 (81%) in Group B, and 25 (86%) in Group C (P = 0.01). Within each group, there were no significant differences among the surface temperature in recovery room. Patients in groups A and B had significantly lower incidence of nausea and vomiting than group C (P = 0.01). Conclusions: Ondansetron and meperidine have similar effects on shivering. We concluded that 8 mg of intravenous ondansetron can control shivering and this is the dose of choice, especially in patients with POS with nausea and vomiting. PMID:25389473

  10. 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

  11. Effects of Normobaric Hyperoxia in Traumatic Brain Injury: A Randomized Controlled Clinical Trial

    PubMed Central

    Taher, Abbas; Pilehvari, Zahra; Poorolajal, Jalal; Aghajanloo, Mashhood

    2016-01-01

    Background Traumatic brain injury (TBI) is one of the important causes of morbidity and mortality throughout the world, especially in young people. In recent years normobaric hyperoxia has become an important and useful step for recovery and improvement of outcome in TBI. Objectives The purpose of this study was to evaluate the effects of normobaric hyperoxia on clinical neurological outcomes of patients with severe traumatic brain injuries. We used the Glasgow outcome scale (GOS), barthel index, and modified rankin scale (mRS) to measure the outcomes of patients with TBI. Patients and Methods Sixty-eight consecutive patients with severe TBI (mean Glasgow coma scale [GCS] score: 7.4) who met the inclusion criteria were entered in this randomized controlled clinical trial. The patients were randomized into two groups, as follows: 1) experimental: received 80% oxygen via mechanical ventilator in the first 6 hours of admission, 2) control: received 50% oxygen by mechanical ventilator in the first 6 hours of admission and then standard medical care. We measured the GOS, Barthel Index, and mRS at the time of discharge from hospital and reassessed these measurements at the 6-month follow-up after injury. Results According to our study, there were no significant sex or age differences between the two groups (P = 0.595 and 0.074). The number of days in the intensive care unit (ICU) in the control group and experimental group were 11.4 and 9.4 days, respectively (P = 0.28), while the numbers of days of general ward admission were 13.9 and 11.4 days (P = 0.137) respectively. The status of GOS at time of discharge were severe = 13 and 10, moderate = 16 and 19, and low = 5 and 5 in the control and experimental groups, respectively (P = 0.723); 6 months after injury, the scores were as follows: moderate = 16 and 9, low = 15 and 25, and severe = 3 and 0 (P = 0.024). The Barthel index scores in the control and experimental groups were 59.7 and 63.9 at time of discharge (P = 0

  12. 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

  13. 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

  14. A comparison between screened NIMH and clinically interviewed control samples on neuroticism and extraversion

    PubMed Central

    Talati, A; Fyer, AJ; Weissman, MM

    2010-01-01

    The National Institute of Mental Health (NIMH) has supported the collection of DNA samples on over 4000 subjects for use primarily as controls in psychiatric genetic studies. These subjects, though screened online, were not directly interviewed or assessed on family history. We compared this sample to one that was directly interviewed using structured diagnostic assessments on comparable measures of neuroticism and extraversion. The screened sample completed an online self-report based on the Composite International Diagnostic Instrument Short-Form (CIDI-SF). The interviewed sample was assessed by clinically trained personnel using the Schedule for Affective Disorders and Schizophrenia (SADS-LA-IV) and Family History Screen; final diagnoses were made blind to trait scores by a clinician using the best-estimate procedure. Neuroticism and extraversion were assessed on the NEO five-factor inventory (NEO-FFI) and the revised Eysenck Personality Questionnaire short form (EPQ-R). We found that subjects in the NIMH-screened sample who did not report any psychiatric symptoms on the self-report were indistinguishable from interviewed diagnosis free and family history negative controls on neuroticism and extraversion. Subjects in the screened sample who screened positive for anxiety disorders, however, deviated significantly on these measures both from the screened subjects with no self-reported symptoms, as well as from subjects in the interviewed sample diagnosed with comparable disorders. These findings suggest that control groups generated from the NIMH sample should ideally be restricted to subjects free of any self-reported symptoms, regardless of the disorder being addressed, in order to maximize their reflection of diagnosis-free populations. PMID:17938631

  15. Quality Control Methods for Optimal BCR-ABL1 Clinical Testing in Human Whole Blood Samples

    PubMed Central

    Stanoszek, Lauren M.; Crawford, Erin L.; Blomquist, Thomas M.; Warns, Jessica A.; Willey, Paige F.S.; Willey, James C.

    2014-01-01

    Reliable breakpoint cluster region (BCR)–Abelson (ABL) 1 measurement is essential for optimal management of chronic myelogenous leukemia. There is a need to optimize quality control, sensitivity, and reliability of methods used to measure a major molecular response and/or treatment failure. The effects of room temperature storage time, different primers, and RNA input in the reverse transcription (RT) reaction on BCR-ABL1 and β-glucuronidase (GUSB) cDNA yield were assessed in whole blood samples mixed with K562 cells. BCR-ABL1 was measured relative to GUSB to control for sample loading, and each gene was measured relative to known numbers of respective internal standard molecules to control for variation in quality and quantity of reagents, thermal cycler conditions, and presence of PCR inhibitors. Clinical sample and reference material measurements with this test were concordant with results reported by other laboratories. BCR-ABL1 per 103 GUSB values were significantly reduced (P = 0.004) after 48-hour storage. Gene-specific primers yielded more BCR-ABL1 cDNA than random hexamers at each RNA input. In addition, increasing RNA inhibited the RT reaction with random hexamers but not with gene-specific primers. Consequently, the yield of BCR-ABL1 was higher with gene-specific RT primers at all RNA inputs tested, increasing to as much as 158-fold. We conclude that optimal measurement of BCR-ABL1 per 103 GUSB in whole blood is obtained when gene-specific primers are used in RT and samples are analyzed within 24 hours after blood collection. PMID:23541592

  16. Controlled clinical trial of selective decontamination for the treatment of severe acute pancreatitis.

    PubMed Central

    Luiten, E J; Hop, W C; Lange, J F; Bruining, H A

    1995-01-01

    OBJECTIVE: A randomized, controlled, multicenter trial was undertaken in 102 patients with objective evidence of severe acute pancreatitis to evaluate whether selective decontamination reduces mortality. SUMMARY BACKGROUND DATA: Secondary pancreatic infection is the major cause of death in patients with acute necrotizing pancreatitis. Controlled clinical trials to study the effect of selective decontamination in such patients are not available. METHODS: Between April 22, 1990 and April 19, 1993, 102 patients with severe acute pancreatitis were admitted to 16 participating hospitals. Patients were entered into the study if severe acute pancreatitis was indicated, on admission, by multiple laboratory criteria (Imrie score > or = 3) and/or computed tomography criteria (Balthazar grade D or E). Patients were randomly assigned to receive standard treatment (control group) or standard treatment plus selective decontamination (norfloxacin, colistin, amphotericin; selective decontamination group). All patients received full supportive treatment, and surveillance cultures were taken in both groups. RESULTS: Fifty patients were assigned to the selective decontamination group and 52 were assigned to the control group. There were 18 deaths in the control group (35%), compared with 11 deaths (22%) in the selective decontamination group (adjusted for Imrie score and Balthazar grade: p = 0.048). This difference was mainly caused by a reduction of late mortality (> 2 weeks) due to significant reduction of gram-negative pancreatic infection (p = 0.003). The average number of laparotomies per patient was reduced in patients treated with selective decontamination (p < 0.05). Failure of selective decontamination to prevent secondary gram-negative pancreatic infection with subsequent death was seen in only three patients (6%) and transient gram-negative pancreatic infection was seen in one (2%). In both groups of patients, all gram-negative aerobic pancreatic infection was preceded by

  17. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for ‘point of care’ management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. Design/methods We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma—the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis—the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will

  18. Robust meta-analytic-predictive priors in clinical trials with historical control information.

    PubMed

    Schmidli, Heinz; Gsteiger, Sandro; Roychoudhury, Satrajit; O'Hagan, Anthony; Spiegelhalter, David; Neuenschwander, Beat

    2014-12-01

    Historical information is always relevant for clinical trial design. Additionally, if incorporated in the analysis of a new trial, historical data allow to reduce the number of subjects. This decreases costs and trial duration, facilitates recruitment, and may be more ethical. Yet, under prior-data conflict, a too optimistic use of historical data may be inappropriate. We address this challenge by deriving a Bayesian meta-analytic-predictive prior from historical data, which is then combined with the new data. This prospective approach is equivalent to a meta-analytic-combined analysis of historical and new data if parameters are exchangeable across trials. The prospective Bayesian version requires a good approximation of the meta-analytic-predictive prior, which is not available analytically. We propose two- or three-component mixtures of standard priors, which allow for good approximations and, for the one-parameter exponential family, straightforward posterior calculations. Moreover, since one of the mixture components is usually vague, mixture priors will often be heavy-tailed and therefore robust. Further robustness and a more rapid reaction to prior-data conflicts can be achieved by adding an extra weakly-informative mixture component. Use of historical prior information is particularly attractive for adaptive trials, as the randomization ratio can then be changed in case of prior-data conflict. Both frequentist operating characteristics and posterior summaries for various data scenarios show that these designs have desirable properties. We illustrate the methodology for a phase II proof-of-concept trial with historical controls from four studies. Robust meta-analytic-predictive priors alleviate prior-data conflicts ' they should encourage better and more frequent use of historical data in clinical trials. PMID:25355546

  19. 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

  20. 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

  1. Automatic quality control in clinical (1) H MRSI of brain cancer.

    PubMed

    Pedrosa de Barros, Nuno; McKinley, Richard; Knecht, Urspeter; Wiest, Roland; Slotboom, Johannes

    2016-05-01

    MRSI grids frequently show spectra with poor quality, mainly because of the high sensitivity of MRS to field inhomogeneities. These poor quality spectra are prone to quantification and/or interpretation errors that can have a significant impact on the clinical use of spectroscopic data. Therefore, quality control of the spectra should always precede their clinical use. When performed manually, quality assessment of MRSI spectra is not only a tedious and time-consuming task, but is also affected by human subjectivity. Consequently, automatic, fast and reliable methods for spectral quality assessment are of utmost interest. In this article, we present a new random forest-based method for automatic quality assessment of (1) H MRSI brain spectra, which uses a new set of MRS signal features. The random forest classifier was trained on spectra from 40 MRSI grids that were classified as acceptable or non-acceptable by two expert spectroscopists. To account for the effects of intra-rater reliability, each spectrum was rated for quality three times by each rater. The automatic method classified these spectra with an area under the curve (AUC) of 0.976. Furthermore, in the subset of spectra containing only the cases that were classified every time in the same way by the spectroscopists, an AUC of 0.998 was obtained. Feature importance for the classification was also evaluated. Frequency domain skewness and kurtosis, as well as time domain signal-to-noise ratios (SNRs) in the ranges 50-75 ms and 75-100 ms, were the most important features. Given that the method is able to assess a whole MRSI grid faster than a spectroscopist (approximately 3 s versus approximately 3 min), and without loss of accuracy (agreement between classifier trained with just one session and any of the other labelling sessions, 89.88%; agreement between any two labelling sessions, 89.03%), the authors suggest its implementation in the clinical routine. The method presented in this article was implemented

  2. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial

    PubMed Central

    Hill, Jacqueline J; Gask, Linda; Lovell, Karina; Chew-Graham, Carolyn; Bower, Peter; Cape, John; Pilling, Stephen; Araya, Ricardo; Kessler, David; Bland, J Martin; Green, Colin; Gilbody, Simon; Lewis, Glyn; Manning, Chris; Hughes-Morley, Adwoa; Barkham, Michael

    2013-01-01

    Objective To compare the clinical effectiveness of collaborative care with usual care in the management of patients with moderate to severe depression. Design Cluster randomised controlled trial. Setting 51 primary care practices in three primary care districts in the United Kingdom. Participants 581 adults aged 18 years and older who met ICD-10 (international classification of diseases, 10th revision) criteria for a depressive episode on the revised Clinical Interview Schedule. We excluded acutely suicidal patients and those with psychosis, or with type I or type II bipolar disorder; patients whose low mood was associated with bereavement or whose primary presenting problem was alcohol or drug abuse; and patients receiving psychological treatment for their depression by specialist mental health services. We identified potentially eligible participants by searching computerised case records in general practices for patients with depression. Interventions Collaborative care, including depression education, drug management, behavioural activation, relapse prevention, and primary care liaison, was delivered by care managers. Collaborative care involved six to 12 contacts with participants over 14 weeks, supervised by mental health specialists. Usual care was family doctors’ standard clinical practice. Main outcome measures Depression symptoms (patient health questionnaire 9; PHQ-9), anxiety (generalised anxiety disorder 7; GAD-7), and quality of life (short form 36 questionnaire; SF-36) at four and 12 months; satisfaction with service quality (client satisfaction questionnaire; CSQ-8) at four months. Results 276 participants were allocated to collaborative care and 305 allocated to usual care. At four months, mean depression score was 11.1 (standard deviation 7.3) for the collaborative care group and 12.7 (6.8) for the usual care group. After adjustment for baseline depression, mean depression score was 1.33 PHQ-9 points lower (95% confidence interval 0.35 to 2

  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. PMID:8073244

  4. 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

  5. The Clinical Learning Environment Review as a model for impactful self-directed quality control initiatives in Clinical Practice.

    PubMed

    Saul, Kenneth; Casamiquela, Kathleen; McCowan, Nancye; Jackson, Jeremy D; Brodell, Robert T

    2016-02-01

    The Clinical Learning Environment Review (CLER) program was designed to assess the learning environment in residencies and fellowships accredited by the Accreditation Council for Graduate Medical Education (ACGME). The program's focus is preventing harm to patients. This effort was purposely separated from the residency survey process so that training programs would be open to identifying and preventing errors without fear of jeopardizing their accreditation status. In our dermatology residency program, we established a resident-centered project for quality assessment/quality improvement (QA/QI). We identified areas of potential patient harm, designed methods to quantifiably assess the problems, and developed focused and cost-effective initiatives to improve patient safety. A new initiative was presented at each monthly faculty meeting. This project jump-started QA/QI efforts in our department and has improved patient safety. Our QA/QI project also has enhanced resident/faculty communication and provided trainees with experience in designing QA/QI efforts. It could serve as a model for postresidency efforts to prevent patient harm. PMID:26919498

  6. 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

  7. Bactercline®-coated implants: Clinical results up to 1 year after loading from a controlled clinical trial

    PubMed Central

    Carinci, Francesco; Grecchi, Emma; Bignozzi, Carlo Alberto; Murmura, Giovanna; Piattelli, Adriano; Scarano, Antonio

    2012-01-01

    Background: Titanium dioxide exists in three different crystal lattices, anatase, rutile, and brookite. Anatase coating releases, under ultraviolet (UV) irradiation, free radicals such as ·OH, O2-, HO2-, and H2O2. This potent oxidizing power characteristically results in the lysis of bacteria and other organic substances. The purpose of this study was to evaluate the bone response to implants made of titanium alloy or coated with a new combination of anatase and Bactercline® product. Materials and Methods: In the period between July 2009 and June 2010, 26 patients (10 females and 16 males; median age 51 ± 11 years, min. 27 years, max. 72 years) were operated and 62 implants were inserted. Lost fixtures and peri-implant bone resorption were considered as predictors of clinical outcomes. Pearson χ2-test was used. Prosthesis and implant failures, any complications after loading, and peri-implant marginal bone-level changes were assessed by a masked assessor. All patients were followed up to 1 year after loading. Results: No implant was lost. Average bone resorption around implant was 0.33 mm (both for 25 standard and 37 Bactercline-coated implants), and thus no statistical difference was detected. Conclusion: These results shown that no adverse effects on osseo-integration were present. PMID:23814572

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. The psychological profile of parents who volunteer their children for clinical research: a controlled study.

