Science.gov

Sample records for controlled clinical polysomnographic

  1. 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.

  2. Case Control Polysomnographic Studies of Sleep Disorders in Parkinson's Disease

    PubMed Central

    Yong, Ming-Hui; Fook-Chong, Stephanie; Pavanni, Ratnagopal; Lim, Li-Ling; Tan, Eng-King

    2011-01-01

    Background The relationship between a number of primary sleep disorders and Parkinson's disease (PD) is still debated. There are limited case control polysomnographic studies in PD and most of these study sample sizes are small. Methodology/Findings We conducted one of the largest case-control studies involving overnight polysomnographic evaluation, with prospective recruitment of unselected Parkinson's disease patients and healthy controls from an Asian population. The cases were recruited from the specialized movement disorder outpatient clinics in a tertiary referral center, and controls from the same geographical locations. All subjects underwent an overnight polysomnographic study and a multiple sleep latency test. A total of 124 subjects including 56 patients and 68 controls frequency-matched for age and sex were included. Multivariate analysis revealed that patients had significantly shorter total sleep time than controls (p = 0.01), lower sleep efficiency (p = 0.001) and increased REM latency (p = 0.007). In patients, multivariate analysis showed that reduced total sleep time was significantly associated with increased age (p = 0.001) and increased levodopa dose (p = 0.032). The mean Insomnia Severity Index was higher in PD patients (9.0±7.1) compared to controls (3.3±3.9, p<0.001). The mean Epworth Sleepiness Scale score was higher in PD patients (9.3±5.9 vs. 5.7±4.8, p<0.001). Nocturnal arousals, obstructive sleep apnea, periodic leg movements and objective abnormal sleepiness were not increased in our patients. Conclusions/Significance Our case-control polysomnographic study, the first-ever performed in an Asian population, revealed altered sleep architecture and reduced sleep in PD patients compared to controls. Reduced total sleep time was associated with increased age and levodopa dose. However, nocturnal arousals, primary sleep disorders and abnormal sleepiness were not increased in our PD patients suggesting that ethnic

  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. 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

  5. NREM-related parasomnias in Machado-Joseph disease: clinical and polysomnographic evaluation.

    PubMed

    Silva, Giselle Melo Fontes; Pedroso, José Luiz; Dos Santos, Diogo Fernandes; Braga-Neto, Pedro; Do Prado, Lucila Bizari Fernandes; De Carvalho, Luciane Bizari Coin; Barsottini, Orlando G P; Do Prado, Gilmar Fernandes

    2016-02-01

    Spinocerebellar ataxias (SCA) are autosomal dominant neurodegenerative disorders that affect the cerebellum and its connections, and have a marked clinical and genetic variability. Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA3)--MJD/SCA3--is the most common SCA worldwide. MJD/SCA3 is characterized classically by progressive ataxia and variable other motor and non-motor symptoms. Sleep disorders are common, and include rapid eye movement (REM) sleep behaviour disorder (RBD), restless legs syndrome (RLS), insomnia, excessive daytime sleepiness, excessive fragmentary myoclonus and sleep apnea. This study aims to focus upon determining the presence or not of non-REM (NREM)-related parasomnias in MJD/SCA 3, using data from polysomnography (PSG) and clinical evaluation. Forty-seven patients with clinical and genetic diagnosis of MJD/SCA3 and 47 control subjects were evaluated clinically and by polysomnography. MJD/SCA3 patients had a higher frequency of arousals from slow wave sleep (P < 0.001), parasomnia complaints (confusional arousal/sleep terrors, P = 0.001; RBD, P < 0.001; and nightmares, P < 0.001), REM sleep without atonia (P < 0.001), periodic limb movements of sleep index (PLMSi) (P < 0.001), percentage of N3 sleep (P < 0.001) and percentage of N1 sleep (P < 0.001). These data show that NREM-related parasomnias must be included in the spectrum of sleep disorders in MJD/SCA3 patients.

  6. 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

  7. Clinical and Polysomnographic Features of Kleine-Levin Syndrome: Case Series

    PubMed Central

    ERDEM, Murat; BOLU, Abdullah; GARİP, Beyazıt; KARAMAN, Dursun; YETKİN, Sinan

    2013-01-01

    Kleine-Levin Syndrome (KLS) is a rare disorder characterized intermittent hypersomnia, hyperphagia, hypersexuality, abnormal behaviors, and confusion. Patients are asymptomatic between episodes. The aim of this case series study was to determine the clinical features of patients with KLS and to compare the polysomnography (PSG) findings between symptomatic and asymptomatic periods. We compared the results of PSG investigations performed in symptomatic and asymptomatic periods in six patients diagnosed with KLS at Gulhane Military Medical Faculty Sleep Research Center between 1998 and 2005. The age at onset of KLS was approximately 18 years, the diagnosis delayed 2.67 years, hypersomnia episodes lasted approximately 11.5 days, until the correct diagnosis, the patients had experienced on average 5 episodes. Total sleep time in KLS patients during symptomatic period and stage 2 sleep percent was higher than in asymptomatic period. REM latency was shorter and stage 3 and REM percent was lower in asymptomatic period. The clinical features including the age of onset and episode duration are compatible with those from the previous studies. It was observed that the sleep architecture during symptomatic period was different from that in asymptomatic period.

  8. Delayed Diagnosis, Range of Severity, and Multiple Sleep Comorbidities: A Clinical and Polysomnographic Analysis of 100 Patients of the Innsbruck Narcolepsy Cohort

    PubMed Central

    Frauscher, Birgit; Ehrmann, Laura; Mitterling, Thomas; Gabelia, David; Gschliesser, Viola; Brandauer, Elisabeth; Poewe, Werner; Högl, Birgit

    2013-01-01

    Study Objectives: Narcolepsy is reported to affect 26-56/100,000 in the general population. We aimed to describe clinical and polysomnographic features of a large narcolepsy cohort in order to comprehensively characterize the narcoleptic spectrum. Methods: We performed a chart- and polysomnographybased review of all narcolepsy patients of the Innsbruck narcolepsy cohort. Results: A total of 100 consecutive narcolepsy patients (87 with cataplexy [NC], 13 without cataplexy [N]) were included in the analysis. All subjects had either excessive daytime sleepiness or cataplexy as their initial presenting clinical feature. Age at symptom onset was 20 (6-69) years. Diagnostic delay was 6.5 (0-39) years. The complete narcolepsy tetrad was present in 36/100 patients; 28/100 patients had three cardinal symptoms; 29/100 had two; and 7/100 had only excessive daytime sleepiness. Severity varied broadly with respect to excessive daytime sleepiness (median Epworth Sleepiness Scale score: 18, range 10-24), cataplexy (8-point Likert scale: median 4.5, range 1-8), hypnagogic hallucinations (median 4.5, range 1-7), and sleep paralysis (median 3, range 1-7). Sleep comorbidity was highly prevalent and ranged from sleeprelated movement disorders (n = 55/100), parasomnias (n = 34/100), and sleeprelated breathing disorders (n = 24/100), to insomnia (n = 28/100). REM sleep without atonia or a periodic limb movement in sleep index > 5/h were present in most patients (90/100 and 75/100). A high percentage of narcoleptic patients in the present study had high frequency leg movements (35%) and excessive fragmentary myoclonus (22%). Of the narcolepsy patients with clinical features of REM sleep behavior disorder (RBD), 76.5% had EMG evidence for RBD on the multiple sleep latency test (MSLT), based on a standard cutoff of a minimum of 18% of 3-sec miniepochs. Conclusion: This study is one of the largest monocentric polysomnographic studies to date of patients with narcolepsy and confirms the

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

    PubMed Central

    Bjurstrom, Martin F.; Irwin, Michael R.

    2015-01-01

    Summary 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. 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

  11. Polysomnographic assessment of spells in sleep: nocturnal seizures versus parasomnias.

    PubMed

    Dyken, M E; Yamada, T; Lin-Dyken, D C

    2001-12-01

    A dilemma can arise when attempting to distinguish a nocturnal seizure from a parasomnia because both phenomena can be characterized by a general increase in motor and autonomic activity with a transient reduction in the level of consciousness. An additional problem is that an accurate clinical diagnosis generally relies heavily on a detailed history. As sleep related disorders occur at a time when the patient is not fully cognizant, polysomnographic analysis can on occasion supplement for the intrinsic paucity of detailed history. Simultaneously, correlating the clinical and polysomnographic analysis immediately prior to, during, and following an event of interest, can be helpful in differentiating nocturnal seizures from parasomnias.

  12. Sleep disorders in spinal and bulbar muscular atrophy (Kennedy's disease): a controlled polysomnographic and self-reported questionnaires study.

    PubMed

    Romigi, Andrea; Liguori, Claudio; Placidi, Fabio; Albanese, Maria; Izzi, Francesca; Uasone, Elisabetta; Terracciano, Chiara; Marciani, Maria Grazia; Mercuri, Nicola Biagio; Ludovisi, Raffaella; Massa, Roberto

    2014-05-01

    No data are available regarding the occurrence of sleep disorders in spinal and bulbar muscular atrophy (SBMA). We investigated the sleep-wake cycle in SBMA patients compared with healthy subjects. Nine SBMA outpatients and nine age-matched and sex-matched healthy controls were evaluated. Subjective quality of sleep was assessed by means of the Pittsburgh Sleep Quality Index (PSQI). The Epworth Sleepiness Scale was used in order to evaluate excessive daytime sleepiness. All participants underwent a 48-h polysomnography followed by the multiple sleep latency test. Time in bed, total sleep time and sleep efficiency were significantly lower in SBMA than controls. Furthermore, the apnea-hypopnea index (AHI) was significantly higher in SBMA than controls. Obstructive sleep apnea (OSA: AHI >5/h) was evident in 6/9 patients (66.6 %). REM sleep without atonia was evident in three patients also affected by OSA and higher AHI in REM; 2/9 (22.2 %) SBMA patients showed periodic limb movements in sleep. The global PSQI score was higher in SBMA versus controls. Sleep quality in SBMA is poorer than in controls. OSA is the most common sleep disorder in SBMA. The sleep impairment could be induced both by OSA or/and the neurodegenerative processes involving crucial areas regulating the sleep-wake cycle.

  13. 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

  14. Polysomnographic analysis of bruxism.

    PubMed

    Trindade, Marilene de Oliveira; Rodriguez, Antonio Gomez

    2014-01-01

    The American Academy of Sleep Medicine (AASM) defines sleep bruxism as a stereotyped movement disorder characterized by clenching and grinding of the teeth during sleep. Bruxism is found in 14%-20% of children, 8% of adults <60 years old, and 3% of adults >60 years old. The mandibular movements of bruxism can be confused with rhythmic mandibular movements associated with other sleep disorders, such as arousals/microarousals, limb movement disorder, and obstructive sleep apnea/hypopnea syndrome. Polysomnography (PSG) is the study of sleep disorders based on the recording of physiological events throughout an entire night of sleep. This system involves electroencephalography, electrooculography, and electromyography of the submental/suprahyoid, tibialis anterior, mentalis, masseter, and temporal muscles, through which signs of sleep bruxism can be identified. The aim of the present study was to identify bruxism during a night of sleep in a laboratory. Thirty patients were analyzed clinically and underwent PSG. The descriptive analysis correlated apnea, arousals, and limb movements in the 12 patients who exhibited signs and symptoms of sleep bruxism. Of these patients, 4 were confirmed through PSG to have bruxism. In a comparison between the 4 patients with confirmed bruxism (PSGB group) and the 8 patients confirmed not to have bruxism (NPSGB group), the respiratory event index was lower in the PSGB group (13.17 and 17.95, respectively). The mean leg movement index was higher in the PSGB group than the NPSGB group in total sleep time (21.36 and 8.42, respectively) and in rapid eye movement sleep time (34.54 and 10.30, respectively).

  15. Exploratory Polysomnographic Evaluation of Pregabalin on Sleep Disturbance in Patients with Epilepsy

    PubMed Central

    de Haas, Sanne; Otte, Andreas; de Weerd, Al; van Erp, Gerard; Cohen, Adam; van Gerven, Joop

    2007-01-01

    Objectives: To evaluate the effects of adjunctive pregabalin 300 mg/day versus placebo on polysomnographic (PSG) variables in patients with well controlled partial seizures and subjectively reported sleep disturbance. Methods: An exploratory, 4-week, double-blind, randomized study in patients with well controlled partial seizures on AED monotherapy and subjective sleep disturbance over the previous 6 months. Mean changes from baseline to endpoint in PSG and subjective sleep variables (MOS Sleep Scale, Groningen Sleep Questionnaire) in patients on adjunctive pregabalin 300 mg/day (n=8) were compared with patients on placebo (n=7). Results: Baseline PSGs showed sleep fragmentation. Mean sleep efficiency improved significantly in both treatment groups in the mean baseline to endpoint change; there was no significant between-group difference. Pregabalin treatment was associated with a significant reduction in number of awakenings (p = 0.02), and improvement in wake time after sleep onset approached significance (p = 0.055), suggesting improvement in sleep continuity that was not observed in the placebo group. Pregabalin was also associated with significant improvements in the MOS sleep disturbance and sleep quantity subscales compared with placebo (p ≤0.03). There were no changes in self-reported seizure control. Conclusions: This exploratory pilot study suggests that pregabalin may improve sleep continuity in patients with clinically relevant sleep disturbance. The effect on disturbed sleep appears independent of seizure control. The effects of pregabalin on disturbed sleep and seizures and their interrelationships warrant further study. Citation: de Haas S; Otte A; de Weerd A; van Erp G; Cohen A; van Gerven J. Exploratory polysomnographic evaluation of pregabalin on sleep disturbance in patients with epilepsy. J Clin Sleep Med 2007;3(5):473-478. PMID:17803010

  16. Polysomnographic Investigation of Sleep and Respiratory Parameters in Women with Temporomandibular Pain Disorders

    PubMed Central

    Dubrovsky, Boris; Raphael, Karen G.; Lavigne, Gilles J.; Janal, Malvin N.; Sirois, David A.; Wigren, Pia E.; Nemelivsky, Lena V.; Klausner, Jack J.; Krieger, Ana C.

    2014-01-01

    Study Objectives: Temporomandibular pain disorders (TMD) and myofascial pain were linked to increased prevalence of insomnia and obstructive sleep apnea (OSA) on clinical grounds. However, the literature lacks an accurate polysomnographic (PSG) characterization of sleep abnormalities associated with TMD, given that prior studies included small or uncontrolled samples of TMD patients. The present investigation aims to objectively evaluate measures of sleep and respiratory disturbance in a large representative sample of TMD cases in comparison with matched controls. Methods: Sleep, respiration, and limb movements were measured using a 2-night attended PSG protocol in 170 women—124 TMD cases with myofascial pain and 46 demographically matched controls. The second night data were compared between the groups using ANCOVAs. In TMD cases, the relationship between pain ratings and sleep parameters was analyzed using multiple regressions. Results: In comparison to healthy controls, TMD cased evidenced a significant increase in stage N1 sleep (12.2% ± 7.6% vs. 9.2% ± 5.0%, p = 0.03), which was only mild relative to normative values. TMD cases also demonstrated mild but significant elevations in arousals associated with all types of respiratory events (6.0/h ± 6.1 vs. 3.5/h ± 3.3 p = 0.02) and in respiratory effort related arousals (RERAs, 4.3/h ± 4.3 vs. 2.6/h ± 2.7, p = 0.02). Myofascial pain predicted a lower sleep efficiency (p = 0.01), more frequent awakenings (p = 0.04), and higher RERA index (p = 0.04) among TMD cases. Conclusions: Myofascial pain in TMD is associated with mild elevation in sleep fragmentation and increased frequency of RERA events. Further research is required to evaluate the clinical significance of these findings. Citation: Dubrovsky B; Raphael KG; Lavigne GJ; Janal MN; Sirois DA; Wigren PE; Nemelivsky LV; Klausner JJ; Krieger AC. Polysomnographic investigation of sleep and respiratory parameters in women with temporomandibular pain

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

    PubMed

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

    2014-06-01

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

  18. 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

  19. Envelope Analysis of the Airflow Signal To Improve Polysomnographic Assessment of Sleep Disordered Breathing

    PubMed Central

    Díaz, Javier A.; Arancibia, José M.; Bassi, Alejandro; Vivaldi, Ennio A.

    2014-01-01

    Study Objectives: Given the detailed respiratory waveform signal provided by the nasal cannula in polysomnographic (PSG) studies, to quantify sleep breathing disturbances by extracting a continuous variable based on the coefficient of variation of the envelope of that signal. Design: Application of an algorithm for envelope analysis to standard nasal cannula signal from actual polysomnographic studies. Setting: PSG recordings from a sleep disorders center were analyzed by an algorithm developed on the Igor scientific data analysis software. Patients or Participants: Recordings representative of different degrees of sleep disordered breathing (SDB) severity or illustrative of the covariation between breathing and particularly relevant factors and variables. Interventions: The method calculated the coefficient of variation of the envelope for each 30-second epoch. The normalized version of that coefficient was defined as the respiratory disturbance variable (RDV). The method outcome was the all-night set of RDV values represented as a time series. Measurements and Results: RDV quantitatively reflected departure from normal sinusoidal breathing at each epoch, providing an intensity scale for disordered breathing. RDV dynamics configured itself in recognizable patterns for the airflow limitation (e.g., in UARS) and the apnea/hypopnea regimes. RDV reliably highlighted clinically meaningful associations with staging, body position, oximetry, or CPAP titration. Conclusions: Respiratory disturbance variable can assess sleep breathing disturbances as a gradual phenomenon while providing a comprehensible and detailed representation of its dynamics. It may thus improve clinical diagnosis and provide a revealing descriptive tool for mechanistic sleep disordered breathing modeling. Respiratory disturbance variable may contribute to attaining simplified screening methodologies, novel diagnostic criteria, and insightful research tools. Citation: Díaz JA; Arancibia JM; Bassi A

  20. Analysis of video-polysomnographic sleep findings in dementia with Lewy bodies.

    PubMed

    Terzaghi, Michele; Arnaldi, Dario; Rizzetti, Maria Cristina; Minafra, Brigida; Cremascoli, Riccardo; Rustioni, Valter; Zangaglia, Roberta; Pasotti, Chiara; Sinforiani, Elena; Pacchetti, Claudio; Manni, Raffaele

    2013-09-01

    Knowledge of sleep architecture and disorders of nocturnal sleep in dementia with Lewy bodies (DLB) is limited by a lack of systematic video-polysomnographic (video-PSG) investigations. We describe video-PSG findings in 29 consecutive subjects diagnosed with DLB. All the patients underwent a clinical interview and overnight video-PSG monitoring. Twenty-nine nondemented patients with Parkinson's disease (PD) matched for age and sex with the DLB cases were selected for comparison. The DLB subjects showed less 1NREM sleep (P = .000) and more 2NREM sleep (P = .000) than the PD subjects. Sleep apnea (30.7% vs. 34.8%) and periodic limb movements (60.9% versus 50.0%) were frequent in both groups. Disruptive motor behavioral manifestations were more frequent in subjects with DLB (69.6% vs. 26.9%, P = .008) and consisted of not only REM sleep behavior disorder (RBD) but also confusional events (30.3% vs. 3.8%, P = .020) and arousal-related episodes mimicking RBD. Subjects with DLB in whom a sleep disturbance had been the presenting symptom performed better than those with other onset symptoms on both the Mini-Mental State Examination (22.2 ± 4.1 vs. 18.1 ± 4.6, P = .019) and the Frontal Assessment Battery (15.8 vs. 10.3, P = .010). Polysomnographic findings in DLB show a complex mix of overlapping sleep alterations: impaired sleep structure, sleep comorbidities, and various motor-behavioral events (not restricted to RBD). Clinicians should be aware of the possibility of misleading symptoms and of the risk of overlooking sleep comorbidities, and consider performing polysomnographic sleep investigations in selected cases. We found evidence that a sleep disturbance as the presenting symptom might indicate a different phenotype of the disease, characterized by milder cognitive impairment.

  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.

  2. Polysomnographic predictors of persistent continuous positive airway pressure adherence in patients with moderate and severe obstructive sleep apnea.

    PubMed

    Chen, Yung-Fu; Hang, Liang-Wen; Huang, Chun-Sen; Liang, Shinn-Jye; Chung, Wei-Sheng

    2015-02-01

    Extensive use of continuous positive airway pressure (CPAP) has positive clinical benefits for most patients with obstructive sleep apnea (OSA). However, patient adherence is a major limiting factor to the effectiveness of CPAP treatment. This study determined the potential and quantifiable factors affecting the willingness of patients with OSA to undertake CPAP treatment by comparing the polysomnographic parameters recorded during diagnosis and titration. Patients with moderate and severe OSA who attended diagnostic polysomnography (PSG) and CPAP titration at the sleep center of China Medical University Hospital (CMUH) were included in the study. A total of 312 patients were divided into persistent users and nonusers of CPAP according to their use of in-home CPAP following titration and a 7-day CPAP trial. Multivariate logistic regression analyses were used to define the potential polysomnographic predictors of persistent CPAP adherence, and odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Most patients were men older than 50 years who were overweight or obese. Among the patients, 146 (46.8%) became persistent CPAP users. A 10% improvement of oxygen desaturation index (ODI) and a 10% increment in deep sleep percentage increased the chance of persistent CPAP use 1.18-fold and 1.07-fold, respectively. In addition, the improved ODI and deep sleep during CPAP titration increased the chance of persistent CPAP user. The polysomnographic parameters obtained from diagnosis and during titration can facilitate the prediction of persistent CPAP use.

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

    PubMed Central

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

    2014-01-01

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

  4. 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

  5. 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.

  6. Evidence of Subthalamic PGO-like Waves During REM Sleep in Humans: A Deep Brain Polysomnographic Study

    PubMed Central

    Fernández-Mendoza, Julio; Lozano, Beatriz; Seijo, Fernando; Santamarta-Liébana, Elena; Ramos-Platón, Maria José; Vela-Bueno, Antonio; Fernández-González, Fernando

    2009-01-01

    Study Objectives: The aim of this study was to examine whether the subthalamic nucleus (STN) plays a role in the transmission of PGO-like waves during REM sleep in humans. Design: Simultaneous recordings from deep brain electrodes to record local field potentials (LFPs), and standard polysomnography to ascertain sleep/wake states. Setting: Main Hospital, department of clinical neurophysiology sleep laboratory. Participants: 12 individuals with Parkinson's disease, with electrodes implanted in the STN; and, as a control for localization purposes, 4 cluster headache patients with electrodes implanted in the posterior hypothalamus. Interventions: All subjects underwent functional neurosurgery for implantation of deep brain stimulation electrodes. Results: Sharp, polarity-reversed LFPs were recorded within the STN during REM sleep in humans. These subthalamic PGO-like waves (2–3 Hz, 80–200 μV, and 300–500 msec) appeared during REM epochs as singlets or in clusters of 3–13 waves. During the pre-REM period, subthalamic PGO-like waves were temporally related to drops in the submental electromyogram and/or onset of muscular atonia. Clusters of PGO-like waves occurred typically before and during the bursts of rapid eye movements and were associated with an enhancement in fast (15–35 Hz) subthalamic oscillatory activity. Conclusion: Subthalamic PGO-like waves can be recorded during pre-REM and REM sleep in humans. Our data suggest that the STN may play an active role in an ascending activating network implicated in the transmission of PGO waves during REM sleep in humans. Citation: Fernández-Mendoza J; Lozano B; Seijo F; Santamarta-Liébana E; Ramos-Platón MJ; Vela-Bueno A; Fernández-González F. Evidence of subthalamic PGO-like waves during REM sleep in humans: a deep brain polysomnographic study. SLEEP 2009;32(9):1117-1126. PMID:19750916

  7. 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

  8. 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

  9. 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.

  10. Sleep/Wake Modulation of Polysomnographic Patterns has Prognostic Value in Pediatric Unresponsive Wakefulness Syndrome

    PubMed Central

    Molteni, Erika; Avantaggiato, Paolo; Formica, Francesca; Pastore, Valentina; Colombo, Katia; Galbiati, Sara; Arrigoni, Filippo; Strazzer, Sandra

    2016-01-01

    Study Objective: Sleep patterns of pediatric patients in unresponsive wakefulness syndrome (UWS) have been poorly investigated, and the prognostic potential of polysomnography (PSG) in these subjects is still uncertain. The goal of the study was to identify quantitative PSG indices to be applied as possible prognostic markers in pediatric UWS. Methods: We performed PSG in 27 children and adolescents with UWS due to acquired brain damage in the subacute phase. Patients underwent neurological examination and clinical assessment with standardized scales. Outcome was assessed after 36 mo. PSG tracks were scored for sleep stages and digitally filtered. The spectral difference between sleep and wake was computed, as the percent difference at specific spectral frequencies. We computed (1) the ratio between percent power in the delta and alpha frequency bands, (2) the ratio between alpha and theta frequency bands, and (3) the power ratio index, during wake and sleep, as proposed in previous literature. The predictive role of several clinical and PSG measures was tested by logistic regression. Results: Correlation was found between the differential measures of electroencephalographic activity during sleep and wake in several frequency bands and the clinical scales (Glasgow Outcome Score, Level of Cognitive Functioning Assessment Scale, and Disability Rating Scale) at follow-up; the Sleep Patterns for Pediatric Unresponsive Wakefulness Syndrome (SPPUWS) scores correlated with the differential measures, and allowed outcome prediction with 96.3% of accuracy. Conclusions: The differential measure of electroencephalographic activity during sleep and wake in the beta band and, more incisively, SPPUWS can help in determining the capability to recover from pediatric UWS well before the confirmation provided by suitable clinical scales. Citation: Molteni E, Avantaggiato P, Formica F, Pastore V, Colombo K, Galbiati S, Arrigoni F, Strazzer S. Sleep/wake modulation of polysomnographic

  11. 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

  12. 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

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

    PubMed

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

    2016-04-19

    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.

  14. 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

  15. Polysomnographic sleep effects of fluoxetine and nefazodone on a seasonal affective disorder patient.

    PubMed

    Shen, Jianhua; Shapiro, Colin

    2002-11-01

    This reported person met DSM-III-R criteria for seasonal affective disorder. In successive years she had two treatments with fluoxetine and one with nefazodone. Every year regular polysomnographic monitoring was carried out during the critical initial 8 weeks of treatment. The results indicate that on both occasions fluoxetine decreased the patient's sleep quality. Nefazodone had no sleep disturbing effects and on withdrawal no relapse has been seen for 3 years.

  16. 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

  17. Alterations in Polysomnographic (PSG) profile in drug-naïve Parkinson's disease

    PubMed Central

    Joy, Sanju P.; Sinha, Sanjib; Pal, Pramod Kumar; Panda, Samhita; Philip, Mariamma; Taly, Arun B.

    2014-01-01

    Objective: We studied the changes in Polysomnographic (PSG) profile in drug-naïve patients of Parkinson's disease (PD) who underwent evaluation with sleep overnight PSG. Materials and Methods: This prospective study included 30 with newly diagnosed levodopa-naïve patients with PD, fulfilling the UK-PD society brain bank clinical diagnostic criteria (M:F = 25:5; age: 57.2 ± 10.7 years). The disease severity scales and sleep related questionnaires were administered, and then patients were subjected to overnight PSG. Results: The mean duration of illness was 9.7 ± 9.5 months. The mean Hoehn and Yahr stage was 1.8 ± 0.4. The mean Unified Parkinson's Disease Rating Scale (UPDRS) motor score improved from 27.7 ± 9.2 to 17.5 ± 8.9 with sustained usage of levodopa. Nocturnal sleep as assessed by Pittsburgh Sleep Quality Index (PSQI) was impaired in 10 (33.3%) patients (mean PSQI score: 5.1 ± 3.1). Excessive day time somnolence was recorded in three patients with Epworth Sleepiness Scale (ESS) score ≥ 10 (mean ESS score: 4.0 ± 3.4). PSG analysis revealed that poor sleep efficiency of <85% was present in 86.7% of patients (mean: 68.3 ± 21.3%). The latencies to sleep onset (mean: 49.8 ± 67.0 minutes) and stage 2 sleep (36.5 ± 13.1%) were prolonged while slow wave sleep was shortened. Respiration during sleep was significantly impaired in which 43.3% had impaired apnoea hyperpnoea index (AHI) ≥5, mean AHI: 8.3 ± 12.1). Apnoeic episodes were predominantly obstructive (obstructive sleep apnea, OSA index = 2.2 ± 5.1). These patients had periodic leg movement (PLM) disorder (56.7% had PLM index of 5 or more, mean PLMI: 27.53 ± 4 9.05) that resulted in excessive daytime somnolence. Conclusions: To conclude, sleep macro-architecture is altered in frequently and variably in levodopa-naïve patients of PD and the alterations are possibly due to disease process per se. PMID:25221397

  18. Polysomnographic Measurement of Sleep Duration and Bodily Pain Perception in the Sleep Heart Health Study

    PubMed Central

    Weingarten, Jeremy A.; Dubrovsky, Boris; Basner, Robert C.; Redline, Susan; George, Liziamma; Lederer, David J.

    2016-01-01

    Study Objectives: To determine whether total sleep time (TST) and specific sleep stage duration are associated with bodily pain perception and whether sex, age, or subjective sleepiness modifies this relationship. Methods: Data from adults ages 39–90 y (n = 5,199) who took part in the Sleep Heart Health Study Exam 1 were analyzed. TST, rapid eye movement (REM) sleep time, and slow wave sleep (SWS) time were measured by unattended, in-home nocturnal polysomnography. Bodily pain perception was measured via the Short Form-36 questionnaire bodily pain component. We used logistic regression to examine associations between total and individual sleep stage durations and bodily pain perception controlling for age, sex, race, body mass index, apnea-hypopnea index, antidepressant use, and important cardiovascular conditions (smoking [pack-years], history of diabetes, and history of percutaneous coronary intervention and/or coronary artery bypass graft). Results: In the fully adjusted model, REM sleep time and SWS time were not associated with “moderate to severe pain,” whereas TST was: Each 1-h decrement in TST was associated with a 7% increased odds of “moderate to severe pain” (odds ratio 1.07, 95% confidence interval 1.002, 1.14). Due to modification of the association between SWS time and “moderate to severe pain” by sex (P for interaction = 0.01), we performed analyses stratified by sex: Each 1-h decrement in SWS time was associated with a 20% higher odds of “moderate to severe pain” among men (odds ratio 1.20, 95% confidence interval 1.03–1.42) whereas an association was not observed among women. Conclusions: Shorter TST among all subjects and shorter SWS time in men was associated with “moderate to severe pain.” REM sleep time was not associated with bodily pain perception in this cohort. Citation: Weingarten JA, Dubrovsky B, Basner RC, Redline S, George L, Lederer DJ. Polysomnographic measurement of sleep duration and bodily pain perception in

  19. 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

  20. 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

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

    PubMed

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

    2015-01-01

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

  2. Atypical Headbanging Presentation of Idiopathic Sleep Related Rhythmic Movement Disorder: Three Cases with Video-Polysomnographic Documentation

    PubMed Central

    Yeh, Shih-Bin; Schenck, Carlos H.

    2012-01-01

    Study Objectives: To describe three cases of sleep related, idiopathic rhythmic movement disorder (RMD) with atypical headbanging, consisting of head punching and head slapping. Methods: Three consecutive patients (2 males [11 and 13 years old) and one female [22 years old]) presented with atypical headbanging of 6 years, 7 years, and 17 years duration. In 2 cases, typical rhythmic headbanging (with use of the head) shifted after 3-4 years to atypical headbanging, with frontal head punching that was quasi-rhythmic. In one case, atypical headbanging (head-slapping) was the initial and only RMD. There was no injury from the headbanging. Prenatal, perinatal, developmental, behavioral-psychological, medical-neurological, and family histories were negative. Clinical evaluations and nocturnal video-polysomnography with seizure montage were performed on all patients. Results: Atypical headbanging was documented in all 3 cases; episodes always emerged late in the sleep cycle: from N2 sleep in 11 episodes, from REM sleep in 4 episodes, and from N1 sleep in 1 episode. Epileptiform activity was not detected. Clonazepam therapy was substantially effective in 1 case but not effective in 2 cases. Conclusions: These 3 cases of idiopathic atypical headbanging expand the literature on this RMD variant, as to our knowledge only one previously documented case has been reported. Citation: Yeh SB; Schenck CH. Atypical headbanging presentation of idiopathic sleep related rhythmic movement disorder: three cases with video-polysomnographic documentation. J Clin Sleep Med 2012;8(4):403-411. PMID:22893771

  3. 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

  4. 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.

  5. 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

  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. Cognitive, psychomotor and polysomnographic effects of trazodone in primary insomniacs.

    PubMed

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

    2011-12-01

    Trazodone is prescribed widely as a sleep aid, although it is indicated for depression, not insomnia. Its daytime cognitive and psychomotor effects have not been investigated systematically in insomniacs. The primary goal of this study was to quantify, in primary insomniacs, the hypnotic efficacy of trazodone and subsequent daytime impairments. Sixteen primary insomniacs (mean age 44 years) participated, with insomnia confirmed by overnight polysomnography (sleep efficiency ≤ 85%). Trazodone 50 mg was administered to participants 30 min before bedtime for 7 days in a 3-week, within-subjects, randomized, double-blind, placebo-controlled design. Subjective effects, equilibrium (anterior/posterior body sway), short-term memory, verbal learning, simulated driving and muscle endurance were assessed the morning after days 1 and 7 of drug administration. Sleep was evaluated with overnight polysomnography and modified Multiple Sleep Latency Tests (MSLT) on days 1 and 7. Trazodone produced small but significant impairments of short-term memory, verbal learning, equilibrium and arm muscle endurance across time-points. Relative to placebo across test days, trazodone was associated with fewer night-time awakenings, minutes of Stage 1 sleep and self-reports of difficulty sleeping. On day 7 only, slow wave sleep was greater and objective measures of daytime sleepiness lower with trazodone than with placebo. Although trazodone is efficacious for sleep maintenance difficulties, its associated cognitive and motor impairments may provide a modest caveat to health-care providers.

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

    PubMed Central

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

    2011-01-01

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

  9. 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

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

    PubMed Central

    Kim, Eui-Joong; Dimsdale, Joel E.

    2014-01-01

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

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

    PubMed

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

    2012-12-01

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

  12. 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... Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control... detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects....

  13. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

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

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

    PubMed

    Yamamoto, Tetsuya

    2010-10-01

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

  15. 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

  16. A comparison of the effects of packing or transseptal suture on polysomnographic parameters in septoplasty.

    PubMed

    Turhan, Murat; Bostancı, Aslı; Akdag, Mehmet; Dinc, Oktay

    2013-03-01

    Our objective is to examine the effects of using nasal packing or transseptal suture in septoplasty in young patients, specifically on the polysomnographic parameters in the post-operative period. A total of 43 patients who had undergone septoplasty surgery after a diagnosis of septum deviation were included in the study. Packing was inserted in 23 patients, and transseptal suture was performed in the other 20 patients. A polysomnography test was performed on the patients on the first day after surgery and during the post-operative period. A post-operative increase was found in the apnea-hypopnea index (AHI) within both the packing and suture groups. The AHI increase in the packing group was statistically significant (p < 0.05). In the post-operative period, the fall in average oxygen desaturation in the packing group was significantly higher compared to suture group (p < 0.001). In addition, the arousal index was significantly higher in the packing group (p < 0.05). The use of nasal packing in young patients after septoplasty surgery reduced the quality of life after surgery and had negative effects on respiration during sleep. The finding that nasal packing caused obstructive sleep apnea syndrome even in young patients leads us to hypothesise that the effect of the packing on comorbid patients' respiratory function during sleep would be even more severe.

