Can an aircraft be piloted via sonification with an acceptable attentional cost? A comparison of blind and sighted pilots.

PubMed

Valéry, Benoît; Scannella, Sébastien; Peysakhovich, Vsevolod; Barone, Pascal; Causse, Mickaël

2017-07-01

In the aeronautics field, some authors have suggested that an aircraft's attitude sonification could be used by pilots to cope with spatial disorientation situations. Such a system is currently used by blind pilots to control the attitude of their aircraft. However, given the suspected higher auditory attentional capacities of blind people, the possibility for sighted individuals to use this system remains an open question. For example, its introduction may overload the auditory channel, which may in turn alter the responsiveness of pilots to infrequent but critical auditory warnings. In this study, two groups of pilots (blind versus sighted) performed a simulated flight experiment consisting of successive aircraft maneuvers, on the sole basis of an aircraft sonification. Maneuver difficulty was varied while we assessed flight performance along with subjective and electroencephalographic (EEG) measures of workload. The results showed that both groups of participants reached target-attitudes with a good accuracy. However, more complex maneuvers increased subjective workload and impaired brain responsiveness toward unexpected auditory stimuli as demonstrated by lower N1 and P3 amplitudes. Despite that the EEG signal showed a clear reorganization of the brain in the blind participants (higher alpha power), the brain responsiveness to unexpected auditory stimuli was not significantly different between the two groups. The results suggest that an auditory display might provide useful additional information to spatially disoriented pilots with normal vision. However, its use should be restricted to critical situations and simple recovery or guidance maneuvers. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

PubMed

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

2015-02-01

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

Impact of Ultrasound on Short Peripheral Intravenous Catheter Placement on Vein Thrombosis Risk.

PubMed

Holder, Max R; Stutzman, Sonja E; Olson, DaiWai M

Approximately 90% of hospitalized patients have a short peripheral intravenous catheter (SPC) placed. Methods of inserting the catheter have evolved over time and now include the use of ultrasound (US)-guided procedures for placement. Little is known about the impact that US-guided procedures have on the vein. This study compared the rate of venous thrombosis in patients with and without US-guided catheter placement. This prospective, single-blind, observational study assessed for venous thrombosis in 153 veins from 135 patients. Veins were evaluated by a research nurse blinded to the method of placement between 48 and 72 hours after the SPC was placed. The Fisher exact test showed a significant difference between vessel compressibility and catheter insertion method (P = .0012). The proportion of noncompressible veins was significantly greater when US was used in comparison with freehand SPC insertion. The Mantel-Haenszel chi-square value of 10.34 (P = .0013) showed that US insertion technique is associated with a higher likelihood of noncompressible veins. This pilot study provides compelling evidence that the use of US to assist with catheter placement is associated with a higher rate of noncompressible veins at day 2 or 3. Further studies are needed with a larger sample to determine the generalizability of the results from this pilot study.

Effects of malicious ocular laser exposure in commercial airline pilots.

PubMed

Palakkamanil, Mathew M; Fielden, Michael P

2015-12-01

Intentional malicious laser strikes on commercial pilots are committed by individuals who target a laser into airplane cockpits during takeoff and landing. Because laser exposure to pilots is a relatively new but growing occurrence, our study investigates the ocular effect of this laser exposure in pilots. Retrospective chart review by a single ophthalmologist. All commercial airline pilots (58 male, 3 female) who experienced a laser strike while flying between April 2012 and November 2014 who presented to our clinic were included. A retrospective chart review was performed in a retinal specialist's practice. Ocular assessment was performed within 3 days of laser exposure. A complete ophthalmic evaluation was conducted, including Early Treatment Diabetic Retinopathy Study visual acuity, colour vision, visual fields, intraocular pressure, slit-lamp examination, dilated fundus examination, colour fundus photographs, and ocular coherence tomography. Sixty-four laser strike incidents involving commercial pilots were included. All pilots in the study experienced some degree of immediate ocular irritation or light sensitivity. No definite cases of ocular damage were attributed to laser strikes. No pilot had any functional ocular deficits. Our study revealed that laser strikes on aircraft did not result in permanent visual functional or structural deficits. However, laser strikes cause immediate visual effects, including glare, flash blindness, and ocular irritation that can interfere with a pilot's visual function. Given the widespread accessibility of high-power lasers and the rapid increase in incidents, laser strikes threaten to jeopardize aviation safety unless effective preventative measures are put in place. Copyright © 2015 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Manual transmission enhances attention and driving performance of ADHD adolescent males: pilot study.

PubMed

Cox, Daniel J; Punja, Mohan; Powers, Katie; Merkel, R Lawrence; Burket, Roger; Moore, Melissa; Thorndike, Frances; Kovatchev, Boris

2006-11-01

Inattention is a major contributor to driving mishaps and is especially problematic among adolescent drivers with ADHD, possibly contributing to their 2 to 4 times higher incidence of collisions. Manual transmission has been demonstrated to be associated with greater arousal. This study tests the hypotheses that manual transmission, compared to automatic transmission, would be associated with better attention and performance on a driving simulator. Ten adolescent drivers with ADHD practice driving on the simulator in the manual and automatic mode. Employing a single-blind, cross-over design, participants drive the simulator at 19:30 and 22:30 hr for 30 min in both transmissions and rate their attention to driving. Subjectively, participants report being more attentive while driving in manual transmission mode. Objectively, participants drive safer in the manual transmission mode. Although in need of replication, this pilot study suggests a behavioral intervention to improve driving performance among ADHD adolescents.

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

PubMed

Tokinobu, Akiko; Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

2016-01-01

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

Cross-Site Reliability of Human Induced Pluripotent Stem-Cell Derived Cardiomyocyte Based Safety Assays using Microelectrode Arrays: Results from a Blinded CiPA Pilot Study.

PubMed

Millard, Daniel; Dang, Qianyu; Shi, Hong; Zhang, Xiaou; Strock, Chris; Kraushaar, Udo; Zeng, Haoyu; Levesque, Paul; Lu, Hua-Rong; Guillon, Jean-Michel; Wu, Joseph C; Li, Yingxin; Luerman, Greg; Anson, Blake; Guo, Liang; Clements, Mike; Abassi, Yama A; Ross, James; Pierson, Jennifer; Gintant, Gary

2018-04-27

Recent in vitro cardiac safety studies demonstrate the ability of human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) to detect electrophysiologic effects of drugs. However, variability contributed by unique approaches, procedures, cell lines and reagents across laboratories makes comparisons of results difficult, leading to uncertainty about the role of hiPSC-CMs in defining proarrhythmic risk in drug discovery and regulatory submissions. A blinded pilot study was conducted to evaluate the electrophysiologic effects of eight well-characterized drugs on four cardiomyocyte lines using a standardized protocol across three microelectrode array (MEA) platforms (18 individual studies). Drugs were selected to define assay sensitivity of prominent repolarizing currents (E-4031 for IKr, JNJ303 for IKs) and depolarizing currents (nifedipine for ICaL, mexiletine for INa) as well as drugs affecting multi-channel block (flecainide, moxifloxacin, quinidine, and ranolazine). Inclusion criteria for final analysis was based on demonstrated sensitivity to IKr block (20% prolongation with E-4031) and L-type calcium current block (20% shortening with nifedipine). Despite differences in baseline characteristics across cardiomyocyte lines, multiple sites and instrument platforms, 10 of 18 studies demonstrated adequate sensitivity to IKr block with E-4031 and ICaL block with nifedipine for inclusion in the final analysis. Concentration-dependent effects on repolarization were observed with this qualified dataset consistent with known ionic mechanisms of single and multi-channel blocking drugs. hiPSC-CMs can detect repolarization effects elicited by single and multi-channel blocking drugs after defining pharmacologic sensitivity to IKr and ICaL block, supporting further validation efforts using hiPSC-CMs for cardiac safety studies.

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

PubMed

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.

Does Granisetron Eliminate the Gag Reflex? A Crossover, Double-Blind, Placebo-Controlled Pilot Study

PubMed Central

Friedlander Barenboim, Silvina; 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. PMID:19562886

Georgia Deaf-Blind Pilot Project: Project EPIC. Final Report. Optional Pilot Projects for Children with Deaf-Blindness.

ERIC Educational Resources Information Center

Georgia State Dept. of Education, Atlanta.

This final report describes activities and accomplishments of Project EPIC (Effective Partner Interaction in the Community), a 3-year federally supported project in Georgia to facilitate the establishment and implementation of effective educational practices with students having deaf-blindness. The project was designed to expand students' present…

Somatropin treatment of spinal muscular atrophy: a placebo-controlled, double-blind crossover pilot study.

PubMed

Kirschner, J; Schorling, D; Hauschke, D; Rensing-Zimmermann, C; Wein, U; Grieben, U; Schottmann, G; Schara, U; Konrad, K; Müller-Felber, W; Thiele, S; Wilichowski, E; Hobbiebrunken, E; Stettner, G M; Korinthenberg, R

2014-02-01

In preclinical studies growth hormone and its primary mediator IGF-1 have shown potential to increase muscle mass and strength. A single patient with spinal muscular atrophy reported benefit after compassionate use of growth hormone. Therefore we evaluated the efficacy and safety of growth hormone treatment for spinal muscular atrophy in a multicenter, randomised, double-blind, placebo-controlled, crossover pilot trial. Patients (n = 19) with type II/III spinal muscular atrophy were randomised to receive either somatropin (0.03 mg/kg/day) or placebo subcutaneously for 3 months, followed by a 2-month wash-out phase before 3 months of treatment with the contrary remedy. Changes in upper limb muscle strength (megascore for elbow flexion and hand-grip in Newton) were assessed by hand-held myometry as the primary measure of outcome. Secondary outcome measures included lower limb muscle strength, motor function using the Hammersmith Functional Motor Scale and other functional tests for motor function and pulmonary function. Somatropin treatment did not significantly affect upper limb muscle strength (point estimate mean: 0.08 N, 95% confidence interval (CI:-3.79;3.95, p = 0.965), lower limb muscle strength (point estimate mean: 2.23 N, CI:-2.19;6.63, p = 0.302) or muscle and pulmonary function. Side effects occurring during somatropin treatment corresponded with well-known side effects of growth hormone substitution in patients with growth hormone deficiency. In this pilot study, growth hormone treatment did not improve muscle strength or function in patients with spinal muscular atrophy type II/III. Copyright © 2013 Elsevier B.V. All rights reserved.

Acetyl-L-carnitine for alcohol craving and relapse prevention in anhedonic alcoholics: a randomized, double-blind, placebo-controlled pilot trial.

PubMed

Martinotti, Giovanni; Reina, Daniela; Di Nicola, Marco; Andreoli, Sara; Tedeschi, Daniela; Ortolani, Ilaria; Pozzi, Gino; Iannoni, Emerenziana; D'Iddio, Stefania; Janiri, Luigi

2010-01-01

The study aimed to evaluate the efficacy of acetyl-l-carnitine (ALC), at different doses, in relapse prevention and craving in anhedonic detoxified alcohol-dependent subjects. Randomized, double-blind, placebo-controlled, pilot study in 64 alcohol-dependent anhedonic patients: 23 received ALC at a dose of 3 g/day, 21 received ALC at a dosage of 1 g/day and 20 were given placebo. Intensity of alcohol craving was evaluated by Visual Analogue Scale. Subjects were evaluated at the beginning of treatment and after 10, 30, 60 and 90 days. Survival analysis showed that patients treated with ALC remained completely abstinent for longer than those treated with placebo (Z = -2.27; P < 0.05). From the 10th day onwards, a greater reduction of craving was observed in the ALC 1 g group than with placebo (P = 0.035). The two groups did not differ in the percentage of subjects remaining abstinent for the entire study period or the number of subjects who relapsed (defined as five or more standard drinks (four for women) on a single occasion or drinking on five or more days in 1 week). The results of this study suggest that ALC can reduce craving and the time to first drink. ALC use was safe. Further studies are needed to clarify to confirm, over longer periods, these short-term outcome benefits.

Binaural Sensory Aid: Case Studies of Its Use by Two Children

ERIC Educational Resources Information Center

Strelow, E. R.; And Others

1978-01-01

The adaptation of the binaural sensory aid for use by blind children is discussed in the context of a pilot study carried out with two blind children; one an intellectually competent 6-year-old girl and the other a developmentally delayed 2-1/2-year-old boy. (Author)

Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

PubMed

Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

2015-02-01

Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

Evaluation of the antihyperalgesic effect of tapentadol in two human evoked pain models - the TapCapMentho pilot trial.

PubMed

Förster, M; Helfert, S; Dierschke, R; Großkopf, M; Hüllemann, P; Keller, T; Baron, R; Binder, A

2016-09-01

Tapentadol is effective in the treatment of neuropathic and nociceptive pain and in acute and chronic pain conditions; two mechanisms combining opioid µ-receptor agonism and noradrenergic reuptake inhibition underlie its analgesic effect. With this single-center, placebo-controlled, double-blind, cross-over pilot-study, we investigated the antihyperalgesic effect of a single oral dose of 100 mg immediate-release tapentadol on thermal and mechanical hyperalgesia in two human models (i.e. 0.6 % topical capsaicin and 40% topical menthol) of evoked neuropathic pain signs in healthy volunteers. No significant differences regarding experimentally induced heat or cold and mechanical (pinprick) hyperalgesia, as assessed by quantitative sensory testing, could be observed between a single dose of drug and placebo (thermal pain thresholds p>0.4, mechanical pain sensitivity p>0.1). Only few mild side effects of tapentadol were reported. The discrepancy between pain models using healthy volunteers and drug trials under real acute and chronic pain conditions in patients as well as methodological aspects may have contributed to this result. The impact of these findings questions the general use of pain models as predictors for early decision making during drug development. The study was registered in ClinicalTrials.gov (NCT01615510).

Early Language Development in Blind and Severely Visually Impaired Children. Interim Report on Pilot Study.

ERIC Educational Resources Information Center

Moore, Vanessa; McConachie, Helen

This study investigated variables that might be associated with outcome differences in language development of 10 children (ages 10-20 months) with blindness or severe visual impairments, attending a developmental vision clinic in southern England. Subjects' early patterns of expressive language development were examined and related to observed…

A single-blinded, randomized, parallel group superiority trial investigating the effects of footwear and custom foot orthoses versus footwear alone in individuals with patellofemoral joint osteoarthritis: a phase II pilot trial protocol.

PubMed

Wyndow, Narelle; Crossley, Kay M; Vicenzino, Bill; Tucker, Kylie; Collins, Natalie J

2017-01-01

Patellofemoral joint osteoarthritis is a common condition, yet information regarding conservative management is lacking. Foot orthoses are an effective intervention for improving pain and function in younger individuals with patellofemoral pain and may be effective in those with patellofemoral osteoarthritis. This pilot study will seek to establish the feasibility of a phase III randomised controlled trial to investigate whether foot orthoses worn in prescribed motion controlled footwear are superior to prescribed motion control footwear alone in the management of patellofemoral osteoarthritis. This phase II pilot clinical trial is designed as a randomized, single-blind, parallel group, two arm, superiority trial. The trial will recruit 44 participants from Queensland and Tasmania, Australia. Volunteers aged 40 years and over must have clinical symptoms and radiographic evidence of patellofemoral osteoarthritis to be eligible for inclusion. Those eligible will be randomized to receive either foot orthoses and prescribed motion control shoes, or prescribed motion control shoes alone, to be worn for a period of 4 months. The feasibility of a phase III clinical trial will be evaluated by assessing factors such as recruitment rate, number of eligible participants, participant compliance with the study protocol, adverse events, and drop-out rate. A secondary aim of the study will be to determine completion rates and calculate effect sizes for patient reported outcome measures such as knee-related symptoms, function, quality of life, kinesiophobia, self-efficacy, general and mental health, and physical activity at 2 and 4 months. Primary outcomes will be reported descriptively while effect sizes and 95% confidence intervals will be calculated for the secondary outcome measures. Data will be analysed using an intention-to-treat principle. The results of this pilot trial will help determine the feasibility of a phase III clinical trial investigating whether foot orthoses plus motion control footwear are superior to motion control footwear alone in individuals with patellofemoral osteoarthritis. A Phase III clinical trial will help guide footwear and foot orthoses recommendations in the clinical management of this disorder. Retrospectively registered with the Australian New Zealand Clinical Trials Registry: ACTRN12615000002583. Date registered: 07/01/15.

Effects of intravenous secretin on language and behavior of children with autism and gastrointestinal symptoms: a single-blinded, open-label pilot study.

PubMed

Lightdale, J R; Hayer, C; Duer, A; Lind-White, C; Jenkins, S; Siegel, B; Elliott, G R; Heyman, M B

2001-11-01

Autism is a severe developmental disorder with poorly understood etiology. A recently published case series describes 3 autistic children with gastrointestinal symptoms who underwent endoscopy and intravenous administration of secretin and were subsequently noted by their parents to demonstrate improved language skills over a 5-week period. This report sparked tremendous public interest, and investigators at several sites moved quickly to design controlled trials to test the efficacy of secretin as a therapy for autistic children. However, this is the first effort specifically designed to replicate the initial reported findings in terms of patient age, presenting symptoms, and drug administration. To rigorously apply the scientific method by assessing the reproducibility of the reported effects of intravenous secretin on the language of young children with autism and gastrointestinal symptoms. We performed a single-blinded, prospective, open-label trial by conducting formal language testing and blinded behavioral rating both before and repeatedly after a standardized infusion of secretin. We selected autistic children who were similar in age and profile to those described in the published retrospective case review. Inclusion criteria for study participation included age (3-6 years), confirmed diagnosis of autism, and reported gastrointestinal symptoms (16 had chronic diarrhea, 2 had gastroesophageal reflux, and 2 had chronic constipation). Twenty children (18 male) were admitted to the Pediatric Clinical Research Center at the University of California, San Francisco after administration of the Preschool Language Scale-3 (PLS-3). A 3 CU/kg dose of secretin (Secretin-Ferring) was administered intravenously (upper endoscopy was not performed). Behavioral ratings were derived using the Autism Observation Scale applied to a 30-minute time sample of the child's behavior consisting of a videotape of the PLS-3 (structured setting) and a second free play session with a standard set of developmentally appropriate toys. Participants then returned for follow-up evaluations, with readministrations of the PLS-3 at 1, 2, 3, and 5 weeks' postinfusion, and videotaping of each session for later blinded review by 2 independent observers using the Autism Observation Scale, uninformed about week of posttreatment. We also surveyed parents of our study children about their impressions of the effects of secretin using a 5-point Likert scale for parents to rate changes seen in their child. With a total study completion rate across all participants of 96%, repeated measures analyses of variance revealed no significant increases in children's language skills from baseline across all 5 study time periods after a single infusion of secretin. Similarly, neither significant decreases in atypical behaviors nor increases in prosocial behaviors and developmentally appropriate play skills emerged. Furthermore, no relationship was found between parental reports of change and observable improvement in the sample. Despite the objective lack of drug effect, 70% of parents in our study reported moderate to high change in their child's language and behavior. Furthermore, 85% of parents reported that they felt that their child would obtain at least some additional benefits from another infusion of secretin. The results of our pilot study indicate that intravenous secretin had no effects in a 5-week period on the language and behavior of 20 children with autism and gastrointestinal symptoms. The open-label, prospective design of our study with blinded reviews of patients both before and after secretin administration follows the scientific method by seeking to reproduce an observed phenomenon using validating and reliable outcome measures. Pilot studies remain a mandatory step for the design of future randomized, clinical trials investigating potential treatments for children with autism.

Services for Children with Deaf-Blindness Pilot Project. Final Report.

ERIC Educational Resources Information Center

Stremel, Kathleen

This final report describes a pilot project, "Quality Service Provision for Infants and Young Children with Deaf-Blindness: A Mechanism for State Intervention Teams," developed and implemented at the University of Southern Mississippi. The project developed a model of an intervention team that provides intensive training and technical…

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

PubMed Central

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

2016-01-01

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

Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: A pilot double-blind randomized trial [ISRCTN45683816

PubMed Central

Akhondzadeh, Shahin; Fallah-Pour, Hasan; Afkham, Khosro; Jamshidi, Amir-Hossein; Khalighi-Cigaroudi, Farahnaz

2004-01-01

Background The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron) with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. Methods Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS) (Group 1) and capsule of imipramine 100 mg/day (TDS) (Group 2) for a 6-week study. Results Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09). In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. Conclusion The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted. PMID:15341662

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

ERIC Educational Resources Information Center

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…

Flight Performance During Exposure to Acute Hypobaric Hypoxia.

PubMed

Steinman, Yuval; van den Oord, Marieke H A H; Frings-Dresen, Monique H W; Sluiter, Judith K

2017-08-01

The purpose of the present study was to examine the influence of hypobaric hypoxia (HH) on a pilot's flight performance during exposure to simulated altitudes of 91, 3048, and 4572 m (300, 10,000, and 15,000 ft) and to monitor the pilot's physiological reactions. In a single-blinded counter-balanced design, 12 male pilots were exposed to HH while flying in a flight simulator that had been placed in a hypobaric chamber. Flight performance of the pilots, pilot's alertness level, Spo2, heart rate (HR), minute ventilation (VE), and breathing frequency (BF) were measured. A significant difference was found in Flight Profile Accuracy (FPA) between the three altitudes. Post hoc analysis showed no significant difference in performance between 91 m and 3048 m. A trend was observed at 4572 m, suggesting a decrease in flight performance at that altitude. Significantly lower alertness levels were observed at the start of the flight at 4572 m compared to 91 m, and at the end of the flight at 4572 m compared to the start at that altitude. Spo2 and BF decreased, and HR increased significantly with altitude. The present study did not provide decisive evidence for a decrease in flight performance during exposure to simulated altitudes of 3048 and 4572 m. However, large interindividual variation in pilots' flight performance combined with a gradual decrease in alertness levels observed in the present study puts into question the ability of pilots to safely fly an aircraft while exposed to these altitudes without supplemental oxygen.Steinman Y, van den Oord MHAH, Frings-Dresen MHW, Sluiter JK. Flight performance during exposure to acute hypobaric hypoxia. Aerosp Med Hum Perform. 2017; 88(8):760-767.

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

PubMed

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.

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

ERIC Educational Resources Information Center

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.…

Estimation and quantification of human DNA in dental calculus: A pilot study.

PubMed

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.

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

PubMed Central

Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

2016-01-01

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

A Double-Blind Randomized Pilot Study Comparing Quetiapine and Divalproex for Adolescent Mania

ERIC Educational Resources Information Center

Delbello, Melissa P.; Kowatch, Robert A.; Adler, Caleb M.; Stanford, Kevin E.; Welge, Jeffrey A.; Barzman, Drew H.; Nelson, Erik; Strakowski, Stephen M.

2006-01-01

Objective: To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania. Method: Fifty adolescents (ages 12-18 years) with bipolar I disorder, manic or mixed episode, were randomized to quetiapine (400-600 mg/day) or divalproex (serum level 80-120 [micro]g/mL) for 28 days for this double-blind study,…

The Blind Leading the Blind: Goalball as Engaged Scholarship

ERIC Educational Resources Information Center

Van Rheenen, Derek

2016-01-01

The paper describes an engaged scholarship course at a large public research university on the west coast of the United States. The pilot course introduces students to the scholarship on disability framed within the cultural studies of sport. Participants engage with existing literature while actively participating in goalball, a sport designed…

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

PubMed

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

2005-09-08

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

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.

PubMed

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.

An Ai Chi-based aquatic group improves balance and reduces falls in community-dwelling adults: A pilot observational cohort study.

PubMed

Skinner, Elizabeth H; Dinh, Tammy; Hewitt, Melissa; Piper, Ross; Thwaites, Claire

2016-11-01

Falls are associated with morbidity, loss of independence, and mortality. While land-based group exercise and Tai Chi programs reduce the risk of falls, aquatic therapy may allow patients to complete balance exercises with less pain and fear of falling; however, limited data exist. The objective of the study was to pilot the implementation of an aquatic group based on Ai Chi principles (Aquabalance) and to evaluate the safety, intervention acceptability, and intervention effect sizes. Pilot observational cohort study. Forty-two outpatients underwent a single 45-minute weekly group aquatic Ai Chi-based session for eight weeks (Aquabalance). Safety was monitored using organizational reporting systems. Patient attendance, satisfaction, and self-reported falls were also recorded. Balance measures included the Timed Up and Go (TUG) test, the Four Square Step Test (FSST), and the unilateral Step Tests. Forty-two patients completed the program. It was feasible to deliver Aquabalance, as evidenced by the median (IQR) attendance rate of 8.0 (7.8, 8.0) out of 8. No adverse events occurred and participants reported high satisfaction levels. Improvements were noted on the TUG, 10-meter walk test, the Functional Reach Test, the FSST, and the unilateral step tests (p < 0.05). The proportion of patients defined as high falls risk reduced from 38% to 21%. The study was limited by its small sample size, single-center nature, and the absence of a control group. Aquabalance was safe, well-attended, and acceptable to participants. A randomized controlled assessor-blinded trial is required.

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

PubMed Central

2010-01-01

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

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rollmann, Denise C.; Novotny, Paul J.; Petersen, Ivy A.

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 overmore » 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.« less

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

PubMed

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.

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.

PubMed

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.

Blinded and unblinded internal pilot study designs for clinical trials with count data.

PubMed

Schneider, Simon; Schmidli, Heinz; Friede, Tim

2013-07-01

Internal pilot studies are a popular design feature to address uncertainties in the sample size calculations caused by vague information on nuisance parameters. Despite their popularity, only very recently blinded sample size reestimation procedures for trials with count data were proposed and their properties systematically investigated. Although blinded procedures are favored by regulatory authorities, practical application is somewhat limited by fears that blinded procedures are prone to bias if the treatment effect was misspecified in the planning. Here, we compare unblinded and blinded procedures with respect to bias, error rates, and sample size distribution. We find that both procedures maintain the desired power and that the unblinded procedure is slightly liberal whereas the actual significance level of the blinded procedure is close to the nominal level. Furthermore, we show that in situations where uncertainty about the assumed treatment effect exists, the blinded estimator of the control event rate is biased in contrast to the unblinded estimator, which results in differences in mean sample sizes in favor of the unblinded procedure. However, these differences are rather small compared to the deviations of the mean sample sizes from the sample size required to detect the true, but unknown effect. We demonstrate that the variation of the sample size resulting from the blinded procedure is in many practically relevant situations considerably smaller than the one of the unblinded procedures. The methods are extended to overdispersed counts using a quasi-likelihood approach and are illustrated by trials in relapsing multiple sclerosis. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy.

PubMed

Preston, Nick; Weightman, Andrew; Gallagher, Justin; Levesley, Martin; Mon-Williams, Mark; Clarke, Mike; O'Connor, Rory J

2016-10-01

To evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on arm function of children with spastic cerebral palsy. A single-blind randomized controlled trial design. Power calculations indicated that 58 children would be required to demonstrate a clinically important difference. Intervention was home-based; recruitment took place in regional spasticity clinics. A total of 15 children with cerebral palsy aged five to 12 years were recruited; eight to the device group. Both study groups received 'usual follow-up treatment' following spasticity treatment with botulinum toxin; the intervention group also received a rehabilitation gaming device. ABILHAND-kids and Canadian Occupational Performance Measure were performed by blinded assessors at baseline, six and 12 weeks. An analysis of covariance showed no group differences in mean ABILHAND-kids scores between time points. A non-parametric analysis of variance on Canadian Occupational Performance Measure scores showed a statistically significant improvement across time points (χ 2 (2,15) = 6.778, p = 0.031), but this improvement did not reach minimal clinically important difference. Mean daily device use was seven minutes. Recruitment did not reach target owing to unanticipated staff shortages in clinical services. Feedback from children and their families indicated that the games were not sufficiently engaging to promote sufficient use that was likely to result in functional benefits. This study suggests that computer-assisted arm rehabilitation gaming does not benefit arm function, but a Type II error cannot be ruled out. © The Author(s) 2015.

Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope.

PubMed

Rey, Jean-Francois; Ogata, Haruhiko; Hosoe, Naoki; Ohtsuka, Kazuo; Ogata, Noriyuki; Ikeda, Keiichi; Aihara, Hiroyuki; Pangtay, Ileana; Hibi, Toshifumi; Kudo, Shin-ei; Tajiri, Hisao

2012-02-01

Passive video capsule endoscopy is the criterion standard for small-bowel exploration but cannot be used for the large gastric cavity. We report the first blinded comparative clinical trial in humans comparing a magnetically guided capsule endoscope (MGCE) and a conventional high-definition gastroscope. To assess the potential of gastric examination with a guided capsule. Blinded, nonrandomized comparative study. Single endoscopy center. The trial involved 61 patients included in a blinded capsule and gastroscopy comparative study. MGCE examination was performed 24 hours after patients had undergone gastroscopy. To remove food residue or mucus, patients drank 900 mL of water in 2 portions. Then to provide the air-water interface required by the guidance system, they drank 400 mL of water at 35°C. Visualization of the gastric pylorus, antrum, body, fundus, and cardia was evaluated as complete in 88.5%, 86.9%, 93.4%, 85.2%, and 88.5% of patients, respectively. Of gastric lesions, 58.3% were detected by both gastroscopy and MGCE at immediate assessment and review of recorded data. Capsule examination missed 14 findings and gastroscopy missed 31 findings seen with MGCE. Overall diagnostic yield was similar for both modalities. Pilot study. Diagnostic results were similar for the 2 methods. After some technical difficulties related to gastric expansion or presence of mucus had been overcome, this study opened a new field for noninvasive gastric examination in countries where high gastric cancer incidence demands a screening tool. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Black blood MRI in suspected large artery primary angiitis of the central nervous system.

PubMed

Pfefferkorn, Thomas; Linn, Jennifer; Habs, Maximilian; Opherk, Christina; Cyran, Clemens; Ottomeyer, Caroline; Straube, Andreas; Dichgans, Martin; Nikolaou, Konstantin; Saam, Tobias

2013-07-01

Single case reports suggest that black blood MRI (T1-weighted fat and blood suppressed sequences with and without contrast injection; BB-MRI) may visualize intracranial vessel wall contrast enhancement (CE) in primary angiitis of the central nervous system (PACNS). In this single-center observational pilot study we prospectively investigated the value of BB-MRI in the diagnosis of large artery PACNS. Patients with suspected large artery PACNS received a standardized diagnostic program including BB-MRI. Vessel wall CE was graded (grade 0-2) by two experienced readers blinded to clinical data and correlated to the final diagnosis. Four of 12 included patients received a final diagnosis of PACNS. All of them showed moderate (grade 1) to strong (grade 2) vessel wall CE at the sites of stenosis. A moderate (grade 1) vessel wall CE grade was also observed in 6 of the remaining 8 patients in whom alternative diagnoses were made: arteriosclerotic disease (n = 4), intracranial dissection (n = 1), and Moyamoya disease (n = 1). Our pilot study demonstrates that vessel wall CE is a frequent finding in PACNS and its mimics. Larger trials will be necessary to evaluate the utility of BB-MRI in the diagnostic workup of PACNS. Copyright © 2012 by the American Society of Neuroimaging.

Reflections on a Pilot Project: Removing the "Dis" from Disability

ERIC Educational Resources Information Center

Yee, Michelle J.

2012-01-01

This paper explores preliminary results of a pilot study whose purpose was to document, through an oral history narrative, the personal and work experiences of a female artist and social entrepreneur who is legally blind. These experiences included the challenges that the research participant has experienced in the U.S. as a woman with an…

Distribution of the two-sample t-test statistic following blinded sample size re-estimation.

PubMed

Lu, Kaifeng

2016-05-01

We consider the blinded sample size re-estimation based on the simple one-sample variance estimator at an interim analysis. We characterize the exact distribution of the standard two-sample t-test statistic at the final analysis. We describe a simulation algorithm for the evaluation of the probability of rejecting the null hypothesis at given treatment effect. We compare the blinded sample size re-estimation method with two unblinded methods with respect to the empirical type I error, the empirical power, and the empirical distribution of the standard deviation estimator and final sample size. We characterize the type I error inflation across the range of standardized non-inferiority margin for non-inferiority trials, and derive the adjusted significance level to ensure type I error control for given sample size of the internal pilot study. We show that the adjusted significance level increases as the sample size of the internal pilot study increases. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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

PubMed

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 < 0.05). The following significant changes in outcome measures were indicated at t(1) compared with t(0) and control group (p < 0.001): an increase in lumbar flexion and extension (mean difference = 9.26◦ (+54%) for flexion and 5.95◦ for extension(+98%)); reduction in VAS score (mean difference = 2.32 (+58%)) and RMQ score (mean difference = 4.9 (−34%)). All changes remained significant at t(fu). At t(0), lumbar flexion was correlated with extension (r = 0.547) and VAS (r = −0.581),whereas the RMQ score correlated with VAS score (r = 0.599) and negatively with lumbar extension (r = −0.665). At t(1),lumbar flexion correlated with extension (r = 0.664) and negatively with RMQ score (r = −0.54). At t(fu), changes in VAS score were negatively correlated with changes in lumbar flexion (r = −0.522), while changes in lumbar flexion correlated with extension (r = 0.58). A functional program of NWB group exercising improves functional, painful status, lumbar flexion and extension ranges of motion in women suffering from NSCLBP.

A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

PubMed

Mader, Julia K; Lilly, Leslie C; Aberer, Felix; Korsatko, Stefan; Strock, Ellie; Mazze, Roger S; Damsbo, Peter; Pieber, Thomas R

2014-05-01

This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.

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

PubMed

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).

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

PubMed

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 value 98.4%. Among the 281 non-IBD subjects, there were 7 cases with discordant results (2.5%) between TRIMprob and the reference standard including 5 false positive results (1.8%) and 2 false negative (0.7%) results. The main limitation of the TRIMprob system is the need for trained operators. The study confirmed that TRIM provides rapid, accurate, convenient and noninvasive means to identify individuals most likely to benefit from colonoscopy.

