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Sample records for blinded pilot study

  1. Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study

    Directory of Open Access Journals (Sweden)

    Zhang Lang

    2007-11-01

    Full Text Available Abstract Background In planning a randomized controlled trial of acupuncture, we conducted a pilot study using validated outcome measures to assess the feasibility of the protocol, and to obtain preliminary data on efficacy and tolerability of 3 different forms of acupuncture treatment as an adjunct for the treatment of chronic pain in patients with Rheumatoid arthritis (RA. Methods The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture (EA, traditional Chinese acupuncture (TCA and sham acupuncture (Sham in patients with RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10. Results From 80 eligible patients, 36 patients with mean age of 58 ± 10 years and disease duration of 9.3 ± 6.4 years were recruited. Twelve patients were randomized to each group. Twelve, 10 and 7 patients from the EA, TCA and Sham group respectively completed the study at 20 weeks (p Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for RA. Trial registration ClinicalTrials.gov NCT00404443

  2. [Pilot study to investigate sleep disorders in the blind and persons with relevant visual impairment].

    Science.gov (United States)

    Dirks, C; Grünewald, D; Young, P; Heidbreder, A

    2018-05-22

    Sleep disorders are associated with serious health problems in blind and visually impaired persons. Loss of light perception may result in a shift of sleep-wake pattern, which may lead to significant impairments in daily life--the so-called non-24-hour sleep-wake disorder. To date, epidemiologic data on non-24 only exist for the USA. This pilot study was conducted to provide first epidemiologic data for the prevalence of non-24 and other sleep disorders among blind and visually impaired persons in Germany. Recruited were 111 blind and visually impaired subjects (36 subjects without light perception; male [m] = 56, 27-85 years, average [Mx] = 59.53, standard deviation [SD] = 14.69) and 111 sighted controls (m = 41, 27-88 years, Mx = 58.32, SD = 14.21), who answered a set of validated questionnaires referring to general health status (SF-36), sleep characteristics (PSQI), and daytime sleepiness (ESS). In addition, a questionnaire to predict non-24-hour sleep-wake disorder, which is not yet validated in German, was provided. The prevalence of 72.2% for the non-24-hour sleep-wake disorder in blind people is in accordance with results from the USA. In contrast, our results indicated non-24 in only 21.3% of the subjects with residual light perception. Furthermore, other sleep disorders like problems falling asleep (100% vs. 79.9%), maintaining sleep (90% vs. 88.1%), sleep-disordered breathing (19.4% vs. 32%), or sleep-related movement disorders (28.1% vs. 32.9%) were also common in the group of blind or visually impaired persons. The non-24-hour sleep-wake disorder is a frequent problem among people with no light perception, associated with problems falling asleep, maintaining sleep, and daytime sleepiness. The perception of light as an external cue for our circadian rhythm plays a key role. However, sleep disruption is not fully explained by non-24, making a detailed sleep history essential.

  3. Evaluation of homoeopathic treatment in polycystic ovary syndrome: A single-blind, randomised, placebo-controlled pilot study

    OpenAIRE

    Chetna Deep Lamba; Praveen Oberai; Raj K Manchanda; Padmalaya Rath; P Hima Bindu; Maya Padmanabhan

    2018-01-01

    Background and Objectives: This study was conducted with the primary objective of evaluating efficacy of Homoeopathy in establishing the menstrual regularity with improvement in either ultrasonological findings or hirsutism/acne. The quality of life was also assessed using polycystic ovary syndrome questionnaire (PCOSQ). Materials and Methods: A single-blind, randomised, placebo-controlled pilot study was conducted from February 2014 to May 2015 at two research centres. The cases fulfilling t...

  4. Tissue resonance interaction accurately detects colon lesions: A double-blind pilot study.

    Science.gov (United States)

    Dore, Maria P; Tufano, Marcello O; Pes, Giovanni M; Cuccu, Marianna; Farina, Valentina; Manca, Alessandra; Graham, David Y

    2015-07-07

    To investigated the performance of the tissue resonance interaction method (TRIM) for the non-invasive detection of colon lesions. We performed a prospective single-center blinded pilot study of consecutive adults undergoing colonoscopy at the University Hospital in Sassari, Italy. Before patients underwent colonoscopy, they were examined by the TRIMprobe which detects differences in electromagnetic properties between pathological and normal tissues. All patients had completed the polyethylene glycol-containing bowel prep for the colonoscopy procedure before being screened. During the procedure the subjects remained fully dressed. A hand-held probe was moved over the abdomen and variations in electromagnetic signals were recorded for 3 spectral lines (462-465 MHz, 930 MHz, and 1395 MHz). A single investigator, blind to any clinical information, performed the test using the TRIMprob system. Abnormal signals were identified and recorded as malignant or benign (adenoma or hyperplastic polyps). Findings were compared with those from colonoscopy with histologic confirmation. Statistical analysis was performed by χ(2) test. A total of 305 consecutive patients fulfilling the inclusion criteria were enrolled over a period of 12 months. The most frequent indication for colonoscopy was abdominal pain (33%). The TRIMprob was well accepted by all patients; none spontaneously complained about the procedure, and no adverse effects were observed. TRIM proved inaccurate for polyp detection in patients with inflammatory bowel disease (IBD) and they were excluded leaving 281 subjects (mean age 59 ± 13 years; 107 males). The TRIM detected and accurately characterized all 12 adenocarcinomas and 135/137 polyps (98.5%) including 64 adenomatous (100%) found. The method identified cancers and polyps with 98.7% sensitivity, 96.2% specificity, and 97.5% diagnostic accuracy, compared to colonoscopy and histology analyses. The positive predictive value was 96.7% and the negative predictive

  5. Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis.

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    Furst, Daniel E; Venkatraman, Manorama M; McGann, Mary; Manohar, P Ram; Booth-LaForce, Cathryn; Sarin, Reshmi; Sekar, P G; Raveendran, K G; Mahapatra, Anita; Gopinath, Jidesh; Kumar, P R Krishna

    2011-06-01

    To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.

  6. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  7. Does granisetron eliminate the gag reflex? A crossover, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Barenboim, Silvina Friedlander; Dvoyris, Vladislav; Kaufman, Eliezer

    2009-01-01

    Although gagging is a frequent problem that, when severe, can jeopardize the dental procedure, no single protocol is used to alleviate this phenomenon. Selective 5-HT3 antagonists, such as granisetron, may attenuate gagging. In this study, granisetron and placebo were administered intravenously, in a crossover, double-blind manner, to 25 healthy volunteers in 2 different sessions. Gagging levels were recorded before and after administration, as were BP, pulse, and O2 saturation. Recorded results were analyzed with the use of tests for nonparametric values (P = .05). A significant increase in the depth of swab insertion was noted after administration of both placebo and drug. The increase in drug effectiveness correlated with decreased body weight. The true efficacy of granisetron in gagger patients with this treatment protocol has yet to be fully established, although it has been theorized that an increased dosage of granisetron may have a better effect.

  8. Influence of selenium supplementation on patients with inflammation: A pilot double blind randomized study.

    Science.gov (United States)

    Freitas, Renata Germano Borges de Oliveira Nascimento; Nogueira, Roberto José Negrão; Cozzolino, Silvia Maria Franciscato; Vasques, Ana Carolina Junqueira; Hessel, Gabriel

    2017-09-01

    The aim of the study was to analyze the effect of selenium supplementation on patients with inflammation receiving PN. This double-blind randomized study included 20 hospitalized patients experiencing an inflammatory process while being fed by PN, who were monitored in three stages: first 72 h (0), day 7 (1), and day 14 (2) of PN. The supplemented patients group (G+S) received 60 μg/d (0.75 μmol) of selenium as selenious acid which was added to the PN bag. The nonsupplemented group (G-S) did not receive selenium. The concentration range of 84 to 100 μg/L (1.07-1.27 μmol/L) was used as a reference of plasma selenium. The study included 20 patients (8 G+S and 12 G-S) mainly diagnosed with cancer and/or sepsis. Most of them were hospitalized in the intensive care unit and were receiving PN for clinical reasons. Plasma selenium was greater in the G+S than in the G-S (P = 0.05) in two stages (0 and 1). Since the start of assessment, C-reactive protein (CRP) levels were elevated; however, there was no statistical difference in CRP values between groups (P > 0.05). There was no significant change of glutathione peroxidase over time or between groups (P > 0.05). The selenium concentration was greater in the G+S than in the G-S, acting independently from CRP behavior. However, supplementation was not enough to reach the reference values. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Double-blind placebo-controlled pilot study of paroxetine for specific phobia.

    Science.gov (United States)

    Benjamin, J; Ben-Zion, I Z; Karbofsky, E; Dannon, P

    2000-04-01

    Drugs are not recognized as a standard treatment for specific phobia, despite its apparent similarities to other kinds of phobia. Reluctance on the part of patients and clinicians to see the disorder as more than normal anxiety may explain the apparent resistance to pharmacotherapy. Eleven patients fulfilling DSM-IV criteria for specific phobia were randomized to 4 weeks of double-blind treatment with placebo or paroxetine up to 20 mg/day. They were assessed weekly with the Fear Questionnaire and the Hamilton Rating Scale for Anxiety. Paroxetine showed significant superiority in reducing all measures (ANCOVA for reductions in phobia scores F=7.9, P=0.02). One out of six patients responded to placebo, compared to three out of five patients on paroxetine. This new therapeutic option (i.e. drug treatment) for specific phobia deserves further examination in a larger trial.

  10. Molecular profiling of complete congenital stationary night blindness: a pilot study on an Indian cohort.

    Science.gov (United States)

    Malaichamy, Sivasankar; Sen, Parveen; Sachidanandam, Ramya; Arokiasamy, Tharigopala; Lancelot, Marie Elise; Audo, Isabelle; Zeitz, Christina; Soumittra, Nagasamy

    2014-01-01

    Congenital stationary night blindness (CSNB) is a non-progressive retinal disorder that shows genetic and clinical heterogeneity. CSNB is inherited as an autosomal recessive, autosomal dominant, or X-linked recessive trait and shows a good genotype-phenotype correlation. Clinically, CSNB is classified as the Riggs type and the Schubert-Bornschein type. The latter form is further sub-classified into complete and incomplete forms based on specific waveforms on the electroretinogram (ERG). There are no molecular genetic data for CSNB in the Indian population. Therefore, we present for the first time molecular profiling of eight families with complete CSNB (cCSNB). The index patients and their other affected family members were comprehensively evaluated for the phenotype, including complete ophthalmic evaluation, ERG, fundus autofluorescence, optical coherence tomography, and color vision test. The known gene defects for cCSNB, LRIT3, TRPM1, GRM6, GPR179, and NYX, were screened by PCR direct sequencing. Bioinformatic analyses were performed using SIFT and PolyPhen for the identified missense mutations. All eight affected index patients and affected family members were identified as having cCSNB based on their ERG waveforms. Mutations in the TRPM1 gene were identified in six index patients. The two remaining index patients each carried a GPR179 and GRM6 mutation. Seven of the patients revealed homozygous mutations, while one patient showed a compound heterozygous mutation. Six of the eight mutations identified are novel. This is the first report on molecular profiling of candidate genes in CSNB in an Indian cohort. As shown for other cohorts, TRPM1 seems to be a major gene defect in patients with cCSNB in India.

  11. Evaluation of homoeopathic treatment in polycystic ovary syndrome: A single-blind, randomised, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Chetna Deep Lamba

    2018-01-01

    Full Text Available Background and Objectives: This study was conducted with the primary objective of evaluating efficacy of Homoeopathy in establishing the menstrual regularity with improvement in either ultrasonological findings or hirsutism/acne. The quality of life was also assessed using polycystic ovary syndrome questionnaire (PCOSQ. Materials and Methods: A single-blind, randomised, placebo-controlled pilot study was conducted from February 2014 to May 2015 at two research centres. The cases fulfilling the eligibility criteria were enrolled (n = 60 and randomised to either the homoeopathic intervention (HI (n = 30 or identical placebo (P (n = 30 with uniform lifestyle modification (LSM for 6 months. Results: The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18 in HI + LSM group and none (n = 0 in control group (P = 0.001. Statistically significant difference (P = 0.016 was observed in reduction of intermenstrual duration (from 76.1 ± 37.7 to 46.6 ± 38.7 days in HI + LSM in comparison to placebo + LSM group (from 93.0 ± 65.2 to 93.9 ± 96.2 days. In PCOSQ, also, significant improvement was observed in HI group in domains of weight, fertility, emotions and menstrual problems (P < 0.05 with no difference in body hair (P = 0.708. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated medicine (n = 12, 40%. Conclusion: HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

  12. Office worker response to an automated venetian blind and electric lighting system: A pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Vine, E.; Lee, E.; Clear, R.; DiBartolomeo, D.; Selkowitz, S.

    1998-03-01

    A prototype integrated, dynamic building envelope and lighting system designed to optimize daylight admission and solar heat gain rejection on a real-time basis in a commercial office building is evaluated. Office worker response to the system and occupant-based modifications to the control system are investigated to determine if the design and operation of the prototype system can be improved. Key findings from the study are: (1) the prototype integrated envelope and lighting system is ready for field testing, (2) most office workers (N=14) were satisfied with the system, and (3) there were few complaints. Additional studies are needed to explain how illuminance distribution, lighting quality, and room design can affect workplans illuminance preferences.

  13. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    Directory of Open Access Journals (Sweden)

    Andrew J. Butler

    2015-01-01

    Full Text Available Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP, would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n=14 were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control. SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control. This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors.

  14. Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

    Science.gov (United States)

    Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

    2014-09-06

    This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

  15. Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study.

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    Ahn, Shin; Kim, Youn-Jung; Sohn, Chang Hwan; Seo, Dong Woo; Lim, Kyoung Soo; Donnino, Michael W; Kim, Won Young

    2018-04-01

    Sodium bicarbonate administration during cardiopulmonary resuscitation (CPR) is controversial. Current guidelines recommend sodium bicarbonate injection in patients with existing metabolic acidosis, but clinical trials, particularly, those involving patients with acidosis, are limited. We aimed to evaluate the efficacy of sodium bicarbonate administration in out-of-hospital cardiac arrest (OHCA) patients with severe metabolic acidosis during prolonged CPR. Prospective, double-blind, randomized placebo-controlled pilot trial was conducted between January 2015 and December 2015, at a single center emergency department (ED). After 10 minutes of CPR, patients who failed to achieve return of spontaneous circulation (ROSC) and with severe metabolic acidosis (pH<7.1 or bicarbonate <10 mEq/L) were enrolled. Sodium bicarbonate (n=25) or normal saline (n=25) were administered. The primary end point was sustained ROSC. The secondary end points were the change of acidosis and good neurologic survival. Sodium bicarbonate group had significant effect on pH (6.99 vs. 6.90, P=0.038) and bicarbonate levels (21.0 vs. 8.0 mEq/L, P=0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% vs. 16.0%, P=0.349) or good neurologic survival at 1 month (0.0% vs. 4.0%, P=1.000). The use of sodium bicarbonate improved acid-base status, but did not improve the rate of ROSC and good neurologic survival. We could not draw a conclusion, but our pilot data could be used to design a larger trial to verify the efficacy of sodium bicarbonate. NCT02303548 (http://www.ClinicalTrials.gov).

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    I. L. Toscano Jr.

    Full Text Available 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.

  18. Differences in two-point discrimination and sensory threshold in the blind between braille and text reading: a pilot study.

    Science.gov (United States)

    Noh, Ji-Woong; Park, Byoung-Sun; Kim, Mee-Young; Lee, Lim-Kyu; Yang, Seung-Min; Lee, Won-Deok; Shin, Yong-Sub; Kang, Ji-Hye; Kim, Ju-Hyun; Lee, Jeong-Uk; Kwak, Taek-Yong; Lee, Tae-Hyun; Kim, Ju-Young; Kim, Junghwan

    2015-06-01

    [Purpose] This study investigated two-point discrimination (TPD) and the electrical sensory threshold of the blind to define the effect of using Braille on the tactile and electrical senses. [Subjects and Methods] Twenty-eight blind participants were divided equally into a text-reading and a Braille-reading group. We measured tactile sensory and electrical thresholds using the TPD method and a transcutaneous electrical nerve stimulator. [Results] The left palm TPD values were significantly different between the groups. The values of the electrical sensory threshold in the left hand, the electrical pain threshold in the left hand, and the electrical pain threshold in the right hand were significantly lower in the Braille group than in the text group. [Conclusion] These findings make it difficult to explain the difference in tactility between groups, excluding both palms. However, our data show that using Braille can enhance development of the sensory median nerve in the blind, particularly in terms of the electrical sensory and pain thresholds.

  19. Double-blind, placebo-controlled pilot study of adjunctive quetiapine SR in the treatment of PMS/PMDD.

    Science.gov (United States)

    Jackson, Christine; Pearson, Brenda; Girdler, Susan; Johnson, Jacqueline; Hamer, Robert M; Killenberg, Susan; Meltzer-Brody, Samantha

    2015-11-01

    Premenstrual dysphoric disorder (PMDD), a more severe form of premenstrual syndrome (PMS), afflicts 5-8% of reproductive age women and results in significant functional impairment. We conducted a double-blind, placebo-controlled trial of adjunctive quetiapine in patients with PMS/PMDD who had inadequate response to selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy for their symptoms. A PMS/PMDD diagnosis was confirmed by 2-month prospective diagnostic assessment of PMS/PMDD using the Prospective Record of the Impact and Severity of Premenstrual Symptoms (PRISM) calendar. Women were randomized equally to receive quetiapine sustained-release (SR) or placebo (25-mg starting dose) during the luteal phase for 3 months. Outcome variables included the Hamilton Depression and Anxiety Scales, Clinical Global Impression Scale, and PRISM. Twenty women were enrolled in the treatment phase. Although the study was underpowered, greater reductions in luteal phase mood ratings were observed in the quetiapine group on the 17-item Hamilton Depression Rating Scale, Clinical Global Impression improvement rating, and PRISM daily score. The quetiapine group showed most improvement in symptoms of mood lability, anxiety, and irritability. This small double-blind study suggests that adjunctive treatment with quetiapine SR may be a useful addition to selective serotonin reuptake inhibitor therapy in women with PMS/PMDD by reducing symptoms and improving quality of life. Copyright © 2015 John Wiley & Sons, Ltd.

  20. Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study.

    Science.gov (United States)

    Hancock, Laura M; Bruce, Jared M; Bruce, Amanda S; Lynch, Sharon G

    2015-01-01

    Between 40-65% of multiple sclerosis patients experience cognitive deficits, with processing speed and working memory most commonly affected. This pilot study investigated the effect of computerized cognitive training focused on improving processing speed and working memory. Participants were randomized into either an active or a sham training group and engaged in six weeks of training. The active training group improved on a measure of processing speed and attention following cognitive training, and data trended toward significance on measures of other domains. Results provide preliminary evidence that cognitive training with multiple sclerosis patients may produce moderate improvement in select areas of cognitive functioning.

  1. Pilot study

    International Nuclear Information System (INIS)

    Hofmeester, G.H.; Swart, A.; Dijk, E. van

    1984-01-01

    In May 1980 it was decided to organize an intercomparison of personal dosimeters for photon radiations. The Commission of the European Communities initiated the intercomparison by starting a pilot study in which three laboratories NPL (United Kingdom), PTB (Germany) and RIV (The Netherlands) were asked to irradiate a series of personal dosemeters from institutes, GSF (Muenchen), CEA (Fontenay-aux-Roses), CNEN (Bologna) and CEGB (Berkeley). The latter institutes are secondary standard laboratories and have a radiation protection service as well. A new aspect of this pilot study is the fact that the irradiations also take place in front of a phantom. Irradiations took place in July and August 1980. The results of 4 institutes show that the personal dosemeters are quite capable of measuring the backscattered photon components

  2. The effect of non-weight bearing group-exercising on females with non-specific chronic low back pain: a randomized single blind controlled pilot study.

    Science.gov (United States)

    Masharawi, Youssef; Nadaf, Nedal

    2013-01-01

    The aim of this study was to investigate the effect of active non-weight-bearing (NWB) group exercising on women with non specific chronic low back pain (NSCLBP). Forty females with NSCLBP were assigned in a randomized control longitudinal single blinded pilot study. 20 of them were assigned to a NWB bi-weekly group exercise class and 20 females were included in the control group. The exercises involved the entire lumbo-pelvic spine aimed at improving lumbar mobility/flexibility and stability. Pain intensity (VAS), back specific disability (Rolland Morris questionnaire-RMQ), and lumbar flexion and extension ranges of motion measurements were taken prior to intervention (t(0)), immediately following 4 weeks of intervention (t(1)) and 8 weeks later (t(fu)). Reliability trials were conducted on 10 females. Non-parametric tests were used for statistical significance (p exercising improves functional, painful status, lumbar flexion and extension ranges of motion in women suffering from NSCLBP.

  3. Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Dass, S; Bowman, S J; Vital, E M; Ikeda, K; Pease, C T; Hamburger, J; Richards, A; Rauz, S; Emery, P

    2008-11-01

    Primary Sjögren syndrome (pSS) causes significant systemic symptoms including fatigue as well as glandular dysfunction. There are currently no effective systemic therapies; however, open label series have suggested that rituximab may be beneficial for systemic and glandular manifestations. Therefore, we performed a double blind, placebo-controlled, randomised pilot study of the efficacy of rituximab in reducing fatigue in pSS. A total of 17 patients with pSS and a score on fatigue visual analogue scale (VAS) >50 were randomised to receive either 2 infusions of rituximab 1 g or placebo; patients also received oral and intravenous steroids. Outcome measures included: the proportion of patients with >20% reduction in fatigue VAS, changes in pSS related symptoms, health related quality of life and immunological parameters of pSS. These were measured 6 months after therapy. There was significant improvement from baseline in fatigue VAS in the rituximab group (p<0.001) in contrast to the placebo group (p = 0.147). There was a significant difference between the groups at 6 months in the social functioning score of SF-36 (p = 0.01) and a trend to significant difference in the mental health domain score of SF-36 (p = 0.06). There was one episode of serum sickness in the rituximab treated group. This is the first double blind study of rituximab in pSS to show benefit; further studies are justified.

  4. Efficacy and safety of Citrus sudachi peel in obese adults: A randomized, double-blind, pilot study

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    Masashi Akaike

    2014-07-01

    Full Text Available Objective: This study was undertaken to explore the efficacy and safety of Citrus sudachi peel for metabolic risk factors in obese male and female adults. Background: Citrus sudachi Hort. ex Shirai (Rutaceae, called “sudachi”, is a small, round, green citrus fruit that is mainly cultivated in Tokushima Prefecture in Japan. Our group reported that Citrus sudachi peel powder improved glucose tolerance and dyslipidemia in Zucher-fatty rats and reduced hyperglycemia and hypertriglyceridemia in GK diabetic rats. Materials and Methods: We conducted a randomized, double-blind, placebo-controlled trial in 40 participants with abdominal obesity and metabolic risk factors including hypertension, impaired glucose tolerance and elevated triglyceride levels. Participants were randomized to receive either tablets that contained 1.3 g dried Citrus sudachi peel powder or placebo tablets for 12 weeks. The sudachi peel group included 14 males and 5 females with a mean age of 54.5 years, and the placebo group included 18 males and 2 females with a mean age of 51.9 years. Results: Physical status including body weight, waist circumference and blood pressure and laboratory markers including metabolic parameters were not different at any observation point between the two groups. However, among participants with serum triglyceride levels of more than 120 mg/dl, body weight, waist circumference and serum triglyceride levels were significantly decreased at several observation points after the start of treatment in the sudachi peel group but not in the placebo group. No serious adverse events were observed in the sudachi peel group. Conclusions: Citrus sudachi peel has the potential effect to safely improve abdominal obesity and lower serum levels of TG in obese individuals with hypertriglyceridemia. A large-scale randomized, double-blind clinical study targeting subjects with both abdominal obesity and high TG levels is needed to confirm the metabolic effects of

  5. A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

    Science.gov (United States)

    Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

    2014-04-01

    To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

  6. BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study

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    Franciska Gyulai

    2015-01-01

    Full Text Available Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the comparison of the results obtained at the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores. The Oswestry scores and Quality of Life Scale scores showed no change. In patients with knee arthrosis, the comparison of the first and second measurements showed no significant improvement in the abovementioned parameters, while the comparison of the first and third scores revealed a significant improvement in the Fatigue Scale scores and in the vitality test on the Quality of Life Scale. Conclusions. Our study showed that BEMER physical vascular therapy reduced pain and fatigue in the short term in patients with chronic low back pain, while long-term therapy appears to be beneficial in patients with osteoarthritis of knee.

  7. Atomoxetine treatment for nicotine withdrawal: a pilot double-blind, placebo-controlled, fixed-dose study in adult smokers

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    Silverstone Peter H

    2012-03-01

    Full Text Available Abstract Background Many effective treatments for nicotine addiction inhibit noradrenaline reuptake. Three recent studies have suggested that another noradrenaline reuptake inhibitor, atomoxetine, may reduce smoking behaviors. Methods The present double-blind, placebo-controlled, fixed-dose study was carried out over 21 days during which administration of 40 mg atomoxetine was compared to placebo in 17 individuals. Of these, nine were randomized to atomoxetine and eight to placebo. Baseline and weekly measurements were made using the Cigarette Dependence Scale (CDS, Cigarette Withdrawal Scale (CWS, Questionnaire of Smoking Urges (QSU, reported number of cigarettes smoked, and salivary cotinine levels. Results The study results showed that all those on placebo completed the study. In marked contrast, of the nine individuals who started on atomoxetine, five dropped out due to side effects. In a completer analysis there were statistically significant differences at 14 and 21 days in several measures between the atomoxetine and placebo groups, including CDS, CWS, QSU, number of cigarettes smoked (decreasing to less than two per day in the treatment group who completed the study, and a trend towards lower mean salivary cotinine levels. However, these differences were not seen in a last observation carried forward (LOCF analysis. Conclusions In summary, this is the first study to examine the use of atomoxetine in non-psychiatric adult smokers for a period of more than 7 days, and the findings suggest that atomoxetine might be a useful treatment for nicotine addiction. However, the dose used in the current study was too high to be tolerated by many adults, and a dose-finding study is required to determine the most appropriate dose for future studies of this potential treatment for smoking cessation.

  8. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

    Science.gov (United States)

    Kong, Moonkyoo; Shin, Sung Hee; Lee, Eunmi; Yun, Eun Kyoung

    2014-01-01

    Background There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT). We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients’ evaluation of pain within the RT field was also assessed. Results In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%), five (33.3%), and five patients (33.3%), respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%), nine (47.4%), two (10.5%), and one patient (5.3%), respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%). The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not statistically significant. Conclusion The results of this study show that laughter therapy can have a beneficial role in preventing radiation dermatitis in patients with breast cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes are required. PMID:25395864

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

    Science.gov (United States)

    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.

  10. Effect of a Protein Supplement on the Gut Microbiota of Endurance Athletes: A Randomized, Controlled, Double-Blind Pilot Study

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    Diego Moreno-Pérez

    2018-03-01

    Full Text Available Nutritional supplements are popular among athletes to improve performance and physical recovery. Protein supplements fulfill this function by improving performance and increasing muscle mass; however, their effect on other organs or systems is less well known. Diet alterations can induce gut microbiota imbalance, with beneficial or deleterious consequences for the host. To test this, we performed a randomized pilot study in cross-country runners whose diets were complemented with a protein supplement (whey isolate and beef hydrolysate (n = 12 or maltodextrin (control (n = 12 for 10 weeks. Microbiota, water content, pH, ammonia, and short-chain fatty acids (SCFAs were analyzed in fecal samples, whereas malondialdehyde levels (oxidative stress marker were determined in plasma and urine. Fecal pH, water content, ammonia, and SCFA concentrations did not change, indicating that protein supplementation did not increase the presence of these fermentation-derived metabolites. Similarly, it had no impact on plasma or urine malondialdehyde levels; however, it increased the abundance of the Bacteroidetes phylum and decreased the presence of health-related taxa including Roseburia, Blautia, and Bifidobacterium longum. Thus, long-term protein supplementation may have a negative impact on gut microbiota. Further research is needed to establish the impact of protein supplements on gut microbiota.

  11. Feasibility of ballistic strength training in sub-acute stroke: A randomized, controlled, assessor-blinded pilot study.

    Science.gov (United States)

    Hendrey, Genevieve; Clark, Ross A; Holland, Anne E; Mentiplay, Benjamin F; Davis, Carly; Windfeld-Lund, Cristie; Raymond, Melissa J; Williams, Gavin

    2018-05-30

    To establish the feasibility and effectiveness of a six week ballistic strength training protocol in people with stroke. Randomized, controlled, assessor-blinded study. Sub-acute inpatient rehabilitation. Consecutively admitted inpatients with a primary diagnosis of first ever stroke with lower limb weakness, functional ambulation category score of ≥3, and ability to walk ≥14m were screened for eligibility to recruit 30 participants for randomization. Participants were randomized to standard therapy or ballistic strength training three times per week for six weeks. The primary aim was to evaluate feasibility and outcomes included recruitment rate, participant retention and attrition, feasibility of the exercise protocol, therapist burden and participant safety. Secondary outcomes included measures of mobility, lower limb muscle strength, muscle power and quality of life. Thirty participants (11% of those screened) with mean age of 50 (SD 18) years were randomized. The median number of sessions attended was 15/18 and 17/18 for the ballistic and control groups respectively. Earlier than expected discharge home (n=4) and illness (n=7) were the most common reasons for non-attendance. Participants performed the exercises safely, with no study-related adverse events. There were significant (pballistic group for comfortable gait velocity (mean difference (MD) 0.31m/s, 95% confidence interval CI: 0.08 to 0.52), muscle power, as measured by peak jump height (MD 8cm, 95% CI: 3 to 13) and peak propulsive velocity (MD 64cm/s, 95% CI: 17 to 112). Ballistic training was safe and feasible in select ambulant people with stroke. Similar rates of retention and attrition suggest that ballistic training was acceptable to patients. Secondary outcomes provide promising results that warrant further investigation in a larger trial. Copyright © 2018. Published by Elsevier Inc.

  12. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

    Directory of Open Access Journals (Sweden)

    Kong M

    2014-11-01

    Full Text Available Moonkyoo Kong,1 Sung Hee Shin,2 Eunmi Lee,3 Eun Kyoung Yun2 1Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, 2College of Nursing Science, Kyung Hee University, 3Department of Quality Improvement, Kyung Hee University Medical Center, Seoul, Republic of Korea Background: There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT. We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods: Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients' evaluation of pain within the RT field was also assessed. Results: In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%, five (33.3%, and five patients (33.3%, respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%, nine (47.4%, two (10.5%, and one patient (5.3%, respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%. The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not

  13. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

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    Rollmann, Denise C. [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Novotny, Paul J. [Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota (United States); Petersen, Ivy A.; Garces, Yolanda I.; Bauer, Heather J.; Yan, Elizabeth S. [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Wahner-Roedler, Dietlind; Vincent, Ann [Department of General Internal Medicine, Mayo Clinic, Rochester, Minnesota (United States); Sloan, Jeff A. [Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota (United States); Issa Laack, Nadia N., E-mail: laack.nadia@mayo.edu [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States)

    2015-07-01

    Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.

  14. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis.

    Science.gov (United States)

    Rollmann, Denise C; Novotny, Paul J; Petersen, Ivy A; Garces, Yolanda I; Bauer, Heather J; Yan, Elizabeth S; Wahner-Roedler, Dietlind; Vincent, Ann; Sloan, Jeff A; Issa Laack, Nadia N

    2015-07-01

    The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

    International Nuclear Information System (INIS)

    Rollmann, Denise C.; Novotny, Paul J.; Petersen, Ivy A.; Garces, Yolanda I.; Bauer, Heather J.; Yan, Elizabeth S.; Wahner-Roedler, Dietlind; Vincent, Ann; Sloan, Jeff A.; Issa Laack, Nadia N.

    2015-01-01

    Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation

  16. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers

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    Udani Jay K

    2010-08-01

    Full Text Available Abstract Background Arabinogalactan from Larch tree (Larix spp. bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia vaccine in healthy adults. Methods This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g at the screening visit (V1-Day 0 and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2. They were monitored the following day (V3-Day 31, as well as 21 days (V4-Day 51 and 42 days (V5-Day 72 after vaccination. Responses by the adaptive immune system (antigen specific were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F and salivary IgA levels. Responses by the innate immune system (non-specific were measured via white blood cell counts, inflammatory cytokines and the complement system. Results Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F at both Day 51 (p = 0.006 and p = 0.002 and at Day 72 (p = 0.008 and p = 0.041. These same subtypes (18C and 23F also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001 and at Day 72 (p = 0.012 and p = 0.003. Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There

  17. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers.

    Science.gov (United States)

    Udani, Jay K; Singh, Betsy B; Barrett, Marilyn L; Singh, Vijay J

    2010-08-26

    Arabinogalactan from Larch tree (Larix spp.) bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia) vaccine in healthy adults. This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g) at the screening visit (V1-Day 0) and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2). They were monitored the following day (V3-Day 31), as well as 21 days (V4-Day 51) and 42 days (V5-Day 72) after vaccination. Responses by the adaptive immune system (antigen specific) were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and salivary IgA levels. Responses by the innate immune system (non-specific) were measured via white blood cell counts, inflammatory cytokines and the complement system. Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F) at both Day 51 (p = 0.006 and p = 0.002) and at Day 72 (p = 0.008 and p = 0.041). These same subtypes (18C and 23F) also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001) and at Day 72 (p = 0.012 and p = 0.003). Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There was no effect from the vaccine or

  18. BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

    Directory of Open Access Journals (Sweden)

    Singh Betsy B

    2009-06-01

    Full Text Available Abstract Background Delayed onset muscle soreness (DOMS is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein and muscle damage (creatine phosphokinase and myoglobin. Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

  19. BounceBack capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study.

    Science.gov (United States)

    Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

    2009-06-05

    Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack, to alleviate the severity of DOMS after standardized eccentric exercise. The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18-45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. In this controlled pilot study, intake of BounceBack capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). BounceBack capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

  20. BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

    Science.gov (United States)

    Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

    2009-01-01

    Background Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results. PMID:19500355

  1. Topical treatment with fresh human milk versus emollient on atopic eczema spots in young children: a small, randomized, split body, controlled, blinded pilot study.

    Science.gov (United States)

    Berents, Teresa Løvold; Rønnevig, Jørgen; Søyland, Elisabeth; Gaustad, Peter; Nylander, Gro; Løland, Beate Fossum

    2015-05-04

    Public health nurses report on effects of fresh human milk as treatment for conjunctivitis, rhinitis and atopic eczema (AE), the latter being highly prevalent in early childhood. Emollients and topical corticosteroids are first line treatment of AE. As many caregivers have steroid phobia, alternative treatment options for mild AE are of interest. The aim of this small pilot study was to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with AE. This was a split body, controlled, randomized and physician blinded pilot study, of children with AE with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient was applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. The severity and area of the eczema spots was evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation. Of nine patients included, six completed the study. Mean age at inclusion was 18.5 months. The spots examined were localized on the arms, legs or cheeks. The spots were similar in severity, but differed in area. In one patient the eczema ceased after inclusion. In four patients both control and intervention areas increased during the intervention. The relative change in eczema area compared to baseline showed less increase in the intervention spots in two patients, whereas the opposite was observed in three. In four children Staphylococcus aureus was found in their eczema once or more. In three of the 28 human milk samples, Staphylococcus aureus, alfa haemolytic streptococci or coagulase negative staphylococci were detected. Staphylococcus aureus was found once both in human milk and in the eczema spots, no clinical signs of infection were however observed. No secondary infection due to milk application was detected. In this small pilot study, no effect was found on eczema

  2. A double-blind, randomized, pilot dose-finding study of maca root (L. meyenii) for the management of SSRI-induced sexual dysfunction.

    Science.gov (United States)

    Dording, Christina M; Fisher, Lauren; Papakostas, George; Farabaugh, Amy; Sonawalla, Shamsah; Fava, Maurizio; Mischoulon, David

    2008-01-01

    We sought to determine whether maca, a Peruvian plant, is effective for selective-serotonin reuptake inhibitor (SSRI)-induced sexual dysfunction. We conducted a double-blind, randomized, parallel group dose-finding pilot study comparing a low-dose (1.5 g/day) to a high-dose (3.0 g/day) maca regimen in 20 remitted depressed outpatients (mean age 36+/-13 years; 17 women) with SSRI-induced sexual dysfunction. The Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ) were used to measure sexual dysfunction. Ten subjects completed the study, and 16 subjects (9 on 3.0 g/day; 7 on 1.5 g/day) were eligible for intent-to-treat (ITT) analyses on the basis of having had at least one postbaseline visit. ITT subjects on 3.0 g/day maca had a significant improvement in ASEX (from 22.8+/-3.8 to 16.9+/-6.2; z=-2.20, P=0.028) and in MGH-SFQ scores (from 24.1+/-1.9 to 17.0+/-5.7; z=-2.39, P=0.017), but subjects on 1.5 g/day maca did not. Libido improved significantly (PMaca was well tolerated. Maca root may alleviate SSRI-induced sexual dysfunction, and there may be a dose-related effect. Maca may also have a beneficial effect on libido.

  3. Daily Intake of Protein from Cod Residual Material Lowers Serum Concentrations of Nonesterified Fatty Acids in Overweight Healthy Adults: A Randomized Double-Blind Pilot Study

    Directory of Open Access Journals (Sweden)

    Iselin Vildmyren

    2018-06-01

    Full Text Available Improved process technologies have allowed fishing vessels to utilize residuals from cod fillet production (head, backbone, skin, cuttings, and entrails and convert this to high-quality protein powders for human consumption. In this double-blind pilot study, 42 healthy overweight or obese adults were randomized to three experimental groups consuming tablets corresponding to 6 g/day of proteins from cod residuals as presscake meal (Cod-PC, presscake and stickwater meal (Cod-PCW, or placebo tablets (control for eight weeks. The primary outcome of this study was changes in metabolites related to glucose regulation in overweight or obese healthy adults after intake of proteins from cod residuals. Cod-PC supplementation decreased postprandial serum nonesterified fatty acids (NEFA concentration and increased gene expressions of diglyceride acyltransferase 1 and 2 in subcutaneous adipose tissue compared with controls. Fasting insulin increased while fasting NEFA and 120-min postprandial glucose decreased within the Cod-PC group, but these changes did not differ from the other groups. In conclusion, supplementation with Cod-PC beneficially affected postprandial serum NEFA concentration compared with the other groups in overweight or obese adults. Supplementation with Cod-PCW, which contains a higher fraction of water-soluble protein compared to Cod-PC, did not affect serum markers of glucose regulation.

  4. Inorganic nitrate as a treatment for acute heart failure: a protocol for a single center, randomized, double-blind, placebo-controlled pilot and feasibility study.

    Science.gov (United States)

    Falls, Roman; Seman, Michael; Braat, Sabine; Sortino, Joshua; Allen, Jason D; Neil, Christopher J

    2017-08-08

    Acute heart failure (AHF) is a frequent reason for hospitalization worldwide and effective treatment options are limited. It is known that AHF is a condition characterized by impaired vasorelaxation, together with reduced nitric oxide (NO) bioavailability, an endogenous vasodilatory compound. Supplementation of inorganic sodium nitrate (NaNO 3 ) is an indirect dietary source of NO, through bioconversion. It is proposed that oral sodium nitrate will favorably affect levels of circulating NO precursors (nitrate and nitrite) in AHF patients, resulting in reduced systemic vascular resistance, without significant hypotension. We propose a single center, randomized, double-blind, placebo-controlled pilot trial, evaluating the feasibility of sodium nitrate as a treatment for AHF. The primary hypothesis that sodium nitrate treatment will result in increased systemic levels of nitric oxide pre-cursors (nitrate and nitrite) in plasma, in parallel with improved vasorelaxation, as assessed by non-invasively derived systemic vascular resistance index. Additional surrogate measures relevant to the known pathophysiology of AHF will be obtained in order to assess clinical effect on dyspnea and renal function. The results of this study will provide evidence of the feasibility of this novel approach and will be of interest to the heart failure community. This trial may inform a larger study.

  5. In Vitro Activation of eNOS by Mangifera indica (Careless™) and Determination of an Effective Dosage in a Randomized, Double-Blind, Human Pilot Study on Microcirculation.

    Science.gov (United States)

    Gerstgrasser, Alexandra; Röchter, Sigrid; Dressler, Dirk; Schön, Christiane; Reule, Claudia; Buchwald-Werner, Sybille

    2016-03-01

    Mangifera indica fruit preparation (Careless™) activates the evolutionary conserved metabolic sensors sirtuin 1 and adenosine monophosphate-activated protein kinase, which have been identified as playing a key role in microcirculation and endothelial function. Here, an acute effect of a single dose of 100 mg or 300 mg Careless™ on microcirculation was investigated in a randomized, double-blind, crossover pilot study in ten healthy women to determine the effective dosage. Microcirculation and endothelial function were assessed by the Oxygen-to-see system and pulse amplitude tonometry (EndoPAT™), respectively. Cutaneous blood flow was increased over time by 100 mg (54% over pre-values, p = 0.0157) and 300 mg (35% over pre-value, p = 0.209) Careless™. The EndoPAT™ reactive hyperemia response was slightly improved 3 h after intake compared to pretesting with 300 mg Careless™. Furthermore, activation of endothelial nitric oxide synthase, as an important regulator for endothelial function, was tested in vitro in primary human umbilical vein endothelial cells. Careless™, after simulation of digestion, increased the activated form of endothelial nitric oxide synthase dose-dependently by 23% (300 µg/mL), 42% (1500 µg/mL), and 60% (3000 µg/mL) compared to the untreated control. In conclusion, the study suggests moderate beneficial effects of Careless™ on microcirculation, which is at least partly mediated by endothelial nitric oxide synthase activation. Georg Thieme Verlag KG Stuttgart · New York.

  6. Neuropsychological Training of Attention Improves MS-Related Fatigue: Results of a Randomized, Placebo-Controlled, Double-Blind Pilot Study.

    Science.gov (United States)

    Flachenecker, Peter; Meissner, Heike; Frey, Rebecca; Guldin, Wolfgang

    2017-01-01

    Attentional deficits may be pathophysiologically relevant in MS-associated fatigue. Thirty MS patients with fatigue and attentional deficits in neuropsychological testing participated in this randomized, placebo-controlled, double-blind trial. The intervention group (IG; n = 14) was treated with 10 h of computerized, specific neuropsychological training performing simple reaction time tasks, whereas the control group (CG; n = 16) also runs through computerized, but unspecific neuropsychological training using tasks without time components. The subjective feeling of fatigue was assessed with the Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) questionnaire, and testing of alertness was used as an objective measure at baseline and after the 2-week study period. Reaction times of alertness were significantly decreased in IG but not CG after 2 weeks. The subjective feeling of fatigue was ameliorated in both groups but more pronounced in IG. Effect sizes were below 0.7 for alertness and WEIMuS scores in CG but large and clinically meaningful in IG for both measures. Our pilot study suggests that neuropsychological training of attention may improve both measures of fatigue. The parallel improvement of attentional deficits and subjective fatigue after specific neuropsychological training support previous findings that fatigue may be at least partially caused by impaired intensity of attention. © 2017 S. Karger AG, Basel.

  7. A randomized, controlled, single-blind, 6-month pilot study to evaluate the efficacy of MS-Line!: a cognitive rehabilitation programme for patients with multiple sclerosis.

    Science.gov (United States)

    Gich, Jordi; Freixanet, Jordi; García, Rafael; Vilanova, Joan Carles; Genís, David; Silva, Yolanda; Montalban, Xavier; Ramió-Torrentà, Lluís

    2015-09-01

    MS-Line! was created to provide an effective treatment for cognitive impairment in multiple sclerosis (MS) patients. To assess the efficacy of MS-Line!. A randomized, controlled, single-blind, 6-month pilot study. Patients were randomly assigned to an experimental group (cognitive rehabilitation with the programme) or to a control group (no cognitive rehabilitation). Randomization was stratified by cognitive impairment level. Cognitive assessment included: selective reminding test, 10/36 spatial recall test (10/36 SPART), symbol digit modalities test, paced auditory serial addition test, word list generation (WLG), FAS test, subtests of WAIS-III, Boston naming test (BNT), and trail making test (TMT). Forty-three patients (22 in the experimental group, 21 in the control group) were analyzed. Covariance analysis showed significant differences in 10/36 SPART (P=0.0002), 10/36 SPART delayed recall (P=0.0021), WLG (P=0.0123), LNS (P=0.0413), BNT (P=0.0007) and TMT-A (P=0.010) scores between groups. The study showed a significant improvement related to learning and visual memory, executive functions, attention and information processing speed, and naming ability in those patients who received cognitive rehabilitation. The results suggest that MS-Line! is effective in improving cognitive impairment in MS patients. © The Author(s), 2015.

  8. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Ingrid Melnikovova

    2015-01-01

    Full Text Available Background/Aims. Products of Lepidium meyenii Walp. (maca are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits.

  9. Adjuvant antifungal therapy using tissue tolerable plasma on oral mucosa and removable dentures in oral candidiasis patients: a randomised double-blinded split-mouth pilot study.

    Science.gov (United States)

    Preissner, Saskia; Kastner, Isabell; Schütte, Eyke; Hartwig, Stefan; Schmidt-Westhausen, Andrea Maria; Paris, Sebastian; Preissner, Robert; Hertel, Moritz

    2016-07-01

    Extended use of antimycotics in oral candidiasis therapy gives rise to problems related to fungal drug resistance. The aim of this pilot study was to investigate the efficacy of tissue tolerable plasma (TTP) in denture stomatitis patients. It was hypothesised that (I): erythema and (IIa): complaint remission would be accelerated and (IIb): colony forming unit (CFU) reduction would be improved. The halves of the upper jaws of eight patients were randomly assigned to control (nystatin, chlorhexidine and placebo treatment) and test sides (nystatin, chlorhexidine and TTP administered six times each 7 days). The patients and the investigators, who were different from the therapists, were both blinded. Compared to the control sides, the erythema surface was reduced significantly more extensively on the test sides between 2 and 6 weeks of antifungal therapy (P ≤ 0.05). Visual analogue scale values and the frequency of moderate or heavy growth of Candida post-treatment did not differ significantly between both sides (P > 0.05). The primary hypothesis was confirmed, which may be interpreted as an accelerated remission. As drug therapy is usually limited to the time in which signs of infection are present, TTP might help reducing antifungal use. Even though the secondary hypotheses were not confirmed, persistence of Candida might be only colonisation. © 2016 Blackwell Verlag GmbH.

  10. Effects of propranolol on conversational reciprocity in autism spectrum disorder: a pilot, double-blind, single-dose psychopharmacological challenge study.

    Science.gov (United States)

    Zamzow, Rachel M; Ferguson, Bradley J; Stichter, Janine P; Porges, Eric C; Ragsdale, Alexandra S; Lewis, Morgan L; Beversdorf, David Q

    2016-04-01

    Pharmacological intervention for autism spectrum disorder (ASD) is an important addition to treatment, yet currently available agents target co-morbid psychiatric concerns, such as aggression and irritability. Propranolol, a beta-adrenergic antagonist with anxiolytic effects, has been shown to improve verbal fluency and working memory in adults and adolescents with ASD in single-dose challenges. The present pilot study explores the acute effects of propranolol on a measure of conversational reciprocity in this population. We also examined whether autonomic activity and anxiety moderate or mediate response to the drug, given relationships between these variables and ASD, as well as the drug's effects. In a within-subject crossover design, 20 individuals with ASD received a single dose of propranolol or placebo during two sessions in a double-blinded, counterbalanced manner. After drug administration, participants performed a conversational reciprocity task by engaging in a short conversation with the researcher. Measurements of autonomic activity and anxiety were obtained before and after drug administration. Propranolol significantly improved performance on the conversational reciprocity task total [d = 0.40] and nonverbal communication domain scores when compared to the placebo condition. However, neither autonomic activity nor anxiety was significantly associated with drug response. Acute propranolol administration improved conversational reciprocity in ASD. Further exploration of these preliminary findings, as well as other potential treatment response predictors, with serial doses is warranted.

  11. A Blind Pilot: Who is a Super-Luminal Observer?

    Directory of Open Access Journals (Sweden)

    Rabounski D.

    2008-04-01

    Full Text Available This paper discusses the nature of a hypothetical super-luminal observer who, as well as a real (sub-light speed observer, perceives the world by light waves. This consideration is due to that fact that the theory of relativity permits different frames of reference, including light-like and super-luminal reference frames. In analogy with a blind pilot on board a supersonic jet aeroplane (or missile, perceived by blind people, it is concluded that the light barrier is observed in the framework of only the light signal exchange experiment.

  12. Randomized and double-blinded pilot clinical study of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus tea, as used in Nigerian Traditional Medicine

    DEFF Research Database (Denmark)

    Campbell-Tofte, Joan I A; Mølgaard, Per; Josefsen, Knud

    2011-01-01

    The aim of this randomized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus (RC) tea in humans. We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic (BKS-db) mice...... resulted in the normalization of blood sugar, reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas. The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk...

  13. Hypocaloric diet supplemented with probiotic cheese improves body mass index and blood pressure indices of obese hypertensive patients - a randomized double-blind placebo-controlled pilot study

    Science.gov (United States)

    2013-01-01

    Background Gut lactobacilli can affect the metabolic functions of healthy humans. We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA (Deutsche Sammlung für Mikroorganismen, DSM 21380) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension. Methods In this 3-week, randomized, double-blind, placebo-controlled, parallel pilot study, 25 subjects ingested probiotic cheese and 15 ingested control cheese. Fifty grams of each cheese provided 175 kcal of energy. Blood pressure (BP), anthropometric characteristics, markers of liver and kidney function, metabolic indices (plasma glucose, lipids, and cholesterol), and urine polyamines were measured. Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods. The data were analyzed by t-test for independent samples and Spearman’s partial correlation analysis. Results The probiotic L. plantarum TENSIA was present in variable amounts (529.6 ± 232.5 gene copies) in 16/25 (64%) study subjects. Body mass index (BMI) was significantly reduced (p = 0.031) in the probiotic cheese group versus the control cheese group. The changes in BMI were closely associated with the water content of the body (r = 0.570, p = 0.0007) when adjusted for sex and age. Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI (r = 0.383, p = 0.0305) and urinary putrescine content (r = 0.475, p = 0.006). In patients simultaneously treated with BP-lowering drugs, similar reductions of BP were observed in both groups. A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP (r = 0.617, p = 0.0248) and a trend toward lower values of morning systolic BP (r = −0.527, p = 0.0640) at the end of the study after adjusting for BMI, age, and sex. Conclusion In a pilot study of obese hypertensive patients, a hypocaloric

  14. An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study

    OpenAIRE

    Nichols, Anna J.; Hughes, Olivia Bosshardt; Canazza, Agnese; Zaiac, Martin N.

    2017-01-01

    Objective: To evaluate the effectiveness of a novel oral supplement, Forti5?, containing green tea extract, omega 3 and 6 fatty acids, cholecalciferol, melatonin, beta-sitosterol, and soy isoflavones, and in the management of subjects with androgenetic alopecia. Design: A prospective case series of 10 subjects. Setting: Open-label, evaluator-blinded, proof-of-concept study. Participants: Ten adult subjects with androgenetic alopecia completed the study. Subjects were not allowed to use oral o...

  15. A pilot double-blind randomised placebo-controlled dose-response trial assessing the effects of melatonin on infertility treatment (MIART): study protocol.

    Science.gov (United States)

    Fernando, Shavi; Osianlis, Tiki; Vollenhoven, Beverley; Wallace, Euan; Rombauts, Luk

    2014-09-01

    High levels of oxidative stress can have considerable impact on the outcomes of in vitro fertilisation (IVF). Recent studies have reported that melatonin, a neurohormone secreted from the pineal gland in response to darkness, has significant antioxidative capabilities which may protect against the oxidative stress of infertility treatment on gametes and embryos. Early studies of oral melatonin (3-4 mg/day) in IVF have suggested favourable outcomes. However, most trials were poorly designed and none have addressed the optimum dose of melatonin. We present a proposal for a pilot double-blind randomised placebo-controlled dose-response trial aimed to determine whether oral melatonin supplementation during ovarian stimulation can improve the outcomes of assisted reproductive technology. We will recruit 160 infertile women into one of four groups: placebo (n=40); melatonin 2 mg twice per day (n=40); melatonin 4 mg twice per day (n=40) and melatonin 8 mg twice per day (n=40). The primary outcome will be clinical pregnancy rate. Secondary clinical outcomes include oocyte number/quality, embryo number/quality and fertilisation rate. We will also measure serum melatonin and the oxidative stress marker, 8-hydroxy-2'-deoxyguanosine at baseline and after treatment and levels of these in follicular fluid at egg pick-up. We will investigate follicular blood flow with Doppler ultrasound, patient sleepiness scores and pregnancy complications, comparing outcomes between groups. This protocol has been designed in accordance with the SPIRIT 2013 Guidelines. Ethical approval has been obtained from Monash Health HREC (Ref: 13402B), Monash University HREC (Ref: CF14/523-2014000181) and Monash Surgical Private Hospital HREC (Ref: 14107). Data analysis, interpretation and conclusions will be presented at national and international conferences and published in peer-reviewed journals. ACTRN12613001317785. Published by the BMJ Publishing Group Limited. For permission to use (where

  16. 'Out of hours' adult CT head interpretation by senior emergency department staff following an intensive teaching session: a prospective blinded pilot study of 405 patients.

    Science.gov (United States)

    Jamal, Karim; Mandel, Laura; Jamal, Leila; Gilani, Shamim

    2014-06-01

    Cranial CT is the gold standard for the investigation of intracranial emergencies. The aim of this pilot study was to audit whether senior emergency physicians were able to report CT head scans accurately and reliably having attended structured teaching. Senior emergency physicians attended a 3 h teaching session. Following this, they independently reported adult CT head scans between 22:00 and 08:00 using a pro forma. CT head examinations performed in this 'out of hours' period were formally reported by a consultant radiologist on the following morning. Data were collected in a blinded fashion over an 8-month period. 405 adult CT head examinations were performed. 360 pro formas were available for analysis, and the rest were excluded either because a consultant radiologist had been rung to discuss the results (five patients) or because the pro forma was not completed (40 patients). Concordance between consultant radiologists and emergency physicians was found in 339 (94%) of the cases (κ coefficient 0.78). None of the discordant cases was managed inappropriately or had an adverse clinical outcome. All cases of extradural, subdural and subarachnoid haemorrhage were detected by emergency physicians. In conclusion, we feel that this model can be employed as a safe and long-term alternative provided that the radiology department are committed to providing ongoing teaching and that a database is maintained to highlight problem areas. Emergency physicians need to remember that the clinical status of the patient must never be ignored, irrespective of their CT head findings. 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.

  17. Head-and-Neck Target Delineation Among Radiation Oncology Residents After a Teaching Intervention: A Prospective, Blinded Pilot Study

    International Nuclear Information System (INIS)

    Bekelman, Justin E.; Wolden, Suzanne; Lee, Nancy

    2009-01-01

    Purpose: We conducted this study to determine the feasibility of incorporating a teaching intervention on target delineation into the educational curriculum of a radiation oncology residency program and to assess the short-term effects on resident skills. Methods and Materials: The study schema consisted of a baseline evaluation, the teaching intervention, and a follow-up evaluation. At the baseline evaluation, the participants contoured three clinical tumor volumes (CTVs) (70 Gy, 59.4 Gy, and 54 Gy) on six contrast-enhanced axial computed tomography images of a de-identified patient with Stage T2N2bM0 squamous cell carcinoma of the right base of the tongue. The participants attended a series of head-and-neck oncology and anatomy seminars. The teaching intervention consisted of a didactic lecture and an interactive hands-on practical session designed to improve the knowledge and skills for target delineation in the head and neck. At the follow-up evaluation, the residents again contoured the CTVs. Results: Of the 14 eligible residents, 11 (79%) actually participated in the study. For all participants, but especially for those who had not had previous experience with head-and-neck target delineation, the teaching intervention was associated with improvement in the delineation of the node-negative neck (CTV 54 Gy contour). Regardless of clinical experience, participants had difficulty determining what should be included in the CTV 59.4 Gy contour to ensure adequate coverage of potential microscopic disease. Conclusion: Incorporating a teaching intervention into the education curriculum of a radiation oncology residency program is feasible and was associated with short-term improvements in target delineation skills. Subsequent interventions will require content refinement, additional validation, longer term follow-up, and multi-institutional collaboration

  18. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial.

    Science.gov (United States)

    Shin, Kyung-Min; Kim, Joo-Hee; Lee, Seunghoon; Shin, Mi-Suk; Kim, Tae-Hun; Park, Hyo-Ju; Lee, Min-Hee; Hong, Kwon-Eui; Lee, Seungdeok; Choi, Sun-Mi

    2013-06-14

    Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t-test and ANCOVA (P <0.05). The

  19. A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting

    Directory of Open Access Journals (Sweden)

    Ka-Rham Kim

    2015-01-01

    Full Text Available Purpose. This study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR. Methods. Patients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy. The pharmacokinetics and pharmacodynamics using RINVR were evaluated. Results. Seventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively. Tmax (h, Cmax (ng/mL, and AUClast (ng·h/mL were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%, two patients (14.3%, and one (5.6% patient and a delayed CINV on day 7 was found in eight (47%, three (21.4%, and five (27.8% patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group and also showed the tendency for decreasing moderate-to-severe CINV. Conclusions. This study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.

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

    Science.gov (United States)

    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.

  1. Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Su-Min Kim

    2008-09-01

    Full Text Available Objective : This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods : 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain and MSSL(Menstrual Symptom Severity List questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25 and a Normal Saline(N/S treatment group(Control group, n=24. The two groups were injected on the CV4, S36, Sp9 and Sp6 acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results : As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05, and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions : The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

  2. A pilot study on efficacy treatment of acne vulgaris using a new method: results of a randomized double-blind trial with Acne Dressing.

    Science.gov (United States)

    Chao, Chao-Ming; Lai, Wei-Yu; Wu, Bai-Yao; Chang, Hung-Chia; Huang, Wei-Shuan; Chen, Yu-Fei

    2006-01-01

    For many years the positive effect of hydrocolloid dressings on skin-related conditions attracted the attention of the medical scientific community. The use of Acne Dressing, a tape of hydrocolloid dressing, for the treatment of acne has not been reported previously. The aim of this study was to evaluate the clinical efficacy and beneficial effect of Acne Dressing on the marker for sebum output evaluations. We also determined the cosmetic outcome of this application during the treatment of acne and whether the material could prevent hand touching and UVB light from reaching the skin surface. The objective of this study was to assess improvement in acne vulgaris and tolerability during one week of short contact treatment with Acne Dressing compared to skin tapes. Efficacy data specific to treatment of acne vulgaris with Acne Dressing (3M Health Care) from a double-blind, randomized, skin types-controlled study is reported. A total of 20 patients with mild-to-moderate acne vulgaris applied the skin tapes or Acne Dressing every two days for up to one week. Twenty patients were enrolled in this study: ten patients received Acne Dressing and ten patients received skin tapes. Both groups showed decreases from baseline to the end of treatment in the mean of the overall severity scale (decrease of 1.37 from 1.8 to 0.43 with Acne Dressing and 0.28 from 1.08 to 0.8 with skin tapes). A statistically significant greater reduction was observed over a period of three to seven days in the overall severity of acne and inflammation in the Acne Dressing group compared with the mono-therapy (skin tapes) group. Similarly, Acne Dressing resulted in a significantly greater improvement in the redness, oiliness, dark pigmentation, and sebum casual level at days 3, 5, and 7. The ratio of transmission of UVB light with Acne Dressing was 7.4%, and 38% with skin tapes, which shows less UVB light reaching the skin surface with the Acne Dressing. No significant adverse events were identified in

  3. Botulinum toxin a in the treatment of chronic tension-type headache with cervical myofascial trigger points: a randomized, double-blind, placebo-controlled pilot study.