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

    PubMed

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

    2015-02-01

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

  18. Sexual behaviors during sleep associated with polysomnographically confirmed parasomnia overlap disorder.

    PubMed

    Cicolin, Alessandro; Tribolo, Antonella; Giordano, Alessandra; Chiarot, Elisabetta; Peila, Elena; Terreni, Anna; Bucca, Caterina; Mutani, Roberto

    2011-05-01

    Parasomnia overlap disorder (POD) refers to a sleep disorder characterized by the association of REM sleep behavior disorder (RBD) with NREM sleep parasomnia in the same patient. Sexual behaviors during sleep (SBS) can include most wakeful sexual activities and are classified in the ICSD-2 as a variant of confusional arousals and sleepwalking, both NREM parasomnias. A case of SBS associated with sleepwalking and possible RBD has been previously described, but it was not confirmed by polysomnography (PSG). We report two patients with SBS associated with POD documented by PSG. In one patient (60-year-old female) SBS was video-polysomnographically demonstrated: a few minute episode of masturbation occurring during slow-wave sleep (SWS) and preceded by hypersynchronous delta pattern. During the episode, the EEG pattern showed the persistence of delta rhythms with increasing alpha activity. When awoken by technicians, the patient was not aware of her sexual behavior and did not report any dream. The other patient, a 41-year-old male with a history of sleepwalking and RBD, was legally charged with repeatedly sexually fondling a young girl during the night. The POD was documented by PSG. The parasomnia defense, including sleepsex, was accepted by the Court and the patient was acquitted. This is an unprecedented report of SBS in patients with PSG-confirmed POD and of SBS documented during video-PSG.

  19. 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.

  20. Concordance of Polysomnographic and Actigraphic Measurement of Sleep and Wake in Older Women with Insomnia

    PubMed Central

    Taibi, Diana M.; Landis, Carol A.; Vitiello, Michael V.

    2013-01-01

    Study Objectives: The objective of this secondary analysis was to evaluate concurrent validity of actigraphy and polysomnography (PSG) in older women with insomnia. Methods: Concurrent validity of actigraphy and PSG was examined through (1) comparison of sleep outcomes from each recording method; (2) calculation of sensitivity, specificity, accuracy, and predictive values from epoch-by-epoch data; and (3) statistical and graphical exploration of the relationship between sleep disturbance severity and concordance of actigraphy and PSG. Subjects were 16 community-dwelling older women (mean age 69.4 ± 8.1) with insomnia who underwent 8 nights of concurrent actigraphy and PSG. Results: Sleep efficiency reflected much greater sleep disturbance on PSG (66.9%) than actigraphy (84.4%). Based on generalized linear models, the parameter estimates for agreement between actigraphy and PSG were statistically significant (p < 0.05) for total sleep time and sleep latency, verged on significance for WASO (p = 0.052), but was not significant for sleep efficiency (p = 0.20). Epoch-by-epoch analysis showed high sensitivity (96.1%), low specificity (36.4%), and modest values on agreement (75.4%) and predictive values of sleep (74.7%) and wake (80.2%). Generalized linear models showed that overall accuracy of actigraphy declined as sleep efficiency declined (unstandardized Beta = 0.741, p < 0.001). Based on this model, sleep efficiency of 73% was the point at which accuracy declined below an acceptable accuracy value of 80%. Conclusions: Actigraphy offers a relatively inexpensive and unobtrusive method for measuring sleep, but it appears to underestimate sleep disturbance, particularly at sleep efficiency levels below 73%, in older women with insomnia. Citation: Taibi DM; Landis CA; Vitiello MV. Concordance of polysomnographic and actigraphic measurement of sleep and wake in older women with insomnia. J Clin Sleep Med 2013;9(3):217-225. PMID:23493815

  1. Selecting control interventions for clinical outcome studies.

    PubMed

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

    2005-04-01

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

  2. [Placebo control and clinical trial of Chinese medicine].

    PubMed

    Wu, Jing

    2010-10-01

    World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

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

    PubMed Central

    Bjurstrom, Martin F.; Olmstead, Richard

    2016-01-01

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

  4. Alteration of serum levels of inflammatory cytokines and polysomnographic indices after uvulopalatal flap surgery in obstructive sleep apnea.

    PubMed

    Mutlu, Murad; Vuralkan, Erkan; Akin, Istemihan; Firat, Hikmet; Ardic, Sadik; Akaydin, Sevgi; Miser, Ece

    2017-02-01

    The aim of the current study was to compare the changes in polysomnographic indices and serum levels of C-reactive protein (CRP), cystatin C, tumor necrosis factor-α (TNF-α), and intercellular adhesion molecule-1 (ICAM-1) in patients with obstructive sleep apnea (OSA) who were treated surgically via a uvulopalatal flap (UPF) technique. Twenty-five patients (14 men, 11 women), average age 46.2 ± 9.3 years, who underwent UPF surgery were included in this study. Serum biochemical analyses and polysomnographic examinations were performed before and 6 months after the surgery. Pre- and postoperative values of apnea hypopnea index (AHI), oxygen desaturation index (ODI), and minimum oxygen concentrations, as well as serum levels of CRP, cystatin C, TNF-α, and ICAM-1 were compared. Comparison of variables before and after UPF surgery demonstrated that AHI (p = 0.001), ODI (p < 0.001) and oxygen saturation (p < 0.001) were significantly improved. In addition, serum levels of CRP (p = 0.036), cystatin C (p = 0.005), TNF-α (p < 0.001), and ICAM-1 (p < 0.001) were significantly reduced 6 months after surgery. Our results suggest that UPF is an effective surgical method that alleviates the severity of OSA. Moreover, it may have the potential to prevent the development of atherosclerosis by attenuating the inflammatory process induced by activation of inflammatory mediators such as CRP, TNF-α, ICAM-1, and cystatin C.

  5. 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.

  6. 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

  7. Quality Control in Clinical Laboratory Samples

    DTIC Science & Technology

    2015-01-01

    misalignment are important aspects to observing shifting L-J charts and adjustments of accuracy over time. Continuous monitoring of quality control testing...calibration misalignment are important aspects to observing shifting L-J charts and 1 adjustments of accuracy over time. Continuous monitoring of...2673rd MDSS, SGSL, Elmendorf AFB, 99506-3702, AK 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/ MONITORING AGENCY NAME(S) AND ADDRESS(ES

  8. Measuring asthma control. Clinic questionnaire or daily diary?

    PubMed

    Juniper, E F; O'Byrne, P M; Ferrie, P J; King, D R; Roberts, J N

    2000-10-01

    Daily symptom, peak expiratory flow rate (PEFR), and medication diaries are often used in clinical trials of treatments for asthma on the assumption that they provide a better estimate of clinical status than does a questionnaire completed in the clinic. We conducted a study with the aim of comparing the measurement properties of the clinic-completed Asthma Control Questionnaire with those of the Asthma Control Diary. The diary is composed of questions and response options almost identical to those of the questionnaire, but uses PEFR instead of FEV(1) as the measure of airway caliber. In an observational study, 50 adults with symptomatic asthma attended a McMaster University asthma clinic at 0, 1, 5, and 9 wk to complete the Asthma Control Questionnaire and other measures of asthma status. For 1 wk before each follow-up visit, patients completed the Asthma Control Diary every morning and evening. Concordance between the questionnaire and diary was high (intraclass correlation coefficient [ICC] = 0.87). Both reliability (ICC: questionnaire = 0.90; diary = 0.86) and responsiveness (responsiveness index: questionnaire = 1.06; diary = 0.90; p = 0.005) were better with the questionnaire than with the diary. Correlations between the two instruments and other measures of clinical asthma status were similar and close to a priori predictions. Both the Asthma Control Questionnaire and the Asthma Control Diary are valid instruments for measuring asthma control, but the questionnaire has slightly better discriminative and evaluative measurement properties than does the diary.

  9. 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

  10. Bed bugs: clinical relevance and control options.

    PubMed

    Doggett, Stephen L; Dwyer, Dominic E; Peñas, Pablo F; Russell, Richard C

    2012-01-01

    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.

  11. 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

  12. Peripheral Blood Leukocyte Gene Expression Patterns and Metabolic Parameters in Habitually Snoring and Non-Snoring Children with Normal Polysomnographic Findings

    PubMed Central

    Khalyfa, Abdelnaby; Gharib, Sina A.; Kim, Jinkwan; Capdevila, Oscar Sans; Kheirandish-Gozal, Leila; Bhattacharjee, Rakesh; Hegazi, Mohamed; Gozal, David

    2011-01-01

    Background: Children who snore but do not have gas exchange abnormalities or alterations of sleep architecture have primary snoring (PS). Since increasing evidence suggest that PS may be associated with morbidity, we hypothesized that assessing genome-wide gene expression in peripheral blood leukocytes (PBL) will identify a distinct signature in PS children. Methods: Children (aged 4–9 years) with and without habitual snoring and a normal PSG were designated as either PS or controls. Whole genome expression profiles of PBL and metabolic parameters in 30 children with PS and 30 age-, gender-, ethnicity-, and BMI-matched controls were compared. Pathway-focused gene network analysis of the PBL transcriptome was performed. Metabolic parameters were measured in an independent follow-up cohort of 98 children (64 PS and 34 controls) to evaluate the computationally derived findings. Results: PS was not associated with a distinct transcriptional signature in PBL. Exploratory functional network analysis of enriched gene sets identified a number of putative pathways—including those mapping to insulin signaling, adipocyte differentiation, and obesity—with significant alterations in glucose metabolism and insulin sensitivity emerging in the follow-up cohort of children with PS, but no differences in lipid profiles. Conclusions: PS children do not exhibit global perturbations in their PBL transcriptional response, suggesting that current normative PSG criteria are overall valid. However, subtle differences in functionally coherent pathways involved in glycemic homeostasis were detected and confirmed in a larger independent pediatric cohort indicating that PS may carry increased risk for end-organ morbidity in susceptible children. Citation: Khalyfa A; Gharib SA; Kim J; Capdevila OS; Kheirandish-Gozal L; Bhattacharjee R; Hegazi M; Gozal D. Peripheral blood leukocyte gene expression patterns and metabolic parameters in habitually snoring and non-snoring children with normal

  13. Mapping clinically useful terminology to a controlled medical vocabulary.

    PubMed Central

    Barrows, R. C.; Cimino, J. J.; Clayton, P. D.

    1994-01-01

    We have mapped clinically used diagnostic terms from a legacy ambulatory care system to the separate controlled vocabulary of our central clinical information system. The methodology combines elements of lexical and morphologic text matching techniques, followed by manual physician review. Results of the automated matching algorithm before and after partial manual review are presented. The results of this effort will permit the migration of coded clinical data from one system to another. Output from the system after the term review process will be fed back to the target vocabulary via automated and semi-automated means to improve its clinical utility. PMID:7949922

  14. [Clinical application of extracts of Echinacea purpurea or Echinacea pallida. Critical evaluation of controlled clinical studies].

    PubMed

    Dorsch, W

    1996-04-01

    The phytotherapy should be understood as being integrated into the rational pharmacotherapy. The modern phytotherapy tries hard to proof effects with pharmacological and clinical studies. The task force E of the federal bureau of health of Germany has made a statement regarding this problem. This article reviews only controlled clinical trials about the application of extracts of echinacea purpura or echinacea pallida.

  15. 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

  16. 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

  17. 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.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-01-01

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

  20. 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.

  1. Clinical trials: active control vs placebo--what is ethical?

    PubMed

    Spławiński, Jacek; Kuźniar, Jerzy

    2004-01-01

    The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs, superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of micro (the difference between a tested drug and comparator) < or = 0 against micro > 0; the latter tests the null hypothesis of micro < or = - delta against, micro > - delta, where delta is the clinical difference from the comparator. In a superiority trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control--following the latest revision of Declaration of Helsinki--is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients' rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless.

  2. 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.

  3. Impulse control disorders in Parkinson's disease: clinical characteristics and implications

    PubMed Central

    Leeman, Robert F; Potenza, Marc N

    2011-01-01

    SUMMARY Impulse control disorders (ICDs), specifically those related to excessive gambling, eating, sex and shopping, have been observed in a subset of people with Parkinson's disease (PD). Although some initial case reports claimed that dopamine replacement therapies, particularly dopamine agonists, cause ICDs, more recent, larger and better controlled studies indicate a more complicated picture. While dopamine replacement therapy use is related to ICDs, other vulnerabilities, some related to PD and/or its treatment directly and others seemingly unrelated to PD, have also been associated with ICDs in PD. This suggests a complex etiology with multiple contributing factors. As ICDs occur in a sizable minority of PD patients and can be associated with significant distress and impairment, further investigation is needed to identify factors that can predict who may be more likely to develop ICDs. Clinical implications are discussed and topics for future research are offered. PMID:21709778

  4. 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.

  5. Neglected tropical diseases: diagnosis, clinical management, treatment and control.

    PubMed

    Utzinger, Jürg; Becker, Sören L; Knopp, Stefanie; Blum, Johannes; Neumayr, Andreas L; Keiser, Jennifer; Hatz, Christoph F

    2012-11-22

    Branded in 2005, "neglected tropical diseases" have gained traction in terms of advocacy, interest for research, enhanced funding and political will for their control and eventual elimination. Starting with an initial set of 13 neglected tropical diseases--seven helminth, three bacterial and three protozoal infections--the list considerably expanded to more than 40 diseases that now also includes viral, fungal and ectoparasitic infections. In this review, we provide a comprehensive overview of the neglected tropical diseases, their causative agents and the current geographical distribution, including their importance for the general practitioners seeing returning travellers and migrants in Switzerland. We characterise the most important of the neglected tropical diseases in terms of at-risk population, estimated number of infections, annual mortality rates and global burden, including current knowledge gaps. With an emphasis on neglected tropical diseases due to helminths, protozoa and ectoparasites, we review common diagnostic methods and current recommendations for treatment at the population level and the individual patient, thereby juxtaposing the situation in highly endemic countries on one side, with Switzerland on the other. We highlight the clinical presentation and management of the neglected tropical diseases in general and then elaborate on two examples, strongyloidiasis and leptospirosis. Our review provides a global perspective of neglected tropical diseases and we hope that it will prove useful for the general practitioner and clinician in Switzerland and elsewhere to enhance their suspicion index, differential diagnosis, clinical management and treatment, including referral to specialised clinics and laboratories when need be.

  6. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services... FR 60143, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made... listed substances for analytical research and clinical trials. No comments or objections have...

  7. 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

  8. 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

  9. 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.

  10. Quality assurance and quality control in clinical cytogenetics.

    PubMed

    Mikhail, Fady M; Watson, Michael S

    2014-07-14

    The goal of any clinical laboratory should be to provide patients with the most accurate test results possible. This is accomplished through various overlapping programs that continuously monitor and optimize all aspects of a test, including decisions by the laboratory to offer a test, the decision of providers to request the test, the testing itself, and the reporting of results to the referral source and patient. The levels at which test performance and accuracy can be optimized are encompassed under quality control (QC) and quality assurance (QA). The monitoring of QC and QA problems allows for the integration of these parameters into a total quality management program. This unit reviews QC and QA guidelines, in addition to discussing how to establish a quality assurance program.

  11. [Textile intolerance in atopic eczema--a controlled clinical study].

    PubMed

    Diepgen, T L; Stäbler, A; Hornstein, O P

    1990-10-01

    In patients suffering from atopic dermatitis (AD), we often find intolerance reactions against wool, whereas irritation by synthetic fibers is still a matter of discussion. In a randomized clinical study on 55 patients with AD and 31 healthy controls, we investigated the irritative capacity of poncho-like shirts made of 4 different materials (A: cotton; B, C, D: synthetics of different fiber structure). The intensity of itching or discomfort due to repeated wearing of these shirts was evaluated by means of a point system (max.comfort = 10 points, max. discomfort = 1 point). Our study clearly showed that the irritative capacity of synthetic shirts is significantly higher in patients with AD, while cotton shirts were best tolerated. We also observed significant difference regarding the surface structure and diameter of the synthetic fibers under investigation.

  12. Acupressure therapy for morning sickness. A controlled clinical trial.

    PubMed

    Hyde, E

    1989-01-01

    A prospective, controlled clinical trial examined the efficacy of acupressure therapy for morning sickness, using a two group, random assignment, crossover design. Subjects in Group 1 (N = 8) used acupressure wristbands for five days, followed by five days without therapy. Subjects in Group 2 (N = 8) had no therapy for five days, followed by five days use of wristbands. The Multiple Affect Adjective Checklist and Sickness Impact Profile were used, and extent of nausea was assessed at baseline, day five, and day ten. Use of acupressure wristbands relieved morning sickness for 12 of 16 subjects (chi 2 = 5.31 with Yates' correction factor, df = 1, p less than .025). Acupressure therapy resulted in statistically significant (p less than .05) reductions in anxiety, depression, behavioral dysfunction, and nausea. Limitations of the study and suggestions for future research are presented.

  13. Monitoring sleep depth: analysis of bispectral index (BIS) based on polysomnographic recordings and sleep deprivation.

    PubMed

    Giménez, Sandra; Romero, Sergio; Alonso, Joan Francesc; Mañanas, Miguel Ángel; Pujol, Anna; Baxarias, Pilar; Antonijoan, Rosa Maria

    2017-02-01

    The assessment and management of sleep are increasingly recommended in the clinical practice. Polysomnography (PSG) is considered the gold standard test to monitor sleep objectively, but some practical and technical constraints exist due to environmental and patient considerations. Bispectral index (BIS) monitoring is commonly used in clinical practice for guiding anesthetic administration and provides an index based on relationships between EEG components. Due to similarities in EEG synchronization between anesthesia and sleep, several studies have assessed BIS as a sleep monitor with contradictory results. The aim of this study was to evaluate objectively both the feasibility and reliability of BIS for sleep monitoring through a robust methodology, which included full PSG recordings at a baseline situation and after 40 h of sleep deprivation. Results confirmed that the BIS index was highly correlated with the hypnogram (0.89 ± 0.02), showing a progressive decrease as sleep deepened, and an increase during REM sleep (awake: 91.77 ± 8.42; stage N1: 83.95 ± 11.05; stage N2: 71.71 ± 11.99; stage N3: 42.41 ± 9.14; REM: 80.11 ± 8.73). Mean and median BIS values were lower in the post-deprivation night than in the baseline night, showing statistical differences for the slow wave sleep (baseline: 42.41 ± 9.14 vs. post-deprivation: 39.49 ± 10.27; p = 0.02). BIS scores were able to discriminate properly between deep (N3) and light (N1, N2) sleep. BIS values during REM overlapped those of other sleep stages, although EMG activity provided by the BIS monitor could help to identify REM sleep if needed. In conclusion, BIS monitors could provide a useful measure of sleep depth in especially particular situations such as intensive care units, and they could be used as an alternative for sleep monitoring in order to reduce PSG-derived costs and to increase capacity in ambulatory care.

  14. A placebo-controlled clinical evaluation of Kharjurapaka in Mamsakshaya

    PubMed Central

    Dhoke, Sujata P.; Dwivedi, Rambabu; Vyas, Mahesh

    2015-01-01

    Introduction: The world is facing most of the health problems due to nutritional imbalance, and Mamsakshaya (wasting) is one of them. Mamsakshaya explained in Kiyantahshirasiya Adhyaya can be considered as a separate entity, and it can be correlated with Karshya vyadhi. Mamsakshaya occurs due to diminished Prithvi and Jala Mahabhuta in the body and also due to improper diet and environmental factors. Kharjurapaka (KP) is having Prithvi and Jala Mahabhuta dominance and Guru (heavy), Shita (cold), Snigdha (unctuous) Guna (property) which are similar to conjugation of Mamsa Dhatu. Aim: The aim of this study is to evaluate Brimhana (nourishment) effect of KP on having signs and symptoms of Mamsakshaya patients. Materials and Methods: The study was therapeutic, interventional, randomized placebo controlled clinical trial carried out on 34 patients of Mamsakshaya. Patients were divided into two Groups. In Group A (trial group), KP (20 g) once in a day with normal water was administered for 30 days, and in Group B (control group), placebo tablet (500 mg) of roasted wheat flour for 30 days duration was administered. Effect of therapy was assessed on subjective and objective parameters, anthropometrical parameters such as body mass index (BMI), weight, and chest circumference. Results: It was found that Group A showed significant results in BMI and sign and symptom of Mamsakshaya in comparison to Group B. Conclusion: KP showed better efficacy in comparison with placebo group. PMID:27833368

  15. 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

  16. In utero Repair of Myelomeningocele: Rationale, Initial Clinical Experience and a Randomized Controlled Prospective Clinical Trial

    PubMed Central

    Danzer, Enrico; Flake, Alan W.

    2008-01-01

    Myelomeningocele (MMC), one of the most common congenital malformations, can result in severe lifelong disabilities, including paraplegia, hydrocephalus, Arnold-Chiari II malformation, incontinence, sexual dysfunction, skeletal deformations, and mental impairment. MMC was the first nonlethal anomaly to be treated by fetal surgery. Studies in animals provide compelling evidence that the primary cause of the neurological deficit associated with MMC is not simply incomplete neurulation but rather chronic mechanical injury and amniotic-fluid-induced chemical trauma that progressively damage the exposed neural tissue during gestation. Initial results suggest that the surgical repair of MMC before 25 weeks of gestation may preserve neurological function, reverse the hindbrain herniation of the Arnold-Chiari II malformation, and obviate the need for postnatal placement of a ventriculoperitoneal shunt. As it is currently unknown whether fetal surgery for MMC is truly beneficial compared to standard postnatal care, a randomized, controlled clinical trial has been initiated within the United States. PMID:22479081

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

    PubMed

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

    2013-06-10

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

  18. 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.

  19. Sleep episodes and daytime somnolence as result of individual susceptibility to different dopaminergic drugs in a PD patient: a polysomnographic study.

    PubMed

    Romigi, A; Brusa, L; Marciani, M G; Pierantozzi, M; Placidi, F; Izzi, F; Sperli, F; Testa, F; Stanzione, P

    2005-01-15

    The association between excessive daytime somnolence (EDS) and idiopathic Parkinson's disease (PD) is often reported but still debated. The possible role of antiparkinsonian therapy or primarily of PD on excessive diurnal sleepiness is controversial. We describe the case of a 61-year-old patient affected by PD who experienced sleep episodes (SE) occurring during pramipexole plus L-Dopa therapy. Polysomnographic sleep studies and subjective evaluations of daytime sleepiness (Epworth Sleepiness Scale) were carried out under administration of pramipexole plus L-Dopa, L-Dopa monotherapy and cabergoline plus L-Dopa. The polysomnography revealed two sleep events during pramipexole plus L-Dopa. Moreover, the polysomnographic data showed an increase of both diurnal and nocturnal sleep under pramipexole plus L-Dopa compared with cabergoline plus L-Dopa and L-Dopa as monotherapy. In addition, while Epworth Sleepiness Scale (ESS) Score showed a mild sleepiness under pramipexole (ESS score=11), ESS scores were normal under both L-Dopa and cabergoline plus L-Dopa. Sleep episodes also disappeared under both L-Dopa and cabergoline plus L-Dopa (2- and 12-month follow-up). We hypothesize that an individual susceptibility to specific antiparkinsonian drug may play a significant role in the genesis of sleepiness in our PD patient.

  20. 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.

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

    PubMed

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

    2012-12-30

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

  2. 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 application to the Drug Enforcement Administration (DEA) for registration as an importer of levorphanol...

  3. 77 FR 67396 - Importer of Controlled Substances; Notice of Application, Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... Enforcement Administration Importer of Controlled Substances; Notice of Application, Fisher Clinical Services..., 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, ] Allentown, Pennsylvania 18106, made application to the Drug Enforcement Administration (DEA) for registration as an importer of Tapentadol...

  4. Clinical characteristics of sleep disorders in patients with Parkinson's disease.

    PubMed

    Mao, Zhi-Juan; Liu, Chan-Chan; Ji, Su-Qiong; Yang, Qing-Mei; Ye, Hong-Xiang; Han, Hai-Yan; Xue, Zheng

    2017-02-01

    In order to investigate the sleep quality and influencing factors in patients with Parkinson's disease (PD), 201 PD patients were enrolled and underwent extensive clinical evaluations. Subjective sleep evaluation was assessed using the Pittsburgh Sleep Quality Index (PSQI), and the Epworth Sleepiness Scale (ESS). It was found that poor sleep quality (77.11%) and excessive daytime sleepiness (32.34%) were commonly seen in PD patients and positively correlated with disease severity. Then 70 out of the 201 PD patients and 70 age- and sex-matched controls underwent a polysomnographic recording. The parameters were compared between PD group and control group and the influencing factors of sleep in PD patients were analyzed. The results showed that sleep efficiency (SE) was significantly decreased (P<0.01), and sleep latency (SL) and the arousal index (AI) were increased (P<0.05) in the PD group as compared with those in the control group. SE and total sleep time (TST) were positively correlated with the Hoehn and Yahr (H&Y) stage. There was significant difference in the extent of hypopnea and hypoxemia between the PD group and the control group (P<0.05). Our results indicate that PD patients have an overall poor sleep quality and a high prevalence of sleep disorder, which may be correlated with the disease severity. Respiratory function and oxygen supply are also affected to a certain degree in PD patients.

  5. 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…

  6. Oncolytic Virus: Regulatory Aspects from Quality Control to Clinical Studies.

    PubMed

    Yamaguchi, Teruhide; Uchida, Eriko

    2017-02-22

    Oncolytic viruses, which include both naturally occurring wild-type viruses/attenuated viruses and genetically modified viruses, have recently been developed for use in innovative cancer therapies. Genetically modified oncolytic viruses possess the unique ability to replicate conditionally as a unique gene therapy product. Since oncolytic viruses exhibit prolonged persistence in patients, viral shedding and transmission to third parties should be major concerns for clinical trials, along with the clinical safety and efficacy. Accordingly, studies are now underway to establish the safety and efficacy of oncolytic viruses.

  7. 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…

  8. 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

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

    PubMed

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

    2003-01-01

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

  10. Latex condom breakage and slippage in a controlled clinical trial.

    PubMed

    Rosenberg, M J; Waugh, M S

    1997-07-01

    Although millions of couples rely on male latex condoms to protect against unintended pregnancy and sexually transmitted infections, their use is limited in part by questions about their performance. Rates of condom breakage and slippage, two measures of performance, vary broadly across studies. This variation in part reflects study variability and limitations, including sample size, reliance on subjects' memory, user populations, and products evaluated. In an effort to define condom performance in a group of monogamous couples typical of those using condoms for contraception, we conducted a clinical trial of a single brand of lubricated condoms (Durex Ramses). A total of 4637 attempts to use the condom were evaluated. Six breaks occurred before intercourse (nonclinical breaks), and 10 condoms broke during intercourse or were only noted to have broken upon withdrawal (clinical breaks), resulting in a nonclinical breakage rate of 0.13% (95% confidence interval, 0.05-0.28%), clinical breakage rate of 0.28% (0.15-0.48%), and a total breakage rate of 0.41% (0.25-0.64%). The rate of complete slippage was 0.63% (0.42-0.90%), and total failure (clinical breaks plus complete slips) was 1.04% (0.76-1.37%). These rates are lower than those in other studies with the exception of one, a prospective investigation in a population of female prostitutes. Results indicate that condoms can, in experienced, motivated populations, provide excellent performance and suggest that their efficacy at preventing pregnancy may equal that of the most reliable forms of contraception. Because this study involved a single condom brand, these results may not be generalizable to other brands.

  11. Controlling the vector of distraction osteogenesis in the management of obstructive sleep apnea

    PubMed Central

    Shilo, Dekel; Emodi, Omri; Aizenbud, Dror; Rachmiel, Adi

    2016-01-01

    Background: Obstructive sleep apnea (OSA) in individuals with craniofacial anomalies can compromise airway and is a serious life-threatening condition. In many cases, tracheostomy is carried out as the treatment of choice. Distraction osteogenesis of the mandible as a treatment modality for OSA is very useful and may spare the need for tracheostomy or allow decannulation, yet controlling the vector of distraction is still a major challenge. We present a method for controlling the vector of distraction. Materials and Methods: Eight patients with severe respiratory distress secondary to a micrognathic mandible were treated by mandibular distraction osteogenesis using either external or internal devices. Temporary anchorage devices (TADs) and orthodontic elastics were used to control the vector of distraction. Cephalometric X-rays, computed tomography, and polysomnographic sleep studies were used to analyze the results. Results: A mean distraction of 22 mm using the internal devices and a mean of 30 mm using the external devices were achieved. Increase in the pharyngeal airway and hyoid bone advancement was also observed. Anterior-posterior advancement of the mandible was noted with no clockwise rotation. Most importantly, clinical improvement in symptoms of OSA, respiratory distress, and feeding was noted. Conclusions: We describe a method for controlling the vector of distraction used as a treatment for OSA. In these cases, TADs were used as an anchorage unit to control the vector of distraction. Our results show excellent clinical and radiographical results. TADs are a simple and nonexpensive method to control the vector of distraction.

  12. 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

  13. 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...

  14. Control and monitoring system for clinically employed pneumatic blood pumps.

    PubMed

    Normann, N A; Henrichsen, D W; Cooper, T G; King, R E; Noon, G P; DeBakey, M E

    1977-01-01

    Instantaneous position of the flexing member in pneumatic blood pumps is monitored on-line by measuring the electrical capacitance across the gas space within the pump. Monitor output is utilized in closed-loop pump control and for automatic pump shutdown in response to operational abnormalities. Thus, safety and efficacy are enhanced through operational optimization, automatic safety features, and facilitated evaluation.

  15. Acromegalic axial arthropathy: a clinical case-control study.

    PubMed

    Scarpa, Raffaele; De Brasi, Davide; Pivonello, Rosario; Marzullo, Paolo; Manguso, Francesco; Sodano, Antonio; Oriente, Pasquale; Lombardi, Gaetano; Colao, Annamaria

    2004-02-01

    Arthropathy is the major cause of morbidity in acromegaly. To feature the spinal involvement, 54 patients with active acromegaly (27 men, 27 women; age range, 21-69 yr) and 54 sex-, age-, and body mass index-matched healthy controls were enrolled in this observational analytical prospective case-control study. A questionnaire to describe onset, duration, and severity of articular symptoms; rheumatological examination, including vertebral and chest mobility, Schober test, thorax expansion, and axial radiological study; and IGF-I, GH, insulin, and glucose level measurement (baseline and after an oral glucose tolerance test) was used to investigate the prevalence of arthropathy and correlate these findings with hormonal parameters. Axial arthropathy was found in 28 patients (52%) and 12 controls (22%; chi(2) = 8.9; P = 0.003). In detail, spinal mobility was reduced in 30 patients (56%) and 10 controls (18%; chi(2) = 14.3; P < 0.0001), thoracic cage was involved in six patients (11%), alterations of spinal profile were observed in 37 patients (68%) and 15 controls (28%; chi(2) = 16.3; P < 0.0001), and increased L2 vertebra diameters were observed in 34 patients (63%) and none of the controls (chi(2) = 46.7; P < 0.0001). Narrowing and widening of L2-L3 disk space were found in 20 (37%) and seven (13%) patients, respectively. Features of diffuse idiopathic skeletal hyperostosis (DISH) were found in 11 patients (20%) and none of the controls (chi(2) = 10.1; P < 0.001). Disease duration was correlated with vertebral body height (P = 0.001) or intervertebral space height (P = 0.02), and lumbar mobility with thorax expansion (P = 0.004); DISH severity was correlated with basal (P = 0.04) and peak (P = 0.01) glucose levels after glucose load. In conclusion, chronic GH and IGF-I excess typically affects the axial skeleton with development of severe alterations of spine morphology and function until features of DISH occur. An early diagnosis of acromegaly is mandatory to reduce

  16. 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

  17. 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.

  18. 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

  19. [Clinical research XI. From the clinical judgment to the case and controls design].

    PubMed

    Talavera, Juan O; Rivas-Ruiz, Rodolfo

    2012-01-01

    The case-control design like the historical cohort carries a number of potential biases as a consequence of the reconstruction of events once the outcome has occurred, and as a consequence of the bias generated by the selection of the control group. This design is characterized by a number of cases (cases), for which we identify a comparison group (controls). It begins at the outcome in direction to the probable cause; therefore, it requires reconstructing events in the opposite direction as it occurs in the phenomenon of causality. However, we must always keep in mind the architectural design, and consider in each section--baseline, maneuver and outcome--characteristics that allow us to demonstrate the effect of the maneuver, avoiding improper assembly, susceptibility, performance and detection bias. The transfer bias can only be controlled with the provision of a defined population, whether it is a population based case-control study or a case-control study nested in a cohort. When a defined population is not possible, this design is only recommended in rare diseases.

  20. 77 FR 60143 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services... renewal to the Drug Enforcement Administration (DEA) for registration as an importer of...

  1. 78 FR 54913 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies... application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer...

  2. 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

    ... Enforcement Administration Importer of Controlled Substances, Notice of Application, Almac Clinical Services... 5, 2013, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of...

  3. 77 FR 24984 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... 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 Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made application by renewal to the...

  4. 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

    ... Enforcement Administration Importer of Controlled Substances; Notice of Application; Almac Clinical Services.... Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on March 5, 2012, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964, made application by renewal to...

  5. 77 FR 47109 - Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies..., 2012, Clinical Supplies ] Management Inc., 342 42nd Street South, Fargo, North Dakota 58103, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of...

  6. Inhibitory motor control in apneic and insomniac patients: a stop task study.

    PubMed

    Sagaspe, Patricia; Philip, Pierre; Schwartz, Sophie

    2007-12-01

    The aim of this study was to assess with a stop task the inhibitory motor control efficiency--a major component of executive control functions--in patients suffering from sleep disorders. Twenty-two patients with untreated obstructive sleep apnea syndrome (OSAS) (mean age 46 +/- 9 years; mean apnea-hypopnea index, AHI = 30 +/- 20) and 13 patients with psychophysiological insomnia (mean age 47 +/- 12 years) were compared with individually matched healthy controls. Sleep disturbances in the patient populations were clinically and polysomnographically diagnosed. The stop task has a frequent visual 'Go' stimulus to set up a response tendency and a less frequent auditory 'Stop' signal to withhold the planned or prepotent response. The stop signal reaction time (SSRT) reflects the time to internally suppress the ongoing response. SSRT was slower for the apneic patients than for their respective controls (248 +/- 107 versus 171 +/- 115 ms, anova, P < 0.05) but not for the insomniac patients compared with their controls (235 +/- 112 versus 194 +/- 109 ms, NS). Moreover, in apneic patients, slower SSRT was associated with lower nocturnal oxygen saturation (r = -0.477, P < 0.05). By contrast, neither apneics nor insomniacs differed from their matched controls for reaction times on Go trials. To conclude, unlike insomniacs, OSAS patients present an impaired inhibitory motor control, an executive function which is required in many common everyday life situations. Inhibitory motor control relies on the integrity of the inferior prefrontal cortex, which could be affected by nocturnal oxyhemoglobin desaturation in apneic patients.