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

PubMed Central

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

2015-01-01

AIM: To investigated the performance of the tissue resonance interaction method (TRIM) for the non-invasive detection of colon lesions. METHODS: 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 χ2 test. RESULTS: 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 value 98.4%. Among the 281 non-IBD subjects, there were 7 cases with discordant results (2.5%) between TRIMprob and the reference standard including 5 false positive results (1.8%) and 2 false negative (0.7%) results. The main limitation of the TRIMprob system is the need for trained operators. CONCLUSION: The study confirmed that TRIM provides rapid, accurate, convenient and noninvasive means to identify individuals most likely to benefit from colonoscopy. PMID:26167085

Hip Abductor Strengthening Improves Physical Function Following Total Knee Replacement: One-Year Follow-Up of a Randomized Pilot Study.

PubMed

Harikesavan, Karvannan; Chakravarty, Raj D; Maiya, Arun G; Hegde, Sanjay P; Y Shivanna, Shivakumar

2017-01-01

Total knee replacement (TKR) is the commonest surgical procedure for patients with severe pain and impaired physical function following end stage knee osteoarthritis. The hip abductors are well renowned in stabilization of the trunk and hip during walking, maintaining the lower limb position, and transferring the forces from the lower limbs to the pelvis. To assess the efficacy of hip abductor strengthening exercise on functional outcome using performance based outcome measures following total knee replacement. An observer blinded randomized pilot trial design was conducted at Manipal hospital, Bangalore, India. Participants designated for elective TKR were randomized to experimental group hip abductor strengthening along with standard rehabilitation (n=10) or control group standard rehabilitation alone (n=10). Participants followed for one year to assess physical function using performance based outcomes, such as timed up and go test, single leg stance test, six minute walk test, knee extensor strength and hip abductor strength. Eighteen participants with a mean age of 63.1 ± 5.5 years (8 Males and 10 Females) completed the study. Improvement in hip abduction strength, single leg stand test was superior in hip abductor strengthening group at 3 months and 1 year when compared to standard rehabilitation alone. Hip abductor strengthening showed superior improvements in single leg stance test and six minute walk test. Hip abductor strengthening exercises has the potential to improve physical function following total knee replacement.

Hip Abductor Strengthening Improves Physical Function Following Total Knee Replacement: One-Year Follow-Up of a Randomized Pilot Study

PubMed Central

Harikesavan, Karvannan; Chakravarty, Raj D.; Maiya, Arun G; Hegde, Sanjay P.; Y. Shivanna, Shivakumar

2017-01-01

Background: Total knee replacement (TKR) is the commonest surgical procedure for patients with severe pain and impaired physical function following end stage knee osteoarthritis. The hip abductors are well renowned in stabilization of the trunk and hip during walking, maintaining the lower limb position, and transferring the forces from the lower limbs to the pelvis. Objective: To assess the efficacy of hip abductor strengthening exercise on functional outcome using performance based outcome measures following total knee replacement. Methods: An observer blinded randomized pilot trial design was conducted at Manipal hospital, Bangalore, India. Participants designated for elective TKR were randomized to experimental group hip abductor strengthening along with standard rehabilitation (n=10) or control group standard rehabilitation alone (n=10). Participants followed for one year to assess physical function using performance based outcomes, such as timed up and go test, single leg stance test, six minute walk test, knee extensor strength and hip abductor strength. Result: Eighteen participants with a mean age of 63.1 ± 5.5 years (8 Males and 10 Females) completed the study. Improvement in hip abduction strength, single leg stand test was superior in hip abductor strengthening group at 3 months and 1 year when compared to standard rehabilitation alone. Conclusion: Hip abductor strengthening showed superior improvements in single leg stance test and six minute walk test. Hip abductor strengthening exercises has the potential to improve physical function following total knee replacement. PMID:28567148

76 FR 26641 - Relay Services for Deaf-Blind Individuals

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-09

... this document, the Commission adopts rules to establish the National Deaf-Blind Equipment Distribution... premises equipment (CPE) to low- income individuals who are deaf-blind. For these purposes, this new... (TRS) Fund. The equipment distributed under the NDBEDP pilot program will make telecommunications...

Study to determine the IFR operational profile and problems of the general aviation single pilot

NASA Technical Reports Server (NTRS)

Weislogel, G. S.

1983-01-01

General aviation single pilot operating under instrument flight rules (GA SPIFR) was studied. The objectives of the study were to (1) develop a GA SPIFR operational profile, (2) identify problems experienced by the GA SPIFR pilot, and (3) identify research tasks which have the potential for eliminating or reducing the severity of the problems. To obtain the information necessary to accomplish these objectives, a mail questionnaire survey of instrument rated pilots was conducted. The general aviation IFR single pilot operational profile and selected data analysis examples are presented.

CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

PubMed

Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

2017-09-01

Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p < 0.001; p < 0.004). This pilot study suggests that the CoDuSe exercise improved balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

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

PubMed Central

2010-01-01

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

What Is Low Vision?

MedlinePlus

... magnifying reading glasses or loupes for seeing the computer screen , sheet music, or for sewing telescopic glasses ... for the Blind services. The Low Vision Pilot Project The American Foundation for the Blind (AFB) has ...

Body composition influenced by progressive elastic band resistance exercise of sarcopenic obesity elderly women: a pilot randomized controlled trial.

PubMed

Huang, Shih-Wei; Ku, Jan-Wen; Lin, Li-Fong; Liao, Chun-De; Chou, Lin-Chuan; Liou, Tsan-Hon

2017-08-01

Sarcopenia involves age-related decreases in muscle strength and muscle mass, leading to frailty and disability in elderly people. When combined with obesity, it is defined as sarcopenic obesity (SO), which can result in more functional limitations and metabolic disorders than either disorder alone. The aim of this study was to investigate body composition changes after elastic band resistance training in elderly women with SO. Randomized single-blinded (assessor blinded) controlled pilot trial. Academic medical center. Thirty-five elderly (>60 years old) women with SO. This pilot randomized controlled trial focused on elderly women with SO. The study group underwent progressive elastic band resistance training for 12 weeks (3 times per week). The control group received only a 40-minute lesson about the exercise concept. Dual-energy X-ray absorptiometry was performed before and after intervention to evaluate body composition. Mann-Whitney U and Wilcoxon signed rank tests were used to analyze the differences within and between these groups. In total, 35 elderly women with SO were enrolled and divided into study (N.=18) and control groups (N.=17). No difference was observed in age, biochemical parameters, or Body Mass Index between both groups. After the intervention, the fat proportion of body composition in the right upper extremity (P=0.03), left upper extremity (P=0.04), total fat (P=0.035), and fat percentage (P=0.012) had decreased, and bone mineral density (BMD) (P=0.026), T-score (P=0.028), and Z-score (P=0.021) had increased in the study group. Besides, statistical difference was observed in outcome measurements of right upper extremity (P=0.013), total fat (P=0.023), and fat percentage (P=0.012) between the groups. Our study demonstrated that progressive elastic band resistance exercise can reduce fat mass and increase BMD in elderly women with SO, and that this exercise program is feasible for this demographic. Additional studies with larger sample sizes and longer intervention periods should be conducted. Twelve weeks of progressive elastic band resistance exercise program is safe and effective for SO elder women.

A Hybrid Web-Based and In-Person Self-Management Intervention to Prevent Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): Protocol for a Pilot Single-Blind Randomized Controlled Trial

PubMed Central

2017-01-01

Background Acute pain frequently transitions to chronic pain after major lower extremity trauma (ET). Several modifiable psychological risk and protective factors have been found to contribute to, or prevent, chronic pain development. Some empirical evidence has shown that interventions, including cognitive and behavioral strategies that promote pain self-management, could prevent chronic pain. However, the efficacy of such interventions has never been demonstrated in ET patients. We have designed a self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). Objective This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and research methods of the intervention, as well as the potential effects of iPACT-E-Trauma, on pain intensity and pain interference with daily activities. Methods A 2-arm single-blind pilot RCT will be conducted. Participants will receive the iPACT-E-Trauma intervention (experimental group) or an educational pamphlet (control group) combined with usual care. Data will be collected at baseline, during iPACT-E-Trauma delivery, as well as at 3 and 6 months post-injury. Primary outcomes are pain intensity and pain interference with daily living activities at 6 months post-injury. Secondary outcomes are pain self-efficacy, pain acceptance, pain catastrophizing, pain-related fear, anxiety and depression symptoms, health care service utilization, and return to work. Results Fifty-three patients were recruited at the time of manuscript preparation. Comprehensive data analyses will be initiated in July 2017. Study results are expected to be available in 2018. Conclusions Chronic pain is an important problem after major lower ET. However, no preventive intervention has yet been successfully proven in these patients. This study will focus on developing a feasible intervention to prevent acute to chronic pain transition in the context of ET. Findings will allow for the refinement of iPACT-E-Trauma and methodological parameters in prevision of a full-scale multi-site RCT. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs) PMID:28652226

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

NASA Technical Reports Server (NTRS)

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

2013-01-01

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

The Effects of a Single Session of Music Therapy on the Agitated Behaviors of Patients Receiving Hospice Care.

PubMed

Cadwalader, Alyssa; Orellano, Shashanna; Tanguay, Carla; Roshan, Ramesh

2016-08-01

Research suggests that agitation is a common symptom for hospice patients, but while studies have examined the outcomes of music therapy on the agitated behaviors of patients in other settings, none have addressed this symptom in patients with terminal illnesses. The study objective was to determine whether a single session of music therapy provided by a board certified music therapist and using the entrainment principle would decrease agitation in hospice patients. This pilot study was a single-blind, pretest/posttest design. Music therapists used the principle of entrainment with live music during the treatment session. Subjects included in the study were 77 patients at a large hospice in south Florida with documented agitation. Agitation was measured using the Overt Agitation Severity Scale (OASS) for 5 minutes prior to and 5 minutes following a 20 minute music therapy intervention. Results from 73 participants were analyzed with a mean difference of -5.77 points from pretest to posttest. Results indicating a decrease in agitation were statistically significant (p < 0.001) for the entire sample. Age, gender, location, and diagnosis were found to have no significant effects on the results. Results indicate that a single session of music therapy using the entrainment principle may be an effective treatment for hospice patients experiencing agitation.

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

PubMed Central

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

2013-01-01

Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370. PMID:23901031

Use of intralesional verapamil to dissolve Peyronie's disease plaque: a long-term single-blind study.

PubMed

Rehman, J; Benet, A; Melman, A

1998-04-01

Multiple conservative therapies for the treatment of Peyronie's disease have been offered with variable and poor response rates. Calcium channel blockers have been shown in vitro and in vivo to inhibit secretion and synthesis of extracellular matrix, including collagen, glycosaminoglycans, and fibronectin, as well as causing increased collagenase and anti transforming growth factor-beta activity. Calcium antagonists, including verapamil, are effective in stimulating the remodeling and degradation of extracellular matrix in tissue by altering the metabolic pathways of fibroblasts. Recently, a pilot study (1994) showed preliminary promising results in treating plaque caused by Peyronie's disease. This randomized single-blind placebo-based study (1994 to 1996) was undertaken to confirm the hypothesis. In this randomized single-blind study, 14 patients completed the study and were divided into two groups: the verapamil treatment group (n = 7) or the control saline group (n = 7). Verapamil or saline was injected directly into the Peyronie's plaque once a week for 6 months. Patients were evaluated before and after treatment with duplex ultrasound to confirm the extent of the lesion and to measure volume of the plaque, and by interview and mailed questionnaire 3 months after treatment. Patients being treated with oral calcium antagonists were excluded from the study. A decreased plaque volume was measured in 57% of the verapamil-treated men versus 28% in the control group (P <0.04). Penile curvature demonstrated an improvement trend of 37.71 +/- 9.3 degrees to 29.57 +/- 7.3 degrees in the verapamil-treated patients, but the difference was not significant (P <0.07). Plaque softening was noted in all patients treated with verapamil. There was significant objective improvement in plaque-associated penile narrowing in all patients in the verapamil group. Subjective plaque-associated erectile dysfunction (quality of erection) showed improvement in 42.87% of the verapamil group versus none in the control group (P <0.02). There was no local or systemic toxicity except for an occasional ecchymosis/bruise at the injection site. After a positive clinical response, plaque size, penile angulation, and symptoms continued to improve. Decrease in plaque size was noted in each of the responders in the first 3 months. This randomized single-blind study suggests that intralesional injection of calcium channel blocker may be a reasonable approach in some selected patients for the treatment of Peyronie's disease with noncalcified plaque and penile angulation of less than 30 degrees. Patients whose plaque failed to respond to intralesional verapamil therapy within 3 months or whose angulation was greater than 30 degrees at presentation were more likely to benefit from surgery.

Lonely Skies: Air-to-Air Training for a 5th Generation Fighter Force

DTIC Science & Technology

2015-06-01

Missing Attitude Indicator….…………………14 4 Lt James Doolittle during Blind Flight Test…..……………………...15 5 An Early Link Trainer Cockpit...during visual flight because it deceived pilots about the actual aircraft attitude and acceleration. 1st Lt James Doolittle used Doctor David Meyers...flying pioneer and leader, Doolittle believed that pilots should learn to ignore their physical sense of motion while flying blind and to trust their

Comparison between self-formulation and compounded-formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross-over trial.

PubMed

Hambly, Jessica L; Haywood, Alison; Hattingh, Laetitia; Nair, Raj G

2017-08-01

There is a lack of appropriate, commercially-available topical corticosteroid formulations for use in oral lichen planus (OLP) and oral lichenoid reaction. Current therapy includes crushing a dexamethasone tablet and mixing it with water for use as a mouth rinse. This formulation is unpleasant esthetically and to use in the mouth, as it is a bitter and gritty suspension, resulting in poor compliance. Thus, the present study was designed to formulate and pilot an effective, esthetically-pleasing formulation. A single-blinded, cross-over trial was designed with two treatment arms. Patients were monitored for 7 weeks. Quantitative and qualitative data was assessed using VAS, numeric pain scales, the Treatment Satisfaction Questionnaire for Medication-9, and thematic analysis to determine primary patient-reported outcomes, including satisfaction, compliance, quality of life, and symptom relief. Nine patients completed the pilot trial. Data analysis revealed the new compounded formulation to be superior to existing therapy due to its convenience, positive contribution to compliance, patient-perceived faster onset of action, and improved symptom relief. Topical dexamethasone is useful in the treatment of OLP. When carefully formulated into a compounded mouth rinse, it improves patient outcomes. © 2016 John Wiley & Sons Australia, Ltd.

Emotional wellbeing of blind patients in a pilot trial with subretinal implants.

PubMed

Peters, Tobias; Klingberg, Stefan; Zrenner, Eberhart; Wilhelm, Barbara

2013-06-01

Participation in first human applications of retinal neuroprosthesis may create psychological stress for blind retinitis pigmentosa patients. The aim of this study was to assess the emotional wellbeing of patients undergoing implantation of a subretinal implant. Nine blind patients participating in a pilot trial with subretinal implants were enlisted. The Brief Symptom Inventory (BSI), a short self-report scale of nine primary symptoms, was used to assess reaction to the psychological distress related to study participation. The number and the intensity of symptoms were analysed, and global scores for overall psychological distress (tGSI), severity of reported symptoms (tPDSI), and level number of self-reported symptoms (tPST) were calculated. The questionnaire was administered before implantation, 2-3 times during the trial and before explantation. There were no significant alterations during the trial for the average scores of the nine primary symptoms. One patient, however, showed values higher than the norm, for six subscores before implantation and for eight subscores before explantation. A significant improvement was found in both the overall psychological distress level (tGSI) and the severity of reported symptoms (tPDSI) at the final visit, compared to those at the study start. The number of self-reported symptoms (tPST) was not significantly altered. In the first ongoing pilot trial with an active, cable-bound subretinal implant, we found that trial participation and the implant procedure and subsequent testing did not have any adverse effects on the participants' emotional wellbeing. Their distress generally improved during study participation, rather than showing signs of decreased wellbeing.

Venous leg ulcer healing with electric stimulation therapy: a pilot randomised controlled trial.

PubMed

Miller, C; McGuiness, W; Wilson, S; Cooper, K; Swanson, T; Rooney, D; Piller, N; Woodward, M

2017-03-02

Compression therapy is a gold standard treatment to promote venous leg ulcer (VLU) healing. Concordance with compression therapy is, however, often sub-optimal. The aim of this study was to evaluate the effectiveness of electric stimulation therapy (EST) to facilitate healing of VLUs among people who do not use moderate-to-high levels of compression (>25 mmHg). A pilot multicentre, single-blinded randomised controlled trial was conducted. Participants were randomised (2:1) to the intervention group or a control group where EST or a sham device was used 4 times daily for 20 minutes per session. Participants were monitored fortnightly for eight weeks. The primary outcome measure was percentage of area (wound size) change. In the 23 patients recruited, an average redution in wound size of 23.15% (standard deviation [SD]: 61.23) was observed for the control group compared with 32.67 % (SD: 42.54) for the intervention. A moderate effect size favouring the intervention group was detected from univariate [F(1,18)=1.588, p=0.224, partial eta squared=0.081] and multivariate repeated measures [F(1,18)=2.053, p=0.169, partial eta squared=0.102] analyses. The pilot study was not powered to detect statistical significance, however, the difference in healing outcomes are encouraging. EST may be an effective adjunct treatment among patients who have experienced difficulty adhering to moderate-to-high levels of compression therapy.

A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

PubMed Central

Zywiak, William H.; Edwards, Steven M.; Tidey, Jennifer W.; Swift, Robert M.; Kenna, George A.

2014-01-01

Rationale There is presently no approved single treatment for dual alcohol and nicotine dependencies. Objective This pilot study investigated baclofen effects in alcoholic smokers. Methods This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment. Results Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type. Conclusions This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies. PMID:24973894

[The study of establishment of the " Chinese provincial Blindness prevention technical guidance group performance evaluation system"].

PubMed

Lu, L N; He, X G; Zhu, J F; Xu, X; Zhang, R; Hu, X; Zou, H D

2016-11-11

Objective: To establish an assessment system, including indexes and scoring methods, that can be used for performance evaluation of the provincial blindness prevention technical guidance group properly and effectively . Methods: The indexes and scoring methods were set based on the core content of The " National Plan of Prevention and Treatment of Blindness (2012-2015)" , the specific requirement and target of the World Health Organization (WHO) "For the General Eye Health: Global plan of Action (2014-2019)" , and the current situation of the China's provinces and autonomous regions. These indexes should be of effectiveness, feasibility, comparability, guidance and advancing. Formed by a literature review of candidate indicators, the framework of the system is built by qualitative assessment. With the Delphi method, the system was further revised and improved. Empirical pilot study was then used to prove the feasibility, followed by the final qualitative analysis that establish the " Chinese provincial Blindness prevention technical guidance group performance evaluation system" . Results: Through the literature review and qualitative assessment, a six dimensional system framework was built, including 6 first-level indicators, 16 second-level indicators, and 29 third-level indicators through Delphi method evaluation. With the variation coefficient method, the coeffiences of the first-level index weight were calculated as: Organization and management 0.15, Development and implementation of blindness prevention plans 0.15, Implementation of blindness prevention projects 0.14, Training 0.17, Health education 0.18, and Cooperation and exchanges 0.21. The specific scoring method for this system is confirmed as: data and files check, field interview, and record interview, sampling investigation. Empirical pilot study was conducted in the Jilin, Guizhou and Gansu provinces, and the self-assessment results from local experts were consistent with the scores from the systems. Conclusion: This system established is appropriate at current time, and it can effectively evaluate the performance of the Chinese provincial Blindness prevention technical guidance group. (Chin J Ophthalmol, 2016, 52:814-824) .

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

PubMed

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.

Implementation of the Twenty-First Century Communications and Video Accessibility Act of 2010, Section 105, Relay Services for Deaf-Blind Individuals. Final rule.

PubMed

2016-09-26

In this document, the Federal Communications Commission (Commission) adopts rules to convert the National Deaf-Blind Equipment Distribution Program (NDBEDP) from a pilot program to a permanent program. The NDBEDP supports the distribution of communications devices to low-income individuals who are deaf-blind.

A Prospective, Randomized, Double-Blinded, Double-Dummy Pilot Study to Assess the Preemptive Effect of Triple Therapy with Aprepitant, Dexamethasone, and Promethazine versus Ondansetron, Dexamethasone and Promethazine on Reducing the Incidence of Postoperative Nausea and Vomiting Experienced by Patients Undergoing Craniotomy Under General Anesthesia.

PubMed

Bergese, Sergio Daniel; Puente, Erika G; Antor, Maria A; Viloria, Adolfo L; Yildiz, Vedat; Kumar, Nicolas Alexander; Uribe, Alberto A

2016-01-01

Postoperative nausea and vomiting (PONV) is among the most common distressing complications of surgery under anesthesia. Previous studies have demonstrated that patients who undergo craniotomy have incidences of nausea and vomiting as high as 50-70%. The main purpose of this pilot study is to assess the incidence of PONV by using two different prophylactic regimens in subjects undergoing a craniotomy. Thus, we designed this study to assess the efficacy and safety of triple therapy with the combination of dexamethasone, promethazine, and aprepitant versus ondansetron to reduce the incidence of PONV in patients undergoing craniotomy. This is a prospective, single center, two-armed, randomized, double-dummy, double-blind, pilot study. Subjects were randomly assigned to one of the two treatment groups. Subjects received 40 mg of aprepitant pill (or matching placebo pill) 30-60 min before induction of anesthesia and 4 mg of ondansetron IV (or 2 ml of placebo saline solution) at induction of anesthesia. In addition, all subjects received 25 mg of promethazine IV and 10 mg of dexamethasone IV at induction of anesthesia. Assessments of PONV commenced for the first 24 h after surgery and were subsequently assessed for up to 5 days. The overall incidence of PONV during the first 24 h after surgery was 31.0% (n = 15) in the aprepitant group and 36.2% (n = 17) for the ondansetron group. The median times to first emetic and significant nausea episodes were 7.6 (2.9, 48.7) and 14.3 (4.4, 30.7) hours, respectively, for the aprepitant group and 6.0 (2.2, 29.5) and 9.6 (0.7, 35.2) hours, respectively, for the ondansetron group. There were no statistically significant differences between these groups. No adverse events directly related to study medications were found. This pilot study showed similar effectiveness when comparing the two PONV prophylaxis regimens. Our data showed that both treatments could be effective regimens to prevent PONV in patients undergoing craniotomy under general anesthesia. Future trials testing new PONV prophylaxis regimens in this surgical population should be performed to gain a better understanding of how to best provide prophylactic treatment.

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

PubMed

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.

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

PubMed Central

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

2014-01-01

Purpose To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Methods 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. Results Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Implications 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. PMID:24439640

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

PubMed Central

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-01-01

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

PubMed

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-08-23

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

Reconstructing Cell Lineages from Single-Cell Gene Expression Data: A Pilot Study

DTIC Science & Technology

2016-08-30

Reconstructing cell lineages from single- cell gene expression data: a pilot study The goal of this pilot study is to develop novel mathematical...methods, by leveraging tools developed in the bifurcation theory, to infer the underlying cell -state dynamics from single- cell gene expression data. Our...proposed method contains two steps. The first step is to reconstruct the temporal order of the cells from gene expression data, whereas the second

Jogging Program for Deaf-Blind Students Improves Condition and Reduces Self-Stimulation.

ERIC Educational Resources Information Center

Alajajian, Lisa D.

Four deaf-blind students at the Massachusetts Association for the Blind were involved in a pilot aerobic program consisting of jogging for 15-20 minutes three times a week. Students were chosen based on their enjoyment of this fast movement and they were given clearance for this activity by both a doctor and a physical therapist. The students'…

Alternative treatments for adults with attention-deficit hyperactivity disorder (ADHD).

PubMed

Arnold, L E

2001-06-01

A previous review of alternative treatments (Tx) of ADHD--those other than psychoactive medication and behavioral/psychosocial Tx--was supplemented with an additional literature search focused on adults with ADHD. Twenty-four alternative Tx were identified, ranging in scientific documentation from discrediting controlled studies through mere hypotheses to positive controlled double-blind clinical trials. Many of them are applicable only to a specific subgroup. Although oligoantigenic (few-foods) diets have convincing double-blind evidence of efficacy for a properly selected subgroup of children, they do not appear promising for adults. Enzyme-potentiated desensitization, relaxation/EMG biofeedback, and deleading also have controlled evidence of efficacy. Iron supplementation, magnesium supplementation, Chinese herbals, EEG biofeedback, massage, meditation, mirror feedback, channel-specific perceptual training, and vestibular stimulation all have promising prospective pilot data, many of these tests reasonably controlled. Single-vitamin megadosage has some intriguing pilot trial data. Zinc supplementation is hypothetically supported by systematic case-control data, but no systematic clinical trial. Laser acupuncture has promising unpublished pilot data and may be more applicable to adults than children. Essential fatty acid supplementation has promising systematic case-control data, but clinical trials are equivocal. RDA vitamin supplementation, non-Chinese herbals, homeopathic remedies, and antifungal therapy have no systematic data in ADHD. Megadose multivitamin combinations are probably ineffective for most patients and are possibly dangerous. Simple sugar restriction seems ineffective. Amino acid supplementation is mildly effective in the short term, but not beyond 2-3 months. Thyroid treatment is effective in the presence of documented thyroid abnormality. Some alternative Tx of ADHD are effective or probably effective, but mainly for certain patients. In some cases, they are the Tx of choice, and initial evaluation should consider the relevant etiologies. A few have failed to prove effective in controlled trials. Most need research to determine whether they are effective and/or to define the applicable subgroup. Some of them, although not safer than standard Tx, may be preferable for an etiologic subgroup.

CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients

PubMed Central

Molloy, Alexander J; Clarke, France; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J

2016-01-01

Introduction Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. Methods and analysis 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0–4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1–2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Ethics and dissemination Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. Trial registration number NCT02377830; Pre-results. PMID:27059469

The 1975 accident experience of civilian pilots with static physical defects.

DOT National Transportation Integrated Search

1977-08-01

The 1974 aircraft accident experience of civilian pilots with eight selected static physical defects has been examined and reported previously. Three categories--blindness or absence of either eye, deficient color vision with a waiver, and deficient ...

Methodology for speech assessment in the Scandcleft project--an international randomized clinical trial on palatal surgery: experiences from a pilot study.

PubMed

Lohmander, A; Willadsen, E; Persson, C; Henningsson, G; Bowden, M; Hutters, B

2009-07-01

To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes across five included languages were developed and tested. PARTICIPANTS AND MATERIALS: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains with nasal consonants. Five experienced speech and language pathologists participated as observers. Narrow phonetic transcription of test consonants translated into cleft speech characteristics, ordinal scale rating of resonance, and perceived velopharyngeal closure (VPC). A velopharyngeal composite score (VPC-sum) was extrapolated from raw data. Intra-agreement comparisons were performed. Range for intra-agreement for consonant analysis was 53% to 89%, for hypernasality on high vowels in single words the range was 20% to 80%, and the agreement between the VPC-sum and the overall rating of VPC was 78%. Pooling data of speakers of different languages in the same trial and comparing speech outcome across trials seems possible if the assessment of speech concerns consonants and is confined to speech units that are phonetically similar across languages. Agreed conventions and rules are important. A composite variable for perceptual assessment of velopharyngeal function during speech seems usable; whereas, the method for hypernasality evaluation requires further testing.

Specific exercise training for reducing neck and shoulder pain among military helicopter pilots and crew members: a randomized controlled trial protocol.

PubMed

Murray, Mike; Lange, Britt; Nørnberg, Bo Riebeling; Søgaard, Karen; Sjøgaard, Gisela

2015-08-19

Flight-related neck/shoulder pain is frequent among military helicopter pilots and crew members. With a lifetime prevalence of 81% for pilots and 84% for crew members, the prevalence of neck pain is considered high compared to the general population. The aim of this study was to investigate whether a specifically tailored exercise intervention would reduce the prevalence and incidence rate of neck/shoulder pain among helicopter pilots and crew members. This study used a prospective, parallel group, single blinded, randomized controlled design. Participants were military helicopter pilots and crew members recruited from the Royal Danish Air Force. Inclusion criteria were: 1) employed within the Royal Danish Air Force as a helicopter pilot or onboard crew member (technician, systems-operator, tactical helicopter observer and/or navigator), 2) maintaining operational flight status at enrollment, and 3) operational flying within the previous 6 months. Primary outcome was change in neck and shoulder pain assessed by 1) a modified version of the "Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms" and by 2) pressure pain threshold measurements. Secondary outcomes included: postural balance, strength, stability, and rate of force development for neck and shoulder muscles. Measurements at baseline and follow-up were conducted at four air force bases in Denmark. Sixty-nine participants were individually randomized to either a training group (TG) or a reference group (RG). Participants in the TG performed 20-weeks of physical exercise training divided into sessions of 3 × 20 min per week. Training was completed within working hours and consisted of specific exercise training for the neck and shoulder muscles based on the principles of "Intelligent Physical Exercise Training". The RG received no training. In spite of the high prevalence of flight related neck/shoulder pain among military helicopter pilots and crew members there are currently no evidence based guidelines for the prevention or clinical handling of neck pain among these occupational groups. Results from this study may therefore be beneficial for future establishment of such guidelines. Ethical committee of Southern Denmark (S-20120121) 29 August, 2012. Clinical Trail Registration (NCT01926262) 16 August, 2013.

Study to determine the IFR operational profile and problems to the general aviation pilot

NASA Technical Reports Server (NTRS)

Weislogel, S.

1983-01-01

A study of the general aviation single pilot operating under instrument flight rules (GA SPIFR) has been conducted for NASA Langley Research Center. The objectives of the study were to (1) develop a GA SPIFR operational profile, (2) identify problems experienced by the GA SPIFR pilot, and (3) identify research tasks which have the potential for eliminating or reducing the severity of the problems. To obtain the information necessary to accomplish these objectives, a mail questionnaire survey of instrument rated pilots was conducted. Complete questionnaire data is reported in NASA CR-165805, "Statistical Summary: Study to Determine the IFR Operational Profile and Problems of the General Aviation Single Pilot'-Based upon the results of the GA SPIFR survey, this final report presents the general aviation IFR single pilot operational profile, illustrates selected data analysis, examples, identifies the problems which he is experiencing, and recommends further research.

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study.

PubMed

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 trial and subsequent main trial will be submitted for publication in a peer-reviewed journal. NCT02466698; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study

PubMed Central

McCreery, Greig; Jones, Philip M; Kidane, Biniam; DeMelo, Vanessa

2017-01-01

Introduction 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. Methods and analysis 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. Ethics and dissemination This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot trial and subsequent main trial will be submitted for publication in a peer-reviewed journal. Trial registration number NCT02466698; Pre-results. PMID:28760801

Blind and sighted pedestrians' road-crossing judgments at a single-lane roundabout.

PubMed

Guth, David A; Long, Richard G; Emerson, Robert S Wall; Ponchillia, Paul E; Ashmead, Daniel H

2013-06-01

The aim of this study was to evaluate the relative risk and efficiency of road crossing experienced by blind and sighted pedestrians at a single-lane roundabout with two levels of traffic volume and at two distances from the roundabout. With the rapid spread of modern roundabouts across the United States,their accessibility to blind pedestrians has become an important concern. To date, accessibility research relevant to blind pedestrians has focused on multilane roundabouts, and single-lane roundabouts have been virtually ignored. Blind and sighted participants made judgments about when they would cross a single-lane roundabout with high and low traffic volumes, at exit and entry lanes, and at the actual crosswalks and at locations farther from the roundabout. Relative to sighted participants, blind participants' judgments about when to cross were more frequently risky, especially when traffic volume was high. Blind participants also were slower to make crossing judgments and accepted fewer crossing opportunities. Both groups made somewhat safer and more efficient judgments at locations farther from the roundabout. Some single-lane roundabouts may pose greater risk to blind pedestrians than to sighted pedestrians, especially when traffic volume is high. Crosswalk location merits further investigation as a design issue. These findings are relevant to transportation planners and engineers who are responsible for the accessibility of public rights-of-way.

A Time History of Control Operation of a C-54 Airplane in Blind Landing Approaches

NASA Technical Reports Server (NTRS)

Talmage, Donald B.

1947-01-01

Tests were made with a C-54 airplane in which airline pilots made several blind approaches to determine whether any special flying techniques were used in blind landings and whether any special handling-qualities requirements would have to be formulated because of such special techniques. It was found that the airplane was flown at all times in the normal manner; that is, all turns were banked turns that were nearly coordinated by use of the rudder so that the sideslip was held close to zero. The pilot expended considerable physical work in continually moving the controls but this wake was due in part to the large friction in the three control systems. The actual control deflections used were small compared to the maximum deflections available.

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

PubMed

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.

