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Sample records for single-blinded pilot study

  1. Professional kinesiology practice for chronic low back pain: single-blind, randomised controlled pilot study.

    PubMed

    Eardley, S; Brien, S; Little, P; Prescott, P; Lewith, G

    2013-01-01

    Chronic low back pain is a highly prevalent condition with no definitive treatment. Professional Kinesiology Practice (PKP) is a little known complementary medicine technique using non-standard muscle testing; no previous effectiveness studies have been performed. This is an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot study with waiting list control (WLC) in private practice UK (2007-2009). 70 participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving 1 treatment weekly for 5 weeks or a WLC. WLC's were re-randomised to real or sham after 6 weeks. The main outcome was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP. With an effect size of 0.7 real treatment was significantly different to sham (mean difference RMDQ score = -2.9, p = 0.04, 95% CI -5.8 to -0.1). Compared to WLC, real and sham groups had significant RMDQ improvements (real -9.0, p < 0.01, 95% CI -12.1 to -5.8; effect size 2.1; sham -6.1, p < 0.01, 95% CI -9.1 to -3.1; effect size 1.4). Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. 3 patients reported minor adverse reactions. Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

  2. Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

    PubMed Central

    2014-01-01

    Background Unstable steel wire cerclage following open heart surgery may result in increased pain, sternal cut-through, non-union, or dehiscence. These complications lead to longer hospital stays, increased cost, higher morbidity, and patient dissatisfaction. The Figure 8 FlatWire Sternal Closure System is a new construct which is a simple, intuitive, and inexpensive alternative for primary sternal repair following open heart surgery. Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire. We present our initial experience in a prospective, randomized, single blinded pilot study utilizing this FDA approved system. Methods Sixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage. All surgeries were performed by a single board certified cardiothoracic surgeon. Data collected included: Age, BMI, pump time, off pump to surgical stop time, length of hospital stay after surgery, cost from time of surgery to discharge, and pain on a visual analog pain scale on the day of discharge, day 30, and day 60. Results The groups were well matched. Patients receiving the Figure 8 FlatWire (33) had a reduction in length of stay compared to patients receiving steel wire circlage (30), but it was not statistically significant (6.8 vs. 7.8 days respectively, p < 0.093). Additionally those with the FlatWire reported significantly decreased pain at day of discharge (3.07 vs. 4.92 points on pain scale, p < 0.0066), with similar pain scores at 30 and 60 days. Off pump to surgery stop time was increased by 15.9 minutes in patients receiving the FlatWire vs. steel wires (55.7 vs. 71.6 minutes, p = 0.00025). Mean cost from surgery until discharge was $87,820.98 in the FlatWire group vs. $91,930.29 in the steel wire group (p < 0.3082). Conclusion Early clinical results suggest that

  3. Effect of Kinesiology Taping on breast cancer-related lymphedema: a randomized single-blind controlled pilot study.

    PubMed

    Smykla, A; Walewicz, K; Trybulski, R; Halski, T; Kucharzewski, M; Kucio, C; Mikusek, W; Klakla, K; Taradaj, J

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  4. Effect of Kinesiology Taping on Breast Cancer-Related Lymphedema: A Randomized Single-Blind Controlled Pilot Study

    PubMed Central

    Trybulski, R.; Kucharzewski, M.; Kucio, C.; Mikusek, W.; Klakla, K.

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785. PMID:24377096

  5. Clinical feasibility of Xbox KinectTM training for stroke rehabilitation: A single-blind randomized controlled pilot study.

    PubMed

    Türkbey, Tuba Alışkan; Kutlay, Sehim; Gök, Haydar

    2017-01-19

    To evaluate the feasibility and safety of Xbox KinectTM training of the upper extremity in subacute stroke rehabilitation. A single-blind, randomized controlled, pilot study. Twenty consecutive patients with stroke. Participants were allocated randomly to 2 groups: the control group received conventional therapy and the experimental group received additional Xbox KinectTM training for 20 sessions. Feasibility and safety were evaluated by treatment attendance rate, patient feedback, proportion of adverse events, and Borg Scale (Borg CR10). Twenty of 131 screened individuals were recruited. Data for 19 patients (73.7% male; mean age 62 years (range 38-79)) were analysed. Treatment attendance ratio for total training time and training time/session was 87% and 90%, respectively. All participants reported that training with the Xbox KinectTM was enjoyable and beneficial. No serious adverse events occurred. Fatigue was the most common adverse event. The mean Borg CR10 score was 7.80, reflecting a very high level of fatigue. The experimental group showed significantly greater improvement than the control group in the Box and Blocks Test, Wolf Motor Function Test and Brunnstrom motor recovery stages. Xbox KinectTM training appears feasible and safe in upper extremity ehabilitation after stroke. It could enhance motor and functional recovery of the affected upper extremity as an adjunctive method.

  6. Brief report: Pilot single-blind placebo lead-in study of acamprosate in youth with autistic disorder.

    PubMed

    Erickson, Craig A; Wink, Logan K; Early, Maureen C; Stiegelmeyer, Elizabeth; Mathieu-Frasier, Lauren; Patrick, Vanessa; McDougle, Christopher J

    2014-04-01

    An excitatory/inhibitory (E:I) imbalance marked by enhanced glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission may contribute to the pathophysiology of autism spectrum disorders (ASD). We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I imbalance, in twelve youth with ASD. We conducted a 12-week single-blind, placebo lead-in study of acamprosate in youth age 5-17 years with autistic disorder. Six of nine subjects who received active drug treatment were deemed treatment responders (defined by a score at final visit of "very much improved" or "much improved" on the Clinical Global Impressions Improvement scale) and ≥25% improvement on the Aberrant Behavior Checklist Social Withdrawal subscale. Future larger-scale dose finding studies of acamprosate in ASD may be warranted given this preliminary indication of benefit.

  7. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    PubMed Central

    Toscano, I. L.; Rezende, M.V.; Mello, L. F.; Pires, L.; Paulillo, D.; Glina, S.

    2016-01-01

    ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week). Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5) score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019) and 50.4° and 42.08° before and after verapamil, respectively (p=0.012). The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23) in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58). In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine. PMID:24893912

  8. Brief Report: Pilot Single-Blind Placebo Lead-in Study of Acamprosate in Youth with Autistic Disorder

    ERIC Educational Resources Information Center

    Erickson, Craig A.; Wink, Logan K.; Early, Maureen C.; Stiegelmeyer, Elizabeth; Mathieu-Frasier, Lauren; Patrick, Vanessa; McDougle, Christopher J.

    2014-01-01

    Rationale: An excitatory/inhibitory (E:I) imbalance marked by enhanced glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission may contribute to the pathophysiology of autism spectrum disorders (ASD). Objectives: We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I…

  9. Brief Report: Pilot Single-Blind Placebo Lead-in Study of Acamprosate in Youth with Autistic Disorder

    ERIC Educational Resources Information Center

    Erickson, Craig A.; Wink, Logan K.; Early, Maureen C.; Stiegelmeyer, Elizabeth; Mathieu-Frasier, Lauren; Patrick, Vanessa; McDougle, Christopher J.

    2014-01-01

    Rationale: An excitatory/inhibitory (E:I) imbalance marked by enhanced glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission may contribute to the pathophysiology of autism spectrum disorders (ASD). Objectives: We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I…

  10. L-lysine as adjunctive treatment in patients with schizophrenia: a single-blinded, randomized, cross-over pilot study

    PubMed Central

    2011-01-01

    Background Accumulating evidence suggests that the brain's nitric oxide (NO) signalling system may be involved in the pathophysiology of schizophrenia and could thus constitute a novel treatment target. The study was designed to investigate the benefit of L-lysine, an amino acid that interferes with NO production, as an add-on treatment for schizophrenia. Methods L-lysine, 6 g/day, was administered to 10 patients with schizophrenia as an adjunctive to their conventional antipsychotic medication. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks. Results L-lysine treatment caused a significant increase in blood concentration of L-lysine and was well tolerated. A significant decrease in positive symptom severity, measured by the Positive And Negative Syndrome Scale (PANSS), was detected. A certain decrease in score was also observed during placebo treatment and the effects on PANSS could not unequivocally be assigned to the L-lysine treatment. Furthermore, performance on the Wisconsin Card Sorting Test was significantly improved compared to baseline, an effect probably biased by training. Subjective reports from three of the patients indicated decreased symptom severity and enhanced cognitive functioning. Conclusions Four-week L-lysine treatment of 6 g/day caused a significant increase in blood concentration of L-lysine that was well tolerated. Patients showed a significant decrease in positive symptoms as assessed by PANSS in addition to self-reported symptom improvement by three patients. The NO-signalling pathway is an interesting, potentially new treatment target for schizophrenia; however, the effects of L-lysine need further evaluation to decide the amino acid's potentially beneficial effects on symptom severity in schizophrenia. Trial registration NCT00996242 PMID

  11. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients

    PubMed Central

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations. PMID:28223950

  12. The mechanical effect of kinesiology tape on rounded shoulder posture in seated male workers: a single-blinded randomized controlled pilot study.

    PubMed

    Han, Jin-Tae; Lee, Jung-Hoon; Yoon, Chul-Han

    2015-02-01

    Single-blinded randomized controlled pilot study. To examine the changes in pectoralis minor length (PML), the supine measurement of rounded shoulder posture (RSP), and the total scapular distance (TSD) in seated male workers with RSP, after rounded-shoulder-taping (RST) using kinesiology tape with (experimental taping) and without stretch (placebo taping). RSP, a postural impairment, is a known cause of upper quarter pain. Fourteen men with RSP, who worked for at least 7 h/d in a seated position, were selected for RST, with the shoulders randomly assigned to two kinesiology taping methods: (1) with 35-40% stretch of its original length; and (2) without stretch. The PML, supine measurements of RSP, and TSD, before and after kinesiology taping, with and without stretch, were assessed. Kinesiology taping with stretch significantly increased the PML and significantly decreased the supine measurement of RSP and TSD; kinesiology taping without stretch did not increase the PML significantly and did not decrease the supine measurement of RSP and TSD. RST using kinesiology tape with stretch produces immediate mechanical correction of RSP in seated male workers.

  13. Effects of Ayurvedic Oil-Dripping Treatment with Sesame Oil vs. with Warm Water on Sleep: A Randomized Single-Blinded Crossover Pilot Study

    PubMed Central

    Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

    2016-01-01

    Abstract Objectives: Ayurvedic oil-dripping treatment (Shirodhara) is often used for treating sleep problems. However, few properly designed studies have been conducted, and the quantitative effect of Shirodhara is unclear. This study sought to quantitatively evaluate the effect of sesame oil Shirodhara (SOS) against warm water Shirodhara (WWS) on improving sleep quality and quality of life (QOL) among persons reporting sleep problems. Methods: This randomized, single-blinded, crossover study recruited 20 participants. Each participant received seven 30-minute sessions within 2 weeks with either liquid. The washout period was at least 2 months. The Shirodhara procedure was conducted by a robotic oil-drip system. The outcomes were assessed by the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, Epworth Sleepiness Scale (ESS) for daytime sleepiness, World Health Organization Quality of Life 26 (WHO-QOL26) for QOL, and a sleep monitor instrument for objective sleep measures. Changes between baseline and follow-up periods were compared between the two types of Shirodhara. Analysis was performed with generalized estimating equations. Results: Of 20 participants, 15 completed the study. SOS improved sleep quality, as measured by PSQI. The SOS score was 1.83 points lower (95% confidence interval [CI], −3.37 to −0.30) at 2-week follow-up and 1.73 points lower (95% CI, −3.84 to 0.38) than WWS at 6-week follow-up. Although marginally significant, SOS also improved QOL by 0.22 points at 2-week follow-up and 0.19 points at 6-week follow-up compared with WWS. After SOS, no beneficial effects were observed on daytime sleepiness or objective sleep measures. Conclusions: This pilot study demonstrated that SOS may be a safe potential treatment to improve sleep quality and QOL in persons with sleep problems. PMID:26669255

  14. Validity of the "streitberger" needle in a chinese population with acupuncture: a randomized, single-blinded, and crossover pilot study.

    PubMed

    Xie, Chang-Cai; Wen, Xiu-Yun; Jiang, Li; Xie, Min-Jun; Fu, Wen Bin

    2013-01-01

    We studied the validity of a "Streitberger" needle as a valid approach in a Chinese population with experience of acupuncture. Volunteers were recruited from students of the School of Acupuncture and Moxibustion, Guangzhou University of Chinese Medicine. Sixty students receiving education in acupuncture theory and experience in practical acupuncture were tested in study determining whether needling with the placebo needle felt any different from conventional acupuncture. Outcomes included measures of penetration sensation, VAS ratings, and Deqi sensation questionnaire. As a result, needle penetration, VAS ratings for either needle and Deqi sensation were not significantly different between two kinds of needles. Our findings show that the use of "Streitberger" needle is credible in a Chinese population with acupuncture experience.

  15. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    NASA Astrophysics Data System (ADS)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-11-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  16. Effect of a single acupuncture treatment on surgical wound healing in dogs: a randomized, single blinded, controlled pilot study

    PubMed Central

    2010-01-01

    Background The aim of the study was to investigate the effect of acupuncture on wound healing after soft tissue or orthopaedic surgery in dogs. Methods 29 dogs were submitted to soft tissue and/or orthopaedic surgeries. Five dogs had two surgical wounds each, so there were totally 34 wounds in the study. All owners received instructions for post operative care as well as antibiotic and pain treatment. The dogs were randomly assigned to treatment or control groups. Treated dogs received one dry needle acupuncture treatment right after surgery and the control group received no such treatment. A veterinary surgeon that was blinded to the treatment, evaluated the wounds at three and seven days after surgery in regard to oedema (scale 0-3), scabs (yes/no), exudate (yes/no), hematoma (yes/no), dermatitis (yes/no), and aspect of the wound (dry/humid). Results There was no significant difference between the treatment and control groups in the variables evaluated three and seven days after surgery. However, oedema reduced significantly in the group treated with acupuncture at seven days compared to three days after surgery, possibly due the fact that there was more oedema in the treatment group at day three (although this difference was nor significant between groups). Conclusions The use of a single acupuncture treatment right after surgery in dogs did not appear to have any beneficial effects in surgical wound healing. PMID:20950467

  17. Acute effects of exergames on cognitive function of institutionalized older persons: a single-blinded, randomized and controlled pilot study.

    PubMed

    Monteiro-Junior, Renato Sobral; da Silva Figueiredo, Luiz Felipe; Maciel-Pinheiro, Paulo de Tarso; Abud, Erick Lohan Rodrigues; Braga, Ana Elisa Mendes Montalvão; Barca, Maria Lage; Engedal, Knut; Nascimento, Osvaldo José M; Deslandes, Andrea Camaz; Laks, Jerson

    2017-06-01

    Improvements on balance, gait and cognition are some of the benefits of exergames. Few studies have investigated the cognitive effects of exergames in institutionalized older persons. To assess the acute effect of a single session of exergames on cognition of institutionalized older persons. Nineteen institutionalized older persons were randomly allocated to Wii (WG, n = 10, 86 ± 7 year, two males) or control groups (CG, n = 9, 86 ± 5 year, one male). The WG performed six exercises with virtual reality, whereas CG performed six exercises without virtual reality. Verbal fluency test (VFT), digit span forward and digit span backward were used to evaluate semantic memory/executive function, short-term memory and work memory, respectively, before and after exergames and Δ post- to pre-session (absolute) and Δ % (relative) were calculated. Parametric (t independent test) and nonparametric (Mann-Whitney test) statistics and effect size were applied to tests for efficacy. VFT was statistically significant within WG (-3.07, df = 9, p = 0.013). We found no statistically significant differences between the two groups (p > 0.05). Effect size between groups of Δ % (median = 21 %) showed moderate effect for WG (0.63). Our data show moderate improvement of semantic memory/executive function due to exergames session. It is possible that cognitive brain areas are activated during exergames, increasing clinical response. A single session of exergames showed no significant improvement in short-term memory, working memory and semantic memory/executive function. The effect size for verbal fluency was promising, and future studies on this issue should be developed. RBR-6rytw2.

  18. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy

    PubMed Central

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-01-01

    Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN

  19. Single-blinded, randomized, and controlled clinical trial evaluating the effects of Omega-3 fatty acids among septic patients with intestinal dysfunction: A pilot study.

    PubMed

    Chen, Huaisheng; Wang, Wei; Hong, Yingcai; Zhang, Huadong; Hong, Chengying; Liu, Xueyan

    2017-08-01

    Sepsis is a systemic inflammatory reaction, which is aggravated by aspects of the immune response that are thought to be inhibited by Omega-3 fatty acids. The aim of the present study was to determine if Omega-3 fatty acid could modulate immunological function and improve survival rate among septic patients with intestinal dysfunction. A total of 48 mechanically ventilated patients with intestinal dysfunction were included in this prospective, randomized and single-blind clinical study. Patients were randomly divided into control (group A) and treatment groups (group B). The treatment protocol for all the participants followed the Sepsis Survival Campaign guidelines, and group B received total parenteral nutrition containing 100 ml of Omega-3 fatty acids (containing 10 g refined fish oil) per day in addition to the standard treatment applied in group A. Group B had a significantly lower mortality rate compared with group A (12.5 vs. 41.7%, P<0.05) during the 28-day follow-up. Group B also had lower Acute Physiology and Chronic Health Evaluation II scores (P<0.05) and lower Marshall scores (P<0.05) at day 7. In addition, group B had a higher ratio of T helper to inducer lymphocytes as well as a higher ratio of CD4 to CD8 lymphocytes (P<0.01 for both) than group A. It was concluded that Omega-3 fatty acids improved T helper/inducer and CD4/CD8 ratios, and may have reduced mortality, among septic patients with intestinal dysfunction.

  20. A single-blind, pilot randomised trial of a weight management intervention for adults with intellectual disabilities and obesity: study protocol.

    PubMed

    Harris, Leanne; Melville, Craig; Jones, Nathalie; Pert, Carol; Boyle, Susan; Murray, Heather; Tobin, Janet; Gray, Fiona; Hankey, Catherine

    2015-01-01

    The prevalence of obesity in adults with intellectual disabilities has consistently been reported to be higher than the general population. Despite the negative impact of obesity on health, there is little evidence of the effectiveness of weight management interventions for adults with intellectual disabilities and obesity. Preliminary results from a single-stranded feasibility study of a multi-component weight management intervention specifically designed for adults with intellectual disabilities and obesity (TAKE 5) and that satisfied clinical recommendations reported that it was acceptable to adults with intellectual disabilities and their carers. This study aims to determine the feasibility of a full-scale clinical trial of TAKE 5. This study will follow a pilot randomised trial design. Sixty-six obese participants (body mass index (BMI) ≥30 kg/m(2)) will be randomly allocated to the TAKE 5 multi-component weight management intervention or a health education 'active' control intervention (Waist Winners Too (WWToo)). Both interventions will be delivered over a 12-month period. Participants' anthropometric measures (body weight, BMI, waist circumference, percentage body fat); indicators of activity (levels of physical activity and sedentary behaviour) and well-being will be measured at three time points: baseline, 6 and 12 months. The researcher collecting outcome measures will be blind to study group allocation. The data from this study will generate pilot data on the acceptability of randomisation, attrition rates and the estimates of patient-centred outcomes of TAKE 5, which will help inform future research and the development of a full-scale randomised clinical trial. ISRCTN52903778.

  1. Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial

    PubMed Central

    2013-01-01

    Background Visual information comprises one of the most salient sources of information used to control walking and the dependence on vision to maintain dynamic stability increases following a stroke. We hypothesize, therefore, that rehabilitation efforts incorporating visual cues may be effective in triggering recovery and adaptability of gait following stroke. This feasibility trial aims to estimate probable recruitment rate, effect size, treatment adherence and response to gait training with visual cues in contrast to conventional overground walking practice following stroke. Methods/design A 3-arm, parallel group, multi-centre, single blind, randomised control feasibility trial will compare overground visual cue training (O-VCT), treadmill visual cue training (T-VCT), and usual care (UC). Participants (n = 60) will be randomly assigned to one of three treatments by a central randomisation centre using computer generated tables to allocate treatment groups. The research assessor will remain blind to allocation. Treatment, delivered by physiotherapists, will be twice weekly for 8 weeks at participating outpatient hospital sites for the O-VCT or UC and in a University setting for T-VCT participants. Individuals with gait impairment due to stroke, with restricted community ambulation (gait speed <0.8m/s), residual lower limb paresis and who are able to take part in repetitive walking practice involving visual cues (i.e., no severe visual impairments, able to walk with minimal assistance and no comorbid medical contraindications for walking practice) will be included. The primary outcomes concerning participant enrolment, recruitment, retention, and health and social care resource use data will be recorded over a recruitment period of 18 months. Secondary outcome measures will be undertaken before randomisation (baseline), after the eight-week intervention (outcome), and at three months (follow-up). Outcome measures will include gait speed and step length symmetry

  2. Effect of lyophilized lactobacilli and 0.03 mg estriol (Gynoflor®) on vaginitis and vaginosis with disrupted vaginal microflora: a multicenter, randomized, single-blind, active-controlled pilot study.

    PubMed

    Donders, G G G; Van Bulck, B; Van de Walle, P; Kaiser, R R; Pohlig, G; Gonser, S; Graf, F

    2010-01-01

    To evaluate the efficacy of lyophilized lactobacilli in combination with 0.03 mg estriol when compared to metronidazole in the treatment of bacterial vaginal infections. Multicenter, randomized, single-blind, active-controlled pilot study in 3 independent gynecological practices in Belgium. Forty-six, 18- to 50-year-old premenopausal women with a disrupted vaginal flora due to a bacterial vaginal infection (bacterial vaginosis, aerobic vaginitis) were included, provided that fresh phase-contrast microscopy of the vaginal fluid showed lactobacillary flora grade 2B or 3. Patients were given a blinded box with either 12 vaginal tablets of Gynoflor® (study medication) or 6 vaginal suppositories containing 500 mg metronidazole (control medication). Eight efficacy variables were studied to assess the status of the vaginal flora at entry, 3-7 days (control 1), 4-6 (control 2) weeks and 4 months after the end of therapy. At control 1, the combined variables equally improved in the lactobacilli group as in the metronidazole group. At control 2, the lactobacillus preparation showed slightly inferior results when compared to metronidazole. At 4 months, this analysis could not be performed due to low numbers, but analysis of recurrence rate and extra medication needed was not different between both groups. Lyophilized lactobacilli in combination with low-dose estriol are equivalent to metronidazole in the short-term treatment of bacterial vaginal infections, but have less effect after 1 month. Further studies are required to evaluate the long-term efficacy of lactobacilli when applied repeatedly. Copyright © 2010 S. Karger AG, Basel.

  3. The efficacy of treatment of different intervention programs for patellofemoral pain syndrome--a single blinded randomized clinical trial. Pilot study.

    PubMed

    Avraham, Feazadeh; Aviv, Saposhnik; Ya'akobi, Pnina; Faran, Hava; Fisher, Zilla; Goldman, Yael; Neeman, Guy; Carmeli, Eli

    2007-08-24

    Patello-femoral pain syndrome (PFPS) is a common knee joint disability. The integration of hip soft tissue regimens are not always emphasized, although current literature implies that there is a significant relationship between the two and there is a lack of randomized clinical trials to substantiate this relationship in clinical practice. A randomized controlled assessor blinded trial was designed to explore different rehabilitation programs related to PFPS. The study was conducted at RAZIEL institute of physical therapy, Netania, Israel with a total of 30 consecutive patients (mean age 35y), diagnosed with PFPS. All patients were randomly allocated into 3 groups. Group I conventional knee rehabilitation program. Included quadriceps strengthening and Trans Electric Neuromuscular Stimulation (TENS). Group II hip oriented rehabilitation program. included stretching, Hip external rotators strengthening and TENS. Group III a combination of the two above programs. Pain and function were documented on initial of the program and again 3 weeks later, on the completion. Pain was assessed by a numeric visual analogue scale (VAS); function was assessed by Patello-femoral joint evaluation scale (PFJES) (0-100 points). At end of trial, all groups showed significant improvements in VAS and PFJES (p<0.0001); these improvements did not vary significantly between the 3 groups. The conclusions were that the explored different rehabilitation programs showed a similar beneficial effect.

  4. Chinese Herbal Medicine (Zi Shen Qing) for Mild-to-Moderate Systematic Lupus Erythematosus: A Pilot Prospective, Single-Blinded, Randomized Controlled Study

    PubMed Central

    Zhong, Linda L. D.; Bian, Zhao Xiang; Gu, Jun Hua; Zhou, Xin; Tian, Yu; Mao, Jian Chun; Chen, Xiang Jun

    2013-01-01

    Objective. The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula Zi Shen Qing (ZSQ) in the treatment of systematic lupus erythematosus (SLE) in Chinese patients. Methods. A randomized controlled trial was conducted over 12 weeks in 84 Chinese patients who reported total scores of SLE Disease Activity Index-2000 (SLEDAI-2000) was from 5 to 14. The primary outcome was the changes of the SLEDAI-2000. The secondary outcomes included score changes of Chinese Medicine Syndromes (CMS), the changes of steroid dosage, the incidence of disease flare-up and biologic markers. Results. ZSQ significantly reduced SLEDAI-2000, the total scores of CMS in the treatment group compared with the controlled group (P < 0.05). Superiority of ZSQ over controlled group was also observed with greater improvement in the withdrawal dosage of corticosteroids and the incidence of disease flare-up (P < 0.05). There were no serious adverse events, and safety indices of whole blood counts, renal and liver functions were normal, both before and after the treatment. Conclusion. ZSQ is safe and effective for decreasing SLE disease activity and withdrawal dosage of corticosteroids in the mild to moderate SLE patients with “Deficiency of Qi and Yin” Pattern. PMID:23737826

  5. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study

    PubMed Central

    Campa-Moran, Irene; Rey-Gudin, Etelvina; Fernández-Carnero, Josué; Paris-Alemany, Alba; Gil-Martinez, Alfonso; Lerma Lara, Sergio; Prieto-Baquero, Almudena; Alonso-Perez, José Luis; La Touche, Roy

    2015-01-01

    Objective. The aim of this study was to compare the efficacy of three interventions for the treatment of myofascial chronic neck pain. Methods. Thirty-six patients were randomly assigned to one of three intervention groups: orthopedic manual therapy (OMT), dry needling and stretching (DN-S), and soft tissue techniques (STT). All groups received two treatment sessions with a 48 h time interval. Outcome measures included neck pain intensity measured using a visual analogue scale, cervical range of motion (ROM), pressure pain threshold for measuring mechanical hyperalgesia, and two self-reported questionnaires (neck disability index and pain catastrophizing scale). Results. The ANOVA revealed significant differences for the group × time interaction for neck disability, neck pain intensity, and pain catastrophizing. The DN-S and OMT groups reduced neck disability. Only the OMT group showed decreases in mechanical hyperalgesia and pain catastrophizing. The cervical ROM increased in OMT (i.e., flexion, side-bending, and rotation) and DN-S (i.e., side-bending and rotation) groups. Conclusions. The three interventions are all effective in reducing pain intensity. Reduction in mechanical hyperalgesia and pain catastrophizing was only observed in the OMT group. Cervical ROM improved in the DN-S and OMT groups and also neck disability being only clinically relevant for OMT group. PMID:26640708

  6. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study.

    PubMed

    Campa-Moran, Irene; Rey-Gudin, Etelvina; Fernández-Carnero, Josué; Paris-Alemany, Alba; Gil-Martinez, Alfonso; Lerma Lara, Sergio; Prieto-Baquero, Almudena; Alonso-Perez, José Luis; La Touche, Roy

    2015-01-01

    Objective. The aim of this study was to compare the efficacy of three interventions for the treatment of myofascial chronic neck pain. Methods. Thirty-six patients were randomly assigned to one of three intervention groups: orthopedic manual therapy (OMT), dry needling and stretching (DN-S), and soft tissue techniques (STT). All groups received two treatment sessions with a 48 h time interval. Outcome measures included neck pain intensity measured using a visual analogue scale, cervical range of motion (ROM), pressure pain threshold for measuring mechanical hyperalgesia, and two self-reported questionnaires (neck disability index and pain catastrophizing scale). Results. The ANOVA revealed significant differences for the group × time interaction for neck disability, neck pain intensity, and pain catastrophizing. The DN-S and OMT groups reduced neck disability. Only the OMT group showed decreases in mechanical hyperalgesia and pain catastrophizing. The cervical ROM increased in OMT (i.e., flexion, side-bending, and rotation) and DN-S (i.e., side-bending and rotation) groups. Conclusions. The three interventions are all effective in reducing pain intensity. Reduction in mechanical hyperalgesia and pain catastrophizing was only observed in the OMT group. Cervical ROM improved in the DN-S and OMT groups and also neck disability being only clinically relevant for OMT group.

  7. Heart Rate Variability modifications induced by high doses of incobotulinumtoxinA and onabotulinumtoxinA in hemiplegic chronic stroke patients: A single blind randomized controlled, crossover pilot study.

    PubMed

    Baricich, Alessio; Grana, Elisa; Carda, Stefano; Santamato, Andrea; Molinari, Claudio; Cisari, Carlo; Invernizzi, Marco

    2017-11-01

    Botulinum toxin type A is a valid and safe treatment for focal spasticity, with documented effects on both sympathetic and parasympathetic systems. Heart rate variability can provide detailed information about the control of the autonomic nervous system on cardiovascular activities. Previous studies in literature showed no significant changes in Heart Rate Variability with doses >600 U of incobotulinumtoxinA in chronic post stroke spastic patients; however, at present time, these results have not been confirmed with doses >600 U of onabotulinumtoxinA. To evaluate changes in Heart Rate Variability induced by high doses (>600 U) of incobotulinumtoxinA or onabotulinumtoxinA in spastic stroke patients over a 1-year period. single blind randomized controlled crossover study design. Rehabilitation Unit of the University Hospital in Novara. 10 stroke survivors with spastic hemiplegia (Modified Ashworth Scale ≥ 2) were recruited and randomly divided in two groups (A and B). In the first part of the study, patients in Group A were injected with incobotulinumtoxinA while patients in Group B with onabotulinumtoxinA; after 6 months, a crossover intervention was performed. All patients were blinded to Botulinum toxin type A type, and performed an ECG registration in the 24 h before injection (t0) and 10 days after treatment (t1), both in the first and in the second part of the study. Functional status was evaluated with Barthel Index, Motricity Index and Functional Ambulation Category scores. Heart Rate Variability analysis showed no significant changes after each Botulinum toxin type A injection in both groups at any evaluation time. Moreover, no statistically significant differences were found regarding each variable between the two groups. Our data show that high doses (>600 U) of incobotulinumtoxinA and onabotulinumtoxinA do not influence the cardiovascular activity of the autonomic nervous system in chronic hemiplegic spastic stroke survivors. Copyright © 2017

  8. A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging

    PubMed Central

    Sapra, Priya; Sapra, Sheetal; Khanna, Julie; Mraud, Kelli; Bonadonna, Jennifer

    2017-01-01

    Objective: To examine the effectiveness of intradermal botulinum toxin type A injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods. Design: A 16-week, single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal botulinum toxin type A injections at Week 0 and intramuscular botulinum toxin type A injections at Week 2. Participants: Ten women aged 35 to 65 years who exhibited static rhytids in the glabellar and periorbital area. Measurements: The primary endpoint was efficacy of split-face treatment of intradermal and intramuscular onabotulinumtoxinA and abobotulinumtoxinA as assessed by a blinded evaluator using baseline and post-treatment photographs. The secondary endpoints included safety as assessed by adverse events and patient satisfaction measured by questionnaires completed at baseline and post-treatment. Results: Intradermal injection of botulinum toxin type A led to a statistically significant improvement in skin texture (p=0.004) while also resulting in mild midface lift (p=0.024), but did not provide a significant reduction of pore size and sebum production. There was no statistically significant difference between onabotulinumtoxinA and abobotulinumtoxinA when injected intradermally or intramuscularly. Conclusion: Intradermal injection of botulinum toxin type A appears to be a safe and effective therapy that provides an improvement in facial skin texture and midface lift. Registry: clinicaltrials.gov (ID#: NCT02907268). PMID:28367260

  9. A randomized, single-blinded pilot study evaluating the effects of kinesiology taping and the tape application techniques in addition to therapeutic exercises in the treatment of congenital muscular torticollis.

    PubMed

    Giray, Esra; Karadag-Saygi, Evrim; Mansiz-Kaplan, Basak; Tokgoz, Duygu; Bayindir, Ozun; Kayhan, Onder

    2017-08-01

    To investigate the effects of kinesiology taping and different types of application techniques of kinesiology taping in addition to therapeutic exercises in the treatment of congenital muscular torticollis. Prospective, single blind, randomized controlled trial. An outpatient rehabilitation clinic in a tertiary university hospital. Infants with congenital muscular torticollis aged 3-12 months. Group 1 included 11 infants who only received exercises, Group 2 included 12 infants who received kinesiology taping applied on the affected side by using inhibition technique in addition to exercises. Group 3 included 10 infants who additionally received kinesiology taping applied on the unaffected side by using facilitation technique and on the affected side by using inhibition technique. Range of motion in lateral flexion and rotation of the neck, muscle function and degree of craniofacial changes were assessed at pretreatment, post treatment and, 1 month and 3 months' post treatment. Friedman analysis of within-group changes over time revealed significant differences for all of the outcome variables in all groups except cervical rotation in Group 3 ( P<0.05). No significant differences were found between groups at any of the follow-up time points for any of the outcome variables ( P>0.05). There is no any additive effect of kinesiology taping to exercises for the treatment of congenital muscular torticollis. Also different techniques of applying kinesiology taping resulted in similar clinical outcomes.

  10. Corticosteroid injection for shoulder pain: single-blind randomized pilot trial in primary care.

    PubMed

    Holt, Tim A; Mant, David; Carr, Andrew; Gwilym, Stephen; Beard, David; Toms, Christy; Yu, Ly-Mee; Rees, Jonathan

    2013-12-10

    Shoulder pain is a very common presentation in primary care. Evidence of benefit for subacromial corticosteroid injection is inconclusive and confined largely to studies with short follow-up. We plan a large, definitive, primary-care-based trial to determine efficacy and safety in patients with rotator cuff tendinopathy, and conducted a pilot trial to explore feasibility. Six general practitioners (GPs) from Oxfordshire, UK underwent update training in assessing painful shoulders and injecting the subacromial space. Each then recruited patients aged 35 to 74 years from primary care complaining of shoulder pain lasting no more than 6 months. Eligible participants were randomized to receive either methylprednisolone acetate 40 mg with lidocaine 1% (total volume 1 ml), or lidocaine 1% alone (total volume 1 ml), injected into the subacromial space. The participants were blinded to treatment allocation. Feasibility outcomes were rates of recruitment, withdrawal, adherence to the protocol, completeness of follow-up, and success of patient masking. Clinical outcomes were the Oxford Shoulder Score (OSS) at baseline and at 4 and 12 weeks, and responses to three satisfaction questions at 2, 4 and 12 weeks. Outcome data were collected by postal questionnaires. A total of 40 participants were randomized (80% of the target 50 participants) over 26 weeks giving an overall recruitment rate of 1.5 participants per week. Rates of follow-up were maintained to a high level for the full 12 weeks. Four participants requested a 'rescue' corticosteroid injection but no patients withdrew. The trial GPs gave high scores for their confidence that the patient had remained blinded to treatment allocation during the procedure. The OSS at 4 and 12 weeks and the responses to the satisfaction questions are reported. It is feasible to recruit participants with shoulder pain in the primary care setting for a blinded, randomized trial of corticosteroid injection. Online randomization of participants

  11. Extracorporeal shock wave therapy for chronic calcific tendinitis of the shoulder: single blind study

    PubMed Central

    Cosentino, R; De Stefano, R; Selvi, E; Frati, E; Manca, S; Frediani, B; Marcolongo, R

    2003-01-01

    Methods: 70 patients showing chronic, symptomatic, calcifying tendinitis of the shoulder were examined. A single blind randomised study was performed with 35 patients undergoing a regular treatment (group 1) and 35 a simulated one (group 2). Pain and functional assessment was carried out according to Constant and Murley. Variations in the dimension of the calcification were evaluated by anteroposterior x ray films. Results: A significant decrease of pain and a significant increase in shoulder function was seen in group 1. Examination by x ray showed partial resorption of the calcium deposits in 40% of cases and complete resorption in 31% of cases in group 1. In the control group no significant decrease of pain and no significant increase in shoulder function was seen. No modifications were observed by x ray examination. Conclusion: Because of its good tolerance, safety, and clinical radiological response, ESWT can be considered as an alternative treatment for chronic calcific tendinitis of the shoulder. PMID:12594112

  12. Olopatadine Hydrochloride and Fluticasone Propionate in Topical Treatment of Allergic Rhinitis: A Single Blind Randomised Study

    PubMed Central

    Jain, Vishal; Ahmed, MD Fazal; Shedge, Swapna; Dokania, Vivek; Bagwe, Vikrant; Agarwal, Ketan

    2016-01-01

    Introduction The use of corticosteroids or antihistaminics in treatment of allergic rhinitis is known and practiced since long. The efficacy of topical use of fluticasone propionate and Olopatadine Hydrochloride (HCL) for symptomatic relief of allergic rhinitis has been studied either individually or with other drugs. But very few studies show comparison between these two drugs. Aim To compare the efficacy of topical use of fluticasone propionate and olopatadine hydrochloride for symptomatic relief of allergic rhinitis. Design In this single blind, randomized control study, the efficacy of topical use of olopatadine HCL was compared with fluticasone propionate for relieving symptoms of allergic rhinitis. Materials and Methods The symptomatic cases were randomized in two groups for treatment using either olopatadine HCL or fluticasone propionate respectively. In each group, the Total Symptom Scores (TSS) and individual symptom scores were recorded before and after treatment with the help of symptom evaluation scale. Statistical Analysis Chi-square test, unpaired t-test, Mann Witney U-test, and Wilcoxon signed Rank test were used during analysis. The results of the comparison were noted and analysed. Results During four week study period both TSS and individual symptom score were reduced (p<0.05) in either groups. The TSS decreased by an average of 85.07% for those treated with olopatadine and by 95.55% for those treated with fluticasone. Conclusion Overall fluticasone propionate was superior to olopatadine in relieving symptoms of allergic rhinitis (p<0.005). PMID:28208892

  13. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study.

    PubMed

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    Objective. Keratosis pilaris (KP) is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2) laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians' global assessment (p = 0.02). Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution.

  14. Olopatadine Hydrochloride and Fluticasone Propionate in Topical Treatment of Allergic Rhinitis: A Single Blind Randomised Study.

    PubMed

    Havle, Abhay; Jain, Vishal; Ahmed, Md Fazal; Shedge, Swapna; Dokania, Vivek; Bagwe, Vikrant; Agarwal, Ketan

    2016-12-01

    The use of corticosteroids or antihistaminics in treatment of allergic rhinitis is known and practiced since long. The efficacy of topical use of fluticasone propionate and Olopatadine Hydrochloride (HCL) for symptomatic relief of allergic rhinitis has been studied either individually or with other drugs. But very few studies show comparison between these two drugs. To compare the efficacy of topical use of fluticasone propionate and olopatadine hydrochloride for symptomatic relief of allergic rhinitis. In this single blind, randomized control study, the efficacy of topical use of olopatadine HCL was compared with fluticasone propionate for relieving symptoms of allergic rhinitis. The symptomatic cases were randomized in two groups for treatment using either olopatadine HCL or fluticasone propionate respectively. In each group, the Total Symptom Scores (TSS) and individual symptom scores were recorded before and after treatment with the help of symptom evaluation scale. Chi-square test, unpaired t-test, Mann Witney U-test, and Wilcoxon signed Rank test were used during analysis. The results of the comparison were noted and analysed. During four week study period both TSS and individual symptom score were reduced (p<0.05) in either groups. The TSS decreased by an average of 85.07% for those treated with olopatadine and by 95.55% for those treated with fluticasone. Overall fluticasone propionate was superior to olopatadine in relieving symptoms of allergic rhinitis (p<0.005).

  15. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    PubMed Central

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    Objective. Keratosis pilaris (KP) is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2) laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians' global assessment (p = 0.02). Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution. PMID:27247936

  16. The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

    PubMed

    Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

    2013-11-01

    In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

  17. Ultrasound-Guided Pulsed Radiofrequency for Carpal Tunnel Syndrome: A Single-Blinded Randomized Controlled Study.

    PubMed

    Chen, Liang-Cheng; Ho, Cheng-Wen; Sun, Chia-Hung; Lee, Jiunn-Tay; Li, Tsung-Ying; Shih, Feng-Mei; Wu, Yung-Tsan

    2015-01-01

    We assessed the therapeutic efficiency of ultrasound-guided pulsed radiofrequency (PRF) treatment of the median nerve in patients with carpal tunnel syndrome (CTS). We conducted a prospective, randomized, controlled, single-blinded study. Forty-four patients with CTS were randomized into intervention or control groups. Patients in the intervention group were treated with PRF and night splint, and the control group was prescribed night splint alone. Primary outcome was the onset time of significant pain relief assessed using the visual analog scale (VAS), and secondary outcomes included evaluation of the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) results, cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity (SNCV) of the median nerve, and finger pinch strength. All outcome measurements were performed at 1, 4, 8, and 12 weeks after treatment. Thirty-six patients completed the study. The onset time of pain relief in the intervention group was significantly shorter (median onset time of 2 days vs. 14 days; hazard ratio = 7.37; 95% CI, 3.04-17.87) compared to the control group (p < 0.001). Significant improvement in VAS and BCTQ scores (p < 0.05) was detected in the intervention group at all follow-up periods compared to the controls (except for the severity subscale of BCTQ at week 1). Ultrasound-guided PRF treatment resulted in a lower VAS score and stronger finger pinch compared to the control group over the entire study. Our study shows that ultrasound-guided PRF serves as a better approach for pain relief in patients with CTS. ClinicalTrials.gov NCT02217293.

  18. Ultrasound-Guided Pulsed Radiofrequency for Carpal Tunnel Syndrome: A Single-Blinded Randomized Controlled Study

    PubMed Central

    2015-01-01

    Objective We assessed the therapeutic efficiency of ultrasound-guided pulsed radiofrequency (PRF) treatment of the median nerve in patients with carpal tunnel syndrome (CTS). Methods We conducted a prospective, randomized, controlled, single-blinded study. Forty-four patients with CTS were randomized into intervention or control groups. Patients in the intervention group were treated with PRF and night splint, and the control group was prescribed night splint alone. Primary outcome was the onset time of significant pain relief assessed using the visual analog scale (VAS), and secondary outcomes included evaluation of the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) results, cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity (SNCV) of the median nerve, and finger pinch strength. All outcome measurements were performed at 1, 4, 8, and 12 weeks after treatment. Results Thirty-six patients completed the study. The onset time of pain relief in the intervention group was significantly shorter (median onset time of 2 days vs. 14 days; hazard ratio = 7.37; 95% CI, 3.04–17.87) compared to the control group (p < 0.001). Significant improvement in VAS and BCTQ scores (p < 0.05) was detected in the intervention group at all follow-up periods compared to the controls (except for the severity subscale of BCTQ at week 1). Ultrasound-guided PRF treatment resulted in a lower VAS score and stronger finger pinch compared to the control group over the entire study. Conclusions Our study shows that ultrasound-guided PRF serves as a better approach for pain relief in patients with CTS. Trial Registration ClinicalTrials.gov NCT02217293 PMID:26067628

  19. Efficacy of peloid therapy in patients with chronic lateral epicondylitis: a randomized, controlled, single blind study.

    PubMed

    Ökmen, Burcu Metin; Eröksüz, Rıza; Altan, Lale; Aksoy, Meliha Kasapoğlu

    2017-06-15

    The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) (n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) (n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 (p < 0.05). In comparison of difference scores between groups, although there was no statistically significant difference between the two groups at W2 when compared to W0 (p > 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 (p < 0.05). Our results have shown that peloid treatment could be effective in providing improvement in pain relief, function, daily life activities, and quality of life in LE patients.

  20. Efficacy of peloid therapy in patients with chronic lateral epicondylitis: a randomized, controlled, single blind study

    NASA Astrophysics Data System (ADS)

    Ökmen, Burcu Metin; Eröksüz, Rıza; Altan, Lale; Aksoy, Meliha Kasapoğlu

    2017-06-01

    The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) (n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) (n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 (p < 0.05). In comparison of difference scores between groups, although there was no statistically significant difference between the two groups at W2 when compared to W0 (p > 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 (p < 0.05). Our results have shown that peloid treatment could be effective in providing improvement in pain relief, function, daily life activities, and quality of life in LE patients.

  1. Dense Cranial Electroacupuncture Stimulation for Major Depressive Disorder—A Single-Blind, Randomized, Controlled Study

    PubMed Central

    Zhang, Zhang-Jin; Ng, Roger; Man, Sui Cheung; Li, Tsui Yin Jade; Wong, Wendy; Tan, Qing-Rong; Wong, Hei Kiu; Chung, Ka-Fai; Wong, Man-Tak; Tsang, Wai-Kiu Alfert; Yip, Ka-chee; Ziea, Eric; Wong, Vivian Taam

    2012-01-01

    Background Previous studies suggest that electroacupuncture possesses therapeutic benefits for depressive disorders. The purpose of this study was to determine whether dense cranial electroacupuncture stimulation (DCEAS) could enhance the antidepressant efficacy in the early phase of selective serotonin reuptake inhibitor (SSRI) treatment of major depressive disorder (MDD). Methods In this single-blind, randomized, controlled study, patients with MDD were randomly assigned to 9-session DCEAS or noninvasive electroacupuncture (n-EA) control procedure in combination with fluoxetine (FLX) for 3 weeks. Clinical outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression-severity (CGI-S), and Self-rating Depression Scale (SDS) as well as the response and remission rates. Results Seventy-three patients were randomly assigned to n-EA (n = 35) and DCEAS (n = 38), of whom 34 in n-EA and 36 in DCEAS group were analyzed. DCEAS-treated patients displayed a significantly greater reduction from baseline in HAMD-17 scores at Day 3 through Day 21 and in SDS scores at Day 3 and Day 21 compared to patients receiving n-EA. DCEAS intervention also produced a higher rate of clinically significant response compared to n-EA procedure (19.4% (7/36) vs. 8.8% (3/34)). The incidence of adverse events was similar in the two groups. Conclusions DCEAS is a safe and effective intervention that augments the antidepressant efficacy. It can be considered as an additional therapy in the early phase of SSRI treatment of depressed patients. Trial Registration Controlled-Trials.com ISRCTN88008690 PMID:22238631

  2. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study

    NASA Astrophysics Data System (ADS)

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-02-01

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)(n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)(n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0(p < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2(p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 (p < 0.05). The results of our study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  3. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study

    NASA Astrophysics Data System (ADS)

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-08-01

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)( n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)( n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0( p < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2( p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 ( p < 0.05). The results of our study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  4. Comparative effectiveness of quetiapine and haloperidol in delirium: A single blind randomized controlled study

    PubMed Central

    Grover, Sandeep; Mahajan, Sudhir; Chakrabarti, Subho; Avasthi, Ajit

    2016-01-01

    AIM To evaluate the effectiveness of quetiapine and haloperidol in patients of delirium referred to psychiatry consultation liaison services. METHODS The study followed a single blind randomised controlled trial design. Thirty-two patients in the haloperidol group and 31 patients in the quetiapine group were assessed at the baseline and 6 consecutive days. Flexible dosing regimen (haloperidol: 0.25-1.25 mg; quetiapine 12.5-75 mg/d) was used. Delirium Rating Scale-Revised-98 (DRS-R-98) and mini mental status examination (MMSE) were the primary and secondary efficacy measures respectively. RESULTS Baseline DRS-R-98 severity score and MMSE scores did not differ between the 2 study groups. From baseline to day 6, there was significant reduction in the total DRS-R-98 scores, DRS-R-98 cognitive domain scores, DRS-R-98 non-cognitive domain scores and significant increase in the MMSE scores in both the groups. Both the groups did not differ on any of the assessments in terms of DRS-R98 and MMSE scores. The effectiveness of both the medications was similar in adult and elderly (≥ 60 years) patients. At the end of the trial, 68.75% and 67.74% of subjects in the haloperidol and quetiapine group respectively had mean DRS-R-98 scores below 10. By 6th day, 12 (37.5%) patients in haloperidol group and 9 (29.03%) patients in the quetiapine group had DRS-R98 score of “0” with no significant difference between the two groups (P = 0.47). CONCLUSION Quetiapine is as effective as haloperidol in the management of delirium. PMID:27679777

  5. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    PubMed

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (P<.05). There were no significant differences between the 2 groups in VAS scores at 2 weeks and 3 months after surgery. Less sufentanil was consumed by the cryotherapy group than the control group for pain relief (P<.01). No significant differences were found in blood loss, ROM, and MEPS between the 2 groups (P>.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. Metoclopramide as an analgesic in severe migraine attacks: an open, single-blind, parallel control study.

    PubMed

    Salazar, G; Fragoso, M; Vergez, L; Sergio, P; Cuello, D

    2011-05-01

    Metoclopramide is a well-known anti-emetic drug with central and peripheral pharmacological effects. Some authors have reported metoclopramide as an adjunct therapy to other analgesics in patients with migraine attacks. Treatment of migraine headache using a mix of metoclopramide and an NSAID has been patented (European Patent EP1014961) as well as a short series showing great efficacy and tolerability of metoclopramide in patients wtih migraine attacks. We decided to conduct an open, single-blind, parallel control study in the emergency department to evaluate the efficacy and tolerability of metoclopramide in patients with severe migraine attacks. 93 consecutive patients with severe migraine attacks were randomized into two groups (groups A and B). Patients in group A received 10mg of intravenous metoclopramide and patients in group B received 1 g of intravenous paracetamol. Patients were evaluated 5 minutes before (baseline), 15, 30, 60 and 120 minutes after drug delivery, and before being discharged from the emergency department They were then contacted by phone 48 hours after being discharged from the hospital (phone questionnaire). Patients treated with either metoclopramide or paracetamol showed a significant reduction in the intensity of pain at the 120 minute time point, with an 86% and 82% improvement respectively. However, patients treated with metoclopramide showed a more rapid improvement at the 15 and 30 minute evaluations. Patients with severe migraine attacks treated with metoclopramide as monotherapy showed a significant improvement in terms of pain relief and a faster improvement in pain intensity compared to those treated with paracetamol. Metoclopramide and other dopamine antagonistic drugs should be considered a therapeutic option in severe migraine headache attacks.

  7. Radial shock wave therapy for lateral epicondylitis: a prospective randomised controlled single-blind study.

    PubMed

    Spacca, G; Necozione, S; Cacchio, A

    2005-03-01

    Despite the lateral epicondylitis or tennis elbow is a common cause of pain in orthopaedic and sports medicine, the results of the different modalities of conservative treatment are still contradictory. The pourpose of this study was to evaluate the efficacy of radial shock wave therapy (RSWT) in the treatment of tennis elbow. In a prospective randomized controlled single-blind study, of 75 eligible patients, 62 with tennis elbow were randomly assigned to study group and control group. There were 31 patients in the study group and 31 patients in the control group. Both groups had received a treatment a week for 4 weeks; the study group had received 2000 impulses of RSWT and the control group 20 impulses of RSWT. All patients were evaluated 3 times: before treatment, at the end of treatment and to 6 months follow-up. The evaluation consisted of assessments of pain, pain-free grip strength test, and functional impairment. Statistical analysis of visual analogue scale (VAS), disabilities of the arm, shoulder, and hand (DASH) questionnaire and pain-free grip strength test scores has shown, both after treatment and to the follow-up at 6 months, significant difference comparing study group versus control group (P <0.001). Statistical analysis within the groups, showed always statistically significant values for the study group. Also the control group showed statistically significant differences for some analyzed parameters. Nevertheless such differences resulted to be more statistics that not clinics as it showed the percentage of satisfied patients in the study group (87% post-treatment; 84% follow-up) in comparison with that of the control group (10% post-treatment; 3% follow-up), and the number needed to treat (NNT) that is of 1.15 at post-treatment and of 1.25 to the 6 months follow-up. The use of RSWT allowed a decrease of pain, and functional impairment, and an increase of the pain-free grip strength test, in patients with tennis elbow. The RSWT is safe and

  8. Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction.

    PubMed

    Trivedi, V R; Satia, M C; Deschamps, A; Maquet, V; Shah, R B; Zinzuwadia, P H; Trivedi, J V

    2016-01-08

    Chitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and safety of a chitosan from fungal origin in treatment of excess weight in the absence of dietary restrictions. A phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical study was conducted by administering chitosan capsules (500 mg, five/day) and indistinguishable placebo capsules as daily supplements to 96 overweight and obese subjects for 90 days. The study participants were divided in 2:1 ratio to receive either chitosan (n = 64) or placebo (n = 32). Efficacy was assessed by measuring body weight, body composition parameters, anthropometric measurements, HbA1C level and lipid profile at day 45 and day 90. Also, short form-36 quality of life (QoL) questionnaire was assessed to evaluate improvement in life-style and dietary habits were recorded for calorie intake. Safety was assessed by evaluating safety parameters and monitoring adverse events. The mean changes in body weight were -1.78 ± 1.37 kg and -3.10 ± 1.95 kg at day 45 and day 90 respectively in chitosan group which were significantly different (p < 0.0001) as compared to placebo. BMI was decreased by10.91 fold compared to placebo after 90 day administration. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Chitosan was also able to reduce HbA1C levels (below 6 %) in subjects who had initial higher values. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. Lipid levels were unaffected and all adverse events were mild in nature and unrelated to study treatment. Chitosan from fungal origin was able to reduce the mean body weight up to 3 kg during the 90 day study

  9. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study.

    PubMed

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-02-16

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)(n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)(n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0(p < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2(p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 (p < 0.05). The results of our study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  10. Perturbation During Treadmill Training Improves Dynamic Balance and Gait in Parkinson's Disease: A Single-Blind Randomized Controlled Pilot Trial.

    PubMed

    Steib, Simon; Klamroth, Sarah; Gaßner, Heiko; Pasluosta, Cristian; Eskofier, Björn; Winkler, Jürgen; Klucken, Jochen; Pfeifer, Klaus

    2017-08-01

    Gait and balance dysfunction are major symptoms in Parkinson's disease (PD). Treadmill training improves gait characteristics in this population but does not reflect the dynamic nature of controlling balance during ambulation in everyday life contexts. To evaluate whether postural perturbations during treadmill walking lead to superior effects on gait and balance performance compared with standard treadmill training. In this single-blind randomized controlled trial, 43 PD patients (Hoehn & Yahr stage 1-3.5) were assigned to either an 8-week perturbed treadmill intervention (n = 21) or a control group (n = 22) training on the identical treadmill without perturbations. Patients were assessed at baseline, postintervention, and at 3 months' follow-up. Primary endpoints were overground gait speed and balance (Mini-BESTest). Secondary outcomes included fast gait speed, walking capacity (2-Minute Walk Test), dynamic balance (Timed Up-and-Go), static balance (postural sway), and balance confidence (Activities-Specific Balance Confidence [ABC] scale). There were no significant between-group differences in change over time for the primary outcomes. At postintervention, both groups demonstrated similar improvements in overground gait speed ( P = .009), and no changes in the Mini-BESTest ( P = .641). A significant group-by-time interaction ( P = .048) existed for the Timed Up-and-Go, with improved performance only in the perturbation group. In addition, the perturbation but not the control group significantly increased walking capacity ( P = .038). Intervention effects were not sustained at follow-up. Our primary findings suggest no superior effect of perturbation training on gait and balance in PD patients. However, some favorable trends existed for secondary gait and dynamic balance parameters, which should be investigated in future trials.

  11. Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial.

    PubMed

    Wang, Xue-Qiang; Pi, Yan-Lin; Chen, Pei-Jie; Chen, Bin-Lin; Liang, Lei-Chao; Li, Xin; Wang, Xiao; Zhang, Juan

    2014-04-02

    Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Chinese Clinical Trial Registry: ChiCTR-TRC-13003708.

  12. Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial

    PubMed Central

    2014-01-01

    Background Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. Methods/Design We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Discussion Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-13003708. PMID:24693945

  13. Photodynamic Therapy Followed by Mohs Micrographic Surgery Compared to Mohs Micrographic Surgery Alone for the Treatment of Basal Cell Carcinoma: Results of a Pilot Single-Blinded Randomised Controlled Trial

    PubMed Central

    Al-Niaimi, Firas; Sheth, Nisith; Kurwa, Habib A; Mallipeddi, Raj

    2015-01-01

    Introduction: Basal cell carcinoma is a common cutaneous malignant tumour. Surgical excision is the “gold standard” treatment for most subtypes, with Mohs micrographic surgery (MMS) offering the highest cure rate. Other treatment modalities used include photodynamic therapy (PDT). Background: We aimed to study the efficacy of combining MMS with PDT to see whether this would reduce the number of stages and final defect size when compared with MMS alone. Materials and Methods: Our study was a single-centre, single-blinded, randomised and controlled pilot study involving a total of 19 patients. Nine patients were randomised to pre-treatment with PDT followed by MMS of whom two withdrew; the remaining 10 patients were randomised to the MMS alone. Follow-up visits were arranged at 3 and 6 months post-surgery. Results: In the PDT arm, five out of the seven treated patients (71%) had their initial tumour size decreased following PDT treatment prior to MMS. The average number of stages in the PDT arm was 1.85, compared to 2.5 in the MMS arm. The average number of sections in the PDT arm was 4.2, in comparison to 5.2 in the MMS arm. Conclusion: Our pilot study showed a promising but limited role for PDT as an adjunct in MMS in the treatment of selected cases of basal cell carcinomas. Larger trials, preferably multi-centred are required to further examine the role of this combination therapy. PMID:26157307

  14. The management of cystic fibrosis with carbocysteine lysine salt: single-blind comparative study with ambroxol hydrochloride.

    PubMed

    Caramia, G; Gagliardini, R; Ruffini, E; Osimani, P; Nobilini, A

    1995-01-01

    The effectiveness of carbocysteine lysine salt monohydrate (SCMC-Lys) and ambroxol hydrochloride (ABX) in the management of respiratory impairment was compared in a single-blind, randomized study of 26 cystic fibrosis patients with similar baseline characteristics. Adults received either SCMC-Lys 900 mg or ABX 33 mg three times a day and children under 14 years of age either SCMC-Lys 270 mg three times a day or ABX 10 mg four times a day. All treatments were given orally for 80 days and at the end of this control period both groups showed significant improvement in chest sound score but improvement in cough score was observed only in those receiving SCMC-Lys. Expectorate viscosity and elasticity decreased significantly in both groups. In SCMC-Lys-treated patients paCO2 decreased and paO2 and Hb O2 saturation increased while only paO2 increased significantly in those treated with ABX. An increase in tidal volume, peak expiratory flow values and forced expiratory volume were evident in those receiving SCMC-Lys while significant increases in forced expiratory flow were recorded in those receiving ABX. SCMC-Lys patient's Shwachmann index improved significantly and conversely to the ABX patients. No adverse events were recorded in either treatment group. The study concluded that SCMC-Lys is at least as effective as ABX in improving respiratory function in patients with cystic fibrosis.

  15. Effectiveness of probiotic, chlorhexidine and fluoride mouthwash against Streptococcus mutans – Randomized, single-blind, in vivo study

    PubMed Central

    Jothika, Mohan; Vanajassun, P. Pranav; Someshwar, Battu

    2015-01-01

    Aim: To determine the short-term efficiency of probiotic, chlorhexidine, and fluoride mouthwashes on plaque Streptococcus mutans level at four periodic intervals. Materials and Methods: This was a single-blind, randomized control study in which each subject was tested with only one mouthwash regimen. Fifty-two healthy qualified adult patients were selected randomly for the study and were divided into the following groups: group 1- 10 ml of distilled water, group 2- 10 ml of 0.2% chlorhexidine mouthwash, group 3- 10 ml of 500 ppm F/400 ml sodium fluoride mouthwash, and group 4- 10 ml of probiotic mouthwash. Plaque samples were collected from the buccal surface of premolars and molars in the maxillary quadrant. Sampling procedure was carried out by a single examiner after 7 days, 14 days, and 30 days, respectively, after the use of the mouthwash. All the samples were subjected to microbiological analysis and statistically analyzed with one-way analysis of variance (ANOVA) and post-hoc test. Results: One-way ANOVA comparison among groups 2, 3, and 4 showed no statistical significance, whereas group 1 showed statistically significant difference when compared with groups 2, 3, and 4 at 7th, 14th, and 30th day. Conclusion: Chlorhexidine, sodium fluoride, and probiotic mouthwashes reduce plaque S. mutans levels. Probiotic mouthwash is effective and equivalent to chlorhexidine and sodium fluoride mouthwashes. Thus, probiotic mouthwash can also be considered as an effective oral hygiene regimen. PMID:25984467

  16. Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study

    PubMed Central

    Abdalla, W; Elgendy, M; Abdelaziz, AA; Ammar, MA

    2016-01-01

    Background: Radiologic data remains the gold standard for the diagnosis of pneumothorax (PTX). The use of ultrasonography (US) has recently emerged as the method of choice with physicians who can perform bedside US. Purpose: To compare the diagnostic accuracy of lung US against bedside chest radiography (CR) for the detection of PTX using thoracic computed tomography (CT) as the gold standard. Materials and Methods: We conducted a prospective, single-blind study on 192 critically ill patients; each patient received lung US examination, bedside CR, followed by thoracic CT scan searching for PTX. Results: Of the studied patients, CT of the chest confirmed the diagnosis of PTX in 36 (18.75%) patients of which 31 were diagnosed by thoracic US while CR detected only 19 cases. Overall lung US showed a considerable higher sensitivity than bedside CR (86.1% vs. 52.7%), lung US also showed higher, negative predictive values, and diagnostic accuracy against CR (96.8% vs. 90.1%), and (95.3% vs. 90.6%), respectively. CR had a slightly higher specificity than lung US (99.4% vs. 97.4%), and higher positive predictive values (95.0% vs. 88.6%). Conclusion: Lung US is an accurate modality more than anteroposterior bedside CR in comparison with CT scanning when evaluating critically ill mechanically ventilated patients, patients underwent thoracocentesis, central venous catheter insertion, or patients with polytrauma. PMID:27375379

  17. Sensitivity for palpating lumbopelvic soft- tissues and bony landmarks and its associated factors: A single-blinded diagnostic accuracy study.

    PubMed

    Ferreira, A P A; Póvoa, L C; Zanier, J F C; Machado, D C; Ferreira, A S

    2017-08-03

    Evidence on the diagnostic performance of palpatory methods and possible confounding factors is scarce. To examine the sensitivity of palpatory methods for location of lumbopelvic landmarks and to assess its association with personal characteristics. Eighty-three participants (41 men, 55.6 (16.5) years, 25.9 (4.8) kg/m2 [mean (SD)]) were enrolled in this single-blinded study. Fourteen body and softy-tissue landmarks were sequentially palpated from the spinous process of L4 to the ischial tuberosity. CT-scan images were used to assess what landmark was located. Sensitivity for location was in range 22-86% for soft-tissues and 26-69% for bony landmarks. Reduction in sensitivity was observed from the quadratus lumborum to the inferior and lateral angle of the sacrum (86-26% and 75-33%, left and right sides, respectively). Palpations of L4 and L5 spinous processes were systematically more cephalic than other landmarks. Gender was weakly correlated to almost all landmarks (rp⁢b= 0.333 or weaker). Body mass index was weakly correlated to the accurate location of ILAS and quadratus lumborum, great trochanter, PSIS, and piriformis (rp⁢b=-0.307 or weaker). Systematic and propagation errors were present using sequential palpatory methods. Palpation in men was more sensitive and higher BMI was associated with lower sensitivity for lumbopelvic landmarks.

  18. Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

    PubMed Central

    Jutley-Neilson, Jagjeet; Russell, Nicholas C. C.; Sackley, Catherine M.

    2016-01-01

    Background. Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy. Methods. Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale. Results. Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs.) and were randomised. 70 commenced the intervention (n = 37) or an equivalent waiting period (n = 33). 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events. Discussion. Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review. Conclusion. A definitive trial is feasible. This trial is registered with ISRCTN84064492. PMID:27418997

  19. High Power Laser for Treatment of Achilles Tendinosis – a Single Blind Randomized Placebo Controlled Clinical Study

    PubMed Central

    Mårdh, Anders; Lund, Iréne

    2016-01-01

    Introduction: Pain in the Achilles tendon during loading is a very common condition. Conservative treatments, such as low level laser therapy (LLLT) have been reported to give varying results. Recently, a new laser treatment technique, high power laser treatment (HPLT) (Swiss DynaLaser®), was introduced in Scandinavia, but has not, to our knowledge, been systematically tested before. The objective of this study was to evaluate the effects of HPLT compared to placebo HPLT in rated pain and assessed pain threshold in patients with chronic Achilles tendinosis. Methods: The study was a randomized, single blind, placebo controlled trial. Patients were randomized to receive 6 treatments of either HPLT or placebo HPLT during a period of 3-4 weeks with a follow up period of 8-12 weeks. Outcome measures were rated pain according to questions of the Foot and Ankle Outcome Score (FAOS, Swedish version LK1.0) and assessment of electro-cutaneous stimulated pain threshold and matched pain (PainMatcher). Results: The results of the study demonstrated significant changes of assessments within groups, that were more pronounced towards lower levels of rated pain in the HPLT group than in the placebo HPLT group. The between group difference were significant in four of nine questions regarding loading activities of the FAOS subscale. Assessed pain thresholds were found increased in the HPLT group, as compared to the placebo HPLT group. At individual level, the results varied. Conclusion: The results indicate that HPLT may provide a future option for treatment of Achilles tendinosis related pain, but further studies are warranted. PMID:27330704

  20. Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study.

    PubMed

    Krymchantowski, Abouch Valenty; Carneiro, Henrique; Barbosa, Jackeline; Jevoux, Carla

    2008-06-01

    Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Society (IHS) (2004) were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM) was available after 2 hours and its use compared between groups. All patients completed the study. At 30 minutes, 0% of the dipyrone group 13% of the LC group were pain free (p=0.46). At 60 and 90 minutes, 2 (13%) and 5 (33%) patients from the dipyrone group and 11 (73%) and 13 (86.7%) patients from the LC group were pain free (p<0.001). At 60 minutes, significantly more patients from the LC group were nausea-free (p<0.001). Regarding photophobia, there were no differences between groups at 60 minutes (p=0.11). The use of RM at 2 hours did not differ among groups (p=0.50). Pain in the site of the injection was reported by more patients of the LC group compared to the dipyrone group (p<0.0001). LC is significantly superior to dipyrone in treating severe migraine attacks. LC promotes significantly more burning at the site of the injection.