  7. A pragmatic guide on how physicians can take over financial control of their clinical practice.

    PubMed

    Jacobs, Volker R; 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.

  8. 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

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

    PubMed

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

    2016-07-06

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

  10. 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

  11. Evening and morning peroxiredoxin-2 redox/oligomeric state changes in obstructive sleep apnea red blood cells: Correlation with polysomnographic and metabolic parameters.

    PubMed

    Feliciano, Amélia; Vaz, Fátima; Torres, Vukosava M; Valentim-Coelho, Cristina; Silva, Rita; Prosinecki, Vesna; Alexandre, Bruno M; Carvalho, Ana S; Matthiesen, Rune; Malhotra, Atul; Pinto, Paula; Bárbara, Cristina; Penque, Deborah

    2017-02-01

    We have examined the effects of Obstructive Sleep Apnea (OSA) on red blood cell (RBC) proteome variation at evening/morning day time to uncover new insights into OSA-induced RBC dysfunction that may lead to OSA manifestations. Dysregulated proteins mainly fall in the group of catalytic enzymes, stress response and redox regulators such as peroxiredoxin 2 (PRDX2). Validation assays confirmed that at morning the monomeric/dimeric forms of PRDX2 were more overoxidized in OSA RBC compared to evening samples. Six month of positive airway pressure (PAP) treatment decreased this overoxidation and generated multimeric overoxidized forms associated with chaperone/transduction signaling activity of PRDX2. Morning levels of overoxidized PRDX2 correlated with polysomnographic (PSG)-arousal index and metabolic parameters whereas the evening level of disulfide-linked dimer (associated with peroxidase activity of PRDX2) correlated with PSG parameters. After treatment, morning overoxidized multimer of PRDX2 negatively correlated with fasting glucose and dopamine levels. Overall, these data point toward severe oxidative stress and altered antioxidant homeostasis in OSA RBC occurring mainly at morning time but with consequences till evening. The beneficial effect of PAP involves modulation of the redox/oligomeric state of PRDX2, whose mechanism and associated chaperone/transduction signaling functions deserves further investigation. RBC PRDX2 is a promising candidate biomarker for OSA severity and treatment monitoring, warranting further investigation and validation.

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

    PubMed

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

    2014-01-13

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

  13. Should we reconsider the routine use of placebo controls in clinical research?

    PubMed Central

    2012-01-01

    Background Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. Methods We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. Results We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Conclusions Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions. PMID:22540350

  14. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study.

    PubMed

    Heinz, Bernd; Kasaj, Adrian; Teich, Marie; Jepsen, Søren

    2010-10-01

    The purpose of the present randomized controlled clinical study was to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a novel nanocrystalline hydroxyapatite (nano-HA) bone graft substitute. Fourteen patients with paired intrabony periodontal defects of ≥ 4 mm participated in this split-mouth design study. The defects in each subject were randomly selected to receive nano-HA paste in conjunction with papilla preservation flaps or papilla preservation flaps alone. Probing bone levels (PBL) from a customized acrylic stent and probing pocket depths (PPD) were measured at baseline and again 6 months following surgery. No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. Both treatments resulted in significant improvements between baseline and 6 months (p < 0.05). At 6 months after therapy, the sites treated with nano-HA paste showed a reduction in mean PPD from 8.3 ± 1.2 to 4.0 ± 1.1 mm and a gain in PBL of 4.3 ± 1.4 mm, whereas in the control group, the mean PPD changed from 7.9 ± 1.2 mm to 5.0 ± 1.2 mm and PBL gain was 2.6 ± 1.4 mm. Results demonstrated statistically greater PPD reduction and PBL gain (p < 0.05) in the test group as compared with the control group. In conclusion, after 6 months, the treatment of intrabony periodontal defects with a nano-HA paste leads to significantly improved clinical outcomes when compared with papilla preservation flap surgery alone.

  15. 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

  16. "Virtual" clinical trials: case control experiments utilizing a health services research workstation.

    PubMed Central

    Weiner, M. G.; Hillman, A. L.

    1998-01-01

    We created an interface to a growing repository of clinical and administrative information to facilitate the design and execution of case-control experiments. The system enables knowledgeable users to generate and test hypotheses regarding associations among diseases and outcomes. The intuitive interface allows the user to specify criteria for selecting cases and defining putative risks. The repository contains comprehensive administrative and selected clinical information on all ambulatory and emergency department visits as well as hospital admissions since 1994. We tested the workstation's ability to determine relationships between outpatient diagnoses including hypertension, osteoarthritis and hypercholesterolemia with the occurrence of admissions for stroke and myocardial infarction and achieved results consistent with published studies. Successful implementation of this Health Services Research Workstation will allow "virtual" clinical trials to validate the results of formal clinical trials on a local population and may provide meaningful analyses of data when formal clinical trials are not feasible. PMID:9929230

  17. Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring.

    PubMed

    Stewart, J; Breslin, W 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

    2016-03-01

    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.

  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.

  20. Glia as the “bad guys”: Implications for improving clinical pain control and the clinical utility of opioids

    PubMed Central

    Watkins, Linda R.; Hutchinson, Mark R.; Ledeboer, Annemarie; Wieseler-Frank, Julie; Milligan, Erin D.; Maier, Steven F.

    2007-01-01

    Within the past decade, there has been increasing recognition that glia are far more than simply “housekeepers” for neurons. This review explores two recently recognized roles of glia (microglia and astrocytes) in: (a) creating and maintaining enhanced pain states such as neuropathic pain, and (b) compromising the efficacy of morphine and other opioids for pain control. While glia have little-to-no role in pain under basal conditions, pain is amplified when glia become activated, inducing the release of proinflammatory products, especially proinflammatory cytokines. How glia are triggered to become activated is a key issue, and appears to involve a number of neuron-to-glia signals including neuronal chemokines, neurotransmitters, and substances released by damaged, dying and dead neurons. In addition, glia become increasingly activated in response to repeated administration of opioids. Products of activated glia increase neuronal excitability via numerous mechanisms, including direct receptor-mediated actions, upregulation of excitatory amino acid receptor function, downregulation of GABA receptor function, and so on. These downstream effects of glial activation amplify pain, suppress acute opioid analgesia, contribute to the apparent loss of opioid analgesia upon repeated opioid administration (tolerance), and contribute to the development of opioid dependence. The potential implications of such glial regulation of pain and opioid actions are vast, suggestive that targeting glia and their proinflammatory products may provide a novel and effective therapy for controlling clinical pain syndromes and increasing the clinical utility of analgesic drugs. PMID:17175134

  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. The STOP-Bang Equivalent Model and Prediction of Severity of Obstructive Sleep Apnea: Relation to Polysomnographic Measurements of the Apnea/Hypopnea Index

    PubMed Central

    Farney, Robert J.; Walker, Brandon S.; Farney, Robert M.; Snow, Gregory L.; Walker, James M.

    2011-01-01

    Background: Various models and questionnaires have been developed for screening specific populations for obstructive sleep apnea (OSA) as defined by the apnea/hypopnea index (AHI); however, almost every method is based upon dichotomizing a population, and none function ideally. We evaluated the possibility of using the STOP-Bang model (SBM) to classify severity of OSA into 4 categories ranging from none to severe. Methods: Anthropomorphic data and the presence of snoring, tiredness/sleepiness, observed apneas, and hypertension were collected from 1426 patients who underwent diagnostic polysomnography. Questionnaire data for each patient was converted to the STOP-Bang equivalent with an ordinal rating of 0 to 8. Proportional odds logistic regression analysis was conducted to predict severity of sleep apnea based upon the AHI: none (AHI < 5/h), mild (AHI ≥ 5 to < 15/h), moderate (≥ 15 to < 30/h), and severe (AHI ≥ 30/h). Results: Linear, curvilinear, and weighted models (R2 = 0.245, 0.251, and 0.269, respectively) were developed that predicted AHI severity. The linear model showed a progressive increase in the probability of severe (4.4% to 81.9%) and progressive decrease in the probability of none (52.5% to 1.1%). The probability of mild or moderate OSA initially increased from 32.9% and 10.3% respectively (SBM score 0) to 39.3% (SBM score 2) and 31.8% (SBM score 4), after which there was a progressive decrease in probabilities as more patients fell into the severe category. Conclusions: The STOP-Bang model may be useful to categorize OSA severity, triage patients for diagnostic evaluation or exclude from harm. Citation: Farney RJ; Walker BS; Farney RM; Snow GL; Walker JM. The STOP-Bang equivalent model and prediction of severity of obstructive sleep apnea: relation to polysomnographic measurements of the apnea/hypopnea index. J Clin Sleep Med 2011;7(5):459-465. PMID:22003340

  3. First clinical experience with the air purge control and electrical remote-controlled tubing clamp in mini bypass.

    PubMed

    Huybregts, Rien M A J M; Veerman, Derk P; Vonk, Alexander B A; Nesselaar, Alfred F; Paulus, Reggie C E; Thone-Passchier, Deirdre H; Smith, Annette L; de Vroege, Roel

    2006-09-01

    Most mini bypass systems do not contain a venous and cardiotomy reservoir in the cardiopulmonary bypass (CPB) circuit and lack the capability to remove venous air. In conjunction with the manufacturer the air purge control system, a system which automatically removes air that is captured in a venous bubble trap, has been developed. This system is combined with an electrical remote clamp, which automatically clamps the arterial line in case air leaves the bubble trap. Twenty consecutive patients undergoing surgery with CPB were included in this clinical validation. Venous air was removed by the air purge control during bypass. The electrical remote clamp was never activated by the system, confirming that the air purge control adequately removed venous air during these cases. The air purge control, in conjunction with the electrical remote clamp, is a valuable safety feature in mini bypass, enhancing patient safety and user friendliness while providing a level of safety equivalent to those of conventional bypass systems.

  4. 78 FR 59064 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services... application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of...

  5. 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.…

  6. 77 FR 50162 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

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

  7. Clinically Referred ODD Children with or without CD and Healthy Controls: Comparisons across Contextual Domains

    ERIC Educational Resources Information Center

    Kolko, David J.; Dorn, Lorah D.; Bukstein, Oscar; Burke, Jeffrey D.

    2008-01-01

    This study compares 6-11-year-old, clinically referred boys and girls diagnosed with Oppositional Defiant Disorder, either with (ODD + CD, n = 40) or without Conduct Disorder (ODD only; n = 136), to a matched sample of healthy control children (HC; n = 69). Multiple informants completed intake diagnostic interviews and self-reports to evaluate…

  8. Translating Research on Myoelectric Control into Clinics-Are the Performance Assessment Methods Adequate?

    PubMed

    Vujaklija, Ivan; Roche, Aidan D; Hasenoehrl, Timothy; Sturma, Agnes; Amsuess, Sebastian; Farina, Dario; Aszmann, Oskar C

    2017-01-01

    Missing an upper limb dramatically impairs daily-life activities. Efforts in overcoming the issues arising from this disability have been made in both academia and industry, although their clinical outcome is still limited. Translation of prosthetic research into clinics has been challenging because of the difficulties in meeting the necessary requirements of the market. In this perspective article, we suggest that one relevant factor determining the relatively small clinical impact of myocontrol algorithms for upper limb prostheses is the limit of commonly used laboratory performance metrics. The laboratory conditions, in which the majority of the solutions are being evaluated, fail to sufficiently replicate real-life challenges. We qualitatively support this argument with representative data from seven transradial amputees. Their ability to control a myoelectric prosthesis was tested by measuring the accuracy of offline EMG signal classification, as a typical laboratory performance metrics, as well as by clinical scores when performing standard tests of daily living. Despite all subjects reaching relatively high classification accuracy offline, their clinical scores varied greatly and were not strongly predicted by classification accuracy. We therefore support the suggestion to test myocontrol systems using clinical tests on amputees, fully fitted with sockets and prostheses highly resembling the systems they would use in daily living, as evaluation benchmark. Agreement on this level of testing for systems developed in research laboratories would facilitate clinically relevant progresses in this field.

  9. 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.

  10. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    PubMed Central

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    Background The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study. Methods We searched the 454,449 records on publications in The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 3, 2005 (CD-ROM version) for possible country of origin. We inspected a random sample of 906 records for information on country and type of trial. Results There was an exponential growth of publications on randomised controlled trials and controlled clinical trials since 1946, but the growth seems to have seized since 2000. We identified the possible country of origin of 210,974 publications (46.4%). The USA is leading with about 46,789 publications followed by UK, Germany, Italy, the Netherlands, Canada, and France. Sweden becomes the leader with 891 publications per million inhabitants during the last 60 years followed by Denmark (n = 864), New Zealand (n = 791), Finland (n = 781), the Netherlands (n = 570), Switzerland (n = 547), and Norway (n = 543). In depth assessment of the random sample backed these findings. Conclusion Many records lacked country of origin, even after the additional scrutiny. The number of publications on clinical trials increased exponentially until the turn of the century. Rather small, democratic, and wealthy countries take the lead when the number of publications on clinical trials is calculated based on million inhabitants. If all countries produced the same number of trials as these countries, this could mean thousands of new effective treatments during the next 60 years. PMID:17326823

  11. First clinical evaluation of the navigated controlled drill at the lateral skull base.

    PubMed

    Hofer, M; Dittrich, E; Scholl, C; Neumuth, T; Strauss, M; Dietz, A; Lüth, T; Strauss, G

    2008-01-01

    Surgery on the lateral skull base puts delicate structures at risk. To support the surgeon in identifying and protecting the risk structures the principle of Navigated Control (NC) can be used for preventing iatrogenic injuries. In this paper the application of Navigated Control for surgery on the lateral skull base was investigated for the first time in clinical use. There was no risk structure damage with NC. Navigated Control in lateral skull base surgery seems to have a great potential for safe risk structure protection, a morbidity reduction and in a relief of strain for the surgeon.

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

    PubMed

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

    2011-11-01

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

  13. The Individualized Quality Control Plan – Coming Soon to Clinical Microbiology Laboratories Everywhere!

    PubMed Central

    Anderson, Nancy

    2016-01-01

    As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP. PMID:26997689

  14. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process.

    PubMed

    Schmitt, Jochen; Langan, Sinéad; Stamm, Tanja; Williams, Hywel C

    2011-03-01

    There is wide variation in the use of outcome measures for eczema. We performed a three-stage web-based international Delphi exercise to develop consensus-based sets of core outcome domains for eczema for "controlled trials" and "clinical recordkeeping". A total of 57 individuals from four stakeholder groups (consumers, clinical experts, regulatory agency representatives, and journal editors) representing 13 countries were asked to rate the importance of 19 outcome domains for eczema and to choose which domains should be included in two core sets of outcomes. Forty-six individuals (81%) participated. Participants received standardized feedback, including the group median, interquartile range, and previous responses, and the assessment was repeated in two subsequent rounds. We defined consensus a priori if at least 60% of the members of at least three stakeholder groups, including consumers, recommended domain inclusion in the core set. Consensus was achieved for inclusion of symptoms, physician-assessed clinical signs, and a measurement for long-term control of flares in the core set of outcome domains for eczema trials. We recommend including these three core outcomes in future eczema trials in order to enhance clinical interpretability and to enable meta-analyses across different studies. For recordkeeping, consensus was reached to regularly monitor eczema symptoms in clinical practice. Future work is needed to select which existing or new scales should be used to measure the domains identified as relevant for the core set.

  15. 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

  16. Randomized controlled clinical trial of Blood Glucose Awareness Training (BGAT III) in Switzerland and Germany.

    PubMed

    Schachinger, Hartmut; Hegar, Karin; Hermanns, Norbert; Straumann, Madeleine; Keller, Ulrich; Fehm-Wolfsdorf, Gabriele; Berger, Willi; Cox, Daniel

    2005-12-01

    Although both diabetes and the efficacy of medical management are international issues, psycho-educational interventions might be culturally bound. Blood Glucose Awareness Training (BGAT) is a psycho-educational program for patients with type 1 diabetes mellitus. It is focused on improving recognition and management of extreme blood glucose levels, and is the best documented American psycho-educational program for this purpose. A randomized controlled clinical trial of BGAT's long-term benefits in a non-American setting has been lacking. One hundred and eleven adults with type 1 diabetes mellitus from Switzerland and Germany participated. After a 6 months baseline assessment, subjects were randomly assigned to receive either 2 months of BGAT (n = 56) or a physician-guided self-help control intervention (n = 55). BGAT improved recognition of low (p = 0.008), high (p = .03), and overall blood glucose (p = 0.001), and reduced frequency of severe hypoglycemia (p = 0.04), without compromising metabolic control. BGAT reduced both the external locus of control (p < 0.02) and fear of hypoglycemia (p < 0.02). BGAT was efficacious in reducing adverse clinical events and achieving clinically desirable goals in a European, as well as American setting.

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

    PubMed

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

    2014-04-30

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

  18. 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

  19. 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

  20. [Quality control of capillary blood measurements in clinical services: follow up by the biologist].

    PubMed

    Desjobert, H; Durand, G; Chérubin, N; Le Moël, G

    2001-04-01

    In Bichat-Claude Bernard Hospital, the study of capillary glucose analyzers in the aim of uniformizing the selection of glucose meters, has shown the relevance of a standardized handling in order to obtain clinically interpretable results. It has been necessary to implement a quality follow up by the biologist. In the first stage, the biochemistry laboratory, with the clinical service supervisor and the supplier, has assured the training of the medical staff habilitated to use the meters and to carry out a quality control. In the second stage, the biologist implemented a monthly control on a total blood control sample, the stability of which has been checked after the necessary addition of glucose. Dosing of that sample, which is used as an external control, is carried out in parallel by the QID Precision glucose analyzer (Abbott) and by the portable Hemocue B Glucose (Vermed), which is selected as a comparison standard. This allows a monthly control of the accuracy of the meter. The condition of the equipment, as well as the weekly control follow up, validated by the nurse, is registered on a sheet prepared by the biologist. In partnership with Vermed, we have developed a processing software of the data stored in the Hemocue, allowing the automatic issue of a report summarizing the equipment condition and the data of weekly and monthly controls follow up. This report, signed by the biologist, is sent to every Service Manager and Supervising Nurse. On the basis of our one year experience, this practice has generated an efficient collaboration between the clinical services and the biochemistry laboratory, allowing to keep the quality of the capillary glucose measurements performed in inpatients.

  1. 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.

  2. 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

  3. 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.

  4. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma.

    PubMed

    Murphy, Anna C; Proeschal, Amandine; Brightling, Christopher E; Wardlaw, Andrew J; Pavord, Ian; Bradding, Peter; Green, Ruth H

    2012-08-01

    Medication non-adherence and the clinical implications in difficult-to-control asthma were audited. Prescription issue data from 115 patients identified sub-optimal adherence (<80%) in 65% of patients on inhaled corticosteroids (ICS) or combined ICS/long-acting β2 agonist (LABA). In those using separate ICS and LABA, adherence to LABA (50%) was significantly better than to ICS (14.3%). Patients with sub-optimal ICS adherence had reduced FEV(1) and higher sputum eosinophil counts. Adherence ratio was an independent predictor of previous ventilation for acute severe asthma (p=0.008). The majority of patients with difficult-to-control asthma are non-adherent with their asthma medication. Non-adherence is correlated with poor clinical outcomes.

  5. Advocating for both Environmental and Clinical Approaches to Control Human Strongyloidiasis

    PubMed Central

    Beknazarova, Meruyert; Whiley, Harriet; Ross, Kirstin

    2016-01-01

    Strongyloidiasis is an underestimated disease caused by the soil-transmitted parasite of the genus Strongyloides. It is prevalent in socioeconomically disadvantaged communities and it is estimated that global infection could be as high as 370 million people. This paper explores current methods of strongyloidiasis treatment, which rely on administration of anthelminthic drugs. However these drugs cannot prevent reinfection and drug resistance has already been observed in veterinary models. This highlights the need for a combined approach for controlling Strongyloides that includes both clinical treatment and environmental control methods. Currently, nematicides are widely used to control plant parasites. The review suggests that due to the species’ similarity and similar modes of action, these nematicides could also be used to control animal and human parasitic nematodes in the environment. PMID:27706031

  6. Advocating for both Environmental and Clinical Approaches to Control Human Strongyloidiasis.

    PubMed

    Beknazarova, Meruyert; Whiley, Harriet; Ross, Kirstin

    2016-09-30

    Strongyloidiasis is an underestimated disease caused by the soil-transmitted parasite of the genus Strongyloides. It is prevalent in socioeconomically disadvantaged communities and it is estimated that global infection could be as high as 370 million people. This paper explores current methods of strongyloidiasis treatment, which rely on administration of anthelminthic drugs. However these drugs cannot prevent reinfection and drug resistance has already been observed in veterinary models. This highlights the need for a combined approach for controlling Strongyloides that includes both clinical treatment and environmental control methods. Currently, nematicides are widely used to control plant parasites. The review suggests that due to the species' similarity and similar modes of action, these nematicides could also be used to control animal and human parasitic nematodes in the environment.

  7. Patient-derived determinants for participation in placebo-controlled clinical trials for fibromyalgia.

    PubMed

    Holman, Andrew J; Neradilek, Moni Blazej; Dryland, David D; Neiman, Richard A; Brown, Paul B; Ettlinger, Robert E

    2010-12-01

    Perspectives of patients with fibromyalgia influence their likelihood of participating in randomized placebo-controlled trials and potentially clash with current, well-established methodology of randomized controlled trial design. Mandates to use only acetaminophen for breakthrough pain and that require discontinuation of concomitant medications, especially in studies lacking an active comparator arm, could bias a trial cohort to thereby reduce the generalizability of study findings and conclusions. This study evaluates factors affecting willingness to participate in such clinical trials, including the impact of altruism, payment, study duration, forced discontinuation of specific medications, and subject demographics for patients seen by rheumatologists proficient and avidly interested in treating fibromyalgia.

  8. Improving completeness of electronic problem lists through clinical decision support: a randomized, controlled trial

    PubMed Central

    Pang, Justine; Feblowitz, Joshua C; Maloney, Francine L; Wilcox, Allison R; McLoughlin, Karen Sax; Ramelson, Harley; Schneider, Louise; Bates, David W

    2012-01-01

    Background Accurate clinical problem lists are critical for patient care, clinical decision support, population reporting, quality improvement, and research. However, problem lists are often incomplete or out of date. Objective To determine whether a clinical alerting system, which uses inference rules to notify providers of undocumented problems, improves problem list documentation. Study Design and Methods Inference rules for 17 conditions were constructed and an electronic health record-based intervention was evaluated to improve problem documentation. A cluster randomized trial was conducted of 11 participating clinics affiliated with a large academic medical center, totaling 28 primary care clinical areas, with 14 receiving the intervention and 14 as controls. The intervention was a clinical alert directed to the provider that suggested adding a problem to the electronic problem list based on inference rules. The primary outcome measure was acceptance of the alert. The number of study problems added in each arm as a pre-specified secondary outcome was also assessed. Data were collected during 6-month pre-intervention (11/2009–5/2010) and intervention (5/2010–11/2010) periods. Results 17 043 alerts were presented, of which 41.1% were accepted. In the intervention arm, providers documented significantly more study problems (adjusted OR=3.4, p<0.001), with an absolute difference of 6277 additional problems. In the intervention group, 70.4% of all study problems were added via the problem list alerts. Significant increases in problem notation were observed for 13 of 17 conditions. Conclusion Problem inference alerts significantly increase notation of important patient problems in primary care, which in turn has the potential to facilitate quality improvement. Trial Registration ClinicalTrials.gov: NCT01105923. PMID:22215056

  9. Text Message Reminders Increase Appointment Adherence in a Pediatric Clinic: A Randomized Controlled Trial

    PubMed Central

    Mistry, Nila; Boneh, Jordana; Li, Hong; Lazebnik, Rina

    2016-01-01

    Background. High no-show rates can burden clinic productivity and affect patient care. Although multiple studies have shown that text messages improve appointment adherence, very little research has focused on low-income and predominantly African American populations in resident clinic settings. Objectives. To determine whether incorporating a text message reminder reduces the no-show rate at an urban, pediatric resident clinic. Methods. A randomized controlled trial was conducted at a tertiary level ambulatory pediatric practice between August 2014 and February 2015. Following a demographic survey, 170 patients were enrolled. Patients were randomized into control or intervention groups. All patients received the standard voice message appointment reminder, but the intervention group additionally received a text message reminder. The primary outcome was no-show rate. Results. 95.3% of the participants were African American, and the overall no-show rate was 30.8%. No-show rate was significantly lower in the intervention group (23.5%) than the control group (38.1%) representing a difference of 14.6% (p = 0.04). No demographic factors were found to alter the association between no-show rate and text message intervention. Conclusions. Text message reminders effectively improve show rates at a resident pediatric practice with high no-show rates, representing a promising approach to improving appointment adherence. PMID:28127311

  10. 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

  11. Clinical assessment of reactive postural control among physiotherapists in Ontario, Canada.

    PubMed

    Sibley, K M; Inness, E L; Straus, S E; Salbach, N M; Jaglal, S B

    2013-09-01

    Reactive postural control, the ability to recover from an external perturbation to stability, ultimately determines whether an individual will fall following a loss of balance and should be routinely incorporated in balance assessment. The purpose of this study was to identify (1) methods used to assess reactive postural control in clinical practice and (2) factors associated with regular assessment of reactive postural control. A cross-sectional survey was conducted. Three hundred and fifty-seven physiotherapists in Ontario, Canada who treated adults with balance impairments answered questions about the components of balance they assess and how they assess reactive control in their practice. Of the 273 respondents who assessed reactive postural control at least some of the time, 15.4% used a standardized measure, 79.1% used a non-standardized approach, and 5.5% used both. Forty-five methods of assessing reactive control were reported. The most common methods used were non-standardized perturbations (43.5%; 104/239 respondents) and movement observation (18.8%; 45/239). The remaining 43 methods were each used by less than 8% of respondents. Practice area had the strongest association with regular assessment of reactive postural control (>60% of the time), and respondents working with neurological disorders were more likely to regularly evaluate reactive control than those working with people with orthopedic conditions. Despite the availability of valid standardized measures to evaluate reactive postural control, respondents relied primarily on non-standardized approaches and observational assessment. Future work should examine the factors influencing choice of reactive control assessment tools and awareness of standardized measures for reactive postural control.

  12. Removal of extrinsic stain using a tartar control whitening dentifrice: a randomized clinical trial.

    PubMed

    Gerlach, R W; White, D J

    2001-01-01

    A nine-week, double blind clinical trial was conducted to evaluate the effectiveness of a novel tartar control whitening dentifrice with a silica-based abrasive system on induced dental stain. The study model involved three weeks of stain induction followed by six weeks of unsupervised brushing to assess efficacy. To induce stain, 222 healthy adult volunteers received a dental prophylaxis, and then began a limited brushing regimen supplemented by three-times daily rinsing with tea and once daily rinsing with 15 ml of 0.12% chlorhexidine. This regimen was suspended, and 187 subjects with tooth stain were entered into a six-week clinical trial where they were randomized to either a silica-based tartar control whitening dentifrice or a marketed regular dentifrice control, balancing for stain levels and smoking status. At baseline, three and six weeks, stain area and stain intensity were measured on the 8 anterior teeth using the Lobene Index. After six weeks' use, composite Lobene means were 35% lower for the whitening dentifrice compared to the regular control. In addition to the overall reductions, there were statistically significant reductions in stain area (p < 0.015) and stain intensity (p < 0.01) at both three and six weeks. The tartar control whitening dentifrice was effective in removing stain on the gingival margins and elsewhere on the body of the tooth. Safety profiles for the two test dentifrices were generally similar. After three and six weeks' use, the tartar control whitening dentifrice reduced chlorhexidine and tea stain compared to the marketed control.

  13. [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.

  14. Clinical characteristics of impaired trunk control in children with spastic cerebral palsy.

    PubMed

    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 ± 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 38.5 out of 58 (66%). Median subscale scores were 18 out of 20 (90%) for the subscale static sitting balance, 16 out of 28 (57%) for the subscale selective movement control and 6 out of 10 (60%) for the subscale dynamic reaching. Total TCMS and subscale scores differed significantly between topographies and severity of motor impairment according to the Gross Motor Function Classification System (GMFCS). Children with hemiplegia obtained the highest scores, followed by children with diplegia and children with quadriplegia obtained the lowest scores. TCMS scores significantly decreased with increasing GMFCS level. In conclusion, trunk control is impaired in children with CP to a various extent, depending on the topography and severity of the motor impairment. The findings of this study also provide specific clues for treatment interventions targeting trunk control to improve their functional abilities.

  15. Suspected collagen disorders in the bleeding disorder clinic: a case-control study.

    PubMed

    Jackson, S C; Odiaman, L; Card, R T; van der Bom, J G; Poon, M-C

    2013-03-01

    Disorders of collagen are associated with a mild bleeding tendency because of the potential abnormal interaction of collagen, von Willebrand factor (VWF) and platelets required during primary haemostasis and due to generalized soft tissue fragility. Abnormal collagen may contribute to bleeding in existing mucocutaneous bleeding disorders, but the prevalence in this setting is unknown. Generalized symptomatic joint hypermobility (SJH) is common in collagen disorders and may be objectively measured. To assess the association between symptomatic joint hypermobility and mucocutaneous bleeding disorders, we performed a case-control study in which case subjects were 55 consecutive individuals who had visited our bleeding disorder clinic with a diagnosis of von Willebrand disease, low von Willebrand factor levels, mild platelet function disorder or undefined bleeding disorder. Controls were 50 subjects without a bleeding disorder, and were age and gender matched to the cases. All subjects were assessed with: (i) Beighton score for joint hypermobility, (ii) revised Brighton criteria, (iii) Condensed MCMDM1-VWD bleeding questionnaire, and (iv) haemostasis laboratory studies. The prevalence of SJH/suspected collagen disorder in the bleeding disorder clinic was 24% (13/55) compared with 2% (1/50) in the control population (OR 15, 95% CI 2-121). Seventy-seven per cent of bleeding disorder clinic SJH subjects (10/13) had a prior personal or family history of Ehlers-Danlos, Benign Joint Hypermobility Syndrome or Osteogenesis Imperfecta (OI). Symptomatic joint hypermobility was associated with increased odds of an underlying mucocutaneous bleeding disorder. These findings suggest that a collagen disorder is common and often unrecognized in the bleeding disorder clinic as a potential contributor to the bleeding symptoms.

  16. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial

    PubMed Central

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by “d” Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength. PMID:28210027

  17. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial.

    PubMed

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by "d" Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength.

  18. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    PubMed

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  19. Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

    PubMed

    Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura

    2017-03-22

    Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms.

  20. 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.

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  3. Laboratory and clinical stain removal evaluations of two tartar control dentifrices.

    PubMed

    Yankell, S L; Emling, R C; Prencipe, M; Rustogi, K; Volpe, A R

    1995-01-01

    The purpose of this research was to evaluate Colgate original Tartar Control dentifrice (TC) and new Colgate Micro Cleansing Tartar Control (MCTC) dentifrice in a laboratory and clinical study for their ability to remove induced stain. In the laboratory study, polished and etched bovine enamel specimens were stained for 4 days with a coffee, tea, and mucin, Sarcina lutea tartox culture in trypticase soy broth. Sixteen specimens were then brushed for 200 strokes with a sodium carboxymethyl cellulose solution to remove loose stain, and then brushed for 300 strokes with a 1:1 toothpaste slurry. Tooth color was measured by reflectance with the CLE L*a*b* scale. The calculated stain removal, 37% for MCTC and 24% for TC, was significantly different (p<0.01) favoring the MCTC dentifrice. In the clinical study, eight-six subjects were given Peridex (0.12% chlorhexidine gluconate) mouthrinse, a low abrasive dentifrice and a soft toothbrush to use twice a day for 8 weeks. Stain was monitored on the buccal and lingual surfaces of the anterior teeth using the Lobene index. The seventy-seven subjects with sufficient total stain were stratified into two balanced groups, given a new soft toothbrush and were randomly assigned to use one of the dentifrices tested, twice a day for 8 weeks. At 4, 6 and 8 weeks in the study, the MCTC dentifrice product had consistent, significantly (p<0.05-0.001) lower total stain scores than the TC dentifrice. In the laboratory and clinical studies conducted, even though stain induction and evaluation procedures differed, the new Colgate Micro Cleansing Tartar Control dentifrice was significantly more effective at removing stain than the Colgate original Tartar Control dentifrice formula.

  4. 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

  5. The impact of prediabetes on glycemic control and clinical outcomes postburn injury.

    PubMed

    Somerset, Amy; Coffey, Rebecca; Jones, Larry; Murphy, Claire V

    2014-01-01

    Poor glucose control and clinical outcomes have been observed in diabetic versus nondiabetic patients postburn injury. Prediabetes is a precursor to diabetes. The purpose of this study was to assess the effects of prediabetes on postinjury glucose control and clinical outcomes. A retrospective review was conducted comparing prediabetics and euglycemic controls. Patients who were admitted for burn care were 18 to 89 years of age and had a hemoglobin A1c (HbA1c) obtained on admission. Prediabetics were defined by an HbA1c of 5.7 to 6.4% and controls by HbA1c < 5.7%. Inpatient glucose levels were recorded, in addition to clinical outcomes. Two hundred eight patients were included: 54 prediabetics and 154 controls. The prediabetic population was older (50.7 vs 39 years; P < .001) with more hypertensives (44.4 vs 16.9%; P < .001), consisted of more African-Americans (20.4 vs 12%; P = .04), and had larger areas of full-thickness burns (4.5 vs 1.75%; P = .02). Median admission HbA1c was 5.9 (5.7-6.0)% among prediabetics and 5.3 (5-5.45)% among controls (P < .001). Prediabetics had significantly higher time-weighted glucose levels (127.7 [105.5-147.6] vs 108.0 [97.1-122.2] mg/dl; P < .001) and more had an average inpatient glucose >150 mg/dl (20.4 vs 9.1%; P = .028). There was no difference in rates of hypoglycemia (glucose <70 mg/dl) or glycemic variability. Prediabetics had lower survival rates (92.6 vs 98.7%; P = .041), but similar rates of unplanned readmission (1.9 vs 3.9%; P = .68), intensive care unit admission (29.6 vs 23.4%; P = .36), mechanical ventilation (24.1 vs 16.2%; P = .20), length of hospital stay (4 [2-8] vs 3 [2-11]; P = .71), and infection (11.1 vs 11.7%; P = .99). Prediabetic status has a significant impact on glucose control and mortality after burn injury.