Prevalence of blindness and cataract surgery in Gandaki Zone, Nepal

PubMed Central

Sapkota, Y D; Pokharel, G P; Nirmalan, P K; Dulal, S; Maharjan, I M; Prakash, K

2006-01-01

Background/aim Himalaya Eye Hospital (HEH), established in 1993, is rendering eye care services in the Gandaki and Dhaulagiri zones. The hospital has extensive community outreach activities along with services for outpatients, emergencies, and subspecialties such as vitreoretinal, paediatric, and low vision. The operation theatre is well equipped to match the surgical needs including phaco surgery for cataract. The hospital has performed more than 14 000 cataract surgeries and 250 000 treatment services during this period. The aim of this study was to estimate the prevalence of blindness, visual impairment, and cataract surgical coverage among the older adult population of three districts of Gandaki Zone, where 80% of the hospital's service recipients reside. Methods People aged 45 years and older were enrolled in the study using a stratified cluster design. Subjects in 25 randomly selected clusters from the listed 806 were recruited through door to door visits. Each recruited subject had visual acuity (VA) and clinical examination conducted by an ophthalmologist. The survey was preceded by pre‐pilot and pilot studies to refine the operational method. To assess quality assurance the interobserver variation in VA measurement was also carried out in five different clusters. Results Out of 5863 selected subjects 85.3% were examined. Blindness defined as presenting VA <6/60 in both eyes was found in 2.6% (95% confidence interval (CI): 2.2 to 3.9), whereas 16.8% individuals examined had vision <6/19 in one or both eyes. Cataract was the principal cause of blindness in 60.5%, and refractive error was the dominant cause of vision impairment (<6/19) 83.3%. Cataract surgical coverage was 59.5% among the cataract blind and associated with younger age, literacy, and male sex. Conclusion The finding suggests a positive impact of the HEH programme on the prevalence of blindness and cataract surgical services in the survey area. Strategies to further improve access and utilisation of facilities and increase cataract surgical coverage need to be developed. PMID:16547315

Cognitive Performance Effects of Bilastine 20 mg During 6 Hours at 8000 ft Cabin Altitude.

PubMed

Valk, Pierre J L; Simons, Ries; Jetten, Andrea M; Valiente, Román; Labeaga, Luis

2016-07-01

Bilastine is a new oral, second generation antihistamine used in the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. It is considered a nonsedating antihistamine and might be recommended for use in pilots, pending research on the effects on flying-related performance under hypobaric conditions that prevail in an airliner. We assessed the effects of a single dose of bilastine 20 mg on alertness and complex task performance of healthy volunteers in a hypobaric chamber at 75.2 kPa (8000 ft/2438 m cabin altitude). In a randomized, double-blind, crossover study, 24 volunteers received a single dose of bilastine 20 mg, hydroxyzine 50 mg (active control), and placebo. Using the Vigilance and Tracking Task, Multi-Attribute Task Battery, and Stanford Sleepiness Scale, assessments were made before and up to 6 h after intake of the study medication. Bilastine 20 mg had no impairing effects on sleepiness levels, vigilance, or complex task performance for up to 6 h post-dose. Hydroxyzine 50 mg (active control) was associated with significant sleepiness and impaired performance across this time period, confirming the sensitivity of the tests. Bilastine 20 mg did not cause sleepiness or impaired performance on tasks related to flying. It is anticipated that a single dose of bilastine 20 mg will not affect flying performance. Bilastine may provide a safe therapeutic alternative for pilots suffering from allergic rhinitis or urticaria. Our findings might also have implications for the treatment of allergic disorders of personnel involved in other safety-sensitive jobs. Valk PJL, Simons R, Jetten AM, Valiente R, Labeaga L. Cognitive performance effects of bilastine 20 mg during 6 hours at 8000 ft cabin altitude. Aerosp Med Hum Perform. 2016; 87(7):622-627.

Spiral tendency in blind flying

NASA Technical Reports Server (NTRS)

Carroll, Thomas; Mcavoy, William H

1929-01-01

The flight path followed by an airplane which was being flown by a blindfolded pilot was observed and recorded. When the pilot attempted to make a straight-away flight there was a tendency to deviate from the straight path and to take up a spiral one.

Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia

PubMed Central

Borba, Christina P.C.; Fan, Xiaoduo; Copeland, Paul M.; Paiva, Alexander; Freudenreich, Oliver; Henderson, David C.

2013-01-01

Objective Few interventions have been successful to prevent or reverse the medical complications associated with antipsychotic agents in the schizophrenia population. In particular, no single agent can correct multiple metabolic abnormalities such as insulin resistance, hyperlipidemia, inflammation, obesity and fat distribution. We now report a randomized placebo-controlled pilot study to examine the effects of ramelteon on obesity and metabolic disturbances among subjects with schizophrenia. Methods A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia. Vital signs, anthropometric measurements, including height, weight, waist circumference, and body fat were assessed and laboratory assays were tracked to monitor changes in metabolic markers. Results Twenty-five subjects were randomly assigned to treatment with study drug or placebo and twenty subjects were included in the final analysis. Ramelteon did not improve anthropometric measurements, glucose metabolism and inflammatory markers. There was, however, a significant decrease in total cholesterol and cholesterol to HDL ratio in the ramelteon group. While the standard anthropometric measures did not show significant change, the DEXA scan showed a trend toward reduction in fat in the abdominal and trunk areas with a moderate effect size. Conclusions While ramelteon decreased cholesterol, treatment may have to be longer than 8 weeks and with a higher dose for maximal effect of ramelteon for body fat and lipid changes. Future studies are needed for patients with schizophrenia with a larger sample size to fully understand ramelteon’s effects on abdominal adiposity and lipids. PMID:21869685

The Effects of Compensatory Auditory Stimulation and High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Tinnitus Perception - A Randomized Pilot Study.

PubMed

Henin, Simon; Fein, Dovid; Smouha, Eric; Parra, Lucas C

2016-01-01

Tinnitus correlates with elevated hearing thresholds and reduced cochlear compression. We hypothesized that reduced peripheral input leads to elevated neuronal gain resulting in the perception of a phantom sound. The purpose of this pilot study was to test whether compensating for this peripheral deficit could reduce the tinnitus percept acutely using customized auditory stimulation. To further enhance the effects of auditory stimulation, this intervention was paired with high-definition transcranial direct current stimulation (HD-tDCS). A randomized sham-controlled, single blind study was conducted in a clinical setting on adult participants with chronic tinnitus (n = 14). Compensatory auditory stimulation (CAS) and HD-tDCS were administered either individually or in combination in order to access the effects of both interventions on tinnitus perception. CAS consisted of sound exposure typical to daily living (20-minute sound-track of a TV show), which was adapted with compressive gain to compensate for deficits in each subject's individual audiograms. Minimum masking levels and the visual analog scale were used to assess the strength of the tinnitus percept immediately before and after the treatment intervention. CAS reduced minimum masking levels, and visual analog scale trended towards improvement. Effects of HD-tDCS could not be resolved with the current sample size. The results of this pilot study suggest that providing tailored auditory stimulation with frequency-specific gain and compression may alleviate tinnitus in a clinical population. Further experimentation with longer interventions is warranted in order to optimize effect sizes.

Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia.

PubMed

Borba, Christina P C; Fan, Xiaoduo; Copeland, Paul M; Paiva, Alexander; Freudenreich, Oliver; Henderson, David C

2011-10-01

Few interventions have been successful to prevent or reverse the medical complications associated with antipsychotic agents in the schizophrenia population. In particular, no single agent can correct multiple metabolic abnormalities such as insulin resistance, hyperlipidemia, inflammation, obesity, and fat distribution. We now report a randomized placebo-controlled pilot study to examine the effects of ramelteon on obesity and metabolic disturbances among subjects with schizophrenia. A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/d to stable outpatients with schizophrenia. Vital signs and anthropometric measurements, including height, weight, waist circumference, and body fat were assessed, and laboratory assays were tracked to monitor changes in metabolic markers. Twenty-five subjects were randomly assigned to treatment with study drug or placebo, and 20 subjects were included in the final analysis. Ramelteon did not improve anthropometric measurements, glucose metabolism, and inflammatory markers. There was, however, a significant decrease in total cholesterol and ratio of cholesterol to high-density lipoprotein in the ramelteon group. Although the standard anthropometric measures did not show significant change, the dual-energy x-ray absorptiometry scan showed a trend toward reduction in fat in the abdominal and trunk areas with a moderate effect size. Although ramelteon decreased cholesterol, treatment may have to be longer than 8 weeks and with a higher dose for maximal effect of ramelteon for body fat and lipid changes. Future studies are needed for patients with schizophrenia with a larger sample size to fully understand ramelteon's effects on abdominal adiposity and lipids.

The 1980 and 1981 accident experience of civil airmen with selected visual pathology.

DOT National Transportation Integrated Search

1983-07-01

In studies of the 1974-76 accident experience of U.S. general aviation pilots with static physical defects, all the significantly increased rates and ratios were for visual defect categories--blindness, or absence of either eye, deficient distant vis...

Pilot Study of Droxidopa With Carbidopa in Adults With ADHD.

PubMed

Adler, Lenard A; Gorny, Stephen W

2015-04-23

We conducted a two-period (open-label and double-blind) pilot investigation of droxidopa, with and without carbidopa, for ADHD. Twenty adult ADHD patients received open-label droxidopa titrated from 200 to 600 mg 3 times per day (TID; Weeks 1-3), then open-label droxidopa plus carbidopa titrated from 25 or 50 mg TID (Weeks 4-6). In Weeks 7 to 8, patients were randomized to continued co-treatment or matching placebo substitution. Improvements in mean total Adult ADHD Investigator Symptom Report Scale (AISRS) scores were seen at Week 1 (p < .0001) and Week 3 (p < .0001). Improvements were maintained but not increased with carbidopa. Thirteen of 20 patients completed open-label treatment. In the double-blind period, mean total AISRS scores were similar between the co-treatment (n = 6) and placebo (n = 5) groups. No serious adverse events were reported. These preliminary findings indicate that droxidopa can improve adult ADHD symptoms. Further studies are warranted to examine the efficacy and safety of droxidopa in ADHD. © 2015 SAGE Publications.

Probiotics for fibromyalgia: study design for a pilot double-blind, randomized controlled trial.

PubMed

Roman, Pablo; Estévez, Ángeles F; Sánchez-Labraca, Nuria; Cañadas, Fernando; Miras, Alonso; Cardona, Diana

2017-10-24

Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by other symptoms such as emotional and cognitive deficits. The FMS patients show a high prevalence of gastrointestinal symptoms. Recently it has been found that microbes in the gut may regulate brain processes through the gut-microbiota-brain axis, modulating thus affection, motivation and higher cognitive functions. Therefore, the use of probiotics might be a new treatment that could improve the physical, psychological and cognitive state in FMS; however, no evidence about this issue is available. This paper describes the design and protocol of a double-blind, placebo-controlled and randomized pilot study. We use validated questionnaires, cognitive task through E-Prime and biological measures like urine cortisol and stool fecal samples. The trial aim is to explore the effects of eight weeks of probiotics therapy in physical (pain, impact of the FMS and quality of life), emotional (depression, and anxiety) and cognitive symptoms (attention, memory, and impulsivity) in FMS patients as compared to placebo. This pilot study is the first, to our knowledge, to evaluate the effects of probiotics in FMS. The primary hypothesis was that FMS patients will show a better performance on cognitive tasks, and an improvement in emotional and physical symptoms. These results will contribute to a better understanding in the gut-brain axis. Here we present the design and protocol of the study.

[Emphasis on promotion of the adaptive technology is the sky point of improving of treatment and prevention level of glaucoma].

PubMed

Wang, Ning-li

2013-11-01

Promoting the control of primary angle-closure glaucoma (PACG) and primary open angle glaucoma (POAG) is most important prevention program of blindness in China. PACG has been incorporated into the prevention program of blindness in China based on the population-based screening studies. However, the clinical screening should be strengthened in POAG. The creation of a series of appropriate technologies suitable for glaucoma prevention and management has been achieved in China, especially for PACG. The technologies have been evaluated in the pilot areas and obtained very good results in China. It is recommended to develop new technology suitable for glaucoma management using the following workflow: research, development, and evaluation by large scale hospitals, and then clinical trial in the pilot areas. After a cost-benefit analysis is made, the new technology can be promoted and applied in clinical practice nationwide. We propose to gradually formed a strategical mode of "screening in township hospitals, intervention in county hospitals, and technical support and tackling in provincial hospitals" in order to improve the level of prevention and treatment of glaucoma and reduce the blindness incidence rate caused by glaucoma.

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

PubMed

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.

Evaluation of a teaching tool to increase the accuracy of pilot balloon palpation for measuring tracheostomy tube cuff pressure.

PubMed

Jiang, Nancy; Del Signore, Anthony G; Iloreta, Alfred M; Malkin, Benjamin D

2013-08-01

The purpose of this study was to evaluate the efficacy of a novel teaching tool to improve health care providers' ability to inflate tracheostomy tube cuffs to the appropriate pressure. Single-blinded, randomized, controlled trial. Subjects were randomized to a control and study group. The control group viewed a video about inflating tracheostomy tube cuffs to safe pressure levels. The study group viewed the same video and also got to palpate the pilot balloons of tracheostomy tube cuffs inflated to three different pressures. All subjects inflated tracheostomy tube cuffs to pressures they believed to be appropriate based on palpation of the pilot balloon preintervention, and immediately, 2 weeks, and 3 months postintervention. Forty-nine health care providers participated in the study. There was no significant difference in the mean preintervention cuff inflation pressures between the two groups (36 cm H2 O vs. 38 cm H2 O, P = 0.4888), with both initially overinflating. Postintervention, the study group inflated the cuffs to significantly lower pressures than the control group, closer to the ideal of 25 cm H2 O (26 cm H2 O vs. 35 cm H2 O, P = 0.0001). This difference was also observed 2 weeks (28 cm H2 O vs. 37 cm H2 O P <0.0001) and 3 months (28 cm H2 O vs. 36 cm H2 O, P = 0.0002) postintervention. The novel teaching tool evaluated in this study is simple, easily reproducible, and low-cost. Its use leads to long-lasting improvement in health care providers' ability to more accurately inflate tracheostomy tube cuffs to safe pressures. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Evaluation of the acceptability, feasibility and effectiveness of two methods of involving patients with disability in developing clinical guidelines: study protocol of a randomized pragmatic pilot trial.

PubMed

Lamontagne, Marie-Eve; Perreault, Kadija; Gagnon, Marie-Pierre

2014-04-10

Despite growing interest in the importance of, and challenges associated with the involvement of patient and population (IPP) in the process of developing and adapting clinical practice guidelines (CPGs), there is a lack of knowledge about the best method to use. This is especially problematic in the field of rehabilitation, where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process. The goal of this pilot trial is to document the acceptability, feasibility and effectiveness of two methods of involving patients with a disability (traumatic brain injury) in CPG development. A single-blind, randomized, crossover pragmatic trial will be performed with 20 patients with traumatic brain injury (TBI). They will be randomized into two groups, and each will try two alternative methods of producing recommendations; a discussion group (control intervention) and a Wiki, a webpage that can be modified by those who have access to it (experimental intervention). The participants will rate the acceptability of the two methods, and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods, and the number of support interventions required. Twenty experts, blinded to the method of producing the recommendations, will independently rate the recommendations produced by the participants for clarity, accuracy, appropriateness and usefulness. Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI. Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings. Clinical trial KT Canada 87776.

The impact of blackcurrant juice on attention, mood and brain wave spectral activity in young healthy volunteers.

PubMed

Watson, A W; Okello, E J; Brooker, H J; Lester, S; McDougall, G J; Wesnes, K A

2018-01-17

There is a growing body of evidence from randomized controlled trials which indicates that consumption of berries has a positive effect upon the cognitive function of healthy adults. It has been recommended that studies combining cognitive and physiological measures be undertaken in order to strengthen the evidence base for the putative effects of flavonoid consumption on cognitive outcomes. This pilot study utilized a randomized, double-blind and placebo controlled crossover design to assess the influence of the acute administration of anthocyanin-rich blackcurrant juice, standardized at 500 mg of polyphenols, on mood and attention. Additionally, this trial used electroencephalography (EEG) to assess if any changes in cognitive performance are associated with changes in localized prefrontal cortex neuronal activity in nine healthy young adults. Outcomes from the pilot EEG data highlight an anxiolytic effect of the consumption of a single serve blackcurrant juice, as indexed by a suppression of α spectral power, and an increase in the slow wave δ and θ spectral powers. There was also an indication of greater alertness and lower fatigue, as indexed by an increase in β power and suppression of α spectral power. Outcomes from the CogTrack™ system indicated a small acute increase in reaction times during the digit vigilance task.

Drug user treatment failure blindness?

PubMed

Einstein, Stan

2012-01-01

An ethnographic case study of a "failed" single goal (abstinence) based individual and group therapy treatment of a New York City, Harlem-based, single, young-adult of color, IDU, mother, which ended in "death by overdose," after a period of abstinence, is presented almost 50 years later, in which complex, multidimensional structural barriers, "normed," consensualized, ideologically-driven preconceptions and an array of contextual, situational and relevant stakeholder factors, which may have resulted in intervention "failure blindness," are reviewed. The need to introduce failure analysis, blindness and management, as well as success analysis, blindness and management, as integral parts of treatment planning, implementation and assessment is raised.

Substance P-induced skin inflammation is not modulated by a single dose of sitagliptin in human volunteers.

PubMed

Grouzmann, Eric; Bigliardi, Paul; Appenzeller, Monique; Pannatier, André; Buclin, Thierry

2011-03-01

Substance P (SP), an undecapeptide belonging to the tachykinin family, is released during the activation of sensory nerves, and causes vasodilation, edema and pain through activation of tissular Neurokinin 1 receptors. SP proinflammatory effects are terminated by angiotensin converting enzyme (ACE) and neutral endopeptidase (NEP), while the aminopeptidase dipeptidylpeptidase IV (DPPIV) can also play a role. The aim of this randomized, crossover, double-blind study was to assess the cutaneous vasoreactivity (flare and wheal reaction, burning pain sensation) to intradermal injection of ascending doses of SP in six volunteers receiving a single therapeutic dose of the DPPIV inhibitor sitagliptin or a matching placebo. Cutaneous SP challenges produced the expected, dose-dependent flare and wheal response, while eliciting mild to moderate local pain sensation with little dose dependency. However, no differences were shown in the responses observed under sitagliptin compared with placebo, while the study would have been sufficiently powered to detect a clinically relevant increase in sensitivity to SP. The results of this pilot study are in line with proteolytic cleavage of SP by ACE and NEP compensating the blockade of DPPIV to prevent an augmentation of its proinflammatory action.

Advanced film-forming gel formula vs spring thermal water and white petrolatum as primary dressings after full-face ablative fractional CO2 laser resurfacing: a comparative split-face pilot study.

PubMed

Marini, L

2018-01-01

Aesthetically pleasing results and fast, uneventful recovery are highly desirable after rejuvenating ablative laser procedures. Wound dressings following ablative laser procedures should ideally improve and optimize the wound healing environment. The purpose of this comparative split-face, single-blinded, prospective observational study was to assess the efficacy and acceptability of two primary wound dressings immediately after a full-face fractional CO 2 laser resurfacing procedure. The assessments of an innovative film-forming dressing called Stratacel (SC) vs spring thermal water + Vaseline (V+) were conducted after a standardized, single-pass, full-face ablative fractional CO 2 laser skin resurfacing procedure. Clinical parameters, such as haemoglobin - HB; surface temperature - ST; micro-textural modifications - MT; superficial melanin - M; intrafollicular porphyrins - P, were assessed at different phases of the healing process using standardized, non-invasive technologies. Five female volunteers were enrolled in this inpatient, controlled pilot study. Most of the clinical parameters considered, including 3D surface texture analysis, revealed a better performance of SC vs. V+ during the early, more delicate phases of the healing process. This preliminary study, even if performed on a small number of volunteers, confirmed a definite advantage of the tested semipermeable film-forming formula (SC) over a more conventional postoperative skin care regime (V+). Clinical results could be explained by a better uniformity of distribution of SC over the micro-irregularities induced by ablative fractional CO 2 laser resurfacing. Its thin, semipermeable film might, in fact, act as an efficient, perfectly biocompatible, full contact, temporary skin barrier, able to protect extremely delicate healing surfaces from potential environmental irritations. © 2017 European Academy of Dermatology and Venereology.

20 CFR 416.327 - Pilot program for photographic identification of disability benefit applicants in designated...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Pilot program for photographic identification of disability benefit applicants in designated geographic areas. 416.327 Section 416.327 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED...

20 CFR 416.327 - Pilot program for photographic identification of disability benefit applicants in designated...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Pilot program for photographic identification of disability benefit applicants in designated geographic areas. 416.327 Section 416.327 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED...

20 CFR 416.327 - Pilot program for photographic identification of disability benefit applicants in designated...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Pilot program for photographic identification of disability benefit applicants in designated geographic areas. 416.327 Section 416.327 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED...

20 CFR 416.327 - Pilot program for photographic identification of disability benefit applicants in designated...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Pilot program for photographic identification of disability benefit applicants in designated geographic areas. 416.327 Section 416.327 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED...

A Pilot Evaluation of On-Road Detection Performance by Drivers with Hemianopia Using Oblique Peripheral Prisms

PubMed Central

Bowers, Alex R.; Tant, Mark; Peli, Eli

2012-01-01

Aims. Homonymous hemianopia (HH), a severe visual consequence of stroke, causes difficulties in detecting obstacles on the nonseeing (blind) side. We conducted a pilot study to evaluate the effects of oblique peripheral prisms, a novel development in optical treatments for HH, on detection of unexpected hazards when driving. Methods. Twelve people with complete HH (median 49 years, range 29–68) completed road tests with sham oblique prism glasses (SP) and real oblique prism glasses (RP). A masked evaluator rated driving performance along the 25 km routes on busy streets in Ghent, Belgium. Results. The proportion of satisfactory responses to unexpected hazards on the blind side was higher in the RP than the SP drive (80% versus 30%; P = 0.001), but similar for unexpected hazards on the seeing side. Conclusions. These pilot data suggest that oblique peripheral prisms may improve responses of people with HH to blindside hazards when driving and provide the basis for a future, larger-sample clinical trial. Testing responses to unexpected hazards in areas of heavy vehicle and pedestrian traffic appears promising as a real-world outcome measure for future evaluations of HH rehabilitation interventions aimed at improving detection when driving. PMID:23316415

Safety, Tolerance, and Enhanced Efficacy of a Bioavailable Formulation of Curcumin With Fenugreek Dietary Fiber on Occupational Stress: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

PubMed

Pandaran Sudheeran, Subash; Jacob, Della; Natinga Mulakal, Johannah; Gopinathan Nair, Gopakumar; Maliakel, Abhilash; Maliakel, Balu; Kuttan, Ramadasan; Im, Krishnakumar

2016-06-01

Drug delivery systems capable of delivering free (unconjugated) curcuminoids is of great therapeutic significance, since the absorption of bioactive and permeable form plays a key factor in mediating the efficacy of a substance which undergoes rapid biotransformation. Considering the recent understanding on the relatively high bioactivities and blood-brain-barrier permeability of free curcuminoids over their conjugated metabolites, the present human study investigated the safety, antioxidant efficacy, and bioavailability of CurQfen (curcumagalactomannoside [CGM]), a food-grade formulation of natural curcumin with fenugreek dietary fiber that has shown to possess improved blood-brain-barrier permeability and tissue distribution in rats. In this randomized double-blinded and placebo-controlled trial, 60 subjects experiencing occupational stress-related anxiety and fatigue were randomized to receive CGM, standard curcumin, and placebo for 30 days (500 mg twice daily). The study demonstrated the safety, tolerance, and enhanced efficacy of CGM in comparison with unformulated standard curcumin. A significant improvement in the quality of life (P < 0.05) with considerable reduction in stress (P < 0.001), anxiety (P < 0.001), and fatigue (P < 0.001) was observed among CGM-treated subjects as compared with the standard curcumin group, when monitored by SF-36, Perceived Stress Scale with 14 items, and Beck Anxiety Inventory scores. Improvement in the quality of life was further correlated with the significant enhancement in endogenous antioxidant markers (P < 0.01) and reduction in lipid peroxidation (P < 0.001). Further comparison of the free curcuminoids bioavailability after a single-dose (500 mg once per day) and repeated-dose (500 mg twice daily for 30 days) oral administration revealed enhanced absorption and improved pharmacokinetics of CGM upon both single- (30.7-fold) and repeated-dose (39.1-fold) administrations.

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

PubMed

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.

College Preparation Program for High School Youth Who Are Blind: The Summer Academy

ERIC Educational Resources Information Center

Coduti, Wendy A.; Herbert, James T.; Chiu, Herbert; Döke, Deniz Aydemir

2017-01-01

Students with disabilities have significantly lower graduation rates in four-year postsecondary institutions than students without disabilities. Although there are many barriers associated with persistence and graduation, for students with vision loss, additional accessibility challenges exist. This paper describes a pilot study that examined the…

Donepezil and flight simulator performance: effects on retention of complex skills.

PubMed

Yesavage, J A; Mumenthaler, M S; Taylor, J L; Friedman, L; O'Hara, R; Sheikh, J; Tinklenberg, J; Whitehouse, P J

2002-07-09

We report a randomized, double-blind, parallel group, placebo-controlled study to test the effects of the acetylcholinesterase inhibitor, donepezil (5 mg/d for 30 days), on aircraft pilot performance in 18 licensed pilots with mean age of 52 years. After 30 days of treatment, the donepezil group showed greater ability to retain the capacity to perform a set of complex simulator tasks than the placebo group, p < 0.05. Donepezil appears to have beneficial effects on retention of training on complex aviation tasks in nondemented older adults.

CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients.

PubMed

Kho, Michelle E; Molloy, Alexander J; Clarke, France; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J

2016-04-08

Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0-4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1-2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. NCT02377830; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

PubMed

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.

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

PubMed Central

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

2015-01-01

[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. PMID:26180348

Enhancing Digital Access to Learning Materials for Canadians with Perceptual Disabilities: A Pilot Study. Research Report

ERIC Educational Resources Information Center

Lockerby, Christina; Breau, Rachel; Zuvela, Biljana

2006-01-01

By exploring the experiences of participants with DAISY (Digital Accessible Information System) Talking Books, the study reported in this article not only discovered how people who are blind, visually impaired, and/or print-disabled read DAISY books, but also identified participants' perceptions of DAISY as being particularly useful in their…

Improving Emotional Face Perception in Autism with Diuretic Bumetanide: A Proof-of-Concept Behavioral and Functional Brain Imaging Pilot Study

ERIC Educational Resources Information Center

Hadjikhani, Nouchine; Zürcher, Nicole R; Rogier, Ophelie; Ruest, Torsten; Hippolyte, Loyse; Ben-Ari, Yehezkel; Lemonnier, Eric

2015-01-01

Clinical observations have shown that GABA-acting benzodiazepines exert paradoxical excitatory effects in autism, suggesting elevated intracellular chloride (Cl-)[subscript i] and excitatory action of GABA. In a previous double-blind randomized study, we have shown that the diuretic NKCC1 chloride importer antagonist bumetanide, that decreases…

Operational problems experienced by single pilots in instrument meteorological conditions

NASA Technical Reports Server (NTRS)

Weislogel, S.

1981-01-01

The development and implementation of a search strategy to extract pertinent reports from the Aviation Safety Reporting System-2 (ASRS-2) database are described. For any particular occurence to be pertinent to the study, it must have satisfied the following conditions: the aircraft must be of the type usually flown by a single pilot; operation on an IFR flight plan in instrument meteorological conditions; pilot experienced an operational problem. The occurances consist of reports by the pilot about his own performance, by the pilot about the system performance, or by an air traffic controller about a pilot's performance.

Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial.

PubMed

Sood, Amit; Sharma, Varun; Schroeder, Darrell R; Gorman, Brian

2014-01-01

To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted. Copyright © 2014. Published by Elsevier Inc.

Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study.

PubMed

Rogan, Slavko; Schmidtbleicher, Dietmar; Radlinger, Lorenz

2014-10-01

This pilot study examined the feasibility outcome recruitment, safety and compliance of the investigation for stochastic resonance whole-body vibration (SR-WBV) training. Another aim was to evaluate the effect size of one SR-WBV intervention session on Short Physical Performance Battery (SPPB), Expanded Timed Get Up-and-Go (ETGUG), isometric maximal voluntary contraction (IMVC) and rate of force development (IRFD) and chair rising (CR). Randomised double-blinded controlled cross-over pilot study. Feasibility outcomes included recruitment, safety and compliance. For secondary outcomes, SPPB, ETGUG, IMVC, IRFD and CR were measured before and 2-min after intervention. Nonparametric Rank-Order Tests of Puri and Sen L Statistics to Ranked Data were proposed. Wilcoxon signed-ranked tests were used to analyse the differences after SR-WBV intervention and sham intervention. Treatment effects between the interventions were compared by a Mann-Whitney U test. Among 24 eligible frail elderly, 12 agreed to participate and 3 drop out. The adherence was 15 of 24 intervention sessions. For secondary outcome, effect sizes (ES) for SR-WBV intervention on SPPB, ETGUG and CR were determined. This pilot study indicate that the training protocol used in this form for frail elderly individuals is feasible but with modification due to the fact that not all defined feasibility outcomes target was met. SR-WBV with 6 Hz, noise level 4 shows benefit improvements on SPPB (ES 0.52), ETGUG (part sit-to-stand movement: ES 0.81; total time: ES 0.85) and CR (ES 0.66). Further research is desired to determine whether a new adapted training protocol is necessary for SR-WBV in the "skilling up" phase in frail elderly individuals.

In-flight automatic detection of vigilance states using a single EEG channel.

PubMed

Sauvet, F; Bougard, C; Coroenne, M; Lely, L; Van Beers, P; Elbaz, M; Guillard, M; Leger, D; Chennaoui, M

2014-12-01

Sleepiness and fatigue can reach particularly high levels during long-haul overnight flights. Under these conditions, voluntary or even involuntary sleep periods may occur, increasing the risk of accidents. The aim of this study was to assess the performance of an in-flight automatic detection system of low-vigilance states using a single electroencephalogram channel. Fourteen healthy pilots voluntarily wore a miniaturized brain electrical activity recording device during long-haul flights ( 10 ±2.0 h, Atlantic 2 and Falcon 50 M, French naval aviation). No subject was disturbed by the equipment. Seven pilots experienced at least a period of voluntary ( 26.8 ±8.0 min, n = 4) or involuntary sleep (N1 sleep stage, 26.6 ±18.7 s, n = 7) during the flight. Automatic classification (wake/sleep) by the algorithm was made for 10-s epochs (O1-M2 or C3-M2 channel), based on comparison of means to detect changes in α, β, and θ relative power, or ratio [( α+θ)/β], or fuzzy logic fusion (α, β). Pertinence and prognostic of the algorithm were determined using epoch-by-epoch comparison with visual-scoring (two blinded readers, AASM rules). The best concordance between automatic detection and visual-scoring was observed within the O1-M2 channel, using the ratio [( α+θ )/β] ( 98.3 ±4.1% of good detection, K = 0.94 ±0.07, with a 0.04 ±0.04 false positive rate and a 0.87 ±0.10 true positive rate). Our results confirm the efficiency of a miniaturized single electroencephalographic channel recording device, associated with an automatic detection algorithm, in order to detect low-vigilance states during real flights.

Oligofructose promotes satiety in healthy human: a pilot study.

PubMed

Cani, P D; Joly, E; Horsmans, Y; Delzenne, N M

2006-05-01

The administration of a fermentable dietary fibre (oligofructose) in rats increases satietogenic gut peptides and lowered spontaneous energy intake. The aim of the study was to assess the relevance of those effects of oligofructose on satiety and energy intake in humans. Single-blinded, crossover, placebo-controlled design, pilot study. Volunteers included five men and five women aged 21-39 years, BMI ranging from 18.5 to 27.4 kg/m(2), were randomly assigned as described below. Subjects were included in two 2-week experimental phases during which they received either fibre (oligofructose (OFS)) or placebo (dextrine maltose (DM)); a 2-week washout period was included between crossover phases. In total, 8 g OFS or 8 g DM were ingested twice daily (16 g/day in total). Energy intake, hunger, satiety, fullness and prospective food consumption were assessed with analogue scales at the end of each experimental phase. During breakfast, OFS significantly increases the satiety (P=0.04) without any difference on other sensations as compared to DM treatment periods. After lunch, no significant differences are observed between treatment period. At dinner, OFS significantly increases satiety (P=0.04), reduces hunger (P=0.04) and prospective food consumption (P=0.05). The energy intake at breakfast and lunch are significantly lower (P=0.01, 0.03, respectively) after OFS treatment than after DM treatment. Total energy intake per day is 5% lower during OFS than in DM period. Oligofructose treatment increases satiety following breakfast and dinner, reduces hunger and prospective food consumption following dinner. This pilot study presents a rationale to propose oligofructose supplements in the management of food intake in overweight and obese patients.

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

PubMed

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.

Blue Laser Induced Retinal Injury in a Commercial Pilot at 1300 ft.

PubMed

Gosling, Daniel B; O'Hagan, John B; Quhill, Fahd M

2016-01-01

We report what may be the first evidence-based report of a retinal laser injury to a pilot during commercial flight from a laser device on the ground. Given the significant subjective (blind spot) and objective evidence of focal retinal damage, coupled with the distance involved, we suspect the laser had a radiant power of several watts, known to be injurious to the human retina. An airline pilot presented to our department complaining of a blind spot in the upper left area of his visual field in the right eye (right supero-nasal scotoma) following exposure to a laser beam while performing a landing maneuver of a commercial aircraft. At around 1300 ft (396 m), a blue laser beam from the ground directly entered his right eye, with immediate flash blindness and pain. Spectral domain ocular coherence tomography highlighted a localized area of photoreceptor disruption corresponding to a well demarcated area of hypofluorescence on fundus autofluorescence, representing a focal outer retinal laser injury. Fundus examination a fortnight later revealed a clinically identifiable lesion in the pilot's right eye commensurate with a retinal-laser burn. The case reports highlights the growing threat to the ocular health of airline crew and, potentially, passenger safety due to the lack of regulatory oversight of high powered laser devices obtained from the internet. We strongly believe high powered handheld laser devices should not be in the possession of the general public.

Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.