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    Harden, R Norman; Cottrill, Jerod; Gagnon, Christine M; Smitherman, Todd A; Weinland, Stephan R; Tann, Beverley; Joseph, Petra; Lee, Thomas S; Houle, Timothy T

    2009-05-01

    To evaluate the efficacy of botulinum toxin A (BT-A) as a prophylactic treatment for chronic tension-type headache (CTTH) with myofascial trigger points (MTPs) producing referred head pain. Although BT-A has received mixed support for the treatment of TTH, deliberate injection directly into the cervical MTPs very often found in this population has not been formally evaluated. Patients with CTTH and specific MTPs producing referred head pain were assigned randomly to receive intramuscular injections of BT-A or isotonic saline (placebo) in a double-blind design. Daily headache diaries, pill counts, trigger point pressure algometry, range of motion assessment, and responses to standardized pain and psychological questionnaires were used as outcome measures; patients returned for follow-up assessment at 2 weeks, 1 month, 2 months, and 3 months post injection. After 3 months, all patients were offered participation in an open-label extension of the study. Effect sizes were calculated to index treatment effects among the intent-to-treat population; individual time series models were computed for average pain intensity. The 23 participants reported experiencing headache on a near-daily basis (average of 27 days/month). Compared with placebo, patients in the BT-A group reported greater reductions in headache frequency during the first part of the study (P = .013), but these effects dissipated by week 12. Reductions in headache intensity over time did not differ significantly between groups (P = .80; maximum d = 0.13), although a larger proportion of BT-A patients showed evidence of statistically significant improvements in headache intensity in the time series analyses (62.5% for BT-A vs 30% for placebo). There were no differences between the groups on any of the secondary outcome measures. The evidence for BT-A in headache is mixed, and even more so in CTTH. However, the putative technique of injecting BT-A directly into the ubiquitous MTPs in CTTH is partially supported

  4. Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: randomized, double-blind crossover pilot study

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    Shammas NW

    2015-03-01

    Full Text Available Nicolas W Shammas,1 Gail A Shammas,1 Kathleen Keyes,2 Shawna Duske,1 Ryan Kelly,1 Michael Jerin3 1Midwest Cardiovascular Research Foundation, 2Cardiovascular Medicine, Private Corporation, 3St Ambrose University, Davenport, IA, USA Background: Patients with ischemic cardiomyopathy (ICM may continue to experience persistent chest pain and/or dyspnea despite pharmacologic therapy and revascularization. We hypothesized that ranolazine would reduce anginal symptoms or dyspnea in optimally treated ICM patients.Methods: In this randomized, double-blind, crossover-design pilot study, 28 patients with ICM (ejection fraction less or equal 40% were included after providing informed consent. A total of 24 patients completed both placebo and ranolazine treatments and were analyzed. All patients were on treatment with a beta blocker, an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker, and at least one additional antianginal drug. After randomization, patients received up to 1,000 mg ranolazine orally twice a day, as tolerated, versus placebo. The primary end point was change in angina as assessed by the Seattle Angina Questionnaire (SAQ, or in dyspnea as assessed by the Rose Dyspnea Scale (RDS. Change in the RDS and SAQ score from baseline was compared, for ranolazine and placebo, using the Wilcoxon signed rank test or paired t-test.Results: Patients had the following demographic and clinical variables: mean age of 71.5 years; male (82.1%; prior coronary bypass surgery (67.9%; prior coronary percutaneous intervention (85.7%; prior myocardial infarction (82.1%; diabetes (67.9%; and mean ejection fraction of 33.1%. No statistical difference was seen between baseline RDS score and that after placebo or ranolazine (n=20 (P≥0.05. There was however, an improvement in anginal frequency (8/10 patients (P=0.058, quality of life (8/10 patients (P=0.048, and mean score of all components of the SAQ questionnaire (n=10 (P=0.047 with ranolazine

  5. Randomized and double-blinded pilot clinical study of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus tea, as used in Nigerian traditional medicine.

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    Campbell-Tofte, Joan I A; Mølgaard, Per; Josefsen, Knud; Abdallah, Zostam; Hansen, Steen Honoré; Cornett, Claus; Mu, Huiling; Richter, Erik A; Petersen, Henning Willads; Nørregaard, Jens Christian; Winther, Kaj

    2011-01-27

    The aim of this randomized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus (RC) tea in humans. We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic (BKS-db) mice resulted in the normalization of blood sugar, reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas. The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk medicine. The RC tea was produced using the Nigerian traditional recipe and tested in the traditional dosage on 23 Danish type 2 diabetes (T2D) patients. The participants were divided into two equivalent groups after stratification by sex, age and BMI, in a 4-month double-blinded, placebo-controlled and randomized clinical trial. Most of the study subjects (19/23) were using oral anti-diabetic agents (OADs). Mean disease duration was 6±4.6 years, mean age was 64±7 years and mean BMI was 28.7±3.8 kg/m(2). Prior to starting the treatment, the participants received individual dietician consultations. At the end of the 4-month treatment period, the treated group showed an 11% decrease in 2-h postprandial plasma glucose relative to the 3% increase in the placebo group (p=0.004). The improvement in blood glucose clearance with RC tea treatment was reflected in a 6% reduction in HbA(1c) (p=0.02) and in a 10% reduction in fasting plasma glucose (p=0.02), when comparing the post 4-month treatment to pre-treatment baseline values. Though the basal levels of phosphorylated acetyl CoA carboxylase enzyme in skeletal muscle were significantly reduced in the treated group (p=0.04), as compared to the placebo, only the pattern of reductions in the tissue fatty acids (FAs) differed in the two groups. While all types of FAs were reduced in placebo, only saturated (SFA) and

  6. A randomized, double blind, placebo and active comparator controlled pilot study of UP446, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin

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    Sampalis John S

    2012-04-01

    Full Text Available Abstract Background Current use of prescribed or over the counter non-steroidal anti-inflammatory drugs (NSAIDs for pain and osteoarthritis (OA have untoward gastrointestinal and cardiovascular related side effects, as a result the need for a safe and effective alternative has become unequivocally crucial. Method A randomized, double blind, placebo and active controlled pilot study of a novel dual pathway, COX1/2 and LOX, inhibitor anti-inflammatory agent of botanical origin, UP446 was conducted. Sixty subjects (age 40-75 with symptomatic OA of the hip or knee were assigned to 4 treatment groups (n = 15; Group A0 (Placebo, CMC capsule, Group A1 (UP446 250 mg/day, Group A2 (UP446 500 mg/day and Group A3 (Celecoxib, 200 mg/day. MOS-SF-36 and Western Ontario and McMaster University Osteoarthritis Index (WOMAC data were collected at baseline and after 30, 60 and 90 days of treatment as a measure of efficacy. Erythrocyte sedimentation rate, C-reactive protein, plasma thrombin time (PTT, fructosamine, Hematology, clinical chemistry and fecal occult blood were monitored for safety. Results Statistically significant decrease in WOMAC pain score were observed for Group A1 at day 90, Group A2 at 30 and 90 days and Group A3 at 60 and 90 days. Statistically significant decrease in WOMAC stiffness score were observed for Group A1 and Group A2 at 30, 60 and 90 days; but not for Group A0 and Group A3. The mean change in WOMAC functional impairment scores were statistically significant for Group A1 and Group A2 respectively at 30 days (p = 0.006 and p = 0.006, at 60 days (p = 0.016 and p = 0.002 and at 90 days (p = 0.018 and p = 0.002, these changes were not significant for Group A0 and Group A3. Based on MOS -SF-36 questionnaires, statistically significant improvements in physical function, endurance and mental health scores were observed for all active treatment groups compared to placebo. No significant changes suggestive of toxicity in routine hematologies

  7. Comparing oxytocin and cortisol regulation in a double-blind, placebo-controlled, hydrocortisone challenge pilot study in children with autism and typical development.

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    Corbett, Blythe A; Bales, Karen L; Swain, Deanna; Sanders, Kevin; Weinstein, Tamara A R; Muglia, Louis J

    2016-01-01

    Children with autism spectrum disorder (ASD) show marked impairment in social functioning and poor adaptation to new and changing contexts, which may be influenced by underlying regulatory processes. Oxytocin (OT) and cortisol are key neuromodulators of biological and behavioral responses, show a synergistic effect, and have been implicated in the neuropathological profile in ASD. However, they are rarely investigated together. The purpose of the pilot study was to evaluate the relationship between cortisol and OT in children with ASD under baseline and physiological stress (hydrocortisone challenge) conditions. Arginine vasopressin (AVP), structurally similar to OT, was also examined. A double-blind, placebo-controlled, randomly assigned, crossover design was employed in 25 children 8-to-12 years with ASD (N = 14) or typical development (TD, N = 11). A low dose of hydrocortisone and placebo were administered via liquid suspension. Analysis of variance (ANOVA) was used to examine the within-subject factor "Condition" (hydrocortisone/placebo) and "Time" (pre and post) and the between-subject factor "Group" (ASD vs. TD). Pearson correlations examined the relationship between hormone levels and clinical profile. There was a significant Time × Condition × Group interaction F (1.23) = 4.18, p = 0.05 showing a rise in OT during the experimental condition (hydrocortisone) and a drop during the placebo condition for the TD group but not the ASD group. There were no group differences for AVP. Hormone levels were associated with social profiles. For the TD group, an inverse relationship was observed. OT increased during physiological challenge suggesting that OT played a stress-buffering role during cortisol administration. In contrast for the ASD group, OT remained unchanged or decreased during both the physiological challenge and the placebo condition, suggesting that OT failed to serve as a stress buffer under conditions of physiological stress. While

  8. Olanzapine plus dialectical behavior therapy for women with high irritability who meet criteria for borderline personality disorder: a double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Linehan, Marsha M; McDavid, Joshua D; Brown, Milton Z; Sayrs, Jennifer H R; Gallop, Robert J

    2008-06-01

    This double-blind study examined whether olanzapine augments the efficacy of dialectical behavior therapy (DBT) in reducing anger and hostility in borderline personality disorder patients. Twenty-four women with borderline personality disorder (DSM-IV criteria) and high levels of irritability and anger received 6 months of DBT. Subjects were randomly assigned to receive either low-dose olanzapine or placebo and were assessed with standardized measures in a double-blind manner. The study was conducted from September 2000 to December 2002. Intent-to-treat analyses indicated that both treatment conditions resulted in significant improvement in irritability, aggression, depression, and self-inflicted injury (p borderline personality disorder. Effect sizes were moderate to large, with the small sample size likely limiting the ability to detect significant results. Overall, there were large and consistent reductions in irritability, aggression, depression, and self-injury for both groups of subjects receiving DBT.

  9. An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study.

    Science.gov (United States)

    Nichols, Anna J; Hughes, Olivia Bosshardt; Canazza, Agnese; Zaiac, Martin N

    2017-02-01

    Objective: To evaluate the effectiveness of a novel oral supplement, Forti5 ® , containing green tea extract, omega 3 and 6 fatty acids, cholecalciferol, melatonin, beta-sitosterol, and soy isoflavones, and in the management of subjects with androgenetic alopecia. Design: A prospective case series of 10 subjects. Setting: Open-label, evaluator-blinded, proof-of-concept study. Participants: Ten adult subjects with androgenetic alopecia completed the study. Subjects were not allowed to use oral or topical hair growth products in the 24 weeks preceding the study or during the study. The nutritional supplement was administered at a dosage of two tablets daily for 24 weeks. Measurements: Clinical evaluations were performed at baseline and at 24 weeks. Efficacy was evaluated using hair mass index measured by cross section trichometer, terminal hair count measured with dermoscopy and Investigator Global Photography Assessment. Results: Overall 80 percent of subjects (8/10) were rated as improved after 24 weeks of supplementation (mean change of +1.4 equivalent to slightly-to-moderately increased). Forty percent of subjects (4/10) were rated as moderately improved (2+), and 10 percent (1/10) were rated as greatly improved (3+). There was a significant improvement in terminal hair count (mean increase of 5.9% or 4.2 more terminal hairs in the area examined, p =0.014) and in Hair Mass Index (mean increase of 9.5% or 4.5 higher Hair Mass Index, p =0.003). Conclusion: These preliminary results indicate that Forti5 ® a novel nutritional supplement that contains cholecalciferol, omega 3 and 6 fatty acids, melatonin, antioxidants, and botanical 5-alpha reductase inhibitors, may be a useful adjunct in the treatment of androgenetic alopecia.

  10. Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study.

    Science.gov (United States)

    Semelka, Richard C; Hernandes, Mateus de A; Stallings, Clifton G; Castillo, Mauricio

    2013-01-01

    The purpose was to objectively evaluate a recently FDA-approved gadolinium-based contrast agent (GBCA) in comparison to our standard GBCA for acute adverse events and image quality by blinded evaluation. Evaluation was made of a recently FDA-approved GBCA, gadobutrol (Gadavist; Bayer), in comparison to our standard GBCA, gadobenate dimeglumine (MultiHance; Bracco), in an IRB- and HIPAA-compliant study. Both the imaging technologist and patient were not aware of the brand of the GBCA used. A total of 59 magnetic resonance studies were evaluated (59 patients, 31 men, 28 women, age range of 5-85 years, mean age of 52 years). Twenty-nine studies were performed with gadobutrol (22 abdominal and 7 brain studies), and 30 studies were performed with gadobenate dimeglumine (22 abdominal and 8 brain studies). Assessment was made of acute adverse events focusing on objective observations of vomiting, hives, and moderate and severe reactions. Adequacy of enhancement was rated as poor, fair and good by one of two experienced radiologists who were blinded to the type of agent evaluated. No patient experienced acute adverse events with either agent. The target minor adverse events of vomiting or hives, and moderate and severe reactions were not observed in any patient. Adequacy of enhancement was rated as good for both agents in all patients. Objective, blinded evaluation is feasible and readily performable for the evaluation of GBCAs. This proof-of-concept study showed that both GBCAs evaluated exhibited consistent good image quality and no noteworthy adverse events. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. A randomized, double-blind, placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain: proof of concept.

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    Tek, Cenk; Ratliff, Joseph; Reutenauer, Erin; Ganguli, Rohan; O'Malley, Stephanie S

    2014-10-01

    Patients with schizophrenia experience higher rates of obesity as well as related morbidity and mortality than the general population does. Women with schizophrenia are at particular risk for antipsychotic-associated weight gain, obesity, and related medical disorders such as diabetes and cardiovascular disease. Given preclinical studies revealing the role of the endogenous opioid systems in human appetite and the potential of antipsychotic medications to interfere with this system, we hypothesized that opioid antagonists may be beneficial in arresting antipsychotic-associated weight gain and promoting further weight loss in women with schizophrenia. In the present study, 24 overweight women with a diagnosis of schizophrenia or schizoaffective disorder were randomized to placebo or naltrexone (NTX) 25 mg/d for 8 weeks. The primary outcome measure was a change in body weight from baseline. The patients in the NTX group had significant weight loss (-3.40 kg) compared with weight gain (+1.37 kg) in the patients in the placebo group. Mainly, nondiabetic subjects lost weight in the NTX arm. These data support the need to further investigate the role of D2 blockade in reducing food reward-based overeating. A larger study addressing the weaknesses of this pilot study is currently underway.

  12. The Efficacy of Treatment of Different Intervention Programs for Patellofemoral Pain Syndrome–A Single Blinded Randomized Clinical Trial. Pilot Study

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    Feazadeh Avraham

    2007-01-01

    Full Text Available 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.

  13. Randomised, prospective, non-blinded pilot study comparing the effect of intramuscular steroid injections and intralesional steroid injections in the management of tennis elbow

    Science.gov (United States)

    Tahir, Hasan; Biro, Izolda; Donnelly, Simon; Greenwood, Mandy

    2016-01-01

    Background Tennis elbow is an overuse injury affecting people performing repetitive forearm movements. It is a soft tissue disorder that causes significant disability and pain. The aim of the study was to establish that an intramuscular steroid injection is effective in the short-term pain relief and functional improvement of tennis elbow. The severity of pain at the injection site was monitored to determine whether the intramuscular injection is better tolerated than the intralesional injection. Methods and results 19 patients, who had no treatment for tennis elbow in the preceding 3 months, were recruited from Whipps Cross University Hospital, London, and were randomised to receive either 80 mg of intramuscular Depo-Medrone or 40 mg of intralesional Depo-Medrone injection. Blinding proved difficult as the injection sites differed and placebo arms were not included in the study. A Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire and a 10-point Likert scale were used to assess primary outcome. Six weeks after the treatment, there was a reduction in pain, improvement in function and total PRTEE scores in both intramuscular and intralesional groups (p=0.008) using a 95% CI for mean treatment difference of −26 to +16 points. A statistically significant result (p=0.001) in favour of intramuscular causing less pain at the injection site was noted. Conclusion Non-inferiority of intramuscular to intralesional injections was not confirmed; however, the intramuscular injection proved to be effective in reducing tennis elbow-related symptoms and was found less painful at the site of injection at the time of administration. Trial registration number EUDRACT Number: 2010-022131-11. REC Number: 10/H0718/76 (NRES, Central London REC 1). PMID:28879024

  14. The effect of balneotherapy on chronic shoulder pain. A randomized, controlled, single-blind follow-up trial. A pilot study.

    Science.gov (United States)

    Tefner, Ildikó Katalin; Kovács, Csaba; Gaál, Ramóna; Koroknai, András; Horváth, Remény; Badruddin, Rakib Mohammed; Borbély, Ildikó; Nagy, Katalin; Bender, Tamás

    2015-06-01

    The effects of balneotherapy on chronic shoulder pain were studied. In this single-blind, randomized, follow-up study involving 46 patients with chronic shoulder pain, one group of patients received physiotherapy--exercise and transcutaneous electrical nerve stimulation--and the other group received balneotherapy in addition to physiotherapy for 4 weeks on 15 occasions. The following parameters were recorded before treatment (at week 0) and after treatment (at weeks 4, 7, and 13): Shoulder Pain and Disability Index (SPADI), the Short Form (36) Health Survey (SF-36) and EuroQuol-5D (EQ-5D) quality of life questionnaires, pain at rest and on movement on the visual analog scale (VAS), and active and passive range of motion. The SPADI pain, function, and total scores and the VAS scores at rest and on movement significantly improved in both groups after treatments. A greater improvement was observed in the balneotherapy group compared to the control group; regarding some parameters (VAS score on movement and SPADI function score at visit 2; VAS score at rest at visits 3 and 4), the difference between the groups was significant. The improvement of SF-36 and EQ-5D quality of life scores and the active range of motion was more pronounced in the balneotherapy group, the difference between the groups was not significant, except for EQ-5D at visit 2. Improvement of passive range of motion was not significant. Balneotherapy may have a beneficial effect on the clinical parameters and quality of life of patients with chronic shoulder pain. The number of patients should be increased.

  15. Preventing ICU Subsyndromal Delirium Conversion to Delirium with Low Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study

    Science.gov (United States)

    Al-Qadheeb, Nada S.; Skrobik, Yoanna; Schumaker, Greg; Pacheco, Manuel; Roberts, Russel; Ruthazer, Robin; Devlin, John W

    2016-01-01

    Objective To compare the efficacy and safety of scheduled low-dose, haloperidol vs. placebo for the prevention of delirium [Intensive Care Delirium Screening Checklist (ICDSC) ≥ 4)] administered to critically ill adults with subsyndromal delirium (ICDSC = 1-3). Design Randomized, double-blind, placebo-controlled trial. Setting Three 10-bed ICUs (2 medical; 1 surgical) at an academic medical center in the U.S. Patients Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery or requiring deep sedation. Interventions Patients were randomly assigned to receive intravenous haloperidol 1 mg or placebo every six hours until either delirium (ICDSC ≥ 4 with psychiatric confirmation), therapy ≥ 10 days or ICU discharge occurred. Measurements and Main Results Baseline characteristics were similar between the haloperidol (n=34) and placebo (n=34) groups. A similar number of patients given haloperidol [12/34 (35%)] and placebo [8/34 (23%)] patients developed delirium (p=0.29). Haloperidol use reduced the hours per study day spent agitated (SAS ≥ 5) (p=0.008), but did not influence the proportion of 12-hour ICU shifts patients’ spent alive without coma (SAS ≤ 2) or delirium (p=0.36), the time to first delirium occurrence (p=0.22) nor delirium duration (p=0.26). Days of mechanical ventilation (p=0.80), ICU mortality (p=0.55) and ICU patient disposition (p=0.22) were similar in the two groups. The proportion of patients who developed QTc-interval prolongation (p=0.16), extrapyramidal symptoms (p=0.31), excessive sedation (p=0.31) or new-onset hypotension (p=1.0) that resulted in study drug discontinuation was comparable between the two groups. Conclusions Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults with subsyndromal delirium. PMID:26540397

  16. Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Al-Qadheeb, Nada S; Skrobik, Yoanna; Schumaker, Greg; Pacheco, Manuel N; Roberts, Russel J; Ruthazer, Robin R; Devlin, John W

    2016-03-01

    To compare the efficacy and safety of scheduled low-dose haloperidol versus placebo for the prevention of delirium (Intensive Care Delirium Screening Checklist ≥ 4) administered to critically ill adults with subsyndromal delirium (Intensive Care Delirium Screening Checklist = 1-3). Randomized, double-blind, placebo-controlled trial. Three 10-bed ICUs (two medical and one surgical) at an academic medical center in the United States. Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery, or requiring deep sedation. Patients were randomly assigned to receive IV haloperidol 1 mg or placebo every 6 hours until delirium occurred (Intensive Care Delirium Screening Checklist ≥ 4 with psychiatric confirmation), 10 days of therapy had elapsed, or ICU discharge. Baseline characteristics were similar between the haloperidol (n = 34) and placebo (n = 34) groups. A similar number of patients given haloperidol (12/34 [35%]) and placebo (8/34 [23%]) developed delirium (p = 0.29). Haloperidol use reduced the hours per study day spent agitated (Sedation Agitation Scale ≥ 5) (p = 0.008), but it did not influence the proportion of 12-hour ICU shifts patients spent alive without coma (Sedation Agitation Scale ≤ 2) or delirium (p = 0.36), the time to first delirium occurrence (p = 0.22), nor delirium duration (p = 0.26). Days of mechanical ventilation (p = 0.80), ICU mortality (p = 0.55), and ICU patient disposition (p = 0.22) were similar in the two groups. The proportion of patients who developed corrected QT-interval prolongation (p = 0.16), extrapyramidal symptoms (p = 0.31), excessive sedation (p = 0.31), or new-onset hypotension (p = 1.0) that resulted in study drug discontinuation was comparable between the two groups. Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults

  17. Clinical evaluation of XaraColl®, a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies

    Directory of Open Access Journals (Sweden)

    Cusack SL

    2012-06-01

    Full Text Available Susan L Cusack,1 Mark Jaros,2 Michael Kuss,3 Harold S Minkowitz,4 Peter Winkle,5 Lisa Hemsen61Cusack Pharmaceutical Consulting, Burlington, NJ, 2Summit Analytical, Denver, CO, USA; 3Premier Research Group, Austin, TX, USA; 4Memorial Hermann Memorial City Medical Center, Houston, TX, USA; 5Advanced Clinical Research Institute, Anaheim, CA, USA; 6Innocoll Technologies, Athlone, IrelandBackground: XaraColl®, a collagen-based implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. Because of differing patient attitudes to postoperative pain control and the inability to assess baseline pain, standard clinical methods for evaluating analgesic efficacy are compromised and justify application of novel integrated approaches.Methods: We conducted two independent, multicenter, double-blind, placebo-controlled studies in men undergoing unilateral inguinal hernioplasty by open laparotomy to evaluate the safety and efficacy of XaraColl at different doses (100 mg and 200 mg of bupivacaine hydrochloride; study 1 and 2, respectively. Enrolled patients (50 in study 1 and 53 in study 2 were randomized to receive active or placebo implants in a 1:1 ratio. Postoperative pain intensity and use of supplementary opioid medication were recorded through 72 hours. Safety was assessed through 30 days. The principal efficacy variables were the summed pain intensity (SPI, total use of opioid analgesia (TOpA, and an integrated endpoint (I-SPI-TOpA. Each variable was analyzed at 24, 48, and 72 hours after implantation. A pooled analysis of both studies was also performed retrospectively.Results: Through 24 and 48 hours, XaraColl-treated patients experienced significantly less pain in study 1 (P < 0.001 and P = 0.012, respectively whereas they took significantly less opioid analgesia in study 2 (P = 0.004 and P = 0.042, respectively. Over the same time intervals in the pooled analysis, treated patients experienced

  18. Andrographis paniculata decreases fatigue in patients with relapsing-remitting multiple sclerosis: a 12-month double-blind placebo-controlled pilot study.

    Science.gov (United States)

    Bertoglio, J C; Baumgartner, M; Palma, R; Ciampi, E; Carcamo, C; Cáceres, D D; Acosta-Jamett, G; Hancke, J L; Burgos, R A

    2016-05-23

    Andrographis paniculata (A. paniculata), a medicinal plant, has shown anti-inflammatory, neuroprotective and antifibrotic effects in animal models as well as clinical efficacy in different studies, including an anti-fatigue effect in autoimmune diseases such as rheumatoid arthritis. In multiple sclerosis (MS), fatigue is rated as one of the most common and disabling symptoms. In the present trial, we investigated the effect of A. paniculata on relapse rate and fatigue in relapsing-remitting MS (RRMS) patients receiving interferon beta. A randomised double-blind placebo-controlled trial assessed the effects of 170 mg of A. paniculata dried extract tablet b.i.d. p.o. on relapse rate and fatigue using the Fatigue Severity Scores (FSS) over 12 months in RRMS patients receiving interferon. The Expanded Disability Status Scale (EDSS) score, inflammatory parameters and radiological findings were also investigated. Twenty-five patients were enrolled, and twenty-two patients were ultimately analysed and randomised to the active or placebo group. Patients treated with A. paniculata showed a significant reduction in their FSS score as compared to the placebo, equivalent to a 44 % reduction at 12 months. No statistically significant differences were observed for relapse rate, EDSS or inflammatory parameters, with a trend in reducing new lesions among the A. paniculata group. One patient in the A. paniculata group presented with a mild and transient skin rash, which was alleviated with anti-histamine treatment for three weeks. A. paniculata was well tolerated in patients and no changes in clinical parameters were observed. A. paniculata significantly reduces fatigue in patients with RRMS receiving interferon beta in comparison to placebo and only interferon beta treatment. ClinicalTrials.gov Identifier: NCT02280876 ; Trial registration date: 20.10.2014.

  19. Effects of the cannabinoid-1 receptor antagonist rimonabant on psychiatric symptoms in overweight people with schizophrenia: a randomized, double-blind, pilot study.

    Science.gov (United States)

    Kelly, Deanna L; Gorelick, David A; Conley, Robert R; Boggs, Douglas L; Linthicum, Jared; Liu, Fang; Feldman, Stephanie; Ball, M Patricia; Wehring, Heidi J; McMahon, Robert P; Huestis, Marilyn A; Heishman, Stephen J; Warren, Kimberly R; Buchanan, Robert W

    2011-02-01

    Weight gain is a major adverse effect of several second-generation antipsychotic medications. Rimonabant is a cannabinoid-1 receptor antagonist that promotes weight loss in the general population. We conducted a 16-week, double-blind, placebo-controlled study of rimonabant (20 mg/d) in people with schizophrenia or schizoaffective disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria, who were clinically stable on second-generation antipsychotics. Participants had a body mass index of 27 kg/m or higher with hyperlipidemia or body mass index of 30 kg/m or higher, and no current substance abuse/dependence (except nicotine), more than weekly cannabis use, or recent depressive symptoms/suicidality. An exercise and dietary counseling group was offered weekly. Target enrollment was 60; the trial was terminated early because of withdrawal of rimonabant from the European market. Fifteen participants were randomized (7 rimonabant, 8 placebo); 5 completed in each group. Rimonabant was associated with a greater reduction in Brief Psychiatric Rating Scale total score versus placebo (mean ± SE difference, -1.9 ± 0.8, P = 0.02), driven by differences in the Brief Psychiatric Rating Scale anxiety/depression (-1.4 ± 0.35, P = 0.0004) and hostility (-0.7 ± 0.3, P = 0.02) factors. Group differences were not significant for the Calgary Depression Scale total score (P = 0.24), Scale for the Assessment of Negative Symptoms total score (P = 0.13), weight, blood pressure, or fasting lipids or glucose. Rimonabant was well tolerated with no significant adverse events. No significant weight loss, metabolic effects, or adverse psychiatric effects were associated with the cannabinoid-1 receptor antagonist rimonabant in this small sample of people with schizophrenia. The endocannabinoid system remains a promising target for pharmacotherapy of schizophrenia and obesity.

  20. Guided tissue regeneration and platelet rich growth factor for the treatment of Grade II furcation defects: A randomized double-blinded clinical trial - A pilot study.

    Science.gov (United States)

    Jenabian, Niloofar; Haghanifar, Sina; Ehsani, Hodis; Zahedi, Ehsan; Haghpanah, Masumeh

    2017-01-01

    The treatment of furcation area defects remained as a challenging issue in periodontal treatments. Regeneration treatment of furcation defects is the most discussed periodontal treatment. Although not completely hopeless in prognosis, the presence of the furcation involvement significantly increases the chance of tooth loss. The current research was conductedeto compare theeadditive effect of combined guided tissue regeneration (GTR) and platelet-rich growth factor (PRGF) on the treatment of furcation bony defects. A randomized, triple-blinded, split-mouth study was designed. It included patients with a moderate to severe chronic periodontitis with bilateral Grade II furcation involvement of first or second mandibular molars. Each side of mouth was randomly allocated for the treatment with either Bio-Gide American Society of Anesthesiologists GTR or a PRGF or PRGF by itself. Plaque index, gingival index, vertical clinical attachment level, vertical probing depth, recession depth (REC), horizontal probing depth, fornix to alveolar crest (FAC), fornix to base of defect (FBD), furcation vertical component and furcation horizontal component (FHC) were recorded. The current research was conducted to compare the additive effect of combined GTR and PRGF on treatment of furcation bony defects. Altman's nomogram, Kolmogorov-Smirnov test, Friedman test, general linear model, repeated measures, and paired t -test were used as statistical analysis in this research. P PRGF group ( P = 0.02). A significant improvement in the Grade II furcation defects treated with either GTR or PRGF/GTR was noticed. Further large-scale trials are needed to reveal differences of mentioned treatment in more details.

  1. Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study.

    Science.gov (United States)

    Majeed, Muhammed; Nagabhushanam, Kalyanam; Natarajan, Sankaran; Sivakumar, Arumugam; Ali, Furqan; Pande, Anurag; Majeed, Shaheen; Karri, Suresh Kumar

    2016-02-27

    Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient, but its efficacy in diarrhea predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated till date. Thus, a double blind placebo controlled multi-centered trial was planned to evaluate the safety and efficacy of B. coagulans MTCC 5856 in diarrhea predominant IBS patients. Thirty six newly diagnosed diarrhea predominant IBS patients were enrolled in three clinical centres. Along with standard care of treatment, 18 patients in group one received placebo while in group two 18 patients received B. coagulans MTCC 5856 tablet containing 2 × 10(9) cfu/day as active for 90 days. Clinical symptoms of IBS were considered as primary end point measures and were evaluated through questionnaires. The visual analog scale (VAS) was used for abdominal pain. Physician's global assessment and IBS quality of life were considered as secondary efficacy measures and were monitored through questionnaires. Laboratory parameters, anthropometric and vital signs were within the normal clinical range during the 90 days of supplementation in placebo and B. coagulans MTCC 5856 group. There was a significant decrease in the clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency in a patient group receiving B. coagulans MTCC 5856 when compared to placebo group (p coagulans MTCC 5856 when compared to placebo group. The study concluded that the B. coagulans MTCC 5856 at a dose of 2 × 10(9) cfu/day along with standard care of treatment was found to be safe and effective in diarrhea predominant IBS patients for 90 days of supplementation. Hence, B. coagulans MTCC 5856 could be a potential agent in the management of diarrhea predominant IBS patients.

  2. The Proteolytic Fraction from Latex of Vasconcellea cundinamarcensis (P1G10) Enhances Wound Healing of Diabetic Foot Ulcers: A Double-Blind Randomized Pilot Study.

    Science.gov (United States)

    Tonaco, Luís A B; Gomes, Flavia L; Velasquez-Melendez, Gustavo; Lopes, Miriam T P; Salas, Carlos E

    2018-04-01

    The aim of the study was to investigate the role of the proteolytic fraction from Vasconcellea cundinamarcensis, designated as P1G10, on the healing of chronic foot ulcers in neuropathic patients with diabetes 2. Fifty patients were enrolled in a prospective, randomized, double-blind trial, to verify the efficacy and safety of a topical dressing formulated with 0.1% P1G10, intended for wound healing, versus a hydrogel (control) protocol. Upon completion of the intervention, the outcome evaluated the number of patients attaining full epithelization (100%), or at least 80% healing. Statistical analysis compared the data on each group for the significance of the differences. Collection of data was finished in week 16, and the results were analyzed by intention to treat. The results showed that, in the control group, 5 patients attained 100% ulcer healing, 3 patients ≥ 80% healing and 11 experienced ulcer changes ≤ 80%, and the remainder showed no changes or their wounds became worse. Meanwhile, in the P1G10 group, 11 patients experienced full healing, 4 had healing ≥ 80% and 5 had ulcer changes ≤ lower than 80%, and the remainder showed no changes or their wounds became worse. The healing incidence for the first endpoint (100% healing) showed that the P1G10 group was 2.95-fold more efficacious than the control group (CI 95%) and 2.52-fold (CI, 95%) higher than its control for the second endpoint (80% healing). These data support the hypothesis that topical application of the proteolytic fraction identified as P1G10 significantly enhances foot ulcer healing compared to hydrogel treatment.

  3. 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.

    Science.gov (United States)

    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.

  4. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

    Directory of Open Access Journals (Sweden)

    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

  5. Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

    Directory of Open Access Journals (Sweden)

    Hossein Pakdaman

    2017-05-01

    Full Text Available Background and Aim: Mild cognitive impairment (MCI is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42 for the MMSE and 3.82 (±6.16 for the ADAS-cog; in the placebo group, they were –2.66 (±3.43 for the MMSE and 4.41 (±6.66 for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001. Only 5 patients (14.7% reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

  6. A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

    Directory of Open Access Journals (Sweden)

    Oberweis D

    2016-02-01

    Full Text Available Didier Oberweis,1 Patrick Madelenat,2 Michelle Nisolle,3 Etienne Demanet4 1Department of Gynecology and Obstetrics, CHU de Charleroi, Hôpital André Vésale, Montigny-le-Tilleul, Belgium; 2Private Consultation, Paris, France; 3Department of Gynecology and Obstetrics, CHR Citadelle, Liège, 4Clinical Research Unit, Charleroi, Belgium Abstract: Endometriosis is one of the most common benign gynecological disorders, affecting almost 10%–15% of all women of reproductive age and >30% of infertile women. The pathology is associated with various distressing symptoms, particularly pelvic pain, which adversely affect patients' quality of life. It is an estrogen-dependent disease. There is evidence both in animals and in humans that metal ions can activate the estrogen receptors. They are defined as a variety of xenoestrogens, called metalloestrogens, which could act as endocrine disruptors. Therefore, it could be considered to act on this gynecological disorder using food supplements containing trace elements (ie, nutripuncture. The assumption is that they could modulate estrogen receptors and thus influence the tropism and the survival of cells involved in endometriosis. By a modulation of the antioxidant system, they might also interact with various parameters influencing tissue biochemistry. The objective of this article is to describe and discuss the design and methodology of an ongoing double-blind, randomized, placebo-controlled study aiming to evaluate the efficacy of metal trace elements on the reduction of pain and improvement of quality of life, in patients with a revised American Fertility Society Score Stages II–IV endometriosis, combined or not with adenomyosis, during a treatment period of 4 months. Trace elements or placebo is proposed in the absence of any other treatment or as an add-on to current therapies, such as sexual hormones, nonsteroidal anti-inflammatory drugs, and surgery. A placebo run-in period of one menstrual cycle or

  7. The ENIQ pilot study: current status

    Energy Technology Data Exchange (ETDEWEB)

    Lemaitre, P; Eriksen, B; Crutzen, S [European Commission, DG Joint Research Centre, Petten (Netherlands); Hansch, M [Preussische Elektrizitaets-AG (Preussenelektra), Hannover (Germany); Whittle, J [AEA Technology, Warrington (United Kingdom)

    1998-11-01

    A pilot study is currently being carried out by ENIQ (European Network for Inspection Qualification) in order to explore the issues involved in inspection qualification applied along the general principles of the European methodology. The components selected for the pilot study are austenitic pipe to pipe and pipe to elbows welds typical of those in BWR recirculation loops. A range of defect parameters has been defined. A suitable inspection procedure designed to find the designated defects will be applied to geometrically representative test pieces. The procedure/equipment will be qualified through open trials and technical justification. The personnel qualification will be done in a blind way. Once all features of the inspection system will have been qualified an in-service inspection will be simulated in order to test the feasibility of the qualification approach followed. In this paper the current status of this pilot study is discussed. (orig.)

  8. Pilot study: a randomised, double blind, placebo controlled trial of pancrealipase for the treatment of postprandial irritable bowel syndrome-diarrhoea.

    Science.gov (United States)

    Money, Mary E; Walkowiak, Jaroslaw; Virgilio, Chris; Talley, Nicholas J

    2011-01-01

    OBJECTIVE: To evaluate the efficacy of pancrealipase (PEZ) compared with placebo in the reduction of postprandial irritable bowel syndrome-diarrhoea (IBS-D). DESIGN: An intention to treat, double blind, randomised, crossover trial comparing PEZ to placebo for reduction of postprandial IBS-D. Patients had to recognise at least two different triggering foods, be willing to consume six baseline 'trigger meals' and again blinded with PEZ and placebo. Patients then chose which drug they preferred for another 25 meals. SETTING: Outpatient internal medicine practice clinic. PATIENTS: 255 patients were screened; 83 met the criteria, including 5 years of symptoms, recognised 'food triggers', no other identifiable cause for the symptoms, either a normal colonoscopy or barium enema while symptomatic and able to discontinue all anticholinergic medications. 69 patients were enrolled, 20 withdrew before randomisation, leaving 49 patients: 14 men, 35 women, mean age 52 years (SD 15.3). Over 60% had experienced symptoms for 11-30 years and 16% for more than 40 years. INTERVENTIONS: After completing six baseline meals, patients were randomised in blocks of four to receive either identical PEZ or a placebo for another six meals, and after a washout period of time received the alternative drug. MAIN OUTCOME MEASURES: The primary analysis was number of patients who chose PEZ over placebo for the extended use. RESULTS: Overall, 30/49 (61%) would have chosen PEZ (p=0.078), with first drug preference for PEZ at 0.002. Among the PEZ subgroup, PEZ use compared with placebo, demonstrated improvement in all symptoms (p≤0.001) for cramping, bloating, borborygami, urge to defecate, global pain and decrease stooling with increase in stool firmness. CONCLUSIONS: PEZ was found in a small group of patients to reduce postprandial IBS-D symptoms and deserves further evaluation.

  9. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  10. Effect of Pregabalin on Cardiovascular Responses to Exercise and Postexercise Pain and Fatigue in Fibromyalgia: A Randomized, Double-Blind, Crossover Pilot Study

    Directory of Open Access Journals (Sweden)

    Andrea T. White

    2015-01-01

    Full Text Available Pregabalin, an approved treatment for fibromyalgia (FM, has been shown to decrease sympathetic nervous system (SNS activity and inhibit sympathetically maintained pain, but its effects on exercise responses have not been reported. Methods. Using a randomized double-blind crossover design, we assessed the effect of 5 weeks of pregabalin (versus placebo on acute cardiovascular and subjective responses to moderate exercise in 19 FM patients. Blood pressure (BP, heart rate (HR, and ratings of perceived exertion (RPE during exercise and ratings of pain, physical fatigue, and mental fatigue before, during, and for 48 hours after exercise were compared in patients on pregabalin versus placebo and also versus 18 healthy controls. Results. On placebo, exercise RPE and BP were significantly higher in FM patients than controls (p0.26. Cardiovascular responses of nonresponders (n=7 were not altered by pregabalin. In responders, pregabalin improved ratings of fatigue and pain (p<0.04, but negative effects on pain and fatigue were seen in nonresponders. Conclusions. These preliminary findings suggest that pregabalin may normalize cardiovascular and subjective responses to exercise in many FM patients.

  11. A pilot study to assess the utility of a freely downloadable mobile application simulator for undergraduate clinical skills training: a single-blinded, randomised controlled trial.

    Science.gov (United States)

    Bartlett, Richard D; Radenkovic, Dina; Mitrasinovic, Stefan; Cole, Andrew; Pavkovic, Iva; Denn, Peyton Cheong Phey; Hussain, Mahrukh; Kogler, Magdalena; Koutsopodioti, Natalia; Uddin, Wasima; Beckley, Ivan; Abubakar, Hana; Gill, Deborah; Smith, Daron

    2017-12-11

    Medical simulators offer an invaluable educational resource for medical trainees. However, owing to cost and portability restrictions, they have traditionally been limited to simulation centres. With the advent of sophisticated mobile technology, simulators have become cheaper and more accessible. Touch Surgery is one such freely downloadable mobile application simulator (MAS) used by over one million healthcare professionals worldwide. Nevertheless, to date, it has never been formally validated as an adjunct in undergraduate medical education. Medical students in the final 3 years of their programme were recruited and randomised to one of three revision interventions: 1) no formal revision resources, 2) traditional revision resources, or 3) MAS. Students completed pre-test questionnaires and were then assessed on their ability to complete an undisclosed male urinary catheterisation scenario. Following a one-hour quarantined revision period, all students repeated the scenario. Both attempts were scored by allocation-blinded examiners against an objective 46-point mark scheme. A total of 27 medical students were randomised (n = 9 per group). Mean scores improved between baseline and post-revision attempts by 8.7% (p = 0.003), 19.8% (p = 0.0001), and 15.9% (p = 0.001) for no resources, traditional resources, and MAS, respectively. However, when comparing mean score improvements between groups there were no significant differences. Mobile simulators offer an unconventional, yet potentially useful adjunct to enhance undergraduate clinical skills education. Our results indicate that MAS's perform comparably to current gold-standard revision resources; however, they may confer significant advantages in terms of cost-effectiveness and practice flexibility. Not applicable.

  12. Hypocaloric diet supplemented with probiotic cheese improves body mass index and blood pressure indices of obese hypertensive patients--a randomized double-blind placebo-controlled pilot study.

    Science.gov (United States)

    Sharafedtinov, Khaider K; Plotnikova, Oksana A; Alexeeva, Ravilay I; Sentsova, Tatjana B; Songisepp, Epp; Stsepetova, Jelena; Smidt, Imbi; Mikelsaar, Marika

    2013-10-12

    Gut lactobacilli can affect the metabolic functions of healthy humans. We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA (Deutsche Sammlung für Mikroorganismen, DSM 21380) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension. In this 3-week, randomized, double-blind, placebo-controlled, parallel pilot study, 25 subjects ingested probiotic cheese and 15 ingested control cheese. Fifty grams of each cheese provided 175 kcal of energy. Blood pressure (BP), anthropometric characteristics, markers of liver and kidney function, metabolic indices (plasma glucose, lipids, and cholesterol), and urine polyamines were measured. Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods. The data were analyzed by t-test for independent samples and Spearman's partial correlation analysis. The probiotic L. plantarum TENSIA was present in variable amounts (529.6 ± 232.5 gene copies) in 16/25 (64%) study subjects. Body mass index (BMI) was significantly reduced (p = 0.031) in the probiotic cheese group versus the control cheese group. The changes in BMI were closely associated with the water content of the body (r = 0.570, p = 0.0007) when adjusted for sex and age. Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI (r = 0.383, p = 0.0305) and urinary putrescine content (r = 0.475, p = 0.006). In patients simultaneously treated with BP-lowering drugs, similar reductions of BP were observed in both groups. A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP (r = 0.617, p = 0.0248) and a trend toward lower values of morning systolic BP (r = -0.527, p = 0.0640) at the end of the study after adjusting for BMI, age, and sex. In a pilot study of obese hypertensive patients, a hypocaloric diet supplemented with a probiotic cheese

  13. Effect of 12 months treatment with chondroitin sulfate on cartilage volume in knee osteoarthritis patients: a randomized, double-blind, placebo-controlled pilot study using MRI.

    Science.gov (United States)

    Railhac, J-J; Zaim, M; Saurel, A-S; Vial, J; Fournie, B

    2012-09-01

    This pilot study aimed to evaluate the correlation between clinical symptoms and cartilage volume through MRI in patients with knee osteoarthritis after 48 weeks of treatment with Structum®. Multicenter, double-blind, placebo-controlled, parallel-group study. Symptomatic knee osteoarthritis patients aged 50-75 years received either Structum® (500 mg twice daily; N = 22) or placebo (N = 21) during 48 weeks. Inclusion criteria were global pain in the target knee ≥30 mm (VAS 0-100) and radiological Kellgren-Lawrence grade 2 or 3. Clinical assessments included Lequesne index and VAS for pain on motion, at baseline, 24 and 48 weeks, and MRI at baseline and at 24 and 48 weeks. Global and compartments cartilage volume, joint cartilage abnormalities, meniscal lesions, ligaments abnormalities, synovitis, synovial effusion, osteophytes, subchondral cysts, popliteal cysts and subchondral oedema were quantified. The quantitative and qualitative reproducibility of MRI was tested by the Spearman correlation coefficient and kappa coefficients, respectively. Treatments were compared by an analysis of covariance with baseline value as covariate. Groups were comparable at baseline for demographics, disease characteristics, and cartilage volumes. A significant inter-readers correlation was seen for the assessment of cartilage volumes, number of cysts, and osteophytes (correlation coefficients from 0.951 to 0.980 within investigator and from 0.714 to 0.957). After 48 weeks, symptoms improved in both groups. The total cartilage volume increased in the Structum® group (+180 mm(3) + SD) which opposed to a loss in the placebo (-46 mm(3) + SD; NS). No statistically significant differences between groups were observed for the other MRI parameters. No correlations were evidenced between key MRI parameters changes and symptoms. The difference in the evolution of cartilage volume between the two groups could reflect a structure modifying effect of Structum

  14. Deep brain stimulation of the basolateral amygdala for treatment-refractory combat post-traumatic stress disorder (PTSD): study protocol for a pilot randomized controlled trial with blinded, staggered onset of stimulation.

    Science.gov (United States)

    Koek, Ralph J; Langevin, Jean-Philippe; Krahl, Scott E; Kosoyan, Hovsep J; Schwartz, Holly N; Chen, James W Y; Melrose, Rebecca; Mandelkern, Mark J; Sultzer, David

    2014-09-10

    Combat post-traumatic stress disorder (PTSD) involves significant suffering, impairments in social and occupational functioning, substance use and medical comorbidity, and increased mortality from suicide and other causes. Many veterans continue to suffer despite current treatments. Deep brain stimulation (DBS) has shown promise in refractory movement disorders, depression and obsessive-compulsive disorder, with deep brain targets chosen by integration of clinical and neuroimaging literature. The basolateral amygdala (BLn) is an optimal target for high-frequency DBS in PTSD based on neurocircuitry findings from a variety of perspectives. DBS of the BLn was validated in a rat model of PTSD by our group, and limited data from humans support the potential safety and effectiveness of BLn DBS. We describe the protocol design for a first-ever Phase I pilot study of bilateral BLn high-frequency DBS for six severely ill, functionally impaired combat veterans with PTSD refractory to conventional treatments. After implantation, patients are monitored for a month with stimulators off. An electroencephalographic (EEG) telemetry session will test safety of stimulation before randomization to staggered-onset, double-blind sham versus active stimulation for two months. Thereafter, patients will undergo an open-label stimulation for a total of 24 months. Primary efficacy outcome is a 30% decrease in the Clinician Administered PTSD Scale (CAPS) total score. Safety outcomes include extensive assessments of psychiatric and neurologic symptoms, psychosocial function, amygdala-specific and general neuropsychological functions, and EEG changes. The protocol requires the veteran to have a cohabiting significant other who is willing to assist in monitoring safety and effect on social functioning. At baseline and after approximately one year of stimulation, trauma script-provoked 18FDG PET metabolic changes in limbic circuitry will also be evaluated. While the rationale for studying DBS

  15. The Importance of Pilot Studies

    OpenAIRE

    Van Teijlingen, Edwin; Hundley, Vanora

    2001-01-01

    The term 'pilot studies' refers to mini versions of a full-scale study (also called 'feasibility' studies), as well as the specific pre-testing of a particular research instrument such as a questionnaire or interview schedule. \\ud Pilot studies are a crucial element of a good study design. Conducting a pilot study does not guarantee success in the main study, but it does increase the likelihood. \\ud Pilot studies fulfil a range of important functions and can provide valuable insights for othe...

  16. Efficacy of treatment of insomnia in migraineurs with eszopiclone (Lunesta®) and its effect on total sleep time, headache frequency, and daytime functioning: A randomized, double-blind, placebo-controlled, parallel-group, pilot study.

    Science.gov (United States)

    Spierings, Egilius L H; McAllister, Peter J; Bilchik, Tanya R

    2015-04-01

    A review on headache and insomnia revealed that insomnia is a risk factor for increased headache frequency and headache intensity in migraineurs. The authors designed a randomized, double blind, placebo-controlled, parallel-group, pilot study in which migraineurs who also had insomnia were enrolled, to test this observation. In the study, the authors treated 79 subjects with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia for 6 weeks with 3 mg eszopiclone (Lunesta(®)) or placebo at bedtime. The treatment was preceded by a 2-week baseline period and followed by a 2-week run-out period. Of the 79 subjects treated, 75 were evaluable, 35 in the eszopiclone group, and 40 in the placebo group. At baseline, the groups were comparable except for sleep latency. Of the three remaining sleep variables, total sleep time, nighttime awakenings, and sleep quality, the number of nighttime awakenings during the 6-week treatment period was significantly lower in the eszopiclone group than in the placebo group (P = 0.03). Of the three daytime variables, alertness, fatigue, and functioning, this was also the case for fatigue (P = 005). The headache variables, frequency, duration, and intensity, did not show a difference from placebo during the 6-week treatment period. The study did not meet primary endpoint, that is, the difference in total sleep time during the 6-week treatment period between eszopiclone and placebo was less than 40 minutes. Therefore, it failed to answer the question as to whether insomnia is, indeed, a risk factor for increased headache frequency and headache intensity in migraineurs.

  17. Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome: a single-blind, randomized, pilot study.

    Science.gov (United States)

    Elkind-Hirsch, Karen E; Paterson, Martha S; Seidemann, Ericka L; Gutowski, Hanh C

    2017-01-01

    To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation. Prospective, randomized, single-blind drug study. Outpatient clinic. Patients (n = 38) with PCOS (aged 18-42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test. Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks. Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio). The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only. This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS. NCT02022007. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  18. Randomised clinical trial: relief of upper gastrointestinal symptoms by an acid pocket-targeting alginate-antacid (Gaviscon Double Action) - a double-blind, placebo-controlled, pilot study in gastro-oesophageal reflux disease.

    Science.gov (United States)

    Thomas, E; Wade, A; Crawford, G; Jenner, B; Levinson, N; Wilkinson, J

    2014-03-01

    The alginate-antacid, Gaviscon Double Action (Gaviscon DA; Reckitt Benckiser, Slough, UK) suppresses reflux after meals by creating a gel-like barrier that caps and displaces the acid pocket distal to the oesophago-gastric junction. The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet been demonstrated with a modern trial design. A pilot study to assess the efficacy and safety of Gaviscon DA compared with matched placebo for decreasing upper gastrointestinal symptoms in symptomatic gastro-oesophageal reflux disease (GERD) patients. A randomised, double-blind, parallel group study was performed in 110 patients with symptoms of GERD. Patients received Gaviscon DA or placebo tablets for 7 consecutive days. The primary endpoint compared the change in overall Reflux Disease Questionnaire (RDQ) symptom score (combined heartburn/regurgitation/dyspepsia). Secondary endpoints assessed individual dimensions, GERD dimension (heartburn and regurgitation) and overall treatment evaluation (OTE). There was a greater decrease in overall RDQ symptom score in the Gaviscon DA group compared with the placebo group (Least Squares Mean difference -0.55; P = 0.0033), and for each of the dimensions independently. Patients in the Gaviscon DA group evaluated their overall treatment response higher than patients in the placebo group [mean (standard deviation) OTE 4.1 (2.44) vs. 1.9 (3.34); P = 0.0005]. No differences in the incidence of adverse events were observed between treatment groups. Gaviscon DA decreases reflux and dyspeptic symptoms in GERD patients compared with matched placebo and has a favourable benefit-risk balance. Larger scale clinical investigations of medications targeting the acid pocket are warranted. (EudraCT, 2012-002188-84). © 2014 John Wiley & Sons Ltd.

  19. Is pulmonary function affected by bilateral dual transversus abdominis plane block? A randomized, placebo-controlled, double-blind, crossover pilot study in healthy male volunteers

    DEFF Research Database (Denmark)

    Petersen, Maria; Elers, Jimmi; Børglum, Jens

    2011-01-01

    : Transversus abdominis plane (TAP) blocks have been shown to reduce postoperative pain after various abdominal surgical procedures in several studies. The motor nerves of the abdominal wall are located in the same plane as the sensory nerves affected by the TAP block. The aim of this study...

  20. A Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of Milnacipran for Chronic Radicular Pain (Sciatica) Associated With Lumbosacral Disc Disease

    OpenAIRE

    Marks, David M.; Pae, Chi-Un; Patkar, Ashwin A.

    2014-01-01

    Objective: The current study investigates whether milnacipran, an equipotent serotonin-norepinephrine reuptake inhibitor, is effective in reducing chronic radicular pain in patients (N = 11) with lumbosacral disc disease.

  1. A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Naltrexone to Counteract Antipsychotic-Associated Weight Gain: Proof of Concept

    OpenAIRE

    Tek, Cenk; Ratliff, Joseph; Reutenauer, Erin; Ganguli, Rohan; O’Malley, Stephanie S.

    2014-01-01

    Patients with schizophrenia suffer from higher rates of obesity and related morbidity and mortality than the general population. Women with schizophrenia are at particular risk for antipsychotic-induced weight gain, obesity, and related medical disorders such as diabetes and cardiovascular disease. Given preclinical studies revealing the role of the endogenous opioid systems in human appetite and the potential of antipsychotic medications to interfere with this system, we hypothesized that op...

  2. Guided tissue regeneration and platelet rich growth factor for the treatment of Grade II furcation defects: A randomized double-blinded clinical trial - A pilot study

    Directory of Open Access Journals (Sweden)

    Niloofar Jenabian

    2017-01-01

    Results: Eight patients were finally enrolled for this study. Overly, general and specific clinical and furcation parameters were improved except REC that was deteriorated insignificantly and FAC improved not significantly. Intergroup comparison revealed better improvement of FHC in GTR/PRGF group (P = 0.02. Conclusion: A significant improvement in the Grade II furcation defects treated with either GTR or PRGF/GTR was noticed. Further large-scale trials are needed to reveal differences of mentioned treatment in more details.

  3. Regular Yoga Practice Improves Antioxidant Status, Immune Function, and Stress Hormone Releases in Young Healthy People: A Randomized, Double-Blind, Controlled Pilot Study.

    Science.gov (United States)

    Lim, Sung-Ah; Cheong, Kwang-Jo

    2015-09-01

    The aim of the present study is to highlight the beneficial effects of yoga practice on bio-parameters, such as oxidative stress, antioxidant components, immune functions, and secretion of stress hormones, in healthy young people. This study was conducted on healthy volunteers recruited from among university students, who were divided into two groups: a control (no yoga intervention, n=13) group and a yoga (n=12) group. Yoga practice was with an instructor for 90 minutes once a week spread over 12 weeks, with recommendations to practice daily at home for 40 minutes with the help of a DVD. The yoga program consisted of yoga body poses (asanas), exercises involving awareness, voluntary regulation of breath (pranayama), and meditational practices. Whole blood samples were collected when the volunteers had fasted for 8 hours at 0 and 12 weeks. The oxidative stress/antioxidant components, immune-related cytokines, and stress hormones were evaluated in serum or plasma. Serum levels of nitric oxide, F2-isoprostane, and lipid peroxide were significantly decreased by yoga practice (pstress and improved antioxidant levels of the body. Moreover, yoga beneficially affected stress hormone releases as well as partially improved immune function.

  4. The effect of Hominis Placenta Pharmacopuncture on Leg spasticity of stroke patients (A Pilot study, Double blind, Randomized, Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ju-hwan Noh

    2009-12-01

    Full Text Available Objective : The purpose of this study is to determine the effect of Hominis Placenta Pharmacopuncture(HPP on lower limb spasticity control in stroke patients. Methods : Twenty stroke patients with Leg spasticity were randomly divided into two groups, a Distilled water Pharmacopuncture(group I and a HPP(group II. The number of Pharmacopuncture was 5 times a week and acupuncture treatment was 3 times a week for 3 weeks. Modified Ashworth Scale(MAS, H-reflex/M-response ratio(H/M ratio, Berg Balance Scale(BBS and Time Up & Go(TUG were used for evaluation of spasticity control before experiment, after 1 week, 2 weeks, 3 weeks. Results : Group I showed significant improvement(p<.05 in BBS but no significant improvement in MAS, H/M ratio, and TUG. Group II showed significant improvement(p<.05 in MAS, BBS, and TUG, but no significant improvement in H/M ratio. The results showed significant difference in TUG, but no significant difference in MAS, H/M ratio and BBS between 2 groups. Conclusion : These results showed that HPP might decrease lower limb spasticity and increase leg motor function in stroke patients. Further studies will be required to examine more cases in the long period for the effect on lower limb in spasticity by HPP.

  5. Comparison of Treatment Effects and Allergic responses to stiff neck between Sweet Bee Venom and Bee Venom Pharmacopuncture (A pilot study, Double blind, Randomized Controlled Clinical Trail

    Directory of Open Access Journals (Sweden)

    Kyoung-hee Lee

    2008-12-01

    Full Text Available Objective : The purpose of this study is to investigate the difference of treatment effects and allergic responses to stiff neck between Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture. Methods : Forty one patients who felt stiff neck were randomly divided into two groups, a Bee Venom Pharmacopuncture group(group Ⅰ and a Sweet Bee Venom Pharmacopuncture group(group Ⅱ. Evaluations of the treatment effects were made before and after a treatment using Visual Analog Scale(VAS, Neck Disability Index(NDI, Clinical Evaluation Grade(CEG. The comparison of allergic responses was measured with VAS. The obtained data were analyzed and compared with SPSS. Results : The group Ⅰ and group Ⅱ showed significant improvement(p<0.05 according to the VAS, NDI, CEG. And the differences between the two groups were insignificant according to VAS, NDI, CEG. But allergic responses such as localized edema, localized itching were significantly lower in group Ⅱ than group Ⅰ. Conclusions : It seems that there are no big different treatment effects between the two groups. Sweet Bee Venom Pharmacopuncture appears to be more effective measurement against allergic reactions than the Bee Venom Pharmacopuncture. Further studies are needed for the comparison of Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture.