  6. 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

  7. Application of traditional clinical pathology quality control techniques to molecular pathology.

    PubMed

    Liang, Shu-Ling; Lin, Ming-Tseh; Hafez, Michael J; Gocke, Christopher D; Murphy, Kathleen M; Sokoll, Lori J; Eshleman, James R

    2008-03-01

    Many molecular diagnostic laboratories have evolved from research laboratories, initially performing low numbers of homebrew assays, but many laboratories now perform more kit-based assays, with ever increasing test volumes. One such assay is assessment of bone marrow transplantation engraftment. Allogeneic bone marrow transplantation is performed primarily in the treatment of hematological malignancies. Monitoring of engraftment was traditionally evaluated using minisatellites (variable number tandem repeats) and Southern blotting, but most laboratories now use Food and Drug Administration-cleared microsatellite (short tandem repeats) kits to assess the extent of engraftment. With the increase in equipment reliability, the use of kit-based assays, and the desire to provide the highest quality clinical data, we began applying traditional clinical pathology quality control tools to the molecular diagnostics laboratory. In this study, we demonstrate this approach using a microsatellite-based bone marrow engraftment assay. We analyzed control samples (pure and mixed) for two different microsatellites to establish quality control parameters and constructed Levey-Jennings charts to monitor both the precision and accuracy of this assay. By incorporating these tools into an overall quality assurance program, a laboratory can identify systematic errors and perform corrective actions before actual assay failure, thereby improving the quality of patient care.

  8. 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

  9. 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

  10. The impact of the Virtual Ophthalmology Clinic on medical students' learning: a randomised controlled trial

    PubMed Central

    Succar, T; Zebington, G; Billson, F; Byth, K; Barrie, S; McCluskey, P; Grigg, J

    2013-01-01

    Aim The Virtual Ophthalmology Clinic (VOC) is an interactive web-based teaching module, with special emphasis on history taking and clinical reasoning skills. The purpose of this study was to determine the impact of VOC on medical students' learning. Methods A randomised controlled trial (RCT) was conducted with medical students from the University of Sydney (n=188) who were randomly assigned into either an experimental (n=93) or a control group (n=95). A pre- and post-test and student satisfaction questionnaire were administered. Twelve months later a follow-up test was conducted to determine the long-term retention rate of graduates. Results There was a statistically significant (P<0.001) within-subject improvement pre- to post rotation in the number of correctly answered questions for both the control and experimental groups (mean improvement for control 10%, 95% CI 1.3–2.6, and for experimental 17.5%, 95% CI 3.0–4.0). The improvement was significantly greater in the experimental group (mean difference in improvement between groups 7.5%, 95% CI 0.8–2.3, P<0.001). At 12 months follow-up testing, the experimental group scored on average 1.6 (8%) (95%CI 0.4 to 2.7, P=0.007) higher than the controls. Conclusion On the basis of a statistically significant improvement in academic performance and highly positive student feedback, the implementation of VOC may provide a means to address challenges to ophthalmic learning outcomes in an already crowded medical curriculum. PMID:23867718

  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. Clinical Effectiveness of Scapulothoracic Joint Control Training Exercises on Shoulder Joint Dysfunction.

    PubMed

    Zhang, Ming; Zhou, Jing-Jie; Zhang, Yu-Ming; Wang, Ji-Hong; Zhang, Qiu-Yang; Chen, Wei

    2015-05-01

    The objective of this study was to examine the clinical effectiveness of scapulothoracic joint control training exercises on shoulder joint dysfunction. Forty patients with traumatic shoulder pain and joint dysfunction were randomized into the treatment or control group. Standard rehabilitation interventions included glenohumeral joint mobilization techniques, ultrasound therapy, traditional Chinese medicine, interference current therapy, and other comprehensive interventions. Patients received scapulothoracic joint control training exercises, including active and passive motions of the scapulothoracic joints, peri-joint muscle exercise, and joint stability exercises for 1 month. Patient status was evaluated by Constant-Murley scales before and after the prescribed interventions. The pain conditions, daily activities, range of movement, strength tests and total scores were significantly improved compared to prior treatment. Moreover, improvements in pain, daily activities, scope of activities, and total scores for patients in the treatment group were statistically significant when compared to the control group (P < 0.05). However, there was no inter-group difference in strength testing. The combination of standard rehabilitation interventions and scapulothoracic joint control training exercises are an effective treatment of the shoulder joint dysfunction. Moreover, the pain outcomes, scope of activities, and total scores were better in the treatment group.

  13. [Controlled clinical study on compound Decumbent Corydalis Rhizome and diclofenac in treatment of knee osteoarthritis].

    PubMed

    Zuo, Chuan; Yin, Geng; Cen, Xiao-Min; Xie, Qi-Bing

    2015-01-01

    To evaluate the efficacy and safety of compound Decumbent Corydalis Rhizome (DCR) in treating patients with knee osteoarthritis (OA). Totally 79 patients with knee osteoarthritis were selected from out-patient and inpatient departments of West China Hospital and randomly divided into the test group and the control group. The test group (n = 41) was given Compound DCR with the dosage of 1.8 g · d(-1), while the control group (n = 38) was administered with diclofenac sodium with the dosage of 75 mg · d(-1). After 12 weeks of treatment, the total efficacy rates based on patients/physicians evaluation for experimental and control groups were 68.29%, 63.41% and 71.05%, 63.16%, respectively, without significant difference between the two groups. Both of the two groups showed significant improvements in the main efficacy indexes (pain on walking 20 m) and minor indexes (tenderness on palpation, Western Ontario and McMaster Universities OA index (WOMAC) and Short-Form Health Survey (SF-36 ), but without significant difference in efficacy between them. The incidence of related adverse events was 24.39% in the test group and 47.37% in the control group, respectively, with significant differences between the two groups (P < 0.05). In the controlled study, compound DCR is as efficient as diclofenac sodium but more tolerable, with a good clinical application prospect.

  14. Sleep architecture and cognitive changes in olanzapine-treated patients with depression: A double blind randomized placebo controlled trial

    PubMed Central

    2014-01-01

    Background Disturbance in sleep quality is a symptom of Major Depressive Disorder (MDD) and Bipolar Disorder (BD) and thus improving quality of sleep is an important aspect of successful treatment. Here, a prospective, double-blind, randomized, placebo-controlled study examined the effect of olanzapine (an atypical antipsychotic) augmentation therapy on sleep architecture, specifically slow wave sleep (SWS), in the treatment of depression. The effect of olanzapine augmentation therapy on other features of sleep (e.g., sleep continuity) and depression (e.g., illness severity and cognitive function) were also determined. Methods Patients currently experiencing a major depressive episode and who were on a stable medication were included. Sleep architecture was measured by overnight ambulatory polysomnography. Illness severity was determined using the Montgomery-Asberg Depression Rating Scale (MADRS). Cognitive function was examined using Cambridge Neuropsychological Test Automated Battery (CANTAB): Spatial Working Memory (SWM), Spatial Span (SSP), and Reaction Time (RTI) tasks. Polysomnographs, clinical measures and cognitive tests were administered at baseline, after 2–4 days of treatment and after 28–31 days of treatment. Twenty-five patients participated in the study (N = 10, N = 15 for placebo and olanzapine treated groups respectively). Results The primary objective of the study was to assess the objective (polysomnographic) changes in sleep quality, defined as changes in SWS, following olanzapine treatment for depression. Latency to but not duration of SWS was found to significantly differ between olanzapine- and placebo-treated participants (Hedge’s g: 0.97, 0.13 respectively). A significant improvement in olanzapine-treated participants over placebo-treated participants was observed in secondary outcome measures, including sleep efficiency, total sleep time, and sleep latency. Secondary objectives assessed the subjective changes in sleep quality

  15. Salmonella enteritidis: clinical epidemiological approaches for prevention and control of S. enteritidis in poultry production.

    PubMed

    Noordhuizen, J P; Frankena, K

    1994-01-01

    Salmonella enteritidis infections in poultry appear to be of major public concern. Prevalence levels in veal calves and pigs are rather low. Because of the complex of socio-psychological, welfare, economic and public health aspects great emphasis should be put on prevention and control. This paper deals with some clinical epidemiological approaches for prevention and control of S. enteritidis. Emphasis is set on multifactorial background of infection occurrence, epidemiological methods and features of monitoring and surveillance for evaluation of measures taken during a follow-up period. Finally, it is stated that the application of Risk Assessment & Analysis principles in this problem area, integrating the concepts previously addressed, might prove to be a valuable perspective.

  16. 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

  17. 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.

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

    PubMed

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

    2016-03-15

    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.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2013-01-15

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

  1. Using clinically approved cyclophosphamide regimens to control the humoral immune response to oncolytic viruses

    PubMed Central

    Peng, K-W; Myers, R; Greenslade, A; Mader, E; Greiner, S; Federspiel, MJ; Dispenzieri, A; Russell, SJ

    2013-01-01

    Oncolytic viruses can be neutralized in the bloodstream by antiviral antibodies whose titers increase progressively with each exposure, resulting in faster virus inactivation and further reductions in efficacy with each successive dose. A single dose of cyclophosphamide (CPA) at 370 mg m−2 was not sufficient to control the primary antiviral immune responses in mice, squirrel monkeys and humans. We therefore tested clinically approved multidose CPA regimens, which are known to kill proliferating lymphocytes, to determine if more intensive CPA therapy can more effectively suppress antiviral antibody responses during virotherapy. In virus-susceptible mice, primary antibody responses to intravenously (i.v.) administered oncolytic measles virus (MV) or vesicular stomatitis virus (VSV) were partially or completely suppressed, respectively, by oral (1 mg × 8 days) or systemic (3 mg × 4 days) CPA regimens initiated 1 day before virus. When MV- or VSV-immune mice were re-challenged with the respective viruses and concurrently treated with four daily systemic doses of CPA, their anamnestic antibody responses were completely suppressed and antiviral antibody titers fell significantly below pre-booster levels. We conclude that the CPA regimen of four daily doses at 370 mg m−2 should be evaluated clinically with i.v. virotherapy to control the antiviral antibody response and facilitate effective repeat dosing. PMID:22476202

  2. Using clinically approved cyclophosphamide regimens to control the humoral immune response to oncolytic viruses.

    PubMed

    Peng, K-W; Myers, R; Greenslade, A; Mader, E; Greiner, S; Federspiel, M J; Dispenzieri, A; Russell, S J

    2013-03-01

    Oncolytic viruses can be neutralized in the bloodstream by antiviral antibodies whose titers increase progressively with each exposure, resulting in faster virus inactivation and further reductions in efficacy with each successive dose. A single dose of cyclophosphamide (CPA) at 370 mg m(-2) was not sufficient to control the primary antiviral immune responses in mice, squirrel monkeys and humans. We therefore tested clinically approved multidose CPA regimens, which are known to kill proliferating lymphocytes, to determine if more intensive CPA therapy can more effectively suppress antiviral antibody responses during virotherapy. In virus-susceptible mice, primary antibody responses to intravenously (i.v.) administered oncolytic measles virus (MV) or vesicular stomatitis virus (VSV) were partially or completely suppressed, respectively, by oral (1 mg × 8 days) or systemic (3 mg × 4 days) CPA regimens initiated 1 day before virus. When MV- or VSV-immune mice were re-challenged with the respective viruses and concurrently treated with four daily systemic doses of CPA, their anamnestic antibody responses were completely suppressed and antiviral antibody titers fell significantly below pre-booster levels. We conclude that the CPA regimen of four daily doses at 370 mg m(-2) should be evaluated clinically with i.v. virotherapy to control the antiviral antibody response and facilitate effective repeat dosing.

  3. The scope of the controlled clinical trial, illustrated by studies of pulmonary tuberculosis*

    PubMed Central

    Fox, Wallace

    1971-01-01

    This report draws attention to the wide use of the controlled clinical trial in the study of tuberculosis in certain countries and centres and to the remarkable neglect of this method in the great majority of countries. Its versatility has been demonstrated by many studies: it has been used to study not only alternative combinations of drugs but also drug dosages, rhythms of administration, the duration of treatment with supplementary drugs or the total duration of treatment, and drug toxicity and its prevention. A particularly valuable use of the method is in the study of policies of therapy—e.g., treatment at home compared with treatment in a sanatorium; the inclusion of routine home visiting in the supervision of patients; the carrying out of pretreatment sensitivity tests as a basis for the selection of chemotherapeutic regimens; and treatment programmes based on short (6-month) intensive courses, as opposed to long-term (18-month) standard courses. It is concluded that well planned controlled clinical trials can be of great help to the epidemiologist and public health administrator as well as to the clinician. PMID:4947491

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

    PubMed

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

    2014-10-15

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

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  6. 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)…

  7. 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

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

    PubMed

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

    2015-04-01

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

  9. Sham Surgery Controls in Parkinson Disease Clinical Trials: Views of Participants

    PubMed Central

    Kim, Scott Y. H.; De Vries, Raymond; Holloway, Robert G.; Wilson, Renee; Parnami, Sonali; Kim, H. Myra; Frank, Samuel; Kieburtz, Karl

    2013-01-01

    Background Sham surgery controls are increasingly used in neurosurgical clinical trials in Parkinson disease (PD), but remain controversial. We interviewed participants of such trials, specifically examining their understanding and attitudes regarding sham surgery. Methods We conducted semi-structured qualitative interviews with participants of three sham surgery controlled trials for PD, focusing on their understanding of sham design, their reactions to it, its impact on decision-making, and their understanding of post-trial availability of the experimental intervention and its impact on decisions to participate. Results All subjects (N=90) understood the two-arm design; most (86%) described the procedural differences between the arms accurately. 92% referred to scientific or regulatory reasons as rationales for the sham control, with 62% specifically referring to the placebo effect. 91% said post-trial availability of the experimental intervention had a strong (48%) or some (43%) influence on their decision to participate but only 68% understood the conditions for post-trial availability. Conclusions Most subjects in sham surgery controlled PD trials comprehend the sham surgery design and its rationale. Although there is room for improvement, most subjects of sham surgery trials appear to be adequately informed. PMID:22927064

  10. Conservative methods for reducing lateral translation postures of the head: a nonrandomized clinical control trial.

    PubMed

    Harrison, Deed E; Cailliet, Rene; Betz, Joseph; Haas, Jason W; Harrison, Donald D; Janik, Tadeusz J; Holland, Burt

    2004-07-01

    Fifty-one retrospective, consecutive patients were compared to twenty-six prospective volunteer controls in a nonrandomized clinical control trial. Both groups had chronic neck pain and lateral head translation posture. For treatment subjects, beginning and follow-up pain scales and anteroposterior (AP) cervical radiographs were obtained after 12.8 weeks of care (average of 37 visits), while the duration was a mean of 12 months for control subjects. Digitized radiographs were analyzed for Risser-Ferguson angles and a horizontal translation distance of C2 from a vertical line through T3. For treatment, patients received the Harrison mirror-image postural methods, which include mechanically assisted manipulation, opposite head posture exercise, and opposite head translation posture traction. While no significant differences were found in the control group subjects' pain scores and AP radiographic measurements, statistically significant improvements were observed in the treatment group subjects' pain scores and lateral translation displacements of C2 compared to T3 (pretrial score: 13.7 mm, posttrial score: 6.8 mm) and in angle measurements.

  11. Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

    PubMed

    Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-08-06

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications.

  12. Yoga for Generalized Anxiety Disorder: Design of a Randomized Controlled Clinical Trial

    PubMed Central

    Hofmann, Stefan G.; Curtiss, Joshua; Khalsa, Sat Bir S.; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-01-01

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N = 95) to both CBT for GAD (N=95) and stress education (N = 40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6 month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. PMID:26255236

  13. 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

  14. Characterization of published randomized controlled trials assessing clinical pharmacy services around the world.

    PubMed

    Rotta, Inajara; Souza, Thais Teles; Salgado, Teresa M; Correr, Cassyano J; Fernandez-Llimos, Fernando

    A critical analysis of the research on clinical pharmacy services with regards to study characteristics has not been undertaken since 1998. However, several meta-analyses have been conducted to demonstrate the impact of pharmacists' interventions in specific medical conditions. These meta-analyses present high heterogeneity in part because the interventions are poorly and inconsistently described in primary studies. The aim of this article is to present the characteristics of randomized control trials (RCTs) that assess clinical pharmacy services to identify areas of improvement in future pharmacy practice research studies. Different emphasis of research across geographic regions of the world were also examined. During these 40 years, 520 articles reporting 439 RCTs assessing clinical pharmacy services were published. Of the 439 studies, 77.7% (n = 341) were published in the year 2000 or thereafter, 41.46% (n = 182) were conducted in the US, 27.56% (n = 121) in Europe, and 30.98% (n = 136) in the rest of the world. Studies in pharmacy practice have improved in terms of design, with an increase in the number of published RCTs after 2000. However, the small sample size of RCTs is still an issue. After 2000, a significantly higher proportion of studies were conducted in community pharmacy, targeting specific medical conditions, and with a higher number of patients randomized to the intervention group. Conversely, a significantly smaller proportion of studies were conducted in the hospital and targeted a single recipient after 2000. Studies conducted in the US had significantly more intervention arms, focused mostly on a specific medical condition, and were performed in primary care. Different health care systems' organization and policies may influence clinical pharmacy services research across countries.

  15. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes.

    PubMed

    Kingery, W S

    1997-11-01

    The purpose of this review was to identify and analyze the controlled clinical trial data for peripheral neuropathic pain (PNP) and complex regional pain syndromes (CRPS). A total of 72 articles were found, which included 92 controlled drug trials using 48 different treatments. The methods of these studies were critically reviewed and the results summarized and compared. The PNP trial literature gave consistent support (two or more trials) for the analgesic effectiveness of tricyclic antidepressants, intravenous and topical lidocaine, intravenous ketamine, carbamazepine and topical aspirin. There was limited support (one trial) for the analgesic effectiveness of oral, topical and epidural clonidine and for subcutaneous ketamine. The trial data were contradictory for mexiletine, phenytoin, topical capsaicin, oral non-steroidal anti-inflammatory medication, and intravenous morphine. Analysis of the trial methods indicated that mexiletine and intravenous morphine were probably effective analgesics for PNP, while non-steroidals were probably ineffective. Codeine, magnesium chloride, propranolol, lorazepam, and intravenous phentolamine all failed to provide analgesia in single trials. There were no long-term data supporting the analgesic effectiveness of any drug and the etiology of the neuropathy did not predict treatment outcome. Review of the controlled trial literature for CRPS identified several potential problems with current clinical practices. The trial data only gave consistent support for analgesia with corticosteroids, which had long-term effectiveness. There was limited support for the analgesic effectiveness of topical dimethylsulfoxyde (DMSO), epidural clonidine and intravenous regional blocks (IVRBs) with bretylium and ketanserin. The trial data were contradictory for intranasal calcitonin and intravenous phentolamine and analysis of the trial methods indicated that both treatments were probably ineffective for most patients. There were consistent trial

  16. The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial

    PubMed Central

    Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachael; Leurent, Baptiste; Sweeting, Michael J; Touquet, Robin; Greene, Linda; Tyrer, Peter; Ward, Helen; Lingford-Hughes, Anne

    2015-01-01

    Objectives To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics. Methods Two-arm, parallel group, assessor blind, pragmatic, randomised controlled trial. 802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment. Brief advice consisted of feedback on alcohol and health, written information and an offer of an appointment with an Alcohol Health Worker. Control participants received a leaflet on health and lifestyle. The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation. The main secondary outcome was unprotected sex during this period. Results Among the 402 randomised to brief advice, 397 (99%) received it. The adjusted mean difference in alcohol consumption at 6 months was −2.33 units per week (95% CI −4.69 to 0.03, p=0.053) among those in the active compared to the control arm of the trial. Unprotected sex was reported by 154 (53%) of those who received brief advice, and 178 (59%) controls (adjusted OR=0.89, 95% CI 0.63 to 1.25, p=0.496). There were no significant differences in costs between study groups at 6 months. Conclusions Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. Trial registration number Current Controlled Trials ISRCTN 99963322. PMID:24936090

  17. 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

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

    PubMed Central

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

    2013-01-01

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

  19. 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

  20. 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

  1. Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial.

    PubMed

    Ben-Ami, Noa; Chodick, Gabriel; Mirovsky, Yigal; Pincus, Tamar; Shapiro, Yair

    2017-02-01

    Study Design Prospective, pragmatic, nonrandomized controlled clinical trial. Background Clinical guidelines recommend physical activity for the treatment of chronic low back pain. But engaging patients in physical activity has proven difficult. Known obstacles to physical activity include low self-efficacy and fear avoidance. Objectives This study tested the effectiveness of an enhanced transtheoretical model intervention (ETMI) aimed at increasing recreational physical activity in patients with chronic low back pain, in comparison to usual physical therapy. Methods Patients (n = 220) referred to physical therapy for chronic low back pain were allocated to ETMI or to a control group. The ETMI was delivered by physical therapists and based on behavior-change principles, combined with increased reassurance, therapeutic alliance, and exposure to reduce fear avoidance. The primary outcome was back pain-related disability (Roland-Morris Disability Questionnaire). Secondary outcomes included pain intensity, mental and physical health, and levels of physical activity. Results Intention-to-treat analysis in 189 patients at 12 months indicated that patients in the ETMI group had significantly lower disability compared to usual physical therapy. The difference in mean change from baseline between the interventions was 2.7 points (95% confidence interval: 0.9, 4.5) on the Roland-Morris Disability Questionnaire. At 12 months, worst pain, physical activity, and physical health were all significantly better in patients receiving ETMI. The average number of sessions was 3.5 for the ETMI group and 5.1 for controls. Conclusion Targeting obstacles to physical activity with an intervention that includes components to address self-efficacy and fear avoidance appears to be more effective than usual physical therapy care in reducing long-term disability. Further research is needed to explore the mechanisms that impact outcomes in this intervention package. Level of Evidence Therapy

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

    PubMed

    Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

    2015-01-01

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

  3. [Effectiveness of IPD treatment for delirium prevention in hospitalized elderly. A controlled randomized clinical trial].

    PubMed

    Bonaventura, Marino; Zanotti, Renzo

    2007-01-01

    Delirium is a common and serious complication for hospitalized elderly people. Early detection of risk and preventive treatment may significantly reduce delirium and its consequences. In Inouye's study of elderly people with delirium (1993), an interesting predictive model was proposed ,but never applied, for hospitalized elderly. The aim of this study was to test the effectiveness of IPD, a standardized package of caring activities, in the prevention of delirium in inpatient elderly The study consisted of an experimental controlled randomized trial with standardized treatment (Prevention of Delirium Interventions - IPD) with 30 subjects in the experimental group and 30 comparable subjects in the control group. Subjects were recruited if they obtained a score of 24 or less in the Mini Mental State Examination (MMSE). All the subjects have been assessed on the first, second, fourth and seventh day of their hospital stay according to the MMSE, Barthel Index, Tinetti Balance and Gait Scale, Neecham Confusion Scale, and Delirium Rating Scale. The method of assessment was the Confusion Assessment protocol. There was a statistically and clinically significant reduction in both the risk of delirium and related events in the treatment group compared to the control. Therefore, the IPD model proved to be highly effective in comparison to traditional care for elderly inpatients.

  4. [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.

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

    PubMed

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

    2016-01-01

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

  6. 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

  7. Bayesian sample sizes for exploratory clinical trials comparing multiple experimental treatments with a control.

    PubMed

    Whitehead, John; Cleary, Faye; Turner, Amanda

    2015-05-30

    In this paper, a Bayesian approach is developed for simultaneously comparing multiple experimental treatments with a common control treatment in an exploratory clinical trial. The sample size is set to ensure that, at the end of the study, there will be at least one treatment for which the investigators have a strong belief that it is better than control, or else they have a strong belief that none of the experimental treatments are substantially better than control. This criterion bears a direct relationship with conventional frequentist power requirements, while allowing prior opinion to feature in the analysis with a consequent reduction in sample size. If it is concluded that at least one of the experimental treatments shows promise, then it is envisaged that one or more of these promising treatments will be developed further in a definitive phase III trial. The approach is developed in the context of normally distributed responses sharing a common standard deviation regardless of treatment. To begin with, the standard deviation will be assumed known when the sample size is calculated. The final analysis will not rely upon this assumption, although the intended properties of the design may not be achieved if the anticipated standard deviation turns out to be inappropriate. Methods that formally allow for uncertainty about the standard deviation, expressed in the form of a Bayesian prior, are then explored. Illustrations of the sample sizes computed from the new method are presented, and comparisons are made with frequentist methods devised for the same situation.

  8. Public health response to a large-scale endoscopy infection control lapse in a nonhospital clinic

    PubMed Central

    Willmore, Jacqueline; Ellis, Edward; Etches, Vera; Labrecque, Lise; Osiowy, Carla; Andonov, Anton; McDermaid, Cameron; Majury, Anna; Achonu, Camille; Maher, Maurica; MacLean, Brenda; Levy, Isra

    2015-01-01

    OBJECTIVE: To determine whether transmission of blood-borne pathogens (BBPs) (hepatitis B virus [HBV], hepatitis C virus [HCV] and HIV) occurred as a result of endoscopy reprocessing failures identified during an inspection of a nonhospital endoscopy clinic in 2011. METHODS: The present analysis was a retrospective cohort study. Registered notification letters were mailed to 6992 patients who underwent endoscopy from 2002 to 2011 at one Canadian nonhospital endoscopy clinic, informing them of the infection control lapse and offering BBP testing. Multimedia communications and a telephone line supplemented notification. A retrospective study of patients with BBPs was performed with viral genetic testing and risk factor assessment for eligible patients. Risk for infection among patients whose procedure was within seven days of a known positive patient was compared with those whose procedure was performed more than seven days after a known postive patient. The seven-day period was selected as the period most likely to present a risk for transmission based on the documented cleaning procedures at the clinic and the available literature on virus survival. RESULTS: Ninety-five percent (6628 of 6992) of patients/estates were contacted and 5042 of 6728 (75%) living patients completed BBP testing. Three were newly diagnosed with HBV and 14 with HCV. Twenty-three and 48 tested positive for previously known HBV or HCV, respectively, 367 were immune to HBV due to natural infection and one was immune to HBV due to immunization. None tested positive for HIV. Sequencing did not reveal any relationships among the 46 unique case patients with viral genetic test results available. Ninety-three percent of patients reported alternative risk factors for BBP. An increased risk for infection among those who underwent a procedure within seven days of a known HBV or HCV case was not demonstrated. CONCLUSIONS: Endoscopy reprocessing failures were not associated with an increased risk for BBP

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

    PubMed Central

    Wiljer, David; Cafazzo, Joseph A

    2016-01-01

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

  10. 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.

  11. 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

  12. Considerations for the control of background fluorescence in clinical flow cytometry.

    PubMed

    Hulspas, Ruud; O'Gorman, Maurice R G; Wood, Brent L; Gratama, Jan W; Sutherland, D Robert

    2009-11-01

    Accurate measurement of antigen-positive cells by flow cytometry can be hampered by background fluorescence of antigen-negative cells and other particles (e.g., debris). This article focuses on three major causes of background (autofluorescence, spectral overlap, and undesirable antibody binding) by reviewing individual aspects of flow cytometric measurements that contribute to these causes. The appropriate use of controls facilitates a thorough understanding of these contributing factors as well as the development of robust cell labeling protocols intended for routine flow cytometric analysis. We present a set of recommendations that enables the user to develop an optimized cell labeling protocol that minimizes background and maximizes the ability to reliably distinguish between a positive and a negative population of cells. These recommendations are also intended to augment existing guidelines designed to aid in the formulation of a consensus regarding the utility of flow cytometry for the analysis of clinical samples.

  13. Chlorambucil dosage in frequently relapsing nephrotic syndrome: a controlled clinical trial.

    PubMed

    Baluarte, H J; Hiner, L; Gruskin, A B

    1978-02-01

    A controlled clinical trial was performed using two dosage regimens of chlorambucil to treat children with frequently relapsing nephrotic syndrome. All children concurrently received prednisone (60 mg/m2 on alternate days). Ten children (Group I) were given chlorambucil as a stable dose (0.2 mg/kg/day) for 56 to 60 days, and 11 children (Group II) received increasing doses (0.2 to 0.63 mg/kg/day) for 42 to 77 days. Two children in each group subsequently relapsed. Follow-up averaged 28.6 and 27.2 months in Groups I and II, respectively. Three children in Group II developed infectious complications. The data indicate that a stable dosage regimen for chlorambucil is as effective as an increasing dose regimen in achieving long-term remission of frequently relapsing nephrotic syndrome.

  14. Butaclamol in the treatment of schizophrenia. A standard-controlled clinical trial.

    PubMed

    Nestoros, J N; Lehmann, H E; Ban, T A

    1978-01-01

    A 16-week, standard-controlled, double-blind study was conducted to compare the efficacy of butaclamol with that of fluphenazine in the treatment of 24 newly admitted schizophrenic patients. Statistically significant improvement occurred in the entire population in the total scores of the BPRS and PAS; in the activation, anergia, thought disturbance and hostile/suspiciousness factor scores of the BPRS; and in the scores of 9 of the 12 factors of the PAS. There were no statistically significant differences between the scores of the two treatment groups on the total or factor scores of either scale during the course of the clinical trial. The most frequently occurring adverse effects in the butaclamol group were rigidity, akathisia and excitement/agitation. The most frequently occurring adverse effects in the fluphenazine group were insomnia, decreased motor activity and tremor. It is concluded that butaclamol exerts potent neuroleptic effects on schizophrenic patients.

  15. 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.

  16. Do hospital employees benefit from the influenza vaccine? A placebo-controlled clinical trial.

    PubMed

    Weingarten, S; Staniloff, H; Ault, M; Miles, P; Bamberger, M; Meyer, R D

    1988-01-01

    Although current guidelines target hospital employees who contact high-risk patients as a high priority for influenza immunization, there are few data to support or refute this recommendation. Therefore, the authors enrolled 179 hospital employees in a randomized double-blind placebo-controlled clinical trial during the 1985-1986 influenza season. Influenza immunization was performed without serious adverse reactions and there was no increase in absenteeism attributable to the vaccination. Among those who developed clinical influenza, there was a trend toward fewer days of illness in the vaccinated group compared with the placebo group (6.0 vs. 8.0, p = 0.07). There were no statistically significant differences between subjects receiving influenza vaccine and those receiving the placebo when comparing incidences of influenza-like illness, severities of illness, and sick absenteeism. Influenza immunization of hospital employees was performed at minimal cost and risk but provided little benefit, most likely because of an unexpected drift of the prevalent influenza strain away from the vaccine type.

  17. [Clinical evaluation of Engström's electrically controlled ELSA for low flow closed circuit anesthesia].

    PubMed

    Igarashi, M; Nakae, Y; Ichimiya, N; Watanabe, H; Iwasaki, H; Namiki, A

    1993-02-01

    Many anesthesiologists are now interested in low flow, closed circuit anesthesia from an economical and environmental point of view. In order to evaluate clinically a newly developed electronically controlled anesthesia machine Engström's ELSA, we compared low flow, closed circuit anesthesia on 38 ASA I-II patients using ELSA, with high flow anesthesia on 12 ASA I-II patients using a conventional anesthesia machine. The results were as follows; 1. We could perform safe and economical low flow, closed circuit anesthesia using ELSA's injection vaporizer and accurate monitoring devices for O2, N2O, CO2 and concentrations of various volatile anesthetic agents. 2. Under low flow anesthesia, isoflurane consumption was 5.3 +/- 1.1 ml.h-1 x Vol.%-1 (mean +/- SE) with ELSA, which is about one fourth of the high flow anesthesia consumption (22.6 +/- 2.1 ml.h-1 x Vol.%-1 (mean +/- SE). 3. Low flow closed circuit anesthesia could maintain significantly higher temperature and humidity compared with high flow anesthesia. 4. Under low flow anesthesia of more than 7hrs, color of soda lime becomes blue, but this does not affect FIO2 nor PaCO2, and the method is clinically safe for patients.

  18. Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial

    PubMed Central

    2011-01-01

    Background Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group). Methods/Design People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy. Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes. Discussion This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594 PMID

  19. Electroacupuncture and cognitive behavioural therapy for sub-syndromal depression among undergraduates: a controlled clinical trial

    PubMed Central

    Guo, Tianwei; Guo, Zhuo; Zhang, Wenyue; Ma, Wenhao; Yang, Xinjing; Yang, Xueqin; Hwang, Jiwon; He, Xiaotian; Chen, Xinyi; Ya, Tu

    2016-01-01

    Background Individuals with sub-syndromal depression (SSD) are at increased risk of incident depressive disorders; however, the ideal therapeutic approach to SSD remains unknown. Objective To evaluate the effects of electroacupuncture (EA) and cognitive behavioural therapy (CBT), alone or in combination, on depressive symptoms. Methods Undergraduate students with SSD were recruited and allocated to one of four groups based on their preferences: EA (n=6), CBT (n=10), EA+CBT (n=6), and untreated control (n=11) groups. Six weeks of treatment were provided in the first three groups. Clinical outcomes were measured using the 17-item Hamilton Depression (HAMD-17) rating scale, Center for Epidemiologic Depression (CES-D) scale, WHO Quality of Life-Brief version (WHOQOL-BREF) questionnaire, and clinical remission rate. Results All 33 subjects were included in an intent-to-treat analysis. Statistically significant improvements in HAMD-17, CES-D, and WHOQOL-BREF scores and a higher remission rate were found in the EA, CBT, and EA+CBT intervention groups compared with the control group (all p<0.05). No significant differences were found between the three intervention groups. HAMD-17 factor score analysis revealed that EA reduced sleep disturbance scores more than CBT or EA+CBT (p<0.05), and CBT reduced retardation scores more than EA (p<0.01). EA+CBT reduced anxiety/somatisation scores more than EA or CBT (p<0.05) and retardation scores more than EA (p<0.05). Conclusions Early intervention may alleviate depressive symptoms in SSD. EA and CBT may have differential effects on certain symptoms. Combination therapy targeting both physical and psychological symptoms may represent an ideal strategy for SSD intervention. However, randomised trials with larger sample sizes are needed. Trial registration number ChiCTR-TRC-10000889; Results. PMID:27083200

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

    PubMed Central

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

    2014-01-01

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

  1. Meta-analysis of randomized controlled trials reveals an improved clinical outcome of using genotype plus clinical algorithm for warfarin dosing.