PubMed

Arnold, Lesley M; Arsenault, Pierre; Huffman, Cynthia; Patrick, Jeffrey L; Messig, Michael; Chew, Marci L; Sanin, Luis; Scavone, Joseph M; Pauer, Lynne; Clair, Andrew G

2014-10-01

Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design. This multicenter study included 6 week single-blind pregabalin CR treatment followed by 13 week double-blind treatment with placebo or pregabalin CR. The starting dose of 165 mg/day was escalated during the first 3 weeks, up to 495 mg/day based on efficacy and tolerability. Patients with ≥50% reduction in average daily pain score at the end of the single-blind phase were randomized to continue pregabalin CR at the optimized dose (330-495 mg/day) or to placebo. The primary endpoint was time to loss of therapeutic response (LTR), defined as <30% pain reduction relative to single-blind baseline or discontinuation owing to lack of efficacy or adverse event (AE). Secondary endpoints included measures of pain severity, global assessment, functional status, tiredness/fatigue, and sleep. ClinicalTrials.gov NCT01271933. A total of 441 patients entered the single-blind phase, and 63 were randomized to pregabalin CR and 58 to placebo. The median time to LTR (Kaplan-Meier analysis) was significantly longer in the pregabalin CR group than placebo (58 vs. 22 days, p = 0.02). By trial end, 34/63 (54.0%) pregabalin CR and 41/58 (70.7%) placebo patients experienced LTR. Significantly more patients reported 'benefit from treatment' (Benefit, Satisfaction, and Willingness to Continue Scale) in the pregabalin CR group; no other secondary endpoints were statistically significant. Most AEs were mild to moderate in severity (most frequent: dizziness, somnolence). The percentage of pregabalin CR patients discontinuing because of AEs was 12.2% and 4.8% in the single-blind and double-blind phases, respectively (placebo, 0%). Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response. Pregabalin CR was well tolerated in most patients. Generalizability may be limited by study duration and selective population.

Changes in co-contraction during stair descent after manual therapy protocol in knee osteoarthritis: A pilot, single-blind, randomized study.

PubMed

Cruz-Montecinos, Carlos; Flores-Cartes, Rodrigo; Montt-Rodriguez, Agustín; Pozo, Esteban; Besoaín-Saldaña, Alvaro; Horment-Lara, Giselle

2016-10-01

Manual therapy has shown clinical results in patients with knee osteoarthritis. However, the biomechanical aspects during functional tasks have not been explored in depth. Through surface electromyography, the medial and lateral co-contractions of the knee were measured while descending stairs, prior and posterior to applying a manual therapy protocol in the knee, with emphasis on techniques of joint mobilization and soft-tissue management. Sixteen females with slight or moderate knee osteoarthritis were recruited (eight experimental, eight control). It was observed that the lateral co-contraction index of the experimental group, posterior to intervention, increased by 11.7% (p = 0.014). The application of a manual therapy protocol with emphasis on techniques of joint mobilization and soft-tissue management modified lateral co-contraction, which would have a protective effect on the joint. Copyright © 2016 Elsevier Ltd. All rights reserved.

Single Agent Polysaccharopeptide Delays Metastases and Improves Survival in Naturally Occurring Hemangiosarcoma

PubMed Central

Brown, Dorothy Cimino; Reetz, Jennifer

2012-01-01

The 2008 World Health Organization World Cancer Report describes global cancer incidence soaring with many patients living in countries that lack resources for cancer control. Alternative treatment strategies that can reduce the global disease burden at manageable costs must be developed. Polysaccharopeptide (PSP) is the bioactive agent from the mushroom Coriolus versicolor. Studies indicate PSP has in vitro antitumor activities and inhibits the growth of induced tumors in animal models. Clear evidence of clinically relevant benefits of PSP in cancer patients, however, is lacking. The investment of resources required to complete large-scale, randomized controlled trials of PSP in cancer patients is more easily justified if antitumor and survival benefits are documented in a complex animal model of a naturally occurring cancer that parallels human disease. Because of its high metastatic rate and vascular origin, canine hemangiosarcoma is used for investigations in antimetastatic and antiangiogenic therapies. In this double-blind randomized multidose pilot study, high-dose PSP significantly delayed the progression of metastases and afforded the longest survival times reported in canine hemangiosarcoma. These data suggest that, for those cancer patients for whom advanced treatments are not accessible, PSP as a single agent might offer significant improvements in morbidity and mortality. PMID:22988473

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

PubMed

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.

An Assessment of Reduced Crew and Single Pilot Operations in Commercial Transport Aircraft Operations

NASA Technical Reports Server (NTRS)

Bailey, Randall E.; Kramer, Lynda J.; Kennedy, Kellie D.; Stephens, Chad L.; Etherington, Timothy J.

2017-01-01

Future reduced crew operations or even single pilot operations for commercial airline and on-demand mobility applications are an active area of research. These changes would reduce the human element and thus, threaten the precept that "a well-trained and well-qualified pilot is the critical center point of aircraft systems safety and an integral safety component of the entire commercial aviation system." NASA recently completed a pilot-in-the-loop high fidelity motion simulation study in partnership with the Federal Aviation Administration (FAA) attempting to quantify the pilot's contribution to flight safety during normal flight and in response to aircraft system failures. Crew complement was used as the experiment independent variable in a between-subjects design. These data show significant increases in workload for single pilot operations, compared to two-crew, with subjective assessments of safety and performance being significantly degraded as well. Nonetheless, in all cases, the pilots were able to overcome the failure mode effects in all crew configurations. These data reflect current-day flight deck equipage and help identify the technologies that may improve two-crew operations and/or possibly enable future reduced crew and/or single pilot operations.

Screening Students with Visual Impairments for Intellectual Giftedness: A Pilot Study

ERIC Educational Resources Information Center

Besnoy, Kevin D; Manning, Sandra; Karnes, Frances A.

2005-01-01

Children with visual impairments who are gifted may be one of the most underserved student populations in our educational system (Johnsen & Corn, 1989). A paucity of current research exists concerning appropriate practices for recognizing these students in publicly funded school settings. In 2004, the American Foundation for the Blind reported…

Olive Oil, Sunflower Oil or no Oil for Baby Dry Skin or Massage: A Pilot, Assessor-blinded, Randomized Controlled Trial (the Oil in Baby SkincaRE [OBSeRvE] Study).

PubMed

Cooke, Alison; Cork, Michael J; Victor, Suresh; Campbell, Malcolm; Danby, Simon; Chittock, John; Lavender, Tina

2016-03-01

Topical oils on baby skin may contribute to development of childhood atopic eczema. A pilot, assessor-blinded, randomized controlled trial assessed feasibility of a definitive trial investigating their impact in neonates. One-hundred and fifteen healthy, full-term neonates were randomly assigned to olive oil, sunflower oil or no oil, twice daily for 4 weeks, stratified by family history of atopic eczema. We measured spectral profile of lipid lamellae, trans-epidermal water loss (TEWL), stratum corneum hydration and pH and recorded clinical observations, at baseline, and 4 weeks post-birth. Recruitment was challenging (recruitment 11.1%; retention 80%), protocol adherence reasonable (79-100%). Both oil groups had significantly improved hydration but significantly less improvement in lipid lamellae structure compared to the no oil group. There were no significant differences in TEWL, pH or erythema/skin scores. The study was not powered for clinical significance, but until further research is conducted, caution should be exercised when recommending oils for neonatal skin.

A randomized, single-blind cross-over design evaluating the effectiveness of an individually defined, targeted physical therapy approach in treatment of children with cerebral palsy.

PubMed

Franki, Inge; Van den Broeck, Christine; De Cat, Josse; Tijhuis, Wieke; Molenaers, Guy; Vanderstraeten, Guy; Desloovere, Kaat

2014-10-01

A pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program. A randomized, single-blind cross-over design. Ten ambulant children with bilateral spastic cerebral palsy, age four to nine years. Participants were randomly assigned into a ten-week individually defined, targeted or a general program, followed by a cross-over. Evaluation was performed using the Gross Motor Function Measure-88 and three-dimensional gait analysis. General outcome parameters were Gross Motor Function Measure-88 scores, time and distance parameters, gait profile score and movement analysis profiles. Individual goal achievement was evaluated using z-scores for gait parameters and Goal Attainment Scale for gross motor function. No significant changes were observed regarding gross motor function. Only after individualized therapy, step- and stride-length increased significantly (p = 0.022; p = 0.017). Change in step-length was higher after the individualized program (p = 0.045). Within-group effects were found for the pelvis in transversal plane after the individualized program (p = 0.047) and in coronal plane after the general program (p = 0.047). Between-program differences were found for changes in the knee in sagittal plane, in the advantage of the individual program (p = 0.047). A median difference in z-score of 0.279 and 0.419 was measured after the general and individualized program, respectively. Functional goal attainment was higher after the individual therapy program compared with the general program (48 to 43.5). The results indicate slightly favorable effects towards the individualized program. To detect clinically significant changes, future studies require a minimal sample size of 72 to 90 participants. © The Author(s) 2014.

Pilot double-blinded study to assess efficacy and tolerability of morphine sulphate oral solution (Oramorph®) given preoperatively as add-on therapy within a multimodal postoperative pain approach in patients undergoing laparoscopic cholecystectomy.

PubMed

Fanelli, A; Ghisi, D; Pergolotti, B; Martinotti, M; Fanelli, G; Danelli, G

2014-01-01

This study aims at investigating the effect of a single pre-operative oral administration of morphine sulphate (Oramorph®) on pain after laparoscopic cholecystectomy (LC). Forty-one ASA I-III patients, aged 18-65 years, undergoing LC were randomly, double-blindly allocated to treatment (N.=20, 30mg Oramorph®, group M) or placebo (N.=21, group P). General anesthesia was maintained with propofol and remifentanil. All patients received ketamine 0.2 mg/kg iv at induction, intraoperative ketorolac 30mg iv and tramadol postoperatively (iv PCA: bolus 50 mg, lock-out 30 min, max 100 mg/4 hours). Numerical rating scale for pain (NRS), White's fast track and PADSS scores, tramadol consumption and adverse events were recorded for the first 24h. All patients underwent State Trait Anxiety Inventory (STAI) and Mini Mental State Examination (MMSE). Anthropometric characteristics, MMSE, STAI, ASA status, NRS rest, White's and PADDS scores, PONV incidence were similar. Group M showed significantly lower NRS on movement during the first 3 hours after awakening. Cumulative tramadol consumption was lower in group M than in group P (185±142 mg versus 263±199 mg, P=0.199). Within a multimodal approach, a single preoperative oral administration of 30 mg of morphine sulphate in patients undergoing LC did not improve pain at rest, but improved NRS on movement during the first 3 hours after awakening. Group P required a higher mean dose of tramadol compared to Group M, although not significantly. The safety profile of Oramorph® allowed fast extubation and awakening times as well as prompt home discharge within 6 hours from surgery.

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.

PubMed

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 use disorder. © 2017 Society for the Study of Addiction.

Morphologic changes in the placentas of HIV-positive women and their association with degree of immune suppression.

PubMed

Vermaak, Anine; Theron, Gerhard B; Schubert, Pawel T; Kidd, Martin; Rabie, Ursula; Adjiba, Benedict M; Wright, Colleen A

2012-12-01

To provide baseline information regarding a possible association between specific histopathologic features of the placentas of HIV-positive women and the degree of immune suppression. A prospective single-blinded laboratory-based pilot study was conducted at Tygerberg Hospital, South Africa. The macroscopic and microscopic features of placentas from HIV-positive (n=91) and HIV-negative women (n=89) were compared and recorded using a standard template. Investigators were blinded to the participants' HIV status and CD4-positive cell count. Placentas from the HIV-positive group were characterized by decreased weight and increased number of marginal infarcts relative to the HIV-negative group. The most important microscopic finding was the increased presence of villitis of unknown etiology (VUE) among the group of untreated HIV-positive women with CD4 cell counts of 200 cells/mm(3) or below. Both macroscopic and microscopic differences relating to the degree of immune suppression were identified, which seemingly contradicts previous reports. Larger studies are warranted to define the function of antiretroviral therapy and VUE in the mechanism of mother-to-fetus transmission of HIV. Furthermore, the potential role of VUE in the pathophysiology of the compromised immune response observed among HIV-exposed but uninfected infants should be investigated. Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Advanced helicopter cockpit and control configurations for helicopter combat missions

NASA Technical Reports Server (NTRS)

Haworth, Loran A.; Atencio, Adolph, Jr.; Bivens, Courtland; Shively, Robert; Delgado, Daniel

1987-01-01

Two piloted simulations were conducted by the U.S. Army Aeroflightdynamics Directorate to evaluate workload and helicopter-handling qualities requirements for single pilot operation in a combat Nap-of-the-Earth environment. The single-pilot advanced cockpit engineering simulation (SPACES) investigations were performed on the NASA Ames Vertical Motion Simulator, using the Advanced Digital Optical Control System control laws and an advanced concepts glass cockpit. The first simulation (SPACES I) compared single pilot to dual crewmember operation for the same flight tasks to determine differences between dual and single ratings, and to discover which control laws enabled adequate single-pilot helicopter operation. The SPACES II simulation concentrated on single-pilot operations and use of control laws thought to be viable candidates for single pilot operations workload. Measures detected significant differences between single-pilot task segments. Control system configurations were task dependent, demonstrating a need for inflight reconfigurable control system to match the optimal control system with the required task.

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.

PubMed

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 P<.001; G2 P=.001; G3 P=.003), and WHODAS 2.0 (G1 P=.018; G2 P=.019; G3 P=.041). Only G3 improved gait speed in 10MWT (P=.11). G1 (P=.014) and G3 (P=.004) improved quality of life. No difference was found between groups. Eight weeks of exergaming can improve the walking capacity of elderly patients with PD. Exergame training 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.

Modafinil for Clozapine-Treated Schizophrenia Patients: A Double-Blind, Placebo-Controlled Pilot Trial

PubMed Central

Freudenreich, Oliver; Henderson, David C.; Macklin, Eric A.; Evins, A. Eden; Fan, Xiaoduo; Cather, Cori; Walsh, Jared P.; Goff, Donald C.

2016-01-01

Background Patients with schizophrenia often suffer from cognitive deficits and negative symptoms that are poorly responsive to antipsychotics including clozapine. Clozapine-induced sedation can worsen cognition and impair social and occupational functioning. Objectives To evaluate the efficacy, tolerability, and safety of modafinil for negative symptoms, cognition, and wakefulness/fatigue in DSM-IV–diagnosed schizophrenia patients treated with clozapine. Method A double-blind, placebo-controlled, flexible-dosed 8-week pilot trial was conducted between September 2003 and September 2007, adding modafinil up to 300 mg/d to stabilized schizophrenia outpatients receiving clozapine. Psychopathology, cognition, and wakefulness/fatigue were assessed with standard rating scales. Results Thirty-five patients were randomly assigned to treatment with study drug and included in the analysis. Modafinil did not reduce negative symptoms or wakefulness/fatigue or improve cognition compared to placebo. Modafinil was well tolerated and did not worsen psychosis. Conclusions Results of this pilot trial do not support routine use of modafinil to treat negative symptoms, cognitive deficits, or wakefulness/fatigue in patients on clozapine. However, given our limited power to detect a treatment effect and the clear possibility of a type II error, larger trials are needed to resolve or refute a potential therapeutic effect of uncertain magnitude. Trial Registration clinicaltrials.gov Identifier: NCT00573417 PMID:19689921

Viewing videotaped identification procedure increases juror sensitivity to single-blind photo-array administration.

PubMed

Modjadidi, Karima; Kovera, Margaret Bull

2018-06-01

We investigated whether watching a videotaped photo array administration or expert testimony could sensitize jurors to the suggestiveness of single-blind eyewitness identification procedures. Mock jurors recruited from the community (N = 231) watched a videotaped simulation of a robbery trial in which the primary evidence against the defendant was an eyewitness identification. We varied whether the witness made an identification from a single- or double-blind photo array, the evidence included a videotape of the photo array procedure, and an expert testified about the effects of single-blind identification procedures on administrators' behaviors and witness accuracy. Watching the videotaped photo array administration sensitized mock jurors to the suggestiveness of the single-blind procedure, causing them to be less likely to convict a defendant identified through single-rather than double-blind procedures. Exposure to the videotaped procedure also decreased the favorability of mock jurors' ratings of the eyewitness, irrespective of whether the lineup was conducted by a single-blind administrator. Expert testimony did not sensitize jurors to administrator bias. Thus, videotaping identification procedures could serve as an important procedural reform that both preserves a record of whether the lineup administration was suggestive and might improve jurors' evaluations of eyewitness evidence. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The efficacy of choline magnesium trisalicylate (CMT) in the management of metastatic bone pain: a pilot study.

PubMed

Johnson, J R; Miller, A J

1994-01-01

Twenty-six patients with painful, bony metastases were recruited into a randomized, double-blind, single dose, two-treatment, three-part crossover study of choline magnesium trisalicylate (CMT) and placebo. Assessments were made prior to and at one, two, three and four hours after dosing. Bone pain caused by metastatic cancer was significantly relieved one hour after the administration of 1500 mg CMT (p = 0.04). At all four time points the pain was less than baseline with CMT and at three time points greater than baseline with placebo but these results did not reach statistical significance. The summed pain intensity difference for patients was greater with CMT than with placebo, but this also did not reach significance. The incidence of volunteered side-effects was similar for both treatments. The results suggest that a nonacetylating, nonsteroidal anti-inflammatory drug may have a role complementary to that of an opioid in the management of metastatic bone pain.

The influence of an auditory-memory attention-demanding task on postural control in blind persons.

PubMed

Melzer, Itshak; Damry, Elad; Landau, Anat; Yagev, Ronit

2011-05-01

In order to evaluate the effect of an auditory-memory attention-demanding task on balance control, nine blind adults were compared to nine age-gender-matched sighted controls. This issue is particularly relevant for the blind population in which functional assessment of postural control has to be revealed through "real life" motor and cognitive function. The study aimed to explore whether an auditory-memory attention-demanding cognitive task would influence postural control in blind persons and compare this with blindfolded sighted persons. Subjects were instructed to minimize body sway during narrow base upright standing on a single force platform under two conditions: 1) standing still (single task); 2) as in 1) while performing an auditory-memory attention-demanding cognitive task (dual task). Subjects in both groups were required to stand blindfolded with their eyes closed. Center of Pressure displacement data were collected and analyzed using summary statistics and stabilogram-diffusion analysis. Blind and sighted subjects had similar postural sway in eyes closed condition. However, for dual compared to single task, sighted subjects show significant decrease in postural sway while blind subjects did not. The auditory-memory attention-demanding cognitive task had no interference effect on balance control on blind subjects. It seems that sighted individuals used auditory cues to compensate for momentary loss of vision, whereas blind subjects did not. This may suggest that blind and sighted people use different sensorimotor strategies to achieve stability. Copyright © 2010 Elsevier Ltd. All rights reserved.

Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

PubMed

Stoller, Oliver; de Bruin, Eling D; Schuster-Amft, Corina; Schindelholz, Matthias; de Bie, Rob A; Hunt, Kenneth J

2013-09-22

After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke. This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained. Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events. This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

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

PubMed

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.

Intrauterine instillation of diluted seminal plasma at oocyte pick-up does not increase the IVF pregnancy rate: a double-blind, placebo controlled, randomized study.

PubMed

von Wolff, M; Rösner, S; Germeyer, A; Jauckus, J; Griesinger, G; Strowitzki, T

2013-12-01

Does intrauterine application of diluted seminal plasma (SP) at the time of ovum pick-up improve the pregnancy rate by ≥14% in IVF treatment? Intrauterine instillation of diluted SP at the time of ovum pick-up is unlikely to increase the pregnancy rate by ≥14% in IVF. SP modulates endometrial function, and sexual intercourse around the time of embryo transfer has been suggested to increase the likelihood of pregnancy. A previous randomized double-blind pilot study demonstrated a strong trend towards increased pregnancy rates following the intracervical application of undiluted SP. As this study was not conclusive and as the finding could have been confounded by sexual intercourse, the intrauterine application of diluted SP was investigated in the present trial. A single-centre, prospective, double-blind, placebo-controlled, randomized, superiority trial on women undergoing IVF was conducted from April 2007 until February 2012 at the University Department of Gynaecological Endocrinology and Reproductive Medicine, Heidelberg, Germany. The study was powered to detect an 14% increase in the clinical pregnancy rate and two sequential tests were planned using the Pocock spending function. At the first interim analysis, 279 women had been randomly assigned to intrauterine diluted SP (20% SP in saline from the patients' partner) (n = 138) or placebo (n = 141) at the time of ovum pick-up. The clinical pregnancy rate per randomized patient was 37/138 (26.8%) in the SP group and 41/141 (29.1%) in the placebo group (difference: -2.3%, 95% confidence interval of the difference: -12.7 to +8.2%; P = 0.69). The live birth rate per randomized patient was 28/138 (20.3%) in the SP group and 33/141 (23.4%) in the placebo group (difference: -3.1%, 95% confidence interval of the difference: -12.7 to +6.6%; P = 0.56). It was decided to terminate the trial due to futility at the first interim analysis, at a conditional power of 62%. The confidence interval of the difference remains wide, thus clinically relevant differences cannot reliably be excluded based on this single study. The results of this study cast doubt on the validity of the concept that SP increases endometrial receptivity and thus implantation in humans. Funding was provided by the department's own research facilities. DRKS00004615.

A randomized, double-blind pilot study of dexmedetomidine versus midazolam for intensive care unit sedation: patient recall of their experiences and short-term psychological outcomes.

PubMed

MacLaren, Robert; Preslaski, Candice R; Mueller, Scott W; Kiser, Tyree H; Fish, Douglas N; Lavelle, James C; Malkoski, Stephen P

2015-03-01

Sedation with dexmedetomidine may facilitate ventilator liberation and limit the occurrence of delirium. No trial has assessed patient recall or the development of psychological outcomes after dexmedetomidine sedation. This pilot study evaluated whether transitioning benzodiazepine sedation to dexmedetomidine alters patient recall and the incidence of anxiety, depression, or acute stress disorder (ASD). This investigation was a randomized, double-blind, single-center study. Existing continuous benzodiazepine sedation was converted to dexmedetomidine or midazolam when patients qualified for daily awakenings. Sedation was titrated to achieve Riker sedation agitation scores of 3 to 4. The intensive care unit (ICU) Stressful Experiences Questionnaire, hospital anxiety and depression scale, and the impact of event scale-revised were administered before hospital discharge to assess recall, anxiety, depression, and manifestations of ASD. A total of 11 patients received dexmedetomidine, and 12 patients received midazolam. Median dosing was 0.61 µg/kg/h for 3.5 days for dexmedetomidine and 3.7 mg/h for 3 days for midazolam. Attainment of goal sedation and analgesia was similar; however, more dexmedetomidine patients experienced agitation and pain. The median duration of mechanical ventilation from study drug initiation to extubation was 3.4 days in dexmedetomidine patients and 2.9 days in midazolam patients. Dexmedetomidine patients remembered 18.5 experiences compared with 8.5 in midazolam patients (P = .015). Rates of anxiety and depression were similar. In all, 5 (62.5%) dexmedetomidine patients and 1 (12.5%) midazolam patient manifested ASD (P = .063), and 1 dexmedetomidine patient and 5 midazolam patients developed new-onset delirium (P = .07). Hypotension occurred in 10 (90.9%) dexmedotomidine patients and 6 (50%) midazolam patients (P = .069). Transitioning benzodiazepine sedation to dexmedetomidine when patients qualify for daily awakenings may reduce the development of delirium and facilitate remembrance of ICU experiences but may lead to manifestations of ASD. Monitoring hypotension is required for both the sedatives. Additional comparative studies focusing on the long-term impact of ICU recall and psychological outcomes are needed. © The Author(s) 2013.

First "glass" education: telementored cardiac ultrasonography using Google Glass- a pilot study.

PubMed

Russell, Patrick M; Mallin, Michael; Youngquist, Scott T; Cotton, Jennifer; Aboul-Hosn, Nael; Dawson, Matt

2014-11-01

The objective of this study was to determine the feasibility of telementored instruction in bedside ultrasonography (US) using Google Glass. The authors sought to examine whether first-time US users could obtain adequate parasternal long axis (PSLA) views to approximate ejection fraction (EF) using Google Glass telementoring. This was a prospective, randomized, single-blinded study. Eighteen second-year medical students were randomized into three groups and tasked with obtaining PSLA cardiac imaging. Group A received real-time telementored education through Google Glass via Google Hangout from a remotely located expert. Group B received bedside education from the same expert. Group C represented the control and received no instruction. Each subject was given 3 minutes to obtain a best PSLA cardiac imaging using a portable GE Vscan. Image clips obtained by each subject were stored. A second expert, blinded to instructional mode, evaluated images for adequacy and assigned an image quality rating on a 0 to 10 scale. Group A was able to obtain adequate images six out of six times (100%) with a median image quality rating of 7.5 (interquartile range [IQR] = 6 to 10) out of 10. Group B was also able to obtain adequate views six out of six times (100%), with a median image quality rating of 8 (IQR = 7 to 9). Group C was able to obtain adequate views one out of six times (17%), with a median image quality of 0 (IQR = 0 to 2). There were no statistically significant differences between Group A and Group B in the achievement of adequate images for E-point septal separation measurement or in image quality. In this pilot/feasibility study, novice US users were able to obtain adequate imaging to determine a healthy patient's EF through telementored education using Google Glass. These preliminary data suggest telementoring as an adequate means of medical education in bedside US. This conclusion will need to be validated with larger, more powerful studies including evaluation of pathologic findings and varying body habitus among models. © 2014 by the Society for Academic Emergency Medicine.

Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

PubMed

Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

2017-09-01

To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

Effect of low-impact aerobic exercise combined with music therapy on patients with fibromyalgia. A pilot study.

PubMed

Espí-López, Gemma V; Inglés, Marta; Ruescas-Nicolau, María-Arántzazu; Moreno-Segura, Noemí

2016-10-01

Fibromyalgia is a pathological entity characterized by chronic widespread musculoskeletal pain and the presence of "tender points". It constitutes a significant health problem because of its prevalence and economic impact. The aim of the present study was to determine the therapeutic benefits of low impact aerobic exercise alone or in combination with music therapy in patients with fibromyalgia. A single-blind randomized controlled pilot trial was performed. Thirty-five individuals with fibromyalgia were divided into three groups: (G1) therapeutic aerobic exercise with music therapy (n=13); (G2) therapeutic aerobic exercise at any rhythm (n=13) and (CG) control (n=9). The intervention period lasted eight weeks. Depression, quality of life, general discomfort and balance were assessed before and after intervention. At post-intervention, group G1 improved in all variables (depression (p=0.002), quality of life (p=0.017), general discomfort (p=0.001), and balance (p=0.000)), while group G2 improved in general discomfort (p=0.002). The change observed in balance was statistically different between groups (p=0.01). Therapeutic aerobic exercise is effective in improving depression and general discomfort in individuals with fibromyalgia. However, effectiveness is higher when combined with music therapy, which brings about further improvements in quality of life and balance. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Efficacy of Arnica in varicose vein surgery: results of a randomized, double-blind, placebo-controlled pilot study].

PubMed

Wolf, M; Tamaschke, C; Mayer, W; Heger, M

2003-10-01

In homeopathy ARNICA is widely used as a woundhealing medication and for the treatment of hematomas. In this pilot study the efficacy and safety of ARNICA D12 in patients following varicose vein surgery were investigated. Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines. The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch. After randomized allocation, 60 patients received either ARNICA D12 or placebo. Start of medication occurred the evening before operation with 5 globules. On the operation day one preoperative and hourly postoperative dosages after awakening were given. On days 2-14 of the study 5 globules 3 times a day were given. OUTCOME CRITERIA: Surface (in cm(2) and using a three-point verbal rating scale) and intensity of hematomas induced by operation, complications of wound healing, and intensity of pain (five-point verbal rating scale) as well as efficacy and safety of the study medication were assessed. Hematoma surface was reduced (from day 7 to day 14) under ARNICA by 75.5% and under placebo by 71.5% (p = 0.4726). The comparison of hematoma surface (small, medium, large) using the verbal rating scale yielded a value of p = 0.1260. Pain score decreased by 1.0 +/- 2.2 points under ARNICA and 0.3 +/- 0.8 points under placebo (p = 0.1977). Remission or improvement of pain was observed in 43.3% of patients in the ARNICA group and in 27.6% of patients in the placebo group. Tolerability was rated as very good in all cases. The results of this pilot study showed a trend towards a beneficial effect of ARNICA D12 with regard to reduction of hematoma and pain during the postoperative course. For a statistically significant proof of efficacy of ARNICA D12 in patients following varicose vein surgery a larger sample size is necessary. Copyright 2003 S. Karger GmbH, Freiburg

Uncontracted or Contracted Braille for Emergent Readers: A Pilot Study

ERIC Educational Resources Information Center

Farnsworth, Charles, Jr.

2007-01-01

To determine the attitudes of teachers of students who are visually impaired or blind about the use of contracted or uncontracted Braille for emergent readers, the author posted a questionnaire on three electronic listservs from October through December 2002 and received responses from 40 teachers in India, Canada, the West Indies, and the United…

Establishing Mobility Measures to Assess the Effectiveness of Night Vision Devices: Results of a Pilot Study

ERIC Educational Resources Information Center

Zebehazy, Kim T.; Zimmerman, George J.; Bowers, Alex R.; Luo, Gang; Peli, Eli

2005-01-01

In addition to their restricted peripheral fields, persons with retinitis pigmentosa (RP) report significant problems seeing in low levels of illumination, which causes difficulty with night travel. Several devices have been developed to support the visual needs of persons who have night blindness. These devices include wide-angle flashlights,…

A Pilot Controlled Trial of Topiramate for Mania in Children and Adolescents with Bipolar Disorder.

ERIC Educational Resources Information Center

DelBello, Melissa P.; Findling, Robert L.; Kushner, Stuart; Wang, Daniel; Olson, William H.; Capece, Julie A.; Fazzio, Lydia; Rosenthal, Norman R.

2005-01-01

Objective: To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type 1. Method: This double-blind, placebo-controlled study was discontinued early when adult mania trials with topiramate failed to show efficacy. Efficacy end points included the Young Mania Rating Scale (YMRS), Brief…

Effects of Maternal Stimulant Medication on Observed Parenting in Mother-Child Dyads with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Chronis-Tuscano, Andrea; Rooney, Mary; Seymour, Karen E.; Lavin, Heather Jones; Pian, Jessica; Robb, Adelaide; Efron, Lisa; Conlon, Charles; Stein, Mark A.

2010-01-01

This pilot study of 23 mothers with attention-deficit/hyperactivity disorder (ADHD) and their offspring with ADHD examined the effects of maternal stimulant medication on observed interactions. Parent-child interactions were observed using a structured protocol before and after mothers underwent a 5-week, double-blind stimulant titration. Despite…

Food Additives and Hyperkinesis: A Controlled Double-Blind Experiment. (Includes NIE Staff Critique).

ERIC Educational Resources Information Center

Conners, C. Keith; And Others

Fifteen hyperkinetic children (6-12 years old) were involved in a pilot study to test B. Feingold's hypothesis that hyperkinesis may be caused by artificial flavors and colors in food. Prior to treatment, parents and teachers completed bi-weekly questionnaires regarding each Ss' behavior both on medication (pretreatment period) and when medication…

Treatment of Palmar Plantar Erythrodysesthesia (PPE) with Topical Sildenafil: A Pilot Study

PubMed Central

Meadows, Kellen L.; Rushing, Christel; Honeycutt, Wanda; Latta, Kenneth; Howard, Leigh; Arrowood, Christy A.; Niedzwiecki, Donna; Hurwitz, Herbert I.

2016-01-01

Purpose Palmar-plantar erythrodysethesia (PPE) is a common chemotherapy and anti-VEGF multi-kinase inhibitor class-related toxicity that often results in debilitating skin changes and often limits the use of active anti-cancer regimens. Mechanistic and anecdotal clinical evidence suggested that topical application of sildenafil cream may help reduce the severity of PPE. Therefore, we conducted a randomized, double-blind, placebo-controlled pilot study to evaluate the feasibility, safety and efficacy of topical sildenafil cream for the treatment of PPE. Methods Eligible subjects were required to have grade 1–3 PPE associated with either capecitabine or sunitinib. Subjects were randomized to receive 1% topical sildenafil cream to the left extremities or right extremities and placebo cream on the opposite extremity. 0.5 mL of cream was applied to each affected hand/foot two times per day. The primary endpoint was improvement in PPE grading at any point on study. Clinical assessments were evaluated by NCI-CTC 4.0 grading and patient self-reported pain. Results Ten subjects were enrolled; 9 were evaluable for safety and efficacy. Five of nine subjects reported some improvement in foot pain and 3 of 8 subjects for hand pain improvement. One of these subjects noted specific improvement in tactile function. No treatment-related toxicities were observed. Conclusions In this limited, single center study, topical cream containing 1% sildenafil is feasible to administer, is well-tolerated, and may mitigate PPE-related symptoms due to anti-cancer therapeutic agents. Further validation is necessary. PMID:25341548

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

PubMed

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

2016-05-01

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

A Pilot Study of Pedestrians with Visual Impairments Detecting Traffic Gaps and Surges Containing Hybrid Vehicles

PubMed Central

Emerson, Robert Wall; Naghshineh, Koorosh; Hapeman, Julie; Wiener, William

2010-01-01

The increasing number of hybrid and quiet internal combustion engine vehicles may impact the travel abilities of pedestrians who are blind. Pedestrians who rely on auditory cues for structuring their travel may face challenges in making crossing decisions in the presence of quiet vehicles. This article describes results of initial studies looking at the crossing decisions of pedestrians who are blind at an uncontrolled crossing (no traffic control) and a light controlled intersection. The presence of hybrid vehicles was a factor in each situation. At the uncontrolled crossing, Toyota hybrids were most difficult to detect but crossing decisions were made more often in small gaps ended by a Honda hybrid. These effects were seen only at speed under 20 mph. At the light controlled intersection, parallel surges of traffic were most difficult to detect when made up only of a Ford Escape hybrid. Results suggest that more controlled studies of vehicle characteristics impacting crossing decisions of pedestrians who are blind are warranted. PMID:21379367

A Pilot Study of Pedestrians with Visual Impairments Detecting Traffic Gaps and Surges Containing Hybrid Vehicles.