  6. Effect of acupuncture for radioactive-iodine-induced anorexia in thyroid cancer patients: a randomized, double-blinded, sham-controlled pilot study.

    Science.gov (United States)

    Jeon, Ju-Hyun; Yoon, Jeungwon; Cho, Chong-Kwan; Jung, In-Chul; Kim, Sungchul; Lee, Suk-Hoon; Yoo, Hwa-Seung

    2015-05-01

    The aim of this study is to evaluate the efficacy and safety of acupuncture for radioactive iodine (RAI)-induced anorexia in thyroid cancer patients. Fourteen thyroid cancer patients with RAI-induced anorexia were randomized to a true acupuncture or sham acupuncture group. Both groups were given 6 true or sham acupuncture treatments in 2 weeks. Outcome measures included the change of the Functional Assessment of Anorexia and Cachexia Treatment (FAACT; Anorexia/Cachexia Subscale [ACS], Functional Assessment of Cancer Therapy-General [FACT-G]), Visual Analogue Scale (VAS), weight, body mass index (BMI), ACTH, and cortisol levels. The mean FAACT ACS scores of the true and sham acupuncture groups increased from baseline to exit in intention-to-treat (ITT) and per protocol (PP) analyses; the true acupuncture group showed higher increase but with no statistical significance. Between groups, from baseline to the last treatment, statistically significant differences were found in ITT analysis of the Table of Index (TOI) score (P = .034) and in PP analysis of the TOI (P = .016), FACT-G (P = .045), FAACT (P = .037) scores. There was no significant difference in VAS, weight, BMI, ACTH, and cortisol level changes between groups. Although the current study is based on a small sample of participants, our findings support the safety and potential use of acupuncture for RAI-induced anorexia and quality of life in thyroid cancer patients. © The Author(s) 2015.

  7. Double-blind, Placebo-controlled Trial to Evaluate the Effectiveness of Polypodium Leucotomos Extract in the Treatment of Melasma in Asian Skin: A Pilot Study.

    Science.gov (United States)

    Goh, Chee-Leok; Chuah, Sai Yee; Tien, Steven; Thng, Guan; Vitale, María Alejandra; Delgado-Rubin, Arancha

    2018-03-01

    Introduction: Melasma is a common pigmentary disorder with a multifactorial etiology that can hinder its management. The aqueous extract of the fern Polypodium leucotomos (PLE), Fernblock ® (IFC, Madrid, Spain), has demonstrated antioxidant and photoprotective activities and has been used for the treatment of several pigmentary disorders. The aim of this study was to evaluate the efficacy and safety of oral PLE in the treatment of melasma in Asian patients. Methods: Forty healthy adult patients with clinical diagnoses of melasma who were receiving treatment with topical 4% hydroquinone cream and sunscreen with a sun protection factor (SPF) of 50+ were recruited for inclusion in this study from the National Skin Centre in Singapore. They were randomized to receive either oral PLE supplementation or placebo for 12 weeks. Patients were assessed at baseline, Day 28, Day 56, and Day 84 using the modified Melasma Area and Severity Index (mMASI); melanin and erythema indexes; VISIA ® photography (Canfield Scientific, Parsippany, New Jersey, USA); and the Melasma Quality of Life (MelasQoL) questionnaire. Adverse events were recorded. Results: Following four, eight, and 12 weeks of treatment, there were statistically significant differences between the mMASI scores of both groups as compared with the baseline scores ( p ≤0.01). mMASI scores of the PLE group at eight and 12 weeks were also significantly lower than those of the placebo group ( p ≤0.05). At the end of the study, a significant improvement was reached in both groups (both p ≤0.01), with no significant differences between them. The scores of the melanin and erythema indices displayed a slight improvement in both groups, without significant differences among them. MelasQoL score showed an improvement in the PLE group versus the placebo group. Our results demonstrate that the PLE aqueous extract product significantly improves and accelerates the outcome reached with hydroquinone and sunscreen almost from

  8. Effect of BCAA supplement timing on exercise-induced muscle soreness and damage: a pilot placebo-controlled double-blind study.

    Science.gov (United States)

    Ra, Song-Gyu; Miyazaki, Teruo; Kojima, Ryo; Komine, Shoichi; Ishikura, Keisuke; Kawanaka, Kentaro; Honda, Akira; Matsuzaki, Yasushi; Ohmori, Hajime

    2017-09-22

    The aim of present study was to compare the effects of branched-chain amino acid (BCAA) supplementation taken before or after exercise on delayed onset muscle soreness (DOMS) and exercise-induced muscle damage (EIMD). Fifteen young men (aged 21.5 ± 0.4 years) were given either BCAA (9.6 g·day-1) or placebo before and after exercise (and for 3 days prior to and following the exercise day) in three independent groups: the Control group (placebo before and after exercise), the PRE group (BCAA before exercise and placebo after exercise), and the POST group (placebo before exercise and BCAA after exercise). Participants performed 30 repetitions of eccentric exercise with the non-dominant arm. DOMS, upper arm circumference (CIR), elbow range of motion (ROM), serum creatine kinase (CK), lactate dehydrogenase (LDH), and aldolase, BCAA, and Beta-hydroxy-Beta-methylbutyrate (3HMB) were measured immediately before and after the exercise and on the following 4 days. Serum BCAA and 3HMB concentrations increased significantly in the PRE group immediately after the exercise, recovering to baseline over the following days. In the days following the exercise day, DOMS, CIR, and ROM were significantly improved in the PRE group compared to the Control group, with weaker effects in the POST group. Serum activities of CK, LDH, and aldolase in the days following the exercise day were significantly suppressed in the PRE group compared to Control group. Present study confirmed that repeated BCAA supplementation before exercise had a more beneficial effect in attenuating DOMS and EIMD induced by eccentric exercise than repeated supplementation after exercise.

  9. Botulinum toxin A versus B in sialorrhea: a prospective, randomized, double-blind, crossover pilot study in patients with amyotrophic lateral sclerosis or Parkinson's disease.

    Science.gov (United States)

    Guidubaldi, Arianna; Fasano, Alfonso; Ialongo, Tamara; Piano, Carla; Pompili, Maurizio; Mascianà, Roberta; Siciliani, Luisa; Sabatelli, Mario; Bentivoglio, Anna Rita

    2011-02-01

    Either botulinum toxins (BoNTs) A and B have been used for improving drooling in different neurological conditions. Consecutive patients affected by Amyotrophic Lateral Sclerosis (ALS) or Parkinson's Disease (PD) accompanied by severe drooling were randomized to receive botulinum neurotoxin type A (BoNT-A) or B (BoNT-B) injections into the salivary glands. Following the first treatment, when sialorrhea returned to baseline (at least three months after the first injection), subjects were re-treated with the other serotype. Ultrasound-guided injections into parotid and submandibular glands were bilaterally performed: total doses were 250 U BoNT-A (Dysport) and 2500 U BoNT-B (Neurobloc). Objective (cotton roll weight) and subjective (ad hoc clinical scales) evaluations were performed at baseline, after 1 and 4 weeks, and every 4 weeks until drooling returned to baseline. Twenty-seven patients (15 ALS and 12 PD) were enrolled, fourteen completed the study. BoNT-A and BoNT-B treatments gave both subjective and objective improvements in all patients. The latency was significantly shorter after BoNT-B treatments (3.2 ± 3.7 days) compared to BoNT-A (6.6 ± 4.1 days; P = 0.002). The mean benefit duration was similar at 75 and 90 days for BoNT-A and BoNT-B, respectively (P = NS). The only toxin-related side effect was a change to saliva thickness. Either 250 U Dysport or 2500 U Neurobloc have similar effectiveness and safety in controlling sialorrhea. BoNT-B has a shorter latency and comparable duration. Cost analysis, considering the doses used in this study protocol favored BoNT-B treatment. Copyright © 2010 Movement Disorder Society.

  10. Viability of human dental pulp in determination of sex of an individual by identifying srygene through DNA analysis: A single blind pilot study

    Directory of Open Access Journals (Sweden)

    Prachi Ravikant Naik

    2012-01-01

    Full Text Available Recognition of importance of human teeth in personal identification has been recognized from time immemorial. In any natural calamity or man-made catastrophe identification of an individual is of paramount importance. Here tooth plays an important role as it is the last one to get affected in a disaster due to its durable nature and good survival rate. This information comes under the aegis of forensic odontology and is of paramount importance from legal and social viewpoints. This analysis uses highly informative genetic markers and can be carried out easily in a typical forensic lab oratory. The SRY gene marker (sex determining region Y is a sex-determining gene on the Y chromosome in the therians (placental mammals and marsupials and this gene marker is considered as a signature gene to differentiate the male from female sex chromosome. The detection of SRY gene in the DNA from a forensic sample can be confirmatory to type the gender as male. This study was taken up to identify the viability of human tooth pulp by identification of SRY gene in gender determination.

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

    Directory of Open Access Journals (Sweden)

    Irene Campa-Moran

    2015-01-01

    Full Text Available 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.

  12. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis.

    Science.gov (United States)

    Irving, Peter M; Iqbal, Tariq; Nwokolo, Chuka; Subramanian, Sreedhar; Bloom, Stuart; Prasad, Neeraj; Hart, Ailsa; Murray, Charles; Lindsay, James O; Taylor, Adam; Barron, Rachel; Wright, Stephen

    2018-03-19

    Cannabidiol (CBD) exhibits anti-inflammatory properties that could improve disease activity in inflammatory bowel disease. This proof-of-concept study assessed efficacy, safety and tolerability of CBD-rich botanical extract in ulcerative colitis (UC) patients. Patients aged 18 years or older, with left-sided or extensive UC, Mayo scores of 4-10 (endoscopy scores ≥1), and on stable 5-aminosalicylic acid dosing, were randomized to 10-weeks' CBD-rich botanical extract or placebo capsules. The primary endpoint was the percentage of patients in remission after treatment. Statistical testing was 2-sided, using a 10% significance level. Patients were less tolerant of CBD-rich botanical extract compared with placebo, taking on average one-third fewer capsules, and having more compliance-related protocol deviations (principally insufficient exposure), prompting identification of a per protocol (PP) analysis set. The primary endpoint was negative; end of treatment remission rates were similar for CBD-rich botanical extract (28%) and placebo (26%). However, PP analysis of total and partial Mayo scores favoured CBD-rich botanical extract (P = 0.068 and P = 0.038, respectively). Additionally, PP analyses of the more subjective physician's global assessment of illness severity, subject global impression of change, and patient-reported quality-of-life outcomes were improved for patients taking CBD-rich botanical extract (P = 0.069, P = 0.003, and P = 0.065, respectively). Adverse events (AEs) were predominantly mild/moderate with many in the CBD-rich botanical extract group potentially attributable to the ∆9-tetrahydrocannabinol content. A greater proportion of gastrointestinal-related AEs, indicative of UC worsening, was seen on placebo. Although the primary endpoint was not reached, several signals suggest CBD-rich botanical extract may be beneficial for symptomatic treatment of UC.

  13. Randomized double-blinded pilot clinical study of the antidiabetic activity of Balanites aegyptiaca and UPLC-ESI-MS/MS identification of its metabolites.

    Science.gov (United States)

    Rashad, Hend; Metwally, Fateheya M; Ezzat, Shahira M; Salama, Maha M; Hasheesh, Adel; Abdel Motaal, Amira

    2017-12-01

    Balanites aegyptiaca Del. (Zygophyllaceae) fruits are traditionally known for the treatment of hyperglycaemia. Several in vitro and in vivo studies proposed some mechanisms of action. However, clinical trials in human beings were never reported to date. To investigate the antidiabetic efficacy of the 70% ethanol extract of the pericarps of B. aegyptiaca (BE) within a nutritional intervention in elderly people. Ultra-performance electrospray ionization-mass spectroscopy (UPLC-ESI-MS/MS) analysis was used for metabolic profiling of BE which was incorporated in hard gelatine capsules (400 mg/day) and tested on 30 type 2 diabetes (T2D) Egyptian patients for 8 weeks. According to sex, age and body mass index participants were divided into two equivalent groups, placebo and treatment. Thirteen compounds were identified in BE using UPLC-ESI-MS/MS analysis among which five steroidal saponins, seven phenolic compounds and a sterol glucoside. At the end of the 8-week treatment, the treated group showed 26.88% decrease in 2 h postprandial plasma glucose relative to 2.6% increase in the placebo group, while fasting plasma glucose was reduced to 10.3%. Treatment with BE capsules for 8 weeks produced significant reduction in the plasma triglyceride, total cholesterol and low-density lipoprotein cholesterol by 9.0, 12.76 and 21.35%, respectively, with 29.8% increase in the high-density lipoprotein cholesterol. Plasma alanine transaminase and aspartate transaminase were reduced by 42.6 and 43.3%, respectively. Administration of the BE capsules to T2D resulted in significant improvements in the glycaemic markers and the lipid profile, without adverse effects or hypoglycaemia.

  14. A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo.

    Science.gov (United States)

    Garza, Dahlia; Murphy, Michael; Tseng, Li-Jung; Riordan, Henry J; Chatterjee, Anjan

    2011-06-01

    Varenicline is an α4β2 partial nicotinic agonist approved for smoking cessation. There have been spontaneous postmarketing reports of neuropsychiatric adverse events (NPAEs) in smokers without a history of psychiatric illness quitting with varenicline. One hundred ten smokers without history of psychiatric illness (screened by Structured Clinical Interview for DSM-IV) were randomized to 12 weeks of varenicline 1 mg twice daily (n = 55) or placebo. Adverse events were solicited systematically. Depressive symptoms, anxiety, aggression, and irritability were measured at baseline and weekly using the Montgomery-Åsberg Depression Rating Scale (MADRS), the Hamilton Anxiety Scale (HAM-A), and the Overt Aggression Scale-Modified (OAS-M). The Profile of Mood States (POMS) was administered daily. Mixed-model analysis of repeated measures was conducted to compare mean changes in scores between groups across study periods. Participants' mean baseline characteristics were 33 years of age, 22 cigarettes/day and Fagerström Test for Nicotine Dependence score > 7. Reported NPAEs were similar between groups. No suicidal events were reported. There were no significant differences between groups for the MADRS (treatment difference vs. placebo = .03, 95% confidence interval [CI] -.68-.73; NS), HAM-A (treatment difference [TD] = .14, 95% CI -.62-.90; NS), OAS-M Aggression subscale (TD = .5, 95% CI -1.18-2.18; NS), OAS-M Irritability subscale (TD = .08, 95% CI -.17-.34; NS), and the POMS total scores (TD = .5, 95% CI -.52-1.53; NS). There were no significant differences between groups on measures of depressive symptoms, anxiety, or aggression/hostility. Systematically solicited NPAEs were similar between the varenicline and placebo groups. Copyright © 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  15. Examining the impact of grape consumption on brain metabolism and cognitive function in patients with mild decline in cognition: A double-blinded placebo controlled pilot study.

    Science.gov (United States)

    Lee, Jooyeon; Torosyan, Nare; Silverman, Daniel H

    2017-01-01

    Natural compounds in grapes such as resveratrol are known for their antioxidant and anti-inflammatory properties. Some studies have shown a potential role for grapes or wine in slowing cognitive decline and other effects of aging. However, well-controlled experimental data obtained in human subjects are still in need of further development. Here we aimed to systematically assess effects of grapes on regional cerebral metabolism. Ten subjects with mild decline in cognition (mean, 72.2±4.7years; 50% female) were included in this analysis. Participants were randomized into an active grape formulation arm or a placebo arm which consumed a formulation free of polyphenols for six months. Cognitive performance was measured through neuropsychological assessments performed at baseline and 6months after initiation of therapy. Changes in brain metabolism occurring with each therapy regimen were assessed by brain PET scans with the radiotracer [F-18] fluorodeoxyglucose (FDG), obtained during initial evaluation and 6months later. Standardized volumes of interest (sVOI) and statistical parametric mapping (SPM) methods were applied to FDG-PET scans to identify significant regional cerebral metabolic changes. In contrast to participants taking the active grape formulation, who displayed no significant decline in metabolism, the placebo arm underwent significant metabolic decline in sVOI's of the right posterior cingulate cortex (p=0.01), and left superior posterolateral temporal cortex (p=0.04). SPM analyses also found significant declines in the placebo group, particularly in left prefrontal, cingulate, and left superior posterolateral temporal cortex (pbrain metabolism in the active formulation arm. No significant differences were seen in scores on the neuropsychological battery of tests between the two groups. However, metabolism in right superior parietal cortex and left inferior anterior temporal cortex was correlated with improvements in attention/working memory, as

  16. Fitzmaurice Voicework Pilot Study.

    Science.gov (United States)

    Watson, Lynn; Nayak, Sadhana

    2015-11-01

    A repeated-measures pilot study was used to investigate acoustic changes in the voices of participants in a Fitzmaurice Voicework (FV) teacher certification program. Maximum phonation time (MPT) was also measured. Eleven participants with no reported voice problems were studied. Pretraining and posttraining recordings were made of each participant. Measures of MPT were made, and the recordings were analyzed for jitter, shimmer, and noise-to-harmonics ratio (NHR). The measure of effect size for MPT was moderate, and there was an overall increase in MPT from pretraining to posttraining, with 70% of participants showing an increase in MPT. The measure of effect sizes for jitter, shimmer, and NHR were small, with measurements showing no significant changes from pretraining to posttraining. There were indications that FV training may have positive outcomes for actors and professional voice users, particularly in increasing MPT. Further studies with larger subject groups are needed to investigate the significance of the increase in MPT noted in this study and to test whether FV training can help to lower rates of shimmer and jitter. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  17. Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial.

    Science.gov (United States)

    Szaflarski, Jerzy P; Ball, Angel L; Vannest, Jennifer; Dietz, Aimee R; Allendorfer, Jane B; Martin, Amber N; Hart, Kimberly; Lindsell, Christopher J

    2015-09-24

    To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours or therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). Clinicians treating patients (CIAT group) did not communicate with other team members to maintain blinding and the testing team members were blinded to treatment group assignment. Overall, the results of this pilot RCT support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. In this pilot RCT intensive language therapy led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial(s) of CIAT or other interventions for post-stroke aphasia.

  18. Clinical effects of buspirone in social phobia : A double-blind placebo-controlled study

    NARCIS (Netherlands)

    denBoer, JA; Westenberg, HGM; Pian, KLH

    Background: The results of open pilot studies suggest that the serotonin-1A (5-HT1A) receptor agonist buspirone might be effective in social phobia. Method: In the present study, the efficacy of buspirone was investigated in patients with social phobia using a 12-week double-blind placebo-controlled

  19. ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study

    NARCIS (Netherlands)

    Lansbergen, M.M.; Dongen-Boomsma, M. van; Buitelaar, J.K.; Slaats-Willemse, D.I.E.

    2011-01-01

    Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo

  20. Pilot plant study

    International Nuclear Information System (INIS)

    Morris, M.E.

    1978-01-01

    Sandia Laboratories undertook the design and fabrication of an 8 ton/day dry sewage sludge irradiatior. The facility is intended (1) to function as a high-gamma-dose rate research facility; (2) to be a testbed for the unique electrical and mechanical components to be used in larger facilities; (3) to fulfill the formal requirements of a pilot plant so that design and construction of a demonstration facility could proceed; and (4) to provide accurate data base on construction and operating experience for the Environmental Impact Assessment (EIA), the Safety Analysis Report (SAR), and the cost analyses for a larger facility. The facility and its component systems are described in detail

  1. A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.

    Science.gov (United States)

    Whitley, Julie Anne; Rich, Bonnie L

    2008-12-01

    To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants. A pilot randomized, double-blind, controlled trial. Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar. The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase. Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group. In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.

  2. Varenicline for opioid withdrawal in patients with chronic pain: a randomized, single-blinded, placebo controlled pilot trial.

    Science.gov (United States)

    Hooten, W Michael; Warner, David O

    2015-03-01

    The objectives of this randomized, single-blinded, placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population. Twenty-one patients were recruited (varenicline=10, placebo=11), and 7 patients in the varenicline and 11 in the placebo group completed the study. Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale, and varenicline-related adverse effects were assessed. Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo. Varenicline was well-tolerated in this population, with no adverse drug effects (including nausea) observed and no effect on improvements in pain severity and depression. This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

    Science.gov (United States)

    van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

    2014-02-01

    Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. 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

    Science.gov (United States)

    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

  5. Speech Alarms Pilot Study

    Science.gov (United States)

    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

  6. Speech Alarms Pilot Study

    Science.gov (United States)

    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.

  7. A pilot randomised double blind controlled trial of the efficacy of purified fatty acids for the treatment of women with endometriosis-associated pain (PurFECT): study protocol.

    Science.gov (United States)

    Abokhrais, Ibtisam M; Saunders, Philippa T K; Denison, Fiona C; Doust, Ann; Williams, Linda; Horne, Andrew W

    2018-01-01

    Endometriosis affects 6-10% of women and is associated with debilitating pelvic pain. It costs the UK > £2.8 billion per year in loss of productivity. Endometriosis can be managed by surgical excision or medically by ovarian suppression. However, ~ 75% symptoms recur after surgery and available medical treatments have undesirable side effects and are contraceptive. Omega-3 purified fatty acids (PUFA) have been shown in animal models to reduce factors that are thought to lead to endometriosis-associated pain, have minimal side effects, and no effects on fertility. This paper presents a protocol for a two-arm, pilot parallel randomised controlled trial (RCT) which aims to inform the planning of a future multicentre trial to evaluate the efficacy of Omega-3 PUFA in the management of endometriosis-associated pain in women. The study will recruit women with endometriosis over a 12-month period in the National Health Service (NHS) Lothian, UK, and randomise them to 8 weeks of treatment with Omega-3 PUFA or comparator (olive oil). The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness/acceptability to participants of the proposed methods of recruitment/randomisation/treatments/questionnaires, to inform the sample size calculation and to refine the research methodology for a future large randomised controlled trial. Response to treatment will be monitored by pain scores and questionnaires assessing physical and emotional function compared at baseline and 8 weeks. We recognise that there may be potential difficulties in mounting a large randomised controlled trial for endometriosis to assess Omega-3 PUFA because they are a dietary supplement readily available over the counter and already used by women with endometriosis. We have therefore designed this pilot study to assess practical feasibility and following the 'Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials

  8. A Randomized Double-Blind Controlled Trial Comparing Davanloo Intensive Short-Term Dynamic Psychotherapy as Internet-Delivered Vs Treatment as Usual for Medically Unexplained Pain: A 6-Month Pilot Study.

    Science.gov (United States)

    Chavooshi, Behzad; Mohammadkhani, Parvaneh; Dolatshahi, Behrouz

    2016-01-01

    Research has shown that Intensive Short-Term Dynamic Psychotherapy (ISTDP) can effectively decrease pain intensity and improve quality of life in patients with medically unexplained pain. Understanding that not all patients with medically unexplained pain have access to in-person ISTDP, this study aims to investigate the efficacy of an Internet-delivered ISTDP for individuals with medically unexplained pain using Skype in comparison with treatment as usual. In this randomized controlled trial, 100 patients were randomly allocated into Internet-delivered ISTDP (n = 50) and treatment-as- usual (n = 50) groups. Treatment intervention consisted of 16 weekly, hour-long therapy sessions. The primary outcome was perceived pain assessed using the Numeric Pain Rating Scale. The secondary outcome included Depression Anxiety Stress Scale-21, Emotion Regulation Questionnaire, Mindful Attention Awareness Scale, and Quality-of-Life Inventory. Blind assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. In the intention-to-treat analysis, pain symptoms in the intervention group were significantly reduced (p Skype can significantly improve pain intensity and clinical symptoms of medically unexplained pain. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  9. Effects of a hops (Humulus lupulus L.) dry extract supplement on self-reported depression, anxiety and stress levels in apparently healthy young adults: a randomized, placebo-controlled, double-blind, crossover pilot study.

    Science.gov (United States)

    Kyrou, Ioannis; Christou, Aimilia; Panagiotakos, Demosthenes; Stefanaki, Charikleia; Skenderi, Katerina; Katsana, Konstantina; Tsigos, Constantine

    2017-04-01

    The Humulus lupulus L. plant (hops) is used as a herbal medicinal product for anxiety/mood disorders. Our aim was to study the effects of a hops dry extract on self-reported depression, anxiety and stress levels in young adults. Apparently healthy young adults from our university completed the Depression Anxiety Stress Scale-21 (DASS-21) and those reporting at least mild depression, anxiety and stress were invited to complete the study intervention. This followed a randomized (1:1), placebo-controlled, double-blind, crossover design with two 4-week intervention periods (Melcalin hops or placebo; two 0.2 gr capsules once daily) separated by a 2-week wash-out. Anthropometric measurements, DASS-21 assessments and measurements of morning cortisol plasma levels were performed at the beginning and the end of the 4-week treatment periods. 36 participants (Females/Males: 31/5; age: 24.7±0.5 years) completed the study intervention (attrition: 6/42). No significant changes in body weight and composition or morning circulating cortisol were noted with the hops or placebo. Significantly decreased DASS-21 anxiety, depression and stress scores were documented with hops (9.2±7.3 vs. 5.1±5.9, 11.9±7.9 vs. 9.2±7.4, and 19.1±8.1 vs. 11.6±8.1; all p values depression, anxietyand stress symptoms, daily supplementation with a hops dry extract can significantly improve all these symptoms over a 4-week period. These beneficial effects agree with the indication of hops for anxiety/mood disorders and restlessness, as approved by the German Commission E.

  10. 90% Compliance Pilot Studies Final Report

    Energy Technology Data Exchange (ETDEWEB)

    None

    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.

  11. Color-Blindness Study: Color Discrimination on the TICCIT System.

    Science.gov (United States)

    Asay, Calvin S.; Schneider, Edward W.

    The question studied whether the specific seven TICCIT system colors used within color coding schemes can be a source of confusion, or not seen at all, by the color-blind segment of target populations. Subjects were 11 color-blind and three normally sighted students at Brigham Young University. After a preliminary training exercise to acquaint the…

  12. Facial recognition and laser surface scan: a pilot study

    DEFF Research Database (Denmark)

    Lynnerup, Niels; Clausen, Maja-Lisa; Kristoffersen, Agnethe May

    2009-01-01

    Surface scanning of the face of a suspect is presented as a way to better match the facial features with those of a perpetrator from CCTV footage. We performed a simple pilot study where we obtained facial surface scans of volunteers and then in blind trials tried to match these scans with 2D...... photographs of the faces of the volunteers. Fifteen male volunteers were surface scanned using a Polhemus FastSCAN Cobra Handheld Laser Scanner. Three photographs were taken of each volunteer's face in full frontal, profile and from above at an angle of 45 degrees and also 45 degrees laterally. Via special...

  13. Liverpool Telecare Pilot: case studies

    Directory of Open Access Journals (Sweden)

    Nigel Barnes

    2006-09-01

    Full Text Available Telecare services use information and communications technology (ICT to support the provision of care to people in their own homes. This paper describes a pilot telecare service employed by Liverpool (UK City Council to support a sample of their frail and elderly social services users. The pilot has been running for over two years and has been deployed for 21 individuals in Liverpool. In this paper we present the pilot system and provide real example cases which help to illustrate the benefits of such a system.

  14. Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Cork Michael J

    2011-05-01

    Full Text Available Abstract Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data; therefore a non-inferiority trial is recommended. Trial registration ISRCTN72285670

  15. Radiation Protection, double-blind studies with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Pujadas, M. C.; Camacho, C.; Guasp, M.; Villaescusa, J. I.

    2009-01-01

    In a double-blind randomized controlled clinical trial (RCT) subjects and researchers do not know the assignment to treatment groups to ovoid the appearance of subjective biases of information. The employment of radiopharmaceuticals in double-blind RCTs raises a dilemma from the point ov view of the radiological protection. On the one hand, the obligation to act in cases of contamination and/or risk of irradiation exists, but on the other hand the duty of keeping the blind study also exists. In this paper some of the possible problems that arise when conducting a double-blind RCT with radiopharmaceuticals from the point of view of the radiological protection are presented. We comment our experience with the radiopharmaceutical Alpharadin and, in addition, we propose useful recommendations based on the randomness of the decontamination process. (Author) 7 refs.

  16. Electrocoagulation project: Pilot study testwork

    Energy Technology Data Exchange (ETDEWEB)

    Donini, J.C.; Garand, D.K.; Hassan, T.A.; Kar, K.L.; Thind, S.S.

    1991-09-01

    When a suspension or emulsion flows between two sacrificial metal electrodes excited by ac, the dispersed phase is consolidated and then settles. Laboratory-scale investigation of this mechanism, called electrocoagulation, and of its areas of application to water treatment were previously completed and a subsequent project was initiated to design and construct pilot-scale equipment consisting of an electrocoagulation cell, power supply, and computerized control system. The constructed pilot plant was used to test the effectiveness of electrocoagulation to clarify coal processing plant effluent. Results obtained with clay suspensions showed that flow conditions in the cell have a major effect on electric power consumption, and a reduction by a factor of three on this crucial cost parameter appeared possible compared to a previously tested batch-scale electrocoagulation system. Results obtained using the coal plant thickener feed closely duplicated those obtained with the clay mixtures. Aluminum electrode consumption, however, remained unchanged compared to the bench-scale tests. Supernatant clarity far exceeded requirements, while settling rate was too low. The settling could be speeded up by appropriate use of chemicals, but such addition affects the coagulation mechanism and reduces supernatant clarity. A tradeoff between settling rate and clarity was thus established. The total cost of treatment was deemed to be in excess of coal company requirements, but the pilot tests revealed much about the electrocoagulation system under continuous flow conditions. The technology is seen as having application in other areas such as municipal and industrial waste treatment. 22 refs., 6 figs., 2 tabs.

  17. Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

    Science.gov (United States)

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

    2014-02-01

    To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial

    Directory of Open Access Journals (Sweden)

    Park Ji-Eun

    2011-12-01

    Full Text Available Abstract Background Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points. The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a randomized, sham-controlled, participant-blinded, pilot trial. Methods Twenty-six participants (identified with either qi (vital energy deficiency or qi excess syndrome were randomly divided into either a moxibustion or sham group. Participants were treated with real or sham moxibustion at 4 acupuncture points, ST23 and ST27, bilaterally, 3 times per week for four weeks. The primary outcome was the frequency of defecations; secondary outcomes were the Bristol stool form scale (BSS and the constipation assessment scale (CAS. Results Of the 26 participants that were randomized, 24 completed the study. Defecation frequency, BSS, and CAS showed no difference between the moxibustion and sham groups. The differences were -0.25 (95% CI: -2.08, 1.58, p = 0.78, -1.22 (95% CI: -2.7, 0.26, p = 0.1, 0.91 (95% CI: -1.46, 3.28, p = 0.44 in defecation frequency, BSS, CAS, respectively. The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group (1.5[-0.5, 2], p = 0.06 and from 2.7 to 3.7 stools per week in the sham group (1[-1, 2], p = 0.15 after four weeks of treatment. The difference between participants with a deficiency or an excess syndrome, determined based on assessment of sweat, facial features, pain, body energy, and pulse type, was significant in only defecation frequency. The difference was 3.3 (95% CI: 0.41, 6.19, p = 0.03. Conclusion Moxibustion treatment appears safe, but showed no positive effect on constipation. The effectiveness of moxibustion treatment may depend on the syndrome pattern, and further long-term studies with a larger number of subjects are warranted. Trial registration Clinical Research Information Service, KCT0000168

  19. Sensory Barrage Stimulation in the Treatment of Elbow Spasticity: A Crossover Double Blind Randomized Pilot Trial.

    Science.gov (United States)

    Slovak, Martin; Chindo, Joseph; Nair, Krishnan Padmakumari Sivaraman; Reeves, Mark L; Heller, Ben; Barker, Anthony T

    2016-02-01

    To assess the feasibility of using a novel form of multichannel electrical stimulation, termed Sensory Barrage Stimulation (SBS) for the treatment of spasticity affecting the elbow flexor muscles and to compare this with conventional single-channel TENS stimulation. Altogether ten participants with spasticity of the flexor muscles of the elbow of Grade 2 or above on the Modified Ashworth Scale (MAS) were recruited to this crossover double blind randomized trial. The participants received two intervention sessions (SBS and TENS), one week apart in a randomized order. Both interventions were applied over the triceps brachii on the affected arm for a duration of 60 minutes. Spasticity was measured using the MAS. Secondary outcome measures were self-reported change in spasticity, measured on a visual analog scale (VAS, 0-100), and therapist-rated strength of elbow extension and strength of elbow flexion. Measurements were taken immediately before each intervention was applied, immediately after the intervention, and one hour after the intervention. Immediately after stimulation spasticity showed a significant reduction for both TENS and SBS groups assessed by MAS -0.9 ± 0.2 vs. -1.1 ± 0.2 and by VAS -15 ± 3 vs. -31 ± 8. For SBS this improvement in MAS was still present at one hour after the stimulation, but not for TENS. Altogether seven SBS responders and four TENS responders were identified. This study demonstrates the feasibility and practicality of applying the new concept of SBS. Promising results indicate it causes a reduction in spasticity. © 2015 International Neuromodulation Society.

  20. Fusion pilot plant scoping study

    International Nuclear Information System (INIS)

    Gierszewski, P.J.; Blevins, P.J.; Brunnader, H.; Natalizio, A.; Cumyn, P.; Dean, B.; Smith, S.; Galambos, J.; Holloway, C.; Stremlaw, J.; Williams, G.

    1994-05-01

    CFFTP Pilot is representative of a class of machines that, like NPD in the CANDU development program, could test the key reactor core technologies on an integrated power reactor relevant system (materials, conditions, configuration). But in order to reduce costs, the machine would operate at reduced neutron flux relative to a power reactor, would not produce electricity, and would not test superconducting magnets. This design shows research directions towards a machine that could provide integrated nuclear testing (but not ignition physics) at a cost of about 1/3 ITER CDA. The test volume - the outboard blanket volume - would be comparable to the test port volume on ITER CDA, while the fluence and power density would be about 1/4 ITER CDA. 91 refs., 43 tabs., 45 figs

  1. Fusion pilot plant scoping study

    Energy Technology Data Exchange (ETDEWEB)

    Gierszewski, P J; Blevins, P J; Brunnader, H; Natalizio, A [Canadian Fusion Fuels Technology Project, Toronto, ON (Canada); Cumyn, P [Canatom Ltd., Montreal, PQ (Canada); Dean, B; Smith, S [Wardrop (W.L.) and Associates Ltd., Winnipeg, MB (Canada); Galambos, J [Oak Ridge National Lab., TN (United States); Holloway, C [Spar Aerospace Ltd., Toronto, ON (Canada); Stremlaw, J [Monenco AGRA Inc., Calgary, AB (Canada); Williams, G [Spectrum Engineering Corp., Peterborough, ON (Canada)

    1994-05-01

    CFFTP Pilot is representative of a class of machines that, like NPD in the CANDU development program, could test the key reactor core technologies on an integrated power reactor relevant system (materials, conditions, configuration). But in order to reduce costs, the machine would operate at reduced neutron flux relative to a power reactor, would not produce electricity, and would not test superconducting magnets. This design shows research directions towards a machine that could provide integrated nuclear testing (but not ignition physics) at a cost of about 1/3 ITER CDA. The test volume - the outboard blanket volume - would be comparable to the test port volume on ITER CDA, while the fluence and power density would be about 1/4 ITER CDA. 91 refs., 43 tabs., 45 figs.

  2. Effect of the glucagon-like peptide-1 analogue liraglutide on coronary microvascular function in patients with type 2 diabetes – a randomized, single-blinded, cross-over pilot study

    DEFF Research Database (Denmark)

    Faber, Rebekka; Zander, Mette; Pena, Adam

    2015-01-01

    dipyridamole induced stress. Peripheral microvascular endothelial function was assessed by Endo-PAT2000®. Interventions were compared by two-sample t-test after ensuring no carry over effect. RESULTS: A total of 24 patients were included. Twenty patients completed the study (15 male; mean age 57 ± 9; mean BMI...

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

    Science.gov (United States)

    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-...

  4. APMP Pilot Study on Transmittance Haze

    Science.gov (United States)

    Liu, Wen-Chun; Hwang, Jisoo; Koo, Annette; Wu, Houping; Leecharoen, Rojana; Yu, Hsueh-Ling

    2018-02-01

    Five NMIs within APMP, including CMS/ITRI, MSL, NIM, NIMT and KRISS from TCPR applied to the APMP technical committee initiative project for funding to carry out a pilot comparison of transmittance haze in 2012. The project started in 2014 and the final report was completed at the end of 2016. In this pilot comparison, three different haze standards were adopted, and transmittance haze for each standard was measured according to ASTM D1003 or ISO 14782. This paper presents the first results of an APMP pilot study of transmittance haze and the analysis of the variation among different haze measurement systems which are commonly used. The study shows that the variables such as sphere multiplier, transmittance distribution, fluorescence of samples and optical path of the incident beam cause discrepancies among NMIs and highlight deficiencies in current documentary standards.

  5. The Association of Bifidobacterium breve BR03 and B632 is Effective to Prevent Colics in Bottle-fed Infants: A Pilot, Controlled, Randomized, and Double-Blind Study.

    Science.gov (United States)

    Giglione, Enza; Prodam, Flavia; Bellone, Simonetta; Monticone, Sonia; Beux, Sheila; Marolda, Agostina; Pagani, Alessia; Di Gioia, Diana; Del Piano, Mario; Mogna, Giovanni; Bona, Gianni

    To assess the effectiveness of Bifidobacterium breve B632 and BR03 association in the reduction of infants crying over time. The second endpoint was to observe the effect of the same strains on daily evacuations and on the number of regurgitations and vomits. Infant colics represent a clinical condition in childhood, characterized by an uncontrollable crying that occurs without any apparent organic cause. An altered intestinal microbiota composition in the very first months may induce intestinal colics in infants. Thus far, no treatment is really effective for this problem, but recent literature shows an increasing attention toward probiotics. A total of 83 subjects were enrolled, 60 breastfed infants and 23 bottle-fed infants. Sixty of them carried out the study: 29 infants were given probiotics, whereas 31 placebo. During the 90 days of the study, parents were asked to give 5 drops of active product (10 viable cells/strain) or placebo and to daily take note of: minutes of crying, number, color, and consistency of evacuations, and number of regurgitations or vomits. No significant differences were detected in the infants treated with probiotics, compared with placebo group (P=0.75). The analysis of the 3 months of treatment demonstrated that during the third month, the probiotic group cried 12.14 minutes on average and the placebo cried 46.65 minutes. This difference is statistically significant (P=0.016). The evidence of the usefulness of some probiotic strains in the treatment and prevention of infant colics is growing, and therefore their use in clinical practice is spreading.

  6. Effect of Probiotic Lactobacillus salivarius UBL S22 and Prebiotic Fructo-oligosaccharide on Serum Lipids, Inflammatory Markers, Insulin Sensitivity, and Gut Bacteria in Healthy Young Volunteers: A Randomized Controlled Single-Blind Pilot Study.

    Science.gov (United States)

    Rajkumar, Hemalatha; Kumar, Manoj; Das, Nilita; Kumar, S Nishanth; Challa, Hanumanth R; Nagpal, Ravinder

    2015-05-01

    This study investigated the effect of 6-week supplementation of a probiotic strain Lactobacillus salivarius UBL S22 with or without prebiotic fructo-oligosaccharide (FOS) on serum lipid profiles, immune responses, insulin sensitivity, and gut lactobacilli in 45 healthy young individuals. The patients were divided into 3 groups (15/group), that is, placebo, probiotic, and synbiotic. After 6 weeks, a significant reduction (P < .05) in total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides and increase in high-density lipoprotein cholesterol was observed in the probiotic as well as in the synbiotic group when compared to placebo; however, the results of total cholesterol and LDL-cholesterol were more pronounced in the synbiotic group. Similarly, when compared to the placebo group, the serum concentrations of inflammatory markers such as high sensitivity C-reactive protein, interleukin (IL) 6, IL-1β, and tumor necrosis factor α were significantly (P < .05) reduced in both the experimental groups, but again the reduction in the synbiotic group was more pronounced. Also, an increase (P < .05) in the fecal counts of total lactobacilli and a decrease (P < .05) in coliforms and Escherichia coli was observed in both the experimental groups after 6 weeks of ingestion. Overall, the combination of L salivarius with FOS was observed to be more beneficial than L salivarius alone, thereby advocating that such synbiotic combinations could be therapeutically exploited for improved health and quality of life. © The Author(s) 2014.

  7. A double-blind, placebo-controlled randomized clinical trial to evaluate the efficacy of tranexamic acid in irrigant solution on blood loss during percutaneous nephrolithotomy: a pilot study from tertiary care center of North India.

    Science.gov (United States)

    Bansal, Ankur; Arora, Aditi

    2017-08-01

    To evaluate the efficacy and safety of 0.1% tranexamic acid in irrigant fluid in reducing blood loss during PCNL. The study involved 400 patients who were planned for PCNL and were prospectively randomized into two equal groups. In tranexamic group, 0.1% tranexamic acid was given in irrigant fluid, while in placebo group, distilled water was added to irrigant fluid during surgery. Operative data were recorded which included fall in hemoglobin, total blood loss, operative time, irrigation fluid, length of stay in hospital, requirement of blood transfusion, complications related to PCNL and adverse events of tranexamic acid. Baseline parameters were comparable between two groups. The fall in hemoglobin and total blood loss in the tranexamic group was significantly lower than placebo group (1.71 vs. 2.67 gm/dL, 154.55 vs. 212.61 mL, respectively, p tranexamic group were significantly less compared to placebo (p tranexamic group versus 82% in placebo (p = 0.12). The blood transfusion requirement was significantly lower in the tranexamic group versus placebo (5 vs. 12.5%, p = 0.012), as was the complication rate (19 vs. 28%, p = 0.044). The requirement of angioembolization in the tranexamic group was significantly less as compared to placebo (0.5 vs. 4%, p = 0.03). No adverse events related to administration of tranexamic acid were noted. 0.1% tranexamic acid in irrigant fluid is safe and significantly reduces perioperative blood loss and requirement of blood transfusion during percutaneous nephrolithotomy. It is associated with lower perioperative complication rates.

  8. A role of Yueju in fast-onset antidepressant action on major depressive disorder and serum BDNF expression: a randomly double-blind, fluoxetine-adjunct, placebo-controlled, pilot clinical study

    Directory of Open Access Journals (Sweden)

    Wu R

    2015-08-01

    Full Text Available Ruyan Wu,1,* Dandan Zhu,1,* Youchun Xia,2,* Haosen Wang,2 Weiwei Tao,1 Wenda Xue,1 Baomei Xia,1 Li Ren,1 Xin Zhou,1 Guochun Li,3 Gang Chen1 1Center for Translational Systems Biology and Neuroscience, Key Laboratory of Integrative Biomedicine of Brain Diseases, Nanjing University of Chinese Medicine, Nanjing, People’s Republic of China; 2The Fourth People’s Hospital of Taizhou, Taizhou, People’s Republic of China; 3School of Basic Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, People’s Republic of China *These authors contributed equally to this work Introduction: Conventional antidepressants, including fluoxetine, have a major disadvantage in delayed onset of efficacy. Yueju, an herbal medicine used to treat mood disorders was recently found to exhibit rapid antidepressant effects. The present study was conducted to evaluate the role of Yueju in rapidly acting on major depressive disorder (MDD.Methods: Participants were MDD patients with scores of 24-item Hamilton Depression Rating Scale (HDRS-24 ≥20 and without history of antidepressant use. They randomly received daily oral doses of Yueju (23 g/day plus fluoxetine (20 mg/day (experimental group or placebo plus fluoxetine (control group for 7 days. HDRS-24 was used as the primary outcome measurement at baseline, and on days 1, 3, 5, and 7. Concentrations of serum brain-derived neurotrophic factor (BDNF were assessed at baseline and on days 1 and 7.Results: In all, 18 participants met the criteria for data analysis. Compared to baseline level, only experimental group showed significant decrease of HDRS-24 score from day 3 to day 7 (P<0.05. Experimental group also showed significant improvement compared with control group from day 3 to day 7 (P<0.05. No correlation between treatment outcomes with serum BDNF levels was observed. However, experimental group showed significant correlation for serum BDNF level on day 1 with day 7 (r=0.721, P=0.028, whereas the control

  9. randomised double blind study to compare effectiveness of honey

    African Journals Online (AJOL)

    2014-02-02

    Feb 2, 2014 ... EAsT AFRICAN MEDICAL JOURNAL. February 2014 .... based randomised double- blinded clinical trial evaluating effectiveness of ... study drugs was undertaken following a random ... included sodium citrate, citric acid monohydrate, ... post-hoc test to carry out pair-wise comparisons of .... self-care market.

  10. Effects of Reiki on Pain, Anxiety, and Blood Pressure in Patients Undergoing Knee Replacement: A Pilot Study.

    Science.gov (United States)

    Baldwin, Ann Linda; Vitale, Anne; Brownell, Elise; Kryak, Elizabeth; Rand, William

    This blinded, controlled pilot study investigated the effects of Reiki on 46 patients undergoing knee replacement surgery. Of the 3 groups, Reiki, Sham Reiki, and Standard of Care, only the Reiki group showed significant reductions in pain, blood pressure, respiration rate, and state anxiety, which provides evidence for a full-scale clinical study.

  11. Learned Helplessness in Children with Visual Handicaps: A Pilot Study of Expectations, Persistence, and Attributions. Final Report.

    Science.gov (United States)

    Head, Dan; And Others

    This report describes the outcomes of a one-year federally funded pilot study of 14 students with low vision or blindness (grades 3-6) and 13 teachers. The study was designed to generate practical classroom assessment procedures for measuring "learned helplessness" and recommendations for a conceptual intervention model for use in the classroom.…

  12. Chiropractic manipulation in Adolescent Idiopathic Scoliosis: a pilot study

    Directory of Open Access Journals (Sweden)

    Stoline Michael R

    2006-08-01

    Full Text Available Abstract Background Adolescent idiopathic scoliosis (AIS remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. Methods Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment, two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. Results Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. Conclusion Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. Trial registration This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. http://www.controlled-trials.com/isrctn/. The number is ISRCTN41221647.

  13. Human Challenge Pilot Study with Cyclospora cayetanensis

    OpenAIRE

    Alfano-Sobsey, Edith M.; 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.

  14. Aspartame Sensitivity? A Double Blind Randomised Crossover Study

    OpenAIRE

    Sathyapalan, Thozhukat; Thatcher, Natalie J.; Hammersley, Richard; Rigby, Alan S.; Pechlivanis, Alexandros; Gooderham, Nigel J.; Holmes, Elaine; le Roux, Carel W.; Atkin, Stephen L.; Courts, Fraser

    2015-01-01

    Background Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. Methods This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight indivi...

  15. Image processing of angiograms: A pilot study

    Science.gov (United States)

    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.

  16. Blinded with Science or Informed by Charts? A Replication Study

    OpenAIRE

    Dragicevic , Pierre; Jansen , Yvonne

    2018-01-01

    International audience; We provide a reappraisal of Tal and Wansink's study "Blinded with Science" , where seemingly trivial charts were shown to increase belief in drug efficacy, presumably because charts are associated with science. Through a series of four replications conducted on two crowdsourcing platforms, we investigate an alternative explanation, namely, that the charts allowed participants to better assess the drug's efficacy. Considered together, our experiments suggest that the ch...

  17. Seaside, Oregon, Tsunami Vulnerability Assessment Pilot Study

    Science.gov (United States)

    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.

  18. The atrial fibrillation ablation pilot study

    DEFF Research Database (Denmark)

    Arbelo, Elena; Brugada, Josep; Hindricks, Gerhard

    2014-01-01

    AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse...... was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial...... tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib...

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

    Science.gov (United States)

    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

  20. USGS Tampa Bay Pilot Study

    Science.gov (United States)

    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

    Many of the nation's estuaries have been environmentally stressed since the turn of the 20th century and will continue to be impacted in the future. Tampa Bay, one the Gulf of Mexico's largest estuaries, exemplifies the threats that our estuaries face (EPA Report 2001, Tampa Bay Estuary Program-Comprehensive Conservation and Management Plan (TBEP-CCMP)). More than 2 million people live in the Tampa Bay watershed, and the population constitutes to grow. Demand for freshwater resources, conversion of undeveloped areas to resident and industrial uses, increases in storm-water runoff, and increased air pollution from urban and industrial sources are some of the known human activities that impact Tampa Bay. Beginning on 2001, additional anthropogenic modifications began in Tampa Bat including construction of an underwater gas pipeline and a desalinization plant, expansion of existing ports, and increased freshwater withdrawal from three major tributaries to the bay. In January of 2001, the Tampa Bay Estuary Program (TBEP) and its partners identifies a critical need for participation from the U.S. Geological Survey (USGS) in providing multidisciplinary expertise and a regional-scale, integrated science approach to address complex scientific research issue and critical scientific information gaps that are necessary for continued restoration and preservation of Tampa Bay. Tampa Bay stakeholders identified several critical science gaps for which USGS expertise was needed (Yates et al. 2001). These critical science gaps fall under four topical categories (or system components): 1) water and sediment quality, 2) hydrodynamics, 3) geology and geomorphology, and 4) ecosystem structure and function. Scientists and resource managers participating in Tampa Bay studies recognize that it is no longer sufficient to simply examine each of these estuarine system components individually, Rather, the interrelation among system components must be understood to develop conceptual and

  1. A Study of Color Transformation on Website Images for the Color Blind

    OpenAIRE

    Siew-Li Ching; Maziani Sabudin

    2010-01-01

    In this paper, we study on color transformation method on website images for the color blind. The most common category of color blindness is red-green color blindness which is viewed as beige color. By transforming the colors of the images, the color blind can improve their color visibility. They can have a better view when browsing through the websites. To transform colors on the website images, we study on two algorithms which are the conversion techniques from RGB colo...

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

    Science.gov (United States)

    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.

  3. Attention Measures of Accuracy, Variability, and Fatigue Detect Early Response to Donepezil in Alzheimer's Disease: A Randomized, Double-blind, Placebo-Controlled Pilot Trial.

    Science.gov (United States)

    Vila-Castelar, Clara; Ly, Jenny J; Kaplan, Lillian; Van Dyk, Kathleen; Berger, Jeffrey T; Macina, Lucy O; Stewart, Jennifer L; Foldi, Nancy S

    2018-04-09

    Donepezil is widely used to treat Alzheimer's disease (AD), but detecting early response remains challenging for clinicians. Acetylcholine is known to directly modulate attention, particularly under high cognitive conditions, but no studies to date test whether measures of attention under high load can detect early effects of donepezil. We hypothesized that load-dependent attention tasks are sensitive to short-term treatment effects of donepezil, while global and other domain-specific cognitive measures are not. This longitudinal, randomized, double-blind, placebo-controlled pilot trial (ClinicalTrials.gov Identifier: NCT03073876) evaluated 23 participants newly diagnosed with AD initiating de novo donepezil treatment (5 mg). After baseline assessment, participants were randomized into Drug (n = 12) or Placebo (n = 11) groups, and retested after approximately 6 weeks. Cognitive assessment included: (a) attention tasks (Foreperiod Effect, Attentional Blink, and Covert Orienting tasks) measuring processing speed, top-down accuracy, orienting, intra-individual variability, and fatigue; (b) global measures (Alzheimer's Disease Assessment Scale-Cognitive Subscale, Mini-Mental Status Examination, Dementia Rating Scale); and (c) domain-specific measures (memory, language, visuospatial, and executive function). The Drug but not the Placebo group showed benefits of treatment at high-load measures by preserving top-down accuracy, improving intra-individual variability, and averting fatigue. In contrast, other global or cognitive domain-specific measures could not detect treatment effects over the same treatment interval. The pilot-study suggests that attention measures targeting accuracy, variability, and fatigue under high-load conditions could be sensitive to short-term cholinergic treatment. Given the central role of acetylcholine in attentional function, load-dependent attentional measures may be valuable cognitive markers of early treatment response.

  4. An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

    Science.gov (United States)

    Brass, D; Fouweather, T; Stocken, D D; Macdonald, C; Wilkinson, J; Lloyd, J; Farr, P M; Reynolds, N J; Hampton, P J

    2017-12-13

    Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective. To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids. Sixty patients with hand eczema unresponsive to clobetasol propionate 0·05% were randomized to receive either immersion PUVA or NB-UVB twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving 'clear' or 'almost clear' Physician's Global Assessment (PGA) response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI). In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, five patients achieved 'clear' and eight 'almost clear' [intention-to-treat (ITT) response rate 43%]. In the NB-UVB group, two achieved 'clear' and five 'almost clear' (ITT response rate 23%). For the secondary outcomes, median mTLSS scores were similar between groups at baseline (PUVA 9·5, NB-UVB 9) and at 12 weeks (PUVA 3, NB-UVB 4). Changes in DLQI were similar, with improvements in both groups. In this randomized pilot trial recruitment was challenging. After randomization, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems - PGA, mTLSS and DLQI - as measures of treatment response, the trial demonstrated that both PUVA and NB-UVB reduced the severity of chronic palmar hand eczema. © 2017 British Association of Dermatologists.

  5. Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial.

    Science.gov (United States)

    Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

    2012-06-01

    Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm(3) in the treatment arm and 29 (8-105) cm(3) in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established.

  6. Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial

    International Nuclear Information System (INIS)

    Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

    2012-01-01

    Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm 3 in the treatment arm and 29 (8-105) cm 3 in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established. (orig.)

  7. Cytogenetics of jaw cysts - a pilot study.

    Science.gov (United States)

    Manor, Esther; Brennan, Peter A; Bodner, Lipa

    2012-07-01

    The pathogenesis of cysts that arise in the jaws is still not certain, and the underlying mechanisms of epithelial proliferation are not fully understood. Cysts of the jaw may involve a reactive, inflammatory, or neoplastic process. Cytogenetics, the study of the number and structure of chromosomes, has provided valuable information about the diagnosis, prognosis, and targeted treatment in many cancers, including oral squamous cell carcinoma. Cytogenetics can also provide information about the possible aetiology or neoplastic potential of a lesion, though to our knowledge no studies of this technique have been used for cysts in the jaws. In this pilot study we used cytogenetics in a series of 10 cysts (3 radicular, 4 dentigerous, 2 of the nasopalatine duct, and 1 dermoid). In all cases we found normal karyotypes. Further work and larger numbers are needed for a definitive study, but we can hypothesise from this pilot study that these cysts do not have cytogenetic aberrations and so have no neoplastic potential. Copyright © 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  8. Doing A Pilot Study: Why Is It Essential?

    OpenAIRE

    Hassan, Zailinawati Abu; Schattner, Peter; Mazza, Danielle

    2006-01-01

    A pilot study is one of the essential stages in a research project. This paper aims to describe the importance of and steps involved in executing a pilot study by using an example of a descriptive study in primary care. The process of testing the feasibility of the project proposal, recruitment of subjects, research tool and data analysis was reported. We conclude that a pilot study is necessary and useful in providing the groundwork in a research project.

  9. DOING A PILOT STUDY: WHY IS IT ESSENTIAL?

    Directory of Open Access Journals (Sweden)

    Zailinawati Abu Hassan

    2006-01-01

    Full Text Available A pilot study is one of the essential stages in a research project. This paper aims to describe the importance of and steps involved in executing a pilot study by using an example of a descriptive study in primary care. The process of testing the feasibility of the project proposal, recruitment of subjects, research tool and data analysis was reported. We conclude that a pilot study is necessary and useful in providing the groundwork in a research project.

  10. Pilot Study for Maintenance Rule at KSNP

    International Nuclear Information System (INIS)

    Choi, Kwang Hee; Jeong, Hyeon Jong; Jee, Moon Hak; Hong, Sung Yull

    2005-01-01

    Maintenance Rule (MR), which was developed to monitor the effectiveness of maintenance in a nuclear power plant (NPP), has been received as highly successful program by and large since its implementation in 1996 in the United States. Korea has initiated two pilot programs to implement the Maintenance Rule program in 2003. Selected plants for the pilot implementation are Kori 3 and 4 units and Ulchin 3 and 4 units, where Kori 3 and 4 units are Westinghouse units and Ulchin 3 and 4 units are Korean Standardized Nuclear Power (KSNP) Plant units. This paper describes the results of each key tasks completed to date and insights gained from pilot study on the KSNP units. Currently, Scoping of the functions of maintenance rule and determination of safety significance level have been completed during first year. As first task, total 607 functions were identified and defined by detailed function analysis on 135 systems that cover all plant systems. About 55% of total functions are selected as within the scope of maintenance rule. Among these inscoped functions, 56% of scoped functions are safety related and 44% are non-safety related functions. Evaluation of safety significance for each function was determined by expert panel consist of eight experts in field of plant maintenance, operation, PSA, work schedule and system engineers. As a result, about 46% of functions were determined to be high safety significant functions and rest of the functions were classified as low safety significant. The remaining tasks that are included determination of performance criteria and preparation of implementing guideline will be performed in following years

  11. Epidemiologic studies of pilots and aircrew.

    Science.gov (United States)

    Boice, J D; Blettner, M; Auvinen, A

    2000-11-01

    During flight, pilots and cabin crew are exposed to increased levels of cosmic radiation which consists primarily of neutrons and gamma rays. Neutron dosimetry is not straightforward, but typical annual effective doses are estimated to range between two and five mSv. Higher dose rates are experienced at the highest altitudes and in the polar regions. Mean doses have been increasing over time as longer flights at higher altitudes have become more frequent. Because there are so few populations exposed to neutrons, studies of airline personnel are of particular interest. However, because the cumulative radiation exposure is so low, statistical power is a major concern. Further, finding an appropriate comparison group is problematic due to selection into these occupations and a number of biases are possible. For example, increased rates of breast cancer among flight attendants have been attributed to reproductive factors such as nulliparity and increased rates of melanoma among pilots have been attributed to excessive sun exposure during leisure time activities. Epidemiologic studies conducted over the last 20 y provide little consistent evidence linking cancer with radiation exposures from air travel.

  12. Nonhuman Primate Studies to Advance Vision Science and Prevent Blindness.

    Science.gov (United States)

    Mustari, Michael J

    2017-12-01

    Most primate behavior is dependent on high acuity vision. Optimal visual performance in primates depends heavily upon frontally placed eyes, retinal specializations, and binocular vision. To see an object clearly its image must be placed on or near the fovea of each eye. The oculomotor system is responsible for maintaining precise eye alignment during fixation and generating eye movements to track moving targets. The visual system of nonhuman primates has a similar anatomical organization and functional capability to that of humans. This allows results obtained in nonhuman primates to be applied to humans. The visual and oculomotor systems of primates are immature at birth and sensitive to the quality of binocular visual and eye movement experience during the first months of life. Disruption of postnatal experience can lead to problems in eye alignment (strabismus), amblyopia, unsteady gaze (nystagmus), and defective eye movements. Recent studies in nonhuman primates have begun to discover the neural mechanisms associated with these conditions. In addition, genetic defects that target the retina can lead to blindness. A variety of approaches including gene therapy, stem cell treatment, neuroprosthetics, and optogenetics are currently being used to restore function associated with retinal diseases. Nonhuman primates often provide the best animal model for advancing fundamental knowledge and developing new treatments and cures for blinding diseases. © The Author(s) 2017. Published by Oxford University Press on behalf of the National Academy of Sciences. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  13. Diabetic Retinopathy Screening Using Telemedicine Tools: Pilot Study in Hungary

    Directory of Open Access Journals (Sweden)

    Dóra J. Eszes

    2016-01-01

    Full Text Available Introduction. Diabetic retinopathy (DR is a sight-threatening complication of diabetes. Telemedicine tools can prevent blindness. We aimed to investigate the patients’ satisfaction when using such tools (fundus camera examination and the effect of demographic and socioeconomic factors on participation in screening. Methods. Pilot study involving fundus camera screening and self-administered questionnaire on participants’ experience during fundus examination (comfort, reliability, and future interest in participation, as well as demographic and socioeconomic factors was performed on 89 patients with known diabetes in Csongrád County, a southeastern region of Hungary. Results. Thirty percent of the patients had never participated in any ophthalmological screening, while 25.7% had DR of some grade based upon a standard fundus camera examination and UK-based DR grading protocol (Spectra™ software. Large majority of the patients were satisfied with the screening and found it reliable and acceptable to undertake examination under pupil dilation; 67.3% were willing to undergo nonmydriatic fundus camera examination again. There was a statistically significant relationship between economic activity, education and marital status, and future interest in participation. Discussion. Participants found digital retinal screening to be reliable and satisfactory. Telemedicine can be a strong tool, supporting eye care professionals and allowing for faster and more comfortable DR screening.