  1. Bilateral compared with unilateral sacral nerve stimulation for faecal incontinence: results of a randomized, single-blinded crossover study.

    PubMed

    Duelund-Jakobsen, J; Buntzen, S; Lundby, L; Sørensen, M; Laurberg, S

    2015-12-01

    This randomized single-blinded crossover study aimed to investigate whether bilateral sacral nerve stimulation (SNS) is more efficient than unilateral stimulation for faecal incontinence (FI). Patients with FI who responded during a unilateral test stimulation, with a minimum improvement of 50% were eligible. Twenty-seven patients who were accepted to enter the trial were bilaterally implanted with two permanent leads and pacemakers. Patients were randomized into three periods of 4 weeks' stimulation including unilateral right, unilateral left and bilateral stimulation. Symptoms scores and bowel habit diaries were collected at baseline and in each study period. A 1-week washout was introduced between each study period. Twenty-seven (25 female) patients with a median age of 63 (36-84) years were bilaterally implanted from May 2009 to June 2012. The median number of episodes of FI per 3 weeks significantly decreased from 17 (3-54) at baseline to 2 (0-20) during stimulation on the right side, 2 (0-42) during stimulation on the left side and 1 (0-25) during bilateral stimulation. The Wexner incontinence score improved significantly from a median of 16 (10-20) at baseline to 9 (0-14) with right-side stimulation, 10 (0-15) with left-side stimulation and 9 (0-14) with bilateral stimulation. The differences between unilateral right or unilateral left and bilateral stimulation were non-significant, for FI episodes (P = 0.3) or for Wexner incontinence score (P = 0.9). Bilateral SNS therapy for FI is not superior to standard unilateral stimulation in the short term. Equal functional results can be obtained regardless of the side of implantation. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

  2. Effectiveness of different memory training programs on improving hyperphagic behaviors of residents with dementia: a longitudinal single-blind study.

    PubMed

    Kao, Chieh-Chun; Lin, Li-Chan; Wu, Shiao-Chi; Lin, Ker-Neng; Liu, Ching-Kuan

    2016-01-01

    Hyperphagia increases eating-associated risks for people with dementia and distress for caregivers. The purpose of this study was to compare the long-term effectiveness of spaced retrieval (SR) training and SR training combined with Montessori activities (SR + M) for improving hyperphagic behaviors of special care unit residents with dementia. The study enrolled patients with dementia suffering from hyperphagia resident in eight institutions and used a cluster-randomized single-blind design, with 46 participants in the SR group, 49 in the SR + M group, and 45 participants in the control group. For these three groups, trained research assistants collected baseline data on hyperphagic behavior, pica, changes in eating habits, short meal frequency, and distress to caregivers. The SR and SR + M groups underwent memory training over a 6-week training period (30 sessions), and a generalized estimating equation was used to compare data of all the three groups of subjects obtained immediately after the training period and at follow-ups 1 month, 3 months, and 6 months later. Results showed that the hyperphagic and pica behaviors of both the SR and SR + M groups were significantly improved (P<0.001) and that the effect lasted for 3 months after training. The improvement of fast eating was significantly superior in the SR + M group than in the SR group. The improvement in distress to caregivers in both intervention groups lasted only until the posttest. Improvement in changes in eating habits of the two groups was not significantly different from that of the control group. SR and SR + M training programs can improve hyperphagic behavior of patients with dementia. The SR + M training program is particularly beneficial for the improvement of rapid eating. Caregivers can choose a suitable memory training program according to the eating problems of their residents.

  3. Effectiveness of different memory training programs on improving hyperphagic behaviors of residents with dementia: a longitudinal single-blind study

    PubMed Central

    Kao, Chieh-Chun; Lin, Li-Chan; Wu, Shiao-Chi; Lin, Ker-Neng; Liu, Ching-Kuan

    2016-01-01

    Background Hyperphagia increases eating-associated risks for people with dementia and distress for caregivers. The purpose of this study was to compare the long-term effectiveness of spaced retrieval (SR) training and SR training combined with Montessori activities (SR + M) for improving hyperphagic behaviors of special care unit residents with dementia. Methods The study enrolled patients with dementia suffering from hyperphagia resident in eight institutions and used a cluster-randomized single-blind design, with 46 participants in the SR group, 49 in the SR + M group, and 45 participants in the control group. For these three groups, trained research assistants collected baseline data on hyperphagic behavior, pica, changes in eating habits, short meal frequency, and distress to caregivers. The SR and SR + M groups underwent memory training over a 6-week training period (30 sessions), and a generalized estimating equation was used to compare data of all the three groups of subjects obtained immediately after the training period and at follow-ups 1 month, 3 months, and 6 months later. Results Results showed that the hyperphagic and pica behaviors of both the SR and SR + M groups were significantly improved (P<0.001) and that the effect lasted for 3 months after training. The improvement of fast eating was significantly superior in the SR + M group than in the SR group. The improvement in distress to caregivers in both intervention groups lasted only until the posttest. Improvement in changes in eating habits of the two groups was not significantly different from that of the control group. Conclusion SR and SR + M training programs can improve hyperphagic behavior of patients with dementia. The SR + M training program is particularly beneficial for the improvement of rapid eating. Caregivers can choose a suitable memory training program according to the eating problems of their residents. PMID:27307717

  4. Validation of a simplified sham acupuncture technique for its use in clinical research: a randomised, single blind, crossover study.

    PubMed

    Kreiner, Marcelo; Zaffaroni, Ana; Alvarez, Ramón; Clark, Glenn

    2010-03-01

    The validity of a new sham acupuncture technique was tested on acupuncture naïve healthy subjects. The procedure was tested in accupoints LI4 and ST6 in a randomised, single blind and crossover study. The participants were blind to which technique they received. 32 healthy volunteers (15 men, 17 women, aged between 20 and 62 years, mean age 34 years) were recruited at the Universidad de la República, Uruguay. Interventions Participants were randomly assigned to one of two groups: (1) real acupuncture or (2) sham acupuncture. After 30 min, the patients were 'needled' again in a crossover design. Main outcome measures A yes/no questionnaire was used to assess the credibility and characteristics of the procedure. For the credibility question (do you think you received real acupuncture?) no statistically significant group differences were evident before or after the crossover. Subjects who answered yes to this question ranged from 14/16 (87.5%) before crossover to 10/16 (62.5%) after crossover for the sham and 12/16 (75%) before crossover to 15/16 (93.8%) after crossover for the real acupuncture. The question that showed a significant difference (only after crossover) was the question, "did you feel the needle penetrating the skin?"; after crossover 12/16 (75%) subjects in the real acupuncture group said yes and 2/16 (12%) subjects in the sham group said yes to this question (p<0.01). These data suggests that this method is credible and constitutes a simple and inexpensive technique for use as a control in clinical research in acupuncture naïve subjects.

  5. Treatment for non-thyroidal illness syndrome in advanced chronic kidney disease: a single-blind controlled study.

    PubMed

    Yan, Wenjun; Wang, Lijuan; Huang, Tianlun; Xu, Gaosi

    2017-08-01

    Non-thyroidal illness syndrome (NTIS) is common among patients with advanced chronic kidney disease (CKD) and is strongly associated with poor prognosis. However, it remains unclear in how to correct this disorder and this study aimed to evaluate the effectiveness of sodium bicarbonate (SB) and N-acetyl-cysteine (NAC) for correcting NTIS status. Patients with CKD stage 3-4 were single-blind, placebo-controlled treated with placebo, SB, or NAC for 18 weeks. The primary end points were the correction of NTIS and the occurrence of end-stage renal disease (ESRD). The secondary point was the change in estimated glomerular filtration rate (eGFR) after the follow-up. The Kaplan-Meier survival analysis showed significant lower correcting ratio of NTIS in control group compared with SB group [Hazard ratio (HR) 0.19, 95 % confidence interval (CI) 0.04-0.89, p = 0.035] and NAC group (HR 0.09, 95 % CI 0.02-0.38, p = 0.001), and increased ESRD risk in control group than in SB group (HR 1.97, 95 % CI 1.02-3.84, p = 0.045) and NAC group (HR 5.50, 95 % CI 2.23-13.57, p < 0.001). The Cox regression analysis demonstrated significantly different effectiveness of placebo, SB and NAC on NTIS correction and ESRD risk, p < 0.05, respectively. Variance analysis displayed a greater reduction in eGFR in controls than in SB (p = 0.044) and NAC group (p < 0.001). SB and NAC are effective in promoting the recovery from NTIS status and delaying the deterioration of renal function in advanced CKD patients.

  6. Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

    PubMed

    Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

    2017-05-01

    The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

  7. Soothing and anti-itch effect of quercetin phytosome in human subjects: a single-blind study

    PubMed Central

    Maramaldi, Giada; Togni, Stefano; Pagin, Ivan; Giacomelli, Luca; Cattaneo, Roberta; Eggenhöffner, Roberto; Burastero, Samuele E

    2016-01-01

    Background We evaluated the ability of quercetin, a natural antioxidant formulated in a specific delivery system, to reduce skin inflammation induced by a variety of stimuli, including UV radiation, stimulation with a histamine solution, or contact with chemical irritants. In particular, we tested the soothing and anti-itch effect of Quercevita®, 1% cream for external use, a formulation characterized by a phospholipids-based delivery system. Patients and methods The study was a monocentric, single blind trial that enrolled a group of 30 healthy volunteers. The back of each subject was examined to identify four quadrants with no previous skin damage or naevi that were treated in order to induce a controlled and reversible form of skin stress. The areas were treated as follows: no product; Quercevita® 1% cream, 2 mg/cm2; placebo; positive control (a commercially available topical formulation containing 1% dexchlorpheniramine). Results Only quercetin phospholipids 1% and dexchlorpheniramine 1% achieved a significant reduction in erythema with comparable results: (–10.05% [P=0.00329] for quercetin phospholipids 1% vs –14.05% [P=0.00046] for the positive control). Moreover, quercetin phospholipids 1% and dexchlorpheniramine 1% were both associated with a significant decrease in mean wheal diameter: (–13.25% and –12.23% for dexchlorpheniramine 1%, respectively). Similar findings were reported for the other tested parameters. Conclusion Quercetin has a skin protective effect against damage caused by a variety of insults, including UV radiation, histamine, or contact with toxic chemical compounds. Indeed, quercetin is able to reduce redness, itching, and inflammation of damaged skin; it may also help restore skin barrier function, increasing hydration, and reducing water loss. PMID:27013898

  8. Comparative effects of artemisia vulgaris and charcoal moxa stimulating Zhongwan (CV 12) on body temperature in healthy participants: a cross-over single-blind randomized study.

    PubMed

    Go, Ho-Yeon; Lee, Ju Ah; Park, Sunyoung; Park, Sunju; Park, Jeong-Su; Cheon, Chunhoo; Ko, Seong-Gyu; Kong, Kyung-Hwan; Jun, Chan-yong; Park, Jong-hyeong; Shin, Mi-Ran; Lee, Se-Hoon

    2015-10-01

    To evaluate the efficacy, safety, satisfaction, discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa. This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan (CV 12) is a cross-over single-blinded, randomized clinical trial. A total of 40 healthy subjects (24 males and 16 females) participated in this study. Two subjects dropped out of the trial. Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design. After treatment, the patients underwent a 30 minute waiting period, and then the temperatures at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4) were measured using digital infrared thermal imaging. After the use of Artemisia vulgaris moxa, the patients' body temperatures were slightly lowered at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After the use of charcoal moxa, the patients' body temperatures were somewhat increased at Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After Artemisia vulgaris moxa use, the body temperature difference between Zhongwan (CV 12) and Guanyuan (CV 4) was significantly increased. After charcoal moxa use, the body temperature difference between Tanzhong (CV 17) and Zhongwan (CV 12) was significantly decreased in males and in the whole group. This change was caused by the difference in the moxibustion type and by gender differences. This pilot study found that moxibustion did not raise the body temperature, but temperature differences between acupoints were affected. Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.

  9. Does myofascial and trigger point treatment reduce pain and analgesic intake in patients undergoing OnabotulinumtoxinA injection due to chronic intractable migraine? A pilot, single-blind randomized controlled trial.

    PubMed

    Gandolfi, Marialuisa; Geroin, Christian; Valè, Nicola; Marchioretto, Fabio; Turrina, Andrea; Dimitrova, Eleonora; Tamburin, Stefano; Serina, Anna; Castellazzi, Paola; Meschieri, Andrea; Ricard, François; Saltuari, Leopold; Picelli, Alessandro; Smania, Nicola

    2017-07-27

    Chronic migraine is a disabling disorder associated with myofascial and trigger point disorders in the neck. Pharmacological management is the first line of treatment; however, rehabilitation procedures aimed at lessening symptoms of myofascial and trigger point disorders may add value in the management of headache symptoms. To evaluate the feasibility of myofascial and trigger point treatment in chronic migraine patients receiving prophylactic treatment with onabotulinumtoxinA. To evaluate the treatment effects on headache frequency and intensity, analgesic consumption, cervical range of motion, trigger point pressure pain threshold, quality of life, and disability. Pilot, single-blind randomized controlled trial with two parallel groups. Neurorehabilitation unit. 22 outpatients with chronic migraine. Patients were randomly assigned to receive either cervicothoracic manipulative treatment (n=12) or transcutaneous electrical nerve stimulation (TENS) in the upper trapezius (n=10). Treatment consisted of 4 sessions (30 min/session, 1 session/week for 4 weeks). A rater blinded to treatment allocation evaluated outcomes before treatment, during treatment, and 1 month after the end of treatment. Consistent with the pilot nature of the study, feasibility was considered the primary outcome and efficacy the secondary outcome. All patients completed the study. No adverse events were reported. No significant between-group differences in pain intensity were observed during the study period. At post-treatment evaluation, the total consumption of analgesics (p=.02) and non-steroidal anti-inflammatory (p=.02) drugs was significantly lower in the manipulative treatment group than in the TENS group. These effects paralleled significant improvements in trigger point sensitivity and cervical active range of motion. Manipulative techniques aimed at reducing peripheral nociceptive triggers might add value in the management of chronic migraine symptoms and lower acute medication use

  10. Effectiveness of balneotherapy in chronic low back pain -- a randomized single-blind controlled follow-up study.

    PubMed

    Balogh, Zoltán; Ordögh, József; Gász, Attila; Német, László; Bender, Tamás

    2005-08-01

    Balneotherapy, a domain of medical science, focuses on utilizing the beneficial effects of medicinal waters. Low back pain is among the most prevalent musculoskeletal disorders affecting a large proportion of the population during their lifetime. Although small in number, all controlled studies published on this subject have demonstrated the benefits of balneotherapy. This present study was undertaken to compare the effects of hydrotherapy with mineral water vs. tap water on low back pain. A single-blind clinical study was carried out to appraise the therapeutic efficacy of reduced sulphurous water on 60 patients with low back pain. 30 subjects took baths in reduced sulphurous mineral water, whereas the other 30 patients used modified tap water of matching odor. Parameters determined at baseline, after balneo-/hydrotherapy, and at the end of the 3-month follow-up period included the results of the Visual Analogue Scale (VAS) score, the modified Oswestry index, mobility of the spine, antalgic posture, tenderness of the paravertebral muscles on palpation, the dose requirements for analgesics, and the efficacy assessed by the investigators and by the patients. Bathing in mineral water resulted in a statistically significant improvement. This was reflected by the VAS (p < 0.01) and manifested by the mitigation of muscle spasm (p < 0.01), the alleviation of local tenderness (p < 0.01), the enhanced flexion-extension and rotation of the spine (p < 0.01) as well as by the improvement of the Schober's index (p < 0.01). All these beneficial changes persisted as long as 3 months after the completion of balneotherapy. By contrast, hydrotherapy with tap water resulted only in the temporary improvement of just a single parameter: the VAS score improved significantly (p < 0.01). Balneotherapy in itself can alleviate low back pain. As demonstrated by this study, the analgesic efficacy and improvement of mobility accomplished by the use of mineral water is significantly superior

  11. Acute effects of beer on endothelial function and hemodynamics: a single-blind, crossover study in healthy volunteers.

    PubMed

    Karatzi, Kalliopi; Rontoyanni, Victoria G; Protogerou, Athanase D; Georgoulia, Aggeliki; Xenos, Konstantinos; Chrysou, John; Sfikakis, Petros P; Sidossis, Labros S

    2013-09-01

    Moderate consumption of beer is associated with lower cardiovascular (CV) risk. The goal of this study was to determine the effect of beer consumption on CV risk. To explore the underlying mechanisms, we studied the acute effects of the constituents of beer (alcohol and antioxidants), on established predictors of CV risk: endothelial function, aortic stiffness, pressure wave reflections and aortic pressure. In a randomized, single-blind, crossover study, 17 healthy, non-smoking, men (ages 28.5 ± 5.2 y with body mass index 24.4 ± 2.5 kg/m(2)) consumed on three separate occasions, at least 1 wk apart: 1. 400 mL of beer and 400 mL water, 2. 800 mL of dealcoholized beer (same amount of polyphenols as in the 400 mL of beer), and 3. 67 mL of vodka and 733 mL water (same amount of alcohol as in the 400 mL of beer). Each time aortic stiffness (pulse wave velocity), pressure wave reflections (AΙx), aortic and brachial pressure (Sphygmocor device), and endothelial function (brachial flow mediated dilatation) were assessed at fast and 1 and 2 h postprandial. Aortic stiffness was significantly and similarly reduced by all three interventions. However, endothelial function was significantly improved only after beer consumption (average 1.33%, 95% confidence interval [CI] 0.15-2.53). Although wave reflections were significantly reduced by all three interventions (average of beer: 9.1%, dealcoholized beer: 2.8%, vodka 8.5%, all CI within limits of significance), the reduction was higher after beer consumption compared with dealcoholized beer (P = 0.018). Pulse pressure amplification (i.e., brachial/aortic) was increased by all three test drinks. Beer acutely improves parameters of arterial function and structure, in healthy non-smokers. This benefit seems to be mediated by the additive or synergistic effects of alcohol and antioxidants and merits further investigation. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. Forced-use therapy for children with cerebral palsy in the community setting: a single-blinded randomized controlled pilot trial.

    PubMed

    Eugster-Buesch, Francisca; de Bruin, Eling D; Boltshauser, Eugen; Steinlin, Maja; Küenzle, Christoph; Müller, Elisabeth; Capone, Andrea; Pfann, Renat; Meyer-Heim, Andreas

    2012-01-01

    The aim of this study was to elucidate the feasibility, efficacy, and sustainability of a home-based, two-week, forced-use therapy (FUT) program for children with hemiplegic cerebral palsy (CP). A single-blinded, randomized controlled design was chosen. The Melbourne Assessment of Unilateral Upper Limb Function (MA) was carried out at baseline, pretest, post-test, and follow-up at two weeks, three months, and 12 months. Additionally, a questionnaire was used to evaluate the clinical relevance and integration of FUT in the home setting. 23 children, ages six to 16 years, took part in the study and were randomized into either an intervention group (n=12, mean age 9.8 ± 3.5 years) or a control group ($n=$ 11, mean age 11.7 ± 3.7 years). The intervention consisted of constraint of the unaffected hand for six hours per day and promotion of different activities of daily living according to an age-related manual for the use of the non-constraint hand. Unpaired t-tests for the change in MA scores relative to the pre-test values showed no difference between the groups at any time point: post-test (p=0.304), two weeks (p=0.193), or three months (p=0.957). Improvements in Activities of Daily Living (ADLs) assessed by questionnaires were observed by 64% of parents of the intervention group. Fifty-five percent of parents stated that the FUT program was exhausting and only 45% indicated that they achieved constraint for 6 hours per day. Our results evaluating a home-based FUT program of 14 days show no statistically significant improvement of upper extremity function in children with CP. The lack of compliance and absence of structured exercises proved to be considerable pitfalls of the home-based FUT program. Therefore, future home based FUT concepts should put special emphasis on the close monitoring and support of children and their families, as well as the integration of structured exercise sessions.

  13. A randomized, single-blind, placebo-controlled, split-face study with pimecrolimus cream 1% for papulopustular rosacea.

    PubMed

    Karabulut, A A; Izol Serel, B; Eksioglu, H M

    2008-06-01

    Rosacea is a common inflammatory skin disorder for which the pathogenesis is unclear. Currently, there is no cure for rosacea, and it seems that standard therapies have focused mainly on minimizing inflammation. The aim of this study is to investigate the potential efficacy, tolerability and safety profile of 1% pimecrolimus cream for the treatment of rosacea. Twenty-five patients with papulopustular rosacea were enrolled to a randomized, single-blinded, placebo-controlled, split-face trial of pimecrolimus cream 1% consisting 4 week treatment and 2 week follow-up period. The patients were instructed to apply first the 'left side cream' labelled placebo cream (Ultrabase cream, Intendis GmbH, Berlin, Germany) to the left hemi-face then the 'right side cream' labelled 1% pimecrolimus cream (Elidel; Novartis Pharma, Nuremberg, Germany) to the right hemi-face, twice daily. They were informed to apply a standard amount of each cream with the fingertip-unit and not allowed to use any other agent concomittantly other than sunblock. Clinical evaluation and subjective severity assessment were obtained along with photographic documentation at baseline, first, second, and fourth weeks of the therapy and at the follow-up visit. Rosacea severity score for each sign of erythema, papules, pustules, oedema, and telengiectesia were graded from 0 to 3. Patients were questioned for the subjective symptoms, overall improvement on appearance and side-effects. Twenty-four patients completed the study with an exceptional compliance and tolerable safety profile. One patient withdrew from the study due to severe flare-up reaction affecting both hemi-faces. The mean baseline total rosacea severity scores were 5.06 + 1.29 for both sides and reduced to 2.5 +/- 1.06 vs. 3.25 +/- 1.24 on pimecrolimus vs. placebo applied sides without the significance (P = 0.06). There was not any significant difference concerning each rosacea sign scores and total rosacea severity scores except for the

  14. Effects of isoflurane, sevoflurane, and desflurane on platelet function: A prospective, randomized, single-blind, in vivo study.

    PubMed

    Bozdogan, Nesrin; Madenoglu, Halit; Dogru, Kudret; Yildiz, Karamehmet; Kotanoglu, Mustafa S; Cetin, Mustafa; Boyaci, Adem

    2005-07-01

    The primary physiologic function of platelets is to facilitate hemostasisby aggregation. Volatile anesthetics have been reported to decrease platelet aggregation in vivo and in vitro. The aim of this study was to investigate the hematologic effectsof the anesthetics isoflurane, sevoflurane, and desflurane on hemoglobin (Hb), hematocrit (Hct), platelet count, activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), and platelet aggregation after minor surgery. Patients aged 20 to 60 years who were scheduled to undergominor surgery and American Society of Anesthesiologists physical status P1 or P2 (healthy or mild systemic disease) were randomized to 1 of 3 groups: 1 minimum alveolar concentration (MAC) of isoflurane, sevoflurane, or desflurane. None of the patients received premedication. Anesthesia was induced using IV thiopental 5 to 6 mg/kg, fentanyl 1 to 2 μg/kg, and vecuronium 0.1 mg/kg, and maintained with 1 MAC of isoflurane, sevoflurane, or desflurane in 66% nitrous oxide and 33% oxygen. Vecuronium 0.03 mg/kg was given when necessary for muscle relaxation. All patients were monitored throughout surgery; isotonic saline was given at a rate of 5 mL/kg · h. Hematologic studies were performed preoperatively, 15 minutes after intubation, and 1 hour after the end of surgery. Platelet aggregation tests were performed in a laboratory using a platelet function analyzer (PFA), collagen/epinephrine PFA test cartridges, collagen/adenosine diphosphate PFA test cartridges, and PFA trigger solution. This prospective, randomized, single-blind, in vivo study was conducted at Gevher Nesibe Teaching Hospital, Erciyes University, Kayseri, Turkey. Thirty patients (15 men, 15 women) were randomized to the 3 treatment groups (each, n = 10). Hb, Hct, platelet count, aPTT, PT, and INR were statistically similar between all 3 groups. The measured parameters were not significantly different between the isoflurane and desflurane

  15. Effects of exercise training on circulating levels of Dickkpof-1 and secreted frizzled-related protein-1 in breast cancer survivors: A pilot single-blind randomized controlled trial

    PubMed Central

    Park, Kyu-Sang; Park, Jeeyeon; Kim, Nahyun; Lee, Jong In; Kong, In Deok

    2017-01-01

    Background Wingless and integration site growth factor (Wnt) signaling is a tumorigenesis-related signaling pathway. Dickkpof-1 (DKK1) and secreted frizzled-related protein-1 (SFRP1) are endogenous negative regulators of Wnt/β-catenin signaling. Accumulating evidence indicates that higher serum levels of DKK1 are correlated with poor prognosis of various types of cancer. Here, we investigated whether exercise training causes changes in the serum levels of DKK1 and SFRP1 in patients with breast cancer. Methods Twenty-four breast cancer survivors, after chemo- or radiotherapy, participated in this single-blind randomized, controlled pilot study. Subjects were randomized to either an exercise program or a control group for 12 weeks and completed pre- and post-training tests for health-related fitness and body composition as well as blood biomarkers. The serum levels of DKK1 and SFRP1 were measured using enzyme-linked immunosorbent assay as the primary outcome. Results Exercise training for 12 weeks remarkably increased muscle strength, endurance, and flexibility and decreased body fat percentage, waist circumference, and visceral fat area (all p < 0.05). Exercise training lowered serum insulin levels and leptin/adiponectin ratios (all p < 0.05). The levels of DKK1 and SFRP1 were also significantly decreased by exercise training in breast cancer survivors (all p < 0.01). Conclusions Our results indicate that DKK1 and SFRP1 may be potentially useful biomarkers for evaluating the beneficial effects of long-term exercise on physical fitness and metabolism as well as the prognosis of patients with cancer. Trial registration ClinicalTrials.gov NCT02895178 PMID:28178355

  16. Combined effects of robot‑assisted gait training and botulinum toxin type A on spastic equinus foot in patients with chronic stroke: a pilot, single blind, randomized controlled trial.

    PubMed

    Picelli, Alessandro; Bacciga, Marco; Melotti, Camilla; LA Marchina, Elisabetta; Verzini, Elisabetta; Ferrari, Federico; Pontillo, Angelo; Corradi, Jessica; Tamburin, Stefano; Saltuari, Leopold; Corradini, Claudio; Waldner, Andreas; Smania, Nicola

    2016-12-01

    Despite the growing evidence about the use of robotic gait training in neurorehabilitation, there is a scant literature about the combined effects of this innovative technological approach and a first‑line treatment for focal spasticity as botulinum toxin type A. In particular, to the best of our knowledge, no previous study evaluated if robotic gait training may enhance the antispastic effect of botulinum toxin type A. To evaluate the combined effects of robot‑assisted gait training and botulinum toxin type A on spastic equinus foot in patients with chronic stroke. Pilot, single blind, randomized controlled trial. University hospital. Twenty‑two adult outpatients with spastic equinus due to chronic stroke. Participants were randomly assigned to two groups: patients allocated to the group 1 received robot‑assisted gait training (30 minutes a day for five consecutive days) after AbobotulinumtoxinA injection into the spastic calf muscles as well as patients allocated to the group 2 were only injected with AbobotulinumtoxinA into the same muscles. All patients were evaluated immediately before and one month after injection. The following outcome measures were considered: the modified Ashworth scale, the Tardieu scale and the 6-minute walking test. No difference was found between groups as to the modified Ashworth scale and the Tardieu scale measured at the affected ankle one month after botulinum toxin injection. A significant difference in the 6-minute walking test was noted between groups at the post‑treatment evaluation (P=0.045). Our preliminary findings support the hypothesis that robot‑assisted gait training does not enhance the effect of botulinum toxin type A on spastic equinus foot in patients with chronic stroke. Our observations should be taken into account in daily clinical rehabilitation practice in order to develop effective treatment protocols based on the enhancement of antispastic drugs effect.

  17. Acceptance and usability of different sunscreen formulations among outdoor workers: a randomized, single-blind, cross-over study.

    PubMed

    Bauer, Andrea; Hault, Kathrin; Püschel, Andrea; Rönsch, Henriette; Knuschke, Peter; Beissert, Stefan

    2014-03-01

    Adequate sun protection is often neglected during occupational outdoor work. To investigate the acceptance and usability of sunscreens during outdoor work a single-blind, randomized-controlled, cross-over trial was performed in 40 subjects. Two sunscreen formulations were used daily on working days for 4 weeks at a time, with a wash-out phase before crossover. The primary outcome was overall acceptance of the products with daily application. More than 80% of the outdoor workers were fully satisfied with the cosmetic properties, sweat resistance, performance and usability of both products under outdoor working conditions. With respect to overall performance, the milk was rated slightly better than the gel. In terms of ease of application, the milk was preferred (p<0.05). Sunscreens for those working outdoors must contain very high, broad-spectrum, photostable filters for both UVB and UVA, they must be easy to apply and sweat resistant, and should not irritate the eyes.

  18. Effect of chiropractic manipulation on vertical jump height in young female athletes with talocrural joint dysfunction: a single-blind randomized clinical pilot trial.

    PubMed

    Hedlund, Sofia; Nilsson, Hans; Lenz, Markus; Sundberg, Tobias

    2014-02-01

    The main objective of this pilot study was to explore the effect of chiropractic high-velocity, low-amplitude (HVLA) manipulation on vertical jump height in young female athletes with talocrural joint dysfunction. This was a randomized assessor-blind clinical pilot trial. Twenty-two female handball players with talocrural joint dysfunction were randomized to receive either HVLA manipulation (n = 11) or sham treatment (n = 11) once a week during a 3-week period. The main outcome was change in vertical jump height from baseline to follow-up within and between groups after 3 weeks. Nineteen athletes completed the study. After 3 weeks, the group receiving HVLA manipulation (n = 11) had a statistically significant mean (SD) improvement in vertical jump height of 1.07 (1.23) cm (P = .017). The sham treatment group (n = 8) improved their vertical jump height by 0.59 (2.03) cm (P = .436). The between groups' change was 0.47 cm (95% confidence interval, -1.31 to 2.26; P = .571) in favor of the group receiving HVLA manipulation. Blinding and sham procedures were feasible, and there were no reported adverse events. The results of this pilot study show that a larger-scale study is feasible. Preliminary results suggest that chiropractic HVLA manipulation may increase vertical jump height in young female athletes with talocrural joint dysfunction. However, the clinical result in favor of HVLA manipulation compared with sham treatment needs statistical confirmation in a larger randomized clinical trial. Copyright © 2014 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

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

    PubMed Central

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

    2015-01-01

    Introduction Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT). Method and analysis According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs. Ethics and dissemination The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals. Trial registration number NCT01741714. PMID:26586317

  20. Chiropractic spinal manipulative therapy for cervicogenic headache: a study protocol of a single-blinded placebo-controlled randomized clinical trial.

    PubMed

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

    2015-01-01

    Cervicogenic headache (CEH) is a secondary headache which affects 1.0-4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for CEH in a single-blinded placebo-controlled randomized clinical trial (RCT). According to the power calculations, we aim to recruit 120 participants to the RCT. Participants will be randomized 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 intervention and 3, 6 and 12 months. Primary end-point is headache frequency, while headache duration, headache intensity, headache index (frequency × duration × intensity) and medicine consumption are secondary end-points. Primary analysis will assess a change in headache frequency from baseline to the end of intervention and to follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Due to two group-comparisons, the results with p values below 0.025 will be considered statistically significant. For all secondary end-points and analyses, the significance level of 0.05 will be used. The results will be presented with the corresponding p values and 95 % confidence intervals. To our knowledge, this is the first prospective manual therapy three-armed single-blinded placebo-controlled RCT to be conducted for CEH. Current RCTs suggest efficacy in headache frequency, duration and intensity. However a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings. The present study design adheres to the recommendations for pharmacological RCTs as far as possible and follows the recommended clinical

  1. Hypertonic dextrose and morrhuate sodium injections (prolotherapy) for lateral epicondylosis (tennis elbow): results of a single-blind, pilot-level, randomized controlled trial.

    PubMed

    Rabago, David; Lee, Ken S; Ryan, Michael; Chourasia, Amrish O; Sesto, Mary E; Zgierska, Aleksandra; Kijowski, Rick; Grettie, Jessica; Wilson, John; Miller, Daniel

    2013-07-01

    Chronic lateral epicondylosis is common, debilitating, and often refractory. Prolotherapy (PrT) is an injection therapy for tendinopathy. The efficacy of two PrT solutions for chronic lateral epicondylosis was evaluated. This study is a three-arm randomized controlled trial. Twenty-six adults (32 elbows) with chronic lateral epicondylosis for 3 mos or longer were randomized to ultrasound-guided PrT with dextrose solution, ultrasound-guided PrT with dextrose-morrhuate sodium solution, or watchful waiting ("wait and see"). The primary outcome was the Patient-Rated Tennis Elbow Evaluation (100 points) at 4, 8, and 16 wks (all groups) and at 32 wks (PrT groups). The secondary outcomes included pain-free grip strength and magnetic resonance imaging severity score. The participants receiving PrT with dextrose and PrT with dextrose-morrhuate reported improved Patient-Rated Tennis Elbow Evaluation composite and subscale scores at 4, 8, and/or 16 wks compared with those in the wait-and-see group (P < 0.05). At 16 wks, compared with baseline, the PrT with dextrose and PrT with dextrose-morrhuate groups reported improved composite Patient-Rated Tennis Elbow Evaluation scores by a mean (SE) of 18.7 (9.6; 41.1%) and 17.5 (11.6; 53.5%) points, respectively. The grip strength of the participants receiving PrT with dextrose exceeded that of the PrT with dextrose-morrhuate and the wait and see at 8 and 16 wks (P < 0.05). There were no differences in magnetic resonance imaging scores. Satisfaction was high; there were no adverse events. PrT resulted in safe, significant improvement of elbow pain and function compared with baseline status and follow-up data and the wait-and-see control group. This pilot study suggests the need for a definitive trial.

  2. Is preoperative high-resolution magnetic resonance imaging accurate in predicting neurovascular compression in patients with trigeminal neuralgia? A single-blind study.

    PubMed

    Benes, Ludwig; Shiratori, Kiyoshi; Gurschi, Mariana; Sure, Ulrich; Tirakotai, Wuttipong; Krischek, Boris; Bertalanffy, Helmut

    2005-04-01

    High-resolution magnetic resonance imaging (HR-MRI) using three-dimensional fast imaging employing steady-state acquisition (3D-FIESTA) and double-dose contrast-enhanced three-dimensional fast spoiled gradient echo (3D-FSPGR) sequences is considered to be a useful tool in detecting neurovascular compression in patients with trigeminal neuralgia. The purpose of this study was to analyze the accuracy and preoperative diagnostic value of these high-resolution imaging techniques in patients with trigeminal neuralgia, in a single-blind study. The preoperative MRI images of 21 consecutive patients were matched to one neuroradiologist, who was blind as to which side exhibited the symptoms. The images and post-processing multiplanar reconstructions were compared with the video-documented operative observations. HR-MRI using only 3D-FSPGR sequences demonstrated neurovascular compression in accordance with the intraoperative finding in 11 patients (52.4%). In the subgroup where, additionally, 3D-FIESTA sequences were available, neurovascular compression was in accordance with the intraoperative finding in 71.4% (n = 7). High-resolution magnetic resonance imaging using double-dose contrast-enhanced 3D-FSPGR and 3D-FIESTA sequences is currently not sufficient enough to make an accurate prediction of neurovascular compression in a single-blind setting. These 3D imaging techniques currently provide only limited information, and one should consider their use carefully when identifying patients with trigeminal neuralgia from operation until image quality is improved by superior image resolution that can accurately discriminate vessels surrounding the trigeminal root entry zone.

  3. Lifestyle changes through the use of delivered meals and dietary counseling in a single-blind study. The STYLIST study.

    PubMed

    Noda, Keita; Zhang, Bo; Iwata, Atsushi; Nishikawa, Hiroaki; Ogawa, Masahiro; Nomiyama, Takashi; Miura, Shin-ichiro; Sako, Hideto; Matsuo, Kunihiro; Yahiro, Eiji; Yanase, Toshihiko; Saku, Keijiro

    2012-01-01

    Dietary habits are associated with obesity, and both are important contributing factors to lifestyle-related diseases. The STYLIST study examined the effects of dietary counseling by registered dietitians and the delivery of proper calorie-controlled meals (UMIN Registration No: 000006582). Two-hundred adult patients with hypertension and/or diabetes mellitus were randomly divided into 2 groups with/without dietary counseling and consumed an ordinary diet for 4 weeks. Each group was then subdivided into 2 groups with/without dietary counseling and received calorie-controlled lunch and dinner boxes for the next 4 weeks. The calories in the delivered meals were based on the subject's ideal body weight (BW) and physical activity level. BW, waist circumference, blood pressure, and laboratory data, including glycoalbumin, were measured at 0, 4, and 8 weeks. BW and the other parameters were significantly reduced during the study period in patients who received diet counseling in the ordinary diet period and/or delivered meal period but not in patients without dietary counseling, as assessed by linear mixed models for longitudinal data. The combination of dietary counseling by dietitians and delivery of calorie-controlled meals was effective in reducing BW, as well as blood pressure and glycoalbumin, in patients with hypertension and/or diabetes mellitus.

  4. Design and implementation of Pharyngeal electrical Stimulation for early de-cannulation in TRACheotomized (PHAST-TRAC) stroke patients with neurogenic dysphagia: a prospective randomized single-blinded interventional study.

    PubMed

    Dziewas, Rainer; Mistry, Satish; Hamdy, Shaheen; Minnerup, Jens; Van Der Tweel, Ingeborg; Schäbitz, Wolf; Bath, Philip M

    2017-06-01

    Rationale Ongoing dysphagia in stroke patients weaned from mechanical ventilation often requires long-term tracheotomy to protect the airway from aspiration. In a recently reported single-centre pilot study, a significantly larger proportion (75%) of tracheotomized dysphagic stroke patients regained sufficient control of airway management allowing tracheotomy tube removal (decannulation) 24-72 h after pharyngeal electrical stimulation (PES) compared to controls who received standard therapy over the same time period (20%). Aim To assess the safety and efficacy of PES in accelerating dysphagia rehabilitation and enabling decannulation of tracheotomized stroke patients. Design International multi-centre prospective randomized controlled single-blind trial in approximately 126 ICU patients (the 90th percentile of the calculated maximum sample size). Study outcomes Primary outcome: proportion of stroke patients considered safe for decannulation 24-72 h after PES compared to control patients who do not receive PES. Key secondary outcomes focus on: dysphagia severity, decannulation rates, decannulation rate after a repeat PES treatment in patients persistently dysphagic after an initial PES treatment, stroke severity, duration of ICU-stay, occurrence of adverse events including pneumonia and need for recannulation over 30 days or until hospital discharge (if earlier). Discussion Dysphagia and related airway complications are reported as one of the main reasons for stroke patients remaining tracheotomized once successfully weaned from ventilation. This study will evaluate if PES can improve airway safety sufficiently enough to allow earlier tracheotomy tube removal.

  5. Effects of treadmill training on cognitive and motor features of patients with mild to moderate Parkinson's disease: a pilot, single-blind, randomized controlled trial.

    PubMed

    Picelli, Alessandro; Varalta, Valentina; Melotti, Camilla; Zatezalo, Vanja; Fonte, Cristina; Amato, Stefania; Saltuari, Leopold; Santamato, Andrea; Fiore, Pietro; Smania, Nicola

    2016-01-01

    The aim of this pilot randomized controlled trial was to evaluate the effects of treadmill training on cognitive and motor performance in patients with Parkinson's disease (PD). Seventeen persons with mild to moderate PD were enrolled. Nine patients were allocated to the Intervention group and received twelve 45-minute sessions of treadmill training: one session a day, three days a week, for four consecutive weeks. Eight patients were allocated to the Control group; these patients did not undergo physical training but were required to have regular social interactions, following a specific lifestyle program. All the patients were evaluated at baseline and one month later. The primary outcome measures were the Frontal Assessment Battery-Italian version (FAB-it) and the 6-minute walking test (6MWT). At the one month evaluation significant differences were found between the groups in their performance on the FAB-it (p=0.005) and the 6MWT (p=0.018). Our findings support the hypothesis that treadmill training might effectively improve cognitive and motor features in patients with PD.

  6. Effects of treadmill training on cognitive and motor features of patients with mild to moderate Parkinson’s disease: a pilot, single-blind, randomized controlled trial

    PubMed Central

    Picelli, Alessandro; Varalta, Valentina; Melotti, Camilla; Zatezalo, Vanja; Fonte, Cristina; Amato, Stefania; Saltuari, Leopold; Santamato, Andrea; Fiore, Pietro; Smania, Nicola

    2016-01-01

    Summary The aim of this pilot randomized controlled trial was to evaluate the effects of treadmill training on cognitive and motor performance in patients with Parkinson’s disease (PD). Seventeen persons with mild to moderate PD were enrolled. Nine patients were allocated to the Intervention group and received twelve 45-minute sessions of treadmill training: one session a day, three days a week, for four consecutive weeks. Eight patients were allocated to the Control group; these patients did not undergo physical training but were required to have regular social interactions, following a specific lifestyle program. All the patients were evaluated at baseline and one month later. The primary outcome measures were the Frontal Assessment Battery-Italian version (FAB-it) and the 6-minute walking test (6MWT). At the one-month evaluation significant differences were found between the groups in their performance on the FAB-it (p=0.005) and the 6MWT (p=0.018). Our findings support the hypothesis that treadmill training might effectively improve cognitive and motor features in patients with PD. PMID:27027891

  7. [Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study)].

    PubMed

    Pujet, J C; Keddad, K; Sévenier, F; Jolivet-Landreau, I

    2002-01-01

    The objective was to compare, during a 5-day therapy, the efficacy and tolerability of an antihistaminic antitussive syrup, oxomemazine, combining a small quantity of guaifenesine (T), with a centrally acting antitussive, clobutinol (S), in adult patients aged from 18 to 70 years and presenting with a dry cough of infectious origin. This study was performed by 22 general practitioners and 130 ambulatory patients were enrolled. The primary criterion of this multicenter, randomized, single blind study was to compare the evolution of cough intensity using a Visual Analog Squale (VAS) graduated from 0 to 10 cm. Nine secondary criteria including tolerability were also assessed. With regard to cough intensity, the treatments were not equivalent. A greater reduction was observed with T (-5.2 +/- 2.3 versus -4.3 +/- 2.3). This result was confirmed by a further reduction in cough intensity at days: 2 (p = 0.04), 4 (p = 0.05), and 5 (p = 0.02). The frequency of cough disappearance before the end of the study was significantly greater for T than for S: 46% versus 29% (p = 0.05). The time before disappearance of the cough was 4.0 + 1.1 days for both medicines. Induction of sleep and the frequency of nocturnal wakening were significantly better for T from day 4 (p = 0.02). The drowsiness induced by T meant that diurnal quality of life was better with S on days 1 (p = 0.002) and 2 (p = 0.01). Tolerability was similar for both medicines. In conclusion, as a symptomatic treatment of dry cough, T is efficient and well tolerated. Moreover, we have observed a tendency towards superior efficacy of T than S. T is therefore a useful alternative in the therapeutic armamentarium available to the general practitioner.

  8. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study.

    PubMed

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

  9. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study

    PubMed Central

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up. PMID:26380359

  10. Effects of a commercial product containing guaraná on psychological well-being, anxiety and mood: a single-blind, placebo-controlled study in healthy subjects.

    PubMed

    Silvestrini, Gianluca Ivan; Marino, Franca; Cosentino, Marco

    2013-05-25

    Guaranà (Paulinia cupana) seed extracts are increasingly popular worldwide for their stimulant, cognitive and behavioral effects. To assess the effects on psychological well-being, anxiety and mood of a commercially available guaranà preparation taken regularly over several days according to the labelled dosages and instructions, 27 healthy volunteers were enrolled in a prospective, randomized, single-blind, placebo-controlled, crossover study. Guaranà 350 mg × 3 daily just after breakfast or placebo were given for 5 consecutive days. Assessment was performed one day after the last intake and included the psychological well-being (PWB) scales, the self-rating anxiety state scale (SAS), and the Bond-Lader mood scales. There were no significant differences between guaranà and placebo in any of the 6 areas of PWB, in SAS, as well as in any of the 16 mood scales. In healthy subjects a 5-day treatment with a commercial preparation of guaranà used according to labelled instructions provided no evidence for any major effects on psychological well-being, anxiety and mood. Considering the increasing popularity of guaranà-containing products sold as dietary supplements for fitness purposes, controlled studies are strongly warranted to assess their benefits in comparison to the labelled claims.

  11. Effects of a commercial product containing guaraná on psychological well-being, anxiety and mood: a single-blind, placebo-controlled study in healthy subjects

    PubMed Central

    2013-01-01

    Background Guaranà (Paulinia cupana) seed extracts are increasingly popular worldwide for their stimulant, cognitive and behavioral effects. To assess the effects on psychological well-being, anxiety and mood of a commercially available guaranà preparation taken regularly over several days according to the labelled dosages and instructions, 27 healthy volunteers were enrolled in a prospective, randomized, single-blind, placebo-controlled, crossover study. Results Guaranà 350 mg × 3 daily just after breakfast or placebo were given for 5 consecutive days. Assessment was performed one day after the last intake and included the psychological well-being (PWB) scales, the self-rating anxiety state scale (SAS), and the Bond–Lader mood scales. There were no significant differences between guaranà and placebo in any of the 6 areas of PWB, in SAS, as well as in any of the 16 mood scales. Conclusions In healthy subjects a 5-day treatment with a commercial preparation of guaranà used according to labelled instructions provided no evidence for any major effects on psychological well-being, anxiety and mood. Considering the increasing popularity of guaranà-containing products sold as dietary supplements for fitness purposes, controlled studies are strongly warranted to assess their benefits in comparison to the labelled claims. PMID:23706111

  12. Sotalol vs metoprolol for ventricular rate control in patients with chronic atrial fibrillation who have undergone digitalization: a single-blinded crossover study.

    PubMed

    Kochiadakis, G E; Kanoupakis, E M; Kalebubas, M D; Igoumenidis, N E; Vardakis, K E; Mavrakis, H E; Vardas, P E

    2001-01-01

    To compare the effects of sotalol and metoprolol on heart rate, during isotonic (ITE) and isometric (IME) exercise and daily activities, in digitalized patients with chronic atrial fibrillation. The study had a randomized, single-blinded, crossover design. Twenty-three patients with chronic atrial fibrillation received placebo for 4 weeks, followed by a 4-week period of treatment with sotalol and metoprolol in random order. At the end of each period, the patients were assessed with 24-h ECG monitoring, a cardiopulmonary exercise test and a handgrip manoeuvre. Both agents produced a lower heart rate than placebo at rest and at all levels of isotonic exercise (P < 0.001) without affecting oxygen uptake. Sotalol produced a lower heart rate than metoprolol only at submaximal exercise (116 +/- 9 bpm for sotalol vs 125 +/- 11 bpm for metoprolol, P < 0.001). During isometric exercise, sotalol produced a lower maximum heart rate than did metoprolol (113 +/- 22 vs 129 +/- 18 bpm, respectively). Both agents produced a lower mean heart rate than placebo over 24 h (P < 0.001 for all), while sotalol produced a lower mean heart rate than metoprolol during the daytime (P < 0.01). Sotalol is a safe and effective agent for control of heart rate in digitalized patients with atrial fibrillation. Sotalol is superior to metoprolol at submaximal exercise, resulting in better rate control during daily activities.

  13. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study.

    PubMed

    Agarwal, Anil; Nath, S S; Goswami, Debolina; Gupta, Devendra; Dhiraaj, Sanjay; Singh, Prabhat K

    2006-10-01

    Postoperative sore throat (POST), although a minor complication, remains a source of postoperative morbidity. We compared the efficacy of dispersible aspirin gargle to benzydamine hydrochloride (a topical nonsteroidal anti inflammatory drug) gargles for prevention of POST. We enrolled 60 consecutive female patients, 16-60 yr of age, ASA physical status I or II, undergoing elective modified radical mastectomy under general anesthesia in this prospective, randomized, placebo-controlled, single-blind study. Patients were randomly divided into 3 groups of 20 subjects each: Group 1 (C) mineral water; Group 2 (AS) tab aspirin 350 mg; and Group 3 (BH) 15 mL of benzydamine hydrochloride (0.15%). All the medications were made into 30 mL of solution. Patients were asked to gargle this mixture for 30 s, 5 min before induction of anesthesia. Grading of POST was done at 0, 2, 4, and 24 h postoperatively on a 4-point scale (0-3). Aspirin gargles reduced the incidence of POST for 4 h whereas benzydamine hydrochloride gargles reduced POST for 24 h. POST was more severe in the control group at 0 and 2 h (P < 0.05). Aspirin and benzydamine hydrochloride gargles significantly reduced the incidence and severity of POST (P < 0.05).

  14. Rotation exercise classes did not improve function in women with non-specific chronic low back pain: A randomized single blind controlled study.

    PubMed

    Segal-Snir, Yael; Lubetzky, V Anat; Masharawi, Youssef

    2016-08-10

    Exercise is considered the first line of treatment for people with non-specific chronic low back pain (NSCLBP) but the ideal exercise type is currently unclear. Given the unique anatomical structure of the lower lumbar spine and the lumbosacral junction transverse-plane rotation exercises may be helpful for people suffering from pain in this region. We aimed to examine the effect of spinal rotation exercises delivered in a group format on range of motion, pain level and function parameters in women with NSCLBP. This was a randomized controlled single-blinded study. Thirty-five women with NSCLBP, participated in either a bi-weekly rotation exercise classes (n= 20) or a `wait-list' control group (n = 15). The exercises aimed at improving lumbar mobility in the transverse plane. Pain rated on a Visual Analog Scale, back specific disability (Rolland Morris questionnaire), and lumbar range of motion (flexion, extension and left and right rotation) were taken prior to intervention, immediately following 4 weeks of intervention and 8 weeks later. There were no significant differences for either group (p> 0.05) on all dependent variables at all times of measurements. A specific group program of rotation exercises had no effect on the functional status, pain level and lumbar range of motion in women with NSCLBP.

  15. A Randomized, Single-Blind, Substitution Study of OROS Methylphenidate (Concerta) in ADHD Adults Receiving Immediate Release Methylphenidate

    ERIC Educational Resources Information Center

    Spencer, Thomas J.; Mick, Eric; Surman, Craig B. H.; Hammerness, Paul; Doyle, Robert; Aleardi, Megan; Kotarski, Meghan; Williams, Courtney G.; Biederman, Joseph

    2011-01-01

    Objective: The main aim of this study was to examine the efficacy, tolerability, and compliance of an extended-release formulation of methylphenidate (OROS-MPH) in adults with ADHD receiving immediate-release methylphenidate (IR-MPH). Method: Participants were outpatient adults with ADHD who were stable on IR-MPH-administered TID. Participants…

  16. A Randomized, Single-Blind, Substitution Study of OROS Methylphenidate (Concerta) in ADHD Adults Receiving Immediate Release Methylphenidate

    ERIC Educational Resources Information Center

    Spencer, Thomas J.; Mick, Eric; Surman, Craig B. H.; Hammerness, Paul; Doyle, Robert; Aleardi, Megan; Kotarski, Meghan; Williams, Courtney G.; Biederman, Joseph

    2011-01-01

    Objective: The main aim of this study was to examine the efficacy, tolerability, and compliance of an extended-release formulation of methylphenidate (OROS-MPH) in adults with ADHD receiving immediate-release methylphenidate (IR-MPH). Method: Participants were outpatient adults with ADHD who were stable on IR-MPH-administered TID. Participants…

  17. A New Method for Sham-Controlled Acupuncture in Experimental Visceral Pain - a Randomized, Single-Blinded Study.

    PubMed

    Juel, Jacob; Liguori, Stefano; Liguori, Aldo; Valeriani, Massimiliano; Graversen, Carina; Olesen, Søren S; Drewes, Asbjørn M

    2016-07-01

    Acupuncture is increasingly used as an alternative to medical therapy for various pain conditions. To study the effect of acupuncture in experimental and clinical studies, a control condition with sham acupuncture is needed. However, as such models have not been established in assessment of acupunctures effect against visceral pain, this study aimed to validate a new method for blinded sham acupuncture in experimental rectal pain. Fifteen subjects underwent a sequence of either sham or real acupuncture in randomized order. In the sham arm, a hollow inner tube with a sharp tip was fitted into an outer tube and subjects were blinded to the stimulations. Before and after the intervention, pain was induced by rectal stimulation with an inflatable balloon distended until the subjects' pain threshold was reached. The resting electroencephalogram (EEG) was quantified by spectral power analysis to explore the central nervous system effects objectively. Additionally, after the second study day, the subject was asked to indicate the sequence of interventions. A significant increase in rectal balloon volume was observed after sham 12 ± 21 mL (P = 0.049) and acupuncture 17 ± 30 mL (P = 0.046). However, the change in volume was not different between groups (P = 0.6). No differences in EEG spectral power distributions between sham and acupuncture were seen (all P > 0.6). The correct sequence of sham and acupuncture was indicated by 36% of the subjects (P = 0.4). The presented sham procedure provides a valid method for blinding of "sham acupuncture" and may be used in future blinded controlled trials of acupuncture for visceral pain. © 2015 World Institute of Pain.

  18. Digital assistance of nasogastric tube insertion in intubated patients under general anesthesia: A single-blinded prospective randomized study

    PubMed Central

    Kandeel, Alrefaey; Elmorhedi, Mohammed; Abdalla, Usama

    2017-01-01

    Background: Nasogastric tube (NGT) insertion may pose a special problem in patients under general anesthesia with first attempt failure rates up to 50%. To increase insertion success rate and decreases related complications, several techniques have been developed. In this study, digital assistance technique is compared to the classic insertion technique in neck flexion. Materials and Methods: In this prospective randomized study, 160 patients were randomly allocated into two groups; control group (Group C, n = 80) where NGT tube will be inserted with the neck in flexion position and digital facilitation group (Group D, n = 80). Results: Overall success rate and first attempt success were statistically higher in Group D compared to Group C (94% vs. 81%, P = 0.02, 80% vs. 62%, P = 0.01 respectively) with significantly lower insertion time in Group D (13 ± 5 s. vs. 10 ± 3 s., P = 0.00). Conclusions: Digital assistance of NGT insertion in the anesthetized or unconscious patient is an effective, fast, and safe method that can be either used as a routine technique or as a rescue in case of failed other methods. PMID:28757827

  19. Digital assistance of nasogastric tube insertion in intubated patients under general anesthesia: A single-blinded prospective randomized study.

    PubMed

    Kandeel, Alrefaey; Elmorhedi, Mohammed; Abdalla, Usama

    2017-01-01

    Nasogastric tube (NGT) insertion may pose a special problem in patients under general anesthesia with first attempt failure rates up to 50%. To increase insertion success rate and decreases related complications, several techniques have been developed. In this study, digital assistance technique is compared to the classic insertion technique in neck flexion. In this prospective randomized study, 160 patients were randomly allocated into two groups; control group (Group C, n = 80) where NGT tube will be inserted with the neck in flexion position and digital facilitation group (Group D, n = 80). Overall success rate and first attempt success were statistically higher in Group D compared to Group C (94% vs. 81%, P = 0.02, 80% vs. 62%, P = 0.01 respectively) with significantly lower insertion time in Group D (13 ± 5 s. vs. 10 ± 3 s., P = 0.00). Digital assistance of NGT insertion in the anesthetized or unconscious patient is an effective, fast, and safe method that can be either used as a routine technique or as a rescue in case of failed other methods.

  20. Effects of psychoeducation on helpful support for complicated grief: a preliminary randomized controlled single-blind study.

    PubMed

    Nam, I S

    2016-01-01

    Complicated grief is a distinct psychological response of individuals facing the loss of a loved one and can lead to many types of adverse health outcomes. Although social support may be beneficial, few studies have examined the beneficial effects of helpful support on complicated grief following bereavement. A randomized controlled trial was conducted. Bereaved participants and supporters were randomized to psychoeducation on complicated grief and helpful social support or psychoeducation on complicated grief. The primary outcome was the Inventory of Complicated Grief. The results showed that psychoeducation of supporters of bereaved individuals has significant beneficial effects. Particularly, symptoms of complicated grief were decreased in bereaved individuals with supporters that received psychoeducation. The results highlight the potential of psychoeducation to facilitate helpful social support and reduce complicated grief.

  1. Massage after exercise--responses of immunologic and endocrine markers: a randomized single-blind placebo-controlled study.

    PubMed

    Arroyo-Morales, Manuel; Olea, Nicolas; Ruíz, Concepción; del Castilo, Juan de Dios Luna; Martínez, Manuel; Lorenzo, Carmen; Díaz-Rodríguez, Lourdes

    2009-03-01

    The effectiveness of massage for postexercise recovery remains unclear, despite numerous studies on this issue. The aim of this study was to determine the effect of massage on endocrine and immune functions of healthy active volunteers after intense exercise. After repeated Wingate tests, the effects of whole-body massage and placebo on salivary cortisol, immunoglobulin A (IgA), and total protein levels were compared using a between-group design. Sixty healthy active subjects (23 women, 37 men) underwent 2 exercise protocol sessions at least 2 weeks apart and at the same time of day. The first session familiarized participants with the protocol. In the second session, after a baseline measurement, subjects performed a standardized warm-up followed by three 30-second Wingate tests. After active recovery, subjects were randomly allocated to massage (40-minute myofascial induction) or placebo (40-minute sham electrotherapy) group. Saliva samples were taken before and after the exercise protocols and after recovery. In both groups, the exercise protocol induced a significant increase in cortisol (p < 0.001), decrease in salivary IgA (sIgA) (p < 0.001), and increase in total proteins (p = 0.01) in saliva. Generalized estimating equations showed a significant effect of massage on sIgA rate (p = 0.05), a tendency toward significant effect on salivary total protein levels (p = 0.10), and no effect on salivary flow rate (p = 0.55) or salivary cortisol (p = 0.39). The sIgA secretion rate was higher after the recovery intervention than at baseline among women in the massage group (p = 0.03) but similar to baseline levels among women in the placebo group (p = 0.29). Massage may favor recovery from the transient immunosuppression state induced by exercise in healthy active women, of particular value between high-intensity training sessions or competitions on the same day.

  2. Acute effects of beer on endothelial function and haemodynamics: a single-blind, cross-over study in healthy volunteers

    PubMed Central

    Karatzi, Kalliopi; Rontoyanni, Victoria G.; Protogerou, Athanase D.; Georgoulia, Aggeliki; Xenos, Konstantinos; Chrysou, John; Sfikakis, Petros P.; Sidossis, Labros S.

    2015-01-01

    Objective Moderate consumption of beer is associated with lower cardiovascular (CV) risk. To explore the underlying mechanisms we studied the acute effects of the constituents of beer (alcohol and antioxidants), on established predictors of CV risk: endothelial function, aortic stiffness, pressure wave reflections and aortic pressure. Research Methods & Proceedures In a randomized, single – blind, cross - over study 17 healthy, non-smoking, volunteers (28.5±5.2 years and 24.4±2.5 BMI) consumed in 3 separate days, at least one week apart: a) 400 ml of beer & 400 ml water, b) 800 ml of dealcoholized beer (same amount of polyphenols), and c) 67 ml of vodka & 733 ml water (same amount of alcohol). Each time aortic stiffness (pulse wave velocity, pressure wave reflections (Aix), aortic and brachial pressure (Sphygmocor device) and endothelial function (brachial flow mediated dilatation) were assessed at fast and 1 and 2 hours postprandial. Results Aortic stiffness was significantly and similarly reduced by all 3 interventions. However, endothelial function was significantly improved only after beer consumption (average of 1.33%, CI 0.15-2.53). Although wave reflections were significantly reduced by all 3 interventions (average of beer: 9.1%, dealcoholized beer: 2.8%, vodka 8.5%, all CI within limits of significance), the reduction was higher after beer consumption compared todealcoholized beer (p=0.018). Pulse pressure amplification (i.e. brachial/aortic) was increased by all 3 test drinks. Conclusions Beer improves acutely parameters of arterial function and structure, in healthy non-smokers. This benefit seems to be mediated by the additive or synergistic effects of alcohol and anti-oxidants and merits further investigation. PMID:23810643

  3. Effects of neuromuscular electrical stimulation on cytokines in peripheral blood for healthy participants: a prospective, single-blinded Study.

    PubMed

    Truong, Alexander D; Kho, Michelle E; Brower, Roy G; Feldman, Dorianne R; Colantuoni, Elizabeth; Needham, Dale M

    2017-05-01

    The effect of exercise on cytokines may improve muscle strength. Neuromuscular electrical stimulation (NMES) is a muscle-preserving therapy that benefits patients unable to participate in active exercise. How NMES alters cytokines is unclear. The aim of this study was to study the effects of 1 NMES session on cytokines associated with protein metabolism during exercise. We evaluated the effects of NMES on IL-1, IL-6, IL-10 and TNF-α levels in peripheral blood. Participants received NMES to bilateral lower extremity muscles (quadriceps, tibialis anterior, gastrocnemius) for 30 min. Blood samples immediately pre- and post-NMES were drawn at 15-min intervals to 2-h follow-up, and the mean values of pre-NMES levels were compared to peak and trough post-NMES levels. For cytokines with significant changes, we conducted a repeated-measures linear regression analysis. We also measured post-NMES lactate and creatine kinase levels. We enrolled nine eligible participants. There was a significant increase in peak IL-6 from the mean pre-NMES value [0·65 (0·89) to 1·04 (0·89) pg ml(-1) , P = 0·001] and a significant decrease in trough IL-1 [0·08 (0·07) to 0·02 (0·02) pg ml(-1) , P = 0·041] and TNF-α [2·42 (0·54) to 2·16 (0·59) pg ml(-1) , P = 0·021]. In repeated-measures regression analysis, we identified significantly higher mean IL-6 values throughout the full 120 min post-NMES period, and a significantly higher mean IL-1 value at 30 min post-NMES. There were no significant differences in peak IL-10, trough IL-6, lactate, or creatine kinase values. In nine healthy humans, 30 min of NMES was temporally associated with changes in cytokines similar to the effects of active exercise and may mediate NMES' observed effects on reducing muscle weakness. © 2015 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

  4. Nailfold capillary microscopy in healthy children and in childhood rheumatic diseases: a prospective single blind observational study

    PubMed Central

    Dolezalova, P; Young, S; Bacon, P; Southwood, T

    2003-01-01

    differ significantly between study groups. Conclusions: This study is unique in measuring objective quantitative and qualitative parameters of the nailfold vasculature across a wide spectrum of age and disease. Differences in capillary morphology and frequency in children with CTD compared with other paediatric diseases and healthy controls were demonstrated. In the clinical situation, an assessment of the general degree of disarrangement may offer a fast tool for assessment of the nailfold vasculature which correlates well with NFC data. PMID:12695158

  5. Recurrent acute rhinosinusitis: a single blind clinical study of N-acetylcysteine vs ambroxol associated to corticosteroid therapy.

    PubMed

    Macchi, A; Terranova, P; Castelnuovo, P

    2012-01-01

    The aim of rhinosinusitis treatment is to restore sinusal eutrophism and to normalize ventilation and mucociliary transport. Frequently the improvement of sinusal physiological conditions is associated with a reduction of infections and pulmonary symptoms. The treatment of these diseases often requires the combination of medical and surgical strategies. In particular, the aim of the medical therapy is multiple: to treat the infection (with antibiotics), to reduce the mucosal swelling (with corticosteroids) and to improve mucus drainage (with mucolytics or muco-regulators). The use of atomized nasal douche, as a washing of the nasal fossas, is chosen because of its local action minimizing systemic adverse effects. The surgical treatment is secondary to medical failure, and it is focused on clearing the sinusal ostia in the sphenoethmoidal recess and the osteomeatal complex. In case of recurrent sinonasal diseases the importance of the surgical operation is represented by the fact that the medical treatment better reaches the target in the sinusal space. This study is focused on the primary medical treatment of acute recurrent rhinosinusitis. The patients who immediately needed surgical treatment were excluded from the study (because of the presence of an anatomical obstruction of the osteomeatal complex and/or the sphenoethmoidal recess, hence non-susceptible to improvement by medical therapy alone), and these patients were immediately addressed to undergo a CT scan examination in order to be involved in a future surgical programme. The medical treatment for those forms which do not require antibiotics (i.e. when infections are not involved), is based on the use of topical corticosteroids. While there are controversies on the real efficacy of adding mucolytic agents to the steroids, they are commonly prescribed in clinical practice, with the rationale of reducing viscosity and improving clearance of mucus in order to help the restoration of the physiological sinus

  6. Different types of exercise in Multiple Sclerosis: Aerobic exercise or Pilates, a single-blind clinical study.

    PubMed

    Kara, Bilge; Küçük, Fadime; Poyraz, Esra Coşkuner; Tomruk, Melda Soysal; İdıman, Egemen

    2017-01-01

    The aim of our study is to examine effects of aerobic and Pilates exercises on disability, cognition, physical performance, balance, depression and fatigue in relapsing-remitting Multiple Sclerosis (MS) patients as compared to healthy controls. The subjects were divided as aerobic exercise (n = 26), Pilates (n = 9), and the healthy control group (n = 21). We used MSFC, physical performance, Berg balance scale, Beck depression scale, fatigue impact scale. All evaluations were performed before and after exercise training. There are statistically meaningful differences between Nine hole testing, PASAT 3, physical performance and fatique impact scale before and after aerobic exercise. Also we found significant difference for physical performance in the Pilates group. There are no significant differences in measures of fatique impact scale and depression between aerobic exercise group and the healthy controls after exercise. We found significant differences between Pilates and control group's after measurements except depression. There were significant differences between the Pilates and aerobic group for cognitive tests in favor of the Pilates group. Aerobic exercise and clinical Pilates exercises revealed moderate changes in levels of cognitive, physical performance, balance, depression, fatigue in MS patients.