    PubMed

    Liao, Zhenqi; Feng, Shaoguang; Ling, Peng; Zhang, Guoqing

    2015-02-01

    Previous studies have raised interest in using the genotyping of CYP2C9 and VKORC1 to guide warfarin dosing. However, there is lack of solid evidence to prove that genotype plus clinical algorithm provides improved clinical outcomes than the single clinical algorithm. The results of recent reported clinical trials are paradoxical and needs to be systematically evaluated. In this study, we aim to assess whether genotype plus clinical algorithm of warfarin is superior to the single clinical algorithm through a meta-analysis of randomized controlled trials (RCTs). All relevant studies from PubMed and reference lists from Jan 1, 1995 to Jan 13, 2014 were extracted and screened. Eligible studies included randomized trials that compared clinical plus pharmacogenetic algorithms group to single clinical algorithm group using adult (≥ 18 years) patients with disease conditions that require warfarin use. We further used fix-effect models to calculate the mean difference or the risk ratios (RRs) and 95% CIs to analyze the extracted data. The statistical heterogeneity was calculated using I(2). The percentage of time within the therapeutic INR range was considered to be the primary clinical outcome. The initial search strategy identified 50 citations and 7 trials were eligible. These seven trials included 1,910 participants, including 960 patients who received genotype plus clinical algorithm of warfarin dosing and 950 patients who received clinical algorithm only. We discovered that the percentage of time within the therapeutic INR range of the genotype-guided group was improved compared with the standard group in the RCTs when the initial standard dose was fixed (95% CI 0.09-0.40; I(2) = 47.8%). However, for the studies using non-fixed initial doses, the genotype-guided group failed to exhibit statistically significant outcome compared to the standard group. No significant difference was observed in the incidences of adverse events (RR 0.94, 95% CI 0.84-1.04; I(2) = 0%, p

  2. Impact of postoperative glycemic control and nutritional status on clinical outcomes after total pancreatectomy

    PubMed Central

    Shi, Hao-Jun; Jin, Chen; Fu, De-Liang

    2017-01-01

    AIM To evaluate the impact of glycemic control and nutritional status after total pancreatectomy (TP) on complications, tumor recurrence and overall survival. METHODS Retrospective records of 52 patients with pancreatic tumors who underwent TP were collected from 2007 to 2015. A series of clinical parameters collected before and after surgery, and during the follow-up were evaluated. The associations of glycemic control and nutritional status with complications, tumor recurrence and long-term survival were determined. Risk factors for postoperative glycemic control and nutritional status were identified. RESULTS High early postoperative fasting blood glucose (FBG) levels (OR = 4.074, 95%CI: 1.188-13.965, P = 0.025) and low early postoperative prealbumin levels (OR = 3.816, 95%CI: 1.110-13.122, P = 0.034) were significantly associated with complications after TP. Postoperative HbA1c levels over 7% (HR = 2.655, 95%CI: 1.299-5.425, P = 0.007) were identified as one of the independent risk factors for tumor recurrence. Patients with postoperative HbA1c levels over 7% had much poorer overall survival than those with HbA1c levels less than 7% (9.3 mo vs 27.6 mo, HR = 3.212, 95%CI: 1.147-8.999, P = 0.026). Patients with long-term diabetes mellitus (HR = 15.019, 95%CI: 1.278-176.211, P = 0.031) and alcohol history (B = 1.985, SE = 0.860, P = 0.025) tended to have poor glycemic control and lower body mass index levels after TP, respectively. CONCLUSION At least 3 mo are required after TP to adapt to diabetes and recover nutritional status. Glycemic control appears to have more influence over nutritional status on long-term outcomes after TP. Improvement in glycemic control and nutritional status after TP is important to prevent early complications and tumor recurrence, and improve survival. PMID:28127200

  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.

  4. 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

  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. 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

  7. [The choice of the type of design in the clinical investigation studies. Case and control studies].

    PubMed

    Posada de la Paz, M

    2004-09-01

    Case-control studies are appropriate designs in neurology sciences to search for risk factors that have already occurred in a group of patients. In them, the subjects are selected on the basis of whether they have the disease or not and then they are compared in regards to the risk factor or prognosis investigated. These sorts of designs can be performed in a shorter and cheaper way than the regular cohort studies. They are appropriate for the evaluation of rare diseases and can examine multiple etiological factors for a single disease. On the contrary, they are not so efficient when rare exposures are involved. Incidence rates in exposed and non-exposed subjects cannot be calculated and on some occasions, the timing between exposure and outcome can be very difficult to establish. The Odds Ratio and its confident intervals is the measurement used for estimating the risk strength in this design. The clinical neurologist should be familiar with these terms, given the frequency of case-control studies described in neurology science literature, and should know their principal advantages and limitations.

  8. 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

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

    PubMed Central

    Parsons, Thomas D.

    2015-01-01

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

  10. 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.

  11. Habit Reversal versus Object Manipulation Training for Treating Nail Biting: A Randomized Controlled Clinical Trial

    PubMed Central

    Ghanizadeh, Ahmad; Bazrafshan, Amir; Dehbozorgi, Gholamreza

    2013-01-01

    Objective This is a parallel, three group, randomized, controlled clinical trial, with outcomes evaluated up to three months after randomization for children and adolescents with chronic nail biting. The current study investigates the efficacy of habit reversal training (HRT) and compares its effect with object manipulation training (OMT) considering the limitations of the current literature. Method Ninety one children and adolescents with nail biting were randomly allocated to one of the three groups. The three groups were HRT (n = 30), OMT (n = 30), and wait-list or control group (n = 31). The mean length of nail was considered as the main outcome. Results The mean length of the nails after one month in HRT and OMT groups increased compared to the waiting list group (P < 0.001, P < 0.001, respectively). In long term, both OMT and HRT increased the mean length of nails (P < 0.01), but HRT was more effective than OMT (P < 0.021). The parent-reported frequency of nail biting did show similar results as to the mean length of nails assessment in long term. The number of children who completely stopped nail biting in HRT and OMT groups during three months was 8 and 7, respectively. This number was zero during one month for the wait-list group. Conclusion This trial showed that HRT is more effective than wait-list and OMT in increasing the mean length of nails of children and adolescents in long terms. PMID:24130603

  12. 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

  13. Development of tuberculosis infection control guidelines in a pediatric HIV clinic in sub-Saharan Africa

    PubMed Central

    Carlucci, J. G.; Jin, L.; Mohapi, E. Q.; Mandalakas, A. M.

    2015-01-01

    Setting: A well-established pediatric human immunodeficiency virus (HIV) clinic in Lesotho with initial infection control (IC) measures prioritizing blood-borne disease. In line with international recommendations, services have been expanded to include the management of patients with tuberculosis (TB). The creation of comprehensive IC guidelines with an emphasis on TB has become a priority. Objective: To provide a model for developing and implementing IC guidelines in ambulatory care facilities in limited-resource settings with high HIV and TB prevalence. Activities: An IC plan that includes guidance covering both general IC measures and TB-specific guidelines was created by integrating local and international recommendations and emphasizing the importance of administrative measures, environmental controls, and disease-specific precautions. An interdisciplinary committee was established to oversee its implementation, monitoring, and evaluation. Discussion: Development and implementation of IC guidelines in resource-limited settings are feasible and should be a priority in high HIV and TB prevalence areas. Education should be the cornerstone of such endeavors. Many interventions can be implemented with minimal expertise and material resources. Administrative support and institutional investment are essential to the sustainability of an effective IC program. PMID:26400595

  14. 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

  15. The counseling african americans to control hypertension (caatch) trial: baseline demographic, clinical, psychosocial, and behavioral characteristics

    PubMed Central

    2011-01-01

    Background Effectiveness of combined physician and patient-level interventions for blood pressure (BP) control in low-income, hypertensive African Americans with multiple co-morbid conditions remains largely untested in community-based primary care practices. Demographic, clinical, psychosocial, and behavioral characteristics of participants in the Counseling African American to Control Hypertension (CAATCH) Trial are described. CAATCH evaluates the effectiveness of a multi-level, multi-component, evidence-based intervention compared with usual care (UC) in improving BP control among poorly controlled hypertensive African Americans who receive primary care in Community Health Centers (CHCs). Methods Participants included 1,039 hypertensive African Americans receiving care in 30 CHCs in the New York Metropolitan area. Baseline data on participant demographic, clinical (e.g., BP, anti-hypertensive medications), psychosocial (e.g., depression, medication adherence, self-efficacy), and behavioral (e.g., exercise, diet) characteristics were gathered through direct observation, chart review, and interview. Results The sample was primarily female (71.6%), middle-aged (mean age = 56.9 ± 12.1 years), high school educated (62.4%), low-income (72.4% reporting less than $20,000/year income), and received Medicaid (35.9%) or Medicare (12.6%). Mean systolic and diastolic BP were 150.7 ± 16.7 mm Hg and 91.0 ± 10.6 mm Hg, respectively. Participants were prescribed an average of 2.5 ± 1.9 antihypertensive medications; 54.8% were on a diuretic; 33.8% were on a beta blocker; 41.9% were on calcium channel blockers; 64.8% were on angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs). One-quarter (25.6%) of the sample had resistant hypertension; one-half (55.7%) reported medication non-adherence. Most (79.7%) reported one or more co-morbid medical conditions. The majority of the patients had a Charlson Co-morbidity score ≥ 2. Diabetes mellitus was

  16. A controlled clinical trial of misonidazole in the radiotherapy of patients with carcinoma of the bronchus

    SciTech Connect

    Saunders, M.I.; Anderson, P.; Dische, S.; Martin, W.M.C.

    1982-03-01

    In 1977, during the initial development period of misonidazole, it was decided to start a double-blind randomized controlled clinical trial in carcinoma of bronchus, using a 6 fraction technique of radiotherapy. The patients included in the study were patients with squamous and large-cell undifferentiated carcinoma of the bronchus who were unsuitable for surgical resection, but where there was no evidence for metastases beyond the thorax. A total of 62 patients were randomized between January 1977 and September 1980. Tomography was performed at 2 monthly intervals and a particular effort was made to obtain post-mortem examinations. Fifty-four of the patients included have now died and post-mortems were obtained in 67%. Assessments of immediate tumor regression, tumor clearance, tumor regrowth and the findings at death were made. Thirty-three of the 62 patients were randomized to receive misonidazole and of these 12 (36%) showed peripheral neuropathy. No significant benefit was obtained with the use of misonidazole, as assessed by the parameters listed above. The full observation of those patients now dead showed that using a 6 fraction technique of radiotherapy, a complete tumor control was obtained in only 2. It was further found that the primary tumor was an important factor causing death in 85% of these patients. No evidence for distance metastases could be obtained in a considerable number of post-mortems. Among the possible reasons for the lack of benefit was the relatively low concentrations of sensitizer in the tumor, the advanced stage of disease and the 6 fraction technique of radiotherapy. The trial did, however, show that in a carefully selected group of patients the control of the primary tumor was important and that further efforts should be made to eradicate tumor.

  17. 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

  18. 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

  19. 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

  20. 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

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

    PubMed

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

    2016-04-01

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

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

    PubMed Central

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

    2013-01-01

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

  3. 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.

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

    PubMed Central

    2016-01-01

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

  5. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    PubMed Central

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  6. Comparison of a minimally invasive procedure versus standard microscopic discotomy: a prospective randomised controlled clinical trial

    PubMed Central

    Greiner-Perth, R.; Boehm, H.; Mahlfeld, K.; Grasshoff, H.; Allam, Y.; Awiszus, F.

    2009-01-01

    A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse surgery by comparing operation duration and clinical outcome. Additionally, the transferability of the results was determined by a bicentric design. The microscopic assisted percutaneous nucleotomy (MAPN) has been advocated as a minimally invasive tubular technique. Proponents have claimed that minimally invasive procedures reduce postoperative pain and accelerate the recovery. In addition, there exist only a limited number of well-designed comparison studies comparing standard microdiscotomy to a tubular minimally invasive technique that support this claim. Furthermore, there are no well-designed studies looking at the transferability of those results and possible learning curve phenomena. We studied 100 patients, who were planned for disc prolapse surgery at two centres [50 patients at the developing centre (index) and 50 patients at the less experienced (transfer) centre]. The randomisation was done separately for each centre, employing a block-randomisation procedure with respect to age and preoperative Oswestry score. Operation duration was chosen as a primary outcome parameter as there was a distinguished shortening observed in a preliminary study at the index centre enabling a sound case number estimation. The following data were compared between the two groups and the centres with a 12-month follow-up: surgical times (operation duration and approach duration), the clinical results, leg and back pain by visual analogue scale, the Oswestry disability index, length of hospital stay, return to work time, and complications. The operation duration was statistically identical for MC (57.8 ± 20.2 min) at the index centre and for MAPN (50.3 ± 18.3 min) and MC (54.7 ± 18.1 min) at the transfer centre. The operation duration was only significantly shorter

  7. Safety and efficacy of a novel tartar control dentifrice containing 3.3% pyrophosphate: a controlled six-month clinical trial.

    PubMed

    Segreto, V A; Stevens, D P; Schulte, M C; Fortna, R H; Gerlach, R W

    1998-01-01

    This study was undertaken to establish the tartar control efficacy and long-term safety of a new tartar control dentifrice that was formulated to enhance aesthetics and consumer acceptability. In a partially randomized, examiner-blind clinical trial, the experimental dentifrice, Crest MultiCare with 3.3% pyrophosphate, was compared to two currently marketed control dentifrices, Crest Regular Paste or Crest Tartar Protection Paste with 5.0% pyrophosphate. The eight-month trial model included a two-month pretest period to establish calculus formation after prophylaxis, followed by a six-month test period to evaluate efficacy and safety. Following the pretest period, 456 subjects were allocated to one of the three treatment groups and then monitored for calculus accumulation. After three and six months' test product use, the Crest MultiCare group experienced reductions in calculus accumulation of 28.9% and 32.3%, respectively compared to the regular control dentifrice. Over the six-month observation period, the experimental tartar control and the marketed tartar control dentifrices were comparable on adverse event frequency, type or severity, and no subject discontinued treatment due to an oral soft tissue adverse event. In this partially randomized and controlled six-month clinical trial, this new dentifrice exhibited tartar control efficacy, with a comparable overall safety profile to a marketed tartar control dentifrice.

  8. 78 FR 39339 - Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ...; Notice of Registration; Clinical Supplies Management, Inc. By Notice dated August 17, 2012, and published in the Federal Register on August 20, 2012, 77 FR 50162, Clinical Supplies Management, Inc., 342 42nd... packaging, labeling, and distributing to customers which are qualified clinical sites, conducting...

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

    PubMed Central

    2011-01-01

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

  10. No Effect of Aspirin on Mammographic Density in a Randomized Controlled Clinical Trial

    PubMed Central

    McTiernan, Anne; Wang, CY; Sorensen, Bess; Xiao, Liren; Buist, Diana S. M.; Bowles, Erin J. Aiello; White, Emily; Rossing, Mary Anne; Potter, John; Urban, Nicole

    2009-01-01

    Background: Epidemiologic studies suggest a reduced risk of breast cancer among women who regularly use aspirin; a plausible mechanism is through aspirin effect on mammographic breast density, a breast cancer risk factor, possibly mediated through aspirin interference with estrogen synthesis. Methods: In a 2-arm randomized placebo-controlled clinical trial, we evaluated the effects of 6-months administration of 325 mg/day aspirin on total mammographic breast dense area and percent of the mammographic breast image occupied by dense areas (% density) in 143 postmenopausal women. Eligible women, recruited 2005-7, were healthy, not taking hormone therapy, with elevated mammographic breast density (American College of Radiology Breast Imaging Reporting and Data System (BI-RADS®) density category 2, 3 or 4) within 6 months prior to enrollment. Results: Women were a mean (s.d.) 59.5 (5.5) years. Geometric mean baseline percent density was 17.6% (95% CI 14.8, 20.9) in women randomized to aspirin and 19.2% (95% CI 16.3, 22.7) in women randomized to placebo. Percent density decreased in women randomized to aspirin by an absolute 0.8% vs. an absolute decrease of 1.2% in controls (p = 0.84). Total breast area and dense area decreased to a similar degree in women assigned to aspirin and in those assigned to placebo, with no differences statistically significantly different between trial arms. Conclusions: A single daily administration of adult-dose aspirin for 6 months had no effect on mammographic density in postmenopausal women. If aspirin affects breast cancer risk in postmenopausal women, it may do so through alternative pathways than mammographic breast density. PMID:19423529

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-04-01

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

  13. 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

  14. 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

  15. 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

  16. Intravenous Amiodarone versus Digoxin in Atrial Fibrillation Rate Control; a Clinical Trial

    PubMed Central

    Shojaee, Majid; Feizi, Bahareh; Miri, Reza; Etemadi, Jalil; Feizi, Amir Hossein

    2017-01-01

    Introduction: Treatment of rapid ventricular response arterial fibrillation (rapid AF) varies depending on the decision of the in-charge physician, condition of the patient, availability of the drug, and the treatment protocol of the hospital. The present study was designed aiming to compare IV digoxin and amiodarone in controlling the heart rate of patients presenting to emergency department with rapid AF and relative contraindication for first line drug in this regard. Method: In the present clinical trial, patients presented to the ED with rapid AF and relative contraindication for calcium channel blockers and beta-blockers were treated with either IV amiodarone or IV digoxin and compared regarding success rate and complication using SPSS version 22. P < 0.05 was considered as statistically significant. Results: 84 patients were randomly allocated to either amiodarone or digoxin treatment groups of 42 (53.6% male). The mean age of the studied patients was 61.8 ± 11.14 years (38 - 79). No significant difference was present regarding baseline characteristics. The rate of treatment failure was 21.4% (9 cases) in amiodarone and 59.5% (25 cases) in digoxin groups (p < 0.001). The mean onset of action was 56.66 ± 39.52 minutes (10 - 180) in amiodarone receivers and 135.38 ± 110.41 minutes (25 - 540) in digoxin group (p < 0.001). None of the patients showed any adverse outcomes of hypotension, bradycardia, and rhythm control. Conclusion: Based on the findings of the present study, rapid AF patients with relative contraindication for calcium channel blockers or beta-blockers who had received amiodarone experienced both higher (about 2 times) treatment success and a more rapid (about 2.5 times) response compared to those who received IV digoxin. PMID:28286836

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

    PubMed

    Heinrich, U; Garbe, B; Tronnier, H

    2007-01-01

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

  18. A case-control study of the clinical diagnosis and course of Lassa fever.

    PubMed

    McCormick, J B; King, I J; Webb, P A; Johnson, K M; O'Sullivan, R; Smith, E S; Trippel, S; Tong, T C

    1987-03-01

    A prospective case-control study of Lassa fever was established in Sierra Leone to measure the frequency and case-fatality ratio of Lassa fever among febrile hospital admissions and to better delineate the clinical diagnosis and course of this disease. Lassa fever was responsible for 10%-16% of all adult medical admissions and for approximately 30% of adult deaths in the two hospitals studied. The case-fatality ratio for 441 hospitalized patients was 16.5%. We found the best predictor of Lassa fever to be the combination of fever, pharyngitis, retrosternal pain, and proteinuria (predictive value together, .81); of outcome, the best predictor was the combination of fever, sore throat, and vomiting (relative risk of death, 5.5). Complications included mucosal bleeding (17%), bilateral or unilateral eighth-nerve deafness (4%), and pleural (3%) or pericardial (2%) effusion. Lassa fever is endemic in this area and is a more-common cause of hospital admission and death than has previously been described; this disease must be considered when diagnosing febrile illness in West Africa.

  19. 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

  20. Threat assessment and locomotion: clinical applications of an integrated model of anxiety and postural control.

    PubMed

    Staab, Jeffrey P; Balaban, Carey D; Furman, Joseph M

    2013-07-01

    Interactions between anxiety and vestibular symptoms have been described since the late 1800s. Typically, they have been conceptualized as bidirectional effects of one condition on the other (i.e., anxiety disorders as a cause of vestibular symptoms and vestibular disorders as a cause of anxiety symptoms). Over the past 30 years, however, a steady progression of neurophysiological investigations of gait and stance under conditions of postural threat, neuroanatomical studies of connections between threat assessment and vestibular pathways in the brain, and clinical research on anxiety-related vestibular conditions has offered the building blocks of a more integrated model. In this newer concept, threat assessment is an integral component of spatial perception, postural control, and locomotion in health and disease. It is not imposed on the vestibular system from the outside or simply reactive to vestibular dysfunction, but an inherently necessary part of every aspect of mobility. In this article, the authors review evidence that supports this model and then use it to examine common neurotologic conditions in which anxiety-related processes play important roles-fear of falling, primary and secondary anxiety disorders in patients with vestibular symptoms, and chronic subjective dizziness.

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

    PubMed

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

    2015-05-19

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

  2. Smectite in acute diarrhea in children: a double-blind placebo-controlled clinical trial.

    PubMed

    Madkour, A A; Madina, E M; el-Azzouni, O E; Amer, M A; el-Walili, T M; Abbass, T

    1993-08-01

    Dioctahedral smectite (DS) a natural adsorbent clay capable of adsorbing viruses, bacteria, and other intestinal irritants in vitro, is claimed to possess beneficial "antidiarrheal" properties. This study tested the effect of DS on the duration of diarrhea and the frequency and amount of liquid stools. Ninety well-nourished boys, aged 3-24 months, with acute watery diarrhea and mild, moderate, or severe dehydration were included in a randomized double-blind, placebo-controlled trial. After initial rehydration, they received DS or placebo (1.5 g freshly dissolved in 50 ml of water, four times daily for 3 days) along with oral rehydration solution (ORS) and adequate feeding. The clinical characteristics of both groups were comparable on admission. Patients in the smectite group had a significantly shorter duration of diarrhea (mean +/- SD, 54 +/- 16 vs. 73 +/- 13 h) and significantly fewer stools (2.6 +/- 0.8 vs. 3 +/- 0.7 on second day; 1.9 +/- 0.7 vs. 2.4 +/- 0.7 on third day; and 11.3 +/- 3.2 vs. 13.8 +/- 3 overall). The amount of liquid stools was not significantly reduced. Weight gain at 24, 48, and 72 h and on recovery was significantly higher in the smectite group despite the comparable fluid and food intake in both groups. These results suggest a beneficial effect of DS in shortening the duration of diarrhea and reducing the frequency of liquid stools in children rehydrated with ORS.

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

    PubMed Central

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

    2015-01-01

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

  4. 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

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

    PubMed

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

    2013-05-01

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

  6. Control of scar tissue formation in the cornea: strategies in clinical and corneal tissue engineering.

    PubMed

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

    2012-09-18

    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.

  7. 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.

  8. 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

  9. [Clinical effectiveness of the infusion therapy under control of the transesophageal dopplerography in acute period of severe combined trauma].

    PubMed

    Vil'chinskiĭ, K E; Gutnikov, A I; Davydova, L A; Tsarenko, S V; Evdokimov, E A

    2011-01-01

    In 72 patients with combined trauma the impact of volume and consistence of infusion therapy on severity of the disease, frequency and severity of infectious complications, duration of MV and ICU stay was assessed. The patients were divided into 2 groups depending on the volemic status control method and infusion algorithm. The main group (35 patients) was controlled by transesophageal dopplerography Cardio Q apparatus ("Deltex Medical", GB) and the infusion therapy was carried out under the control of stroke volume and Ftc. In the control group (37 patients) the volemic status was assessed clinically: BP, CVP, HR, diuresis. The volume of the infusion therapy during the first 12 hours in the main group was significantly higher than in the control group which proved that patients were suffering from hypovolemia, which was not diagnosed by traditional clinical criteria. The ICU stay in the main group was significantly shorter compared to the control group 15.3 +/- 8.2 and 29.5 +/- 10.4 days respectively. Infectious complications occurred in 12 patients out of 35 in main group and 25 out of 37 in the control group. The conclusion of this study is that infusion therapy control with central hemodynamic parameters can shorten the MV time and ICU stay an lower the rate of infectious complications in patients with combined trauma. A mortality decrease in patients with transesophageal dopplerography controlled infusion is not shown.

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

    PubMed Central

    2013-01-01

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

  11. Effectiveness of clinical practice guideline implementation on lower third molar management in improving clinical decision-making: a randomized controlled trial.

    PubMed

    van der Sanden, Wil J M; Mettes, Dirk G; Plasschaert, Alphons J M; Grol, Richard P T M; Mulder, Jan; Verdonschot, Emiel H

    2005-10-01

    The objective of this study was twofold, namely to evaluate the effectiveness of a dental clinical practice guideline on the management of asymptomatic impacted lower third molars (i) on referral rates and (ii) on dentists' change in knowledge. A two-arm cluster randomized controlled trial, with pre- and post-test assessments, was conducted. A guideline was implemented by multifaceted interventions (i.e. feedback, reminders, and an interactive meeting). The effect was evaluated after 1 yr by repeating the baseline questionnaire and by monitoring the number of patients who were referred for removal of their asymptomatic impacted mandibular third molars. Instruments were questionnaires for detecting changes in knowledge, patient records, and panoramic radiographs. The knowledge of dentists regarding asymptomatic mandibular third molar management was found to increase significantly in the intervention group as compared to the control group. There was no statistically significant difference between the groups in guideline-consistent patient referral rates at the post-test assessment. It was concluded that the methodology employed for dissemination and implementation of a clinical practice guideline on asymptomatic mandibular third molar management improves dentists' knowledge on this topic and is effective in improving decision-making in simulated cases; however, no clinical effect was demonstrated.

  12. Clinical outcomes of Single-Visit oral Prophylaxis: A practice-based randomised controlled trial

    PubMed Central

    2011-01-01

    Background Practice-based general dental practitioners routinely provide "scale and polish" or "oral prophylaxis" to patients attending their practices. Despite its routine provision, there is no evidence to support the clinical effectiveness of single-visit scale and polish, nor the frequency at which it should be provided. A recent systematic review recommended that future trials investigating scale and polish should involve dental practice patients. Methods A practice-based parallel randomised controlled trial with 24-month follow-up was conducted. Healthy adults (Basic Periodontal Examination [BPE] codes <3) were randomly assigned to 3 groups (6-month, 12-month, or 24-month interval between scale and polish). The primary outcome was gingival bleeding with the hypothesis that 6-monthly scale and polish would result in lower prevalence than 12-month or 24-month frequency. Follow-up measurements were recorded by examiners blinded to the allocation. 125, 122 and 122 participants were randomised to the 6-month, 12-month and 24-month groups respectively. Complete data set analyses were conducted for 307 participants: 107, 100, and 100 in the 6-month, 12-month and 24-month groups respectively. Chi-square test and ANOVA were used to compare treatment groups at follow-up. Logistic regression and ANCOVA were used to estimate the relationship between outcome and treatment group, adjusted for baseline values. Multiple imputation analyses were also carried out for participants with incomplete data sets. Results Prevalence of gingival bleeding at follow-up was 78.5% (6-month), 78% (12-month) and 82% (24-month) (p = 0.746). There were no statistically significant differences between groups with respect to follow-up prevalence of plaque and calculus. Statistically significant differences detected in the amount (millimetres) of calculus were too small to be clinically significant. Seventeen (4.6%) participants were withdrawn from the trial to receive additional treatment

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

    EPA Science Inventory

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

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

  14. 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…

  15. 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

    ... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled clinical... evidence from independent studies using appropriate statistical methods. The purpose of the public workshop... describes best practices for the conduct of meta-analyses and FDA's intended approach for the use of...

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  17. 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

  18. 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.

  19. 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

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

    PubMed Central

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

    2014-01-01

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

  1. Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study.

    PubMed

    Kucera, Miroslav; Barna, Milos; Horàcek, Ondrej; Kàlal, Jan; Kucera, Alexander; Hladìkova, Marie

    2005-01-01

    The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.

  2. 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

  3. 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

  4. 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

  5. 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…

  6. Patient in control in clinical trials - European initiatives for improving patient empowerment in clinical trials through technical implementation of legal norms.

    PubMed

    Forgó, Nikolaus; Góralczyk, Magdalena; Hänold, Stefanie

    2013-01-01

    Patient empowerment is acclaimed as one of the major trends in the health care area bringing forward new conceptions how to involve patients in clinical research in a more (inter)active way. Patients and clinicians could benefit from more flexible consent-management and improved communication processes. This is where technology comes as an asset - the novel technological approaches promise to give more control to the patient, lessen the burdens on the researchers and all that in compliance with the legal and ethical requirements (e.g. data protection). The views of the European projects EURECA and p-medicine serve as examples for European approaches to patient empowerment.

  7. ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

    PubMed

    Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

    2012-03-01

    In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts.

  8. 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

  9. 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

  10. [Effectiveness and difficulty of education on nosocomial infection control for pre-clinical practice in the clinic, so-called inclusive clinical practice phase I, for students in the Faculty of Dentistry, Tokyo Medical and Dental University].

    PubMed

    Sunakawa, Mitsuhiro; Matsumoto, Hiroyuki

    2009-03-01

    It has been planned to give pre-clinical practice in the clinic, so-called inclusive clinical practice phase I, for fifth-grade students in the School of Dentistry, Faculty of Dentistry, Tokyo Medical and Dental University, to give them the clinical training needed to perform dental practice and clinical practicum for comprehensive patient care, namely inclusive clinical practice phase II. This study analyzed the educative efficiency of the class on nosocomial infection control (NIC) by comparing achievements pre- and post-test, and discussed appropriate education planning on the NIC for dental students. Sixty-two fifth-grade students in the 2007 academic year sat the pre- and post-tests; the mean score and standard deviation of these tests were 5.30 +/- 1.26 (n = 56) and 8.59 +/- 1.18 (n = 59), respectively. There was a statistically significant difference between them (paired t-test, p < 0.01). Another finding was that students with high scores in the post-test did not necessarily achieve high ratings in the pre-test. It is suggested that the introduction of pre- and post-tests and the clarification of main points in the class as a theme of NIC could be a useful tool for increasing the comprehension of students on the theme. Since students at lower grades will attend clinical practice in the university hospital, it is thought that students should be given NIC training early in the clinical course, and the current curriculum should be improved to increase the opportunity for students to study this important issue.

  11. Psychosocial Profile and Quality of Life in Children With Type 1 Narcolepsy: A Case-Control Study

    PubMed Central

    Rocca, Francesca Letizia; Finotti, Elena; Pizza, Fabio; Ingravallo, Francesca; Gatta, Michela; Bruni, Oliviero; Plazzi, Giuseppe

    2016-01-01

    Study Objectives: To investigate behavioral aspects and quality of life in children and adolescents with type 1 narcolepsy (NT1). Methods: We performed a case-control study comparing 29 patients with NT1 versus sex- and age-matched patients with idiopathic epilepsy (n = 39) and healthy controls (n = 39). Behavior and quality of life were evaluated by self-administered questionnaires (Child Behavior Checklist, Pediatric Quality of Life Inventory). Patient groups were contrasted and scale results were correlated with clinical and polysomnographic parameters, and cerebrospinal fluid hypocretin-1 levels. Results: Young patients with NT1 showed increased internalizing problems associated with aggressive behavior. Emotional profile in patients with NT1 positively correlated with age at onset, diagnostic delay, and subjective sleepiness, whereas treatment and disease duration were associated with fewer behavioral problems (attention problems, aggressive behavior, and attention deficit/hyperactivity disorder). Psychosocial health domains of pediatric NT1 were worse than in healthy controls, whereas the physical health domains were comparable. Conclusions: Young NT1 patients show a discrete pattern of altered behavioral, thought, and mood profile in comparison with healthy controls and with idiopathic epilepsy patients thus suggesting a direct link with sleepiness. Further studies investigating behavior in patients with idiopathic hypersomnia or type 2 narcolepsy are needed to disentangle the role of REM sleep dysfunction and hypocretin deficiency in psychiatric disorders. Symptoms of withdrawal, depression, somatic complaints, thought problems, and aggressiveness were common, NT1 children perceived lower school competencies than healthy children, and their parents also reported worse psychosocial health. Our data suggest that early effective treatment and disease self-awareness should be promoted in NT1 children for their positive effect on behavior and psychosocial health

  12. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    PubMed Central

    Stegink-Jansen, Caroline W.

    2015-01-01

    Introduction. Patients with chronic lateral elbow (LE) tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1) to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE) for patients with chronic LE tendinopathy, and (2) to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment. Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities. Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows) were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows) or EE treatment (56 elbows). Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments. Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047) and in maximum grip strength (p = 0.008) than EE subjects. Astym therapy also resolved 20/21 (95.7%) of the EE non-responders, who showed improvements in DASH scores (p < 0.005), pain with activity (p = 0.002), and function (p = 0.004) following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported. Conclusion. This study

  13. Stock Versus CAD/CAM Customized Zirconia Implant Abutments – Clinical and Patient‐Based Outcomes in a Randomized Controlled Clinical Trial

    PubMed Central

    Meijer, Henny J.A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco

    2016-01-01

    Abstract Background Single‐tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. Purpose This randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant abutments with respect to preservation of marginal bone level and several clinical and patient‐based outcome measures. Material and Methods Fifty participants with a missing premolar were included and randomly assigned to standard (ZirDesign, DentsplySirona Implants, Mölndal, Sweden) or computer aided design/computer aided manufacturing (CAD/CAM) customized (Atlantis, DentsplySirona Implants, Mölndal, Sweden) zirconia abutment therapy. Peri‐implant bone level (primary outcome), Plaque‐index, calculus formation, bleeding on probing, gingiva index, probing pocket depth, recession, appearance of soft tissues and patients' contentment were assessed shortly after placement and one year later. Results No implants were lost and no complications related to the abutments were observed. Statistically significant differences between stock and CAD/CAM customized zirconia abutments could not be demonstrated for any of the operationalized variables. Conclusion The use of a CAD/CAM customized zirconia abutment in single tooth replacement of a premolar is not associated with an improvement in clinical performance or patients' contentment when compared to the use of a stock zirconia abutment. PMID:27476829

  14. Validity of Self-reported Sleep Bruxism among Myofascial Temporomandibular Disorder Patients and Controls

    PubMed Central

    Raphael, Karen G.; Janal, Malvin N.; Sirois, David A.; Dubrovsky, Boris; Klausner, Jack J.; Krieger, Ana C.; Lavigne, Gilles J.

    2015-01-01

    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 orofacial problems, including temporomandibular disorders (TMD). Since 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 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 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

  15. Bronchial hyperresponsiveness in the assessment of asthma control: Airway hyperresponsiveness in asthma: its measurement and clinical significance.

    PubMed

    Brannan, John D

    2010-08-01

    The two key pathophysiologic features of asthma are bronchial hyperresponsiveness (BHR) and airway inflammation. Symptoms and lung function are the most accessible clinical markers for the diagnosis of asthma as well as for assessing asthma control using the most effective treatment of asthma, inhaled corticosteroids (ICS). However, BHR and inflammation usually take longer to resolve using ICS compared with symptoms and lung function. BHR can be assessed using "direct" stimuli that act on the airway smooth muscle (eg, methacholine) or "indirect" stimuli that require the presence of airway inflammation (eg, exercise, osmotic stimuli). Although there are practical limitations in using BHR to assess asthma control, efforts have been made to make BHR more accessible and standardized. Some studies have demonstrated that treatment aimed to decrease BHR with direct stimuli can lead to improved asthma control; however, it often results in the use of higher doses of ICS. Furthermore, BHR to direct stimuli does not usually resolve using ICS because of a fixed component. By contrast, BHR with an indirect stimulus indicates a responsive smooth muscle that occurs only in the presence of inflammation sensitive to ICS (eg, mast cells, eosinophils). BHR to indirect stimuli does resolve using ICS. Because ICS target both key pathophysiologic features of asthma, assessing indirect BHR in the presence of ICS will identify resolution or persistence of BHR and airway inflammation. This may provide a more clinically relevant marker for asthma control that may also lead to improving the clinical usefulness of ICS.