  14. Microwave Imaging of Human Forearms: Pilot Study and Image Enhancement

    Directory of Open Access Journals (Sweden)

    Colin Gilmore

    2013-01-01

    Full Text Available We present a pilot study using a microwave tomography system in which we image the forearms of 5 adult male and female volunteers between the ages of 30 and 48. Microwave scattering data were collected at 0.8 to 1.2 GHz with 24 transmitting and receiving antennas located in a matching fluid of deionized water and table salt. Inversion of the microwave data was performed with a balanced version of the multiplicative-regularized contrast source inversion algorithm formulated using the finite-element method (FEM-CSI. T1-weighted MRI images of each volunteer’s forearm were also collected in the same plane as the microwave scattering experiment. Initial “blind” imaging results from the utilized inversion algorithm show that the image quality is dependent on the thickness of the arm’s peripheral adipose tissue layer; thicker layers of adipose tissue lead to poorer overall image quality. Due to the exible nature of the FEM-CSI algorithm used, prior information can be readily incorporated into the microwave imaging inversion process. We show that by introducing prior information into the FEM-CSI algorithm the internal anatomical features of all the arms are resolved, significantly improving the images. The prior information was estimated manually from the blind inversions using an ad hoc procedure.

  15. Intraoperative music application in children and adolescents - a pilot study.

    Science.gov (United States)

    Buehler, P K; Spielmann, N; Buehrer, S; Schmidt, A R; Weiss, M; Schmitz, A

    2017-09-01

    Hospitalization, surgery and anaesthesia may lead to new-onset maladaptive behaviour, emotional distress and trauma. This pilot study aims to investigate the influence of intraoperatively applied music on post-operative behaviour in children and adolescents. Children with an ASA physical state classification of I or II, aged from 4 to 16 years and scheduled for elective circumcision or inguinal hernia repair under combined general and caudal anaesthesia were included. The children were randomized into two groups. They wore headphones during surgery, and were either exposed to music or not. All involved staff were blinded. Post-operative behaviour was documented by parents on day 7, 14 and 28 after surgery, using a questionnaire adapted from the "Post Hospitalization Behavioural Questionnaire" (PHBQ). Overall occurrence of at least one item indicating maladaptive behaviour was the primary outcome. Data are presented as median (interquartile range). In total, 135 children aged 6.6 (5.3-8.5) years, weighing 22 (19-29) kg, were included, with 112 completed questionnaires returned. Overall occurrence of at least one maladaptive item was lower in the music group, with a significantly lower incidence on day 7 (51% vs. 77% in controls; P music application in children undergoing minor surgical procedures may reduce the incidence of post-operative maladaptive behaviour within the first week. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  16. DU-AGG pilot plant design study

    International Nuclear Information System (INIS)

    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

  17. Location Independent Professional Project: A Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    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.

  18. A STUDY ON PREVALENCE AND CAUSES OF CORNEAL BLINDNESS IN PAEDIATRIC AGE GROUP

    Directory of Open Access Journals (Sweden)

    E. Ramadevi

    2017-12-01

    Full Text Available BACKGROUND Corneal disease is responsible for less than 2% of blindness in children in industrialised countries. In poor countries of the world, corneal scarring occurs due to vitamin A deficiency, measles and ophthalmia neonatorum. Thus, corneal disease is an important cause of blindness among children living in developing nations, which already carry a major burden of blindness. The aim of the study is to study the1. Prevalence of corneal blindness in the paediatric age group. 2. Causes of corneal blindness in the paediatric age group. 3. Morbidity of corneal blindness in the paediatric age group. MATERIALS AND METHODS It was cross-sectional observational study. Study Period- December 2014 to August 2016. Study Done- Government General Hospital, Kakinada. Sample Size- 50 patients. Inclusion Criteria- Children of age group 6 to 12 years with corneal blindness who have attended the outpatient department during the study period. Exclusion Criteria- Children with childhood blindness other than corneal pathology. Study Tools- Predesigned, semi-structured questionnaire regarding age, sex and age of onset of visual loss, laterality, history of ocular injury, vitamin A immunisation, family history of consanguinity and place of residence and socioeconomic status was taken. Visual acuity was measured using an E optotype and Landolt broken C chart with best corrected vision. Visual loss was classified according to the WHO categories of visual impairment. Ophthalmic examination was done by slit lamp and B scan. RESULTS Ocular trauma and corneal ulcers are most common cause of corneal blindness. 84% of corneal blindness cases were preventable and curable. CONCLUSION Trauma was the commonest cause of corneal blindness followed by infectious keratitis. 84% of corneal blindness was preventable and curable. Most causes of corneal blindness were avoidable.

  19. The Pilot Staffing Conundrum: A Delphi Study

    Science.gov (United States)

    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

  20. The incidence of venous thromboembolism in commercial airline pilots: a cohort study of 2630 pilots.

    Science.gov (United States)

    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.

  1. Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study

    DEFF Research Database (Denmark)

    Nejrup, Kirsten; Olivarius, Niels de Fine; Jacobsen, Judith L.

    2008-01-01

    The primary objective of this double-blind, randomised, controlled trial was to determine if implanting gold beads at five acupuncture points around the knee joint improves 1-year outcomes for patients with osteoarthritis (OA) of the knee. Participants were 43 adults aged 18-80 years with pain...... and stiffness from non-specific OA of the knee for over a year. The intervention was blinded implantation of gold beads at five acupuncture points around the affected knee through a hypodermic needle, or needle insertion alone. Primary outcome measures were knee pain, stiffness and function assessed...... acupuncture had greater relative improvements in self-assessed outcomes. The treatment was well tolerated. This 1-year pilot study indicates that extraarticular gold bead implantation is a promising treatment modality for patients with OA of the knee. The new treatment should be tested in a larger trial...

  2. Management of ocular trauma in emergency (MOTE trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma

    Directory of Open Access Journals (Sweden)

    Ting Joseph

    2009-01-01

    Full Text Available Background: It is unclear whether local anesthetic eye drops can be safely used for the topical anesthesia of patients with minor corneal injury who are discharged from the emergency department (ED. Objectives: To assess whether topical 0.4% amethocaine self-administered to a maximum recommended frequency of once every hour for 36-48 h is safe in the management of uncomplicated corneal injury in patients discharged from the ED. Patients and Methods: A pilot randomized double-blinded trial comparing topical 0.4% amethocaine with topical normal saline. Results: Forty-seven subjects were recruited, with 22 randomized to receive amethocaine and 25 to receive placebo (normal saline . Baseline characteristics, including corneal injury type, were similar in both groups. There were no significant functional or clinical adverse sequelae in the majority of enrolled patients who could be contacted at 2 weeks (17/22 for amethocaine and 21/25 for placebo. Follow-up for the primary study outcome was suboptimal, with only 7/22 from the amethocaine group and 9/25 from the saline group presenting for 36-48 h review; there was a statistically nonsignificant trend for persistence of the corneal defect in the amethocaine group as compared with the saline group (2/7 and 1/9, respectively. Conclusion: Compared with saline drops, amethocaine eye drops are not definitely safe but they are effective for topical analgesia in minor corneal injury. Until further definitive studies, topical nonsteroidal agents or long-lasting artificial tears may be preferred for the topical analgesia of minor corneal injury. Return for corneal re-evaluation will necessarily remain suboptimal in an otherwise self-limiting condition, leading to a bias even if study recruitment is good.

  3. A Study of Curriculum Development and Reform in Residential Schools for the Blind in the United States: Three Case Studies

    Science.gov (United States)

    Holiday, Jeremiah

    2013-01-01

    This study was conducted to understand curriculum development in residential schools for the blind after the enactment of NCLB and was guided by the research question, "How do residential schools for the blind and visually impaired develop their curriculum to meet the unique needs of students who are blind and visually impaired?" In the…

  4. Pilot study for natural radiation survey

    International Nuclear Information System (INIS)

    Brown, L.; Driscoll, C.M.H.; Green, B.M.R.; Miles, J.C.H.

    1983-01-01

    NRPB's national survey of natural radiation exposure in homes commenced in 1982 and will run until 1984. A pilot survey was undertaken in over 100 homes for one year, using passive thermoluminescent dosemeters to measure external radiation from terrestrial and cosmic sources and passive radon dosemeters to measure the radon-222 gas concentration. A preliminary analysis of the results obtained from the pilot survey is given. The main value of the pilot survey was in providing experience and various administrative and scientific procedures have been simplified or automated for the national survey. (U.K.)

  5. Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial.

    Science.gov (United States)

    Monjezi, Saeideh; Negahban, Hossein; Tajali, Shirin; Yadollahpour, Nava; Majdinasab, Nastaran

    2017-02-01

    To investigate the effects of dual-task balance training on postural performance in patients with multiple sclerosis as compared with single-task balance training. Double-blind, pretest-posttest, randomized controlled pilot trial. Local Multiple Sclerosis Society. A total of 47 patients were randomly assigned to two equal groups labeled as single-task training and dual-task training groups. All patients received supervised balance training sessions, 3 times per week for 4 weeks. The patients in the single-task group performed balance activities, alone. However, patients in dual-task group practiced balance activities while simultaneously performing cognitive tasks. The 10-Meter Walk Test and Timed Up-and-Go under single-task and dual-task conditions, in addition to Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment were assessed pre-, and post intervention and also 6-weeks after the end of intervention. Only 38 patients completed the treatment plan. There was no difference in the amount of improvement seen between the two study groups. In both groups there was a significant effect of time for dual-10 Meter Walk Test (F 1, 36 =11.33, p=0.002) and dual-Timed Up-and-Go (F 1, 36 =14.27, p=0.001) but not for their single-tasks. Moreover, there was a significant effect of time for Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment ( Ppilot study did not show more benefits from undertaking dual-task training than single-task training. A power analysis showed 71 patients per group would be needed to determine whether there was a clinically relevant difference for dual-task gait speed between the groups.

  6. PPAR-gamma agonist pioglitazone modifies craving intensity and brain white matter integrity in patients with primary cocaine use disorder: a double-blind randomized controlled pilot trial.

    Science.gov (United States)

    Schmitz, Joy M; Green, Charles E; Hasan, Khader M; Vincent, Jessica; Suchting, Robert; Weaver, Michael F; Moeller, F Gerard; Narayana, Ponnada A; Cunningham, Kathryn A; Dineley, Kelly T; Lane, Scott D

    2017-10-01

    Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocaine use disorder (CUD). We tested the effects of PIO on targeted mechanisms relevant to CUD: cocaine craving and brain white matter (WM) integrity. Feasibility, medication compliance and tolerability were evaluated. Two-arm double-blind randomized controlled proof-of-concept pilot trial of PIO or placebo (PLC). Single-site out-patient treatment research clinic in Houston, TX, USA. Thirty treatment-seeking adults, 18 to 60 years old, with CUD. Eighteen participants (8 = PIO; 10 = PLC) completed diffusion tensor imaging (DTI) of WM integrity at pre-/post-treatment. Study medication was dispensed at thrice weekly visits along with once-weekly cognitive behavioral therapy for 12 weeks. Measures of target engagement mechanisms of interest included cocaine craving assessed by the Brief Substance Craving Scale (BSCS), the Obsessive Compulsive Drug Use Scale (OCDUS), a visual analog scale (VAS) and change in WM integrity. Feasibility measures included number completing treatment, medication compliance (riboflavin detection) and tolerability (side effects, serious adverse events). Target engagement change in mechanisms of interest, defined as a ≥ 0.75 Bayesian posterior probability of an interaction existing favoring PIO over PLC, was demonstrated on measures of craving (BSCS, VAS) and WM integrity indexed by fractional anisotropy (FA) values. Outcomes indicated greater decrease in craving and greater increase in FA values in the PIO group. Feasibility was demonstrated by high completion rates among those starting treatment (21/26 = 80%) and medication compliance (≥ 80%). There were no reported serious adverse events for PIO. Compared with placebo, patients receiving pioglitazone show a higher likelihood of reduced cocaine craving and improved brain white matter integrity as a function of time in treatment. Pioglitazone shows good feasibility as a treatment for cocaine

  7. A Pilot Study of Omalizumab in Eosinophilic Esophagitis

    Science.gov (United States)

    Loizou, Denise; Enav, Benjamin; Komlodi-Pasztor, Edina; Hider, Pamela; Kim-Chang, Julie; Noonan, Laura; Taber, Tabitha; Kaushal, Suhasini; Limgala, Renuka; Brown, Margaret; Gupta, Raavi; Balba, Nader; Goker-Alpan, Ozlem; Khojah, Amer; Alpan, Oral

    2015-01-01

    Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE), once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE) levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy. Trial Registration ClinicalTrials.gov NCT01040598 PMID:25789989

  8. A pilot study of omalizumab in eosinophilic esophagitis.

    Directory of Open Access Journals (Sweden)

    Denise Loizou

    Full Text Available Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE, once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy.

  9. Nationwide incidence of blindness in South Korea: a 12-year study from 2002 to 2013.

    Science.gov (United States)

    Rim, Tyler Hyungtaek; Kim, Dong Wook; Chung, Eun Jee; Kim, Sung Soo

    2017-11-01

    Blindness is an important public health issue. The background of the study is to determine the incidence of blindness in South Korea. Nationwide population-based retrospective study. All individuals from South Korea (n = 47 516 098). Patients confirmed with legal blindness based on the worse-seeing and better-seeing eyes between 1 January 2002 and 31 December 2013 were included. The Korean National Health Insurance Service (KNHIS) database was used. Using the World Health Organization definition, blindness was defined as best-corrected visual acuity in the worse-seeing and better-seeing eyes of blindness during the 12-year period was estimated. The population of South Korea was estimated using census data in 2005 and 2010. The total number of legal blindness cases in the KNHIS database. We identified 195 004 and 20 492 cases of newly developed legal blindness based on the worse-seeing and better-seeing eyes, respectively, and the mean incidences of blindness were 34.2 and 3.6 cases/100 000 person-years, respectively. The prevalence of blindness based on the worse-seeing and better-seeing eyes was 425.3 and 57.7 cases/100 000 persons, respectively. The incidence of blindness based on the worse-seeing eye was higher in men than in women overall. Additionally, the incidence increased with age and showed a decreasing trend from 2002 to 2013. The prevalence of blindness showed an increasing trend from 2002 to 2013. The findings of our study will help in the assessment of the blindness-related socio-economic burden and in healthcare planning. © 2017 Royal Australian and New Zealand College of Ophthalmologists.

  10. A Double-Blind, Randomized Pilot Trial of Chromium Picolinate for Overweight Individuals with Binge-Eating Disorder: Effects on Glucose Regulation.

    Science.gov (United States)

    Sala, Margarita; Breithaupt, Lauren; Bulik, Cynthia M; Hamer, Robert M; La Via, Maria C; Brownley, Kimberly A

    2017-03-04

    Chromium treatment has been shown to improve glucose regulation in some populations. The purpose of this study was to evaluate whether chromium picolinate (CrPic) supplementation improves glucose regulation in overweight individuals with binge-eating disorder (BED). In this double-blinded randomized pilot trial, participants (N = 24) were randomized to high (HIGH, 1000 mcg/day, n = 8) or moderate (MOD, 600 mcg/day, n = 9) dose of CrPic or placebo (PL, n = 7) for 6 months. Participants completed an oral glucose tolerance test (OGTT) at baseline, 3 months, and 6 months. Fixed effects models were used to estimate mean change in glucose area under the curve (AUC), insulin AUC , and insulin sensitivity index (ISI). Results revealed a significant group and time interaction (p < 0.04) for glucose AUC , with glucose AUC increasing significantly in the PL group (p < 0.02) but decreasing significantly in the MOD group (p < 0.03) at 6 months. Insulin AUC increased significantly over time (main effect, p < 0.02), whereas ISI decreased significantly over time (main effect, p < 0.03). As anticipated, a moderate dose of CrPic was associated with improved glycemic control, whereas PL was associated with decreased glycemic control. It was unexpected that the improved glycemic control seen in the MOD dose group was not seen in the HIGH dose group. However, although participants randomized to the HIGH dose group did not have improved glycemic control, they had better glycemic control than participants randomized to the PL group. These findings support the need for larger trials.

  11. Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Gillis, Chelsia; Loiselle, Sarah-Eve; Fiore, Julio F; Awasthi, Rashami; Wykes, Linda; Liberman, A Sender; Stein, Barry; Charlebois, Patrick; Carli, Francesco

    2016-05-01

    A previous comprehensive prehabilitation program, providing nutrition counseling with whey protein supplementation, exercise, and psychological care, initiated 4 weeks before colorectal surgery for cancer, improved functional capacity before surgery and accelerated functional recovery. Those receiving standard of care deteriorated. The specific role of nutritional prehabilitation alone on functional recovery is unknown. This study was undertaken to estimate the impact of nutrition counseling with whey protein on preoperative functional walking capacity and recovery in patients undergoing colorectal resection for cancer. We conducted a double-blinded randomized controlled trial at a single university-affiliated tertiary center located in Montreal, Quebec, Canada. Colon cancer patients (n=48) awaiting elective surgery for nonmetastatic disease were randomized to receive either individualized nutrition counseling with whey protein supplementation to meet protein needs or individualized nutrition counseling with a nonnutritive placebo. Counseling and supplementation began 4 weeks before surgery and continued for 4 weeks after surgery. The primary outcome was change in functional walking capacity as measured with the 6-minute walk test. The distance was recorded at baseline, the day of surgery, and 4 weeks after surgery. A change of 20 m was considered clinically meaningful. The whey group experienced a mean improvement in functional walking capacity before surgery of +20.8 m, with a standard deviation of 42.6 m, and the placebo group improved by +1.2 (65.5) m (P=0.27). Four weeks after surgery, recovery rates were similar between groups (P=0.81). Clinically meaningful improvements in functional walking capacity were achieved before surgery with whey protein supplementation. These pilot results are encouraging and justify larger-scale trials to define the specific role of nutrition prehabilitation on functional recovery after surgery. Copyright © 2016 Academy of

  12. Aspirating and Nonaspirating Swallow Sounds in Children: A Pilot Study.

    Science.gov (United States)

    Frakking, Thuy; Chang, Anne; O'Grady, Kerry; David, Michael; Weir, Kelly

    2016-12-01

    Cervical auscultation (CA) may be used to complement feeding/swallowing evaluations when assessing for aspiration. There are no published pediatric studies that compare the properties of sounds between aspirating and nonaspirating swallows. To establish acoustic and perceptual profiles of aspirating and nonaspirating swallow sounds and determine if a difference exists between these 2 swallowing types. Aspiration sound clips were obtained from recordings using CA simultaneously undertaken with videofluoroscopic swallow study. Aspiration was determined using the Penetration-Aspiration Scale. The presence of perceptual swallow/breath parameters was rated by 2 speech pathologists who were blinded to the type of swallow. Acoustic data between groups were compared using Mann Whitney U-tests, while perceptual differences were determined by a test of 2 proportions. Combinations of perceptual parameters of 50 swallows (27 aspiration, 23 no aspiration) from 47 children (57% male) were statistically analyzed using area under a receiver operating characteristic (aROC), sensitivity, specificity, and positive and negative predictive values to determine predictors of aspirating swallows. The combination of post-swallow presence of wet breathing and wheeze and absence of GRS and normal breathing was the best predictor of aspiration (aROC = 0.82, 95% CI, 0.70-0.94). There were no significant differences between these 2 swallow types for peak frequency, duration, and peak amplitude. Our pilot study has shown that certain characteristics of swallow obtained using CA may be useful in the prediction of aspiration. However, further research comparing the acoustic swallowing sound profiles of normal children to children with dysphagia (who are aspirating) on a larger scale is required. © The Author(s) 2016.

  13. Pilot study of a three-step diagnostic pathway for young and old patients with Parkinson's disease dementia: screen, test and then diagnose.

    NARCIS (Netherlands)

    Robben, S.H.M.; Sleegers, M.J.; Dautzenberg, P.LJ.; Bergen, F.S. van; Bruggen, J.P.; Olde Rikkert, M.G.M.

    2010-01-01

    OBJECTIVE: To pilot a three-step diagnostic model for young and old patients with Parkinson's disease dementia (PDD). METHODS: Prospective investigator-blinded study. We developed a screening questionnaire for patients with Parkinson's disease (PD) and their caregivers. Further, patients were

  14. Climatotherapy in Japan: a pilot study

    Science.gov (United States)

    Kanayama, Hitomi; Kusaka, Yukinori; Hirai, Takayoshi; Inoue, Hiroyuki; Agishi, Yuko; Schuh, Angela

    2017-12-01

    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. Pilot plant study for ethanol production

    Energy Technology Data Exchange (ETDEWEB)

    Kim, J S [Korea Inst. of Science and Technology, Seoul (Korea, Republic of)

    1996-02-01

    Most of domestic alcohol fermentation factory adopt batch process of which productivity is lower than continuous fermentation process. They have made great effort to increase productivity by means of partial unit process automatization and process improvement with their accumulated experience but there is technical limitation in productivity of batch fermentation process. To produce and supply fuel alcohol, economic aspects must be considered first of all. Therefore, development of continuous fermentation process, of which productivity is high, is prerequisite to produce and use fuel alcohol but only a few foreign company possess continuous fermentation technic and use it in practical industrial scale fermentation. We constructed pilot plant (5 Stage CSTR 1 kl 99.5 v/v% ethanol/Day scale) to study some aspects stated below and our ultimate aims are production of industrial scale fuel alcohol and construction of the plant by ourselves. Some study concerned with energy saving separation and contamination control technic were entrusted to KAIST, A-ju university and KIST respectively. (author) 67 refs., 100 figs., 58 tabs.

  16. Setting a standard for electricity pilot studies

    International Nuclear Information System (INIS)

    Davis, Alexander L.; Krishnamurti, Tamar; Fischhoff, Baruch; Bruine de Bruin, Wandi

    2013-01-01

    In-home displays, dynamic pricing, and automated devices aim to reduce residential electricity use—overall and during peak hours. We present a meta-analysis of 32 studies of the impacts of these interventions, conducted in the US or Canada. We find that methodological problems are common in the design of these studies, leading to artificially inflated results relative to what one would expect if the interventions were implemented in the general population. Particular problems include having volunteer participants who may have been especially motivated to reduce their electricity use, letting participants choose their preferred intervention, and having high attrition rates. Using estimates of bias from medical clinical trials as a guide, we recalculate impact estimates to adjust for bias, resulting in values that are often less than half of those reported in the reviewed studies. We estimate that in-home displays were the most effective intervention for reducing overall electricity use (∼4% using reported data; ∼3% after adjusting for bias), while dynamic pricing significantly reduced peak demand (∼11% reported; ∼6% adjusted), especially when used in conjunction with home automation (∼25% reported; ∼14% adjusted). We conclude with recommendations that can improve pilot studies and the soundness of decisions based on their results. -- Highlights: •We conduct a meta-analysis of field studies of in-home displays, dynamic pricing, and automation on overall and peak use. •Studies were assessed and adjusted for risk-of-bias from inadequate experimental design. •Most studies were at high risk-of-bias from multiple sources. •In-home displays provided the best overall reduction in energy use, approximately 3% after adjustment for risk-of-bias. •Even after adjustment, automation approximately doubled the effectiveness of dynamic pricing on peak reduction from 6% to 14%

  17. Uranium-contaminated soil pilot treatment study

    International Nuclear Information System (INIS)

    Turney, W.R.J.R.; Mason, C.F.V.; Michelotti, R.A.

    1996-01-01

    A pilot treatment study is proving to be effective for the remediation of uranium-contaminated soil from a site at the Los Alamos National Laboratory by use of a two-step, zero-discharge, 100% recycle system. Candidate uranium-contaminated soils were characterized for uranium content, uranium speciation, organic content, size fractionization, and pH. Geochemical computer codes were used to forecast possible uranium leach scenarios. Uranium contamination was not homogenous throughout the soil. In the first step, following excavation, the soil was sorted by use of the ThemoNuclean Services segmented gate system. Following the sorting, uranium-contaminated soil was remediated in a containerized vat leach process by use of sodium-bicarbonate leach solution. Leach solution containing uranium-carbonate complexes is to be treated by use of ion-exchange media and then recycled. Following the treatment process the ion exchange media will be disposed of in an approved low-level radioactive landfill. It is anticipated that treated soils will meet Department of Energy site closure guidelines, and will be given open-quotes no further actionclose quotes status. Treated soils are to be returned to the excavation site. A volume reduction of contaminated soils will successfully be achieved by the treatment process. Cost of the treatment (per cubic meter) is comparable or less than other current popular methods of uranium-contamination remediation

  18. Are headache and temporomandibular disorders related? A blinded study.

    Science.gov (United States)

    Ballegaard, V; Thede-Schmidt-Hansen, P; Svensson, P; Jensen, R

    2008-08-01

    To investigate overlaps between headache and temporomandibular disorders (TMD) in a clinical headache population and to describe the prevalence of TMD in headache patients, 99 patients referred to a specialized headache centre were diagnosed according to Research Diagnostic Criteria for TMD (RDC/TMD) and classified in headache groups according to the International Classification of Headache Disorders, second edition for headache diagnoses in a blinded design. The prevalence of TMD in the headache population was 56.1%. Psychosocial dysfunction caused by TMD pain was observed in 40.4%. No significant differences in TMD prevalence were revealed between headache groups, although TMD prevalence tended to be higher in patients with combined migraine and tension-type headache. Moderate to severe depression was experienced by 54.5% of patients. Patients with coexistent TMD had a significantly higher prevalence of depression-most markedly in patients with combined migraine and tension-type headache. Our studies indicate that a high proportion of headache patients have significant disability because of ongoing chronic TMD pain. The trend to a higher prevalence of TMD in patients with combined migraine and tension-type headache suggests that this could be a risk factor for TMD development. A need for screening procedures and treatment strategies concerning depression in headache patients with coexistent TMD is underlined by the overrepresentation of depression in this group. Our findings emphasize the importance of examination of the masticatory system in headache sufferers and underline the necessity of a multidimensional approach in chronic headache patients.

  19. Topiramate for the management of methamphetamine dependence: a pilot randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Rezaei, Farzin; Ghaderi, Ebrahim; Mardani, Roya; Hamidi, Seiran; Hassanzadeh, Kambiz

    2016-06-01

    To date, no medication has been approved as an effective treatment for methamphetamine dependence. Topiramate has attracted considerable attention as a treatment for the dependence on alcohol and stimulants. Therefore, this study aimed to evaluate the effect of topiramate for methamphetamine dependence. This study was a double-blind, randomized, placebo-controlled trial. In the present investigation, 62 methamphetamine-dependent adults were enrolled and randomized into two groups, and received topiramate or a placebo for 10 weeks in escalating doses from 50 mg/day to the target maintenance dose of 200 mg/day. Addiction severity index (ASI) and craving scores were registered every week. The Beck questionnaire was also given to each participant at baseline and every 2 weeks during the treatment. Urine samples were collected at baseline and every 2 weeks during the treatment. Fifty-seven patients completed 10 weeks of the trial. There was no significant difference between both groups in the mean percentage of prescribed capsules taken by the participants. At week six, the topiramate group showed a significantly lower proportion of methamphetamine-positive urine tests in comparison with the placebo group (P = 0.01). In addition, there were significantly lower scores in the topiramate group in comparison with the placebo group in two domains of ASI: drug use severity (P methamphetamine dependence. © 2016 Société Française de Pharmacologie et de Thérapeutique.

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

    Science.gov (United States)

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

    2012-07-01

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

  1. The Citizenship Safety Project: a pilot study.

    Science.gov (United States)

    Frederick, K; Barlow, J

    2006-02-01

    The Government White Paper Saving Lives: Our Healthier Nation (1999) provides a clear indication that accidents are a serious public health problem and have been targeted by the Department of Health as a key area for prevention over the next 10 years. School-based injury prevention programmes have been identified as one of the key settings for the implementation of the White Paper's heath promotion strategies. The Citizen Safety Project (CSP) is a peer-delivered injury prevention programme for Year 10 students (14-15 years) and Year 2 pupils (6-7 years). This paper summarizes the findings of a pilot study that assessed the feasibility of implementing the CSP in schools and of conducting a larger study. Working as part of their Personal Social Health Education lessons, 11 pairs (n = 22) of Year 10 students developed a project to take one accident prevention theme of their choice into a primary school to teach small groups of five or six Year 2 pupils (n = 55). A formative evaluation was conducted, based on interviews with Year 2 and Year 10 teachers (n = 2), and the diaries of Year 10 students. Knowledge of accident prevention and risk awareness was measured in Year 2 pupils using the Draw and Write technique, and impact on Year 10 students was measured using self-esteem and locus of control inventories. Using both statistical and thematic analysis the study concludes that the CSP is well accepted, improves knowledge in Year 2 pupils and boosts confidence in Year 10 students, while concurrently achieving key stage attainment targets. Implications of the study are discussed in terms of future research, as are recommendations with regard to modifications to the project.

  2. Statin use and peripheral sensory perception: a pilot study.

    Science.gov (United States)

    West, Brenton; Williams, Cylie M; Jilbert, Elise; James, Alicia M; Haines, Terry P

    2014-06-01

    Peripheral sensory neuropathy is a neurological deficit resulting in decreased detection of sensation through the peripheral nervous system. Peripheral sensory neuropathy is commonly diagnosed with the use of a monofilament and either a tuning fork or neurothesiometer. Statins are a widely used medication and there has been some debate of association with their use and peripheral sensory neuropathy. This pilot study aimed to test the sensory perception of participants with long-term statin use and compare these results to their peers who were not taking statins. Thirty participants were recruited and equally divided into a statin and non-statin group. Healthy participants were screened by their medical and medication history, Australian Type 2 Diabetes Risk assessment, and random blood glucose level. An assessor who was blinded to the participant group conducted sensory assessments using a 10 g monofilament and neurothesiometer. There was no difference in monofilament testing results between the groups. The statin group was less sensate at the styloid process (p = 0.031) and medial malleolus (p = 0.003) than the control group. Results at the hallux were not statistically significant (p = 0.183). This result is suggestive of a potential association between long-term statin use and a decrease in peripheral sensory perception. This may be because of peripheral sensory neuropathy. Limitations such as consideration of participant height, participant numbers, and inability to analyze results against statin groups are reported. As statins are a life-saving medication, careful consideration should be applied to these results and further research be conducted to determine if these results are applicable to larger populations.

  3. Botulinum toxin in the treatment of orofacial tardive dyskinesia : A single blind study

    NARCIS (Netherlands)

    Slotema, Christina W.; van Harten, Peter N.; Bruggeman, Richard; Hoek, Hans W.

    2008-01-01

    Objective: Orofacial tardive dyskinesia (OTD) is difficult to treat and Botulinium Toxin A (BTA) may be an option. Methods: In a single blind (raters were blind) study (N= 12, duration 33 weeks) OTD was treated with Botulinum Toxin A in three consecutive sessions with increasing dosages. The

  4. Experiences from the ITRAP pilot study

    International Nuclear Information System (INIS)

    Schmitzer, C.; Beck, P.

    2001-01-01

    Illicit trafficking and inadvertent movement of nuclear and other radioactive materials is not a new phenomenon. However, concern about such activities has increased remarkably in the last decade. Although the number of such incidents has risen, the overall extent of the problem is not restricted to Europe and not to nuclear proliferation. A few percent of these incidents involve so-called 'special nuclear materials', which may be used for nuclear weapons and therefore cause a threat of nuclear proliferation. The vast majority of these incidents, however, involve radioactive sources, low-enriched, natural or depleted uranium, which are not usable for weapons. There have been instances in which loss of control over radioactive materials has led to serious, even fatal, consequences to persons. Examples include unintentional incorporation of radioactive materials into recycled steel, recovery of lost radioactive sources by unsuspecting individuals, and deliberate purloining of radioactive material. The ITRAP project - financed by the Austrian Government and executed by the Austrian Research Center in close cooperation with the IAEA, World Customs Organisation (WCO) and Interpol - aimed at finding international consensus on specifications for detection equipment and instrumentation as well as verification of such specifications in laboratory tests and field installations. Under the umbrella of the pilot study, 23 international companies participated in the study and many of them devised improvements of their monitoring equipment. An important element of this study was the harmonized establishment of detection thresholds for practical implementation at borders or similar checkpoints. However, equally important was the verification of agreed specifications in controlled laboratory conditions and in realistic operating environments (field tests). All crucial parameters, as inter alia the false alarm rate, were verified by a significant testing effort as compared to

  5. Collagenous sprue cross-sectional imaging: a comparative blinded study.

    Science.gov (United States)

    Al-Bawardy, Badr; Sheedy, Shannon P; Herberts, Michelle B; Murray, Joseph A; Rubio-Tapia, Alberto; Rajan, Elizabeth; Bruining, David H; Hansel, Stephanie L; Barlow, John M; Fletcher, Joel G; Fidler, Jeff L

    2017-02-01

    Collagenous sprue (CS) is a rare enteropathy characterized by villous atrophy and a thickened subepithelial collagen band. The aim of this study is to describe the cross-sectional imaging findings of CS. A case-control, retrospective study with cases of all CS patients from January 2000 to 2015 was performed. Inclusion criteria were (1) Histopathologic diagnosis and (2) Imaging with computed tomography abdomen/pelvis (CT A/P), CT enterography (CTE), or magnetic resonance enterography within 6 months of small bowel (SB) biopsy. Control subjects were irritable bowel syndrome (IBS) patients who underwent CTE. Imaging studies were examined by two GI radiologists, blinded to patient data. 108 patients (54 CS; 54 IBS) were included. Mean age was 56.7 ± 16.5 years, and 68% were female (72% in CS group vs. 63% in IBS group; p = 0.3). CS patients were significantly older (67 ± 12 vs. 47 ± 15 year; p reversal (46% vs. 6%; p < 0.001), SB dilation (28% vs. 0%; p < 0.001), SB conformational change (28% vs. 6%; p = 0.002), SB wall thickening (13% vs. 2%; p = 0.03), and ulcerative jejunoileitis (4% vs. 0%; p = 0.01). Radiologists suspected malabsorption in 72% in the CS group and 2% in the IBS group (p < 0.001). Imaging findings suggestive of mucosal malabsorption are commonly demonstrated in CS.

  6. ORIGINAL ARTICLE ORIG ORIGI A pilot study evaluating erect chest ...

    African Journals Online (AJOL)

    2009-11-19

    Nov 19, 2009 ... South African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases ... After obtaining consent from departmental and institutional ethics com- mittees, a pilot study ... informed consent from parents or legal guardians.

  7. Answering Fixed Response Items in Chemistry: A Pilot Study.

    Science.gov (United States)

    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)

  8. Pilot Study: Foam Wedge Chin Support Static Tolerance Testing

    Science.gov (United States)

    2017-10-24

    AFRL-SA-WP-SR-2017-0026 Pilot Study: Foam Wedge Chin Support Static Tolerance Testing Austin M. Fischer, BS1; William W...COVERED (From – To) April – October 2017 4. TITLE AND SUBTITLE Pilot Study: Foam Wedge Chin Support Static Tolerance Testing 5a. CONTRACT NUMBER...PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) USAF School of Aerospace

  9. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study.

    Directory of Open Access Journals (Sweden)

    Lynne Shinto

    Full Text Available Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS. Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30. Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months.ClinicalTrials.gov NCT00122954.

  10. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    Bom, T. van der; Winter, M.M.; Bouma, B.J.; Groenink, M.; Vliegen, H.W.; Pieper, P.G.; Dijk, A.P.J. van; Sieswerda, G.T.; Roos-Hesselink, J.W.; Zwinderman, A.H.; Mulder, B.J.

    2013-01-01

    BACKGROUND: The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. METHODS AND RESULTS: We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  11. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a

  12. Effect of Valsartan on Systemic Right Ventricular Function A Double-Blind, Randomized, Placebo-Controlled Pilot Trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    Background-The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. Methods and Results-We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  13. Aspartame sensitivity? A double blind randomised crossover study.

    Directory of Open Access Journals (Sweden)

    Thozhukat Sathyapalan

    Full Text Available Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008 and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04, reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that

  14. Aspartame sensitivity? A double blind randomised crossover study.

    Science.gov (United States)

    Sathyapalan, Thozhukat; Thatcher, Natalie J; Hammersley, Richard; Rigby, Alan S; Courts, Fraser L; Pechlivanis, Alexandros; Gooderham, Nigel J; Holmes, Elaine; le Roux, Carel W; Atkin, Stephen L

    2015-01-01

    Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg)-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics. Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008) and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04), reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects. Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of

  15. A Double-Blind Randomized Controlled Pilot Trial of N-Acetylcysteine in Veterans with PTSD and Substance Use Disorders

    Science.gov (United States)

    Back, Sudie E.; McCauley, Jenna L.; Korte, Kristina J.; Gros, Daniel F.; Leavitt, Virginia; Gray, Kevin M.; Hamner, Mark B.; DeSantis, Stacia M.; Malcolm, Robert; Brady, Kathleen T.; Kalivas, Peter W.

    2016-01-01

    Objective The antioxidant N-Acetylcysteine (NAC) is being increasingly investigated as a therapeutic agent in the treatment of substance use disorders. Preclinical and clinical findings suggest that NAC normalizes extracellular glutamate by restoring the activity of glutamate transporters and antiporters in the nucleus accumbens. This study explored the efficacy of NAC in the treatment of post-traumatic stress disorder (PTSD), which frequently co-occurs with substance use disorders (SUD) and shares impaired prefrontal cortex regulation of basal ganglia circuitry, in particular at glutamate synapses in the nucleus accumbens. Method Veterans with current PTSD and SUD (N=35) were randomly assigned to receive a double-blind, 8-week course of NAC (2400 mg/day) or placebo plus outpatient group cognitive-behavioral therapy for SUD. Primary outcome measures included PTSD symptoms (Clinician Administered PTSD Scale, PTSD Checklist-Military) and craving (Visual Analogue Scale). Depression (Beck Depression Inventory-II) and substance use (Timeline Follow Back, urine drug screens) were also assessed. Results Participants treated with NAC, as compared to placebo, evidenced significant improvements in PTSD symptoms, craving, and depression. Substance use at the start of treatment was low for both the NAC and placebo groups and no significant between-group differences were observed. NAC was well tolerated and retention was high. Conclusions This is the first randomized controlled trial to investigate NAC as a pharmacological treatment for PTSD. The findings show a significant treatment effect on symptoms of PTSD and drug craving, and provide initial support for the use of NAC in combination with cognitive-behavioral therapy among individuals with co-occurring PTSD and SUD. PMID:27736051

  16. SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

    Science.gov (United States)

    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 ...

  17. Cardiac Auscultation Using Smartphones: Pilot Study.

    Science.gov (United States)

    Kang, Si-Hyuck; Joe, Byunggill; Yoon, Yeonyee; Cho, Goo-Yeong; Shin, Insik; Suh, Jung-Won

    2018-02-28

    Cardiac auscultation is a cost-effective, noninvasive screening tool that can provide information about cardiovascular hemodynamics and disease. However, with advances in imaging and laboratory tests, the importance of cardiac auscultation is less appreciated in clinical practice. The widespread use of smartphones provides opportunities for nonmedical expert users to perform self-examination before hospital visits. The objective of our study was to assess the feasibility of cardiac auscultation using smartphones with no add-on devices for use at the prehospital stage. We performed a pilot study of patients with normal and pathologic heart sounds. Heart sounds were recorded on the skin of the chest wall using 3 smartphones: the Samsung Galaxy S5 and Galaxy S6, and the LG G3. Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks. We assessed diagnostic accuracy, as well as sensitivity, specificity, and predictive values. A total of 46 participants underwent heart sound recording. After audio file processing, 30 of 46 (65%) heart sounds were proven interpretable. Atrial fibrillation and diastolic murmur were significantly associated with failure to acquire interpretable heart sounds. The diagnostic algorithm classified the heart sounds into the correct category with high accuracy: Galaxy S5, 90% (95% CI 73%-98%); Galaxy S6, 87% (95% CI 69%-96%); and LG G3, 90% (95% CI 73%-98%). Sensitivity, specificity, positive predictive value, and negative predictive value were also acceptable for the 3 devices. Cardiac auscultation using smartphones was feasible. Discrimination using convolutional neural networks yielded high diagnostic accuracy. However, using the built-in microphones alone, the acquisition of reproducible and interpretable heart sounds was still a major challenge. ClinicalTrials.gov NCT03273803; https://clinicaltrials.gov/ct2/show/NCT03273803 (Archived by WebCite at http://www.webcitation.org/6x6g1f

  18. Foreground-background segmentation and attention: a change blindness study.

    Science.gov (United States)

    Mazza, Veronica; Turatto, Massimo; Umiltà, Carlo

    2005-01-01

    One of the most debated questions in visual attention research is what factors affect the deployment of attention in the visual scene? Segmentation processes are influential factors, providing candidate objects for further attentional selection, and the relevant literature has concentrated on how figure-ground segmentation mechanisms influence visual attention. However, another crucial process, namely foreground-background segmentation, seems to have been neglected. By using a change blindness paradigm, we explored whether attention is preferentially allocated to the foreground elements or to the background ones. The results indicated that unless attention was voluntarily deployed to the background, large changes in the color of its elements remained unnoticed. In contrast, minor changes in the foreground elements were promptly reported. Differences in change blindness between the two regions of the display indicate that attention is, by default, biased toward the foreground elements. This also supports the phenomenal observations made by Gestaltists, who demonstrated the greater salience of the foreground than the background.

  19. A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

    Science.gov (United States)

    Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

    2015-07-01

    Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

  20. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and

  1. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Bertrand, Helene; Kyriazis, Marylene; Reeves, K Dean; Lyftogt, John; Rabago, David

    2015-11-01

    Capsaicin specifically activates, and then gradually exhausts, the transient receptor potential vanilloid type 1 (TRPV1) receptor, a key receptor in neuropathic pain. Activation of the TRPV-1 receptor is accompanied by burning pain. A natural substance or medication that can reduce the burning pain resulting from capsaicin application may have therapeutic potential in neuropathic pain. To assess the pain-relieving effects of a mannitol-containing cream in a capsaicin-based pain model. Randomized, placebo-controlled, double-blind clinical trial. Outpatient pain clinic. Twenty-five adults with pain-free lips. Capsaicin .075% cream was applied to both halves of each participant's upper lip, inducing pain via stimulation of the transient receptor potential vanilloid 1 (TRPV1, capsaicin) receptor, then removed after 5 minutes or when participants reported a burning pain of 8/10, whichever came first. A cream containing mannitol and the same cream without mannitol (control) were then immediately applied, 1 on each side of the lip, in an allocation-masked manner. Participants self-recorded a numeric rating scale (NRS, 0-10) pain score for each side of the lip per minute for 10 minutes. A t-test was performed to evaluate the pain score change from baseline between each side of the lip at each recording. Area under the curve (AUC) analysis was used to determine the overall difference between groups. Participants reached a capsaicin-induced pain level of 7.8 ± 1.0 points in 3.3 ± 1.6 minutes that was equal on both sides of the lip. Both groups reported progressive diminution of pain over the 10-minute study period. However, participants reported significantly reduced pain scores on the mannitol cream half-lip compared to control at 3 through 10 minutes (P < .05) and in AUC analysis (P < .001). Mannitol cream reduced self-reported pain scores in a capsaicin pain model more rapidly than a control cream, potentially via a TRPV1 receptor effect. Copyright © 2015 American

  2. A double blinded, placebo-controlled pilot study to examine reduction of CD34+/CD117+/CD133+ lymphoma progenitor cells and duration of remission induced by neoadjuvant valspodar in dogs with large B-cell lymphoma [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Daisuke Ito

    2017-02-01

    Full Text Available We previously described a population of lymphoid progenitor cells (LPCs in canine B-cell lymphoma defined by retention of the early progenitor markers CD34 and CD117 and “slow proliferation” molecular signatures that persist in the xenotransplantation setting. We examined whether valspodar, a selective inhibitor of the ATP binding cassette B1 transporter (ABCB1, a.k.a., p-glycoprotein/multidrug resistance protein-1 used in the neoadjuvant setting would sensitize LPCs to doxorubicin and extend the length of remission in dogs with therapy naïve large B-cell lymphoma. Twenty dogs were enrolled into a double-blinded, placebo controlled study where experimental and control groups received oral valspodar (7.5 mg/kg or placebo, respectively, twice daily for five days followed by five treatments with doxorubicin 21 days apart with a reduction in the first dose to mitigate the potential side effects of ABCB1 inhibition. Lymph node and blood LPCs were quantified at diagnosis, on the fourth day of neoadjuvant period, and 1-week after the first chemotherapy dose. Valspodar therapy was well tolerated. There were no differences between groups in total LPCs in lymph nodes or peripheral blood, nor in event-free survival or overall survival. Overall, we conclude that valspodar can be administered safely in the neoadjuvant setting for canine B-cell lymphoma; however, its use to attenuate ABCB1+ cells does not alter the composition of lymph node or blood LPCs, and it does not appear to be sufficient to prolong doxorubicin-dependent remissions in this setting.

  3. A double blinded, placebo-controlled pilot study to examine reduction of CD34+/CD117+/CD133+ lymphoma progenitor cells and duration of remission induced by neoadjuvant valspodar in dogs with large B-cell lymphoma [version 3; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Daisuke Ito

    2017-04-01

    Full Text Available We previously described a population of lymphoid progenitor cells (LPCs in canine B-cell lymphoma defined by retention of the early progenitor markers CD34 and CD117 and “slow proliferation” molecular signatures that persist in the xenotransplantation setting. We examined whether valspodar, a selective inhibitor of the ATP binding cassette B1 transporter (ABCB1, a.k.a., p-glycoprotein/multidrug resistance protein-1 used in the neoadjuvant setting would sensitize LPCs to doxorubicin and extend the length of remission in dogs with therapy naïve large B-cell lymphoma. Twenty dogs were enrolled into a double-blinded, placebo controlled study where experimental and control groups received oral valspodar (7.5 mg/kg or placebo, respectively, twice daily for five days followed by five treatments with doxorubicin 21 days apart with a reduction in the first dose to mitigate the potential side effects of ABCB1 inhibition. Lymph node and blood LPCs were quantified at diagnosis, on the fourth day of neoadjuvant period, and 1-week after the first chemotherapy dose. Valspodar therapy was well tolerated. There were no differences between groups in total LPCs in lymph nodes or peripheral blood, nor in event-free survival or overall survival. Overall, we conclude that valspodar can be administered safely in the neoadjuvant setting for canine B-cell lymphoma; however, its use to attenuate ABCB1+ cells does not alter the composition of lymph node or blood LPCs, and it does not appear to be sufficient to prolong doxorubicin-dependent remissions in this setting.

  4. ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design.

    Science.gov (United States)

    Manini, Todd M; Anton, Stephen D; Beavers, Daniel P; Cauley, Jane A; Espeland, Mark A; Fielding, Roger A; Kritchevsky, Stephen B; Leeuwenburgh, Christiaan; Lewis, Kristina H; Liu, Christine; McDermott, Mary M; Miller, Michael E; Tracy, Russell P; Walston, Jeremy D; Radziszewska, Barbara; Lu, Jane; Stowe, Cindy; Wu, Samuel; Newman, Anne B; Ambrosius, Walter T; Pahor, Marco

    2017-09-01

    To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults. The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels. Five university-based research centers. Target enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk. Participants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3. IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured. Results from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial. The ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  5. A mixed method pilot study: the researchers' experiences.

    Science.gov (United States)

    Secomb, Jacinta M; Smith, Colleen

    2011-08-01

    This paper reports on the outcomes of a small well designed pilot study. Pilot studies often disseminate limited or statistically meaningless results without adding to the body knowledge on the comparative research benefits. The design a pre-test post-test group parallel randomised control trial and inductive content analysis of focus group transcripts was tested specifically to increase outcomes in a proposed larger study. Strategies are now in place to overcome operational barriers and recruitment difficulties. Links between the qualitative and quantitative arms of the proposed larger study have been made; it is anticipated that this will add depth to the final report. More extensive reporting on the outcomes of pilot studies would assist researchers and increase the body of knowledge in this area.

  6. The benefits of hypopharyngeal packing in nasal surgery: a pilot study.

    LENUS (Irish Health Repository)

    Fennessy, B G

    2012-02-01

    BACKGROUND: Hypopharyngeal packs are used in nasal surgery to reduce the risk of aspiration and postoperative nausea and vomiting. Side effects associated with their use range from throat pain to retained packs postoperatively. AIM: To evaluate, as a pilot study, postoperative nausea\\/vomiting and throat pain scores for patients undergoing nasal surgery in whom a wet or dry hypopharyngeal pack was placed compared with patients who received no packing. METHODS: A randomized, double-blind prospective trial in a general ENT unit. RESULTS: The study failed to show a statistically significant difference between the three groups in terms of their postoperative nausea\\/vomiting and throat pain scores at 2 and 6 h postoperatively. This is the first study in which dry packs have been compared with wet and absent packs. CONCLUSION: Based on our findings, the authors recommend against placing hypopharyngeal packs for the purpose of preventing postoperative nausea and vomiting.

  7. A Pilot Randomized, Single Blind, Placebo-Controlled Trial of Traditional Acupuncture for Vasomotor Symptoms and Mechanistic Pathways of Menopause

    Science.gov (United States)

    Painovich, Jeannette M.; Shufelt, Chrisandra L.; Azziz, Ricardo; Yang, Yuching; Goodarzi, Mark O.; Braunstein, Glenn D.; Karlan, Beth Y.; Stewart, Paul M.; Merz, C. Noel Bairey

    2011-01-01

    Objective To conduct a pilot study for feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) to sham acupuncture (SA) and waiting control (WC) on menopause related vasomotor symptoms (VMS), quality of life (QOL), and the hypothalamic-pituitary-adrenal (HPA) axis in peri and post-menopausal women. Methods Thirty-three peri and post-menopausal women with at least 7 VMS daily were randomized to TA, SA or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, MENQOL questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24 hour urine cortisol and metabolites, and ACTH stimulation testing. Results Both TA and SA groups demonstrated improved VMS trends compared to WC (Δ −3.5±3.00 vs. −4.1±3.79 vs. −1.2±2.4, respectively, p=.20), and significantly improved MENQOL vasomotor scores (Δ − 1.5±2.02 vs. −1.8±1.52 vs. 0.3±0.64, respectively, p=.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA vs the SA or WC in total cortisol metabolites (4,658.9±1,670.9 vs 7,735.8±3,747.9 vs 5,166.0±2,234.5, p=0.03, respectively) and DHEA (41.4±27.46, 161.2±222.77, 252.4±385.40, respectively, p=0.05). The ACTH stimulation cortisol response data also trended in the hypothesized direction (p=0.17). Conclusion Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared to WC; however, TA alone may impact the HPA axis. This association is viewed as preliminary and hypothesis-generating and should be explored in a large clinical trial. PMID:21968279

  8. A comparative study of simple auditory reaction time in blind (congenitally) and sighted subjects.

    Science.gov (United States)

    Gandhi, Pritesh Hariprasad; Gokhale, Pradnya A; Mehta, H B; Shah, C J

    2013-07-01

    Reaction time is the time interval between the application of a stimulus and the appearance of appropriate voluntary response by a subject. It involves stimulus processing, decision making, and response programming. Reaction time study has been popular due to their implication in sports physiology. Reaction time has been widely studied as its practical implications may be of great consequence e.g., a slower than normal reaction time while driving can have grave results. To study simple auditory reaction time in congenitally blind subjects and in age sex matched sighted subjects. To compare the simple auditory reaction time between congenitally blind subjects and healthy control subjects. STUDY HAD BEEN CARRIED OUT IN TWO GROUPS: The 1(st) of 50 congenitally blind subjects and 2(nd) group comprises of 50 healthy controls. It was carried out on Multiple Choice Reaction Time Apparatus, Inco Ambala Ltd. (Accuracy±0.001 s) in a sitting position at Government Medical College and Hospital, Bhavnagar and at a Blind School, PNR campus, Bhavnagar, Gujarat, India. Simple auditory reaction time response with four different type of sound (horn, bell, ring, and whistle) was recorded in both groups. According to our study, there is no significant different in reaction time between congenital blind and normal healthy persons. Blind individuals commonly utilize tactual and auditory cues for information and orientation and they reliance on touch and audition, together with more practice in using these modalities to guide behavior, is often reflected in better performance of blind relative to sighted participants in tactile or auditory discrimination tasks, but there is not any difference in reaction time between congenitally blind and sighted people.

  9. Evaluation of efficacy of metoprolol in patients having heart failure with preserved ejection fraction: A randomized, double-blind, placebo-controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Niti Mittal

    2017-01-01

    Conclusion: Hence, this pilot study showed that metoprolol succinate possibly has some beneficial role in HFpEF as reflected by improvement in some parameters. The findings highlight the need of a larger study with longer follow-up to provide a definitive answer.

  10. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

    Science.gov (United States)

    Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

    2016-12-15

    The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

  11. 77 FR 12312 - Electronic Submission of Nonclinical Study Data; Notice of Pilot Project

    Science.gov (United States)

    2012-02-29

    ...] Electronic Submission of Nonclinical Study Data; Notice of Pilot Project AGENCY: Food and Drug Administration... and Research (CBER) is announcing an invitation to participate in a pilot evaluation program to test.... Participation in the pilot program is open to all sponsors. The pilot program is intended to provide industry...

  12. Pilot studies: one swallow does not make a summer... Editorial

    NARCIS (Netherlands)

    Gelder, T. van; Smits, P.

    2003-01-01

    What should we expect from pilot studies, done in small series of patients? In the literature there are many examples of small studies with very promising results, that in subsequent larger or better controlled studies proved to be much less promising, or even disastrous. In some instances the

  13. Pilot study approach and qualification dossier components

    International Nuclear Information System (INIS)

    Ammirato, F.; Ashwin, P.

    2000-01-01

    The aim of the Pilot Project is to evaluate the IAEA Guidelines and methodology for the benefit of IAEA Member States trough a simulation of qualification activities. The Project is based on a real component and available data - NPP Kozloduy unit 5, weld 3. The initial phase is limited to the Qualification dossier. The Project relies on the input from the team members and Member States. Team organization and responsibilities are presented. The components of the Qualification Dossier (technical specification, inspection procedure and preliminary review, qualification procedure) and their current status are also presented. A comparison is done with their qualification programs. The characteristics of performance demonstrations are discussed. The results show that the teamwork has been successful and the IAEA methodology covers all situations. It is expected that the End Project will become 'Benchmark's' for future qualification activities

  14. Effect of a steam foot spa on geriatric inpatients with cognitive impairment: a pilot study

    Science.gov (United States)

    Koike, Yoshihisa; Kondo, Hideki; Kondo, Satoshi; Takagi, Masayuki; Kano, Yoshio

    2013-01-01

    Purpose To investigate whether a steam foot spa improves cognitive impairment in geriatric inpatients. Methods Geriatric inpatients with cognitive impairment were given a steam foot spa treatment at 42°C for 20 minutes for 2 weeks (5 days/week). Physiological indicators such as blood pressure, percutaneous oxygen saturation, pulse, tympanic temperature, and sleep time and efficiency were assessed. Cognitive function and behavioral and psychological symptoms of dementia were assessed using the Mini-Mental State Examination, Dementia Mood Assessment Scale, and Dementia Behavior Disturbance scale. Results Significant decreases in systolic (P steam foot spas. A significant improvement was seen in the Mini-Mental State Examination score (P steam foot baths. In this study, a control group was not used. Raters and enforcers were not blinded. Conclusion The results of this pilot study suggest that steam foot spas mitigate cognitive impairment in geriatric inpatients. PMID:23717038

  15. Aesthetics of movement with sight disabled children - pilot study

    Directory of Open Access Journals (Sweden)

    Mirosław Górny

    2010-01-01

    Full Text Available The aim of the study was to establish the aesthetics of movement in people with vision defects. This knowledge will provide tools to improve the methodology of study in the area of assessment of movement aesthetics in people with disabilities. In order to establish its level a test was used which measured its selected elements such as precision, rhythm, harmony, fluidity and speed. The aesthetics of movement was assessed using exercise tests which were to represent the components of aesthetics of movement. Individual tests were carried out on blind and partially sighted children aged 6 to 15 years and on a group of healthy children of the same age. Using the test tasks a general indicator of movement aesthetics in blind children was obtained. The participants of the study were 145 children from four School and Education Centres for Blind Children in Poland and the control group consisted of 310 children from a primary school in Poznań. The studies confirmed a lower level of movement aesthetics in children with vision defects, but the differences in groups between the partially sighted children and children with correct vision were definitely smaller. A higher level of aesthetics of movement characterised children from older groups irrespective of their sex. The best developed property in blind and partially sighted children was precision.

  16. Prevalence and causes of low vision and blindness in an urban population: The Chennai Glaucoma Study.

    Science.gov (United States)

    Vijaya, Lingam; George, Ronnie; Asokan, Rashima; Velumuri, Lokapavani; Ramesh, Sathyamangalam Ve

    2014-04-01

    To evaluate the prevalence and causes of low vision and blindness in an urban south Indian population. Population-based cross-sectional study. Exactly 3850 subjects aged 40 years and above from Chennai city were examined at a dedicated facility in the base hospital. All subjects had a complete ophthalmic examination that included best-corrected visual acuity. Low vision and blindness were defined using World Health Organization (WHO) criteria. The influence of age, gender, literacy, and occupation was assessed using multiple logistic regression. Chi-square test, t-test, and multivariate analysis were used. Of the 4800 enumerated subjects, 3850 subjects (1710 males, 2140 females) were examined (response rate, 80.2%). The prevalence of blindness was 0.85% (95% CI 0.6-1.1%) and was positively associated with age and illiteracy. Cataract was the leading cause (57.6%) and glaucoma was the second cause (16.7%) for blindness. The prevalence of low vision was 2.9% (95% CI 2.4-3.4%) and visual impairment (blindness + low vision) was 3.8% (95% CI 3.2-4.4%). The primary causes for low vision were refractive errors (68%) and cataract (22%). In this urban population based study, cataract was the leading cause for blindness and refractive error was the main reason for low vision.