  7. Comparative Analysis of Local Anesthesia with 2 Different Concentrations of Adrenaline: A Randomized and Single Blind Study

    PubMed Central

    Managutti, Anil; Prakasam, Michael; Puthanakar, Nagraj; Menat, Shailesh; Shah, Disha; Patel, Harsh

    2015-01-01

    Background: Local anesthetic agents are more commonly used in dentistry to have painless procedure during surgical intervention in bone and soft tissue. There are many local anesthetic agents available with the wide selection of vaso-constrictive agents that improve the clinical efficacy and the duration of local anesthesia. Most commonly lignocaine with adrenaline is used in various concentrations. Systemically adrenaline like drugs can cause a number of cardiovascular disturbances while most are short lived, permanent injury or even death may follow in drug induced ventricular fibrillation, myocardial infarction or cerebro-vascular accidents. This study compared the efficacy and cardiovascular effects with the use of 2% lignocaine with two different concentrations. Materials and Methods: Forty patients underwent extractions of mandibular bilateral teeth using 2% lignocaine with two different concentrations - one with 1:80000 and the other with 1:200000. Results: There was no significant difference in the efficacy and duration with the 2% lignocaine with 2 different concentrations. 2% lignocaine with 1:80000 adrenaline concentration has significantly increased the heart rate and blood pressure especially systolic compared with the lignocaine with 1:200000. Conclusion: Though 2% lignocaine with 1:80000 is widely used in India, 1:200000 adrenaline concentrations do not much affect the cardiovascular parameters. So it is recommended to use 2% lignocaine with 1:200000 for cardiac patients. PMID:25878474

  8. Rehabilitation of the hemiparetic gait by nociceptive withdrawal reflex-based functional electrical therapy: a randomized, single-blinded study.

    PubMed

    Spaich, Erika Geraldina; Svaneborg, Niels; Jørgensen, Helle Rovsing Møller; Andersen, Ole Kæseler

    2014-05-07

    Gait deficits are very common after stroke and improved therapeutic interventions are needed. The objective of this study was therefore to investigate the therapeutic use of the nociceptive withdrawal reflex to support gait training in the subacute post-stroke phase. Individuals were randomly allocated to a treatment group that received physiotherapy-based gait training supported by withdrawal reflex stimulation and a control group that received physiotherapy-based gait training alone. Electrical stimuli delivered to the arch of the foot elicited the withdrawal reflex at heel-off with the purpose of facilitating the initiation and execution of the swing phase. Gait was assessed before and immediately after finishing treatment, and one month and six months after finishing treatment. Assessments included the Functional Ambulation Category (FAC) test, the preferred and maximum gait velocities, the duration of the stance phase in the hemiparetic side, the duration of the gait cycle, and the stance time symmetry ratio. The treatment group showed an improved post treatment preferred walking velocity (p < 0.001) and fast walking velocity (p < 0.001) compared to the control group. Furthermore, subjects in the treatment group with severe walking impairment at inclusion time showed the best improvement as assessed by a longer duration of the stance phase in the hemiparetic side (p < 0.002) and a shorter duration of the gait cycle (p < 0.002). The stance time symmetry ratio was significantly better for the treatment than the control group after finishing training (p < 0.02). No differences between groups were detected with the FAC test after finishing training (p = 0.09). Withdrawal reflex-based functional electrical therapy was useful in the rehabilitation of the hemiparetic gait of severely impaired patients.

  9. Rectus sheath block for postoperative analgesia in patients with mesenteric vascular occlusion undergoing laparotomy: A randomized single-blinded study

    PubMed Central

    Elbahrawy, Khaled; El-Deeb, Alaa

    2016-01-01

    Background: Acute mesenteric ischemia is a life-threatening vascular emergency that requires early diagnosis, immediate anticoagulation, and intervention to restore mesenteric blood flow adequately. Aims: To investigate the effect of rectus sheath block (RSB) for postoperative analgesia in patients with mesenteric vascular occlusion. Settings and Design: Forty patients with mesenteric vascular occlusion, American Society of Anesthesiologists physical status I or II or III, scheduled for laparotomy were enrolled in this study. Subjects and Methods: Patients were randomized into two groups; control group (C Group) and rectus block group (RB Group). In both groups, general anesthesia was induced fentanyl 1 μg/kg with sleeping dose of propofol and 0.15 mg/kg cisatracurium. Then, anesthesia was maintained with sevoflurane in oxygen 100%. In RB Group, under aseptic condition, RSB guided by ultrasound was performed. Surgery is then continued and intravenous fentanyl patient-controlled analgesia pump started. Postoperative pain, sedation, and opioid side effects were assessed. Statistical Analysis Used: Statistical analysis was done using Statistical Package for Social Sciences (SPSS 19.0, Chicago, IL, USA). Results: Patients in the RB Group consumed statistically significant less opioid in comparison to control group either intraoperatively or postoperatively. Mean pain scores were statistically significant less in RB Group than in the control group at 2, 4, and 6 h postoperatively. Sedation score, incidence of nausea and vomiting were statistically significant less in the RB Group in comparison to control group. More patients’ satisfaction was reported in the RB Group. Conclusions: Ultrasound-guided RSB resulted in postoperative reduction of pain scores and opioid consumption compared with general anesthesia alone. Moreover, RSB was associated with better patient satisfaction and less nausea and vomiting. PMID:27746544

  10. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study.

    PubMed

    Jouen, Anne-Lise; Narzisi, Antonio; Xavier, Jean; Tilmont, Elodie; Bodeau, Nicolas; Bono, Valentina; Ketem-Premel, Nabila; Anzalone, Salvatore; Maharatna, Koushik; Chetouani, Mohamed; Muratori, Filippo; Cohen, David

    2017-01-01

    To meet the required hours of intensive intervention for treating children with autism spectrum disorder (ASD), we developed an automated serious gaming platform (11 games) to deliver intervention at home (GOLIAH) by mapping the imitation and joint attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. Here, we report the results of a 6-month matched controlled exploratory study. From two specialized clinics, we included 14 children (age range 5-8 years) with ASD and 10 controls matched for gender, age, sites, and treatment as usual (TAU). Participants from the experimental group received in addition to TAU four 30-min sessions with GOLIAH per week at home and one at hospital for 6 months. Statistics were performed using Linear Mixed Models. Children and parents participated in 40% of the planned sessions. They were able to use the 11 games, and participants trained with GOLIAH improved time to perform the task in most JA games and imitation scores in most imitation games. GOLIAH intervention did not affect Parental Stress Index scores. At end-point, we found in both groups a significant improvement for Autism Diagnostic Observation Schedule scores, Vineland socialization score, Parental Stress Index total score, and Child Behavior Checklist internalizing, externalizing and total problems. However, we found no significant change for by time × group interaction. Despite the lack of superiority of TAU + GOLIAH versus TAU, the results are interesting both in terms of changes by using the gaming platform and lack of parental stress increase. A large randomized controlled trial with younger participants (who are the core target of ESDM model) is now discussed. This should be facilitated by computing GOLIAH for a web platform. Trial registration Clinicaltrials.gov NCT02560415.

  11. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

    PubMed Central

    Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

    2015-01-01

    Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

  12. Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial

    PubMed Central

    2010-01-01

    Background This randomised, single-blind controlled pilot trial aimed to determine the effectiveness of a physiotherapy program, including exercise and manual therapy, in reducing impairments and improving physical function and health-related quality of life in people with a history of painful osteoporotic vertebral fracture. Methods 20 participants were randomly allocated to an intervention (n = 11) or control (n = 9) group. The intervention group attended individual sessions with an experienced clinician once a week for 10 weeks and performed daily home exercises with adherence monitored by a self-report diary. The control group received no treatment. Blinded assessment was conducted at baseline and 11 weeks. Questionnaires assessed self-reported changes in back pain, physical function, and health-related quality of life. Objective measures of thoracic kyphosis, back and shoulder muscle endurance (Timed Loaded Standing Test), and function (Timed Up and Go test) were also taken. Results Compared with the control group, the intervention group showed significant reductions in pain during movement (mean difference (95% CI) -1.8 (-3.5 to -0.1)) and at rest (-2.0 (-3.8 to -0.2)) and significantly greater improvements in Qualeffo physical function (-4.8 (-9.2 to -0.5)) and the Timed Loaded Standing test (46.7 (16.1 to 77.3) secs). For the perceived change in back pain over the 10 weeks, 9/11 (82%) participants in the intervention group rated their pain as 'much better' compared with only 1/9 (11%) participants in the control group. Conclusion Despite the modest sample size, these results support the benefits of exercise and manual therapy in the clinical management of patients with osteoporotic vertebral fractures, but need to be confirmed in a larger sample. Trail registration NCT00638768 PMID:20163739

  13. Pharmacokinetics and Bioavailability of Plant Lignan 7-Hydroxymatairesinol and Effects on Serum Enterolactone and Clinical Symptoms in Postmenopausal Women: A Single-Blinded, Parallel, Dose-Comparison Study

    PubMed Central

    Udani, Jay K.; Brown, Donald J.; Tan, Maria Olivia C.; Hardy, Mary

    2013-01-01

    Objective 7-Hydroxymaitairesinol (7-HMR) is a naturally occurring plant lignan found in whole grains and the Norway spruce (Piciea abies). The purpose of this study was to evaluate the bioavailability of a proprietary 7-HMR product (HMRlignan, Linnea SA, Locarno, Switzerland) through measurement of lignan metabolites and metabolic precursors. Methods A single-blind, parallel, pharmacokinetic and dose-comparison study was conducted on 22 post-menopausal females not receiving hormone replacement therapy. Subjects were enrolled in either a 36 mg/d (low-dose) or 72 mg/d dose (high-dose) regimen for 8 weeks. Primary measured outcomes included plasma levels of 7-HMR and enterolactone (ENL), and single-dose pharmacokinetic analysis was performed on a subset of subjects in the low-dose group. Safety data and adverse event reports were collected as well as data on hot flash frequency and severity. Results Pharmacokinetic studies demonstrated 7-HMR Cmax = 757.08 ng/ml at 1 hour and ENL Cmax = 4.8 ng/ml at 24 hours. From baseline to week 8, plasma 7-HMR levels increased by 191% in the low-dose group (p < 0.01) and by 1238% in the high-dose group (p < 0.05). Plasma ENL levels consistently increased as much as 157% from baseline in the low-dose group and 137% in the high-dose group. Additionally, the mean number of weekly hot flashes decreased by 50%, from 28.0/week to 14.3/week (p < 0.05) in the high-dose group. No significant safety issues were identified in this study. Conclusion The results demonstrate that HMRlignan is quickly absorbed into the plasma and is metabolized to ENL in healthy postmenopausal women. Clinically, the data demonstrate a statistically significant improvement in hot flash frequency. Doses up to 72 mg/d HMRlignan for 8 weeks were safe and well tolerated in this population. PMID:24606716

  14. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

    PubMed Central

    2010-01-01

    Background It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST) which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process), advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the international discussion

  15. A Randomized Single Blind Parallel Group Study Comparing Monoherbal Formulation Containing Holarrhena Antidysenterica Extract with Mesalamine in Chronic Ulcerative Colitis Patients

    PubMed Central

    Johari, Sarika; Gandhi, Tejal

    2016-01-01

    Background: Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment. Aims and Objectives: This study aims to compare the treatment with monoherbal formulation of Holarrhena antidysenterica with Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse. Settings and Design: Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design. Materials and Methods: The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rd Jan 2013. Three groups (n = 10) were treated with drug Mesalamine (Group I), monoherbal tablet (Group II) and combination of both (Group III) respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study. Statistical Analysis Used: Results were expressed as mean ± SEM. Data was statistically evaluated using t-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6. Results: All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with diarrhea and

  16. Clinical evaluation of efficacy of Majoon Ushba and Roghane Hindi in the management of psoriasis: A randomized single-blind, placebo-controlled study.

    PubMed

    Lone, Azad Hussain; Ahmad, Tanzeel; Naiyar, A H

    2011-01-01

    Psoriasis is a common dermatological disease affecting up to 1-2% of the world's population. It is associated with both organic and psychosocial complications like psoriatic arthropathy, nephritis, infection, hyperuricemia, hypoproteinemia, depression, and stress, and is responsible for hindering patients' daily activities. The present study was conducted to assess the safety and efficacy of two pharmacopeial Unani formulations (Majoon Ushba and Roghane Hindi) in the management of psoriasis on scientific parameters. Thirty diagnosed psoriasis patients, satisfying the inclusion criteria, were selected for a randomized, single-blind, placebo-controlled study in the Department of Moalajat (Medicine), National Institute of Unani Medicine, Bangalore. The patients were divided by the method of Random Table Numbers into test and control groups after obtaining informed consent. The experimental group comprised 20 patients to whom Majoon Ushba 5 g was administered orally twice daily and Roghane Hindi was applied locally twice daily. The control group comprised 10 patients who were given placebo drugs orally and topically. The duration of the trial was 8 weeks and follow-up was done fortnightly. The severity of psoriasis and efficacy of the drug was assessed by the Psoriasis Area and Severity Index (PASI) Scale. The results of both groups were compared and analyzed statistically. The study showed significant reduction in the PASI score in the test group (P < 0.01) as compared to placebo. No obnoxious side effects were observed in the test group: toxicological parameters were within normal limits even after 2 months of treatment. It was therefore concluded that Majoon Ushba and Roghane Hindi are safe and effective in the management of psoriasis.

  17. The effect of cold application in combination with standard analgesic administration on pain and anxiety during chest tube removal: a single-blinded, randomized, double-controlled study.

    PubMed

    Demir, Yurdanur; Khorshid, Leyla

    2010-09-01

    The aim of this study was to investigate the effect of cold application on pain and anxiety during chest tube removal (CTR) in patients who had undergone cardiac surgery. A single-blinded randomized design was used in this study. Ninety patients aged 18-74 years, hospitalized in the intensive care unit (ICU), who had a chest tube for a duration of at least 24 hours were used for this convenience sample. The application of cold, placebo, or control therapies was randomized into three different groups. Sixty minutes before CTR was scheduled, an ICU nurse administered 10mg/kg paracetamol intravenously to all study subjects. Cold and warm packs covered with gauze dressing were applied to the area surrounding the chest tubes for 20 minutes. Pain intensity, pain quality and situational anxiety for CTR were measured. Variance analysis and the latent growth model were used in the analysis of the data. Patients in the cold group had significantly lower pain intensity than the placebo group. The perception of pain intensity measured by visual analog scores of patients in the cold group showed the least variation. There was no statistically significant difference in McGill Melzack Pain Questionnaire scores or in change of anxiety level between the three groups. The application of cold prolonged the length of time until analgesics were needed after CTR. Results showed that cold application reduced patients' intensity of pain due to CTR but did not affect anxiety levels or the type of pain. Cold application is recommended as a pain-relieving technique during CTR.

  18. Efficacy and tolerability of a polysaccharide-resin-honey based cough syrup as compared to carbocysteine syrup for children with colds: a randomized, single-blinded, multicenter study.

    PubMed

    Cohen, Herman Avner; Hoshen, Moshe; Gur, Shmuel; Bahir, Arie; Laks, Yoseph; Blau, Hannah

    2017-02-01

    Available pediatric treatments for acute cough are limited by lack of demonstrated efficacy. The objective of this trial is to compare the effects of a polysaccharide-resin-honey based cough syrup, and carbocysteine syrups on nocturnal and daytime cough associated with childhood upper respiratory tract infections (URIs). Using a single-blind randomization design, the study recruited children from 4 general pediatric community clinics. Participants included 150 children aged 2 to 5 years with an URI, nocturnal and daytime cough and illness duration of ≤7 days. To be eligible, children had to be free of medication on the day before presentation. A survey was administered to parents on 4 consecutive days beginning from the day of presentation in clinic. Children received the study preparation on the first evening and then 3 times per day for 3 further days. Main outcome measures were cough frequency, cough severity, bothersome nature of cough, and quality of sleep for both child and parent. Both preparations were well tolerated and cough improved over the study period. After one night and on all survey days, there was a significantly better result for polysaccharide-resin-honey (P<0.05) for all the main outcome measures. The trend of improvement over the 4 days was steeper for polysaccharide-resin-honey (P<0.05) with regards to all cough parameters. Both polysaccharide-resin-honey and carbocysteine cough syrups were well tolerated in children over 2 years of age. The polysaccharide-resin-honey syrup was associated with a more rapid and greater improvement in all clinical cough symptoms measured, beginning from the first night of therapy. Both nocturnal and daytime cough improved, as did sleep quality for both children and parents.

  19. Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)

    PubMed Central

    2013-01-01

    Background Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer’s disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers. Methods/design In this multi-centre, single-blind randomised controlled trial, 480 people with early-stage dementia, each with a carer, will be randomised to receive either treatment as usual or cognitive rehabilitation (10 therapy sessions over 3 months, followed by 4 maintenance sessions over 6 months). We will compare the effectiveness of cognitive rehabilitation with that of treatment as usual with regard to improving self-reported and carer-rated goal performance in areas identified as causing concern by people with early-stage dementia; improving quality of life, self-efficacy, mood and cognition of people with early-stage dementia; and reducing stress levels and ameliorating quality of life for carers of participants with early-stage dementia. The incremental cost-effectiveness of goal-oriented cognitive rehabilitation compared to treatment as usual will also be examined. Discussion If the study confirms the benefits and cost-effectiveness of cognitive rehabilitation, it will be important to examine how the goal-oriented cognitive rehabilitation approach can most effectively be integrated into routine health-care provision. Our aim is to provide training and develop materials to support the implementation of this approach following trial completion. Trial registration Current Controlled Trials ISRCTN21027481 PMID:23710796

  20. A single-blind randomised controlled trial of the effects of a web-based decision aid on self-testing for cholesterol and diabetes. Study protocol.

    PubMed

    Ickenroth, Martine H P; Grispen, Janaica E J; de Vries, Nanne K; Dinant, Geert-Jan; Elwyn, Glyn; Ronda, Gaby; van der Weijden, Trudy

    2012-01-04

    Self-tests, tests on body materials to detect medical conditions, are widely available to the general public. Self-testing does have advantages as well as disadvantages, and the debate on whether self-testing should be encouraged or rather discouraged is still ongoing. One of the concerns is whether consumers have sufficient knowledge to perform the test and interpret the results. An online decision aid (DA) with information on self-testing in general, and test specific information on cholesterol and diabetes self-testing was developed. The DA aims to provide objective information on these self-tests as well as a decision support tool to weigh the pros and cons of self-testing. The aim of this study is to evaluate the effect of the online decision aid on knowledge on self-testing, informed choice, ambivalence and psychosocial determinants. A single blind randomised controlled trial in which the online decision aid 'zelftestwijzer' is compared to short, non-interactive information on self-testing in general. The entire trial will be conducted online. Participants will be selected from an existing Internet panel. Consumers who are considering doing a cholesterol or diabetes self-test in the future will be included. Outcome measures will be assessed directly after participants have viewed either the DA or the control condition. Weblog files will be used to record participants' use of the decision aid. Self-testing does have important pros and cons, and it is important that consumers base their decision whether they want to do a self-test or not on knowledge and personal values. This study is the first to evaluate the effect of an online decision aid for self-testing. Dutch Trial Register: NTR3149.

  1. Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study.

    PubMed

    Cho, Yoon Soo; Joo, So Young; Cui, Huisong; Cho, Sung-Rae; Yim, Haejun; Seo, Cheong Hoon

    2016-08-01

    Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients. A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy (medication, physical therapy, and burn rehabilitation massage therapy) were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cm (0.05-0.15 mJ/mm) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores. The characteristics of patients between the 2 study groups were balanced (P >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables (P <0.001, P <0.001, P = 0.013, respectively). The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128). ESWT significantly reduced scar pain in burn patients after wound recovery.

  2. Efficacy and safety of ketoprofen lysine salt mouthwash versus benzydamine hydrochloride mouthwash in acute pharyngeal inflammation: a randomized, single-blind study.

    PubMed

    Passàli, D; Volonté, M; Passàli, G C; Damiani, V; Bellussi, L

    2001-09-01

    Pharyngodynia, or sore throat, is one of the symptoms most frequently reported by patients to primary care physicians. The purpose of this study was to compare the efficacy and tolerability of mouthwash formulations of ketoprofen lysine salt (KLS), an anti-inflammatory agent, and benzydamine hydrochloride (BH), a local anesthetic, in patients with acute inflammation of the pharyngeal cavity. In this randomized, multicenter, parallel-group, single-blind study, patients (who were blinded) were assigned to receive undiluted BH 15 mL (22.5 mg) or KLS 10 mL (160 mg) diluted in 100 mL of water. Both agents were gargled twice daily until pain remission or up to 7 days. A physical examination of the oropharyngeal cavity was performed, and severity of edema and hyperemia was assessed after 3 days of treatment and, if symptoms had not resolved, after pain remission. Of the 241 patients (120 KLS, 121 BH), 239 were included in the safety analysis and 232 were in the intent-to-treat population. The differences between groups in the duration of analgesic effect after the first dose of drug and the time course of pain were found to be statistically significant (P = 0.006 and P = 0.017, respectively), favoring KLS. Adverse drug-related effects reported included numbness of the tissues in the oral cavity, sensation of tingling in the tissues in the oral cavity, dry mouth, thirst, and nausea. A significantly greater proportion of BH-treated patients reported adverse events (P = 0.001 for all adverse events and drug-related adverse events). KLS mouthwash exerts a significantly longer first-application analgesic action with significantly greater local tolerability than BH in patients with pharyngeal pain of inflammatory and/or infectious origin.

  3. A single-blind randomised controlled trial of the effects of a web-based decision aid on self-testing for cholesterol and diabetes. study protocol

    PubMed Central

    2012-01-01

    Background Self-tests, tests on body materials to detect medical conditions, are widely available to the general public. Self-testing does have advantages as well as disadvantages, and the debate on whether self-testing should be encouraged or rather discouraged is still ongoing. One of the concerns is whether consumers have sufficient knowledge to perform the test and interpret the results. An online decision aid (DA) with information on self-testing in general, and test specific information on cholesterol and diabetes self-testing was developed. The DA aims to provide objective information on these self-tests as well as a decision support tool to weigh the pros and cons of self-testing. The aim of this study is to evaluate the effect of the online decision aid on knowledge on self-testing, informed choice, ambivalence and psychosocial determinants. Methods/Design A single blind randomised controlled trial in which the online decision aid 'zelftestwijzer' is compared to short, non-interactive information on self-testing in general. The entire trial will be conducted online. Participants will be selected from an existing Internet panel. Consumers who are considering doing a cholesterol or diabetes self-test in the future will be included. Outcome measures will be assessed directly after participants have viewed either the DA or the control condition. Weblog files will be used to record participants' use of the decision aid. Discussion Self-testing does have important pros and cons, and it is important that consumers base their decision whether they want to do a self-test or not on knowledge and personal values. This study is the first to evaluate the effect of an online decision aid for self-testing. Trial registration Dutch Trial Register: NTR3149 PMID:22216905

  4. Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study

    PubMed Central

    Kaminski, Robert W.; Di Paolo, Claudio; Porter, Chad K.; Gutierrez, Ramiro L.; Clarkson, Kristen A.; Weerts, Hailey E.; Duplessis, Christopher; Castellano, Amy; Alaimo, Cristina; Paolino, Kristopher; Gormley, Robert

    2016-01-01

    Several candidate vaccines against Shigella spp. are in development, but the lack of a clear correlate of protection from challenge with the induction of adequate immune responses among the youngest age groups in the developing world has hampered Shigella vaccine development over the past several decades. Bioconjugation technology, exploited here for an Shigella flexneri 2a candidate vaccine, offers a novel and potentially cost-effective way to develop and produce vaccines against a major pathogen of global health importance. Flexyn2a, a novel S. flexneri 2a bioconjugate vaccine made of the polysaccharide component of the S. flexneri 2a O-antigen, conjugated to the exotoxin protein A of Pseudomonas aeruginosa (EPA), was evaluated for safety and immunogenicity among healthy adults in a single-blind, phase I study with a staggered randomization approach. Thirty subjects (12 receiving 10 μg Flexyn2a, 12 receiving Flexyn2a with aluminum adjuvant, and 6 receiving placebo) were administered two injections 4 weeks apart and were followed for 168 days. Flexyn2a was well-tolerated, independently of the adjuvant and number of injections. The Flexyn2a vaccine elicited statistically significant S. flexneri 2a lipopolysaccharide (LPS)-specific humoral responses at all time points postimmunization in all groups that received the vaccine. Elicited serum antibodies were functional, as evidenced by bactericidal activity against S. flexneri 2a. The bioconjugate candidate vaccine Flexyn2a has a satisfactory safety profile and elicited a robust humoral response to S. flexneri 2a LPS with or without inclusion of an adjuvant. Moreover, the bioconjugate also induced functional antibodies, showing the technology's features in producing a promising candidate vaccine. (This study has been registered at ClinicalTrials.gov under registration no. NCT02388009.) PMID:27581434

  5. A Single-Blinded, Direct Observational Study of PGY-1 Interns and PGY-2 Residents in Evaluating their History-Taking and Physical-Examination Skills

    PubMed Central

    Sharma, Sandeep

    2011-01-01

    Background: Internal Medicine residents and interns are often the first contact for newly admitted patients in a teaching hospital. The proper evaluation, diagnosis, and treatment may depend on this initial encounter. Objectives: To evaluate the history-taking and physical-examination skills of interns/residents on new admissions to the medical floors; to compare data from the patient encounter to the chart for evidence of accuracy; to measure the time spent on the initial encounter. Methods: An independent medical observer used a yes/no checklist with 60 variables in a single-blinded observational study. Frequency tables were generated and results were based on descriptive statistics. Results: In 7 categories specifically aimed at chart review for accuracy, discrepancies were found between what medical post-graduate year (PGY)-1 interns and PGY-2 residents (interns/residents) recorded in the patient's chart and the observed actions during the patient encounter. There were 25 encounters observed. In 64%, the time spent on history taking was <7 minutes. In 68%, the time spent for the physical examination was <5 minutes. In 72%, patients were notasked about family medical history. None ofthe observed interns/residents took their own measurements of the patient's blood pressure. No intern/resident asked about recent weight loss, weight gain, level of salt intake, despite patients with history of hypertension; nor did they perform any examinations of the eye fundi and accommodation, thyroid, carotids, or hearing. The majority of patients were asked about chest pain, cough, nausea, vomiting, chief complaint, and the onset of symptoms. Conclusions: This study documents the poor overall performance in the quality of history-taking and physical-examination skills on newly admitted patients. PMID:22319412

  6. Safety and immunogenicity of a candidate bioconjugate vaccine against Shigella dysenteriae type 1 administered to healthy adults: A single blind, partially randomized Phase I study.

    PubMed

    Hatz, Christoph F R; Bally, Bettina; Rohrer, Susanne; Steffen, Robert; Kramme, Stefanie; Siegrist, Claire-Anne; Wacker, Michael; Alaimo, Cristina; Fonck, Veronica Gambillara

    2015-08-26

    Shigellae cause severe disease in endemic countries, especially in children. Several efficacy trials have been conducted with candidate vaccines against Shigellae, but the lack of protection, the safety concerns, or manufacturing challenges hindered successful market approval. Conjugated vaccines have been shown to be safe and effective for different pathogens (i.e., Neisseria meningitidis, Shigella pneumonia, Haemophilus influenzae). The bio-conjugation technology, exploited here for the Shigella dysenteriae candidate vaccine, offers a novel and potentially simpler way to develop and produce vaccines against one of the major causes of morbidity and mortality in developing countries. A novel S. dysenteriae bioconjugate vaccine (GVXN SD133) made of the polysaccharide component of the Shigella O1 lipopolysaccharide, conjugated to the exotoxin protein A of Pseudomonas aeruginosa (EPA), was evaluated for immunogenicity and safety in healthy adults in a single blind, partially randomized Phase I study. Forty subjects (10 in each dose group; 2 μg or 10 μg with or without aluminium adjuvant) received two injections 60 days apart and were followed-up for 150 days. Both doses and formulations were well tolerated; the safety and reactogenicity profiles were consistent with that of other conjugated vaccines, adjuvanted or not, independent of the dose and the number of injections. The GVXN SD133 vaccine elicited statistically significant O1 specific humoral responses at all time points in all vaccination groups. Between-group comparisons did not show statistically significant differences in geometric mean titers of immunoglobulin G and A at any post-vaccination time point. This study demonstrated that the GVXN SD133 vaccine has a satisfactory safety profile. It elicited a significant humoral response to Shigella O1 polysaccharides at all doses tested. The protein carrier also elicited functional antibodies, showing the technology's advantages in preserving both sugar and

  7. Efficacy of an essential fatty acid-enriched diet in managing canine atopic dermatitis: a randomized, single-blinded, cross-over study.

    PubMed

    Bensignor, Emmanuel; Morgan, David M; Nuttall, Tim

    2008-06-01

    Evidence suggests that high-quality diets enriched with essential fatty acids (EFA) and other nutrients can ameliorate canine atopic dermatitis (AD). This study compared such a diet (Eukanuba Veterinary Diets Dermatosis FP) with a home-cooked equivalent (fish and potato) in a randomised, single-blinded, cross-over trial. Twenty dogs with perennial AD were randomly assigned to receive either the test (group A) or the control diet (group B) for 1 month, followed by the contrasting diet for a further month. Canine Atopic Dermatitis Extent and Severity Index (CADESI version 2) and pruritus (visual analogue scale) scores were recorded at days 0, 30 and 60. Eight dogs in each group completed the study. CADESI scores significantly declined when dogs were fed the test diet (group A P < 0.01; group B P < 0.001), and increased (group A P < 0.05) or remained steady (group B) on the control diet. CADESI scores decreased in 15 of 16 dogs fed the test diet, but this was less than 50% in all cases. Pruritus scores also declined when dogs were fed the test diet compared to the control diet, but this was only significant for group A (P = 0.027). Pruritus was reduced in 11 of 16 dogs fed the test diet, but this was 50% or more in only two dogs. This trial provides evidence for the efficacy of Eukanuba Veterinary Diets Dermatosis FP in canine AD, although it is likely that most cases will require adjunct therapy. The mechanism is unclear, but may involve increased and balanced EFA levels.

  8. Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study.

    PubMed

    Paris, Adeline; Nogueira da Gama Chaves, Daniel; Cornu, Catherine; Maison, Patrick; Salvat-Mélis, Muriel; Ribuot, Christophe; Brandt, Christian; Bosson, Jean-Luc; Hommel, Marc; Cracowski, Jean-Luc

    2007-04-01

    Writing an informed consent form (ICF) for biomedical research is a difficult task. We conducted a multicenter single-blind randomized controlled trial to identify whether a working group or the systematic improvement in lexico-syntactic readability or an association of the two could increase the comprehension of the written information given to healthy volunteers enrolled in biomedical research. Participants were randomized to read one of four versions of the ICF: unchanged ICF (A), ICF with systematic lexico-syntactic readability improvement (B), ICF modified by a working group (C), and ICF modified by the working group followed by systematic lexico-syntactic improvement (D). The primary end-point was the objective comprehension score at day 0 for each study group. The scores of objective comprehension at day 0 were statistically different between the four study groups (anovaP = 0.020). The pairwise analysis showed an improvement in the working group vs. the unchanged group (P = 0.003), and a tendency to improvement in the group who read the ICF modified using lexico-syntactic readability and in the group who read the ICF modified using the two methods (P = 0.020 and 0.027 respectively). We conducted a two-way anova to identify some characteristics of the population which could explain this score. There was a significant interaction between the type of informed consent document (ICD) and the gender. Improving the ICD in phase I biomedical research leads to better comprehension, whether the method used is systematic lexico-syntactic improvement or a review by a working group. The improvement is specifically observed in men compared with women. Conversely, while both methods diverge in their effect on lexico-syntactic readability, their association is not mandatory. We suggest that in all phase I clinical trials, the ICF be improved by either method.

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

    PubMed Central

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

    2017-01-01

    Isomaltulose, a naturally-occurring isomer of sucrose, is commonly used as an alternative sweetener in foods and beverages. The goal of this study was to determine the effect of isomaltulose together with green tea on postprandial plasma glucose and insulin concentration, as well as antioxidant capacity in healthy subjects. In a randomized, single-blind, crossover study, 15 healthy subjects (eight women and seven men; ages 23.5 ± 0.7 years; with body mass index of 22.6 ± 0.4 kg/m2) consumed five beverages: (1) 50 g sucrose in 400 mL water; (2) 50 g isomaltulose in 400 mL of water; (3) 400 mL of green tea; (4) 50 g sucrose in 400 mL of green tea; and (5) 50 g isomaltulose in 400 mL of green tea. Incremental area under postprandial plasma glucose, insulin, ferric reducing ability of plasma (FRAP) and malondialdehyde (MDA) concentration were determined during 120 min of administration. Following the consumption of isomaltulose, the incremental 2-h area under the curve (AUC0–2 h) indicated a higher reduction of postprandial glucose (43.4%) and insulin concentration (42.0%) than the consumption of sucrose. The addition of green tea to isomaltulose produced a greater suppression of postprandial plasma glucose (20.9%) and insulin concentration (37.7%). In accordance with antioxidant capacity, consumption of sucrose (40.0%) and isomaltulose (28.7%) caused the reduction of green tea-induced postprandial increases in FRAP. A reduction in postprandial MDA after drinking green tea was attenuated when consumed with sucrose (34.7%) and isomaltulose (17.2%). In conclusion, green tea could enhance the reduction of postprandial glucose and insulin concentration when consumed with isomaltulose. In comparison with sucrose, isomaltulose demonstrated less alteration of plasma antioxidant capacity after being consumed with green tea. PMID:28481230

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

    PubMed

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

    2017-05-06

    Isomaltulose, a naturally-occurring isomer of sucrose, is commonly used as an alternative sweetener in foods and beverages. The goal of this study was to determine the effect of isomaltulose together with green tea on postprandial plasma glucose and insulin concentration, as well as antioxidant capacity in healthy subjects. In a randomized, single-blind, crossover study, 15 healthy subjects (eight women and seven men; ages 23.5 ± 0.7 years; with body mass index of 22.6 ± 0.4 kg/m²) consumed five beverages: (1) 50 g sucrose in 400 mL water; (2) 50 g isomaltulose in 400 mL of water; (3) 400 mL of green tea; (4) 50 g sucrose in 400 mL of green tea; and (5) 50 g isomaltulose in 400 mL of green tea. Incremental area under postprandial plasma glucose, insulin, ferric reducing ability of plasma (FRAP) and malondialdehyde (MDA) concentration were determined during 120 min of administration. Following the consumption of isomaltulose, the incremental 2-h area under the curve (AUC0-2 h) indicated a higher reduction of postprandial glucose (43.4%) and insulin concentration (42.0%) than the consumption of sucrose. The addition of green tea to isomaltulose produced a greater suppression of postprandial plasma glucose (20.9%) and insulin concentration (37.7%). In accordance with antioxidant capacity, consumption of sucrose (40.0%) and isomaltulose (28.7%) caused the reduction of green tea-induced postprandial increases in FRAP. A reduction in postprandial MDA after drinking green tea was attenuated when consumed with sucrose (34.7%) and isomaltulose (17.2%). In conclusion, green tea could enhance the reduction of postprandial glucose and insulin concentration when consumed with isomaltulose. In comparison with sucrose, isomaltulose demonstrated less alteration of plasma antioxidant capacity after being consumed with green tea.

  11. Does addition of 'mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study.

    PubMed

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  12. Does addition of `mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study

    NASA Astrophysics Data System (ADS)

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  13. A Randomized, Single-Blind, Placebo-Controlled Study on the Efficacy of the Arthrokinematic Approach-Hakata Method in Patients with Chronic Nonspecific Low Back Pain

    PubMed Central

    Kogure, Akira; Kotani, Kazuhiko; Katada, Shigehiko; Takagi, Hiroshi; Kamikozuru, Masahiro; Isaji, Takashi; Hakata, Setsuo

    2015-01-01

    Study design cized, single-blind, controlled trial. Objective To investigate the efficacy of the Arthrokinematic approach (AKA)-Hakata (H) method for chronic low back pain. Summary of Background Data The AKA-H method is used to manually treat abnormalities of intra-articular movement. Methods One hundred eighty-six patients with chronic nonspecific low back pain randomly received either the AKA-H method (AKA-H group) or the sham technique (S group) monthly for 6 months. Data were collected at baseline and once a month. Outcome measures were pain intensity (visual analogue scale [VAS]) and quality of life (the Roland-Morris Disability Questionnaire [RDQ] and Short Form SF-36 questionnaire [SF-36]). Results At baseline, the VAS, RDQ, and SF-36 scores showed similar levels between the groups. After 6 months, the AKA-H group had more improvement in the VAS (42.8% improvement) and RDQ score (31.1% improvement) than the sham group (VAS: 10.4% improvement; RDQ: 9.8% improvement; both, P < 0.001). The respective scores for the SF-36 subscales (physical functioning, role physical, bodily pain, social functioning, general health perception, role emotional, and mental health) were also significantly more improved in the AKA-H group than in the sham group (all, P < 0.001). The scores for the physical, psychological, and social aspects of the SF-36 subscales showed similar improvement in the AKA-H group. Conclusion The AKA-H method can be effective in managing chronic low back pain. Trial Registration UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006250. PMID:26646534

  14. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study.

    PubMed

    Capeding, Maria Rosario Z; Jica, Corina; Macura-Biegun, Anna; Rauscher, Martina; Alberto, Edison

    2014-02-07

    Combination vaccines against diphtheria, tetanus and pertussis (DTP) represent the core of childhood vaccination programs. Quinvaxem, a fully-liquid, pentavalent combination vaccine containing inactivated hepatitis B (HepB), Haemophilus influenzae type b (Hib) and whole-cell pertussis (wP) antigens, and tetanus and diphtheria toxoids, has been shown to be suitable for boosting children primed in infancy with another DTwP-HepB-Hib vaccine. This single-blind, randomized, controlled study was designed to demonstrate non-inferiority of a primary vaccination course (6-10-14 week schedule) of Tritanrix HB+Hib (first dose) and Quinvaxem (second/third doses) versus three doses of Quinvaxem with respect to the seroprotection/seroconversion rates for all antigens one month after vaccination course completion. Four hundred healthy subjects eligible for the local Expanded Program on Immunization were enrolled and equally randomized to the two treatment regimens. All subjects achieved seroprotection for tetanus and Hib, all except one for diphtheria, and all except two achieved seroconversion against Bordetella pertussis. Seroprotection against hepatitis B was achieved by 97.4% of Tritanrix HB+Hib followed by Quinvaxem and 94.9% of Quinvaxem subjects. Therefore, one month after vaccination course completion, seroprotection rates (seroconversion rate for B. pertussis) of Tritanrix HB+Hib followed by Quinvaxem were non-inferior to those elicited by Quinvaxem only, thus meeting the primary objective. Adverse events were comparable between the groups and were in line with the safety profile of the vaccines. The switch of vaccine had no apparent effect on safety endpoints. Our results support the use of Quinvaxem interchangeably with Tritanrix HB+Hib in a primary vaccination course and provides further evidence for the interchangeability of pentavalent vaccines (Clinical Trials.gov registry: NCT01357720). Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Safety and efficacy of dual-lead thalamic deep brain stimulation for patients with treatment-refractory multiple sclerosis tremor: a single-centre, randomised, single-blind, pilot trial.

    PubMed

    Oliveria, Seth F; Rodriguez, Ramon L; Bowers, Dawn; Kantor, Daniel; Hilliard, Justin D; Monari, Erin H; Scott, Bonnie M; Okun, Michael S; Foote, Kelly D

    2017-09-01

    Efficacy in previous studies of surgical treatments of refractory multiple sclerosis tremor using lesioning or deep brain stimulation (DBS) has been variable. The aim of this study was to investigate the safety and efficacy of dual-lead thalamic DBS (one targeting the ventralis intermedius-ventralis oralis posterior nucleus border [the VIM lead] and one targeting the ventralis oralis anterior-ventralis oralis posterior border [the VO lead]) for the treatment of multiple sclerosis tremor. We did a single centre, single-blind, prospective, randomised pilot trial at the University of Florida Center for Movement Disorders and Neurorestoration clinic (Gainesville, FL, USA). We recruited adult patients with a clinical diagnosis of multiple sclerosis tremor refractory to previous medical therapy. Before surgery to implant both leads, we randomly assigned patients (1:1) to receive 3 months of optimised single-lead DBS-either VIM or VO. We did the randomisation with a computer-generated sequence, using three blocks of four patients, and independent members of the Center did the assignment. Patients and all clinicians other than the DBS programming nurse were masked to the choice of lead. Patients underwent surgery 1 month after their baseline visit for implantation of the dual lead DBS system. A pulse generator and two extension cables were implanted in a second surgery 3-4 weeks later. Patients then received an initial 3-month period of continuous stimulation of either the VIM or VO lead followed by blinded safety assessment of their tremor with the Tolosa-Fahn-Marin Tremor Rating Scale (TRS) during optimised VIM or VO lead stimulation at the end of the 3 months. After this visit, both leads were activated in all patients for an additional 3 months, and optimally programmed during serial visits as dictated by a prespecified programming algorithm. At the 6-month follow-up visit, TRS score was measured, and mood and psychological batteries were administered under four

  16. PA01.17. A clinical study to evaluate the effect of extract based herbal formulation on hypertension- a single blinded standard controlled randomized study

    PubMed Central

    Agrawal, Satish; Pol, Hemant

    2012-01-01

    Purpose: In Ayurveda although there is no such terminology like hypertension but still this work is an approach to establish relationship between Hypertension & vitiated functioning of three governing forces of our body i.e. Tridosha and to treat Hypertension on Ayurvedic principles. The logic behind such correlation is based on the fact that, like other physiological processes, B.P. too is normal phenomenon of our body which is governed by Tridosha. After going through modern pathogenesis of primary hypertension and its symptomology, in present study it has been correlated with Vata Kaphaja Vikara with Rasavaha, Raktavaha and Manovahi Srotas as the seat of disease. Looking at its pathogenesis, the term Uccha Vyan Bala (exaggerated physiological functioning of Vyan Vayu leading to increase contractility of heart & blood vessels) can be coined for hypertension. Method: Subjective criteria Headache, Palpitation, Vertigo, Dyspnoea on walks and Fatigue. Objective criteria BP value recorded by sphygmomanometer in supine position. Final assessment of results; Subjective assessment 75 to 100% disappearance of symptoms effectively cured. 50 to 74% disappearance of symptoms well cured. 25 to 49% disappearance of symptoms fairly cured. 0 to 24% disappearance of symptoms poorly cured. Objective assessment Patient showing reduction in BP by 10mmHg Poorly cured; Patient showing reduction in BP between 11 to 20mmHg Fairly cured; Patient showing reduction in BP between 21 to 30 mmHg Well cured; Patient showing reduction in BP by more than 30 mmHg Effectively cured. Research methodology Type of study-Single blinded comparative study. Study site IPD and OPD department of Shubhdeep ayurved medical college, Indore (MP). Sample size 50 patients divided randomly into two equal groups. Group A given trial drug whereas Group B given control drug. Drug dosage and vehicle 1 capsule twice daily with lukewarm water after meals. Duration of treatment one month (examined at weekly intervals

  17. UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study

    PubMed Central

    Koek, Mayke BG; Buskens, Erik; Steegmans, Paul HA; van Weelden, Huib; Bruijnzeel-Koomen, Carla AFM; Sigurdsson, Vigfús

    2006-01-01

    Background Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis"). Methods We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. Discussion In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to

  18. UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study.

    PubMed

    Koek, Mayke B G; Buskens, Erik; Steegmans, Paul H A; van Weelden, Huib; Bruijnzeel-Koomen, Carla A F M; Sigurdsson, Vigfús

    2006-08-01

    Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis"). We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as

  19. A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia

    PubMed Central

    Bergese, Sergio D; Puente, Erika G; Marcus, R-Jay L; Krohn, Randall J; Docsa, Steven; Soto, Roy G; Candiotti, Keith A

    2017-01-01

    Background Traditionally, anesthesiologists have relied on nonspecific subjective and objective physical signs to assess patients’ comfort level and depth of anesthesia. Commercial development of electrical monitors, which use low- and high-frequency electroencephalogram (EEG) signals, have been developed to enhance the assessment of patients’ level of consciousness. Multiple studies have shown that monitoring patients’ consciousness levels can help in reducing drug consumption, anesthesia-related adverse events, and recovery time. This clinical study will provide information by simultaneously comparing the performance of the SNAP II (a single-channel EEG device) and the bispectral index (BIS) VISTA (a dual-channel EEG device) by assessing their efficacy in monitoring different anesthetic states in patients undergoing general anesthesia. Objective The primary objective of this study is to establish the range of index values for the SNAP II corresponding to each anesthetic state (preinduction, loss of response, maintenance, first purposeful response, and extubation). The secondary objectives will assess the range of index values for BIS VISTA corresponding to each anesthetic state compared to published BIS VISTA range information, and estimate the area under the curve, sensitivity, and specificity for both devices. Methods This is a multicenter, prospective, double-arm, parallel assignment, single-blind study involving patients undergoing elective surgery that requires general anesthesia. The study will include 40 patients and will be conducted at the following sites: The Ohio State University Medical Center (Columbus, OH); Northwestern University Prentice Women's Hospital (Chicago, IL); and University of Miami Jackson Memorial Hospital (Miami, FL). The study will assess the predictive value of SNAP II versus BIS VISTA indices at various anesthetic states in patients undergoing general anesthesia (preinduction, loss of response, maintenance, first purposeful

  20. A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia.

    PubMed

    Bergese, Sergio D; Uribe, Alberto A; Puente, Erika G; Marcus, R-Jay L; Krohn, Randall J; Docsa, Steven; Soto, Roy G; Candiotti, Keith A

    2017-02-03

    Traditionally, anesthesiologists have relied on nonspecific subjective and objective physical signs to assess patients' comfort level and depth of anesthesia. Commercial development of electrical monitors, which use low- and high-frequency electroencephalogram (EEG) signals, have been developed to enhance the assessment of patients' level of consciousness. Multiple studies have shown that monitoring patients' consciousness levels can help in reducing drug consumption, anesthesia-related adverse events, and recovery time. This clinical study will provide information by simultaneously comparing the performance of the SNAP II (a single-channel EEG device) and the bispectral index (BIS) VISTA (a dual-channel EEG device) by assessing their efficacy in monitoring different anesthetic states in patients undergoing general anesthesia. The primary objective of this study is to establish the range of index values for the SNAP II corresponding to each anesthetic state (preinduction, loss of response, maintenance, first purposeful response, and extubation). The secondary objectives will assess the range of index values for BIS VISTA corresponding to each anesthetic state compared to published BIS VISTA range information, and estimate the area under the curve, sensitivity, and specificity for both devices. This is a multicenter, prospective, double-arm, parallel assignment, single-blind study involving patients undergoing elective surgery that requires general anesthesia. The study will include 40 patients and will be conducted at the following sites: The Ohio State University Medical Center (Columbus, OH); Northwestern University Prentice Women's Hospital (Chicago, IL); and University of Miami Jackson Memorial Hospital (Miami, FL). The study will assess the predictive value of SNAP II versus BIS VISTA indices at various anesthetic states in patients undergoing general anesthesia (preinduction, loss of response, maintenance, first purposeful response, and extubation). The SNAP

  1. The effect of clove-based herbal mouthwash on radiation-induced oral mucositis in patients with head and neck cancer: a single-blind randomized preliminary study

    PubMed Central

    Kong, Moonkyoo; Hwang, Deok-Sang; Yoon, Seong Woo; Kim, Jinsung

    2016-01-01

    Purpose This study was performed to evaluate the efficacy and safety of clove-based herbal mouthwash in ameliorating radiation-induced oral mucositis in patients with head and neck cancer. Methods Fourteen patients were prospectively enrolled in this study and randomized to either an experimental group or a control group. The patients of the experimental group swished their mouths with a clove-based herbal mouthwash during radiotherapy (RT), while the patients of the control group swished with clear water. The primary end point of this study was incidence of radiation-induced oral mucositis. The secondary end points were time to onset of radiation-induced oral mucositis, duration of radiation-induced oral mucositis, incidence of supplemental nutrition through feeding tube, maximum pain score, body weight loss, incidence of RT interruption, and duration of RT interruption. Results The use of clove-based herbal mouthwash shortened the duration of grade ≥2 mucositis (24.3 days vs 37.1 days, P=0.044) and reduced body weight loss during RT (3.1% vs 7.4%, P=0.023) compared with clear water. The use of clove-based herbal mouthwash also reduced the incidence of grade 3 mucositis (28.6% vs 57.1%), supplemental nutrition (0% vs 28.6%), and RT interruption (14.3% vs 28.6%), and reduced the duration of grade 3 mucositis (5.1 days vs 17.7 days) and RT interruption (1 days vs 8.5 days). In addition, clove-based herbal mouthwash delayed the time to onset of mucositis (26.6 days vs 24.5 days) and reduced the maximum pain score (4.1 vs 4.9). However, these differences were not statistically significant. Conclusion Although we could not find significant differences in some end points, this single-blind randomized study showed that a clove-based herbal mouthwash can have a potentially beneficial effect on minimizing or preventing radiation-induced oral mucositis in patients with head and neck cancer. To confirm the results of our study, well-designed randomized studies with large

  2. Increased masticatory activity and quality of life in elderly persons with dementia-a longitudinal matched cluster randomized single-blind multicenter intervention study

    PubMed Central

    2013-01-01

    Background Worldwide, millions of people are suffering from dementia and this number is rising. An index of quality of life (QoL) can describe the impact a disease or treatment has on a person’s wellbeing. QoL comprises many variables, including physical health and function, and mental health and function. QoL is related to masticatory ability and physical activity. Animal studies show that disruption of mastication due to loss of teeth or a soft diet leads to memory loss and learning problems. Since these are common complaints in dementia, it is hypothesized that improvement of masticatory function and normalization of diet consistency can increase QoL in elderly persons suffering from dementia. Therefore, the goal of the present study is to examine whether an increase in masticatory activity, achieved by increased food consistency and enhancement of masticatory function through improved oral health care has a positive effect on QoL, including cognition, mood, activities of daily living (ADL), and circadian rhythm in elderly persons with dementia. Methods and design The described study is a prospective longitudinal matched cluster randomized single-blind multicenter study. Participants are elderly persons living in the Netherlands, suffering from dementia and receiving psychogeriatric care. An intervention group will receive improved oral health care and a diet of increased consistency. A control group receives care as usual. Participants will be assessed four times; outcome variables besides QoL are cognition, mood, independence, rest-activity rhythm, blood pressure, and masticatory function. Discussion This research protocol investigates the effect of an intervention executed by daily caregivers. The intervention will increase masticatory activity, which is achieved by three different actions, (providing oral health care, increasing food consistency, or a combination of both). There is a certain amount of variety in the nature of the interventions due to local

  3. Ultrastructural changes in rat thyroid tissue after acute organophosphate poisoning and effects of antidotal therapy with atropine and pralidoxime: A single-blind, ex vivo study

    PubMed Central

    Satar, Deniz; Satar, Salim; Mete, Ufuk Ozgu; Suchard, Jeffrey R.; Topal, Metin; Karakoc, Emre; Kaya, Mehmet

    2008-01-01

    Background: Organophosphate (OP) insecticides are widely used in both agricultural and landscape pest control, and the potential for human exposure to these compounds is significant. Objectives: The aims of this study were to investigate the effects of acute poisoning with the OP methamidophos and the effects of antidotal therapy with atropine and pralidoxime on rat thyroid tissue ultrastructure. Methods: In this single-blind, ex vivo study, male Wistar albino rats weighing 220 to 230 g were divided into 4 treatment groups. Group 1 received a median lethal dose of methamidophos (30 mg/kg) via oral gavage. Group 2 received saline via oral gavage and served as the control group for group 1. Group 3 received methamidophos (30 mg/kg) via oral gavage, and after 8 minutes atropine 0.05 mg/kg and pralidoxime chloride (2-FAM) (40 mg/kg) were administered intraperitoneally (IP). Atropine was titrated to reverse signs of cholinergic excess. Group 4 received saline via oral gavage followed by IP injections and served as the control for group 3. Rat thyroid tissues were examined using electron microscopy, and the histologic changes were examined by a histopathologist who was blinded to treatment. All rats were euthanized by intracardiac blood collection. The rats in groups 1 and 2 were euthanized 8 minutes after treatment. The rats in groups 3 and 4 were euthanized 96 hours after treatment. Results: Thirty-four male rats (aged 16 weeks) were included in the study. The rats were grouped accordingly: group 1 (n = 10); group 2 (n = 7); group 3 (n = 10); and group 4 (n = 7). The mean (SD) pseudocholinesterase (FCE) activity was significantly lower in the methamidophos-treated rats (group 1) compared with the corresponding control group (group 2) (32.6 [17.0] vs 579.4 [59.0] U/L, respectively; P < 0.001). PCE activity was significantly higher in rats treated with atropine and 2-PAM (group 3) (392.5 [39.4] U/L; P < 0.001) compared with those not receiving antidotal therapy (group 1

  4. Injection therapy for enthesopathies causing axial spine pain and the "failed back syndrome": a single blinded, randomized and cross-over study.

    PubMed

    Wilkinson, Harold A

    2005-04-01

    Enthesopathies are a common cause of axial pain that is amenable to "minimally invasive" therapy. To evaluate the effectiveness of injection therapy for enthesopathies. Single blinded, randomized, and cross-over study. Thirty-five patients diagnosed as having painful enthesopathies as a major pain generator were studied. Of the patients studied, 86% of patients had undergone prior lumbar spine surgery and all were referred for neurosurgical evaluation for possible surgery. Patients were injected either with anesthetics alone or with anesthetics combined with phenol-glycerol proliferant prolotherapy. Outcomes were analyzed both clinically at the time of regular follow-ups, and by a series of multipart questionnaires. Patients received a total of 86 injections, 39 with local anesthetics, and 47 with prolotherapy. By clinical assessment patients obtained excellent to good relief of pain and tenderness after 80% of prolotherapy injections, but only 47% after anesthetics alone. By questionnaire, 66% reported excellent to good relief after prolotherapy vs. 34% after anesthetics alone. Patients reported improvement in work capacity and social functioning following both types of injections, but a greater reduction in focal pain intensity following prolotherapy injections. The mean and median durations of persistent relief were 2.4 and 1.75 months with prolotherapy vs. 1.8 and 0.75 months with anesthetics alone. Roughly 10% obtained greater than six months of relief from either injection. In the crossover portion of the study, patients reported that prolotherapy injections following initial anesthetic-only injections provided much better relief than that achieved after their anesthetic-only injections, and that anesthetic-only injections following initial prolotherapy injections failed to provide relief as good as that achieved after their prolotherapy. Subsequent to this study, only four of 35 patients required additional spine surgery, but 29 of the 35 patients requested

  5. Monitoring Cortical Excitability during Repetitive Transcranial Magnetic Stimulation in Children with ADHD: A Single-Blind, Sham-Controlled TMS-EEG Study

    PubMed Central

    Helfrich, Christian; Pierau, Simone S.; Freitag, Christine M.; Roeper, Jochen; Ziemann, Ulf; Bender, Stephan

    2012-01-01

    Background Repetitive transcranial magnetic stimulation (rTMS) allows non-invasive stimulation of the human brain. However, no suitable marker has yet been established to monitor the immediate rTMS effects on cortical areas in children. Objective TMS-evoked EEG potentials (TEPs) could present a well-suited marker for real-time monitoring. Monitoring is particularly important in children where only few data about rTMS effects and safety are currently available. Methods In a single-blind sham-controlled study, twenty-five school-aged children with ADHD received subthreshold 1 Hz-rTMS to the primary motor cortex. The TMS-evoked N100 was measured by 64-channel-EEG pre, during and post rTMS, and compared to sham stimulation as an intraindividual control condition. Results TMS-evoked N100 amplitude decreased during 1 Hz-rTMS and, at the group level, reached a stable plateau after approximately 500 pulses. N100 amplitude to supra-threshold single pulses post rTMS confirmed the amplitude reduction in comparison to the pre-rTMS level while sham stimulation had no influence. EEG source analysis indicated that the TMS-evoked N100 change reflected rTMS effects in the stimulated motor cortex. Amplitude changes in TMS-evoked N100 and MEPs (pre versus post 1 Hz-rTMS) correlated significantly, but this correlation was also found for pre versus post sham stimulation. Conclusion The TMS-evoked N100 represents a promising candidate marker to monitor rTMS effects on cortical excitability in children with ADHD. TMS-evoked N100 can be employed to monitor real-time effects of TMS for subthreshold intensities. Though TMS-evoked N100 was a more sensitive parameter for rTMS-specific changes than MEPs in our sample, further studies are necessary to demonstrate whether clinical rTMS effects can be predicted from rTMS-induced changes in TMS-evoked N100 amplitude and to clarify the relationship between rTMS-induced changes in TMS-evoked N100 and MEP amplitudes. The TMS-evoked N100 amplitude

  6. A randomised, single-blind technical study comparing the ultrasonic visibility of smooth-surfaced and textured needles in a soft embalmed cadaver model.

    PubMed

    Munirama, S; Joy, J; Columb, M; Habershaw, R; Eisma, R; Corner, G; Cochran, S; McLeod, G

    2015-05-01

    Visibility of the needle tip and shaft is important during ultrasound-guided regional anaesthesia in order to prevent nerve trauma. Tip and shaft visibility is reduced when needles are inserted in-plane at wide angles and out-of-plane at narrow angles to the ultrasound probe. Although textured needles are more reflective than smooth needles, we hypothesised that poor visibility of the tip and shaft still remained using the above angle-probe combinations. In a single-blind study, we compared the visibility of a textured Tuohy needle, a textured single-shot needle and a conventional smooth-surfaced Tuohy needle when inserted into the biceps and deltoid muscles of a soft embalmed cadaver. One hundred and forty-four needles were block-randomised to in-plane and out-of-plane insertions at 30°, 45°, 60° and 75° to the ultrasound beam. Two blinded raters assessed needle tip visibility on video recordings of the insertions using a binary scale (0 = not visible, 1 = visible) and shaft visibility using a 5-point Likert scale. The median (IQR [range]) proportions of visible needle tips were 83% (67-83 [50-100]%) for the textured Tuohy, 75% (67-83 [33-83]%) for the textured single-shot needle and 33% (33-46 [0-50]%) for the smooth-surfaced Tuohy (p = 0.0007). Median (IQR [range]) needle shaft visibility was rated as 4.0 (3.5-4.7 [3.0-4.9]) for the textured Tuohy, 4.0 (3.8-4.5 [2.7-4.9]) for the textured single-shot needle and 3.0 (2.4-3.3 [2.3-3.5]) for the smooth-surfaced Tuohy (p = 0.015). Nevertheless, visibility was reduced at wide angles in-plane and narrow angles out-of-plane both for needle tips (p = 0.004) and shafts (p = 0.005). © 2014 Crown copyright. Anaesthesia © 2014 The Association of Anaesthetists of Great Britain and Ireland.

  7. A randomised, controlled, single-blinded study on the impact of a single rhythmical massage (anthroposophic medicine) on well-being and salivary cortisol in healthy adults.

    PubMed

    Kanitz, Jenny Lena; Reif, Marcus; Rihs, Carolina; Krause, Ingrid; Seifert, Georg

    2015-10-01

    Rhythmical massage (RM) has evolved from classical massage and is based on the principles of Anthroposophic medicine. The goal of this randomized, single-blinded study was to assess the efficacy of a single RM intervention with either aroma oil (RA) or a neutral oil (RM) compared to a sham massage (SM) on several dimensions of well-being and salivary cortisol in a laboratory setting. 118 healthy adults (mean age: 25.2 years; SD: 4.7) were randomized to one of three groups (RM, RA or SM). After baseline measurements, all subjects were exposed to an experimental stressful situation (Trier Social Stress Test, TSST), before receiving a single massage intervention of about 60 min including a 20-minute rest period. Well-being as the main outcome parameter was assessed by standardized questionnaires (MDBF, Bf-S, B-L) and visual analogue scales (VAS) prior to the beginning of the massage and subsequently. Salivary cortisol and heart rate variability (data are shown elsewhere) were also measured. Participants who received RM or RA showed no statistically significant improvements (MDBF, Bf-S, B-L) compared to the SM group after adjusting for baseline differences observed between the treatment groups. Furthermore, no statistically significant differences were found between the RM and RA groups in any of the analyses. Within a follow-up survey all participants from the RA and 82% from the RM group described the intervention as "relaxing" compared with 42% in the SM group. Salivary cortisol did not differ statistically significantly between the three groups over time. We found no significant effect within this trial. This may be due to the methodological complexity of massage research and especially the sham-controlled design with only one single intervention examined. The influence of the setting, and the expectations of and interaction between participant and practitioner seem to play a role that needs to be verified. Therefore the true potential of rhythmical massage

  8. Anesthetic Efficacy of Combinations of 0.5 M Mannitol and Lidocaine With Epinephrine in Inferior Alveolar Nerve Blocks: A Prospective Randomized, Single-Blind Study

    PubMed Central

    Wolf, Ronald; Reader, Al; Drum, Melissa; Nusstein, John; Beck, Mike

    2011-01-01

    The purpose of this prospective, randomized, single-blind study was to determine the anesthetic efficacy of lidocaine with epinephrine compared to lidocaine with epinephrine plus 0.5 M mannitol in inferior alveolar nerve (IAN) blocks. Forty subjects randomly received an IAN block in 3 separate appointments spaced at least 1 week apart using the following formulations: a 1.8 mL solution of 36 mg lidocaine with 18 µg epinephrine (control solution); a 2.84 mL solution of 36 mg lidocaine with 18 µg epinephrine (1.80 mL) plus 0.5 M mannitol (1.04 mL); and a 5 mL solution of 63.6 mg lidocaine with 32 µg epinephrine (3.18 mL) plus 0.5 M mannitol (1.82 mL). Mandibular teeth were blindly electric pulp tested at 4-minute cycles for 60 minutes postinjection. No response from the subject to the maximum output (80 reading) of the pulp tester was used as the criterion for pulpal anesthesia. Mean percent total pulpal anesthesia was defined as the total of all the times of pulpal anesthesia (80 readings) over the 60 minutes. Pain of solution deposition and postoperative pain were also measured. The results demonstrated that 2.84 mL of lidocaine with epinephrine plus 0.5 M mannitol was significantly better than 1.8 mL of lidocaine with epinephrine for the molars and premolars. The 5 mL of lidocaine with epinephrine plus 0.5 M mannitol was statistically better than 1.8 mL of lidocaine with epinephrine and 2.84 mL of lidocaine with epinephrine plus 0.5 M mannitol for all teeth except the central incisor. Solution deposition pain and postoperative pain were not statistically different among the mannitol formulations and the lidocaine formulation without mannitol. We concluded that adding 0.5 M mannitol to lidocaine with epinephrine formulations significantly improved effectiveness in achieving a greater percentage of total pulpal anesthesia compared with a lidocaine formulation without mannitol for IAN block. PMID:22168805

  9. Comparison of the effects of lornoxicam versus diclofenac in pain management after cardiac surgery: A single-blind, randomized, active-controlled study

    PubMed Central

    Daglar, Bahadir; Kocoglu, Hasan; Adnan Celkan, M.; Goksu, Sitki; Kazaz, Hakki; Kayiran, Celalettin

    2005-01-01

    Background: Inadequate pain management after cardiac surgery may result 10 in increased morbidity and length of hospital stay. Although opioids are the mainstay of postoperative analgesia, nonsteroidal anti-inflammatory drugs (NSAIDs) may be used instead to avoid the adverse effects (AEs) associated with opioids. Lornoxicam is a newly developed NSAID, the use of which is increasing. However, lornoxicam has not been studied for use in pain management after cardiac surgery. Objective: The objective of this study was to compare the efficacy and tolerability 10 of lornoxicam and diclofenac sodium, an NSAID well established for use in pain management after major surgery, in pain management after coronary artery bypass grafting (CABG). Methods: This single-blind, randomized, active-controlled study was conducted 10 at the Gaziantep University Hospital, Gaziantep, Turkey. Adult patients scheduled to undergo valve or CABG surgery for the first time were included. Patients were premedicated with diazepam 10 mg PO at 10 PM on the evening before surgery. General anesthesia was induced using fentanyl, midazolam, and propofol, and maintained using fentanyl and isoflurane in pure oxygen. After extubation and when they stated that they felt pain, patients were randomly assigned to 1 of 2 treatment groups: lornoxicam 8 mg IM q8h or diclofenac 75 mg IM q12h, for 48 hours. Meperidine 1 mg/kg IM was given for additional analgesia when needed (rescue medication). Pain relief was assessed using an I1-point visual analog scale (0 = no pain to 10 = worst pain imaginable) immediately before the first injection (baseline), and at 15 and 30 minutes and 1, 2, 3, 4, 6, 12, 18, 24, and 48 hours after the first injection. Sedation was assessed using a 5-point scale (0 = awake and alert to 4 = deep sedation) at the same time points. Tolerability was assessed by monitoring of AEs using patient interview and laboratory analyses. Results: Forty patients were enrolled in the study (30 men, 10 women

  10. [Simulation-based training and OR apprenticeship for medical students : A prospective, randomized, single-blind study of clinical skills].

    PubMed

    Ott, T; Schmidtmann, I; Limbach, T; Gottschling, P F; Buggenhagen, H; Kurz, S; Pestel, G

    2016-11-01

    Simulation-based training (SBT) has developed into an established method of medical training. Studies focusing on the education of medical students have used simulation as an evaluation tool for defined skills. A small number of studies provide evidence that SBT improves medical students' skills in the clinical setting. Moreover, they were strictly limited to a few areas, such as the diagnosis of heart murmurs or the correct application of cricoid pressure. Other studies could not prove adequate transferability from the skills gained in SBT to the patient site. Whether SBT has an effect on medical students' skills in anesthesiology in the clinical setting is controversial. To explore this issue, we designed a prospective, randomized, single-blind trial that was integrated into the undergraduate anesthesiology curriculum of our department during the second year of the clinical phase of medical school. This study intended to explore the effect of SBT on medical students within the mandatory undergraduate anesthesiology curriculum of our department in the operating room with respect to basic skills in anesthesiology. After obtaining ethical approval, the participating students of the third clinical semester were randomized into two groups: the SIM-OR group was trained by a 225 min long SBT in basic skills in anesthesiology before attending the operating room (OR) apprenticeship. The OR-SIM group was trained after the operating room apprenticeship by SBT. During SBT the students were trained in five clinical skills detailed below. Further, two clinical scenarios were simulated using a full-scale simulator. The students had to prepare the patient and perform induction of anesthesia, including bag-mask ventilation after induction in scenario 1 and rapid sequence induction in scenario 2. Using the five-point Likert scale, five defined skills were evaluated at defined time points during the study period. 1) application of the safety checklist, 2) application of

  11. Study of the therapeutic effects of a hippotherapy simulator in children with cerebral palsy: a stratified single-blind randomized controlled trial.