    PubMed

    Harth, S C; Johnstone, R R; Thong, Y H

    1992-06-01

    Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects. PMID:1619628

  14. The psychological profile of parents who volunteer their children for clinical research: a controlled study.

    PubMed Central

    Harth, S C; Johnstone, R R; Thong, Y H

    1992-01-01

    Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects. PMID:1619628

  15. 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

  16. Noninvasive control of dental caries in children with active initial lesions. A randomized clinical trial.

    PubMed

    Hausen, H; Seppa, L; Poutanen, R; Niinimaa, A; Lahti, S; Kärkkäinen, S; Pietilä, I

    2007-01-01

    The aim of this study was to investigate whether DMFS increment can be decreased among children with active initial caries by oral hygiene and dietary counseling and by using noninvasive preventive measures. Except for mentally disabled and handicapped children attending special schools, all 11- to 12-year-olds in Pori, Finland, with at least one active initial caries lesion were invited to participate in the study and were then randomized into two groups. Children in the experimental group (n = 250) were offered an individually designed patient-centered preventive program aimed at identifying and eliminating factors that had led to the presence of active caries. The program included counseling sessions with emphasis on enhancing use of the children's own resources in everyday life. Toothbrushes, fluoride toothpaste and fluoride and xylitol lozenges were distributed to the children. They also received applications of fluoride/chlorhexidine varnish. The children in the control group (n = 247) received basic prevention offered as standard in the public dental clinics in Pori. For both groups, the average follow-up period was 3.4 years. A community level program of oral health promotion was run in Pori throughout this period. Mean DMFS increments for the experimental and control groups were 2.56 (95% CI 2.07, 3.05) and 4.60 (3.99, 5.21), respectively (p < 0.0001): prevented fraction 44.3% (30.2%, 56.4%). The results show that by using a regimen that includes multiple measures for preventing dental decay, caries increment can be significantly reduced among caries-active children living in an area where the overall level of caries experience is low. PMID:17713339

  17. Controlled test and clinical evaluation of dienbendazole against naturally acquired gastrointestinal parasites in ponies.

    PubMed

    Bello, T R

    1989-11-01

    A controlled test was performed to titrate the anthelmintic dosage of dienbendazole in 24 mixed-breed ponies naturally infected with Strongylus vulgaris, S edentatus, and small strongyle species, as determined by parasitic egg and larval counts in feces. Comparison of results of treatment was made among 3 dienbendazole dosages--2.5, 5, and 10 mg/kg of body weight--and a gum (excipient) mixture given by nasogastric intubation. All ponies were euthanatized and necropsied at 7 or 8 days after treatment. Trichostrongylus axei, Habronema muscae, S vulgaris, S edentatus, small strongyles, and Oxyuris equi were efficaciously eliminated in response to all doses of dienbendazole; Gasterophilus spp were not affected by any dose. There were not sufficient numbers of Draschia megastoma, Anoplocephala spp, or Parascaris equorum in the ponies to evaluate drug effect. Changes in the appearance of the intestinal lining were dose-dependent; in the ponies treated with 5 and 10 mg of dienbendazole/kg, the mucosa appeared clean and smooth, though in ponies given 2.5 mg/kg, it appeared clean, but was nodular and moderately reactive to embedded immature small strongyles. In the gum mixture-treated ponies, the large intestinal mucosa was inflamed, with edematous areas, in response to infections caused by large and small strongyles. A limited clinical titration was done in 12 ponies that were fecal culture negative for S vulgaris larvae, although other strongyles were detected. Two ponies in each of 6 groups were given the following dosages: 0 (gum mixture only), 0.5, 1, 2.5, and 5 mg of dienbendazole/kg. One group of 2 ponies was given 5 mg of fenbendazole/kg as a standard treatment control.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2619127

  18. 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

  19. A controlled greedy supervised approach for co-reference resolution on clinical text.

    PubMed

    Chowdhury, Md Faisal Mahbub; Zweigenbaum, Pierre

    2013-06-01

    Identification of co-referent entity mentions inside text has significant importance for other natural language processing (NLP) tasks (e.g. event linking). However, this task, known as co-reference resolution, remains a complex problem, partly because of the confusion over different evaluation metrics and partly because the well-researched existing methodologies do not perform well on new domains such as clinical records. This paper presents a variant of the influential mention-pair model for co-reference resolution. Using a series of linguistically and semantically motivated constraints, the proposed approach controls generation of less-informative/sub-optimal training and test instances. Additionally, the approach also introduces some aggressive greedy strategies in chain clustering. The proposed approach has been tested on the official test corpus of the recently held i2b2/VA 2011 challenge. It achieves an unweighted average F1 score of 0.895, calculated from multiple evaluation metrics (MUC, B(3) and CEAF scores). These results are comparable to the best systems of the challenge. What makes our proposed system distinct is that it also achieves high average F1 scores for each individual chain type (Test: 0.897, Person: 0.852, PROBLEM: 0.855, TREATMENT: 0.884). Unlike other works, it obtains good scores for each of the individual metrics rather than being biased towards a particular metric. PMID:23562650

  20. 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

  1. 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

  2. Mucosa-associated lymphoid tissue (MALT) lymphoma of the stomach: results of a controlled clinical trial.

    PubMed

    Avilés, Agustin; Nambo, María Jesús; Neri, Natividad; Talavera, Alejandra; Cleto, Sergio

    2005-01-01

    Treatment of patients with early stage gastric mucosa-associated lymphoid tissue (MALT) remains undefined. We began a controlled clinical trial to evaluate efficacy and toxicity of the most common therapies. Two hundred and forty-one patients with gastric low-grade MALT lymphoma in early stage (IE and IIE) were randomized to surgery (80 cases), radiotherapy (78 cases), and chemotherapy (83 cases). With a median follow-up of 7.5 yr, actuarial curves at 10 yr showed that event-free survival was 52% in patients treated with surgery, 52% in radiotherapy arm, and 87% in the chemotherapy group (p < 0.01). However, overall survival did not showed any statistical differences: 80%, 75% and 87%, respectively (p = 0.4). Acute and late toxicities were mild. No death-related treatments were observed. No clear differences were observed between the most common therapies in patients with primary gastric MALT lymphoma in early stages, probably because this type of lymphoma has an high response rate to salvage treatment after failure to local treatment (surgery and radiotherapy). Thus considered, chemotherapy alone is an effective and safe therapeutic approach in this setting of patients. Surgery or radiotherapy will be reserved to patients that are not candidates for chemotherapy. PMID:15750197

  3. 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

  4. Protirelin tartrate (TRH-T) in upper motoneuron syndrome: a controlled neurophysiological and clinical study.

    PubMed

    Civardi, C; Naldi, P; Cantello, R; Gianelli, M; Mutani, R

    1994-11-01

    This randomised, single-blind, placebo-controlled study involved 20 patients with chronic upper motoneuron syndrome due to ischemic cerebrovascular lesions, selected in order to ensure the greatest possible homogeneity in terms of the severity of the syndrome. All of them were treated with protirelin tartrate 4 mg/die i.m. The study included semiquantitative clinical evaluations of neurological examinations, with particular attention being paid to weakness and spasticity. These were accompanied by neurophysiological evaluations (F-waves, magnetic motor evoked potentials). Extended biohumoral investigations of possible side effects were also carried out. The results indicate a slight but statistically significant absolute improvement in spasticity and muscular strength following protirelin tartrate, especially in the lower limbs; at the same time, the drug also proved to be capable as favourably modifying the response of the biceps femoris muscle to transcranial magnetic stimulation (reappearance, increased amplitude and a reduction in the threshold of motor evoked potentials). The drug was generally well tolerated. PMID:7875957

  5. 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

  6. Risk assessment of feline tooth resorption: a Portuguese clinical case control study.

    PubMed

    Mestrinho, Lisa A; Runhau, Jens; Bragança, Mauro; Niza, Maria M R E

    2013-01-01

    Tooth resorption (TR) is one of the most common dental diseases in cats. Determination of risk factors has not yet been fully assessed and, to the best knowledge of the authors, this disease has never been studied in Portuguese cats. The objective of this case-control study was to determine type and distribution of TR lesions, evaluate risk factors, and establish relationships between variables in this disease. The study included data from 71 cats admitted for general anesthesia for various reasons. The cats were randomly selected. The inclusion criteria were availability of clinical history and owner permission. Cats with known oral disease were not excluded from the study. All cats received ultrasonic scaling and polishing of the teeth, a thorough oral examination, and full-mouth radiographs. A strong statistical relation was found between age and TR. The age group of 10 to 15-years showed an increased risk of 6.56 times for TR occurrence compared with the group 0 to 4-years of age. Presence of gingivitis in all index levels was related to an increased risk for TR. No relation was found between age or gingivitis index and lesion type. Mandibular third premolar and molar teeth were most commonly affected by TR, especially for type 1 lesions. Canine teeth were statistically more likely to have type 2 lesions. The trend for the canine teeth to be more affected with type 2 lesions needs further verification. PMID:24006716

  7. Metabolic Control of Dendritic Cell Activation and Function: Recent Advances and Clinical Implications

    PubMed Central

    Everts, Bart; Pearce, Edward J.

    2014-01-01

    Dendritic cells (DCs) are key regulators of both immunity and tolerance by controlling activation and polarization of effector T helper cell and regulatory T cell responses. Therefore, there is a major focus on developing approaches to manipulate DC function for immunotherapy. It is well known that changes in cellular activation are coupled to profound changes in cellular metabolism. Over the past decade there is a growing appreciation that these metabolic changes also underlie the capacity of immune cells to perform particular functions. This has led to the concept that the manipulation of cellular metabolism can be used to shape innate and adaptive immune responses. While most of our understanding in this area has been gained from studies with T cells and macrophages, evidence is emerging that the activation and function of DCs are also dictated by the type of metabolism these cells commit to. We here discuss these new insights and explore whether targeting of metabolic pathways in DCs could hold promise as a novel approach to manipulate the functional properties of DCs for clinical purposes. PMID:24847328

  8. 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

    2015-09-01

    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

  9. Comparative randomised active drug controlled clinical trial of a herbal eye drop in computer vision syndrome.

    PubMed

    Chatterjee, Pranab Kr; Bairagi, Debasis; Roy, Sudipta; Majumder, Nilay Kr; Paul, Ratish Ch; Bagchi, Sunil Ch

    2005-07-01

    A comparative double-blind placebo-controlled clinical trial of a herbal eye drop (itone) was conducted to find out its efficacy and safety in 120 patients with computer vision syndrome. Patients using computers for more than 3 hours continuously per day having symptoms of watering, redness, asthenia, irritation, foreign body sensation and signs of conjunctival hyperaemia, corneal filaments and mucus were studied. One hundred and twenty patients were randomly given either placebo, tears substitute (tears plus) or itone in identical vials with specific code number and were instructed to put one drop four times daily for 6 weeks. Subjective and objective assessments were done at bi-weekly intervals. In computer vision syndrome both subjective and objective improvements were noticed with itone drops. Itone drop was found significantly better than placebo (p<0.01) and almost identical results were observed with tears plus (difference was not statistically significant). Itone is considered to be a useful drug in computer vision syndrome. PMID:16366195

  10. A Comparison of Patient Controlled Epidural Analgesia With Intravenous Patient Controlled Analgesia for Postoperative Pain Management After Major Gynecologic Oncologic Surgeries: A Randomized Controlled Clinical Trial

    PubMed Central

    Moslemi, Farnaz; Rasooli, Sousan; Baybordi, Ali; Golzari, Samad E.J.

    2015-01-01

    Background: Postoperative pain after major open gynecologic surgeries requires appropriate pain management. Objectives: This study aimed at comparing perioperative patient controlled epidural analgesia (PCEA) and patient controlled intravenous analgesia (PCA) after gynecologic oncology surgeries. Patients and Methods: In this clinical trial study, 90 patients with American society of anesthesiologists (ASA) class I or II scheduled for gynecologic oncologic surgeries were randomly allocated to two groups (45 patients each group) to receive: patient-controlled epidural analgesia with bupivacaine and fentanyl (PCEA group), or patient controlled intravenous analgesia (IV PCA group) with fentanyl, pethidine and ondansetron. Postoperative pain was assessed over 48 hours using the visual analog scale (VAS). The frequency of rescue analgesia was recorded. Occurrence of any concomitant events such as nausea, vomiting, ileus, purities, sedation and respiratory complications were recorded postoperatively. Results: There were no statistically significant differences in demographic data including; age, weight, ASA physical status, duration of surgery, intraoperative bleeding, and the amount of blood transfusion (P > 0.05), between the two studied groups. Severity of postoperative pain was not significantly different between the two groups (P > 0.05); however, after first patient mobilization, pain was significantly lower in the epidural group than the IV group (P < 0.001). There was no significant difference between the two groups regarding the incidence of complications such as nausea, vomiting, purities or ileus (P > 0.05). Nevertheless, the incidence and severity of sedation was significantly higher in the IV group (P < 0.001). Respiratory depression was higher in the IV group than the epidural group; this difference, however, was not significant (P = 0.11). In the epidural group, only 10 patients (22.2%) had mild and transient lower extremities parenthesis. Conclusions

  11. 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

  12. Effectiveness of a 1-Year Resident Training Program in Clinical Research: A Controlled Before-and-After Study

    PubMed Central

    Hartmann, Mechthild; Wild, Beate; Nikendei, Christoph; Kroenke, Kurt; Niehoff, Dorothea; Henningsen, Peter; Zipfel, Stephan; Herzog, Wolfgang

    2007-01-01

    Background To increase the number of clinician scientists and to improve research skills, a number of clinical research training programs have been recently established. However, controlled studies assessing their effectiveness are lacking. Objective To investigate the effectiveness of a 1-year resident training program in clinical research. Design Controlled before-and-after study. The training program included a weekly class in clinical research methods, completion of a research project, and mentorship. Participants Intervention subjects were 15 residents participating in the 1-year training program in clinical research. Control subjects were 22 residents not participating in the training program. Measurements and Main Results Assessments were performed at the beginning and end of the program. Outcomes included methodological research knowledge (multiple-choice progress test), self-assessed research competence, progress on publications and grant applications, and evaluation of the program using quantitative and qualitative methods. Results Intervention subjects and controls were well matched with respect to research experience (5.1 ± 2.2 vs 5.6 ± 5.8 years; p = .69). Methodological knowledge improved significantly more in the intervention group compared to the control group (effect size = 2.5; p < .001). Similarly, self-assessed research competence increased significantly more in the intervention group (effect size = 1.1; p = .01). At the end of the program, significantly more intervention subjects compared to controls were currently writing journal articles (87% vs 36%; p = .003). The intervention subjects evaluated the training program as highly valuable for becoming independent researchers. Conclusions A 1-year training program in clinical research can substantially increase research knowledge and productivity. The program design makes it feasible to implement in other academic settings. PMID:17922168

  13. 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

  14. Caries-preventive effect of sodium fluoride mouthrinses: a systematic review of controlled clinical trials.

    PubMed

    Twetman, Svante; Petersson, Lars; Axelsson, Susanna; Dahlgren, Helena; Holm, Anna-Karin; Källestål, Carina; Lagerlöf, Folke; Lingström, Peter; Mejàre, Ingegerd; Nordenram, Gunilla; Norlund, Anders; Söder, Birgitta