  17. Prevalence and causes of low vision and blindness in an urban population: The Chennai Glaucoma Study

    Directory of Open Access Journals (Sweden)

    Lingam Vijaya

    2014-01-01

    Full Text Available Aim: To evaluate the prevalence and causes of low vision and blindness in an urban south Indian population. Settings and Design: Population-based cross-sectional study. Exactly 3850 subjects aged 40 years and above from Chennai city were examined at a dedicated facility in the base hospital. Materials and Methods: All subjects had a complete ophthalmic examination that included best-corrected visual acuity. Low vision and blindness were defined using World Health Organization (WHO criteria. The influence of age, gender, literacy, and occupation was assessed using multiple logistic regression. Statistical Analysis: Chi-square test, t-test, and multivariate analysis were used. Results: Of the 4800 enumerated subjects, 3850 subjects (1710 males, 2140 females were examined (response rate, 80.2%. The prevalence of blindness was 0.85% (95% CI 0.6-1.1% and was positively associated with age and illiteracy. Cataract was the leading cause (57.6% and glaucoma was the second cause (16.7% for blindness. The prevalence of low vision was 2.9% (95% CI 2.4-3.4% and visual impairment (blindness + low vision was 3.8% (95% CI 3.2-4.4%. The primary causes for low vision were refractive errors (68% and cataract (22%. Conclusions: In this urban population based study, cataract was the leading cause for blindness and refractive error was the main reason for low vision.

  18. Prevalence and causes of low vision and blindness in an urban population: The Chennai Glaucoma Study

    Science.gov (United States)

    Vijaya, Lingam; George, Ronnie; Asokan, Rashima; Velumuri, Lokapavani; Ramesh, Sathyamangalam Ve

    2014-01-01

    Aim: To evaluate the prevalence and causes of low vision and blindness in an urban south Indian population. Settings and Design: Population-based cross-sectional study. Exactly 3850 subjects aged 40 years and above from Chennai city were examined at a dedicated facility in the base hospital. Materials and Methods: All subjects had a complete ophthalmic examination that included best-corrected visual acuity. Low vision and blindness were defined using World Health Organization (WHO) criteria. The influence of age, gender, literacy, and occupation was assessed using multiple logistic regression. Statistical Analysis: Chi-square test, t-test, and multivariate analysis were used. Results: Of the 4800 enumerated subjects, 3850 subjects (1710 males, 2140 females) were examined (response rate, 80.2%). The prevalence of blindness was 0.85% (95% CI 0.6–1.1%) and was positively associated with age and illiteracy. Cataract was the leading cause (57.6%) and glaucoma was the second cause (16.7%) for blindness. The prevalence of low vision was 2.9% (95% CI 2.4–3.4%) and visual impairment (blindness + low vision) was 3.8% (95% CI 3.2–4.4%). The primary causes for low vision were refractive errors (68%) and cataract (22%). Conclusions: In this urban population based study, cataract was the leading cause for blindness and refractive error was the main reason for low vision. PMID:23619490

  19. Attitudes Toward Guarani and Spanish: A Pilot Study in Paraguay.

    Science.gov (United States)

    Rhodes, Nancy C.

    This study analyzes the language attitudes of the Paraguayan people toward their two languages, Guarani and Spanish. To study the bilingual situation in the South American country, a pilot survey was carried out in the capital city addressing the major topics of language attitudes, language usage, and language varieties. The goals of the survey…

  20. Technical Writing Redesign and Assessment: A Pilot Study

    Science.gov (United States)

    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…

  1. Indonesian EFL Students' Perspective on Writing Process: A Pilot Study

    Science.gov (United States)

    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…

  2. Forces exerted by jumping children: A pilot study

    NARCIS (Netherlands)

    Moes, C.C.M.; Bakker, H.E.

    1998-01-01

    This article reports on a pilot study of the loads exerted vertically by children when jumping. The subjects of the study were 17 children, aged from two to twelve years. Measurements were made using video recordings and a force-plate. The influence of the stiffness of the base and of jumping with

  3. Clean indoor air increases physical independence : a pilot study

    NARCIS (Netherlands)

    Snijders, M.C.L.; Koren, L.G.H.; Kort, H.S.M.; Bronswijk, van J.E.M.H.

    2001-01-01

    Clean indoor air enhances health. In a pilot study, we examined whether a good indoor air quality increases the activity potential of older persons with chronic lung disease. Five older persons were studied while performing kitchen activities. Body movement and heart rate were monitored.

  4. Motivation and Performance of Older Australian Academics: A Pilot Study.

    Science.gov (United States)

    Little, Len; Peter, Hollis

    A pilot study of the Australian higher education system was conducted to determine the following: (1) whether department heads follow a client-centered, diagnostic/prescriptive model as developed by the Australian Committee of Directors and Principals in Advanced Education (ACDP), and if not, which process is used; (2) which developmental…

  5. Effects of aquajogging in obese adults : A pilot study

    NARCIS (Netherlands)

    Wouters, E.J.M.; van Nunen, A.M.A.; Geenen, R.; Kolotkin, R.L.; Vingerhoets, A.J.J.M.

    2010-01-01

    Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat

  6. Causes of Mortality among American College Students: A Pilot Study

    Science.gov (United States)

    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…

  7. Assessing the Flipped Classroom in Operations Management: A Pilot Study

    Science.gov (United States)

    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. Feasibility of the Dutch ICF Activity Inventory: a pilot study

    NARCIS (Netherlands)

    Bruijning, J.E.; van Nispen, R.M.A.; van Rens, G.H.M.B.

    2010-01-01

    Background. Demographic ageing will lead to increasing pressure on visual rehabilitation services, which need to be efficiently organised in the near future. The Dutch ICF Activity Inventory (D-AI) was developed to assess the rehabilitation needs of visually impaired persons. This pilot study tests

  9. Outcome evaluation of a pilot study using "nudges"

    Science.gov (United States)

    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...

  10. Classifying patients' complaints for regulatory purposes : A Pilot Study

    NARCIS (Netherlands)

    Bouwman, R.J.R.; Bomhoff, Manja; Robben, Paul; Friele, R.D.

    2018-01-01

    Objectives: It is assumed that classifying and aggregated reporting of patients' complaints by regulators helps to identify problem areas, to respond better to patients and increase public accountability. This pilot study addresses what a classification of complaints in a regulatory setting

  11. Consumer Understanding of Nutrition Marketing Terms: A Pilot Study

    Science.gov (United States)

    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…

  12. Effects of aquajogging in obese adults: a pilot study

    NARCIS (Netherlands)

    PhD Ronette Kolotkin; MSc Annemieke van Nunen; PhD Rinie Geenen; PhD Ad Vingerhoets; MD E.J.M. Wouters

    2009-01-01

    Aim and method: To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results: Total fat mass

  13. Can Markers Detect Contract Cheating? Results from a Pilot Study

    Science.gov (United States)

    Dawson, Phillip; Sutherland-Smith, Wendy

    2018-01-01

    Contract cheating is the purchasing of custom-made university assignments with the intention of submitting them. Websites providing contract cheating services often claim this form of cheating is undetectable, and no published research has examined this claim. This paper documents a pilot study where markers were paid to mark a mixture of real…

  14. Critical Thinking in Nurse Anesthesia Education: A Pilot Study

    Science.gov (United States)

    Burns, Shari; Mendel, Shaun; Fisher, Rodney; Cooper, Kimball; Fisher, Michael

    2013-01-01

    Critical thinking is pivotal for student success in health professions education. Knowing the critical thinking ability of the learner helps educators tailor curriculum to enhance critical thinking. A quantitative comparative pilot study assessed critical thinking ability for students at two distinct points in a nurse anesthesia program…

  15. Physical activity in Georgia state parks: A pilot study

    Science.gov (United States)

    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).

  16. Transferring manual ultrasonic inspection procedures - results of a pilot study

    International Nuclear Information System (INIS)

    Anderson, M.; Taylor, T.; Kadenko, I.

    2002-01-01

    Results of a manual ultrasonic pilot study for NDE specialists at RBMK nuclear reactor sites are presented. Probabilities of detection and false calls, using two different grading criteria, are estimated. Analyses of performance parameters lead to conclusions regarding attributes for improved test discrimination capabilities. (orig.)

  17. Application of digital human modeling and simulation for vision analysis of pilots in a jet aircraft: a case study.

    Science.gov (United States)

    Karmakar, Sougata; Pal, Madhu Sudan; Majumdar, Deepti; Majumdar, Dhurjati

    2012-01-01

    Ergonomic evaluation of visual demands becomes crucial for the operators/users when rapid decision making is needed under extreme time constraint like navigation task of jet aircraft. Research reported here comprises ergonomic evaluation of pilot's vision in a jet aircraft in virtual environment to demonstrate how vision analysis tools of digital human modeling software can be used effectively for such study. Three (03) dynamic digital pilot models, representative of smallest, average and largest Indian pilot population were generated from anthropometric database and interfaced with digital prototype of the cockpit in Jack software for analysis of vision within and outside the cockpit. Vision analysis tools like view cones, eye view windows, blind spot area, obscuration zone, reflection zone etc. were employed during evaluation of visual fields. Vision analysis tool was also used for studying kinematic changes of pilot's body joints during simulated gazing activity. From present study, it can be concluded that vision analysis tool of digital human modeling software was found very effective in evaluation of position and alignment of different displays and controls in the workstation based upon their priorities within the visual fields and anthropometry of the targeted users, long before the development of its physical prototype.

  18. Change-readiness of the blind: a hospital based study in a coastal town of South India.

    Science.gov (United States)

    Shetty, Ramya; Kulkarni, Uma D

    2014-01-01

    Blindness is a devastating condition with psychosocial and economic effects. The shortcomings result in a burden to the blind person, the family and society. Rehabilitation of the blind can transform their lives. The aim of this study was to assess the "change-readiness" of the blind to undergo a "change-management". The study was a semi-structured pre-tested questionnaire-based study of 50 blind subjects in a medical college hospital. The blind participants were assessed for depression using the Beck Depression Inventory II, for the perceived effect of blindness on family, social life and occupation. The participants were counseled to undergo psychiatric management, vocational training, use blind aids and learn Braille. The willingness of the participants with reasons was assessed using a verbal analogue scale. Pearson Chi-square test, ANOVA and the t-test were used for statistical analysis. Over two-thirds of the subjects were depressed. Family life, social life and occupation were perceived to be affected by 44%, 66% and 74%, respectively. Change-readiness scores were low for low vision and blind aids, vocational training, psychiatric management, change of job and learning Braille. The low score was due to the associated taboo, dependence, lack of skills, embarrassment, etc., The most valuable feature was the family cohesiveness. The results suggest that there is a need to modify health policy to include blind rehabilitation, to improve visibility of blind rehabilitation centers, to include family members and co-professionals while managing the blind so that we treat the "blind person" and not a "pair of blind eyes".

  19. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial.

    Science.gov (United States)

    Ferraz, Daniel Dominguez; Trippo, Karen Valadares; Duarte, Gabriel Pereira; Neto, Mansueto Gomes; Bernardes Santos, Kionna Oliveira; Filho, Jamary Oliveira

    2018-05-01

    To compare the effects of functional training, bicycle exercise, and exergaming on walking capacity of elderly with Parkinson disease (PD). A pilot randomized, controlled, single-blinded trial. A state reference health care center for elderly, a public reference outpatient clinic for the elderly. Elderly individuals (≥60 years of age; N=62) with idiopathic PD (stage 2 to 3 of modified Hoehn and Yahr staging scale) according to the London Brain Bank. The participants were randomly assigned to three groups. Group 1 (G1) participated in functional training (n=22); group 2 (G2) performed bicycle exercise (n=20), and group 3 (G3) trained with Kinect Adventures (Microsoft, Redmond, WA) exergames (n=20). The primary outcome measure was the 6-minute walk test (6MWT); secondary outcome measures were the 10-m walk test (10MWT), sitting-rising test (SRT), body mass index, Parkinson Disease Questionnaire-39, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), and 15-item Geriatric Depression Scale. All groups showed significant improvements in 6MWT (G1 P=.008; G2 P=.001; G3 P=.005), SRT (G1 Ptraining had similar outcomes compared with functional training and bicycle exercise. The three physical exercise modalities presented significant improvements on walking capacity, ability to stand up and sit, and functionality of the participants. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. High doses of biotin in chronic progressive multiple sclerosis: a pilot study.

    Science.gov (United States)

    Sedel, Frédéric; Papeix, Caroline; Bellanger, Agnès; Touitou, Valérie; Lebrun-Frenay, Christine; Galanaud, Damien; Gout, Olivier; Lyon-Caen, Olivier; Tourbah, Ayman

    2015-03-01

    No drug has been found to have any impact on progressive multiple sclerosis (MS). Biotin is a vitamin acting as a coenzyme for carboxylases involved in key steps of energy metabolism and fatty acids synthesis. Among others, biotin activates acetylCoA carboxylase, a potentially rate-limiting enzyme in myelin synthesis. The aim of this pilot study is to assess the clinical efficacy and safety of high doses of biotin in patients suffering from progressive MS. Uncontrolled, non-blinded proof of concept study 23 consecutive patients with primary and secondary progressive MS originated from three different French MS reference centers were treated with high doses of biotin (100-300mg/day) from 2 to 36 months (mean=9.2 months). Judgement criteria varied according to clinical presentations and included quantitative and qualitative measures. In four patients with prominent visual impairment related to optic nerve injury, visual acuity improved significantly. Visual evoked potentials in two patients exhibited progressive reappearance of P100 waves, with normalization of latencies in one case. Proton magnetic resonance spectroscopy (H-MRS) in one case showed a progressive normalization of the Choline/Creatine ratio. One patient with left homonymous hemianopia kept on improving from 2 to 16 months following treatment׳s onset. Sixteen patients out of 18 (89%) with prominent spinal cord involvement were considered as improved as confirmed by blinded review of videotaped clinical examination in 9 cases. In all cases improvement was delayed from 2 to 8 months following treatment׳s onset. These preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS. Two double-blind placebo-controlled trials are on going. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  1. Information Communication Technology to support and include Blind students in a school for all An Interview study of teachers and students’ experiences with inclusion and ICT support to blind students

    OpenAIRE

    Rony, Mahbubur Rahman

    2017-01-01

    The topic of this is this study is how blind students and teachers experiences Information Communication Technology as a tool to support and include blind students in a school for all. The study investigates how Information and Communication Technologies (ICT) enables blind students to adjust into non-special schools. The research method used to collect data is interview. The goal is to get insight to teachers and students’ experiences with inclusion and ICT as a tool to support blind student...

  2. A pilot study into a possible relationship between diet and stuttering.

    Science.gov (United States)

    Hum, Jean; Rietveld, Toni; Wiedijk, Piet; van Lieshout, Pascal

    2017-06-01

    There are theoretical and empirical reasons to consider a potential role for copper metabolism in the brain in how it could influence stuttering. However, a link between stuttering and dietary intake has never been researched in a systematic way. This pilot study therefore aimed to explore a possible association between ingested amounts of copper and thiamine (vitamin B1) with stuttering frequency using a double blind cross-over longitudinal paradigm. 19 adults who stutter between 20 and 51 years old filled out an online survey for 9 consecutive weeks. The survey consisted of self-assessed fluency and mood state scales, as well as food journals. After 4 weeks, the participants consumed either copper or thiamine supplements for 2 weeks, followed by a 1-week washout period, and another period of two weeks taking the other supplement. Formal speech assessments were done pre/post baseline and at the end of each supplement intake. Participants were not informed about the nature of the supplements during the experiment and the investigators were blinded to the order of the supplements. The results demonstrated that copper and thiamine had no measurable effect on the amount of stuttering (self and formal assessments) but there was a moderate, significant correlation between mood state and fluency. The findings do not support notions of dietary influences of ingested copper or thiamine on stuttering but do provide modest support for a relationship between variations in stuttering and self-perceived anxiety. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Dissolution studies with pilot plant and actual INTEC calcines

    International Nuclear Information System (INIS)

    Herbst, R.S.; Garn, T.G.

    1999-01-01

    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 3 ) 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

  4. Analytic study of the Tadoma method: language abilities of three deaf-blind subjects.

    Science.gov (United States)

    Chomsky, C

    1986-09-01

    This study reports on the linguistic abilities of 3 adult deaf-blind subjects. The subjects perceive spoken language through touch, placing a hand on the face of the speaker and monitoring the speaker's articulatory motions, a method of speechreading known as Tadoma. Two of the subjects, deaf-blind since infancy, acquired language and learned to speak through this tactile system; the third subject has used Tadoma since becoming deaf-blind at age 7. Linguistic knowledge and productive language are analyzed, using standardized tests and several tests constructed for this study. The subjects' language abilities prove to be extensive, comparing favorably in many areas with hearing individuals. The results illustrate a relatively minor effect of limited language exposure on eventual language achievement. The results also demonstrate the adequacy of the tactile sense, in these highly trained Tadoma users, for transmitting information about spoken language sufficient to support the development of language and learning to produce speech.

  5. Nursing Student Perceptions of Digital Textbooks: A Pilot Study.

    Science.gov (United States)

    Mennenga, Heidi A

    2016-01-01

    Digital textbooks are increasing in popularity, often resulting from the perception that students demand the use of technology in academics. However, few studies have been done on student perceptions of digital textbooks. A pilot study was conducted with students enrolled in a nursing research course; 123 nursing students participated. This study found that students overwhelmingly preferred print textbooks over digital textbooks. More research needs to be done before assuming students would prefer digital textbooks over print.

  6. Introducing technology into medical education: two pilot studies.

    Science.gov (United States)

    George, Paul; Dumenco, Luba; Dollase, Richard; Taylor, Julie Scott; Wald, Hedy S; Reis, Shmuel P

    2013-12-01

    Educators are integrating new technology into medical curriculum. The impact of newer technology on educational outcomes remains unclear. We aimed to determine if two pilot interventions, (1) introducing iPads into problem-based learning (PBL) sessions and (2) online tutoring would improve the educational experience of our learners. We voluntarily assigned 26 second-year medical students to iPad-based PBL sessions. Five students were assigned to Skype for exam remediation. We performed a mixed-method evaluation to determine efficacy. Pilot 1: Seventeen students completed a survey following their use of an iPad during the second-year PBL curriculum. Students noted the iPad allows for researching information in real time, annotating lecture notes, and viewing sharper images. Data indicate that iPads have value in medical education and are a positive addition to the curriculum. Pilot 2: Students agreed that online tutoring is at least or more effective than in-person tutoring. In our pilot studies, students experienced that iPads and Skype are beneficial in medical education and can be successfully employed in areas such as PBL and remediation. Educators should continue to further examine innovative opportunities for introducing technology into medical education. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  7. Recognition Memory for Braille or Spoken Words: An fMRI study in Early Blind

    OpenAIRE

    Burton, Harold; Sinclair, Robert J.; Agato, Alvin

    2011-01-01

    We examined cortical activity in early blind during word recognition memory. Nine participants were blind at birth and one by 1.5 yrs. In an event-related design, we studied blood oxygen level-dependent responses to studied (“old”) compared to novel (“new”) words. Presentation mode was in Braille or spoken. Responses were larger for identified “new” words read with Braille in bilateral lower and higher tier visual areas and primary somatosensory cortex. Responses to spoken “new” words were la...

  8. Self moving patients to the operation theatre - a pilot study

    DEFF Research Database (Denmark)

    Qvarfordh, Anna Pernilla; Rovsing, Marie Louise; Esbensen, Bente Appel

    2010-01-01

    The purpose of this pilot study was to investigate patients' satisfaction with walking to the operation theatre instead of being driven in a bed or wheel chair, and to identify the need for information. In total, 75 patients (aged 15-83 years) participated in the study. A questionnaire was develo......The purpose of this pilot study was to investigate patients' satisfaction with walking to the operation theatre instead of being driven in a bed or wheel chair, and to identify the need for information. In total, 75 patients (aged 15-83 years) participated in the study. A questionnaire...... was developed for this study with two focus areas: "Satisfaction with walking instead of being driven" and "Satisfaction with information". In total, 93pct. reported, that it was a good experience to be allowed to walk to the operation theatre, prior to their surgery. About the same proportion found...

  9. Transient monocular blindness and the risk of vascular complications according to subtype : a prospective cohort study

    NARCIS (Netherlands)

    Volkers, Eline J; Donders, Richard C J M; Koudstaal, Peter J; van Gijn, Jan; Algra, Ale; Jaap Kappelle, L

    Patients with transient monocular blindness (TMB) can present with many different symptoms, and diagnosis is usually based on the history alone. In this study, we assessed the risk of vascular complications according to different characteristics of TMB. We prospectively studied 341 consecutive

  10. Transient monocular blindness and the risk of vascular complications according to subtype: a prospective cohort study

    NARCIS (Netherlands)

    Volkers, E.J. (Eline J.); R. Donders (Rogier); P.J. Koudstaal (Peter Jan); van Gijn, J. (Jan); A. Algra (Ale); L. Jaap Kappelle

    2016-01-01

    textabstractPatients with transient monocular blindness (TMB) can present with many different symptoms, and diagnosis is usually based on the history alone. In this study, we assessed the risk of vascular complications according to different characteristics of TMB. We prospectively studied 341

  11. Pilot-model analysis and simulation study of effect of control task desired control response

    Science.gov (United States)

    Adams, J. J.; Gera, J.; Jaudon, J. B.

    1978-01-01

    A pilot model analysis was performed that relates pilot control compensation, pilot aircraft system response, and aircraft response characteristics for longitudinal control. The results show that a higher aircraft short period frequency is required to achieve superior pilot aircraft system response in an altitude control task than is required in an attitude control task. These results were confirmed by a simulation study of target tracking. It was concluded that the pilot model analysis provides a theoretical basis for determining the effect of control task on pilot opinions.

  12. Baseline risk factors for incidence of blindness in a South Indian population: the chennai eye disease incidence study.

    Science.gov (United States)

    Vijaya, Lingam; Asokan, Rashima; Panday, Manish; Choudhari, Nikhil S; Ramesh, Sathyamangalam Ve; Velumuri, Lokapavani; Boddupalli, Sachi Devi; Sunil, Govindan T; George, Ronnie

    2014-08-07

    To report the baseline risk factors and causes for incident blindness. Six years after the baseline study, 4419 subjects from the cohort underwent a detailed examination at the base hospital. Incident blindness was defined by World Health Organization criteria as visual acuity of less than 6/120 (3/60) and/or a visual field of less than 10° in the better-seeing eye at the 6-year follow-up, provided that the eye had a visual acuity of better than or equal to 6/120 (3/60) and visual field greater than 10° at baseline. For incident monocular blindness, both eyes should have visual acuity of more than 6/120 (3/60) at baseline and developed visual acuity of less than 6/120 (3/60) in one eye at 6-year follow-up. For incident blindness, 21 participants (0.48%, 95% confidence interval [CI], 0.3-0.7) became blind; significant baseline risk factors were increasing age (P = 0.001), smokeless tobacco use (P blindness was found in 132 participants (3.8%, 95% CI, 3.7-3.8); it was significantly more (P blindness and monocular blindness. No history of cataract surgery was a risk factor for blindness and a protective factor for monocular blindness. Copyright 2014 The Association for Research in Vision and Ophthalmology, Inc.

  13. A remotely piloted aircraft system in major incident management: concept and pilot, feasibility study.

    Science.gov (United States)

    Abrahamsen, Håkon B

    2015-06-10

    Major incidents are complex, dynamic and bewildering task environments characterised by simultaneous, rapidly changing events, uncertainty and ill-structured problems. Efficient management, communication, decision-making and allocation of scarce medical resources at the chaotic scene of a major incident is challenging and often relies on sparse information and data. Communication and information sharing is primarily voice-to-voice through phone or radio on specified radio frequencies. Visual cues are abundant and difficult to communicate between teams and team members that are not co-located. The aim was to assess the concept and feasibility of using a remotely piloted aircraft (RPA) system to support remote sensing in simulated major incident exercises. We carried out an experimental, pilot feasibility study. A custom-made, remotely controlled, multirotor unmanned aerial vehicle with vertical take-off and landing was equipped with digital colour- and thermal imaging cameras, a laser beam, a mechanical gripper arm and an avalanche transceiver. We collected data in five simulated exercises: 1) mass casualty traffic accident, 2) mountain rescue, 3) avalanche with buried victims, 4) fisherman through thin ice and 5) search for casualties in the dark. The unmanned aerial vehicle was remotely controlled, with high precision, in close proximity to air space obstacles at very low levels without compromising work on the ground. Payload capacity and tolerance to wind and turbulence were limited. Aerial video, shot from different altitudes, and remote aerial avalanche beacon search were streamed wirelessly in real time to a monitor at a ground base. Electromagnetic interference disturbed signal reception in the ground monitor. A small remotely piloted aircraft can be used as an effective tool carrier, although limited by its payload capacity, wind speed and flight endurance. Remote sensing using already existing remotely piloted aircraft technology in pre

  14. HERMES probabilistic risk assessment. Pilot study

    International Nuclear Information System (INIS)

    Parisot, F.; Munoz, J.

    1993-01-01

    The study was performed in 1989 of the contribution of probabilistic analysis for the optimal construction of system safety status in aeronautical and European nuclear industries, shows the growing trends towards incorporation of quantitative safety assessment and lead to an agreement to undertake a prototype proof study on Hermes. The main steps of the study and results are presented in the paper

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

    Science.gov (United States)

    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 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

  16. Pilot study of erlotinib in patients with acute myeloid leukemia.

    Science.gov (United States)

    Sayar, Hamid; Czader, Magdalena; Amin, Chirag; Cangany, Mary; Konig, Heiko; Cripe, Larry D

    2015-02-01

    We conducted a pilot study to investigate clinical efficacy of tyrosine kinase inhibitor erlotinib in the treatment of acute myeloid leukemia (AML). A total of 11 patients with de novo AML were treated, including 2 with relapsed and/or refractory disease and 9 older patients with previously untreated AML. Patients with high baseline leukocyte count were excluded. Erlotinib was given orally at 150 mg per day continuously in 28-day cycles. The treatment was tolerated well, and no toxicities were observed. An initial reduction in circulating blasts, followed by disease progression, was observed in 2 patients. Nine other patients did not demonstrate any response in blood or bone marrow. Baseline and post-cycle 1 flow-cytometry were performed on bone marrow blasts to investigate signs of differentiation. No immunophenotypic changes suggestive of differentiation were observed. This pilot study did not demonstrate response to standard doses of erlotinib in patients with AML. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. The Flower Workshop in psychosocial rehabilitation: a pilot study.

    Science.gov (United States)

    Pereira, Alfredo; Pereira, Maria Alice Ornellas

    2009-01-01

    We report a pilot study with the Flower Workshop, a new modality of psychosocial rehabilitation group activity. Cognitive performance in schizophrenia and other mental conditions can be impaired depending on the tasks to be executed and their respective social context. The vulnerability of these individuals can be reduced by means of cognitive and socio-affective facilitation. We conducted a pilot study to introduce the Flower Workshop in a public Mental Health Service in the city of Ribeirão Preto (São Paulo-Brasil) with 12 participants during 18 months (2002-2003). With cognitive and socio-affective facilitation, participants were able to construct vases and make flower arrangements successfully.

  18. Peer Mentoring for Male Parolees: A CBPR Pilot Study.

    Science.gov (United States)

    Marlow, Elizabeth; Grajeda, William; Lee, Yema; Young, Earthy; Williams, Malcolm; Hill, Karen

    2015-01-01

    Formerly incarcerated adults are impoverished, have high rates of substance use disorders, and have long histories of imprisonment. This article describes the development of a peer mentoring program for formerly incarcerated adults and the pilot study designed to evaluate it. The research team, which included formerly incarcerated adults and academic researchers, developed the peer mentoring program to support formerly incarcerated adults' transition to the community after prison. The purposes of the pilot evaluation study were to (1) assess the feasibility of implementing a peer-based intervention for recently released men developed using a community-based participatory research (CBPR) approach; (2) establish preliminary data on the program's impact on coping, self-esteem, abstinence self-efficacy, social support, and participation in 12-step meetings; and (3) establish a CBPR team of formerly incarcerated adults and academic researchers to develop, implement, and test interventions for this population. This pilot evaluation study employed a mixed-methods approach with a single group pretest/posttest design with 20 men on parole released from prison within the last 30 days. Quantitative findings showed significant improvement on two abstinence self-efficacy subscales, negative affect and habitual craving. Qualitative findings revealed the relevance and acceptance of peer mentoring for this population. This study demonstrated the feasibility and import of involving formerly incarcerated adults in the design, implementation, and testing of interventions intended to support their reintegration efforts.

  19. A single dose desensitization for summer hay fever. Results of a double blind study-1988.

    Science.gov (United States)

    Fell, P; Brostoff, J

    1990-01-01

    A new type of desensitising vaccine, enzyme potentiated was subjected to a double-blind randomised study during the hay fever season. The vaccine is a convenient single injection given in March and the results show good protection throughout the grass pollen season.

  20. Textual Input Enhancement for Vowel Blindness: A Study with Arabic ESL Learners

    Science.gov (United States)

    Alsadoon, Reem; Heift, Trude

    2015-01-01

    This study explores the impact of textual input enhancement on the noticing and intake of English vowels by Arabic L2 learners of English. Arabic L1 speakers are known to experience "vowel blindness," commonly defined as a difficulty in the textual decoding and encoding of English vowels due to an insufficient decoding of the word form.…

  1. Building automation and perceived control : a field study on motorized exterior blinds in Dutch offices

    NARCIS (Netherlands)

    Meerbeek, B.W.; te Kulve, Marije; Gritti, T.; Aarts, M.P.J.; Loenen, van E.J.; Aarts, E.H.L.

    2014-01-01

    As a result of the technological advances and increasing focus on energy efficient buildings, simple forms of building automation including automatic motorized blinds systems found their ways into today's office environments. In a five-month field study, qualitative and quantitative methods were

  2. Sucralfate versus cimetidine in reflux esophagitis. A single-blind multicenter study

    NARCIS (Netherlands)

    Hameeteman, W.; v d Boomgaard, D. M.; Dekker, W.; Schrijver, M.; Wesdorp, I. C.; Tytgat, G. N.

    1987-01-01

    A single-blind randomized multicenter study was performed in 42 patients with endoscopically documented reflux esophagitis. Patients were randomly given 400 mg cimetidine q.i.d. or a suspension of 1 g sucralfate q.i.d. for a period of 8 weeks. Forty patients were evaluated after 8 weeks. Symptomatic

  3. A double-blind, placebo-controlled study of sertraline with naltrexone for alcohol dependence.

    LENUS (Irish Health Repository)

    Farren, Conor K

    2009-01-01

    Significant preclinical evidence exists for a synergistic interaction between the opioid and the serotonin systems in determining alcohol consumption. Naltrexone, an opiate receptor antagonist, is approved for the treatment of alcohol dependence. This double-blind placebo-controlled study examined whether the efficacy of naltrexone would be augmented by concurrent treatment with sertraline, a selective serotonin receptor uptake inhibitor (SSRI).

  4. Mefloquine prophylaxis prevents malaria during pregnancy: a double-blind, placebo-controlled study

    NARCIS (Netherlands)

    Nosten, F.; ter Kuile, F.; Maelankiri, L.; Chongsuphajaisiddhi, T.; Nopdonrattakoon, L.; Tangkitchot, S.; Boudreau, E.; Bunnag, D.; White, N. J.

    1994-01-01

    A double-blind, placebo-controlled study of mefloquine antimalarial prophylaxis in pregnancy (> 20 weeks of gestation) was conducted in 339 Karen women living in an area of multidrug-resistant malaria transmission on the Thai-Burmese border. Mefloquine gave > or = 86% (95% confidence interval [CI],

  5. Human norovirus inactivation in oysters by high hydrostatic pressure processing: A randomized double-blinded study

    Science.gov (United States)

    This randomized, double-blinded, clinical trial assessed the effect of high hydrostatic pressure processing (HPP) on genogroup I.1 human norovirus (HuNoV) inactivation in virus-seeded oysters when ingested by subjects. The safety and efficacy of HPP treatments were assessed in three study phases wi...

  6. Generation Y students’ attitudes towards facebook advertising: pilot study results

    OpenAIRE

    Hilda Bongazana Mahlangu; Ayesha Lian Bevan-Dye

    2013-01-01

    The purpose of this paper is to report on the results of a pilot study conducted on the determinants and inhibitors of Generation Y students’ attitudes towards Facebook advertising. The findings suggest that Generation Y students have a positive attitude towards the information value, entertainment value, credibility, self-brand congruity of advertising on Facebook and attitude towards the social interaction value of Facebook. Their attitudes towards trust in the site and trust in the members...

  7. LAM Pilot Study with Imatinib Mesylate (LAMP-1)

    Science.gov (United States)

    2017-10-01

    AWARD NUMBER: W81XWH-14-1-0132 TITLE: LAM Pilot Study with Imatinib Mesylate (LAMP-1) PRINCIPAL INVESTIGATOR: Charlie Strange, MD...regarding imatinib mesylate (imatinib) in the treatment of Lymphangioleiomyomatosis ( LAM ) sufficient to power and design a phase 3 imatinib vs. placebo...clinical trial. The hypothesis is that imatinib will be equivalent to rapamycin in short term efficacy and safety. Currently, most LAM patients are

  8. Human biomonitoring pilot study DEMOCOPHES in Germany

    DEFF Research Database (Denmark)

    Schwedler, Gerda; Seiwert, Margarete; Fiddicke, Ulrike

    2017-01-01

    , cadmium, cotinine and several phthalate metabolites in urine of 6–11 year old children and their mothers in an urban and a rural region. Seventeen European countries simultaneously conducted this cross-sectional DEMOCOPHES feasibility study. The German study population was taken in the city of Bochum...... and in the Higher Sauerland District, comprising 120 mother-child pairs. In the present paper features of the study implementation are presented. German exposure concentrations of the pollutants are reported and compared with European average concentrations from DEMOCOPHES and with those measured......Human biomonitoring (HBM) is an effective tool to assess human exposure to environmental pollutants, but comparable HBM data in Europe are lacking. In order to expedite harmonization of HBM studies on a European scale, the twin projects COPHES (Consortium to Perform Human Biomonitoring...

  9. Restoring effective sleep tranquility (REST): A feasibility and pilot study.

    Science.gov (United States)

    Eakman, Aaron M; Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E

    2017-06-01

    The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre-post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [ t  = 3.29, p  = .02]), reduced nightmares: t  = 2.79, p  = .03; fewer dysfunctional sleep beliefs: t  = 3.63, p  = .01, and greater ability to participate in social roles: t  = -2.86, p  = .03, along with trends towards improved satisfaction with participation and reduced pain interference. The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver.

  10. Lived Experience of Self-Care in Blind Individuals: A Phenomenological Study

    Directory of Open Access Journals (Sweden)

    Mahmood Shamshir i

    2016-06-01

    Full Text Available Background and Objectives: Blindness is a serious condition, which can affect mental balance and general organized personality of blind person. This study was carried out with the purpose of explaining the lived experience of self-care in blind individuals. Methods: in this study, interpretive phenomenology was used to conduct the study. Through a purposeful sampling, 8 in-depth semi structured interviews were performed for 8 participants, which their duration was between 50-120 minutes. The method introduced by van Manen was used to perform the research and extract the concepts. Results: Analysis of the data led to three concepts, including “Being through discipline”, “independent through discipline”, and “protection of discipline”, which finally caused the appearance of the main concept, “self-care through a disciplined life”. Conclusion: Blind individuals benefit from a disciplined lifestyle to have an independent life, and also expect this kind of discipline from others. Therefore, it is necessary that family members and health care providers consider the concept of disciplined life.

  11. Low-Cost Radon Reduction Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Rose, William B. [Partnership for Advanced Residential Retrofit, Champaign, IL (United States); Francisco, Paul W. [Partnership for Advanced Residential Retrofit, Champaign, IL (United States); Merrin, Zachary [Partnership for Advanced Residential Retrofit, Champaign, IL (United States)

    2015-09-01

    The aim of the research was to conduct a primary scoping study on the impact of air sealing between the foundation and the living space on radon transport reduction across the foundation-living space floor assembly. Fifteen homes in the Champaign, Illinois area participated in the study. These homes were instrumented for hourly continuous radon measurements and simultaneous temperature and humidity the foundation was improved. However, this improved isolation did not lead to significant reductions in radon concentration in the living space. Other factors such as outdoor temperature were shown to have an impact on radon concentration.

  12. Pilot study of a multimodal intervention

    DEFF Research Database (Denmark)

    Jarden, Mary Ellen; Hovgaard, Doris; Boesen, Ellen

    2007-01-01

    Substantial physical and functional deconditioning and diminished psychological wellbeing are all potential adverse effects of allogeneic stem cell transplantation (allo-HSCT). The aim of this study was to evaluate the feasibility, safety and benefits (physical and functional capacity) of a 4-6 w...

  13. Educational Optimism among Parents: A Pilot Study

    Science.gov (United States)

    Räty, Hannu; Kasanen, Kati

    2016-01-01

    This study explored parents' (N = 351) educational optimism in terms of their trust in the possibilities of school to develop children's intelligence. It was found that educational optimism could be depicted as a bipolar factor with optimism and pessimism on the opposing ends of the same dimension. Optimistic parents indicated more satisfaction…

  14. Motivation in the Classroom: A Pilot Study.

    Science.gov (United States)

    Schilling, Deanna E.

    Purposes of this study were to (1) investigate the validity of Maslow's Hierarchy of Needs as it applies to young children; (2) determine developmental shifts in expressed motivational needs; (3) gather information concerning the worries and fears of young children, particularly those of low socioeconomic status; and (4) gather data regarding…

  15. Pilot-scale study of ballasted-flocculation technology

    International Nuclear Information System (INIS)

    Liem, L.E.; Brant, W.H.; Gagne, B.; Michaud, J.; Beaudet, J.-F.; Landry, D.; Braden, K.; Campbell, D.

    2002-01-01

    A ballasted-flocculation pilot-scale study was undertaken to treat a wide-range river water turbidity (17 to 2,608 NTU). The pilot-scale unit was operated at flowrates of 30 to 63 m 3 /h, which corresponded to loading rates of 40 to 84 m/h. Coagulants, polymers, and microsand were added to enhance the floc agglomeration. The weighted flocs settled rapidly resulting in excellent turbidity removals of 94.7 to 99.9%. At the peak turbidity, the unit had a 99.9% removal performance (2.7 from 2,608 NTU) at a loading rate of 40 m/h. In this case, polyaluminum silicosulfate and anionic polymer dosages were 82 and 1 mg/L, respectively. The microsand recycle rate was kept constant at 4.5 m 3 /h, and 1mg microsand was added for each liter of water treated. (author)

  16. Visual and Motor Recovery After "Cognitive Therapeutic Exercises" in Cortical Blindness: A Case Study.

    Science.gov (United States)

    De Patre, Daniele; Van de Winckel, Ann; Panté, Franca; Rizzello, Carla; Zernitz, Marina; Mansour, Mariam; Zordan, Lara; Zeffiro, Thomas A; OʼConnor, Erin E; Bisson, Teresa; Lupi, Andrea; Perfetti, Carlo

    2017-07-01

    Spontaneous visual recovery is rare after cortical blindness. While visual rehabilitation may improve performance, no visual therapy has been widely adopted, as clinical outcomes are variable and rarely translate into improvements in activities of daily living (ADLs). We explored the potential value of a novel rehabilitation approach "cognitive therapeutic exercises" for cortical blindness. The subject of this case study was 48-year-old woman with cortical blindness and tetraplegia after cardiac arrest. Prior to the intervention, she was dependent in ADLs and poorly distinguished shapes and colors after 19 months of standard visual and motor rehabilitation. Computed tomographic images soon after symptom onset demonstrated acute infarcts in both occipital cortices. The subject underwent 8 months of intensive rehabilitation with "cognitive therapeutic exercises" consisting of discrimination exercises correlating sensory and visual information. Visual fields increased; object recognition improved; it became possible to watch television; voluntary arm movements improved in accuracy and smoothness; walking improved; and ADL independence and self-reliance increased. Subtraction of neuroimaging acquired before and after rehabilitation showed that focal glucose metabolism increases bilaterally in the occipital poles. This study demonstrates feasibility of "cognitive therapeutic exercises" in an individual with cortical blindness, who experienced impressive visual and sensorimotor recovery, with marked ADL improvement, more than 2 years after ischemic cortical damage.Video Abstract available for additional insights from the authors (see Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A173).

  17. The Expanded Core Curriculum at the Indiana School for the Blind and Visually Impaired: A Case Study

    Science.gov (United States)

    Ringwalt, Gail Mulholland

    2013-01-01

    This case study investigated how the Expanded Core Curriculum (ECC) was taught to high school students who are blind or visually impaired at the Indiana School for the Blind and Visually Impaired (ISBVI). The study focused on three students pursing different academic tracks with varying degrees of vision. The students were observed throughout…

  18. Low-cost Radon Reduction Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Rose, William B. [Univ. of Illinois, Urbana-Champaign, IL (United States); Francisco, Paul W. [Univ. of Illinois, Urbana-Champaign, IL (United States); Merrin, Zachary [Univ. of Illinois, Urbana-Champaign, IL (United States)

    2015-09-01

    The U.S. Department of Energy's Building America research team Partnership for Advanced Residential Retrofits conducted a primary scoping study on the impact of air sealing between the foundation and the living space on radon transport reduction across the foundation and living space floor assembly. Fifteen homes in the Champaign, Illinois, area participated in the study. These homes were instrumented for hourly continuous radon measurements and simultaneous temperature and humidity measurements. Blower door and zone pressure diagnostics were conducted at each house. The treatments consisted of using air-sealing foams at the underside of the floor that separated the living space from the foundation and providing duct sealing on the ductwork that is situated in the foundation area. The hypothesis was that air sealing the floor system that separated the foundation from the living space should better isolate the living space from the foundation; this isolation should lead to less radon entering the living space from the foundation. If the hypothesis had been proven, retrofit energy-efficiency programs may have chosen to adopt these isolation methods for enhanced radon protection to the living space.

  19. High-Resolution Scintimammography: A Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Rachel F. Brem; Joelle M. Schoonjans; Douglas A. Kieper; Stan Majewski; Steven Goodman; Cahid Civelek

    2002-07-01

    This study evaluated a novel high-resolution breast-specific gamma camera (HRBGC) for the detection of suggestive breast lesions. Methods: Fifty patients (with 58 breast lesions) for whom a scintimammogram was clinically indicated were prospectively evaluated with a general-purpose gamma camera and a novel HRBGC prototype. The results of conventional and high-resolution nuclear studies were prospectively classified as negative (normal or benign) or positive (suggestive or malignant) by 2 radiologists who were unaware of the mammographic and histologic results. All of the included lesions were confirmed by pathology. Results: There were 30 benign and 28 malignant lesions. The sensitivity for detection of breast cancer was 64.3% (18/28) with the conventional camera and 78.6% (22/28) with the HRBGC. The specificity with both systems was 93.3% (28/30). For the 18 nonpalpable lesions, sensitivity was 55.5% (10/18) and 72.2% (13/18) with the general-purpose camera and the HRBGC, respectively. For lesions 1 cm, 7 of 15 were detected with the general-purpose camera and 10 of 15 with the HRBGC. Four lesions (median size, 8.5 mm) were detected only with the HRBGC and were missed by the conventional camera. Conclusion: Evaluation of indeterminate breast lesions with an HRBGC results in improved sensitivity for the detection of cancer, with greater improvement shown for nonpalpable and 1-cm lesions.

  20. Treadmill Desks at LANL - Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Fellows, Samara Kia [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-07-28

    It is well established that sedentariness is the largest, preventable contributor to premature death, eclipsing smoking in recent years. One approach to reduce sedentariness is by using a treadmill desk to perform office work while walking at a low speed.We found an increased interest level when the treadmill desks were first introduced to LANL, but after a few months interest appeared to drop. It is possible that treadmill desk use was occurring, but subjects did not record their use. The treadmill desks will not be readily available for purchase by employees due to the study outcome. Additionally, conclusive changes in body measurements could not be performed due to lack of follow up by 58% of the participants.

  1. Medical exposure to children - a pilot study

    International Nuclear Information System (INIS)

    Ingilizova, K.; Borisova, R.

    2008-01-01

    Patient dose assessment during medical exposure in paediatric diagnostic radiology is of highest importance in view of the greater radiation hazard to children compared to adults. It is conditioned by their higher sensitivity to ionizing radiation and their greater life expectancy. The risk of stochastic effects is several times greater for children than for adults. The attributive risk to children exposed to ionizing radiation during the first 10 years is 3 to 5 times greater than the risk to adults exposed between 30 and 40 years of age, and 6 to 7 times greater compared to the risk to adults exposed after their 50 year. The children dose distribution studies are carried out in order to elaborate national diagnostic reference levels. The dose assessment is complicated by the great variation in body size and anatomical features of children belonging to different age groups. There is a series of difficulties in the definition of image quality criteria and guidelines for good practice due to the dynamically changing body proportions and the anatomical features as a result of the active growth process from infancy through early childhood to adolescence. (author)

  2. Frailty Testing Pilot Study: Pros and Pitfalls.

    Science.gov (United States)

    Adlam, Taylor; Ulrich, Elizabeth; Kent, Missy; Malinzak, Lauren

    2018-02-01

    Frailty can be defined as an inflammatory state with a loss of physiologic reserve in multiple systems that manifests as a decreased ability to respond to stressors that ultimately leads to an increased risk of adverse outcomes. The aim of this study was to determine the ease of frailty testing in a pre-kidney transplant clinic and the resources required to do so. A secondary goal was to better understand the utility of frailty testing when evaluating potential kidney transplant recipients. Frailty testing was conducted at a pre-kidney transplant clinic in three phases using Fried's frailty phenotype (shrinking, exhaustion, low physical activity, slowness, and grip strength). A total of 132 frailty tests were completed on 128 patients. Frail patients had significantly higher rates of shrinking (26% vs. 8.5%, P testing was most complete when an examiner dedicated to frailty testing performed the testing. Frailty testing is feasible to complete in a pre-transplant clinic with an appropriate investment in personnel and resources.

  3. Social dysfunction in bipolar disorder: pilot study.

    Science.gov (United States)

    de Almeida Rocca, Cristiana Castanho; de Macedo-Soares, Marcia Britto; Gorenstein, Clarice; Tamada, Renata Sayuri; Issler, Cilly Kluger; Dias, Rodrigo Silva; Schwartzmann, Angela Maria; Lafer, Beny

    2008-08-01

    The purpose of the present study was to assess the social skills of euthymic patients with bipolar disorder. A group of 25 outpatients with bipolar disorder type I were evaluated in comparison with a group of 31 healthy volunteers who were matched in terms of level of education, age, sex and intelligence. Both groups were assessed using a self-report questionnaire, the Brazilian Inventario de Habilidades Sociais (IHS, Social Skills Inventory). Two Wechsler Adult Intelligence Scale subtests (Picture Arrangement and Comprehension) were also used in order to assess subject ability to analyse social situations and to make judgements, respectively. Patients with bipolar disorder had lower IHS scores for the domains that assessed conversational skills/social self-confidence and social openness to new people/situations. Patients with anxiety disorders had high scores for the domain that assessed self-confidence in the expression of positive emotions. No differences were found between patients and controls in performance on the Wechsler Adult Intelligence Scale Picture Arrangement and Comprehension subtests. Euthymic patients with bipolar disorder present inhibited and overattentive behaviour in relation to other people and their environment. This behaviour might have a negative impact on their level of social functioning and quality of life.

  4. Telemedicine and Plastic Surgery: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Denis Souto Valente

    2015-01-01

    Full Text Available Background. Telemedicine can be defined as the use of electronic media for transmission of information and medical data from one site to another. The objective of this study is to demonstrate an experience of telemedicine in plastic surgery. Methods. 32 plastic surgeons received a link with password for real-time streaming of a surgery. At the end of the procedure, the surgeons attending the procedure by the Internet answered five questions. The results were analyzed with descriptive statistics. Results. 27 plastic surgeons attended the online procedure in real-time. 96.3% considered the access to the website as good or excellent and 3.7% considered it bad. 14.8% reported that the transmission was bad and 85.2% considered the quality of transmission as good or excellent. 96.3% classified the live broadcasting as a good or excellent learning experience and 3.7% considered it a bad experience. 92.6% reported feeling able to perform this surgery after watching the demo and 7.4% did not feel able. 100% of participants said they would like to participate in other surgical demonstrations over the Internet. Conclusion. We conclude that the use of telemedicine can provide more access to education and medical research, for plastic surgeons looking for medical education from distant regions.

  5. Work stress in radiologists. A pilot study.

    Science.gov (United States)

    Magnavita, N; Fileni, A; Magnavita, G; Mammi, F; Mirk, P; Roccia, K; Bergamaschi, A

    2008-04-01

    We studied occupational stress and its psychosocial effects in a sample of Italian radiologists and radiotherapists: Radiologists and radiotherapists attending two medical conferences were invited to complete a questionnaire comprising four sections investigating the risk of occupational stress (organisational discomfort, Karasek's Job Content Questionnaire, Siegrist's Effort-Reward Imbalance, Warr's Job Satisfaction) and four sections investigating the health effects of such stress (Goldberg's Anxiety and Depression Scales, General Health Questionnaire, Lifestyles Questionnaire). Radiologists and radiotherapists generally expressed high levels of control, reward and satisfaction. However, 38.5% complained of severe organisational discomfort, 24% reported job strain, 28% reported effort/reward imbalance and 25% were dissatisfied. Female radiologists and radiotherapists showed higher levels of organisational discomfort than their male colleagues. Younger and less experienced radiologists and radiotherapists had higher strain scores than their older and more experienced colleagues. A significant correlation was observed between stress predictors and the effects of stress on health, including depression and anxiety, psychological distress and unhealthy lifestyles. Radiologists and radiotherapists are exposed to major occupational stress factors, and a significant percentage of them suffer from workplace stress. A special effort is required to prevent this condition.

  6. Feature study of hysterical blindness EEG based on FastICA with combined-channel information.

    Science.gov (United States)

    Qin, Xuying; Wang, Wei; Hu, Lintao; Wang, Xu; Yuan, Xiaojie

    2015-01-01

    An appropriate feature study of hysteria electroencephalograms (EEG) would provide new insights into neural mechanisms of the disease, and also make improvements in patient diagnosis and management. The objective of this paper is to provide an explanation for what causes a particular visual loss, by associating the features of hysterical blindness EEG with brain function. An idea for the novel feature extraction for hysterical blindness EEG, utilizing combined-channel information, was applied in this paper. After channels had been combined, the sliding-window-FastICA was applied to process the combined normal EEG and hysteria EEG, respectively. Kurtosis features were calculated from the processed signals. As the comparison feature, the power spectral density of normal and hysteria EEG were computed. According to the feature analysis results, a region of brain dysfunction was located at the occipital lobe, O1 and O2. Furthermore, new abnormality was found at the parietal lobe, C3, C4, P3, and P4, that provided us with a new perspective for understanding hysterical blindness. Indicated by the kurtosis results which were consistent with brain function and the clinical diagnosis, our method was found to be a useful tool to capture features in hysterical blindness EEG.

  7. Pilot study of nitrogen utilisation in maize

    International Nuclear Information System (INIS)

    Futo, I.; Palcsu, L.; Vodila, G.

    2012-01-01

    Complete text of publication follows. In the cooperation between KITE Ltd., Nadudvar, Hungary and the Hertelendi Laboratory of Environmental Studies, the aim was to determine the ideal locations of fertilising, the ideal distance of rows for the ideal production yield. To track the nitrogen utilisation of maize (Zea mays) 15 N enriched NH 4 NO 3 fertiliser was introduced among the usual fertilisers in the maize field of KITE Ltd. Nadudvar, Hungary on 30 th March 2012, before sowing. Four maize samples were taken from different areas of different fertiliser treatment (non-fertilised and non-labelled, fertilised and non-labelled, fertilised and labelled between the rows and fertilised and labelled within the rows) and from different development stages of the plant on 22 nd May, 8 th June, 6 th July and 7 th September being sampling periods 1-4, respectively. The plant samples were subsampled based on organs: root, stem and leaf. Samples were dried to constant mass and pulverised. The 15 N measurements were made by a Thermo Finnigan Delta PLUS XP isotope ratio mass spectrometer coupled with an elemental analyser. In case of non-fertilised and non-labelled plants, all the three organs were getting 15 N depleted with time, most intensively the stem and the less intensively the root (Figure 1). For the leaves and stems of the fertilised and non-labelled plants, the tendency in time is very similar to the ones of the non-fertilised and non-labelled plants, however, the roots of the fertilised and non-labelled plants got significantly enriched in the sample of September. In case of the fertilised and labelled between-the-rows samples, labelling is slightly seen as the delta values are positive. These values are significantly lower than the ones for the fertilised and labelled-within-the-rows plants. It is seen that fertiliser got to the vegetation in the largest extent in this layout. Labelling showed its maximum intensity in the second sampling (8 th June) showing that

  8. A nationwide population-based study of low vision and blindness in South Korea.

    Science.gov (United States)

    Park, Shin Hae; Lee, Ji Sung; Heo, Hwan; Suh, Young-Woo; Kim, Seung-Hyun; Lim, Key Hwan; Moon, Nam Ju; Lee, Sung Jin; Park, Song Hee; Baek, Seung-Hee

    2014-12-18

    To investigate the prevalence and associated risk factors of low vision and blindness in the Korean population. This cross-sectional, population-based study examined the ophthalmologic data of 22,135 Koreans aged ≥5 years from the fifth Korea National Health and Nutrition Examination Survey (KNHANES V, 2010-2012). According to the World Health Organization criteria, blindness was defined as visual acuity (VA) less than 20/400 in the better-seeing eye, and low vision as VA of 20/60 or worse but 20/400 or better in the better-seeing eye. The prevalence rates were calculated from either presenting VA (PVA) or best-corrected VA (BCVA). Multivariate regression analysis was conducted for adults aged ≥20 years. The overall prevalence rates of PVA-defined low vision and blindness were 4.98% and 0.26%, respectively, and those of BCVA-defined low vision and blindness were 0.46% and 0.05%, respectively. Prevalence increased rapidly above the age of 70 years. For subjects aged ≥70 years, the population-weighted prevalence rates of low vision, based on PVA and BCVA, were 12.85% and 3.87%, respectively, and the corresponding rates of blindness were 0.49% and 0.42%, respectively. The presenting vision problems were significantly associated with age (younger adults or elderly subjects), female sex, low educational level, and lowest household income, whereas the best-corrected vision problems were associated with age ≥ 70 years, a low educational level, and rural residence. This population-based study provides useful information for planning optimal public eye health care services in South Korea. Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.

  9. Preliminary Hydrogeologic Characterization Results from the Wallula Basalt Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    B.P. McGrail; E. C. Sullivan; F. A. Spane; D. H. Bacon; G. Hund; P. D. Thorne; C. J. Thompson; S. P. Reidel; F. S. Colwell

    2009-12-01

    The DOE's Big Sky Regional Carbon Sequestration Partnership has completed drilling the first continental flood basalt sequestration pilot borehole to a total depth (TD) of 4,110 feet on the Boise White Paper Mill property at Wallula, Washington. Site suitability was assessed prior to drilling by the 2007-2008 acquisition, processing and analysis of a four-mile, five-line three component seismic swath, which was processed as a single data-dense line. Analysis of the seismic survey data indicated a composite basalt formation thickness of {approx}8,000 feet and absence of major geologic structures (i.e., faults) along the line imaged by the seismic swath. Drilling of Wallula pilot borehole was initiated on January 13, 2009 and reached TD on April 6, 2009. Based on characterization results obtained during drilling, three basalt breccia zones were identified between the depth interval of 2,716 and 2,910 feet, as being suitable injection reservoir for a subsequent CO2 injection pilot study. The targeted injection reservoir lies stratigraphically below the massive Umtanum Member of the Grande Ronde Basalt, whose flow-interior section possesses regionally recognized low-permeability characteristics. The identified composite injection zone reservoir provides a unique and attractive opportunity to scientifically study the reservoir behavior of three inter-connected reservoir intervals below primary and secondary caprock confining zones. Drill cuttings, wireline geophysical logs, and 31one-inch diameter rotary sidewall cores provided geologic data for characterization of rock properties. XRF analyses of selected rock samples provided geochemical characterizations of the rocks and stratigraphic control for the basalt flows encountered by the Wallula pilot borehole. Based on the geochemical results, the pilot borehole was terminated in the Wapshilla Ridge 1 flow of the Grande Ronde Basalt Formation. Detailed hydrologic test characterizations of 12 basalt interflow

  10. Newly blind persons using virtual environment system in a traditional orientation and mobility rehabilitation program: a case study.

    Science.gov (United States)

    Lahav, Orly; Schloerb, David W; Srinivasan, Mandayam A

    2012-09-01

    This paper presents a virtual reality system (the BlindAid) developed for orientation and mobility training of people who are newly blind. The BlindAid allows users to interact with different virtual structures and objects via auditory and haptic feedback. This case study aims to examine if and how the BlindAid, in conjunction with a traditional rehabilitation programme, can help people who are newly blind develop new orientation and mobility methods. Follow-up research based on this study, with a large experiment and control group, could contribute to the area of orientation and mobility rehabilitation training for the newly blind. The case study research focused on A., a woman who is newly blind, for 17 virtual sessions spanning ten weeks, during the 12 weeks of her traditional orientation and mobility rehabilitation programme. The research was implemented by using virtual environment (VE) exploration and orientation tasks in VE and physical spaces. The research methodology used both qualitative and quantitative methods, including interviews, questionnaire, videotape recording, and user computer logs. The results of this study helped elucidate several issues concerning the contribution of the BlindAid system to the exploration strategies and learning processes experienced by the participant in her encounters with familiar and unfamiliar physical surroundings. [Box: see text].

  11. Fecal Microbiome and Food Allergy in Pediatric Atopic Dermatitis: A Cross-Sectional Pilot Study.

    Science.gov (United States)

    Fieten, Karin B; Totté, Joan E E; Levin, Evgeni; Reyman, Marta; Meijer, Yolanda; Knulst, André; Schuren, Frank; Pasmans, Suzanne G M A

    2018-01-01

    Exposure to microbes may be important in the development of atopic disease. Atopic diseases have been associated with specific characteristics of the intestinal microbiome. The link between intestinal microbiota and food allergy has rarely been studied, and the gold standard for diagnosing food allergy (double-blind placebo-controlled food challenge [DBPCFC]) has seldom been used. We aimed to distinguish fecal microbial signatures for food allergy in children with atopic dermatitis (AD). Pediatric patients with AD, with and without food allergy, were included in this cross-sectional observational pilot study. AD was diagnosed according to the UK Working Party criteria. Food allergy was defined as a positive DBPCFC or a convincing clinical history, in combination with sensitization to the relevant food allergen. Fecal samples were analyzed using 16S rRNA microbial analysis. Microbial signature species, discriminating between the presence and absence food allergy, were selected by elastic net regression. Eighty-two children with AD (39 girls) with a median age of 2.5 years, and 20 of whom were diagnosed with food allergy, provided fecal samples. Food allergy to peanut and cow's milk was the most common. Six bacterial species from the fecal microbiome were identified, that, when combined, distinguished between children with and without food allergy: Bifidobacterium breve, Bifidobacterium pseudocatenulatum, Bifidobacterium adolescentis, Escherichia coli, Faecalibacterium prausnitzii, and Akkermansia muciniphila (AUC 0.83, sensitivity 0.77, specificity 0.80). In this pilot study, we identified a microbial signature in children with AD that discriminates between the absence and presence of food allergy. Future studies are needed to confirm our findings. © 2018 The Author(s) Published by S. Karger AG, Basel.