    PubMed

    Herrero, Pablo; Gómez-Trullén, Eva M; Asensio, Angel; García, Elena; Casas, Roberto; Monserrat, Esther; Pandyan, Anand

    2012-12-01

    To investigate whether hippotherapy (when applied by a simulator) improves postural control and balance in children with cerebral palsy. Stratified single-blind randomized controlled trial with an independent assessor. Stratification was made by gross motor function classification system levels, and allocation was concealed. Children between 4 and 18 years old with cerebral palsy. Participants were randomized to an intervention (simulator ON) or control (simulator OFF) group after getting informed consent. Treatment was provided once a week (15 minutes) for 10 weeks. Gross Motor Function Measure (dimension B for balance and the Total Score) and Sitting Assessment Scale were carried out at baseline (prior to randomization), end of intervention and 12 weeks after completing the intervention. Thirty-eight children participated. The groups were balanced at baseline. Sitting balance (measured by dimension B of the Gross Motor Function Measure) improved significantly in the treatment group (effect size = 0.36; 95% CI 0.01-0.71) and the effect size was greater in the severely disabled group (effect size = 0.80; 95% CI 0.13-1.47). The improvements in sitting balance were not maintained over the follow-up period. Changes in the total score of the Gross Motor Function Measure and the Sitting Assessment Scale were not significant. Hippotherapy with a simulator can improve sitting balance in cerebral palsy children who have higher levels of disability. However, this did not lead to a change in the overall function of these children (Gross Motor Function Classification System level V).

  12. A single-blind, placebo-controlled study of glycosaminoglycan-peptide complex ('Rumalon') in patients with osteoarthritis of the hip or knee.

    PubMed

    Gramajo, R J; Cutroneo, E J; Fernandez, D E; Gibson, J L; Cáceres Maldonado, J C; Romero, F L; Houssay, R H

    1989-01-01

    A randomized, single-blind, placebo-controlled trial was carried out in 62 patients (30 with osteoarthritis of the hip, 32 with osteoarthritis of the knee) to examine the efficacy of glycosaminoglycan-peptide complex in the treatment of osteoarthritis. Patients received 8-week courses of trial medication, each consisting of intramuscular injections of 3 x 2 ml ampoules per week, alternating with 8-week periods free of trial medication, in addition to conventional drug therapy and physiotherapy, as required. After 2-years' treatment, glycosaminoglycan-peptide-treated patients showed significant improvements, as compared with placebo, in relation to night pain, pain during the day, joint mobility and walking ability. Similar results were seen with both osteoarthritis of the hip and knee. In osteoarthritis of the knee it was also possible to assess joint swelling and this also showed a significant improvement. There were no significant changes in range of joint movement except for a significant decrease in active flexion in the patients with osteoarthritis of the knee treated with placebo. In contrast with many anti-osteoarthritic drugs, glycosaminoglycan-peptide complex was very well tolerated. These results suggest that glycosaminoglycan-peptide complex may be a valuable alternative form of long-term therapy for patients with osteoarthritis.

  13. Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.

    PubMed

    Happe, Svenja; Evers, Stefan; Thiedemann, Christian; Bunten, Sabine; Siegert, Rudolf

    2016-11-15

    Treatment of restless legs syndrome (RLS) is primarily based on drugs. Since many patients report improvement of symptoms due to cooling their legs, we examined the efficacy of cryotherapy in RLS. 35 patients (28 women, 60.9±12.5years) with idiopathic RLS and symptoms starting not later than 6pm were randomized into three groups: cold air chamber at -60°C (n=12); cold air chamber at -10°C (n=12); local cryotherapy at -17°C (n=11). After a two week baseline, the different therapies were applied three minutes daily at 6pm over two weeks, followed by a four week observation period. The patients completed several questionnaires regarding RLS symptoms, sleep, and quality of life on a weekly basis (IRLS, ESS), VAS and sleep/morning protocol were completed daily, MOSS/RLS-QLI were completed once in each period. Additionally, the PLM index was measured by a mobile device at the end of baseline, intervention, and follow-up. The IRLS score was chosen as primary efficacy parameter. At the end of follow-up, significant improvement of RLS symptoms and quality of life could be observed only in the -60°C group as compared to baseline (IRLS: p=0.009; RLS-QLI: p=0.006; ESS: p=0.020). Local cryotherapy led to improvement in quality of life (VAS4: p=0.028; RLS-QLI: p=0.014) and sleep quality (MOSS: p=0.020; MOSS2: p=0.022) but not in IRLS and ESS. In the -10°C group, the only significant effect was shortening of number of wake phases per night. Serious side-effects were not reported. Whole body cryotherapy at -60°C and, to a less extent, local cryotherapy seem to be a treatment option for RLS in addition to conventional pharmacological treatment. However, the exact mode of cryotherapy needs to be established. Copyright © 2016. Published by Elsevier B.V.

  14. Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495].

    PubMed

    van Hout, Hein P J; Nijpels, Giel; van Marwijk, Harm W J; Jansen, Aaltje P D; Van't Veer, Petronella J; Tybout, Willemijn; Stalman, Wim A B

    2005-09-08

    The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Main study: The main study concerns a randomized controlled in primary care practices (PCP) with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1) visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2) determine the care priorities together with the patient; (3) design and execute interventions according to protocols; (4) and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search): 1) Vulnerable Elders Screen, 2) Strawbridge's frailty screen, and 3) COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. The design holds several unique elements such as early identification of frail persons combined with case-management by nurses. From two pilots we learned that of three

  15. Effectiveness of an education intervention to strengthen nurses' readiness for evidence-based practice: A single-blind randomized controlled study.

    PubMed

    Saunders, Hannele; Vehviläinen-Julkunen, Katri; Stevens, Kathleen R

    2016-08-01

    Nurses' lack of readiness for evidence-based practice slows down the uptake, adoption, and implementation of evidence-based practice which is of international concern as it impedes attainment of the highest quality of care and best patient outcomes. There is limited evidence about the most effective approaches to strengthen nurses' readiness for evidence-based practice. To evaluate the effectiveness of an Advanced Practice Nurse-delivered education program to strengthen nurses' readiness for evidence-based practice at a university hospital. A single-blind randomized controlled trial with repeated measures design, with measures completed during spring and fall 2015, before the education program (T0), within 1week after (T1), 8weeks after (T2), and 4months after completion of education interventions (T3). One large university hospital system in Finland, consisting of 15 acute care hospitals. The required sample size, calculated by a priori power analysis and including a 20% estimated attrition rate, called for 85 nurse participants to be recruited. Nurses working in different professional nursing roles and care settings were randomly allocated into two groups: intervention (evidence-based practice education, N=43) and control (research utilization education, N=34). The nurse participants received live 4-h education sessions on the basic principles of evidence-based practice (intervention group) and on the principles of research utilization (control group). The intervention group also received a web-based interactive evidence-based practice education module with a booster mentoring intervention. Readiness for evidence-based practice data, previous experience with evidence-based practice, and participant demographics were collected using the Stevens' EBP Readiness Inventory. Nurses' confidence in employing evidence-based practice and actual evidence-based practice knowledge were lower at T0, compared with the post-education scores, specifically at T1. The improvement

  16. Piloted rover technology study

    NASA Technical Reports Server (NTRS)

    Thrasher, D. L.

    1990-01-01

    This is the May 25, 1990 summary report for Space Transfer Concepts and Analyses (STCA) Study, special study task 9.1, Piloted Rovers Technology Study. Piloted rover concepts, mission scenarios, and the requirements necessary for completion of these missions resulting in the establishment of a lunar base. These tasks were intended to lead to a logical conclusion concerning which piloted rovers technologies are needed to accomplish the various missions, along with a recommended schedule for the development of these technologies.

  17. Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn’s Disease in a Randomized Single-Blinded Placebo Controlled Study

    PubMed Central

    Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

    2016-01-01

    Background Ingestion of AndoSanTM, based on the mushroom Agaricus blazei Murill, has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn’s disease (CD). In this randomized single-blinded placebo-controlled study we examined whether intake of AndoSanTM also resulted in clinical effects. Methods and Findings 50 patients with symptomatic CD were randomized for oral daily consumption of AndoSanTM or placebo for a 21-day experimental period, in this per-protocol study. Patients reported validated scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSanTM group (n = 25) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.52 (4.64–6.40), 4.48 (3.69–5.27) and 4.08 (3.22–4.94) (p<0,001). We found significant improvements in symptom score for both genders in the AndoSanTM group, and no significant changes in the placebo (n = 25) group. There were however no significant differences between the groups (p = 0.106), although a marginal effect in symptom score for men (p = 0.054). There were comparable improvements in physical, mental and total fatigue for both groups. HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the AndoSanTM group and for vitality and social functioning in the placebo group. No crucial changes in general blood samples and fecal calprotectin were detected. Conclusions The results from this single-blinded randomized clinical trial shows significant improvement on symptoms, for both genders, in the AndoSanTM group, but no significant differences between the study groups. The results on fatigue, HRQoL, fecal calprotectin and blood samples were quite similar compared with placebo. The patients did not report any harms or unintended effects of AndoSanTM. CD patients with

  18. RAPP, a systematic e-assessment of postoperative recovery in patients undergoing day surgery: study protocol for a mixed-methods study design including a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies

    PubMed Central

    Dahlberg, K; Odencrants, S; Hagberg, L

    2016-01-01

    Introduction Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient-related outcomes such as mobile applications. This article describes the Recovery Assessment by Phone Points (RAPP) study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost-effective and improves postoperative recovery, health and quality of life. Methods and analysis This study has a mixed-methods study design that includes a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies. 1000 patients >17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (ie, no follow-up). The primary aim is cost-effectiveness. Secondary aims are (A) to explore whether a systematic e-assessment follow-up after day surgery has a positive effect on postoperative recovery, health-related quality of life (QoL) and overall health; (B) to determine whether differences in postoperative recovery have an association with patient characteristic, type of surgery and anaesthesia; (C) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health and QoL; and (D) to describe day surgery patient and staff experiences with a systematic e-assessment follow-up after day surgery. The primary aim will be measured at 2 weeks postoperatively and secondary outcomes (A–C) at 1 and 2 weeks and (D) at 1 and 4 months. Trial registration number NCT02492191; Pre

  19. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial.

    PubMed

    Gilliaux, Maxime; Renders, Anne; Dispa, Delphine; Holvoet, Dominique; Sapin, Julien; Dehez, Bruno; Detrembleur, Christine; Lejeune, Thierry M; Stoquart, Gaëtan

    2015-02-01

    Several pilot studies have evoked interest in robot-assisted therapy (RAT) in children with cerebral palsy (CP). To assess the effectiveness of RAT in children with CP through a single-blind randomized controlled trial. Sixteen children with CP were randomized into 2 groups. Eight children performed 5 conventional therapy sessions per week over 8 weeks (control group). Eight children completed 3 conventional therapy sessions and 2 robot-assisted sessions per week over 8 weeks (robotic group). For both groups, each therapy session lasted 45 minutes. Throughout each RAT session, the patient attempted to reach several targets consecutively with the REAPlan. The REAPlan is a distal effector robot that allows for displacements of the upper limb in the horizontal plane. A blinded assessment was performed before and after the intervention with respect to the International Classification of Functioning framework: body structure and function (upper limb kinematics, Box and Block test, Quality of Upper Extremity Skills Test, strength, and spasticity), activities (Abilhand-Kids, Pediatric Evaluation of Disability Inventory), and participation (Life Habits). During each RAT session, patients performed 744 movements on average with the REAPlan. Among the variables assessed, the smoothness of movement (P < .01) and manual dexterity assessed by the Box and Block test (P = .04) improved significantly more in the robotic group than in the control group. This single-blind randomized controlled trial provides the first evidence that RAT is effective in children with CP. Future studies should investigate the long-term effects of this therapy. © The Author(s) 2014.

  20. Evaluation of the Immediate Effect of Auricular Acupuncture on Pain and Electromyographic Activity of the Upper Trapezius Muscle in Patients with Nonspecific Neck Pain: A Randomized, Single-Blinded, Sham-Controlled, Crossover Study

    PubMed Central

    Silva, Andréia Cristina de Oliveira; Biasotto-Gonzalez, Daniela Aparecida; dos Santos, Douglas Meira; Melo, Nivea Cristina De; Gomes, Cid André Fidelis de Paula; Amorim, César Ferreira; Politti, Fabiano

    2015-01-01

    Background. The aim of the present study was to assess the immediate effects of auricular acupuncture (AA) on the electromyographic (EMG) activity of the upper trapezius muscle and pain in nonspecific neck pain (NS-NP) patients. Twelve patients with NS-NP (NS-NP group) and 12 healthy subjects (HS Group) were enrolled in a randomized, single-blinded, crossover study. Each subject received a single session of AA and sham AA (SAA). Surface EMG activity was measured in the upper trapezius muscle at different “step contractions” of isometric shoulder elevation (15%, 20%, 25%, and 30% MVC). The outcome measure in patients with NS-NP was based on the numerical pain rating scale (NRS). AA treatment led to a significant decrease in EMG activity in both groups (NS-NP group: p = 0.0001; HS group: p < 0.0001—ANOVA test). This was not the case for the SAA treatment (NS-NP group: p = 0.71; HS group: p < 0.54). Significant decreases (p < 0.001) in the NRS were found for both treatments (AA and SAA). This study demonstrated the immediate effect of auricular acupuncture on the electromyographic activity of the upper trapezius muscle but the effect of this intervention on pain symptoms in patients with nonspecific neck pain was inconclusive. PMID:26451155

  1. Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study.

    PubMed

    Bier, Nathalie; Grenier, Sébastien; Brodeur, Catherine; Gauthier, Serge; Gilbert, Brigitte; Hudon, Carol; Lepage, Émilie; Ouellet, Marie-Christine; Viscogliosi, Chantal; Belleville, Sylvie

    2015-03-01

    Several studies have suggested that cognitive training is a potentially effective way to improve cognition and postpone cognitive decline in older adults with mild cognitive impairment (MCI). The MEMO+ study is a randomized, controlled, single-blind trial designed to test the efficacy, specificity, and long-term effect of a cognitive training intervention and a psychosocial intervention in persons with MCI. One hundred and sixty-two participants with MCI will be recruited. They will be randomized into three groups: cognitive training, psychosocial intervention, and no-contact. Each intervention will last for eight weeks (one session per week) and a booster training session will be provided three months after the end of the intervention. Various proximal and distal outcomes will be measured at pre-intervention as well as at one week, three months, and six months post-training. Proximal outcomes include memory and psychological health measures. Distal outcomes focus on self-rated functioning in complex daily activities and strategies used in daily life to enhance function. Socio-demographic factors (age, gender, and education), general cognition, personality traits, engagement in activities, and self-efficacy will be used as moderators. Enrolment began in April 2012 and will be completed by December 2014. This study is likely to have a significant impact on the well-being of persons with MCI by contributing to the development of adapted and scientifically supported cognitive and psychosocial interventions.

  2. Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study.

    PubMed

    Morris, Jacqui H; Kelly, Chris; Toma, Madalina; Kroll, Thilo; Joice, Sara; Mead, Gillian; Donnan, Peter; Williams, Brian

    2014-09-28

    Benefits of art participation after stroke are becoming increasingly recognized. Qualitative studies suggest that participation in visual arts creative engagement interventions (CEIs) during rehabilitation after stroke may improve mood, self-esteem, hope and some aspects of physical recovery. This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness. This trial is a two arm, single-blind, randomized controlled feasibility trial within in-patient stroke rehabilitation. We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland (40 patients in each arm). Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists. Artists will follow an intervention protocol with specific components that enable participants to set, achieve and review artistic goals. Participants will receive up to eight intervention sessions, four within a group and four one-to-one with the artist. Control group participants will receive usual care only.Data collection will occur at baseline, post-intervention and three-month follow-up. Stroke-related health status is the primary outcome; mood, self-esteem, self-efficacy, perceived recovery control and hope are secondary outcomes. Semi-structured interviews will be conducted with purposively selected patients, artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes. Recruitment rates, retention rates and patient preference for art participation will also be collected. Data will indicate, with confidence intervals, the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial. Summary data will indicate potential variability, magnitude and direction of difference between groups

  3. A prospective, single-blind, multicenter, dose escalation study of intracoronary iNOS lipoplex (CAR-MP583) gene therapy for the prevention of restenosis in patients with de novo or restenotic coronary artery lesion (REGENT I extension).

    PubMed

    von der Leyen, Heiko E; Mügge, Andreas; Hanefeld, Christoph; Hamm, Christian W; Rau, Mathias; Rupprecht, Hans J; Zeiher, Andreas M; Fichtlscherer, Stephan

    2011-08-01

    Neointimal hyperplasia causing recurrent stenosis is a limitation of the clinical utility of percutaneous transluminal coronary interventions (PCI). Nitric oxide (NO) inhibits smooth muscle cell proliferation, platelet activation, and inflammatory responses, all of which have been implicated in the pathogenesis of restenosis. In animals, neointimal proliferation after balloon injury has been shown to be effectively reduced by gene transfer of the inducible NO synthase (iNOS). The primary objective of this first multicenter, prospective, single-blind, dose escalation study was to obtain safety and tolerability information of the iNOS lipoplex (CAR-MP583) gene therapy for reducing restenosis following PCI. Local coronary intramural CAR-MP583 delivery was achieved using the Infiltrator balloon catheter. A total of 30 patients were treated in the study (six patients, 0.5 μg; six patients, 2.0 μg; six patients, 5.0 μg; and 12 patients, 10 μg). There were no complications related to local application of CAR-MP583. In one patient, PCI procedure-related transient vessel occlusion occurred with consecutive troponin elevation. There were no signs of inflammatory responses or hepatic or renal toxicity. No dose relationship was seen with regard to adverse events across the dose groups. Thus, coronary intramural lipoplex-enhanced iNOS gene therapy during PCI is feasible and appears to be safe. These initial clinical results are encouraging to support further clinical research, in particular in conjunction with new local drug delivery technologies.

  4. Intramuscular Administration of Drotaverine Hydrochloride Decreases Both Incidence of Urinary Retention and Time to Micturition in Orthopedic Patients under Spinal Anesthesia: A Single Blinded Randomized Study

    PubMed Central

    Bałkota, Mariusz

    2015-01-01

    Purpose. Postoperative urinary retention (POUR) increases the duration of hospitalization and frequency and risk of urinary bladder catheterization. The objective of this study was to analyze the efficacy of intramuscularly administered drotaverine hydrochloride in the prevention of POUR in orthopedic patients. Methods. Two hundred and thirty patients 17–40 years of age undergoing lower limb orthopedic procedures under spinal anesthesia were enrolled in the study. The study group received 40 mg of drotaverine hydrochloride intramuscularly; the second group was the control. The main outcome measure was (1) the time to micturition and (2) the incidence of urinary bladder catheterization and time to catheterization. Results. Two hundred and one patients of 230 enrolled participants completed the study. Compared to the control group, the male patients in study group exhibited a shorter time to spontaneous micturition (441 versus 563 minutes, 95% CI of the difference of means between 39 and 205 minutes) and a lower incidence of urinary bladder catheterization (4/75 versus 10/54) (RR 0.29, 95% CI: 0.1–0.87; P = 0.0175). Conclusions. Intramuscular administration of drotaverine hydrochloride decreased the time to spontaneous micturition and decreased the incidence of urinary bladder catheterization in male patients who underwent orthopedic surgery under spinal anesthesia. This trial is registered with NCT02026427. PMID:26185766

  5. Participatory organizational intervention for improved use of assistive devices for patient transfer: study protocol for a single-blinded cluster randomized controlled trial.

    PubMed

    Jakobsen, Markus D; Aust, Birgit; Dyreborg, Johnny; Kines, Pete; Illum, Maja B; Andersen, Lars L

    2016-12-20

    Epidemiological studies have shown that patient transfer is a risk factor for back pain, back injuries and long term sickness absence, whereas consistent use of assistive devices during patient transfer seems to be protective. While classical ergonomic interventions based on education and training in lifting and transferring techniques have not proven to be effective in preventing back pain, participatory ergonomics, that is meant to engage and motivate the involved parties while at the same time making the intervention maximally relevant, may represent a better solution. However, these findings are largely based on uncontrolled studies and thus lack to be confirmed by studies with better study designs. In this article, we present the design of a study which aims to evaluate the effect and process of a participatory organizational intervention for improved use of assistive devices. The study was performed as a cluster randomized controlled trial. We recruited 27 departments (clusters) from five hospitals in Denmark to participate in the study. Prior to randomization, interviews, observations and questionnaire answers (baseline questionnaire) were collected to gain knowledge of barriers and potential solutions for better use of assistive devices. In April 2016, the 27 departments were randomly allocated using a random numbers table to a participatory intervention (14 clusters, 324 healthcare workers) or a control group (13 clusters, 318 healthcare workers). The participatory intervention will consist of workshops with leaders and selected healthcare workers of each department. Workshop participants will be asked to discuss the identified barriers, develop solutions for increasing the use of assistive devices and implement them in their department. Use of assistive devices (using digital counters -, primary outcome, and accelerometers and questionnaire - secondary outcome), perceived physical exertion during patient transfer, pain intensity in the lower back

  6. Transcutaneous Electrical Acupoint Stimulation in Children with Autism and Its Impact on Plasma Levels of Arginine-Vasopressin and Oxytocin: A Prospective Single-Blinded Controlled Study

    ERIC Educational Resources Information Center

    Zhang, Rong; Jia, Mei-Xiang; Zhang, Ji-Sui; Xu, Xin-Jie; Shou, Xiao-Jing; Zhang, Xiu-Ting; Li, Li; Li, Ning; Han, Song-Ping; Han, Ji-Sheng

    2012-01-01

    Acupuncture increases brain levels of arginine-vasopressin (AVP) and oxytocin (OXT), which are known to be involved in the modulation of mammalian social behavior. Transcutaneous electrical acupoint stimulation (TEAS) is often used clinically to produce a similar stimulation to that of acupuncture on the acupoints. In the present study, TEAS was…

  7. Transcutaneous Electrical Acupoint Stimulation in Children with Autism and Its Impact on Plasma Levels of Arginine-Vasopressin and Oxytocin: A Prospective Single-Blinded Controlled Study

    ERIC Educational Resources Information Center

    Zhang, Rong; Jia, Mei-Xiang; Zhang, Ji-Sui; Xu, Xin-Jie; Shou, Xiao-Jing; Zhang, Xiu-Ting; Li, Li; Li, Ning; Han, Song-Ping; Han, Ji-Sheng

    2012-01-01

    Acupuncture increases brain levels of arginine-vasopressin (AVP) and oxytocin (OXT), which are known to be involved in the modulation of mammalian social behavior. Transcutaneous electrical acupoint stimulation (TEAS) is often used clinically to produce a similar stimulation to that of acupuncture on the acupoints. In the present study, TEAS was…

  8. Comparison of the urinary excretion of quercetin glycosides from red onion and aglycone from dietary supplements in healthy subjects: a randomized, single-blinded, cross-over study.

    PubMed

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

    Some intervention studies have shown that quercetin supplementation can regulate certain biomarkers, but it is not clear how the doses given relate to dietary quercetin (e.g. from onion). We conducted a two-period, two-sequence crossover study to compare the bioavailability of quercetin when administered in the form of a fresh red onion meal (naturally glycosylated quercetin) or dietary supplement (aglycone quercetin) under fasting conditions. Six healthy, non-smoking, adult males with BMI 22.7 ± 4.0 kg m(-2) and age 35.3 ± 12.3 y were grouped to take the two study meals in random order. In each of the 2 study periods, one serving of onion soup (made from 100 g fresh red onion, providing 156.3 ± 3.4 μmol (47 mg) quercetin) or a single dose of a quercetin dihydrate tablet (1800 ± 150 μmol (544 mg) of quercetin) were administered following 3 d washout. Urine samples were collected up to 24 h, and after enzyme deconjugation, quercetin was quantified by LC-MS. The 24 h urinary excretion of quercetin (1.69 ± 0.79 μmol) from red onion in soup was not significantly different to that (1.17 ± 0.44 μmol) for the quercetin supplement tablet (P = 0.065, paired t-test). This means that, in practice, 166 mg of quercetin supplement would be comparable to about 10 mg of quercetin aglycone equivalents from onion. These data allow intervention studies on quercetin giving either food or supplements to be more effectively compared.

  9. fMRI Neurofeedback Training for Increasing Anterior Cingulate Cortex Activation in Adult Attention Deficit Hyperactivity Disorder. An Exploratory Randomized, Single-Blinded Study

    PubMed Central

    Slaats-Willemse, Dorine; Kan, Cornelis C.; Goebel, Rainer; Buitelaar, Jan K.

    2017-01-01

    Attention Deficit Hyperactivity Disorder (ADHD) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex (dACC). In the current study, we investigated for the first time whether real-time fMRI neurofeedback (rt-fMRI) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning. An exploratory randomized controlled treatment study with blinding of the participants was conducted. Participants with ADHD (n = 7 in the neurofeedback group, and n = 6 in the control group) attended four weekly MRI training sessions (60-min training time/session), during which they performed a mental calculation task at varying levels of difficulty, in order to learn how to up-regulate dACC activation. Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC. Before and after the training, ADHD symptoms and relevant cognitive functioning was assessed. Results showed that both groups achieved a significant increase in dACC activation levels over sessions. While there was no significant difference between the neurofeedback and control group in clinical outcome, neurofeedback participants showed stronger improvement on cognitive functioning. The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients. Due to the study’s small sample size, potential clinical benefits need to be further investigated in future studies. Trial Registration: ISRCTN12390961 PMID:28125735

  10. Histological evaluation of Accell Connexus(®) and Bio-Oss(®) on quality and rate of bone healing: a single blind experimental study on rabbit's calvarium.

    PubMed

    Khorsand, A; Rasouli Ghahroudi, A A R; Motahhari, P; Rezaei Rad, M; Soleimani Shayesteh, Y

    2012-01-01

    The objective of this study was to evaluate the effect of Accell Connexus(®) on the quality and rate of healing in experimental defects of rabbit calvarium compared to Bio-Oss®. Twelve 2.5-3.5 kg weighing New Zealand white rabbits were used. Three defects (3×6 mm) were created in the cranium of the animals subsequently filled with Accell Connexus(®), Bio-Oss® or served as controls. The animals were sacrificed four, six and eight weeks postoperatively and the histology blocks were studied in terms of inflammation, trabeculation thickness, bone type regeneration, foreign body and remained biomaterial by light microscope. The data were subject to Mann-Whitney U test. Increased inflammatory reaction, foreign body reaction, delayed bone formation and lower rate of ossification were observed in DBM-filled defects compared to Bio-Oss® or controls. However, no significant differences were observed in bone formation between Bio-Oss®, Accell Connexus(®) and control specimens in the three time intervals. Furthermore, no significant differences were noted between Bio-Oss® and control groups. Accell Connexus(®) showeda lower rate of ossification and bone healing compared to Bio-Oss® or controlgroups. Other studies in this field seem necessary.

  11. [Results of a single blind study placebo vs Diallil-Tiosulphinate, Nucipherine and Diosgenin in patients reponders to Tadalafil 5 mg].

    PubMed

    Scaduto, Giovanna; Daricello, Giuseppe; Pavone, Carlo

    2015-01-01

    The aim of the study is to evaluate the efficacy of Diallil-Tiosulphinate, Nuciepherine and Diosgenin in the treatment of erectile dysfunction. In our study were selected 120 men affected by erectile dysfunction. They were filled in a self-administered questionnaire International Index of Sexual Medicine. 74 of them reported a moderate erectile dysfunction and 46 reported a severe ED. All patients were treated with Tadalafil 5 mg once a day for 90 days. They were re-evaluated with the same questionnaire after three months of therapy. In 75% of the patients there was an improvement of IIEF-5 score. Only the 90 patients responders to Tadalafil once a day were randomized and divided into two groups, each formed by 45 subjects. The group A was treated with the association of Diallil-Tiosulfinate, Nucipherine and Diosgenin on alternate days. The patients of group B were treated with placebo. After three months, there was a new evaluation with IIEF-5 score. In group A we reported a maintenance of improvement post-Tadalafil in 36 patients;in group B, only 18 patients have maintained the previous improvement, according to IIEF-5 score. The ?2 test is 13,38, with a p-value of about 0,00013.The maintenance's odds ratio, confronting the two groups, is 6 with a confidence's interval of 95%. The study shows that the utilization of the association therapy in patients with erectile dysfunction responders to Tadalafil once a day is able to duplicate the odds of maintenance's improvement compared to placebo.

  12. Modulating arithmetic fact retrieval: a single-blind, sham-controlled tDCS study with repeated fMRI measurements.

    PubMed

    Clemens, Benjamin; Jung, Stefanie; Zvyagintsev, Mikhail; Domahs, Frank; Willmes, Klaus

    2013-06-01

    Transcranial direct current stimulation (tDCS) is a non-invasive technique which has been used to modulate various cognitive functions in healthy participants as well as stroke patients. Despite the increasing number of tDCS studies, it still remains questionable whether tDCS is suitable for modulating performance in arithmetic tasks and whether a single tDCS session may cause brain activity changes that can be detected with functional magnetic resonance imaging (fMRI). We asked healthy participants to repeatedly solve simple multiplication tasks in three conditions: STIMULATION (anodal tDCS over the right angular gyrus, AG), SHAM (identical electrode set-up without stimulation), and CONTROL (no electrodes attached). Before and after tDCS, we used fMRI to examine changes in brain activity. Behavioural results indicate that a single session of tDCS did not modulate task performance significantly. However, fMRI measurements revealed that the neural correlates of multiplication were modified following a single session of anodal tDCS. In the bilateral AG, activity was significantly higher for multiplication problems rehearsed during active tDCS, as compared to multiplication problems rehearsed without tDCS or during sham tDCS. In sum, we present first neuro-functional evidence that tDCS modulates arithmetic processing. Implications of these findings for future tDCS studies and for the rehabilitation of acalculic patients with deficits in arithmetic fact retrieval are discussed.

  13. Stress-related psycho-physiological disorders: randomized single blind placebo controlled naturalistic study of psychometric evaluation using a radio electric asymmetric treatment

    PubMed Central

    2011-01-01

    Background The aim of this study is to investigate the effects of a radio electric asymmetric treatment on psycho-physiological disorders (PPD). PPD are often stress related and are under the unconscious control of the patient and cannot be traced back to any serious physical disease. The brain stimulation treatment protocol used is called Neuro Psycho Physical Optimization (NPPO) with a Radio Electric Asymmetric Conveyer (REAC) device. Methods Psychological stress and PPD were measured for a group of 888 subjects using the Psychological Stress Measure (PSM) test, a self-administered questionnaire. Data were collected immediately before and after the 4-weeks of REAC treatment cycle. Results This study showed a significant reduction in scores measuring subjective perceptions of stress for subjects treated with a cycle of NPPO REAC treatment. At the end-point the number of subjects reporting symptoms of stress-related PPD on the PSM test was significantly reduced, whereas in the placebo group the difference was not significant. Conclusion A cycle of NPPO treatment with REAC was shown to reduce subjective perceptions of stress measured by the PSM test and in particular on PPD. Trial Registration This trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with the number: ACTRN12607000463471. PMID:21771304

  14. The efficacy and safety of a monophasic hyaluronic acid filler in the correction of nasolabial folds: A randomized, multicenter, single blinded, split-face study.

    PubMed

    Kwon, Hyun Jung; Ko, Eun Jung; Choi, Sun Young; Choi, Eun Ja; Jang, Yu-Jin; Kim, Beom Joon; Lee, Yang Won

    2017-09-14

    The different rheological properties of hyaluronic acid (HA) filler reflect their specific manufacturing processes and resultant physicochemical characteristics. However, there are few researches about the relationship between product differences and clinical outcome when HA fillers are used for nasolabial folds (NLFs). This study sought to compare the rheological properties, efficacy and safety of a monophasic HA filler, and a well-studied biphasic HA filler, in the treatment of NLFs. A total of 72 Korean subjects with moderate to severe NLFs were randomized to receive injections with monophasic HA or biphasic HA on the left or right side of the face. Efficacy was evaluated by the change in the Wrinkle Severity Rating Scale (WSRS) at 2, 10, 18, 26, and 52 weeks. Safety was assessed on the basis of all abnormal reactions during the clinical test period. To compare the rheological characteristics of two cross-linked HA fillers, viscoelastic analysis was performed. At week 26, the mean WSRS was 2.26±0.56 for the monophasic HA side and 2.24±0.54 for the biphasic HA side. Both treatments were well tolerated. The adverse reactions were mild and transient. Monophasic HA filler had lower elasticity and higher viscosity than biphasic HA filler. Despite a number of different rheological properties, monophasic HA is noninferior to biphasic HA in the treatment of moderate to severe NLFs for 52 weeks. Therefore, monophasic HA provides an alternative option for NLFs correction. © 2017 Wiley Periodicals, Inc.

  15. Photodynamic therapy using chlorophyll-a in the treatment of acne vulgaris: a randomized, single-blind, split-face study.

    PubMed

    Song, Byong Han; Lee, Dong Hun; Kim, Byung Chul; Ku, Sang Hyeon; Park, Eun Joo; Kwon, In Ho; Kim, Kwang Ho; Kim, Kwang Joong

    2014-10-01

    Chlorophyll-a is a novel photosensitizer recently tested for the treatment of acne vulgaris. We sought to evaluate the clinical efficacy and safety of chlorophyll-a photodynamic therapy used for acne treatment. Subjects with acne on both sides of the face were included. Eight treatment sessions were performed over a 4-week duration. Half of the face was irradiated using a blue and red light-emitting diode after topical application of chlorophyll-lipoid complex. The other half underwent only light-emitting diode phototherapy. The lesion counts and acne severity were assessed by a blinded examiner. Sebum secretion, safety, and histologic changes were also evaluated. In total, 24 subjects completed the study. Facial acne improved on both treated sides. On the chlorophyll-a photodynamic therapy-treated side, there were significant reductions in acne lesion counts, acne severity grades, and sebum levels compared with the side treated with light-emitting diode phototherapy alone. The side effects were tolerable in all the cases. All the subjects were of Asian descent with darker skin types, which may limit the generalizability of the study. A chlorophyll-a arm alone is absent, as is a no-treatment arm. We suggest that chlorophyll-a photodynamic therapy for the treatment of acne vulgaris can be effective and safe with minimal side effects. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  16. Potential of Spirulina Platensis as a Nutritional Supplement in Malnourished HIV-Infected Adults in Sub-Saharan Africa: A Randomised, Single-Blind Study

    PubMed Central

    Azabji-Kenfack, M.; Dikosso, S. Edie; Loni, E.G.; Onana, E.A.; Sobngwi, E.; Gbaguidi, E.; Kana, A.L. Ngougni; Nguefack-Tsague, G.; Von der Weid, D.; Njoya, O.; Ngogang, J.

    2011-01-01

    compared between the two groups at the end of the trial, FFM was significantly higher in the spirulina group (42.2 vs. 39.0 Kg, P = 0.01). The haemoglobin level rose significantly within groups (P < 0.001 for each group) with no difference between groups (P = 0.77). Serum albumin level did not increase significantly within groups (P < 0.90 vs. P < 0.82) with no difference between groups (P = 0.39). The increase in CD4 cell count within groups was significant (P < 0.01 in both groups), with a significantly higher CD4 count in the spirulina group compared to subjects on soya beans at the end of the study (P = 0.02). Within each group, HIV viral load significantly reduced at the end of the study (P < 0.001 and P = 0.04 for spirulina and soya beans groups respectively). Between the groups, the viral load was similar at baseline but significantly reduced in the spirulina group at the end of the study (P = 0.02). Conclusion: We therefore conclude in this preliminary study, firstly, that both spirulina and soja improve on nutritional status of malnourished HIV-infected patients but in terms of quality of nutritional improvement, subjects on spirulina were better off than subjects on soya beans. Secondly, nutritional rehabilitation improves on immune status with a consequent drop in viral load but further investigations on the antiviral effects of this alga and its clinical implications are strongly needed. PMID:23946659

  17. DDD versus VVIR versus VVI mode in patients with indication to dual-chamber stimulation: a prospective, randomized, controlled, single-blind study.

    PubMed

    Moro, Eugenio; Caprioglio, Francesco; Berton, Giuseppe; Marcon, Carlo; Riva, Umberto; Corbucci, Giorgio; Delise, Pietro

    2005-09-01

    The aim of this study was to compare VVI, VVIR and DDD modes in patients with indication to dual-chamber stimulation, depending on left ventricular function. Two groups of patients were implanted with a DDD pacemaker: Group I with ejection fraction > 40% and Group II with ejection fraction < 40%. Patients with a history of atrial arrhythmia or retrograde conduction were excluded. At follow-up (1 month each) quality of life (QoL), patient preference and echo parameters were collected. At hospital discharge all patients were programmed in DDD for 1 month and then randomized to VVI or VVIR mode. At the end of the period in VVI or VVIR mode each patient underwent a control period in DDD and then was programmed in VVIR or VVI mode. Seventeen patients out of 23 preferred DDD mode and 6 did not perceive any subjective difference among DDD, VVI and VVIR modes (4/9 in Group I and 2/14 in Group II, p = 0.0017). QoL was significantly different between the two groups and at each follow-up showed the best values in DDD. The correlation between QoL and Tei index was 0.62 in Group I (p < 0.001) and 0.35 in Group II (p = 0.001). Neither ejection fraction nor fractional shortening showed any significant difference during the three phases of the study. Most patients preferred the DDD mode. The Tei index showed a good correlation with QoL and both QoL and Tei index significantly improved with DDD mode as compared to VVI and VVIR.

  18. Cervical stability training with and without core stability training for patients with cervical disc herniation: A randomized, single-blind study.

    PubMed

    Buyukturan, B; Guclu-Gunduz, A; Buyukturan, O; Dadali, Y; Bilgin, S; Kurt, E E

    2017-11-01

    This study aims at evaluating and comparing the effects of cervical stability training to combined cervical and core stability training in patients with neck pain and cervical disc herniation. Fifty patients with neck pain and cervical disc herniation were included in the study, randomly divided into two groups as cervical stability and cervical-core stability. Training was applied three times a week in three phases, and lasted for a total duration of 8 weeks. Pain, activation and static endurance of deep cervical flexor muscles, static endurance of neck muscles, cross-sectional diameter of M. Longus Colli, static endurance of trunk muscles, disability and kinesiophobia were assessed. Pain, activation and static endurance of deep cervical flexors, static endurance of neck muscles, cross-sectional diameter of M. Longus Colli, static endurance of trunk muscles, disability and kinesiophobia improved in both groups following the training sessions (p < 0.05). Comparison of the effectiveness of these two training methods revealed that the cervical stability group produced a greater increase in the right transverse diameter of M. Longus Colli (p < 0.05). However, static endurance of trunk muscles and kinesiophobia displayed better improvement in the cervical-core stability group (p < 0.05). Cervical stability training provided benefit to patients with cervical disc herniation. The addition of core stability training did not provide any additional significant benefit. Further research is required to investigate the efficacy of combining other techniques with cervical stability training in patients with cervical disc herniation. Both cervical stability training and its combination with core stability training were significantly and similarly effective on neck pain and neck muscle endurance in patients with cervical disc herniation. © 2017 European Pain Federation - EFIC®.

  19. Negative predictive value and potential cost savings of acute nuclear myocardial perfusion imaging in low risk patients with suspected acute coronary syndrome: A prospective single blinded study

    PubMed Central

    Forberg, Jakob L; Hilmersson, Catarina E; Carlsson, Marcus; Arheden, Håkan; Björk, Jonas; Hjalte, Krister; Ekelund, Ulf

    2009-01-01

    Background Previous studies from the USA have shown that acute nuclear myocardial perfusion imaging (MPI) in low risk emergency department (ED) patients with suspected acute coronary syndrome (ACS) can be of clinical value. The aim of this study was to evaluate the utility and hospital economics of acute MPI in Swedish ED patients with suspected ACS. Methods We included 40 patients (mean age 55 ± 2 years, 50% women) who were admitted from the ED at Lund University Hospital for chest pain suspicious of ACS, and who had a normal or non-ischemic ECG and no previous myocardial infarction. All patients underwent MPI from the ED, and the results were analyzed only after patient discharge. The current diagnostic practice of admitting the included patients for observation and further evaluation was compared to a theoretical "MPI strategy", where patients with a normal MPI test would have been discharged home from the ED. Results Twenty-seven patients had normal MPI results, and none of them had ACS. MPI thus had a negative predictive value for ACS of 100%. With the MPI strategy, 2/3 of the patients would thus have been discharged from the ED, resulting in a reduction of total hospital cost by some 270 EUR and of bed occupancy by 0.8 days per investigated patient. Conclusion Our findings in a Swedish ED support the results of larger American trials that acute MPI has the potential to safely reduce the number of admissions and decrease overall costs for low-risk ED patients with suspected ACS. PMID:19545365

  20. Efficacy of EMLA cream phonophoresis comparison with ultrasound therapy on myofascial pain syndrome of the trapezius: a single-blind, randomized clinical study.

    PubMed

    Ustun, Nilgun; Arslan, Fatma; Mansuroglu, Ayhan; Inanoglu, Deniz; Yagız, Abdullah Erman; Guler, Hayal; Turhanoglu, Ayse Dicle

    2014-04-01

    The aim of this study is to investigate whether eutectic mixture of local anesthetics (EMLA) cream phonophoresis superior to conventional US over the trigger points (TPs) in terms of improvements of pain, range of motion and disability in myofascial pain syndrome (MPS). Fifty patients (42 female, 8 male) diagnosed with MPS were included in the study. Patients were randomly assigned into two treatment groups including phonophoresis (PH) group (n = 25) and ultrasound (US) group (n = 25). PH group received EMLA cream phonophoresis (2.5 % lidocaine, 2.5 % prilocaine); US group received conventional ultrasound therapy over the all active TPs on trapezius muscle for 10 min a day for 15 sessions. Outcome measures were performed before the treatment course and at the end of a 15-session course of treatment. Student T, Mann-Whitney U, chi-square and Wilcoxon tests were used for statistical analysis. At the end of the therapy, there was statistically significant decrease in both PH group and US group in terms of number of trigger point (NTP) (p = 0.001, p = 0.029), pain intensity on movement (p = 0.001 vs. 0.002) and right/left cervical lateral ROMs (p = 0.001/p = 0.001, p = 0.009/p = 0.020) relative to baseline. The NTP decrease in PH group was significantly higher than that in US group (1.84 ± 1.46 vs. 0.72 ± 1.45; p = 0.01). Pain intensity at rest (p = 0.001) and NPDI scores (p = 0.001) were statistically improvement in only PH group. EMLA cream phonophoresis is more effective than conventional ultrasound therapy in terms of pain and associated neck disability, and it seems the complementary treatment option for MPS.

  1. Lesion remyelinating activity of GSK239512 versus placebo in patients with relapsing-remitting multiple sclerosis: a randomised, single-blind, phase II study.

    PubMed

    Schwartzbach, Caryl J; Grove, Richard A; Brown, Robert; Tompson, Debra; Then Bergh, Florian; Arnold, Douglas L

    2017-02-01

    Histamine H3 receptor blockade may enhance lesion remyelination in multiple sclerosis (MS). The efficacy (using a magnetic resonance imaging marker of myelination, magnetisation transfer ratio [MTR]), safety and pharmacokinetics of GSK239512, a potent and brain penetrant H3 receptor antagonist/inverse agonist on lesion remyelination in relapsing-remitting MS (RRMS) were assessed. This was a phase II, randomised, parallel-group, placebo-controlled, double-blind (sponsor-unblinded), international, multicentre study (NCT01772199). Patients aged 18-50 with RRMS, receiving intramuscular interferon-β1a or glatiramer acetate, were randomised 1:1 to once-daily oral GSK239512 or placebo, up-titrated over 4-5 weeks to a maximum tolerable dose up to 80 µg and maintained until Week 48. The co-primary endpoints were mean changes in post-lesion MTR in gadolinium-enhanced (GdE) or Delta-MTR defined lesions from pre-lesion values. Adverse events (AE) and withdrawals were monitored. Of the 131 patients randomised, 114 patients completed the study (GSK239512, n = 51; placebo, n = 63) and 27 (GSK239512) and 28 (placebo) patients contributed lesions to the primary analysis. GSK239512 was associated with positive effect sizes of 0.344 [90% confidence interval (CI) 0.018, 0.671] and 0.243 (90% CI -0.112, 0.598) for adjusted mean changes in the normalised MTR for GdE and Delta-MTR lesions, respectively. The overall incidence of AEs was similar between GSK239512 and placebo during the treatment phase although some AEs including insomnia were more common with GSK239512, particularly during the titration period. A small but positive effect of GSK239512 on remyelination was observed. MTR assessment represents a promising method for detecting lesion remyelination in RRMS.

  2. Impact of patient audio-visual re-education through a smartphone on quality of bowel preparation before colonoscopy; a single-blinded randomized study.

    PubMed

    Back, Su Young; Kim, Hyun Gun; Ahn, Eu Mi; Park, Suyeon; Jeon, Seong Ran; Im, Hee Hyuk; Kim, Jin-Oh; Ko, Bong Min; Lee, Joon Seong; Lee, Tae Hee; Cho, Jun-Hyung

    2017-09-19

    Preparation education is essential for successful colonoscopy. This study aimed to evaluate the impact of audio-visual (AV) re-education through a smartphone before colonoscopy on bowel preparation quality. A prospective, endoscopist-blinded, randomized, controlled study was performed. Patients who underwent colonoscopy with 3 purgatives, including 4 L polyethylene glycol (4L-PEG), 2 L PEG with ascorbic acid (2L-PEG/Asc) and sodium picosulfate with magnesium citrate (SPMC), were enrolled, and randomized into AV re-education through smartphone group (AV group, n=160) and a control group (n=160). The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included instruction adherence using adherence score (AS) and patient satisfaction with education using a visual analogue scale (VAS). A total of 283 patients (AV group: n=139, control group: n=144) were analyzed per protocol. The mean BBPS (7.53 vs. 6.29, p<0.001) and the proportion of adequate preparation were higher in the AV group. The mean BBPS of the AV group was significantly higher than that of the control group in the 2L PEG/Asc and SPMC preparations, but not in the 4L-PEG preparation. The mean AS and the mean VAS score were all significantly higher in the AV group. Among the 3 purgatives, the mean AS was lowest in the 4L-PEG group (p=0.041). AV re-education via smartphone was easy and convenient, and enhanced preparation quality, patient adherence to instructions, and patient satisfaction. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  3. Single Blinded Left-to-Right Comparison Study of Excimer Laser Versus Pulsed Dye Laser for the Treatment of Nail Psoriasis.

    PubMed

    Al-Mutairi, Nawaf; Noor, Tarek; Al-Haddad, Ahmed

    2014-12-01

    Nail psoriasis is relatively difficult to treat. Excimer laser has been approved for the treatment of psoriasis since 2000. Pulsed dye laser (PDL) in psoriasis therapy has shown good response rates, with extended remissions. This is the first study assessing both the excimer and PDL lasers in nail psoriasis. In a comparison study, excimer laser versus PDL for the treatment of nail psoriasis was evaluated in 42 patients. The right hand nails were treated with excimer laser twice weekly and the left hand nails were treated with PDL once every 4 weeks, for total 12 weeks. The patients were then followed up after a further 12 weeks. Nail Psoriasis Severity Index (NAPSI) scores were recorded at baseline, weeks 4, 8, and 12, and then at week 24. Patients were also asked to grade the clinical response to each treatment. A total of 304 nail changes, 148 with excimer laser and 156 with PDL, were treated. The mean NAPSI score in nails treated with excimer laser was 29.8 at baseline, reduced to 16.3 at week 24. In PDL-treated nails, the NAPSI scores dropped from 29.5 at baseline to 3.2 at week 24. NAPSI improvement was significantly greater in PDL than excimer (P = 0.001; Wilcoxon signed-rank test). Thirty-four (81%) hands achieved NAPSI-50, and 23 (55%) achieved NAPSI-75 at week 12, while complete nail recovery was shown in 6 (14%) hands treated with PDL. Regarding the hands treated with excimer laser, only 16 (38%) hands achieved NAPSI-50, while no hands achieved NAPSI-75 at week 12. In general, subungual hyperkeratosis and onycholysis improved significantly, while nail pitting was least responsive. Oil drops and splinter hemorrhages showed moderate response. When compared to excimer laser, PDL demonstrated a good response for treating nail psoriasis, with minimal side effects.

  4. Kojic Acid vis-a-vis its Combinations with Hydroquinone and Betamethasone Valerate in Melasma: A Randomized, Single Blind, Comparative Study of Efficacy and Safety

    PubMed Central

    Deo, Kirti S.; Dash, Kedar N.; Sharma, Yugal K.; Virmani, Neha C.; Oberai, Chetan

    2013-01-01

    Background: Melasma is a relatively common, acquired symmetric hypermelanosis characterized by irregular light to gray-brown macules involving sun-exposed areas. Kojic acid, with its depigmenting potential due to tyrosinase inhibition and suppression of melanogenesis, has become a vital component of the dermatologists’ armamentarium against melasma. Aim: To study and compare the efficacy of kojic acid 1% alone, vis-a-vis its separate combinations with 2% hydroquinone or 0.1% betamethasone valerate and a combination of all these three agents with respect to the duration of symptoms and level of pigmentation in the therapy of melasma. Materials and Methods: Eighty patients from a single tertiary care center objectively assessed by calculating the melasma area severity index (MASI) and randomized (simple randomization) into four parallel groups (A, B, C, and D) of 20 each were prescribed once daily local application at night, (participants blinded regarding the difference in identity of interventions), as follows: Group A – kojic acid 1% cream. Group B – kojic acid 1% and hydroquinone 2% cream. Group C – kojic acid 1% and betamethasone valerate 0.1% cream. Group D – kojic acid 1%, hydroquinone 2%, and betamethasone valerate 0.1% cream. Strict photoprotection and use of a SPF 15 sunscreen was advised during the day. Patients were evaluated every 2 weeks and a fall in MASI score was calculated at the end of the study period of 12 weeks by the same investigator. Results: The response was compared according to percentage decrease in MASI score. Efficacy was evaluated among the groups at the end of 3 months using bivariate analysis and calculated by using the paired ‘t’ test. The clinical efficacy of group B was the highest followed closely by group D and group A, that of group C being the lowest. Conclusion: Kojic acid in synergy with hydroquinone is a superior depigmenting agent as compared with other combinations. PMID:23918998

  5. Effects of aripiprazole versus risperidone on brain activation during planning and social-emotional evaluation in schizophrenia: A single-blind randomized exploratory study.

    PubMed

    Liemburg, Edith J; van Es, Frank; Knegtering, Henderikus; Aleman, André

    2017-10-03

    Impaired function of prefrontal brain networks may be the source of both negative symptoms and neurocognitive problems in psychotic disorders. Whereas most antipsychotics may decrease prefrontal activation, the partial dopamine D2-receptor agonist aripiprazole is hypothesized to improve prefrontal function. This study investigated whether patients with a psychotic disorder would show stronger activation of prefrontal areas and associated regions after treatment with aripiprazole compared to risperidone treatment. In this exploratory pharmacological neuroimaging study, 24 patients were randomly assigned to either aripiprazole or risperidone. At baseline and after nine weeks treatment they underwent an interview and MRI session. Here we report on brain activation (measured with arterial spin labeling) during performance of two tasks, the Tower of London and the Wall of Faces. Aripiprazole treatment decreased activation of the middle frontal, superior frontal and occipital gyrus (ToL) and medial temporal and inferior frontal gyrus, putamen and cuneus (WoF), while activation increased after risperidone. Activation increased in the ventral anterior cingulate and posterior insula (ToL), and superior frontal, superior temporal and precentral gyrus (WoF) after aripiprazole treatment and decreased after risperidone. Both treatment groups had increased ventral insula activation (ToL) and middle temporal gyrus (WoF), and decreased occipital cortex, precuneus and caudate head activation (ToL) activation. In conclusion, patients treated with aripiprazole may need less frontal resources for planning performance and may show increased frontotemporal and frontostriatal reactivity to emotional stimuli. More research is needed to corroborate and extend these preliminary findings. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial.

    PubMed

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Kristensen, Anne Zoëga; Jay, Kenneth; Stelter, Reinhard; Lavendt, Ebbe; Aagaard, Per; Andersen, Lars L

    2014-04-07

    The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder (primary outcome) and physical

  7. Participatory ergonomic intervention versus strength training on chronic pain and work disability in slaughterhouse workers: study protocol for a single-blind, randomized controlled trial

    PubMed Central

    2013-01-01

    Background The prevalence of musculoskeletal pain in the shoulder, arm and hand is high among slaughterhouse workers, allegedly due to the highly repetitive and forceful exposure of these body regions during work. Work disability is a common consequence of these pains. Lowering the physical exposure through ergonomics intervention is the traditional strategy to reduce the workload. An alternative strategy could be to increase physical capacity of the worker through strength training. This study investigates the effect of two contrasting interventions, participatory ergonomics versus strength training on pain and work disability in slaughterhouse workers with chronic pain. Methods/design 66 slaughterhouse workers were allocated to 10 weeks of (1) strength training of the shoulder, arm and hand muscles for 3 x 10 minutes per week, or (2) participatory ergonomics involving counseling on workstation adjustment and optimal use of work tools (~usual care control group). Inclusion criteria were (1) working at a slaughterhouse for at least 30 hours per week, (2) pain intensity in the shoulder, elbow/forearm, or hand/wrist of at least 3 on a 0–10 VAS scale during the last three months, (3) pain lasting for more than 3 months, (4) frequent pain (at least 3 days per week) (5) at least moderate work disability, (6) no strength training during the last year, (7) no ergonomics instruction during the last year. Perceived pain intensity (VAS scale 0–10) of the shoulder, elbow/forearm and hand/wrist (primary outcome) and Disability of the Arm, Shoulder and Hand (Work module, DASH questionnaire) were measured at baseline and 10-week follow-up. Further, total muscle tenderness score and muscle function were assessed during clinical examination at baseline and follow-up. Discussion This RCT study will provide experimental evidence of the effectiveness of contrasting work-site interventions aiming at reducing chronic pain and work disability among employees engaged in

  8. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial

    PubMed Central

    2014-01-01

    Background The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. Methods/Design This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder

  9. Efficacy of botulinum toxin type B for the treatment of primary palmar hyperhidrosis: a prospective, open, single-blind, multi-centre study.

    PubMed

    Basciani, Mario; Di Rienzo, Filomena; Bizzarrini, Massimo; Zanchi, Malvina; Copetti, Massimiliano; Intiso, Domenico

    2014-07-01

    Primary palmar hyperhidrosis is a distressing and disabling condition that can produce social, psychological and occupational problems. Although the use of botulinum toxin type A (BoNT-A) has been reported as an efficacious and safe intervention to improve palmar hyperhidrosis, only one study concerned botulinum toxin type B (BoNT-B) in this disorder. The aim of study was to evaluate the efficacy and safety of BoNT-B in treating primary palmar hyperhidrosis. Participants were injected with 5,000 IU of BoNT-B in each palm. Visual analogue test (VAS) to evaluate the intensity of decrease in sweat production, Minor's iodine starch test and measurement of paper towels' weight were used to ascertain palmar sweating at baseline, 4, 12 and 24 weeks after BoNT-B injections by a blind examiner. Thirty-two subjects (12 males, 20 females, mean age 31 ± 11) were enrolled. Significant reduction of palmar sweating was detected after BoNT-B injection: 2.9 ± 1.4, 0.3 ± 0.4, 0.9 ± 0.8, and 2.1 ± 1.5 g (p < 0.001) of paper towels' weight for the right palm at baseline, 4, 12 and 24 weeks; and 2.8 ± 1.7, 0.5 ± 0.6, 0.8 ± 0.7, and 1.8 ± 1.25 g (p < 0.001) at same time, respectively for the left palm. Significant reduction of mean VAS values were also detected after BoNT-B injections: 8.6 ± 1.1, 0.6 ± 0.8, 3.5 ± 2.5, and 7.1 ± 2.4 (p < 0.0001) at baseline, 4, 12 and 24 weeks, respectively. Mild side effects consisting in local pain and hand weakness were observed in 4 (12.5%) subjects. The findings indicated that the use of 5,000 IU BoNT-B injection in each palm was safe and significantly improved the severity of palmar hyperhidrosis.

  10. Skin Antiageing and Systemic Redox Effects of Supplementation with Marine Collagen Peptides and Plant-Derived Antioxidants: A Single-Blind Case-Control Clinical Study.

    PubMed

    De Luca, Chiara; Mikhal'chik, Elena V; Suprun, Maxim V; Papacharalambous, Michael; Truhanov, Arseniy I; Korkina, Liudmila G

    2016-01-01

    Recently, development and research of nutraceuticals based on marine collagen peptides (MCPs) have been growing due to their high homology with human collagens, safety, bioavailability through gut, and numerous bioactivities. The major concern regarding safety of MCPs intake relates to increased risk of oxidative stress connected with collagen synthesis (likewise in fibrosis) and to ROS production by MCPs-stimulated phagocytes. In this clinical-laboratory study, fish skin MCPs combined with plant-derived skin-targeting antioxidants (AO) (coenzyme Q10 + grape-skin extract + luteolin + selenium) were administered to volunteers (n = 41). Skin properties (moisture, elasticity, sebum production, and biological age) and ultrasonic markers (epidermal/dermal thickness and acoustic density) were measured thrice (2 months before treatment and before and after cessation of 2-month oral intake). The supplementation remarkably improved skin elasticity, sebum production, and dermal ultrasonic markers. Metabolic data showed significant increase of plasma hydroxyproline and ATP storage in erythrocytes. Redox parameters, GSH/coenzyme Q10 content, and GPx/GST activities were unchanged, while NO and MDA were moderately increased within, however, normal range of values. Conclusions. A combination of MCPs with skin-targeting AOs could be effective and safe supplement to improve skin properties without risk of oxidative damage.

  11. The plaque- and gingivitis-inhibiting capacity of a commercially available essential oil product. A parallel, split-mouth, single blind, randomized, placebo-controlled clinical study.

    PubMed

    Preus, Hans Ragnar; Koldsland, Odd Carsten; Aass, Anne Merete; Sandvik, Leiv; Hansen, Bjørn Frode

    2013-11-01

    Studies have reported commercially available essential oils with convincing plaque and gingivitis preventing properties. However, no tests have compared these essential oils, i.e. Listerine(®), against their true vehicle controls. To compare the plaque and gingivitis inhibiting effect of a commercially-available essential oil (Listerine(®) Total Care) to a negative (22% hydro-alcohol solution) and a positive (0.2% chlorhexidine (CHX)) control in an experimental gingivitis model. In three groups of 15 healthy volunteers, experimental gingivitis was induced and monitored over 21 days, simultaneously treated with Listerine(®) Total Care (test), 22% hydro-alcohol solution (negative control) and 0.2% chlorhexidine solution (positive control), respectively. The upper right quadrant of each individual received mouthwash only, whereas the upper left quadrant was subject to both rinses and mechanical oral hygiene. Plaque, gingivitis and side-effects were assessed at day 7, 14 and 21. After 21 days, the chlorhexidine group showed significantly lower average plaque and gingivitis scores than the Listerine(®) and alcohol groups, whereas there was little difference between the two latter. Listerine(®) Total Care had no statistically significant effect on plaque formation as compared to its vehicle control.

  12. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study.

    PubMed

    Lee, Jin Young; Park, Yongbum; Park, Ki Deok; Lee, Ju Kang; Lim, Oh Kyung

    2014-12-01

    The objective of this study is to evaluate the degree of symptom improvement and the change of electrophysiological and ultrasonographic findings after sonographically guided local steroid injection using an in-plane ulnar approach in carpal tunnel syndrome (CTS). Seventy-five cases of 44 patients diagnosed with CTS were included and evaluated at baseline and at 4 and 12 weeks after injection. All patients received injection with 40 mg of triamcinolone mixed with 1 mL of 1% lidocaine into the carpal tunnel using an in-plane Ultrasound (US)-guided ulnar approach, out-plane US-guided approach, and blind injection. For clinical evaluation, we used the Boston Carpal Tunnel Questionnaire (BCTQ) and electrophysiological tests. The ultrasonographic findings were also evaluated with regard to cross-sectional area and the flattening ratio of the median nerve. Subjective symptoms measured by BCTQ and median nerve conduction parameters showed significant improvement at 4 weeks in the in-plane ulnar approach group compared with the out-plane ulnar approach and blind injection. This improvement was still observed at 12 weeks. The flattening ratio and cross-sectional area of the median nerve showed a more significant decrease with the in-plane ulnar approach than with the out-plane ulnar approach and blind injection (P < 0.05). US-guided local steroid injection using an in-plane ulnar approach in the CTS may be more effective than out-plane or blind injection.

  13. Clinical trial: 2-L polyethylene glycol-based lavage solutions for colonoscopy preparation - a randomized, single-blind study of two formulations.

    PubMed

    Cohen, L B; Sanyal, S M; Von Althann, C; Bodian, C; Whitson, M; Bamji, N; Miller, K M; Mavronicolas, W; Burd, S; Freedman, J; Aisenberg, J

    2010-09-01

    The 2-L polyethylene glycol (PEG) lavage solutions provide efficacy similar to that of standard 4-L PEG formulations in spite of the reduced volume. The comparative efficacy and tolerability of two formulations of 2-L PEG solution remain unknown. To assess the efficacy, safety and tolerability of PEG + Bis compared with PEG + Asc, and to study the effect of bowel cleansing quality on adenoma detection rates. Patients were randomized to receive either 2-L PEG with ascorbic acid (PEG + Asc) or 2-L PEG plus bisacodyl 10 mg (PEG + Bis). The primary endpoint was overall colon cleansing score, assessed by blinded investigators using a validated four-point scale. Secondary endpoints included adenoma detection rate, patient tolerability and compliance and adverse events. Fifty-two patients received PEG + Asc and 55 patients received PEG + Bis. Overall colon cleansing scores (+/-s.d.) were 1.40 +/- 0.69 and 1.75 +/- 0.70 (P < 0.003) in the PEG + Asc and PEG + Bis groups, respectively. Excellent and good ratings were recorded in 69% and 23% receiving PEG + Asc compared to 38% and 51% (P = 0.01) of patients receiving PEG + Bis. More adenomas were detected in colonoscopies performed with PEG + Asc (39%) than in those performed with PEG + Bis (20%) (P = 0.04). Patient tolerability and safety were similar with both preparations. The use of PEG + Asc resulted in better colon cleansing and higher adenoma detection rates compared with PEG + Bis. 2010 Blackwell Publishing Ltd.

  14. The Effect of Chronic Opioid Use on End-Tidal Concentration of Sevoflurane Necessary to Maintain a Bispectral Index Below 50: A Prospective, Single-Blind Study.

    PubMed

    Oh, Tak Kyu; Eom, Woosik; Yim, Jiyeon; Kim, Namwoo; Kwon, Kyungho; Kim, Seong-Eun; Kim, Dae Hyun

    2017-07-01

    Opioid analgesics decrease the minimum alveolar concentration of inhalation agents during the acute phase response. However, the effect of chronic opioid exposure on minimum alveolar concentration of inhalation agents remains unknown. This study aimed to determine the concentration of sevoflurane necessary to maintain a bispectral index (BIS) <50 (SEVOBIS50) in patients with chronic opioid use compared with those naïve to opioid use. We included chronic opioid users who received a stable dose of oral morphine of at least 60 mg/d according to the morphine equivalent daily dose for at least 4 weeks and opioid-naïve patients. General anesthesia that included thiopental, vecuronium, and sevoflurane in oxygen was administered to all patients. Anesthesia was maintained using predetermined end-tidal sevoflurane concentrations. Fifteen minutes after achieving the determined end-tidal sevoflurane concentration through closed circuit anesthesia, BIS was measured for 1 minute in both groups. SEVOBIS50 was determined using Dixon's up-down method and probit analysis. Nineteen and 18 patients from the chronic opioid and control groups, respectively, were included in the final analysis. SEVOBIS50values for the chronic opioid and control patients were 0.84 (95% confidence interval, 0.58-1.11) and 1.18 (95% confidence interval, 0.96-1.40), respectively (P = .0346). Our results suggest that the end-tidal concentration of sevoflurane necessary to maintain a BIS <50 is lower for chronic opioid users than for opioid-naïve patients.

  15. Does Hamulotomy during Palatoplasty Have Any Effect on Hearing Ability in Nonsyndromic Cleft Palate Patients? A Prospective, Single Blind, Comparative Study

    PubMed Central

    Jain, Anuj; Nimonkar, Pranali; Bhola, Nitin; Borle, Rajiv; Sharma, Shishir; Oswal, Shrenik

    2016-01-01

    The primary goal of palatoplasty is to achieve a tension-free palatal closure ensuring no postoperative complications. Many surgeons fracture the pterygoid hamulus to minimize tension during palatoplasty. However, this maneuver gained criticism by some authors on the grounds that it may lead to Eustachian Tube dysfunction. Our study intended to figure out the relationship of hamulus fracture with the postoperative state of middle ear in cleft palate children. Fifty consecutive cleft palate patients with an age range of 10 months to 5 years were recruited. All the patients were assigned to either hamulotomy or nonhamulotomy group preoperatively. The patients were subjected to otoscopic examination and auditory function evaluation by brainstem evoked response audiometry (BERA) preoperatively and 1 month and 6 months postoperatively. Otoscopy revealed that the difference in the improvement of middle ear status in both groups was statistically insignificant. Moreover, there was no significant difference in the BERA outcomes of the fracture and nonfracture populations. Complication rate in both groups was also statistically not significant. It can be concluded that hamulotomy does not have any effect on the hearing ability in cleft palate population, so hamulotomy can be performed for tension-free closure during palatoplasty. PMID:27006862

  16. Skin Antiageing and Systemic Redox Effects of Supplementation with Marine Collagen Peptides and Plant-Derived Antioxidants: A Single-Blind Case-Control Clinical Study

    PubMed Central

    De Luca, Chiara; Mikhal'chik, Elena V.; Suprun, Maxim V.; Papacharalambous, Michael; Truhanov, Arseniy I.; Korkina, Liudmila G.