    2004-08-01

    The Swedish Council on Technology Assessment in Health Care launched a project group in 1999 to systematically review and evaluate the existing literature on different caries-preventive methods. The aim of this article was to report the findings concerning the caries-preventive effect of fluoride mouthrinses (FMRs) in various age groups, with special reference to background fluorides. A systematic search in electronic databases for literature published between 1966 and August 2003 was conducted with the inclusion criteria of a randomized or controlled clinical trial, at least 2 years' follow-up, and caries increment in the permanent dentition (DeltaDMFS/T) as endpoint. Out of 174 articles originally identified, 62 met the inclusion criteria. These studies were assessed independently by at least two reviewers and scored A-C according to predetermined criteria for methodology and performance. The measure of effect was the prevented fraction (PF) expressed as percent. The level of evidence was based on 25 articles. The results revealed limited evidence (evidence level 3) for the caries-preventive effect (PF 29%) of daily or weekly sodium fluoride rinses compared with placebo in permanent teeth of schoolchildren and adolescents with no additional fluoride exposure and for a caries-preventive effect on root caries in older adults. Inconclusive evidence (evidence level 4) was found regarding the effect of FMRs in schoolchildren and adolescents exposed to additional fluoride sources such as daily use of fluoride toothpaste. No firm support for the use of FMRs was disclosed in a small number of studies designed for patients at caries risk. Furthermore, no association between the frequency of the rinses and prevented fraction or saved surfaces per year was found. In conclusion, this systematic review suggests that sodium fluoride mouthrinses may have an anti-caries effect in children with limited background of fluoride exposure, while its additional effect in children with

  15. Periodontal Tissue Regeneration Using Fibroblast Growth Factor -2: Randomized Controlled Phase II Clinical Trial

    PubMed Central

    Kitamura, Masahiro; Nakashima, Keisuke; Kowashi, Yusuke; Fujii, Takeo; Shimauchi, Hidetoshi; Sasano, Takashi; Furuuchi, Toshi; Fukuda, Mitsuo; Noguchi, Toshihide; Shibutani, Toshiaki; Iwayama, Yukio; Takashiba, Shogo; Kurihara, Hidemi; Ninomiya, Masami; Kido, Jun-ichi; Nagata, Toshihiko; Hamachi, Takafumi; Maeda, Katsumasa; Hara, Yoshitaka; Izumi, Yuichi; Hirofuji, Takao; Imai, Enyu; Omae, Masatoshi; Watanuki, Mitsuru; Murakami, Shinya

    2008-01-01

    Background The options for medical use of signaling molecules as stimulators of tissue regeneration are currently limited. Preclinical evidence suggests that fibroblast growth factor (FGF)-2 can promote periodontal regeneration. This study aimed to clarify the activity of FGF-2 in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation. Methodology/Principal Findings We used recombinant human FGF-2 with 3% hydroxypropylcellulose (HPC) as vehicle and conducted a randomized double-blinded controlled trial involving 13 facilities. Subjects comprised 74 patients displaying a 2- or 3-walled vertical bone defect as measured ≥3 mm apical to the bone crest. Patients were randomly assigned to 4 groups: Group P, given HPC with no FGF-2; Group L, given HPC containing 0.03% FGF-2; Group M, given HPC containing 0.1% FGF-2; and Group H, given HPC containing 0.3% FGF-2. Each patient underwent flap operation during which we administered 200 µL of the appropriate investigational drug to the bone defect. Before and for 36 weeks following administration, patients underwent periodontal tissue inspections and standardized radiography of the region under investigation. As a result, a significant difference (p = 0.021) in rate of increase in alveolar bone height was identified between Group P (23.92%) and Group H (58.62%) at 36 weeks. The linear increase in alveolar bone height at 36 weeks in Group P and H was 0.95 mm and 1.85 mm, respectively (p = 0.132). No serious adverse events attributable to the investigational drug were identified. Conclusions Although no statistically significant differences were noted for gains in clinical attachment level and alveolar bone gain for FGF-2 groups versus Group P, the significant difference in rate of increase in alveolar bone height (p = 0.021) between Groups P and H at 36 weeks suggests that some efficacy could be expected from FGF-2 in stimulating regeneration of

  16. 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

  17. 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

  18. 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…

  19. 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...

  20. 78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... FR 67396, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Tapentadol...

  1. A review of the expected effects of antimicrobials in bovine respiratory disease treatment and control using outcomes from published randomized clinical trials with negative controls.

    PubMed

    DeDonder, Keith D; Apley, Michael D

    2015-03-01

    Bovine respiratory disease (BRD) remains a major disease from an economic and an animal welfare standpoint in beef production systems. Antimicrobial administration is a mainstay in the control of and therapeutic treatment of acute BRD. Judicious use of antimicrobials remains paramount to ensure efficacy of treatment remains acceptable. A systemic review was conducted in the scientific literature, the objective of which was to present a cumulative review of the data from published randomized clinical trials using a negative control in the treatment and control of BRD and using the number needed to treat as a means to effectively convey this information to bovine practitioners. PMID:25578389

  2. 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

  3. On the transition from a nurse-led hypertension clinic to hypertension control in primary care: identifying barriers to and factors acting against continuous hypertension control.

    PubMed

    Overgaard Andersen, Ulla; Ibsen, Hans; Tobiassen, Minja

    2016-08-01

    Many hypertensive patients are not treated to target and hence do not benefit fully from the blood pressure-related improvements in cardiovascular health. Hypertensive patients who had primarily been treated to a target goal in a nurse-led hypertension clinic were re-examined to evaluate whether their target goal blood pressure was maintained after their discharge from the hypertension clinic for further control in primary care, and to evaluate potential barriers to and factors acting against continuous hypertension control. The median observation time was 3.6 years (range 3 months to 7.9 years). Only 45.2% of the patients were well controlled at the time of re-examination. No patient-related factors (age, body mass index, gender, attitudes towards medication) predicted the outcome. Two factors were significant in the reduction in continuous hypertension control: the cooperation between the patient and health personnel and the shared commitment towards the target goal were discontinued; and many patients did not make control visits to the general practitioner's office. In conclusion, maintained strict control of hypertension requires both continued close collaboration between the patient and health personnel, with an emphasis on treatment goals, and systematic control visits. PMID:27090684

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial

    PubMed Central

    Summers, C Gail; Connett, John E; Holleschau, Ann M; Anderson, Jennifer L; De Becker, Inge; McKay, Brian S; Brilliant, Murray H

    2014-01-01

    Background Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism. Design Prospective, randomized, placebo-controlled, double-masked randomized clinical trial conducted at the University of Minnesota Participants 45 subjects with albinism Methods Subjects with albinism were randomly assigned to one of three treatment arms: levodopa 0.76 mg/kg with 25% carbidopa, levodopa 0.51 mg/kg with 25% carbidopa, or placebo and followed for 20 weeks, with best-corrected visual acuity measured at enrollment, and at weeks 5, 10, 15, and 20 after enrollment. Side effects were recorded with a symptom survey. Blood was drawn for genotyping. Main Outcome Measures Side effects and best-corrected visual acuity 20 weeks after enrollment. Results All subjects had at least one mutation found in a gene known to cause albinism. Mean age was 14.5 years (range: 3.5 to 57.8 years). Follow-up was 100% and compliance was good. Minor side effects were reported; there were no serious adverse events. There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa. Conclusions Levodopa, in the doses used in this trial and for the time course of administration, did not improve visual acuity in subjects with albinism. PMID:24641678

  11. 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

  12. [Risk factors for clinical signs of PMWS and PDNS in pigs in The Netherlands: a case-control study].

    PubMed

    Elbers, A R W; de Jong, M F; Wellenberg, G J

    2006-05-01

    Potential risk factors for clinical signs of post-weaning multisystemic wasting syndrome (PMWS) and porcine dermatitis and nephropathy syndrome (PDNS) in pigs in the Netherlands were investigated in a matched case-control study using a questionnaire (personal interview). Eighty-two pig farmers were questioned about management, hygiene, husbandry systems, disease history, and preventive health care. In this study, 30 pig herds with (cases) and 30 pig herds without (controls) characteristic clinical signs of PMWS were compared. For PDNS, 11 pig herds with (cases) and II pig herds without (controls) characteristic clinical signs of PDNS were compared. Univariate analysis (P < 0.10) showed that the following occurred relatively more often in the PMWS case herds than in the control herds: 1) clinical signs of PDNS, porcine reproductive and respiratory syndrome (PRRS), porcine parvovirus (PPV) infections, meningitis, coccidiosis, and pre-weaning diarrhoea observed by the farmer; 2) vaccination against PRRS and mycoplasma; 3) non-optimal climatic conditions in the nursery rooms, a large variation in weaning age, a high occurrence of cross-fostering of piglets, a large number of sows with lactation problems, poor colostrum intake by piglets; and 4) (historical) use of breeding stock (including semen for artificial insemination) of Anglo-Saxon origin. In the final multivariate statistical model, one variable remained significantly associated with PMWS case herds, namely, the presence of clinical signs of PRRS (and/or the associated use of vaccination against PRRS). It should be noted that in almost all cases animals were vaccinated against PRRS because of clinical signs of PRRS that appeared a few months after the first occurrence of clinical signs of PMWS. This excludes PRRS vaccination as a primary factor in causing PMWS. Analysis of the PDNS case-control data showed comparable results with those of the PMWS study. In the final statistical model, the presence of clinical

  13. 77 FR 38084 - Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ... U.S.C. 823(a) and 952(a) and determined that the registration of Clinical Supplies Management, Inc... laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and... FR 24984, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103,...

  14. 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…

  15. Clinical Hurdles and Possible Solutions in the Implementation of Closed-Loop Control in Type 1 Diabetes Mellitus

    PubMed Central

    Zisser, Howard

    2011-01-01

    From an engineering perspective, controlling blood glucose appears to be a fairly straightforward single input (glucose), single output (insulin) control problem. Unfortunately, mimicking Mother Nature turns out to be a complex endeavor. The primary hurdle in developing a useful, safe closed-loop control algorithm for an artificial pancreas is the time delays associated with current continuous glucose monitors and subcutaneously delivered insulins. This article will provide a brief history of the artificial pancreas, outline the main clinical hurdles restricting its current implementation, and list possible solutions for success. PMID:22027329

  16. [Parasitological characteristics, epidemiological and clinical features, and current control approaches for three major kinds of human schistosomiasis].

    PubMed

    Xu, Xiao-Lin; Zhu, Rong; Zhang, Li-Juan; Guo, Jia-Gang

    2013-06-01

    Schistosomiasis is a tropical disease, which could do serious damage to the people's health, and it hinders the development of the social economy but may be neglected. After a positive control, some countries and regions have blocked the spread of schistosomiasis. However, in the past few years, with the development of social economy, due to the global movement of people, schistosomiasis not only poses a threat to control areas, but also may cause new endemic areas. This article reviews the parasitological characteristics, clinical manifestations, epidemiological situation, and control approaches of three major kinds of human schistosomiasis, schistosomiasis japonica, schistosomiasis haematobia, and schistosomiasis mansoni. PMID:24024456

  17. Clinical Correlates of Between-Limb Synchronization of Standing Balance Control and Falls During Inpatient Stroke Rehabilitation

    PubMed Central

    Mansfield, Avril; Mochizuki, George; Inness, Elizabeth L.; McIlroy, William E.

    2016-01-01

    Background Stroke-related sensorimotor impairment potentially contributes to impaired balance. Balance measures that reveal underlying limb-specific control problems, such as a measure of the synchronization of both lower limbs to maintain standing balance, may be uniquely informative about poststroke balance control. Objective This study aimed to determine the relationships between clinical measures of sensorimotor control, functional balance, and fall risk and between-limb synchronization of balance control. Methods The authors conducted a retrospective chart review of 100 individuals with stroke admitted to inpatient rehabilitation. Force plate–based measures were obtained while standing on 2 force plates, including postural sway (root mean square of anteroposterior and mediolateral center of pressure [COP]), stance load asymmetry (percentage of body weight borne on the less-loaded limb), and between-limb synchronization (cross-correlation of the COP recordings under each foot). Clinical measures obtained were motor impairment (Chedoke-McMaster Stroke Assessment), plantar cutaneous sensation, functional balance (Berg Balance Scale), and falls experienced in rehabilitation. Results Synchronization was significantly related to motor impairment and prospective falls, even when controlling for other force plate–based measures of standing balance control (ie, postural sway and stance load symmetry). Conclusions Between-limb COP synchronization for standing balance appears to be a uniquely important index of balance control, independent of postural sway and load symmetry during stance. PMID:22275158

  18. 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

  19. 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

  20. Clinical values of control over pain and pain coping strategies in surgical treatment for patients with lumbar spinal stenosis

    PubMed Central

    2016-01-01

    Background Control over pain and pain coping strategies are associated with pain intensity as well as psychological status and subjective disability in patients experiencing pain. The present study assessed the clinical values of control over pain and pain coping strategies in surgical treatment for patients with lumbar spinal stenosis using mediation analysis. Methods Sixty-two patients with lumbar spinal stenosis (median age, 70 years; 34 men, 28 women) were evaluated before surgery. The pain intensity and area, psychological status/subjective disability (Japanese Orthopaedic Association Back Pain Evaluation Questionnaire), and control over pain/pain coping strategies (Coping Strategies Questionnaire) were assessed. Mediation analysis, which consisted of serial regression analyses, mainly tested whether (1) control over pain/pain coping strategies were predicted by pain characteristics and (2) control over pain/pain coping strategies predicted psychological status/subjective disability after controlling for pain characteristics. Results Control over pain was predicted by pain intensity (regression coefficient, -0.33; p = 0.01); moreover, it predicted walking ability (standardized partial regression coefficient, 0.31; p = 0.01) and social function (0.38; p = 0.00) after controlling for pain intensity. Although increasing activity level, one pain coping strategy, was predicted by pain intensity (regression coefficient, -0.30; p = 0.02), it did not predict walking ability (standardized partial regression coefficient, 0.07; p = 0.53) or social function (0.13; p = 0.33) when considering pain intensity. Conclusions In this cohort, mediation analysis demonstrated that pain intensity did not directly affect perceived walking ability or social function, but did affect control over pain; moreover, control over pain affected walking ability and social function. Clinical relevance These findings are useful for a deep understanding of the relationships between pain and

  1. 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

  2. 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. PMID:26210387

  3. Zen Meditation and Behavioral Self-Control. Similarities, Differences and Clinical Applications

    ERIC Educational Resources Information Center

    Shapiro, Deane H. Jr.; Zifferblatt, Steven M.

    1976-01-01

    After briefly reviewing the clinical outcome literature for both strategies, the article concludes with a discussion of the rehabilitative and preventive benefits that may be gained from a combination of the two techniques. (Author/AM)

  4. Smoking reduction fails to improve clinical and biological markers of cardiac disease: a randomized controlled trial.

    PubMed

    Joseph, Anne M; Hecht, Stephen S; Murphy, Sharon E; Lando, Harry; Carmella, Steven G; Gross, Myron; Bliss, Robin; Le, Chap T; Hatsukami, Dorothy K

    2008-03-01

    Cigarette reduction has been proposed as a treatment goal for smokers who are not interested in stopping completely. This randomized controlled trial was designed to determine the effect of a smoking reduction intervention on smoking behavior, symptoms of heart disease, and biomarkers of tobacco exposure. It included 152 patients with heart disease who did not intend to stop smoking in the next 30 days. Participants were randomly assigned to smoking reduction (SR) or usual care (UC). SR subjects received counseling and nicotine replacement therapy to encourage > or =50% reduction in cigarettes per day (CPD). They were followed at 1, 3, 6, 12 and 18 months to assess smoking, heart disease symptoms, quality of life and nicotine, cotinine, carbon monoxide (CO), white blood cell (WBC) count, fibrinogen, hs-C-reactive protein (hs-CRP), F2-isoprostane, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL), and 1-hydroxypyrene (1-HOP). At 6 months SR participants reduced by 10.9 CPD, compared with 7.4 CPD in UC (difference NS). At 18 months, 9/78 SR vs. 9/74 UC participants quit smoking. There were no significant differences between treatment groups in angina, quality of life or adverse events, nicotine, cotinine, CO, WBC count, fibrinogen, hs-CRP, F2-isoprostane, total NNAL or 1-HOP levels at any time point. To determine if smoking reduction, regardless of treatment condition, was associated with improved outcomes, we compared all subjects at 6 months to baseline (mean reduction in CPD from 27.4 to 18.1, p<.01). There were no significant changes in outcome variables except CO, which decreased by 5.5 ppm (p<.01). There were also no significant improvements considering only subjects who reduced by > or =50%, or those who had no history of reduction prior to enrollment in the study. The SR intervention did not significantly reduce CPD or toxin exposure, or improve smoking cessation or clinical outcomes compared to UC. These results emphasize the

  5. 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

  6. 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

  7. 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

  8. Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices

    PubMed Central

    2011-01-01

    Background Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices. Methods This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety. Results The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial. Conclusions To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice

  9. Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial.