PubMed

Emerson, Robert Wall; Naghshineh, Koorosh; Hapeman, Julie; Wiener, William

2011-03-01

The increasing number of hybrid and quiet internal combustion engine vehicles may impact the travel abilities of pedestrians who are blind. Pedestrians who rely on auditory cues for structuring their travel may face challenges in making crossing decisions in the presence of quiet vehicles. This article describes results of initial studies looking at the crossing decisions of pedestrians who are blind at an uncontrolled crossing (no traffic control) and a light controlled intersection. The presence of hybrid vehicles was a factor in each situation. At the uncontrolled crossing, Toyota hybrids were most difficult to detect but crossing decisions were made more often in small gaps ended by a Honda hybrid. These effects were seen only at speed under 20 mph. At the light controlled intersection, parallel surges of traffic were most difficult to detect when made up only of a Ford Escape hybrid. Results suggest that more controlled studies of vehicle characteristics impacting crossing decisions of pedestrians who are blind are warranted.

Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study

PubMed Central

2013-01-01

Introduction We sought to investigate whether the use of balanced solutions reduces the incidence of hyperchloraemic acidosis without increasing the risk for intracranial hypertension in patients with severe brain injury. Methods We conducted a single-centre, two-arm, randomised, double-blind, pilot controlled trial in Nantes, France. Patients with severe traumatic brain injury (Glasgow Coma Scale score ≤8) or subarachnoid haemorrhage (World Federation of Neurosurgical Society grade III or higher) who were mechanically ventilated were randomised within the first 12 hours after brain injury to receive either isotonic balanced solutions (crystalloid and hydroxyethyl starch; balanced group) or isotonic sodium chloride solutions (crystalloid and hydroxyethyl starch; saline group) for 48 hours. The primary endpoint was the occurrence of hyperchloraemic metabolic acidosis within 48 hours. Results Forty-two patients were included, of whom one patient in each group was excluded (one consent withdrawn and one use of forbidden therapy). Nineteen patients (95%) in the saline group and thirteen (65%) in the balanced group presented with hyperchloraemic acidosis within the first 48 hours (hazard ratio = 0.28, 95% confidence interval [CI] = 0.11 to 0.70; P = 0.006). In the saline group, pH (P = .004) and strong ion deficit (P = 0.047) were lower and chloraemia was higher (P = 0.002) than in the balanced group. Intracranial pressure was not different between the study groups (mean difference 4 mmHg [-1;8]; P = 0.088). Seven patients (35%) in the saline group and eight (40%) in the balanced group developed intracranial hypertension (P = 0.744). Three patients (14%) in the saline group and five (25%) in the balanced group died (P = 0.387). Conclusions This study provides evidence that balanced solutions reduce the incidence of hyperchloraemic acidosis in brain-injured patients compared to saline solutions. Even if the study was not powered sufficiently for this endpoint, intracranial pressure did not appear different between groups. Trial registration EudraCT 2008-004153-15 and NCT00847977 The work in this trial was performed at Nantes University Hospital in Nantes, France. PMID:23601796

Single pilot scanning behavior in simulated instrument flight

NASA Technical Reports Server (NTRS)

Pennington, J. E.

1979-01-01

A simulation of tasks associated with single pilot general aviation flight under instrument flight rules was conducted as a baseline for future research studies on advanced flight controls and avionics. The tasks, ranging from simple climbs and turns to an instrument landing systems approach, were flown on a fixed base simulator. During the simulation the control inputs, state variables, and the pilots visual scan pattern including point of regard were measured and recorded.

What we know now: the Evanston Illinois field lineups.

PubMed

Steblay, Nancy K

2011-02-01

A Freedom of Information Act lawsuit secured 100 eyewitness identification reports from Evanston, Illinois, one of three cities of the Illinois Pilot Program. The files provide empirical evidence regarding three methodological aspects of the Program's comparison of non-blind simultaneous to double-blind sequential lineups. (1) A-priori differences existed between lineup conditions. For example, the simultaneous non-blind lineup condition was more likely to involve witnesses who had already identified the suspect in a previous lineup or who knew the offender (non-stranger identifications), and this condition also entailed shorter delays between event and lineup. (2) Verbatim eyewitness comments were recorded more often in double-blind sequential than in non-blind simultaneous lineup reports (83% vs. 39%). (3) Effective lineup structure was used equally in the two lineup conditions.

Effect of single-dose low-level helium-neon laser irradiation on orthodontic pain: a split-mouth single-blind placebo-controlled randomized clinical trial.

PubMed

Sobouti, Farhad; Khatami, Maziar; Chiniforush, Nasim; Rakhshan, Vahid; Shariati, Mahsa

2015-01-01

Pain is the most common complication of orthodontic treatment. Low-level laser therapy (LLLT) has been suggested as a new analgesic treatment free of the adverse effects of analgesic medications. However, it is not studied thoroughly, and the available studies are quite controversial. Moreover, helium neon (He-Ne) laser has not been assessed before. This split-mouth placebo-controlled randomized clinical trial was performed on 16 male and 14 female orthodontic patients requiring bilateral upper canine retraction. The study was performed at a private clinic in Sari, Iran, in 2014. It was single blind: patients, orthodontist, and personnel were blinded of the allocations, but the laser operator (periodontist) was not blinded. Once canine retractor was activated, a randomly selected maxillary quarter received a single dose of He-Ne laser irradiation (632.8 nm, 10 mw, 6 j/cm(2) density). The other quarter served as the placebo side, treated by the same device but powered off. In the first, second, fourth, and seventh days, blinded patients rated their pain sensed on each side at home using visual analog scale (VAS) questionnaires. There was no harm identified during or after the study. Pain changes were analyzed using two- and one-way repeated-measures ANOVA, Bonferroni, and t-test (α = 0.01, β > 0.99). This trial was not registered. It was self-funded by the authors. Sixteen males and 11 females remained in the study (aged 12-21). Average pain scores sensed in all 4 intervals on control and laser sides were 4.06 ± 2.85 and 2.35 ± 1.77, respectively (t-test P < 0.0001). One-way ANOVA showed significant pain declines over time, in each group (P < 0.0001). Two-way ANOVA showed significant effects for LLLT (P < 0.0001) and time (P = <0.0001). Single-dose He-Ne laser therapy might reduce orthodontic pain caused by retracting maxillary canines.

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

PubMed

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.

Use of oral trazodone for sedation in cats: a pilot study.

PubMed

Orlando, Jillian M; Case, Beth C; Thomson, Andrea E; Griffith, Emily; Sherman, Barbara L

2016-06-01

Resistance to transportation and stressful veterinary visits are major causes for a decrease in feline veterinary care. Few options exist for oral sedatives to reduce cats' anxiety prior to veterinary visits. The purpose of this study was to evaluate the safety and efficacy of oral trazodone for use as a single dose agent for sedation in cats. Six laboratory cats were given single 50, 75 and 100 mg doses of trazodone and placebo. Trazodone 100 mg and placebo treatments were randomized. Pre- and post-study laboratory values and physical examinations were compared. During each 4 h period post-treatment, sedation was measured via accelerometers and video observations scored by an observer blinded to treatment. Examinations were performed on the cats 90 mins after treatment, and their behavioral responses scored by the same blinded observer. No adverse effects or changes in physical examinations or laboratory values were detected as a result of trazodone administration. Accelerometer data showed trazodone 50, 75 and 100 mg caused sedation as measured by activity reduction (83%, 46% and 66%, respectively). In contrast, there was a 14% activity increase after placebo. There was a significant reduction in video observation scores when cats were given trazodone 100 mg compared with placebo. Mean latency to peak sedation for trazodone 100 mg occurred at 2 h. Scores for behavioral response to examination, performed at 90 mins post-treatment, were not significantly different between cats receiving trazodone 100 mg and placebo. Trazodone was well tolerated in this population of cats and caused appreciable sedation at all doses. Behavior during examination was not significantly different when cats received trazodone 100 mg compared with placebo. Further studies are recommended to investigate the use of oral trazodone in cats for the purpose of decreasing anxiety assocaited with transportation and examination. © ISFM and AAFP 2015.

A New Autonomy-Supportive Way of Teaching That Increases Conceptual Learning: Teaching in Students' Preferred Ways

ERIC Educational Resources Information Center

Jang, Hyungshim; Reeve, Johnmarshall; Halusic, Marc

2016-01-01

We tested the educational utility of "teaching in students' preferred ways" as a new autonomy-supportive way of teaching to enhance students' autonomy and conceptual learning. A pilot test first differentiated preferred versus nonpreferred ways of teaching. In the main study, a hired teacher who was blind to the purpose of the study…

Effects of Dog-Assisted Therapy on Communication and Basic Social Skills of Adults with Intellectual Disabilities: A Pilot Study

ERIC Educational Resources Information Center

Scorzato, Ivano; Zaninotto, Leonardo; Romano, Michela; Menardi, Chiara; Cavedon, Lino; Pegoraro, Alessandra; Socche, Laura; Zanetti, Piera; Coppiello, Deborah

2017-01-01

Thirty-nine adults with severe to profound intellectual disability (ID) were randomly assigned to either an experimental group (n = 21) or a control group (n = 18). Assessment was blinded and included selected items from the International Classification of Functioning, Disability and Health (ICF), the Behavioral Assessment Battery (BAB), and the…

Propofol interruption of ECT seizure to reduce side-effects: a pilot study.

PubMed

Warnell, Ronald L; Swartz, Conrad M; Thomson, Alice

2010-01-30

Fifteen depressed subjects received six bitemporal electroconvulsive therapy (ECT) treatments under etomidate anesthesia. They were randomized to blindly either receive propofol 0.5mg/kg 15s post-stimulus or not. Propofol infusion significantly prevented long seizures, and prevented cognitive decrements in most neuropsychological tests, several significantly. Propofol interruption may clinically help reduce ECT side-effects.

In Vitro and in vivo antioxidant and anti-inflammatory capacities of an antioxidant-rich fruit and berry juice blend. Results of a pilot and randomized, double-blinded, placebo-controlled, crossover study

USDA-ARS?s Scientific Manuscript database

This study investigated the in vitro and in vivo antioxidant and anti-inflammatory properties of a juice blend (JB), MonaVie Active, containing a mixture of fruits and berries with known antioxidant activity, including acai, a palm fruit, as the predominant ingredient. The phytochemical antioxidants...

Single pilot IFR accident data analysis

NASA Technical Reports Server (NTRS)

Harris, D. F.

1983-01-01

The aircraft accident data recorded by the National Transportation and Safety Board (NTSR) for 1964-1979 were analyzed to determine what problems exist in the general aviation (GA) single pilot instrument flight rule (SPIFR) environment. A previous study conducted in 1978 for the years 1964-1975 provided a basis for comparison. This effort was generally limited to SPIFR pilot error landing phase accidents but includes some SPIFR takeoff and enroute accident analysis as well as some dual pilot IFR accident analysis for comparison. Analysis was performed for 554 accidents of which 39% (216) occurred during the years 1976-1979.

Single-Lever Power Control for General Aviation Aircraft Promises Improved Efficiency and Simplified Pilot Controls

NASA Technical Reports Server (NTRS)

Musgrave, Jeffrey L.

1997-01-01

General aviation research is leading to major advances in internal combustion engine control systems for single-engine, single-pilot aircraft. These advances promise to increase engine performance and fuel efficiency while substantially reducing pilot workload and increasing flight safety. One such advance is a single-lever power control (SLPC) system, a welcome departure from older, less user-friendly, multilever engine control systems. The benefits of using single-lever power controls for general aviation aircraft are improved flight safety through advanced engine diagnostics, simplified powerplant operations, increased time between overhauls, and cost-effective technology (extends fuel burn and reduces overhaul costs). The single-lever concept has proven to be so effective in preliminary studies that general aviation manufacturers are making plans to retrofit current aircraft with the technology and are incorporating it in designs for future aircraft.

Efficacy and safety of combined treatment of miniscalpel acupuncture and non-steroidal anti-inflammatory drugs: an assessor-blinded randomized controlled pilot study.

PubMed

Jun, Seungah; Lee, Jung Hee; Gong, Han Mi; Chung, Yeon-Joong; Kim, Ju-Ran; Park, Chung A; Choi, Seong Hun; Lee, Geon-Mok; Lee, Hyun-Jong; Kim, Jae Soo

2018-01-12

Chronic neck pain is a common musculoskeletal disease during the lifespan of an individual. With an increase in dependence on computer technology, the prevalence of chronic neck pain is expected to rise and this can lead to socioeconomic problems. We have designed the current pilot study to evaluate the efficacy and safety of miniscalpel acupuncture treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) in patients with chronic neck pain. This seven-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms. Thirty-six patients will be recruited and randomly allocated to three treatment groups: miniscalpel acupuncture treatment; NSAIDs; and miniscalpel acupuncture treatment combined with NSAIDs. Patients in the miniscalpel acupuncture and combined treatment groups will receive three sessions of miniscalpel acupuncture over a three-week period. Patients in the NSAIDs and combined treatment groups will receive zaltoprofen (one oral tablet, three times a day for three weeks). Primary and secondary outcomes will be measured at weeks 0 (baseline), 1, 2, 3 (primary end point), and 7 (four weeks after treatment completion) using the visual analogue scale and the Neck Disability Index, EuroQol 5-dimension questionnaire, and Patients' Global Impression of Change scale, respectively. Adverse events will also be recorded. This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture treatment combined with NSAIDs for chronic neck pain. Korean Clinical Research Information Service registry, KCT0002258 . Registered on 9 March 2017.

Evaluation of the Effect of a Single Intra-articular Injection of Allogeneic Neonatal Mesenchymal Stromal Cells Compared to Oral Non-Steroidal Anti-inflammatory Treatment on the Postoperative Musculoskeletal Status and Gait of Dogs over a 6-Month Period after Tibial Plateau Leveling Osteotomy: A Pilot Study.

PubMed

Taroni, Mathieu; Cabon, Quentin; Fèbre, Marine; Cachon, Thibaut; Saulnier, Nathalie; Carozzo, Claude; Maddens, Stéphane; Labadie, Fabrice; Robert, Clément; Viguier, Eric

2017-01-01

Compare the clinical and pressure walkway gait evolution of dogs after a tibial plateau leveling osteotomy (TPLO) for a cranial cruciate ligament rupture (CrCLR) and treatment with either a 1-month course of non-steroidal anti-inflammatory drugs (NSAIDs) or a single postoperative intra-articular (IA) injection of allogeneic neonatal mesenchymal stromal cells (MSCs). Prospective, double-blinded, randomized, controlled, monocentric clinical study. Sixteen client-owned dogs. Dogs with unilateral CrCLR confirmed by arthroscopy were included. Allogeneic neonatal canine MSCs were obtained from fetal adnexa retrieved after C-section performed on healthy pregnant bitches. The dogs were randomly allocated to either the "MSCs group," receiving an IA injection of MSCs after TPLO, followed by placebo for 1 month, or the "NSAIDs group," receiving IA equivalent volume of MSCs vehicle after TPLO, followed by oral NSAID for 1 month. One of the three blinded evaluators assessed the dogs in each group before and after surgery (1, 3, and 6 months). Clinical score and gait and bone healing process were assessed. The data were statistically compared between the two groups for pre- and postoperative evaluations. Fourteen dogs (nine in the MSCs group, five in the NSAIDs group) completed the present study. No significant difference was observed between the groups preoperatively. No local or systemic adverse effect was observed after MSCs injection at any time point considered. At 1 month after surgery, bone healing scores were significantly higher in the MSCs group. At 1, 3, and 6 months after surgery, no significant difference was observed between the two groups for clinical scores and gait evaluation. A single IA injection of allogeneic neonatal MSCs could be a safe and valuable postoperative alternative to NSAIDs for dogs requiring TPLO surgery, particularly for dogs intolerant to this class of drugs.

Polarity-Dependent Misperception of Subjective Visual Vertical during and after Transcranial Direct Current Stimulation (tDCS).

PubMed

Santos-Pontelli, Taiza E G; Rimoli, Brunna P; Favoretto, Diandra B; Mazin, Suleimy C; Truong, Dennis Q; Leite, Joao P; Pontes-Neto, Octavio M; Babyar, Suzanne R; Reding, Michael; Bikson, Marom; Edwards, Dylan J

2016-01-01

Pathologic tilt of subjective visual vertical (SVV) frequently has adverse functional consequences for patients with stroke and vestibular disorders. Repetitive transcranial magnetic stimulation (rTMS) of the supramarginal gyrus can produce a transitory tilt on SVV in healthy subjects. However, the effect of transcranial direct current stimulation (tDCS) on SVV has never been systematically studied. We investigated whether bilateral tDCS over the temporal-parietal region could result in both online and offline SVV misperception in healthy subjects. In a randomized, sham-controlled, single-blind crossover pilot study, thirteen healthy subjects performed tests of SVV before, during and after the tDCS applied over the temporal-parietal region in three conditions used on different days: right anode/left cathode; right cathode/left anode; and sham. Subjects were blind to the tDCS conditions. Montage-specific current flow patterns were investigated using computational models. SVV was significantly displaced towards the anode during both active stimulation conditions when compared to sham condition. Immediately after both active conditions, there were rebound effects. Longer lasting after-effects towards the anode occurred only in the right cathode/left anode condition. Current flow models predicted the stimulation of temporal-parietal regions under the electrodes and deep clusters in the posterior limb of the internal capsule. The present findings indicate that tDCS over the temporal-parietal region can significantly alter human SVV perception. This tDCS approach may be a potential clinical tool for the treatment of SVV misperception in neurological patients.

Impact of dry ejaculation caused by highly selective alpha1A-blocker: randomized, double-blind, placebo-controlled crossover pilot study in healthy volunteer men.

PubMed

Shimizu, Fumitaka; Taguri, Masataka; Harada, Yoshiko; Matsuyama, Yutaka; Sase, Kazuhiro; Fujime, Makoto

2010-03-01

Dry ejaculation with loss of seminal emission is reported in patients who have been administered silodosin, an alpha1A-adrenoceptor antagonist. We investigated the impact of dry ejaculation caused by orally administered silodosin on orgasmic function. In a double-blind crossover study, 50 healthy volunteer men were randomly assigned to receive either a single dose of 4-mg silodosin or placebo with 3 days of washout before crossover. Subjects masturbated 4 hours after administering agents. Numerical rating scale (NRS) score from 0 (highest) to 10 (lowest) for subjective quality of orgasm, the subjective number of contractions of the bulbocavernosus/pelvic floor muscles, and the amount of semen were examined. Results. After the administration of silodosin, the NRS score worsened by 1.3 points (P = 0.003), the number of contractions of the bulbocavernosus/pelvic floor muscles decreased by about 1 (P = 0.003), and there was a decrease of 1.8 mL in the amount of semen produced (P < 0.0001). Eleven men overall (22%) on silodosin administration had less than a 50% decrease from baseline in the amount of semen. Silodosin may adversely affect the subjective orgasmic function by causing an abnormal ejaculation with decreased (or no) semen discharge and a decrease in the number of bulbocavernosus/pelvic floor muscle contractions. Semen passing through the urethra and sufficient rhythmic contraction of the muscle of the pelvic floor may contribute to the subjective pleasure of orgasm.

The effect of therapeutic horseback riding on balance in community-dwelling older adults: a pilot study.

PubMed

Homnick, Tamara D; Henning, Kim M; Swain, Charlene V; Homnick, Douglas N

2015-02-01

Equine assisted activities (hippotherapy and therapeutic riding) improve balance in patients with disabilities such as cerebral palsy, but have not been systematically studied in older adults, at risk of falls due to balance deficits. We conducted a 10-week, single blind, controlled trial of the effect of a therapeutic horseback riding course on measures of balance in community-dwelling adults 65 years and older. Nine riders and six controls completed the trial. Controls were age matched to riders and all participants were recruited from the local community. Both groups showed improvements in balance during the trial, but did not reach statistical significance. Sample size was small, participants had relatively high initial balance scores, and controls tended to increase their physical activities, likely influencing outcomes. No adverse events occurred and the supervised therapeutic riding program appeared to be a safe and effective form of exercise to improve balance in older adults. A power analysis was performed to estimate numbers of participants needed for a larger study. © The Author(s) 2012.

The superiority of antidepressant medication to cognitive behavior therapy in melancholic depressed patients: a 12-week single-blind randomized study.

PubMed

Parker, G; Blanch, B; Paterson, A; Hadzi-Pavlovic, D; Sheppard, E; Manicavasagar, V; Synnott, H; Graham, R K; Friend, P; Gilfillan, D; Perich, T

2013-10-01

To pursue the previously long-standing but formally untested clinical view that melancholia is preferentially responsive to antidepressant medication in comparison with psychotherapy [specifically Cognitive Behavior Therapy (CBT)]. Second, to determine whether a broader action antidepressant medication sequencing regimen is superior to a Selective Serotonin Reuptake Inhibitor (SSRI) alone. We sought to recruit a large sample of participants with melancholic depression for a 12-week trial but inclusion criteria compromised recruitment and testing the second hypothesis. The first hypothesis was evaluated by comparing 18 participants receiving antidepressant medication to 11 receiving CBT. Primary study measures were the Hamilton Rating Scale for Depression (HAM-D) and the Hamilton Endogenous Subscale (HES), rated blindly, while several secondary measures also evaluated outcome. Participants receiving medication had a superior 12-week outcome to those receiving CBT, with significant differences present on primary measures as early as 4 weeks. At trial conclusion, the percentage improvement in HAM-D scores was 61.1% vs. 34.4%, respectively [Number Needed to Treat (NNT) = 3.7] and with those in receipt of medication returning non-significantly higher HAM-D responder (66.6% vs. 36.4%, NNT = 2.8) and remission (66.7% vs. 45.4%, NNT = 4.7) rates. As the sample size was small and participants evidenced only moderate levels of depression severity, the study risked being underpowered and idiosyncratic. Despite the small sample, the superiority of antidepressant medication to CBT in those with a melancholic depression was distinctive in this pilot study. © 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study.

PubMed

Komen, Helga; Brunt, L Michael; Deych, Elena; Blood, Jane; Kharasch, Evan D

2018-05-25

Approximately 50 million US patients undergo ambulatory surgery annually. Postoperative opioid overprescribing is problematic, yet many patients report inadequate pain relief. In major inpatient surgery, intraoperative single-dose methadone produces better analgesia and reduces opioid use compared with conventional repeated dosing of short-duration opioids. This investigation tested the hypothesis that in same-day ambulatory surgery, intraoperative methadone, compared with short-duration opioids, reduces opioid consumption and pain, and determined an effective intraoperative induction dose of methadone for same-day ambulatory surgery. A double-blind, dose-escalation protocol randomized 60 patients (2:1) to intraoperative single-dose intravenous methadone (initially 0.1 then 0.15 mg/kg ideal body weight) or conventional as-needed dosing of short-duration opioids (eg, fentanyl, hydromorphone; controls). Intraoperative and postoperative opioid consumption, pain, and opioid side effects were assessed before discharge. Patient home diaries recorded pain, opioid use, and opioid side effects daily for 30 days postoperatively. Primary outcome was in-hospital (intraoperative and postoperative) opioid use. Secondary outcomes were 30 days opioid consumption, pain intensity, and opioid side effects. Median (interquartile range) methadone doses were 6 (5-6) and 9 (8-9) mg in the 0.1 and 0.15 mg/kg methadone groups, respectively. Total opioid consumption (morphine equivalents) in the postanesthesia care unit was significantly less compared with controls (9.3 mg, 1.3-11.0) in subjects receiving 0.15 mg/kg methadone (0.1 mg, 0.1-3.3; P < .001) but not 0.1 mg/kg methadone (5.0 mg, 3.3-8.1; P = .60). Dose-escalation ended at 0.15 mg/kg methadone. Total in-hospital nonmethadone opioid use after short-duration opioid, 0.1 mg/kg methadone, and 0.15 mg/kg methadone was 35.3 (25.0-44.0), 7.1 (3.7-10.0), and 3.3 (0.1-5.8) mg morphine equivalents, respectively (P < .001 for both versus control). In-hospital pain scores and side effects were not different between groups. In the 30 days after discharge, patients who received methadone 0.15 mg/kg had less pain at rest (P = .02) and used fewer opioid pills than controls (P < .0001), whereas patients who received 0.1 mg/kg had no difference in pain at rest (P = .69) and opioid use compared to controls (P = .08). In same-day discharge surgery, this pilot study identified a single intraoperative dose of methadone (0.15 mg/kg ideal body weight), which decreased intraoperative and postoperative opioid requirements and postoperative pain, compared with conventional intermittent short-duration opioids, with similar side effects.

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale.

PubMed

Charles, David; Tolleson, Christopher; Davis, Thomas L; Gill, Chandler E; Molinari, Anna L; Bliton, Mark J; Tramontana, Michael G; Salomon, Ronald M; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T; Neimat, Joseph S; Konrad, Peter E

2012-01-01

Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

PubMed Central

Charles, David; Tolleson, Christopher; Davis, Thomas L.; Gill, Chandler E.; Molinari, Anna L.; Bliton, Mark J.; Tramontana, Michael G.; Salomon, Ronald M.; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T.; Neimat, Joseph S.; Konrad, Peter E.

2014-01-01

Background Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. Objective We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. Methods We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Results Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. Conclusions This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease. PMID:23938229

U-2 Pilot Post-Mission Fatigue Questionnaire

DTIC Science & Technology

2014-10-01

conduct missions in a single- seat aircraft at altitudes above 70,000 feet, requiring the pilot to wear a full pressure suit and breathe 100% oxygen...2014 1.0 SUMMARY U-2 pilots routinely conduct missions in a single- seat aircraft at altitudes above 70,000 feet, requiring the pilot to wear a...pilots, the physical discomfort resulting from prolonged immobility in a single- seat aircraft may contribute to subjective pain and fatigue. Prolonged

High Dose Vitamin D Therapy for Chronic Pain in Children and Adolescents with Sickle Cell Disease: Results of a Randomized Double Blind Pilot Study

PubMed Central

I, Osunkwo; TR, Ziegler; J, Alvarez; C, McCracken; K, Cherry; CE, Osunkwo; SF, Ofori-Acquah; S, Ghosh; A, Ogunbobode; J, Rhodes; JR, Eckman; CD, Dampier; V, Tangpricha

2012-01-01

Summary We report results of a pilot study of high-dose vitamin D in sickle cell disease (SCD). Subjects were followed for 6 months after receiving a six-week course of oral high-dose cholecalciferol or placebo. Vitamin D insufficiency and deficiency was present at baseline in 82.5% and 52.5% of subjects, respectively. Subjects who received high-dose vitamin D achieved higher serum 25-hydroxyvitamin D, experienced fewer pain days per week, and had higher physical activity quality-of-life scores. These findings suggest a potential benefit of vitamin D in reducing the number of pain days in SCD. Larger prospective studies with longer duration are needed to confirm these effects. PMID:22924607

Storytelling in the early bereavement period to reduce emotional distress among surrogates involved in a decision to limit life support in the ICU: A pilot feasibility trial

PubMed Central

Barnato, Amber E.; Schenker, Yael; Tiver, Greer; Dew, Mary Amanda; Arnold, Robert M.; Nunez, Eduardo R.; Reynolds, Charles F.

2017-01-01

Background Surrogate decision makers involved in decisions to limit life support for an incapacitated patient in the ICU have high rates of adverse emotional health outcomes distinct from normal processes of grief and bereavement. Narrative self-disclosure (storytelling) reduces emotional distress after other traumatic experiences. Objective To assess the feasibility, acceptability, and tolerability of storytelling among bereaved surrogates involved in a decision to limit life support in the ICU. Methods We conducted a pilot single-blind trial of storytelling among bereaved surrogates from 5 ICUs across 3 hospitals within a single health system between June 2013 and November 2014. Both storytelling and control conditions involved printed bereavement materials and follow-up assessments. Storytelling involved a single 1–2 hour home or telephone visit by a trained interventionist who elicited the surrogate’s story. The primary outcomes were feasibility (rates of enrollment, intervention receipt, 3- and 6-month follow up), acceptability (closed and open-ended end-of-study feedback at 6 months), and tolerability (acute mental health services referral). Results Of 53 eligible surrogates, 32 (60%) consented to treatment allocation. Surrogates’ mean age was 55.5 (SD=11.8) and they were making decisions for their parent (47%) spouse (28%), sibling (13%), child (3%) or other relation (8%). We allocated 14 to control and 18 to storytelling, 17/18 (94%) received storytelling, 14/14 (100%) and 13/14 (94%) control subjects and 16/18 (89%) and 17/18 (94%) storytelling subjects completed their 3- and 6-month telephone assessments. At 6-months, 9/13 (69%) control participants and 16/17 (94%) storytelling subjects reported feeling “better” or “much better,” and none felt “much worse”. One (8%) control subject and 1 (6%) storytelling subject said the study was burdensome, and 1 (8%) control subject wished they had not participated. No subjects required acute mental health services referral. Conclusion A clinical trial of storytelling in this study population is feasible, acceptable, and tolerable. PMID:27618273

Storytelling in the Early Bereavement Period to Reduce Emotional Distress Among Surrogates Involved in a Decision to Limit Life Support in the ICU: A Pilot Feasibility Trial.

PubMed

Barnato, Amber E; Schenker, Yael; Tiver, Greer; Dew, Mary Amanda; Arnold, Robert M; Nunez, Eduardo R; Reynolds, Charles F

2017-01-01

Surrogate decision makers involved in decisions to limit life support for an incapacitated patient in the ICU have high rates of adverse emotional health outcomes distinct from normal processes of grief and bereavement. Narrative self-disclosure (storytelling) reduces emotional distress after other traumatic experiences. We sought to assess the feasibility, acceptability, and tolerability of storytelling among bereaved surrogates involved in a decision to limit life support in the ICU. Pilot single-blind trial. Five ICUs across three hospitals within a single health system between June 2013 and November 2014. Bereaved surrogates of ICU patients. Storytelling and control conditions involved printed bereavement materials and follow-up assessments. Storytelling involved a single 1- to 2-hour home or telephone visit by a trained interventionist who elicited the surrogate's story. The primary outcomes were feasibility (rates of enrollment, intervention receipt, 3- and 6-mo follow-up), acceptability (closed and open-ended end-of-study feedback at 6 mo), and tolerability (acute mental health services referral). Of 53 eligible surrogates, 32 (60%) consented to treatment allocation. Surrogates' mean age was 55.5 (SD, 11.8), and they were making decisions for their parent (47%), spouse (28%), sibling (13%), child (3%), or other relation (8%). We allocated 14 to control and 18 to storytelling, 17 of 18 (94%) received storytelling, 14 of 14 (100%) and 13 of 14 (94%) control subjects and 16 of 18 (89%) and 17 of 18 (94%) storytelling subjects completed their 3- and 6-month telephone assessments. At 6 months, nine of 13 control participants (69%) and 16 of 17 storytelling subjects (94%) reported feeling "better" or "much better," and none felt "much worse." One control subject (8%) and one storytelling subject (6%) said that the study was burdensome, and one control subject (8%) wished they had not participated. No subjects required acute mental health services referral. A clinical trial of storytelling in this study population is feasible, acceptable, and tolerable.

Pilot Study of a Parent Training Program for Young Children with Autism: The PLAY Project Home Consultation Program

ERIC Educational Resources Information Center

Solomon, Richard; Necheles, Jonathan; Ferch, Courtney; Bruckman, David

2007-01-01

The PLAY Project Home Consultation (PPHC) program trains parents of children with autistic spectrum disorders using the DIR/Floortime model of Stanley Greenspan MD. Sixty-eight children completed the 8-12 month program. Parents were encouraged to deliver 15 hours per week of 1:1 interaction. Pre/post ratings of videotapes by blind raters using the…

Simvastatin as an Adjunct to Conventional Therapy of Non-infectious Uveitis: A Randomized, Open-Label Pilot Study.

PubMed

Shirinsky, Ivan V; Biryukova, Anastasia A; Shirinsky, Valery S

2017-12-01

Statins have been shown to reduce ocular inflammation in animal models of uveitis and to prevent development of uveitis in observational studies. There have been no experimental human studies evaluating statins' efficacy and safety in uveitis. In this study, we aimed to investigate efficacy and safety of simvastatin in patients with uveitis. For this single-center, open-label, randomized study, we enrolled patients with acute non-infectious uveitis. The patients were randomized to receive 40 mg simvastatin per day for 2 months in addition to conventional treatment or conventional treatment alone. The studied outcomes were the rate of steroid-sparing control of ocular inflammation, measures of ocular inflammation, intraocular pressure, and visual acuity. Fifty patients were enrolled in the study. Twenty-five patients were randomly assigned to receive simvastatin with conventional treatment and 25 to conventional treatment alone. Simvastatin was associated with significantly higher rates of steroid-sparing ocular inflammation control, decrease in anterior chamber inflammation, and improvement in visual acuity. The treatment was well tolerated, no serious adverse effects were observed. Our findings suggest that statins may have therapeutic potential in uveitis. These results need to be confirmed in double-blind, randomized, controlled studies.