    2016-01-01

    Recently, development and research of nutraceuticals based on marine collagen peptides (MCPs) have been growing due to their high homology with human collagens, safety, bioavailability through gut, and numerous bioactivities. The major concern regarding safety of MCPs intake relates to increased risk of oxidative stress connected with collagen synthesis (likewise in fibrosis) and to ROS production by MCPs-stimulated phagocytes. In this clinical-laboratory study, fish skin MCPs combined with plant-derived skin-targeting antioxidants (AO) (coenzyme Q10 + grape-skin extract + luteolin + selenium) were administered to volunteers (n = 41). Skin properties (moisture, elasticity, sebum production, and biological age) and ultrasonic markers (epidermal/dermal thickness and acoustic density) were measured thrice (2 months before treatment and before and after cessation of 2-month oral intake). The supplementation remarkably improved skin elasticity, sebum production, and dermal ultrasonic markers. Metabolic data showed significant increase of plasma hydroxyproline and ATP storage in erythrocytes. Redox parameters, GSH/coenzyme Q10 content, and GPx/GST activities were unchanged, while NO and MDA were moderately increased within, however, normal range of values. Conclusions. A combination of MCPs with skin-targeting AOs could be effective and safe supplement to improve skin properties without risk of oxidative damage. PMID:26904164

  17. A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study.

    PubMed

    Prosser, James M; Yard, Samantha; Steele, Annie; Cohen, Lisa J; Galynker, Igor I

    2009-05-26

    Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS), the Hamilton Anxiety Scale (Ham-A), the Hamilton Depression Rating Scale (Ham-D), the Sheehan Panic Anxiety Scale-Patient (SPAS-P), and the Clinical Global Impression scale (CGI). All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. ClinicalTrials.gov Identifier: NCT100457106.

  18. Transcutaneous electrical acupoint stimulation in children with autism and its impact on plasma levels of arginine-vasopressin and oxytocin: a prospective single-blinded controlled study.

    PubMed

    Zhang, Rong; Jia, Mei-Xiang; Zhang, Ji-Sui; Xu, Xin-Jie; Shou, Xiao-Jing; Zhang, Xiu-Ting; Li, Li; Li, Ning; Han, Song-Ping; Han, Ji-Sheng

    2012-01-01

    Acupuncture increases brain levels of arginine-vasopressin (AVP) and oxytocin (OXT), which are known to be involved in the modulation of mammalian social behavior. Transcutaneous electrical acupoint stimulation (TEAS) is often used clinically to produce a similar stimulation to that of acupuncture on the acupoints. In the present study, TEAS was applied to children with autism to assess its therapeutic efficacy. Seventy-six autistic children receiving rehabilitation training were divided into 2 groups: a treatment group receiving TEAS 30min per day, 5 days per week for 12 weeks (n=37) and a control group without TEAS treatment (n=39). A series of rating scales was used in outcome assessment. Plasma levels of AVP and OXT were determined by enzyme immunoassay (EIA) before and after treatment. The TEAS group showed a significant improvement over the control in their emotional response, fear or anxiety, level/consistency of intellective relations and general impressions on the Childhood Autism Rating Scale (CARS) as well as improvements in the sensory and related factors in the Autism Behavior Checklist (ABC). In addition, the varieties of accepted food increased after TEAS treatment. It appears that TEAS was effective in autistic children who showed passive and aloof behavior, but not in those who were active but odd. The plasma level of AVP was significantly higher in the TEAS group than in the control group after the intervention. In addition, the change in the plasma AVP level paralleled the improvement of some of the behavior factors in CARS, including adaptation to environmental change, listening response, perceptive response and fear or anxiety. It is concluded that TEAS is effective for the treatment of autistic children with a passive and aloof social interaction style. Changes in plasma levels of AVP and possibly OXT may be involved in mediating the therapeutic effect of TEAS. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. HYADD 4 versus methylprednisolone acetate in symptomatic knee osteoarthritis: a single-centre single blind prospective randomised controlled clinical study with 1-year follow-up.

    PubMed

    Bisicchia, Salvatore; Bernardi, Gabriele; Tudisco, Cosimo

    2016-01-01

    The aim of the present study was to compare the clinical results and the quality of life in patients with symptomatic knee osteoarthritis randomised to either a new HA (HYADD 4) or corticosteroid (CS). A separate rationale was to evaluate the safety profile of HYADD 4. All the patients presenting for unilateral symptomatic primary knee osteoarthritis were prospectively randomly assigned to receive 2 injections of either HYADD 4 or CS, and were evaluated before the injections and at 6, 12, 26 and 52 weeks. Primary end point was WOMAC score at 26 weeks; secondary end points were WOMAC score, VAS for pain, and SF-36 score at any time point. There were 53 females and 22 males in the HYADD 4 group (mean age 71.5±10.6 years), and 50 females and 25 males in the CS group (mean age 68.6±9.9 years). The observed sided effects were mild and their incidence was similar in the two groups. Patients in the HYADD 4 group reported significantly better WOMAC scores at 26 weeks. The patients improved in all considered outcomes after the injections, with a peak of therapeutic effect between 6 and 12 weeks. Patients in the HYADD 4 group obtained significantly better scores than the CS group up to 26 weeks. At the 1-year follow-up no statistically significant differences between treatments were detected. HYADD 4 did not have significantly higher side effects when compared to CS injections and provided better short-term (but not long-term) control of symptoms in patients with mild to moderate knee osteoarthritis. Patients with less pain and dysfunction at baseline may be the best candidates for HYADD 4 injections.

  20. Acid-base effects of a bicarbonate-balanced priming fluid during cardiopulmonary bypass: comparison with Plasma-Lyte 148. A randomised single-blinded study.

    PubMed

    Morgan, T J; Power, G; Venkatesh, B; Jones, M A

    2008-11-01

    Fluid-induced metabolic acidosis can be harmful and can complicate cardiopulmonary bypass. In an attempt to prevent this disturbance, we designed a bicarbonate-based crystalloid circuit prime balanced on physico-chemical principles with a strong ion difference of 24 mEq/l and compared its acid-base effects with those of Plasma-Lyte 148, a multiple electrolyte replacement solution containing acetate plus gluconate totalling 50 mEq/l. Twenty patients with normal acid-base status undergoing elective cardiac surgery were randomised 1:1 to a 2 litre prime of either bicarbonate-balanced fluid or Plasma-Lyte 148. With the trial fluid, metabolic acid-base status was normal following bypass initiation (standard base excess 0.1 (1.3) mEq/l, mean, SD), whereas Plasma-Lyte 148 produced a slight metabolic acidosis (standard base excess -2.2 (2.1) mEq/l). Estimated group difference after baseline adjustment was 3.6 mEq/l (95% confidence interval 2.1 to 5.1 mEq/l, P=0.0001). By late bypass, mean standard base excess in both groups was normal (0.8 (2.2) mEq/l vs. -0.8 (1.3) mEq/l, P=0.5). Strong ion gap values were unaltered with the trial fluid, but with Plasma-Lyte 148 increased significantly on bypass initiation (15.2 (2.5) mEq/l vs. 2.5 (1.5) mEq/l, P < 0.0001), remaining elevated in late bypass (8.4 (3.4) mEq/l vs. 5.8 (2.4) mEq/l, P < 0.05). We conclude that a bicarbonate-based crystalloid with a strong ion difference of 24 mEq/l is balanced for cardiopulmonary bypass in patients with normal acid-base status, whereas Plasma-Lyte 148 triggers a surge of unmeasured anions, persisting throughout bypass. These are likely to be gluconate and/or acetate. Whether surges of exogenous anions during bypass can be harmful requires further study.

  1. Sensory-motor training targeting motor dysfunction and muscle weakness in long-term care elderly combined with motivational strategies: a single blind randomized controlled study.

    PubMed

    Rogan, Slavko; Radlinger, Lorenz; Baur, Heiner; Schmidtbleicher, Dietmar; de Bie, Rob A; de Bruin, Eling D

    2016-01-01

    This study evaluated the effects of a combined innovative training regime consisting of stochastic resonance whole-body vibration (SR-WBV) and a dance video game (DVG) on physical performance and muscle strength in long-term-care dwelling elderly. Thirthy long-term-care elderly were randomly allocated to an intervention group (IG; n = 16) receiving combined SR-WBV training and DVG, or a sham group (SG; n = 14). IG performed five sets one minute of SR-WBV, with one minute rest between sets (base frequency 3 Hz up to 6 Hz, Noise 4) during the first five weeks on three days per week. From week five to eight a DVG was added to SR-WBV for IG on three days per week. SG performed a five-set SR-WBV program (1 Hz, Noise 1) lasting five times one minute, with one minute rest in between, three days a week. From week five to eight stepping exercises on a trampoline were added on three days per week. Short physical performance battery (SPPB). Secondary outcome: isometric maximal voluntary contraction (IMVC), and sub phases of IMVC (Fsub), isometric rate of force development (IRFD) and sub time phases of IRFD (IRFDsub) were measured at baseline, after four and eight weeks. ANOVA with repeated measures was used for analyses of time and interaction effects and MANOVA determined between group intervention effects. Between group effects revealed significant effects on the SPPB primary outcome after four weeks F(1, 27) = 6.17; p = 0.02) and after eight weeks F(1,27) = 11.8; p = 0.002). Secondary muscle function related outcome showed significant between group effects in IG on IRFD, Fsub 30 ms, 100 ms, 200 ms and IRFDsub 0-30 ms, 0-50 ms, 0-100 ms and 100-200 ms compared to SG (all p < 0.05). Eight weeks SR-WBV and DVG intervention improved lower extremity physical function and muscle strength compared to a sham intervention in long-term-care elderly. SR-WBV and DVG seems to be effective as a training regime for skilling up in long

  2. The comparison of the effects of three physiotherapy techniques on hamstring flexibility in children: a prospective, randomized, single-blind study.

    PubMed

    Czaprowski, Dariusz; Leszczewska, Justyna; Kolwicz, Aleksandra; Pawłowska, Paulina; Kędra, Agnieszka; Janusz, Piotr; Kotwicki, Tomasz

    2013-01-01

    The aim of the study was to evaluate changes in hamstring flexibility in 120 asymptomatic children who participated in a 6-week program consisting of one physiotherapy session per week and daily home exercises. The recruitment criteria included age (10-13 years), no pain, injury or musculoskeletal disorder throughout the previous year, physical activity limited to school sport. Subjects were randomly assigned to one of the three groups: (1) post-isometric relaxation - PIR (n = 40), (2) static stretch combined with stabilizing exercises - SS (n = 40) and (3) stabilizing exercises - SE (n = 40). Hamstring flexibility was assessed with straight leg raise (SLR), popliteal angle (PA) and finger-to-floor (FTF) tests. The examinations were conducted by blinded observers twice, prior to the program and a week after the last session with the physiotherapist. Twenty-six children who did not participate in all six exercise sessions with physiotherapists were excluded from the analysis. The results obtained by 94 children were analyzed (PIR, n = 32; SS, n = 31; SE, n = 31). In the PIR and SS groups, a significant (P<0.01) increase in SLR, PA, FTF results was observed. In the SE group, a significant (P<0.001) increase was observed in the SLR but not in the PA and FTF (P>0.05). SLR result in the PIR and SS groups was significantly (P<0.001) higher than in the SE group. As far as PA results are concerned, a significant difference was observed only between the SS and SE groups (P = 0.014). There were no significant (P = 0.15) differences regarding FTF results between the three groups. Post-isometric muscle relaxation and static stretch with stabilizing exercises led to a similar increase in hamstring flexibility and trunk forward bend in healthy 10-13-year-old children. The exercises limited to straightening gluteus maximus improved the SLR result, but did not change the PA and FTF results.

  3. Reduction of radiation exposure during atrial fibrillation ablation using a novel fluoroscopy image integrated 3-dimensional electroanatomic mapping system: A prospective, randomized, single-blind, and controlled study.

    PubMed

    Huo, Yan; Christoph, Marian; Forkmann, Mathias; Pohl, Matthias; Mayer, Julia; Salmas, Jozef; Sitzy, Judith; Wunderlich, Carsten; Piorkowski, Christopher; Gaspar, Thomas

    2015-09-01

    We explored whether the use of a novel fluoroscopy image integrated 3-dimensional electroanatomic mapping (F-EAM) system could result in a reduction of overall fluoroscopy time and radiation doses during the whole procedure of atrial fibrillation (AF) ablation. Eighty patients (44 men (55%); mean age 63 ± 10 years) who underwent catheter ablation due to paroxysmal AF were recruited consecutively in the present study. Patients were randomized (1:1) into 2 arms for AF ablation: one using a conventional 3-dimensional electroanatomical mapping (EAM) system and the other using the F-EAM system. Fluoroscopy time (10:42 [interquartile range {IQR} 8:45-12:46] minutes:seconds vs 1:45 [IQR 1:05-2:22] minutes:seconds; P < .001) and radiation doses (2440 [IQR 1593-3091] cGy·cm(2) vs 652 [IQR 326-1489] cGy·cm(2); P < .001) in the EAM group were significantly greater than those in the F-EAM group. The majority of reduction of radiation exposure was achieved after transseptal puncture, which was near-zero fluoroscopic exposure. In total, approximately 84% of fluoroscopy time and 73% of radiation doses have been reduced during the AF ablation procedure using the F-EAM system compared to using the conventional EAM system. However, procedure time did not differ significantly (1:39 [IQR 1:18-2:10] hours:minutes vs 1:37 [IQR 1:17-1:50] hours:minutes; P = .362). During follow-up (5.9 ± 1.3 months), 61 patients (76.3%) had no recurrence of atrial arrhythmias. The recurrence rate between the 2 groups did not differ. AF catheter ablation using the F-EAM system was safe and resulted in a significant reduction of radiation exposure to patients and staff without complicating the workflow of the procedure. A near-zero fluoroscopic catheter ablation procedure could be performed without compromising acute/mid-term efficacy and safety. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  4. A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial.

    PubMed

    Ho, Derek; Kraeva, Ekaterina; Wun, Ted; Isseroff, R Rivkah; Jagdeo, Jared

    2016-08-02

    Skin fibrosis is involved in a variety of pathologic conditions ranging from scar formation secondary to surgery or trauma to immune-mediated processes. Skin fibrosis is a significant international health problem with an estimated incidence of greater than 100 million people affected per year worldwide with few effective treatment options available. Preliminary in vitro data generated by our research group suggests that red light can function as a stand-alone treatment for skin fibrosis. To our knowledge, no prior clinical trials have been performed to determine the safety of high-fluence (dose) light-emitting diode-red light (LED-RL) phototherapy. The goal of this study is to evaluate the safety of LED-RL fluences from 160 J/cm(2) up to 640 J/cm(2) in healthy subjects. This is a single-blind, dose escalation, randomized controlled, phase I study to evaluate the safety of high-fluence LED-RL on human skin. The protocol for dose escalation requires subjects be enrolled sequentially in groups of five. Within each group, three subjects will be randomized to LED-RL phototherapy and two subjects randomized to mock therapy. Subjects in group 1 randomized to LED-RL phototherapy will receive the maximum recommended starting dose (160 J/cm(2)). LED-RL dose will be escalated in subsequent groups (320 J/cm(2), 480 J/cm(2) and 640 J/cm(2)). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered to be the upper limit of subject tolerance. After either a MTD has been established, or the study endpoint of 640 J/cm(2) has been achieved, an additional 27 LED-RL phototherapy subjects (for a total of 30) and 18 mock therapy subjects (for a total of 20) (determined randomly) will be enrolled. Each subject will receive a total of nine procedures, three times per week for three consecutive weeks. This study may provide important safety information on the effects of high-fluence LED

  5. Effects of Reiki on Pain and Vital Signs When Applied to the Incision Area of the Body After Cesarean Section Surgery: A Single-Blinded, Randomized, Double-Controlled Study.

    PubMed

    Sagkal Midilli, Tulay; Ciray Gunduzoglu, Nazmiye

    This study was conducted to determine the effects of Reiki on pain and vital signs when applied for 15 minutes to the incision area of the body after cesarean section surgery. The study was single-blinded, randomized, and double-controlled (Reiki, sham Reiki, and control groups). Forty-five patients, equalized by age and number of births, were randomly assigned to the Reiki, sham Reiki, and control groups. The treatment, which was applied to the patients in these 3 groups, was applied for 15 minutes to the incision area of body in the first 24 and 48 hours after the operation within 4 to 8 hours of the application of standard analgesics. The study data were collected using a patient follow-up form and a visual analog scale. Mean visual analog scale measurement values were significantly different from each other according to groups and times (P < .05). A reduction in pain of 76.06% was determined in the Reiki group patients between day 1 pre-tx and after application on the second day (day 2 post-tx) measurements. Mean breathing rate and systolic blood pressure measurement values were significantly different from each other according to groups (P < .05). The Reiki group was observed to use fewer analgesics throughout the study and to need them after a longer time than the sham Reiki and control groups (P < .05). It was concluded that Reiki applied for 15 minutes to the incision area after a cesarean operation had the expected effects on pain and the need for the use of analgesics, but it had no effect on vital signs.

  6. Efficacy and safety of intensive statin therapy in Chinese patients with atherosclerotic intracranial arterial stenosis: a single-center, randomized, single-blind, parallel-group study with one-year follow-up.

    PubMed

    Zhou, Peiyang; Lu, Zuneng; Gao, Ping; Wang, Puqing; Cao, Zhihua; Zhang, Guibin; Wang, Shouan; Feng, Yuhua; Wang, Pu

    2014-05-01

    The purpose of this study is to validate the efficacy of intensive statin therapy for patients with atherosclerotic intracranial arterial stenosis (AICAS). In this study, we performed a single-center, randomized, single-blind, parallel-group clinical trial. A total of 120 Chinese patients with AICAS were enrolled and randomly divided into three groups [low-dose atorvastatin therapy (LAT, 10mg/day), standard-dose atorvastatin therapy (SAT, 20mg/day), and intensive-dose atorvastatin therapy (IAT, 40mg/day) groups] in a 1:1:1 ratio. Evaluation variables, including changes in serum lipid profiles, degree of stenosis, and perfusion-related parameters derived from computed tomography perfusion (CTP) imaging from baseline to weeks 26 and 52, as well as the occurrence of cerebrovascular events during the study period, were used to compare the benefits of these three statin therapies. After 52 weeks of treatment, improvement of serum lipid profiles, degree of stenosis, and perfusion-related parameters were all significantly better in the IAT group. In addition, the cumulative probability of cerebrovascular events at 52 weeks was significantly lower in the IAT group than in the LAT group, although there was no statistical difference between the IAT group and the SAT group. The proportion of patients experiencing any adverse event was similar among the three treatment groups. Adverse events caused by IAT were generally mild; no serious adverse events occurred throughout the entire period of study. In conclusion, long-term use of IAT appears to be a safe and effective treatment at least for Chinese patients with AICAS. Copyright © 2014 Elsevier B.V. All rights reserved.

  7. Efficacy of topical 10% urea-based lotion in patients with ichthyosis vulgaris: a two-center, randomized, controlled, single-blind, right-vs.-left study in comparison with standard glycerol-based emollient cream.

    PubMed

    Tadini, Gianluca; Giustini, Sandra; Milani, Massimo

    2011-12-01

    Ichthyoses are genetic disorders of keratinization which are uncomfortable due to their conspicuous scaling, itching and cosmetic problems. Ichthyoses can lead to social discrimination and psychological problems. Ichthyosis vulgaris (IV) is the most common form of these geno-dermatoses. IV is a chronic disorder that often requires continuous therapy. Emollient and keratolytic products are the mainstay treatments of IV. It is important that efficient, safe and well tolerated therapies should be available. Direct comparative data regarding efficacy of different emollient products in IV patients are very few. The aim of the study was to investigate the keratolytic and moisturizing properties as well as the tolerance of a new urea topical formulation (Ureadin Rx10) when applied to hyperkeratotic and dry skin in patients with (IV) in comparison with a standard emollient cream. The study was conducted as a two-center, randomized, controlled, single-blind, intra-patient (right-vs.-left) trial design. A total of 30 patients with IV between 8 and 65 (mean age: 25 years) treated with a 10% urea-based lotion, Ureadin Rx 10 * *Ureadin RX 10 is a registered trade name of ISDIN, Spain. (URx), for 4 weeks or a glycerol-based emollient cream, Dexeryl † †Dexeryl is a registered trade name of Pierre Fabre Dermatologie. (DC), in a right-vs.-left study design. Primary outcome was a 5-point SRRC Index score (evaluating scaling roughness, redness and cracks) evaluated at baseline and after 2 and 4 weeks of treatment. As secondary endpoints patients evaluated also the global efficacy (GE) and global tolerability (GT) scores with the help of a 10 cm visual analogue scale (0 = no efficacy at all/very bad tolerability; 10: excellent efficacy/excellent tolerability). At baseline the mean (SD) SRRC score was 9.5 (1.9) in the URx treated sites and 9.5 (1.9) in the DC treated sites. A total of 27 patients (90%) concluded the study period. Three patients were withdrawn prematurely

  8. Aromatic effects of a Japanese citrus fruit-yuzu (Citrus junos Sieb. ex Tanaka)-on psychoemotional states and autonomic nervous system activity during the menstrual cycle: a single-blind randomized controlled crossover study.

    PubMed

    Matsumoto, Tamaki; Kimura, Tetsuya; Hayashi, Tatsuya

    2016-01-01

    Yuzu (Citrus junos Sieb. ex Tanaka), a yellow-golden colored citrus fruit, has traditionally been used to promote psychosomatic health in Japan. While the yuzu produces a distinctive, pleasing aroma of citrus and floral, the efficacy of its fragrance remains unknown. The present study investigated the soothing effects of the fragrance of yuzu essential oil from the perspective of autonomic nervous system activity, which plays a crucial role in the integrity of the mind-body connection. Twenty one women in their 20s participated in a single-blind randomized controlled crossover study. Subjects were examined twice each in the follicular and late-luteal phases. Two kinds of aromatic stimulation (yuzu and water as a control) were used. This experiment measured heart rate variability (HRV) reflecting autonomic nervous system activity and used the Profile of Mood States (POMS) as a psychological index before and after the aromatic stimulation. Only a 10-min inhalation of the yuzu scent significantly decreased heart rate and increased high frequency power of HRV reflecting parasympathetic nervous system activity, regardless of menstrual phase. This significant physiological effect continued for at least 25 min. In addition, the POMS tests revealed that inhalation of the aromatic yuzu oil significantly decreased total mood disturbance, a global measure of affective state, together with two POMS subscales-tension-anxiety and fatigue, as long as 35 min after the aroma stimulation, both in the symptomatic late-luteal and non-symptomatic follicular phases. The present study provides the novel information that yuzu's aromatic effects could serve to alleviate negative emotional stress, which, at least in part, would contribute to the improvement of parasympathetic nervous system activity.

  9. Probiotic strain Lactobacillus plantarum 299v increases iron absorption from an iron-supplemented fruit drink: a double-isotope cross-over single-blind study in women of reproductive age.

    PubMed

    Hoppe, Michael; Önning, Gunilla; Berggren, Anna; Hulthén, Lena

    2015-10-28

    Iron deficiency is common, especially among young women. Adding probiotics to foods could be one way to increase iron absorption. The aim of this study was to test the hypothesis that non-haem iron absorption from a fruit drink is improved by adding Lactobacillus plantarum 299v (Lp299v). Iron absorption was studied in healthy women of reproductive age using a single-blind cross-over design in two trials applying the double-isotope (55Fe and 59Fe) technique. In Trial 1, iron absorption from a fruit drink containing 109 colony-forming units (CFU) Lp299v was compared with that from a control drink without Lp299v. Trial 2 had the same design but 1010 CFU were used. The test and control drinks contained approximately 5 mg of iron as ferrous lactate and were labelled with 59Fe (B) and 55Fe (A), respectively, and consumed on 4 consecutive days in the order AABB. Retention of the isotopes was measured with whole-body counting and in blood. Mean iron absorption from the drink containing 109 CFU Lp299v (28·6(sd 12·5) %) was significantly higher than from the control drink (18·5(sd 5·8) %), n 10, P<0·028). The fruit drink with 1010 CFU Lp299v gave a mean iron absorption of 29·1(sd 17·0) %, whereas the control drink gave an absorption of (20·1(sd 6·4) %) (n 11, P<0·080). The difference in iron absorption between the 109 CFU Lp299v and the 1010 CFU Lp299v drinks was not significant (P=0·941). In conclusion, intake of probiotics can increase iron absorption by approximately 50 % from a fruit drink having an already relatively high iron bioavailability.

  10. Comparative Evaluation of Continuous Thoracic Paravertebral Block and Thoracic Epidural Analgesia Techniques for Post-operative Pain Relief in Patients Undergoing Open Nephrectomy: A Prospective, Randomized, Single-blind Study.

    PubMed

    Gautam, Sujeet Kumar Singh; Das, Pravin Kumar; Agarwal, Anil; Kumar, Sanjay; Dhiraaj, Sanjay; Keshari, Abhishek; Patro, Abinash

    2017-01-01

    Open surgical procedures are associated with substantial postoperative pain; an alternative method providing adequate pain relief with minimal side effects is very much required. The aim of this study was a comparative evaluation of the efficacy of continuous thoracic paravertebral block (PVB) and thoracic epidural analgesia (EA) for postoperative pain relief in patients undergoing open nephrectomy. Prospective, randomized, and single-blind study. Sixty adult patients undergoing open nephrectomy under general anesthesia were randomized to receive a continuous thoracic epidural infusion (Group E) or continuous thoracic paravertebral infusion (Group P) with bupivacaine 0.1% with 1 μg/ml fentanyl at 7 ml/h; both infusions were started after induction of anesthesia. The primary outcome measures were postoperative pain during rest (static pain), deep inspiration, coughing, and movement (getting up from supine to sitting position); the secondary outcome measures were postoperative nausea and vomiting, requirement of rescue antiemetic, hypotension, sedation, pruritus, motor block, and respiratory depression. These were assessed till the morning of the third postoperative day. Results were analyzed by the one-way ANOVA, Chi-square test, and Mann-Whitney U-test. P < 0.05 was considered significant. Both the groups were similar with regard to demographic factors (P > 0.05). The visual analog scale scores at rest, deep breathing, coughing and movement, and postoperative fentanyl consumption were similar in the two groups (P > 0.05); the incidence of side effects was also similar in the two groups (P > 0.05). Continuous thoracic PVB is as effective as continuous thoracic EA in providing pain relief in patients undergoing open nephrectomy in the postoperative period. The side effect profile of the two techniques was also similar.

  11. Anesthetic Efficacy of a Combination of 0.9 M Mannitol Plus 68.8 mg of Lidocaine With 50 μg Epinephrine in Inferior Alveolar Nerve Blocks: A Prospective Randomized, Single Blind Study

    PubMed Central

    Cohen, Howard; Reader, Al; Drum, Melissa; Nusstein, John; Beck, Mike

    2013-01-01

    The purpose of this prospective randomized, single blind study was to determine the anesthetic efficacy of 68.8 mg of lidocaine with 50 μg epinephrine compared to 68.8 mg lidocaine with 50 μg epinephrine plus 0.9 M mannitol in inferior alveolar nerve (IAN) blocks. Forty subjects randomly received 2 IAN blocks consisting of a 1.72-mL formulation of 68.8 mg lidocaine with 50 μg epinephrine and a 5-mL formulation of 68.8 mg lidocaine with 50 μg epinephrine (1.72 mL) plus 0.9 M mannitol (3.28 mL) in 2 separate appointments spaced at least 1 week apart. Mandibular anterior and posterior teeth were blindly electric pulp tested at 4-minute cycles for 60 minutes postinjection. No response from the subject to the maximum output (80 reading) of the pulp tester was used as the criterion for pulpal anesthesia. Total percent pulpal anesthesia was defined as the total of all the times of pulpal anesthesia (80 readings), for each tooth, over the 60 minutes. One hundred percent of the subjects had profound lip numbness with both inferior alveolar nerve blocks. The results demonstrated that the 5 mL-formulation of 68.8 mg lidocaine with 50 μg epinephrine plus 0.9 M mannitol was significantly better than the 1.72-mL formulation of 68.8 mg lidocaine with 50 μg epinephrine for all teeth, except the lateral incisor. We concluded that adding 0.9 M mannitol to a lidocaine with epinephrine formulation was significantly more effective in achieving a greater percentage of total pulpal anesthesia (as defined in this study) than a lidocaine formulation without mannitol. However, the 0.9 M mannitol/lidocaine formulation would not provide 100% pulpal anesthesia for all the mandibular teeth. PMID:24423417

  12. Slow-release L-cysteine capsule prevents gastric mucosa exposure to carcinogenic acetaldehyde: results of a randomised single-blinded, cross-over study of Helicobacter-associated atrophic gastritis.

    PubMed

    Hellström, Per M; Hendolin, Panu; Kaihovaara, Pertti; Kronberg, Leif; Meierjohann, Axel; Millerhovf, Anders; Paloheimo, Lea; Sundelin, Heidi; Syrjänen, Kari; Webb, Dominic-Luc; Salaspuro, Mikko

    2017-02-01

    Helicobacter-induced atrophic gastritis with a hypochlorhydric milieu is a risk factor for gastric cancer. Microbes colonising acid-free stomach oxidise ethanol to acetaldehyde, a recognised group 1 carcinogen. To assess gastric production of acetaldehyde and its inert condensation product, non-toxic 2-methyl-1,3-thiazolidine-4-carboxylic acid (MTCA), after alcohol intake under treatment with slow-release L-cysteine or placebo. Seven patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17 were studied in a cross-over single-blinded design. On separate days, patients randomly received 200 mg slow-release L-cysteine or placebo with intragastric instillation of 15% (0.3 g/kg) ethanol. After intake, gastric concentrations of ethanol, acetaldehyde, L-cysteine and MTCA were analysed. Administration of L-cysteine increased MTCA (p < .0004) and decreased gastric acetaldehyde concentrations by 68% (p < .0001). The peak L-cysteine level was 7552 ± 2687 μmol/L at 40 min and peak MTCA level 196 ± 98 μmol/L at 80 min after intake. Gastric L-cysteine and MTCA concentrations were maintained for 3 h. The AUC for MTCA was 11-fold higher than acetaldehyde, indicating gastric first-pass metabolism of ethanol. With placebo, acetaldehyde remained elevated also at low ethanol concentrations representing 'non-alcoholic' beverages and food items. After gastric ethanol instillation, slow-release L-cysteine eliminates acetaldehyde to form inactive MTCA, which remains in gastric juice for up to 3 h. High acetaldehyde levels indicate a marked gastric first-pass metabolism of ethanol resulting in gastric accumulation of carcinogenic acetaldehyde. Local exposure of the gastric mucosa to acetaldehyde can be mitigated by slow-release L-cysteine capsules.

  13. Anesthetic Efficacy of a Combination of 0.5 M Mannitol Plus 127.2 mg of Lidocaine With 50 μg Epinephrine in Inferior Alveolar Nerve Blocks: A Prospective Randomized, Single-Blind Study

    PubMed Central

    Smith, Steven; Reader, Al; Drum, Melissa; Nusstein, John; Beck, Mike

    2013-01-01

    The purpose of this prospective, randomized, single-blind study was to determine the anesthetic efficacy of 127.2 mg lidocaine with 50 μg epinephrine compared to 127.2 mg lidocaine with 50 μg epinephrine plus 0.5 M mannitol in inferior alveolar nerve (IAN) blocks. Forty subjects randomly received 2 IAN blocks consisting of a 3.18 mL formulation of 127.2 mg lidocaine with 50 μg epinephrine and a 5 mL formulation of 127.2 mg lidocaine with 50 μg epinephrine (3.18 mL) plus 0.5 M mannitol (1.82 mL) in 2 separate appointments spaced at least 1 week apart. Mandibular anterior and posterior teeth were blindly electric pulp tested at 4-minute cycles for 60 minutes postinjection. Pain of solution deposition and postoperative pain were also measured. No response from the subject to the maximum output (80 reading) of the pulp tester was used as the criterion for pulpal anesthesia. Total percent pulpal anesthesia was defined as the total of all the times of pulpal anesthesia (80 readings) over the 60 minutes. One hundred percent of the subjects had profound lip numbness with both inferior alveolar nerve blocks. The results demonstrated that a 5 mL formulation of 127.2 mg lidocaine with 50 μg epinephrine plus 0.5 M mannitol was significantly better than the 3.18 mL formulation of 127.2 mg lidocaine with 50 μg epinephrine for all teeth. Solution deposition pain and postoperative pain were not statistically different between the lidocaine/mannitol formulation and the lidocaine formulation without mannitol. We concluded that adding 0.5 M mannitol to a lidocaine with epinephrine formulation was significantly more effective in achieving a greater percentage of total pulpal anesthesia than a lidocaine formulation without mannitol. PMID:23506277

  14. Pharmacokinetic and pharmacodynamic effects of midodrine on blood pressure, the autonomic nervous system, and plasma natriuretic peptides: a prospective, randomized, single-blind, two-period, crossover, placebo-controlled study.

    PubMed

    Lamarre-Cliche, Maxime; Souich, Patrick du; Champlain, Jacques de; Larochelle, Pierre

    2008-09-01

    Midodrine is an alpha-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP). The present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers. This was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration. Fifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At Cmax, midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL (P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm (P = 0.022). A significant correlation was found between DGM concentration and HR ( varphi -0.61; P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed. This study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous

  15. Clinical effectiveness of a staff training intervention in mental health inpatient rehabilitation units designed to increase patients' engagement in activities (the Rehabilitation Effectiveness for Activities for Life [REAL] study): single-blind, cluster-randomised controlled trial.

    PubMed

    Killaspy, Helen; Marston, Louise; Green, Nicholas; Harrison, Isobel; Lean, Melanie; Cook, Sarah; Mundy, Tim; Craig, Thomas; Holloway, Frank; Leavey, Gerard; Koeser, Leonardo; McCrone, Paul; Arbuthnott, Maurice; Omar, Rumana Z; King, Michael

    2015-01-01

    Mental health inpatient rehabilitation services focus on people with complex psychosis who have, for example, treatment-refractory symptoms, cognitive impairment, and severe negative symptoms, which impair functioning and require lengthy admission. Engagement in activities could lead to improvement in negative symptoms and function, but few trials have been done. We aimed to investigate the effectiveness of a staff training intervention to increase patients' engagement in activities. We did a single-blind, two-arm, cluster-randomised controlled trial in 40 mental health inpatient rehabilitation units across England. Units were randomly allocated to either a manual-based staff training programme delivered by a small intervention team (intervention group, n=20) or standard care (control group, n=20). The primary outcome was patients' engagement in activities 12 months after randomisation, measured with the time use diary. With this measure, both the degree of engagement in an activity and its complexity are recorded four times a day for a week, rated on a scale of 0-4 for every period (maximum score of 112). Analysis was by intention-to-treat. Random-effects models were used to compare outcomes between study groups. Cost-effectiveness was assessed by combining service costs with the primary outcome. This study is registered with Current Controlled Trials (ISRCTN25898179). Patients' engagement in activities did not differ between study groups (coefficient 1·44, 95% CI -1·35 to 4·24). An extra £101 was needed to achieve a 1% increase in patients' engagement in activities with the study intervention. Our training intervention did not increase patients' engagement in activities after 12 months of follow-up. This failure could be attributable to inadequate implementation of the intervention, a high turnover of patients in the intervention units, competing priorities on staff time, high levels of patients' morbidity, and ceiling effects because of the high quality of

  16. Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan™, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study

    PubMed Central

    Therkelsen, Stig Palm; Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

    2016-01-01

    Background Ingestion of AndoSan™, based on the mushroom Agaricus blazei Murill, has previously been shown to exhibit anti-inflammatory effects because of reduction of pro-inflammatory cytokines in healthy individuals and patients with ulcerative colitis. In this randomized single-blinded placebo controlled study we examined whether intake of AndoSan™ also resulted in clinical effects. Methods and Findings 50 patients with symptomatic ulcerative colitis were block-randomized and blinded for oral daily intake of AndoSan™ or placebo for the 21 days’ experimental period. The patients reported scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSan™ group (n = 24) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.88 (4.92–6.83), 4.71 (3.90–5.52) (p = 0.002) and 4.50 (3.70–5.30) (p = 0.001). Corresponding improved mean scores (±SD) for total fatigue were 16.6 (5.59), 14.1 (4.50) (p = 0.001) and 15.1 (4.09) (p = 0.023). These scores in the placebo group (n = 26) were not improved. When comparing the two study groups using mixed model statistics, we found significant better scores for the AndoSan™-patients. HRQoL for dimensions bodily pain, vitality, social functioning and mental health improved in the AndoSan™ group. There were no alterations in general blood samples and fecal calprotectin. Conclusions Beneficiary effects on symptoms, fatigue and HRQoL from AndoSan™ consumption were demonstrated in this per-protocol study, supporting its use as a supplement to conventional medication for patients with mild to moderate symptoms from ulcerative colitis. The patients did not report any harms or unintended effects of AndoSan™ in this study. Trial Registration ClinicalTrials.gov NCT01496053 PMID:26933886

  17. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m[sup 3]) of tertiary oil have been recovered. Microbial activity has increased CO[sub 2] content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  18. Single blind randomized Phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background The treatment results of external beam radiotherapy for intermediate and high risk prostate cancer patients are insufficient with five-year biochemical relapse rates of approximately 35%. Several randomized trials have shown that dose escalation to the entire prostate improves biochemical disease free survival. However, further dose escalation to the whole gland is limited due to an unacceptable high risk of acute and late toxicity. Moreover, local recurrences often originate at the location of the macroscopic tumor, so boosting the radiation dose at the macroscopic tumor within the prostate might increase local control. A reduction of distant metastases and improved survival can be expected by reducing local failure. The aim of this study is to investigate the benefit of an ablative microboost to the macroscopic tumor within the prostate in patients treated with external beam radiotherapy for prostate cancer. Methods/Design The FLAME-trial (Focal Lesion Ablative Microboost in prostatE cancer) is a single blind randomized controlled phase III trial. We aim to include 566 patients (283 per treatment arm) with intermediate or high risk adenocarcinoma of the prostate who are scheduled for external beam radiotherapy using fiducial markers for position verification. With this number of patients, the expected increase in five-year freedom from biochemical failure rate of 10% can be detected with a power of 80%. Patients allocated to the standard arm receive a dose of 77 Gy in 35 fractions to the entire prostate and patients in the experimental arm receive 77 Gy to the entire prostate and an additional integrated microboost to the macroscopic tumor of 95 Gy in 35 fractions. The secondary outcome measures include treatment-related toxicity, quality of life and disease-specific survival. Furthermore, by localizing the recurrent tumors within the prostate during follow-up and correlating this with the delivered dose, we can obtain accurate dose-effect information

  19. Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective, Randomized, Single-blinded Food and Drug Administration Investigational Device Exemption Study.

    PubMed

    Arnold, Paul M; Sasso, Rick C; Janssen, Michael E; Fehlings, Michael G; Smucker, Joseph D; Vaccaro, Alexander R; Heary, Robert F; Patel, Ashvin I; Goulet, Benoit; Kalfas, Iain H; Kopjar, Branko

    2016-07-01

    A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial. The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months. At 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P < 0.0001), and high Neurological Success rate (93.71% and 93.01%, respectively, noninferiority P < 0.0001). There was no difference in the rate of adverse events (83.64% and 82.47% in the i-Factor and autograft groups, respectively, P = 0.8814). Overall success rate consisting of fusion, NDI, Neurological Success and Safety Success was higher in i-Factor subjects than in autograft subjects (68.75% and 56.94%, respectively, P = 0.0382). Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups). i-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. i-Factor and autograft

  20. Anesthetic Efficacy of a Combination of 0.5 M Mannitol Plus 36.8 mg of Lidocaine With 18.4 μg Epinephrine in Maxillary Infiltration: A Prospective, Randomized, Single-Blind Study

    PubMed Central

    Younkin, Kevin; Reader, Al; Drum, Melissa; Nusstein, John; Beck, Mike

    2014-01-01

    The purpose of this prospective, randomized, single-blind study was to determine the anesthetic efficacy of lidocaine with epinephrine compared to lidocaine with epinephrine plus 0.5 M mannitol in maxillary lateral incisor infiltrations. Forty-one subjects randomly received 2 maxillary lateral infiltrations consisting of a 1.84-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (control solution) and a 2.90-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (1.84 mL) plus 0.5 M mannitol (1.06 mL) in 2 separate appointments spaced at least 1 week apart. The maxillary lateral incisor was blindly electric pulp–tested in 2-minute cycles for 60 minutes postinjection. No response from the subject to the maximum output (a reading of 80) of the pulp tester was used as the criterion for pulpal anesthesia. Total percent pulpal anesthesia was defined as the total of all pulpal anesthesia readings (at output of 80) over the 60-minute test period. Pain during solution deposition and postoperative pain were also measured. The results demonstrated that a 2.90-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (1.84 mL) plus 0.5 M mannitol (1.06 mL) was not statistically significantly superior to a 1.84-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine. The pain of solution deposition was lower with the lidocaine/mannitol formulation. Postoperative pain was not statistically significantly different between the lidocaine/mannitol formulation and the lidocaine formulation without mannitol. We concluded that adding 0.5 M mannitol to a lidocaine with epinephrine formulation was not significantly more effective in achieving a greater percentage of total pulpal anesthesia (as defined in this study) than a lidocaine formulation without mannitol in the maxillary lateral incisor. PMID:24932979

  1. Anesthetic efficacy of a combination of 0.5 M mannitol plus 36.8 mg of lidocaine with 18.4 μg epinephrine in maxillary infiltration: a prospective, randomized, single-blind study.

    PubMed

    Younkin, Kevin; Reader, Al; Drum, Melissa; Nusstein, John; Beck, Mike

    2014-01-01

    The purpose of this prospective, randomized, single-blind study was to determine the anesthetic efficacy of lidocaine with epinephrine compared to lidocaine with epinephrine plus 0.5 M mannitol in maxillary lateral incisor infiltrations. Forty-one subjects randomly received 2 maxillary lateral infiltrations consisting of a 1.84-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (control solution) and a 2.90-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (1.84 mL) plus 0.5 M mannitol (1.06 mL) in 2 separate appointments spaced at least 1 week apart. The maxillary lateral incisor was blindly electric pulp-tested in 2-minute cycles for 60 minutes postinjection. No response from the subject to the maximum output (a reading of 80) of the pulp tester was used as the criterion for pulpal anesthesia. Total percent pulpal anesthesia was defined as the total of all pulpal anesthesia readings (at output of 80) over the 60-minute test period. Pain during solution deposition and postoperative pain were also measured. The results demonstrated that a 2.90-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (1.84 mL) plus 0.5 M mannitol (1.06 mL) was not statistically significantly superior to a 1.84-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine. The pain of solution deposition was lower with the lidocaine/mannitol formulation. Postoperative pain was not statistically significantly different between the lidocaine/mannitol formulation and the lidocaine formulation without mannitol. We concluded that adding 0.5 M mannitol to a lidocaine with epinephrine formulation was not significantly more effective in achieving a greater percentage of total pulpal anesthesia (as defined in this study) than a lidocaine formulation without mannitol in the maxillary lateral incisor.

  2. The Pilot Training Study: Personnel Flow and the PILOT Model.

    ERIC Educational Resources Information Center

    Mooz, W. E.

    The results of the Rand study of pilot flows and the computer-operated decision model, called the PILOT model, are described. The flows of pilots within the Air Force are caused by policies that require the career-development rotation of pilots from cockpit jobs to desk jobs, the maintenance of a supplement of pilots in excess of cockpit-related…

  3. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.

    1991-12-06

    The objective of this project is to perform a microbial enhanced oil recovery field pilot test in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate-reducing bacteria will be stimulated to selectively plug flow paths which have been preferentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. During this quarter an additional tracer study was performed in the field to determine pre-treatment flow paths and the first nutrients were injected. 2 figs.

  4. Microbial Field Pilot Study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1990-11-01

    This report covers progress made during the first year of the Microbial Field Pilot Study project. Information on reservoir ecology and characterization, facility and treatment design, core experiments, bacterial mobility, and mathematical modeling are addressed. To facilitate an understanding of the ecology of the target reservoir analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. A preliminary design of facilities for the operation of the field pilot test was prepared. In addition, procedures for facilities installation and for injection treatments are described. The Southeast Vassar Vertz Sand Unit (SEVVSU), the site of the proposed field pilot study, is described physically, historically, and geologically. The fields current status is presented and the ongoing reservoir simulation is discussed. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. Two possible mechanisms, relative permeability effects and changes in the capillary number, are discussed and related to four Berea core experiments' results. The experiments were conducted at reservoir temperature using SEVVSU oil, brine, and bacteria. The movement and activity of bacteria in porous media were investigated by monitoring the growth of bacteria in sandpack cores under no flow conditions. The rate of bacteria advancement through the cores was determined. A mathematical model of the MEOR process has been developed. The model is a three phase, seven species, one dimensional model. Finite difference methods are used for solution. Advection terms in balance equations are represented with a third- order upwind differencing scheme to reduce numerical dispersion and oscillations. The model is applied to a batch fermentation example. 52 refs., 26 figs., 21 tabs.

  5. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year`s report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  6. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year's report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  7. Electrically Assisted Movement Therapy in Chronic Stroke Patients With Severe Upper Limb Paresis: A Pilot, Single-Blind, Randomized Crossover Study.

    PubMed

    Carda, Stefano; Biasiucci, Andrea; Maesani, Andrea; Ionta, Silvio; Moncharmont, Julien; Clarke, Stephanie; Murray, Micah M; Millán, José Del R

    2017-08-01

    To evaluate the effects of electrically assisted movement therapy (EAMT) in which patients use functional electrical stimulation, modulated by a custom device controlled through the patient's unaffected hand, to produce or assist task-specific upper limb movements, which enables them to engage in intensive goal-oriented training. Randomized, crossover, assessor-blinded, 5-week trial with follow-up at 18 weeks. Rehabilitation university hospital. Patients with chronic, severe stroke (N=11; mean age, 47.9y) more than 6 months poststroke (mean time since event, 46.3mo). Both EAMT and the control intervention (dose-matched, goal-oriented standard care) consisted of 10 sessions of 90 minutes per day, 5 sessions per week, for 2 weeks. After the first 10 sessions, group allocation was crossed over, and patients received a 1-week therapy break before receiving the new treatment. Fugl-Meyer Motor Assessment for the Upper Extremity, Wolf Motor Function Test, spasticity, and 28-item Motor Activity Log. Forty-four individuals were recruited, of whom 11 were eligible and participated. Five patients received the experimental treatment before standard care, and 6 received standard care before the experimental treatment. EAMT produced higher improvements in the Fugl-Meyer scale than standard care (P<.05). Median improvements were 6.5 Fugl-Meyer points and 1 Fugl-Meyer point after the experimental treatment and standard care, respectively. The improvement was also significant in subjective reports of quality of movement and amount of use of the affected limb during activities of daily living (P<.05). EAMT produces a clinically important impairment reduction in stroke patients with chronic, severe upper limb paresis. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  8. Pilot Field Test Study

    NASA Technical Reports Server (NTRS)

    Sherriff, Abigail

    2015-01-01

    The Field Test study is currently in full swing, preceded by the successful completion of the Pilot Field Test study that paved the way for collecting data on the astronauts in the medical tent in Kazakhstan. Abigail Sherriff worked alongside Logan Dobbe on one Field Test aspect to determine foot clearance over obstacles (5cm, 10cm, and 15cm) using APDM Inc. Internal Measurement Units (IMU) worn by the astronauts. They created a program to accurately calculate foot clearance using the accelerometer, magnetometer, and gyroscope data with the IMUs attached to the top of the shoes. To validate the functionality of their program, they completed a successful study on test subjects performing various tasks in an optical motion studio, considered a gold standard in biomechanics research. Future work will include further validation and expanding the program to include other analyses.

  9. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study.

    PubMed

    Gonzalez, Pablo; Vila, Ricardo; Cirigliano, Marcela

    2012-12-01

    Topical combination therapy, such as that with fixed-dose clindamycin/benzoyl peroxide (BPO) or adapalene/BPO, is the recommended first-line approach for the treatment of facial acne. To compare the tolerability of clindamycin 1%/BPO 5% gel vs. adapalene 0.1% BPO 2.5% gel for the first 2 weeks of treatment in patients with facial acne. Using a randomized, single-blind, split-face method, 48 patients with acne received both clindamycin/BPO and adapalene/BPO once daily for 2 weeks. The primary endpoint was investigator-assessed tolerability. Treatment efficacy, patient-assessed tolerability and satisfaction, and safety were also investigated. Forty-five patients completed treatment. Investigator-rated scores for erythema, dryness, and peeling were significantly higher with adapalene/BPO than clindamycin/BPO. Patients rated clindamycin/BPO as significantly more tolerable than adapalene/BPO for redness, dryness, burning, itching, and scaling. Investigator Static Global Assessment scores and lesion counts improved with both products, with no significant difference between treatments. Patients' Global Change Assessment showed a statistically significant difference in favor of clindamycin/BPO at week 1, but not week 2. Overall, >80% of patients were "satisfied" or "very satisfied" with treatment at week 2, but 63% of patients stated that they preferred clindamycin/BPO. Both products were well tolerated, with no serious adverse events (AEs), but a post hoc analysis indicated that treatment-related AEs, including irritation, dryness and erythema, were significantly less common with clindamycin/BPO. Clindamycin/BPO had a better tolerability profile than adapalene/BPO during 2 weeks of split-face treatment. Treatment satisfaction was highest with clindamycin/BPO. © 2012 Wiley Periodicals, Inc.

  10. An improved dosage regimen of sertraline hydrochloride in the treatment for premature ejaculation: an 8-week, single-blind, randomized controlled study followed by a 4-week, open-label extension study.

    PubMed

    Xu, G; Jiang, H-W; Fang, J; Wen, H; Gu, B; Liu, J; Zhang, L-M; Ding, Q; Zhang, Y-F

    2014-02-01

    This study aimed at evaluating the safety and efficacy of an improved dosage regimen of sertraline in patients with premature ejaculation (PE) and to examine whether the premature ejaculation diagnostic tool (PEDT) can be used as a measure of treatment response in these patients. A total of 218 PE patients were randomized into control (n = 61) and treatment (n = 157) groups to receive mycelium of cordyceps sinensis C4 and sertraline 50 mg daily for 8 weeks, respectively. Following this blinded stage, sixty-three patients chose to take sertraline 100 mg daily for an additional 4-week period, and 80 other patients continued treatment with sertraline 50 mg. Main outcome measures include intravaginal ejaculatory latency time (IELT), PEDT score and Clinical Global Impression of Change (CGIC) score. At weeks 4 and 8, mean IELT of patients who subsequently chose to take 100 mg of sertraline was significantly lower than that of patients who continued taking 50 mg of sertraline, although the IELT value was comparable between the two groups of patients at baseline. However, with an additional 4-week treatment, the mean IELT increased significantly more in the 100-mg group than in the 50-mg continuation group. Similar results were also obtained in the analyses of the PEDT and CGIC scores. Both regimens were well tolerated, and relapse rate did not differ significantly between the two groups. These findings suggest that PE patients not responding to an 8-week treatment with sertraline 50 mg can benefit from an additional 4-week treatment with sertraline 100 mg and that the PEDT may be a valid measure of treatment response in PE patients. © 2013 John Wiley & Sons Ltd.

  11. Strategies to promote healthier food purchases: a pilot supermarket intervention study.

    PubMed

    Ni Mhurchu, Cliona; Blakely, Tony; Wall, Joanne; Rodgers, Anthony; Jiang, Yannan; Wilton, Jenny

    2007-06-01

    To pilot the design and methodology for a large randomised controlled trial (RCT) of two interventions to promote healthier food purchasing: culturally appropriate nutrition education and price discounts. A 12-week, single-blind, pilot RCT. Effects on food purchases were measured using individualised electronic shopping data ('Shop 'N Go' system). Partial data were also collected on food expenditure at other (non-supermarket) retail outlets. A supermarket in Wellington, New Zealand. Eligible customers were those who were the main household shoppers, shopped mainly at the participating store, and were registered to use the Shop 'N Go system. Ninety-seven supermarket customers (72% women; age 40 +/- 9.6 years, mean +/- standard deviation) were randomised to one of four intervention groups: price discounts, nutrition education, a combination of price discounts and nutrition education, or control (no intervention). There was a 98% follow-up rate of participants, with 85% of all reported supermarket purchases being captured via the electronic data collection system. The pilot did, however, demonstrate difficulty recruiting Maori, Pacific and low-income shoppers using the electronic register and mail-out. This pilot study showed that electronic sales data capture is a viable way to measure effects of study interventions on food purchases in supermarkets, and points to the feasibility of conducting a large-scale RCT to evaluate the effectiveness of price discounts and nutrition education. Recruitment strategies will, however, need to be modified for the main trial in order to ensure inclusion of all ethnic and socio-economic groups.

  12. Conducting pilot and feasibility studies.

    PubMed

    Cope, Diane G

    2015-03-01

    Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
.

  13. Framework for planning and conducting pilot studies.

    PubMed

    Smith, Lisa Janette; Harrison, Margaret B

    2009-12-01

    Researchers working with partners in home care to plan a pragmatic multicenter community-based, randomized, controlled trial for leg ulcer compression treatment realized a smaller pilot study would be necessary. Because no framework for conducting pilot studies could be found, the authors developed a framework for pilot study methodology to inform the planning of such research. To this end, an integrative literature review was conducted, guided by an explicit search strategy, retrieval procedures, and appraisal process, to identify recognized pilot study aims, processes, and methodologies used in previously reported community pilot studies. Factors influencing study inclusion were recognized pilot study aims and purposes and a concise working definition of pilot study. Methodologies used in previously conducted community pilot studies were reviewed. Although relevant published research was limited, 11 pilot studies met the inclusion criteria for this review and contained suggestions to further develop or improve plans for larger definitive trials to enable a better fit of protocols within the delivery systems and scopes of practice. Pilot research processes could be divided into two stages: early planning and pilot trial. Direction for procedures and methods was gained relative to planning for an effective pilot study regarding eligibility, recruitment and data collection, management, and analysis. The results were used to develop an organizing framework for the authors' pilot study and named the Pilot Research Process (PReP) Framework. The process was instrumental in working with the authors' research team and clinical partners in the planning of their leg ulcer treatment pilot study. This framework may provide a foundation for others to analyze or develop a pilot study methodology in planning a large-scale study.

  14. Transfer Readiness Pilot Study.

    ERIC Educational Resources Information Center

    Scott-Skillman, Thelma; And Others

    The California Community Colleges (CCC) has implemented a prototype model for determining student transfer readiness as a primary means of assessing community college transfer effectiveness. This report provides definitions of transfer readiness and guidelines for colleges participating in the CCC transfer readiness study. First, a memorandum from…

  15. Speech Alarms Pilot Study

    NASA Technical Reports Server (NTRS)

    Sandor, A.; Moses, H. R.

    2016-01-01

    Currently on the International Space Station (ISS) and other space vehicles Caution & Warning (C&W) alerts are represented with various auditory tones that correspond to the type of event. This system relies on the crew's ability to remember what each tone represents in a high stress, high workload environment when responding to the alert. Furthermore, crew receive a year or more in advance of the mission that makes remembering the semantic meaning of the alerts more difficult. The current system works for missions conducted close to Earth where ground operators can assist as needed. On long duration missions, however, they will need to work off-nominal events autonomously. There is evidence that speech alarms may be easier and faster to recognize, especially during an off-nominal event. The Information Presentation Directed Research Project (FY07-FY09) funded by the Human Research Program included several studies investigating C&W alerts. The studies evaluated tone alerts currently in use with NASA flight deck displays along with candidate speech alerts. A follow-on study used four types of speech alerts to investigate how quickly various types of auditory alerts with and without a speech component - either at the beginning or at the end of the tone - can be identified. Even though crew were familiar with the tone alert from training or direct mission experience, alerts starting with a speech component were identified faster than alerts starting with a tone. The current study replicated the results from the previous study in a more rigorous experimental design to determine if the candidate speech alarms are ready for transition to operations or if more research is needed. Four types of alarms (caution, warning, fire, and depressurization) were presented to participants in both tone and speech formats in laboratory settings and later in the Human Exploration Research Analog (HERA). In the laboratory study, the alerts were presented by software and participants were

  16. Speech Alarms Pilot Study

    NASA Technical Reports Server (NTRS)

    Sandor, Aniko; Moses, Haifa

    2016-01-01

    Speech alarms have been used extensively in aviation and included in International Building Codes (IBC) and National Fire Protection Association's (NFPA) Life Safety Code. However, they have not been implemented on space vehicles. Previous studies conducted at NASA JSC showed that speech alarms lead to faster identification and higher accuracy. This research evaluated updated speech and tone alerts in a laboratory environment and in the Human Exploration Research Analog (HERA) in a realistic setup.

  17. Histological evaluation of Accell Connexus® and Bio-Oss® on quality and rate of bone healing: a single blind experimental study on rabbit’s calvarium

    PubMed Central

    Khorsand, A.; Rasouli Ghahroudi, A. A. R.; Motahhari, P.; Rezaei Rad, M.; Soleimani Shayesteh, Y.

    2012-01-01

    Objective: The objective of this study was to evaluate the effect of Accell Connexus® on the quality and rate of healing in experimental defects of rabbit calvarium compared to Bio-Oss®. Materials and Methods: Twelve 2.5–3.5 kg weighing New Zealand white rabbits were used. Three defects (3×6 mm) were created in the cranium of the animals subsequently filled with Accell Connexus®, Bio-Oss® or served as controls. The animals were sacrificed four, six and eight weeks postoperatively and the histology blocks were studied in terms of inflammation, trabeculation thickness, bone type regeneration, foreign body and remained biomaterial by light microscope. The data were subject to Mann-Whitney U test. Results: Increased inflammatory reaction, foreign body reaction, delayed bone formation and lower rate of ossification were observed in DBM-filled defects compared to Bio-Oss® or controls. However, no significant differences were observed in bone formation between Bio-Oss®, Accell Connexus® and control specimens in the three time intervals. Furthermore, no significant differences were noted between Bio-Oss® and control groups. Conclusion: Accell Connexus® showeda lower rate of ossification and bone healing compared to Bio-Oss® or controlgroups. Other studies in this field seem necessary. PMID:23066476

  18. The effect of a triclosan/copolymer/fluoride 
toothpaste on plaque formation, gingivitis, and 
dentin hypersensitivity: A single-blinded 
randomized clinical study.

    PubMed

    Al Habashneh, Rola; Farasin, Rawan; Khader, Yousef

    2017-01-01

    The daily removal of supragingival dental plaque is a key factor in the prevention of gingivitis. The aim of the study was to compare the gingival health benefits of a triclosan/copolymer/fluoride toothpaste (Colgate Total, a fluoride toothpaste containing an antiseptic) to a commercially available toothpaste containing 0.243% sodium fluoride in a silica base (Colgate Herbal, a conventional fluoride toothpaste with herbal extracts). A total of 50 patients with gingivitis and at least one sensitive tooth were included. The subjects were randomly stratified into two groups: Colgate Total toothpaste, and Colgate Herbal toothpaste. After a 4-week pre-experimental phase, baseline Plaque Index (Quigley-Hein Index) (PI), Gingival Index (GI), Gingival Bleeding Index (GBI), and Visual Analog Scale (VAS) were assessed. The PI, GI, GBI, and VAS were reexamined at weeks 4, 12, and 24 after the baseline. Fifty subjects complied with the protocol and completed the study. The conventional fluoride toothpaste with herbal extracts group and the fluoride toothpaste containing an antiseptic group exhibited significant reductions in PI, GI, GBI, and VAS over time. The amount of reduction after 6 months of the treatment was higher in the Total group compared to Herbal group (1.82 vs 1.39, P = .015 for PI; 0.67 vs 0.37, P < .005 for GI; and 56.64% vs 34.26%, P < .005 for GBI). No significant difference was seen for VAS. Twice daily brushing with a toothpaste containing 0.3% triclosan and polyvinyl methyl ether and maleic acid copolymer provides a more effective level of plaque control and gingival health with no effect on decreasing dentin hypersensitivity compared to conventional fluoride toothpaste. Toothpastes containing triclosan/copolymer, in addition to fluoride, result in a higher reduction in plaque, gingival inflammation, and gingival bleeding when compared with fluoride toothpastes without triclosan/copolymer.

  19. A comparison of the efficacy, safety, and longevity of two different hyaluronic acid dermal fillers in the treatment of severe nasolabial folds: a multicenter, prospective, randomized, controlled, single-blind, within-subject study

    PubMed Central

    Goodman, Greg J; Bekhor, Phillip; Rich, Michael; Rosen, Robert H; Halstead, Michael B; Rogers, John D

    2011-01-01

    Background Commercially available hyaluronic acid (HA)-based fillers have distinct physicochemical properties related to their specific manufacturing technology, including HA concentration, cross-linking percentage, and particle size. These factors may determine treatment effectiveness, safety, and longevity; however, this requires confirmation in the clinic. Methods To compare the efficacy, safety, and longevity of two distinct HA-based dermal fillers in the correction of severe nasolabial folds (NLFs), a 24 mg/mL smooth gel (Juvederm ULTRA PLUS™ [JUP]) and a 20 mg/mL particulate gel (Perlane® [PER]) were injected in a total of 80 normal, healthy subjects using a split face design and were followed for 12 months in this prospective, randomized, controlled, multicenter study. Results Both fillers achieved a clinically relevant NLF correction (one point or more improvement, based on a validated NLF severity scale). However, JUP displayed greater longevity, with this correction maintained in a significantly larger percentage of NLFs after 6 months (physician’s evaluation) or 9 months (subject’s evaluation) and thereafter for the remainder of the study (70% vs 45%; P = 0.0002 and 62.5% vs 46.3%; P = 0.01 at month 12, based on physician and subject assessments, respectively). At month 12, 71.4% of the subjects nominated a preference for the NLF injected with JUP (P < 0.0001). Both treatments were well tolerated. Conclusion These results suggest that different physicochemical properties of HA-based fillers, associated with distinct manufacturing technologies, may influence treatment longevity in the correction of volume deficits. This may relate to a differential resistance to hyaluronidase and/or free radical degradation as previously documented in vitro. PMID:22253545

  20. A comparison of the efficacy, safety, and longevity of two different hyaluronic acid dermal fillers in the treatment of severe nasolabial folds: a multicenter, prospective, randomized, controlled, single-blind, within-subject study.

    PubMed

    Goodman, Greg J; Bekhor, Phillip; Rich, Michael; Rosen, Robert H; Halstead, Michael B; Rogers, John D

    2011-01-01

    Commercially available hyaluronic acid (HA)-based fillers have distinct physicochemical properties related to their specific manufacturing technology, including HA concentration, cross-linking percentage, and particle size. These factors may determine treatment effectiveness, safety, and longevity; however, this requires confirmation in the clinic. To compare the efficacy, safety, and longevity of two distinct HA-based dermal fillers in the correction of severe nasolabial folds (NLFs), a 24 mg/mL smooth gel (Juvederm ULTRA PLUS™ [JUP]) and a 20 mg/mL particulate gel (Perlane(®) [PER]) were injected in a total of 80 normal, healthy subjects using a split face design and were followed for 12 months in this prospective, randomized, controlled, multicenter study. Both fillers achieved a clinically relevant NLF correction (one point or more improvement, based on a validated NLF severity scale). However, JUP displayed greater longevity, with this correction maintained in a significantly larger percentage of NLFs after 6 months (physician's evaluation) or 9 months (subject's evaluation) and thereafter for the remainder of the study (70% vs 45%; P = 0.0002 and 62.5% vs 46.3%; P = 0.01 at month 12, based on physician and subject assessments, respectively). At month 12, 71.4% of the subjects nominated a preference for the NLF injected with JUP (P < 0.0001). Both treatments were well tolerated. These results suggest that different physicochemical properties of HA-based fillers, associated with distinct manufacturing technologies, may influence treatment longevity in the correction of volume deficits. This may relate to a differential resistance to hyaluronidase and/or free radical degradation as previously documented in vitro.

  1. A multicentre, randomized, single-blind, parallel-group study comparing the efficacy and tolerability of benzoyl peroxide 3%/clindamycin 1% with azelaic acid 20% in the topical treatment of mild-to-moderate acne vulgaris.

    PubMed

    Schaller, M; Sebastian, M; Ress, C; Seidel, D; Hennig, M

    2016-06-01

    Mild-to-moderate acne vulgaris is treated with a range of mono- and combination therapies; however, clinical evidence is still required to optimize treatment recommendations. To compare the efficacy, tolerability and safety of a combination of benzoyl peroxide 3% and clindamycin 1% (BPO + CLN) with azelaic acid 20% (AzA) for the topical treatment of mild-to-moderate acne vulgaris. This was a randomized, assessor-blinded, parallel-group, multicentre study conducted in Germany. Patients with a confirmed diagnosis of acne vulgaris, aged 12-45 years, were randomized 1 : 1 to once-daily BPO + CLN gel or twice-daily AzA cream for up to 12 weeks. The primary endpoint was the percentage change in inflammatory lesions from baseline at Week 4. Secondary endpoints included total and inflammatory lesion counts and tolerability assessments. For selected secondary endpoints, inductive statistical analysis was performed post hoc. Patient safety was assessed by adverse event (AE) monitoring. Efficacy was assessed in the modified intent-to-treat (mITT) population [patients using ≥1 dose of study medication (ITT), plus baseline and ≥1 post-baseline lesion count (n = 215)]. There was a statistically significant difference in the primary endpoint, with a median decrease of -52.6% for BPO + CLN (n = 107) vs.-38.8% for AzA (n = 108; P = 0.0004). There was also a greater difference in secondary lesion endpoints at Week 12, with a median decrease in inflammatory lesions of -78.8% and -65.3% and total lesions of -69.0% and -53.9% with BPO + CLN and AzA, respectively (both P < 0.0001). Tolerability was acceptable for both treatments. Overall, 55.6% (BPO + CLN) and 69.7% (AzA) of patients reported treatment-emergent AEs, and 15.7% and 35.8% of patients experienced application site reactions with BPO + CLN (24 events; 17 patients) and AzA (60 events; 39 patients) treatment, respectively (ITT population). BPO + CLN demonstrated greater efficacy than AzA in the treatment of mild

  2. A comparison of ketamine-midazolam and ketamine-propofol combinations used for sedation in the endobronchial ultrasound-guided transbronchial needle aspiration: a prospective, single-blind, randomized study

    PubMed Central

    Dal, Tülay; Sazak, Hilal; Şahin, Şaziye; Yılmaz, Aydın

    2014-01-01

    Objective We aimed to compare the effectiveness and safety of ketamine-midazolam and ketamine-propofol combinations for procedural sedation in endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Methods Sixty patients who were undergoing EBUS-TBNA were included in this study. Patients were randomly divided into two groups. Group 1 was given 0.25 mg/kg intravenous (iv) ketamine, 2 min later than 0.05 mg/kg iv midazolam. Group 2 received 0.125 mg/kg ketamine-propofol mixture (ketofol), 2 min subsequent to injection of 0.25 mg/kg each. Sedation was maintained with additional doses of ketamine 0.25 mg/kg, and ketofol 0.125 mg/kg each in Group 1 and Group 2, respectively. Blood pressure, heart rate (HR), peripheral oxygen saturation, respiratory rate (RR), Ramsay Sedation Score (RSS), and severity of cough were recorded prior to and after administration of sedation agent in the beginning of fiberoptic bronchoscopy (FOB) and every 5 min of the procedure. The consumption of the agents, the satisfactions of the bronchoscopist and the patients, and the recovery time were also recorded. Results HR in the 10th min and RSS value in the 35th min of induction in Group 1 were higher than the other group (P<0.05). The recovery time in Group 1 was statistically longer than Group 2 (P<0.05). There was no statistically significant difference between groups with respect to other parameters (P>0.05). Conclusions It was concluded that both ketamine-midazolam and ketamine-propofol combinations for sedation during EBUS-TBNA were similarly effective and safe without remarkable side effects. PMID:24976998

  3. A study of airline pilot morbidity.

    PubMed

    Sykes, Adrian J; Larsen, Peter D; Griffiths, Robin F; Aldington, Sarah

    2012-10-01

    It has long been believed that airline pilots are healthier than the general population. There are a number of reasons why this should be the case. However, there is very little evidence to support this belief as fact. This study investigates the health of the pilot population of an Oceanic based airline compared to the health of the general population. Pilots who conducted their medical certificate renewal at the airline's medical unit between 1 November 2009 and 31 October 2010 were included. A medical questionnaire was completed by each pilot at the time of their medical certificate renewal. Data from the questionnaire was entered into a database as well as the pilot's BMI, blood pressure, lipid profile, and blood glucose level. The comparison population was the population who completed the New Zealand Health Survey (NZHS) between 2006-2007. Demographic, lifestyle characteristics, and health status data from the pilots was compared to the NZHS using a Chi-squared test. Included in the study were 595 pilots. With respect to most medical conditions, pilots had a lower prevalence when compared to the general population. Pilots had a higher prevalence of kidney disease (3.3% vs 0.6%) and melanoma skin cancer (19 per 1000 vs 0.4 per 1000). This study suggests that pilots in New Zealand are healthier than the general population with respect to most medical conditions. The two medical conditions that were identified as being overrepresented in pilots may be the result of the occupational environment.