  12. Development and pilot testing of daily Interactive Voice Response (IVR) calls to support antiretroviral adherence in India: A mixed-methods pilot study

    OpenAIRE

    Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

    2015-01-01

    This two-phase pilot study aimed to design, pilot, and refine an automated Interactive Voice Response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board (CAB) for IVR message development, one-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients’ dosing schedules, with brief messages (

  13. Are headache and temporomandibular disorders related? A blinded study

    DEFF Research Database (Denmark)

    Ballegaard, V.; Thede-Schmidt-Hansen, P.; Svensson, P.

    2008-01-01

    differences in TMD prevalence were revealed between headache groups, although TMD prevalence tended to be higher in patients with combined migraine and tension-type headache. Moderate to severe depression was experienced by 54.5% of patients. Patients with coexistent TMD had a significantly higher prevalence...... of depression-most markedly in patients with combined migraine and tension-type headache. Our studies indicate that a high proportion of headache patients have significant disability because of ongoing chronic TMD pain. The trend to a higher prevalence of TMD in patients with combined migraine and tension......-type headache suggests that this could be a risk factor for TMD development. A need for screening procedures and treatment strategies concerning depression in headache patients with coexistent TMD is underlined by the overrepresentation of depression in this group. Our findings emphasize the importance...

  14. Increased neutrophil–lymphocyte ratio in delirium: a pilot study

    Directory of Open Access Journals (Sweden)

    Egberts A

    2017-07-01

    Full Text Available Angelique Egberts, Francesco US Mattace-Raso Section of Geriatric Medicine, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands Aim: Delirium is a common and severe complication among older hospitalized patients. The pathophysiology is poorly understood, but it has been suggested that inflammation and oxidative stress may play a role. The aim of this pilot study was to investigate levels of the neutrophil–lymphocyte ratio (NLR – a marker of systemic inflammation and oxidative stress – in patients with and without delirium. Methods: This pilot study was performed within a retrospective chart review study that included acutely ill patients, 65 years and older, who were admitted to the ward of geriatrics of the Erasmus University Medical Center. All patients in whom the differential white blood cell (WBC counts as well as the C-reactive protein (CRP level were determined within 24 h after admission were included in the present study. Differences in NLR between patients with and without delirium were investigated using univariate analysis of variance, with adjustments for age, sex, comorbidities, CRP level, and total WBC count. Results: Eighty-six patients were included. Thirteen patients were diagnosed with delirium. In adjusted models, higher mean NLR values were found in patients with, than in those without, delirium (9.10 vs 5.18, P=0.003. Conclusion: In this pilot study, we found increased NLR levels in patients with delirium. This finding might suggest that an inadequate response of the immune system and oxidative stress may play a role in the pathogenesis of delirium. Further studies are needed to confirm the association between NLR and delirium. Keywords: delirium, pathology, biomarkers, leukocytes, immune system, brain 

  15. Ketamine Patient Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator Controlled, Blinded, Pilot Trial

    Science.gov (United States)

    2017-01-11

    include hypertension , tachycardia, hallucinatory effects, and laryngospasm [7,14]. Notably, ketamine lacks the dose-limiting side effects of central...assessed as a secondary outcome. Median daily pain scores measured via the NRS were also evaluated. All opioid requirements were measured in mg of IV... blood pressure. Conversely, opioid use may lead to reduced heart rate and blood pressure [21]. Studies have shown that ketamine provides analgesia when

  16. Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study

    Directory of Open Access Journals (Sweden)

    Charu Singh

    2016-01-01

    Full Text Available True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg weekly for a period of 6 weeks and Group B (20 patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

  17. Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study.

    Science.gov (United States)

    Singh, Charu; Kawatra, Rahul; Gupta, Jaya; Awasthi, Vishnu; Dungana, Homnath

    2016-01-01

    True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases) received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg) weekly for a period of 6 weeks and Group B (20) patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS) after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

  18. Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study.

    Science.gov (United States)

    Guarda-Nardini, Luca; Manfredini, Daniele; Salamone, Milena; Salmaso, Luigi; Tonello, Stefano; Ferronato, Giuseppe

    2008-04-01

    The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

  19. Pilot Study on Harmonisation of Reactor Safety in WENRA Countries

    International Nuclear Information System (INIS)

    2003-03-01

    Most of the objectives, set for the Pilot Study, were met. It can be concluded that the methodology was adequate for its purpose. National requirements on selected safety issues have been systematically compared and the major gaps and differences have been identified. Convenient overviews have been provided of differences and similarities between the countries. Furthermore, the conclusions are based on a safety justification and are detailed enough to provide input to a further more detailed analysis on the national level. It was not possible, however, to provide fully verified conclusions about the implementation of the reference levels in the different countries. This has to do with the following constraints on the study: In line with the Terms of Reference, the comparison of formal requirements did not address the more detailed use of criteria and methods to verify compliance. The same requirement could be enforced differently in different regulatory systems, and hence lead to different implementation. The Pilot Study also assessed the implementation, but it was not possible to do this in sufficient detail to identify such differences. The implementation was assessed on the basis of current knowledge of the respective regulatory body, but it was not possible to provide the panels with evidence of the implementation. For these reasons, conclusions about implemented safety provisions in the different countries should be drawn with precaution. The introduction of the panel assessments greatly improved the quality and consistency of the comparison assessments. Uncertainties in the assessments are mainly connected with lack of time to make a detailed analysis in some cases. The reliability of the assessments seems to be sufficient for the objectives of the Pilot Study. The introduction of the IAEA safety standards in the study proved to be helpful and provided confidence in the scope and strictness of the reference levels. This Pilot Study has contributed to

  20. A randomised double-blind placebo-controlled pilot trial of a combined extract of sage, rosemary and melissa, traditional herbal medicines, on the enhancement of memory in normal healthy subjects, including influence of age.

    Science.gov (United States)

    Perry, N S L; Menzies, R; Hodgson, F; Wedgewood, P; Howes, M-J R; Brooker, H J; Wesnes, K A; Perry, E K

    2018-01-15

    To evaluate for the first time the effects of a combination of sage, rosemary and melissa (Salvia officinalis L., Rosmarinus officinalis L. and Melissa officinalis L.; SRM), traditional European medicines, on verbal recall in normal healthy subjects. To devise a suitable study design for assessing the clinical efficacy of traditional herbal medicines for memory and brain function. Forty-four normal healthy subjects (mean age 61 ± 9.26y SD; m/f 6/38) participated in this study. A double-blind, randomised, placebo-controlled pilot study was performed with subjects randomised into an active and placebo group. The study consisted of a single 2-week term ethanol extract of SRM that was chemically-characterised using high resolution LC-UV-MS/MS analysis. Immediate and delayed word recall were used to assess memory after taking SRM or placebo (ethanol extract of Myrrhis odorata (L.) Scop.). In addition analysis was performed with subjects divided into younger and older subgroups (≤ 62 years mean age n = 26: SRM n = 10, Placebo n = 16; ≥ 63 years n = 19: SRM n = 13, Placebo n = 6). Overall there were no significant differences between treatment and placebo change from baseline for immediate or delayed word recall. However subgroup analysis showed significant improvements to delayed word recall in the under 63 year age group (p memory in healthy subjects under 63 years of age. Short- and long- term supplementation with SRM extract merits more robust investigation as an adjunctive treatment for patients with Alzheimer's disease and in the general ageing population. The study design proved a simple cost effective trial protocol to test the efficacy of herbal medicines on verbal episodic memory, with future studies including broader cognitive assessment. Copyright © 2017 Elsevier GmbH. All rights reserved.

  1. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Michelle L Dossett

    Full Text Available It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1 either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2 either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41, however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01. Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this

  2. Adaptive changes in early and late blind: a fMRI study of Braille reading.

    Science.gov (United States)

    Burton, H; Snyder, A Z; Conturo, T E; Akbudak, E; Ollinger, J M; Raichle, M E

    2002-01-01

    Braille reading depends on remarkable adaptations that connect the somatosensory system to language. We hypothesized that the pattern of cortical activations in blind individuals reading Braille would reflect these adaptations. Activations in visual (occipital-temporal), frontal-language, and somatosensory cortex in blind individuals reading Braille were examined for evidence of differences relative to previously reported studies of sighted subjects reading print or receiving tactile stimulation. Nine congenitally blind and seven late-onset blind subjects were studied with fMRI as they covertly performed verb generation in response to reading Braille embossed nouns. The control task was reading the nonlexical Braille string "######". This study emphasized image analysis in individual subjects rather than pooled data. Group differences were examined by comparing magnitudes and spatial extent of activated regions first determined to be significant using the general linear model. The major adaptive change was robust activation of visual cortex despite the complete absence of vision in all subjects. This included foci in peri-calcarine, lingual, cuneus and fusiform cortex, and in the lateral and superior occipital gyri encompassing primary (V1), secondary (V2), and higher tier (VP, V4v, LO and possibly V3A) visual areas previously identified in sighted subjects. Subjects who never had vision differed from late blind subjects in showing even greater activity in occipital-temporal cortex, provisionally corresponding to V5/MT and V8. In addition, the early blind had stronger activation of occipital cortex located contralateral to the hand used for reading Braille. Responses in frontal and parietal cortex were nearly identical in both subject groups. There was no evidence of modifications in frontal cortex language areas (inferior frontal gyrus and dorsolateral prefrontal cortex). Surprisingly, there was also no evidence of an adaptive expansion of the somatosensory or

  3. Mindfulness-based stress reduction for Tourette Syndrome and Chronic Tic Disorder: a pilot study.

    Science.gov (United States)

    Reese, Hannah E; Vallejo, Zayda; Rasmussen, Jessica; Crowe, Katherine; Rosenfield, Elizabeth; Wilhelm, Sabine

    2015-03-01

    In this pilot study we sought to develop and test a modified form of mindfulness-based stress reduction (MBSR-tics) for the treatment of Tourette Syndrome (TS) and Chronic Tic Disorder (CTD). Our specific aims were: 1) To determine the feasibility and acceptability of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD and 2) To determine the efficacy of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD. Eighteen individuals age 16-67 completed an uncontrolled open trial of MBSR-tics. The intervention consisted of 8 weekly 2-hour classes and one 4hour retreat in the fifth or sixth week of the program. Symptomatic assessments were performed at baseline, post-treatment, and one-month follow-up. MBSR-tics proved to be a feasible and acceptable intervention. It resulted in significant improvement in tic severity and tic-related impairment. 58.8% of subjects were deemed treatment responders. Therapeutic gains were maintained at 1-month follow-up. Improvements in tic severity were correlated with increases in self-reported levels of mindfulness. This small open pilot study provides preliminary support for the feasibility, acceptability, and efficacy of MBSR-tics for individuals 16 or older with TS or CTD. A larger randomized controlled trial with blind assessment is necessary to confirm these initial, promising findings. Trial Registration Partners Clinical Trials Registry Number 2011P000606 (clinicaltrials.partners.org). Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Effect of Diet on Gulf War Illness: A Pilot Study

    Science.gov (United States)

    2017-10-01

    Award Number: W81XWH-15-1-0636 TITLE: Effect of Diet on Gulf War Illness: A Pilot Study PRINCIPAL INVESTIGATOR: Ashok Tuteja, M.D. M.P.H...CONTRACT NUMBER Effect of Diet on Gulf War Illness 5b. GRANT NUMBER W81XWH-15-1-0636 5c. PROGRAM ELEMENT NUMBER 6 . AUTHOR(S) 5d. PROJECT NUMBER...headache) in Veterans with Gulf War Illness. We will also determine if the change in gut flora is a mechanism for improvement in symptoms of IBS and GW

  5. Hydrologic studies for the Waste Isolation Pilot Plant

    International Nuclear Information System (INIS)

    Davies, P.B.

    1994-01-01

    The objective of this paper is to provide a general overview of hydrologic conditions at the Waste Isolation Pilot Plant (WIPP) by describing several key hydrologic studies that have been carried out as part of the site characterization program over the last 20 years. The paper is composed of three parts: background information about general objectives of the WIPP project; information about the geologic and hydrologic setting of the facility; and information about three aspects of the hydrologic system that are important to understanding the long-term performance of the WIPP facility. For additional detailed information, the reader is referred to the references cited in the text

  6. Teaching Billing and Coding to Medical Students: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Jiaxin Tran

    2013-08-01

    Full Text Available Complex billing practices cost the US healthcare system billions of dollars annually. Coding for outpatient office visits [known as Evaluation & Management (E&M services] is commonly particularly fraught with errors. The best way to insure proper billing and coding by practicing physicians is to teach this as part of the medical school curriculum. Here, in a pilot study, we show that medical students can learn well the basic principles from lectures. This approach is easy to implement into a medical school curriculum.

  7. Effects of Aquajogging in Obese Adults: A Pilot Study

    OpenAIRE

    Wouters, Eveline J. M.; Van Nunen, Annemieke M. A.; Geenen, Rinie; Kolotkin, Ronette L.; Vingerhoets, Ad J. J. M.

    2009-01-01

    Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat mass and waist circumference decreased 1.4 kg (P = .03) and 3.1 cm (P = .005), respectively. The distance in the Six-Minute Walk Test increased 41 meters (P = .001). Three scales of the Impact of Weig...

  8. Indonesian EFL Students’ Perspective on Writing Process: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Imelda Hermilinda Abas

    2016-06-01

    Full Text Available 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 Academic Writing and Research Methodology courses taken in UUM; (2 had written an unpublished thesis during their undergraduate studies in Indonesia and they are writing their master or doctoral thesis in English; (3 used English extensively in writing their assignments, and in daily activities. Pseudonyms were used to refer to the participants as Sukarno and Suharto. The data were collected through in-depth interviews with the participants. The interview sessions took approximately 15-20 minutes for each participant and were videotaped and audiotaped. Semi-structured interview with 15 questions and probes were used. The results showed that the two participants had positive feelings and attitudes towards writing in English. Although they had a hard time in English writing during their undergraduate in Indonesia, they become fond of writing in English in their postgraduate time due to the exposure to English extensively. In composing, they used brainstorming, drafting, pausing, revising and editing in a recursive manner. Keywords: in-depth interview, pilot study, writing process, English as a Foreign Language (EFL

  9. What is a pilot or feasibility study? A review of current practice and editorial policy

    Directory of Open Access Journals (Sweden)

    Cooper Cindy L

    2010-07-01

    Full Text Available Abstract Background In 2004, a review of pilot studies published in seven major medical journals during 2000-01 recommended that the statistical analysis of such studies should be either mainly descriptive or focus on sample size estimation, while results from hypothesis testing must be interpreted with caution. We revisited these journals to see whether the subsequent recommendations have changed the practice of reporting pilot studies. We also conducted a survey to identify the methodological components in registered research studies which are described as 'pilot' or 'feasibility' studies. We extended this survey to grant-awarding bodies and editors of medical journals to discover their policies regarding the function and reporting of pilot studies. Methods Papers from 2007-08 in seven medical journals were screened to retrieve published pilot studies. Reports of registered and completed studies on the UK Clinical Research Network (UKCRN Portfolio database were retrieved and scrutinized. Guidance on the conduct and reporting of pilot studies was retrieved from the websites of three grant giving bodies and seven journal editors were canvassed. Results 54 pilot or feasibility studies published in 2007-8 were found, of which 26 (48% were pilot studies of interventions and the remainder feasibility studies. The majority incorporated hypothesis-testing (81%, a control arm (69% and a randomization procedure (62%. Most (81% pointed towards the need for further research. Only 8 out of 90 pilot studies identified by the earlier review led to subsequent main studies. Twelve studies which were interventional pilot/feasibility studies and which included testing of some component of the research process were identified through the UKCRN Portfolio database. There was no clear distinction in use of the terms 'pilot' and 'feasibility'. Five journal editors replied to our entreaty. In general they were loathe to publish studies described as 'pilot'. Conclusion

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

    Science.gov (United States)

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

    2017-12-01

    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 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. Endoscopic procedure with a modified Reiki intervention: a pilot study.

    Science.gov (United States)

    Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan

    2010-01-01

    This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

  12. A study of pilot modeling in multi-controller tasks

    Science.gov (United States)

    Whitbeck, R. F.; Knight, J. R.

    1972-01-01

    A modeling approach, which utilizes a matrix of transfer functions to describe the human pilot in multiple input, multiple output control situations, is studied. The approach used was to extend a well established scalar Wiener-Hopf minimization technique to the matrix case and then study, via a series of experiments, the data requirements when only finite record lengths are available. One of these experiments was a two-controller roll tracking experiment designed to force the pilot to use rudder in order to coordinate and reduce the effects of aileron yaw. One model was computed for the case where the signals used to generate the spectral matrix are error and bank angle while another model was computed for the case where error and yaw angle are the inputs. Several anomalies were observed to be present in the experimental data. These are defined by the descriptive terms roll up, break up, and roll down. Due to these algorithm induced anomalies, the frequency band over which reliable estimates of power spectra can be achieved is considerably less than predicted by the sampling theorem.

  13. [Dental caries and early childhood development: a pilot study].

    Science.gov (United States)

    Núñez, F Loreto; Sanz, B Javier; Mejía, L Gloria

    2015-01-01

    To investigate the association between dental caries and early childhood development in 3-year-olds from Talca, Chile. A pilot study with a convenience sample of 3-year-olds from Talca (n = 39) who attend public healthcare centers. Child development was measured by the Psychomotor Development Index (PDI), a screening tool used nationally among pre-school children to assess language development, fine motor skills and coordination areas. Dental caries prevalence was evaluated by decayed, missing, filled teeth (DFMT) and decayed, missing, filled tooth surfaces (DFMS) ceo-d and ceo-s indexes. The children were divided into two groups according to the PDIscore: those with a score of 40 or more were considered developmentally normal (n = 32), and those with a score below 40 were considered as having impaired development (n = 7). The severity of caries (DMFT) was negatively correlated with PDI (r = -0.82), and children with the lowest TEPSI score had the highest DFMT values. The average DMFT in children with normal development was 1.31, and 3.57 for those with impaired development. This pilot study indicates that the severity of dental caries is correlated with early childhood development. Copyright © 2015. Publicado por Elsevier España, S.L.U.

  14. Feasibility Pilot Study: Training Soft Skills in Virtual Worlds.

    Science.gov (United States)

    Abshier, Patricia

    2012-04-01

    In a world where funding is limited, training for healthcare professionals is turning more and more to distance learning in an effort to maintain a knowledgeable and skilled work force. In 2010, Cicatelli Associates, Inc. began exploring the feasibility of using games and virtual worlds as an alternative means to teach skills-training in a distance-learning environment. The pilot study was conducted with six individuals familiar with general counseling and communication skills used by the healthcare industry to promote behavior change. Participants reported that the venue, although challenging at first, showed great potential for use with healthcare providers, as it allowed for more interaction and activities than traditional Webinars. However, there are significant limitations that must be overcome in order for this healthcare training modality to be utilized on a large scale. These limitations included a lack of microgestures and issues regarding the technology being used. In spite of the limitations, however, the potential use of virtual worlds for the training of healthcare providers exists and should be researched further. This article discusses the need and intended benefits of virtual world training as well as the results and conclusions of the pilot study.

  15. Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).

    Science.gov (United States)

    Haupt, E; Ledermann, H; Köpcke, W

    2005-02-01

    The aim of the study was to evaluate the efficacy of benfotiamine administered over three weeks (allithiamine; a lipid-soluble vitamin B1 prodrug with high bioavailability) to patients with diabetic polyneuropathy in a randomized, placebo-controlled, double-blind, two-center pilot study. Forty inpatients (23 male, 18 female, age range 18 - 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of not longer than two years, were included in the study. Twenty Patients received two 50 mg benfotiamine tablets four times daily and 20 patients received placebo over the three-week study period. Two clinical units were involved with 10 patients receiving placebo and 10 patients benfotiamine in each. The neuropathy score according to Katzenwadel et al. [1987] was used to evaluate symptoms of polyneuropathy, vibration perception threshold and both the physician's and the patient's own assessment were documented. A statistically significant (p = 0.0287) improvement in the neuropathy score was observed in the group given active drug when compared to the placebo-treated controls. There was no statistically significant change observed in the tuning fork test. The most pronounced effect on complaints was a decrease in pain (p = 0.0414). More patients in the benfotiamine-treated group than in the placebo group considered their clinical condition to have improved (p = 0.052). No side effects attributable to benfotiamine were observed. The differences between the groups cannot be attributed to a change in metabolic parameters since there were no significant alterations in the HbA1 levels and blood sugar profiles. The body mass index of the two groups did not differ. This pilot investigation (BEDIP Study) has confirmed the results of two earlier randomized controlled trials and has provided further evidence for the beneficial effects of benfotiamine in patients with diabetic neuropathy.

  16. HandTutor™ enhanced hand rehabilitation after stroke--a pilot study.

    Science.gov (United States)

    Carmeli, Eli; Peleg, Sara; Bartur, Gadi; Elbo, Enbal; Vatine, Jean-Jacques

    2011-12-01

    This study assessed the potential therapeutic benefi t of using HandTutor™ in combination with traditional rehabilitation in a post-stroke sub-acute population. The study compares an experimental group receiving traditional therapy combined with HandTutorTM treatment, against a control group receiving only traditional therapy. An assessor-blinded, randomized controlled pilot trial, was conducted in the Reuth rehabilitation unit in Israel. Thirty-one stroke patients in the sub-acute phase, were randomly assigned to one of the two groups (experimental or control) in sets of three. The experimental group (n = 16) underwent a hand rehabilitation programme using the HandTutorTM combined with traditional therapy. The control group (n = 15) received only traditional therapy. The treatment schedules for both groups were of similar duration and frequency. Improvements were evaluated using three indicators: 1) The Brunnström-Fugl-Meyer (FM) test, 2) the Box and Blocks (B&B) test and 3) improvement parameters as determined by the HandTutorTM software. Following 15 consecutive treatment sessions, a signifi cant improvement was observed within the experimental group (95% confi dence intervals) compared with the control group: B&B p = 0.015; FM p = 0.041, HandTutor™ performance accuracy on x axis and performance accuracy on y axis p stroke hand function rehabilitation.

  17. A pilot study of short-duration sputum pretreatment procedures for optimizing smear microscopy for tuberculosis.

    Directory of Open Access Journals (Sweden)

    Peter Daley

    2009-05-01

    Full Text Available Direct sputum smear microscopy for tuberculosis (TB lacks sensitivity for the detection of acid fast bacilli. Sputum pretreatment procedures may enhance sensitivity. We did a pilot study to compare the diagnostic accuracy and incremental yield of two short-duration (<1 hour sputum pretreatment procedures to optimize direct smears among patients with suspected TB at a referral hospital in India.Blinded laboratory comparison of bleach and universal sediment processing (USP pretreated centrifuged auramine smears to direct Ziehl-Neelsen (ZN and direct auramine smears and to solid (Loweinstein-Jensen (LJ and liquid (BACTEC 460 culture. 178 pulmonary and extrapulmonary TB suspects were prospectively recruited during a one year period. Thirty six (20.2% were positive by either solid or liquid culture. Direct ZN smear detected 22 of 36 cases and direct auramine smears detected 26 of 36 cases. Bleach and USP centrifugation detected 24 cases each, providing no incremental yield beyond direct smears. When compared to combined culture, pretreated smears were not more sensitive than direct smears (66.6% vs 61.1 (ZN or 72.2 (auramine, and were not more specific (92.3% vs 93.0 (ZN or 97.2 (auramine.Short duration sputum pretreatment with bleach and USP centrifugation did not increase yield as compared to direct sputum smears. Further work is needed to confirm this in a larger study and also determine if longer duration pre-treatment might be effective in optimizing smear microscopy for TB.

  18. Blindness and visual impairment in retinitis pigmentosa: a Cameroonian hospital-based study

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    André Omgbwa Eballe

    2010-06-01

    Full Text Available André Omgbwa Eballe1, Godefroy Koki2, Claude Bernard Emche2, Lucienne Assumpta Bella2, Jeanne Mayouego Kouam2, Justin Melong31Faculty of Medicine and Pharmaceutical Sciences, University of Douala; 2Faculty of Medicine and Biomedical Sciences, University of Yaoundé; 3Translation Unit, Ministry of Public Health, Yaoundé, CameroonAim: We performed a retrospective, analytical study in February 2010 on all retinitis pigmentosa cases seen during ophthalmologic consultation at the Gyneco-Obstetrics and Pediatric Hospital of Yaounde between March 2002 and December 2009 (82 months. The aim of this research was to determine the significance of blindness and visual impairment associated with retinitis pigmentosa in Cameroon.Results: Forty cases were reported, corresponding to a hospital prevalence of 1.6/1000 (21 men and 19 women. The average age of the patients was 43.3 ± 18 years, ranging between 6 and 74 years. Bilateral blindness and low vision was noted in 30% and 27.5% of patients, respectively. The average age of patients with low vision was 40.38 ± 16.27 years and the average age of those with bilateral blindness was 51.08 ± 15.79 years. Retinitis pigmentosa was bilateral in all cases and isolated (without any eye or general additional disease in 67.5% of cases.Conclusion: Visual impairment is common and becomes even more severe with aging. Patients should be screened to enable them to benefit from management focusing on both appropriate treatment and genetic counseling.Keywords: retinitis pigmentosa, Cameroon, blindness, Yaoundé

  19. Blind deblurring of spiral CT images - comparative studies on edge-to-noise ratios

    International Nuclear Information System (INIS)

    Jiang Ming; Wan Ge; Skinner, Margaret W.; Rubinstein, Jay T.; Vannier, Michael W.

    2002-01-01

    A recently developed blind deblurring algorithm based on the edge-to-noise ratio has been applied to improve the quality of spiral CT images. Since the discrepancy measure used to quantify the edge and noise effects is not symmetric, there are several ways to formulate the edge-to-noise ratio. This article is to investigate the performance of those ratios with phantom and patient data. In the phantom study, it is shown that all the ratios share similar properties, validating the blind deblurring algorithm. The image fidelity improvement varies from 29% to 33% for different ratios, according to the root mean square error (RMSE) criterion; the optimal iteration number determined for each ratio varies from 25 to 35. Those ratios that are associated with most satisfactory performance are singled out for the image fidelity improvement of about 33% in the numerical simulation. After automatic blind deblurring with the selected ratios, the spatial resolution of CT is substantially refined in all the cases tested

  20. Parental Grief and Marital Issues Aftermath: A Pilot Study

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    Nur Atikah Mohamed Hussin

    2016-06-01

    Full Text Available The death of a child is difficult to the bereaved parents. Literature had associated the loss with marriage disruption. The issues on that the difficulties to communicate, gender-related coping mechanisms and sexual need were discussed as reasons for bereaved parents to have conflict in their relationship. However there is limited knowledge about this issue. A pilot study has been conducted among six bereaved parents. The bereaved parents were Malaysian Muslim bereaved parents. They were interviewed individually to explore the challenges or conflicts that they had experienced after the death of their child. This study revealed that there were situations which bereaved parents described as having difficulties in their relationship. However, this study also revealed that the mutual understanding and respect to each other are the most of important components for bereaved parents to maintain their relationship post-loss. This study suggested the importance of suggesting couple counselling to bereaved parents after the death of their child.

  1. A single center, pilot, double-blinded, randomized, comparative, prospective clinical study to evaluate improvements in the structure and function of facial skin with tazarotene 0.1% cream alone and in combination with GliSODin® Skin Nutrients Advanced A

    Directory of Open Access Journals (Sweden)

    Goldberg LD

    2014-05-01

    Full Text Available Lawrence D Goldberg, Corina CryslerShaft Medical San Diego, San Diego, CA, USABackground: Superoxide dismutase (SOD reduces the reactive oxygen species formation associated with oxidative stress. An imbalance between free radicals and antioxidants can lead to accelerated aging. GliSODin® Skin Nutrients Advanced Anti-Aging Formula (GAAF is an SOD-containing dietary nutricosmetic formulated with other nutraceuticals that promote improvements in the structure and function of the skin, including hydration, elasticity, structural integrity, and photoaging caused by oxidative stress. Tazarotene cream 0.1% (TAZ is a United States Food and Drug Administration-approved drug indicated for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines when taken in conjunction with a comprehensive skin care and sun avoidance program.Objective: To determine if the antioxidant, anti-aging, hydrating and skin-rejuvenating properties of GAAF complement the retinoic actions of TAZ to improve the structure and function of facial skin.Method: A 90-day comparative study of ten subjects with facial photodamage; daily topical application of TAZ was used in combination with three capsules of GAAF (780 mg each or placebo orally, with food, per the randomization allocation.Results: After 90 days of treatment, TAZ alone and in combination with GAAF improved fine wrinkles (↓1.2 versus 2.0, mottled hyperpigmentation (↓2.2 versus 2.8 and overall photodamage (↓1.0 versus 1.8, as well as patient-reported response to treatment (↓2.0 versus 1.6. At week 12, TAZ/GAAF combination treatment (Group A versus TAZ treatment alone (Group C was of significant clinical benefit, with respect to fine wrinkling (14.7%/41.7%, overall photodamage (15.6%/53.0%, skin moisture (19.1%/103.2%, skin elasticity (12.8%/87.7%, and response to treatment (8.8%/21.4%.Conclusion: The study suggests GAAF in combination with TAZ is safe and

  2. Team Development Measure in Interprofessional Graduate Education: A Pilot Study.

    Science.gov (United States)

    Beebe, Lora Humphrey; Roman, Marian; Skolits, Gary; Raynor, Hollie; Thompson, Dixie; Franks, Andrea

    2018-04-01

    A faculty team developed the 4-week Recovery-Based Interprofessional Distance Education (RIDE) rotation for graduate students in their disciplines. The evaluation team identified the Team Development Measure (TDM) as a potential alternative to reflect team development during the RIDE rotation. The TDM, completed anonymously online, was piloted on the second student cohort (N = 18) to complete the RIDE rotation. The overall pretest mean was 60.73 points (SD = 11.85) of a possible 100 points, indicating that students anticipated their RIDE team would function at a moderately high level during the 4-week rotation. The overall posttest mean, indicating student perceptions of actual team functioning, was 72.71 points (SD = 23.31), an average increase of 11.98 points. Although not statistically significant, Cohen's effect size (d = 0.43) indicates an observed difference of large magnitude. No other published work has used the TDM as a pre-/posttest measure of team development. The authors believe the TDM has several advantages as a measure of student response to interprofessional education offerings, particularly in graduate students with prior experience on health care teams. Further work is needed to validate and extend the findings of this pilot study. [Journal of Psychosocial Nursing and Mental Health Services, 56(4), 18-22.]. Copyright 2018, SLACK Incorporated.

  3. Using singing to nurture children's hearing? A pilot study.

    Science.gov (United States)

    Welch, Graham F; Saunders, Jo; Edwards, Sian; Palmer, Zoe; Himonides, Evangelos; Knight, Julian; Mahon, Merle; Griffin, Susanna; Vickers, Deborah A

    2015-09-01

    This article reports a pilot study of the potential benefits of a sustained programme of singing activities on the musical behaviours and hearing acuity of young children with hearing impairment (HI). Twenty-nine children (n=12 HI and n=17 NH) aged between 5 and 7 years from an inner-city primary school in London participated, following appropriate ethical approval. The predominantly classroom-based programme was designed by colleagues from the UCL Institute of Education and UCL Ear Institute in collaboration with a multi-arts charity Creative Futures and delivered by an experienced early years music specialist weekly across two school terms. There was a particular emphasis on building a repertoire of simple songs with actions and allied vocal exploration. Musical learning was also supported by activities that drew on visual imagery for sound and that included simple notation and physical gesture. An overall impact assessment of the pilot programme embraced pre- and post-intervention measures of pitch discrimination, speech perception in noise and singing competency. Subsequent statistical data analyses suggest that the programme had a positive impact on participant children's singing range, particularly (but not only) for HI children with hearing aids, and also in their singing skills. HI children's pitch perception also improved measurably over time. Findings imply that all children, including those with HI, can benefit from regular and sustained access to age-appropriate musical activities.

  4. Comparative evaluation of hemodynamic, vasoconstrictive, and SpO2variability during different stages of periodontal surgery performed using 0.5% ropivacaine or 2% lignocaine HCl (1:80,000 adrenaline local anesthesia: A randomized, double-blind, split-mouth pilot study

    Directory of Open Access Journals (Sweden)

    Ashank Mishra

    2018-01-01

    Full Text Available Aim: The aim of this study is to compare anesthetic, hemodynamic, vasoconstrictive, and SpO2variability of 0.5% ropivacaine to the “gold standard” lignocaine (2% with epinephrine (1:80,000 during periodontal surgery. Materials and Methods: A total of 20 systemically healthy controls meeting the inclusion criteria were selected from the Outpatient Department of Sri Sai College of Dental Surgery. Preoperatively, all participants were infiltrated with 0.5 ml of 0.5% ropivacaine intradermally as test solution to record any allergic reaction. Open flap debridement was performed using local anesthesia containing 2% lignocaine hydrochloride with 1:80,000 epinephrine or 0.5% ropivacaine. Recordings were made of the time of onset, duration of action, the intensity, and depth of anesthesia and various hemodynamic changes throughout the surgical procedure. In addition, blood loss volume and postoperative pain were also assessed. Results: Ropivacaine showed statistically longer duration of action (mean±SD =5.3±0.71 hrs than lignocaine with epinephrine (mean=2.14±0.98 hrs. Blood loss during flap surgery was comparatively less when performed under ropivacaine. No statistical differences were observed in systolic BP, diastolic BP, SpO2 and heart rate during different stages of periodontal surgery between either of the local anesthetic agents Conclusion: Ropivacaine demonstrates comparable efficacy as lignocaine with added advantage of longer duration of action and superior postoperative pain control. No adverse events from this newer anesthetic were noted, and hence, it can be used safely as a viable local anesthetic for periodontal surgical procedures.

  5. Flight simulation using a Brain-Computer Interface: A pilot, pilot study.

    Science.gov (United States)

    Kryger, Michael; Wester, Brock; Pohlmeyer, Eric A; Rich, Matthew; John, Brendan; Beaty, James; McLoughlin, Michael; Boninger, Michael; Tyler-Kabara, Elizabeth C

    2017-01-01

    As Brain-Computer Interface (BCI) systems advance for uses such as robotic arm control it is postulated that the control paradigms could apply to other scenarios, such as control of video games, wheelchair movement or even flight. The purpose of this pilot study was to determine whether our BCI system, which involves decoding the signals of two 96-microelectrode arrays implanted into the motor cortex of a subject, could also be used to control an aircraft in a flight simulator environment. The study involved six sessions in which various parameters were modified in order to achieve the best flight control, including plane type, view, control paradigm, gains, and limits. Successful flight was determined qualitatively by evaluating the subject's ability to perform requested maneuvers, maintain flight paths, and avoid control losses such as dives, spins and crashes. By the end of the study, it was found that the subject could successfully control an aircraft. The subject could use both the jet and propeller plane with different views, adopting an intuitive control paradigm. From the subject's perspective, this was one of the most exciting and entertaining experiments she had performed in two years of research. In conclusion, this study provides a proof-of-concept that traditional motor cortex signals combined with a decoding paradigm can be used to control systems besides a robotic arm for which the decoder was developed. Aside from possible functional benefits, it also shows the potential for a new recreational activity for individuals with disabilities who are able to master BCI control. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. A Component-Based Study of the Effect of Diameter on Bond and Anchorage Characteristics of Blind-Bolted Connections.

    Directory of Open Access Journals (Sweden)

    Muhammad Nasir Amin

    Full Text Available Structural hollow sections are gaining worldwide importance due to their structural and architectural advantages over open steel sections. The only obstacle to their use is their connection with other structural members. To overcome the obstacle of tightening the bolt from one side has given birth to the concept of blind bolts. Blind bolts, being the practical solution to the connection hindrance for the use of hollow and concrete filled hollow sections play a vital role. Flowdrill, the Huck High Strength Blind Bolt and the Lindapter Hollobolt are the well-known commercially available blind bolts. Although the development of blind bolts has largely resolved this issue, the use of structural hollow sections remains limited to shear resistance. Therefore, a new modified version of the blind bolt, known as the "Extended Hollo-Bolt" (EHB due to its enhanced capacity for bonding with concrete, can overcome the issue of low moment resistance capacity associated with blind-bolted connections. The load transfer mechanism of this recently developed blind bolt remains unclear, however. This study uses a parametric approach to characterising the EHB, using diameter as the variable parameter. Stiffness and load-carrying capacity were evaluated at two different bolt sizes. To investigate the load transfer mechanism, a component-based study of the bond and anchorage characteristics was performed by breaking down the EHB into its components. The results of the study provide insight into the load transfer mechanism of the blind bolt in question. The proposed component-based model was validated by a spring model, through which the stiffness of the EHB was compared to that of its components combined. The combined stiffness of the components was found to be roughly equivalent to that of the EHB as a whole, validating the use of this component-based approach.

  7. A Component-Based Study of the Effect of Diameter on Bond and Anchorage Characteristics of Blind-Bolted Connections.

    Science.gov (United States)

    Amin, Muhammad Nasir; Zaheer, Salman; Alazba, Abdulrahman Ali; Saleem, Muhammad Umair; Niazi, Muhammad Umar Khan; Khurram, Nauman; Amin, Muhammad Tahir

    2016-01-01

    Structural hollow sections are gaining worldwide importance due to their structural and architectural advantages over open steel sections. The only obstacle to their use is their connection with other structural members. To overcome the obstacle of tightening the bolt from one side has given birth to the concept of blind bolts. Blind bolts, being the practical solution to the connection hindrance for the use of hollow and concrete filled hollow sections play a vital role. Flowdrill, the Huck High Strength Blind Bolt and the Lindapter Hollobolt are the well-known commercially available blind bolts. Although the development of blind bolts has largely resolved this issue, the use of structural hollow sections remains limited to shear resistance. Therefore, a new modified version of the blind bolt, known as the "Extended Hollo-Bolt" (EHB) due to its enhanced capacity for bonding with concrete, can overcome the issue of low moment resistance capacity associated with blind-bolted connections. The load transfer mechanism of this recently developed blind bolt remains unclear, however. This study uses a parametric approach to characterising the EHB, using diameter as the variable parameter. Stiffness and load-carrying capacity were evaluated at two different bolt sizes. To investigate the load transfer mechanism, a component-based study of the bond and anchorage characteristics was performed by breaking down the EHB into its components. The results of the study provide insight into the load transfer mechanism of the blind bolt in question. The proposed component-based model was validated by a spring model, through which the stiffness of the EHB was compared to that of its components combined. The combined stiffness of the components was found to be roughly equivalent to that of the EHB as a whole, validating the use of this component-based approach.

  8. Using interactive video technology in nursing education: a pilot study.

    Science.gov (United States)

    Zerr, Daria M; Pulcher, Karen L

    2008-02-01

    A pilot study was conducted to analyze the benefits of using interactive technology with external assessors and graduating senior nursing students during Senior Nurse Leadership Assessment Day at the University of Central Missouri. The primary aim was to determine whether videoconferencing technology would promote recruitment and retention of professional nurse external assessors without compromising student learning. Among the issues discussed are the advantages and disadvantages of using interactive videoconferencing technology in education and the influence of external assessors in nursing education. The study results indicate that interactive videoconferencing is an effective, accepted format for educational opportunities such as Senior Nurse Leadership Assessment Day, based on the lived experiences of the study participants. In addition, the results demonstrate that interactive videoconferencing does not compromise student learning or assessment by external assessors.

  9. A novel magnetic stimulator increases experimental pain tolerance in healthy volunteers - a double-blind sham-controlled crossover study.

    Directory of Open Access Journals (Sweden)

    Rudie Kortekaas

    Full Text Available UNLABELLED: The 'complex neural pulse'(TM (CNP is a neuromodulation protocol employing weak pulsed electromagnetic fields (PEMF. A pioneering paper reported an analgesic effect in healthy humans after 30 minutes of CNP-stimulation using three nested whole head coils. We aimed to devise and validate a stimulator with a novel design entailing a multitude of small coils at known anatomical positions on a head cap, to improve applicability. The main hypothesis was that CNP delivery with this novel device would also increase heat pain thresholds. Twenty healthy volunteers were enrolled in this double-blind, sham-controlled, crossover study. Thirty minutes of PEMF (CNP or sham was applied to the head. After one week the other treatment was given. Before and after each treatment, primary and secondary outcomes were measured. Primary outcome was heat pain threshold (HPT measured with thermal quantitative sensory testing. Other outcomes were warmth detection threshold, and aspects of cognition, emotion and motor performance. As hypothesized heat pain threshold was significantly increased after the PEMF stimulation. All other outcomes were unaltered by the PEMF but there was a trend level reduction of cognitive performance after PEMF stimulation as measured by the digit-symbol substitution task. Results from this pilot study suggest that our device is able to stimulate the brain and to modulate its function. This is in agreement with previous studies that used similar magnetic field strengths to stimulate the brain. Specifically, pain control may be achieved with PEMF and for this analgesic effect, coil design does not appear to play a dominant role. In addition, the flexible configuration with small coils on a head cap improves clinical applicability. TRIAL REGISTRATION: Dutch Cochrane Centre NTR1093.

  10. Estimation and quantification of human DNA in dental calculus: A pilot study.

    Science.gov (United States)

    Singh, Udita; Goel, Saurabh

    2017-01-01

    Identification using DNA has proved its accuracy multiple times in the field of forensic investigations. Investigators usually rely on either teeth or bone as the DNA reservoirs. However, there are instances where the skeletal or dental remains are not available or not preserved properly. Moreover, due to religious beliefs, the family members of the dead do not allow the investigating team to damage the remains for the sole purpose of identification. To investigate the presence of human DNA in dental calculus and to quantify the amount, if present. This prospective single-blinded pilot study included twenty subjects selected from the patients visiting a dental college. The samples of dental calculus were collected from the thickest portion of calculus deposited on the lingual surfaces of mandibular incisors. These samples were decontaminated and subjected to gel electrophoresis for DNA extraction. DNA was found in 85% cases. The amount of DNA varied from 21 to 37 μg/ml of dental calculus. Dental calculus is a rich reservoir of human DNA.

  11. Competence feedback improves CBT competence in trainee therapists: A randomized controlled pilot study.

    Science.gov (United States)

    Weck, Florian; Kaufmann, Yvonne M; Höfling, Volkmar

    2017-07-01

    The development and improvement of therapeutic competencies are central aims in psychotherapy training; however, little is known about which training interventions are suitable for the improvement of competencies. In the current pilot study, the efficacy of feedback regarding therapeutic competencies was investigated in cognitive behavioural therapy (CBT). Totally 19 trainee therapists and 19 patients were allocated randomly to a competence feedback group (CFG) or control group (CG). Two experienced clinicians and feedback providers who were blind to the treatment conditions independently evaluated therapeutic competencies on the Cognitive Therapy Scale at five treatment times (i.e., at Sessions 1, 5, 9, 13, and 17). Whereas CFG and CG included regular supervision, only therapists in the CFG additionally received written qualitative and quantitative feedback regarding their demonstrated competencies in conducting CBT during treatment. We found a significant Time × Group interaction effect (η² = .09), which indicates a larger competence increase in the CFG in comparison to the CG. Competence feedback was demonstrated to be suitable for the improvement of therapeutic competencies in CBT. These findings may have important implications for psychotherapy training, clinical practice, and psychotherapy research. However, further research is necessary to ensure the replicability and generalizability of the findings.

  12. Microencapsulated foods as a functional delivery vehicle for omega-3 fatty acids: a pilot study

    Directory of Open Access Journals (Sweden)

    David Robert M

    2009-05-01

    Full Text Available Abstract It is well established that the ingestion of the omega-3 (N3 fatty acids docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA positively benefit a variety of health indices. Despite these benefits the actual intake of fish derived N3 is relatively small in the United States. The primary aim of our study was to examine a technology capable of delivering omega-3 fatty acids in common foods via microencapsulation (MicroN3 in young, healthy, active participants who are at low risk for cardiovascular disease. Accordingly, we randomized 20 participants (25.4 ± 6.2 y; 73.4 ± 5.1 kg to receive the double blind delivery of a placebo-matched breakfast meal (~2093 kJ containing MicroN3 (450–550 mg EPA/DHA during a 2-week pilot trial. Overall, we observed no differences in overall dietary macronutrient intake other than the N3 delivery during our treatment regimen. Post-test ANOVA analysis showed a significant elevation in mean (SE plasma DHA (91.18 ± 9.3 vs. 125.58 ± 11.3 umol/L; P

  13. 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.

    Directory of Open Access Journals (Sweden)

    Tae Ho Kim

    Full Text Available 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.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.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.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.ClinicalTrials.gov NCT02895178.

  14. PILOT STUDY: Report on the CCPR Pilot Comparison: Spectral Responsivity 10 nm to 20 nm

    Science.gov (United States)

    Scholze, Frank; Vest, Robert; Saito, Terubumi

    2010-01-01

    The CCPR Pilot Comparison on spectral responsivity in the 10 nm to 20 nm spectral range was carried out within the framework of the CIPM Mutual Recognition Arrangement by three laboratories: PTB (Germany), NIST (USA), and NMIJ/AIST (Japan) with PTB acting as the central and reporting laboratory. All participating laboratories used monochromatized synchrotron radiation. PTB and NIST used a cryogenic radiometer as the primary standard detector and NMIJ, an ionization chamber with extrapolation by a wavelength-independent detector. The aim of the pilot comparison was to check the accuracy of the radiometric scale of spectral responsivity in the short wavelength EUV spectral range which has recently gained in technological importance. The wavelengths of measurement were from 11.5 nm to 20 nm in 0.5 nm steps and additionally 12.2 nm. The comparison was carried out through the calibration of a group of transfer standard detectors. Two sets of three diodes of types AXUV and SXUV from International Radiation Detectors, Inc. were used for the comparison. The comparison had the form of a star comparison: Pilot-lab A-pilot-lab B-pilot, PTB acting as the pilot laboratory. All results were communicated directly to the pilot laboratory. The report describes in detail the measurements made at PTB and summarizes the reports submitted by the participants. Measurements carried out by the pilot laboratory before and after the circulation of the detectors proved that the stability of the detectors was sufficient for the comparison. For the type AXUV detectors, however, changes in their responsivity contributed to the uncertainty of the comparison. Measurement results from participants and their associated uncertainties were analyzed in this report according to the Guidelines for CCPR Comparison Report Preparation. The uncertainty contributions were separated, as to whether they are wavelength dependent or not. All bilateral DoE are well within the respective k = 2 expanded uncertainty

  15. Acupressure for smoking cessation – a pilot study

    Directory of Open Access Journals (Sweden)

    Moody Russell C

    2007-03-01

    Full Text Available Abstract Background Tobacco smoking is a serious risk to health: several therapies are available to assist those who wish to stop. Smokers who approach publicly funded stop-smoking clinics in the UK are currently offered nicotine replacement therapy (NRT or bupropion, and group behaviour therapy, for which there is evidence of effectiveness. Acupuncture and acupressure are also used to help smokers, though a systematic review of the evidence of their effectiveness was inconclusive. The aim of this pilot project was to determine the feasibility of a study to test acupressure as an adjunct to one anti-smoking treatment currently offered, and to inform the design of the study. Methods An open randomised controlled pilot study was conducted within the six week group programme offered by the Smoking Advice Service in Plymouth, UK. All participants received the usual treatment with NRT and group behavioural therapy, and were randomised into three groups: group A with two auricular acupressure beads, group B with one bead, and group C with no additional therapy. Participants were taught to press the beads when they experienced cravings. Beads were worn in one ear for four weeks, being replaced as necessary. The main outcome measures assessed in the pilot were success at quitting (expired CO ≤ 9 ppm, the dose of NRT used, and the rating of withdrawal symptoms using the Mood and Symptoms Scale. Results From 49 smokers attending four clinics, 24 volunteered to participate, 19 attended at least once after quitting, and seven remained to the final week. Participants who dropped out reported significantly fewer previous quit attempts, but no other significant differences. Participants reported stimulating the beads as expected during the initial days after quitting, but most soon reduced the frequency of stimulation. The discomfort caused by the beads was minor, and there were no significant side effects. There were technical problems with adhesiveness of

  16. Cold flow model study of an oxyfuel combustion pilot plant

    Energy Technology Data Exchange (ETDEWEB)

    Guio-Perez, D.C.; Tondl, G.; Hoeltl, W.; Proell, T.; Hofbauer, H. [Vienna University of Technology, Institute of Chemical Engineering, Vienna (Austria)

    2011-12-15

    The fluid-dynamic behavior of a circulating fluidized bed pilot plant for oxyfuel combustion was studied in a cold flow model, down-scaled using Glicksman's criteria. Pressures along the unit and the global circulation rate were used for characterization. The analysis of five operating parameters and their influence on the system was carried out; namely, total solids inventory and the air velocity of primary, secondary, loop seal and support fluidizations. The cold flow model study shows that the reactor design allows stable operation at a wide range of fluidization rates, with results that agree well with previous observations described in the literature. (Copyright copyright 2011 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim)

  17. Physiologic Pressure and Flow Changes During Parabolic Flight (Pilot Study)

    Science.gov (United States)

    Pantalos, George; Sharp, M. Keith; Mathias, John R.; Hargens, Alan R.; Watenpaugh, Donald E.; Buckey, Jay C.

    1999-01-01

    The objective of this study was to obtain measurement of cutaneous tissue perfusion central and peripheral venous pressure, and esophageal and abdominal pressure in human test subjects during parabolic flight. Hemodynamic data recorded during SLS-I and SLS-2 missions have resulted in the paradoxical finding of increased cardiac stroke volume in the presence of a decreased central venous pressure (CVP) following entry in weightlessness. The investigators have proposed that in the absence of gravity, acceleration-induced peripheral vascular compression is relieved, increasing peripheral vascular capacity and flow while reducing central and peripheral venous pressure, This pilot study seeks to measure blood pressure and flow in human test subjects during parabolic flight for different postures.

  18. A double-blind, randomized, placebo-controlled pilot trial to determine the efficacy and safety of ibudilast, a potential glial attenuator, in chronic migraine

    Directory of Open Access Journals (Sweden)

    Kwok YH

    2016-10-01

    Full Text Available Yuen H Kwok,1 James E Swift,1 Parisa Gazerani,2 Paul Rolan1 1Discipline of Pharmacology, University of Adelaide, Level 5 Medical School North, South Australia, Australia; 2Department of Health Science & Technology, Aalborg University, Aalborg, Denmark Background: Chronic migraine (CM is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods: The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results: A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion: Using the current regimen, ibudilast does not improve migraine with CM participants. Keywords: chronic migraine, glia, ibudilast, headache, immune system

  19. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol.

    Science.gov (United States)

    Drahota, Amy; Gal, Diane; Windsor, Julie; Dixon, Simon; Udell, Julie; Ward, Derek; Soilemezi, Dia; Dean, Taraneh; Severs, Martin

    2011-12-01

    Falls are an issue disproportionately affecting older people who are at increased risk of falls and injury. This protocol describes a pilot study investigating shock-absorbing flooring for fall-related injuries in wards for older people. To inform future research by evaluating fall-related injuries on the intervention and existing flooring, assessing the sustainability of the flooring in ward environments, estimating the cost-effectiveness of the floor and assessing how the floor affects patients and other users. This study uses mixed methods a pilot cluster randomised controlled trial, observation via mechanical testing and interviews. Eight participating wards (clusters) are randomised using a computer-generated list. No blinding is incorporated into the study. Each site has a baseline period of approximately 6 months. Then, four sites receive the intervention floor, while four continue using standard floors. Sites are then followed up for approximately 1 year. Any person admitted to a bed in the 'study area' of a participating ward can be entered into the trial. Orientated patients, visitors and any hospital staff who use the floor in a study area are eligible for inclusion in an interview. An 8.3 mm thick vinyl floor covering with polyvinyl chloride foam backing (Tarkett Omnisports EXCEL). The primary outcome is fall-related injuries. Severity of injuries, falls, cost-effectiveness, user views and mechanical performance (shock absorbency and slip resistance) are also being assessed.

  20. NONINVASIVE DIAGNOSIS OF BLADDER CANCER BY CROSS-POLARIZATION OPTICAL COHERENCE TOMOGRAPHY: A BLIND STATISTICAL STUDY

    Directory of Open Access Journals (Sweden)

    O. S. Streltsova

    2014-07-01

    Full Text Available Whether cross-polarization (CP optical coherence tomography (OCT could be used to detect early bladder cancer was ascertained; it was compared with traditional OCT within the framework of blind (closed clinical statistical studies. One hundred and sixteen patients with local nonexophytic (flat pathological processes of the bladder were examined; 360 CP OCT images were obtained and analyzed. The study used an OCT 1300-U CP optical coherence tomographer. CP OCT showed a high (94% sensitivity and a high (84% specificity in the identification of suspected nonexophytic areas in the urinary bladder.

  1. Recognition memory for Braille or spoken words: an fMRI study in early blind.

    Science.gov (United States)

    Burton, Harold; Sinclair, Robert J; Agato, Alvin

    2012-02-15

    We examined cortical activity in early blind during word recognition memory. Nine participants were blind at birth and one by 1.5years. In an event-related design, we studied blood oxygen level-dependent responses to studied ("old") compared to novel ("new") words. Presentation mode was in Braille or spoken. Responses were larger for identified "new" words read with Braille in bilateral lower and higher tier visual areas and primary somatosensory cortex. Responses to spoken "new" words were larger in bilateral primary and accessory auditory cortex. Auditory cortex was unresponsive to Braille words and occipital cortex responded to spoken words but not differentially with "old"/"new" recognition. Left dorsolateral prefrontal cortex had larger responses to "old" words only with Braille. Larger occipital cortex responses to "new" Braille words suggested verbal memory based on the mechanism of recollection. A previous report in sighted noted larger responses for "new" words studied in association with pictures that created a distinctiveness heuristic source factor which enhanced recollection during remembering. Prior behavioral studies in early blind noted an exceptional ability to recall words. Utilization of this skill by participants in the current study possibly engendered recollection that augmented remembering "old" words. A larger response when identifying "new" words possibly resulted from exhaustive recollecting the sensory properties of "old" words in modality appropriate sensory cortices. The uniqueness of a memory role for occipital cortex is in its cross-modal responses to coding tactile properties of Braille. The latter possibly reflects a "sensory echo" that aids recollection. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. Recognition Memory for Braille or Spoken Words: An fMRI study in Early Blind

    Science.gov (United States)

    Burton, Harold; Sinclair, Robert J.; Agato, Alvin

    2012-01-01

    We examined cortical activity in early blind during word recognition memory. Nine participants were blind at birth and one by 1.5 yrs. In an event-related design, we studied blood oxygen level-dependent responses to studied (“old”) compared to novel (“new”) words. Presentation mode was in Braille or spoken. Responses were larger for identified “new” words read with Braille in bilateral lower and higher tier visual areas and primary somatosensory cortex. Responses to spoken “new” words were larger in bilateral primary and accessory auditory cortex. Auditory cortex was unresponsive to Braille words and occipital cortex responded to spoken words but not differentially with “old”/“new” recognition. Left dorsolateral prefrontal cortex had larger responses to “old” words only with Braille. Larger occipital cortex responses to “new” Braille words suggested verbal memory based on the mechanism of recollection. A previous report in sighted noted larger responses for “new” words studied in association with pictures that created a distinctiveness heuristic source factor which enhanced recollection during remembering. Prior behavioral studies in early blind noted an exceptional ability to recall words. Utilization of this skill by participants in the current study possibly engendered recollection that augmented remembering “old” words. A larger response when identifying “new” words possibly resulted from exhaustive recollecting the sensory properties of “old” words in modality appropriate sensory cortices. The uniqueness of a memory role for occipital cortex is in its cross-modal responses to coding tactile properties of Braille. The latter possibly reflects a “sensory echo” that aids recollection. PMID:22251836

  3. Pilot Implementations

    DEFF Research Database (Denmark)

    Manikas, Maria Ie

    by conducting a literature review. The concept of pilot implementation, although commonly used in practice, is rather disregarded in research. In the literature, pilot implementations are mainly treated as secondary to the learning outcomes and are presented as merely a means to acquire knowledge about a given...... objective. The prevalent understanding is that pilot implementations are an ISD technique that extends prototyping from the lab and into test during real use. Another perception is that pilot implementations are a project multiple of co-existing enactments of the pilot implementation. From this perspective......This PhD dissertation engages in the study of pilot (system) implementation. In the field of information systems, pilot implementations are commissioned as a way to learn from real use of a pilot system with real data, by real users during an information systems development (ISD) project and before...

  4. Study Skills Analysis: A Pilot Study Linking a Success and Psychology Course

    Science.gov (United States)

    Urciuoli, Jannette Alejandra; Bluestone, Cheryl

    2013-01-01

    This study explored a concept that learning study skills in the context of the content area under study may transfer across courses, multiplying the benefits towards academic success. Methods that have been reported to influence academic growth at the community college level include success courses and applied study skills. In this pilot project…

  5. Social media in adolescent health literacy education: a pilot study.

    Science.gov (United States)

    Tse, Carrie Kw; Bridges, Susan M; Srinivasan, Divya Parthasarathy; Cheng, Brenda Ss

    2015-03-09

    While health literacy has gained notice on a global stage, the initial focus on seeking associations with medical conditions may have overlooked its impact across generations. Adolescent health literacy, specifically in dentistry, is an underexplored area despite the significance of this formative stage on an individual's approach to healthy lifestyles and behaviors. The aim is to conduct a pilot study to evaluate the efficacy of three major social media outlets - Twitter, Facebook, and YouTube - in supporting adolescents' oral health literacy (OHL) education. A random sample of 22 adolescents (aged 14-16 years) from an English-medium international school in Hong Kong provided informed consent. Sociodemographic information, including English language background, social media usage, and dental experience were collected via a questionnaire. A pre- and post-test of OHL (REALD-30) was administered by two trained, calibrated examiners. Following pre-test, participants were randomly assigned to one of three social media outlets: Twitter, Facebook, or YouTube. Participants received alerts posted daily for 5 consecutive days requiring online accessing of modified and original OHL education materials. One-way ANOVA ( analysis of variance) was used to compare the mean difference between the pre- and the post-test results among the three social media. No associations were found between the social media allocated and participants' sociodemographics, including English language background, social media usage, and dental experience. Of the three social media, significant differences in literacy assessment scores were evident for participants who received oral health education messages via Facebook (P=.02) and YouTube (P=.005). Based on the results of the pilot study, Facebook and YouTube may be more efficient media outlets for OHL promotion and education among adolescent school children when compared to Twitter. Further analyses with a larger study group is warranted.

  6. Hair regrowth with topical triiodothyronine ointment in patients with alopecia areata: a double-blind, randomized pilot clinical trial of efficacy.

    Science.gov (United States)

    Nasiri, S; Haghpanah, V; Taheri, E; Heshmat, R; Larijani, B; Saeedi, M

    2012-05-01

    Thyroid hormone receptors are expressed in hair follicles and it is known that thyroid hormones can have a positive effect on hair growth, i.e. process which is disrupted in alopecia areata. The aim of this study was to determine the efficacy of topical triiodothyronine in patients with patchy alopecia areata. Ten patients with patchy alopecia areata were treated with triiodothyronine and placebo applied twice daily to either of two bilaterally symmetrical patches for 12 weeks. The two sides were randomly assigned following simple randomization procedure to one of the two treatment groups. The patients and the investigator were blinded to the content of the tubes. Hair regrowth was evaluated every 4 weeks. Blood samples for measurements of complete blood count along with thyroid function (T3, T4 and TSH) and liver function tests were taken at the baseline and at the end of study. After 12 weeks of treatment, there was no statistically significant difference between the outcome in terms of reduction of the patch size and hair regrowth. No adverse effects were noted. Triiodothyronine in the studied dosage and formulation was safe but not more effective than placebo. However, newer thyroid hormone analogues might be more effective and evaluating their effects probably warrants further consideration. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

  7. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

    2015-05-01

    Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Individual differences in fluid intelligence predicts inattentional blindness in a sample of older adults: a preliminary study.