Deep Brain Stimulation in Early Parkinson’s Disease: Enrollment Experience from a Pilot Trial

PubMed Central

Charles, PD; Dolhun, RM; Gill, CE; Davis, TL; Bliton, MJ; Tramontana, MG; Salomon, RM; Wang; Hedera, P; Phibbs, FT; Neimat, JS; Konrad, PE

2011-01-01

Background Deep brain stimulation (DBS) of the subthalamic nucleus is an accepted therapy for advanced Parkinson’s disease (PD). In animal models, pharmacologic ablation and stimulation of the subthalamic nucleus have resulted in clinical improvement and, in some cases, improved survival of dopaminergic neurons. DBS has not been studied in the early stages of PD, but early application should be explored to evaluate safety, efficacy, and the potential to alter disease progression. Methods We are conducting a prospective, randomized, single-blind clinical trial of optimal drug therapy (ODT) compared to medication plus DBS (ODT + DBS) in subjects with Hoehn & Yahr Stage II idiopathic PD who are without motor fluctuations or dementia. We report here subject screening, enrollment, baseline characteristics, and adverse events. Results 30 subjects (average age 60 ± 6.9 years, average duration of medicine 2.1 ± 1.3 years, average UPDRS-III scores 14.9 on medication and 27.0 off medication) are enrolled in the ongoing study. Twelve of 15 subjects randomized to DBS experienced perioperative adverse events, the majority of which were related to the procedure or device and resolved without sequelae. Frequently reported adverse events included wound healing problems, headache, edema, and confusion. Conclusion This report demonstrates that subjects with early stage PD can be successfully recruited, consented and retained in a long term clinical trial of DBS. Our ongoing pilot investigation will provide important preliminary safety and tolerability data concerning the application of DBS in early stage PD. PMID:22104012

Evaluation of self-care skills training and solution-focused counselling for health professionals in psychiatric medicine: a pilot study.

PubMed

Mache, Stefanie; Bernburg, Monika; Baresi, Lisa; Groneberg, David A

2016-11-01

The purpose of this pilot study was to implement and to evaluate a self-care skills training with solution-focused counselling to support psychiatrists in handling their daily work challenges. A total of 72 psychiatrists working in a psychiatric clinic were randomised in a single-blind trial to either an intervention group or a control group. Outcomes were measured at baseline and at the end of the training (follow-up 1: after 3 months; follow-up 2: after 6 months). A validated questionnaire including the Perceived Stress Questionnaire, the Copenhagen Psychosocial Questionnaire, Brief Resilient Coping Scale, Self-Efficacy Scale and the Quality of Relationship Inventory was used. Psychiatrists in the intervention group reached a significant reduction in perceived job stress (p = 0.01, d = 0.05), improvements in job satisfaction (p = 0.02, d = 0.04), resilience (p = 0.02, d = 0.04) and self-efficacy (p = 0.04, d = 0.02) from baseline to all follow-ups with no comparable results seen in the control group. Psychiatrists stated an improved quality of physician-patient relationship (e.g. support, conflict management; p < 0.05). A self-care skills training, including solution-focused counselling, for psychiatrists was associated with significant improvements in perceived stress, job satisfaction, individual protective skills and quality of relationship to patients. This training is suitable to implement as a group training program for psychiatrists.

Combined effects of sensory cueing and limb activation on unilateral neglect in subacute left hemiplegic stroke patients: a randomized controlled pilot study.

PubMed

Fong, Kenneth N K; Yang, Nicole Y H; Chan, Marko K L; Chan, Dora Y L; Lau, Andy F C; Chan, Dick Y W; Cheung, Joyce T Y; Cheung, Hobby K Y; Chung, Raymond C K; Chan, Chetwyn C H

2013-07-01

To compare the effects of contralesional sensory cueing and limb activation with that of sham control in the treatment of unilateral neglect after stroke. A randomized, single-blinded, sham-controlled pilot study. Two rehabilitation hospitals. Forty subacute left hemiplegic stroke inpatients with unilateral neglect. Participants were assigned randomly to 1 of 2 groups. The experimental group wore a wristwatch cueing device over the hemiplegic arm for three hours a day, five days per week, for three weeks, and also underwent conventional rehabilitation. Patients were encouraged to move their hemiplegic arm five consecutive times after each prompt. The sham group underwent the same rehabilitation process, except they wore a sham device. Neglect, arm motor performance, and overall functioning were assessed pre- and posttraining, and at follow-up. There were no significant differences between groups in outcome measures except the neglect drawing tasks (p = 0.034) (the mean gain score from baseline to follow-up assessment was 5.2 (3.7) in the experimental group and 1.9 (3.5) in the sham group), across three time intervals. The experimental group showed greater improvement in arm motor performance than did the sham group. The results did not confirm that sensory cueing and limb activation treatment is effective when compared with those receiving placebo to reduce unilateral neglect, but it might be useful for promoting hemiplegic arm performance in stroke patients.

[A cross-sectional study of moderate or severe visual impairment and blindness in residents with type 2 diabetes living in Xinjing Town, Shanghai].

PubMed

Bai, X L; Xu, X; Lu, M; He, J N; Xu, X; Du, X; Zhang, B; He, X G; Lu, L N; Zhu, J F; Zou, H D; Zhao, J L

2016-11-11

Objective: To investigate the prevalence, underlying causes and risk factors of moderate or severe visual impairment and blindness in a population with type 2 diabetes in Xinjing Town, Shanghai, China. Methods: A cross-sectional survey among local Han adult residents, who were previously diagnosed as type 2 diabetes, was conducted between October 2014 and January 2015. The survey was preceded by a pilot study; operational methods were refined and quality assurance evaluation was carried out. The best corrected visual acuity was recorded and classified following the modified World Health Organization grading system. Assigned ophthalmic doctors assured the leading causes of every blind or visually impaired eye. Binary logistic regression analysis was used to determine the related factors of blindness and moderate or severe visual impairment. Results: A total of 2 216 type 2 diabetic residents were enrolled, and 166 eyes (3.7%, 166/4 432) were blind. Cataract was the leading cause of blindness (39.8%); macular degeneration (18.0%) and eyeball atrophy (11.4%) were the second and third leading causes of blindness, respectively. Moderate or severe visual impairment was found in 376 eyes (8.5%, 376/4 432), and the most frequent cause was cataract (65.7%), followed by diabetic retinopathy (9.8%) and macular degeneration (9.4% ). Older age, female gender, earlier onset diabetes and a lower spherical equivalent in the better eye were associated with best corrected visual acuity<20/63 in the better eye. Conclusion: The prevalences of moderate or severe visual impairment and blindness in our population with type 2 diabetes were high. (Chin J Ophthalmol, 2016, 52: 825-830) .

Anti-dazzling protection for Air Force pilots

NASA Astrophysics Data System (ADS)

Donval, Ariela; Fisher, Tali; Lipman, Ofir; Oron, Moshe

2012-06-01

Under certain conditions, laser directed at aircraft can be a hazard. The most likely scenario is when a bright visible laser causes distraction or temporary flash blindness to a pilot, during a critical phase of flight such as landing or takeoff. It is also possible, that a visible or invisible beam could cause permanent harm to a pilot's eyes. We present a non-linear, solid-state dynamic filter solutions protecting from dazzling and damage in a passive way. Our filters limit the transmission, only if the power exceeds a certain threshold as opposed to spectral filters that block a certain wavelength permanently.

Sulforaphane Treatment of Children with Autism Spectrum Disorder

DTIC Science & Technology

2017-07-01

the course of the study . To date, the Pilot trial of 10 children has been completed, and 36 out of the target 50 children for the Main trial have... study will enroll 50 children with moderate to severe autism, between 3 and 12 years old, in a randomized, double-blind, placebo-controlled phase-2... children were unable to cooperate, and because in some cases study participants took the study drug in the morning and then went to school for the

The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive-behavioural therapy.

PubMed

Langdon, Peter E; Murphy, Glynis H; Shepstone, Lee; Wilson, Edward C F; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

2016-03-01

There is a growing interest in using cognitive-behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. None. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

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

PubMed

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.

Clinical relevance of IgG antibodies against food antigens in Crohn's disease: a double-blind cross-over diet intervention study.

PubMed

Bentz, S; Hausmann, M; Piberger, H; Kellermeier, S; Paul, S; Held, L; Falk, W; Obermeier, F; Fried, M; Schölmerich, J; Rogler, G

2010-01-01

Environmental factors are thought to play an important role in the development of Crohn's disease (CD). Immune responses against auto-antigens or food antigens may be a reason for the perpetuation of inflammation. In a pilot study, 79 CD patients and 20 healthy controls were examined for food immunoglobulin G (IgG). Thereafter, the clinical relevance of these food IgG antibodies was assessed in a double-blind cross-over study with 40 patients. Based on the IgG antibodies, a nutritional intervention was planned. The interferon (IFN)gamma secretion of T cells was measured. Eosinophil-derived neurotoxin was quantified in stool. The pilot study resulted in a significant difference of IgG antibodies in serum between CD patients and healthy controls. In 84 and 83% of the patients, respectively, IgG antibodies against processed cheese and yeast were detected. The daily stool frequency significantly decreased by 11% during a specific diet compared with a sham diet. Abdominal pain reduced and general well-being improved. IFNgamma secretion of T cells increased. No difference for eosinophil-derived neurotoxin in stool was detected. A nutritional intervention based on circulating IgG antibodies against food antigens showed effects with respect to stool frequency. The mechanisms by which IgG antibodies might contribute to disease activity remain to be elucidated.

Low efficacy of mebendazole against hookworm in Vietnam: two randomized controlled trials.

PubMed

Flohr, Carsten; Tuyen, Luc Nguyen; Lewis, Sarah; Minh, Truong Tan; Campbell, Jim; Britton, John; Williams, Hywel; Hien, Tran Tinh; Farrar, Jeremy; Quinnell, Rupert J

2007-04-01

Vietnam is participating in a global de-worming effort that aims to treat 650 million school children regularly by 2010. The treatment used in Vietnam is single dose oral mebendazole (Phardazone) 500 mg. We tested the efficacy of single dose mebendazole 500 mg in the therapy of hookworm infection in a randomized double-blind placebo-controlled trial among 271 Vietnamese schoolchildren. The treatment efficacy of single dose mebendazole in children did not differ significantly from placebo, with a reduction in mean eggs per gram of feces relative to placebo of 31% (95% CI -9 to 56%, P = 0.1). In light of these findings we then carried out a similar randomized trial comparing triple dose mebendazole, single dose albendazole, and triple dose albendazole against placebo in 209 adults in the same area. The estimated reduction in mean post-treatment eggs per gram of feces relative to placebo was 63% (95% CI 30-81%) for triple mebendazole, 75% (47-88%) for single albendazole, and 88% (58-97%) for triple albendazole. Our results suggest that single dose oral mebendazole has low efficacy against hookworm infection in Vietnam, and that it should be replaced by albendazole. These findings are of major public health relevance given the opportunity costs of treating entire populations with ineffective therapies. We recommend that efficacy of anti-helminth therapies is pilot tested before implementation of national gut worm control programs.

GAME (Goals - Activity - Motor Enrichment): protocol of a single blind randomised controlled trial of motor training, parent education and environmental enrichment for infants at high risk of cerebral palsy.

PubMed

Morgan, Catherine; Novak, Iona; Dale, Russell C; Guzzetta, Andrea; Badawi, Nadia

2014-10-07

Cerebral palsy is the most common physical disability of childhood and early detection is possible using evidence based assessments. Systematic reviews indicate early intervention trials rarely demonstrate efficacy for improving motor outcomes but environmental enrichment interventions appear promising. This study is built on a previous pilot study and has been designed to assess the effectiveness of a goal - oriented motor training and enrichment intervention programme, "GAME", on the motor outcomes of infants at very high risk of cerebral palsy (CP) compared with standard community based care. A two group, single blind randomised controlled trial (n = 30) will be conducted. Eligible infants are those diagnosed with CP or designated "at high risk of CP" on the basis of the General Movements Assessment and/or abnormal neuroimaging. A physiotherapist and occupational therapist will deliver home-based GAME intervention at least fortnightly until the infant's first birthday. The intervention aims to optimize motor function and engage parents in developmental activities aimed at enriching the home learning environment. Primary endpoint measures will be taken 16 weeks after intervention commences with the secondary endpoint at 12 months and 24 months corrected age. The primary outcome measure will be the Peabody Developmental Motor Scale second edition. Secondary outcomes measures include the Gross Motor Function Measure, Bayley Scales of Infant and Toddler Development, Affordances in the Home Environment for Motor Development - Infant Scale, and the Canadian Occupational Performance Measure. Parent well-being will be monitored using the Depression Anxiety and Stress Scale. This paper presents the background, design and intervention protocol of a randomised trial of a goal driven, motor learning approach with customised environmental interventions and parental education for young infants at high risk of cerebral palsy. This trial is registered on the Australian New Zealand Clinical Trial register: ACTRN12611000572965.

Effects of Guided Imagery on Postoperative Outcomes in Patients Undergoing Same-Day Surgical Procedures: A Randomized, Single-Blind Study

DTIC Science & Technology

2010-06-01

2O0O;9Ot3):706-712. 20. Bertrand P, Maye J. A description of the indices of heart rate variabil- ity in orofacial pain paticnis. Bcihcsda, MD: National...neck proce- dures were randomly assigned into 2 groups for this single-blind investigation. Anxiety and baseline pain levels were documented...control group patients received no intervention. Data were collected on pain and nar- cotic consumption at 7- and 2-hour postoperative inter- vals. In

Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial

PubMed Central

2013-01-01

Background After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke. Methods/Design This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject’s inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained. Discussion Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events. Trial registration This trial is registered with the Clinical Trials.gov Registry (NCT01679600). PMID:24053609

Pilot Evaluation of the Feasibility and Acceptability of StressOFF Strategies: A Single-Session School-Based Stress Management Program for Adolescents

ERIC Educational Resources Information Center

Shapiro, Amy J.; Heath, Nancy L.; Carsley, Dana

2016-01-01

The present study reports the pilot evaluation of the feasibility and acceptability of StressOFF Strategies, a "single-session" (45 min) adolescent-targeted, school-based psychoeducational program, which introduces cognitive behavioral techniques and mindfulness-based techniques. Five hundred and sixty-five Grade 9 students (57% female;…

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

PubMed Central

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.

2015-01-01

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. PMID:26421049

Facial recognition and laser surface scan: a pilot study.

PubMed

Lynnerup, Niels; Clausen, Maja-Lisa; Kristoffersen, Agnethe May; Steglich-Arnholm, Henrik

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 software (MIMICS and Photoshop) the surface scans were matched with the photographs in blind trials. The matches were graded as: a good fit; possible fit; and no fit. All the surface scans and photos were matched correctly, although one surface scan could be matched with two angled photographs, meaning that the discriminatory value was 86.7%. We also tested the surface scanner in terms of reliability in establishing point measures on skulls, and compared with physical measurements performed by calipers. The variation was on average 1 mm for five cranial measures. We suggest how surface scanning might be applied in forensic facial identification.

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

PubMed

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C; Milella, Luigi

2015-01-01

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.

A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks.

PubMed

Chang, Anne Lynn S; Alora-Palli, Maria; Lima, Xinaida T; Chang, Tiffany C; Cheng, Carol; Chung, Connie M; Amir, Omar; Kimball, Alexa B

2012-03-01

Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features. To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage. Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage. There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug. A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings.

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

PubMed

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.

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

NASA Astrophysics Data System (ADS)

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

2016-11-01

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

Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study.

PubMed

Lainé, Fabrice; Laviolle, Bruno; Bardou-Jacquet, Edouard; Fatih, Nadia; Jezequel, Caroline; Collet, Nicolas; Ropert, Martine; Morcet, Jeff; Hamon, Catherine; Reymann, Jean-Michel; Loréal, Olivier

2017-10-01

Hepcidin, secreted by hepatocytes, controls iron metabolism by limiting iron egress in plasma. Hepcidin is upregulated during inflammation through the activation of the signal transducer and activator of transcription 3 (STAT3) transduction pathway, which decreases iron bioavailability and may explain the anemia of chronic inflammatory disease. In vitro, it has been shown that curcumin can decrease hepcidin synthesis by decreasing STAT3 activity. We conducted a proof-of-concept study to assess the effect of curcuma on hepcidin synthesis in human. This was a placebo-controlled, randomized, double-blind, cross-over, two-period study performed in 18 healthy male volunteers. Subjects received a single oral dose of 6 g curcuma containing 2% of curcumin or placebo. Serum hepcidin and iron parameters were assessed repeatedly until 48 h after dosing. When compared with a placebo curcuma decreased hepcidin levels significantly at 6 h (-19%, P = 0.004), 8 h (-17%, P = 0.009), and 12 h (-17%, P = 0.007) and tended to decrease hepcidin at 24 h (-15%, P = 0.076). Curcuma also significantly increased serum ferritin levels at 6 and 8 h (+7% for both times, P = 0.018, 0.030, respectively) and had no effects on serum iron, transferrin, and transferrin saturation. This pilot study showed that curcuma decreases serum hepcidin levels in human and supports the idea that curcuma could be useful in treating hepcidin overproduction during inflammatory processes. Confirmatory studies in patients with chronic inflammation are now required to determine the optimal dose and therapeutic scheme of curcuma. © 2017 Société Française de Pharmacologie et de Thérapeutique.

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

PubMed

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 spots treated with topical application of fresh human milk. (ClinicalTrials.gov Identifier, NCT02381028 ).

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

PubMed

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

2015-12-01

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

Computer simulation of a single pilot flying a modern high-performance helicopter

NASA Technical Reports Server (NTRS)

Zipf, Mark E.; Vogt, William G.; Mickle, Marlin H.; Hoelzeman, Ronald G.; Kai, Fei; Mihaloew, James R.

1988-01-01

Presented is a computer simulation of a human response pilot model able to execute operational flight maneuvers and vehicle stabilization of a modern high-performance helicopter. Low-order, single-variable, human response mechanisms, integrated to form a multivariable pilot structure, provide a comprehensive operational control over the vehicle. Evaluations of the integrated pilot were performed by direct insertion into a nonlinear, total-force simulation environment provided by NASA Lewis. Comparisons between the integrated pilot structure and single-variable pilot mechanisms are presented. Static and dynamically alterable configurations of the pilot structure are introduced to simulate pilot activities during vehicle maneuvers. These configurations, in conjunction with higher level, decision-making processes, are considered for use where guidance and navigational procedures, operational mode transfers, and resource sharing are required.

Feasibility of a home-based program to improve handwriting after stroke: a pilot study.

PubMed

Simpson, Bronwyn; McCluskey, Annie; Lannin, Natasha; Cordier, Reinie

2016-01-01

To test the feasibility of a handwriting retraining program with adults after stroke; specifically the feasibility of: (i) recruiting people with stroke to the study, (ii) delivering the handwriting retraining program and (iii) outcome measures of handwriting performance. A quasi-experimental pre-test post-test design was used. A four-week, home-based handwriting retraining program was delivered by an occupational therapist using task-specific practice. Legibility, speed, pen control and self-perception of handwriting were measured at baseline and completion of the program. Legibility was scored by a blinded rater. Seven adults with stroke were recruited (eligibility fraction 43% of those screened, and enrolment fraction 78% of those eligible). There were no dropouts. Although, recruitment was slow the intervention was feasible and acceptable to adults with stroke. No statistically or clinically significant changes in legibility were reported in this small sample, but a ceiling effect was evident for some outcome measures. The study was not powered to determine efficacy. Delivery of a four-week handwriting intervention with eight supervised sessions in the community was feasible; however, recruitment of an adequate sample size would require greater investment than the single site used in this pilot. Handwriting difficulty is common following hemiparesis after stroke, however research addressing handwriting retraining for adults with stroke is lacking. A four-week home-based handwriting program using task-specific practice and feedback was feasible to deliver and appropriate for adults with stroke. Improving handwriting legibility and neatness across a range of tasks were important goals for adults with handwriting impairment.

Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery.

PubMed

Ganry, L; Hersant, B; Sidahmed-Mezi, M; Dhonneur, G; Meningaud, J P

2018-01-06

Preoperative anxiety may lead to medical and surgical complications, behavioral problems and emotional distress. The most common means of prevention are based on using medication and, more recently, hypnosis. The aim of our study was to determine whether a virtual reality (VR) program presenting natural scenes could be part of a new therapy to reduce patients' preoperative anxiety. Our prospective pilot study consisted of a single-blind trial in skin cancer surgery at the Henri-Mondor teaching hospital in France. In the outpatient surgery department, 20 patients with a score of >11 on the Amsterdam preoperative anxiety and information scale (APAIS) were virtually immersed into a natural universe for 5minutes. Their stress levels were assessed before and after this experience by making use of a visual analog scale (VAS), by measuring salivary cortisol levels, and by determining physiological stress based on heart coherence scores. The VAS score was significantly reduced after the simulation (P<0.009) as was the level of salivary cortisol (P<0.04). Heart coherence scores remained unchanged (P=0.056). VR allows patients to be immersed in a relaxing, peaceful environment. It represents a non-invasive way to reduce preoperative stress levels with no side effects and no need for additional medical or paramedical staff. Our results indicate that VR may provide an effective complementary technique to manage stress in surgery patients. Randomized trials are necessary to determine precise methods and benefits. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Increase in PAS-induced neuroplasticity after a treatment course of intranasal ketamine for depression. Report of three cases from a placebo-controlled trial.

PubMed

Gálvez, Verònica; Nikolin, Stevan; Ho, Kerrie-Anne; Alonzo, Angelo; Somogyi, Andrew A; Loo, Colleen K

2017-02-01

Animal studies suggest that neural plasticity may play a role in the antidepressant effects of a single ketamine dose. However, the potential effects of repeated ketamine treatments on human neuroplasticity are unknown. This pilot RCT study measured plasticity-induced changes before and after a ketamine course, in three treatment-resistant depressed subjects, who were randomized to receive 8 intranasal treatments of 100mg ketamine or 4.5mg midazolam. Mood ratings were performed by a trained blinded rater at baseline and 24h-48h after the ketamine course, using the Montgomery Asberg Depression Rating Scale (MADRS). Neuroplasticity was assessed in the motor cortex using a paired associative stimulation (PAS) paradigm at baseline and 24h-48h after the treatment course. No changes in current psychotropic medication or dosage were permitted for 4weeks prior to trial entry and throughout the trial. The subject receiving ketamine, but not those receiving midazolam, presented a marked increase in neural plasticity after the treatment course. However, mood changes were not associated with changes in neural plasticity. Pilot study with small sample size. Concomitant antidepressant medications taken. Plasticity was tested in the motor cortex only, thus the generalizability of these findings to other brain areas cannot be assumed. These results suggest that a course of intranasal ketamine may enhance synaptic plasticity in subjects with depression, but this was not associated with antidepressant effects. Further research on this topic is warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

Memory strength and lineup presentation moderate effects of administrator influence on mistaken identifications.

PubMed

Zimmerman, David M; Chorn, Jacqueline Austin; Rhead, Lindsey M; Evelo, Andrew J; Kovera, Margaret Bull

2017-12-01

Administrator/witness pairs (N = 313) were randomly assigned to target-absent lineups in a 2 (Suspect/Perpetrator Similarity: High Suspect Similarity vs. Low Suspect Similarity) × 2 (Retention Interval: 30 min vs. 1 week) × 2 (Lineup Presentation: Simultaneous vs. Sequential) × 2 (Administrator Knowledge: Single-Blind vs. Double-Blind) factorial design to test whether suspect similarity and memory strength constrain interpersonal expectancy effects on eyewitness identification accuracy. Administrators who knew which lineup member was the suspect (single-blind) or who administered simultaneous lineups were more likely to emit verbal and nonverbal behaviors that suggested to the witness who the suspect was. Additionally, single-blind administrators exerted more pressure on witnesses to choose the suspect as opposed to fillers. Administrator knowledge interacted with retention interval and lineup presentation to influence mistaken identifications of innocent suspects; witnesses were more likely to mistakenly identify an innocent suspect from single-blind than double-blind lineups when witness retention intervals were long and photographs were presented simultaneously. Contrary to our predictions, suspect/perpetrator similarity did not interact with other manipulated variables to influence identification decisions. Both sequential and double-blind procedures should be used to reduce the use of suggestive behavior during lineup administration. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Lack of Effect of Vortioxetine on the Pharmacokinetics and Pharmacodynamics of Ethanol, Diazepam, and Lithium.

PubMed

Chen, Grace; Nomikos, George G; Affinito, John; Zhao, Zhen

2016-09-01

Because the multimodal antidepressant vortioxetine is likely to be coadministered with other central nervous system (CNS)-active drugs, potential drug-drug interactions warrant examination. These studies evaluated whether there are pharmacokinetic and/or pharmacodynamic interactions between vortioxetine and ethanol, diazepam, or lithium. This series of phase I studies included healthy men and women (only men in the lithium study) aged 18-45 years. The ethanol study was a randomized, double-blind, two-parallel group, four-period crossover study in which subjects received a single dose of vortioxetine (20 or 40 mg) or placebo with or without ethanol, and the diazepam study was a randomized, double-blind, placebo-controlled, two-sequence, two-period crossover study in which subjects received a single dose of diazepam following multiple doses of vortioxetine 10 mg/day or placebo. These two studies evaluated the effect of coadministration on standardized psychomotor parameters and on selected pharmacokinetic parameters of each drug. The lithium study was a single-blind, single-sequence study evaluating the effect of multiple doses of vortioxetine 10 mg/day on the steady-state pharmacokinetics of lithium. Concomitant administration of vortioxetine and single doses of either ethanol or diazepam had no significant effect on the psychomotor performance of subjects compared with administration of ethanol or diazepam alone. Vortioxetine had no significant effect on the pharmacokinetics of ethanol, diazepam, or lithium, and ethanol had no significant effect on the pharmacokinetics of vortioxetine. Concomitant administration of these agents with vortioxetine was generally well tolerated, with no clinically relevant drug-drug pharmacokinetic or pharmacodynamic interactions identified.

Effects of a Velocity-Vector Based Command Augmentation System and Synthetic Vision System Terrain Portrayal and Guidance Symbology Concepts on Single-Pilot Performance

NASA Technical Reports Server (NTRS)

Liu, Dahai; Goodrich, Kenneth H.; Peak, Bob

2010-01-01

This study investigated the effects of synthetic vision system (SVS) concepts and advanced flight controls on the performance of pilots flying a light, single-engine general aviation airplane. We evaluated the effects and interactions of two levels of terrain portrayal, guidance symbology, and flight control response type on pilot performance during the conduct of a relatively complex instrument approach procedure. The terrain and guidance presentations were evaluated as elements of an integrated primary flight display system. The approach procedure used in the study included a steeply descending, curved segment as might be encountered in emerging, required navigation performance (RNP) based procedures. Pilot performance measures consisted of flight technical performance, perceived workload, perceived situational awareness and subjective preference. The results revealed that an elevation based generic terrain portrayal significantly improved perceived situation awareness without adversely affecting flight technical performance or workload. Other factors (pilot instrument rating, control response type, and guidance symbology) were not found to significantly affect the performance measures.

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

PubMed

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a larger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic intervention addressing both the negative psychosocial and functional physical effects of HL among older adults. ClinicalTrials.gov, NCT02662192 . Registered on 14 January 2016.

The immediate effects of thoracic transverse mobilization in patients with the primary complaint of mechanical neck pain: a pilot study.

PubMed

McGregor, CIndy; Boyles, Robert; Murahashi, Laura; Sena, Tanya; Yarnall, Robert

2014-11-01

Posterior-to-anterior (PA) vertebral mobilization to the thoracic spine has been studied as an intervention for neck pain. Our purpose was to explore effects of a different mobilization technique, transverse vertebral pressure, on cervical range of motion (ROM) and pain when applied to the thoracic spine among participants with neck pain. A single-blinded quasi-experimental study with a one-group pretest-posttest design. A transverse group consisted of 21 participants whose neck pain increased with active movements. A non-intervention group of 20 asymptomatic participants was included simply to ensure rater blinding. The treatment group received Grades IV to IV+ transverse mobilizations at T1 through T4 bilaterally. Measurements taken immediately after intervention included pre/post cervical ROM, distant pressure pain threshold (PPT), and a numerical pain rating scale (NPRS). Analysis utilized t-tests and ordinal counterparts. The transverse group demonstrated significant gains in extension and bilateral rotation (P≤0.005) but not flexion or side-bend. A total of 57% of mobilized participants reported clinically meaningful decreased pain (P<0.001). Seven participants exceeded the PPT MDC95 of 0.36 kg/cm(2). The non-intervention group had no significant changes in ROM or NPRS scores. After 8 minutes of transverse mobilization to the upper thoracic spine, significant gains in cervical extension and bilateral rotation, and decreased pain scores were found. There were no adverse effects. Unlike other mobilization studies, PPT changes at a remote site were statistically but not clinically meaningful. Findings suggest that transverse mobilization would be a productive topic for controlled clinical trials.

The immediate effects of thoracic transverse mobilization in patients with the primary complaint of mechanical neck pain: a pilot study

PubMed Central

McGregor, CIndy; Boyles, Robert; Murahashi, Laura; Sena, Tanya; Yarnall, Robert

2014-01-01

Objective: Posterior-to-anterior (PA) vertebral mobilization to the thoracic spine has been studied as an intervention for neck pain. Our purpose was to explore effects of a different mobilization technique, transverse vertebral pressure, on cervical range of motion (ROM) and pain when applied to the thoracic spine among participants with neck pain. Methods: A single-blinded quasi-experimental study with a one-group pretest–posttest design. A transverse group consisted of 21 participants whose neck pain increased with active movements. A non-intervention group of 20 asymptomatic participants was included simply to ensure rater blinding. The treatment group received Grades IV to IV+ transverse mobilizations at T1 through T4 bilaterally. Measurements taken immediately after intervention included pre/post cervical ROM, distant pressure pain threshold (PPT), and a numerical pain rating scale (NPRS). Analysis utilized t-tests and ordinal counterparts. Results: The transverse group demonstrated significant gains in extension and bilateral rotation (P≤0.005) but not flexion or side-bend. A total of 57% of mobilized participants reported clinically meaningful decreased pain (P<0.001). Seven participants exceeded the PPT MDC95 of 0.36 kg/cm2. The non-intervention group had no significant changes in ROM or NPRS scores. Discussion: After 8 minutes of transverse mobilization to the upper thoracic spine, significant gains in cervical extension and bilateral rotation, and decreased pain scores were found. There were no adverse effects. Unlike other mobilization studies, PPT changes at a remote site were statistically but not clinically meaningful. Findings suggest that transverse mobilization would be a productive topic for controlled clinical trials. PMID:25395827

[Spanish translation and cross-cultural adaptation of the ARMS-scale for measuring medication adherence in polypathological patients].

PubMed

González-Bueno, Javier; Calvo-Cidoncha, Elena; Sevilla-Sánchez, Daniel; Espaulella-Panicot, Joan; Codina-Jané, Carles; Santos-Ramos, Bernardo

2017-10-01

Translate the ARMS scale into Spanish ensuring cross-cultural equivalence for measuring medication adherence in polypathological patients. Translation, cross-cultural adaptation and pilot testing. Secondary hospital. (i)Forward and blind-back translations followed by cross-cultural adaptation through qualitative methodology to ensure conceptual, semantic and content equivalence between the original scale and the Spanish version. (ii)Pilot testing in non-institutionalized polypathological patients to assess the instrument for clarity. The Spanish version of the ARMS scale has been obtained. Overall scores from translators involved in forward and blind-back translations were consistent with a low difficulty for assuring conceptual equivalence between both languages. Pilot testing (cognitive debriefing) in a sample of 40 non-institutionalized polypathological patients admitted to an internal medicine department of a secondary hospital showed an excellent clarity. The ARMS-e scale is a Spanish-adapted version of the ARMS scale, suitable for measuring adherence in polypathological patients. Its structure enables a multidimensional approach of the lack of adherence allowing the implementation of individualized interventions guided by the barriers detected in every patient. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

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

PubMed

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

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

Polarity-Dependent Misperception of Subjective Visual Vertical during and after Transcranial Direct Current Stimulation (tDCS)

PubMed Central

Santos-Pontelli, Taiza E. G.; Rimoli, Brunna P.; Favoretto, Diandra B.; Mazin, Suleimy C.; Truong, Dennis Q.; Leite, Joao P.; Pontes-Neto, Octavio M.; Babyar, Suzanne R.; Reding, Michael; Bikson, Marom; Edwards, Dylan J.

2016-01-01

Pathologic tilt of subjective visual vertical (SVV) frequently has adverse functional consequences for patients with stroke and vestibular disorders. Repetitive transcranial magnetic stimulation (rTMS) of the supramarginal gyrus can produce a transitory tilt on SVV in healthy subjects. However, the effect of transcranial direct current stimulation (tDCS) on SVV has never been systematically studied. We investigated whether bilateral tDCS over the temporal-parietal region could result in both online and offline SVV misperception in healthy subjects. In a randomized, sham-controlled, single-blind crossover pilot study, thirteen healthy subjects performed tests of SVV before, during and after the tDCS applied over the temporal-parietal region in three conditions used on different days: right anode/left cathode; right cathode/left anode; and sham. Subjects were blind to the tDCS conditions. Montage-specific current flow patterns were investigated using computational models. SVV was significantly displaced towards the anode during both active stimulation conditions when compared to sham condition. Immediately after both active conditions, there were rebound effects. Longer lasting after-effects towards the anode occurred only in the right cathode/left anode condition. Current flow models predicted the stimulation of temporal-parietal regions under the electrodes and deep clusters in the posterior limb of the internal capsule. The present findings indicate that tDCS over the temporal-parietal region can significantly alter human SVV perception. This tDCS approach may be a potential clinical tool for the treatment of SVV misperception in neurological patients. PMID:27031726

Hydrotherapy vs. conventional land-based exercise for improving walking and balance after stroke: a randomized controlled trial.