  4. Forskolin versus sodium cromoglycate for prevention of asthma attacks: a single-blinded clinical trial.

    PubMed

    González-Sánchez, R; Trujillo, X; Trujillo-Hernández, B; Vásquez, C; Huerta, M; Elizalde, A

    2006-01-01

    To determine the efficacy of forskolin in preventing asthma attacks, we performed a single-blinded clinical study in children and adult out-patients at a public hospital in Mexico. Forty patients of either sex with mild persistent or moderate persistent asthma were assigned randomly to 6 months of treatment with forskolin at 10 mg/day orally (capsules) or with two inhalations of sodium cromoglycate every 8 h, i.e. three times a day. The number of patients who had asthma attacks during the treatment period was significantly lower among those receiving forskolin (8/20, 40%) than among those receiving sodium cromoglycate (17/20, 85%). Values of forced expiratory volume in 1 s and forced expiratory flow, mid-phase, A similar in the two groups during the treatment period. We conclude that forskolin is more effective than sod cromoglycate in preventing asthma attacks in patients with mild persistent or moderate persistent asthma.

  5. Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study.

    PubMed

    Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

    2015-03-01

    The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV.

  6. 90% Compliance Pilot Studies Final Report

    SciTech Connect

    2013-06-01

    In early 2010, the U.S. Department of Energy (DOE) announced an opportunity for states to participate in energy code compliance evaluation pilot studies. DOE worked with five Regional Energy Efficiency Organizations (REEOs, formerly referred to as Energy Efficiency Partnerships, or EEPs) to fund pilot studies covering nine states. This report details conclusions stated in individual state reports, as well as conclusions drawn by DOE based on their oversight of the pilot studies, and based on discussions held with the REEOs and representatives from the pilot study states and their contractors.

  7. Classroom acoustics: Three pilot studies

    NASA Astrophysics Data System (ADS)

    Smaldino, Joseph J.

    2005-04-01

    This paper summarizes three related pilot projects designed to focus on the possible effects of classroom acoustics on fine auditory discrimination as it relates to language acquisition, especially English as a second language. The first study investigated the influence of improving the signal-to-noise ratio on the differentiation of English phonemes. The results showed better differentiation with better signal-to-noise ratio. The second studied speech perception in noise by young adults for whom English was a second language. The outcome indicated that the second language learners required a better signal-to-noise ratio to perform equally to the native language participants. The last study surveyed the acoustic conditions of preschool and day care classrooms, wherein first and second language learning occurs. The survey suggested an unfavorable acoustic environment for language learning.

  8. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial.

    PubMed

    Wu, Yung-Tsan; Ho, Tsung-Yen; Chou, Yu-Ching; Ke, Ming-Jen; Li, Tsung-Ying; Huang, Guo-Shu; Chen, Liang-Cheng

    2017-12-01

    Recently, a few small reports with short follow-up period have shown clinical benefits of platelet-rich plasma (PRP) for peripheral neuropathy including one pilot study and one small, non-randomized trial in patients with carpal tunnel syndrome (CTS). Therefore, we conducted a randomized, single-blind, controlled trial to assess the 6-month effect of PRP in patients with CTS. Sixty patients with unilateral mild-to-moderate CTS were randomized into two groups of 30, namely the PRP and control groups. In the PRP group, patients were injected with one dose of 3 mL of PRP using ultrasound guidance and the control group received a night splint through the study period. The primary outcome measure was the visual analog scale (VAS) and secondary outcome measures included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score, the cross-sectional area (CSA) of the median nerve (MN), electrophysiological findings of the MN, and finger pinch strength. The evaluation was performed before treatment and at 1, 3, and 6 months post-injection. The PRP group exhibited a significant reduction in the VAS score, BCTQ score, and CSA of MN compared to the those of control group 6 months post-treatment (p < 0.05). Our study demonstrates that PRP is a safe modality that effectively relieves pain and improves disability in the patients with CTS.

  9. Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: a multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction.

    PubMed

    Nyolczas, Noémi; Gyöngyösi, Mariann; Beran, Gilbert; Dettke, Markus; Graf, Senta; Sochor, Heinz; Christ, Günther; Edes, István; Balogh, László; Krause, Korff T; Jaquet, Kai; Kuck, Karl-Heinz; Benedek, Imre; Hintea, Theodora; Kiss, Róbert; Préda, István; Kotevski, Vladimir; Pejkov, Hristo; Dudek, Darius; Heba, Grzegorz; Sylven, Christer; Charwat, Silvia; Jacob, Ronaldo; Maurer, Gerald; Lang, Irene; Glogar, Dietmar

    2007-02-01

    Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery. The primary end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points relate to evaluation of (1) the safety and feasibility of the application modes, (2) the changes in left ventricular wall motion score index (transthoracic echocardiography), (3) myocardial voltage and segmental wall motion (NOGA mapping), (4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and (5) the clinical symptoms (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients. The Myocardial Stem Cell Administration After Acute Myocardial Infarction Trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.

  10. Adolescent Project Pilot for an Outcome Study.

    ERIC Educational Resources Information Center

    Louden, Jenifer H.; Kamara, Sheku G.

    This report describes a 7-week pilot study conducted to estimate probable participation rates for a planned substance abuse treatment outcomes study. The pilot program tested whether acceptable response rates might be obtained by contacting clients whose records had been examined by an earlier study (retrospective) or by contacting current clients…

  11. Efficacy and safety of Tinospora cordifolia lotion in Sarcoptes scabiei var hominis-infected pediatric patients: A single blind, randomized controlled trial

    PubMed Central

    Castillo, Agnes L.; Osi, Marina O.; Ramos, John Donnie A.; De Francia, Jean L.; Dujunco, Marylaine U.; Quilala, Peter F.

    2013-01-01

    Objective: To evaluate the clinical efficacy and safety of Tinospora cordifolia lotion including its cure rate and clearance time compared with permethrin lotion. Materials and Methods: A single blind, randomized, controlled, pilot clinical study was performed in three government institutions to investigate clinical efficacy of T. cordifolia lotion in sixty-six clinically-diagnosed scabies-infected patients. The patients were treated with T. cordifolia or permethrin lotions for three consecutive days for two weeks and clinical assessment of each patient was performed for five weeks. Results: T. cordifolia lotion and permethrin significantly reduced the mean global evaluation score after four weeks of treatment. The two lotions showed comparable effects as anti-scabies agent. Moreover, the clearance time (days) and cure rate using the two lotions did not differ. Clinical improvement, mean clearance time and cure rate of T. cordifolia lotion are comparable with permethrin. Conclusions: Tinospora cordifolia lotion exhibits anti-scabies activity comparable with permethrin. Its incorporation as therapeutic reagent in Sarcoptes scabiei infections is highly recommended. PMID:23662023

  12. Cerebellar transcranial direct current stimulation in children with ataxic cerebral palsy: A sham-controlled, crossover, pilot study.

    PubMed

    Grecco, Luanda André Collange; Oliveira, Claudia Santos; Duarte, Natália de Almeida Carvalho; Lima, Vânia L C Carvalho; Zanon, Nelci; Fregni, Felipe

    2017-04-01

    The aim of the present study was to analyze the use of anodal tDCS of the cerebellar region combined with treadmill training to improve balance and functional performance in children with ataxic cerebral palsy. Single-blind, sham-controlled, crossover, pilot study. Rehabilitation center and research motion analysis laboratory. Children (N = 6) with ataxic cerebral palsy and balance deficit. Static balance (oscillations of the center of pressure), functional balance (Pediatric Balance Scale) and functional performance (Pediatric Evaluation of Disability Inventory) were evaluated. Significant reductions occurred in oscillations of the center of pressure with eyes closed after active anodal tDCS only. The effects of treadmill training on functional balance and functional performance in mobility were maintained in the active tDCS group only. These preliminary data support the notion that anodal tDCS of the cerebellar region combined with treadmill training improves balance in children with ataxic cerebral palsy.

  13. Postural control and shoulder steadiness in F-16 pilots: a randomized controlled study.

    PubMed

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S; Toft, Palle; Jørgensen, Marie B; Søgaard, Karen; Sjøgaard, Gisela

    2014-04-01

    During maneuvering, fighter pilots experience loads of up to 50-70 kg on their necks. Neck disorders are common and have been linked to impairment in muscle control. We conducted an intervention study introducing targeted training for 24 wk that reduced neck pain. The current study reports the results of the secondary objective, which was to increase the understanding of possible mechanisms underlying such neck pain and its intervention-related relief. In a parallel, single-blinded, randomized controlled study, 55 F-16 pilots were evaluated at baseline and randomized to a control group (CG; N = 28) or training group (TG; N = 27). Postural control was tested in four different settings: Romberg with open and closed eyes, unilateral stance, and perturbation. Maximal voluntary contraction and force steadiness was measured for shoulder elevation. At follow-up, there was a significant between-group difference in the Romberg test with closed eyes only (95% confidence ellipse area; CG: 761 +/- 311 mm2; TG: 650 +/- 405 mm2). Prior to randomization, there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within the previous 3 mo and 25 pilots without such pain. Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity, and there may be a ceiling effect in the ability to improve these parameters. For individuals with highly developed physiological capacity, a battery of tests with more stringent demands should be considered, e.g., increased number of repetitions, prolonged duration of the tests, or testing with eyes closed.

  14. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial.

    PubMed

    Maguire, Clare; Sieben, Judith M; Erzer, Florian; Goepfert, Beat; Frank, Matthias; Ferber, Georg; Jehn, Melissa; Schmidt-Trucksäss, Arno; de Bie, Robert A

    2012-03-30

    Annually, some 9000 people in Switzerland suffer a first time stroke. Of these 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise activity of the hemiplegic side increase ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" (a corset with elasticated strapping) significantly increases hemiplegic muscle activity during gait. The aim of the present study is to investigate the long term effects on the recovery of gait, balance and social participation of gait rehabilitation with TheraTogs compared to gait rehabilitation with a cane following first time acute stroke. Multi-centre, single blind, randomised trial with 120 patients after first stroke. When subjects have reached Functional Ambulation Category 3 they will be randomly allocated into TheraTogs or cane group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardised procedure. Cane walking held at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with only the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented. The intervention will continue for five weeks or until patients have reached Functional Ambulation category 5. Outcome measures will be assessed the day before begin of intervention, the day after completion, 3 months, 6 months and 2 years. Timed "up and go" test, secondary outcomes: peak surface EMG of gluteus maximus and gluteus medius, activation patterns of hemiplegic leg musculature, temporo-spatial gait parameters, hemiplegic hip kinematics in the frontal and sagittal planes, dynamic balance, daily activity measured by accelerometry, Stroke Impact Scale. Significance levels will be 5% with 95% CI's. IntentionToTreat analyses will be

  15. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial

    PubMed Central

    2012-01-01

    Background Annually, some 9000 people in Switzerland suffer a first time stroke. Of these 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise activity of the hemiplegic side increase ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" (a corset with elasticated strapping) significantly increases hemiplegic muscle activity during gait. The aim of the present study is to investigate the long term effects on the recovery of gait, balance and social participation of gait rehabilitation with TheraTogs compared to gait rehabilitation with a cane following first time acute stroke. Methods/Design Multi-centre, single blind, randomised trial with 120 patients after first stroke. When subjects have reached Functional Ambulation Category 3 they will be randomly allocated into TheraTogs or cane group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardised procedure. Cane walking held at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with only the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented. The intervention will continue for five weeks or until patients have reached Functional Ambulation category 5. Outcome measures will be assessed the day before begin of intervention, the day after completion, 3 months, 6 months and 2 years. Primary outcome: Timed "up and go" test, secondary outcomes: peak surface EMG of gluteus maximus and gluteus medius, activation patterns of hemiplegic leg musculature, temporo-spatial gait parameters, hemiplegic hip kinematics in the frontal and sagittal planes, dynamic balance, daily activity measured by accelerometry, Stroke Impact Scale. Significance levels will be 5% with 95

  16. Effects of closed-loop stimulation vs. DDD pacing on haemodynamic variations and occurrence of syncope induced by head-up tilt test in older patients with refrac\\tory cardioinhibitory vasovagal syncope: the Tilt test-Induced REsponse in Closed-loop Stimulation multicentre, prospective, single blind, randomized study.

    PubMed

    Palmisano, Pietro; Dell'Era, Gabriele; Russo, Vincenzo; Zaccaria, Maria; Mangia, Rolando; Bortnik, Miriam; De Vecchi, Federica; Giubertoni, Ailia; Patti, Fabiana; Magnani, Andrea; Nigro, Gerardo; Rago, Anna; Occhetta, Eraldo; Accogli, Michele

    2017-04-12

    Closed-loop stimulation (CLS) seemed promising in preventing the recurrence of vasovagal syncope (VVS) in patients with a cardioinhibitory response to head-up tilt test (HUTT) compared with conventional pacing. We hypothesized that the better results of this algorithm are due to its quick reaction in high-rate pacing delivered in the early phase of vasovagal reflex, which increase the cardiac output and the blood pressure preventing loss of consciousness. This prospective, randomized, single-blind, multicentre study was designed as an intra-patient comparison and enrolled 30 patients (age 62.2 ± 13.5 years, males 60.0%) with cardioinhibitory VVS, carrying a dual-chamber pacemaker incorporating CLS algorithm. Two HUTTs were performed one week apart: one during DDD-CLS 60-130/min pacing and the other during DDD 60/min pacing; patients were randomly and blindly assigned to two groups: in one the first HUTT was performed in DDD-CLS (n = 15), in the other in DDD (n = 15). Occurrence of syncope and haemodynamic variations induced by HUTT was recorded during the tests. Compared with DDD, DDD-CLS significantly reduced the occurrence of syncope induced by HUTT (30.0% vs. 76.7%; P < 0.001). In the patients who had syncope in both DDD and DDD-CLS mode, DDD-CLS significantly delayed the onset of syncope during HUTT (from 20.8 ± 3.9 to 24.8 ± 0.9 min; P = 0.032). The maximum fall in systolic blood pressure recorded during HUTT was significantly lower in DDD-CLS compared with DDD (43.2 ± 30.3 vs. 65.1 ± 25.8 mmHg; P = 0.004). In patients with cardioinhibitory VVS, CLS reduces the occurrence of syncope induced by HUTT, compared with DDD pacing. When CLS is not able to abort the vasovagal reflex, it seems to delay the onset of syncope.

  17. Forskolin compared with beclomethasone for prevention of asthma attacks: a single-blind clinical trial.

    PubMed

    Huerta, M; Urzúa, Z; Trujillo, X; González-Sánchez, R; Trujillo-Hernández, B

    2010-01-01

    This single-blind study compared the efficacy of oral forskolin versus inhaled beclomethasone for mild or moderately persistent adult asthma. Patients were randomly assigned to receive forskolin (one 10-mg capsule orally per day; n = 30) or beclomethasone (two 50 microg inhalations every 12 h; n = 30) for 2 months. No statistically significant improvement occurred in any lung function parameter in the forskolin-treated patients. Subjects in the beclomethasone-treated group presented a slight but statistically significant improvement in percentage forced expiratory volume in 1 s (FEV(1)), percentage forced expiratory flow in the middle (25 - 75%) expiratory phase (FEF(25 - 75%)) and percentage forced vital capacity (FVC) after 2 months of treatment, though the improvement in absolute values for FEV(1), FEF(25 - 75%), FVC and FEV(1):FVC did not reach statistical significance. There was no statistically significant difference between the forskolin and beclomethasone treatment groups for any lung function parameter at baseline or after treatment. None of the beclomethasone-treated patients had an asthma attack and one forskolin-treated patient had a mild asthma attack during the 2-month study period. More studies are needed in adult asthma patients to confirm whether forskolin may be a useful preventive treatment for mild or moderately persistent adult asthma.

  18. A single-blind trial of reflexology for irritable bowel syndrome.

    PubMed Central

    Tovey, Philip

    2002-01-01

    BACKGROUND: Irritable bowel syndrome (IBS) is a significant problem for primary care, as treatment options are limited and it can frequently develop into a chronic condition. Complementary and alternative medicine, including reflexology, is being turned to increasingly in an attempt to manage symptoms. There are currently no studies which address the effectiveness of reflexology for IBS. Despite this, it continues to be advocated and used. AIM: To provide the first evidence on the effectiveness of reflexology in the management of the core defining symptoms of IBS. DESIGN OF STUDY: A single-blind trial carried out in primary care settings. SETTING: Thirty-four participants diagnosed with IBS on the basis of the Rome Criteria. METHOD: Participants were allocated to receive either a reflexology foot massage or a non-reflexology foot massage control group. RESULTS: On none of the three symptoms monitored--abdominal pain, constipation/diarrhoea, and abdominal distention--was there a statistically or clinically significant difference between reflexology and control groups. CONCLUSION: On the basis of these results there is nothing to suggest that reflexology produces any specific benefit for patients with IBS. There is currently no evidence to support its use. However this was one (relatively) small scale study; further research that, for example, assesses the impact of therapist (professional and lay) versus therapy, is still needed. PMID:11791811

  19. BIMOMASS GASIFICATION PILOT PLANT STUDY

    EPA Science Inventory

    The report gives results of a gasification pilot program using two biomass feedstocks: bagasse pellets and wood chips. he object of the program was to determine the properties of biomass product gas and its suitability as a fuel for gas-turbine-based power generation cycles. he f...

  20. BIMOMASS GASIFICATION PILOT PLANT STUDY

    EPA Science Inventory

    The report gives results of a gasification pilot program using two biomass feedstocks: bagasse pellets and wood chips. he object of the program was to determine the properties of biomass product gas and its suitability as a fuel for gas-turbine-based power generation cycles. he f...

  1. Effect of rhubarb (Rheum emodi) in primary dysmenorrhoea: a single-blind randomized controlled trial.

    PubMed

    Rehman, Hina; Begum, Wajeeha; Anjum, Farzana; Tabasum, Humyra; Zahid, Shabnam

    2015-03-01

    The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea. A randomized, single-blind, standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles. Experimental group (n=30) received capsules of R. emodi powder two times a day, two days before the expected date of menstruation, and continued first three days of menstruation, while control group (n=15) participants received mefenamic acid capsules three times a day on the same protocol. The primary outcome measures were reduced in severity and duration of pain, assessed by visual analogue scale (VAS) and verbal multidimensional scoring system (VMSS), and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life (QOL). Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test. The menstrual pain was significantly decreased in both groups after three-cycle intervention. Significant changes were observed in VAS (p<0.001) and VMSS (p<0.001) in the experimental group. There is a significant (p<0.001) reduction in duration of pain in both the groups. Associated symptoms and QOL were markedly improved after treatment (p<0.001). It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea. It can serve as an alternative treatment without any apparent side effects. These results deserve further investigations.

  2. Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial.

    PubMed

    Chaibi, Aleksander; Knackstedt, Heidi; Tuchin, Peter J; Russell, Michael Bjørn

    2017-07-24

    Cervicogenic headache is a disabling headache where pharmacological management have limited effect. Thus, non-pharmacological management is warranted. Our objective was therefore to investigate the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continued usual but non-manual management) for cervicogenic headache in a prospective 3-armed single-blinded, placebo, randomized controlled trial of 17 months' duration. Nineteen participants were equally randomized into the three groups, and 12 participants completed the randomized controlled trial. Headache frequency improved at all time points in the chiropractic spinal manipulative therapy and the placebo group. Headache index improved in the chiropractic spinal manipulative therapy group at all time points, while it improved at 6 and 12 months' follow-up in the placebo group. The control group remained unchanged during the whole study period. Adverse events were few, mild and transient. Blinding was concealed throughout the RCT. Thus, our results suggest that manual-therapy might be a safe treatment option for participants with cervicogenic headache, but data need to be confirmed in a randomized controlled trial with sufficient sample size and statistical power. Trial registration ClinicalTrials.gov identifier: NCT01687881, 11 September 2012.

  3. Effects of a fish oil enriched diet on aspirin intolerant asthmatic patients: a pilot study.

    PubMed

    Picado, C; Castillo, J A; Schinca, N; Pujades, M; Ordinas, A; Coronas, A; Agusti-Vidal, A

    1988-02-01

    The effect of a fish oil enriched diet containing about 3 g of eicosapentaenoic acid was studied in 10 patients with aspirin intolerant asthma. Subjects were studied during six weeks on a control diet followed by six weeks on the fish oil diet in a single blind study design. They were asked to record their peak expiratory flow (PEF) twice daily, bronchodilator and steroid doses, and subjective ratings of pulmonary symptoms on diary cards. There were no significant changes in symptom scores over the six weeks of either the control diet or the fish oil diet. PEF values, however, were significantly lower during the fifth and sixth week of the fish oil diet than during the control diet (308 v 262 l/min week 5 and 306 v 256 l/min week 6). Bronchodilator usage was also greater during the fifth and sixth week of the fish oil diet than during the control period (12.0 v 7.4 and 13.0 v 7.4 puffs a day in weeks 5 and 6). This pilot study suggests that fish diets may have a deleterious effect on patients with aspirin intolerant asthma.

  4. Distance education and diabetes empowerment: A single-blind randomized control trial.

    PubMed

    Zamanzadeh, Vahid; Zirak, Mohammad; Hemmati Maslakpak, Masomeh; Parizad, Naser

    2016-12-21

    Diabetes is one of the biggest problems in healthcare systems and kills many people every year. Diabetes management is impossible when only utilizing medication. So, patients must be educated to manage their diabetes. This study aims to assess the effect of education by telephone and short message service on empowering patients with type 2 diabetes (primary outcome). A single-blind randomized controlled trial was conducted in the Urmia diabetes association in Iran. Sixty six participants with definitive diagnosis of type 2 diabetes entered into the study. Patients with secondary health problems were excluded. Patients were selected by simple random sampling then allocated into intervention (n=33) and control (n=33) groups. The intervention group received an educational text message daily and instructive phone calls three days a week for three months along with usual care. The Diabetes Empowerment Scale (DES) with confirmed validity and reliability was used for collecting data. Data was analyzed using SPSS V6.1. Independent t-test, paired t-test and chi-square were used to analyze the data. The empowerment of the intervention group compared with the control group significantly improved after three months of distance education (p<0.00, EF=1. 16). The study findings show that the distance education has a significant effect on empowering patients with type 2 diabetes. Therefore, using distance education along with other diabetes management intervention is highly effective and should be part of the care in diabetes treatment. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  5. Microcurrent application as analgesic treatment in venous ulcers: a pilot study.

    PubMed

    Korelo, Raciele Ivandra Guarda; Valderramas, Silvia; Ternoski, Bruno; Medeiros, Danilo Sanches; Andres, Letícia Fernandes; Adolph, Sandra Mara Meireles

    2012-01-01

    This study aimed to evaluate the effect of microcurrent electrical stimulation on pain and area of venous ulcers. In a pilot study for a single-blind controlled clinical trial, carried out at an outpatient clinic during four weeks, 14 subjects with venous ulcers (mean age 62±9 years) were divided in two groups: microcurrent (n=8) and control group (n=6). Pain (by Visual Analogue Scale) and the ulcer area were measured by planimetry. There was a significant difference between the two groups with respect to pain (microcurrent group from 8.5 (6.5-9.75) to 3.5 (1-4.75) and control group from 7.5 (5.75-10) to 8.5 (5.5-10), p<0.01). Non-significant changes were found with respect to ulcer area (planimetry by graph paper, p=0.41 and by Image J, p=0.41). In conclusion, the application of microcurrent improves the pain of patients with venous ulcers (ClinicalTrials.gov: NCT01372020).

  6. Mutans streptococci in xerostomic cancer patients after pilocarpine therapy: a pilot study.

    PubMed

    Chambers, Mark S; Keene, Harris J; Toth, Béla B; Lemon, James C; Gallagher, Susan C; Martin, Charles G; Martin, Jack W

    2005-02-01

    Opiod- and/or radiation-induced xerostomia in cancer patients is frequently associated with elevated levels of cariogenic mutans streptococci (MS). In a single-center, single blind 8-week clinical trial at The University of Texas M. D. Anderson Cancer Center, and from an initial sample of 32 patients, we evaluated MS counts in 28 cancer patients receiving chronic analgesic treatment for cancer pain. All patients received escalating doses of pilocarpine (Salagen) tablets, either 2.5 mg to 5 mg or 5 mg to 7.5 mg qid for 6 weeks, followed by placebo qid for a 2-week washout period. Whole resting saliva flow rates (g/5 min) and MS counts were evaluated at pretreatment, 3 weeks, 6 weeks, and 8 weeks. MS samples were obtained by 5-mL saline rinse (15 sec) at each visit prior to sialometry. In 19 patients (59%), MS counts exceeded 10(5) CFU/mL. At the end of the 6-week trial, 96% of patients showed a positive response to pilocarpine following a 30-minute postdosing evaluation (P=.001). MS counts were lower in 17 patients, higher in 6 patients, and nondetectable before and after pilocarpine in 5 patients (P=.03). The reduced MS counts associated with improved saliva flow rates following pilocarpine therapy in this short-term pilot study are encouraging, but further investigation in a larger group of patients over a longer study period is indicated.

  7. Histological Mohs Maps Improve the Accuracy of Dermatology Residents' Interpretations of Mohs Slides: A Pilot Study.

    PubMed

    Tiger, Jeffrey B; Ganesh, Zai; Mouzakis, John; Iwamoto, Satori

    2017-08-01

    Effective Mohs surgery depends on accurate histopathological identification and mapping of tumor burden to ensure complete removal of tumor. The purpose of this study is to evaluate whether using a photograph of the histopathological slide as the Mohs map improves mapping accuracy. Single-blinded pilot study. Five dermatology residents at one academic institution mapped 11 cases of basal cell carcinoma using both traditional hand-drawn maps and color photographic maps. Residents' marked maps were assessed for global diagnostic accuracy, sensitivity, and specificity compared with the Mohs map verified by the attending surgeon on the day of surgery. Diagnostic accuracy, sensitivity, and specificity were higher using the photographic Mohs maps compared with using the traditional hand-drawn maps (58.2% vs 29.1%, 84.5% vs 76.4%, and 87.1% vs 70.8%, respectively). These results were statistically significant for accuracy and specificity, but not for sensitivity. Using histopathological photographs as the Mohs map significantly improved accuracy and specificity within a small group of residents with limited Mohs experience. More research is warranted to evaluate whether using histopathological photographs improves accuracy of Mohs mapping for experienced Mohs surgeons in a real-world setting, and whether this translates to improved clinical outcomes.

  8. Effects of electroacupuncture on overactive bladder refractory to anticholinergics: a single-blind randomised controlled trial.

    PubMed

    Zhang, Jie; Cheng, Wei; Cai, Mingming

    2015-10-01

    To investigate the clinical effects and safety of electroacupuncture (EA) in the treatment of overactive bladder (OAB) refractory to first-line anticholinergic treatment. Women diagnosed with OAB who were refractory to first-line anticholinergic treatment were referred for EA therapy. 50 women enrolled in this single-blind randomised controlled trial and were randomised 1:1 to EA or sham EA (SEA). The EA and SEA groups were treated with 30 sessions (5 sessions a week for 6 weeks), and each session lasted 30 min. OAB symptom scores (OABSS), King's Health Questionnaire scores (KHQ) and urodynamic parameters were used to assess treatment effects. Safety was also evaluated. 45 women completed all aspects of the study (23 in the EA group and 22 in the SEA group). The OABSS and KHQ showed statistically significant improvements in the EA group compared with the SEA group after 6 weeks of treatment (p<0.05). There were no statistical differences in the maximum flow rate and postvoid residual (p>0.05), but there were statistical improvements in the first sensation of bladder filling, first urge to void and maximum cystometric capacity (p<0.05) in the EA group compared with the SEA group. No serious adverse events occurred in either group. EA appears to be an effective, safe and minimally invasive treatment for women with OAB. Further studies with longer follow-up are needed to evaluate whether it could be a therapeutic option for OAB refractory to treatment with anticholinergics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  9. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial.

    PubMed

    Goudakos, John K; Markou, Konstantinos D; Psillas, George; Vital, Victor; Tsaligopoulos, Miltiadis

    2014-05-01

    IMPORTANCE The management of patients with unilateral acute vestibular neuritis (VN) has not been established to date. OBJECTIVE To compare the use of vestibular exercises vs corticosteroid therapy in the recovery of patients with acute VN. DESIGN, SETTING, AND PARTICIPANTS Prospective, single-blind, randomized clinical trial at a primary referral center. Among all patients with acute vertigo, those having VN were eligible for inclusion in the study. INTERVENTIONS Forty patients with acute VN were randomly assigned to perform vestibular exercises or to receive corticosteroid therapy. After a baseline examination, follow-up evaluations were performed at 1, 6, and 12 months. MAIN OUTCOMES AND MEASURES Efficacy outcomes included clinical, canal, and otolith recovery. Scores on the European Evaluation of Vertigo Scale and the Dizziness Handicap Inventory were used for the evaluation of clinical recovery. Findings of caloric irrigation and vestibular evoked myogenic potentials indicated canal and otolith improvement, respectively. RESULTS Comparing the 2 treatment groups, no statistically significant differences were found in clinical, canal, or otolith recovery. At the 6-month examination, the number of patients with complete disease resolution in the corticosteroids group was significantly higher than that in the vestibular exercises group. However, at the end of the follow-up period, 45%(9 of 20) of patients in the vestibular exercises group and 50% (10 of 20) of patients in the corticosteroids group had complete disease resolution (P > .05). CONCLUSIONS AND RELEVANCE Treating patients who have acute VN with vestibular exercises seems equivalently effective as treating them with corticosteroid therapy in clinical, caloric, and otolith recovery. Corticosteroid therapy seems to enhance earlier complete acute VN resolution, with no added benefit in the long-term prognosis.

  10. Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study.

    PubMed

    Maggiani, Alberto; Tremolizzo, Lucio; Della Valentina, Andrea; Mapelli, Laurent; Sosio, Silvia; Milano, Valeria; Bianchi, Manuel; Badi, Francesco; Lavazza, Carolina; Grandini, Marco; Corna, Giovanni; Prometti, Paola; Lunetta, Christian; Riva, Nilo; Ferri, Alessandra; Lanfranconi, Francesca

    2016-01-01

    Current interventions in amyotrophic lateral sclerosis (ALS) are focused on supporting quality of life (QoL) and easing pain with a multidisciplinary approach. Primary aim of this pilot work assessed feasibility, safety, tolerability and satisfaction of osteopathic manual treatment (OMT) in 14 ALS outpatients. Patients were randomized according to an initial single-blind design (12 weeks, T0-T1), in order to receive OMT (weekly for 4 weeks, and fortnightly for the following 8 weeks) versus usual-care (n=7 each group), followed by an OMT open period (T1-T2, once a week for 8 weeks, n=10). Secondary aims included blind osteopathic assessment of somatic dysfunctions (SD) for goal attainment scale (GAS) calculation, Brief Pain Inventory-short form and McGill QoL-16 items. OMT was demonstrated feasible and safe and patients displayed high satisfaction (T1-VAS=8.34 ± 0.46; T2-VAS=8.52 ± 0.60). Considering secondary aims no significant differences emerged. Finally, at study entry (T0), a cervico-dorsal SD was found in 78% of ALS patients versus 28% of healthy matched controls (p<0.01). OMT was found feasible, safe and satisfactory in ALS. The lack of secondary aim differences can be due to the limited sample size. OMT could be an interesting option to explore in ALS.

  11. Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study

    PubMed Central

    Maggiani, Alberto; Tremolizzo, Lucio; Valentina, Andrea Della; Mapelli, Laurent; Sosio, Silvia; Milano, Valeria; Bianchi, Manuel; Badi, Francesco; Lavazza, Carolina; Grandini, Marco; Corna, Giovanni; Prometti, Paola; Lunetta, Christian; Riva, Nilo; Ferri, Alessandra; Lanfranconi, Francesca

    2016-01-01

    Background: Current interventions in amyotrophic lateral sclerosis (ALS) are focused on supporting quality of life (QoL) and easing pain with a multidisciplinary approach. Objective: Primary aim of this pilot work assessed feasibility, safety, tolerability and satisfaction of osteopathic manual treatment (OMT) in 14 ALS outpatients. Methods: Patients were randomized according to an initial single-blind design (12 weeks, T0-T1), in order to receive OMT (weekly for 4 weeks, and fortnightly for the following 8 weeks) versus usual-care (n=7 each group), followed by an OMT open period (T1-T2, once a week for 8 weeks, n=10). Secondary aims included blind osteopathic assessment of somatic dysfunctions (SD) for goal attainment scale (GAS) calculation, Brief Pain Inventory-short form and McGill QoL-16 items. Results: OMT was demonstrated feasible and safe and patients displayed high satisfaction (T1-VAS=8.34 ± 0.46; T2-VAS=8.52 ± 0.60). Considering secondary aims no significant differences emerged. Finally, at study entry (T0), a cervico-dorsal SD was found in 78% of ALS patients versus 28% of healthy matched controls (p<0.01). Conclusion: OMT was found feasible, safe and satisfactory in ALS. The lack of secondary aim differences can be due to the limited sample size. OMT could be an interesting option to explore in ALS. PMID:27651843

  12. PILOT STUDY: THE TAMPA ASTHMATIC CHILDREN'S STUDY (TACS)

    EPA Science Inventory

    The Tampa Asthmatic Children's Study (TACS) was a pilot research study that focused on developing and evaluating air pollution exposure assessment methods and participant recruiting tools for children in the age range of 1-5 years old. The pilot study focused on (a) simple, cost-...

  13. Microbial field pilot study. Final report

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m{sup 3}) of tertiary oil have been recovered. Microbial activity has increased CO{sub 2} content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  14. Human Challenge Pilot Study with Cyclospora cayetanensis

    PubMed Central

    Eberhard, Mark L.; Seed, John R.; Weber, David J.; Won, Kimberly Y.; Nace, Eva K.; Moe, Christine L.

    2004-01-01

    We describe a pilot study that attempted to infect human volunteers with Cyclospora cayetanensis. Seven healthy volunteers ingested an inoculum of Cyclospora oocysts (approximately 200–49,000 oocysts). The volunteers did not experience symptoms of gastroenteritis, and no oocysts were detected in any stool samples during the 16 weeks volunteers were monitored. PMID:15200870

  15. A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis

    PubMed Central

    2013-01-01

    Background Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study’s primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. Methods/Design A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, twomonths post treatment, and six monthspost treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. Discussion The results from the post

  16. Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial.

    PubMed

    Mennini, Maurizio; Tolone, Carlo; Frassanito, Antonella; Midulla, Fabio; Cucchiara, Salvatore; Aloi, Marina

    2017-04-01

    Oral rehydration therapy is the recommended treatment for acute childhood gastroenteritis. The aim of this study was to assess the efficacy and safety of gelatin tannate plus oral rehydration compared with oral rehydration alone. We conducted a multicenter, parallel, randomized, controlled, single-blind, prospective, open-label trial. A central randomization center used computer generated tables to allocate treatments. The study was performed in two medical centers in Italy. Sixty patients 3-72 months of age with acute gastroenteritis were recruited (median age 18 months; age range 3-66 months): 29 received an oral rehydration solution (ORS) and 31 an ORS plus gelatin tannate (ORS + G). The primary outcome was the number of bowel movements 48 and 72 h after initiating treatment. Secondary outcomes were: duration of diarrhea, stool characteristics and adverse events. No patient was lost at follow-up. No significant difference in the number of bowel movements after 48 h was reported (2.7 ± 1.3 ORS + G; 3.2 ± 0.8 ORS; p = 0.06), although the ORS + G group showed a significant improvement in stool consistency (3.7 ± 1.0 vs. 4.3 ± 0.8; p = 0.005). At 72 h, a significant reduction in bowel movements was reported in the ORS + G group compared with the ORS group (1.0 ± 1.4 vs. 2.0 ± 1.7; p = 0.01). Mean duration of diarrhea was significantly lower in the ORS + G group than in the ORS only group (76.8 ± 19.2 vs. 108 ± 24.0 h; p < 0.0001). No adverse events were reported. Gelatin tannate added to oral rehydration in children with acute diarrhea was associated with a significant decrease in bowel movements at 72 h, with an early improvement in the stool consistency and shorter disease duration. NCT02644200-Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis ( https://www.clinicaltrials.gov ).

  17. Image processing of angiograms: A pilot study

    NASA Technical Reports Server (NTRS)

    Larsen, L. E.; Evans, R. A.; Roehm, J. O., Jr.

    1974-01-01

    The technology transfer application this report describes is the result of a pilot study of image-processing methods applied to the image enhancement, coding, and analysis of arteriograms. Angiography is a subspecialty of radiology that employs the introduction of media with high X-ray absorption into arteries in order to study vessel pathology as well as to infer disease of the organs supplied by the vessel in question.

  18. Seaside, Oregon, Tsunami Vulnerability Assessment Pilot Study

    NASA Astrophysics Data System (ADS)

    Dunbar, P. K.; Dominey-Howes, D.; Varner, J.

    2006-12-01

    The results of a pilot study to assess the risk from tsunamis for the Seaside-Gearhart, Oregon region will be presented. To determine the risk from tsunamis, it is first necessary to establish the hazard or probability that a tsunami of a particular magnitude will occur within a certain period of time. Tsunami inundation maps that provide 100-year and 500-year probabilistic tsunami wave height contours for the Seaside-Gearhart, Oregon, region were developed as part of an interagency Tsunami Pilot Study(1). These maps provided the probability of the tsunami hazard. The next step in determining risk is to determine the vulnerability or degree of loss resulting from the occurrence of tsunamis due to exposure and fragility. The tsunami vulnerability assessment methodology used in this study was developed by M. Papathoma and others(2). This model incorporates multiple factors (e.g. parameters related to the natural and built environments and socio-demographics) that contribute to tsunami vulnerability. Data provided with FEMA's HAZUS loss estimation software and Clatsop County, Oregon, tax assessment data were used as input to the model. The results, presented within a geographic information system, reveal the percentage of buildings in need of reinforcement and the population density in different inundation depth zones. These results can be used for tsunami mitigation, local planning, and for determining post-tsunami disaster response by emergency services. (1)Tsunami Pilot Study Working Group, Seaside, Oregon Tsunami Pilot Study--Modernization of FEMA Flood Hazard Maps, Joint NOAA/USGS/FEMA Special Report, U.S. National Oceanic and Atmospheric Administration, U.S. Geological Survey, U.S. Federal Emergency Management Agency, 2006, Final Draft. (2)Papathoma, M., D. Dominey-Howes, D.,Y. Zong, D. Smith, Assessing Tsunami Vulnerability, an example from Herakleio, Crete, Natural Hazards and Earth System Sciences, Vol. 3, 2003, p. 377-389.

  19. Breakthrough Listen on MWA Pilot Study

    NASA Astrophysics Data System (ADS)

    Croft, S.; Siemion, A.; Kaplan, D. L.; Tremblay, S.

    2016-07-01

    We propose a pilot study, using the Voltage Capture System, for Breakthrough Listen on the MWA. Breakthrough Listen (BL) is a major new project that aims to dramatically improve the coverage of parameter space in the search for intelligent life beyond Earth. BL has already deployed hardware and software to the Green Bank Telescope, and will bring a similar program with the Parkes Telescope online in the second half of 2016. The low frequency sky is however currently very poorly explored. The superb capabilities of the MWA (large field of view, low frequency of operation, and location in a very radio quiet site) provide a unique opportunity for a pilot study to obtain voltage data for a SETI (Search For Extraterrestrial Intelligence) study of the Galactic Plane. We propose commensal observations, piggybacking on the proposed pulsar search of Tremblay et al. Using existing VCS software, combined with the pipeline developed for Breakthrough Listen at GBT and Parkes, we will perform a blind search for candidate signals from extraterrestrial intelligence. Although the chances of a detection are not large, particularly for a pilot study such as that proposed here, the Breakthrough Listen team plan to perform extensive testing and analysis on the data obtained which should be useful for other users of the MWA VCS. We will make the secondary SETI data products and associated documentation available as a resource to the community via the Breakthrough Listen online archive.

  20. The Role and Interpretation of Pilot Studies in Clinical Research

    PubMed Central

    Leon, Andrew C.; Davis, Lori L.; Kraemer, Helena C.

    2010-01-01

    Pilot studies represent a fundamental phase of the research process. The purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to be used in a larger scale study. The roles and limitations of pilot studies are described here using a clinical trial as an example. A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and implementation of the novel intervention. A pilot study is not a hypothesis testing study. Safety, efficacy and effectiveness are not evaluated in a pilot. Contrary to tradition, a pilot study does not provide a meaningful effect size estimate for planning subsequent studies due to the imprecision inherent in data from small samples. Feasibility results do not necessarily generalize beyond the inclusion and exclusion criteria of the pilot design. A pilot study is a requisite initial step in exploring a novel intervention or an innovative application of an intervention. Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study. Investigators should be forthright in stating these objectives of a pilot study. Grant reviewers and other stakeholders should expect no more. PMID:21035130

  1. USGS Tampa Bay Pilot Study

    USGS Publications Warehouse

    Yates, K.K.; Cronin, T. M.; Crane, M.; Hansen, M.; Nayeghandi, A.; Swarzenski, P.; Edgar, T.; Brooks, G.R.; Suthard, B.; Hine, A.; Locker, S.; Willard, D.A.; Hastings, D.; Flower, B.; Hollander, D.; Larson, R.A.; Smith, K.

    2007-01-01

    Providing a web-based digital information management system of information for scientists and the public, including a system that supports the work of those officials who must make decisions that affect the state of the bay. The Tampa Bay Study is in its sixth year and will continue through September 2007. This paper presents a non-inclusive summary of key findings associated with the six primary project components listed above. Component 4 (above) is described in detail in the following chapter 13. More information on the Tampa Bay Study is available from our on-line digital information system for the Tampa Bay Study at http://gulfsci.usgs.gov.

  2. Centrifuge Study of Pilot Tolerance to Acceleration and the Effects of Acceleration on Pilot Performance

    NASA Technical Reports Server (NTRS)

    Creer, Brent Y.; Smedal, Harald A.; Wingrove, Rodney C.

    1960-01-01

    A research program the general objective of which was to measure the effects of various sustained accelerations on the control performance of pilots, was carried out on the Aviation Medical Acceleration Laboratory centrifuge, U.S. Naval Air Development Center, Johnsville, PA. The experimental setup consisted of a flight simulator with the centrifuge in the control loop. The pilot performed his control tasks while being subjected to acceleration fields such as might be encountered by a forward-facing pilot flying an atmosphere entry vehicle. The study was divided into three phases. In one phase of the program, the pilots were subjected to a variety of sustained linear acceleration forces while controlling vehicles with several different sets of longitudinal dynamics. Here, a randomly moving target was displayed to the pilot on a cathode-ray tube. For each combination of acceleration field and vehicle dynamics, pilot tracking accuracy was measured and pilot opinion of the stability and control characteristics was recorded. Thus, information was obtained on the combined effects of complexity of control task and magnitude and direction of acceleration forces on pilot performance. These tests showed that the pilot's tracking performance deteriorated markedly at accelerations greater than about 4g when controlling a lightly damped vehicle. The tentative conclusion was also reached that regardless of the airframe dynamics involved, the pilot feels that in order to have the same level of control over the vehicle, an increase in the vehicle dynamic stability was required with increases in the magnitudes of the acceleration impressed upon the pilot. In another phase, boundaries of human tolerance of acceleration were established for acceleration fields such as might be encountered by a pilot flying an orbital vehicle. A special pilot restraint system was developed to increase human tolerance to longitudinal decelerations. The results of the tests showed that human tolerance

  3. Learner Intonation -- A Pilot Study.

    ERIC Educational Resources Information Center

    Backman, Nancy

    This study is concerned with problems in language learners' intonation of English. Ten intonation problems were found in the learner speech of two adult Spanish-speaking males: (1) range of pitch, (2) initial rise, (3) final fall, (4) rise to final stressed syllable, (5) placement of prominence, (6) final rise for questions, (7) total question…

  4. Pre-Study Walkthrough with a Commercial Pilot for a Preliminary Single Pilot Operations Experiment

    NASA Technical Reports Server (NTRS)

    O'Connor-Dreher, Ryan; Roberts, Z.; Ziccardi, J.; Vu, K-P. L.; Strybel, T.; Koteskey, Robert William; Lachter, Joel B.; Vi Dao, Quang; Johnson, Walter W.; Battiste, V.

    2013-01-01

    The number of crew members in commercial flights has decreased to two members, down from the five-member crew required 50 years ago. One question of interest is whether the crew should be reduced to one pilot. In order to determine the critical factors involved in safely transitioning to a single pilot, research must examine whether any performance deficits arise with the loss of a crew member. With a concrete understanding of the cognitive and behavioral role of a co-pilot, aeronautical technologies and procedures can be developed that make up for the removal of the second aircrew member. The current project describes a pre-study walkthrough process that can be used to help in the development of scenarios for testing future concepts and technologies for single pilot operations. Qualitative information regarding the tasks performed by the pilots can be extracted with this technique and adapted for future investigations of single pilot operations.

  5. Tinnitus Treatment with Oxytocin: A Pilot Study.

    PubMed

    Azevedo, Andreia Aparecida; Figueiredo, Ricardo Rodrigues; Elgoyhen, Ana Belen; Langguth, Berthold; Penido, Norma De Oliveira; Schlee, Winfried

    2017-01-01

    Tinnitus is the perception of sound in the absence of an external stimulus. It is a frequent condition for which there is as yet no pharmacological treatment approved. Auditory and non-auditory pathways are involved in tinnitus' pathophysiology. Oxytocin is a neurohormone and eventual neurotransmitter that plays a complex role in social cognition and behavior. To evaluate the potential of oxytocin as a tinnitus treatment. Two studies were performed. Study 1 was a long-term open pilot study, while study 2 investigated short-term effects with a double-blinded placebo-controlled cross-over study. Ambulatory ENT care. In study 1, 15 patients were investigated over a 10-week period in an open pilot study. In study 2, 16 patients were included in a placebo-controlled crossover trial to investigate short-term effects following a single dose. For the long-term study (study 1), analysis of variance revealed a significant decrease in tinnitus sensation, both for the Tinnitus Handicap Inventory and Clinical Global Impression (CGI). Also, the short-term effects in study 2 revealed a significant reduction of tinnitus because of the oxytocin nasal spray as measured with the Visual Analog Scale and the CGI Scale. These preliminary studies demonstrated that oxytocin may represent a helpful tool for treating tinnitus and further larger controlled studies are warranted.

  6. Helicopter pilot back pain: a preliminary study.

    PubMed

    Shanahan, D F; Reading, T E

    1984-02-01

    Because of the high prevalence of back pain experienced by U.S. Army helicopter pilots, a study was conducted to ascertain the feasibility of reproducing these symptoms in the laboratory. A mock-up of a UH-1H seat and control configuration was mounted to a multi-axis vibration simulator (MAVS). Eleven subjects were tested on the apparatus for two 120-min periods. During one period, the MAVS was programmed to reproduce vibrations recorded from a UH-1H in cruise flight. The subjects received no vibration during the other test period. All subjects reported back pain which they described as identical to the pain they experience during flight, during one or more of their test periods. There was no statistical difference between the vibration and nonvibration test conditions (p greater than 0.05) in terms of time of onset of pain or intensity of pain as measured by a visual analog scale. It appears the vibration at the frequencies and amplitudes tested plays little or no role in the etiology of the back symptoms reported by these pilots. It is proposed that the primary etiological factor for these symptoms is the poor posture pilots are obliged to assume for extended periods while operating helicopters.

  7. Probing the Process of Information Source Selection Using Palm Pilots: A Pilot Study.

    ERIC Educational Resources Information Center

    Shim, Wonsik

    2002-01-01

    This pilot study was conducted to determine the feasibility of using PDAs (personal digital assistants or palm pilots) as a data collection device in studying information seeking behaviors of undergraduate students. Discusses results that shows heavy use of Internet search engines and that most information searches do not extend beyond the first…

  8. An oral appliance with or without elastic bands to control mouth opening during sleep-a randomized pilot study.

    PubMed

    Norrhem, Niclas; Marklund, Marie

    2016-09-01

    Oral appliances (OAs) hold the lower jaw forward to reduce obstructive sleep apneas. Some OA designs allow mouth opening, which influences the forward positioning of the lower jaw. The aim of this pilot study was to compare the efficacy of an adjustable, custom-made OA (Narval®) in its original design, which allowed mouth opening, with the same OA with elastic bands that restricted mouth opening. Consecutive patients with an apnea-hypopnea index (AHI) of ≥15 were randomized to start with an OA either with or without elastic bands in a single-blinded, crossover, pilot study. The patients underwent acclimatization and titration. After 3 weeks use of each device, they had renewed sleep apnea recordings and responded to questionnaires. Washout periods took place between the tests. Ten subjects with a median AHI of 19.7 (interquartile range (IQR) 17.3 to 31.8) were included. The AHI decreased to 3.1 (IQR 1.5-14.7) (p < 0.01) with the OA and to 5.1 (IQR 2.4-14.3) (p < 0.01) with the OA with elastic bands, with no difference between them (p = 0.7). The two subjects with severe obstructive sleep apnea (OSA) almost halved their supine AHI with, as compared to without, elastic bands. The majority of the patients preferred to use the elastic bands. This pilot study indicates that elastic bands markedly reduced the supine AHI in two subjects with severe sleep apnea as compared to without elastic bands. The majority of the patients preferred the use of elastic bands, although no significant difference in the AHI was observed with versus without the elastic bands in the whole sample.

  9. [Pilot study on hairdresser eczema].

    PubMed

    Zelger, J

    1999-11-01

    From 1990 to 1992 the allergy profile of 1042 prospective hairdressers (personal and family history, atopic skin, serum IgE, patch and prick tests) was determined and their occupational suitability was evaluated. Up to 1997 a follow up of 375 hairdressers was obtained by way of questionnaires, re-examination, official reports and expert opinions of the social accident insurance. The frequency of initial eczema was 30%. A change of occupation on account of hairdresser eczema was documented in 11%. The prognostic evaluation of occupational suitability proved to be unsatisfactory. In this longitudinal study, the frequency of pre-occupational skin symptoms increased from 13 to 18%. The other atopic criteria indicated no uniform tendency. There was a significant increase in nickel allergy from 18.7 to 45.5% resulting partly from sensitization after entering the occupation and partly from an increase in nickel allergy at time of entry. Both atopic skin and pre-occupational nickel allergy increase the risk of hairdresser eczema, it is not so great as to justify dissuading such young people from entering the profession.

  10. The efficacy of peloid therapy in management of hand osteoarthritis: a pilot study

    NASA Astrophysics Data System (ADS)

    Kasapoğlu Aksoy, Meliha; Altan, Lale; Eröksüz, Rıza; Metin Ökmen, Burcu

    2017-08-01

    Hand osteoarthritis (OA) is associated with pain, reduced grip strength, loss of range of motion (ROM), and joint stiffness, leading to impaired hand function and difficulty in performance of daily living activities. Mud bath therapy has been reported to play a primary role in the prevention and management of OA. Thus, we planned to conduct a study aimed at investigating the effects of peloid therapy on pain, functional state, grip strength, and the quality of life and performing a comparative analysis of the outcomes of peloid therapy. In this randomized, controlled, single-blind, pilot study, patients (n = 33) underwent peloid therapy over 2 weeks, 5 sessions a week, for a total of 10 sessions and home exercise program in group 1. Patients in group 2 (control, n = 30) received only the same home exercise program as in group 1. Patients were evaluated just before, and 2 and 6 weeks after the start of the study with Visual Analogue Scale (VAS), Australian/Canadian Hand Osteoarthritis Index (AUSCAN), Health Assessment Questionnaire (HAQ), hand grip strength (HGS), and pinch strength (PS). Statistically significant improvements were observed in all parameters assessed at week 2 and week 6 in the group 1 (p < 0.05). Statistically significant differences were observed in HGS scores in the group 2 at week 2 and in AUSCAN scores at week 6 (p < 0.05). Intergroup comparisons of the scores revealed significant differences between the peloid therapy group and control group in VAS, HAQ, AUSCAN, HGS, and PS scores at week 2 and week 6 (p < 0.05). This study demonstrates that peloid therapy might be an effective and confident treatment modality in the management of symptomatic osteoarthritis of the hand and may provide effective pain control and improvements in the hand functions, quality of life, and grip strength.

  11. Spaceborne synthetic aperture radar pilot study

    NASA Technical Reports Server (NTRS)

    1974-01-01

    A pilot study of a spaceborne sidelooking radar is summarized. The results of the system trade studies are given along with the electrical parameters for the proposed subsystems. The mechanical aspects, packaging, thermal control and dynamics of the proposed design are presented. Details of the data processor are given. A system is described that allows the data from a pass over the U. S. to be in hard copy form within two hours. Also included are the proposed schedule, work breakdown structure, and cost estimate.

  12. NORTHWEST ORGEON PILOT STUDY AREA (USA): THE USE OF LANDSCAPE SCIENCE FOR ENVIRONMENTAL ASSESSMENT PILOT STUDY

    EPA Science Inventory

    The Northwest Oregon Pilot Study Area encompasses approximately 59,167 km2 and varies in elevation from sea level to 3,200 m. Annual precipitation varies with elevation and meridian and ranges from 25 - 460cm. The study area comprises a mixture of federal, state, and privately ow...

  13. NORTHWEST ORGEON PILOT STUDY AREA (USA): THE USE OF LANDSCAPE SCIENCE FOR ENVIRONMENTAL ASSESSMENT PILOT STUDY

    EPA Science Inventory

    The Northwest Oregon Pilot Study Area encompasses approximately 59,167 km2 and varies in elevation from sea level to 3,200 m. Annual precipitation varies with elevation and meridian and ranges from 25 - 460cm. The study area comprises a mixture of federal, state, and privately ow...

  14. Assisted autogenic drainage in infants and young children hospitalized with uncomplicated pneumonia, a pilot study.

    PubMed

    Corten, Lieselotte; Jelsma, Jennifer; Human, Anri; Rahim, Sameer; Morrow, Brenda M

    2017-07-19

    Pneumonia is the most important respiratory problem in low-to-middle income countries. Airway clearance therapy continues to be used in children with pneumonia and secretion retention; however, there is lack of evidence to support or reject this treatment. This study aimed to investigate the feasibility of a randomized controlled trial (RCT) on the efficacy and safety of assisted autogenic drainage (AAD) compared to standard nursing care in children hospitalized with uncomplicated pneumonia. A single-blinded pilot RCT was conducted on 29 children (median age 3.5 months, IQR 1.5-9.4) hospitalized with uncomplicated pneumonia. The intervention group received standard nursing care with additional bi-daily AAD, for 10 to 30 min. The control group only received standard nursing care, unless otherwise deemed necessary by the physician or physiotherapist. The primary outcome measure was duration of hospitalization. The secondary outcome measures included days of fever and supplemental oxygen support; respiratory rate (RR) and heart rate adjusted for age; RR and oxygen saturation pre-, post-, and 1-hr post-treatment; oxygen saturation; adverse events; and mortality. No difference was found for duration of hospitalization (median 7.5 and 7.0 days for the control and intervention groups, respectively); however, Kaplan-Meier analysis revealed a strong tendency towards a shorter time to discharge in the intervention group (p = .06). No significant differences were found for the other outcome measures at time of discharge. No adverse events were reported. Within the intervention group, a significant reduction in RR adjusted for age was found. As no adverse events were reported, and AAD did not prolong hospitalization; AAD might be considered as safe and effective in young children with uncomplicated pneumonia. However, a larger multicentred RCT is warranted to determine the efficacy of AAD compared to standard nursing care. Copyright © 2017 John Wiley & Sons, Ltd.

  15. Comparison of self-citation by peer reviewers in a journal with single-blind peer review versus a journal with open peer review.

    PubMed

    Levis, Alexander W; Leentjens, Albert F G; Levenson, James L; Lumley, Mark A; Thombs, Brett D

    2015-12-01

    Some peer reviewers may inappropriately, or coercively request that authors include references to the reviewers' own work. The objective of this study was to evaluate whether, compared to reviews for a journal with single-blind peer review, reviews for a journal with open peer review included (1) fewer self-citations; (2) a lower proportion of self-citations without a rationale; and (3) a lower ratio of proportions of citations without a rationale in self-citations versus citations to others' work. Peer reviews for published manuscripts submitted in 2012 to a single-blind peer review journal, the Journal of Psychosomatic Research, were previously evaluated (Thombs et al., 2015). These were compared to publically available peer reviews of manuscripts published in 2012 in an open review journal, BMC Psychiatry. Two investigators independently extracted data for both journals. There were no significant differences between journals in the proportion of all reviewer citations that were self-citations (Journal of Psychosomatic Research: 71/225, 32%; BMC Psychiatry: 90/315, 29%; p=.50), or in the proportion of self-citations without a rationale (Journal of Psychosomatic Research: 15/71, 21%; BMC Psychiatry: 12/90, 13%; p=.21). There was no significant difference between journals in the proportion of self-citations versus citations to others' work without a rationale (p=.31). Blind and open peer review methodologies have distinct advantages and disadvantages. The present study found that, in reasonably similar journals that use single-blind and open review, there were no substantive differences in the pattern of peer reviewer self-citations. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. A Piloted Simulation Study of Wake Turbulence on Final Approach

    NASA Technical Reports Server (NTRS)

    Stewart, Eric C.

    1998-01-01

    A piloted simulation study has been conducted in a research simulator to provide a means to estimate the effects of different levels of wake turbulence on final approach. A worst-case methodology was used to ensure conservative estimates. Fourteen airline pilots voluntarily participated in the study and flew almost 1000 approaches. The pilots rated the subjective severity of the disturbances using a special rating scale developed for this study. Several objective measures of the airplane/pilot response to the simulated wake turbulence were also made. All the data showed a large amount of variation between pilots and to a lesser extent for a given pilot. Therefore, the data were presented at 50, 70, 90 percentile levels as a function of vortex strength. The data allow estimates of the vortex strength for a given subjective or objective response and vice versa. The results of this study appear to be more conservative than the results of previous studies.

  17. A pilot study of the utility of a laboratory-based spinal fixation training program for neurosurgical residents.

    PubMed

    Sundar, Swetha J; Healy, Andrew T; Kshettry, Varun R; Mroz, Thomas E; Schlenk, Richard; Benzel, Edward C

    2016-05-01

    OBJECTIVE Pedicle and lateral mass screw placement is technically demanding due to complex 3D spinal anatomy that is not easily visualized. Neurosurgical and orthopedic surgery residents must be properly trained in such procedures, which can be associated with significant complications and associated morbidity. Current training in pedicle and lateral mass screw placement involves didactic teaching and supervised placement in the operating room. The objective of this study was to assess whether teaching residents to place pedicle and lateral mass screws using navigation software, combined with practice using cadaveric specimens and Sawbones models, would improve screw placement accuracy. METHODS This was a single-blinded, prospective, randomized pilot study with 8 junior neurosurgical residents and 2 senior medical students with prior neurosurgery exposure. Both the study group and the level of training-matched control group (each group with 4 level of training-matched residents and 1 senior medical student) were exposed to a standardized didactic education regarding spinal anatomy and screw placement techniques. The study group was exposed to an additional pilot program that included a training session using navigation software combined with cadaveric specimens and accessibility to Sawbones models. RESULTS A statistically significant reduction in overall surgical error was observed in the study group compared with the control group (p = 0.04). Analysis by spinal region demonstrated a significant reduction in surgical error in the thoracic and lumbar regions in the study group compared with controls (p = 0.02 and p = 0.04, respectively). The study group also was observed to place screws more optimally in the cervical, thoracic, and lumbar regions (p = 0.02, p = 0.04, and p = 0.04, respectively). CONCLUSIONS Surgical resident education in pedicle and lateral mass screw placement is a priority for training programs. This study demonstrated that compared with a

  18. Ballet and stress. A pilot study.

    PubMed

    Tomei, G; Casale, T; Rosati, M V; Melcarne, R; Sinibaldi, F; Capozzella, A; Di Giorgio, V; Giubilati, R; Sacco, C; Tomei, F; Sancini, A

    2015-01-01

    Work-related stress is a complex problem requiring a work environment-based assessment. Artists like dancers represent a category of atypical workers potentially at high risk for work-related stress. Aim of our pilot study is to evaluate organizational stress in a population of professional dancers, using the HSE Indicator Tool for Work Related Stress. We administered the Italian version of the HSE Indicator Tool to 38 ballet dancers, males and females. The questionnaire evaluates 7 key organizational dimensions: demand, control, managers' support, peer support, relationships, role and change. The standards required-ideal conditions are achieved in none of the above-mentioned dimensions. Change is the only dimension for which results fall between the 20th and the 50th percentile, while for other dimensions results fall below the 20th percentile suggesting the need for immediate corrective action. In male dancers an acceptable situation is highlighted for the dimension "change" compared to female dancers. In both sexes there is a high frequency of subjects complaining of verbal abuse, bullying and harassment. Despite the small sample size, our pilot study highlights the presence of heightened levels of organizational stress. Preventive measures targeted towards improving communication between managers and dancers and aimed at team building should be implemented.

  19. Community parenteral therapy project: a pilot study.

    PubMed

    Foster, L; McMurray, A

    1998-01-01

    The pilot study reported in this paper was devised to develop and compare service delivery models that would achieve the provision of high quality parenteral therapy care to patients in the Gold Coast District Health Service community. All data were collected on 113 patients for a 12-month period, January to December 1996. The study compared the provision of outreach nursing services and contracted nursing services on measures of satisfaction and cost. The study showed that patient and carers indicated a preference for community care, medical officers advocated the benefits of administering parenteral therapies in the community, general practitioners were interested in managing future community parenteral therapies, and contracted (nurse) service providers endorsed the development of a parenteral therapy resource centre. The findings also revealed considerable potential cost savings in community-based care.

  20. A prospective, single-blind, randomized controlled trial of petroleum jelly/Vaseline for recurrent paediatric epistaxis.

    PubMed

    Loughran, S; Spinou, E; Clement, W A; Cathcart, R; Kubba, H; Geddes, N K

    2004-06-01

    The aim of the study was to determine if petroleum jelly was an effective treatment for paediatric epistaxis. A single-blind, prospective, randomized controlled trial was undertaken in an otolaryngology outpatient clinic of a paediatric hospital from March 2001 to March 2002. A total of 105 children referred with recurrent epistaxis were randomized into the study, 52 into the treatment arm and 53 into the control arm. Children in the treatment arm applied Vaseline twice a day bilaterally for 4 weeks and were monitored for any bleeds for the next 4 weeks. Children in the control arm were simply given an 8-week appointment and the number of bleeds were monitored for the 4 weeks prior to their appointment. The outcome measure was the proportion of children in each group without nosebleeds in the preceding 4 weeks. Both groups were equally distributed in age, duration of symptoms and duration of each bleed. Fourteen of 51 (27.5%) patients of the treatment arm and 18 of 53 (34%) of the control arm did not bleed in the 4 weeks before review (chi-square test, P = 0.472). It can be concluded that Vaseline alone confers no benefit over simple observation in recurrent childhood epistaxis.

  1. The use of ice-lollies for pain relief post-paediatric tonsillectomy. A single-blinded, randomised, controlled trial.

    PubMed

    Sylvester, D C; Rafferty, A; Bew, S; Knight, L C

    2011-12-01

    To assess whether the use of ice-lollies after tonsillectomy with or without adenoidectomy in children aged 2-12 reduces pain in the immediate postoperative period. A prospective, randomised, single-blinded study design consisting of two groups with an intention to treat analysis. Tertiary referral centre. Children aged 2-12 undergoing tonsillectomy with or without adenoidectomy. Pain assessment by nursing staff in the form of the validated modified Children's Hospital of Eastern Ontario Pain Scale at 15, 30 and 60 min and 4 h. Ninety-two patients were recruited into the study with 46 allocated to receive an ice-lolly and 41 not to receive an ice-lolly after exclusion of those with incomplete data. The two groups were comparable for number, age, sex and diagnosis. The pain score at every time interval was lower in the group that had received the ice-lolly compared with the group that had not. This was statistically significant at 30 (P = 0.008) and 60 min (P = 0.049). Our data suggest that ice-lollies are a cheap, effective and safe method of reducing postoperative pain up to one hour following paediatric tonsillectomy. © 2011 Blackwell Publishing Ltd.

  2. Comparison of Pap smear quality with anatomical spatula and convenience (spatula-cytobrush) methods: a single blind clinical trial.