    PubMed

    Richter, Linda; Rotheram-Borus, Mary Jane; Van Heerden, Alastair; Stein, Alan; Tomlinson, Mark; Harwood, Jessica M; Rochat, Tamsen; Van Rooyen, Heidi; Comulada, W Scott; Tang, Zihling

    2014-04-01

    Throughout Africa, Peer Mentors who are women living with HIV (WLH) are supporting pregnant WLH at antenatal and primary healthcare clinics (McColl in BMJ 344:e1590, 2012). We evaluate a program using this intervention strategy at 1.5 months post-birth. In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for their WLH to receive either: standard care (SC), based on national guidelines to prevent mother-to-child transmission (4 clinics; n = 656 WLH); or an enhanced intervention (EI; 4 clinics; n = 544 WLH). The EI consisted of four antenatal and four postnatal small group sessions led by Peer Mentors, in addition to SC. WLH were recruited during pregnancy and 70 % were reassessed at 1.5 months post-birth. EI's effect was ascertained on 16 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall effectiveness. Among EI WLH reassessed, 87 % attended at least one intervention session (mean 4.1, SD 2.0). Significant overall benefits were found in EI compared to SC using the binomial test. However, it is important to note that EI WLH were significantly less likely to adhere to ARV during pregnancy compared to SC. Secondarily, compared to SC, EI WLH were more likely to ask partners to test for HIV, better protected their infants from HIV transmission, and were less likely to have depressed mood and stunted infants. Adherence to clinic intervention groups was low, yet, there were benefits for maternal and infant health at 1.5 months post-birth. PMID:24469222

  10. Pregnant Women Living with HIV (WLH) Supported at Clinics by Peer WLH: A Cluster Randomized Controlled Trial

    PubMed Central

    Richter, Linda; Rotheram-Borus, Mary Jane; Van Heerden, Alastair; Stein, Alan; Tomlinson, Mark; Harwood, Jessica M.; Rochat, Tamsen; Van Rooyen, Heidi; Comulada, W. Scott; Tang, Zihling

    2014-01-01

    Throughout Africa, Peer Mentors who are women living with HIV (WLH) are supporting pregnant WLH at antenatal and primary healthcare clinics (McColl in BMJ 344:e1590, 2012). We evaluate a program using this intervention strategy at 1.5 months post-birth. In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for their WLH to receive either: standard care (SC), based on national guidelines to prevent mother-to-child transmission (4 clinics; n = 656 WLH); or an enhanced intervention (EI; 4 clinics; n = 544 WLH). The EI consisted of four antenatal and four postnatal small group sessions led by Peer Mentors, in addition to SC. WLH were recruited during pregnancy and 70 % were reassessed at 1.5 months post-birth. EI's effect was ascertained on 16 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall effectiveness. Among EI WLH reassessed, 87 % attended at least one intervention session (mean 4.1, SD 2.0). Significant overall benefits were found in EI compared to SC using the binomial test. However, it is important to note that EI WLH were significantly less likely to adhere to ARV during pregnancy compared to SC. Secondarily, compared to SC, EI WLH were more likely to ask partners to test for HIV, better protected their infants from HIV transmission, and were less likely to have depressed mood and stunted infants. Adherence to clinic intervention groups was low, yet, there were benefits for maternal and infant health at 1.5 months post-birth. PMID:24469222

  11. Patient-controlled encrypted genomic data: an approach to advance clinical genomics

    PubMed Central

    2012-01-01

    Background The revolution in DNA sequencing technologies over the past decade has made it feasible to sequence an individual’s whole genome at a relatively low cost. The potential value of the information generated by genomic technologies for medicine and society is enormous. However, in order for exome sequencing, and eventually whole genome sequencing, to be implemented clinically, a number of major challenges need to be overcome. For instance, obtaining meaningful informed-consent, managing incidental findings and the great volume of data generated (including multiple findings with uncertain clinical significance), re-interpreting the genomic data and providing additional counselling to patients as genetic knowledge evolves are issues that need to be addressed. It appears that medical genetics is shifting from the present “phenotype-first” medical model to a “data-first” model which leads to multiple complexities. Discussion This manuscript discusses the different challenges associated with integrating genomic technologies into clinical practice and describes a “phenotype-first” approach, namely, “Individualized Mutation-weighed Phenotype Search”, and its benefits. The proposed approach allows for a more efficient prioritization of the genes to be tested in a clinical lab based on both the patient’s phenotype and his/her entire genomic data. It simplifies “informed-consent” for clinical use of genomic technologies and helps to protect the patient’s autonomy and privacy. Overall, this approach could potentially render widespread use of genomic technologies, in the immediate future, practical, ethical and clinically useful. Summary The “Individualized Mutation-weighed Phenotype Search” approach allows for an incremental integration of genomic technologies into clinical practice. It ensures that we do not over-medicalize genomic data but, rather, continue our current medical model which is based on serving the patient’s concerns

  12. Clinical review: Strict or loose glycemic control in critically ill patients - implementing best available evidence from randomized controlled trials

    PubMed Central

    2010-01-01

    Glycemic control aiming at normoglycemia, frequently referred to as 'strict glycemic control' (SGC), decreased mortality and morbidity of adult critically ill patients in two randomized controlled trials (RCTs). Five successive RCTs, however, failed to show benefit of SGC with one trial even reporting an unexpected higher mortality. Consequently, enthusiasm for the implementation of SGC has declined, hampering translation of SGC into daily ICU practice. In this manuscript we attempt to explain the variances in outcomes of the RCTs of SGC, and point out other limitations of the current literature on glycemic control in ICU patients. There are several alternative explanations for why the five negative RCTs showed no beneficial effects of SGC, apart from the possibility that SGC may indeed not benefit ICU patients. These include, but are not restricted to, variability in the performance of SGC, differences among trial designs, changes in standard of care, differences in timing (that is, initiation) of SGC, and the convergence between the intervention groups and control groups with respect to achieved blood glucose levels in the successive RCTs. Additional factors that may hamper translation of SGC into daily ICU practice include the feared risk of severe hypoglycemia, additional labor associated with SGC, and uncertainties about who the primarily responsible caregiver should be for the implementation of SGC. PMID:20550725

  13. Effect of acute doses of controlled-release carbamazepine on clinical, psychomotor, electrophysiological, and cognitive parameters of brain function.

    PubMed

    van der Meyden, C H; Bartel, P R; Sommers, D K; Blom, M; Becker, P; Erasmus, S; Griesel, D

    1992-01-01

    The neurotoxic effect of acute doses of carbamazepine controlled-release (CBZ-CR) divitabs (800, 1,200, and 1,600 mg) was assessed on clinical, psychomotor, electrophysiological, and cognitive parameters of brain function in 10 healthy volunteers in a double-blind, randomised, placebo-controlled, phase I study. Significant changes compared to placebo were demonstrated for the clinical scales, ataxia (AT), convergence of the near-point (CNP), peak saccadic velocity (PSV), critical flicker fusion (CFF), spectral analysis of the EEG, and brainstem auditory evoked potential (BAEP) tests. Digit repetition, digit symbol substitution, Sternberg memory scanning time, Sternberg choice reaction time, saccadic latency, and saccadic accuracy showed important negative findings. Significant clinical tolerance to side effects developed within 20 to 33 h after CBZ-CR dosage during a period in which the mean CBZ blood levels remained virtually unchanged. CBZ-CR, 800, 1,200, and 1,600 mg yielded low, medium, and high therapeutic blood levels, respectively, for +10 to +33 h after dosage without the development of severe clinical side effects. PMID:1547763

  14. Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial.

    PubMed

    Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

    2015-01-01

    OBJECTIVE To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. METHOD This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). RESULTS There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). CONCLUSION Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b. PMID:25992820

  15. 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.

  16. Controlling tuberculosis in a llama (Lama glama) herd using clinical signs, tuberculin skin testing and serology.

    PubMed

    Twomey, D F; Collins, R; Cranwell, M P; Crawshaw, T R; Higgins, R J; Dean, G S; Vordermeier, H M; Hollingdale, A; de la Rua-Domenech, R

    2012-05-01

    An outbreak of tuberculosis (TB), caused by Mycobacterium bovis, was investigated in a small herd of llamas (Lama glama). Based on three ante-mortem diagnostic methods (clinical signs, tuberculin skin test reactions, and 'Rapid Test' serology), 12 llamas were selected for examination post-mortem. Grossly visible lesions suspicious of TB were observed in eight animals, four of which had exhibited clinical signs, one was a skin test 'reactor', and three had been seropositive. M. bovis was isolated from seven of these eight animals. Clinical signs combined with serology were found to be useful in identifying infected animals, but tuberculin skin testing had limited negative predictive value as four llamas that were subsequently confirmed as infected were not detected using this assay. PMID:21704542

  17. Randomised controlled trial of clinical decision support tools to improve learning of evidence based medicine in medical students

    PubMed Central

    Leung, Gabriel M; Johnston, Janice M; Tin, Keith Y K; Wong, Irene O L; Ho, Lai-Ming; Lam, Wendy W T; Lam, Tai-Hing

    2003-01-01

    Objective To assess the educational effectiveness on learning evidence based medicine of a handheld computer clinical decision support tool compared with a pocket card containing guidelines and a control. Design Randomised controlled trial. Setting University of Hong Kong, 2001. Participants 169 fourth year medical students. Main outcome measures Factor and individual item scores from a validated questionnaire on five key self reported measures: personal application and current use of evidence based medicine; future use of evidence based medicine; use of evidence during and after clerking patients; frequency of discussing the role of evidence during teaching rounds; and self perceived confidence in clinical decision making. Results The handheld computer improved participants' educational experience with evidence based medicine the most, with significant improvements in all outcome scores. More modest improvements were found with the pocket card, whereas the control group showed no appreciable changes in any of the key outcomes. No significant deterioration was observed in the improvements even after withdrawal of the handheld computer during an eight week washout period, suggesting at least short term sustainability of effects. Conclusions Rapid and convenient access to valid and relevant evidence on a portable computing device can improve learning in evidence based medicine, increase current and future use of evidence, and boost students' confidence in clinical decision making. PMID:14604933

  18. Standard requirement of a microbiological quality control program for the manufacture of human mesenchymal stem cells for clinical use.

    PubMed

    Gálvez, Patricia; Clares, Beatriz; Bermejo, Maria; Hmadcha, Abdelkrim; Soria, Bernat

    2014-05-15

    The manufacturing of human mesenchymal stem cells (hMSCs) as cell-based products for clinical use should be performed with appropriate controls that ensure its safety and quality. The use of hMSCs in cell therapy has increased considerably in the past few years. In line with this, the assessment and management of contamination risks by microbial agents that could affect the quality of cells and the safety of patients have to be considered. It is necessary to implant a quality control program (QCP) covering the entire procedure of the ex vivo expansion, from the source of cells, starting materials, and reagents, such as intermediate products, to the final cellular medicine. We defined a QCP to detect microbiological contamination during manufacturing of autologous hMSCs for clinical application. The methods used include sterility test, Gram stain, detection of mycoplasma, endotoxin assay, and microbiological monitoring in process according to the European Pharmacopoeia (Ph. Eur.) and each analytical technique was validated in accordance with three different cell cultures. Results showed no microbiological contamination in any phases of the cultures, meeting all the acceptance criteria for sterility test, detection of mycoplasma and endotoxin, and environmental and staff monitoring. Each analytical technique was validated demonstrating the sensitivity, limit of detection, and robustness of the method. The quality and safety of MSCs must be controlled to ensure their final use in patients. The evaluation of the proposed QCP revealed satisfactory results in order to standardize this procedure for clinical use of cells. PMID:24417334

  19. Standard Requirement of a Microbiological Quality Control Program for the Manufacture of Human Mesenchymal Stem Cells for Clinical Use

    PubMed Central

    Clares, Beatriz; Bermejo, Maria

    2014-01-01

    The manufacturing of human mesenchymal stem cells (hMSCs) as cell-based products for clinical use should be performed with appropriate controls that ensure its safety and quality. The use of hMSCs in cell therapy has increased considerably in the past few years. In line with this, the assessment and management of contamination risks by microbial agents that could affect the quality of cells and the safety of patients have to be considered. It is necessary to implant a quality control program (QCP) covering the entire procedure of the ex vivo expansion, from the source of cells, starting materials, and reagents, such as intermediate products, to the final cellular medicine. We defined a QCP to detect microbiological contamination during manufacturing of autologous hMSCs for clinical application. The methods used include sterility test, Gram stain, detection of mycoplasma, endotoxin assay, and microbiological monitoring in process according to the European Pharmacopoeia (Ph. Eur.) and each analytical technique was validated in accordance with three different cell cultures. Results showed no microbiological contamination in any phases of the cultures, meeting all the acceptance criteria for sterility test, detection of mycoplasma and endotoxin, and environmental and staff monitoring. Each analytical technique was validated demonstrating the sensitivity, limit of detection, and robustness of the method. The quality and safety of MSCs must be controlled to ensure their final use in patients. The evaluation of the proposed QCP revealed satisfactory results in order to standardize this procedure for clinical use of cells. PMID:24417334

  20. 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

  1. Computer decision support software safely improves glycemic control in the burn intensive care unit: a randomized controlled clinical study

    PubMed Central

    Mann, Elizabeth A.; Jones, John A.; Wolf, Steven E.; Wade, Charles E.

    2011-01-01

    Objective The optimal method for glycemic control in the critically burned patient is unknown. The purpose of this randomized controlled study was to determine the safety and efficacy of computer decision support software (CDSS) to control serum glucose concentration in a burn intensive care unit. Methods Eighteen adult burn/trauma patients receiving continuous insulin infusion were initially randomized to receive glucose management via a traditional paper-based protocol (PP) or a computer protocol (CP) for 72 hours, then crossed over to the alternate method for an additional 72 hours. Results Time in target glucose range (80-110 mg/dl) was higher in the CP group (47 ± 17% versus 41 ± 16.6%; p ≤ 0.05); time over target range was not significantly reduced in the CP group (49 ± 17.8% versus 54 ± 17.1; p = 0.08); and no difference was noted in time under target range of 80 mg/dl (CP 4.5 ± 2.8, PP 4.8 ± 3.3%; p = 0.8), under 60 mg/dl (p = 0.7), and under 40 mg/dl (p = 1.0). Severe hypoglycemic events (< 40 mg/dl) did not differ from the CP group compared to historical controls for patients receiving no insulin (p = 0.6). More glucose measurements were performed in the CP group (p = 0.0003), and nursing staff compliance with CP recommendations was greater (p < 0.0001). Conclusions Glycemic control using CDSS is safe and effective for the critically burned patient. Time in target range improved without increase in hypoglycemic events. CDSS enhanced consistency in practice, providing standardization among nursing staff. PMID:21240001

  2. 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

  3. [Controlled clinical study of the action of mebeverine hydrochloride in the treatment of irritable colon].