PubMed

Zhu, Zhizhong; Cui, Liling; Yin, Miaomiao; Yu, Yang; Zhou, Xiaona; Wang, Hongtu; Yan, Hua

2016-06-01

To investigate the effects of hydrotherapy on walking ability and balance in patients with chronic stroke. Single-blind, randomized controlled pilot trial. Outpatient rehabilitation clinic at a tertiary neurological hospital in China. A total of 28 participants with impairments in walking and controlling balance more than six months post-stroke. After baseline evaluations, participants were randomly assigned to a land-based therapy (control group, n = 14) or hydrotherapy (study group, n = 14). Participants underwent individual sessions for four weeks, five days a week, for 45 minutes per session. After four weeks of rehabilitation, all participants were evaluated by a blinded assessor. Functional assessments included the Functional Reach Test, Berg Balance Scale, 2-minute walk test, and Timed Up and Go Test. After four weeks of treatment, the Berg Balance Scale, functional reach test, 2-minute walk test, and the Timed Up and Go Test scores had improved significantly in each group (P < 0.05). The mean improvement of the functional reach test and 2-minute walk test were significantly higher in the aquatic group than in the control group (P < 0.01). The differences in the mean values of the improvements in the Berg Balance Scale and the Timed Up and Go Test were not statistically significant. The results of this study suggest that a relatively short programme (four weeks) of hydrotherapy exercise resulted in a large improvement in a small group (n = 14) of individuals with relatively high balance and walking function following a stroke. © The Author(s) 2015.

Magnetic resonance imaging-ultrasound fusion biopsy for prediction of final prostate pathology.

PubMed

Le, Jesse D; Stephenson, Samuel; Brugger, Michelle; Lu, David Y; Lieu, Patricia; Sonn, Geoffrey A; Natarajan, Shyam; Dorey, Frederick J; Huang, Jiaoti; Margolis, Daniel J A; Reiter, Robert E; Marks, Leonard S

2014-11-01

We explored the impact of magnetic resonance imaging-ultrasound fusion prostate biopsy on the prediction of final surgical pathology. A total of 54 consecutive men undergoing radical prostatectomy at UCLA after fusion biopsy were included in this prospective, institutional review board approved pilot study. Using magnetic resonance imaging-ultrasound fusion, tissue was obtained from a 12-point systematic grid (mapping biopsy) and from regions of interest detected by multiparametric magnetic resonance imaging (targeted biopsy). A single radiologist read all magnetic resonance imaging, and a single pathologist independently rereviewed all biopsy and whole mount pathology, blinded to prior interpretation and matched specimen. Gleason score concordance between biopsy and prostatectomy was the primary end point. Mean patient age was 62 years and median prostate specific antigen was 6.2 ng/ml. Final Gleason score at prostatectomy was 6 (13%), 7 (70%) and 8-9 (17%). A tertiary pattern was detected in 17 (31%) men. Of 45 high suspicion (image grade 4-5) magnetic resonance imaging targets 32 (71%) contained prostate cancer. The per core cancer detection rate was 20% by systematic mapping biopsy and 42% by targeted biopsy. The highest Gleason pattern at prostatectomy was detected by systematic mapping biopsy in 54%, targeted biopsy in 54% and a combination in 81% of cases. Overall 17% of cases were upgraded from fusion biopsy to final pathology and 1 (2%) was downgraded. The combination of targeted biopsy and systematic mapping biopsy was needed to obtain the best predictive accuracy. In this pilot study magnetic resonance imaging-ultrasound fusion biopsy allowed for the prediction of final prostate pathology with greater accuracy than that reported previously using conventional methods (81% vs 40% to 65%). If confirmed, these results will have important clinical implications. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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.

PubMed

Vildmyren, Iselin; Cao, Huy John Vu; Haug, Lina Bowitz; Valand, Ida Ulrikke; Eng, Øyvin; Oterhals, Åge; Austgulen, Maren Hoff; Halstensen, Alfred; Mellgren, Gunnar; Gudbrandsen, Oddrun A

2018-06-05

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.

Effect of Silymarin Administration on Cisplatin Nephrotoxicity: Report from A Pilot, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

PubMed

Shahbazi, Foroud; Sadighi, Sanambar; Dashti-Khavidaki, Simin; Shahi, Farhad; Mirzania, Mehrzad; Abdollahi, Alireza; Ghahremani, Mohammad-Hossein

2015-07-01

Despite several introduced preventive modalities, cisplatin nephrotoxicity remains a clinical problem. Some in vitro and in vivo studies have addressed the protective effects of silymarin against cisplatin nephrotoxicity. This study evaluated the effects of silymarin administration on cisplatin nephrotoxicity as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of oral silymarin 420 mg daily in three divided doses starting 24-48 h before the initiation of cisplatin infusion and continuing to the end of three 21-day cisplatin-containing chemotherapy courses on cisplatin-induced renal electrolytes wasting and kidney function were assessed. Cisplatin-associated acute kidney injury (AKI) occurred in 8% of the patients. Urine neutrophil gelatinase-associated lipocalin to urine creatinine ratio (NGAL/Cr) and urinary magnesium and potassium wasting increased significantly after cisplatin infusion in both groups. Significant positive correlation was found between cumulative dose of cisplatin and urine NGAL/Cr after three courses of cisplatin infusion. Incidence of AKI and the magnitude of urinary magnesium and potassium wasting did not differ between silymarin and placebo groups. No adverse reaction was reported by silymarin administration. Prophylactic administration of conventional form of silymarin tablets could not prevent cisplatin-induced urine electrolyte wasting or renal function impairment. Copyright © 2015 John Wiley & Sons, Ltd.

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

PubMed

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.

Integrating culturally informed approaches into the physiotherapy assessment and treatment of chronic pain: protocol for a pilot randomised controlled trial

PubMed Central

Veljanova, Irena; Schabrun, Siobhan; Chipchase, Lucinda

2017-01-01

Introduction There is strong evidence that biopsychosocial approaches are efficacious in the management of chronic pain. However, implementation of these approaches in clinical practice is known not to account for the beliefs and values of culturally and linguistically diverse (CALD) patients. This limitation in translation of research contributes to the disparities in outcomes for CALD patients with chronic pain adding to the socioeconomic burden of this prevalent condition. Cultural adaptation of chronic pain assessment and management is urgently required. Thus, the aim of this pilot randomised controlled trial (RCT) is to determine the feasibility, participant acceptance with and clinical effectiveness of a culturally adapted physiotherapy assessment and treatment approach when contrasted with ‘usual evidence based physiotherapy care’ for three CALD communities. Methods and analysis Using a participant-blinded and assessor-blinded randomised controlled pilot design, patients with chronic pain who self-identify as Assyrian, Mandaean or Vietnamese will be randomised to either 'culturally adapted physiotherapy assessment and treatment' or ‘evidence informed usual physiotherapy care'. We will recruit 16 participants from each ethnocultural community that will give a total of 24 participants in each treatment arm. Both groups will receive physiotherapy treatment for up to 10 sessions over 3 months. Outcomes including feasibility data, acceptance with the culturally adapted intervention, functional and pain-related measures will be collected at baseline and 3 months by a blinded assessor. Analysis will be descriptive for feasibility outcomes, while measures for clinical effectiveness will be explored using independent samples t-tests and repeated measures analysis of variance. This analysis will inform sample size estimates while also allowing for identification of revisions in the protocol or intervention prior to a larger scale RCT. Ethics and dissemination This trial has full ethical approval (HREC/16/LPOOL/194). The results from this pilot RCT will be presented at scientific meetings and published in peer-reviewed journals. Trial registration number ACTRN12616000857404 PMID:28501812

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

PubMed

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.

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

PubMed Central

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

CDI Sensitivity and Crosstrack Error on Nonprecision Approaches

DOT National Transportation Integrated Search

1991-01-01

This study was conducted to determine the influence of course deviation : indicator (CDI) sensitivity on pilot tracking error during nonprecision approaches. : Twelve pilots flew an instrumented single-engine airplane on 144 approaches at six : diffe...

A Double Blind, Randomized Study of Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT A) versus Oral Oxybutynin in SCI Patients with NDO (11 09 10 04)

DTIC Science & Technology

2017-10-01

Overactive bladder is a condition resulting from disruption of the normal micturition process. It is a syndrome complex characterized by urinary...from our pilot study in patients with another model of bladder dysfunction (i.e. interstitial cystitis/painful bladder syndrome (IC/PBS)) implanted...increased risk with exposure to ONAboNT-A including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis. 17

Considerations in the Treatment of the Adult Blind Patient.

ERIC Educational Resources Information Center

Shulman, Dennis G.

1986-01-01

Contends that blindness is not a single clinical determinant, but, rather, that two groups of blind people exist. For those congenitally blind, lack of vision can cause developmental difficulties. For those who later acquire blindness, the premorbid psychodynamics and object relationships are most important in understanding the persons' reactions…

Design and Real-World Evaluation of Eyes-Free Yoga: An Exergame for Blind and Low-Vision Exercise

PubMed Central

Rector, Kyle; Vilardaga, Roger; Lansky, Leo; Lu, Kellie; Bennett, Cynthia L.; Ladner, Richard E.; Kientz, Julie A.

2017-01-01

People who are blind or low vision may have a harder time participating in exercise due to inaccessibility or lack of encouragement. To address this, we developed Eyes-Free Yoga using the Microsoft Kinect that acts as a yoga instructor and has personalized auditory feedback based on skeletal tracking. We conducted two different studies on two different versions of Eyes-Free Yoga: (1) a controlled study with 16 people who are blind or low vision to evaluate the feasibility of a proof-of-concept and (2) an 8-week in-home deployment study with 4 people who are blind or low vision, with a fully functioning exergame containing four full workouts and motivational techniques. We found that participants preferred the personalized feedback for yoga postures during the laboratory study. Therefore, the personalized feedback was used as a means to build the core components of the system used in the deployment study and was included in both study conditions. From the deployment study, we found that the participants practiced Yoga consistently throughout the 8-week period (Average hours = 17; Average days of practice = 24), almost reaching the American Heart Association recommended exercise guidelines. On average, motivational techniques increased participant’s user experience and their frequency and exercise time. The findings of this work have implications for eyes-free exergame design, including engaging domain experts, piloting with inexperienced users, using musical metaphors, and designing for in-home use cases. PMID:29104712

Single oral doses of netazepide (YF476), a gastrin receptor antagonist, cause dose-dependent, sustained increases in gastric pH compared with placebo and ranitidine in healthy subjects.

PubMed

Boyce, M; David, O; Darwin, K; Mitchell, T; Johnston, A; Warrington, S

2012-07-01

Nonclinical studies have shown netazepide (YF476) to be a potent, selective, competitive and orally active gastrin receptor antagonist. To administer to humans for the first time single oral doses of netazepide, to assess their tolerability, safety, pharmacokinetics and effect on 24-h gastric pH. We did two randomised double-blind single-dose studies in healthy subjects. The first (n = 12) was a six-way incomplete crossover pilot study of rising doses of netazepide (range 0.5-100 mg) and placebo. The second (n = 20) was a five-way complete crossover study of netazepide 5, 25 and 100 mg, ranitidine 150 mg and placebo. In both trials we collected frequent blood samples, measured plasma netazepide and calculated pharmacokinetic parameters. In the comparative trial we measured gastric pH continuously for 24 h and compared treatments by percentage time gastric pH ≥4. Netazepide was well tolerated. Median t (max) and t (½) for the 100 mg dose were about 1 and 7 h, respectively, and the pharmacokinetics were dose-proportional. Netazepide and ranitidine each increased gastric pH. Onset of activity was similarly rapid for both. All netazepide doses were more effective than placebo (P ≤ 0.023). Compared with ranitidine, netazepide 5 mg was as effective, and netazepide 25 and 100 mg were much more effective (P ≤ 0.010), over the 24 h after dosing. Activity of ranitidine lasted about 12 h, whereas that of netazepide exceeded 24 h. In human: netazepide is an orally active gastrin antagonist, and gastrin has a major role in controlling gastric acidity. Repeated-dose studies are justified. NCT01538784 and NCT01538797. © 2012 Blackwell Publishing Ltd.

The Effect of Pre-Emptive Administration of Dextromethorphan on Postoperative Pain in Patients Undergoing Interval Laparoscopic Tubal Sterilization

DTIC Science & Technology

2001-10-01

requirements following surgery. Dextromethorphan , a readily available nonopioid antitussive in clinical use for more than 40 years, is one such NMDA...receptor Anticosti. This prospective, randomized, double blind pilot study compared the effects over time when patients received dextromethorphan versus...groups. Group I received 60 mg of dextromethorphan orally, and Group II received an oral placebo. Postoperative pain was assessed using an 11 point

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

PubMed

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.

Treatment of dogs with compensated myxomatous mitral valve disease with spironolactone-a pilot study.

PubMed

Hezzell, M J; Boswood, A; López-Alvarez, J; Lötter, N; Elliott, J

2017-08-01

Spironolactone improves outcome in dogs with advanced myxomatous mitral valve disease (MMVD). Its efficacy in preclinical MMVD is unknown. The hypothesis was the administration of spironolactone to dogs with compensated MMVD demonstrating risk factors for poorer prognosis will decrease the rate of disease progression. The aim was to provide pilot data to evaluate preliminary effects and sample size calculation for a definitive clinical trial. Twenty-five client-owned dogs with MMVD with at least one of the following; left atrial to aortic ratio (LA:Ao) ≥ 1.5, normalized left ventricular internal diameter in diastole ≥ 1.6), N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 550 pmol/L, cardiac troponin I > 0.025 ng/mL. Prospective, single-center, equally randomized, placebo-controlled, double-blinded, parallel grouped pilot study. No dogs were receiving medications for cardiac disease before the enrollment. Twelve dogs received placebo; 13 received spironolactone. One dog in the spironolactone group died suddenly, 1 developed congestive heart failure, and 2 received suboptimal spironolactone doses. At enrollment, NT-proBNP was significantly higher in the spironolactone group (p=0.005). Left atrial to aortic ratio (p=0.002) and left ventricular internal diameter in diastole (p=0.005) increased over time in the placebo group, but not the spironolactone group; the change did not differ significantly between groups. The change in biomarker concentrations did not differ significantly between groups; there was a tendency toward an increase in NT-proBNP over time in the placebo group. Enrollment of 76 dogs would be necessary to demonstrate a difference in the change in LA:Ao over 6 months between the groups. Preliminary results support undertaking a larger clinical trial of treatment of dogs with preclinical MMVD with spironolactone. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of whole-body vibration on plasma sclerostin level in healthy women.

PubMed

Çidem, Muharrem; Karakoç, Yunus; Ekmekçi, Hakan; Küçük, Suat Hayri; Uludağ, Murat; Gün, Kerem; Karamehmetoğlu, Safak Sahir; Karacan, İlhan

2014-01-01

To determine whether plasma sclerostin levels are affected by applying whole-body vibration treatments. Following a pilot study, the pretsent prospective, randomized, controlled single-blind study was performed on 16 healthy volunteer women (ages 20 to 40 years). Subjects were randomly divided into 2 groups, and whole-body vibration was applied to the treatment group but not to the controls. The plasma sclerostin levels were measured before the treatment and at the 10th minute after whole-body vibration on the 1st, 2nd, and 5th days of application. The plasma sclerostin level measured at 10 min after the whole-body vibration treatment increased 91% (P = 0.024) on the 1st day and decreased 31.5% (P = 0.03) on the 5th day in the whole-body vibration group. In the control group, there was no change in the plasma sclerostin level at any time. A progressive increase in baseline plasma sclerostin levels during the 5 days of vibration sessions was also found. Our study demonstrated that whole-body vibration can change plasma sclerostin levels, and that this change is detectable 10 min after whole-body vibration treatments.

Does enhanced insulin sensitivity improve sleep measures in patients with obstructive sleep apnea: A randomized, placebo-controlled pilot study

PubMed Central

Liu, Alice; Kim, Sun H.; Ariel, Danit; Abbasi, Fahim; Lamendola, Cindy; Cardell, James; Xu, Shiming; Patel, Shailja; Tomasso, Vanessa; Mojaddidi, Hafasa; Grove, Kaylene; Tsao, Philip S.; Kushida, Clete A.; Reaven, Gerald M.

2016-01-01

Background High fasting insulin levels have been reported to predict development of observed apneas, suggesting that insulin resistance may contribute to the pathogenesis of obstructive sleep apnea (OSA). The study aim was to determine whether enhancing insulin sensitivity in individuals with OSA would improve sleep measures. Patients/Methods Insulin-resistant, nondiabetic individuals with untreated OSA were randomized (2:1) to pioglitazone (45mg/day) or placebo for 8 weeks in this single-blind study. All individuals had repeat measurements pertaining to sleep (overnight polysomnography and Functional Outcomes of Sleep Questionnaire) and insulin action (insulin suppression test). Results Forty-five overweight/obese men and women with moderate/severe OSA were randomized to pioglitazone (n=30) or placebo (n=15). Although insulin sensitivity increased 31% among pioglitazone-treated as compared to no change among individuals receiving placebo ((p<0.001 for between-group difference), no improvements in quantitative or qualitative sleep measurements were observed. Conclusions Pioglitazone administration increased insulin sensitivity in otherwise untreated individuals with OSA, without any change in polysomnographic sleep measures over an 8-week period. These findings do not support a causal role for insulin resistance in the pathogenesis of OSA. PMID:27544837

Real-Time Monitoring and Prediction of the Pilot Vehicle System (PVS) Closed-Loop Stability

NASA Astrophysics Data System (ADS)

Mandal, Tanmay Kumar

Understanding human control behavior is an important step for improving the safety of future aircraft. Considerable resources are invested during the design phase of an aircraft to ensure that the aircraft has desirable handling qualities. However, human pilots exhibit a wide range of control behaviors that are a function of external stimulus, aircraft dynamics, and human psychological properties (such as workload, stress factor, confidence, and sense of urgency factor). This variability is difficult to address comprehensively during the design phase and may lead to undesirable pilot-aircraft interaction, such as pilot-induced oscillations (PIO). This creates the need to keep track of human pilot performance in real-time to monitor the pilot vehicle system (PVS) stability. This work focused on studying human pilot behavior for the longitudinal axis of a remotely controlled research aircraft and using human-in-the-loop (HuIL) simulations to obtain information about the human controlled system (HCS) stability. The work in this dissertation is divided into two main parts: PIO analysis and human control model parameters estimation. To replicate different flight conditions, this study included time delay and elevator rate limiting phenomena, typical of actuator dynamics during the experiments. To study human control behavior, this study employed the McRuer model for single-input single-output manual compensatory tasks. McRuer model is a lead-lag controller with time delay which has been shown to adequately model manual compensatory tasks. This dissertation presents a novel technique to estimate McRuer model parameters in real-time and associated validation using HuIL simulations to correctly predict HCS stability. The McRuer model parameters were estimated in real-time using a Kalman filter approach. The estimated parameters were then used to analyze the stability of the closed-loop HCS and verify them against the experimental data. Therefore, the main contribution of this dissertation is the design of an unscented Kalman filter-based algorithm to estimate McRuer model parameters in real time, and a framework to validate this algorithm for single-input single-output manual compensatory tasks to predict instabilities.

Breakthrough Listen on MWA Pilot Study

NASA Astrophysics Data System (ADS)

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

2016-07-01

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

A Pilot Study Assessing ECG versus ECHO Ventriculoventricular Optimization in Pediatric Resynchronization Patients.

PubMed

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 < 0.01). Mean 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.

Psychoeducational Intervention for Symptom Management of Fatigue, Pain, and Sleep Disturbance Cluster Among Cancer Patients: A Pilot Quasi-Experimental Study.

PubMed

Nguyen, Ly Thuy; Alexander, Kimberly; Yates, Patsy

2018-06-01

To assess the feasibility of conducting a trial of a psychoeducational intervention involving the provision of tailored information and coaching to improve management of a cancer-related symptom cluster (fatigue, pain, and sleep disturbance) and reduce symptom cluster impacts on patient health outcomes in the Vietnamese context and to undertake a preliminary evaluation of the intervention. A parallel-group single-blind pilot quasi-experimental trial was conducted with 102 cancer patients in one Vietnamese hospital. The intervention group received one face-to-face session and two phone sessions delivered by a nurse one week apart, and the comparison group received usual care. Patient outcomes were measured at baseline before the chemotherapy cycle and immediately preceding the next chemotherapy cycle. Separate linear mixed models were used to evaluate the impact of the intervention on total symptom cluster severity, symptom scores, functional status, depressive symptoms, and health-related quality of life. The study design was feasible with a recruitment rate of 22.6% and attrition rate of 9.8%. Compared to the control group, the intervention group showed a significant reduction in symptom cluster severity, fatigue severity, fatigue interference, sleep disturbance, depression, and anxiety. Significant differences were not observed for pain severity, pain interference, functional status, and health-related quality of life. The intervention was acceptable to the study population, with a high attendance rate of 78% and adherence rate of 95.7%. On the basis of the present study findings, future randomized controlled trials are needed to test the effectiveness of a symptom cluster psychoeducational intervention in Vietnam. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

A randomised controlled trial of adjunctive yoga and adjunctive physical exercise training for cognitive dysfunction in schizophrenia.

PubMed

Bhatia, Triptish; Mazumdar, Sati; Wood, Joel; He, Fanyin; Gur, Raquel E; Gur, Ruben C; Nimgaonkar, Vishwajit L; Deshpande, Smita N

2017-04-01

Yoga and physical exercise have been used as adjunctive intervention for cognitive dysfunction in schizophrenia (SZ), but controlled comparisons are lacking. Aims A single-blind randomised controlled trial was designed to evaluate whether yoga training or physical exercise training enhance cognitive functions in SZ, based on a prior pilot study. Consenting, clinically stable, adult outpatients with SZ (n=286) completed baseline assessments and were randomised to treatment as usual (TAU), supervised yoga training with TAU (YT) or supervised physical exercise training with TAU (PE). Based on the pilot study, the primary outcome measure was speed index for the cognitive domain of 'attention' in the Penn computerised neurocognitive battery. Using mixed models and contrasts, cognitive functions at baseline, 21 days (end of training), 3 and 6 months post-training were evaluated with intention-to-treat paradigm. Speed index of attention domain in the YT group showed greater improvement than PE at 6 months follow-up (p<0.036, effect size 0.51). In the PE group, 'accuracy index of attention domain showed greater improvement than TAU alone at 6-month follow-up (p<0.025, effect size 0.61). For several other cognitive domains, significant improvements were observed with YT or PE compared with TAU alone (p<0.05, effect sizes 0.30-1.97). Both YT and PE improved attention and additional cognitive domains well past the training period, supporting our prior reported beneficial effect of YT on speed index of attention domain. As adjuncts, YT or PE can benefit individuals with SZ.

Trial of early noninvasive ventilation for ALS: A pilot placebo-controlled study.

PubMed

Jacobs, Teresa L; Brown, Devin L; Baek, Jonggyu; Migda, Erin M; Funckes, Timothy; Gruis, Kirsten L

2016-11-01

To evaluate the use and tolerability of noninvasive positive pressure ventilation (NIV) in patients with amyotrophic lateral sclerosis (ALS) early in their disease by comparing active NIV and sham NIV in patients not yet eligible for NIV use as recommended by practice guidelines. This was a single-center, prospective, double-blind, randomized, placebo (sham)-controlled pilot trial. Patients with ALS were randomized to receive either sham NIV or active NIV and underwent active surveillance approximately every 3 months until they reached a forced vital capacity (FVC) <50% or required NIV for clinical symptom management. In total, 54 participants were randomized. The mean NIV use was 2.0 hours (95% confidence interval [CI] 1.1-3.0) per day in the sham NIV treatment group and 3.3 hours (CI 2.0-4.6) per day in the active NIV group, which did not differ by treatment group (p = 0.347). The majority of sham NIV participants (88%) and active NIV participants (73%) reported only mild or no problem with NIV use. Difference of change in FVC through the treatment period by group (0.44 per month) favored active NIV (p = 0.049). Survival and changes in maximal inspiratory or expiratory pressure did not differ between treatment groups. The efficacy of early NIV in ALS should be tested in randomized, placebo-controlled trials. The trial is registered on clinicaltrials.gov (NCT00580593). This study provides Class II evidence that for patients with ALS, adherence with NIV and sham NIV are similar. © 2016 American Academy of Neurology.

A pilot randomized controlled trial of the Occupational Goal Intervention method for the improvement of executive functioning in patients with treatment-resistant schizophrenia.

PubMed

Vizzotto, Adriana D B; Celestino, Diego L; Buchain, Patricia C; Oliveira, Alexandra M; Oliveira, Graça M R; Di Sarno, Elaine S; Napolitano, Isabel C; Elkis, Helio

2016-11-30

Schizophrenia is a chronic disabling mental disorder that involves impairments in several cognitive domains, especially in executive functions (EF), as well as impairments in functional performance. This is particularly true in patients with Treatment-Resistant Schizophrenia (TRS). The aim of this study was to test the efficacy of the Occupational Goal Intervention (OGI) method for the improvement of EF in patients with TRS. In this randomized, controlled, single-blind pilot study, 25 TRS patients were randomly assigned to attend 30 sessions of either OGI or craft activities (control) over a 15-week period and evaluated by the Behavioural Assessment of the Dysexecutive Syndrome (BADS) as the primary outcome and the Direct Assessment of Functional Status (DAFS-BR) as well as the Independent Living Skills Survey (ILSS-BR) as secondary outcomes, all adapted for the Brazilian population. The Positive and Negative Syndrome Scale (PANSS) was used for monitoring symptom severity. Results showed significant statistical differences, favoring the OGI group in terms of improvement on the BADS, both in subtests (Action Program and Key Search) and the total score. Improvements in EFs were observed by families in various dimensions as measured by different subtests of the ILSS-BR inventory. The OGI group showed no significant results in secondary outcomes (DAFS-BR) except in terms of improvement of communication skills. Although preliminary, our results indicate that the OGI method is efficacious and effective for patients with TRS. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Single-Pilot Workload Management

NASA Technical Reports Server (NTRS)

Rogers, Jason; Williams, Kevin; Hackworth, Carla; Burian, Barbara; Pruchnicki, Shawn; Christopher, Bonny; Drechsler, Gena; Silverman, Evan; Runnels, Barry; Mead, Andy

2013-01-01

Integrated glass cockpit systems place a heavy cognitive load on pilots (Burian Dismukes, 2007). Researchers from the NASA Ames Flight Cognition Lab and the FAA Flight Deck Human Factors Lab examined task and workload management by single pilots. This poster describes pilot performance regarding programming a reroute while at cruise and meeting a waypoint crossing restriction on the initial descent.

High dose vitamin D therapy for chronic pain in children and adolescents with sickle cell disease: results of a randomized double blind pilot study.

PubMed

Osunkwo, Ifeyinwa; Ziegler, Thomas R; Alvarez, Jessica; McCracken, Courtney; Cherry, Korin; Osunkwo, Chinyere E; Ofori-Acquah, Solomon F; Ghosh, Samit; Ogunbobode, Adeolu; Rhodes, Jim; Eckman, James R; Dampier, Carlton; Tangpricha, Vin

2012-10-01

We report results of a pilot study of high-dose vitamin D in sickle cell disease (SCD). Subjects were given a 6-week course of oral high-dose cholecalciferol (4000-100 000 IU per week) or placebo and monitored prospectively for a period of six months. Vitamin D insufficiency and deficiency was present at baseline in 82·5% and 52·5% of subjects, respectively. Subjects who received high-dose vitamin D achieved higher serum 25-hydroxyvitamin D, experienced fewer pain days per week, and had higher physical activity quality-of-life scores. These findings suggest a potential benefit of vitamin D in reducing the number of pain days in SCD. Larger prospective studies with longer duration are needed to confirm these effects. © 2012 Blackwell Publishing Ltd.

Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study.

PubMed

Younger, Jarred; Mackey, Sean

2009-01-01

Fibromyalgia is a chronic pain disorder that is characterized by diffuse musculoskeletal pain and sensitivity to mechanical stimulation. In this pilot clinical trial, we tested the effectiveness of low-dose naltrexone in treating the symptoms of fibromyalgia. Participants completed a single-blind, crossover trial with the following time line: baseline (2 weeks), placebo (2 weeks), drug (8 weeks), and washout (2 weeks). Ten women meeting criteria for fibromyalgia and not taking an opioid medication. Naltrexone, in addition to antagonizing opioid receptors on neurons, also inhibits microglia activity in the central nervous system. At low doses (4.5 mg), naltrexone may inhibit the activity of microglia and reverse central and peripheral inflammation. Participants completed reports of symptom severity everyday, using a handheld computer. In addition, participants visited the lab every 2 weeks for tests of mechanical, heat, and cold pain sensitivity. Low-dose naltrexone reduced fibromyalgia symptoms in the entire cohort, with a greater than 30% reduction of symptoms over placebo. In addition, laboratory visits showed that mechanical and heat pain thresholds were improved by the drug. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient. Baseline erythrocyte sedimentation rate predicted over 80% of the variance in drug response. Individuals with higher sedimentation rates (indicating general inflammatory processes) had the greatest reduction of symptoms in response to low-dose naltrexone. We conclude that low-dose naltrexone may be an effective, highly tolerable, and inexpensive treatment for fibromyalgia.

Screening for diabetic retinopathy in primary care with a mobile fundal camera--evaluation of a South African pilot project.

PubMed

Mash, Bob; Powell, Di; du Plessis, Felicity; van Vuuren, Unita; Michalowska, Margaret; Levitt, Naomi

2007-12-01

In South Africa diabetes makes a significant contribution to the burden of disease. Diabetic retinopathy is a leading cause of adult blindness, and screening can reduce the incidence. This project aimed to implement and evaluate a new service for retinal screening that uses a non-mydriatic mobile fundal camera in primary care. This is the first time such a service has been evaluated in an African primary care context. The service was implemented as an operational research study at three community health centres and data were collected to evaluate the operational issues, screening, reporting and referral of patients. Out of 400 patients screened 84% had a significantly reduced visual acuity, 63% had retinopathy (22% severe nonproliferative, 6% proliferative and 15% maculopathy), 2% of eyes could not be screened and 14% of patients required dilatation. Referral was necessary in 27% of cases for cataracts, in 7% for laser treatment and in 4% for other specialist services. Repeat photography was needed in 8% and urgent follow-up in 12%. A SWOT analysis of the pilot project was completed and recommendations were made on how to integrate it into the district health system. Screening with a fundal camera improved the quality of care for diabetic patients and is feasible in the South African public sector, primary care setting. A single technician should be able to photograph almost 10,000 patients a year.

A Pilot Study of Integrated Listening Systems for Children with Sensory Processing Problems

ERIC Educational Resources Information Center

Schoen, Sarah A.; Miller, Lucy J.; Sullivan, Jillian

2015-01-01

This pilot study explored the effects of Integrated Listening Systems (iLs) Focus Series on individualized parent goals for children with sensory processing impairments. A nonconcurrent multiple baseline, repeated measure across participants, single-case study design was employed (n = 7). The 40-session intervention was delivered at home and in…

Single-channel mixed signal blind source separation algorithm based on multiple ICA processing

NASA Astrophysics Data System (ADS)

Cheng, Xiefeng; Li, Ji

2017-01-01

Take separating the fetal heart sound signal from the mixed signal that get from the electronic stethoscope as the research background, the paper puts forward a single-channel mixed signal blind source separation algorithm based on multiple ICA processing. Firstly, according to the empirical mode decomposition (EMD), the single-channel mixed signal get multiple orthogonal signal components which are processed by ICA. The multiple independent signal components are called independent sub component of the mixed signal. Then by combining with the multiple independent sub component into single-channel mixed signal, the single-channel signal is expanded to multipath signals, which turns the under-determined blind source separation problem into a well-posed blind source separation problem. Further, the estimate signal of source signal is get by doing the ICA processing. Finally, if the separation effect is not very ideal, combined with the last time's separation effect to the single-channel mixed signal, and keep doing the ICA processing for more times until the desired estimated signal of source signal is get. The simulation results show that the algorithm has good separation effect for the single-channel mixed physiological signals.

Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

PubMed

Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

2014-02-01

The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

Effects of Weighted Vests on Classroom Behavior for Children with Autism and Cognitive Impairments

ERIC Educational Resources Information Center

Hodgetts, Sandra; Magill-Evans, Joyce; Misiaszek, John

2011-01-01

This randomized controlled single-case study investigated the effects of weighted vests for 10 children with autism in a classroom setting. Blinded observers rated targeted behaviors through video taken during structured table-top activities typically part of the classroom routine. Blinded teachers rated each child's behavior with the Conners'…

SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial.

PubMed

Carlsson, Håkan; Rosén, Birgitta; Pessah-Rasmussen, Hélène; Björkman, Anders; Brogårdh, Christina

2018-04-17

Many stroke survivors suffer from sensory impairments of their affected upper limb (UL). Although such impairments can affect the ability to use the UL in everyday activities, very little attention is paid to sensory impairments in stroke rehabilitation. The purpose of this trial is to investigate if sensory re-learning in combination with task-specific training may prove to be more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation, and life satisfaction. This study is a single-blinded pilot randomized controlled trial (RCT) with two treatment arms. The participants will be randomly assigned either to sensory re-learning in combination with task-specific training (sensory group) or to task-specific training only (control group). The training will consist of 2.5 h of group training per session, 2 times per week for 5 weeks. The primary outcome measures to assess sensory function are as follows: Semmes-Weinstein monofilament, Shape/Texture Identification (STI™) test, Fugl-Meyer Assessment-upper extremity (FMA-UE; sensory section), and tactile object identification test. The secondary outcome measures to assess motor function are as follows: Box and Block Test (BBT), mini Sollerman Hand Function Test (mSHFT), Modified Motor Assessment Scale (M-MAS), and Grippit. To assess the ability to use the hand in daily activities, perceived participation, and life satisfaction, the Motor Activity Log (MAL), Canadian Occupational Performance Measure (COPM), Stroke Impact Scale (SIS) participation domain, and Life Satisfaction checklist will be used. Assessments will be performed pre- and post-training and at 3-month follow-up by independent assessors, who are blinded to the participants' group allocation. At the 3-month follow-up, the participants in the sensory group will also be interviewed about their general experience of the training and how effective they perceived the training. The results from this study can add new knowledge about the effectiveness of sensory re-learning in combination with task-specific training on UL functioning after stroke. If the new training approach proves efficient, the results can provide information on how to design a larger RCT in the future in persons with sensory impairments of the UL after stroke. ClinicalTrials.gov, NCT03336749 . Registered on 8 November 2017.