    PubMed

    Abdali, Khadijeh; Soleimani, Marzieh; Khajehei, Marjan; Tabatabaee, Hamid Reza; Komar, Perikala V; Montazer, Nader Riaz

    2010-01-01

    The Papanicolaou smear is a standard test for cervical cancer screening; however, the most important challenge is high false negative results. Several factors contribute to this problem and one the most important is inappropriate sampling. The aim of this study was to compare the quality of smears obtained by either an anatomical spatula or a spatula-cyto brush. One hundred married women participated in this single blind clinical trial. After all participants were interviewed, two samples were obtained from each: one with a spatula-cytobrush and another with an anatomical spatula. Slides were prepared and assessed by two pathologists for kappa coefficient analysis. Cell adequacy was 96.1 % in anatomical spatula method and 91.2 % in spatula-cyto brush method (p= 0.016). The rates for endocervical cells and metaplasia cells were 70.6%and 24.5%, respectively, with the anatomical spatula method and 69.6% and 24.5% using a spatula-cytobrush (p<0.001). No one reported pain and the amount of bleeding was 38.2% in both methods (p>0.05). In addition, there were no statistically significant differences regarding infection and inflammatory reactions (p>0.05). Based on the findings of this study, the results of sampling with anatomical spatula were more acceptable and better than those of spatula-cytobrush sampling.

  3. Effect of transdermal magnesium cream on serum and urinary magnesium levels in humans: A pilot study

    PubMed Central

    Tanner, Amy; Sullivan, Keith; McAuley, William; Plesset, Michael

    2017-01-01

    Background Oral magnesium supplementation is commonly used to support a low magnesium diet. This investigation set out to determine whether magnesium in a cream could be absorbed transdermally in humans to improve magnesium status. Methods and findings In this single blind, parallel designed pilot study, n = 25 participants (aged 34.3+/-14.8y, height 171.5+/-11cm, weight 75.9 +/-14 Kg) were randomly assigned to either a 56mg/day magnesium cream or placebo cream group for two weeks. Magnesium serum and 24hour urinary excretion were measured at baseline and at 14 days intervention. Food diaries were recorded for 8 days during this period. Mg test and placebo groups’ serum and urinary Mg did not differ at baseline. After the Mg2+ cream intervention there was a clinically relevant increase in serum magnesium (0.82 to 0.89 mmol/l,p = 0.29) that was not seen in the placebo group (0.77 to 0.79 mmol/L), but was only statistically significant (p = 0.02)) in a subgroup of non-athletes. Magnesium urinary excretion increased from baseline slightly in the Mg2+ group but with no statistical significance (p = 0.48). The Mg2+ group showed an 8.54% increase in serum Mg2+ and a 9.1% increase in urinary Mg2+ while these figures for the placebo group were smaller, i.e. +2.6% for serum Mg2+ and -32% for urinary Mg2+. In the placebo group, both serum and urine concentrations showed no statistically significant change after the application of the placebo cream. Conclusion No previous studies have looked at transdermal absorbency of Mg2+ in human subjects. In this pilot study, transdermal delivery of 56 mg Mg/day (a low dose compared with commercial transdermal Mg2+ products available) showed a larger percentage rise in both serum and urinary markers from pre to post intervention compared with subjects using the placebo cream, but statistical significance was achieved only for serum Mg2+ in a subgroup of non-athletes. Future studies should look at higher dosage of magnesium cream for

  4. Effect of transdermal magnesium cream on serum and urinary magnesium levels in humans: A pilot study.

    PubMed

    Kass, Lindsy; Rosanoff, Andrea; Tanner, Amy; Sullivan, Keith; McAuley, William; Plesset, Michael

    2017-01-01

    Oral magnesium supplementation is commonly used to support a low magnesium diet. This investigation set out to determine whether magnesium in a cream could be absorbed transdermally in humans to improve magnesium status. In this single blind, parallel designed pilot study, n = 25 participants (aged 34.3+/-14.8y, height 171.5+/-11cm, weight 75.9 +/-14 Kg) were randomly assigned to either a 56mg/day magnesium cream or placebo cream group for two weeks. Magnesium serum and 24hour urinary excretion were measured at baseline and at 14 days intervention. Food diaries were recorded for 8 days during this period. Mg test and placebo groups' serum and urinary Mg did not differ at baseline. After the Mg2+ cream intervention there was a clinically relevant increase in serum magnesium (0.82 to 0.89 mmol/l,p = 0.29) that was not seen in the placebo group (0.77 to 0.79 mmol/L), but was only statistically significant (p = 0.02)) in a subgroup of non-athletes. Magnesium urinary excretion increased from baseline slightly in the Mg2+ group but with no statistical significance (p = 0.48). The Mg2+ group showed an 8.54% increase in serum Mg2+ and a 9.1% increase in urinary Mg2+ while these figures for the placebo group were smaller, i.e. +2.6% for serum Mg2+ and -32% for urinary Mg2+. In the placebo group, both serum and urine concentrations showed no statistically significant change after the application of the placebo cream. No previous studies have looked at transdermal absorbency of Mg2+ in human subjects. In this pilot study, transdermal delivery of 56 mg Mg/day (a low dose compared with commercial transdermal Mg2+ products available) showed a larger percentage rise in both serum and urinary markers from pre to post intervention compared with subjects using the placebo cream, but statistical significance was achieved only for serum Mg2+ in a subgroup of non-athletes. Future studies should look at higher dosage of magnesium cream for longer durations. ISRCTN registry ID No. ISRTN

  5. Sleep EEG effects of anti-gluco- and anti-mineralocorticoids in old-aged men: pilot study.

    PubMed

    Demiralay, Cüneyt; Agorastos, Agorastos; Steiger, Axel; Wiedemann, Klaus

    2014-05-01

    Age-related sleep changes have been associated with altered hypothalamic-pituitary-adrenal axis reactivity and impaired feedback inhibition at the glucocorticoid (GR) and mineralocorticoid (MR) receptor level. To further investigate the specific role of this binary receptor system in the elderly, sleep electroencephalogram (EEG) effects of the MR antagonist spironolactone and GR antagonist mifepristone in old-aged men were compared in this pilot study. Old-aged healthy men (n = 6, 65-91 years) were treated on three occasions in a single-blinded design in random order with mifepristone, spironolactone and placebo, respectively, and nocturnal sleep EEG was recorded. Mifepristone led to increased wake time, decreased stage 2 and rapid eye movement (REM) sleep and prolonged REM sleep latency in the first half of the night, whereas spironolactone had no considerable effects on sleep EEG. GR antagonism can potentiate age-related sleep pattern alterations and further support the role of impaired GR signaling in age-related changes in sleep architecture. © 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology.

  6. Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study.

    PubMed

    Dronkers, Jaap; Veldman, André; Hoberg, Ellen; van der Waal, Cees; van Meeteren, Nico

    2008-02-01

    To investigate the feasibility and effects of preoperative inspiratory muscle training on the incidence of atelectasis in patients at high risk of postoperative pulmonary complications scheduled for elective abdominal aortic aneurysm surgery. Single-blind randomized controlled pilot study. Gelderse Vallei Hospital Ede, the Netherlands. Twenty high-risk patients undergoing elective abdominal aortic aneurysm surgery were randomly assigned to receive preoperative inspiratory muscle training or usual care. Effectiveness outcome variables were atelectasis, inspiratory muscle strength and vital capacity, and feasibility outcome variables were adverse effects and patient satisfaction with inspiratory muscle training. Despite randomization, patients in the intervention group were significantly older than the patients in the control group (70 +/- 6 years versus 59 +/- 6 years, respectively; P = 0.001). Eight patients in the control group and three in the intervention group developed atelectasis (P = 0.07). The median duration of atelectasis was 0 days in the intervention group and 1.5 days in the control group (P = 0.07). No adverse effects of preoperative inspiratory muscle training were observed and patients considered that inspiratory muscle training was a good preparation for surgery. Mean postoperative inspiratory pressure was 10% higher in the intervention group. Preoperative inspiratory muscle training is well tolerated and appreciated and seems to reduce the incidence of atelectasis in patients scheduled for elective abdominal aortic aneurysm surgery.

  7. Significant Reduction in Helicobacter pylori Load in Humans with Non-viable Lactobacillus reuteri DSM17648: A Pilot Study.

    PubMed

    Holz, Caterina; Busjahn, Andreas; Mehling, Heidrun; Arya, Stefanie; Boettner, Mewes; Habibi, Hajar; Lang, Christine

    2015-06-01

    Reducing the amount of Helicobacter pylori in the stomach by selective bacterial-bacterial cell interaction was sought as an effective and novel method for combating the stomach pathogen. Lactobacillus reuteri DSM17648 was identified as a highly specific binding antagonist to H. pylori among more than 700 wild-type strains of Lactobacillus species. Applying a stringent screening procedure, the strain DSM17648 was identified as selective binder to H. pylori cells under in vivo gastric conditions. The strain DSM17648 co-aggregates the pathogen in vivo and in vitro. The specific co-aggregation occurs between Lact. reuteri DSM17648 and different H. pylori strains and serotypes, as well as H. heilmannii, but not with Campylobacter jejuni or other commensal oral and intestinal bacteria. Lact. reuteri DSM17648 was shown in a proof-of-concept single-blinded, randomized, placebo-controlled pilot study to significantly reduce the load of H. pylori in healthy yet infected adults. Reducing the amount of H. pylori in the stomach by selective bacterial-bacterial cell interaction might be an effective and novel method for combating the stomach pathogen. Lact. reuteri DSM17648 might prove useful as an adhesion blocker in antibiotic-free H. pylori therapies.

  8. Effect of low-impact aerobic exercise combined with music therapy on patients with fibromyalgia. A pilot study.

    PubMed

    Espí-López, Gemma V; Inglés, Marta; Ruescas-Nicolau, María-Arántzazu; Moreno-Segura, Noemí

    2016-10-01

    Fibromyalgia is a pathological entity characterized by chronic widespread musculoskeletal pain and the presence of "tender points". It constitutes a significant health problem because of its prevalence and economic impact. The aim of the present study was to determine the therapeutic benefits of low impact aerobic exercise alone or in combination with music therapy in patients with fibromyalgia. A single-blind randomized controlled pilot trial was performed. Thirty-five individuals with fibromyalgia were divided into three groups: (G1) therapeutic aerobic exercise with music therapy (n=13); (G2) therapeutic aerobic exercise at any rhythm (n=13) and (CG) control (n=9). The intervention period lasted eight weeks. Depression, quality of life, general discomfort and balance were assessed before and after intervention. At post-intervention, group G1 improved in all variables (depression (p=0.002), quality of life (p=0.017), general discomfort (p=0.001), and balance (p=0.000)), while group G2 improved in general discomfort (p=0.002). The change observed in balance was statistically different between groups (p=0.01). Therapeutic aerobic exercise is effective in improving depression and general discomfort in individuals with fibromyalgia. However, effectiveness is higher when combined with music therapy, which brings about further improvements in quality of life and balance. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Vitamin D and omega-3 polyunsaturated fatty acid supplementation in athletes with exercise-induced bronchoconstriction: a pilot study.

    PubMed

    Price, Oliver J; Hull, James H; Howatson, Glyn; Robson-Ansley, Paula; Ansley, Les

    2015-06-01

    The aim of this pilot study was to determine the combined effect of vitamin D and omega-3 polyunsaturated fatty acid (PUFA) supplementation on airway function and inflammation in recreational athletes with exercise-induced bronchoconstriction (EIB). Ten recreational athletes with EIB participated in a single-blind, placebo-controlled trial over six consecutive weeks. All subjects attended the laboratory on three occasions. Each visit was separated by a period of 3 weeks: visit 1 (usual diet), visit 2 (placebo) and visit 3 (SMARTFISH® NutriFriend 2000; 30 µg vitamin D3-3000 mg eicosapentaenoic acid, 3000 mg docosahexaenoic acid) consumed once daily for a period of 3 weeks. Venous blood was collected at the beginning of each trial to determine vitamin D status. Spirometry was performed pre- and post-eucapnic voluntary hyperpnoea (EVH). The Maximum fall in FEV1 (ΔFEV1max) post-EVH was not different between visits (usual diet: -15.9 ± 3.6%, placebo: -16.1 ± 6.1%, vitamin D + omega-3 PUFA: -17.8 ± 7.2%). Serum vitamin D remained unchanged between visits. Vitamin D and omega-3 PUFA supplementation does not attenuate the reduction in lung function post-EVH. This finding should be viewed as preliminary until the results of randomised controlled trials are made available.

  10. Piloted studies of Enhanced or Synthetic Vision display parameters

    NASA Technical Reports Server (NTRS)

    Harris, Randall L., Sr.; Parrish, Russell V.

    1992-01-01

    This paper summarizes the results of several studies conducted at Langley Research Center over the past few years. The purposes of these studies were to investigate parameters of pictorial displays and imaging sensors that affect pilot approach and landing performance. Pictorial displays have demonstrated exceptional tracking performance and improved the pilots' spatial awareness. Stereopsis cueing improved pilot flight performance and reduced pilot stress. Sensor image parameters such as increased field-of-view. faster image update rate, and aiding symbology improved flare initiation. Finer image resolution and magnification improved attitude control performance parameters.

  11. DU-AGG pilot plant design study

    SciTech Connect

    Lessing, P.A.; Gillman, H.

    1996-07-01

    The Idaho National Engineering Laboratory (INEL) is developing new methods to produce high-density aggregate (artificial rock) primarily consisting of depleted uranium oxide. The objective is to develop a low-cost method whereby uranium oxide powder (UO[sub 2], U[sub 3]O[sub ]8, or UO[sub 3]) can be processed to produce high-density aggregate pieces (DU-AGG) having physical properties suitable for disposal in low-level radioactive disposal facilities or for use as a component of high-density concrete used as shielding for radioactive materials. A commercial company, G-M Systems, conducted a design study for a manufacturing pilot plant to process DU-AGG. The results of that study are included and summarized in this report. Also explained are design considerations, equipment capacities, the equipment list, system operation, layout of equipment in the plant, cost estimates, and the proposed plan and schedule.

  12. Location Independent Professional Project: A Pilot Study

    SciTech Connect

    Hudson, J.A.; Long, J.P.; Miller, M.M.

    1999-02-01

    This pilot study project explored the problem of providing access to the nomadic worker who desires to connect a computer through network access points at a number of different locations within the SNL/NM campus as well as outside the campus. The design and prototype development gathered knowledge that may allow a design to be developed that could be extended to a larger number of SNL/NM network drop boxes. The focus was to provide a capability for a worker to access the SNL IRN from a network drop box (e.g. in a conference room) as easily as when accessing the computer network from the office normally used by the worker. Additional study was done on new methods to authenticate the off campus worker, and protect and control access to data.

  13. Teaching veterinary radiography by e-learning versus structured tutorial: a randomized, single-blinded controlled trial.

    PubMed

    Vandeweerd, Jean-Michel E F; Davies, John C; Pinchbeck, Gina L; Cotton, Jo C

    2007-01-01

    Case-based e-learning may allow effective teaching of veterinary radiology in the field of equine orthopedics. The objective of this study was to investigate the effectiveness of a new case-based e-learning tool, compared with a standard structured tutorial, in altering students' knowledge and skills about interpretation of radiographs of the digit in the horse. It was also designed to assess students' attitudes toward the two educational interventions. A randomized, single-blinded, controlled trial of 96 fourth-year undergraduate veterinary students, involving an educational intervention of either structured tutorial or case-based e-learning, was performed. A multiple-choice examination based on six learning outcomes was carried out in each group after the session, followed by an evaluation of students' attitudes toward their session on a seven-point scale. Text blanks were available to students to allow them to comment on the educational interventions and on their learning outcomes. Students also rated, on a Likert scale from 1 to 7, their performance for each specific learning outcome and their general ability to use a systematic approach in interpreting radiographs. Data were analyzed using the Mann-Whitney test, the t-test, and the equivalence test. There was no significant difference in student achievement on course tests. The results of the survey suggest positive student attitudes toward the e-learning tool and illustrate the difference between objective ratings and subjective assessments by students in testing a new educational intervention.

  14. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial

    PubMed Central

    Eftekharsadat, Bina; Babaei-Ghazani, Arash; Zeinolabedinzadeh, Vahideh

    2016-01-01

    Background: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar extension[ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. Results: The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (p<0.001). Comparison of the ROMDF and ROMPE did not reveal any significant changes after four weeks of intervention in the case and control groups (p=0.7 and p=0.65, respectively). The mean of MDC7 and SEM5 scores in the case group were significantly lower than the control group following four weeks of intervention (p<0.001). Conclusion: Despite the insignificant effect on ROMDF and ROMPE, trigger point dry needling, by improving the severity of heel pain, can be used as a good alternative option before proceeding to more invasive therapies of plantar fasciitis. PMID:27683642

  15. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial.

    PubMed

    Eftekharsadat, Bina; Babaei-Ghazani, Arash; Zeinolabedinzadeh, Vahideh

    2016-01-01

    This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients' plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar extension[ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (p<0.001). Comparison of the ROMDF and ROMPE did not reveal any significant changes after four weeks of intervention in the case and control groups (p=0.7 and p=0.65, respectively). The mean of MDC7 and SEM5 scores in the case group were significantly lower than the control group following four weeks of intervention (p<0.001). Despite the insignificant effect on ROMDF and ROMPE, trigger point dry needling, by improving the severity of heel pain, can be used as a good alternative option before proceeding to more invasive therapies of plantar fasciitis.

  16. A prospective, randomized, single-blinded controlled trial on biodegradable synthetic polyurethane foam as a packing material after septoplasty.

    PubMed

    Kim, Yoo Suk; Kim, Young Hoon; Kim, Na Hyun; Kim, Si Hong; Kim, Kyung Rok; Kim, Kyung-Su

    2011-01-01

    We evaluated synthetic polyurethane foam (SPF; Polyganics BV, Groningen, The Netherlands) as a packing material used after septoplasty compared with Merocel (Medtronic Xomed Surgical Products, Jacksonville, FL) in the aspects of clinical efficacy and the subjective severity of symptoms. A prospective, randomized, single-blinded controlled study was performed in 64 patients who had undergone septoplasty. The patients were randomized to receive Merocel or SPF after septoplasty. Assessments of clinical efficacy on bleeding and pain were done and subjective symptoms related to packing materials were evaluated using questionnaires quantified by the visual analog scale. There was no difference in repacking or additional packing due to postoperative bleeding, bleeding and/or septal hematoma on the removal of packing, and the mucosal condition after packing removal during postoperative period between the Merocel and SPF groups. Bleeding and pain during packing removal was significantly lower in patients with SPF packing. Also, in the SPF group, patient's general satisfaction and willingness to reuse the material were higher compared with the Merocel group. SPF is as suitable as Merocel to be used after septoplasty with beneficial effects on bleeding and pain at packing removal.

  17. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial.

    PubMed

    Kwok, Timothy; Wong, Bel; Ip, Isaac; Chui, Kenny; Young, Daniel; Ho, Florence

    2013-01-01

    Many family caregivers of persons with dementia (PWD) are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann-Whitney U tests were used to compare the differences between the intervention and control groups. The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed.

  18. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial

    PubMed Central

    Kwok, Timothy; Wong, Bel; Ip, Isaac; Chui, Kenny; Young, Daniel; Ho, Florence

    2013-01-01

    Purpose Many family caregivers of persons with dementia (PWD) are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. Subjects and methods In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann–Whitney U tests were used to compare the differences between the intervention and control groups. Results The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. Conclusion A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed. PMID:24072965

  19. The incidence of venous thromboembolism in commercial airline pilots: a cohort study of 2630 pilots.

    PubMed

    Kuipers, S; Venemans-Jellema, A; Cannegieter, S C; van Haften, M; Middeldorp, S; Büller, H R; Rosendaal, F R

    2014-08-01

    Airline pilots may be at increased risk of venous thromboembolism (VTE) because air travel has recently been established as a risk factor for VTE. The aim of this study was to assess the risk of VTE in a cohort of Dutch airline pilots. Airline pilots who had been active members of the Dutch aviation society (VNV) were questioned for the occurrence of VTE, presence of risk factors for VTE and number of flight hours per year and rank. Incidence rates among pilots were compared with those of the general Dutch population and with a population of frequently flying employees of multinational organizations. A total of 2630 male pilots were followed-up for a total of 20420 person-years (py). Six venous thromboses were reported, yielding an incidence rate of 0.3 per 1000 py. The standardized morbidity ratio, comparing these pilots with the general Dutch population adjusted for age, was 0.8. Compared with the international employee cohort, the standardized morbidity ratio was 0.7 when all employees were included and 0.6 when only the frequently travelling employees were included. The incidence rate did not increase with number of flight hours per year and did not clearly vary by rank. We conclude that the risk of VTE is not increased amongst airline pilots. © 2014 International Society on Thrombosis and Haemostasis.

  20. The Pilot Staffing Conundrum: A Delphi Study

    DTIC Science & Technology

    2009-06-01

    Project, AFIT/ GMO /LAL/98J-2. School of Logistics and Acquisition Management, Air Force Institute of Technology (AU), Wright Patterson AFB, OH, June...Kafer, John H. Relationship of Airline Pilot Demand and Air Force Pilot Retention. Graduate Research Project, AFIT/ GMO /LAL/98J-11. School of Logistics

  1. Immigration and HIV infection: a pilot study.

    PubMed

    Loue, S; Oppenheim, S

    1994-02-01

    This pilot study was conducted to determine areas in which additional education regarding the human immunodeficiency virus (HIV) is needed by the undocumented and recently immigrated HIV-infected population, and to obtain preliminary information on the ability of this community to access medical treatment for HIV. Information regarding health status, immigration status, and the use of medical services was obtained from all HIV-infected undocumented and recently immigrated individuals who sought services from a Southern California nonprofit agency between July 1, 1990 and December 31, 1990. A total of 54 such individuals presented for services. Thirteen individuals reported participating in shared needle usage for the administration of medication or vitamins, in addition to other known risk factors for HIV. Only one of these 13 individuals had access to nonemergency medical care. Additional research is necessary to determine the reasons for these needle sharing behaviors. Educational outreach is needed to address these behaviors as a possible risk factor for HIV transmission.

  2. EXPOSURE ASSESSMENT METHODS DEVELOPMENT PILOTS FOR THE NATIONAL CHILDREN'S STUDY

    EPA Science Inventory

    Accurate exposure classification tools are needed to link exposure with health effects. EPA began methods development pilot studies in 2000 to address general questions about exposures and outcome measures. Selected pilot studies are highlighted in this poster. The “Literature Re...

  3. School Nurses' Support for Bereaved Students: A Pilot Study

    ERIC Educational Resources Information Center

    Lohan, Janet A.

    2006-01-01

    Children may have difficulty with schoolwork because of grief over the death of an important person in their lives. School nurses provide support to these children. This pilot study consisted of a Web-based survey completed by 6 school nurses in a 3-county area in Washington state. The purpose of this pilot study was to assess the need for…

  4. EXPOSURE ASSESSMENT METHODS DEVELOPMENT PILOTS FOR THE NATIONAL CHILDREN'S STUDY

    EPA Science Inventory

    Accurate exposure classification tools are needed to link exposure with health effects. EPA began methods development pilot studies in 2000 to address general questions about exposures and outcome measures. Selected pilot studies are highlighted in this poster. The “Literature Re...

  5. Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale.

    PubMed

    Charles, David; Tolleson, Christopher; Davis, Thomas L; Gill, Chandler E; Molinari, Anna L; Bliton, Mark J; Tramontana, Michael G; Salomon, Ronald M; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T; Neimat, Joseph S; Konrad, Peter E

    2012-01-01

    Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

  6. Study of occupational stress among railway engine pilots.

    PubMed

    Kumar, Devesh; Singh, Jai Vir; Kharwar, Poonam S

    2011-01-01

    Traffic volume and speed is going to be increased in Indian Railways successively, leading to higher stress in staff connected with train operations. The jobs of railway engine pilots come under the category of high-strain jobs, necessitating a need to conduct multicentric study to unfold the factors associated with occupational stress and organizational strategies. Present study covered 185 railway engine pilots and office clerks working in various railway zones by incidental method. Occupational Stress Index (OSI) test developed by Srivastva and Singh, questionnaire of specific stressors constructed by authors and laboratory test battery for psychological screening of high-speed train pilots were used as tools. Means of OSI and all the 12 occupational stressors of railway engine pilots were found significantly higher to that of office clerks. Means of OSI and occupational stressors of goods train pilots were significantly higher in comparison to high-speed train pilots and passenger train pilots. Study revealed positive correlation of speed perception and complex reaction time tests and negative correlation of other constituent tests of laboratory test battery to OSI test. Highest subgroup of stressor observedwas role overload followed by role conflict. These findings provide a prima facie evidence of higher occupational stress among railway engine pilots because of identified specific stressors prevalent in their job and explore the possible intervention strategies for its reduction. Significant correlation is noticed between OSI and laboratory test results, indicating its relevant utility in preliminary psychological screening.

  7. Study of occupational stress among railway engine pilots

    PubMed Central

    Kumar, Devesh; Singh, Jai Vir; Kharwar, Poonam S.

    2011-01-01

    Background: Traffic volume and speed is going to be increased in Indian Railways successively, leading to higher stress in staff connected with train operations. The jobs of railway engine pilots come under the category of high-strain jobs, necessitating a need to conduct multicentric study to unfold the factors associated with occupational stress and organizational strategies. Materials and Methods: Present study covered 185 railway engine pilots and office clerks working in various railway zones by incidental method. Occupational Stress Index (OSI) test developed by Srivastva and Singh, questionnaire of specific stressors constructed by authors and laboratory test battery for psychological screening of high-speed train pilots were used as tools. Results: Means of OSI and all the 12 occupational stressors of railway engine pilots were found significantly higher to that of office clerks. Means of OSI and occupational stressors of goods train pilots were significantly higher in comparison to high-speed train pilots and passenger train pilots. Study revealed positive correlation of speed perception and complex reaction time tests and negative correlation of other constituent tests of laboratory test battery to OSI test. Highest subgroup of stressor observedwas role overload followed by role conflict. Conclusions: These findings provide a prima facie evidence of higher occupational stress among railway engine pilots because of identified specific stressors prevalent in their job and explore the possible intervention strategies for its reduction. Significant correlation is noticed between OSI and laboratory test results, indicating its relevant utility in preliminary psychological screening. PMID:21808497

  8. Ozone Treatment on Dentin Hypersensitivity Surfaces – A Pilot Study

    PubMed Central

    Lena, Karlsson; Marianne, Kjaeldgaard

    2017-01-01

    Background: Dentin hypersensitivity (DH) is a frequent condition in adults and difficult to treat. The aim of this single-blind, randomised controlled clinical trial was to investigate immediate and long-term effect of ozone treatment (Prozone, W&H NORDIC AB) for 12 seconds on hypersensitive teeth compared to placebo treatment, using a split-mouth design. Methods: 26 patients (12 M, 14 F, mean age 44+ 2) were included in the study having at least two teeth with confirmed DH in different quadrants of the dentition (each subject had one test and one control tooth). A visual analogue scale (VAS) was used to measure the patients´ pain perception immediately and at a long-term follow-up three months later. Results: Significant reduction in pain perception from DH surfaces was demonstrated from ozone treated test teeth as well as in placebo treated control teeth. We found a moderate (16.2%) but significant pain relief (p< 0.012) over time in 57.7% of all treated teeth. Conclusion: Results from this study confirm previously published results showing no significant effect of ozone treatment on hypersensitive teeth compared to placebo treatment. PMID:28356999

  9. STAM protocol in dementia: a multicenter, single-blind, randomized, and controlled trial.

    PubMed

    Ceccato, Enrico; Vigato, Giovanna; Bonetto, Chiara; Bevilacqua, Albina; Pizziolo, Paolo; Crociani, Susanna; Zanfretta, Emanuele; Pollini, Lorenza; Caneva, Paolo Alberto; Baldin, Lorella; Frongillo, Cristina; Signorini, Andrea; Demoro, Sara; Barchi, Elisabetta

    2012-08-01

    The Sound Training for Attention and Memory in Dementia (STAM-Dem) is a manualized music-based protocol designed to be used in the rehabilitation of cognitive functions in elderly patients with dementia (PWD). This was a multicenter, single-blind, randomized, and controlled trial that involved 51 PWD. The objective was to test the STAM-Dem efficacy. Patients in the experimental group followed the STAM-Dem for 2 weekly sessions of 45 minutes for 12 weeks (in addition to standard care). Those in the control group continued with the normal "standard care" provided. In the experimental group, the instruments immediate prose memory test (MPI), deferred prose memory test (MPD), attentional matrices, activities of daily living, Music Therapy Activity Scale (SVAM) and Geriatric Music Therapy Profile (GMP) increase significantly from pre to post-test (P < .05). The protocol is feasible and data suggest that there was an effect on attentino (matrices) and prose memory skills (MPI and MPD). The effect size reveals a general improvement in the results of the experimental group.

  10. A single-blinded phenobarbital-controlled trial of levetiracetam as mono-therapy in dogs with newly diagnosed epilepsy.

    PubMed

    Fredsø, N; Sabers, A; Toft, N; Møller, A; Berendt, M

    2016-02-01

    Treatment of canine epilepsy is problematic. Few antiepileptic drugs have proven efficacy in dogs and undesirable adverse effects and pharmacoresistance are not uncommon. Consequently, the need for investigation of alternative treatment options is ongoing. The objective of this study was to investigate the efficacy and tolerability of levetiracetam as mono-therapy in dogs with idiopathic epilepsy. The study used a prospective single-blinded parallel group design. Twelve client-owned dogs were included and were randomised to treatment with levetiracetam (30 mg/kg/day or 60 mg/kg/day divided into three daily dosages) or phenobarbital (4 mg/kg/day divided twice daily). Control visits were at days 30, 60 and then every 3 months for up to 1 year. Two or more seizures within 3 months led to an increase in drug dosage (levetiracetam: 10 mg/kg/day, phenobarbital: 1 mg/kg/day). Five of six levetiracetam treated dogs and one of six phenobarbital treated dogs withdrew from the study within 2-5 months due to insufficient seizure control. In the levetiracetam treated dogs there was no significant difference in the monthly number of seizures before and after treatment, whereas in the phenobarbital treated dogs there were significantly (P = 0.013) fewer seizures after treatment. Five phenobarbital treated dogs were classified as true responders (≥50% reduction in seizures/month) whereas none of the levetiracetam treated dogs fulfilled this criterion. Adverse effects were reported in both groups but were more frequent in the phenobarbital group. In this study levetiracetam was well tolerated but was not effective at the given doses as mono-therapy in dogs with idiopathic epilepsy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Cutaneous side-effects of transdermal iontophoresis with and without surfactant pretreatment: a single-blinded, randomized controlled trial.

    PubMed

    Li, G L; Van Steeg, T J; Putter, H; Van Der Spek, J; Pavel, S; Danhof, M; Bouwstra, J A

    2005-08-01

    Iontophoresis, a method that facilitates drug transport across skin by an external electrical field, offers the possibility for long-term transdermal delivery of compounds in a well-controlled manner. In general, the literature supports the contention that iontophoresis is a safe procedure. However, there are important medical issues concerning the epidermal and dermal effects of iontophoresis that have not been extensively investigated. Specific and strictly controlled studies on the dermal effect of iontophoresis are scarce. The aim of this study was to investigate the cutaneous side-effects of transdermal iontophoresis application in healthy human volunteers. This was a single-blinded, randomized and parallel design study. In one group (n=12) subjects were treated nonocclusively with a surfactant formulation followed by iontophoresis (3-h application at a current density of 250 microA cm(-2)). In another group (n=12) iontophoresis alone was performed. No drug was included in these studies. The corresponding passive treatments served as controls. Noninvasive methods including sensation record, transepidermal water loss (TEWL), skin colour and the visual scoring were used to assess cutaneous effects. Tingling and itching were commonly experienced in the first 30 min of the current application. Iontophoresis in combination with the pretreatment induced significant increases in TEWL values and in skin redness, and resulted in slight to mild erythema and oedema compared with the control. Compared with the iontophoresis alone, the presence of surfactant pretreatment caused slightly more skin irritation (erythema and oedema) but did not further disturb the skin barrier function. The transdermal iontophoresis challenges the skin barrier function and induces transient mild skin irritation, but does not cause any permanent damage to the skin when applied for 3 h at a current density of 0.25 mA cm(-2).

  12. Pilot study of pyridostigmine in constipated patients with autonomic neuropathy

    PubMed Central

    Bharucha, Adil E.; Camilleri, Michael; Burton, Duane; Low, Phillip A.; Gehrking, Tonette L.; Zinsmeister, Alan R.

    2008-01-01

    Background The effects of cholinesterase inhibitors, which increase colonic motility in health, on chronic constipation are unknown. Our aims were to evaluate the efficacy of cholinesterase inhibitors for dysautonomia and chronic constipation and to assess whether acute effects could predict the long term response. Methods In this single-blind study, 10 patients with autonomic neuropathy and constipation were treated with placebo (2 weeks), followed by an escalating dose of pyridostigmine to the maximum tolerated dose (i.e., 180–540 mg daily) for 6 weeks. Symptoms and gastrointestinal transit were assessed at 2 and 8 weeks. The acute effects of neostigmine on colonic transit and motility were also assessed. Results At baseline, 4, 6, and 3 patients had delayed gastric, small intestinal, and colonic transit respectively. Pyridostigmine was well tolerated in most patients, improved symptoms in 4 patients, and accelerated the geometric center for colonic transit at 24 h by ≥0.7 unit in 3 patients. The effects of i.v. neostigmine on colonic transit and compliance predicted (P < 0.05) the effects of pyridostigmine on colonic transit. Conclusions Pyridostigmine improves colonic transit and symptoms in some patients with autonomic neuropathy and constipation. The motor response to neostigmine predicted the response to oral pyridostigmine. PMID:18622640

  13. Pilot study of pyridostigmine in constipated patients with autonomic neuropathy.

    PubMed

    Bharucha, Adil E; Low, Phillip A; Camilleri, Michael; Burton, Duane; Gehrking, Tonette L; Zinsmeister, Alan R

    2008-08-01

    The effects of cholinesterase inhibitors, which increase colonic motility in health, on chronic constipation are unknown. Our aims were to evaluate the efficacy of cholinesterase inhibitors for dysautonomia and chronic constipation and to assess whether acute effects could predict the long term response. In this single-blind study, 10 patients with autonomic neuropathy and constipation were treated with placebo (2 weeks), followed by an escalating dose of pyridostigmine to the maximum tolerated dose (i.e., 180-540 mg daily) for 6 weeks. Symptoms and gastrointestinal transit were assessed at 2 and 8 weeks. The acute effects of neostigmine on colonic transit and motility were also assessed. At baseline, 4, 6, and 3 patients had delayed gastric, small intestinal, and colonic transit respectively. Pyridostigmine was well tolerated in most patients, improved symptoms in 4 patients, and accelerated the geometric center for colonic transit at 24 h by > or =0.7 unit in 3 patients. The effects of i.v. neostigmine on colonic transit and compliance predicted (P < 0.05) the effects of pyridostigmine on colonic transit. Pyridostigmine improves colonic transit and symptoms in some patients with autonomic neuropathy and constipation. The motor response to neostigmine predicted the response to oral pyridostigmine.

  14. Climatotherapy in Japan: a pilot study

    NASA Astrophysics Data System (ADS)

    Kanayama, Hitomi; Kusaka, Yukinori; Hirai, Takayoshi; Inoue, Hiroyuki; Agishi, Yuko; Schuh, Angela

    2017-08-01

    Twenty-nine urban inhabitants participated in a half-day climatotherapy programme at the moderate mountain area and lowland area in the northwest part of the main island of Japan. The current study was aimed to investigate physically and mentally the objective and subjective influence of our short programme, which was a prospective pilot study of single intervention. Blood pressure was significantly descended during terrain cure at the uphill mountain path and returned after fresh-air rest cure, while there was no significant change throughout the programme at lowland flat path. Heart rate was significantly ascended and descended at both area, and more clearly changed at the mountain path. Profile of Mood Status brief form Japanese version administered before and after our half-day programme. Age adjusted T score of negative subscales, `tension-anxiety', `depression', `anger-hostility', `fatigue' and `confusion' were significantly lower after climatotherapy at both sites. Whereas, there was no significant change concerning `vigour' score. This short-version climatotherapy programme has been designed for people without enough time for long stay at health resort. It turned out our half-day climatotherapy programme contribute to mood status improvement. In addition, repeated practice of our short-version programme including endurance exercise with cool body shell using uphill path can be expected that blood pressure will go toward the normal range and heart rate will decrease both in usual time and during exercise. Therefore, health benefits can be expected of this climatotherapy programme.

  15. A pilot study of intraoral temperature changes.

    PubMed

    Youngson, C C; Barclay, C W

    2000-09-01

    The aim of this in vivo pilot study was to record variations in temperature at various sites in a subject's mouth in response to a standardised thermal challenge and to determine a more realistic thermocycling regimen for future use. A volunteer who suffered from no dentinal hypersensitivity had modified study models prepared for constructing vacuum-formed PVC splints. Perforations 2 mm in diameter were placed for thermocouples facially and lingually in the midcoronal sites of the upper and lower central incisors, canines, second premolars, and second molars to measure temperatures at these sites. A standardised drinking regimen was followed of hot black coffee (72.5 degrees C) followed by cold orange juice (6.0 degrees C). Contralateral sites experienced similar temperature changes of short duration. A maximum of 68.0 degrees C and a minimum of 15.4 degrees C were recorded. Less extreme temperatures were experienced posteriorly, and little or no discernible changes were noted at the facial aspects of the upper second molars or lingually on the lower second molars. Most commonly used thermocycling regimens are clinically unrealistic, and temperatures vary widely throughout the mouth when hot or cold drinks are taken.

  16. The DOE Water Cycle Pilot Study

    SciTech Connect

    Miller, N.L.; King, A.W.; Miller, M.A.; Springer, E.P.; Wesely, M.L.; Bashford, K.E.; Conrad, M.E.; Costigan, K.; Foster, P.N.; Gibbs, H.K.; Jin, J.; Klazura, J.; Lesht, B.M.; Machavaram, M.V.; Pan, F.; Song, J.; Troyan, D.; Washington-Allen, R.A.

    2003-09-20

    A Department of Energy (DOE) multi-laboratory Water Cycle Pilot Study (WCPS) investigated components of the local water budget at the Walnut River Watershed in Kansas to study the relative importance of various processes and to determine the feasibility of observational water budget closure. An extensive database of local meteorological time series and land surface characteristics was compiled. Numerical simulations of water budget components were generated and, to the extent possible, validated for three nested domains within the Southern Great Plains; the DOE Atmospheric Radiation Measurement/Cloud Atmospheric Radiation Testbed (ARM/CART), the Walnut River Watershed (WRW), and the Whitewater Watershed (WW), Kansas A 2-month Intensive Observation Period (IOP) was conducted to gather detailed observations relevant to specific details of the water budget, including fine-scale precipitation, streamflow, and soil moisture measurements not made routinely by other programs. Event and season al water isotope (delta 18O, delta D) sampling in rainwater, streams, soils, lakes, and wells provided a means of tracing sources and sinks within and external to the WW, WRW, and the ARM/CART domains. The WCPS measured changes in leaf area index for several vegetation types, deep groundwater variations at two wells, and meteorological variables at a number of sites in the WRW. Additional activities of the WCPS include code development toward a regional climate model with water isotope processes, soil moisture transect measurements, and water level measurements in ground water wells.

  17. GAME (Goals - Activity - Motor Enrichment): protocol of a single blind randomised controlled trial of motor training, parent education and environmental enrichment for infants at high risk of cerebral palsy.

    PubMed

    Morgan, Catherine; Novak, Iona; Dale, Russell C; Guzzetta, Andrea; Badawi, Nadia

    2014-10-07

    Cerebral palsy is the most common physical disability of childhood and early detection is possible using evidence based assessments. Systematic reviews indicate early intervention trials rarely demonstrate efficacy for improving motor outcomes but environmental enrichment interventions appear promising. This study is built on a previous pilot study and has been designed to assess the effectiveness of a goal - oriented motor training and enrichment intervention programme, "GAME", on the motor outcomes of infants at very high risk of cerebral palsy (CP) compared with standard community based care. A two group, single blind randomised controlled trial (n = 30) will be conducted. Eligible infants are those diagnosed with CP or designated "at high risk of CP" on the basis of the General Movements Assessment and/or abnormal neuroimaging. A physiotherapist and occupational therapist will deliver home-based GAME intervention at least fortnightly until the infant's first birthday. The intervention aims to optimize motor function and engage parents in developmental activities aimed at enriching the home learning environment. Primary endpoint measures will be taken 16 weeks after intervention commences with the secondary endpoint at 12 months and 24 months corrected age. The primary outcome measure will be the Peabody Developmental Motor Scale second edition. Secondary outcomes measures include the Gross Motor Function Measure, Bayley Scales of Infant and Toddler Development, Affordances in the Home Environment for Motor Development - Infant Scale, and the Canadian Occupational Performance Measure. Parent well-being will be monitored using the Depression Anxiety and Stress Scale. This paper presents the background, design and intervention protocol of a randomised trial of a goal driven, motor learning approach with customised environmental interventions and parental education for young infants at high risk of cerebral palsy. This trial is registered on the Australian

  18. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis.

    PubMed

    Shapiro, Shane A; Kazmerchak, Shari E; Heckman, Michael G; Zubair, Abba C; O'Connor, Mary I

    2017-01-01

    Bone marrow aspirate concentrate (BMAC) is increasingly used as a regenerative therapy for musculoskeletal pathological conditions despite limited evidence-based support. BMAC will prove feasible, safe, and efficacious for the treatment of pain due to mild to moderate degenerative joint disease of the knee. Randomized controlled trial; Level of evidence, 2. In this prospective, single-blind, placebo-controlled trial, 25 patients with bilateral knee pain from bilateral osteoarthritis were randomized to receive BMAC into one knee and saline placebo into the other. Fifty-two milliliters of bone marrow was aspirated from the iliac crests and concentrated in an automated centrifuge. The resulting BMAC was combined with platelet-poor plasma for an injection into the arthritic knee and was compared with a saline injection into the contralateral knee, thereby utilizing each patient as his or her own control. Safety outcomes, pain relief, and function as measured by Osteoarthritis Research Society International (OARSI) measures and the visual analog scale (VAS) score were tracked initially at 1 week, 3 months, and 6 months after the procedure. There were no serious adverse events from the BMAC procedure. OARSI Intermittent and Constant Osteoarthritis Pain and VAS pain scores in both knees decreased significantly from baseline at 1 week, 3 months, and 6 months ( P ≤ .019 for all). Pain relief, although dramatic, did not differ significantly between treated knees ( P > .09 for all). Early results show that BMAC is safe to use and is a reliable and viable cellular product. Study patients experienced a similar relief of pain in both BMAC- and saline-treated arthritic knees. Further study is required to determine the mechanisms of action, duration of efficacy, optimal frequency of treatments, and regenerative potential. Registration: ClinicalTrials.gov record 12-004459.

  19. Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial.

    PubMed

    Sebio García, Raquel; Yáñez-Brage, Maria Isabel; Giménez Moolhuyzen, Esther; Salorio Riobo, Marta; Lista Paz, Ana; Borro Mate, Jose María

    2017-08-01

    To investigate the effects of a preoperative pulmonary rehabilitation programme in patients with lung cancer undergoing video-assisted thoracic surgery. Randomized, single-blind controlled trial. Teaching hospital. Patients with suspected or confirmed lung cancer undergoing video-assisted thoracic surgery. Participants were randomized to either a prehabilitation group or a control group. Participants in the prehabilitation group underwent a combination of moderate endurance and resistance training plus breathing exercises three to five times per week. The primary outcome of the study was exercise capacity. Secondary outcomes were muscle strength (Senior Fitness Test), health-related quality of life (Short-Form 36) and the postoperative outcomes. Patients were evaluated at baseline (before randomization), presurgery (only the prehabilitation group), after surgery and three months post-operatively. A total of 40 patients were randomized and 22 finished the study (10 in the prehabilitation group and 12 in the control group). Three patients were lost to follow-up at three months. After the training, there was a statistically significant improvement in exercise tolerance (+397 seconds, p = 0.0001), the physical summary component of the SF-36 (+4.4 points, p = 0.008) and muscle strength ( p < 0.01). There were no significant differences between groups after surgery. However, three months postoperatively, significant differences were found in the mean change of exercise capacity ( p = 0.005), physical summary component ( p = 0.001) and upper and lower body strength ( p = 0.045 and p = 0.002). A pulmonary rehabilitation programme before video-assisted thoracic surgery seems to improve patients' preoperative condition and may prevent functional decline after surgery. Clinical Registration Number: NCT01963923 (Registration date 10/10/2013).

  20. Perceptive rehabilitation and trunk posture alignment in patients with Parkinson disease: a single blind randomized controlled trial.

    PubMed

    Morrone, Michelangelo; Miccinilli, Sandra; Bravi, Marco; Paolucci, Teresa; Melgari, Jean M; Salomone, Gaetano; Picelli, Alessandro; Spadini, Ennio; Ranavolo, Alberto; Saraceni, Vincenzo M; DI Lazzaro, Vincenzo; Sterzi, Silvia

    2016-12-01

    Recent studies aimed to evaluate the potential effects of perceptive rehabilitation in Parkinson Disease reporting promising preliminary results for postural balance and pain symptoms. To date, no randomized controlled trial was carried out to compare the effects of perceptive rehabilitation and conventional treatment in patients with Parkinson Disease. To evaluate whether a perceptive rehabilitation treatment could be more effective than a conventional physical therapy program in improving postural control and gait pattern in patients with Parkinson Disease. Single blind, randomized controlled trial. Department of Physical and Rehabilitation Medicine of a University Hospital. Twenty outpatients affected by idiopathic Parkinson Disease at Hoehn and Yahr stage ≤3. Recruited patients were divided into two groups: the first one underwent individual treatment with Surfaces for Perceptive Rehabilitation (Su-Per), consisting of rigid wood surfaces supporting deformable latex cones of various dimensions, and the second one received conventional group physical therapy treatment. Each patient underwent a training program consisting of ten, 45-minute sessions, three days a week for 4 consecutive weeks. Each subject was evaluated before treatment, immediately after treatment and at one month of follow-up, by an optoelectronic stereophotogrammetric system for gait and posture analysis, and by a computerized platform for stabilometric assessment. Kyphosis angle decreased after ten sessions of perceptive rehabilitation, thus showing a substantial difference with respect to the control group. No significant differences were found as for gait parameters (cadence, gait speed and stride length) within Su-Per group and between groups. Parameters of static and dynamic evaluation on stabilometric platform failed to demonstrate any statistically relevant difference both within-groups and between-groups. Perceptive training may help patients affected by Parkinson Disease into restoring

  1. Shockwave treatment for medial tibial stress syndrome in military cadets: A single-blind randomized controlled trial.

    PubMed

    Gomez Garcia, Santiago; Ramon Rona, Silvia; Gomez Tinoco, Martha Claudia; Benet Rodriguez, Mikhail; Chaustre Ruiz, Diego Mauricio; Cardenas Letrado, Francia Piedad; Lopez-Illescas Ruiz, África; Alarcon Garcia, Juan Maria

    2017-09-05

    Medial tibial stress syndrome (MTSS) is a common injury in athletes and soldiers. Several studies have demonstrated the effectiveness of extracorporeal shockwave treatment (ESWT) in athletes with MTSS. To assess whether one session of focused ESWT is effective in the treatment of military cadets with MTSS. A randomized, prospective, controlled, single-blind, parallel-group clinical study. Ib. Military School of Cadets of the Colombian Army. Forty-two military cadets with unilateral chronic MTSS were randomly assigned to either one session of focused electromagnetic ESWT (1500 pulses at 0.20 mJ/mm(2)) plus a specific exercise programme (muscle stretching and strengthening exercises) or the exercise programme alone. The primary endpoint was change in asymptomatic running test (RT) duration at four weeks from baseline. Secondary endpoints were changes in the visual analogue scale (VAS) after running and modified Roles and Maudsley (RM) score also at four weeks from baseline. ESWT patients were able to run longer. Mean RT after four weeks was 17 min 33 s (SE: 2.36) compared to 4 min 48 s (SE: 1.03) in the exercise-only group (p = 0.000). Mean VAS after running was 2.17 (SE: 0.44) in the ESWT group versus 4.26 (SE: 0.36) in the exercise-only group (p = 0.001). The ESWT group had a significantly higher RM score, with excellent or good results for 82.6% of patients vs. 36.8% in the exercise-only group (p = 0.002). No significant adverse effects of ESWT were observed. A single application of focused shockwave treatment in combination with a specific exercise programme accelerates clinical and functional recovery in military cadets with MTSS. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  2. Myofascial Pain Syndrome in the Elderly and Self-Exercise: A Single-Blind, Randomized, Controlled Trial

    PubMed Central

    Kim, Minhee; Lee, Minyoung; Kim, Yushin; Oh, Sejun; Lee, Dongshin

    2016-01-01

    Abstract Objective: This study aimed to demonstrate the effect of self-exercise with a therapeutic inflatable ball (SEIB) in elderly patients with myofascial pain syndrome. Design: Single-blind, randomized, controlled noninferiority trial. Setting: University campus. Participants: Forty elderly patients with myofascial pain syndrome completed the study. They were randomly allocated to SEIB (n = 22; mean age, 70.23 ± 6.11 years) or ultrasound (US) therapy (n = 18; mean age, 67.99 ± 5.64 years). Intervention: SEIB and US therapy (twice weekly for 4 consecutive weeks). Outcome measures: Visual analog scale (VAS), pressure pain threshold (PPT), and cervical lateral flexion (CLF) were measured at baseline and at 1, 2, 3, and 4 weeks. Results: The noninferiority test indicated that SEIB was not inferior to US for VAS, PPT, and CLF. Between-group comparisons showed no significant differences in the VAS (F = 2.579; p = 0.117), the PPT (F = 0.245; p = 0.624), and the CLF (F = 2.072; p = 0.159). In within-group comparisons, both groups presented significant differences in VAS (SEIB after 1 week and US after 1 week), PPT (SEIB after 3 weeks and US after 4 weeks), and CLF (SEIB after 4 weeks and US after 4 weeks) compared with baseline values. Conclusions: SEIB for 4 weeks has an effect similar to that of US for desensitizing myofascial pain and increasing joint flexibility. High accessibility and low cost would make SEIB a practical self-treatment method in elderly patients with myofascial pain syndrome. PMID:26910293

  3. Myofascial Pain Syndrome in the Elderly and Self-Exercise: A Single-Blind, Randomized, Controlled Trial.

    PubMed

    Kim, Minhee; Lee, Minyoung; Kim, Yushin; Oh, Sejun; Lee, Dongshin; Yoon, BumChul

    2016-03-01

    This study aimed to demonstrate the effect of self-exercise with a therapeutic inflatable ball (SEIB) in elderly patients with myofascial pain syndrome. Single-blind, randomized, controlled noninferiority trial. University campus. Forty elderly patients with myofascial pain syndrome completed the study. They were randomly allocated to SEIB (n = 22; mean age, 70.23 ± 6.11 years) or ultrasound (US) therapy (n = 18; mean age, 67.99 ± 5.64 years). SEIB and US therapy (twice weekly for 4 consecutive weeks). Visual analog scale (VAS), pressure pain threshold (PPT), and cervical lateral flexion (CLF) were measured at baseline and at 1, 2, 3, and 4 weeks. The noninferiority test indicated that SEIB was not inferior to US for VAS, PPT, and CLF. Between-group comparisons showed no significant differences in the VAS (F = 2.579; p = 0.117), the PPT (F = 0.245; p = 0.624), and the CLF (F = 2.072; p = 0.159). In within-group comparisons, both groups presented significant differences in VAS (SEIB after 1 week and US after 1 week), PPT (SEIB after 3 weeks and US after 4 weeks), and CLF (SEIB after 4 weeks and US after 4 weeks) compared with baseline values. SEIB for 4 weeks has an effect similar to that of US for desensitizing myofascial pain and increasing joint flexibility. High accessibility and low cost would make SEIB a practical self-treatment method in elderly patients with myofascial pain syndrome.

  4. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial.

    PubMed

    Guétin, Stéphane; Giniès, Patrick; Siou, Didier Kong A; Picot, Marie-Christine; Pommié, Christelle; Guldner, Elisabeth; Gosp, Anne-Marie; Ostyn, Katelyne; Coudeyre, Emmanuel; Touchon, Jacques

    2012-05-01

    A music intervention method in the management of pain was recently developed while taking account of recommendations in the scientific literature. The objective of this study was to assess the usefulness of this music intervention to the management of patients with chronic pain. A controlled, single-blind, randomized trial was used. Eighty-seven patients presenting with lumbar pain, fibromyalgia, inflammatory disease, or neurological disease were included in the study. During their hospitalization, the intervention arm (n=44) received at least 2 daily sessions of music listening between D0 and D10, associated with their standard treatment, and then pursued the music intervention at home until D60 using a multimedia player in which the music listening software program had been installed. The control arm received standard treatment only (n=43). The end points measured at D0, D10, D60, and D90 were: pain (VAS), anxiety-depression (HAD) and the consumption of medication. At D60 in the music intervention arm, this technique enabled a more significant reduction (P<0.001) in pain (6.3 ± 1.7 at D0 vs. 3 ± 1.7 at D60) when compared with the arm without music intervention (6.2 ± 1.5 at D0 vs. 4.6 ± 1.7 at D60). In addition, music intervention contributed to significantly reducing both anxiety/depression and the consumption of anxiolytic agents. These results confirm the value of music intervention to the management of chronic pain and anxiety/depression. This music intervention method appears to be useful in managing chronic pain as it enables a significant reduction in the consumption of medication.

  5. Role of Omega-3 Fatty Acids on Lipid Profile in Diabetic Dyslipidaemia: Single Blind, Randomised Clinical Trial.

    PubMed

    Chauhan, Shaylika; Kodali, Hanish; Noor, Jawad; Ramteke, Karuna; Gawai, Vidisha

    2017-03-01

    Diabetic dyslipidaemia is characterised by hypertriglyceridaemia, low High Density Lipoprotein (HDL), postprandial lipimea, small and dense LDL particles is considered to be a major predisposing factor for various macrovascular complications. Omega-3 fatty acids are fish oil derivative introduced in the market for dyslipidaemia associated with increased triglyceride level. To study the effect of omega-3 fatty acids on lipid profile in Type II diabetes patients. This study was prospective, single blind, randomized comparative trial. Hundred patients were randomized into three groups. Group I received metformin 500 mg twice daily and placebo, Group II received metformin 500 mg twice daily and omega-3 fatty acids (1 gram) once daily and the Group III received metformin 500 mg twice daily and omega-3 fatty acids (1 gram) twice daily. ANOVA test was applied for analysis. Group II was effective in reducing the triglyceride level from 144.59±14.18 mg/dl to 101±13.31 mg/dl which was significant as compared to Group I from 147.67±18.57 mg/dl to 145.8±19.86 mg/dl respectively. Group III containing 1 g of omega-3 fatty acids twice daily showed decrease from 144.83±22.17 mg/dl to 86±17.46 mg/dl and was more effective in reducing triglyceride levels than Group II containing 1 gram of omega-3 fatty acids once daily. Omega-3 fatty acids can be given in conjunction with metformin to reduce triglyceride levels in diabetic dyslipidaemia without any adverse drug reactions or any drug interaction. Omega-3 fatty acids were effective in reducing the triglyceride level significantly as compared to placebo. Two grams of omega-3 fatty acids were more effective than 1 gram of omega-3 fatty acids in reducing triglyceride levels.

  6. Role of Omega-3 Fatty Acids on Lipid Profile in Diabetic Dyslipidaemia: Single Blind, Randomised Clinical Trial

    PubMed Central

    Kodali, Hanish; Noor, Jawad; Ramteke, Karuna; Gawai, Vidisha

    2017-01-01

    Introduction Diabetic dyslipidaemia is characterised by hypertriglyceridaemia, low High Density Lipoprotein (HDL), postprandial lipimea, small and dense LDL particles is considered to be a major predisposing factor for various macrovascular complications. Omega-3 fatty acids are fish oil derivative introduced in the market for dyslipidaemia associated with increased triglyceride level. Aim To study the effect of omega-3 fatty acids on lipid profile in Type II diabetes patients. Materials and Methods This study was prospective, single blind, randomized comparative trial. Hundred patients were randomized into three groups. Group I received metformin 500 mg twice daily and placebo, Group II received metformin 500 mg twice daily and omega-3 fatty acids (1 gram) once daily and the Group III received metformin 500 mg twice daily and omega-3 fatty acids (1 gram) twice daily. ANOVA test was applied for analysis. Results Group II was effective in reducing the triglyceride level from 144.59±14.18 mg/dl to 101±13.31 mg/dl which was significant as compared to Group I from 147.67±18.57 mg/dl to 145.8±19.86 mg/dl respectively. Group III containing 1 g of omega-3 fatty acids twice daily showed decrease from 144.83±22.17 mg/dl to 86±17.46 mg/dl and was more effective in reducing triglyceride levels than Group II containing 1 gram of omega-3 fatty acids once daily. Conclusion Omega-3 fatty acids can be given in conjunction with metformin to reduce triglyceride levels in diabetic dyslipidaemia without any adverse drug reactions or any drug interaction. Omega-3 fatty acids were effective in reducing the triglyceride level significantly as compared to placebo. Two grams of omega-3 fatty acids were more effective than 1 gram of omega-3 fatty acids in reducing triglyceride levels. PMID:28511427

  7. Aesthetic comparison between synthetic glue and subcuticular sutures in thyroid and parathyroid surgery: a single-blinded randomised clinical trial.

    PubMed

    Alicandri-Ciufelli, M; Piccinini, A; Grammatica, A; Molteni, G; Spaggiari, A; DI Matteo, S; Tassi, S; Ghidini, A; Izzo, L; Gioacchini, F M; Marchioni, D; DI Saverio, S; Presutti, L

    2014-12-01

    The aim of our study was to compare, in terms of aesthetic results, the use of synthetic glue to intradermal absorbable sutures in postthyroidectomy and parathyroidectomy wound closure in a single blinded, randomised, per protocol equivalence study. From September 2008 to May 2010, patients undergoing thyroid or parathyroid surgery (with an external approach) at the Otolaryngology Department of the University Hospital of Modena were assessed for eligibility. In total, 42 patients who had had synthetic glue application on surgical incisions (A) and 47 patients who had subcuticular sutures on their surgical incisions (B) were enrolled. The mean of the endpoint (based on the Wound Registry Scale) of group A at 10 days was 1.4, while that in group B (based on the Stony Brook Scar Evaluation Scale) was 2.9. Statistically significant (p = 0.002) and clinically significant (difference of the means = 1.5) differences in the aesthetic results were found between groups A and B at 10 days, with better results in group B. On the other hand, at 3 months, the mean of the endpoint in group A was 3.1 while that in group B was 2.8; no statistically significant (p = 0.62) or clinically significant (difference in means = 0.3) differences were found between groups A and B. In conclusion, synthetic glue differs from subcuticular suture in post-thyroidectomy or post-parathyroidectomy incision for early aesthetic results, with better outcomes for subcuticular sutures. At 3 months, there were no differences in aesthetic outcomes between groups. Moreover, sex, incision length, age, cold/hot blade and correspondence of the incision with a wrinkle in the skin did not seem to influence aesthetic outcomes with this type of incision.

  8. Piloted simulation study of two tilt-wing control concepts

    NASA Technical Reports Server (NTRS)

    Birckelbaw, Lourdes G.; Corliss, Lloyd D.

    1992-01-01

    A two phase piloted simulation study was conducted to investigate alternative wing and flap controls for tilt-wing aircraft. The initial phase of the study compared the flying qualities of both a conventional (programmed) flap and an innovative geared flap. The second phase of the study introduced an alternate method of pilot control for the geared flap and further studied the flying qualities of the programmed flap, and two geared flap configurations. In general, the pilot ratings showed little difference between the programmed flap and the geared flap control concepts, although differences between the two control concepts were noticed and are discussed in this paper. The addition of pitch attitude stabilization in the second phase of the study greatly enhanced the aircraft flying qualities. This paper describes the simulated tilt-wing aircraft and the flap control concepts, and presents the results of both the first and second phases of the piloted simulation study.

  9. Effect of a wound cleansing solution on wound bed preparation and inflammation in chronic wounds: a single-blind RCT.

    PubMed

    Bellingeri, A; Falciani, F; Traspedini, P; Moscatelli, A; Russo, A; Tino, G; Chiari, P; Peghetti, A

    2016-03-01

    Research into surfactant solutions for the debridement of chronic wounds suggests that surfactants may support wound bed preparation (WBP) in chronic wounds, however their efficacy has not been evaluated in randomised controlled trials (RCTs). Our aim was to assess the clinical efficacy of a propylbetaine-polihexanide (PP) solution versus normal saline (NS) solution in WBP, assessing inflammatory signs and wound size reduction in patients with pressure ulcers (PUs) or vascular leg ulcers. In a single-blinded randomised controlled trial (RCT) patients were randomly allocated to two groups and treated with either propylbetaine-polihexanide (PP) solution (Prontosan) or NS. Wounds were assessed using the Bates-Jensen wound assessment tool (BWAT). Assessments took place at inclusion (T0), day 7 (T1), day 14 (T2), day 21 (T3), and day 28 (T4). Outcomes were analysed using a two-tailed Student's t-test. A total of 289 patients were included. Both groups had similar demographics, clinical status, and wound characteristics. Data analysis showed statistically significant differences between T0 and T4 for the following outcomes: BWAT total score, p=0.0248; BWAT score for inflammatory items, p=0.03; BWAT scores for wound size reduction (p=0.049) and granulation tissue improvement (p=0.043), all in favour of PP. The assessment of pain did not show any significant difference between the two groups. The study results showed significantly higher efficacy of the PP solution versus NS solution, in reducing inflammatory signs and accelerating the healing of vascular leg ulcers and PUs. This evidence supports the update of protocols for the care of chronic wounds. The authors have no conflict of interest regarding this research. This is an investigator initiated trial. B. Braun Milano SpA kindly provided the material under investigation for both treatment groups, and paid the Ethics Committees' application fees in all participating centres.

  10. The effectiveness of a standardised preoperative preparation in reducing child and parent anxiety: a single-blind randomised controlled trial.

    PubMed

    Fincher, Wendy; Shaw, Jane; Ramelet, Anne-Sylvie

    2012-04-01

    To evaluate the effect of a structured preoperative preparation on child and parent state anxiety, child behavioural change and parent satisfaction. It is estimated that around 50-70% of hospitalised children experience severe anxiety and distress prior to surgery. Children who are highly anxious and distressed preoperatively are likely to be distressed on awakening and have negative postoperative behaviour. Although education before surgery has been found to be useful mostly in North America, the effectiveness of preoperative preparation programme adapted to the Australian context remains to be tested. This single-blind randomised controlled study was conducted at a tertiary referral hospital for children in Western Australia. Following ethics approval and parental consent, 73 children and one of their carers (usually a parent) were randomly assigned into two groups. The control group had standard practice with no specific preoperative education and the experimental group received a preoperative preparation, including a photo file, demonstration of equipment using a role-modelling approach and a tour. The preoperative preparation reduced parent state anxiety significantly (-2·32, CI -4·06 to -0·56, p = 0·009), but not child anxiety (-0·59, CI -1·23 to 0·06, p = 0·07). There was no significant difference in child postoperative behaviour or parent satisfaction between the groups. There was a significant two-point pain score reduction in the preoperative preparation group, when compared with the control group median 2 (IQR 5) and 4 (IQR 4), respectively (p = 0·001). Preoperative preparation was more efficient on parent than child. Although the preoperative preparation had limited effect on child anxiety, it permitted to decrease pain experience in the postoperative period. Parents should be actively involved in their child preoperative preparation. © 2012 Blackwell Publishing Ltd.

  11. Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial.

    PubMed

    Chaibi, A; Benth, J Š; Tuchin, P J; Russell, M B

    2017-01-01

    To investigate the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs. This was a prospective three-armed, single-blinded, placebo, randomized controlled trial (RCT) of 17 months duration including 104 migraineurs with at least one migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1-month run-in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow-up. The primary end-point was the number of migraine days per month, whereas secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption. Migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo group at all follow-up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (P > 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow-up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT. It is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response. © 2016 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

  12. First "glass" education: telementored cardiac ultrasonography using Google Glass- a pilot study.

    PubMed

    Russell, Patrick M; Mallin, Michael; Youngquist, Scott T; Cotton, Jennifer; Aboul-Hosn, Nael; Dawson, Matt

    2014-11-01

    The objective of this study was to determine the feasibility of telementored instruction in bedside ultrasonography (US) using Google Glass. The authors sought to examine whether first-time US users could obtain adequate parasternal long axis (PSLA) views to approximate ejection fraction (EF) using Google Glass telementoring. This was a prospective, randomized, single-blinded study. Eighteen second-year medical students were randomized into three groups and tasked with obtaining PSLA cardiac imaging. Group A received real-time telementored education through Google Glass via Google Hangout from a remotely located expert. Group B received bedside education from the same expert. Group C represented the control and received no instruction. Each subject was given 3 minutes to obtain a best PSLA cardiac imaging using a portable GE Vscan. Image clips obtained by each subject were stored. A second expert, blinded to instructional mode, evaluated images for adequacy and assigned an image quality rating on a 0 to 10 scale. Group A was able to obtain adequate images six out of six times (100%) with a median image quality rating of 7.5 (interquartile range [IQR] = 6 to 10) out of 10. Group B was also able to obtain adequate views six out of six times (100%), with a median image quality rating of 8 (IQR = 7 to 9). Group C was able to obtain adequate views one out of six times (17%), with a median image quality of 0 (IQR = 0 to 2). There were no statistically significant differences between Group A and Group B in the achievement of adequate images for E-point septal separation measurement or in image quality. In this pilot/feasibility study, novice US users were able to obtain adequate imaging to determine a healthy patient's EF through telementored education using Google Glass. These preliminary data suggest telementoring as an adequate means of medical education in bedside US. This conclusion will need to be validated with larger, more powerful studies including evaluation of

  13. 1999 ANNUAL REPORT NATO/CCMS PILOT STUDY

    EPA Science Inventory

    This annual report present the proceedings of the second annual NATO/CCMS pilot study meeting in Belfast, UK in March 1999. Guest speakers focused on efforts in the research arena of clean products, clean processes, and pollution prevention tools.

  14. 1999 ANNUAL REPORT NATO/CCMS PILOT STUDY

    EPA Science Inventory

    This annual report present the proceedings of the second annual NATO/CCMS pilot study meeting in Belfast, UK in March 1999. Guest speakers focused on efforts in the research arena of clean products, clean processes, and pollution prevention tools.

  15. Answering Fixed Response Items in Chemistry: A Pilot Study.

    ERIC Educational Resources Information Center

    Hateley, R. J.