  16. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study

    PubMed Central

    Roshdy, Eman; Rajaratnam, Veera; Maitra, Sarbani; Sabry, Mohamed; Allah, Abdou S Ait; Al-Hendy, Ayman

    2013-01-01

    Background Uterine fibroids (UFs, also known as leiomyoma) affect 70% of reproductive-age women. Imposing a major burden on health-related quality-of-life (HRQL) of premenopausal women, UF is a public health concern. There are no effective medicinal treatment options currently available for women with symptomatic UF. Objectives To evaluate the efficacy and safety of green tea extract (epigallocatechin gallate [EGCG]) on UF burden and quality of life in women with symptomatic UF, in a double-blinded, placebo-controlled randomized clinical trial. Methods A total of 39 reproductive-age women (age 18–50 years, day 3 serum follicle-stimulating hormone <10 \\U/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm3 or larger, as confirmed by transvaginal ultrasonography. The subjects were randomized to oral daily treatment with either 800 mg of green tea extract (45% EGCG) or placebo (800 mg of brown rice) for 4 months, and UF volumes were measured at the end, also by transvaginal ultrasonography. The fibroid-specific symptom severity and HRQL of these UF patients were scored at each monthly visit, using the symptom severity and quality-of-life questionnaires. Student’s t-test was used to evaluate statistical significance of treatment effect between the two groups. Results Of the final 39 women recruited for the study, 33 were compliant and completed all five visits of the study. In the placebo group (n = 11), fibroid volume increased (24.3%) over the study period; however, patients randomized to green tea extract (n = 22, 800 mg/day) treatment showed significant reduction (32.6%, P = 0.0001) in total UF volume. In addition, EGCG treatment significantly reduced fibroid-specific symptom severity (32.4%, P = 0.0001) and induced significant improvement in HRQL (18.53%, P = 0.01) compared to the placebo group. Anemia also significantly improved by 0.7 g/dL (P = 0.02) in the EGCG treatment group, while average blood loss

  17. 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)

  18. The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs.

    PubMed

    Vray, Muriel; Hamelin, Bernard; Jaillon, Patrice

    2005-01-01

    The respective roles of controlled clinical trials and observational studies (cohort or case-control studies) in evaluating the efficacy, safety and usefulness of a drug were analysed. A randomised, controlled, double-blind study is the best method of estimating the efficacy of a treatment. It provides the least biased and most robust estimate of the causal relationship. In certain situations and on the basis of certain criteria, observational studies can have a proof-of-efficacy value. Randomised, controlled, pre- and postmarketing authorisation (MA) clinical studies identify the rarer adverse effects and compare them with those resulting from the reference treatment. Before the MA, the pooled safety data from different controlled trials can provide an estimation of relatively frequent adverse events and subjects at risk. However, an observational study is the most appropriate method of evaluating the safety of a drug in the currently used conditions. By definition, a drug influences the health of a population if it directly or indirectly improves its health. A drug would have a major role in public health if it reduced mortality or morbidity related to a particular disease or if it improved the quality of life of patients with this disease. Prior to marketing a product, modelling is the approach of choice to quantify the expected effect. Pragmatic, postmarketing trials and observational studies are the reference methods used to define the population affected, the efficacy and safety of the drug in a real situation and its usefulness for public health. In conclusion, randomised clinical trials remain the reference approach for evaluating efficacy, while observational studies have a confirmatory value. Observational studies are the most appropriate way of evaluating safety in the currently used conditions, as the clinical trial has limited indications. In the interests of public health, modelling is the pre-marketing approach of choice, while pragmatic trials and

  19. 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

  20. Clinical Effectiveness of Different Polishing Systems and Self-Etch Adhesives in Class V Composite Resin Restorations: Two-Year Randomized Controlled Clinical Trial.

    PubMed

    Jang, J-H; Kim, H-Y; Shin, S-M; Lee, C-O; Kim, D S; Choi, K-K; Kim, S-Y

    The aim of this randomized controlled clinical trial was to compare the clinical effectiveness of different polishing systems and self-etch adhesives in class V composite resin restorations. A total of 164 noncarious cervical lesions (NCCLs) from 35 patients were randomly allocated to one of four experimental groups, each of which used a combination of polishing systems and adhesives. The two polishing systems used were Sof-Lex XT (Sof), a multistep abrasive disc, and Enhance/Pogo (EP), a simplified abrasive-impregnated rubber instrument. The adhesive systems were Clearfil SE bond (CS), a two-step self-etch adhesive, and Xeno V (XE), a one-step self-etch adhesive. All NCCLs were restored with light-cured microhybrid resin composites (Z250). Restorations were evaluated at baseline and at 6, 12, 18, and 24 months by two blinded independent examiners using modified FDI criteria. The Fisher exact test and generalized estimating equation analysis considering repeated measurements were performed to compare the outcomes between the polishing systems and adhesives. Three restorations were dislodged: two in CS/Sof and one in CS/EP. None of the restorations required any repair or retreatment except those showing retention loss. Sof was superior to EP with regard to surface luster, staining, and marginal adaptation (p<0.05). CS and XE did not show differences in any criteria (p>0.05). Sof is clinically superior to EP for polishing performance in class V composite resin restoration. XE demonstrates clinically equivalent bonding performance to CS.

  1. A Clinical Tool to Measure Trunk Control in Children with Cerebral Palsy: The Trunk Control Measurement Scale

    ERIC Educational Resources Information Center

    Heyrman, Lieve; Molenaers, Guy; Desloovere, Kaat; Verheyden, Geert; De Cat, Jos; Monbaliu, Elegast; Feys, Hilde

    2011-01-01

    In this study the psychometric properties of the Trunk Control Measurement Scale (TCMS) in children with cerebral palsy (CP) were examined. Twenty-six children with spastic CP (mean age 11 years 3 months, range 8-15 years; Gross Motor Function Classification System level I n = 11, level II n = 5, level III n = 10) were included in this study. To…

  2. Cervical spinal cord dimensions and clinical outcomes in adults with klippel-feil syndrome: a comparison with matched controls.

    PubMed

    Cho, Woojin; Lee, Dong-Ho; Auerbach, Joshua D; Sehn, Jennifer K; Nabb, Colin E; Riew, K Daniel

    2014-12-01

    Study Design Retrospective case-control study. Objectives To confirm the fact that spinal cord dimensions are smaller in adults with Klippel-Feil syndrome (KFS) than in pediatric patients with KFS and to compare the clinical characteristics and outcomes of neurologic complications in patients with KFS with matched controls. Methods We performed an independent 1:2 case-control retrospective radiographic and chart review of a consecutive series of adults with KFS who underwent surgical intervention. The control group consisted of consecutive non-KFS surgical patients. Patients were matched in 1:2 case-control manner. Their charts were reviewed and the clinical characteristics were compared. Axial T2-weighted magnetic resonance imaging (MRI) was used to measure the anteroposterior and mediolateral axial spinal cord and spinal canal at the operative levels and measurements were compared. Results A total of 22 patients with KFS and 44 controls were identified. The KFS group had a tendency of more myeloradiculopathy, and the control group had a tendency toward more radiculopathy. Both tendencies, however, were not significantly different. MRIs of 10 patients from the KFS group and 22 controls were available. There was no difference in the area of both spinal cord and canal at the operative levels. Conclusion Contrary to the finding in previous reports on pediatric patients, there were no differences between KFS and well-matched control groups in terms of age of onset, presentation, revision rate, complication rate, surgical outcome, and cross-sectional spinal cord and canal dimensions at the operative level.

  3. 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

  4. Effect of Borago Officinalis Extract on Moderate Persistent Asthma: A Phase two Randomized, Double Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Khashkhashi Moghaddam, Sara; Saeedi, Parisa; Ghaffari, Sakineh

    2016-01-01

    Background: Borago officinalis and its derivatives are used in folk medicine to treat asthma because of its special effect on allergic disorders. It suppresses the tumor necrosis factor-alpha (TNF-alpha) and delivers gamma-linolenic acid. The objective of this clinical trial was to determine the effect of Borago officinalis on clinical and physiological findings in moderate persistent asthma. Materials and Methods: This prospective, randomized, double blind, placebo-controlled, clinical trial was conducted on patients aged 15–90 years with moderate asthma and forced expiratory volume in one second (FEV1) of 60–79% of predicted who presented to a sub-specialty clinic of pulmonary medicine. We randomly allocated subjects to receive either Borago extract (5 mL three times a day) or a matched placebo for one month. The primary outcome was the asthma control test (ACT) score and fractional exhaled nitric oxide (FENO) test. Secondary outcomes included clinical findings, spirometry, and sputum cytology including inflammatory cells. Results: Thirty-eight subjects with a mean age of 46.8±15.3 years and mean duration of asthma of 71±103 months were enrolled in our study. Cough, dyspnea, wheezing, nocturnal symptoms, and airway hyper-responsiveness reduced significantly in the Borago group after the treatment and ACT scores improved significantly (10.8±5.26 before and 15.4±5.12 after the trial). Flare up of asthma and emergency department visits in the Borago group also decreased significantly (3.6±2.33 to 2±1.86 flare ups per month and 0.62±0.9 to 0.05±0.23 for emergency department visits per month). Physiological parameters including spirometry, FENO, and sputum cytology including eosinophil and neutrophil did not change significantly. Conclusion: Borago improved the clinical findings of asthma, but it was not able to suppress the inflammation involved in asthma. PMID:28210282

  5. Computer-assisted orthognathic surgery for correction of facial asymmetry: results of a randomised controlled clinical trial.

    PubMed

    De Riu, Giacomo; Meloni, Silvio Mario; Baj, Alessandro; Corda, Andrea; Soma, Damiano; Tullio, Antonio

    2014-03-01

    In this randomised controlled clinical trial, 2 homogeneous groups of patients with facial asymmetry (n=10 in each) were treated by either classic or computer-assisted orthognathic corrective surgery. Differences between the 2 groups in the alignment of the lower interincisal point (p=0.03), mandibular sagittal plane (p=0.01), and centering of the dental midlines (p=0.03) were significant, with the digital planning group being more accurate.

  6. Clinical Characteristics and Outcomes of Gastric Cancer Patients Aged over 80 Years: A Retrospective Case-Control Study

    PubMed Central

    Jung, Hwoon-Yong; Lee, Jeong Hoon; Jung, Kee Wook; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho; Han, Seungbong

    2016-01-01

    Background and Aims The average human life expectancy is increasing worldwide, thus the proportion of elderly gastric cancer patients is also increasing. In this case-control study, we investigated the clinical and oncologic outcomes of gastric cancer in patients over 80 years old. Methods From January 2004 to December 2010, 291 patients aged over 80 years old (case group) were diagnosed and treated with gastric cancer at Asan Medical Center, Seoul, Korea. From the same period, 291 patients aged 18 to 80 years old were selected as the control group. The clinical findings and clinical outcomes of gastric cancer were retrospectively reviewed and compared between the two groups. Results There were significant differences in the overall 5-year survival rate between the case and control groups (30.9% vs. 73.8%, respectively; P<0.001). In patients who received the curative treatment, overall 3- and 5-year survival rates showed 74.3% and 57.9% in case group and 91.6% and 86.5% in the control group. When analysis was confined to resectable elderly patients with a favorable performance, the curative resection group showed significantly better overall 3- and 5-year survival rates than the conservative treatment group (73.7% and 58.8% vs. 29.8% and 0%, respectively). Conclusions Although elderly gastric cancer patients show an advanced stage at diagnosis and poor prognosis compared with non-elderly patients, elderly patients with good performance could benefit from curative resection. Thus, the clinical decision whether to undergo curative resection or conservative management should be made on an individualized basis. PMID:27942044

  7. Clinical study to assess the stain removal efficacy of two tartar control dentifrices and a low abrasive dentifrice.

    PubMed

    Yankell, S L; Emling, R C; Prencipe, M; Rustogi, K; Volpe, A R

    1994-01-01

    Significant differences in stain removal have been demonstrated in a laboratory study comparing two tartar control dentifrices: Platinum, containing 1.3% soluble pyrophosphate and 1.5% of a copolymer, and Crest Tartar Control, containing 5% soluble pyrophosphate. The purpose of this clinical study was to evaluate the same tartar control dentifrices, and a low abrasive dentifrice for their ability to reduce Peridex-induced stain. Eighty-five subjects were given Peridex (0.12% chlorhexidine digluconate) and a low abrasive dentifrice for 4 weeks. The 76 subjects with sufficient stain were stratified using the Lobene index on buccal and lingual surfaces of anterior teeth, and randomly assigned one of the three dentifrices for 8 weeks. At the end of the study, total stain evaluations were significantly lower in the Platinum dentifrice group (mean 0.84) compared to both Crest Tartar Control dentifrice (1.08) and the low abrasive dentifrice (1.09) at p<0.05 by ANOVA. In this 8-week clinical study, Platinum dentifrice was significantly more effective than Crest Tartar Control dentifrice or a low abrasive dentifrice in reducing Peridex-induced stain, and this finding correlates well with laboratory data on removal of tea and coffee stain.

  8. 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

  9. Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomized controlled trial

    PubMed Central

    Wilson, S. Jo-Anne; Wells, Philip S.; Kovacs, Michael J.; Lewis, Geoffrey M.; Martin, Janet; Burton, Erica; Anderson, David R.

    2003-01-01

    Background There is growing evidence that better outcomes are achieved when anticoagulation is managed by anticoagulation clinics rather than by family physicians. We carried out a randomized controlled trial to evaluate these 2 models of anticoagulant care. Methods We randomly allocated patients who were expected to require warfarin sodium for 3 months either to anticoagulation clinics located in 3 Canadian tertiary hospitals or to their family physician practices. We evaluated the quality of oral anticoagulant management by comparing the proportion of time that the international normalized ratio (INR) of patients receiving warfarin sodium was within the target therapeutic range ± 0.2 INR units (expanded therapeutic range) while they were managed in anticoagulation clinics as opposed to family physicians' care over 3 months. We measured the rates of thromboembolic and major hemorrhagic events and patient satisfaction in the 2 groups. Results Of the 221 patients enrolled, 112 were randomly assigned to anticoagulation clinics and 109 to family physicians. The INR values of patients who were managed by anticoagulation clinics were within the expanded therapeutic range 82% of the time versus 76% of the time for those managed by family physicians (p = 0.034). High-risk INR values (defined as being < 1.5 or > 5.0) were more commonly observed in patients managed by family physicians (40%) than in patients managed by anticoagulation clinics (30%, p = 0.005). More INR measurements were performed by family physicians than by anticoagulation clinics (13 v. 11, p = 0.001). Major bleeding events (2 [2%] v. 1 [1%]), thromboembolic events (1 [1%] v. 2 [2%]) and deaths (5 [4%] v. 6 [6%]) occurred at a similar frequency in the anticoagulation clinic and family physician groups respectively. Of the 170 (77%) patients who completed the patient satisfaction questionnaire, more were satisfied when their anticoagulant management was managed through anticoagulation clinics than by

  10. The clinical effectiveness and cost-effectiveness of brief intervention for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial (SHEAR).

    PubMed Central

    Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachael; Leurent, Baptiste; Lingford-Hughes, Anne; Sweeting, Michael; Touquet, Robin; Tyrer, Peter; Ward, Helen

    2014-01-01

    BACKGROUND Excessive use of alcohol is associated with poor sexual health, but the clinical effectiveness and cost-effectiveness of brief alcohol intervention in this setting has not been investigated. OBJECTIVE To examine the effects and cost-effectiveness of brief intervention for excessive alcohol consumption among people who attend sexual health clinics. DESIGN A two-arm, parallel-group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by clinic. SETTING Study participants were recruited from three sexual health clinics in central and west London. PARTICIPANTS For inclusion, potential participants had to be aged ≥ 19 years, drink excessive alcohol according to the Modified-Single Alcohol Screening Question, and be willing to provide written informed consent. We excluded those who were unable to communicate in English sufficiently well to complete the baseline assessment and those who could not provide contact details for the follow-up assessment. INTERVENTIONS Brief advice was delivered by the treating clinician and comprised feedback on the possible health consequences of excessive drinking, a discussion of whether the participant's clinic attendance was linked to current alcohol use, written information on alcohol and health and an offer of an appointment with an alcohol health worker (AHW). Appointments with AHWs took place either in person or by telephone, lasted up to 30 minutes, and used the 'FRAMES' (Feedback about the adverse effects of alcohol, an emphasis on personal Responsibility for changing drinking behaviour, Advice about alcohol consumption, a Menu of options for further help and advice, an Empathic stance towards the patient and an emphasis on Self-efficacy) approach. Those in the control arm of the trial were offered a copy of a leaflet providing general information on health and lifestyle. MAIN OUTCOME MEASURES

  11. A Strategy to Use Soft Data Effectively in Randomized Controlled Clinical Trials.

    ERIC Educational Resources Information Center

    Kraemer, Helena Chmura; Thiemann, Sue

    1989-01-01

    Sees soft data, measures having substantial intrasubject variability due to errors of measurement or response inconsistency, as important measures of response in randomized clinical trials. Shows that using intensive design and slope of response on time as outcome measure maximizes sample retention and decreases within-group variability, thus…

  12. Clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (acronym CLARITY): a multicentre phase IIb randomised active-controlled clinical trial

    PubMed Central

    Sivaprasad, Sobha; Prevost, A Toby; Bainbridge, James; Edwards, Rhiannon Tudor; Hopkins, David; Kelly, Joanna; Luthert, Phil; Murphy, Caroline; Ramu, Jayashree; Sarafraz-Shekary, Negin; Vasconcelos, Joana; White-Alao, Beverley; Hykin, Philip

    2015-01-01

    Introduction Proliferative diabetic retinopathy (PDR) is the main cause of severe visual loss in people with diabetes mellitus. The standard treatment for this condition is panretinal photocoagulation (PRP). This laser treatment is inherently destructive, with predictable adverse effects on visual function, and a safer alternative is required. Intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors can induce short-term regression of retinal neovascularisation. The aim of this randomised controlled trial is to determine the efficacy, safety and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and placental growth factor (PLGF), in PDR, and to investigate the impact on local oxygenation. Methods and analysis This is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of PDR. 220 participants with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or PRP for a period of 52 weeks. The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks. Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness. Ocular and non-ocular adverse events will also be reported over 52 weeks. Ethics and dissemination The study has been approved by the National Research Ethics Service (NRES) committee with respect to scientific content and compliance with applicable research and human subjects’ regulations. Findings will be reported through scientific publications and research conferences. The results of this study will provide clinical evidence for the feasibility, efficacy safety and cost-effectiveness of intravitreal aflibercept for PDR. Trial registration number ISRCTN 32207582. PMID:26369798

  13. Effect of low-dose citrate anticoagulation on the clinical safety and efficacy of direct adsorption of lipoproteins (DALI apheresis) in hypercholesterolemic patients: a prospective controlled clinical trial.

    PubMed

    Bosch, T; Heinemann, O; Duhr, C; Wendler, T; Keller, C; Fink, E; Kirschner, T; Klebert, S; Samtleben, W

    2000-10-01

    Direct adsorption of lipoproteins (DALI) is the first lipid apheresis system compatible with whole blood with the advantage of a very simple procedure. A mixture of heparin plus citrate (ACD-A) is used for the anticoagulation regimen (AR). A clinical, prospective, controlled crossover study was performed to test the safety and efficacy of low-dose citrate (LDC) anticoagulation in DALI. Five chronic DALI patients suffering from coronary heart disease and hypercholesterolemia underwent 3 DALI sessions each using the LDC anticoagulation regimen (60 IU heparin/kg body weight as initial bolus; 1:40 ACD-A: blood as perfusion). This was compared to 3 sessions per patient with the standard AR (bolus of 20 IU heparin/kg, 1:20 ACD-A as perfusion). Patient blood volumes (1.6; average of 7,040 ml) were treated with 750 ml adsorber gel per session at a blood flow rate of 60 ml/min. Mean LDL and Lp(a) reductions exceeded 60% with both AR. No clinical side effects were observed. Both AR controlled the coagulation well as evidenced by a sufficient prolongation of the partial prothrombin time (PTT) and activated clotting time as well as low thrombin-antithrombin (TAT) formation. Biocompatibility parameters exhibited favorable results (low activation of complement and cells, and only slight formation of C3a, C5a, beta-thromboglobulin, elastase, and TNF-alpha). The asymptomatic bradykinin generation was comparable in both study arms. LDC optimized the ionized calcium levels and pH in the efferent blood postadsorber. LDC anticoagulation was safe and effective, and may further improve the tolerance of DALI apheresis in hypercholesterolemic patients.

  14. Clinical outcomes and antiretroviral therapy in 'elite' controllers: a review of the literature.

    PubMed

    Crowell, Trevor A; Hatano, Hiroyu

    2015-04-01

    Elite controllers naturally suppress HIV viraemia below the level of detection using standard methods, but demonstrate persistent inflammation and low-level viraemia that is detectable via ultrasensitive assays. These factors may contribute to an increased risk of non-AIDS-related morbidity and mortality among elite controllers. Data suggest that cardiovascular disease may be of particular concern in elite controllers, as evidenced by an increased burden of subclinical cardiovascular disease upon radiographic screening and an elevated rate of hospitalisations for cardiovascular disease as compared to non-controllers who are treated with antiretroviral therapy (ART). Widespread use of ART among non-controllers has led to significant declines in morbidity and mortality, but guidelines are generally silent on the role of ART in the care of elite controllers. Multiple small studies have demonstrated that laboratory markers of inflammation, immune activation and HIV burden improve after initiation of ART in elite controllers. Clinicians must consider these potential benefits of ART when deciding whether to initiate treatment in asymptomatic elite controllers.

  15. 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

  16. Increased sleep need and daytime sleepiness 6 months after traumatic brain injury: a prospective controlled clinical trial.

    PubMed

    Imbach, Lukas L; Valko, Philipp O; Li, Tongzhou; Maric, Angelina; Symeonidou, Evangelia-Regkina; Stover, John F; Bassetti, Claudio L; Mica, Ladislav; Werth, Esther; Baumann, Christian R

    2015-03-01

    Post-traumatic sleep-wake disturbances are common after acute traumatic brain injury. Increased sleep need per 24 h and excessive daytime sleepiness are among the most prevalent post-traumatic sleep disorders and impair quality of life of trauma patients. Nevertheless, the relation between traumatic brain injury and sleep outcome, but also the link between post-traumatic sleep problems and clinical measures in the acute phase after traumatic brain injury has so far not been addressed in a controlled and prospective approach. We therefore performed a prospective controlled clinical study to examine (i) sleep-wake outcome after traumatic brain injury; and (ii) to screen for clinical and laboratory predictors of poor sleep-wake outcome after acute traumatic brain injury. Forty-two of 60 included patients with first-ever traumatic brain injury were available for follow-up examinations. Six months after trauma, the average sleep need per 24 h as assessed by actigraphy was markedly increased in patients as compared to controls (8.3 ± 1.1 h versus 7.1 ± 0.8 h, P < 0.0001). Objective daytime sleepiness was found in 57% of trauma patients and 19% of healthy subjects, and the average sleep latency in patients was reduced to 8.7 ± 4.6 min (12.1 ± 4.7 min in controls, P = 0.0009). Patients, but not controls, markedly underestimated both excessive sleep need and excessive daytime sleepiness when assessed only by subjective means, emphasizing the unreliability of self-assessment of increased sleep propensity in traumatic brain injury patients. At polysomnography, slow wave sleep after traumatic brain injury was more consolidated. The most important risk factor for developing increased sleep need after traumatic brain injury was the presence of an intracranial haemorrhage. In conclusion, we provide controlled and objective evidence for a direct relation between sleep-wake disturbances and traumatic brain injury, and for clinically significant underestimation of post

  17. [The Levinsky Walk-in Clinic in Tel Aviv: holistic services to control sexually transmitted diseases in the community].

    PubMed

    Mor, Zohar; Goor, Yael; de Musquita, Sarah Bueno; Shohat, Tamy

    2010-08-01

    The Israeli Ministry of Health inaugurated two walk-in community sexually transmitted disease (STD) clinics in 2002. This review focuses on the Levinsky Clinic in Tel Aviv. The clinics were established as a response to the increase in N. gonorrhea morbidity during the late 1990's, especially in the Tel Aviv district and following the rise in trafficking of women into Israel. The target populations were later extended to include other individuals at risk of developing STD, such as prostitutes, drug addicts, men who have sex with men, persons who have multiple sex partners or individuals considering themselves to be at high-risk. The clinic is operated by a multi-professional team, including physicians, nurses, social and community workers, and volunteers. Each patient is interviewed by a nurse or social-worker to stratify her/his risk of acquiring STD. Laboratory tests and physical examinations are performed as indicated. The services are free of charge and the clients have the option to remain anonymous in order to hamper possible barriers in accessing the clinic. The medical and psycho-social services of the Levinsky Clinic are tailored for the target populations. Therefore, some of the services are provided by a mobile unit outreaching the streets, brothels, shelters for trafficked women and refugees, correctional facilities, gay venues and drug trade locations. The staff employs the harm reduction strategy, is sensitive to the status of the individual in the community, and attentive to the influence of the environment over the clients' ability to control their risks of acquiring STD. The staff encourages an open and direct conversation with the clients about sex and sexuality, in a non-judgmental and respectful fashion. Many of those interventions are provided by community workers, who are familiar with the unique social behaviors, language, values and life style of the vulnerable populations, and aware of the limitations in adopting safe sex practices.

  18. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks

  19. 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

  20. 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

  1. 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

  2. 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.

  3. Clinical Control of HIV-1 by Cytotoxic T Cells Specific for Multiple Conserved Epitopes

    PubMed Central

    Murakoshi, Hayato; Akahoshi, Tomohiro; Koyanagi, Madoka; Chikata, Takayuki; Naruto, Takuya; Maruyama, Rie; Tamura, Yoshiko; Ishizuka, Naoki; Gatanaga, Hiroyuki; Oka, Shinichi

    2015-01-01

    ABSTRACT Identification and characterization of CD8+ T cells effectively controlling HIV-1 variants are necessary for the development of AIDS vaccines and for studies of AIDS pathogenesis, although such CD8+ T cells have been only partially identified. In this study, we sought to identify CD8+ T cells controlling HIV-1 variants in 401 Japanese individuals chronically infected with HIV-1 subtype B, in which protective alleles HLA-B*57 and HLA-B*27 are very rare, by using comprehensive and exhaustive methods. We identified 13 epitope-specific CD8+ T cells controlling HIV-1 in Japanese individuals, though 9 of these epitopes were not previously reported. The breadths of the T cell responses to the 13 epitopes were inversely associated with plasma viral load (P = 2.2 × 10−11) and positively associated with CD4 count (P = 1.2 × 10−11), indicating strong synergistic effects of these T cells on HIV-1 control in vivo. Nine of these epitopes were conserved among HIV-1 subtype B-infected individuals, whereas three out of four nonconserved epitopes were cross-recognized by the specific T cells. These findings indicate that these 12 epitopes are strong candidates for antigens for an AIDS vaccine. The present study highlighted a strategy to identify CD8+ T cells controlling HIV-1 and demonstrated effective control of HIV-1 by those specific for 12 conserved or cross-reactive epitopes. IMPORTANCE HLA-B*27-restricted and HLA-B*57-restricted cytotoxic T lymphocytes (CTLs) play a key role in controlling HIV-1 in Caucasians and Africans, whereas it is unclear which CTLs control HIV-1 in Asian countries, where HLA-B*57 and HLA-B*27 are very rare. A recent study showed that HLA-B*67:01 and HLA-B*52:01-C*12:02 haplotypes were protective alleles in Japanese individuals, but it is unknown whether CTLs restricted by these alleles control HIV-1. In this study, we identified 13 CTLs controlling HIV-1 in Japan by using comprehensive and exhaustive methods. They included 5 HLA-B*52

  4. 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

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

    PubMed

    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.

  6. Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers.

    PubMed

    Wahid, Rahnuma; Holt, Renee; Hjorth, Richard; Berlanda Scorza, Francesco

    2016-10-26

    With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization's (WHO's) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic. Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China. The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements. Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs.

  7. Aspirin, nonsteroidal anti-inflammatory drugs, acetaminophen, and pancreatic cancer risk: a clinic-based case-control study.

    PubMed

    Tan, Xiang-Lin; Reid Lombardo, Kaye M; Bamlet, William R; Oberg, Ann L; Robinson, Dennis P; Anderson, Kristin E; Petersen, Gloria M

    2011-11-01

    Aspirin and other nonsteroidal anti-inflammatory drugs (NSAID) show indisputable promise as cancer chemoprevention agents. However, studies have been inconsistent as to whether aspirin has a protective effect in development of pancreatic cancer. To further evaluate the association between aspirin, NSAID, and acetaminophen use with pancreatic cancer risk, we used a clinic-based case-control study of 904 rapidly ascertained histologically or clinically documented pancreatic ductal adenocarcinoma cases, and 1,224 age- and sex-matched healthy controls evaluated at Mayo Clinic from April 2004 to September 2010. Overall, there is no relationship between non-aspirin NSAID or acetaminophen use and risk of pancreatic cancer. Aspirin use for 1 d/mo or greater was associated with a significantly decreased risk of pancreatic cancer (OR = 0.74, 95% CI: 0.60-0.91, P = 0.005) compared with never or less than 1 d/mo. Analysis by frequency and frequency-dosage of use categories showed reduced risk (P = 0.007 and 0.022, respectively). This inverse association was also found for those who took low-dose aspirin for heart disease prevention (OR = 0.67, 95% CI: 0.49-0.92, P = 0.013). In subgroup analyses, the association between aspirin use and pancreatic cancer was not significantly affected by pancreatic cancer stage, smoking status, or body mass index. Our data suggest that aspirin use, but not non-aspirin NSAID use, is associated with lowered risk of developing pancreatic cancer.

  8. 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.

  9. Oral Zinc Sulfate as Adjuvant Treatment in Children With Nephrolithiasis: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Yousefichaijan, Parsa; Cyrus, Ali; Dorreh, Fatemeh; Rafeie, Mohammad; Sharafkhah, Mojtaba; Frohar, Faryar; Safi, Fatemeh

    2015-01-01

    Background: Nephrolithiasis in children is associated with a high rate of complications and recurrence. Objectives: Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. Patients and Methods: This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups). Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day) oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment) assessing size and number of stones in the kidneys. Results: Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84) (P = 0.001) and size (cm) (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39) (P = 0.001) of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P < 0.0001) in a way that the decrease in the intervention group showed no difference with the control group. Conclusions: Adjuvant treatment with zinc is not more effective than consecutive treatment in children with nephrolithiasis. However, further studies are recommended due to the lack of clinical evidence in this field. PMID:26635934

  10. 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

  11. 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.

  12. 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.

  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

    ... Sufentanil (9740), a basic class of controlled substance listed in schedule II. The company plans to import... registration is consistent with the public interest. The investigation has included inspection and testing...

  14. 78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ...), a basic class of controlled substance listed in schedule II. The company plans to import the listed... registration is consistent with the public interest. The investigation has included inspection and testing...

  15. Sleep-related breathing disorders in acute respiratory failure assisted by non-invasive ventilatory treatment: utility of portable polysomnographic system.

    PubMed

    Resta, O; Guido, P; Foschino Barbaro, M P; Picca, V; Talamo, S; Lamorgese, V

    2000-02-01

    In the majority of patients admitted to an Intensive Care Unit with acute respiratory failure (ARF), the aetiology for ARF is quite evident. In a minority of patients no obvious aetiology is apparent at presentation. In this group a previously unrecognized sleep-related breathing disorder (SRBD) may be the cause of the ARF. In spite of clinical suspicion SRBD remains infrequently diagnosed in ARF also because the technology necessary for this type of diagnosis (polysomnography) is usually unavailable in Intensive Care Units. The aim of this study was to evaluate the utility of portable polysomnography system (PSGp) in a group of patients with ARF of unclear aetiology and with a clinical suspicion of SRBD. We studied a selected group of 14 patients (eight males, six females) admitted to an Intermediate Intensive care unit with varying degree of acute respiratory failure. Mean (SD) age was 57 (13) years, pH 7.28 (0.04), PaO2 5.6 (0.7) kPa), PaO2 (8.8 (1.6) kPa), Body mass index 42.7 (9.6) kg m(-2). The patients had no history of skeletal, neuromuscular or cardiovascular disease. None of them had a history of overt chronic lung diseases or had obvious respiratory tract infections. They were submitted to cardiac and respiratory functional evaluation and to nightly PSGp (VITALOG HMS 5000, Respironics Inc., Redwood City, CA, U.S.A.) which was performed in an intermediate intensive care unit. Ten subjects had obstructive sleep apnoea-hypopnoea syndrome (OSAS), with mean respiratory disorder index h(-1) (RDI) 60.1 (25.9) [in five associated with obesity-hypoventilation syndrome (OHS)]; two had central sleep apnoea with mean RDI 45 (28.3) (one with hypothyroidism and one with cerebral multiple infarctions and right hemidiaphragmatic paralysis) and two had OHS with mean RDI 12.5 (3.5). Nocturnal hypoventilation was present in almost all patients. Continuous positive airway pressure (CPAP) was effective in three patients. Eight patients needed to be treated with BILEVEL (Bi

  16. Quetiapine improves visual hallucinations in Parkinson disease but not through normalization of sleep architecture: results from a double-blind clinical-polysomnography study.

    PubMed

    Fernandez, Hubert H; Okun, Michael S; Rodriguez, Ramon L; Malaty, Irene A; Romrell, Janet; Sun, Anqi; Wu, Samuel S; Pillarisetty, Sandeep; Nyathappa, Anand; Eisenschenk, Stephan

    2009-01-01

    Polysomnographic studies of Parkinson's disease (PD) patients with visual hallucinations (VH) usually reveal short, fragmented rapid eye movement (REM) sleep, with lower sleep efficiency and reduced total REM sleep. Quetiapine has been demonstrated in open-label trials to be effective for the treatment of insomnia and VH in PD. To confirm quetiapine's efficacy in improving VH, and to determine whether the mechanism was due to its effect on REM sleep architecture, we performed a pilot, double-blind, placebo-controlled study. Sixteen PD patients experiencing VH were recruited. Eight patients were randomized to quetiapine and eight patients to placebo. Patients underwent pre- and post-treatment polysomnography. The Clinical Global Impression Scale (CGIS), Brief Psychiatric Rating Scale (BPRS), and Unified Parkinson Disease Rating Scale (UPDRS) motor subscale were obtained. There were no differences in baseline characteristics between the treatment arms except that the placebo group had more sleep in stage REM (74.7 min vs. 40.1 min; p < .001). Data were imputed for all patients who prematurely discontinued (four quetiapine and one placebo) in an intention-to-treat analysis. The average quetiapine dose was 58.3 mg/day. While there was no significant difference in the change in REM duration pre- vs. post-treatment in either arm, patients randomized to quetiapine improved on the CGIS (p = .03) and the hallucination item of the BPRS (p = .02). No difference was noted in the UPDRS motor scores. Despite the small sample, this is the first double-blind trial to show quetiapine's efficacy over placebo in controlling VH in the PD population. However, normalization of sleep architecture was not supported as the mechanism.

  17. 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.

  18. 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.

  19. Clinical and microbiological effects of controlled-release locally delivered minocycline in periodontitis.

    PubMed

    Jones, A A; Kornman, K S; Newbold, D A; Manwell, M A

    1994-11-01

    The clinical efficacy of minocycline in a subgingival local delivery system was evaluated alone (M) or as an adjunct to scaling and root planing (M + SRP), in comparison to scaling and root planing (SRP) or to no subgingival treatment (NoTx) in adult periodontitis. Fifty-one adult patients with > or = 7 mm periodontal pockets demonstrating the presence by culture of Porphyromonas gingivalis (Pg), Prevotella intermedia (P(i)), or Actinobacillus actinomycetemcomitans (Aa) were randomized into one of the above 4 treatment groups. All sites > or = 5 mm in the most diseased quadrant in each patient received the therapy. Other quadrants were not treated. All patients received standardized oral hygiene instructions at the beginning of the study. At 0, 1, 3 and 6 months following therapy the 7 mm experimental sites were evaluated for selected periodontal pathogens by DNA probe analysis. At these same time points, the plaque index, gingival index, and bleeding on probing were evaluated as well as probing depth and relative clinical attachment level which were assessed by means of an automated probe. Probing depth reduction with M + SRP was significantly greater than all other groups at one month and significantly greater than NoTx and SRP at 3 months. There were no differences in probing depth reduction among groups at 6 months. At 6 months the gain in clinical attachment level was significantly greater for SRP than for either the NoTx or M groups. The prevalence of Pg decreased significantly in the M and M + SRP groups at one month.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. Biochemical, physiological and clinical effects of l-methylfolate in schizophrenia: a randomized controlled trial.