    PubMed

    Secco, G B; Di Somma, C; Arnulfo, G; Ricci, C

    1983-03-31

    The results of a study about the mebeverina administered in 45 cases of irritable colon are reported. The clinical and laboratory findings together with the results of colometrography under psychic stimulation, have shown the therapeutic efficacy of the new formulation, specially in irritable colon with abdominal pain. Its tolerance was excellent. PMID:6339996

  4. 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

  5. Clinical significance of barriers to blood glucose control in type 2 diabetes patients with insufficient glycemic control

    PubMed Central

    Suzuki, Takeo; Takei, Ryoko; Inoguchi, Toyoshi; Sonoda, Noriyuki; Sasaki, Shuji; Kaise, Toshihiko; Takayanagi, Ryoichi

    2015-01-01

    Background The purpose of this study was to assess actual barriers to blood glucose control in patients with type 2 diabetes mellitus and to investigate barrier-related factors in an exploratory manner. Methods This cross-sectional study assessed patients with type 2 diabetes mellitus treated as outpatients at medical institutions within Fukuoka Prefecture, Japan. Barriers to blood glucose control were examined in patients with glycated hemoglobin ≥6.9% using a nine-item questionnaire. Answers were also obtained from physicians in charge of the patients for seven of nine questions. Results Seven hundred and thirteen patients answered the questionnaire. Many physicians and patients described barriers that involved difficulty in complying with diet therapy. For six of the seven barriers, patient awareness was lower than physician awareness. Patient-reported lack of concern for diabetes mellitus was more prevalent among patients with macrovascular complications. Patients who reported difficulty in compliance with exercise therapy and fear of hypoglycemia were more likely to suffer from microvascular complications. Conclusion For many of the barriers to blood glucose control, patients were less aware than physicians, suggesting that we need to take action to raise patient awareness. Of interest are the observations that the relevant barriers differed for macrovascular and microvascular complications and that the relationship between presence of macrovascular complications and lack of concern about diabetes mellitus. PMID:26170633

  6. 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

  7. 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

  8. A population-based case-control study of canine mammary tumours and clinical use of medroxyprogesterone acetate.

    PubMed

    Støvring, M; Moe, L; Glattre, E

    1997-08-01

    We investigated whether or not an association could be found between mammary tumours and prior clinical use of medroxyprogesterone acetate (MPA) in bitches. A population-based retrospective age-matched case-control study was designed based on interviews with the owners of the bitches. The proportion of bitches with diagnosed mammary tumours (group MT+, n = 98) that had received progestin injections was compared with the proportion in a control group without mammary tumours (group MT-, n = 98). In the case group 39%, and in the control group 21% of the bitches had been treated with MPA. A significantly higher number of bitches with mammary tumours had been exposed to progestins, compared with the control group without mammary tumours (odds ratio = 2.32, Chi-square = 7.01, p = 0.008). Bitches treated clinically with low doses of MPA to avoid oestrus were at a greater risk of developing mammary tumours, the majority of which were histologically malignant (91%). PMID:9298095

  9. 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

  10. 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

  11. Randomized, Placebo-controlled Clinical Trial of an Aerosolized β2-Agonist for Treatment of Acute Lung Injury

    PubMed Central

    2011-01-01

    Rationale: β2-Adrenergic receptor agonists accelerate resolution of pulmonary edema in experimental and clinical studies. Objectives: This clinical trial was designed to test the hypothesis that an aerosolized β2-agonist, albuterol, would improve clinical outcomes in patients with acute lung injury (ALI). Methods: We conducted a multicenter, randomized, placebo-controlled clinical trial in which 282 patients with ALI receiving mechanical ventilation were randomized to receive aerosolized albuterol (5 mg) or saline placebo every 4 hours for up to 10 days. The primary outcome variable for the trial was ventilator-free days. Measurements and Main Results: Ventilator-free days were not significantly different between the albuterol and placebo groups (means of 14.4 and 16.6 d, respectively; 95% confidence interval for the difference, −4.7 to 0.3 d; P = 0.087). Rates of death before hospital discharge were not significantly different between the albuterol and placebo groups (23.0 and 17.7%, respectively; 95% confidence interval for the difference, −4.0 to 14.7%; P = 0.30). In the subset of patients with shock before randomization, the number of ventilator-free days was lower with albuterol, although mortality was not different. Overall, heart rates were significantly higher in the albuterol group by approximately 4 beats/minute in the first 2 days after randomization, but rates of new atrial fibrillation (10% in both groups) and other cardiac dysrhythmias were not significantly different. Conclusions: These results suggest that aerosolized albuterol does not improve clinical outcomes in patients with ALI. Routine use of β2-agonist therapy in mechanically ventilated patients with ALI cannot be recommended. Clinical trial registered with www.clinicaltrials.gov (NCT 00434993). PMID:21562125

  12. 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…

  13. [System of internal laboratory control over the quality of clinical biochemical research].

    PubMed

    Marinov, S; Tsvetkova, R; Parashkevova, E

    1987-01-01

    An analysis and testing of the system of on-laboratory control on the quality of biochemical investigations with the use of control cards, has been performed. The system provides for the working out of control cards, the carrying out of control investigations, the evaluation of the results, and the correction of the control cards. Data for the built-up of the cards has been obtained with the practice of as many as 30 replications with one and the same sample, under the same conditions, the values of the average quadratic deviation (S) being in compliance with Tonks criterion. The action of control is substantiated through doubling the study of 10 per cent of the samples of each batch for each analysis and evaluation of the differences with regard to S by a two-mark system. An average mark from 0.00 to 2.00 per batch of samples is formed for each analysis. Filled in control cards for the total calcium and inorganic phosphorus are presented as an example. The changes in the S values are followed up after the introduction of control cards for 9 indices. With 7 indices reproducibility has proved higher. A total of 90 series of analyses have been controlled and evaluated--54 series (60 per cent) have proved 'good' (from 1.5 to 2.00), 22 series (24.44 per cent)--'satisfactory' (from 1.00 to 1.49), and 14 series (15.56 per cent)--'bad' (from 0.00 to 1.00 or at differences greater than 2.5 S) which implied that the respective analyses of the series of samples had to be replicated. A total of 24 control cards for various indices have been built up. PMID:3617472

  14. Mild clinical behaviour of Crohn disease in elderly patients in a Latin American country: A case-control study

    PubMed Central

    Yamamoto-Furusho, Jesús K; Sarmiento-Aguilar, Andrea

    2015-01-01

    BACKGROUND: Crohn disease is characterized by fluctuating clinical behaviour, which is influenced by various factors. There are no data from Latin America that evaluate the clinical behaviour of Crohn disease in elderly patients. OBJECTIVE: To evaluate the clinical course of elderly onset Crohn disease compared with younger onset in the Mexican population. METHODS: The present analysis was a case-control study that included 132 patients with a histopathological diagnosis of Crohn disease between 1983 and 2013 in an inflammatory bowel disease clinic of a tertiary care centre. Statistical analysis was performed using SPSS version 17 (IBM Corporation, USA) and descriptive statistics, χ2 and Fisher’s exact test for categorical variables and Student’s t test for numerical variables. Univariate and multivariate analysis were performed to identify associated risk factors and OR was calculated. RESULTS: A total of 132 patients (73 men and 59 women) were divided into two groups according to age at diagnosis: 27 cases (>60 years of age) and 105 controls (≤60 years of age). Factors influencing the clinical course of Crohn disease in the elderly were: female sex (OR 2.55 [95% CI 1.06 to 6.10]; P=0.02); colonic location (OR 0.22 [95% CI 0.03 to 0.89]; P=0.02); mild clinical behaviour of disease (OR 10.08 [95% CI 3.74 to 27.17]; P=0.0001); response to medical treatment (OR 2.85 [95% CI 1.08 to 7.48]; P=0.02); frequent use of sulfasalazine (OR 4.46 [95% CI 1.22 to 16.28]; P=0.03); less use of azathioprine (OR 0.38 [95% CI 0.13 to 1.03]; P=0.04); and long-term remission (OR 4.96 [95% CI 1.70 to 14.48]; P=0.002). CONCLUSION: Elderly patients with Crohn disease had a mild clinical course characterized by the lack of escalation to immunosuppressive and anti-tumour necrosis factor therapy, as well as long-term remission. PMID:25996614

  15. Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive–behavioural approaches

    PubMed Central

    Hewlett, S; Ambler, N; Almeida, C; Blair, P S; Choy, E; Dures, E; Hammond, A; Hollingworth, W; Kirwan, J; Plummer, Z; Rooke, C; Thorn, J; Tomkinson, K; Pollock, J

    2015-01-01

    Introduction Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive–behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability. Methods and analysis This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10–16 patients with RA (fatigue severity ≥6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5–6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5–8 patients will attend 6×2 h sessions (weeks 1–6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively. Ethics and dissemination Approval was given by an NHS Research Ethics Committee, and participants will provide written

  16. Distinguishing malaria and influenza: Early clinical features in controlled human experimental infection studies☆

    PubMed Central

    Lillie, Patrick J.; Duncan, Christopher J.A.; Sheehy, Susanne H.; Meyer, Joel; O'Hara, Geraldine A.; Gilbert, Sarah C.; Hill, Adrian V.S.

    2012-01-01

    Summary During the H1N1 influenza pandemic (pH1N1/09) diagnostic algorithms were developed to guide antiviral provision. However febrile illnesses are notoriously difficult to distinguish clinically. Recent evidence highlights the importance of incorporating travel history into diagnostic algorithms to prevent the catastrophic misdiagnosis of life-threatening infections such as malaria. We applied retrospectively the UK pH1N1/09 case definition to a unique cohort of healthy adult volunteers exposed to Plasmodium falciparum malaria or influenza to assess the predictive value of this case definition, and to explore the distinguishing clinical features of early phase infection with these pathogens under experimental conditions. For influenza exposure the positive predictive value of the pH1N1/09 case definition was only 0.38 (95% CI: 0.06–0.60), with a negative predictive value of 0.27 (95% CI: 0.02–0.51). Interestingly, 8/11 symptomatic malaria-infected adults would have been inappropriately classified with influenza by the pH1N1/09 case definition, while 5/8 symptomatic influenza-exposed volunteers would have been classified without influenza (P = 0.18 Fisher's exact). Cough (P = 0.005) and nasal symptoms (P = 0.001) were the only clinical features that distinguished influenza-exposed from malaria-exposed volunteers. An open mind regarding the clinical cause of undifferentiated febrile illness, particularly in the absence of upper respiratory tract symptoms, remains important even during influenza pandemic settings. These data support incorporating travel history into pandemic algorithms. PMID:22531678

  17. 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

  18. Automated Tools for Clinical Research Data Quality Control using NCI Common Data Elements

    PubMed Central

    Hudson, Cody L.; Topaloglu, Umit; Bian, Jiang; Hogan, William; Kieber-Emmons, Thomas

    2014-01-01

    Clinical research data generated by a federation of collection mechanisms and systems often produces highly dissimilar data with varying quality. Poor data quality can result in the inefficient use of research data or can even require the repetition of the performed studies, a costly process. This work presents two tools for improving data quality of clinical research data relying on the National Cancer Institute’s Common Data Elements as a standard representation of possible questions and data elements to A: automatically suggest CDE annotations for already collected data based on semantic and syntactic analysis utilizing the Unified Medical Language System (UMLS) Terminology Services’ Metathesaurus and B: annotate and constrain new clinical research questions though a simple-to-use “CDE Browser.” In this work, these tools are built and tested on the open-source LimeSurvey software and research data analyzed and identified to contain various data quality issues captured by the Comprehensive Research Informatics Suite (CRIS) at the University of Arkansas for Medical Sciences. PMID:25717402

  19. 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

  20. Correlation between clinical indicators of lead poisoning and oxidative stress parameters in controls and lead-exposed workers.

    PubMed

    Gurer-Orhan, Hande; Sabir, Handan U; Ozgüneş, Hilal

    2004-02-15

    The present study was undertaken to investigate the involvement of oxidative damage in lead-induced toxicity in humans and to enlighten whether oxidative stress indicators are correlated with the known indices of lead toxicity. For these purposes, selected oxidative stress parameters along with some clinical indices of lead poisoning were determined in blood of battery plant workers and control subjects. Workers had significantly increased erythrocyte malondialdehyde (MDA) levels, catalase and glucose-6-phosphate dehydrogenase (G6PD) activities, and decreased blood glutathione:glutathione disulfide ratio compared to the controls. Increased blood lead concentrations and zinc protoporphyrin (ZPP) levels, and decreased delta-aminolevulinic acid dehydratase (ALAD) activity were used as clinical indices of lead toxicity. Statistically significant correlation between oxidative stress parameters and clinical indices implies that disrupted prooxidant/antioxidant balance might contribute to lead-induced toxicity in erythrocytes. A significant correlation was found between ALAD activity and blood lead levels in human subjects. Similarly significant correlation between ALAD activity and erythrocyte MDA concentrations was shown. Present data indicates that ALAD can serve as a valuable biomarker of oxidative stress in lead-exposed hematological system as well as being a biochemical indicator of lead exposure. PMID:14751670

  1. 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.

  2. Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics

    PubMed Central

    2014-01-01

    Background Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers, but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients. Methadone clinic-based, directly observed therapy (DOT) programs for HIV and tuberculosis improve adherence and clinical outcomes, but have not been evaluated for smoking cessation. We describe a randomized controlled trial to evaluate whether a methadone clinic-based, directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment. Methods/Design We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual (self-administered varenicline) for 12 weeks. Our outcome measures are: 1) pill count adherence and 2) carbon monoxide-verified tobacco abstinence. We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models. Discussion This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based, directly observed varenicline for improving adherence and smoking cessation outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment. Trial Registration clinicaltrials.gov NCT01378858 PMID:24928218

  3. Expression of the CDR1 efflux pump in clinical Candida albicans isolates is controlled by a negative regulatory element

    SciTech Connect

    Gaur, Naseem Akhtar; Manoharlal, Raman; Saini, Preeti; Prasad, Tulika; Mukhopadhyay, Gauranga; Hoefer, Milan; Morschhaeuser, Joachim; Prasad, Rajendra . E-mail: rp47@hotmail.com

    2005-06-24

    Resistance to azole antifungal drugs in clinical isolates of the human fungal pathogen Candida albicans is often caused by constitutive overexpression of the CDR1 gene, which encodes a multidrug efflux pump of the ABC transporter superfamily. To understand the relevance of a recently identified negative regulatory element (NRE) in the CDR1 promoter for the control of CDR1 expression in the clinical scenario, we investigated the effect of mutation or deletion of the NRE on CDR1 expression in two matched pairs of azole-sensitive and resistant clinical isolates of C. albicans. Expression of GFP or lacZ reporter genes from the wild type CDR1 promoter was much higher in the azole-resistant C. albicans isolates than in the azole-susceptible isolates, reflecting the known differences in CDR1 expression in these strains. Deletion or mutation of the NRE resulted in enhanced reporter gene expression in azole-sensitive strains, but did not further increase the already high CDR1 promoter activity in the azole-resistant strains. In agreement with these findings, electrophoretic mobility shift assays showed a reduced binding to the NRE of nuclear extracts from the resistant C. albicans isolates as compared with extracts from the sensitive isolates. These results demonstrate that the NRE is involved in maintaining CDR1 expression at basal levels and that this repression is overcome in azole-resistant clinical C. albicans isolates, resulting in constitutive CDR1 overexpression and concomitant drug resistance.

  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. PMID:26010126

  5. Developing a Controlled Vocabulary for the Columbia-Presbyterian Medical Center Outpatient Clinical Information System

    PubMed Central

    Clark, Anthony S.; Shea, Steven

    1990-01-01

    This paper describes the development of a Controlled Vocabulary for medication and problem/diagnostic lists in an ambulatory patient care information system within the institution's overall IAIMS framework. This Controlled Vocabulary is used in a spell-checking filter for uploading existing free text data and for on-line entry of new data by physicians. The Controlled Vocabulary consists of a reference file, keyed by code, and an inverted word index file to access it. It is currently loaded with an in-house produced set of medication codes and SNOMED Level 1 Disease codes supplemented by additional user entries.

  6. 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

  7. 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.

  8. 77 FR 24985 - Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... September 23, 1975, 40 FR 43745-46, all applicants for registration to import the basic class of any... controlled substances: Drug Schedule Oxycodone (9143) II Hydromorphone (9150) II Tapentadol (9780)...

  9. 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... following basic classes of controlled substances: Drug Schedule Methylphenidate (1724) II Sufentanil...