    1979-01-01

    Presents a pilot study on student thinking in chemistry. Verbal comments of a group of six college students were recorded and analyzed to identify how each student arrives at the correct answer in fixed response items in chemisty. (HM)

  16. Effect of transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance: a pilot randomized study

    PubMed Central

    2014-01-01

    Background Impaired glucose tolerance (IGT) is a pre-diabetic state of hyperglycemia that is associated with insulin resistance, increased risk of type II diabetes, and cardiovascular pathology. Recently, investigators hypothesized that decreased vagus nerve activity may be the underlying mechanism of metabolic syndrome including obesity, elevated glucose levels, and high blood pressure. Methods In this pilot randomized clinical trial, we compared the efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) and sham taVNS on patients with IGT. 72 participants with IGT were single-blinded and were randomly allocated by computer-generated envelope to either taVNS or sham taVNS treatment groups. In addition, 30 IGT adults were recruited as a control population and not assigned treatment so as to monitor the natural fluctuation of glucose tolerance in IGT patients. All treatments were self-administered by the patients at home after training at the hospital. Patients were instructed to fill in a patient diary booklet each day to describe any side effects after each treatment. The treatment period was 12 weeks in duration. Baseline comparison between treatment and control group showed no difference in weight, BMI, or measures of systolic blood pressure, diastolic blood pressure, fasting plasma glucose (FPG), 2-hour plasma glucose (2hPG), or glycosylated hemoglobin (HbAlc). Results 100 participants completed the study and were included in data analysis. Two female patients (one in the taVNS group, one in the sham taVNS group) dropped out of the study due to stimulation-evoked dizziness. The symptoms were relieved after stopping treatment. Compared with sham taVNS, taVNS significantly reduced the two-hour glucose tolerance (F(2) = 5.79, p = 0.004). In addition, we found that taVNS significantly decreased (F(1) = 4.21, p = 0.044) systolic blood pressure over time compared with sham taVNS. Compared with the no-treatment control group, patients

  17. Freshman Strategy Seminar. A Pilot Study.

    ERIC Educational Resources Information Center

    Magid, Annette; And Others

    In fall 1987, a Freshman Strategy Seminar (FSS) was pilot tested and evaluated at Erie Community College's (ECC's) South Campus to assist students lacking basic English and mathematics skills. Developmental class sections in writing, reading and math were reserved for the FSS students, in the hope that a cluster course approach would reduce…

  18. The Pilot Training Study: Precommissioning Training.

    ERIC Educational Resources Information Center

    Cook, J. W.

    The cost of training, as conducted by the Air Force Academy, Reserve Officer Training Corps, and Officer Training School, and leading to the commissioning of new Air Force officers is presented. The student flows, personnel resources required to support the flows, and costs of pilot candidates graduating from each of the three commissioning…

  19. Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation.

    PubMed

    Kaur, Navaldeep; Figueiredo, Sabrina; Bouchard, Vanessa; Moriello, Carolina; Mayo, Nancy

    2017-09-01

    Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word 'pilot' or 'feasibility' was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. The specific purposes of piloting were stated in only 58% ( n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources.

  20. SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

    EPA Science Inventory

    This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

  1. Effects of transcutaneous electric acupoint stimulation on drug use and responses to cue-induced craving: a pilot study

    PubMed Central

    2012-01-01

    Background Transcutaneous electric acupoint stimulation (TEAS) avoids the use of needles, and instead delivers a mild electric current at traditional acupoints. This technique has been used for treating heroin addiction, but has not been systematically tested for other drugs of abuse. This study aims to investigate the effects of TEAS on drug addiction. Methods Volunteers who were either cocaine-dependent (n = 9) or cannabis-dependent (n = 11) but were not seeking treatment for their dependence participated in a within-subject, single-blind study. Treatment consisted of twice daily 30-minute sessions of TEAS or sham stimulation for 3.5 days. The active TEAS levels were individually adjusted to produce a distinct twitching response in the fingers, while the sham stimulation involved 2 minutes of stimulation at threshold levels followed by 28 minutes of stimulation below the detection levels. The participants recorded their drug use and drug cravings daily. At 1 hour after the last morning session of TEAS or sham stimulation, a cue-induced craving EEG evaluation was conducted. Event-related P300 potentials (ERPs) were recorded, sorted, and analyzed for specific image types (neutral objects, non-drug-related arousing images, or drug-related images). Results TEAS treatment did not significantly reduce the drug use or drug cravings, or significantly alter the ERP peak voltage or latency to peak response. However, the TEAS treatment did significantly modulate several self-reported measures of mood and anxiety. Conclusion The results of this pilot study with a limited sample size suggest that the acupoint stimulation techniques and protocol used in this trial alone do not significantly reduce cravings for or use of cocaine or cannabis. The findings that TEAS modulates mood and anxiety suggest that TEAS could be used as an adjunct in a multimodal therapy program to treat cocaine and cannabis dependence if confirmed in a full randomized controlled clinical trial

  2. Depressive Symptoms and Physical Performance in the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) Study

    PubMed Central

    Matthews, Margaret M.; Hsu, Fang-Chi; Walkup, Michael P.; Barry, Lisa C.; Patel, Kushang V.; Blair, Steven N.

    2011-01-01

    OBJECTIVES To determine whether the presence of high depressive symptoms diminished physical performance benefits after a comprehensive physical activity intervention in older adults. STUDY DESIGN A post-hoc analysis of data from the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) study which was a single blind randomized controlled trial comparing a moderate intensity physical activity intervention (PA) with a successful aging control (SA). SETTING Multi-center U.S. sites participating in the LIFE-P trial. PARTICIPANTS LIFE-P trial participants included 424 sedentary, non-institutionalized adults (70–89 years). MEASUREMENTS Depressive symptoms were assessed by the Centers for Epidemiological Studies Depression Scale (CES-D). Physical performance tests included the Short Physical Performance Battery (SPPB) and 400 meter walk time (400 mw) at baseline, 6 and 12 months. RESULTS Of the participants, 15.8% had high depressive symptom scores (CES-D ≥ 14). For participants with low depressive symptoms, SPPB scores improved in the PA versus the SA group over 12 months (adjusted score difference: +0.70; p = <0.001 at 6 months and +0.58; p=0.004 at 12 months) while the 400 mw times improved in the PA group at 6 months (adjusted score difference −0.41 min.; p=0.021). For those with high depressive symptoms, a trend toward statistical improvement in the SPPB was observed in the PA versus SA group (adjusted score difference +0.76 (p=0.176) at 6 months and +0.94 (p=0.116) at 12 months). CONCLUSION The presence of high depressive symptoms did not substantially diminish physical performance benefits realized after a PA intervention in sedentary older adults. PMID:21391940

  3. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial.

    PubMed

    Dilek, Banu; Gözüm, Mehtap; Şahin, Ebru; Baydar, Meltem; Ergör, Gül; El, Ozlem; Bircan, Çigdem; Gülbahar, Selmin

    2013-04-01

    To evaluate the efficacy of paraffin bath therapy on pain, function, and muscle strength in patients with hand osteoarthritis. Prospective single-blinded randomized controlled trial. Department of physical medicine and rehabilitation in a university hospital. Patients with bilateral hand osteoarthritis (N=56). Patients were randomized into 2 groups with a random number table by using block randomization with 4 patients in a block. Group 1 (n=29) had paraffin bath therapy (5 times per week, for 3-week duration) for both hands. Group 2 (n=27) was the control group. All patients were informed about joint-protection techniques, and paracetamol intake was recorded. The primary outcome measures were pain (at last 48h) at rest and during activities of daily living (ADL), assessed with a visual analog scale (0-10cm) at 12 weeks. The secondary outcome measures were the Australian Canadian Osteoarthritis Hand Index (AUSCAN) and the Dreiser Functional Index (DFI), used for subjective functional evaluation, loss of range of motion (ROM), grip and pinch strength, painful and tender joint counts, and paracetamol intake. A researcher blind to group allocation recorded the measures for both hands at baseline, 3 weeks, and 12 weeks at the hospital setting. At baseline, there were no significant differences between groups in any of the parameters (P>.05). After treatment, the paraffin group exhibited significant improvement in pain at rest and during ADL, ROM of the right hand, and pain and stiffness dimensions of the AUSCAN (P<.05). There was no significant improvement in functional dimension of the AUSCAN and the DFI (P>.05). The control group showed a significant deterioration in right hand grip and bilateral lateral pinch and right chuck pinch strength (P<.05), but there was no significant change in the other outcome measures. When the 2 groups were compared, pain at rest, both at 3 and 12 weeks, and the number of painful and tender joints at 12 weeks significantly decreased in

  4. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial.

    PubMed

    Enander, Jesper; Andersson, Erik; Mataix-Cols, David; Lichtenstein, Linn; Alström, Katarina; Andersson, Gerhard; Ljótsson, Brjánn; Rück, Christian

    2016-02-02

    To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. A 12 week single blind parallel group randomised controlled trial. Academic medical centre. 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high. CBT can be delivered safely via the internet to patients with body

  5. Long-term effects of transcranial direct-current stimulation in chronic post-stroke aphasia: a pilot study.

    PubMed

    Vestito, Lucilla; Rosellini, Sara; Mantero, Massimo; Bandini, Fabio

    2014-01-01

    Transcranial direct-current stimulation (tDCS) has been suggested to improve language function in patients with post-stroke aphasia. Most studies on aphasic patients, however, were conducted with a very limited follow-up period, if any. In this pilot, single-blind study on chronic post-stroke aphasic patients, we aimed to verify whether or not tDCS is able to extend its beneficial effects for a longer period of time (21 weeks after the end of stimulation). Three aphasic patients underwent anodal tDCS (A-tDCS, 20 min, 1.5 mA) and sham stimulation (S-tDCS) over the left frontal (perilesional) region, coupled with a simultaneous naming training (on-line tDCS). Ten consecutive sessions (5 days per week for 2 weeks) were implemented. In the first five sessions, we used a list of 40 figures, while in the subsequent five sessions we utilized a second set of 40 figures differing in word difficulty. At the end of the stimulation period, we found a significant beneficial effect of A-tDCS (as compared to baseline and S-tDCS) in all our subjects, regardless of word difficulty, although with some inter-individual differences. In the follow-up period, the percentage of correct responses persisted significantly better until the 16th week, when an initial decline in naming performance was observed. Up to the 21st week, the number of correct responses, though no longer significant, was still above the baseline level. These results in a small group of aphasic patients suggest a long-term beneficial effect of on-line A-tDCS.

  6. Long-Term Effects of Transcranial Direct-Current Stimulation in Chronic Post-Stroke Aphasia: A Pilot Study

    PubMed Central

    Vestito, Lucilla; Rosellini, Sara; Mantero, Massimo; Bandini, Fabio

    2014-01-01

    Transcranial direct-current stimulation (tDCS) has been suggested to improve language function in patients with post-stroke aphasia. Most studies on aphasic patients, however, were conducted with a very limited follow-up period, if any. In this pilot, single-blind study on chronic post-stroke aphasic patients, we aimed to verify whether or not tDCS is able to extend its beneficial effects for a longer period of time (21 weeks after the end of stimulation). Three aphasic patients underwent anodal tDCS (A-tDCS, 20 min, 1.5 mA) and sham stimulation (S-tDCS) over the left frontal (perilesional) region, coupled with a simultaneous naming training (on-line tDCS). Ten consecutive sessions (5 days per week for 2 weeks) were implemented. In the first five sessions, we used a list of 40 figures, while in the subsequent five sessions we utilized a second set of 40 figures differing in word difficulty. At the end of the stimulation period, we found a significant beneficial effect of A-tDCS (as compared to baseline and S-tDCS) in all our subjects, regardless of word difficulty, although with some inter-individual differences. In the follow-up period, the percentage of correct responses persisted significantly better until the 16th week, when an initial decline in naming performance was observed. Up to the 21st week, the number of correct responses, though no longer significant, was still above the baseline level. These results in a small group of aphasic patients suggest a long-term beneficial effect of on-line A-tDCS. PMID:25352798

  7. Cardiovascular effect of dental anesthesia with articaine (40 mg with epinefrine 0,5 mg % and 40 mg with epinefrine 1 mg%) versus mepivacaine (30 mg and 20 mg with epinefrine 1 mg%) in medically compromised cardiac patients: a cross-over, randomized, single blinded study.

    PubMed

    Torres-Lagares, Daniel; Serrera-Figallo, María-Ángeles; Machuca-Portillo, Guillermo; Corcuera-Flores, José-Ramón; Machuca-Portillo, Carmen; Castillo-Oyagüe, Raquel; Gutiérrez-Pérez, José-Luis

    2012-07-01

    The aim of the present study is to compare cardiovascular safety profiles of two dental anesthetics: articaine versus two standard mepivacaine solutions used during etiological periodontal treatment in cardiovascular patients. Using a cross-over study design, ten cardiovascular patients were randomly assigned to dental treatment with 1.8 mL of a local anesthetic injected on each quadrant of the mouth: Articaine (40 mg with Epinephrine 0.5 mg % and 40 mg with Epinephrine 1mg %) or Mepivacaine (30 mg and 20 mg with Epinephrine 1mg %). A computer programme enabled continuous longitudinal data collection: O2 saturation, blood pressure (BP) and heart rate (HR). No severe clinical side effects were observed. During the treatment period, we observed statistically significant differences as regards HR between injections with and without adrenalin (p< 0.039) and as regards systolic (p< 0.046) and diastolic (p < 0.046) blood pressure during the stabilization period. In both cases, the parameters under study increase. Age, gender, jaw treated, treatment duration and the rest of cardiovascular variables did not affect the results. None of the patients underwent ischemic alterations or any other complication derived from the treatment or the anesthesia. According to the results of our study, dental anesthetics with standard concentrations of Epinephrine seem to alter HR and BP. Although no cardiac ischemic alterations or any other cardiovascular complications have been observed, we must be cautious with the administration of anesthetics containing vasoconstrictors in patients with cardiovascular diseases.

  8. Effect of tomato consumption on high-density lipoprotein cholesterol level: a randomized, single-blinded, controlled clinical trial

    PubMed Central

    Cuevas-Ramos, Daniel; Almeda-Valdés, Paloma; Chávez-Manzanera, Emma; Meza-Arana, Clara Elena; Brito-Córdova, Griselda; Mehta, Roopa; Pérez-Méndez, Oscar; Gómez-Pérez, Francisco J

    2013-01-01

    Introduction Epidemiologic evidence suggests that tomato-based products could reduce the risk of cardiovascular diseases. One of the main cardiovascular risk factors is low levels of high-density lipoprotein cholesterol (HDL-C). This study aimed to prospectively evaluate the effect of tomato consumption on HDL-C levels. Subject and methods We conducted a randomized, single-blinded, controlled clinical trial. We screened 432 subjects with a complete lipid profile. Those individuals with low HDL-C (men <40 mg/dL and women <50 mg/dL) but normal triglyceride levels (<150 mg/dL) were included. Selected participants completed a 2-week run-in period on an isocaloric diet and then were randomized to receive 300 g of cucumber (control group) or two uncooked Roma tomatoes a day for 4 weeks. Results A total of 50 individuals (women = 41; 82%) with a mean age of 42 ± 15.5 years and a mean body mass index of 27.6 ± 5.0 kg/m2 completed the study. A significant increase in HDL-C levels was observed in the tomato group (from 36.5 ± 7.5 mg/dL to 41.6 ± 6.9 mg/dL, P < 0.0001 versus the control group). After stratification by gender, the difference in HDL-C levels was only significant in women. The mean HDL-C increase was 5.0 ± 2.8 mg/dL (range 1–12 mg/dL). Twenty patients (40%) finished the study with levels >40 mg/dL. A linear regression model that adjusted for those parameters that impact HDL-C levels (age, gender, waist-to-hip ratio, body mass index, fasting triglyceride concentration, simple sugars, alcohol, physical activity, and omega-3 consumption) showed an independent association between tomato consumption and the increase in HDL-C (r2 = 0.69; P < 0.0001). Conclusion Raw tomato consumption produced a favorable effect on HDL-C levels in overweight women. PMID:23935376

  9. Cardiovascular effect of dental anesthesia with articaine (40 mg with epinefrine 0,5 mg % and 40 mg with epinefrine 1 mg%) versus mepivacaine (30mg and 20 mg with epinefrine 1 mg%) in medically compromised cardiac patients: A cross-over, randomized, single blinded study

    PubMed Central

    Torres-Lagares, Daniel; Serrera-Figallo, María Á.; Corcuera-Flores, José R.; Machuca-Portillo, Carmen; Castillo-Oyagüe, Raquel; Gutiérrez-Pérez, José L.

    2012-01-01

    Objectives: The aim of the present study is to compare cardiovascular safety profiles of two dental anesthetics: articaine versus two standard mepivacaine solutions used during etiological periodontal treatment in cardiovascular patients. Study Design: Using a cross-over study design, ten cardiovascular patients were randomly assigned to dental treatment with 1.8mL of a local anesthetic injected on each quadrant of the mouth: Articaine (40mg with Epinephrine 0.5mg % and 40mg with Epinephrine 1mg %) or Mepivacaine (30mg and 20mg with Epinephrine 1mg %). A computer programme enabled continuous longitudinal data collection: O2 saturation, blood pressure (BP) and heart rate (HR). Results: No severe clinical side effects were observed. During the treatment period, we observed statistically significant differences as regards HR between injections with and without adrenalin (p< 0.039) and as regards systolic (p< 0.046) and diastolic (p < 0.046) blood pressure during the stabilization period. In both cases, the parameters under study increase. Age, gender, jaw treated, treatment duration and the rest of cardiovascular variables did not affect the results. None of the patients underwent ischemic alterations or any other complication derived from the treatment or the anesthesia. Conclusions: According to the results of our study, dental anesthetics with standard concentrations of Epinephrine seem to alter HR and BP. Although no cardiac ischemic alterations or any other cardiovascular complications have been observed, we must be cautious with the administration of anesthetics containing vasoconstrictors in patients with cardiovascular diseases. Key words:Dental anesthesia, cardiovascular diseases, chronic periodontitis, drug toxicity. PMID:22322521

  10. Feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke: a randomized controlled pilot study.

    PubMed

    Lin, Li-Fong; Lin, Yi-Jia; Lin, Zi-Hao; Chuang, Li-Yun; Hsu, Wei-Chun; Lin, Yuan-Hsiang

    2017-06-19

    Wearable devices based on inertial measurement units through wireless sensor networks have many applications such as real-time motion monitoring and functional outcome assessment of stroke rehabilitation. However, additional investigations are warranted to validate their clinical value, particularly in detecting the synergy patterns of movements after stroke. To explore the feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke and to compare the intervention effects (e.g., neurological recovery, active range of motion, and deviation angle) with those in a control group. A single-blind, randomized-controlled pilot study. Rehabilitation ward. A total of 18 patients with chronic stroke were randomly distributed into a device group and control group. Both groups received conventional rehabilitation; nevertheless, the device group was additionally subjected to 15 daily sessions at least three times a week for 5 weeks. The outcome measures included the upper extremity subscores of the Fugl-Meyer assessment, active range of motion, and deviation angle. These measurements were performed pre- and post-treatment. All five Fugl-Meyer assessment subscores improved in both the device and control groups after intervention; in particular, the "shoulder/elbow/forearm" subscore (p = 0.02, 0.03) and "total score" (p = 0.03, 0.03) substantially improved. The active range of motion of shoulder flexion and abduction substantially improved at pre-post treatment in both the device (p = 0.02, 0.03) and control (p = 0.02, 0.03) groups. The deviation angle of shoulder external rotation during shoulder abduction substantially improved in the device group (p = 0.02), but not in the control group. The designed wearable devices are practical and efficient for use in chronic patients with stroke. Wearable devices are expected to be useful for future internet-of-things rehabilitation clinical trials at home and in long-term care institutions.

  11. Piloted simulation study of two tilt-wing control concepts

    NASA Technical Reports Server (NTRS)

    Birckelbaw, Lourdes G.; Corliss, Lloyd D.

    1994-01-01

    A two-phase piloted simulation study was conducted to investigate alternative wing and flap controls for tilt-wing aircraft. The initial phase of the study compared the flying qualities of both a conventional (programmed) flap and an innovative geared flap. The second phase of the study introduced an alternate method of pilot control for the geared flap and further studied the flying qualities of the programmed flap, and two geared flap configurations. In general, the pilot rating showed little variation between the programmed flap and the geared flap control concepts. Some differences between the two concepts were noticed and are discussed in this paper. The addition of pitch attitude stabilization in the second phase of the study greatly enhanced the aircraft flying qualities. This paper describes the simulated tilt-wing aircraft and the flap control concepts and presents the results of both phases of the simulation study.

  12. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial.

    PubMed

    Free, Caroline; Knight, Rosemary; Robertson, Steven; Whittaker, Robyn; Edwards, Phil; Zhou, Weiwei; Rodgers, Anthony; Cairns, John; Kenward, Michael G; Roberts, Ian

    2011-07-02

    Smoking cessation programmes delivered via mobile phone text messaging show increases in self-reported quitting in the short term. We assessed the effect of an automated smoking cessation programme delivered via mobile phone text messaging on continuous abstinence, which was biochemically verified at 6 months. In this single-blind, randomised trial, undertaken in the UK, smokers willing to make a quit attempt were randomly allocated, using an independent telephone randomisation system, to a mobile phone text messaging smoking cessation programme (txt2stop), comprising motivational messages and behavioural-change support, or to a control group that received text messages unrelated to quitting. The system automatically generated intervention or control group texts according to the allocation. Outcome assessors were masked to treatment allocation. The primary outcome was self-reported continuous smoking abstinence, biochemically verified at 6 months. All analyses were by intention to treat. This study is registered, number ISRCTN 80978588. We assessed 11,914 participants for eligibility. 5800 participants were randomised, of whom 2915 smokers were allocated to the txt2stop intervention and 2885 were allocated to the control group; eight were excluded because they were randomised more than once. Primary outcome data were available for 5524 (95%) participants. Biochemically verified continuous abstinence at 6 months was significantly increased in the txt2stop group (10·7% txt2stop vs 4·9% control, relative risk [RR] 2·20, 95% CI 1·80-2·68; p<0·0001). Similar results were obtained when participants that were lost to follow-up were treated as smokers (268 [9%] of 2911 txt2stop vs 124 [4%] of 2881 control [RR 2·14, 95% CI 1·74-2·63; p<0·0001]), and when they were excluded (268 [10%] of 2735 txt2stop vs 124 [4%] of 2789 control [2·20, 1·79-2·71; p<0·0001]). No significant heterogeneity was shown in any of the prespecified subgroups. The txt2stop smoking

  13. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial

    PubMed Central

    Free, Caroline; Knight, Rosemary; Robertson, Steven; Whittaker, Robyn; Edwards, Phil; Zhou, Weiwei; Rodgers, Anthony; Cairns, John; Kenward, Michael G; Roberts, Ian

    2011-01-01

    Summary Background Smoking cessation programmes delivered via mobile phone text messaging show increases in self-reported quitting in the short term. We assessed the effect of an automated smoking cessation programme delivered via mobile phone text messaging on continuous abstinence, which was biochemically verified at 6 months. Methods In this single-blind, randomised trial, undertaken in the UK, smokers willing to make a quit attempt were randomly allocated, using an independent telephone randomisation system, to a mobile phone text messaging smoking cessation programme (txt2stop), comprising motivational messages and behavioural-change support, or to a control group that received text messages unrelated to quitting. The system automatically generated intervention or control group texts according to the allocation. Outcome assessors were masked to treatment allocation. The primary outcome was self-reported continuous smoking abstinence, biochemically verified at 6 months. All analyses were by intention to treat. This study is registered, number ISRCTN 80978588. Findings We assessed 11 914 participants for eligibility. 5800 participants were randomised, of whom 2915 smokers were allocated to the txt2stop intervention and 2885 were allocated to the control group; eight were excluded because they were randomised more than once. Primary outcome data were available for 5524 (95%) participants. Biochemically verified continuous abstinence at 6 months was significantly increased in the txt2stop group (10·7% txt2stop vs 4·9% control, relative risk [RR] 2·20, 95% CI 1·80–2·68; p<0·0001). Similar results were obtained when participants that were lost to follow-up were treated as smokers (268 [9%] of 2911 txt2stop vs 124 [4%] of 2881 control [RR 2·14, 95% CI 1·74–2·63; p<0·0001]), and when they were excluded (268 [10%] of 2735 txt2stop vs 124 [4%] of 2789 control [2·20, 1·79–2·71; p<0·0001]). No significant heterogeneity was shown in any of the

  14. Epidural Electrical Stimulation for Stroke Rehabilitation: Results of the Prospective, Multicenter, Randomized, Single-Blinded Everest Trial.

    PubMed

    Levy, Robert M; Harvey, Richard L; Kissela, Brett M; Winstein, Carolee J; Lutsep, Helmi L; Parrish, Todd B; Cramer, Steven C; Venkatesan, Lalit

    2016-02-01

    This prospective, single-blinded, multicenter study assessed the safety and efficacy of electrical epidural motor cortex stimulation (EECS) in improving upper limb motor function of ischemic stroke patients with moderate to moderately severe hemiparesis. Patients ≥ 4 months poststroke were randomized 2:1 to an investigational (n = 104) or control (n = 60) group, respectively. Investigational patients were implanted (n = 94) with an epidural 6-contact lead perpendicular to the primary motor cortex and a pulse generator. Both groups underwent 6 weeks of rehabilitation, but EECS was delivered to investigational patients during rehabilitation. The primary efficacy endpoint (PE) was defined as attaining a minimum improvement of 4.5 points in the upper extremity Fugl-Meyer (UEFM) scale as well as 0.21 points in the Arm Motor Ability Test (AMAT) 4 weeks postrehabilitation. Follow-up assessments were performed 1, 4, 12, and 24 weeks postrehabilitation. Safety was evaluated by monitoring adverse events (AEs) that occurred between enrollment and the end of rehabilitation. Primary intent-to-treat analysis showed no group differences at 4 weeks, with PE being met by 32% and 29% of investigational and control patients, respectively (P = .36). Repeated-measures secondary analyses revealed no significant treatment group differences in mean UEFM or AMAT scores. However, post hoc comparisons showed that a greater proportion of investigational (39%) than control (15%) patients maintained or achieved PE (P = .003) at 24 weeks postrehabilitation. Investigational group mean AMAT scores also improved significantly (P < .05) when compared to the control group at 24 weeks postrehabilitation. Post hoc analyses also showed that 69% (n = 9/13) of the investigational patients who elicited movement thresholds during stimulation testing met PE at 4 weeks, and mean UEFM and AMAT scores was also significantly higher (P < .05) in this subgroup at the 4-, 12-, and 24-week assessments when

  15. THE EFFECT OF THERMAL ENVIRONMENT ON LEARNING, A PILOT STUDY.

    ERIC Educational Resources Information Center

    PECCOLO, CHARLES

    THIS IS A REPORT OF A FIRST PILOT STUDY WHICH PRECEDES A SERIES OF STUDIES BEING CONDUCTED BY THE IOWA CENTER FOR RESEARCH IN SCHOOL ADMINISTRATION AND LENNOX INDUSTRIES INC., MARSHALLTOWN, IOWA. IT IS A DIGEST OF A THESIS BY DR. CHARLES PECCOLO WHO SERVED AS RESEARCHER ON THIS FIRST STUDY. THE STUDY AIMED AT MEASURING THE EFFECTS OF THERMAL…

  16. Pilot Biofeedback Training in the Cognitive Awareness Training Study (CATS)

    NASA Technical Reports Server (NTRS)

    Uenking, M.

    2000-01-01

    One of the ongoing problems that pilots face today is a diminished state of awareness such as boredom, sleepiness, or fatigue during cruise conditions that could result in various pilot errors. This study utilized a cognitive training exercise to sharpen the pilot's awareness during simulated flight thereby providing them with a means to overcome these diminished states of awareness. This study utilizes psychophysiological methods in an attempt to assess a pilot's state of awareness more directly. In turn, the pilots will be able to train themselves to recognize these states of awareness and be more mentally sharp during mundane tasks such as those experienced in cruise conditions. The use of these measurement tools may be beneficial for researchers working within the NASA Aviation Safety Program. This paper will provide the reader with some background information concerning the motivation for the study, a brief description of the experimental setup and design matrix, the dependent and independent variables that were employed, and some preliminary findings based on some of the subjective and objective data that was collected. These preliminary findings are of part of an ongoing study being conducted at the NASA Langley Research Center in Hampton, Virginia.

  17. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial

    PubMed Central

    Andersson, Erik; Mataix-Cols, David; Lichtenstein, Linn; Alström, Katarina; Andersson, Gerhard; Ljótsson, Brjánn; Rück, Christian

    2016-01-01

    Objectives To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. Design A 12 week single blind parallel group randomised controlled trial. Setting Academic medical centre. Participants 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. Interventions Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. Main outcome measures The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. Results BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference −7.1 points, 95% confidence interval −9.8 to −4.4), depression (MADRS-S group difference −4.5 points, −7.5 to −1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self

  18. Olanzapine vs. Risperidone in Treating Aggressive Behaviours in Adults with Intellectual Disability: A Single Blind Study

    ERIC Educational Resources Information Center

    Amore, M.; Bertelli, M.; Villani, D.; Tamborini, S.; Rossi, M.

    2011-01-01

    Background: Aggressive behaviour represents a frequent symptom in people with intellectual disability (PWID). Despite uncertain evidence of effectiveness, the use of antipsychotics (APs) drugs to treat aggressive behaviour is very common. Antipsychotic medication of aggressivity in PWID has recently become one of the most debated issues in mental…

  19. Olanzapine vs. Risperidone in Treating Aggressive Behaviours in Adults with Intellectual Disability: A Single Blind Study

    ERIC Educational Resources Information Center

    Amore, M.; Bertelli, M.; Villani, D.; Tamborini, S.; Rossi, M.

    2011-01-01

    Background: Aggressive behaviour represents a frequent symptom in people with intellectual disability (PWID). Despite uncertain evidence of effectiveness, the use of antipsychotics (APs) drugs to treat aggressive behaviour is very common. Antipsychotic medication of aggressivity in PWID has recently become one of the most debated issues in mental…

  20. Preparation, piloting and validation for a longitudinal birth cohort study.

    PubMed

    Golding, Jean

    2009-07-01

    No longitudinal study should go into the field prior to detailed piloting and validation studies of the measures and techniques to be used. Preparation should also involve the training of staff, the acquisition of space and appropriate equipment, and liaison with the community and ethical committees as well as with scientific collaborators. Because different measures will continually be introduced as the participants age, the preparation, piloting and validation studies have to be ongoing. Here we describe some of the different strategies that should be used.

  1. Automatic Generation of Test Oracles - From Pilot Studies to Application

    NASA Technical Reports Server (NTRS)

    Feather, Martin S.; Smith, Ben

    1998-01-01

    There is a trend towards the increased use of automation in V&V. Automation can yield savings in time and effort. For critical systems, where thorough V&V is required, these savings can be substantial. We describe a progression from pilot studies to development and use of V&V automation. We used pilot studies to ascertain opportunities for, and suitability of, automating various analyses whose results would contribute to V&V. These studies culminated in the development of an automatic generator of automated test oracles. This was then applied and extended in the course of testing an Al planning system that is a key component of an autonomous spacecraft.

  2. Art as an Evaluative Tool: A Pilot Study.

    ERIC Educational Resources Information Center

    Sontag, Mary-Ann; Graham, Michelle

    2001-01-01

    Reports on a pilot study completed in preparation for a multisite study of the effectiveness of children's grief support groups. Uses art therapy to assess children's perspectives of their experience in a grief support group. Results of study support the use of art as an effective qualitative tool that can be utilized in future evaluations of…

  3. Say yes to life: a pilot study.

    PubMed

    Wood, C; Keen, A

    1988-03-01

    In an attempt to assess whether there are any characteristics which a majority of ordinary people regard as life-affirming or life-denying, a questionnaire was given to a pilot group of 167 respondents, representing three different age and social categories. Five life-affirming and five life-denying characteristics were mentioned by more than 10% of respondents. Of the former, Drive, Sociability, Happiness and Optimism were endorsed by 15-20%. Of the latter, Unsociability and Poor Coping were mentioned by 22%, making them distinctly more frequent than the following categories of Pessimism, Lack of Drive and Unhappiness (11-14%). It is suggested that a number of these subjectively determined characteristics, which the general public perceive as being life-affirming or denying, do indeed influence physical or mental health, illness or illness behaviour. It may therefore be of value to utilize this set of public perceptions in future programmes of health education.

  4. Say yes to life: a pilot study.

    PubMed Central

    Wood, C; Keen, A

    1988-01-01

    In an attempt to assess whether there are any characteristics which a majority of ordinary people regard as life-affirming or life-denying, a questionnaire was given to a pilot group of 167 respondents, representing three different age and social categories. Five life-affirming and five life-denying characteristics were mentioned by more than 10% of respondents. Of the former, Drive, Sociability, Happiness and Optimism were endorsed by 15-20%. Of the latter, Unsociability and Poor Coping were mentioned by 22%, making them distinctly more frequent than the following categories of Pessimism, Lack of Drive and Unhappiness (11-14%). It is suggested that a number of these subjectively determined characteristics, which the general public perceive as being life-affirming or denying, do indeed influence physical or mental health, illness or illness behaviour. It may therefore be of value to utilize this set of public perceptions in future programmes of health education. PMID:3357158

  5. Differential effect of beetroot bread on postprandial DBP according to Glu298Asp polymorphism in the eNOS gene: a pilot study.

    PubMed

    Hobbs, D A; George, T W; Lovegrove, J A

    2014-12-01

    Our objective was to investigate whether the presence of Glu298Asp polymorphism in the endothelial NO synthase (eNOS) gene differentially affects the postprandial blood pressure response to dietary nitrate-rich beetroot bread. A randomised, single-blind, controlled, crossover acute pilot study was performed in 14 healthy men (mean age: 34±9 years) who were retrospectively genotyped for Glu298Asp polymorphism (7GG; T carriers 7). Volunteers were randomised to receive 200 g beetroot-enriched bread (1.1 mmol nitrate) or control bread (no beetroot; 0.01 mmol nitrate) on two separate occasions 10 days apart. Baseline and incremental area under the curve of blood pressure and NOx (nitrate/nitrite) were measured for a 6-h postprandial period. A treatment × genotype interaction was observed for diastolic blood pressure (P<0.02), which was significantly lower in T carriers (P<0.01) after consumption of beetroot bread compared with control bread. No significant differences were observed in the GG group. The beneficial diastolic blood pressure reduction was observed only in the T carriers of the Glu298Asp polymorphism in the eNOS gene after consumption of nitrate-rich beetroot bread. These data require confirmation in a larger population group.

  6. PILOT STUDY: CCQM-P13 pilot study. Metals in artificial food digest

    NASA Astrophysics Data System (ADS)

    Wolff Briche, C. S. J.

    2003-01-01

    The accuracy of elemental analyses in complex matrices is usually assessed by analysis of a suitable matrix reference material. The reference value is ascribed by consensus mean and by application of primary methods of analysis. However, the quality of this value will be affected by problems such as matrix-induced interferences, moisture corrections and heterogeneity. Pilot study CCQM-P13 was undertaken to assess the capabilities of National Metrology Institutes to analyse Ca, Cu and Cd in an acidic solution that simulates the digest of a food sample. This study filled the gap between the analysis of a gravimetrically prepared calibration solution and the analysis of an unknown in a complex matrix requiring extensive sample preparation. Having an independent reference value, with a small uncertainty, allowed a more rigorous estimation of the reliability of the institutes' analysis and uncertainty estimates, without including issues around sample digestion. The reference values were: 1.6617 +/- 0.0020 µmol/g for Ca, 7.037 +/- 0.012 nmol/g for Cu and 45.57 +/- 0.10 pmol/g for Cd (expanded uncertainties are quoted with coverage factor of 2). The other elements in the matrix were: Na (~25 µg/g), K (~90 µg/g), Cl (~120 µg/g), Fe (~100 ng/g), Mg (~5 µg/g), P (~5 µg/g), Sn (~80 ng/g) and Zn (~200 ng/g). Twelve international laboratories, representing eight countries, determined the amount content of the analytes. A range of techniques that include ID-ICP-MS (high resolution and collision cell), ICP-MS, ICP-OES, AAS, voltametry and potentiometry were used. The results for this pilot study averaged: 1.654 +/- 0.058 µmol/g for Ca (n = 10), 7.26 +/- 0.53 nmol/g for Cu (n = 12) and 45.2 +/- 5.1 pmol/g for Cd (n = 11) where the values associated with the averages are the standard deviations of n participants. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database

  7. Soil vapor extraction pilot study at a Piedmont UST site

    SciTech Connect

    Widdowson, M.A.; Aelion, C.M.; Ray, R.P.; Reeves, H.W.

    1995-12-31

    A pilot study of soil vapor extraction (SVE) at a gasoline-contaminated site in the Piedmont physiographic region of South Carolina is presented. The objective of the pilot study is to determine the efficacy of SVE in remediating petroleum-contaminated Piedmont sites. Soil of the Piedmont region is characterized by fine-grained materials that exhibit a stratified, anisotropic structure, often dominated by zones of low permeability. The pilot remediation project consists of a multiple-well SVE and air sparging system located in the contaminant source area. Hourly measurement of mass extraction rates show elevated hydrocarbon (HC) concentrations during the first hour of operation and a rapid decline to asymptotic values. Time-averaged hydrocarbon mass extraction rates range from 22 to 68 kg HC per day for eight SVE wells operating 6 to 8 h per day. Elevated levels of CO{sub 2} in extracted soil vapors indicate microbial activity contributing to bioremediation at the site.

  8. First Breath prenatal smoking cessation pilot study: preliminary findings.

    PubMed

    Jehn, Lisette; Lokker, Nicole; Matitz, Debra; Christiansen, Bruce

    2003-01-01

    Despite the many dangers associated with smoking during pregnancy, it remains a salient public health problem for Wisconsin women. The First Breath pilot program was developed in an attempt to reduce rates of smoking during pregnancy among low-income women. Preliminary results suggest that the First Breath counseling-based approach is effective, with a quit rate of 43.8% among First Breath enrollees at 1 month postpartum. Women receiving First Breath cessation counseling also had higher quit rates at every measurement period versus women in a comparison group who were receiving whatever cessation care was available in their county in the absence of First Breath. The First Breath pilot study has demonstrated success in helping pregnant women quit smoking and in creating a model for integration of cessation services into prenatal health care service provision. It is through this success that First Breath is expanding beyond the pilot study stage to a statewide program in 2003.

  9. Evaluating midwifery units (EMU): lessons from the pilot study.

    PubMed

    Monk, Amy R; Tracy, Sally K; Foureur, Maralyn; Tracy, Mark

    2013-08-01

    this paper describes the pilot study that was undertaken to test the feasibility of the recruitment plan designed to recruit women who booked to give birth in two freestanding midwifery units in NSW, Australia. The pilot preceded the full prospective cohort study, Evaluating Midwifery Units (EMU), which aimed to examine the antenatal, birth and postnatal outcomes of women planning to give birth in freestanding midwifery units compared to those booked to give birth in tertiary level maternity units in Australia and New Zealand. a prospective cohort study with two mutually-exclusive cohorts. two freestanding midwifery units in NSW and their corresponding tertiary referral hospitals. a total of 146 women with few identified risk factors recruited between 13 September 2009 and 31 March 2010 whose planned place of birth was either a freestanding midwifery unit or tertiary maternity unit. the pilot study identified the feasibility of relying on the booking midwife to recruit eligible women from several antenatal booking clinics to the study. Low rates of eligible women were invited resulting in a lower than expected consent rate. In addition, although mostly only low-risk women were invited to participate, some women requiring medical consultation at the time of booking were inadvertently recruited into the study. The results of this pilot study led us to revise the study protocol to find ways of including the outcomes of all women without identified risk factors who booked at either the freestanding midwifery units or the tertiary referral hospital in that area. This paper describes the revisions that were made to the study plan. five lessons were learned from the pilot study. We found that recruitment protocols employed for the cohort study were too complicated and required simplification to maximise the potential of the study. The study protocol needed to be changed for the main study to ensure a larger sample size and to ensure the risk profile of each cohort was as

  10. A Computerized Adaptive Mathematics Screening Test: A Pilot Study.

    ERIC Educational Resources Information Center

    McBride, James R.

    A pilot study of a computerized adaptive test of mathematics achievement was conducted in May and June 1989 in selected schools of the San Diego Unified School District. The study evaluated the usefulness of the test for determining eligibility for Chapter 1 programs in mathematics. The test was a prototype battery of three adaptive tests: (1)…

  11. Behavioral Activation for Depressed Teens: A Pilot Study

    ERIC Educational Resources Information Center

    Ritschel, Lorie A.; Ramirez, Cynthia L.; Jones, Meredith; Craighead, W. Edward

    2011-01-01

    Behavioral activation (BA) is a psychosocial intervention that has shown promising treatment outcome results with depressed adults. The current pilot study evaluated a version of BA adapted for depressed adolescents. Six teens (3 male, 3 female, ages 14-17) who met criteria for major depressive disorder participated in the study. Participants were…

  12. Technical Writing Redesign and Assessment: A Pilot Study

    ERIC Educational Resources Information Center

    Winter, Gaye Bush

    2010-01-01

    The purpose of this study was to compare scores on writing assignments from traditional, fully online courses in technical writing to pilot, hybrid courses at a southern university. A total of 232 students' assignments were compared in this study. All writing assignments were scored by six trained instructors of English using the same five point…

  13. Behavioral Activation for Depressed Teens: A Pilot Study

    ERIC Educational Resources Information Center

    Ritschel, Lorie A.; Ramirez, Cynthia L.; Jones, Meredith; Craighead, W. Edward

    2011-01-01

    Behavioral activation (BA) is a psychosocial intervention that has shown promising treatment outcome results with depressed adults. The current pilot study evaluated a version of BA adapted for depressed adolescents. Six teens (3 male, 3 female, ages 14-17) who met criteria for major depressive disorder participated in the study. Participants were…

  14. Indonesian EFL Students' Perspective on Writing Process: A Pilot Study

    ERIC Educational Resources Information Center

    Hermilinda Abas, Imelda; Aziz, Noor Hashima Abd

    2016-01-01

    The study was aimed at understanding the EFL Indonesian students' perspective on the writing process. The pilot study involved two male Indonesian postgraduate students in Universiti Utara Malaysia. The Indonesian students were selected based on the following criteria: (1) had enough knowledge in English writing, indicated by the completion of…

  15. The Effects of Compensatory Auditory Stimulation and High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Tinnitus Perception – A Randomized Pilot Study

    PubMed Central

    Smouha, Eric; Parra, Lucas C.

    2016-01-01

    Background Tinnitus correlates with elevated hearing thresholds and reduced cochlear compression. We hypothesized that reduced peripheral input leads to elevated neuronal gain resulting in the perception of a phantom sound. Objective The purpose of this pilot study was to test whether compensating for this peripheral deficit could reduce the tinnitus percept acutely using customized auditory stimulation. To further enhance the effects of auditory stimulation, this intervention was paired with high-definition transcranial direct current stimulation (HD-tDCS). Methods A randomized sham-controlled, single blind study was conducted in a clinical setting on adult participants with chronic tinnitus (n = 14). Compensatory auditory stimulation (CAS) and HD-tDCS were administered either individually or in combination in order to access the effects of both interventions on tinnitus perception. CAS consisted of sound exposure typical to daily living (20-minute sound-track of a TV show), which was adapted with compressive gain to compensate for deficits in each subject's individual audiograms. Minimum masking levels and the visual analog scale were used to assess the strength of the tinnitus percept immediately before and after the treatment intervention. Results CAS reduced minimum masking levels, and visual analog scale trended towards improvement. Effects of HD-tDCS could not be resolved with the current sample size. Conclusions The results of this pilot study suggest that providing tailored auditory stimulation with frequency-specific gain and compression may alleviate tinnitus in a clinical population. Further experimentation with longer interventions is warranted in order to optimize effect sizes. PMID:27832140

  16. Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

    PubMed Central

    Charles, David; Tolleson, Christopher; Davis, Thomas L.; Gill, Chandler E.; Molinari, Anna L.; Bliton, Mark J.; Tramontana, Michael G.; Salomon, Ronald M.; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T.; Neimat, Joseph S.; Konrad, Peter E.

    2014-01-01

    Background Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. Objective We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. Methods We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Results Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. Conclusions This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease. PMID:23938229

  17. Understanding nutritional health in older adults. A pilot study.

    PubMed

    Callen, Bonnie

    2004-01-01

    A pilot study of adults ages 65 and older admitted to an acute care setting was conducted to compare nutritional risk as measured by hospital dieticians with two Nutrition Screening Initiative tools, the DETERMINE Your Nutritional Health Checklist and the Level I Screen, and to elicit from patients their own perceptions of nutritional health. Ten community-living older adults were interviewed. Although all 10 were at nutritional risk as measured by both hospital assessment and nutritional risk screening tools, none of these patients believed themselves to be at risk. One conclusion of this pilot is that interventions and education need to be tailored to the perceptions of targeted individuals.

  18. 78 FR 23941 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ... HUMAN SERVICES Food and Drug Administration Pilot Program for Early Feasibility Study Investigational... the Early Feasibility Study Investigational Device Exemption (IDE) Applications pilot program to May 8... ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including...

  19. 76 FR 70152 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration Pilot Program for Early Feasibility Study Investigational... technologies to participate in a pilot program for early feasibility study investigational device exemption... entitled ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies...

  20. Tantrums and Anxiety in Early Childhood: A Pilot Study

    ERIC Educational Resources Information Center

    Mireault, Gina; Trahan, Jessica

    2007-01-01

    Tantrums, or emotional reactions that are out of proportion to a situation, appear to be a common childhood phenomenon--yet have drawn little research attention. This pilot study describes tantrum precipitants; their frequency, intensity, and duration; and parental responses in a small community sample (N = 33) of 3- to 5-year-olds. Tantrum…

  1. Tai Chi for People with Visual Impairments: A Pilot Study

    ERIC Educational Resources Information Center

    Miszko, Tanya A.; Ramsey, Vincent K.; Blasch, Bruce B.

    2004-01-01

    This pilot study assessed the physical and psychological outcomes of a tai chi exercise program for eight adults with visual impairments. It found that after eight weeks of orientation and mobility training and tai chi practice, the participants' single leg-stance time and total knee flexion work and power improved, as did their frequency of,…

  2. Results of the "In Control: No Alcohol!" Pilot Study

    ERIC Educational Resources Information Center

    Mares, Suzanne H. W.; van der Vorst, Haske; Vermeulen-Smit, Evelien; Lichtwarck-Aschoff, Anna; Verdurmen, Jacqueline E. E.; Engels, Rutger C. M. E.

    2012-01-01

    More than 50% of Dutch 12-year olds already started drinking. Since it is known that delaying the onset of alcohol use results in a lower risk of alcohol-related problems, the recently developed "In control: No alcohol!" prevention program is targeted at elementary school children and their mothers. In this pilot study, the success of…

  3. Human Exposures to PAHs: an Eastern United States Pilot Study

    EPA Science Inventory

    Personal exposure monitoring for select polycyclic aromatic hydrocarbons (PAHs) was performed as part of the National Human Exposure Assessment Survey (NHEXAS) Pilot Study in Baltimore, MD and in four surrounding counties (NHEXAS-Maryland). An objective of this effort was to esta...

  4. The Effect of Background Music on Bullying: A Pilot Study

    ERIC Educational Resources Information Center

    Ziv, Naomi; Dolev, Einat

    2013-01-01

    School bullying is a source of growing concern. A number of intervention programs emphasize the importance of a positive school climate in preventing bullying behavior. The aim of the presented pilot study was to examine whether calming background music, through its effect on arousal and mood, could create a pleasant atmosphere and reduce bullying…

  5. Assessing Student Engagement: HSSSE Pilot Study with Independent Schools

    ERIC Educational Resources Information Center

    Torres, Amanda

    2014-01-01

    NAIS and the NAIS Commission on Accreditation recently launched a three-year pilot study on the use of the High School Survey of Student Engagement (HSSSE) among independent schools. HSSSE, administered by Indiana University, is a survey designed to investigate the attitudes, perceptions, and beliefs of high school students about their work. This…

  6. Initial Scale Development: Sample Size for Pilot Studies

    ERIC Educational Resources Information Center

    Johanson, George A.; Brooks, Gordon P.

    2010-01-01

    Pilot studies are often recommended by scholars and consultants to address a variety of issues, including preliminary scale or instrument development. Specific concerns such as item difficulty, item discrimination, internal consistency, response rates, and parameter estimation in general are all relevant. Unfortunately, there is little discussion…

  7. Assessing the Flipped Classroom in Operations Management: A Pilot Study

    ERIC Educational Resources Information Center

    Prashar, Anupama

    2015-01-01

    The author delved into the results of a flipped classroom pilot conducted for an operations management course module. It assessed students' perception of a flipped learning environment after making them experience it in real time. The classroom environment was construed using a case research approach and students' perceptions were studied using…

  8. The Effect of Background Music on Bullying: A Pilot Study

    ERIC Educational Resources Information Center

    Ziv, Naomi; Dolev, Einat

    2013-01-01

    School bullying is a source of growing concern. A number of intervention programs emphasize the importance of a positive school climate in preventing bullying behavior. The aim of the presented pilot study was to examine whether calming background music, through its effect on arousal and mood, could create a pleasant atmosphere and reduce bullying…

  9. Nutrition education program for food bank clients: A pilot study

    USDA-ARS?s Scientific Manuscript database

    Many low income families depend on foods from food banks. The objective of the study was to determine program content and examine feasibility of a pilot nutrition education program for food bank clients. Formative research was conducted with staff at a local food bank and its pantries and adult clie...

  10. Physical activity in Georgia state parks: A pilot study

    Treesearch

    Lincoln R. Larson; Jason W. Whiting; Gary T. Green

    2012-01-01

    This pilot study assessed the role of Georgia State Parks in the promotion of physical activity among different racial/ethnic and age groups. Data were collected at three state parks in north Georgia during the summer of 2009 using two research methods: behavior observations (N=2281) and intercept surveys (N=473).

  11. Evaluation Study of "Language, Literacy, & Vocabulary!" Spring 2006 Pilot

    ERIC Educational Resources Information Center

    McNabb, Mary

    2006-01-01

    Purpose: A pilot study of the "Language, Literacy, & Vocabulary!" program was conducted by Learning Gauger, Inc., for National Geographic School Publishing, in spring 2006. The program evaluation examined the classroom adoption approaches used by participating teachers and the subsequent impact of the "Language, Literacy, &…

  12. CSO DISINFECTION PILOT STUDY: SPRING CREEK CSO STORAGE FACILITY UPGRADE

    EPA Science Inventory

    This research summary presents the results of a pilot-scale disinfection study performed for the New York City Department of Environmental Protection and the U.S. Environmental Protection Agency (US EPA) under a contract to Camp Dresser & McKee of Woodbury, New York. The main ob...

  13. Elderly Homosexual Women and Men: Report on a Pilot Study.

    ERIC Educational Resources Information Center

    Minnigerode, Fred A.; Adelman, Marcy R.

    1978-01-01

    A pilot study is described in which four- to five-hour tape-recorded interviews were conducted with 11 homosexual women and men, 60-77 years of age. Areas examined included: physical change and physical health; work, retirement and leisure time; social behavior; psychological functioning; sexual behavior; and personal perspectives on the life…

  14. Job Rotation at Cardiff University Library Service: A Pilot Study

    ERIC Educational Resources Information Center

    Earney, Sally; Martins, Ana

    2009-01-01

    This paper presents case study research of a job rotation pilot involving six library assistants in Cardiff University Library Service (ULS). Firstly, it investigates whether job rotation improves motivation and secondly, whether there is an improvement in skills, both technical and "soft". Following a review of the literature,…

  15. Pasadena City College SIGI Project Research Design. Pilot Study.

    ERIC Educational Resources Information Center

    Risser, John J.; Tulley, John E.

    A pilot study evaluation of SIGI (System of Interactive Guidance and Information) at Pasadena City College in 1974-75 tested the effectiveness of an experimental research design for an expanded field test of the system the following year. (SIGI is a computer based career guidance program designed by Educational Testing Service to assist community…

  16. Pasadena City College SIGI Project Research Design. Pilot Study.

    ERIC Educational Resources Information Center

    Risser, John J.; Tulley, John E.

    A pilot study evaluation of SIGI (System of Interactive Guidance and Information) at Pasadena City College in 1974-75 tested the effectiveness of an experimental research design for an expanded field test of the system the following year. (SIGI is a computer based career guidance program designed by Educational Testing Service to assist community…

  17. Outcome evaluation of a pilot study using "nudges"

    USDA-ARS?s Scientific Manuscript database

    Every school day, over 31 million U.S. children eat school lunches. Unfortunately, students often do not choose the healthy options in the school cafeteria. This paper describes outcome results of a pilot study using "nudges" to improve elementary school students' fruits and vegetables selections. A...

  18. Consumer Understanding of Nutrition Marketing Terms: A Pilot Study

    ERIC Educational Resources Information Center

    Haroldson, Amber; Yen, Chih-Lun

    2016-01-01

    The purpose of this pilot study was to examine the validity of a questionnaire developed to assess adult consumer understanding of nutrition marketing terms and the resulting impact on consumer behavior. Participants (n = 40) completed an electronic questionnaire. Efforts to establish validity and reliability suggest that the questionnaire is a…

  19. Will More Diversified Staffs Diversify Newspaper Content? A Pilot Study.

    ERIC Educational Resources Information Center

    Fedler, Fred; and Others

    A pilot study asked 94 students enrolled in introductory newswriting classes at three separate universities to evaluate 18 news stories. About half the stories concerned topics that proponents of multiculturalism have suggested would receive more emphasis if newspapers employed more women and minorities: topics such as breast cancer, divorce,…

  20. Causes of Mortality among American College Students: A Pilot Study

    ERIC Educational Resources Information Center

    Turner, James C.; Leno, E. Victor; Keller, Adrienne

    2013-01-01

    This pilot study from self-selected institutions of higher education provides an estimate of the causes and rates of mortality among college students between the ages of 18 and 24 years old. One hundred fifty-seven 4-year colleges participated in an online survey of student deaths during one academic year. A total of 254 deaths were reported. The…

  1. SIGI: Report of a Pilot Study Under Field Conditions.

    ERIC Educational Resources Information Center

    Chapman, Warren; And Others

    This paper describes the procedures and results of a pilot study of a computer-based System of Interactive Guidance and Information (SIGI) which was designed to help community college students make rational career decisions. A number of the important features of the system are summarized in terms of the source of the value dimensions used in SIGI,…

  2. Causes of Mortality among American College Students: A Pilot Study

    ERIC Educational Resources Information Center

    Turner, James C.; Leno, E. Victor; Keller, Adrienne

    2013-01-01

    This pilot study from self-selected institutions of higher education provides an estimate of the causes and rates of mortality among college students between the ages of 18 and 24 years old. One hundred fifty-seven 4-year colleges participated in an online survey of student deaths during one academic year. A total of 254 deaths were reported. The…

  3. Assessing Student Engagement: HSSSE Pilot Study with Independent Schools

    ERIC Educational Resources Information Center

    Torres, Amanda

    2014-01-01

    NAIS and the NAIS Commission on Accreditation recently launched a three-year pilot study on the use of the High School Survey of Student Engagement (HSSSE) among independent schools. HSSSE, administered by Indiana University, is a survey designed to investigate the attitudes, perceptions, and beliefs of high school students about their work. This…

  4. Achieving Competence: Army-VOTEC School Partnership Pilot Studies.

    ERIC Educational Resources Information Center

    Stout, Mary W.

    To reduce Army training costs, the Training and Doctrine Command (TRADOC) investigated use of training at civilian secondary and postsecondary vocational-technical (VOTEC) institutions as an alternative to initial job training in Army service schools. Three models were used in the pilot study: the preservice training model in which…

  5. Human Exposures to PAHs: an Eastern United States Pilot Study

    EPA Science Inventory

    Personal exposure monitoring for select polycyclic aromatic hydrocarbons (PAHs) was performed as part of the National Human Exposure Assessment Survey (NHEXAS) Pilot Study in Baltimore, MD and in four surrounding counties (NHEXAS-Maryland). An objective of this effort was to esta...

  6. CSO DISINFECTION PILOT STUDY: SPRING CREEK CSO STORAGE FACILITY UPGRADE

    EPA Science Inventory

    This research summary presents the results of a pilot-scale disinfection study performed for the New York City Department of Environmental Protection and the U.S. Environmental Protection Agency (US EPA) under a contract to Camp Dresser & McKee of Woodbury, New York. The main ob...

  7. Danish Health Professionals' Experiences of Being Coached: A Pilot Study

    ERIC Educational Resources Information Center

    Ammentorp, Jette; Jensen, Hanne Irene; Uhrenfeldt, Lisbeth

    2013-01-01

    Introduction: In recent years, coaching, as a supplement to professional development, has received increased attention, especially in nursing. Still, only little is known about how health professionals experience participating in coaching sessions. The purpose of this pilot study was to describe and analyze health professionals' experiences from…

  8. Assessing the Flipped Classroom in Operations Management: A Pilot Study

    ERIC Educational Resources Information Center

    Prashar, Anupama

    2015-01-01

    The author delved into the results of a flipped classroom pilot conducted for an operations management course module. It assessed students' perception of a flipped learning environment after making them experience it in real time. The classroom environment was construed using a case research approach and students' perceptions were studied using…

  9. Consumer Understanding of Nutrition Marketing Terms: A Pilot Study

    ERIC Educational Resources Information Center

    Haroldson, Amber; Yen, Chih-Lun

    2016-01-01

    The purpose of this pilot study was to examine the validity of a questionnaire developed to assess adult consumer understanding of nutrition marketing terms and the resulting impact on consumer behavior. Participants (n = 40) completed an electronic questionnaire. Efforts to establish validity and reliability suggest that the questionnaire is a…

  10. Danish Health Professionals' Experiences of Being Coached: A Pilot Study

    ERIC Educational Resources Information Center

    Ammentorp, Jette; Jensen, Hanne Irene; Uhrenfeldt, Lisbeth

    2013-01-01

    Introduction: In recent years, coaching, as a supplement to professional development, has received increased attention, especially in nursing. Still, only little is known about how health professionals experience participating in coaching sessions. The purpose of this pilot study was to describe and analyze health professionals' experiences from…

  11. Teaching Speech Communication with a Foreign Accent: A Pilot Study.

    ERIC Educational Resources Information Center

    Chen, Guo-Ming; Chung, Jensen

    A pilot study examined problems encountered by foreign instructors teaching in American colleges. Fourteen Chinese-born instructors teaching in Speech Communication answered a questionnaire containing 12 open-ended questions. Recurring themes were coded from the answers, and then organized into three categories: cultural differences; linguistic…

  12. Pilot interaction with cockpit automation 2: An experimental study of pilots' model and awareness of the Flight Management System

    NASA Technical Reports Server (NTRS)

    Sarter, Nadine B.; Woods, David D.

    1994-01-01

    Technological developments have made it possible to automate more and more functions on the commercial aviation flight deck and in other dynamic high-consequence domains. This increase in the degrees of freedom in design has shifted questions away from narrow technological feasibility. Many concerned groups, from designers and operators to regulators and researchers, have begun to ask questions about how we should use the possibilities afforded by technology skillfully to support and expand human performance. In this article, we report on an experimental study that addressed these questions by examining pilot interaction with the current generation of flight deck automation. Previous results on pilot-automation interaction derived from pilot surveys, incident reports, and training observations have produced a corpus of features and contexts in which human-machine coordination is likely to break down (e.g., automation surprises). We used these data to design a simulated flight scenario that contained a variety of probes designed to reveal pilots' mental model of one major component of flight deck automation: the Flight Management System (FMS). The events within the scenario were also designed to probe pilots' ability to apply their knowledge and understanding in specific flight contexts and to examine their ability to track the status and behavior of the automated system (mode awareness). Although pilots were able to 'make the system work' in standard situations, the results reveal a variety of latent problems in pilot-FMS interaction that can affect pilot performance in nonnormal time critical situations.

  13. Pilot interaction with cockpit automation 2: An experimental study of pilots' model and awareness of the Flight Management System

    NASA Technical Reports Server (NTRS)

    Sarter, Nadine B.; Woods, David D.

    1994-01-01

    Technological developments have made it possible to automate more and more functions on the commercial aviation flight deck and in other dynamic high-consequence domains. This increase in the degrees of freedom in design has shifted questions away from narrow technological feasibility. Many concerned groups, from designers and operators to regulators and researchers, have begun to ask questions about how we should use the possibilities afforded by technology skillfully to support and expand human performance. In this article, we report on an experimental study that addressed these questions by examining pilot interaction with the current generation of flight deck automation. Previous results on pilot-automation interaction derived from pilot surveys, incident reports, and training observations have produced a corpus of features and contexts in which human-machine coordination is likely to break down (e.g., automation surprises). We used these data to design a simulated flight scenario that contained a variety of probes designed to reveal pilots' mental model of one major component of flight deck automation: the Flight Management System (FMS). The events within the scenario were also designed to probe pilots' ability to apply their knowledge and understanding in specific flight contexts and to examine their ability to track the status and behavior of the automated system (mode awareness). Although pilots were able to 'make the system work' in standard situations, the results reveal a variety of latent problems in pilot-FMS interaction that can affect pilot performance in nonnormal time critical situations.

  14. The CITRA pilot studies program: mentoring translational research.

    PubMed

    Wethington, Elaine; Breckman, Risa; Meador, Rhoda; Reid, M Carrington; Sabir, Myra; Lachs, Mark; Pillemer, Karl A

    2007-12-01

    We developed an innovative pilot studies program to foster partnerships between university researchers and agencies serving older people in New York City. The development of researchers willing to collaborate with frontline service agencies and service agencies ready to partner with researchers is critical for translating scientific research into evidence-based practice that benefits community-dwelling older adults. We adapted the traditional academic pilot studies model to include key features of community-based participatory research. In partnership with a network of 265 senior centers and service agencies, we built a multistep program to recruit and educate scientific investigators and agencies in the principles of community-based research and to fund research partnerships that fulfilled essential elements of research translation from university to community: scientific rigor, sensitivity to community needs, and applicability to frontline practice. We also developed an educational and monitoring infrastructure to support projects. Pilot studies programs developing community-based participatory research require an infrastructure that can supplement individual pilot investigator efforts with centralized resources to ensure proper implementation and dissemination of the research. The financial and time investment required to maintain programs such as those at the Cornell Institute for Translational Research on Aging, or CITRA, may be a barrier to establishing similar programs.

  15. Dissolution studies with pilot plant and actual INTEC calcines

    SciTech Connect

    Herbst, R.S.; Garn, T.G.

    1999-04-01

    The dissolution of Idaho Nuclear Technology and Engineering Center (INTEC) pilot plant calcines was examined to determine solubility of calcine matrix components in acidic media. Two representatives pilot plant calcine types were studied: Zirconia calcine and Zirconia/Sodium calcine. Dissolution of these calcines was evaluated using lower initial concentrations of nitric acid than used in previous tests to decrease the [H+] concentration in the final solutions. Lower [H+] concentrations contribute to more favorable TRUEX/SREX solvent extraction flowsheet performance. Dissolution and analytical results were also obtained for radioactive calcines produced using high sodium feeds blended with non-radioactive Al(NO{sub 3}){sub 3} solutions to dilute the sodium concentration and prevent bed agglomeration during the calcination process. Dissolution tests indicated {gt}95 wt.% of the initial calcine mass can be dissolved using the baseline dissolution procedure, with the exception that higher initial nitric acid concentrations are required. The higher initial acid concentration is required for stoichiometric dissolution of the oxides, primarily aluminum oxide. Statistically designed experiments using pilot plant calcine were performed to determine the effect of mixing rate on dissolution efficiency. Mixing rate was determined to provide minimal effects on wt.% dissolution. The acid/calcine ratio and temperature were the predominate variables affecting the wt.% dissolution, a result consistent with previous studies using other similar types of pilot plant calcines.

  16. Dissolution Studies With Pilot Plant and Actual INTEC Calcines

    SciTech Connect

    Herbst, Ronald Scott; Garn, Troy Gerry

    1999-04-01

    The dissolution of Idaho Nuclear Technology and Engineering Center (INTEC) pilot plant calcines was examined to determine solubility of calcine matrix components in acidic media. Two representatives pilot plant calcine types were studied: Zirconia calcine and Zirconia/ Sodium calcine. Dissolution of these calcines was evaluated using lower initial concentrations of nitric acid than used in previous tests to decrease the [H+] concentration in the final solutions. Lower [H+] concentrations contribute to more favorable TRUEX/SREX solvent extraction flowsheet performance. Dissolution and analytical results were also obtained for radioactive calcines produced using high sodium feeds blended with non-radioactive A1(NO3)3 solutions to dilute the sodium concentration and prevent bed agglomeration during the calcination process. Dissolution tests indicated >95 wt. % of the initial calcine mass can be dissolved using the baseline dissolution procedure, with the exception that higher initial nitric acid concentrations are required. The higher initial acid concentration is required for stoichiometric dissolution of the oxides, primarily aluminum oxide. Statistically designed experiments using pilot plant calcine were performed to determine the effect of mixing rate on dissolution efficiency. Mixing rate was determined to provide minimal effects on wt. % dissolution. The acid/calcine ratio and temperature were the predominate variables affecting the wt. % dissolution, a result consistent with previous studies using other similar types of pilot plant calcines.

  17. A Study of the Characteristics of Human-Pilot Control Response to Simulated Aircraft Lateral Motions

    NASA Technical Reports Server (NTRS)

    Cheatham, Donald C

    1954-01-01

    Report presents the results of studies made in an attempt to provide information on the control operations of the human pilot. These studies included an investigation of the ability of pilots to control simulated unstable yawing oscillations, a study of the basic characteristics of human-pilot control response, and a study to determine whether and to what extent pilot control response can be represented in an analytical form.

  18. Acute feTal behavioral Response to prenatal Yoga: a single, blinded, randomized controlled trial (TRY yoga).

    PubMed

    Babbar, Shilpa; Hill, James B; Williams, Karen B; Pinon, Maria; Chauhan, Suneet P; Maulik, Dev

    2016-03-01

    In 2012, yoga was practiced by 20 million Americans, of whom 82% were women. A recent literature review on prenatal yoga noted a reduction in some pregnancy complications (ie, preterm birth, lumbar pain, and growth restriction) in those who practiced yoga; to date, there is no evidence on fetal response after yoga