    PubMed

    Roffman, J L; Petruzzi, L J; Tanner, A S; Brown, H E; Eryilmaz, H; Ho, N F; Giegold, M; Silverstein, N J; Bottiglieri, T; Manoach, D S; Smoller, J W; Henderson, D C; Goff, D C

    2017-03-14

    Folic acid supplementation confers modest benefit in schizophrenia, but its effectiveness is influenced by common genetic variants in the folate pathway that hinder conversion to its active form. We examined physiological and clinical effects of l-methylfolate, the fully reduced and bioactive form of folate, in schizophrenia. In this randomized, double-blind trial, outpatients with schizophrenia (n=55) received l-methylfolate 15 mg or placebo for 12 weeks. Patients were maintained on stable doses of antipsychotic medications. The pre-defined primary outcome was change in plasma methylfolate at 12 weeks. Secondary outcomes included change in symptoms (Positive and Negative Syndrome Scale (PANSS), Scale for Assessment of Negative Symptoms, Calgary Depression Scale for Schizophrenia), cognition (Measurement and Treatment Research to Improve Cognition in Schizophrenia composite) and three complementary magnetic resonance imaging measures (working memory-related activation, resting connectivity, cortical thickness). Primary, mixed model, intent-to-treat analyses covaried for six genetic variants in the folate pathway previously associated with symptom severity and/or response to folate supplementation. Analyses were repeated without covariates to evaluate dependence on genotype. Compared with placebo, l-methylfolate increased plasma methylfolate levels (d=1.00, P=0.0009) and improved PANSS Total (d=0.61, P=0.03) as well as PANSS Negative and General Psychopathology subscales. Although PANSS Total and General Psychopathology changes were influenced by genotype, significant PANSS Negative changes occurred regardless of genotype. No treatment differences were seen in other symptom rating scales or cognitive composite scores. Patients receiving l-methylfolate exhibited convergent changes in ventromedial prefrontal physiology, including increased task-induced deactivation, altered limbic connectivity and increased cortical thickness. In conclusion, l

  1. Retrospective analysis of the clinical response of palmoplantar pustulosis after dental infection control and dental metal removal.

    PubMed

    Kouno, Michiyoshi; Nishiyama, Akihiro; Minabe, Masaki; Iguchi, Naohiko; Ukichi, Kenichiro; Nomura, Takeshi; Katakura, Akira; Takahashi, Shinichi

    2017-02-02

    Both metal allergy and dental focal infection have been considered as causative factors for palmoplantar pustulosis, and several case reports described that the skin lesions were ameliorated after dental metal removal or dental infection control. However, limited data are available to evaluate the association of these factors with disease severity of palmoplantar pustulosis. This study is designed to analyze the clinical outcome of 85 palmoplantar pustulosis patients after dental infection control (n = 70), tonsillectomy (n = 6) and dental metal removal (n = 9). More than half of the patients (63%, 44/70) showed positive clinical outcome after dental infection control. The skin lesions of all patients with tonsillitis were improved after tonsillectomy (100%, 6/6). On the other hand, one-third of patients (33%, 3/9) showed positive response after dental metal removal. These results suggest that focal infection is more closely associated with palmoplantar pustulosis than dental metal allergy. According to our findings, palmoplantar pustulosis patients should be preferentially examined for focal infections.

  2. 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.

  3. 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.

  4. NeuroControl of movement: system identification approach for clinical benefit.

    PubMed

    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.

  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. Neutrophil-to-lymphocyte ratio in patients with peripheral vertigo: a prospective controlled clinical study.

    PubMed

    Ozbay, Isa; Kahraman, Cuneyt; Balikci, Hasan Huseyin; Kucur, Cuneyt; Kahraman, Nilufer Kuzeyli; Ozkaya, Derya Pınar; Oghan, Fatih

    2014-01-01

    We aimed to investigate the relationship between peripheral vertigo and inflammation by using the neutrophil-to-lymphocyte ratio (NLR) as an inflammatory marker. We recruited 103 patients with peripheral vertigo (71 women, 32 men; mean age, 39.8 ± 14.7 years) who presented to the Otolaryngology Department of Dumlupinar University Hospital. Vertigo patients with systemic diseases, neurological disorders, malignancy or any inflammatory disease that could alter the NLR were excluded from the study. We also enrolled 103 age- and sex-matched healthy subjects (controls; 82 women, 21 men; mean age, 36.7 ± 13.5 years) who underwent routine checkups in our hospital. The vertigo patients underwent full otolaryngologic and neurologic examinations and audiometric tests to rule out any other pathology causing the peripheral vertigo. NLR was calculated in all subjects and was compared between the patient and control groups. There were no significant differences between the study and control groups in terms of lipid profiles, liver-function tests, white blood cell (WBC) count, hemoglobin level, mean platelet volume, and vitamin B12 and folate levels. The mean NLR was significantly higher in the patients than in the controls (P<0.05). In conclusion, this study, which was the first to investigate the relationship between the NLR and peripheral vertigo, found that the NLR is significantly higher among peripheral vertigo patients than among healthy controls. This result suggests that the NLR is a novel potential marker of stress in peripheral vertigo patients.

  7. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial

    PubMed Central

    Henderson, John C.; Neradilek, Moni B.; Moyer, Nicolas A.; Ashcraft, Kristine C.; Thirumaran, Ranjit K.

    2017-01-01

    Background In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients. Methods and findings This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32–1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27–0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31–1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34–0.99; P = 0.045). Differences in composite outcomes at

  8. Clinical evaluation of a simultaneous closed-loop anaesthesia control system for depth of anaesthesia and neuromuscular blockade*.

    PubMed

    Janda, M; Simanski, O; Bajorat, J; Pohl, B; Noeldge-Schomburg, G F E; Hofmockel, R

    2011-12-01

    We developed a closed-loop system to control the depth of anaesthesia and neuromuscular blockade using the bispectral index and the electromyogram simultaneously and evaluated the clinical performance of this combined system for general anaesthesia. Twenty-two adult patients were included in this study. Anaesthesia was induced by a continuous infusion of remifentanil at 0.4 μg.kg(-1) .min(-1) (induction dose) and then 0.25 μg.kg(-1) .min(-1) (maintenance dose) and propofol at 2 mg.kg(-1) 3 min later. The combined automatic control was started 2 min after tracheal intubation. The depth of anaesthesia was recorded using bispectral index monitoring using a target value of 40. The target value of neuromuscular blockade, using mivacurium, was a T1/T1(0) twitch height of 10%. The precision of the system was calculated using internationally defined performance parameters. Twenty patients were included in the data analysis. The mean (SD) duration of simultaneous control was 129 (69) min. No human intervention was necessary during the computer-controlled administration of propofol and mivacurium. All patients assessed the quality of anaesthesia as 'good' to 'very good'; there were no episodes of awareness. The mean (SD) median performance error, median absolute performance error and wobble for the control of depth of anaesthesia and for neuromuscular blockade were -0.31 (1.78), 6.76 (3.45), 6.32 (2.93) and -0.38 (1.68), 3.75 (4.83), 3.63 (4.69), respectively. The simultaneous closed-loop system using propofol and mivacurium was able to maintain the target values with a high level of precision in a clinical setting.

  9. 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.

  10. Clinical inquiries: Do glucosamine and chondroitin worsen blood sugar control in diabetes?

    PubMed

    Marshall, Peter D; Poddar, Sourav; Tweed, Elizabeth M; Brandes, Lisa

    2006-12-01

    Despite theoretical risks based on animal models given high intravenous doses, glucosamine/chondroitin (1500 mg/1200 mg daily) does not adversely affect short-term glycemic control for patients whose diabetes is well-controlled, or for those without diabetes or glucose intolerance (SOR: A, consistent, good-quality patient-oriented evidence). Some preliminary evidence suggests that glucosamine may worsen glucose intolerance for patients with untreated or undiagnosed glucose intolerance or diabetes (SOR: C, extrapolation from disease-oriented evidence). Long-term effects are unknown; however, no compelling theoretical or incidental data suggest that long-term results should be different (SOR: C, expert opinion). Further studies are required to clarify the effects of glucosamine on patients with poorly controlled diabetes or glucose intolerance.

  11. 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

  12. Clinical effectiveness and safety of gemifloxacin versus cefpodoxime in acute exacerbation of chronic bronchitis: A randomized, controlled trial

    PubMed Central

    Chatterjee, S.; Biswas, T.; Dutta, A.; Sengupta, G.; Mitra, A.; Kundu, S.

    2011-01-01

    Objective: Acute exacerbation of chronic bronchitis (AECB) is a commonly encountered problem and those suspected to be due to bacterial infections require antibiotic therapy. This randomized, controlled trial was designed to evaluate the effectiveness and safety of gemifloxacin, a new fluoroquinolone, versus cefpodoxime, an oral third-generation cephalosporin, for the treatment of mild to moderately severe cases of AECB. Materials and Methods: Adult subjects diagnosed with chronic bronchitis with clinical symptoms suggestive of an Anthonisen type II acute exacerbation (any two of the following criteria – increased dyspnea, cough, sputum purulence) were eligible and those fulfilling the subject selection criteria were randomized to receive either gemifloxacin 320 mg once daily or cefpodoxime 200 mg twice daily orally for 7 days. The primary outcome measure was clinical success rate at day 14 visit and the secondary outcome measures were changes in Clinical Global impression (CGI) scales and incidence of adverse events (AEs). Fifty-two subjects were enrolled: 26 in gemifloxacin group and 24 in the other and 2 were lost to follow-up. Results: The clinical success rates were comparable (84.6% in gemifloxacin group versus 83.3% in cefpodoxime group) and no statistically significant difference was observed between the groups. AEs were mild, self-limiting and few (two in gemifloxacin and three in cefpodoxime arm) and tolerability was also good. Conclusion: The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients. PMID:21455420

  13. Randomized Clinical Trial of Portion-Controlled Prepackaged Foods to Promote Weight Loss

    PubMed Central

    Rock, Cheryl L.; Flatt, Shirley W.; Pakiz, Bilgé; Barkai, Hava-Shoshana; Heath, Dennis D.; Krumhar, Kim C.

    2017-01-01

    Objective Providing portion-controlled prepackaged foods in a behavioral counseling intervention may promote more weight and fat loss than a standard self-selected diet. Methods: The primary aim was to test whether providing portion-controlled prepackaged lunch and dinner entrées within a behavioral weight loss intervention promotes greater weight loss at 12 weeks in overweight/obese adults compared to self-selected foods. Other aims were to examine effects on biological factors, fitness, and meal satisfaction. One-half of those assigned to prepackaged entrées were provided items with a higher protein level (>25% energy) as an exploratory aim. Results Participants (N=183) had a baseline weight of 95.9 (15.6) kg (mean [SD]) and BMI of 33.2 (3.5) kg/m2. Weight data at 12 weeks were available for 180 subjects. Weight loss for regular entrée, higher protein entrée and control groups was 8.6 (3.9), 7.8 (5.1), and 6.0 (4.4)%, respectively (P<0.05, intervention vs. control). Intervention participants lost more body fat than controls (5.7 [3.4] vs. 4.4 [3.3] kg, P<0.05). Conclusions A meal plan incorporating portion-controlled prepackaged entrées promotes greater weight and fat loss than a standard self-selected diet, with comparable meal satisfaction. Initial weight loss predicts long-term weight loss so these results are relevant to likelihood of longer term success. PMID:27225596

  14. Internal Structure and Clinical Utility of the Anxiety Control Questionnaire-Revised (ACQ-R) Spanish Version.

    PubMed

    Osma, Jorge; Barrada, Juan Ramón; García-Palacios, Azucena; Navarro-Haro, María; Aguilar, Alejandra

    2016-10-03

    Perceived control has shown predictive value for anxiety severity symptoms as well as cognitive-behavior therapy outcomes. The most commonly used measure of perceived control is the Anxiety Control Questionnaire (ACQ), and more recently the ACQ Revised (ACQ-R). However, both questionnaires have shown structural inconsistencies among several studies. Also, although the ACQ and ACQ-R seem to be multidimensional instruments, a single total score have been commonly used. This study examined the internal structure of the ACQ-R Spanish version using exploratory factor and exploratory bi-factor analysis in a sample of 382 college students and 52 people diagnosed of panic disorder (with or without agoraphobia). Also, in this study we assessed the preliminary diagnostic value of the ACQ-R scores. The results indicated that the ACQ-R Spanish version structure consisted of two factors: one related with perceived control of internal emotional reactions (Emotion Control) and another related with perceived control of external events (Threat and Stress Control). Both specific factors can be adequately summarized by a general factor (General Anxiety Perception of Control; CFI = .973, TLI = .954, RMSEA = .039; p = .002), which accounted for 70% of the common explained variance. The correlations between the ACQ-R scores and with variables like anxiety (r = -.66) or anxiety sensitivity (r = -.50) presented the expected pattern of results. Either the two dimensions structure or the total score have proved to be a good tool to distinguish between participants with panic disorder and non-clinical samples (area under the curve = 0.79).

  15. Correlation of Clinical Neuromusculoskeletal and Central Somatosensory Performance: Variability in Controls and Patients With Severe and Mild Focal Hand Dystonia

    PubMed Central

    Byl, Nancy N.; Nagarajan, Srikantan S.; Merzenich, Michael M.; Roberts, Tim; McKenzie, Alison

    2002-01-01

    Focal hand dystonia (FHd) is a recalcitrant, disabling movement disorder, characterized by involuntary co-contractions of agonists and antagonists, that can develop in patients who overuse or misuse their hands. The aim of this study was to document clinical neuromusculoskeletal performance and somatosensory responses (magnetoencephalography) in healthy controls and in FHd subjects with mild versus severe hand dystonia. The performance of healthy subjects (n = 17) was significantly better than that of FHd subjects (n = 17) on all clinical parameters. Those with mild dystonia (n = 10) demonstrated better musculoskeletal skills, task-specific motor performance, and sensory discrimination, but the performance of sensory and fine motor tasks was slower than that of patients with severe dystonia. In terms of somatosensory evoked field responses (SEFs), FHd subjects demonstrated a significant difference in the location of the hand representation on the x and y axes, lower amplitude of SEFs integrated across latency, and a higher ratio of mean SEF amplitude to latency than the controls. Bilaterally,. those with FHd (mild and severe) lacked progressive sequencing of the digits from inferior to superior. On the affected digits, subjects with severe dystonia had a significantly higher ratio of SEF amplitude to latency and a significantly smaller mean volume of the cortical hand representation than those with mild dystonia. Severity of dystonia positively correlated with the ratio of SEF mean amplitude to latency (0.9029 affected, 0.8477 unaffected; p<0.01). The results of the present study strengthen the evidence that patients with FHd demonstrate signs of somatosensory degradation of the hand that correlates with clinical sensorimotor dysfunction, with characteristics of the dedifferentiation varying by the severity of hand dystonia. If these findings represent aberrant learning, then effective rehabilitation must incorporate the principles of neuroplasticity. Training must

  16. 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

  17. Evaluation of clinical, antiinflammatory and antiinfective properties of amniotic membrane used for guided tissue regeneration: A randomized controlled trial

    PubMed Central

    Kumar, Aravind; Chandra, Rampalli Viswa; Reddy, Aileni Amarender; Reddy, Bavigadda Harish; Reddy, Chakravarthy; Naveen, Anumala

    2015-01-01

    Background: The objective of this study was to evaluate the antiinflammatory, antiinfective and clinical properties of amniotic membrane (AM) when used for guided tissue regeneration (GTR) in contained interdental defects. Materials and Methods: A total of 30 subjects participated in this study. Two sites in each subject were randomly assigned into each of the following experimental groups; test group: AM with bone graft and control group: Bone graft only. Clinical parameters included recording site-specific measures of plaque, gingivitis, probing pocket depth (PPD), and clinical attachment loss (CAL). The levels of interleukin-1β (IL-1β) and human beta-defensin-2 (hBD-2) levels in gingival crevicular fluid (GCF) from the test and control sites were measured by using commercially available enzyme linked immunosorbent assay kits. The evaluation of bone fill was performed by using digital subtraction technique and morphometric area analysis. One-way analysis of variance followed by the post-hoc test was used for intragroup and intergroup comparison. A P < 0.05 was considered as statistically significant. Results: Combination therapy using an AM increased bone fill and reduced PPD and CAL when compared to controls. AM also resulted in a significant reduction of GCF IL-1β levels and insignificant increase in the hBD-2 levels. Conclusion: From this trial conducted over a period of 24 weeks, AM demonstrated a marked antiinflammatory effect and its use resulted in an improvement in periodontal parameters. AM has the potential to function as a barrier for GTR and the unique properties associated with this material can augment its potential as a matrix for periodontal regeneration. PMID:25878677

  18. Persistent current blockers of voltage-gated sodium channels: a clinical opportunity for controlling metastatic disease.

    PubMed

    Djamgoz, Mustafa B A; Onkal, Rustem

    2013-01-01

    A range of experimental and clinical data suggests strongly (i) that metastatic progression in carcinomas is accompanied (maybe even preceded) by upregulation of functional voltage-gated sodium channels (VGSCs) and (ii) that VGSC activity enhances cancer cell invasiveness. First, this review outlines the available in vitro and in vivo evidence for the VGSC expression and its proposed pathophysiological role. Second, we question the mechanism(s) whereby VGSC activity can induce such a cancer-promoting effect. We advance the hypothesis that it is the hypoxia-sensitive persistent component of the VGSC current (INaP) that is central to the phenomenon. Indeed, blockers of INaP are very effective in suppressing cancer cell invasiveness in vitro. Based upon these data, UK and international patent applications have been filed which describe the use of INaP blockers, like ranolazine ("Ranexa") and riluzole ("Rilutex"), as anti-metastatic agents. Importantly, since these drugs are already in clinical use, against conditions like cardiac angina and amyotrophic lateral scelerosis, there are no issues of dosage, unacceptable side effects or long-term use. Thus, INaP blockers have the potential to turn cancer into a chronic condition.

  19. Clinical use of deslorelin for the control of reproduction in the bitch.

    PubMed

    Romagnoli, S; Stelletta, C; Milani, C; Gelli, D; Falomo, M E; Mollo, A

    2009-07-01

    This study was conducted to evaluate clinical efficacy of deslorelin for inhibiting reproduction in the bitch. Ten adult healthy bitches or bitches with mammary neoplasia for which owners were requesting suppression of cyclicity without performing gonadectomy were administered a 4.7- or a 9.4-mg deslorelin implant subcutaneously. The first implant of deslorelin was administered in anoestrus (n = 5) or in dioestrus (n = 5). Treatment was repeated every 5 months for as long as necessary based on the clinical situation of the dog and owner's desires. Some of the bitches implanted in anoestrus came in heat within 4-15 days after treatment, while none of the bitches implanted in dioestrus showed heat during treatment. Suppression of reproductive cyclicity was successfully achieved in 6/10 bitches for 1-4 years. No behavioural and local/general side-effects were observed in any of the treated bitches. The 4.7-mg deslorelin implant may work well for suppression of cyclicity provided that it is administered in dioestrus and at intervals of 4.5 months. A 9.4-mg implant may be more suitable for this use although its efficacy may also be shorter than 12 months. Owner compliance is an important limiting factor.

  20. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 3: Design considerations.

    PubMed

    Ball, Greg; Silverman, Michael H

    2011-09-01

    Ongoing safety monitoring of clinical trials of investigational treatments must operate at levels that range from the minute and detailed - namely, mathematical treatment of trial data - to the philosophical and societal - namely, ethical concerns for individuals and populations. Between those two poles lies a realm of environmental and pragmatic considerations that reflect the goals, biases, risk-tolerance, and constraints of study sponsors and organizers. These factors, while more difficult to quantify or, at times, to justify, also have a meaningful impact on the approach to safety monitoring and the resulting actions and outcomes. This paper considers the influence and interaction of two such factors, study design and statistical framework, on continuous safety monitoring procedures. Group sequential designs have been generally preferred for clinical trials over continuous sequential designs because of practical considerations. The group means and greater time for deliberation when using a group sequential procedure, as opposed to a continuous sequential procedure, can improve the quality of the analyses with minimal loss in sensitivity. However, undertaking any sequential analysis within a frequentist framework provokes considerable theoretical and practical difficulties. Continuous monitoring with a likelihood based method, on the other hand, has the advantages that all available information, including new data, can be used; sample sizes need not be fixed; and decisions can be made at any time without statistical penalty, irrespective of trial design. Such responsive statistical rules are needed to provide guidance to the human beings charged with trial monitoring.

  1. 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

  2. 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

  3. Olanzapine and clozapine differently affect sleep in patients with schizophrenia: results from a double-blind, polysomnographic study and review of the literature.

    PubMed

    Kluge, Michael; Schacht, Alexander; Himmerich, Hubertus; Rummel-Kluge, Christine; Wehmeier, Peter M; Dalal, Mira; Hinze-Selch, Dunja; Kraus, Thomas; Dittmann, Ralf W; Pollmächer, Thomas; Schuld, Andreas

    2014-01-01

    Schizophrenia is associated with impaired sleep continuity. The second generation antipsychotics clozapine and olanzapine have been reported to improve sleep continuity but also to rarely induce restless legs syndrome (RLS). The aims of this randomized double-blind study were to compare the effects of clozapine and olanzapine on sleep and the occurrence of RLS. Therefore, polysomnographies were recorded and RLS symptoms were assessed in 30 patients with schizophrenia before and after 2, 4 and 6 weeks of treatment with either clozapine or olanzapine. Treatment with both antipsychotics increased total sleep time, sleep period time and sleep efficiency and decreased sleep onset latency. These changes were similar in both groups, occurred during the first 2 treatment weeks and were sustained. For example, sleep efficiency increased from 83% (olanzapine) and 82% (clozapine) at baseline to 95% at week 2 and 97% at week 6 in both treatment groups. Sleep architecture was differently affected: clozapine caused a significantly stronger increase of stage 2 sleep (44%) than olanzapine (11%) but olanzapine a significantly stronger increase of REM-sleep. Olanzapine caused an 80% increase of slow wave sleep whereas clozapine caused a 6% decrease. No patient reported any of 4 RLS defining symptoms at baseline. During treatment, 1 patient of each group reported at one visit all 4 symptoms, i.e. met the diagnosis of an RLS. In conclusion, sleep continuity similarly improved and sleep architecture changed more physiologically with olanzapine. Neither of the antipsychotics induced RLS symptoms that were clinically relevant.

  4. Transcutaneous electrical nerve stimulation therapy: An adjuvant pain controlling modality in TMD patients — A clinical study

    PubMed Central

    Shanavas, Muhammad; Chatra, Laxmikanth; Shenai, Prashanth; Rao, Prasanna Kumar; Jagathish, Veena; Kumar, Sreeja Prasanna; Naduvakkattu, Bilahari

    2014-01-01

    Background: The use of transcutaneous electrical nerve stimulation (TENS) in dentistry was first described in 1967, by Shane and Kessler, but it has yet to gain widespread acceptance in dentistry. A study was undertaken to evaluate the effectiveness of TENS therapy as an adjuvant modality and to compare it with the conventional medication in controlling pain in temporomandibular disorder (TMD) patients. Materials and Methods: The study was carried out in the Department of Oral Medicine and Radiology, Yenepoya Dental College and Hospital, Mangalore. A total of 40 patients with the clinical symptom of pain associated with TMDs were randomly divided into two groups. Group A (control) patients were treated with medication (analgesics and muscle relaxants) alone, while group B patients were treated with TENS therapy in combination with medication. The intensity of the pain was assessed using the Visual Analog Scale (VAS). The results were analyzed with the student's ‘t’ test. A P-value < 0.05 was considered as significant. Results: A significant improvement was observed in both the TENS and the control group in terms of pain control. On comparative analysis, adjuvant TENS therapy was found to be more effective than medication alone, in controlling pain. (P value = 0.019). Conclusion: The observed data suggest that TENS therapy can be used as an adjuvant modality in the management of pain associated with TMDs. This study justifies the use of TENS therapy in the management of TMD. PMID:25540662

  5. Obsessive-Compulsive Symptomatology, Religiosity Levels and the Illusion-of-Control Paradigm in a Non-Clinical Undergraduate Sample.

    PubMed

    Vassiliou, Andreas

    2015-10-01

    The present research employed the illusion-of-control paradigm to investigate the relationships between Obsessive-Compulsive disorder (OCD) symptoms, religiosity levels, and illusory sense of control (SC). An opportunistic sample of 60 undergraduate students was presented with a pre-programmed series of neutral visual stimuli (i.e. lines) and was expected to try to control the sequence through the use of keyboard presses. Participants assessed their perceived level of control twice throughout the computerised task. In addition, the study was interested at examining the relationship between religiosity and OC behaviour and the Santa Clara Strength of Religious Faith Questionnaire (SCSRF) was employed. In proportion to predictions, OCD symptoms were correlated with higher illusory SC; furthermore, religiosity levels were related to some degree to OCD symptoms. The essential role of mental control in OCD is discussed, particularly the significant clinical implications of such an association. Furthermore, the possible contribution of religious affiliations to the maintenance of OC behaviour is further discussed.

  6. 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…

  7. A Controlled Study to Assess the Clinical Efficacy of Totally Self-Administered Systematic Desensitization

    ERIC Educational Resources Information Center

    Rosen, Gerald M.; And Others

    1976-01-01

    Highly anxious self-referred snake phobics received either (a) therapist-administered desensitization, (b) self-administered desensitization with weekly therapist phone calls, (c) totally self-administered desensitization, (d) self-administered double-blind placebo control, or (e) no treatment. Pretreatment to posttreatment measures revealed…

  8. Radiation Therapy without Surgery for Spinal Metastases: Clinical Outcome and Prognostic Factors Analysis for Pain Control.

    PubMed

    Matsumura, Akira; Hoshi, Manabu; Takami, Masatsugu; Tashiro, Takahiko; Nakamura, Hiroaki

    2012-09-01

    The purpose of radiation therapy (RT) for patients with spinal metastases is pain relief and control of paralysis. The aim of the present study was to assess pain relief using RT and to evaluate prognostic factors for pain control. We evaluated 97 consecutive patients, of mean age 62.7 years (range 28 to 86), with spinal metastases that had been treated by RT. We evaluated the effects of RT using pain level assessed using a drug grading scale based on the World Health Organization standards. The following potential prognostic factors for pain control of RT were evaluated using multivariate logistic regression analysis: age, gender, tumor type, performance status (PS), number of spinal metastases, and a history of chemotherapy. Among the 97 patients who underwent RT for pain relief, 68 patients (70.1%) presented with pain reduction. PS (odds ratio: 1.931; 95% confidence interval: 1.244 to 2.980) was revealed by multivariate logistic regression analysis to be the most important prognostic factor for pain control using RT. In conclusion, we found that RT was more effective for patients with spinal metastases while they maintained their PS.

  9. 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…

  10. 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

  11. 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

  12. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial

    PubMed Central

    Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2010-01-01

    Objective To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Methods Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. Results For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of ‘late’ DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of ‘late’ DSTs (p=0.57) compared with the control. Conclusions Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting. PMID:21113076

  13. 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.

  14. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial.

    PubMed

    dos Santos, Gisele Munhoes; Bento, Ricardo Ferreira; de Medeiros, Italo Roberto Torres; Oiticcica, Jeanne; da Silva, Eleonora Csipai; Penteado, Silvio

    2014-07-23

    Hearing aids with an integrated sound generator have been used to enhance the treatment of tinnitus. The main aim of this study was to verify whether the combined use of amplification and sound generator is more effective than conventional amplification alone in reducing tinnitus annoyance by means of the use of a new hearing aid with an integrated sound generator. A total of 49 patients underwent a blind randomized clinical trial. Tinnitus annoyance was measured by Tinnitus Handicap Inventory and numerical scales, and psychoacoustic measures of tinnitus were also performed. The sound generator was set at the lowest intensity capable of providing relief from tinnitus. Results showed that 62.5% of the patients presented a reduction in tinnitus annoyance in the combined fitting group and in the group with amplification alone, 78% showed a reduction. This difference between the groups was not statistically significant.

  15. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    PubMed

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  16. Routine quality control of clinical nuclear medicine instrumentation: a brief review.

    PubMed

    Zanzonico, Pat

    2008-07-01

    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, gamma-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.

  17. 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

  18. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial.

    PubMed

    Xiong, Hong-Yan; Liu, Yang; Shu, Duan-Chao; Zhang, Sheng-Li; Qian, Xinhong; Duan, Wei-Xun; Cheng, Liang; Yu, Shi-Qiang; Jin, Zhen-Xiao

    2016-01-01

    The effects of sevoflurane inhalation during cardiopulmonary bypass (CPB) on postoperative courses and serum cardiac troponin I (cTnI) concentrations in pediatric patients undergoing cardiac surgery have not been extensively investigated. In this single-center, prospective, randomized trial, an anesthetic regimen containing 2% sevoflurane used throughout the CPB process was compared with a total intravenous anesthesia (TIVA) regimen. One hundred and three patients undergoing congenital heart defect repair with CPB were included in this prospective randomized controlled study. They were randomized into two groups: the sevoflurane group, who received 2% sevoflurane during CPB via an oxygenator, and the control group, who received only an oxygen-air mixture. The pre- and intra-operative parameters were comparable between the two groups. There was a slight but significant increase of arterial diastolic pressure in the sevoflurane group immediately after CPB compared with control patients (46.9 ± 9.3 mm Hg vs. 43.6 ± 8.9 mm Hg; p = 0.033). There was no death in either group. The postoperative ventilation time (in mean [95% confidence interval]) was shorter in the sevoflurane group than that in the control group (26.1 [19.2, 33.0] h vs. 37.7 [24.4, 50.9] h; p = 0.014). The postoperative ICU time, hospital days, and serial serum cTnI concentrations were not significantly different between the two groups. Inhalation of 2% sevoflurane during CPB is beneficial to the recovery of pediatric patients undergoing cardiac surgery but has no significant effect on postoperative cTnI release.

  19. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: A randomized control study.

    PubMed

    Bini, S A; Mahajan, J

    2017-02-01

    Introduction Successful post-operative telerehabilitation following total knee replacement (TKR) has been documented using synchronous (real-time) video. Bandwidth and the need for expensive hardware are cited as barriers to implementation. Web-based asynchronous visual platforms promise to address these problems but have not been evaluated. We performed a randomized control study comparing an asynchronous video-based software platform to in-person outpatient physical therapy visits following TKR. Materials and methods Fifty-one patients were randomized to either the intervention group, using an asynchronous video application on a mobile device, or the traditional group undergoing outpatient physical therapy. Outcome data were collected using validated instruments prior to surgery and at a minimum three-month follow-up. Results Twenty-nine patients completed the study. There were no statistically significant differences in any clinical outcome between groups. The satisfaction with care was equivalent between groups. Overall utilization of hospital-based resources was 60% less than for the traditional group. Discussion We report that clinical outcomes following asynchronous telerehabilitation administered over the web and through a hand-held device were not inferior to those achieved with traditional care. Outpatient resource utilization was lower. Patient satisfaction was high for both groups. The results suggest that asynchronous telerehabilitation may be a more practical alternative to real-time video visits and are clinically equivalent to the in-person care model.

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    PubMed Central

    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

  5. Zygomatic miniplates for skeletal anchorage in orthopedic correction of Class III malocclusion: A controlled clinical trial

    PubMed Central

    Yüksel, Alime Sema; Bozkaya, Süleyman

    2017-01-01

    Objective To evaluate the effects of facemask therapy, which was anchored from the zygomatic buttresses of the maxilla by using two miniplates, in skeletal Class III patients with maxillary deficiency. Methods Eighteen skeletal Class III patients (10 girls and 8 boys; mean age, 11.4 ± 1.28 years) with maxillary deficiency were treated using miniplate-anchored facemasks, and their outcomes were compared with those of a Class III control group (9 girls and 9 boys; mean age, 10.6 ± 1.12 years). Two I-shaped miniplates were placed on the right and left zygomatic buttresses of the maxilla, and a facemask was applied with a 400 g force per side. Intragroup comparisons were made using the Wilcoxon test, and intergroup comparisons were made using the Mann-Whitney U-test (p < 0.05). Results In the treatment group, the maxilla moved 3.3 mm forward, the mandible showed posterior rotation by 1.5°, and the lower incisors were retroclined after treatment. These results were significantly different from those in the control group (p < 0.05). No significant anterior rotation of the palatal plane was observed after treatment. Moreover, changes in the sagittal positions of the maxillary incisors and molars were similar between the treatment and control groups. Conclusions Skeletally anchored facemask therapy is an effective method for correcting Class III malocclusions, which also minimizes the undesired dental side effects of conventional methods in the maxilla. PMID:28337421

  6. Acupuncture for Preventing Complications after Radical Hysterectomy: A Randomized Controlled Clinical Trial

    PubMed Central

    Yi, Wei-min; Chen, Qing; Liu, Chang-hao; Hou, Jia-yun; Chen, Liu-dan; Wu, Wei-kang

    2014-01-01

    We aimed to investigate the preventive effects of acupuncture for complications after radical hysterectomy. A single-center randomized controlled single-blinded trial was performed in a western-style hospital in China. One hundred and twenty patients after radical hysterectomy were randomly allocated to two groups and started acupuncture from sixth postoperative day for five consecutive days. Sanyinjiao (SP6), Shuidao (ST28), and Epangxian III (MS4) were selected with electrical stimulation and Zusanli (ST36) without electrical stimulation for thirty minutes in treatment group. Binao (LI14) was selected as sham acupuncture point without any stimulation in control group. The main outcome measures were bladder function and prevalence of postoperative complications. Compared with control group, treatment group reported significantly improved bladder function in terms of maximal cystometric capacity, first voiding desire, maximal flow rate, residual urine, and bladder compliance, and decreased bladder sensory loss, incontinence, and urinary retention on fifteenth and thirtieth postoperative days. Treatment group showed significant advantage in reduction of urinary tract infection on thirtieth postoperative day. But no significant difference between groups was observed for lymphocyst formation. By improving postoperative bladder function, early intervention of acupuncture may provide a valuable alternative method to prevent bladder dysfunctional disorders and urinary tract infection after radical hysterectomy. PMID:24839455

  7. 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

  8. Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?

    PubMed Central

    Luo, Jian; Liu, Dan; Liu, Chun-Tao

    2015-01-01

    Abstract Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics. From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV1, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots. Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV1 (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001). Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25

  9. A tale of two RCTs: using randomized controlled trials to benchmark routine clinical (psychological) treatments for chronic pain.