    Science.gov (United States)

    O'Shea, Deirdre M; Fieo, Robert A

    2015-07-01

    Previous research has shown that aging increases susceptibility to inattentional blindness (Graham and Burke, Psychol Aging 26:162, 2011) as well as individual differences in cognitive ability related to working memory and executive functions in separate studies. Therefore, the present study was conducted in an attempt to bridge a gap that involved investigating 'age-sensitive' cognitive abilities that may predict inattentional blindness in a sample of older adults. We investigated whether individual differences in general fluid intelligence and speed of processing would predict inattentional blindness in our sample of older adults. Thirty-six healthy older adults took part in the study. Using the inattentional blindness paradigm developed by Most et al. (Psychol Rev 112:217, 2005), we investigated whether rates of inattentional blindness could be predicted by participant's performance on the Raven's Advanced Progressive Matrices and a choice-reaction time task. A Mann-Whitney U test revealed that a higher score on the Raven's Advanced Progressive Matrices was significantly associated with lower incidences of inattentional blindness. However, a t test revealed that choice-reaction times were not significantly associated with inattentional blindness. Preliminary results from the present study suggest that individual differences in general fluid intelligence are predictive of inattentional blindness in older adults but not speed of processing. Moreover, our findings are consistent with previous studies that have suggested executive attention control may be the source of these individual differences. These findings also highlight the association between attention and general fluid intelligence and how it may impact environmental awareness. Future research would benefit from repeating these analyses in a larger sample and also including a younger comparison group.

  9. Concurrent chemoradiotherapy for advanced cervical cancer. A pilot study

    International Nuclear Information System (INIS)

    Kodama, Junichi; Hashimoto, Ichiro; Seki, Noriko; Hongo, Atsushi; Mizutani, Yasushi; Miyagi, Yasunari; Yoshinouchi, Mitsuo; Kudo, Takafumi

    2001-01-01

    Recently, attempts have made to use radiotherapy in combination with chemotherapy in various solid tumors including cervical cancer. Twenty-four patients with locally advanced cervical cancer were treated with concurrent Carboplatin (16-24 mg/m 2 /day) or Nedaplatin (20 mg/m 2 /week) and conventional radiotherapy. Of 13 evaluable patients, there were nine complete responders and four partial responders. There was no renal damage or grade 4 hematological toxicity. Gastrointestinal adverse reactions were mild. One patient had grade 3 dermatologic toxicity after delayed radiation therapy. This pilot study suggests that daily Carboplatin or weekly Nedaplatin administered with standard radiation therapy is safe, well-tolerated, and thus may be useful as a radiation sensitizer in the treatment of locally advanced cervical cancer. (author)

  10. Entrepreneurial behavior among employees. Pilot study: Employees from Bucharest

    Directory of Open Access Journals (Sweden)

    Ionuţ Constantin

    2015-12-01

    Full Text Available Many objective or subjective factors influence the decision to open a business. The most important factors are: the existence of an adequate opportunity or a market, perception that starting a business could be difficult because of bureaucracy, financial barriers or the need to acquire new skills, a lack of money, etc. Also, entrepreneurial behavior is generally influenced by socio-economic status of the family of origin [1]. Thus, children from wealthy families have the “competitive advantage” to receive an education appropriate for managing a business and of course have the necessary financial resources and its start [2]. However, abilities of every individual can “correct’’ these benefits are completely eliminated/reduced exogenous barriers [3]. In this article I will present the results of a pilot study conducted in 2014 at Bucharest employees to observe their entrepreneurial behavior.

  11. Impact of nutrition messages on children's food choice: pilot study.

    Science.gov (United States)

    Bannon, Katie; Schwartz, Marlene B

    2006-03-01

    This pilot study tested the influence of nutrition message framing on snack choice among kindergarteners. Three classrooms were randomly assigned to watch one of the following 60s videos: (a) a gain-framed nutrition message (i.e. the positive benefits of eating apples) (n=14); (b) a loss-framed message (i.e. the negative consequences of not eating apples) (n=18); or (c) a control scene (children playing a game) (n=18). Following this, the children were offered a choice between animal crackers and an apple for their snack. Among the children who saw one of the nutrition message videos, 56% chose apples rather than animal crackers; in the control condition only 33% chose apples. This difference was statistically significant (chi2=7.56, p<0.01). These results suggest that videos containing nutritional messages may have a positive influence on children's short-term food choices.

  12. A Pilot Study on Measuring Customer’s Satisfaction Level

    Directory of Open Access Journals (Sweden)

    Vide Boltez

    2013-01-01

    Full Text Available RQ: Determine the level of customer satisfaction of a company’s products and services to obtain information on needed improvements.Purpose: The purpose of measuring customer’s satisfaction level is to obtain information directly from the final buyer that bought our product. The next step is to analyze the information obtained and to take the results into consideration to improve the working process in production and in other departments of the company.Method: The method used for the pilot study to measure customer satisfaction was a short questionnaire that was given to 10 customers of our product and 10 completed questionnaires were obtained.Results: The results showed the level of satisfaction of final buyers of roof tiles and roofs that the company has achieved through their products and services. The results facilitate the production, logistics, purchasing and sales department to obtain information on positive satisfaction levels and areas that need change. At the same time, the final buyer was identified (i.e., name, surname, address, and so forth, which up until now had not been.Organization: The organization will save time and money in the future, because it will continuously measure customer satisfaction to improve production and other departments in the organization towards creating satisfied customers.Society: Final buyers of roofs are, and will be, more satisfied with their decisions, because the organization carries out after-sales satisfaction levels.Originality: The research was original, because up to this date the organization has not conducted research in such a manner.Limitations: The pilot study used 10 completed questionnaires that represent a very small sample to make any generalizations.

  13. A pilot double-blind placebo-controlled trial of pioglitazone as adjunctive treatment to risperidone: Effects on aberrant behavior in children with autism.

    Science.gov (United States)

    Ghaleiha, Ali; Rasa, Soudeh Mohebbi; Nikoo, Mohammadali; Farokhnia, Mehdi; Mohammadi, Mohammad-Reza; Akhondzadeh, Shahin

    2015-09-30

    To assess the safety and efficacy of pioglitazone added to risperidone in the treatment of irritability in autistic disorder (AD), we conducted this study. In a 10-week, randomized, double-blind, parallel-group, placebo-controlled clinical trial, 44 outpatients of both genders aged 4-12 years with a diagnosis of AD and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale were included. Mean change of ABC-C irritability subscale score as primary outcome, change in other ABC-C subscale scores and partial and complete responses were compared between two groups. Twenty patients completed the trial in each group. Level of reduction and effect of time×treatment interaction in the treatment group were significant for irritability (P=0.03), lethargy/social withdrawal (P=0.04) and hyperactivity/non-compliance (P=0.03) but not for stereotypic behavior and inappropriate speech subscales compared with the placebo group. Vomiting and headache were the most frequent reported side-effects. Results of this preliminary study indicate positive effects of pioglitazone compared with placebo in improving the behavioral symptoms of AD. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  14. The Nonuse, Misuse, and Proper Use of Pilot Studies in Experimental Evaluation Research

    Science.gov (United States)

    Westlund, Erik; Stuart, Elizabeth A.

    2017-01-01

    This article discusses the nonuse, misuse, and proper use of pilot studies in experimental evaluation research. The authors first show that there is little theoretical, practical, or empirical guidance available to researchers who seek to incorporate pilot studies into experimental evaluation research designs. The authors then discuss how pilot…

  15. 2000 Annual report NATO/CCMS Pilot Study, Clean Products and Processes (Phase I)

    DEFF Research Database (Denmark)

    Wenzel, Henrik; Molin, Christine; Hauschild, Michael Zwicky

    2001-01-01

    The NATO/Committee on the Challenges of Modern Society third Pilot Study meeting on Clean Products and Processes was held in Copenhagen, Denmark on May 7-12, 2000. This meeting maintained the momentum generated during the of the first two years of the pilot study, focusing on progress made on sev...... homepage....

  16. "Live high-train low" using normobaric hypoxia: a double-blinded, placebo-controlled study

    DEFF Research Database (Denmark)

    Siebenmann, Christoph; Robach, Paul; Jacobs, Robert A

    2012-01-01

    The combination of living at altitude and training near sea level [live high-train low (LHTL)] may improve performance of endurance athletes. However, to date, no study can rule out a potential placebo effect as at least part of the explanation, especially for performance measures. With the use o...... of a placebo-controlled, double-blinded design, we tested the hypothesis that LHTL-related improvements in endurance performance are mediated through physiological mechanisms and not through a placebo effect. Sixteen endurance cyclists trained for 8 wk at low altitude (...

  17. A pilot study of a Medication Rationalization (MERA) intervention.

    Science.gov (United States)

    Whitty, Rachel; Porter, Sandra; Battu, Kiran; Bhatt, Pranjal; Koo, Ellen; Kalocsai, Csilla; Wu, Peter; Delicaet, Kendra; Bogoch, Isaac I; Wu, Robert; Downar, James

    2018-02-16

    Many seriously ill and frail inpatients receive potentially inappropriate or harmful medications and do not receive medications for symptoms of advanced illness. We developed and piloted an interprofessional Medication Rationalization (MERA) approach to deprescribing inappropriate medications and prescribing appropriate comfort medications. We conducted a single-centre pilot study of inpatients at risk of 6-month mortality from advanced age or morbidity. The MERA team reviewed the patients' medications and made recommendations on the basis of guidelines. We measured end points for feasibility, acceptability, efficiency and effectiveness. We enrolled 61 of 115 (53%) eligible patients with a mean age of 79.6 years (standard deviation [SD] 11.7 yr). Patients were taking an average of 11.5 (SD 5.2) medications before admission and had an average of 2.1 symptoms with greater than 6/10 severity on the revised Edmonton Symptom Assessment System. The MERA team recommended 263 medication changes, of which 223 (85%) were accepted by both the medical team and the patient. MERA team's recommendations resulted in the discontinuation of 162 medications (mean 3.1 per patient), dose changes for 48 medications (mean 0.9 per patient) and the addition of 13 medications (mean 0.2 per patient). Patients who received the MERA intervention stopped significantly more inappropriate medications than similar non-MERA comparison patients for whom data were collected retrospectively (3.1 v. 0.9 medications per patient, p < 0.01). The MERA approach was highly acceptable to patients and medical team members. The MERA intervention is feasible, acceptable, efficient and possibly effective for changing medication use among seriously ill and frail elderly inpatients. Scalability and effectiveness may be improved through automation and integration with medication reconciliation programs. Copyright 2018, Joule Inc. or its licensors.

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

    Directory of Open Access Journals (Sweden)

    Vasanop Vachiramon

    2016-01-01

    Full Text Available 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.

  19. A Double-Blind, Randomized, Controlled Pilot Trial of N-Acetylcysteine in Veterans With Posttraumatic Stress Disorder and Substance Use Disorders.

    Science.gov (United States)

    Back, Sudie E; McCauley, Jenna L; Korte, Kristina J; Gros, Daniel F; Leavitt, Virginia; Gray, Kevin M; Hamner, Mark B; DeSantis, Stacia M; Malcolm, Robert; Brady, Kathleen T; Kalivas, Peter W

    2016-11-01

    The antioxidant N-acetylcysteine is being increasingly investigated as a therapeutic agent in the treatment of substance use disorders (SUDs). This study explored the efficacy of N-acetylcysteine in the treatment of posttraumatic stress disorder (PTSD), which frequently co-occurs with SUD and shares impaired prefrontal cortex regulation of basal ganglia circuitry, in particular at glutamate synapses in the nucleus accumbens. Veterans with PTSD and SUD per DSM-IV criteria (N = 35) were randomly assigned to receive a double-blind, 8-week course of N-acetylcysteine (2,400 mg/d) or placebo plus cognitive-behavioral therapy for SUD (between March 2013 and April 2014). Primary outcome measures included PTSD symptoms (Clinician-Administered PTSD Scale, PTSD Checklist-Military) and craving (Visual Analog Scale). Substance use and depression were also assessed. Participants treated with N-acetylcysteine compared to placebo evidenced significant improvements in PTSD symptoms, craving, and depression (β values acetylcysteine was well tolerated, and retention was high. This is the first randomized controlled trial to investigate N-acetylcysteine as a pharmacologic treatment for PTSD and SUD. Although preliminary, the findings provide initial support for the use of N-acetylcysteine in combination with psychotherapy among individuals with co-occurring PTSD and SUD. ClinicalTrials.gov identifier: NCT02499029. © Copyright 2016 Physicians Postgraduate Press, Inc.

  20. Radiographer and radiologist perception error in reporting double contrast barium enemas: A pilot study

    International Nuclear Information System (INIS)

    Booth, Alison M.; Mannion, Richard A.J.

    2005-01-01

    Purpose: The practice of radiographers performing double contrast barium enemas (DCBE) is now widespread and in many centres the radiographer's opinion is, at least, contributing to a dual reporting system [Bewell J, Chapman AH. Radiographer performed barium enemas - results of a survey to assess progress. Radiography 1996;2:199-205; Leslie A, Virjee JP. Detection of colorectal carcinoma on double contrast barium enema when double reporting is routinely performed: an audit of current practice. Clin Radiol 2001;57:184-7; Culpan DG, Mitchell AJ, Hughes S, Nutman M, Chapman AH. Double contrast barium enema sensitivity: a comparison of studies by radiographers and radiologists. Clin Radiol 2002;57:604-7]. To ensure this change in practice does not lead to an increase in reporting errors, this study aimed to compare the perception abilities of radiographers with those of radiologists. Methods: Three gastro-intestinal (GI) radiographers and three consultant radiologists independently reported on a selection of 50 DCBE examinations, including the level of certainty in their comments for each examination. A blinded comparison of the results with an independent 'standard report' was recorded. Results: The results demonstrate there was no significant difference in perception error for any of the levels of certainty, for single reporting, for double reading by a radiographer/radiologist or by two radiologists. Conclusions: The study shows that radiographers can perceive abnormalities on DCBE at similar sensitivities and specificities as radiologists. While the participants in the study may be typical of a district general hospital, the nature of the study gives it limited external validity. As a pilot, the results demonstrate that, with slight modification, the methodology could be used for a larger study

  1. First "glass" education: telementored cardiac ultrasonography using Google Glass- a pilot study.

    Science.gov (United States)

    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

  2. Examination of staphylococcal stethoscope contamination in the emergency department (pilot) study (EXSSCITED pilot study).

    Science.gov (United States)

    Tang, Patrick H P; Worster, Andrew; Srigley, Jocelyn A; Main, Cheryl L

    2011-07-01

    The objective of this study was to determine the prevalence of Staphylococcus-contaminated stethoscopes belonging to emergency department (ED) staff and to identify the proportion of these that were Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA). We conducted a prospective observational cohort study of bacterial cultures from 100 ED staff members' stethoscopes at three EDs. Study participants were asked to complete a questionnaire. Fifty-four specimens grew coagulase-negative staphylococci and one grew methicillin-susceptible S. aureus. No MRSA was cultured. Only 8% of participants, all of whom were nurses, reported cleaning their stethoscope before or after each patient assessment. Alcohol-based wipes were most commonly used to clean stethoscopes. A lack of time, being too busy, and forgetfulness were the most frequently reported reasons for not cleaning the stethoscope in the ED. This study indicates that although stethoscope contamination rates in these EDs are high, the prevalence of S. aureus or MRSA on stethoscopes is low.

  3. Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study.

    Science.gov (United States)

    McCreery, Greig; Jones, Philip M; Kidane, Biniam; DeMelo, Vanessa; Mele, Tina

    2017-07-31

    Clostridium difficile infections (CDI) are common, costly and potentially life threatening. Most CDI will respond to antibiotic therapy, but 3%-10% of all patients with CDI will progress to a severe, life-threatening course. Complete removal of the large bowel is indicated for severe CDI. However, the 30-day mortality following surgical intervention for severe CDI ranges from 20% to 70%. A less invasive approach using surgical faecal diversion and direct colonic lavage with polyethylene glycol (PEG) and vancomycin has demonstrated a relative mortality reduction of approximately 50%. As an alternative to these operative approaches, we propose to treat patients with bedside intestinal lavage with PEG and vancomycin instillation via nasojejunal tube, in addition to usual antibiotic management. Preliminary data collected by our research group are encouraging. We will conduct a 1-year, single-centre, pilot randomised controlled trial to study this new treatment strategy for patients with severe CDI and additional risk factors for fulminant or complicated infection. After informed consent, patients with severe-complicated CDI without immediate indication for surgery will be randomised to either usual antibiotic treatment or usual antibiotic treatment with the addition of 8 L of PEG lavage via nasojejunal tube. This pilot trial will evaluate our eligibility and enrolment rate, protocol compliance and adverse event rates and provide further data to inform a more robust sample size calculation and protocol modifications for a definitive multicentre trial design. Based on historical data, we anticipate enrolling approximately 24 patients during the 1-year pilot study period.As a pilot study, data will be reported in aggregate. Between-group differences will be assessed in a blinded fashion for evidence of harm, and to further refine our sample size calculation. This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot

  4. A pilot study of MD (psychiatry) theses-based research.

    Science.gov (United States)

    Srivastava, Shrikant; Agarwal, Vivek; Subramanyam, Alka; Srivastava, Mona; Sathyanarayana Rao, T S; Rao, G Prasad; Khurana, Hitesh; Singh, Archana

    2018-01-01

    Undertaking a research project is mandatory for MD Psychiatry trainees. The present study was undertaken to assess the type of research activity being undertaken as part of MD Psychiatry dissertation, and its contribution to national and international literature. Three medical colleges supplied the data about the topic, names of the supervisor and the candidate, collaboration, funding accrued, and publication details of MD-based research carried out between years 2000 and 2010 inclusive; 95 records were collected for the final analysis. The details of the publications provided were cross-checked on the internet, which would have taken care of missed publications as well. Most studies were single-point assessment clinical studies. Only 2 studies had been funded, 11 had collaboration with other departments within the same institute, and 5 had inter-institute collaborations. Majority of the studies were not published. Only 30 were published as full paper and 9 as abstracts. Of these 30 full publications, only 3 were published in journals having JCI impact factor values (1.4, 1.3, and 1.4, respectively). The main finding of this pilot study was that MD-based research has low contribution to the national and international literature, and those articles which are published are in low impact journals. Suggestions for modifying this state of affairs are discussed.

  5. HERMES docking/berthing system pilot study. Quantitative assessment

    International Nuclear Information System (INIS)

    Munoz Blasco, J.; Goicoechea Sanchez, F.J.

    1993-01-01

    This study falls within the framework of the incorporation of quantitative risk assessment to the activities planned for the ESA-HERMES project (ESA/ CNES). The main objective behind the study was the analysis and evaluation of the potential contribution of so-called probabilistic or quantitative safety analysis to the optimization of the safety development process for the systems carrying out the safety functions required by the new and complex HERMES Space Vehicle. For this purpose, a pilot study was considered a good start in quantitative safety assessments (QSA), as this approach has been frequently used in the past to establish a solid base in large-scale QSA application programs while avoiding considerable economic risks. It was finally decided to select the HERMES docking/berthing system with Man Tender Free Flyer as the case-study. This report describes the different steps followed in the study, along with the main insights obtained and the general conclusions drawn from the study results. (author)

  6. Aprotinin decreases the incidence of cognitive deficit following CABG and cardiopulmonary bypass: a pilot randomized controlled study.

    LENUS (Irish Health Repository)

    Harmon, Dominic C

    2012-02-03

    PURPOSE: Cognitive deficit after coronary artery bypass surgery (CABG) has a high prevalence and is persistent. Meta-analysis of clinical trials demonstrates a decreased incidence of stroke after CABG when aprotinin is administrated perioperatively. We hypothesized that aprotinin administration would decrease the incidence of cognitive deficit after CABG. METHODS: Thirty-six ASA III-IV patients undergoing elective CABG were included in a prospective, randomized, single-blinded pilot study. Eighteen patients received aprotinin 2 x 10(6) KIU (loading dose), 2 x 10(6) KIU (added to circuit prime) and a continuous infusion of 5 x 10(5) KIU.hr(-1). A battery of cognitive tests was administered to patients and spouses (n = 18) the day before surgery, four days and six weeks postoperatively. RESULTS: Four days postoperatively new cognitive deficit (defined by a change in one or more cognitive domains using the Reliable Change Index method) was present in ten (58%) patients in the aprotinin group compared to 17 (94%) in the placebo group [95% confidence interval (CI) 0.10-0.62, P = 0.005); (P = 0.01)]. Six weeks postoperatively, four (23%) patients in the aprotinin group had cognitive deficit compared to ten (55%) in the placebo group (95% CI 0.80-0.16, P = 0.005); (P = 0.05). CONCLUSION: In this prospective pilot study, the incidence of cognitive deficit after CABG and cardiopulmonary bypass is decreased by the administration of high-dose aprotinin.

  7. Including health economic analysis in pilot studies: lessons learned from a cost-utility analysis within the PROSPECTIV pilot study

    Directory of Open Access Journals (Sweden)

    Richéal M. Burns

    2017-07-01

    Full Text Available PurposeTo assess feasibility and health economic benefits and costs as part of a pilot study for a nurse-led, psychoeducational intervention (NPLI for prostate cancer in order to understand the potential for cost effectiveness as well as contribute to the design of a larger scale trial.MethodsMen with stable prostate cancer post-treatment were recruited from two cancer centres in the UK. Eighty-three men were randomised to the NLPI plus usual care or usual care alone (UCA (42 NLPI and 41 UCA; the NLPI plus usual care was delivered in the primary-care setting (the intervention and included an initial face-to-face consultation with a trained nurse, with follow-up tailored to individual needs. The study afforded the opportunity to undertake a short-term within pilot analysis. The primary outcome measure for the economic evaluation was quality of life, as measured by the EuroQol five dimensions questionnaire (EQ-5D (EQ-5D-5L instrument. Costs (£2014 assessed included health-service resource use, out-of-pocket expenses and losses from inability to undertake usual activities.ResultsTotal and incremental costs varied across the different scenarios assessed, with mean cost differences ranging from £173 to £346; incremental effect, as measured by the change in utility scores over the duration of follow-up, exhibited wide confidence intervals highlighting inconclusive effectiveness (95% CI: -0.0226; 0.0438. The cost per patient of delivery of the intervention would be reduced if rolled out to a larger patient cohort.ConclusionsThe NLPI is potentially cost saving depending on the scale of delivery; however, the results presented are not considered generalisable.

  8. The effects of caffeine abstinence on sleep: a pilot study.

    Science.gov (United States)

    Ho, Shuk Ching; Chung, Joanne Wai Yee

    2013-05-01

    The aim of this study was to examine whether caffeine abstinence in the evening could improve the sleep quality of those who habitually consume coffee. A double-blind control group design (caffeine and caffeine-free groups). A university. A convenience sampling of 10 students (mean age 21.4 years). It was a 14-day experiment. For the first 7 days, all participants consumed caffeinated coffee. In the following 7 days, subjects consumed caffeinated or decaffeinated coffee according to their assigned group. Sleep-wake parameters, self-reported sleep quality and level of refreshment. There were no significant differences (p>.05) among the data of the two groups identified. No significant changes (p>.05) were found in the sleep quality of either group during the study. This study confirms that caffeine abstinence in the evening might not be helpful in sleep promotion. It highlights the need to implement evidence-based practice in health promotion. Copyright © 2013 Elsevier Inc. All rights reserved.

  9. Evaluation of an oral telomerase activator for early age-related macular degeneration - a pilot study

    Directory of Open Access Journals (Sweden)

    Dow CT

    2016-01-01

    Full Text Available Coad Thomas Dow,1,2 Calvin B Harley3 1McPherson Eye Research Institute, University of Wisconsin-Madison, Madison, WI, USA; 2Chippewa Valley Eye Clinic, Eau Claire, Wisconsin, WI, USA; 3Independent Telomere Biology Consultant, Murphys, CA, USA Purpose: Telomere attrition and corresponding cellular senescence of the retinal pigment epithelium contribute to the changes of age-related macular degeneration. Activation of the enzyme telomerase can add telomeric DNA to retinal pigment epithelium chromosomal ends and has been proposed as a treatment for age-related macular degeneration. We report the use of a small molecule, oral telomerase activator (TA-65 in early macular degeneration. This study, focusing on early macular degeneration, provides a model for the use of TAs in age-related disease.Method: Thirty-eight (38 patients were randomly assigned to a 1-year, double-blinded, placebo-controlled interventional study with arms for oral TA-65 or placebo. Macular functions via micro-perimetry were the primary measured outcomes.Results: The macular function in the arm receiving the TA-65 showed significant improvement relative to the placebo control. The improvement was manifest at 6 months and was maintained at 1 year: macular threshold sensitivity (measured as average dB [logarithmic decibel scale of light attenuation] improved 0.97 dB compared to placebo (P-value 0.02 and percent reduced thresholds lessened 8.2% compared to the placebo arm (P-value 0.04. Conclusion: The oral TA significantly improved the macular function of treatment subjects compared to controls. Although this study was a pilot and a larger study is being planned, it is noteworthy in that it is, to our knowledge, the first randomized placebo-controlled study of a TA supplement. Keywords: drusen, macular degeneration, micro-perimetry, senescence, telomerase activation, telomere

  10. Mental disorder in children with physical conditions: a pilot study.

    Science.gov (United States)

    Butler, Alexandra; Van Lieshout, Ryan J; Lipman, Ellen Louise; MacMillan, Harriet L; Gonzalez, Andrea; Gorter, Jan Willem; Georgiades, Kathy; Speechley, Kathy N; Boyle, Michael H; Ferro, Mark A

    2018-01-03

    Methodologically, to assess the feasibility of participant recruitment and retention, as well as missing data in studying mental disorder among children newly diagnosed with chronic physical conditions (ie, multimorbidity). Substantively, to examine the prevalence of multimorbidity, identify sociodemographic correlates and model the influence of multimorbidity on changes in child quality of life and parental psychosocial outcomes over a 6-month follow-up. Prospective pilot study. Two children's tertiary-care hospitals. Children aged 6-16 years diagnosed in the past 6 months with one of the following: asthma, diabetes, epilepsy, food allergy or juvenile arthritis, and their parents. Response, participation and retention rates. Child mental disorder using the Mini International Neuropsychiatric Interview at baseline and 6 months. Child quality of life, parental symptoms of stress, anxiety and depression, and family functioning. All outcomes were parent reported. Response, participation and retention rates were 90%, 83% and 88%, respectively. Of the 50 children enrolled in the study, the prevalence of multimorbidity was 58% at baseline and 42% at 6 months. No sociodemographic characteristics were associated with multimorbidity. Multimorbidity at baseline was associated with declines over 6 months in the following quality of life domains: physical well-being, β=-4.82 (-8.47, -1.17); psychological well-being, β=-4.10 (-7.62, -0.58) and school environment, β=-4.17 (-8.18, -0.16). There was no association with parental psychosocial outcomes over time. Preliminary evidence suggests that mental disorder in children with a physical condition is very common and has a negative impact on quality of life over time. Based on the strong response rate and minimal attrition, our approach to study child multimorbidity appears feasible and suggests that multimorbidity is an important concern for families. Methodological and substantive findings from this pilot study have

  11. Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

    Science.gov (United States)

    Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

    2018-05-01

     Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating

  12. Levosimendan versus milrinone in neonates and infants after corrective open-heart surgery: a pilot study.

    Science.gov (United States)

    Lechner, Evelyn; Hofer, Anna; Leitner-Peneder, Gabriele; Freynschlag, Roland; Mair, Rudolf; Weinzettel, Robert; Rehak, Peter; Gombotz, Hans

    2012-09-01

    Low cardiac output syndrome commonly complicates the postoperative course after open-heart surgery in children. To prevent low cardiac output syndrome, prophylactic administration of milrinone after cardiopulmonary bypass is commonly used in small children. The aim of this study was to compare the effect of prophylactically administered levosimendan and milrinone on cardiac index in neonates and infants after corrective open-heart surgery. Prospective, single-center, double-blind, randomized pilot study. Tertiary care center, postoperative pediatric cardiac intensive care unit. After written informed consent, 40 infants undergoing corrective open-heart surgery were included. At weaning from cardiopulmonary bypass, either a 24-hr infusion of 0.1 μg/kg/min levosimendan or of 0.5 μg/kg/min milrinone were administered. Cardiac output was evaluated at 2, 6, 9, 12, 18, 24, and 48 hrs after cardiopulmonary bypass using a transesophageal Doppler technique (Cardio-QP, Deltex Medical, Chichester, UK). Cardiac index was calculated from cardiac output and the patients' respective body surface area. Intention-to-treat data of 39 patients (19 in the levosimendan and 20 in the milrinone group) were analyzed using analysis of variance for repeated measurements for statistics. Analysis of variance revealed for both, cardiac index and cardiac output, similar results with no significant differences of the factors group and time. A significant interaction for cardiac output (p = .005) and cardiac index (p = .007) was found, which indicates different time courses of cardiac index in the two groups. Both drugs were well tolerated; no death or serious adverse event occurred. In our small study, postoperative cardiac index over time was similar in patients with prophylactically administered levosimendan and patients with prophylactically given milrinone. We observed an increase in cardiac output and cardiac index over time in the levosimendan group, whereas cardiac output and cardiac

  13. Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

    2016-03-22

    There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson's disease, Parkinson's disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke's Cognitive Examination - III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient's Parkinson's disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients' perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients' objective cognitive performance (on tests of memory and executive function) and satisfaction with goal

  14. A pilot study of workplace violence towards paramedics.

    Science.gov (United States)

    Boyle, Malcolm; Koritsas, Stella; Coles, Jan; Stanley, Janet

    2007-11-01

    International studies have shown that some 60% of paramedics have experienced physical violence in the workplace, and between 21-78% have experienced verbal abuse. To date, there is no Australian literature describing Australian paramedics' experience of workplace violence. To identify the percentage of paramedics who had experienced six different forms of workplace violence. A questionnaire was developed to explore paramedics' experience of workplace violence. Six forms of violence were included: verbal abuse, property damage or theft, intimidation, physical abuse, sexual harassment, and sexual assault. The questionnaire also included a series of demographic questions. The questionnaire was piloted using a reference group and changes made accordingly. The questionnaire was distributed to 500 rural Victorian paramedics and 430 metropolitan South Australian paramedics. Ethics approval was granted for this study. The overall response rate was 28%, with 75% being male and 25% female. The median age of respondents was 40.7 years, range 21-62 years. The median number of years experience as a paramedic was 14.3 years, range 6 months to 39 years. There were 87.5% of paramedics exposed to workplace violence. Verbal abuse was the most prevalent form of workplace violence (82%), with intimidation (55%), physical abuse (38%), sexual harassment (17%), and sexual assault (4%). This study lays the foundation for further studies investigating paramedic experience of workplace violence. This study demonstrates that workplace violence is prevalent for paramedics and highlights the need for prevention and education within the profession.

  15. MRI study of the morphometry of the cervical musculature in F-16 pilots

    NARCIS (Netherlands)

    de Loose, Veerle; van den Oord, Marieke; Keser, Ilke; Burnotte, Frédéric; van Tiggelen, Damien; Dumarey, Alexandre; Cagnie, Barbara; Witvrouw, Erik; Danneels, Lieven

    2009-01-01

    INTRODUCTION: In fighter pilots neck muscle strengthening exercises are often recommended to protect the neck against pathologies. The aim of the current study was to compare the relative cross-sectional area (rCSA) and muscle:fat ratio of the cervical musculature of F-16 pilots experiencing neck

  16. A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F; Bilenberg, Niels; Dalsgaard, Søren

    2017-08-01

    The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD). Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo had significant beneficial effects on working memory, both with large effect sizes. Although no significant differences were found between groups on any measure, there were significant intra-group changes for each group.

  17. A comparison of dental ultrasonic technologies on subgingival calculus removal: a pilot study.

    Science.gov (United States)

    Silva, Lidia Brión; Hodges, Kathleen O; Calley, Kristin Hamman; Seikel, John A

    2012-01-01

    This pilot study compared the clinical endpoints of the magnetostrictive and piezoelectric ultrasonic instruments on calculus removal. The null hypothesis stated that there is no statistically significant difference in calculus removal between the 2 instruments. A quasi-experimental pre- and post-test design was used. Eighteen participants were included. The magnetostrictive and piezoelectric ultrasonic instruments were used in 2 assigned contra-lateral quadrants on each participant. A data collector, blind to treatment assignment, assessed the calculus on 6 predetermined tooth sites before and after ultrasonic instrumentation. Calculus size was evaluated using ordinal measurements on a 4 point scale (0, 1, 2, 3). Subjects were required to have size 2 or 3 calculus deposit on the 6 predetermined sites. One clinician instrumented the pre-assigned quadrants. A maximum time of 20 minutes of instrumentation was allowed with each technology. Immediately after instrumentation, the data collector then conducted the post-test calculus evaluation. The repeated analysis of variance (ANOVA) was used to analyze the pre- and post-test calculus data (p≤0.05). The null hypothesis was accepted indicating that there is no statistically significant difference in calculus removal when comparing technologies (p≤0.05). Therefore, under similar conditions, both technologies removed the same amount of calculus. This research design could be used as a foundation for continued research in this field. Future studies include implementing this study design with a larger sample size and/or modifying the study design to include multiple clinicians who are data collectors. Also, deposit removal with periodontal maintenance patients could be explored.

  18. Caffeine supplementation improves countermovement jump in youth soccer players: a pilot study

    Directory of Open Access Journals (Sweden)

    Juan Diego Hernández-Camacho

    2017-07-01

    Full Text Available Introduction: The objective of this study was to analyze the effect of caffeine ingestion in soccer performance, particularly in the countermovement jump test (CMJ. Material and methods: A total of 17 players from a U-19 amateur Spanish team participated in this pilot study. A double-blind placebo-controlled randomized experimental design was used in 2 different sessions (1.5 hour per session separated by 1 week. CMJ was collected at the beginning and at the end of sessions; Rating of Perceived Exertion (RPE was recorded. Players ingested caffeine or placebo at the beginning of session (minute 0 of session, providing a total of 4 mg of caffeine or a placebo per kg of body mass. Side effects from caffeine and placebo ingestions were analyzed. The effect sizes (ES were calculated using values for Cohen’s and Quantitative differences were assessed qualitatively (QA. Results: The jump height with caffeine supplementation at the beginning of training was 37.03 (±3.87 cm and at the end was 39.35 (±4.05 cm, obtaining significant improvements (p<0.05; ES: 0.56; QA: 99/1/0. Significant differences on CMJ at the end of the training session between caffeine and placebo groups were observed (39.35 [±4.05] cm vs. 36.85 [±3.15] cm; p<0.05; ES: 0.65; QA: 0/1/99. Significant differences on RPE between groups were observed. A non-significant tendency to suffer more side effects with caffeine ingestion was obtained. Conclusions: This study shows how the ingestion of 4 mg of caffeine per kg of body mass could be an ergogenic aid to improve soccer performance. However, further studies with bigger soccer players sample would be necessary to refute the present results.

  19. Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

    Science.gov (United States)

    Frank, Bryan L

    2017-10-01

    Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

  20. Fibromyalgia with Gabapentin and Osteopathic Manipulative Medicine: A Pilot Study.

    Science.gov (United States)

    Marske, Cynthia; Bernard, Natasha; Palacios, Alison; Wheeler, Cary; Preiss, Ben; Brown, Mackenzie; Bhattacharya, Saveri; Klapstein, Gloria

    2018-04-01

    This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms. This study was an 8-week prospective, single center feasibility study. Forty subjects were recruited from Solano, Sonoma, and Contra Costa counties of California in 2006-2009. Subjects were aged 18-65 and met the American College of Rheumatology (ACR) 1990 criteria for fibromyalgia. This study had three treatment arms: gabapentin only (900 mg/day), osteopathic manipulative medicine (OMM) only, and combined treatment of gabapentin plus OMM. OMM treatment was administered by advanced medical students for 30 min, once a week. The trial lasted for 8 weeks, which included 6 weeks of treatment plus initial and final visits. Key outcome measures included Wong-Baker FACES Pain Rating Scale (WBF), Clinical Global Impression of Health (CGI), Fibromyalgia Impact Questionnaire (FIQ), and number of tender points. Twenty-nine subjects completed the trial; 8 subjects received gabapentin only, 11 patients received OMM only, and 10 patients received gabapentin plus OMM. Subjects receiving OMM alone and subjects receiving the combined treatment of OMM and gabapentin displayed clinical improvements based on WBF (p treatment and gabapentin are safe and clinically efficacious treatment of pain and other constitutional and somatic symptoms associated with fibromyalgia. A larger trial using the new ACR 2010 Fibromyalgia criteria is needed to confirm these findings.

  1. EEG activity in Muslim prayer: A pilot study

    Directory of Open Access Journals (Sweden)

    Haider H. Alwasiti

    2010-12-01

    Full Text Available Almost all religions incorporate some form of meditation. Muslim prayer is the meditation of Islam. It is an obligatory prayer for all Muslims that is performed five times a day. Although a large body of literature exists on EEG changes in meditation, to date there has been no research published in a peer-reviewed journal on EEG changes during Muslim prayer. The purpose of this pilot study is to encourage further investigation on this type of meditation. Results of EEG analysis in twenty-five trials of Muslim prayer are reported. Some of the findings are consistent with the majority of the previous meditation studies (alpha rhythm slowing, increased alpha rhythm coherence. However, Muslim prayer does not show an increase in alpha and/or theta power like most of the results of other meditation studies. The possible cause of this discrepancy in meditation-related studies is highlighted and a systematic and standardised roadmap for future Muslim prayer EEG research is proposed.

  2. Radon in drinking water in Co. Wicklow. A pilot study

    International Nuclear Information System (INIS)

    Ryan, T.P.; Sequeira, S.; McKittrick, L.; Colgan, P.A.

    2003-02-01

    Attention has been focused on the issue of radon in drinking water by a European Commission recommendation proposing that surveys should be undertaken in Member States to determine the scale and nature of exposures caused by radon in domestic drinking water supplies. The Commission recommends 1000 Bq/l as the radon activity concentration in private drinking water supplies above which remedial action to reduce the concentration should be taken. The logic behind the proposed action level is that it would broadly correspond to the risk posed to an individual from exposure to radon in the home at the current Reference Level of 200 Bq/m3 in air. A pilot study to assess the distribution and concentrations of radon in private ground water supplies was recently completed in Co. Wicklow. County Wicklow was selected for the study primarily on the basis that the underlying geology is predominantly granite with elevated uranium content. Furthermore, there is an estimated 1200 to 5000 private ground water supplies in use in the county and high radon activity concentrations in air in a significant number of dwellings have previously been predicted. As part of the pilot study, a number of scientific issues were addressed in order to underpin the results obtained and these are also discussed in the report. Radon activity concentrations were measured in the private ground water supplies of 166 houses in Co. Wicklow. In all cases the ground water was the principal source of drinking water for the house occupants. Four supplies had activity concentrations in excess of the Recommended EC action level of 1000 Bq/l, fifteen had activity concentrations between 500 and 1000 Bq/l, 51 were between 100 and 500 Bq/l and 96 had activity concentrations below 100 Bq/l. The doses estimated for the ingestion of radon bearing water vary significantly with the quantity of drinking water consumed and the degree to which the water has been processed prior to consumption. However dose estimates based

  3. Radon in drinking water in Co. Wicklow. A pilot study

    International Nuclear Information System (INIS)

    Ryan, T.P.; Sequeira, S.; McKittrick, L.; Colgan, P.A.

    2003-01-01

    Attention has been focused on the issue of radon in drinking water by a European Commission recommendation proposing that surveys should be undertaken in Member States to determine the scale and nature of exposures caused by radon in domestic drinking water supplies. The Commission recommends 1000 Bq/l as the radon activity concentration in private drinking water supplies above which remedial action to reduce the concentration should be taken. The logic behind the proposed action level is that it would broadly correspond to the risk posed to an individual from exposure to radon in the home at the current Reference Level of 200 Bq/m 3 in air. A pilot study to assess the distribution and concentrations of radon in private ground water supplies was recently completed in Co. Wicklow. County Wicklow was selected for the study primarily on the basis that the underlying geology is predominantly granite with elevated uranium content. Furthermore, there is an estimated 1200 to 5000 private ground water supplies in use in the county and high radon activity concentrations in air in a significant number of dwellings have previously been predicted. As part of the pilot study, a number of scientific issues were addressed in order to underpin the results obtained and these are also discussed in the report. Radon activity concentrations were measured in the private ground water supplies of 166 houses in Co. Wicklow. In all cases the ground water was the principal source of drinking water for the house occupants. Four supplies had activity concentrations in excess of the Recommended EC action level of 1000 Bq/l, fifteen had activity concentrations between 500 and 1000 Bq/l, 51 were between 100 and 500 Bq/l and 96 had activity concentrations below 100 Bq/l. The doses estimated for the ingestion of radon bearing water varies significantly with the quantity of drinking water consumed and the degree to which the water has been processed prior to consumption. However dose estimates

  4. Factors associated with childhood ocular morbidity and blindness in three ecological regions of Nepal: Nepal pediatric ocular disease study.

    Science.gov (United States)

    Adhikari, Srijana; Shrestha, Mohan Krishna; Adhikari, Kamala; Maharjan, Nhukesh; Shrestha, Ujjowala Devi

    2014-10-23

    Nepal Pediatric Ocular Diseases Study is a three year longitudinal population based study. Here we present the baseline survey report which aims to investigate various risk factors associated with childhood ocular morbidity and blindness in three ecological regions of Nepal. This baseline survey is a population based cross sectional study. The investigation was conducted in a district from each of the following regions: Terai, Hill and Mountain. The Village Development Committees (VDCs) from each district were selected by random sampling. Three Community health workers were given training on vision screening and identification of abnormal ocular signs in children. They conducted a house to house survey in their respected districts examining the children and gathering a standardized set of data variables. Children with abnormal vision or ocular signs were then further examined by pediatric ophthalmologists. A total of 10950 children aged 0-10 years (5403 from Terai, 3204 from the hills, 2343 from the mountains) were enrolled in the study. However 681 (6.2%) were non responders. The male to female ratio was 1.03. The overall prevalence of ocular morbidity was 3.7% (95% CI of 3.4%-4%) and blindness was 0.07% (95% CI of 0.02%-0.12%). Ocular morbidity was more prevalent in the mountain region whereas blindness was more prevalent in the Terai region.Children from the Terai region were more likely to suffer from congenital ocular anomalies compared to the other regions. Children whose mother smoked, drank alcohol, or was illiterate were significantly afflicted with ocular diseases (p Blindness was more prevalent in children who suffered from a systemic illness. Females and under-nourished children were more likely to have ocular morbidity and blindness. It was found that childhood blindness was more prevalent in the Terai region, the undernourished, females and in those with co-morbid systemic illnesses. This study strongly suggests that prevention of childhood

  5. The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kemp, Joanne L; Coburn, Sally L; Jones, Denise M; Crossley, Kay M

    2018-04-01

    Study Design A pilot double-blind randomized controlled trial (RCT). Background The effectiveness of physical therapy for femoroacetabular impingement syndrome (FAIS) is unknown. Objectives To determine the feasibility of an RCT investigating the effectiveness of a physical therapy intervention for FAIS. Methods Participants were 17 women and 7 men (mean ± SD age, 37 ± 8 years; body mass index, 25.4 ± 3.4 kg/m 2 ) with FAIS who received physical therapy interventions provided over 12 weeks. The FAIS-specific physical therapy group received personalized progressive strengthening and functional retraining. The control group received standardized stretching exercises. In addition, both groups received manual therapy, progressive physical activity, and education. The primary outcome was feasibility, including integrity of the protocol, recruitment and retention, outcome measures, randomization procedure, and sample-size estimate. Secondary outcomes included hip pain and function (international Hip Outcome Tool-33 [iHOT-33]) and hip muscle strength. Poststudy interviews were conducted to determine potential improvements for future studies. Results Twenty-four (100%) patients with known eligibility agreed to participate. Four patients (17%) were lost to follow-up. All participants and the tester remained blinded, and the control intervention was acceptable to participants. The between-group mean differences in change scores were 16 (95% confidence interval [CI]: -9, 38) for the iHOT-33 and 0.24 (95% CI: 0.02, 0.47) Nm/kg for hip adduction strength, favoring the FAIS-specific physical therapy group. Using an effect size of 0.61, between-group improvements for the iHOT-33 suggest that 144 participants are required for a full-scale RCT. Conclusion A full-scale RCT of physical therapy for FAIS is feasible. A FAIS-specific physical therapy program has the potential for a moderate to large positive effect on hip pain, function, and hip adductor strength. Level of Evidence

  6. Effects of Taping on Pain and Functional Outcome of Patients with Knee Osteoarthritis: A Pilot Randomized Single-blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Parisa Taheri

    2017-01-01

    Full Text Available Background: To determine the effects of knee taping in combination with exercise and medical treatment on functional outcome and pain of patients with knee osteoarthritis (OA. Materials and Methods: In a randomized single-blinded clinical trial, 36 patients with knee OA were randomly assigned to two study groups. Both groups received exercise and medical therapy for 6 weeks. In addition, the first group (20 patients received taping in the first 3 weeks. Pain severity (assessed by visual analog scaling, weekly amount of analgesics consumption, timed get up and go test (TUG, and step tests were recorded at baseline, 3 and 6 weeks after the treatment and were further compared between two study groups. Results: There was no significant difference between two groups in pain severity score (P = 0.228, step test score (P = 0.771, TUG test score (P = 0.821 and weekly amount of analgesics consumption (P = 0.873 at baseline. After 3 weeks, weekly amount of analgesics consumption (P = 0.006, pain severity (P < 0.001 was significantly lower in taping group whereas step test score (P = 0.006 was significantly higher in the taping group. After 6 weeks, patients in taping group had significantly lower pain severity (P = 0.011 and higher step test score (P = 0.042. However, there was no significant difference in TUG test score (P = 0.443 and weekly amount of analgesics consumption (P = 0.270 between two groups. Conclusion: Therapeutic knee taping may be an effective method for short-term management of pain and disability in patients with knee OA.

  7. Developing the Pediatric Refractory Epilepsy Questionnaire: a pilot study.

    Science.gov (United States)

    Purusothaman, Vaishnavi; Ryther, Robin C C; Bertrand, Mary; Harker, Lisa A; Jeffe, Donna B; Wallendorf, Michael; Smyth, Matthew D; Limbrick, David D

    2014-08-01

    Up to 14% of children with epilepsy continue to experience seizures despite having appropriate medical therapy and develop medically refractory epilepsy (MRE). Assessing clinical outcomes and therapeutic efficacy in children with MRE undergoing palliative epilepsy surgery has been challenging because of the lack of a quantitative instrument capable of estimating the clinical status of these patients. The ideal instrument would at once consider seizure control, neurodevelopment, caregiver burden, and quality of life. The purpose of this study was to develop and pilot the Pediatric Refractory Epilepsy Questionnaire (PREQ), a quantitative instrument to assess the severity and individual burden of epilepsy in children with MRE undergoing palliative epilepsy treatments. The caregivers of 25 patients with MRE completed the PREQ and the Quality of Life in Childhood Epilepsy (QOLCE) measure and participated in a semistructured interview. Medical records of the patients were reviewed, an Early Childhood Epilepsy Severity Scale (E-CHESS) score was calculated, and a Global Assessment of Severity of Epilepsy (GASE) score was obtained for each patient. The initial PREQ was modified based on the analysis of responses, association with previously validated scales, comments from caregivers, and expertise of the PREQ panelists. Pediatric Refractory Epilepsy Questionnaire subscale scores were calculated based on clinical paradigm and compared with independent measures of seizure severity and quality of life. Significant correlations were observed between the seizure severity subscale and the GASE score (r=0.55) and between the mood subscale and the well-being score (r=0.61) on the QOLCE. Significant correlations were also observed between the caregiver rating of seizure severity and the GASE score (r=0.53), the social activity score (r=0.57), and the behavior score (r=0.43) on the QOLCE. Correlations between the caregiver rating of quality of life and the quality of life score (r=0

  8. Hydroxyurea: a radiation potentiator in carcinoma of the uterine cervix. A randomized double-blind study

    International Nuclear Information System (INIS)

    Piver, M.S.; Barlow, J.J.; Vongtama, V.; Blumenson, L.

    1983-01-01

    From June, 1972, to December, 1976, 40 patients with FIGO (International Federation of Gynaecology and Obstetrics) Stage IIB carcinoma of the uterine cervix were entered into a prospective, double-blind, randomized study to evaluate the possible radiation-potentiating properties (i.e., improved survival) of the S-phase cell cycle-specific inhibitor of DNA synthesis, hydroxyurea. All patients were documented to be without aortic lymph node metastasis by pretherapy staging para-aortic lymphadenectomy. All 40 patients were followed up for longer than 5 years (5.2 to 9.2 years) or until death. The double-blind code was not broken until all patients had been followed up for a minimum of 2 to 5 years. Leukopenia (white blood cell count less than 2,500 mm3) was significantly increased in the patients given hydroxyurea as compared to those given placebo (P less than 0.0001). There was no statistically significant difference relative to anemia, thrombocytopenia, radiation-induced skin reaction, and radiation-induced intestinal reaction between the patients given placebo or those given hydroxyurea. Life-table survival for the patients given hydroxyurea was 94% as compared to 53% for the patients given placebo (P . 0.006). Only one (5%) patient given hydroxyurea died of cervical cancer. Of the other patients who died in the group given hydroxyurea, all were confirmed by postmortem examination to have been without recurrent cervical cancer. In contrast, 45% (nine) of the patients given placebo died of cervical cancer

  9. Effects of Combining a Brief Cognitive Intervention with Transcranial Direct Current Stimulation on Pain Tolerance: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Powers, Abigail; Madan, Alok; Hilbert, Megan; Reeves, Scott T; George, Mark; Nash, Michael R; Borckardt, Jeffrey J

    2018-04-01

    Cognitive behavioral therapy has been shown to be effective for treating chronic pain, and a growing literature shows the potential analgesic effects of minimally invasive brain stimulation. However, few studies have systematically investigated the potential benefits associated with combining approaches. The goal of this pilot laboratory study was to investigate the combination of a brief cognitive restructuring intervention and transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex in affecting pain tolerance. Randomized, double-blind, placebo-controlled laboratory pilot. Medical University of South Carolina. A total of 79 healthy adult volunteers. Subjects were randomized into one of six groups: 1) anodal tDCS plus a brief cognitive intervention (BCI); 2) anodal tDCS plus pain education; 3) cathodal tDCS plus BCI; 4) cathodal tDCS plus pain education; 5) sham tDCS plus BCI; and 6) sham tDCS plus pain education. Participants underwent thermal pain tolerance testing pre- and postintervention using the Method of Limits. A significant main effect for time (pre-post intervention) was found, as well as for baseline thermal pain tolerance (covariate) in the model. A significant time × group interaction effect was found on thermal pain tolerance. Each of the five groups that received at least one active intervention outperformed the group receiving sham tDCS and pain education only (i.e., control group), with the exception of the anodal tDCS + education-only group. Cathodal tDCS combined with the BCI produced the largest analgesic effect. Combining cathodal tDCS with BCI yielded the largest analgesic effect of all the conditions tested. Future research might find stronger interactive effects of combined tDCS and a cognitive intervention with larger doses of each intervention. Because this controlled laboratory pilot employed an acute pain analogue and the cognitive intervention did not authentically represent cognitive behavioral

  10. Do chiropractic college faculty understand informed consent: a pilot study

    Directory of Open Access Journals (Sweden)

    Hondras Maria A

    2006-12-01

    Full Text Available Abstract Background The purpose of this study was to survey full-time faculty at a single chiropractic college concerning their knowledge of Institutional Review Board (IRB policies in their institution as they pertain to educational research. Methods All full-time faculty were invited to participate in an anonymous survey. Four scenarios involving educational research were described and respondents were asked to select from three possible courses of action for each. In addition, respondents were queried about their knowledge of IRB policies, how they learned of these policies and about their years of service and departmental assignments. Results The response rate was 55%. In no scenario did the level of correct answers by all respondents score higher than 41% and in most, the scores were closer to just under 1 in 3. Sixty-five percent of respondents indicated they were unsure whether Palmer had any policies in place at all, while 4% felt that no such policies were in place. Just over one-quarter (27% were correct in noting that students can decline consent, while more than half (54% did not know whether there were any procedures governing student consent. Conclusion Palmer faculty have only modest understanding about institutional policies regarding the IRB and human subject research, especially pertaining to educational research. The institution needs to develop methods to provide knowledge and training to faculty. The results from this pilot study will be instrumental in developing better protocols for a study designed to survey the entire chiropractic academic community.

  11. A pilot study on mindfulness based stress reduction for smokers

    Directory of Open Access Journals (Sweden)

    Baker Timothy B

    2007-01-01

    Full Text Available Abstract Background Mindfulness means paying attention in the present moment, non-judgmentally, without commentary or decision-making. We report results of a pilot study designed to test the feasibility of using Mindfulness Based Stress Reduction (MBSR (with minor modifications as a smoking intervention. Methods MBSR instructors provided instructions in mindfulness in eight weekly group sessions. Subjects attempted smoking cessation during week seven without pharmacotherapy. Smoking abstinence was tested six weeks after the smoking quit day with carbon monoxide breath test and 7-day smoking calendars. Questionnaires were administered to evaluate changes in stress and affective distress. Results 18 subjects enrolled in the intervention with an average smoking history of 19.9 cigarettes per day for 26.4 years. At the 6-week post-quit visit, 10 of 18 subjects (56% achieved biologically confirmed 7-day point-prevalent smoking abstinence. Compliance with meditation was positively associated with smoking abstinence and decreases in stress and affective distress. Discussions and conclusion The results of this study suggest that mindfulness training may show promise for smoking cessation and warrants additional study in a larger comparative trial.

  12. The Hong Kong vision study: a pilot assessment of visual impairment in adults.

    OpenAIRE

    Van Newkirk, M R

    1997-01-01

    PURPOSE: The Hong Kong Adult Vision Pilot Study is a population based study of the distribution and determinants of eye disease in a random sample of the Chinese population age 40 and over. The present pilot study identifies the extent and causes of visual loss using methods developed in the United States and Australia. The pilot study uses the prevalence data to estimate the sample size necessary to predict the size of an effect a larger study may detect and the confidence with which that ef...

  13. A Pilot Study Assessing ECG versus ECHO Ventriculoventricular Optimization in Pediatric Resynchronization Patients.

    Science.gov (United States)

    Punn, Rajesh; Hanisch, Debra; Motonaga, Kara S; Rosenthal, David N; Ceresnak, Scott R; Dubin, Anne M

    2016-02-01

    Cardiac resynchronization therapy indications and management are well described in adults. Echocardiography (ECHO) has been used to optimize mechanical synchrony in these patients; however, there are issues with reproducibility and time intensity. Pediatric patients add challenges, with diverse substrates and limited capacity for cooperation. Electrocardiographic (ECG) methods to assess electrical synchrony are expeditious but have not been extensively studied in children. We sought to compare ECHO and ECG CRT optimization in children. Prospective, pediatric, single-center cross-over trial comparing ECHO and ECG optimization with CRT. Patients were assigned to undergo either ECHO or ECG optimization, followed for 6 months, and crossed-over to the other assignment for another 6 months. ECHO pulsed-wave tissue Doppler and 12-lead ECG were obtained for 5 VV delays. ECG optimization was defined as the shortest QRSD and ECHO optimization as the lowest dyssynchrony index. ECHOs/ECGs were interpreted by readers blinded to optimization technique. After each 6 month period, these data were collected: ejection fraction, velocimetry-derived cardiac index, quality of life, ECHO-derived stroke distance, M-mode dyssynchrony, study cost, and time. Outcomes for each optimization method were compared. From June 2012 to December 2013, 19 patients enrolled. Mean age was 9.1 ± 4.3 years; 14 (74%) had structural heart disease. The mean time for optimization was shorter using ECG than ECHO (9 ± 1 min vs. 68 ± 13 min, P cost for charges was $4,400 ± 700 less for ECG. No other outcome differed between groups. ECHO optimization of synchrony was not superior to ECG optimization in this pilot study. ECG optimization required less time and cost than ECHO optimization. © 2015 Wiley Periodicals, Inc.

  14. Pilot study of dornase alfa (Pulmozyme) therapy for acquired ventilator-associated infection in preterm infants.

    Science.gov (United States)

    Scala, Melissa; Hoy, Deborah; Bautista, Maria; Palafoutas, Judith Jones; Abubakar, Kabir

    2017-06-01

    Evaluate the feasibility, safety, and efficacy of adjunctive treatment with dornase alfa in preterm patients with ventilator-associated pulmonary infection (VAPI) compared to standard care. We hypothesize that therapy with dornase alfa will be safe and well tolerated in the preterm population with no worsening of symptoms, oxygen requirement, or need for respiratory support. Prospective, randomized, blinded, pilot study comparing adjunctive treatment with dornase alfa to sham therapy. In addition to standard care, infants were randomized to receive dornase alfa 2.5 mg nebulized via endotracheal tube (ETT) every 12 hr for 7 days or sham therapy. ETT secretion gram stain and culture and chest X-ray (CXR) findings were evaluated. Respiratory support data were downloaded from the ventilator. Fourteen infants developed VAPI between 2012 and 2014; 11 enrolled in the study. Six received dornase alfa and five received sham therapy. Average gestational age at birth was 25 weeks and age at study entry was 31 days. There were no differences in demographics, ETT white blood cell count (WBC), CXR, or mean airway pressure (MAP) between the two groups. There was a trend towards decreased oxygen requirement (FiO2) in the treatment group that did not reach statistical significance. No side effects were observed in the treatment group. Treatment with dornase alfa is safe and treated infants had some improvement in FiO 2 requirement but no improvement in MAP. A larger randomized trial is needed to evaluate the efficacy of this therapy. Pediatr Pulmonol. 2017; 52:787-791. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  15. A pilot study to determine whether external stabilisation of the chest ...

    African Journals Online (AJOL)

    2009-02-02

    Feb 2, 2009 ... positive airways pressure (NCPAP) are of interest.1 NCPAP together with ... Design. This was a non-blinded prospective randomised controlled study. .... Respiratory rate, heart rate, blood pressure and oxygen saturations ...