  10. Perceived athletic competence and physical activity in children with developmental coordination disorder who are clinically referred, and control children.

    PubMed

    Noordstar, Johannes J; Stuive, Ilse; Herweijer, Hester; Holty, Lian; Oudenampsen, Chantal; Schoemaker, Marina M; Reinders-Messelink, Heleen A

    2014-12-01

    The relationship between perceived athletic competence (PAC) and physical activity (PA) in children with developmental coordination disorder (DCD) is still unclear. This study investigated differences in PAC and PA between, and within, a group of children with DCD that were clinically referred (n = 31) and a group of control children (n = 38), aged 7-12 years. All children were categorized in four groups: (1) children with DCD/low PAC, (2) children with DCD/normal to high PAC, (3) control children/low PAC, and (4) control children/normal to high PAC. PAC was assessed with the Self-Perception Profile for Children, and PA was assessed with the Modifiable Activity Questionnaire. Children with DCD participated less in unorganized PA, but not in organized PA, compared with control children. Normal to high PAC was found in more than half of the children (64.5%) with DCD. Children with DCD/low PAC and children with DCD/normal to high PAC participated significantly less in unorganized physical activity compared with control children/normal to high PAC, but not compared with control children/low PAC. The results indicate that there are large individual differences in PAC in children with DCD. PMID:25244693

  11. 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

  12. Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension

    PubMed Central

    Rifkin, Dena E.; Abdelmalek, Joseph A.; Miracle, Cynthia M.; Low, Chai; Barsotti, Ryan; Rios, Phil; Stepnowsky, Carl; Agha, Zia

    2014-01-01

    Objective Older adults with chronic kidney disease have a high rate of uncontrolled hypertension. Home monitoring of blood pressure (BP) is an integral part of management, but requires that patients bring records to clinic visits. Telemonitoring interventions, however, have not targeted older, less technologically-skilled populations. Methods Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were randomized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub, which wirelessly transmitted readings (n= 28), or usual care (n= 15). Home recordings were reviewed weekly and telemonitoring participants were contacted if BP was above goal. The prespecified primary endpoints were improved data exchange and device acceptability. Secondary endpoint was BP change. Results Forty-three participants (average age 68 years, 75% white) completed the 6-month study. Average start-of-study BP was 147/78mmHg. Those in the intervention arm had a median of 29 (IQR 22, 53) transmitted BP readings per month, with 78% continuing to use the device regularly, whereas only 20% of those in the usual care group brought readings to in-person visits. The median number of telephone contacts triggered by the wireless monitoring was 2 (IQR 1, 4) per patient. Both groups had a significant improvement in systolic BP (P< 0.05, for both changes); systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5mmHg in usual care participants (P for comparison 0.31). Conclusion This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months. PMID:23275313

  13. A controlled trial of automated classification of negation from clinical notes

    PubMed Central

    Elkin, Peter L; Brown, Steven H; Bauer, Brent A; Husser, Casey S; Carruth, William; Bergstrom, Larry R; Wahner-Roedler, Dietlind L

    2005-01-01

    Background Identification of negation in electronic health records is essential if we are to understand the computable meaning of the records: Our objective is to compare the accuracy of an automated mechanism for assignment of Negation to clinical concepts within a compositional expression with Human Assigned Negation. Also to perform a failure analysis to identify the causes of poorly identified negation (i.e. Missed Conceptual Representation, Inaccurate Conceptual Representation, Missed Negation, Inaccurate identification of Negation). Methods 41 Clinical Documents (Medical Evaluations; sometimes outside of Mayo these are referred to as History and Physical Examinations) were parsed using the Mayo Vocabulary Server Parsing Engine. SNOMED-CT™ was used to provide concept coverage for the clinical concepts in the record. These records resulted in identification of Concepts and textual clues to Negation. These records were reviewed by an independent medical terminologist, and the results were tallied in a spreadsheet. Where questions on the review arose Internal Medicine Faculty were employed to make a final determination. Results SNOMED-CT was used to provide concept coverage of the 14,792 Concepts in 41 Health Records from John's Hopkins University. Of these, 1,823 Concepts were identified as negative by Human review. The sensitivity (Recall) of the assignment of negation was 97.2% (p < 0.001, Pearson Chi-Square test; when compared to a coin flip). The specificity of assignment of negation was 98.8%. The positive likelihood ratio of the negation was 81. The positive predictive value (Precision) was 91.2% Conclusion Automated assignment of negation to concepts identified in health records based on review of the text is feasible and practical. Lexical assignment of negation is a good test of true Negativity as judged by the high sensitivity, specificity and positive likelihood ratio of the test. SNOMED-CT had overall coverage of 88.7% of the concepts being negated

  14. 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

  15. 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

  16. When Ethics Constrains Clinical Research: Trial Design of Control Arms in “Greater Than Minimal Risk” Pediatric Trials

    PubMed Central

    de Melo-Martín, Inmaculada; Sondhi, Dolan

    2011-01-01

    Abstract 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. PMID:21446781

  17. Development and Clinical Application of a Precise Temperature-Control Device as an Alternate for Conventional Moxibustion Therapy

    PubMed Central

    Takayama, Shin; Takashima, Shigeru; Okajima, Junnosuke; Watanabe, Masashi; Kamiya, Tetsuharu; Seki, Takashi; Yamasaki, Miyako; Yaegashi, Nobuo; Yambe, Tomoyuki; Maruyama, Shigenao

    2012-01-01

    Moxibustion therapy has been used in East Asian medicine for more than a thousand years. However, there are some problems associated with this therapy in clinical practice. These problems include lack of control over the treatment temperature, emission of smoke, and uneven temperature distribution over the treatment region. In order to resolve these problems, we developed a precise temperature-control device for use as an alternate for conventional moxibustion therapy. In this paper, we describe the treatment of a single patient with paralytic ileus that was treated with moxibustion. We also describe an evaluation of temperature distribution on the skin surface after moxibustion therapy, the development of a heat-transfer control device (HTCD), an evaluation of the HTCD, and the clinical effects of treatment using the HTCD. The HTCD we developed can heat the skin of the treatment region uniformly, and its effect may be equivalent to conventional moxibustion, without the emission of smoke and smell. This device can be used to treat ileus, abdominal pain, and coldness of abdomen in place of conventional moxibustion in modern hospitals. PMID:22754583

  18. 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. PMID:27147120

  19. 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. PMID:25737785

  20. Minimally Invasive Surgical Technique in Periodontal Regeneration: A Randomized Controlled Clinical Trial Pilot Study.

    PubMed

    Ghezzi, Carlo; Ferrantino, Luca; Bernardini, Luigi; Lencioni, Margherita; Masiero, Silvia

    2016-01-01

    The purpose of this study was to compare two minimally invasive surgical techniques (MISTs) for the treatment of periodontal defects: (1) guided tissue regeneration (GTR) using resorbable minimembrane and particulate xenograft (DBBM); and (2) inductive periodontal regeneration (IPR) using enamel matrix derivatives and DBBM. A sample of 20 infrabony periodontal defects in 20 patients were randomly assigned to either the GTR or the IPR group. A follow-up was performed at 12 months postoperative. Significant improvement in clinical parameters was observed in both groups, although no intergroup differences were found. MIST with GTR or IPR demonstrated very good outcomes 1 year after surgery, with no differences between treatment groups. PMID:27333004

  1. 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. PMID:24059649

  2. Efficacy of sodium butyrate adjunct therapy in shigellosis: a randomized, double-blind, placebo-controlled clinical trial

    PubMed Central

    2012-01-01

    Background Treatment of shigellosis in rabbits with butyrate reduces clinical severity and counteracts the downregulation of cathelicidin (CAP-18) in the large intestinal epithelia. Here, we aimed to evaluate whether butyrate can be used as an adjunct to antibiotics in the treatment of shigellosis in patients. Methods A randomized, double-blind, placebo-controlled, parallel-group designed clinical trial was conducted. Eighty adult patients with shigellosis were randomized to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40). The Intervention group was given an enema containing sodium butyrate (80 mM), twice daily for 3 days, while the Placebo group received the same dose of normal saline. The primary endpoint of the trial was to assess the efficacy of butyrate in improving clinical, endoscopic and histological features of shigellosis. The secondary endpoint was to study the effect of butyrate on the induction of antimicrobial peptides in the rectum. Clinical outcomes were assessed and concentrations of antimicrobial peptides (LL-37, human beta defensin1 [HBD-1] and human beta defensin 3 [HBD-3]) and pro-inflammatory cytokines (interleukin-1β [IL-1β] and interleukin-8 [IL-8]) were measured in the stool. Sigmoidoscopic and histopathological analyses, and immunostaining of LL-37 in the rectal mucosa were performed in a subgroup of patients. Results Compared with placebo, butyrate therapy led to the early reduction of macrophages, pus cells, IL-8 and IL-1β in the stool and improvement in rectal histopathology. Butyrate treatment induced LL-37 expression in the rectal epithelia. Stool concentration of LL-37 remained significantly higher in the Intervention group on days 4 and 7. Conclusion Adjunct therapy with butyrate during shigellosis led to early reduction of inflammation and enhanced LL-37 expression in the rectal epithelia with prolonged release of LL-37 in the stool. Trial Registration Clinical

  3. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial

    PubMed Central

    Khosrawi, Saeid; Emadi, Masoud; Mahmoodian, Amir Ebrahim

    2016-01-01

    Background: The Study aimed to compare the effectiveness of two commonly used conservative treatments, splinting and local steroid injection in improving clinical and nerve conduction findings of the patients with severe carpal tunnel syndrome (CTS). Materials and Methods: In this randomized control clinical trial, the patients with severe CTS selected and randomized in two interventional groups. Group A was prescribed to use full time neutral wrist splint and group B was injected with 40 mg Depo-Medrol and prescribed to use the full time neutral wrist splint for 12 weeks. Clinical and nerve conduction findings of the patients was evaluated at baseline, 4 and 12 weeks after interventions. Results: Twenty-two and 21 patients were allocated in group A and B, respectively. Mean of clinical symptoms and functional status scores, nerve conduction variables and patients’ satisfaction score were not significant between group at baseline and 4 and 12 weeks after intervention. Within the group comparison, there was significant improvement in the patients’ satisfaction, clinical and nerve conduction items between the baseline level and 4 weeks after intervention and between the baseline and 12 weeks after intervention (P < 0.01). The difference was significant for functional status score between 4 and 12 weeks after intervention in group B (P = 0.02). Conclusion: considering some findings regarding the superior effect of splinting plus local steroid injection on functional status scale and median nerve distal motor latency, it seems that using combination therapy could be more effective for long-term period specially in the field of functional improvement of CTS. PMID:26962518

  4. Clinical effect of azithromycin as an adjunct to non-surgical treatment of chronic periodontitis: a meta-analysis of randomized controlled clinical trials.

    PubMed

    Zhang, Z; Zheng, Y; Bian, X

    2016-06-01

    The results of recent published studies focusing on the effect of azithromycin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis are inconsistent. We conducted a meta-analysis of randomized controlled clinical trials to examine the effect of azithromycin combined with SRP on periodontal clinical parameters as compared to SRP alone. An electronic search was carried out on Pubmed, Embase and the Cochrane Central Register of Controlled Trials from their earliest records through December 28, 2014 to identify studies that met pre-stated inclusion criteria. Reference lists of retrieved articles were also reviewed. Data were extracted independently by two authors. Either a fixed- or random-effects model was used to calculate the overall effect sizes of azithromycin on probing depth, attachment level (AL) and bleeding on probing (BOP). Heterogeneity was evaluated using the Q test and I(2) statistic. Publication bias was evaluated by Begg's test and Egger's test. A total of 14 trials were included in the meta-analysis. Compared with SRP alone, locally delivered azithromycin plus SRP statistically significantly reduced probing depth by 0.99 mm (95% CI 0.42-1.57) and increased AL by 1.12 mm (95% CI 0.31-1.92). In addition, systemically administered azithromycin plus SRP statistically significantly reduced probing depth by 0.21 mm (95% CI 0.12-0.29), BOP by 4.50% (95% CI 1.45-7.56) and increased AL by 0.23 mm (95% CI 0.07-0.39). Sensitivity analysis yielded similar results. No evidence of publication bias was observed. The additional benefit of systemic azithromycin was shown at the initially deep probing depth sites, but not at shallow or moderate sites. The overall effect sizes of systemic azithromycin showed a tendency to decrease with time, and meta-regression analysis suggested a negative relation between the length of follow-up and net change in probing depth (r = -0.05, p = 0.02). This meta-analysis provides further

  5. 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

  6. 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

  7. 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

  8. Is painless synovitis different from painful synovitis? A controlled, ultrasound, radiographic, clinical trial

    PubMed Central

    Pereira, Daniele Freitas; Natour, Jamil; de Buosi, Ana Leticia Pirozzi; Ferreira, Fernando Bernardes Maia Diniz; da Rocha Corrêa Fernandes, Artur; Furtado, Rita Nely Vilar

    2014-01-01

    OBJECTIVE: This study compares the clinical, ultrasonography, radiography, and laboratory outcomes of painless and painful chronic synovitis in patients with established rheumatoid arthritis. METHODS: This cross-sectional study involved 60 patients with rheumatoid arthritis and synovitis in the metacarpophalangeal joints; 30 of the patients did not experience pain, and 30 had experienced pain for at least 6 months prior to the study. The radiocarpal, distal radioulnar, and metacarpophalangeal joints were evaluated using the ultrasound gray scale, power Doppler, and radiography. Past and present clinical and laboratory findings were also evaluated. RESULTS: There were no statistically significant differences between the groups for most of the outcomes. The group with pain scored worse on the disease activity indices (e.g., DAS 28 and SDAI), function questionnaires (HAQ and Cochin), and pinch strength test. A logistic regression analysis revealed that the use of an immunobiological agent was associated with a 3-fold greater chance of belonging to the group that experienced pain. The painless group had worse erosion scores in the second and fifth metacarpophalangeal with odd ratios (ORs) of 6.5 and 3.5, respectively. The painless group had more cartilage with grade 4 damage in the third metacarpophalangeal. CONCLUSIONS: The rheumatoid arthritis patients with both painless and painful synovitis exhibited similar disease histories and radiographic and ultrasound findings. However, the ultrasonography evaluation revealed worse scores in the second and fifth metacarpophalangeal of the synovitis patients who did not experience pain. PMID:24519199

  9. Cellular reprogramming for pancreatic β-cell regeneration: clinical potential of small molecule control

    PubMed Central

    2014-01-01

    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. PMID:24679123

  10. Treatment of adult asthma: controlled double-blind clinical trial of oxitropium bromide.

    PubMed

    Taytard, A; Auzerie, J; Vergeret, J; Tozon, N; Freour, P

    1984-01-01

    Sixteen young adult sufferers from extrinsic paroxysmal asthma with pollen hypersensitivity took part in a therapeutic trial of the synthetic anticholinergic agent oxitropium bromide administered by a metered dose inhaler. The study comprised three 3-week periods. The first, run-in period was carried out to confirm the ability of the patients to maintain a daily record of symptoms. During the second and third periods, the patient received 3 X 2 inhalations of drug or placebo in a cross-over design. The medical staff was blind to the nature of the aerosol (drug or placebo), which was given in random order. The run-in clinical score was high. Asymptomatic days were relatively infrequent and daily drug consumption was high. Functional studies between the cross-over periods showed flow-rate values close to normal, with an increase in residual volume and functional residual capacity. During treatment either with placebo or oxitropium, there was a statistically significant decrease in clinical scores. Results for oxitropium bromide treatment were significantly better than the run-in values (p less than 0.005) and the placebo period (p less than 0.02). There was no significant change in non-trial drug consumption. Functional values showed no difference in terms of flow rate, although oxitropium did cause a significant improvement in the RV/TLC ratio (p less than 0.05). No adverse reactions were reported. PMID:6376144

  11. Examination of weight control practices in a non-clinical sample of college women.

    PubMed

    Hayes, S; Napolitano, M A

    2012-09-01

    The current study examined healthy weight control practices among a sample of college women enrolled at an urban university (N=715; age=19.87±1.16; 77.2% Caucasian; 13.4% African American, 7.2% Asian, 2.2% other races). Participants completed measures as part of an on-line study about health habits, behaviors, and attitudes. Items from the Three Factor Eating Questionnaire were selected and evaluated with exploratory factor analysis to create a healthy weight control practices scale. Results revealed that college women, regardless of weight status, used a comparable number (four of eight) of practices. Examination of racial differences between Caucasian and African American women revealed that normal weight African American women used significantly fewer strategies than Caucasian women. Of note, greater use of healthy weight control practices was associated with higher cognitive restraint, drive for thinness, minutes of physical activity, and more frequent use of compensatory strategies. Higher scores on measures of binge and disinhibited eating, body dissatisfaction, negative affect, and depressive symptoms were associated with greater use of healthy weight control practices by underweight/normal weight but not by overweight/obese college women. Results suggest that among a sample of college females, a combination of healthy and potentially unhealthy weight control practices occurs. Implications of the findings suggest the need for effective weight management and eating disorder prevention programs for this critical developmental life stage. Such programs should be designed to help students learn how to appropriately use healthy weight control practices, as motivations for use may vary by weight status. PMID:23086250

  12. 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

  13. Preventive effect of vitamin D3 supplementation on conversion of optic neuritis to clinically definite multiple sclerosis: a double blind, randomized, placebo-controlled pilot clinical trial.