    PubMed

    Fenton, Grania; Morley, Stephen

    2013-10-01

    This article reports the development of natural history and active treatment benchmarks for psychological treatments of chronic pain. The benchmarks were derived from randomized controlled trials (RCTs) reported in a published meta-analysis. In two preliminary studies we surveyed small samples of active clinicians working in U.K. pain management programs. Study 1 assessed the fit between routine clinical treatment and the selected RCTs. In study 2 Delphi methodology was used to determine a set of outcome domains to be used in the development of benchmarks. In study 3 we extracted data from a set of RCTs where both pre- and post-treatment data were reported. Measures were allocated to 1 of 5 outcome domains (cognitive coping and appraisal, pain experience, pain behavior, emotional functioning, and physical functioning). Pre-treatment to post-treatment effect sizes (Cohen's d) were computed and, where necessary, aggregated within trial so that each trial contributed a single estimate to outcome domain. Effect size (ES) benchmarks were computed for all trials and those trials with an explicit cognitive behavior therapy protocol. In no case did the ES estimates for the untreated control deviate from 0. The average ES across outcome domains for the treatment arms was approximately 0.35. These benchmarks may be used to assess the effectiveness of routine clinical treatments for chronic pain. The application of these data and the limitations of the study are discussed.

  10. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial.

    PubMed

    Lao, Lixing; Huang, Yi; Feng, Chiguang; Berman, Brian M; Tan, Ming T

    2012-03-30

    Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.

  11. 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

  12. Efficacy of Acupuncture in Itch: A Systematic Review and Meta-Analysis of Clinical Randomized Controlled Trials

    PubMed Central

    Yu, Chi; Lv, Zheng-Tao; Li, Jing-Jing; Wu, Cai-Hua; Gao, Fang; Yuan, Xiao-Cui; Zhang, Jing; He, Wei; Jing, Xiang-Hong

    2015-01-01

    Background. Itch (pruritus) is a sensitive state that provokes the desire to scratch. It is not only a common symptom of skin diseases but it also occurs in some systemic diseases. Clinical studies on the efficacy of the acupuncture therapy in alleviating itch are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This systematic review aims to assess the effectiveness of acupuncture therapy for itch. Materials and Methods. A comprehensive literature search of eight databases was performed up to June 2014, and randomized controlled trials which compared acupuncture therapy and placebo acupuncture or no treatment group were identified. Accordingly, a meta-analysis was conducted. Results. This review included three articles of randomized controlled trials (RCTs) from a total of 2530 articles. The results of Meta-analysis showed that acupuncture therapy was effective to alleviate itch compared with placebo acupuncture and no treatment group. Conclusion. Based on the findings of this systematic review, we cautiously suggest that acupuncture therapy could improve the clinical efficacy of itch. However, this conclusion needs more studies on various ethnic samples to confirm our final conclusion. PMID:26064156

  13. Efficacy of Acupuncture in Itch: A Systematic Review and Meta-Analysis of Clinical Randomized Controlled Trials.

    PubMed

    Yu, Chi; Zhang, Pei; Lv, Zheng-Tao; Li, Jing-Jing; Li, Hong-Ping; Wu, Cai-Hua; Gao, Fang; Yuan, Xiao-Cui; Zhang, Jing; He, Wei; Jing, Xiang-Hong; Li, Man

    2015-01-01

    Background. Itch (pruritus) is a sensitive state that provokes the desire to scratch. It is not only a common symptom of skin diseases but it also occurs in some systemic diseases. Clinical studies on the efficacy of the acupuncture therapy in alleviating itch are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This systematic review aims to assess the effectiveness of acupuncture therapy for itch. Materials and Methods. A comprehensive literature search of eight databases was performed up to June 2014, and randomized controlled trials which compared acupuncture therapy and placebo acupuncture or no treatment group were identified. Accordingly, a meta-analysis was conducted. Results. This review included three articles of randomized controlled trials (RCTs) from a total of 2530 articles. The results of Meta-analysis showed that acupuncture therapy was effective to alleviate itch compared with placebo acupuncture and no treatment group. Conclusion. Based on the findings of this systematic review, we cautiously suggest that acupuncture therapy could improve the clinical efficacy of itch. However, this conclusion needs more studies on various ethnic samples to confirm our final conclusion.

  14. Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial

    PubMed Central

    Chang, Chun-Shin; Wallace, Christopher Glenn; Hsiao, Yen-Chang; Chang, Chee-Jen; Chen, Philip Kuo-Ting

    2014-01-01

    Background Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. Methods In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths. Results 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. Conclusion Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. Trial Registration ClinicalTrials.gov NCT01429402 PMID:25541942

  15. Comparison between intranasal and intravenous midazolam sedation (with or without patient control) in a dental phobia clinic.

    PubMed

    Kaufman, E; Davidson, E; Sheinkman, Z; Magora, F

    1994-08-01

    Two new modes of sedation; patient-controlled sedation (PCS) and intranasal sedation (INS) were compared with the traditional bolus intravenous sedation (BIVS) while delivering dental care to apprehensive patients in a specialized dental fear clinic. Effective sedation was evaluated in a randomized, prospective study in 42 ASA 1 and 2 patients, in a factorial design. Eighteen patients were sedated with .5% midazolam INS. Ten patients received intravenous PCS via a patient-controlled analgesia pump containing midazolam, and 14 patients received intermittent intravenous boluses of 1 mg midazolam given as needed (BIVS). Appropriate local anesthetic nerve blocks with 2% lidocaine with 1:100,000 epinephrine, and supplementary inhalation of nitrous oxide and oxygen via a nasal mask, were also given to all patients in the study. The dosage requirement with PCS was higher than that found with INS or BIVS. However, PCS produced some anxiety reduction when compared with INS and BIVS. It also reduced interfering movements during treatment more effectively than the other sedation modes. No complications were detected in any of the patients and they were able to leave the clinic within 1 hour after completion of treatment.

  16. 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.

  17. 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

  18. Favorable effect of rehabilitation on balance in ankylosing spondylitis: a quasi-randomized controlled clinical trial.

    PubMed

    Demontis, Alessandra; Trainito, Sabina; Del Felice, Alessandra; Masiero, Stefano

    2016-03-01

    Balance impairment is a frequent and undertreated manifestation in ankylosing spondylitis, leading to increased risk of falls and lower quality of life. Our aim was to assess supervised training and home-based rehabilitation efficacy on balance improvement in ankylosing spondylitis subjects on biologic agents. This was a single-blinded, quasi-randomized parallel study in a single outpatient Rehabilitation Clinic of a tertiary referral center. Subjects with ankylosing spondylitis on biologic agents were assigned either to supervised training and home-based rehabilitation program (rehabilitation group) plus educational-behavioral therapy, or to educational-behavioral therapy alone (educational groups). The same therapist provided therapy. Outcome measures were assessed at baseline (T0), end of treatment (T1) and at 7-month follow-up (T2). Rheumatologic outcomes were Bath Ankylosing Spondylitis Metrology Index, Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index. Balance parameters (anterior-posterior oscillation, latero-lateral oscillation, sway area, sway density and sway path) were evaluated by stabilometry in a condition of open and closed eyes. Forty-six subjects (36 M, 10 F) were enrolled. Demographic data and clinical status at baseline were comparable between the two groups (22 rehabilitation group, 20 educational group). Primary outcome was sway density that improved both at T1 (SDy: open eyes p = 0.003, closed eyes p = 0.004) and at T2 (SDx: open eyes p = 0.0015, closed eyes p = 0.032). A trend toward improvement in the rehabilitation group rather than in the educational group emerged for balance parameters, especially those measured with closed eyes (0.004 < p < 0.048 at T1 and 0.004 < p < 0.036 at T2). Supervised training and home exercise lead to balance improvement in people with ankylosing spondylitis. Eyes-closed trials show a more marked trend toward improvement, and this may suggest a

  19. 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

  20. 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

  1. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya

    PubMed Central

    Cohen, Craig R.; Grossman, Daniel; Onono, Maricianah; Blat, Cinthia; Newmann, Sara J.; Burger, Rachel L.; Shade, Starley B.; Bett, Norah; Bukusi, Elizabeth A.

    2017-01-01

    Objectives To determine if integration of family planning (FP) and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices) and decreased pregnancy rates. Design Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration) sites and oversaw integrated services at the original intervention (early integration) sites. Setting Eighteen health facilities in Kenya. Subjects Women aged 18–45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2. Intervention “One-stop shop” approach to integrating FP and HIV services. Main outcome measures Use of more effective contraceptive methods and incident pregnancy across two years of follow-up. Results Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR) = 1.39 (1.19–1.63). Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%). Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60–0.87). Conclusions Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model. Trial registration ClinicalTrials.gov NCT01001507 PMID:28328966

  2. 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

  3. 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

  4. Parallel placebo-controlled clinical study of a mixture of herbs sold as a remedy for cellulite.

    PubMed

    Lis-Balchin, M

    1999-11-01

    Cellasene, a product containing Ginkgo biloba, sweet clover, sea-weed, grape seed oil, lecithins and evening primrose oil, has been marketed all over the world as a miracle cure for cellulite. As the efficacy of the product was in doubt, a parallel placebo-controlled clinical study was undertaken in a group of women to see whether the product had any effect on cellulite, or on the body weight, fat content, circumference of thighs, hips, etc. No significant changes were found in these parameters compared with the starting values, nor compared with the placebo control after a 2 month course of Cellasene, except for an increase in the cellulite, assessed by the author, compared with that initially. Seven of 11 women taking Cellasene gained weight, as did eight in the placebo control group, taking Colonease, where significance was achieved. The weight gain in both groups was apparent after the first 2 weeks, and all women had to reduce their food consumption. Only three of the women in the Cellasene group thought that their cellulite had slightly improved against two women in the control group.

  5. Anticalculus efficacy and safety of a novel whitening dentifrice containing sodium hexametaphosphate: a controlled six-month clinical trial.

    PubMed

    Liu, Henry; Segreto, Vincent A; Baker, Robert A; Vastola, Kathleen A; Ramsey, Lorie L; Gerlach, Robert W

    2002-01-01

    This study was undertaken to establish the tartar control efficacy and long-term safety of a new dentifrice containing sodium hexametaphosphate. In a randomized, examiner blind, parallel group clinical trial, the experimental dentifrice with 7% sodium hexametaphosphate (5% hexametaphosphate anion), a non-abrasive cleaning agent that provides whitening and tartar control benefits, was compared to two currently marketed controls, a regular sodium fluoride dentifrice and a triclosan/copolymer dentifrice. The 8-month trial model included a 2-month pretest period to establish calculus formation after prophylaxis, and a 6-month test period to evaluate anti-calculus efficacy and safety. Following the pretest period, 551 subjects were allocated to one of the three treatment groups and then monitored for calculus accumulation and soft tissue tolerance. After 6 months, the sodium hexametaphosphate group exhibited superior calculus inhibition compared to the regular sodium fluoride dentifrice and triclosan/copolymer dentifrice (p < 0.01). Over the 6-month observation period, the sodium hexametaphosphate and the marketed control dentifrices were comparable in terms of adverse event type and severity, and no subject discontinued treatment due to an oral soft tissue adverse event.

  6. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention) or control treatment (a leaflet on healthy living). Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic intervention for excessive

  7. 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

  8. The Effectiveness of a New Hemostatic Agent (Ankaferd Blood Stopper) for the Control of Bleeding following Tooth Extraction in Hemophilia: A Controlled Clinical Trial

    PubMed Central

    Kazancıoğlu, Hakkı Oğuz; Çakır, Onur; Ak, Gülsüm; Zülfikar, Bülent

    2013-01-01

    Objective: To assess the hemostatic efficacy of a new local hemostatic agent, Ankaferd Blood Stopper (ABS), for the control of bleeding following tooth extraction in hemophiliacs. Materials and Methods: Simple tooth extractions were performed in 27 hemophilia A patients. In the treatment group (n=17) local hemostasis was achieved via application of ABS to the extraction sockets, whereas in the control group (n=10) local hemostasis was achieved via direct packing with gauze. Results: In all, 57 (21 primary and 36 permanent) teeth extractions were performed in 27 hemophilia A patients. There were no significant differences in age or factor VIII level distribution between the 2 groups (p>0.05). The most significant clinical difference between the groups was associated with the use of ABS; those in the treatment group had significantly shorter duration of bleeding (p=0.002). Conclusion: This is the first study to evaluate the efficacy of ABS for the control of bleeding following tooth extraction in hemophiliacs. ABS can be considered an alternative local hemostatic agent for reducing clotting factor concentrates in hemophilia patients. Conflict of interest:None declared. PMID:24385748

  9. 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

  10. Padua prediction score or clinical judgment for decision making on antithrombotic prophylaxis: a quasi-randomized controlled trial.

    PubMed

    Germini, Federico; Agnelli, Giancarlo; Fedele, Marta; Galli, Maria Giulia; Giustozzi, Michela; Marcucci, Maura; Paganelli, Gloria; Pinotti, Emanuele; Becattini, Cecilia

    2016-10-01

    The Padua prediction score (PPS) has been suggested as the best available model for the assessment of the risk of venous thromboembolism (VTE) in hospitalized medical patients. The impact of its use in clinical practice has never been prospectively evaluated. According to a quasi-randomized study design, consecutive patients admitted to Internal Medicine Section 1 were allocated to a PPS-based decisional strategy suggesting thromboprophylaxis in patients with PPS score ≥4, and those admitted to Section 2 to a clinical judgment-based strategy. Study patients underwent complete compression ultrasonography of the lower limbs at discharge. The primary outcome was symptomatic or asymptomatic VTE during hospital stay. Secondary outcomes were VTE excluding isolated distal deep vein thrombosis, bleedings, and appropriate thromboprophylaxis. 628 patients were included in the analysis, 235 in the PPS group, and 393 in the clinical judgment group. The two groups differed for length of hospital stay, prevalence of recent trauma or surgery, and stroke. Compared with control, the PPS group had a significantly lower incidence of VTE (8.5 vs. 15.5 %, OR 0.51, 95 % CI 0.30-0.86), also after adjusting for thromboprophylaxis use and patient PPS-risk category (OR 0.54, 95 % CI 0.31-0.94). In conclusion, the use of PPS was associated with a higher rate of appropriate thromboprophylaxis prescription; no significant differences were found in the other secondary outcomes. The use of PPS for the assessment of risk for VTE is associated with a reduced incidence of VTE compared with the clinical judgment. These result needs to be confirmed in future studies.

  11. Low-level laser therapy and myofacial pain dysfunction syndrome: a randomized controlled clinical trial.

    PubMed

    Shirani, Amir Mansour; Gutknecht, Norbert; Taghizadeh, Mahshid; Mir, Maziar

    2009-09-01

    Myofacial pain dysfunction syndrome (MPDS) is the most common reason for pain and limited function of the masticatory system. The effects of low-level lasers (LLLs) for controlling the discomfort of patients are investigated frequently. However, the aim of this study was to evaluate the efficacy of a particular source producing 660 nm and 890 nm wavelengths that was recommended to reduce of the pain in the masticatory muscles. This was a double-blind and placebo-controlled trial. Sixteen MPDS patients were randomly divided into two groups. For the laser group, two diode laser probes (660 nm (nanometers), 6.2 J/cm(2), 6 min, continuous wave, and 890 nm, 1 J/cm(2) (joules per square centimetre), 10 min, 1,500 Hz (Hertz)) were used on the painful muscles. For the control group, the treatment was similar, but the patients were not irradiated. Treatment was given twice a week for 3 weeks. The amount of patient pain was recorded at four time periods (before and immediately after treatment, 1 week after, and on the day of complete pain relief). A visual analog scale (VAS) was selected as the method of pain measurement. Repeated-measures analysis of variance (ANOVA), the t-test and the paired t-test were used to analyze the data. In each group the reduction of pain before and after the treatment was meaningful, but, between the two groups, low-level laser therapy (LLLT) was more effective (P = 0.031) According to this study, this type of LLLT was the effective treatment for pain reduction in MPDS patients.

  12. 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

  13. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 2: Statistical considerations.

    PubMed

    Ball, Greg; Piller, Linda B

    2011-09-01

    If the primary objective of a trial is to learn about the ability of a new treatment to help future patients without sacrificing the safe and effective treatment of the current patients, then a Bayesian design with frequent assessments of the accumulating data should be considered. Unfortunately, Bayesian analyses typically do not have standard approaches, and because of the subjectivity of prior probabilities and the possibility for introducing bias, statisticians have developed other methods for statistical inference that only depend on deductive probabilities. However, these frequentist probabilities are just theories about how certain relative frequencies will develop over time. They have no real meaning in a single experiment. Designed to work well in the long run, p-values become hard to explain for individual experiments. Fortunately, the controversy surrounding Bayes' theorem comes, not from the representation of evidence, but from the use of probabilities to measure belief. A prior distribution is not necessary. The likelihood function contains all of the information in a trial relevant for making inferences about the parameters. Monitoring clinical trials is a dynamic process which requires flexibility to respond to unforeseen developments. Likelihood ratios allow the data to speak for themselves, without regard for the probability of observing weak or misleading evidence, and decisions to stop, or continue, a trial can be made at any time, with all of the available information. A likelihood based method is needed.

  14. A controlled clinical trial with De-Nol (tripotassium dicitrato bismuthate) in patients with gastric ulcer.

    PubMed

    Patty, I; Deák, G; Jávor, T; Mózsik, G; Nagy, L; Tárnok, F

    1983-01-01

    The efficacy of local-acting De-Nol liquid (tripotassium dicitrato bismuthate) was investigated in patients with endoscopically verified gastric ulcer. In a prospective-type clinical trial, 16 outpatients received De-Nol and 24 outpatients received an antacid mixture (sodium bicarbonate, calcium carbonate, magnesium trisilicate in equal parts). The period of study was 4 weeks, the endoscopy being performed on the 14th and 28th day after commencement of treatment. We Registration was made of the degree of ulcer healing (ulcer is healed, or not healed but reduced by 50%, or slightly healed, or unchanged), the degree of pain (0 = none, 1 = slight, 2 = moderate, 3 = severe), body weight, different biochemical and haematological examinations, side-effects and some other parameters. Of those patients given De-Nol treatment, the ulcer healed in 69% within four weeks, as compared with 33% of those given antacid therapy. There was also a significant (p less than 0.001, p less than 0.02) difference between the two groups in the size of the ulceration which remained and in the decrease of pain. Side-effects were not recorded. These data suggest the beneficial effect of De-Nol liquid in the treatment of patients with gastric ulceration.

  15. Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trial.

    PubMed

    Monteiro, E P; Franzoni, L T; Cubillos, D M; de Oliveira Fagundes, A; Carvalho, A R; Oliveira, H B; Pantoja, P D; Schuch, F B; Rieder, C R; Martinez, F G; Peyré-Tartaruga, L A

    2017-03-01

    We compare the effects of Nordic walking training (NW) and Free walk (FW) on functional parameters (motor symptoms, balance) and functional mobility (Timed Up and Go at Self-selected Speed - TUGSS, and at forced speed, TUGFS; Self-selected Walking Speed, SSW; locomotor rehabilitation index, LRI) of Parkinson's disease (PD) patients. The study included 33 patients with clinical diagnosis of idiopathic PD, and staging between 1 and 4 in the Hoehn and Yahr scale (H&Y) randomized into two groups: NW (N = 16) and FW (N = 17) for 6 weeks. Baseline characteristics were compared trough a one-way ANOVA. Outcomes were analyzed using the Generalized Estimation Equations (GEE) with a Bonferroni post-hoc. Data were analyzed using SPSS v.20.0. Improvements in UPDRS III (P < 0.001), balance scores (P < 0.035), TUGSS distance (P < 0.001), TUGFS distance (P < 0.001), SSW (P < 0.001), and LRI (P < 0.001) were found for both groups. However, the NW group showed significant differences (P < 0.001) when compared to the FW group for the functional mobility. We conclude the NW improves functional parameters and walking mobility demonstrating that NW is as effective as the FW, including benefits for FW on the functional mobility of people with PD.

  16. [Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    PubMed

    Ruiz de Gopegui Bordes, Enrique; Serrano, M del Remedio Guna; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Cardona, Concepción Gimeno

    2011-12-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons of the 2010 controls. As a whole, the results obtained in 2010 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls to ensure maximal quality of microbiological tests(1).

  17. 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

  18. Randomized Controlled Trials and real life studies. Approaches and methodologies: a clinical point of view.

    PubMed

    Saturni, S; Bellini, F; Braido, F; Paggiaro, P; Sanduzzi, A; Scichilone, N; Santus, P A; Morandi, L; Papi, A

    2014-04-01

    Randomized Controlled Trials (RCTs) are the "gold standard" for evaluating treatment outcomes providing information on treatments "efficacy". They are designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason they have high internal validity. The strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in conditions very different from real life usual care. Conversely, real life studies inform on the "effectiveness" of a treatment, that is, the measure of the extent to which an intervention does what is intended to do in routine circumstances. At variance to RCTs, real life trials have high generalizability, but low internal validity. Recently the number of real life studies has been rapidly growing in different areas of respiratory medicine, particularly in asthma and COPD. The role of such studies is becoming a hot topic in respiratory medicine, attracting research interest and debate. In the first part of this review we discuss some of the advantages and disadvantages of different types of RCTs and analyze the strengths and weaknesses of real life trials, considering the recent examples of some studies conducted in COPD. We then discuss methodological approaches and options to overcome some of the limitations of real life studies. Comparing the conclusions of effectiveness and efficacy trials can provide important pieces of information. Indeed, these approaches can result complementary, and they can guide the interpretation of each other results.

  19. 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

  20. 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

  1. [Preventive measures for the control of fungal infections in the clinic].

    PubMed

    Seeliger, H P; Schröter, G

    1984-06-01

    Hospital acquired infections due to fungi are primarily caused by yeast species of the genus Candida and mould species of the genus Aspergillus. Underlying disease with severely impaired defence mechanisms as well as certain forms of immunosuppressive and aggressive chemotherapy are the most important prerequisites for such secondary fungal infections. Aspergillus spec. usually infect man via exogenous routes, whereas Candida spec. mostly originate from the patient's own microbial flora. Under certain circumstances invasion of tissues follows (endomycoses). Exogenous Candida infections may likewise occur through contaminated hands of personnel and medical devices. The density of yeast cell distribution in hospital wards decreases with the distance from the primary source: the Candida infected human patient. Preventive measures protecting the patient at risk include: Permanent surveillance by routine cultural and serological examinations for the detection of an early infection of the skin, mouth, oesophagus, urinary tract, vagina and the bowel. Monitoring of patients is essential for early detection of dissemination and contributes to the control of fungal decontamination measures. Selective local decontamination is effected by the use of nonabsorbable compounds such as nystatin and amphotericin B in the gastrointestinal tract, and in oral and genital mucous membranes. Oral administration of ketoconazole has also been recommended. For the disinfection of skin appropriate chemicals are available. In the control of the environment of the endangered patient special attention must be paid to meticulous management of catheters.(ABSTRACT TRUNCATED AT 250 WORDS)

  2. 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

  3. A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia.

    PubMed

    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

    2015-11-01

    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.

  4. 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

  5. Toward comprehensive management tailored to prognostic factors of patients with clinical stages I and II in Hodgkin's disease. The EORTC Lymphoma Group controlled clinical trials: 1964-1987.

    PubMed

    Tubiana, M; Henry-Amar, M; Carde, P; Burgers, J M; Hayat, M; Van der Schueren, E; Noordijk, E M; Tanguy, A; Meerwaldt, J H; Thomas, J

    1989-01-01

    From 1964 to 1987, the EORTC Lymphoma Group conducted four consecutive controlled clinical trials on clinical stages I and II Hodgkin's disease in which 1,579 patients were entered. From the onset the main aim of these trials was to identify the subsets of patients who could be treated safely by regional radiotherapy (RT). Therefore, several prognostic indicators were prospectively registered and progressively used in the trial protocols for the delineation of the favorable and unfavorable subgroups as soon as they were recognized of high predictive value. In the H2 trial (1972 to 1976), the histologic subtype was the only variable taken into account for the therapeutic strategy and the staging laparotomy findings were found to be of prognostic value only in patients with favorable prognostic indicators. In the H5 trial (1977 to 1982), patients were subdivided into two subgroups according to six prognostic indicators. Patients with favorable features were submitted to a staging laparotomy (lap); lap negative patients were randomized between mantle field RT and mantle field plus paraaortic RT. Disease free survival (DFS) and total survival (S) were similar in the two arms. Among patients with unfavorable features, DFS and S were significantly higher in the arm treated by combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT than in the arm treated by total nodal irradiation. Nevertheless, in patients below the age of 40, the overall survival rates were equivalent in the two arms. In the H6 trial, the delineation of the favorable subgroup was based on (a) absence of systemic symptoms and elevated ESR, (b) no more than one or two lymph node areas involved. The aim of the study was to assess the impact on survival of a therapeutic strategy including staging laparotomy. At a 4-year follow-up, no difference in survival was evidenced. In patients with unfavorable prognostic indicators, 3 MOPP-RT-3 MOPP were compared with 3

  6. Azithromycin vs. Placebo for the Clinical Outcome in Campylobacter concisus Diarrhoea in Adults: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

    PubMed Central

    Nielsen, Hans Linde; Kirk, Karina Frahm; Bodilsen, Jacob; Ejlertsen, Tove; Nielsen, Henrik

    2016-01-01

    Campylobacter concisus has been associated with prolonged mild diarrhoea, but investigations regarding the efficacy of antimicrobial treatment have not been reported previously. We initiated a phase 3, single-centre, randomized, double-blinded, placebo-controlled study comparing the efficacy of 500 mg once-daily dose of azithromycin with a 500 mg once-daily dose of placebo for three days, for the treatment of C. concisus diarrhoea in adult patients with a follow-up period of ten days. If symptoms persisted at day ten, the patient was offered cross-over study treatment of three days and another ten-day follow-up period. The primary efficacy endpoint was the clinical response, defined as time to cessation of diarrhoea (<3 stools/day or reversal of accompanying symptoms). Our estimated sample size was 100 patients. We investigated a total of 10,036 diarrheic stool samples from 7,089 adult patients. Five-hundred and eighty-eight C. concisus positive patients were assessed for eligibility, of which 559 were excluded prior to randomization. The three main reasons for exclusion were duration of diarrhoea longer than 21 days (n = 124), previous antibiotic treatment (n = 113), and co-pathogens in stools (n = 87). Therefore, 24 patients completed the trial with either azithromycin (n = 12) or placebo (n = 12). Both groups presented symptoms of mild, prolonged diarrhoea with a mean duration of 18 days (95% CI: 16–19). One person in the azithromycin group and four from the placebo group chose to continue with crossover medication after the initial ten-day period. In the azithromycin group, there was a mean of seven days (95% CI: 5–9) to clinical cure and for the placebo group it was ten days (95% CI: 6–14) (OR—3 (95% CI: -7–1). We observed no differences in all examined outcomes between azithromycin treatment and placebo. However, due to unforeseen recruitment difficulties we did not reach our estimated sample size of 100 patients and statistical power to conclude on

  7. Randomised controlled study of clinical efficacy of spacer therapy in asthma with regard to electrostatic charge

    PubMed Central

    Dompeling, E; Oudesluys-Murphy, A; Janssens, H; Hop, W; Brinkman, J; Sukhai, R; de Jongste, J C

    2001-01-01

    BACKGROUND—Inhalation therapy using a pressured metered dose inhaler (pMDI) and a spacer is frequently used in the treatment of airway disease in children. Several laboratory studies found a clear negative influence of electrostatic charge (ESC) on plastic spacers on the delivery of aerosol.
AIMS—To investigate whether ESC on plastic spacers could diminish bronchodilating responses to salbutamol.
METHODS—Ninety asthmatic children (aged 4-8 years) were randomised into three groups: metal Nebuchamber, plastic Volumatic, and plastic Aerochamber. The bronchodilating response was measured by the change in peak expiratory flow rate (PEF) after 100 µg and 400µg salbutamol. Within the Volumatic and Aerochamber groups, a crossover comparison was made between electrostatic and non-electrostatic spacers.
RESULTS—We found no significant effect of ESC on the bronchodilating response to salbutamol with any of the doses in the Aerochamber and Volumatic groups. For the plastic spacers, the mean difference of the change in PEF after 100 µg salbutamol between non-electrostatic and electrostatic spacers was only +1.7% (95% CI −1.3% to 4.7%). After 400 µg salbutamol this was +1.9% (95% CI −1.4% to 5.1%). A comparable efficacy was found for the Nebuchamber, the Aerochamber, and Volumatic with respect to the change in PEF after 100 and 400 µg salbutamol.
CONCLUSION—This study showed no negative influence of ESC on plastic spacers with regard to clinical efficacy of a β2 agonist (salbutamol) in children with asthma. The metal Nebuchamber, plastic Aerochamber, and plastic Volumatic were equally effective.

 PMID:11159302

  8. Periodontal treatment during pregnancy decreases the rate of adverse pregnancy outcome: a controlled clinical trial

    PubMed Central

    SANT’ANA, Adriana Campos Passanezi; de CAMPOS, Marinele R.; PASSANEZI, Selma Campos; de REZENDE, Maria Lúcia Rubo; GREGHI, Sebastião Luiz Aguiar; PASSANEZI, Euloir

    2011-01-01

    Objectives The aim of this study was to evaluate the effects of non-surgical treatment of periodontal disease during the second trimester of gestation on adverse pregnancy outcomes. Material and Methods Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center were divided into 2 groups: NIG – "no intervention" (n=17) or IG- "intervention" (n=16). IG patients were submitted to a non-surgical periodontal treatment performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). NIG received PROPH and OHI during pregnancy and were referred for treatment after delivery. Periodontal evaluation was performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes were preterm birth (<37 weeks), low birth weight (<2.5 kg), late abortion (14-24 weeks) or abortion (<14 weeks). The results obtained were statistically evaluated according to OR, unpaired t test and paired t test at 5% significance level. Results No significant differences were observed between groups at baseline examination. Periodontal treatment resulted in stabilization of CAL and PI (p>0.05) at IG and worsening of all periodontal parameters at NIG (p<0.0001), except for PI. Significant differences in periodontal conditions of IG and NIG were observed at 2nd examination (p<0.001). The rate of adverse pregnancy outcomes was 47.05% in NIG and 6.25% in IG. Periodontal treatment during pregnancy was associated to a decreased risk of developing adverse pregnancy outcomes [OR=13.50; CI: 1.47-123.45; p=0.02]. Conclusions Periodontal treatment during the second trimester of gestation contributes to decrease adverse pregnancy outcomes. PMID:21552714

  9. Metformin in Amnestic Mild Cognitive Impairment: results of a pilot randomized placebo controlled clinical trial

    PubMed Central

    Luchsinger, José A.; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Devangere P.; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (AMCI) with the goal of collecting preliminary data on feasiblity, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with AMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake (rCMRgl) in the posterior cingulate-precuneus in brain Fluorodeoxyglucose Positron Emission Tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty % of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7 ± 8.5 vs. 5.3 ± 8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD. PMID:26890736

  10. Metformin in Amnestic Mild Cognitive Impairment: Results of a Pilot Randomized Placebo Controlled Clinical Trial.

    PubMed

    Luchsinger, José A; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Davangere P; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (aMCI) with the goal of collecting preliminary data on feasibility, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with aMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake in the posterior cingulate-precuneus in brain fluorodeoxyglucose positron emission tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty percent of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7±8.5 versus 5.3±8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD.

  11. [Oral hydratation with a low osmolality solution in dehydrated children with diarrheic diseases: controlled clinical trial].

    PubMed

    Bernal, Carlos; Velásquez, Claudia; García, Guillermo; Uribe, Gustavo; Palacio, Carlos Mauricio

    2003-03-01

    A clinical trial was conducted to compare the efficacy of a low-osmolarity solution (245 mOsm/L), and a standard oral rehydration solution (ORS) recommended by WHO for children dehydrated by diarrhea. Group 1 (69 children) received WHO/ORS (311 mOsml/L) and group 2 (71 children) received a low-osmolarity solution (245 mOsm/L). Rehydration was successful in 88.4% in group 1 and 92.9% in group 2 (p = 0.35). Rehydration was completed in 5.2 h (SD +/- 1.8) in group 1 and 5.5 (SD +/- 1.7) in group 2 (p = 0.31). Stool output was 6.3 g/kg/h (SD +/- 5.0) in group 1 and 5.6 g/kg/h (SD +/- 5.1) in group 2 (p = 0.94). Sodium at rehydration-completion was 139.3 mEq/L (SD +/- 7.1) in group 1 and 136.7 mEq/L (SD +/- 4.3) in group 2 (p = 0.014). Group 1 was under observation for 21 hours (SD +/- 5.7) and group 2, for 22 hours (SD +/- 5.6). Stool output in group 1 was 5.2 g/kg/h (SD 4.1) and 4.2 gr./kg/h (SD +/- 4.1) in group 2 (p = 0.16). In group 1, 23.1% required intravenous solutions and 9.8% in group 2 (p = 0.03). In treating dehydrated children, the low-osmolarity solution diminished the need for intravenous solutions, corrected most plasmatic sodium disorders, and produced no-risk of developing hyponatremia.

  12. The Effect of Probiotic Yogurt on Constipation in Pregnant Women: A Randomized Controlled Clinical Trial

    PubMed Central

    Mirghafourvand, Mojgan; Homayouni Rad, Aziz; Mohammad Alizadeh Charandabi, Sakineh; Fardiazar, Zahra; Shokri, Kolsoum

    2016-01-01

    Background Probiotics can alter the colonic microbiota and might improve bowel function. Objectives The aim of this study was to evaluate the effect of the consumption of yogurt, enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 (CFU) on the symptoms of constipated pregnant women. Materials and Methods This triple-blind randomized controlled trial was conducted on 60 constipated pregnant women who were diagnosed by the ROME III criteria in Tabriz, Iran from December 2014 to July 2015. Participants were randomly put into two groups including the treatment and the control group through block randomization. The treatment group received 300 g of yogurt enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 colony forming units (CFU) (n = 30) while the control group received conventional yogurt (n = 30) for 4 weeks. The defecation frequency, stool consistency, straining during defecation, sensation of anorectal obstruction, sensation of incomplete evacuation and manual manoeuvres to facilitate defecation were primary outcomes while the amount of defecation, stool colure, and quality of life were secondary outcomes. Results The frequency of defecation was increased from 2.1 (0.8) at baseline to 8.3 (4.4) in the probiotic yogurt group vs. 2.3 (0.7) at baseline to 8.1 (4.3) in the conventional yogurt group at the end of 4th week. These results were based on the repeated measure ANOVA test and there was no statistically significant difference between the two groups (mean difference: 0.1; Confidence Interval 95%: -1.4 to 1.7; P = 0.872). Constipation symptoms including straining, anorectal obstruction, manipulation to facilitate defecation, consistency of stool and color of stool were improved significantly (P < 0.05) in both groups. In addition, the amount of defecation was significantly increased in both groups (P < 0.05), while incomplete evacuation was significantly reduced in the treatment group (P = 0.01). There was no statistically significant

  13. Chiropractic spinal manipulative therapy for migraine: a study protocol of a single-blinded placebo-controlled randomised clinical trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Tuchin, Peter J; Russell, Michael Bjørn

    2015-01-01

    Introduction Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT). Method and analysis According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs. Ethics and dissemination The RCT