  16. Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis

    Science.gov (United States)

    Gurung, Vinita; Williamson, Catherine; Chappell, Lucy; Chambers, Jenny; Briley, Annette; Pipkin, Fiona Broughton; Thornton, Jim

    2009-01-01

    Background Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 4500 women per year in the UK. Affected women develop itching and occasionally jaundice. More importantly, the condition is associated with premature delivery, fetal distress and is believed to be an important cause of stillbirth. However, even now, there is no clear evidence as to whether the most popular treatment, a drug called ursodeoxycholic acid is beneficial to the baby, or even if it is safe in pregnancy. Nor do we know whether planned early delivery of the baby at 37–38 weeks, another popular treatment, does more good than harm. A randomised trial to evaluate both ursodeoxycholic acid and timed delivery is needed but will be complicated and expensive. We plan a preliminary study, Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis (Acronym PITCH- Pregnancy Intervention Trial in Cholestasis) trial, to evaluate the feasibility of a larger trial. The trial is funded by the NHS Research for Patient Benefit (RfPB) Programme. Methods PITCH is a multi-centre, double blinded, randomised, controlled, factorial design trial. The trial is being run in six UK centres and women with obstetric cholestasis will be recruited for eighteen months. In this pilot trial we aim to collect data to finalise the design for the main trial. This will include measuring trial recruitment rate, including recruitment to each factorial comparison separately. We will also measure the spectrum of disease among recruits and non-recruits and compliance with the four possible treatment allocations. We will use these data to design the main trial. Discussion The ultimate aim of the main trial is to enable clinicians to manage this condition more effectively. If it transpires that ursodeoxycholic acid and early delivery are both safe and effective then steps will be taken to ensure that all women with OC who could benefit from them receives this treatment

  17. A new in situ model to study erosive enamel wear, a clinical pilot study.

    NARCIS (Netherlands)

    Ruben, J.L.; Truin, G.J.; Bronkhorst, E.M.; Huysmans, M.C.D.N.J.M.

    2017-01-01

    OBJECTIVES: To develop an in situ model for erosive wear research which allows for more clinically relevant exposure parameters than other in situ models and to show tooth site-specific erosive wear effect of an acid challenge of orange juice on enamel. METHODS: This pilot study included 6

  18. Phlebitis induced by parenteral treatment with flucloxacillin and cloxacillin: a double-blind study.

    Science.gov (United States)

    Svedhem, A; Alestig, K; Jertborn, M

    1980-01-01

    Two studies were performed on a total of 54 patients with staphylococcal infections. Study I compares with phlebitogenic properties of flucloxacillin after intravenous infusions when either saline or sterile water was used as a solvent. No difference was observed between the two solvents, and the frequency of phlebitis for the total material without respect to solvents was 5% after 1 day of treatment and 13% after 2 days. Study II was a double-blind comparison of phlebitis caused by intravenous infusions of either flucloxacillin or cloxacillin. The frequencies of phlebitis were found to be 18 and 13%, respectively. After 2 days of treatment the frequency of phlebitis increased dramatically for both drugs. All infusions were given through a plastic cannula of 5-cm length and 1.2-mm diameter. PMID:7447412

  19. Oral cancer awareness in Spain: A pilot study.

    Science.gov (United States)

    Varela-Centelles, P; Estany-Gestal, A; Bugarín-González, R; Seoane-Romero, J M

    2018-03-01

    To investigate the level of oral cancer knowledge and awareness in a Spanish general population. A cross-sectional study using an anonymous questionnaire applied in the community to randomly selected laypersons. Sample size for the general population was determined by quota sampling, resulting in 1,041 individuals. A total of 1,707 pedestrians were approached (response: 61%). When the participants were asked about what cancers had they heard about (up to ten), oral cancer was mentioned in first place by 2% of the sample and by 22% in any order. When specifically asked about oral cancer, the percentage of interviewees who were familiar with it raised to 72%. Participants were also asked about the main signs or symptoms of oral cancer, and the most frequently (22%) mentioned as the first warning sign was a non-healing ulcer. Tobacco smoking generally was recognised as the most important (57%) risk factor for oral cancer. This pilot study revealed a low awareness of oral cancer, and a poor knowledge of its signs and symptoms and risk factors. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. All rights reserved.

  20. Task rotation in an underground coal mine: A pilot study.

    Science.gov (United States)

    Jones, Olivia F; James, Carole L

    2018-01-01

    Task rotation is used to decrease the risk of workplace injuries and improve work satisfaction. To investigate the feasibility, benefits and challenges of implementing a task rotation schedule within an underground coalmine in NSW, Australia. A mixed method case control pilot study with the development and implementation of a task rotation schedule for 6 months with two work crews. A questionnaire including The Nordic Musculoskeletal Questionnaire, The Need for Recovery after Work Scale, and The Australian WHOQOL- BREF Australian Edition was used to survey workers at baseline, 3 and 6 months. A focus group was completed with the intervention crew and management at the completion of the study. In total, twenty-seven participants completed the survey. Significant improvements in the psychological and environmental domains of the WHOQOL-BREF questionnaire were found in the intervention crew. Musculoskeletal pain was highest in the elbow, lower back and knee, and fatigue scores improved, across both groups. The intervention crew felt 'mentally fresher', 'didn't do the same task twice in a row', and 'had more task variety which made the shift go quickly'. Task rotation was positively regarded, with psychological benefits identified. Three rotations during a 9-hour shift were feasible and practical in this environment.

  1. Thermoacoustic CT of the breast: pilot study observations

    Science.gov (United States)

    Kruger, Robert A.; Kiser, William L., Jr.; Romilly, A. P.; Scmidt, Phyllis

    2001-06-01

    In order to assess the potential clinical utility of using thermoacoustic computer tomography (TCT) to image the breast, we conducted a retrospective pilot study of 78 patients. We recruited patients in three age groups (50 years). The study population was further segregated into normal and suspicious based on the results of the previous x-ray mammography and ultrasound. Image quality was evaluated qualitatively by consensus of two trained mammographers using a 4-point scale. The appearance of normal anatomy, cysts, benign disease and cancer was noted. Patients were also asked to rate the comfort of the TCT exam and to indicate a personal preference for x-ray mammography or TCT. Analysis of the data indicated that TCT image quality was dependent upon both patient age and breast density, improving with both increasing breast density and decreasing patient age. Fibrocystic disease was well seen, cysts appearing as areas of low RF absorption. Fibroadenomas did not demonstrate contrast enhancement with the exception of one patient with associated atypical hyperplasia. Cancer displayed higher RF absorption than surrounding tissues in 4/7 patients in whom cancer was confirmed, including one patient with a 7-mm ductal carcinoma in situ (DCIS).

  2. Socioeconomic impact of children's burns-a pilot study.

    Science.gov (United States)

    Kilburn, Nadia; Dheansa, Baljit

    2014-12-01

    This pilot study aimed to gain empirical data on the social and economic impacts of child burns on children and parents, in the context of the outpatient setting. A questionnaire was completed by 52 parents of paediatric patients attending the burns outpatient department at Queen Victoria Hospital (QVH), East Grinstead, for at least the third time. Children's medical notes were used to extract demographic and medical data. Quantitative data was analyzed statistically and qualitative data was analyzed manually using content analysis. The financial burden related to the injury posed the greatest impact on parents, and was mainly associated with making the journey to the hospital, with lower income households being most affected. Self-employed parents and those who had to attend more than 6 hospital appointments also ran into difficulties. On the whole, there was not a considerable social impact on the burn-injured child, which may reflect the minor nature of burns in this study (mean depth partial thickness, median TBSA 1.0%). Parents were shown to perceive a greater impact from their child's burn injury than their child. Certain groups of parents were identified as requiring additional support following the burn injury. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

  3. Interproximal periodontal defect model in dogs: a pilot study.

    Science.gov (United States)

    Jung, U-W; Chang, Y-Y; Um, Y-J; Kim, C-S; Cho, K-S; Choi, S-H

    2011-01-01

    This study aimed to evaluate the validity of a surgically created interproximal periodontal defect in dogs. Surgery was performed in the interproximal area between the maxillary second and third premolars in two beagle dogs. Following an incision and reflection of the gingival flap, a 3-mm wide and 5-mm high defect was prepared surgically at the interproximal area. A thorough root planing was performed and the flap was coronally positioned and sutured. The contra-lateral area was served as the control with no surgical intervention. After 8 weeks of healing, the animals were killed and the defect was analysed histometrically and radiographically. The interproximal periodontal defect resembled a naturally occurring defect and mimicked a clinical situation. After healing, the defect showed limited bone (0.89±0.02mm) and cementum regeneration (1.50± 0.48mm). Within the limitations of this pilot study, the interproximal periodontal defect showed limited bone and cementum regeneration. Thus, it can be considered as a standardized, reproducible defect model for testing new biomaterials. © 2010 John Wiley & Sons A/S.

  4. Daily personal exposure to black carbon: A pilot study

    Science.gov (United States)

    Williams, Ryan D.; Knibbs, Luke D.

    2016-05-01

    Continuous personal monitoring is the benchmark for air pollution exposure assessment. Black carbon (BC) is a strong marker of primary combustion like vehicle and biomass emissions. There have been few studies that quantified daily personal BC exposure and the contribution that different microenvironments make to it. In this pilot study, we used a portable aethalometer to measure BC concentrations in an individual's breathing zone at 30-s intervals while he performed his usual daily activities. We used a GPS and time-activity diary to track where he spent his time. We performed twenty 24-h measurements, and observed an arithmetic mean daily exposure concentration of 603 ng/m3. We estimated that changing commute modes from bus to train reduced the 24-h mean BC exposure concentration by 29%. Switching from open windows to closed windows and recirculated air in a car led to a reduction of 32%. Living in a home without a wood-fired heater caused a reduction of 50% compared with a wood-heated home. Our preliminary findings highlight the potential utility of simple approaches to reduce a person's daily BC exposure.

  5. Observing position and movements in hydrotherapy: a pilot study.

    Science.gov (United States)

    Stark, Mary Ann; Rudell, Barb; Haus, George

    2008-01-01

    To observe and describe the positions and movements women choose while immersed in water during the first stage of labor. Descriptive, observational pilot study. A rural community hospital that provided hydrotherapy in labor. Women (N = 7) who intended to use hydrotherapy in labor were recruited prenatally from a midwife-managed practice. For 15 minutes of each hour during the first stage of labor, position and movements of the participants were observed and recorded on a laptop computer. The observational tool was developed for this study from a review of the literature and interviews with nursing experts; 435 observations were recorded. Women were free to choose when and how long to use hydrotherapy and had no restriction on their positions and movements. Only 3 of the 7 participants labored in the tub. Women demonstrated a greater range of positions and movements in the tub than in bed, both throughout labor and during late first-stage labor (7-10 cm of dilatation). Women had more contractions and made more rhythmic movements while in the tub than in bed. Hydrotherapy may encourage upright positions and movements that facilitate labor progress and coping, helping women avoid unnecessary interventions.

  6. A pilot study of bendamustine in advanced bile duct cancer.

    Science.gov (United States)

    Schoppmeyer, Konrad; Kreth, Florian; Wiedmann, Marcus; Mössner, Joachim; Preiss, Rainer; Caca, Karel

    2007-07-01

    We performed a pilot study to evaluate the safety and tolerability of bendamustine in patients with advanced hilar bile duct cancer and impaired liver function. Six patients with histologically proven, unresectable adenocarcinoma of the hilar bile duct were treated with bendamustine 140 mg/m intravenously on day 1 of the first cycle and with bendamustine 100 mg/m on days 1 and 2 of the second to fourth cycle. Treatment cycles were repeated every 21 days. Primary endpoint was the safety and tolerability of the treatment; secondary endpoints were response rate, time to progression and overall survival. Transient lymphopenia grade 3 occurred in all six patients. No other grade 3 or 4 toxicities were present. The most common nonhematologic toxicity was mouth dryness grade 2 in six patients. Three patients had stable disease. No partial or complete responses were observed. Median time to progression was 3.3 months; median overall survival was 6 months. Our study demonstrates that bendamustine can be safely administered in patients with hilar bile duct cancer and impaired liver function. A potential role of bendamustine in combination therapies for bile duct cancer will be a subject of further trials.

  7. Leading teams during simulated pediatric emergencies: a pilot study

    Science.gov (United States)

    Coolen, Ester H; Draaisma, Jos M; den Hamer, Sabien; Loeffen, Jan L

    2015-01-01

    Purpose Leadership has been identified as a key variable for the functioning of teams and as one of the main reasons for success or failure of team-based work systems. Pediatricians often function as team leaders in the resuscitation of a critically ill child. However, pediatric residents often report having little opportunity to perform in the role of team leader during residency. In order to gain more insight into leadership skills and behaviors, we classified leadership styles of pediatric residents during simulated emergencies. Methods We conducted a prospective quantitative study to investigate leadership styles used by pediatric residents during simulated emergencies with clinical deterioration of a child at a pediatric ward. Using videotaped scenarios of 48 simulated critical events among 12 residents, we were able to classify verbal and nonverbal communication into different leadership styles according to the situational leadership theory. Results The coaching style (mean 54.5%, SD 7.8) is the most frequently applied by residents, followed by the directing style (mean 35.6%, SD 4.1). This pattern conforms to the task- and role-related requirements in our scenarios and it also conforms to the concept of situational leadership. We did not find any significant differences in leadership style according to the postgraduate year or scenario content. Conclusion The model used in this pilot study helps us to gain a better understanding of the development of effective leadership behavior and supports the applicability of situational leadership theory in training leadership skills during residency. PMID:25610010

  8. Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP Trial

    Directory of Open Access Journals (Sweden)

    Hurley D

    2008-03-01

    Full Text Available Abstract Background Evidence supports the use of exercise for chronic low back pain (CLBP; however, adherence is often poor due to ongoing pain. Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts. It may be a useful adjunct to exercise in managing CLBP; however, there is only limited evidence to support its use with this patient group. Methods/Design This study was designed to test the feasibility of an assessor-blind randomised controlled trial which assess the effects on clinical outcomes and exercise adherence of adding manual auricular acupuncture to a personalised and supervised exercise programme (PEP for CLBP. No sample size calculation has been carried out as this study aims to identify CLBP referral rates within the catchment area of the study site. The researchers aim to recruit four cohorts of n = 20 participants to facilitate a power analysis for a future randomised controlled trial. A computer generated random allocation sequence will be prepared centrally and used to allocate participants by cohort to one of the following interventions: 1 six weeks of PEP plus manual auricular acupuncture; 2 six weeks of PEP alone. Both groups will also complete a further six weeks of self-paced exercise with telephone follow-up support. In addition to a baseline and exit questionnaire at the beginning and end of the study, the following outcomes will be collected at baseline, and after 7, 13 and 25 weeks: pain frequency and bothersomeness, back-specific function, objective assessment and recall of physical activity, use of analgesia, perceived self-efficacy, fear avoidance beliefs, and beliefs about the consequences of back pain. Since this is a feasibility study, significance tests will not be presented, and treatment effects will be represented by point estimates and confidence intervals. For each outcome variable, analysis of covariance will be performed on

  9. Pilot study to verify the calibration of electrometers

    International Nuclear Information System (INIS)

    Becker, P.; Meghzifene, A.

    2002-01-01

    National Laboratory for Electrical Measurements has not yet developed its capability for the standardization of small electrical charge produced by DC, the IRD is trying to verify its standardization procedures of the electrical charge through a comparison programme. This subject was discussed with a major electrometer manufacturer that has offered to provide free of charge, three of their electrometer calibration standards for a pilot run. The model to be provided consists of four calibrated resistors and two calibrated capacitors, covering the charge/current range of interest. For producing charge or current a standard DC voltage must be applied to these components. Since practically all-modern electrometers measure using virtual ground, this methodology is viable. The IRD, in collaboration with the IAEA, wishes to invite interested laboratories to participate in this pilot comparison programme. This exercise is expected to be useful for all participants and will hopefully open the way for the establishment of routine comparisons in this area. The results will be discussed and published in an appropriate journal. Interested institutions should contact directly Mr. Paulo H. B. Becker through e-mail (pbecker at ird.gov.br) or fax +55 21 24421950 informing him of the model and manufacturer of the electrometer to be used for the pilot study and discuss all practical details. (author)

  10. Effect of a steam foot spa on geriatric inpatients with cognitive impairment: a pilot study

    Directory of Open Access Journals (Sweden)

    Koike Y

    2013-05-01

    Full Text Available Yoshihisa Koike,1 Hideki Kondo,2 Satoshi Kondo,1 Masayuki Takagi,1 Yoshio Kano31Department of Occupational Therapy, Prefectural University of Hiroshima, Mihara, Japan; 2Yoshiigawa Hospital, Okayama, Japan; 3Department of Occupational Therapy, Kibi International University, Takahashi, JapanPurpose: To investigate whether a steam foot spa improves cognitive impairment in geriatric inpatients.Methods: Geriatric inpatients with cognitive impairment were given a steam foot spa treatment at 42°C for 20 minutes for 2 weeks (5 days/week. Physiological indicators such as blood pressure, percutaneous oxygen saturation, pulse, tympanic temperature, and sleep time and efficiency were assessed. Cognitive function and behavioral and psychological symptoms of dementia were assessed using the Mini-Mental State Examination, Dementia Mood Assessment Scale, and Dementia Behavior Disturbance scale.Results: Significant decreases in systolic (P < 0.01 and diastolic blood pressure (P < 0.05 along with a significant increase in tympanic temperature (P < 0.01 were observed after the steam foot spas. A significant improvement was seen in the Mini-Mental State Examination score (P < 0.01 and the overall dementia severity items in Dementia Mood Assessment Scale (P < 0.05.Limitations: Japanese people are very fond of foot baths. However, it is difficult to understand why inpatients cannot receive steam foot baths. In this study, a control group was not used. Raters and enforcers were not blinded.Conclusion: The results of this pilot study suggest that steam foot spas mitigate cognitive impairment in geriatric inpatients.Keywords: steam foot spa, geriatric inpatients, cognitive impairment, tympanic temperature

  11. Prevalence and Severity of Dysphonia in Patients with Cystic Fibrosis: A Pilot Study.

    Science.gov (United States)

    Willis, John; Michael, Deirdre D; Boyer, Holly; Misono, Stephanie

    2015-07-01

    To assess the prevalence and severity of dysphonia in patients with cystic fibrosis sinusitis. We hypothesized that patients with CF sinusitis, compared with 2 control groups, would have higher self-reported prevalence of dysphonia and greater severity of dysphonia, according to patient-reported outcome measures as well as auditory-perceptual evaluation by expert listeners. Cross-sectional comparative pilot study. Academic tertiary care clinic. Analysis included 37 study participants: 17 patients with CF sinusitis, 10 healthy individuals, and 10 patients with non-CF sinusitis. All participants completed the 10-item Voice Handicap Index (VHI-10) questionnaire and provided voice samples. On all samples, 6 blinded speech-language pathologists independently performed auditory-perceptual evaluation, using Consensus Auditory-Perceptual Evaluation of Voice. To assess severity of sinonasal symptoms, we used the 20-item Sinonasal Outcome Test (SNOT-20). Standard parametric and nonparametric statistical analysis was performed. The differences between the 3 groups in prevalence of abnormal VHI-10 scores were not statistically significant. SNOT-20 scores were similar in the 2 sinusitis patient groups. VHI-10 scores were highest in patients with CF sinusitis, intermediate in patients with non-CF sinusitis, and lowest in healthy individuals (P = .005). Auditory-perceptual evaluation demonstrated greater overall severity of dysphonia in patients with CF sinusitis compared with the 2 control groups (P = .0005). Cystic fibrosis sinusitis appeared to be associated with worse vocal function as measured by patient self-report as well as auditory-perceptual evaluation of voice compared with patients with non-CF sinusitis and healthy controls. Further investigation in this area is warranted. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

  12. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study.

    Science.gov (United States)

    Quattrocchi, Carlo Cosimo; de Pandis, Maria Francesca; Piervincenzi, Claudia; Galli, Manuela; Melgari, Jean Marc; Salomone, Gaetano; Sale, Patrizio; Mallio, Carlo Augusto; Carducci, Filippo; Stocchi, Fabrizio

    2015-01-01

    The present study shows the results of a double-blind sham-controlled pilot trial to test whether measurable stimulus-specific functional connectivity changes exist after Automatic Mechanical Peripheral Stimulation (AMPS) in patients with idiopathic Parkinson Disease. Eleven patients (6 women and 5 men) with idiopathic Parkinson Disease underwent brain fMRI immediately before and after sham or effective AMPS. Resting state Functional Connectivity (RSFC) was assessed using the seed-ROI based analysis. Seed ROIs were positioned on basal ganglia, on primary sensory-motor cortices, on the supplementary motor areas and on the cerebellum. Individual differences for pre- and post-effective AMPS and pre- and post-sham condition were obtained and first entered in respective one-sample t-test analyses, to evaluate the mean effect of condition. Effective AMPS, but not sham stimulation, induced increase of RSFC of the sensory motor cortex, nucleus striatum and cerebellum. Secondly, individual differences for both conditions were entered into paired group t-test analysis to rule out sub-threshold effects of sham stimulation, which showed stronger connectivity of the striatum nucleus with the right lateral occipital cortex and the cuneal cortex (max Z score 3.12) and with the right anterior temporal lobe (max Z score 3.42) and of the cerebellum with the right lateral occipital cortex and the right cerebellar cortex (max Z score 3.79). Our results suggest that effective AMPS acutely increases RSFC of brain regions involved in visuo-spatial and sensory-motor integration. This study provides Class II evidence that automatic mechanical peripheral stimulation is effective in modulating brain functional connectivity of patients with Parkinson Disease at rest. Clinical Trials.gov NCT01815281.

  13. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study

    Science.gov (United States)

    Piervincenzi, Claudia; Galli, Manuela; Melgari, Jean Marc; Salomone, Gaetano; Sale, Patrizio; Mallio, Carlo Augusto; Carducci, Filippo; Stocchi, Fabrizio

    2015-01-01

    Objective The present study shows the results of a double-blind sham-controlled pilot trial to test whether measurable stimulus-specific functional connectivity changes exist after Automatic Mechanical Peripheral Stimulation (AMPS) in patients with idiopathic Parkinson Disease. Methods Eleven patients (6 women and 5 men) with idiopathic Parkinson Disease underwent brain fMRI immediately before and after sham or effective AMPS. Resting state Functional Connectivity (RSFC) was assessed using the seed-ROI based analysis. Seed ROIs were positioned on basal ganglia, on primary sensory-motor cortices, on the supplementary motor areas and on the cerebellum. Individual differences for pre- and post-effective AMPS and pre- and post-sham condition were obtained and first entered in respective one-sample t-test analyses, to evaluate the mean effect of condition. Results Effective AMPS, but not sham stimulation, induced increase of RSFC of the sensory motor cortex, nucleus striatum and cerebellum. Secondly, individual differences for both conditions were entered into paired group t-test analysis to rule out sub-threshold effects of sham stimulation, which showed stronger connectivity of the striatum nucleus with the right lateral occipital cortex and the cuneal cortex (max Z score 3.12) and with the right anterior temporal lobe (max Z score 3.42) and of the cerebellum with the right lateral occipital cortex and the right cerebellar cortex (max Z score 3.79). Conclusions Our results suggest that effective AMPS acutely increases RSFC of brain regions involved in visuo-spatial and sensory-motor integration. Classification of Evidence This study provides Class II evidence that automatic mechanical peripheral stimulation is effective in modulating brain functional connectivity of patients with Parkinson Disease at rest. Trial Registration Clinical Trials.gov NCT01815281 PMID:26469868

  14. A functional neuroimaging study of sound localization: visual cortex activity predicts performance in early-blind individuals.

    Directory of Open Access Journals (Sweden)

    Frédéric Gougoux

    2005-02-01

    Full Text Available Blind individuals often demonstrate enhanced nonvisual perceptual abilities. However, the neural substrate that underlies this improved performance remains to be fully understood. An earlier behavioral study demonstrated that some early-blind people localize sounds more accurately than sighted controls using monaural cues. In order to investigate the neural basis of these behavioral differences in humans, we carried out functional imaging studies using positron emission tomography and a speaker array that permitted pseudo-free-field presentations within the scanner. During binaural sound localization, a sighted control group showed decreased cerebral blood flow in the occipital lobe, which was not seen in early-blind individuals. During monaural sound localization (one ear plugged, the subgroup of early-blind subjects who were behaviorally superior at sound localization displayed two activation foci in the occipital cortex. This effect was not seen in blind persons who did not have superior monaural sound localization abilities, nor in sighted individuals. The degree of activation of one of these foci was strongly correlated with sound localization accuracy across the entire group of blind subjects. The results show that those blind persons who perform better than sighted persons recruit occipital areas to carry out auditory localization under monaural conditions. We therefore conclude that computations carried out in the occipital cortex specifically underlie the enhanced capacity to use monaural cues. Our findings shed light not only on intermodal compensatory mechanisms, but also on individual differences in these mechanisms and on inhibitory patterns that differ between sighted individuals and those deprived of vision early in life.

  15. Effects of a multidisciplinary group rehabilitation programme on participation of the visually impaired elderly : a pilot study

    NARCIS (Netherlands)

    Alma, Manna A.; Groothoff, Johan W.; Melis-Dankers, Bart J. M.; Post, Marcel W. M.; Suurmeijer, Theo P. B. M.; van der Mei, Sijrike F.

    2012-01-01

    Purpose: To pilot test the newly developed multidisciplinary group rehabilitation programme Visually Impaired elderly Persons Participating (VIPP). Method: A single group pretest-posttest design pilot study included 29 visually impaired persons (>= 55 years). The intervention (20 weekly meetings)

  16. Pilot case-control study of paediatric falls from windows.

    Science.gov (United States)

    Johnston, Brian D; Quistberg, D Alexander; Shandro, Jamie R; Partridge, Rebecca L; Song, Hyun Rae; Ebel, Beth E

    2011-12-01

    Unintentional falls from windows are an important cause of paediatric morbidity. There have been no controlled studies to identify modifiable environmental risk factors for window falls in young children. The authors have piloted a case-control study to test procedures for case identification, subject enrolment, and environmental data collection. Case windows were identified when a child 0-9 years old presented for care after a fall from that window. Control windows were identified (1) from the child's home and (2) from the home of an age- and gender-matched child seeking care for an injury diagnosis not related to a window fall. Study staff visited enrolled homes to collect window measurements and conduct window screen performance tests. The authors enrolled and collected data on 18 case windows, 18 in-home controls, and 14 matched community controls. Six potential community controls were contacted for every one enrolled. Families who completed the home visit viewed study procedures positively. Case windows were more likely than community controls to be horizontal sliders (100% vs 50%), to have deeper sills (6.28 vs 4.31 inches), to be higher above the exterior surface (183 vs 82 inches), and to have screens that failed below a threshold derived from the static pressure of a 3-year-old leaning against the mesh (60.0% vs 16.7%). Case windows varied very little from in-home controls. Case-control methodology can be used to study risk factors for paediatric falls from windows. Recruitment of community controls is challenging but essential, because in-home controls tend to be over-matched on important variables. A home visit allows direct measurement of window type, height, sill depth, and screen performance. These variables should all be investigated in subsequent, larger studies covering major housing markets.

  17. Visual consequences of electronic reader use: a pilot study.

    Science.gov (United States)

    Maducdoc, Marlon M; Haider, Asghar; Nalbandian, Angèle; Youm, Julie H; Morgan, Payam V; Crow, Robert W

    2017-04-01

    With the increasing prevalence of electronic readers (e-readers) for vocational and professional uses, it is important to discover if there are visual consequences in the use of these products. There are no studies in the literature quantifying the incidence or severity of eyestrain, nor are there clinical characteristics that may predispose to these symptoms with e-reader use. The primary objective of this pilot study was to assess the degree of eyestrain associated with e-reader use compared to traditional paper format. The secondary outcomes of this study were to assess the rate of eyestrain associated with e-reader use and identify any clinical characteristics that may be associated with the development of eyestrain. Forty-four students were randomly assigned to study (e-reader iPAD) and control (print) groups. Participant posture, luminosity of the room, and reading distance from reading device were measured during a 1-h session for both groups. At the end of the session, questionnaires were administered to determine symptoms. Significantly higher rates of eyestrain (p = 0.008) and irritation (p = 0.011) were found among the iPAD study group as compared to the print 'control' group. The study group was also 4.9 times more likely to report severe eyestrain (95 % CI [1.4, 16.9]). No clinical characteristics predisposing to eyestrain could be identified. These findings conclude that reading on e-readers may induce increased levels of irritation and eyestrain. Predisposing factors, etiology, and potential remedial interventions remain to be determined.

  18. Liberal Versus Restrictive Fluid Management in Knee Arthroplasty: A Randomized, Double-Blind Study

    DEFF Research Database (Denmark)

    Holte, Kathrine; Kristensen, Billy Bjarne; Valentiner, Lotte

    2007-01-01

    BACKGROUND: There are few data describing the relationship between amount of perioperative fluid and organ function. In this study we investigated the effects of two levels of intravascular fluid administration ("liberal" versus "restrictive") in knee arthroplasty on physiological recovery...... with a standardized volume of colloid. All other aspects of perioperative management (including anesthesia, preoperative fluid status, and postoperative management) were standardized. Primary outcome variables included pulmonary function (spirometry), exercise capacity ("timed up and go" test), coagulation...... as the primary outcome variable. METHODS: In a double-blind study, 48 ASA I-III patients undergoing fast-track elective knee arthroplasty were randomized to restrictive or liberal perioperative intravascular fluid administration. Patients received a fixed rate infusion of Ringer's lactate solution...

  19. Pterygium excision with or without postoperative irradiation, a double-blind study

    Energy Technology Data Exchange (ETDEWEB)

    de Keizer, R.J.W. (Amsterdam Univ. (Netherlands). Academisch Ziekenhuis)

    1982-01-29

    A double-blind study (covering 40 months) of 40 eyes with a pterygium which had not previously been operated on, was carried out to study the effect of post-operative irradiation. Nineteen eyes were treated by the 'bare sclera' operation technique only and in 13 cases (68%) a recurrence occurred within 4 months. In 18 eyes from the group of patients treated with Sr 90 irradiation on the 1st, 7th and 14th postoperative day (maximum 3 x 1000 rad) no recurrences were seen. Patients with a recurrent pterygium and diplopia, symblepharon, visual disturbances (growth over the pupil or severe astigmatism) or many previous operations, were treated by lamellar keratoplasty (Dake, 1980). The recurrences without these complications were treated with success by the 'bare sclera' technique and postoperative irradiation. Complications did not occur in any of the series.

  20. Familiar trespassers in histopathology: An obstacle in diagnosis? A single-blind study

    Directory of Open Access Journals (Sweden)

    P Shashikala

    2017-01-01

    Full Text Available Background: Histopathologists encounter strange structures in tissue sections that appear unrelated to tissues, and these artifacts may be misinterpreted and misdiagnosed as pathological lesions. These substances may either be present within the tissues or can get implanted into tissue during biopsy procedure or laboratory handling or processing. Aims: The aim of this study is to observe the microscopic appearance of different abnormal structures like commonly implanted food particles or easily incorporated substances during tissue processing with their probable histological misdiagnosis. Materials and Methods: Certain food particles, suture materials, wood pieces, insects, and filter paper were intentionally introduced in the tissue specimens of uterus and lung. Following routine processing and hematoxylin and eosin staining, the slides were subjected to single-blind study and viewed under light and polarizing microscope. Results: The vivid appearances of these structures lead to histological misdiagnosis. Conclusion: Knowledge and familiarity of these commonly encountered extraneous substances will help to prevent misinterpretation.

  1. Pregabalin for anxiety in patients with schizophrenia - A randomized, double-blind placebo-controlled study

    DEFF Research Database (Denmark)

    Schjerning, Ole; Damkier, Per; Lykkegaard, Signe Engelhardt

    2017-01-01

    INTRODUCTION: Anxiety is frequent in patients with schizophrenia and poses a major impact on patients perceived quality of life, daily functioning and risk of suicide. Pregabalin has shown effective in the treatment of generalized anxiety disorder and has been suggested for the treatment of anxiety...... in patients with schizophrenia. As evidence is sparse regarding treatment of anxiety in this patient group, we aimed to investigate the use of pregabalin for anxiety in patients with schizophrenia. METHODS: A randomized, double-blind placebo controlled study was used. Patients were randomized to either...... placebo or pregabalin (≤600mg/d) as add-on treatment. Primary analyses were intention-to-treat based with change in Hamilton Anxiety Scale after 4 and 8weeks of treatment as primary outcome. Secondary outcomes were change in psychopathology, quality-of-life, cognitive functioning and sleep. The study used...

  2. Lung cancer correlates in Lebanese adults: A pilot case–control study

    Directory of Open Access Journals (Sweden)

    Joseph Aoun

    2013-12-01

    Conclusion: In this pilot study, it was found that in addition to smoking, outdoor and indoor pollution factors were potential risk factors of lung cancer. Additional studies would be necessary to confirm these findings.

  3. Customized photorefractive keratectomy to correct high ametropia after penetrating keratoplasty: A pilot study

    Directory of Open Access Journals (Sweden)

    Giuseppe De Rosa

    2015-07-01

    Conclusion: Our pilot study suggests that customized PRK can be a safe and effective method for treating ametropia and irregular astigmatisms after PK. Future studies with larger samples and longer follow-ups should be performed to confirm these results.

  4. Arctic Ice Dynamics Joint Experiment (AIDJEX) Second Pilot Study, March - May 1972: A Documentary Film

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The project described in this documentary was a pilot study conducted in 1972 in preparation for the AIDJEX main experiment of 1975 to 1976. The study included a...

  5. Azithromycin in the extremely low birth weight infant for the prevention of Bronchopulmonary Dysplasia: a pilot study

    Directory of Open Access Journals (Sweden)

    Anstead Michael I

    2007-06-01

    Full Text Available Abstract Background Azithromycin reduces the severity of illness in patients with inflammatory lung disease such as cystic fibrosis and diffuse panbronchiolitis. Bronchopulmonary dysplasia (BPD is a pulmonary disorder which causes significant morbidity and mortality in premature infants. BPD is pathologically characterized by inflammation, fibrosis and impaired alveolar development. The purpose of this study was to obtain pilot data on the effectiveness and safety of prophylactic azithromycin in reducing the incidence and severity of BPD in an extremely low birth weight (≤ 1000 grams population. Methods Infants ≤ 1000 g birth weight admitted to the University of Kentucky Neonatal Intensive Care Unit (level III, regional referral center from 9/1/02-6/30/03 were eligible for this pilot study. The pilot study was double-blinded, randomized, and placebo-controlled. Infants were randomized to treatment or placebo within 12 hours of beginning mechanical ventilation (IMV and within 72 hours of birth. The treatment group received azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for the duration of the study. Azithromycin or placebo was continued until the infant no longer required IMV or supplemental oxygen, to a maximum of 6 weeks. Primary endpoints were incidence of BPD as defined by oxygen requirement at 36 weeks gestation, post-natal steroid use, days of IMV, and mortality. Data was analyzed by intention to treat using Chi-square and ANOVA. Results A total of 43 extremely premature infants were enrolled in this pilot study. Mean gestational age and birth weight were similar between groups. Mortality, incidence of BPD, days of IMV, and other morbidities were not significantly different between groups. Post-natal steroid use was significantly less in the treatment group [31% (6/19] vs. placebo group [62% (10/16] (p = 0.05. Duration of mechanical ventilation was significantly less in treatment survivors, with a median of 13 days (1–47

  6. Adjustable recessions in horizontal comitant strabismus: A pilot study

    Directory of Open Access Journals (Sweden)

    Siddharth Agrawal

    2015-01-01

    Full Text Available Aim: To compare the surgical outcome of adjustable with the conventional recession in patients with horizontal comitant strabismus. Patients and Methods: A prospective comparative nonrandomized interventional pilot study was performed on patients with horizontal comitant strabismus. Fifty-four patients (27 in each group were allocated into 2 groups to undergo either adjustable suture (AS recession or non-AS (NAS recession along with conventional resection. The patients were followed up for 6 months. A successful outcome was defined as deviation ±10 prism diopters at 6 months. The results were statistically analyzed by Chi-square test, Fisher′s exact test, and Student′s t-test. Results: A successful outcome was found in 24 (88.8% patients in AS and 17 (62.9% in NAS group (P = 0.02. The postoperative adjustment was done in 13 (48.1% patients in AS group. There was one complication (tenon′s cyst in AS group. Conclusion: AS recession may be considered in all cooperative patients undergoing strabismus surgery for comitant deviations.

  7. Perceived harmfulness of substance use: A pilot study

    Directory of Open Access Journals (Sweden)

    Siddharth Sarkar

    2014-01-01

    Full Text Available Background: Harm ratings of substances help in understanding the perception toward substance use and formulating policies. Evidence of such harm ratings by substance users and their caregivers provides a clearer perspective of those who experience and observe such harm closely. Materials and Methods: Substance users and their caregivers were recruited from the Drug De-addiction and Treatment Centre of PGIMER, Chandigarh. Sociodemographic details of the subjects were noted. The subjects were then asked to rate a list of psychoactive preparations according to the harms they thought the preparation caused. The list of substances was developed taking into consideration substance commonly encountered in the geographical area. The harm ratings were transformed on a scale of 0-100. Results: All subjects were males and majority of them were educated above 10 th standard, were not employed and belonged to urban background. Most of them had taken psychoactive substances in their lifetimes but were currently abstinent. Most of the subjects endorsed intravenous drugs as the most harmful, followed by heroin. Beer and chewable tobacco considered the least harmful substances. Greater degree of education was associated with lower harm rankings for heroin, cannabis, dextropropoxyphene, and raw opium; while urban residence was associated with greater harm ratings for cannabis and raw opium. Differences in the harms were perceived for different preparations of the same active compound for alcohol and nicotine. Conclusion: Harm ratings of substances can be a useful guide while formulating policies and allocating resources. Need for further research extending this pilot study is emphasized.

  8. Evaluating and operationalizing an environmental auditing program: a pilot study.

    Science.gov (United States)

    Gordon, Laura; Bruce, Natalie; Suh, Kathryn N; Roth, Virginia

    2014-07-01

    Environmental auditing is an important tool to ensure consistent and effective cleaning. Our pilot study compared an alcohol-based fluorescent marking product and an adenosine-5'-triphosphate bioluminescence product for use in an environmental auditing program to determine which product was more practical and acceptable to users. Both products were tested on 15 preselected high touch objects in randomly selected patient rooms, following regular daily cleaning. A room was considered a "pass" if ≥80% of surfaces were adequately cleaned as defined by manufacturers' guidelines. A qualitative survey assessed user preference and operational considerations. Using fluorescent marking, 9 of 37 patient rooms evaluated (24%) were considered a "pass" after daily cleaning. Using adenosine-5'-triphosphate bioluminescence, 21 of 37 patient rooms passed (57%). There was great variability in results between different high touch objects. Eighty percent of users preferred the alcohol-based fluorescent marking product because it provided an effective visual aid to coach staff on proper cleaning techniques and allowed simple and consistent application. Environmental auditing using translucent, alcohol-based fluorescent marking best met the requirements of our organization. Our results reinforce the importance of involving a multidisciplinary team in evaluating and operationalizing an environmental auditing program. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  9. Pilot study on microvascular anastomosis: performance and future educational prospects.

    Science.gov (United States)

    Berretti, G; Colletti, G; Parrinello, G; Iavarone, A; Vannucchi, P; Deganello, A

    2017-11-30

    The introduction of microvascular free flaps has revolutionised modern reconstructive surgery. Unfortunately, access to training opportunities at standardised training courses is limited and expensive. We designed a pilot study on microvascular anastomoses with the aim of verifying if a short course, easily reproducible, could transmit microvascular skills to participants; if the chosen pre-test was predictive of final performance; and if age could influence the outcome. A total of 30 participants (10 students, 10 residents and 10 surgeons) without any previous microvascular experience were instructed and tested during a single 3 to 5 hour course. The two microanastomoses evaluated were the first ever performed by each participant. More than the half of the cohort was able to produce both patent microanastomoses in less than 2 hours; two-thirds of the attempted microanastomoses were patent. The pretest predicted decent scores from poor performances with a sensitivity of 61.5%, specificity of 100%, positive predictive value of 100% and negative predictive value of 40%. Students and residents obtained significantly higher scores than surgeons. Since our course model is short, cost-effective and highly reproducible, it could be introduced and implemented anywhere as an educational prospect for preselecting young residents showing talent and natural predisposition and having ambitions towards microvascular reconstructive surgery. © Copyright by Società Italiana di Otorinolaringologia e Chirurgia Cervico-Facciale.

  10. Sociomoral Reasoning in Adults with ADHD: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Kate E. Thomason

    2014-08-01

    Full Text Available Attention Deficit Hyperactivity Disorder (ADHD is frequently linked with antisocial behaviour, yet less is known about its relationship with sociomoral reasoning, and the possible mediating effect of intelligence. A pilot study was designed to investigate the relationship between antisocial personality traits, intelligence and sociomoral reasoning in adults with ADHD. Twenty two adults with ADHD and 21 healthy controls, matched for age, gender and IQ completed a battery of measures including the National Adult Reading Test, Gough Socialisation Scale and Sociomoral Reflection Measure-Short Form. There was no difference between the groups and levels of sociomoral reasoning, despite the ADHD group reporting greater antisocial personality traits. Sociomoral reasoning was positively correlated with intelligence. Results from a hierarchical multiple regressions indicated that both antisocial traits and IQ were significant predictors of sociomoral reasoning, with IQ proving the most powerful predictor. Whilst antisocial personality traits may explain some of the variance in levels of sociomoral reasoning, a diagnosis of ADHD does not appear to hinder the development of mature moral reasoning. Intellectual functioning appears to facilitate the development of sociomoral reasoning. A further analysis showed that both ADHD and low sociomoral reasoning were significant predictors of antisocial traits. The current findings have important treatment implications.

  11. Gene Expression Correlation for Cancer Diagnosis: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Binbing Ling

    2014-01-01

    Full Text Available Poor prognosis for late-stage, high-grade, and recurrent cancers has been motivating cancer researchers to search for more efficient biomarkers to identify the onset of cancer. Recent advances in constructing and dynamically analyzing biomolecular networks for different types of cancer have provided a promising novel strategy to detect tumorigenesis and metastasis. The observation of different biomolecular networks associated with normal and cancerous states led us to hypothesize that correlations for gene expressions could serve as valid indicators of early cancer development. In this pilot study, we tested our hypothesis by examining whether the mRNA expressions of three randomly selected cancer-related genes PIK3C3, PIM3, and PTEN were correlated during cancer progression and the correlation coefficients could be used for cancer diagnosis. Strong correlations (0.68≤r≤1.0 were observed between PIK3C3 and PIM3 in breast cancer, between PIK3C3 and PTEN in breast and ovary cancers, and between PIM3 and PTEN in breast, kidney, liver, and thyroid cancers during disease progression, implicating that the correlations for cancer network gene expressions could serve as a supplement to current clinical biomarkers, such as cancer antigens, for early cancer diagnosis.

  12. GLOBE Aerosol Field Campaign - U.S. Pilot Study 2016

    Science.gov (United States)

    Pippin, Margaret; Marentette, Christina; Bujosa, Robert; Taylor, Jessica; Lewis, Preston

    2016-01-01

    During the spring of 2016, from April 4 - May 27, sixteen GLOBE schools participated in the GLOBE Aerosol Field Campaign - U.S. Pilot Study. Thirteen teachers from these schools had previously participated in the NASA LEARN program (Long-term Experience in Authentic Research with NASA) where they were GLOBE trained in Atmosphere protocols, and engaged in 1-3 years of research under the mentorship of NASA scientists. Each school was loaned two aerosol instruments for the Campaign duration, either 2 GLOBE sun photometers, 2 Calitoo sun photometers, or 1 of each. This allowed for students to make measurements side-by-side and in the case of the Calitoos, to compare AOT results immediately with each other for better consistency in data collection. Additionally, as part of the Field Campaign evaluation, multiple instruments allow for an assessment of the ease of use of each instrument for grade level of students, whether in middle school or high school. Before the Campaign, all GLOBE and Calitoo instruments were 'checked out' against an AERONET, then checked again upon return after the Campaign. By examining all data, before, during and after the Campaign, this gives an indication of instrument performance and proficiency obtained by the students. Support was provided to each teacher and their students at the level requested, via email, phone or video conferencing.

  13. Compensatory stepping responses in individuals with stroke: a pilot study.

    Science.gov (United States)

    Lakhani, Bimal; Mansfield, Avril; Inness, Elizabeth L; McIlroy, William E

    2011-05-01

    Impaired postural control and a high incidence of falls are commonly observed following stroke. Compensatory stepping responses are critical to reactive balance control. We hypothesize that, following a stroke, individuals with unilateral limb dyscontrol will be faced with the unique challenge of controlling such rapid stepping reactions that may eventually be linked to the high rate of falling. The objectives of this exploratory pilot study were to investigate compensatory stepping in individuals poststroke with regard to: (1) choice of initial stepping limb (paretic or non-paretic); (2) step characteristics; and (3) differences in step characteristics when the initial step is taken with the paretic vs. the non-paretic limb. Four subjects following stroke (38-165 days post) and 11 healthy young adults were recruited. Anterior and posterior perturbations were delivered by using a weight drop system. Force plates recorded centre-of-pressure excursion prior to the onset of stepping and step timing. Of the four subjects, three only attempted to step with their non-paretic limb and one stepped with either limb. Time to foot-off was generally slow, whereas step onset time and swing time were comparable to healthy controls. Two of the four subjects executed multistep responses in every trial, and attempts to force stepping with the paretic limb were unsuccessful in three of the four subjects. Despite high clinical balance scores, these individuals with stroke demonstrated impaired compensatory stepping responses, suggesting that current clinical evaluations might not accurately reflect reactive balance control in this population.

  14. A Problem Solving Intervention for hospice caregivers: a pilot study.

    Science.gov (United States)

    Demiris, George; Oliver, Debra Parker; Washington, Karla; Fruehling, Lynne Thomas; Haggarty-Robbins, Donna; Doorenbos, Ardith; Wechkin, Hope; Berry, Donna

    2010-08-01

    The Problem Solving Intervention (PSI) is a structured, cognitive-behavioral intervention that provides people with problem-solving coping skills to help them face major negative life events and daily challenges. PSI has been applied to numerous settings but remains largely unexplored in the hospice setting. The aim of this pilot study was to demonstrate the feasibility of PSI targeting informal caregivers of hospice patients. We enrolled hospice caregivers who were receiving outpatient services from two hospice agencies. The intervention included three visits by a research team member. The agenda for each visit was informed by the problem-solving theoretical framework and was customized based on the most pressing problems identified by the caregivers. We enrolled 29 caregivers. Patient's pain was the most frequently identified problem. On average, caregivers reported a higher quality of life and lower level of anxiety postintervention than at baseline. An examination of the caregiver reaction assessment showed an increase of positive esteem average and a decrease of the average value of lack of family support, impact on finances, impact on schedules, and on health. After completing the intervention, caregivers reported lower levels of anxiety, improved problem solving skills, and a reduced negative impact of caregiving. Furthermore, caregivers reported high levels of satisfaction with the intervention, perceiving it as a platform to articulate their challenges and develop a plan to address them. Findings demonstrate the value of problem solving as a psycho-educational intervention in the hospice setting and call for further research in this area.

  15. Effects of Aquajogging in Obese Adults: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Eveline J. M. Wouters

    2010-01-01

    Full Text Available Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat mass and waist circumference decreased 1.4 kg (P=.03 and 3.1 cm (P=.005, respectively. The distance in the Six-Minute Walk Test increased 41 meters (P=.001. Three scales of the Impact of Weight on Quality of Life-Lite questionnaire improved: physical function (P=.008, self-esteem (P=.004, and public distress (P=.04. Increased perceived exercise benefits (P=.02 and decreased embarrassment (P=.03 were observed. Conclusions. Aquajogging was associated with reduced body fat and waist circumference and improved aerobic fitness and quality of life. These findings suggest the usefulness of conducting a randomized controlled trial with long-term outcome assessments.

  16. Intensive mothering ideology in France: A pilot study.

    Science.gov (United States)

    Loyal, D; Sutter Dallay, A-L; Rascle, N

    2017-12-01

    The aim of this pilot study was to adapt the intensive mothering ideology concept in a French sample and to get an assessment tool. First, the Intensive Parenting Attitudes Questionnaire (IPAQ), a U.S. scale comprising 25 items, was translated and submitted online to French mothers and mothers-to-be (n=250). Structural validity was tested through confirmatory factor analysis with poor results. Secondly, to increase the cultural validity of a new tool, new items were derived from French women speech. French mothers and mothers-to-be (n=22) were asked about their views regarding motherhood and childcare (semi-structured interviews). A thematic content analysis was performed with good inter-judge agreement (0.53-0.86) and 27 items were created. Finally, the total set of 52 items was submitted online to French mothers and mothers-to-be (n=474). The structure was tested through exploratory factor analysis. A new tool called the Measure of Intensive Mothering Ideology (MIMI) was obtained. This 21 items scale with 6 dimensions (Essentialism, Consuming Fulfillment, Child-centrism, Challenge, Sacrifice and Stimulation) explains 59.75% of variance. Internal consistencies were satisfactory (0.61-0.83) and most dimensions were positively and moderately correlated (0.17-0.38). The MIMI is the first French-language scale assessing IMI and offers interesting research avenues notably regarding perinatal parental adaptation. Copyright © 2017 L'Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  17. NEREDA Pilot Studies 2003 - 2010; NEREDA Pilotonderzoeken 2003 - 2010

    Energy Technology Data Exchange (ETDEWEB)

    Berkhof, D.; De Bruin, B.; Kerstholt, M.; Kraan, R.; Miska, V.; Peeters, T.; Van der Roest, H.; Verschoor, J. [DHV, Amersfoort (Netherlands); De Kreuk, M.; Van Loosdrecht, M. [Technische Universiteit Delft TUD, Delft (Netherlands)

    2010-10-15

    Since the nineties of last century research has been conducted on the development of the aerobic granular sludge technology for wastewater treatment. A first STOWA pilot research project was executed at Ede, Netherlands. In 2005 a technological breakthrough was accomplished and was the starting sign for a broader national development program (NNOP). Next to STOWA, Delft University of Delft and DHV, six Waterboards are involved within this development program. Main goal of the NNOP is to develop a new competitive biological wastewater treatment technology (Nereda). After the Ede project additional pilot research projects were conducted at four locations in the Netherlands. Within these pilot research projects the following aspects were investigated: granulation on different wastewater types; stability of granular sludge; optimization of nitrogen and phosphate removal, especially during winter time; control of effluent suspended solids concentration; and obtain technological design parameters for full scale WWTPs (waste water treatment plants) [Dutch] In dit rapport staan de resultaten beschreven van de tussen 2003 en 2010 uitgevoerde pilots met de aeroob-korrelslibtechnologie Nereda. Dit is een nieuwe zuiveringstechnologie waarbij het reinigende actief slib geen vlokken maar korrels vormt. Hierdoor bezinkt het slib sneller en makkelijker. De technologie wordt gekenmerkt door hoge zuiveringsrendementen, weinig ruimtebeslag (voor bezinking) en relatief lage energiekosten. De resultaten van de pilots zijn dermate goed, dat drie van de vijf deelnemende waterschappen hebben besloten om 1 van hun rwzi's (rioolwaterzuiveringsinstallaties) aan te passen op basis van de Nereda-technologie.

  18. A pilot study to delimit tsetse target populations in Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Gerald Chikowore

    2017-05-01

    Full Text Available Tsetse (Glossina sensu stricto are cyclical vectors of human and animal trypanosomoses, that are presently targeted by the Pan African Tsetse and Trypanosomiasis Eradication Campaign (PATTEC coordinated by the African Union. In order to achieve effective control of tsetse, there is need to produce elaborate plans to guide intervention programmes. A model intended to aid in the planning of intervention programmes and assist a fuller understanding of tsetse distribution was applied, in a pilot study in the Masoka area, Mid-Zambezi valley in Zimbabwe, and targeting two savannah species, Glossina morsitans morsitans and Glossina pallidipes.The field study was conducted between March and December 2015 in 105 sites following a standardized grid sampling frame. Presence data were used to study habitat suitability of both species based on climatic and environmental data derived from MODIS and SPOT 5 satellite images. Factors influencing distribution were studied using an Ecological Niche Factor Analysis (ENFA whilst habitat suitability was predicted using a Maximum Entropy (MaxEnt model at a spatial resolution of 250 m. Area Under the Curve (AUC, an indicator of model performance, was 0.89 for G. m. morsitans and 0.96 for G. pallidipes. We then used the predicted suitable areas to calculate the probability that flies were really absent from the grid cells where they were not captured during the study based on a probability model using a risk threshold of 0.05. Apart from grid cells where G. m. morsitans and G. pallidipes were captured, there was a high probability of presence in an additional 128 km2 and 144 km2 respectively.The modelling process promised to be useful in optimizing the outputs of presence/absence surveys, allowing the definition of tsetse infested areas with improved accuracy. The methodology proposed here can be extended to all the tsetse infested parts of Zimbabwe and may also be useful for other PATTEC national initiatives in other

  19. Efficacy of Synbiotics to Reduce Acute Radiation Proctitis Symptoms and Improve Quality of Life: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

    International Nuclear Information System (INIS)

    Nascimento, Mariana; Aguilar-Nascimento, José Eduardo; Caporossi, Cervantes; Castro-Barcellos, Heloisa Michelon; Motta, Rodrigo Teixeira

    2014-01-01

    Purpose: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. Methods and Materials: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10 8  colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire were the main endpoints. Results: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer

  20. Efficacy of Synbiotics to Reduce Acute Radiation Proctitis Symptoms and Improve Quality of Life: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

    Energy Technology Data Exchange (ETDEWEB)

    Nascimento, Mariana, E-mail: mari1980hemato@yahoo.com.br [Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso (Brazil); Aguilar-Nascimento, José Eduardo [Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso (Brazil); Caporossi, Cervantes; Castro-Barcellos, Heloisa Michelon; Motta, Rodrigo Teixeira [Department of Medicine, Federal University of Mato Grosso (UFMT), Cuiabá, Mato Grosso (Brazil)

    2014-10-01

    Purpose: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. Methods and Materials: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10{sup 8} colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire were the main endpoints. Results: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.

  1. A Comparative Study of the Manneristic Behaviour of Blind and Sighted Children. Research Series No. 1.

    Science.gov (United States)

    Indian National Inst. for the Visually Handicapped, Dehra Dun.

    Examination of the manneristic behavior (stereotyped or repetitive movement) of 542 blind and 365 sighted children was undertaken. Seventeen types of manneristic behavior were investigated, including head movement, eye poking and rubbing, body rocking, kicking, and posture distortion. Comparison of the behaviors observed in sighted and blind Ss…

  2. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Directory of Open Access Journals (Sweden)

    Sandra M Eldridge

    Full Text Available We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  3. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Science.gov (United States)

    Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L; Bond, Christine M

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  4. Free online otolaryngology educational modules: a pilot study.

    Science.gov (United States)

    Cabrera-Muffly, Cristina; Bryson, Paul C; Sykes, Kevin J; Shnayder, Yelizaveta

    2015-04-01

    Otolaryngology residents need concise, easily accessible modules to expand educational opportunities between surgical cases. These modules should be inexpensive to create and improve learning outcomes. The purpose of this pilot study was to assess whether otolaryngology residents at multiple institutions used online video modules to supplement their studying for the Otolaryngology Training Exam, whether the modules had any effect on their Otolaryngology Training Examination Scores, and to obtain survey feedback about the modules. This randomized trial was conducted in 3 academic departments of otolaryngology in the United States among 37 residents enrolled in 3 otolaryngology residency programs. Residents were randomized into 2 groups, one with access to the educational modules and the other with no access. Otolaryngology training examination scores were obtained from the year prior to the intervention (2012) and the year following module access (2013). Residents with access to the modules were also surveyed to assess use and obtain feedback about the modules. Otolaryngology training examination scores improved significantly from 2012 to 2013 among both residents who had access to the modules and those who did not in the sections of head and neck, laryngology, and sleep medicine. However, scores in the sections of pediatric otolaryngology (8% increase, P = .03), otology (7% increase, P = .02), and facial plastic surgery (10% increase, P = .02) improved from 2012 to 2013 only among residents with access to the modules. All respondents rated the videos as very helpful, with a rating of 4 of 5 on a Likert scale. Online otolaryngology educational modules are an inexpensive way to expand resident learning opportunities. Despite the lack of quantifiable improvement in otolaryngology training examination scores in this study, use of online modules sends a message to otolaryngology residents that their education is a priority; self-study outside the hospital

  5. Verneuil's disease, innate immunity and vitamin D: a pilot study.

    Science.gov (United States)

    Guillet, A; Brocard, A; Bach Ngohou, K; Graveline, N; Leloup, A-G; Ali, D; Nguyen, J-M; Loirat, M-J; Chevalier, C; Khammari, A; Dreno, B

    2015-07-01

    Verneuil's disease is a chronic inflammatory skin disease of the follicles in apocrine glands rich area of the skin (axillary, inguinal, anogenital) and is associated with a deficient skin innate immunity. It is characterized by the occurrence of nodules, abscesses, fistulas, scars. Recently, vitamin D has been shown to stimulate skin innate immunity. The primary objective of the study was to assess whether Verneuil's disease was associated with vitamin D deficiency. The secondary objective was to determine whether vitamin D supplementation could improve inflammatory lesions. First, 25(OH) vitamin D3 serum levels in patients with Verneuil's disease followed at Nantes University Hospital were compared to those of healthy donors from the French Blood Bank. Then, a pilot study was conducted in 14 patients supplemented with vitamin D according to their vitamin D level at baseline at months 3 and 6. The endpoints at 6 months were decreased by at least 20% in the number of nodules and in the frequency of flare-ups. Twenty-two patients (100%) had vitamin D deficiency (level vitamin D deficiency (91%) of whom 14% were severely deficient. In 14 patients, the supplementation significantly decreased the number of nodules at 6 months (P = 0.01133), and the endpoints were achieved in 79% of these patients. A correlation between the therapeutic success and the importance of the increase in vitamin D level after supplementation was observed (P = 0.01099). Our study shows that Verneuil's disease is associated with a major vitamin D deficiency, correlated with the disease severity. It suggests that vitamin D could significantly improve the inflammatory nodules, probably by stimulating the skin innate immunity. A larger randomized study is needed to confirm these findings. © 2014 European Academy of Dermatology and Venereology.

  6. Probabilistic assessment of fire related events in CWPH (Pilot study)

    International Nuclear Information System (INIS)

    Chatterjee, D.; Maity, S.C.; Guptan, Rajee; Mohan, Nalini; Ghadge, S.G.; Bajaj, S.S.

    2006-01-01

    As a part of Fire PSA for KAPS, a pilot study has been taken up identifying CWPH as the important zone vulnerable to fire. As the CWPH houses pumps belonging to all important cooling (APWC, FFW, NAHPPW, NALPW, etc.) of both the units, a single fire leads to failure of multiple safety/safety support system cooling affecting the safety of the plant. The objective of this study is as follows: Familiarising with the various published Fire-PSA study, comparing and finalisation of the computer code amongst various codes available with DAE, identifying and sequencing different activities involved for carrying out Fire PSA, i.e. Zoning and Sub-Zoning of Fire Source Area, Fire vulnerability of System and Component surrounding Fire Source, etc., finalization of report format and documentation. Computer Code FDS is used to carry out Fire Hazard Analysis. FDS is the latest state-of the-art software package extensively used for Fire Hazard Analysis. It develops a 3D scenario for any given fire giving credit to actual physical location of fire load and ventilation. It gives the time dependent of any fire in a specific zone crediting the time required by operator to take necessary preventive action which helps in quantifying the probability of error for any particular operator's for PSA study. To identify the most vulnerable sub-zone in CWPH, a walk down was organized and physical location of each load; their separation, fire barrier, ventilator in the room, arrangement of fire protection/fighting system, localized operator's room were reviewed. Fire in the middle diesel tank with pump is considered as initiating event in the sub-zone of CWPH. The Event Tree for this initiating event for CWPH was developed. Event Tree end states are identified as large fire i.e. fire which is failed to be detected by both means, i.e. early and late and failure in fighting by both means i.e. early and late. (author)

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

    Science.gov (United States)

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

    2018-01-01

    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 morta