    PubMed

    Derakhshandi, Hajar; Etemadifar, Masoud; Feizi, Awat; Abtahi, Seyed-Hossein; Minagar, Alireza; Abtahi, Mohammad-Ali; Abtahi, Zahra-Alsadat; Dehghani, Alireza; Sajjadi, Sepideh; Tabrizi, Nasim

    2013-09-01

    Multiple sclerosis (MS) presents with optic neuritis (ON) in 20 % of cases and 50 % of ON patients develop MS within 15 years. In this study, we evaluated the preventive effects of vitamin D3 administration on the conversion of ON to MS (primary outcome) and on the MRI lesions (secondary outcome) of ON patients with low serum 25 (OH) D levels. Thirty ON patients (15 in each of 2 groups, aged 20-40 years) with serum 25 (OH) D levels of less than 30 ng/ml were enrolled in a double blind, randomized, parallel-group trial. The treatment group (cases) received 50,000 IU of vitamin D3 weekly for 12 months and the control group (controls) received a placebo weekly for 12 months. Finally, the subsequent relapse rate and changes in MRI plaques were compared between the two groups. Risk reduction was 68.4 % for the primary outcome in the treatment group (relative risk = 0.316, p = 0.007). After 12 months, patients in the treatment group had a significantly lower incidence rate of cortical, juxtacortical, corpus callosal, new T2, new gadolinium-enhancing lesions and black holes. The mean number of total plaques showed a marginally significant decrease in the group receiving vitamin D3 supplementation as compared with the placebo group (p = 0.092). Administration of vitamin D3 supplements to ON patients with low serum vitamin 25 (OH) D levels may delay the onset of a second clinical attack and the subsequent conversion to MS. PMID:23250818

  14. 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…

  15. 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…

  16. 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…

  17. Application of dietary fiber in clinical enteral nutrition: A meta-analysis of randomized controlled trials

    PubMed Central

    Yang, Gang; Wu, Xiao-Ting; Zhou, Yong; Wang, Ying-Li

    2005-01-01

    AIM: To evaluate the effects of dietary fiber (DF) as a part of enteral nutrition (EN) formula on diarrhea, infection, and length of hospital stay. METHODS: Following electronic databases were searched for randomized controlled trials about DF: Chinese Biomedicine Database (CBM), MEDLINE, EMBASE and Cochrane Controlled Trials Register. RevMan 4.1 was used for statistical analysis. RESULTS: Seven randomized controlled trials with 400 pat-ients were included. The supplement of DF in EN was compared with standard enteral formula in five trials. Combined analysis did not show a significant reduction in occurrence of diarrhea, but there were valuable results for non-critically ill patients. Combined analysis of two trials observing the infection also did not show any valid evidence that DF could decrease the infection rate, though the length of hospital stay was reduced significantly. CONCLUSION: Based on the current eligible randomized controlled trials, there is no evidence that the value of DF in the diarrhea can be proved. Though length of hospital stay was shortened by the use of DF, there is no available evidence in preventing infection by DF. Further studies are needed for evaluating the value of DF in EN. PMID:15991297

  18. 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

  19. 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

  20. 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

  1. Immunologic profiles of persons recruited for a randomized, placebo-controlled clinical trial of hookworm infection.

    PubMed

    Blount, Daniel; Hooi, Doreen; Feary, Johanna; Venn, Andrea; Telford, Gary; Brown, Alan; Britton, John; Pritchard, David

    2009-11-01

    Data from epidemiologic studies suggest that hookworm infections, in establishing an immunologic phenotype conducive to parasite survival, may protect against the development of allergic disease. We describe immunologic findings from a clinical study designed to investigate the safety of iatrogenic hookworm infection in participants with allergic rhinitis. The low, relatively safe level of hookworm infection used in this study was immunogenic, inducing eosinophilia and a significant specific IgG response. Importantly, no potentiation of IgE responses to the environmental allergens to which the participants were sensitized was seen. However, no evidence of systemic immune regulation was seen in infected participants. This finding may indicate that the level of infection or the frequency of infection may have to be altered in future trials to induce a therapeutically conducive immunologic phenotype. PMID:19861631

  2. 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.

  3. Conservative management of canine tracheal collapse with stanozolol: a double blinded, placebo control clinical trial.

    PubMed

    Adamama-Moraitou, K K; Pardali, D; Athanasiou, L V; Prassinos, N N; Kritsepi, M; Rallis, T S

    2011-01-01

    The objective of this study is to determine the efficacy of stanozolol in the treatment of tracheal collapse (TC) in dogs, which is the analogous disease to tracheomalacia (TM) in humans. Twenty-two dogs with endoscopically confirmed and graded TC were enrolled into five groups. Groups S1 (n=5), S2 (n=5) and S3 (n=4) with grade 1, 2 and 3 TC, respectively, received stanozolol orally for 75 days, while groups P1 (n=4) and P2 (n=4) with grade 1 and 2 TC, respectively, received placebo. The clinical score was evaluated every 15 days, whereas TC grade was reassessed at the end of the experiment. Clinical improvement was detected from the 30th day in S2 and S3 group dogs and from the 45th day in S1 group dogs and continued until the end of the experiment. Also, statistically significant differences were seen between S2 and P2 dogs from the 30th day, and between S1 and P1 dogs from the 60th day, and continued until the end of the study. Amelioration of the TC grade was seen in 13 of 14 (92.9%) dogs, which received stanozolol. Of the 14 dogs, 57.1% were cured and 35.8% demonstrated a less severe TC grade, while only one dog (7.1%) did not improve at all. Stanozolol seems to be an effective drug in the management of canine TC and it may have potential for use in humans with TM. PMID:21496393

  4. Effects of a Web-Based Patient Activation Intervention to Overcome Clinical Inertia on Blood Pressure Control: Cluster Randomized Controlled Trial

    PubMed Central

    Thiboutot, Jeffrey; Falkner, Bonita; Kephart, Donna K; Stuckey, Heather L; Adelman, Alan M; Curry, William J; Lehman, Erik B

    2013-01-01

    frequent discussions about tetanus and pneumonia vaccines and reported more tetanus (30, 13.8% vs 15, 5.3%; P=.02) and pneumonia (25, 11.5% vs 16, 5.7%; P=.02) vaccinations after 12 months. Conclusions The use of an interactive website designed to overcome clinical inertia for hypertension care did not lead to improvements in blood pressure control. Participant adherence to the intervention was high. The control intervention led to positive changes in the use of preventive services (eg, tetanus immunization) and the intervention condition led to more discussions of hypertension-relevant tests (eg, serum creatinine and urine protein). By providing patients with individually tailored questions to ask during PCP visits, this study demonstrated that participants were likely to discuss the questions with PCPs. These discussions did not, however, lead to improvements in blood pressure control. Trial Registration ClinicalTrials.gov NCT00377208; http://clinicaltrials.gov/ct2/show/NCT00377208 (Archived by WebCite at http://www.webcitation.org/6IqWiPLon). PMID:24004475

  5. 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

  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 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

  8. Azithromycin therapy of papillomatosis in dogs: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

    PubMed

    Yağci, Buğrahan Bekir; Ural, Kerem; Ocal, Naci; Haydardedeoğlu, Ali Evren

    2008-08-01

    Azithromycin, an azalide subclass macrolide antibiotic, is an effective, well-tolerated and safe therapeutic option for treatment of papillomatosis in humans. This study reports the clinical and histopathological results from a prospective, randomized, double-blinded, placebo-controlled trial of 17 dogs of various breeds with diagnosis of oral (n = 12) and cutaneous papillomatosis (n = 5) treated with azithromycin. Papillomas appeared as whitish, verrucous, hyperkeratotic papules 1-2.7 mm in size. The cases were randomly assigned to azithromycin (n = 10) and placebo treatment groups (n = 7). Both owners and investigators were blinded to the allocation to the groups. Azithromycin (10 mg/kg) was administered per os every 24 h for 10 days. Clinical evaluations were done by the same investigator throughout the trial. Azithromycin treatment significantly decreased clinical scores (P < 0.001), whereas there was no change seen in the placebo group. In the azithromycin treatment group, skin lesions disappeared in 10-15 days. One case in the placebo had spontaneous regression of its papillomas by day 41, but lesions were still evident at day 50 in the remaining six cases. There was no recurrence of papillomatosis in the azithromycin treated dogs (follow up 8 months). No adverse effects were seen in either group. In conclusion, azithromycin appears to be a safe and effective treatment for canine papillomatosis. PMID:18494759

  9. 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

  10. Expanded role of the dietitian in the Diabetes Control and Complications Trial: implications for clinical practice. The DCCT Research Group.

    PubMed

    Delahanty, L; Simkins, S W; Camelon, K

    1993-07-01

    Initially, the dietitians' role in the Diabetes Control and Complications Trial (DCCT) was specifically defined to include evaluation of potential study volunteers, collection of dietary histories, provision of nutrition education, and participation in team management meetings. As the study progressed, recognition of the importance of adherence to diet in achieving hemoglobin A1c goals and the occurrence of undesirable weight gain in patients assigned randomly to intensive therapy provided an opportunity for dietitians to use their skills intensively and broadly. The need for dietary adherence made DCCT teams aware that dietitians needed to become more active in recruiting and selecting study volunteers and in implementing and evaluating all aspects of intensive diabetes treatment. Increased involvement in these activities allowed dietitians to develop relationships with research patients that were necessary to negotiate treatment goals and improve insights into dietary issues affecting care. Recognition of the importance of dietitians to the DCCT and the empowering nature of the annual meeting of DCCT dietitians fostered continued expansion of the dietitians' role in the clinical centers and in studywide activities such as promotion of dietary adherence, ancillary studies, and publications. Dietitians participating in clinical trials are encouraged to develop their communication and counseling skills, seek out alliances with other team members, and explore opportunities for ancillary research. Such efforts will help to perpetuate this expanded model of the dietitians' role in clinical trials. PMID:8320401

  11. SEX DIFFERENCES IN ASTHMA SYMPTOM 1 PROFILES AND CONTROL IN THE AMERICAN LUNG ASSOCIATION ASTHMA CLINICAL RESEARCH CENTERS

    PubMed Central

    McCallister, Jennifer W.; Holbrook, Janet T.; Wei, Christine Y.; Parsons, Jonathan P.; Benninger, Cathy G.; Dixon, Anne E.; Gerald, Lynn B.; Mastronarde, John G.

    2013-01-01

    Objective Important differences between men and women with asthma have been demonstrated, with women describing more symptoms and worse asthma-related quality of life (QOL) despite having similar or better pulmonary function. While current guidelines focus heavily on assessing asthma control, they lack information about whether sex-specific approaches to asthma assessment should be considered. We sought to determine if sex differences in asthma control or symptom profiles exist in the well-characterized population of participants in the American Lung Association Asthma Clinical Research Centers (ALA-ACRC) trials. Methods We reviewed baseline data from four trials published by the ALA-ACRC to evaluate individual item responses to three standardized asthma questionnaires: the Juniper Asthma Control Questionnaire (ACQ), the multi-attribute Asthma Symptom Utility Index (ASUI), and Juniper Mini Asthma Quality of Life Questionnaire (mini-AQLQ). Results In the poorly-controlled population, women reported similar overall asthma control (mean ACQ 1.9 vs. 1.8; p=0.54), but were more likely to report specific symptoms such as nocturnal awakenings, activity limitations, and shortness of breath on individual item responses. Women reported worse asthma-related QOL on the mini-AQLQ (mean 4.5 vs. 4.9; p<0.001) and more asthma-related symptoms with a lower mean score on the ASUI (0.73 vs. 0.77; p=<0.0001) and were more likely to report feeling bothered by particular symptoms such as coughing, or environmental triggers. Conclusions In participants with poorly-controlled asthma, women had outwardly similar asthma control, but had unique symptom profiles on detailed item analyses which were evident on evaluation of three standardized asthma questionnaires. PMID:23972381

  12. 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

  13. 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. PMID:22668450

  14. 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

  15. 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. PMID:25891979

  16. Determination of efficacy of reflexology in managing patients with diabetic neuropathy: a randomized controlled clinical trial.

    PubMed

    Dalal, Krishna; Maran, V Bharathi; Pandey, Ravindra M; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy. PMID:24527055

  17. Clinical Outcomes of Metabolic Surgery: Efficacy of Glycemic Control, Weight Loss, and Remission of Diabetes.

    PubMed

    Schauer, Philip R; Mingrone, Geltrude; Ikramuddin, Sayeed; Wolfe, Bruce

    2016-06-01

    Since the 2007 Diabetes Surgery Summit in Rome, Italy, and the subsequent publishing of the world's first guidelines for the surgical treatment of type 2 diabetes (T2D), much new evidence regarding the efficacy and safety of metabolic surgery has emerged. Additional observational cohort studies support the superior effects of surgery over medical treatment with respect to glycemic control, weight loss, and even reduction in mortality and microvascular complications associated with T2D. Furthermore, new safety data suggest that the perioperative morbidity and mortality of metabolic surgery (5% and 0.3%, respectively) are now similar to that of common low-risk procedures, such as cholecystectomy and hysterectomy. The largest advance, however, has been the completion of 11 randomized controlled trials from around the globe that compare surgery with medical treatment of T2D. These studies with follow-up duration of 1-5 years involve nearly 800 patients without surgical mortality and with major complication rates of less than 5% and a reoperation rate of 8%. All but 1 of the 11 randomized controlled trials have shown the superiority of surgery over medical management at achieving remission or glycemic improvement. Surgery was also superior to medical treatment with respect to improving cardiovascular risk factors, such as weight loss and dyslipidemia, while reducing medication burden. This new efficacy and safety evidence should help guide physicians across the globe to the appropriate use of surgery as an effective treatment for patients suffering from T2D and obesity. PMID:27222548

  18. Emotional responses to images of food in adults with an eating disorder: a comparative study with healthy and clinical controls.

    PubMed

    Hay, Phillipa; Katsikitis, Mary

    2014-08-01

    Emotive responses to foods in people with eating disorders are incompletely understood in relation to whether the extent of emotional response is due to the eating disorder or non-specific emotional states. The aims of the present study were to investigate negative and positive emotive responses to food images in adults with an eating disorder, and to compare responses to a (i) healthy and a (ii) clinic (psychiatry) control group. Participants viewed 20 images (16 of foods previously found to evoke fear, disgust and happiness and 4 neutral images) at half-minute intervals and rated emotive responses on 3 visual analogue scales for each image. Participants with an eating disorder (n=26) were found to have significantly increased negative emotive (disgust and fear) responses and reduced positive (happiness) responses to the images compared to the 20 clinic and 61 healthy participants. Differences between groups remained significant when controlling for baseline levels of fear, disgust and happiness. Thus, the emotive responses to foods did not appear due to non-specific increases in anxiety or depression but rather was due to the presence of an eating disorder. PMID:25064283

  19. 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

  20. 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

  1. N of 1, two contemporary arm, randomised controlled clinical trial for bilateral epicondylitis: a new study design

    PubMed Central

    Fante, Claudia Del; Perotti, Cesare; Pavesi, Claudio Francesco; Coscia, Davide; Scotti, Valeria; Tinelli, Carmine

    2011-01-01

    Objective To investigate the use of a novel study design in analysis of bilateral elbow pain. Design N of 1, two contemporary arm, open label, randomised controlled clinical trial. Setting A clinical epidemiologist at a university hospital in Pavia, Italy. Participants Two elbows with epicondylitis. Interventions Autologous platelet lysate versus “wait and see” strategy. Main outcome measures Visual analogue scale for pain on elbow extension and resisted wrist extension. Results Over six months’ follow-up, the patient experienced bilateral improvement in pain, but higher in the treated arm, with a drop in visual analogue scale for pain from 28 to 4 for right (control) arm (drop of 24 points) and from 67 to 10.5 for left (treated) arm (drop of 56.5 points). Conclusions Platelet lysate might (or might not) work. Competing interests and lack of blinding might be relevant issues in the interpretation of trial results. However, the new study design can be applied to a number of conditions such as bilateral sport or trauma injuries, bilateral otitis, or any condition affecting chiral organs or limbs. PMID:22187187

  2. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

    PubMed Central

    2010-01-01

    Background Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. Methods/Design We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. Discussion This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. Trial Registration http://www.clinicaltrials.gov identifier NCT00888498. PMID:20958995

  3. 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

  4. Clinical Decision Support and Closed-Loop Control for Cardiopulmonary Management and Intensive Care Unit Sedation Using Expert Systems

    PubMed Central

    Gholami, Behnood; Bailey, James M.; Haddad, Wassim M.; Tannenbaum, Allen R.

    2013-01-01

    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. PMID:23620646

  5. 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. PMID:23620646

  6. 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

  7. Metformin use among type 2 diabetics and risk of pancreatic cancer in a clinic-based case-control study.

    PubMed

    Walker, Evan J; Ko, Andrew H; Holly, Elizabeth A; Bracci, Paige M

    2015-03-15

    A better understanding of the association between diabetes and pancreatic cancer (PC) may inform prevention and/or early detection strategies. Metformin has been associated with reduced risk of certain cancers, including PC, in some observational clinical studies. We assessed whether metformin use was associated with PC risk among those with type 2 diabetes (DM2), and whether metformin use modulated the association between DM2 and risk of PC. In total, 536 PC cases and 869 frequency-matched controls were recruited predominantly from University of California San Francisco medical clinics from 2006 to 2011. Eligible participants completed direct interviews using a structured risk factor questionnaire. The association between metformin use and PC risk was assessed using propensity score-weighted unconditional logistic regression methods in analyses restricted to diabetics and adjusted multivariable logistic models in the total study population. Ever use of metformin was not associated with PC risk in analyses restricted to DM2 (N = 170) participants (adjusted OR: 1.01, 95% CI: 0.61-1.68). In the total study population (N = 1,405) using nondiabetics as the referent group, PC risk was inversely associated with diabetes duration (ptrend  < 0.001). Further, when DM2 participants were grouped by ever/never use of metformin and compared with nondiabetics, metformin use did not affect the association between DM2 and PC risk (never users: OR: 1.44, 95% CI: 0.78-2.67; ever users: OR: 1.19, 95% CI: 0.72-1.99). Results from our clinic-based case-control study suggest that metformin use is not associated with PC risk among those with DM2 and does not alter the association between DM2 and PC risk. PMID:25091126

  8. 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

  9. Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya.

    PubMed

    Lowther, Keira; Harding, Richard; Ahmed, Aabid; Gikaara, Nancy; Ali, Zippy; Kariuki, Hellen; Sherr, Lorraine; Simms, Victoria; Selman, Lucy

    2016-01-01

    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 should be

  10. 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

  11. Rest versus exercise as treatment for patients with low back pain and Modic changes. a randomized controlled clinical trial

    PubMed Central

    2012-01-01

    Background Clinical experience suggests that many patients with Modic changes have relatively severe and persistent low back pain (LBP), which typically appears to be resistant to treatment. Exercise therapy is the recommended treatment for chronic LBP, however, due to their underlying pathology, Modic changes might be a diagnostic subgroup that does not benefit from exercise. The objective of this study was to compare the current state-of-the art treatment approach (exercise and staying active) with a new approach (load reduction and daily rest) for people with Modic changes using a randomized controlled trial design. Methods Participants were patients from an outpatient clinic with persistent LBP and Modic changes. They were allocated using minimization to either rest therapy for 10 weeks with a recommendation to rest for two hours daily and the option of using a flexible lumbar belt or exercise therapy once a week for 10 weeks. Follow-up was at 10 weeks after recruitment and 52 weeks after intervention and the clinical outcome measures were pain, disability, general health and global assessment, supplemented by weekly information on low back problems and sick leave measured by short text message (SMS) tracking. Results In total, 100 patients were included in the study. Data on 87 patients at 10 weeks and 96 patients at one-year follow-up were available and were used in the intention-to-treat analysis. No statistically significant differences were found between the two intervention groups on any outcome. Conclusions No differences were found between the two treatment approaches, 'rest and reduced load' and 'exercise and staying active', in patients with persistent LBP and Modic changes. Trial Registration ClinicalTrials.gov: NCT00454792 PMID:22376791

  12. 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

  13. 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. PMID:26126595

  14. 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

  15. 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

  16. 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

  17. A randomised, controlled clinical trial comparing chlorhexidine gel and low-dose fluoride toothpaste to prevent early childhood caries.

    PubMed

    Pukallus, Margaret L; Plonka, Kathryn A; Barnett, Adrian G; Walsh, Laurence J; Holcombe, Trevor F; Seow, W Kim

    2013-05-01

    OBJECTIVES.  This randomised, controlled trial compared the effectiveness of 0.12% chlorhexidine (CHX) gel and 304% fluoride toothpaste to prevent early childhood caries (ECC) in a birth cohort by 24 months. METHODS.  The participants were randomised to receive either (i) twice daily toothbrushing with toothpaste and once daily 0.12% CHX gel (n = 110) or (ii) twice daily toothbrushing with toothpaste only (study controls) (n = 89). The primary outcome measured was caries incidence and the secondary outcome was percentage of children with mutans streptococci (MS). All mothers were contacted by telephone at 6, 12, and 18 months. At 24 months, all children were examined at a community dental clinic. RESULTS.  At 24 months, the caries prevalence was 5% (3/61) in the CHX and 7% (4/58) in the controls (P = 0.7). There were no differences in percentages of MS-positive children between the CHX and control groups (54%vs 53%). Only 20% applied the CHX gel once daily and 80% less than once daily. CONCLUSIONS.  Toothbrushing using 304% fluoride toothpaste with or without the application of chlorhexidine gel (0.12%) reduces ECC from 23% found in the general community to 5-7%. The lack of effect with chlorhexidine is likely to be due to low compliance. PMID:22713081

  18. Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    PubMed Central

    Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

    2014-01-01

    Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients. PMID:25276758

  19. 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

  20. Effects of Safflower Yellow on the Treatment of Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial

    PubMed Central

    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

  1. Clinical Decision Support System to Enhance Quality Control of Spirometry Using Information and Communication Technologies

    PubMed Central

    2014-01-01

    Background We recently demonstrated that quality of spirometry in primary care could markedly improve with remote offline support from specialized professionals. It is hypothesized that implementation of automatic online assessment of quality of spirometry using information and communication technologies may significantly enhance the potential for extensive deployment of a high quality spirometry program in integrated care settings. Objective The objective of the study was to elaborate and validate a Clinical Decision Support System (CDSS) for automatic online quality assessment of spirometry. Methods The CDSS was done through a three step process including: (1) identification of optimal sampling frequency; (2) iterations to build-up an initial version using the 24 standard spirometry curves recommended by the American Thoracic Society; and (3) iterations to refine the CDSS using 270 curves from 90 patients. In each of these steps the results were checked against one expert. Finally, 778 spirometry curves from 291 patients were analyzed for validation purposes. Results The CDSS generated appropriate online classification and certification in 685/778 (88.1%) of spirometry testing, with 96% sensitivity and 95% specificity. Conclusions Consequently, only 93/778 (11.9%) of spirometry testing required offline remote classification by an expert, indicating a potential positive role of the CDSS in the deployment of a high quality spirometry program in an integrated care setting. PMID:25600957

  2. A randomized, controlled clinical trial of in virtuo and in vivo exposure for spider phobia.

    PubMed

    Michaliszyn, David; Marchand, André; Bouchard, Stéphane; Martel, Marc-Olivier; Poirier-Bisson, Joannie

    2010-12-01

    The present study compared the efficacy of virtual reality (VR) in virtuo exposure and in vivo exposure in the treatment of spider phobia. Two treatment conditions were compared to a waiting-list condition. A 3-month follow-up evaluation was conducted in order to assess the durability of the treatment effects. Participants were randomly assigned to the treatment groups. A total of 16 participants received the in virtuo treatment, and 16 received the in vivo treatment. The waiting-list condition included 11 participants. Participants received eight 1.5-hour treatment sessions. Efficacy was measured with the Fear of Spiders Questionnaire, the Spider Beliefs Questionnaire (SBQ-F), and a Behavioral Avoidance Test (BAT). In addition, a clinician administered the Structured Interview for DSM-IV to assess DSM-IV's criteria for specific phobia and severity. Clinical and statistically significant improvements were found for both groups. Differences in treatment groups were found on one of five measures of fear: greater improvement on the SBQ-F beliefs subscale was associated with in vivo exposure. PMID:21142994

  3. 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.

  4. 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

  5. Asymptomatic Bacteriuria in Clinical Urological Practice: Preoperative Control of Bacteriuria and Management of Recurrent UTI

    PubMed Central

    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

  6. 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

  7. 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

  8. 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

  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. Implementation of Strategies to Recognize and Control Hypertension in a Multispecialty Clinic, Montana, 2012-2013.

    PubMed

    Wall, Julie; McLaury, Marilyn M; Gohdes, Dorothy; Oser, Carrie S; Fogle, Crystelle C; Helgerson, Steven D; Harwell, Todd S

    2015-01-01

    Benefis Medical Group, in Great Falls, Montana, improved identification and treatment of hypertension through multifaceted interventions. The interventions included adopting policies for collection of vital signs, enhancing system-level reporting capability, tracking patients for the registry, and conducting patient outreach activities. From baseline to follow-up (December 2012 through September 2013), the percentage of patients with a documented blood pressure increased from 67% to 80%, the percentage diagnosed with hypertension increased from 16% to 36%, and the percentage with blood pressure control increased from 41% to 64%. Benefis Medical Group plans to sustain the successful evidence-based strategies that were adopted. PMID:26226066

  11. Implementation of Strategies to Recognize and Control Hypertension in a Multispecialty Clinic, Montana, 2012–2013

    PubMed Central

    Wall, Julie; Gohdes, Dorothy; Oser, Carrie S.; Fogle, Crystelle C.; Helgerson, Steven D.; Harwell, Todd S.

    2015-01-01

    Benefis Medical Group, in Great Falls, Montana, improved identification and treatment of hypertension through multifaceted interventions. The interventions included adopting policies for collection of vital signs, enhancing system-level reporting capability, tracking patients for the registry, and conducting patient outreach activities. From baseline to follow-up (December 2012 through September 2013), the percentage of patients with a documented blood pressure increased from 67% to 80%, the percentage diagnosed with hypertension increased from 16% to 36%, and the percentage with blood pressure control increased from 41% to 64%. Benefis Medical Group plans to sustain the successful evidence-based strategies that were adopted. PMID:26226066

  12. Grip Force Modulation Characteristics as a Marker for Clinical Disease Progression in Individuals With Parkinson Disease: Case-Control Study

    PubMed Central

    Scherer, Reinhold; Matsuoka, Yoky; Kelly, Valerie E.

    2015-01-01

    Background Upper extremity deficits are prevalent in individuals with Parkinson disease (PD). In the early stages of PD, such deficits can be subtle and challenging to document on clinical examination. Objective The purpose of this study was to use a novel force sensor system to characterize grip force modulation, including force, temporal, and movement quality parameters, during a fine motor control task in individuals with early stage PD. Design A case-control study was conducted. Methods Fourteen individuals with early stage PD were compared with a control group of 14 healthy older adults. The relationship of force modulation parameters with motor symptom severity and disease chronicity also was assessed in people with PD. Force was measured during both precision and power grasp tasks using an instrumented twist-cap device capable of rotating in either direction. Results Compared with the control group, the PD group demonstrated more movement arrests during both precision and power grasp and longer total movement times during the power grasp. These deficits persisted when a concurrent cognitive task was added, with some evidence of force control deficits in the PD group, including lower rates of force production during the precision grasp task and higher peak forces during the power grasp task. For precision grasp, a higher number of movement arrests in single- and dual-task conditions as well as longer total movement times in the dual-task condition were associated with more severe motor symptoms. Limitations The sample was small and consisted of individuals in the early stages of PD with mild motor deficits. The group with PD was predominantly male, whereas the control group was predominantly female. Conclusion The results suggest that assessing grip force modulation deficits during fine motor tasks is possible with instrumented devices, and such sensitive measures may be important for detecting and tracking change early in the progression of PD. PMID:25476717

  13. 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

  14. 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

  15. 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

  16. 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

  17. A Quality Control Program within a Clinical Trial Consortium for PCR Protocols To Detect Plasmodium Species

    PubMed Central

    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.

    2014-01-01

    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. PMID:24740073

  18. Does enriched acoustic environment in humans abolish chronic tinnitus clinically and electrophysiologically? A double blind placebo controlled study.

    PubMed

    Vanneste, Sven; van Dongen, Marijn; De Vree, Bjorn; Hiseni, Senad; van der Velden, Eddy; Strydis, Christos; Joos, Kathleen; Norena, Arnaud; Serdijn, Wouter; De Ridder, Dirk

    2013-02-01

    Animal research has shown that loss of normal acoustic stimulation can increase spontaneous firing in the central auditory system and induce cortical map plasticity. Enriched acoustic environment after noise trauma prevents map plasticity and abolishes neural signs of tinnitus. In humans, the tinnitus spectrum overlaps with the area of hearing loss. Based on these findings it can be hypothesized that stimulating the auditory system by presenting music compensating specifically for the hearing loss might also suppress chronic tinnitus. To verify this hypothesis, a study was conducted in three groups of tinnitus patients. One group listened just to unmodified music (i.e. active control group), one group listened to music spectrally tailored to compensate for their hearing loss, and a third group received music tailored to overcompensate for their hearing loss, associated with one (in presbycusis) or two notches (in audiometric dip) at the edge of hearing loss. Our data indicate that applying overcompensation to the hearing loss worsens the patients' tinnitus loudness, the tinnitus annoyance and their depressive feelings. No significant effects were obtained for the control group or for the compensation group. These clinical findings were associated with an increase in current density within the left dorsal anterior cingulate cortex in the alpha2 frequency band and within the left pregenual anterior cingulate cortex in beta1 and beta2 frequency band. In addition, a region of interest analysis also demonstrated an associated increase in gamma band activity in the auditory cortex after overcompensation in comparison to baseline measurements. This was, however, not the case for the control or the compensation groups. In conclusion, music therapy compensating for hearing loss is not beneficial in suppressing tinnitus, and overcompensating hearing loss actually worsens tinnitus, both clinically and electrophysiologically. PMID:23104014

  19. The mPED randomized controlled