A simulator investigation of the use of digital data link for pilot/ATC communications in a single pilot operation

NASA Technical Reports Server (NTRS)

Hinton, David A.; Lohr, Gary W.

1988-01-01

Studies have shown that radio communications between pilots and air traffic control contribute to high pilot workload and are subject to various errors. These errors result from congestion on the voice radio channel, and missed and misunderstood messages. The use of digital data link has been proposed as a means of reducing this workload and error rate. A critical factor, however, in determining the potential benefit of data link will be the interface between future data link systems and the operator of those systems, both in the air and on the ground. The purpose of this effort was to evaluate the pilot interface with various levels of data link capability, in simulated general aviation, single-pilot instrument flight rule operations. Results show that the data link reduced demands on pilots' short-term memory, reduced the number of communication transmissions, and permitted the pilots to more easily allocate time to critical cockpit tasks while receiving air traffic control messages. The pilots who participated unanimously indicated a preference for data link communications over voice-only communications. There were, however, situations in which the pilot preferred the use of voice communications, and the ability for pilots to delay processing the data link messages, during high workload events, caused delays in the acknowledgement of messages to air traffic control.

The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive–behavioural therapy

PubMed Central

Murphy, Glynis H.; Shepstone, Lee; Wilson, Edward C.F.; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

2016-01-01

Background There is a growing interest in using cognitive–behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. Aims To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Method Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. Results The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence. PMID:27703772

New counter-countermeasure techniques for laser anti-dazzling spectacles

NASA Astrophysics Data System (ADS)

Donval, Ariela; Partouche, Eran; Lipman, Ofir; Gross, Noam; Fisher, Tali; Oron, Moshe

2016-05-01

Aviation, commercial and military, is new area in optics that is suffering from laser threats in the last years. Dazzling and damage to pilot's eyes by laser pointers is a common threat lately. Under certain conditions, laser light, directed at aircraft can be hazardous. The most likely scenario is when bright visible laser light causes distraction and/or temporary flash blindness to the pilot, during a critical phase of flight like landing or takeoff. It is also possible, that a visible or invisible beam could cause permanent damage to a pilot's eyes. This paper presents a novel technology for protection of the human eye against laser threats in the visible range.

A summary and integration of research concerning single pilot IFR operational problems

NASA Technical Reports Server (NTRS)

Chapman, G. C.

1983-01-01

A review of seven research studies pertaining to Single Pilot IFR (SPIFR) operations was performed. Two studies were based on questionnaire surveys; two based on National Transportation Safety Board (NTSB) reports; two were based on Aviation Safety Reporting System (ASRS) incident reports, and one report used event analysis and statistics to forecast problems. The results obtained in each study were extracted and integrated. Results were synthesized and key issues pertaining to SPIFR operations problems were identified. The research that was recommended by the studies and that addressed the key issues is catalogued for each key issue.

Effect of transdermal magnesium cream on serum and urinary magnesium levels in humans: A pilot study.

PubMed

Kass, Lindsy; Rosanoff, Andrea; Tanner, Amy; Sullivan, Keith; McAuley, William; Plesset, Michael

2017-01-01

Oral magnesium supplementation is commonly used to support a low magnesium diet. This investigation set out to determine whether magnesium in a cream could be absorbed transdermally in humans to improve magnesium status. In this single blind, parallel designed pilot study, n = 25 participants (aged 34.3+/-14.8y, height 171.5+/-11cm, weight 75.9 +/-14 Kg) were randomly assigned to either a 56mg/day magnesium cream or placebo cream group for two weeks. Magnesium serum and 24hour urinary excretion were measured at baseline and at 14 days intervention. Food diaries were recorded for 8 days during this period. Mg test and placebo groups' serum and urinary Mg did not differ at baseline. After the Mg2+ cream intervention there was a clinically relevant increase in serum magnesium (0.82 to 0.89 mmol/l,p = 0.29) that was not seen in the placebo group (0.77 to 0.79 mmol/L), but was only statistically significant (p = 0.02)) in a subgroup of non-athletes. Magnesium urinary excretion increased from baseline slightly in the Mg2+ group but with no statistical significance (p = 0.48). The Mg2+ group showed an 8.54% increase in serum Mg2+ and a 9.1% increase in urinary Mg2+ while these figures for the placebo group were smaller, i.e. +2.6% for serum Mg2+ and -32% for urinary Mg2+. In the placebo group, both serum and urine concentrations showed no statistically significant change after the application of the placebo cream. No previous studies have looked at transdermal absorbency of Mg2+ in human subjects. In this pilot study, transdermal delivery of 56 mg Mg/day (a low dose compared with commercial transdermal Mg2+ products available) showed a larger percentage rise in both serum and urinary markers from pre to post intervention compared with subjects using the placebo cream, but statistical significance was achieved only for serum Mg2+ in a subgroup of non-athletes. Future studies should look at higher dosage of magnesium cream for longer durations. ISRCTN registry ID No. ISRTN15136969.

Levosimendan versus milrinone in neonates and infants after corrective open-heart surgery: a pilot study.

PubMed

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 index remained stable in the milrinone group. This pilot study has primarily served to obtain experience using the new drug levosimendan in neonates and infants and to initiate further multicenter trials in pediatric patients.

Perception-action relationships reconsidered in light of spatial display instruments

NASA Technical Reports Server (NTRS)

Shebilske, Wayne L.

1989-01-01

Spatial display instruments convey information about both the identity and the location of objects in order to assist surgeons, astronauts, pilots, blind individuals, and others in identification, remote manipulations, navigation, and obstacle avoidance. Scientists believe that these instruments have not reached their full potential and that progress toward new applications, including the possibility of restoring sight to the blind, will be accelerated by advancing the understanding of perceptual processes. This stimulating challenge to basic researchers was advanced by Paul Bach-Y-Rita (1972) and by the National Academy of Science (1986) report on Electronic Aids for the Blind. Although progress has been made, new applications of spatial display instruments in medicine, space, aviation, and rehabilitation await improved theoretical and empirical foundations.

Teaching Young People Who Are Blind and Have Autism to Make Requests Using a Variation on the Picture Exchange Communication System with Tactile Symbols: A Preliminary Investigation

ERIC Educational Resources Information Center

Lund, Shelley K.; Troha, Jeanette M.

2008-01-01

This study used a single-subject multiple baseline across participants design to evaluate the effectiveness of a modified picture exchange communication system (PECS) teaching protocol with tactile symbols. Three students (two male, one female) aged 12-17 years who had autism and were blind participated in the study. The instructional program…

Metformin plus sibutramine for olanzapine-associated weight gain and metabolic dysfunction in schizophrenia: a 12-week double-blind, placebo-controlled pilot study.

PubMed

Baptista, Trino; Uzcátegui, Euderruh; Rangel, Nairy; El Fakih, Yamily; Galeazzi, Tatiana; Beaulieu, Serge; de Baptista, Enma Araujo

2008-05-30

Metformin (850-1700 mg) plus sibutramine (10-20 mg, n=13) or placebo (n=15) was administered for 12 weeks in olanzapine-treated chronic schizophrenia patients. Weight loss was similar in both groups: -2.8+/-3.2 kg vs. -1.4+/-2.6 kg. Except for preventing a triglyceride increase, the drug combination lacked efficacy for metabolic control in this clinical population.

The 1980 and 1981 Accident Experience of Civil Airmen with Selected Visual Pathology,

DTIC Science & Technology

1983-07-01

contact lens users did not. The present study examined the 1980-81 accident experience of 4,169 monocular pilots, 1,299 with amblyopia , 969 with aphakia...organic lesions, and others had an entry of "no fusion" on their reports of examination, the amblyopia and tropia categories were also scheduled for...the 10 selected eye pathologies (diplopia, tropia, aphakia, lens implants, blindness or absence of an eye, amblyopia , right hyperphoria >1 diopter

Pilot-model measurements of pilot responses in a lateral-directional control task

NASA Technical Reports Server (NTRS)

Adams, J. J.

1976-01-01

Pilot response during an aircraft bank-angle compensatory control task was measured by using an adaptive modeling technique. In the main control loop, which is the bank angle to aileron command loop, the pilot response was the same as that measured previously in single-input, single-output systems. The pilot used a rudder to aileron control coordination that canceled up to 80 percent of the vehicle yawing moment due to aileron deflection.

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.

PubMed

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.

Skin adhesive low-level light therapy for dysmenorrhoea: a randomized, double-blind, placebo-controlled, pilot trial.

PubMed

Shin, Yong-Il; Kim, Nam-Gyun; Park, Kyoung-Jun; Kim, Dong-Wook; Hong, Gi-Youn; Shin, Byung-Cheul

2012-10-01

The cause of dysmenorrhoea is an abnormal function of smooth muscles in the uterus due to long-term deficient blood supply into smooth muscle tissue. The purpose of this study was to evaluate the effectiveness of skin adhesive low-level light therapy (LLLT) in participants with dysmenorrhoea. Thirty-one women were included in this randomized, double-blind, placebo-controlled, pilot trial. Twenty-one women were treated with active LLLT and ten women were treated with placebo one. The therapy was performed in a laboratory room for 20 min a day over a period of 5 days prior to the expected onset of menstruation. The outcome was measured using a visual analog scale (VAS) for each participant's dysmenorrhoeal pain severity. VAS of each subject was measured every month for 6 months. In the active LLLT group, 16 women reported successful results during their first menstrual cycle just after active LLLT and 5 women had successful results from the second menstrual cycle after active LLLT. The pain reduction rate was 83 % in the active LLLT group, whereas there was only a slight and temporary reduction in pain in the placebo LLLT group. Changes of VAS within 6 months of LLLT showed statistical significance (p = 0.001) over placebo control. Our study suggests that skin adhesive LLLT on acupuncture points might be an effective, simple and safe non-pharmacological treatment for dysmenorrhoea.

Bee venom acupuncture point injection for central post stroke pain: a preliminary single-blind randomized controlled trial.

PubMed

Cho, Seung-Yeon; Park, Joo-Young; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Park, Seong-Uk

2013-06-01

We investigated apipuncture, or acupuncture point injection with diluted bee venom, as a promising new treatment for central post stroke pain (CPSP). Bee venom, diluted to 0.005% in normal saline, was administered to the treatment group, and normal saline given to control group as twice-weekly injections for three weeks. The points were LI15, GB21, LI11, GB31, ST36 and GB39 of the affected side and the amount of injection was 0.05 ml at each point. Eight patients in each group were included in the analysis. After three weeks there were significant decreases in visual analogue pain scores compared with baseline in both groups and the treatment group improved more significantly than the control group (p = 0.009). Apipuncture significantly improved CPSP in this pilot trial. Further studies of its mechanisms and a larger and long-term follow-up trial will be needed to determine more definitely the efficacy of apipuncture and to elucidate duration of improvement. Copyright © 2013 Elsevier Ltd. All rights reserved.

Low-dose hydrocortisone replacement improves wellbeing and pain tolerance in chronic pain patients with opioid-induced hypocortisolemic responses. A pilot randomized, placebo-controlled trial.

PubMed

Nenke, Marni A; Haylock, Clare L; Rankin, Wayne; Inder, Warrick J; Gagliardi, Lucia; Eldridge, Crystal; Rolan, Paul; Torpy, David J

2015-06-01

Long-term opioid therapy has been associated with low cortisol levels due to central suppression of the hypothalamic-pituitary-adrenal axis. The implications of hypocortisolism on wellbeing have not been established. Our aim was to determine whether intervention with physiologic glucocorticoid replacement therapy improves wellbeing and analgesic responses in patients with chronic non-cancer pain on long-term opioid therapy with mild cortisol deficiency. We performed a pilot randomized, double-blind, placebo-controlled crossover study of oral hydrocortisone replacement therapy in 17 patients recruited from a Pain Clinic at a single tertiary center in Adelaide, Australia. Patients were receiving long-term opioid therapy (≥ 20 mg morphine equivalents per day for ≥ 4 weeks) for chronic non-cancer pain with mild hypocortisolism, as defined by a plasma cortisol response ≤ 350 nmol/L at 60 min following a cold pressor test. The crossover intervention included 28-day treatment with either 10mg/m(2)/day of oral hydrocortisone in three divided doses or placebo. Improvement in wellbeing was assessed using Version 2 of the Short Form-36 (SF-36v2), Brief Pain Inventory-Short Form, and Addison's disease quality of life questionnaires; improvement in analgesic response was assessed using cold pressor threshold and tolerance times. Following treatment with hydrocortisone, the bodily pain (P=0.042) and vitality (P=0.013) subscales of the SF-36v2 were significantly better than scores following treatment with placebo. There was also an improvement in pain interference on general activity (P=0.035), mood (P=0.03) and work (P=0.04) following hydrocortisone compared with placebo. This is the first randomized, double-blind placebo-controlled trial of glucocorticoid replacement in opioid users with chronic non-cancer pain and mild hypocortisolism. Our data suggest that physiologic hydrocortisone replacement produces improvements in vitality and pain experiences in this cohort compared with placebo. Therapeutic Goods Administration Clinical Trials Notification Scheme (Drugs), Trial Number 2012/0476. Copyright © 2015 Elsevier Ltd. All rights reserved.

Spatial memory and integration processes in congenital blindness.

PubMed

Vecchi, Tomaso; Tinti, Carla; Cornoldi, Cesare

2004-12-22

The paper tests the hypothesis that difficulties met by the blind in spatial processing are due to the simultaneous treatment of independent spatial representations. Results showed that lack of vision does not impede the ability to process and transform mental images; however, blind people are significantly poorer in the recall of more than a single spatial pattern at a time than in the recall of the corresponding material integrated into a single pattern. It is concluded that the simultaneous maintenance of different spatial information is affected by congenital blindness, while cognitive processes that may involve sequential manipulation are not.

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

PubMed

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 arabinogalactan on salivary IgA, white blood cell count, inflammatory cytokines or complement. The proprietary arabinogalactan extract (ResistAid), tested in this randomized, double-blind, placebo-controlled, parallel-group pilot study, increased the antibody response of healthy volunteers to the 23-valent pneumococcal vaccine compared to placebo. ISRCTN98817459.

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

PubMed Central

2010-01-01

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 was no effect from the vaccine or arabinogalactan on salivary IgA, white blood cell count, inflammatory cytokines or complement. Conclusions The proprietary arabinogalactan extract (ResistAid™), tested in this randomized, double-blind, placebo-controlled, parallel-group pilot study, increased the antibody response of healthy volunteers to the 23-valent pneumococcal vaccine compared to placebo. Trial Registration ISRCTN98817459 PMID:20796315

Flying by Ear: Blind Flight with a Music-Based Artificial Horizon

NASA Technical Reports Server (NTRS)

Simpson, Brian D.; Brungart, Douglas S.; Dallman, Ronald C.; Yasky, Richard J., Jr.; Romigh, Griffin

2008-01-01

Two experiments were conducted in actual flight operations to evaluate an audio artificial horizon display that imposed aircraft attitude information on pilot-selected music. The first experiment examined a pilot's ability to identify, with vision obscured, a change in aircraft roll or pitch, with and without the audio artificial horizon display. The results suggest that the audio horizon display improves the accuracy of attitude identification overall, but differentially affects response time across conditions. In the second experiment, subject pilots performed recoveries from displaced aircraft attitudes using either standard visual instruments, or, with vision obscured, the audio artificial horizon display. The results suggest that subjects were able to maneuver the aircraft to within its safety envelope. Overall, pilots were able to benefit from the display, suggesting that such a display could help to improve overall safety in general aviation.

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

PubMed

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

2017-09-01

Efficacy in previous studies of surgical treatments of refractory multiple sclerosis tremor using lesioning or deep brain stimulation (DBS) has been variable. The aim of this study was to investigate the safety and efficacy of dual-lead thalamic DBS (one targeting the ventralis intermedius-ventralis oralis posterior nucleus border [the VIM lead] and one targeting the ventralis oralis anterior-ventralis oralis posterior border [the VO lead]) for the treatment of multiple sclerosis tremor. We did a single centre, single-blind, prospective, randomised pilot trial at the University of Florida Center for Movement Disorders and Neurorestoration clinic (Gainesville, FL, USA). We recruited adult patients with a clinical diagnosis of multiple sclerosis tremor refractory to previous medical therapy. Before surgery to implant both leads, we randomly assigned patients (1:1) to receive 3 months of optimised single-lead DBS-either VIM or VO. We did the randomisation with a computer-generated sequence, using three blocks of four patients, and independent members of the Center did the assignment. Patients and all clinicians other than the DBS programming nurse were masked to the choice of lead. Patients underwent surgery 1 month after their baseline visit for implantation of the dual lead DBS system. A pulse generator and two extension cables were implanted in a second surgery 3-4 weeks later. Patients then received an initial 3-month period of continuous stimulation of either the VIM or VO lead followed by blinded safety assessment of their tremor with the Tolosa-Fahn-Marin Tremor Rating Scale (TRS) during optimised VIM or VO lead stimulation at the end of the 3 months. After this visit, both leads were activated in all patients for an additional 3 months, and optimally programmed during serial visits as dictated by a prespecified programming algorithm. At the 6-month follow-up visit, TRS score was measured, and mood and psychological batteries were administered under four stimulation conditions: VIM on, VO on, both on, and both off (the order of testing was chosen by a computer-generated random sequence, assigned by independent members of the centre, and enacted by an unmasked DBS programming nurse). Each of four stimulation settings were tested over 4 consecutive days, with stimulation settings held constant for at least 12 h before testing. The primary outcome was change in mean total TRS score at the 6-month postoperative assessment with both leads activated, compared with the preoperative baseline mean TRS score. Analysis was by intention to treat. Safety was analysed in all patients who received the surgical implantation except in one patient who discontinued before the safety assessment. This trial is registered with ClinicalTrials.gov, number NCT00954421. Between Jan 16, 2007, and Dec 17, 2013, we enrolled 12 patients who were randomly assigned either to 3 initial months of VIM-only or VO-only stimulation. One patient from the VO-only group developed an infection necessitating DBS explantation, and was excluded from the assessment of the primary outcome. Compared with the mean baseline TRS score of 57·0 (SD 10·2), the mean score at 6 months decreased to 40·1 (17·6), -29·6% reduction; t=-0·28, p=0·03. Three of 11 patients did not respond to surgical intervention. One patient died suddenly 2 years after surgery, but this was judged to be unrelated to DBS implantation. Serious adverse events included a superficial wound infection in one patient that resolved with antibiotic therapy, and transient altered mental status and late multiple sclerosis exacerbation in another patient. The most common non-serious adverse events were headache and fatigue. Dual lead thalamic DBS might be a safe and effective option for improving severe, refractory multiple sclerosis tremor. Larger studies are necessary to show whether this technique is widely applicable, safe in the long-term, and effective in treating multiple sclerosis tremor or other severe tremor disorders. US National Institutes of Health, the Cathy Donnellan, Albert E Einstein, and Birdie W Einstein Fund, and the William Merz Professorship. Copyright © 2017 Elsevier Ltd. All rights reserved.

Protocol for a randomised, placebo-controlled pilot study for assessing feasibility and efficacy of faecal microbiota transplantation in a paediatric ulcerative colitis population: PediFETCh trial

PubMed Central

Popov, Jelena

2017-01-01

Introduction Ulcerative colitis (UC) is a chronic, relapsing condition characterised by colonic inflammation. Increasing prevalence in early-age diagnosis provides opportunities for additional complications in later life as a result of prolonged exposure to inflammatory and therapeutic insults, necessitating novel avenues for therapeutics which may result in fewer side effects. Faecal microbiota transplantation (FMT) has previously demonstrated potential therapeutic benefit in an adult randomised-controlled trial and several recurrent Clostridium difficile infection studies. This phase Ib pilot will be the first randomised, single-blinded, placebo-controlled trial to assess feasibility and patient outcomes in a paediatric inflammatory bowel disease (IBD) population. Methods and analysis Fifty patients will be randomised 1:1 to receive normal saline control or active sample. Enema administrations will be performed two times per week for 6 weeks, followed at a 6-month follow-up period. Feasibility outcomes will include measures of patient eligibility, recruitment, willingness to participate, samples collections, hospitalizations and drop-out rate. Improvements in disease symptoms will determine the efficacy of treatment. Clinical disease scores will be taken throughout the study period using the Paediatric Ulcerative Colitis Activity Index (PUCAI). Monitoring of inflammatory markers in blood and stool will be performed at regular intervals. Microbiome analysis will be conducted on stool samples collected throughout the trials period. Imaging and endoscopic surveillance will be conducted if clinically necessary. Ethics and dissemination Ethics was obtained from local hospital research ethics boards across all three sites. Health Canada and FDA approval was obtained for the use of an Investigatory New Drug product. Results from this trial will be presented in international conferences and published in peer-review journals. Trial registration number Trial registration number: NCT02487238; preresults. PMID:28827258

Review of immunomodulation by photopheresis: treatment of cutaneous T-cell lymphoma, autoimmune disease, and allograft rejection.

PubMed

Wolfe, J T; Lessin, S R; Singh, A H; Rook, A H

1994-12-01

Photopheresis is an apheresis-based therapy that is currently available at approximately 70 medical centers worldwide. Recent evidence indicates that extracorporeal photopheresis can significantly prolong life as well as induce a 60-75% response rate among individuals with advanced cutaneous T-cell lymphoma (CTCL). Moreover, a 10-15% cure rate, in response to photopheresis alone, or in combination with interferon-alpha, has been obtained at our institution. These complete responses have been characterized by the complete disappearance of morphologically atypical cells from the skin and blood. Southern blot analysis of peripheral blood specimens has also confirmed the indefinite disappearance of the malignant T-cell clone from the blood of patients with complete responses. Current immunological data obtained from in vitro human studies and from animal models suggest that the basis for the responses of CTCL patients are related to activation of treated macrophages resulting in release of cytokines, including substantial levels of tumor necrosis factor alpha (TNF-alpha), and perhaps, to the induction of anticlonotypic immunity directed against pathogenic clones of T lymphocytes. In addition to the treatment of CTCL, a potential role for photopheresis in the therapy of autoimmune disease has been suggested by recent pilot studies of pemphigus vulgaris, rheumatoid arthritis, and systemic lupus erythematosus. Furthermore, a randomized, single-blinded trial involving 79 patients with early onset, aggressive systemic sclerosis suggested that photopheresis could benefically affect the course of the cutaneous thickening in this form of the disease. Lastly, two independent pilot studies of cardiac transplantation have indicated that photopheresis can reverse acute cardiac allograft rejection and potentially suppress ongoing chronic rejection. Randomized, controlled trials for these new indications for photopheresis therapy are currently in the early stages of implementation.

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

PubMed

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

2017-06-01

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

Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial.

PubMed

Huang, Jia; McCaskey, Michael A; Yang, Shanli; Ye, Haicheng; Tao, Jing; Jiang, Cai; Schuster-Amft, Corina; Balzer, Christian; Ettlin, Thierry; Schupp, Wilfried; Kulke, Hartwig; Chen, Lidian

2015-12-02

A majority of stroke survivors present with cognitive impairments. Attention disturbance, which leads to impaired concentration and overall reduced cognitive functions, is strongly associated with stroke. The clinical efficacy of acupuncture with Baihui (GV20) and Shenting (GV24) as well as computer-assisted cognitive training in stroke and post-stroke cognitive impairment have both been demonstrated in previous studies. To date, no systematic comparison of these exists and the potential beneficial effects of a combined application are yet to be examined. The main objective of this pilot study is to evaluate the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The second objective is to test the effects of a combined cognitive intervention that incorporates computer-assisted cognitive training and acupuncture (ACoTrain). An international multicentre, single-blinded, randomised controlled pilot trial will be conducted. In a 1:1:1 ratio, 60 inpatients with post-stroke cognitive dysfunction will be randomly allocated into either the acupuncture group, the computer-assisted cognitive training group, or the ACoTrain group in addition to their individual rehabilitation programme. The intervention period of this pilot trial will last 4 weeks (30 minutes per day, 5 days per week, Monday to Friday). The primary outcome is the test battery for attentional performance. The secondary outcomes include the Trail Making Test, Test des Deux Barrages, National Institute of Health Stroke Scale, and Modified Barthel Index for assessment of daily life competence, and the EuroQol Questionnaire for health-related quality of life. This trial mainly focuses on evaluating the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The results of this pilot trial are expected to provide new insights on how Eastern and Western medicine can complement one another and improve the treatment of cognitive impairments in early stroke rehabilitation. Including patients with different cultural backgrounds allows a more generalisable interpretation of the results but also poses risks of performance bias. Using standardised and well-described assessments, validated for each region, is pivotal to allow pooling of the data. Clinical Trails.gov ID: NCT02324959 (8 December 2014).

Using CALMERSS to Enhance Teacher Well-Being: A Pilot Study

ERIC Educational Resources Information Center

Taylor, Mark J.

2018-01-01

Prior research has shown that cognitive behavioural therapy, relaxation, mindfulness, exercise and positive psychology interventions, when conducted as single interventions, have a useful effect on depression and also increasing well-being. The purpose of this study was to conduct a pilot programme to determine the efficacy of a multi-modal…

A pilot randomized double-blind placebo-controlled trial on topical chamomile (Matricaria chamomilla L.) oil for severe carpal tunnel syndrome.

PubMed

Hashempur, Mohammad Hashem; Lari, Zeinab Nasiri; Ghoreishi, Parissa Sadat; Daneshfard, Babak; Ghasemi, Mohammad Sadegh; Homayouni, Kaynoosh; Zargaran, Arman

2015-11-01

To assess the effectiveness of standardized topical Chamomile (Matricaria chamomilla L.) oil in patients with severe carpal tunnel syndrome, as a complementary treatment. A pilot randomized double-blind placebo-controlled trial was conducted. Twenty six patients with documented severe carpal tunnel syndrome were treated in two parallel groups with a night splint plus topical chamomile oil or placebo. They were instructed to use their prescribed oil for 4 weeks, twice daily. Symptomatic and functional status of the patients and their electrodiagnostic parameters were evaluated when enrolled and after the trial period, as our outcome measures. A significant improvement of symptomatic and functional status of patients in the chamomile oil group was observed (p = 0.019 and 0.016, respectively) compared with those in the placebo group. However, electrodiagnostic parameters showed no significant changes between the two groups. Chamomile oil improved symptomatic and functional status of patients with severe carpal tunnel syndrome. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Randomized Controlled Pilot Trial of Different Mobile Messaging Interventions for Problem Drinking Compared to Weekly Drink Tracking

PubMed Central

van Stolk-Cooke, Katherine; Kuerbis, Alexis; Stadler, Gertraud; Baumel, Amit; Shao, Sijing; McKay, James R.; Morgenstern, Jon

2017-01-01

Introduction Recent evidence suggests that text messaging may help to reduce problem drinking as an extension to in-person services, but very little is known about the effectiveness of remote messaging on problem drinking as a stand-alone intervention, or how different types of messages may improve drinking outcomes in those seeking to moderate their alcohol consumption. Methods We conducted an exploratory, single-blind randomized controlled pilot study comparing four different types of alcohol reduction-themed text messages sent daily to weekly drink self-tracking texts in order to determine their impact on drinking outcomes over a 12-week period in 152 participants (≈ 30 per group) seeking to reduce their drinking on the internet. Messaging interventions included: weekly drink self-tracking mobile assessment texts (MA), loss-framed texts (LF), gain-framed texts (GF), static tailored texts (ST), and adaptive tailored texts (TA). Poisson and least squares regressions were used to compare differences between each active messaging group and the MA control. Results When adjusting for baseline drinking, participants in all messaging groups except GF significantly reduced the number of drinks consumed per week and the number of heavy drinking days compared to MA. Only the TA and GF groups were significantly different from MA in reducing the number of drinking days. While the TA group yielded the largest effect sizes on all outcome measures, there were no significant differences between active messaging groups on any outcome measure. 79.6% of individuals enrolled in the study wanted to continue receiving messages for an additional 12 weeks at the end of the study. Discussion Results of this pilot study indicate that remote automated text messages delivered daily can help adult problem drinkers reduce drinking frequency and quantity significantly more than once-a-week self-tracking messages only, and that tailored adaptive texts yield the largest effect sizes across outcomes compared to MA. Larger samples are needed to understand differences between messaging interventions and to target their mechanisms of efficacy. PMID:28146560

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

...] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot... Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and...

Pilot study of pyridostigmine in constipated patients with autonomic neuropathy.

PubMed

Bharucha, Adil E; Low, Phillip A; Camilleri, Michael; Burton, Duane; Gehrking, Tonette L; Zinsmeister, Alan R

2008-08-01

The effects of cholinesterase inhibitors, which increase colonic motility in health, on chronic constipation are unknown. Our aims were to evaluate the efficacy of cholinesterase inhibitors for dysautonomia and chronic constipation and to assess whether acute effects could predict the long term response. In this single-blind study, 10 patients with autonomic neuropathy and constipation were treated with placebo (2 weeks), followed by an escalating dose of pyridostigmine to the maximum tolerated dose (i.e., 180-540 mg daily) for 6 weeks. Symptoms and gastrointestinal transit were assessed at 2 and 8 weeks. The acute effects of neostigmine on colonic transit and motility were also assessed. At baseline, 4, 6, and 3 patients had delayed gastric, small intestinal, and colonic transit respectively. Pyridostigmine was well tolerated in most patients, improved symptoms in 4 patients, and accelerated the geometric center for colonic transit at 24 h by > or =0.7 unit in 3 patients. The effects of i.v. neostigmine on colonic transit and compliance predicted (P < 0.05) the effects of pyridostigmine on colonic transit. Pyridostigmine improves colonic transit and symptoms in some patients with autonomic neuropathy and constipation. The motor response to neostigmine predicted the response to oral pyridostigmine.

Effects of Vitamin B6 (Pyridoxine) and a B Complex Preparation on Dreaming and Sleep.

PubMed

Aspy, Denholm J; Madden, Natasha A; Delfabbro, Paul

2018-06-01

Anecdotal evidence indicates that supplementation with vitamin B6 (pyridoxine) before bed can enhance dream vividness and recall. In a single pilot study, Ebben, Lequerica, and Spielman (2002) found that vitamin B6 had a dose-dependent effect of increasing scores on a composite measure of dream vividness, bizarreness, emotionality, and color. The present research replicated this study using a larger and more diverse sample of 100 participants from across Australia. We conducted a randomized, double-blind, placebo-controlled investigation of the effects on dreaming and sleep of ingesting 240 mg vitamin B6 (pyridoxine hydrochloride) before bed for five consecutive days. We also included an exploratory condition involving a B complex preparation containing a range of B vitamins. We found that vitamin B6 significantly increased the amount of dream content participants recalled but did not significantly affect dream vividness, bizarreness, or color, nor did it significantly affect other sleep-related variables. In contrast, participants in the B complex group showed significantly lower self-rated sleep quality and significantly higher tiredness on waking. We discuss the potential for using vitamin B6 in research on lucid dreaming.

Multiday Transcranial Direct Current Stimulation Causes Clinically Insignificant Changes in Childhood Dystonia: A Pilot Study.

PubMed

Bhanpuri, Nasir H; Bertucco, Matteo; Young, Scott J; Lee, Annie A; Sanger, Terence D

2015-10-01

Abnormal motor cortex activity is common in dystonia. Cathodal transcranial direct current stimulation may alter cortical activity by decreasing excitability while anodal stimulation may increase motor learning. Previous results showed that a single session of cathodal transcranial direct current stimulation can improve symptoms in childhood dystonia. Here we performed a 5-day, sham-controlled, double-blind, crossover study, where we measured tracking and muscle overflow in a myocontrol-based task. We applied cathodal and anodal transcranial direct current stimulation (2 mA, 9 minutes per day). For cathodal transcranial direct current stimulation (7 participants), 3 subjects showed improvements whereas 2 showed worsening in overflow or tracking error. The effect size was small (about 1% of maximum voluntary contraction) and not clinically meaningful. For anodal transcranial direct current stimulation (6 participants), none showed improvement, whereas 5 showed worsening. Thus, multiday cathodal transcranial direct current stimulation reduced symptoms in some children but not to a clinically meaningful extent, whereas anodal transcranial direct current stimulation worsened symptoms. Our results do not support transcranial direct current stimulation as clinically viable for treating childhood dystonia. © The Author(s) 2015.

Shiatsu as an adjuvant therapy for depression in patients with Alzheimer's disease: A pilot study.

PubMed

Lanza, Giuseppe; Centonze, Stella Silvia; Destro, Gera; Vella, Veronica; Bellomo, Maria; Pennisi, Manuela; Bella, Rita; Ciavardelli, Domenico

2018-06-01

Among the complementary and alternative medicine, Shiatsu might represent a feasible option for depression in Alzheimer's disease (AD). We evaluated Shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Single-blind randomized controlled study. Dedicated Community Center for patients with AD. AD patients with depression were randomly assigned to the "active group" (Shiatsu + physical activity) or the "control group" (physical activity alone). Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination - MMSE), depressive symptoms (Geriatric Depression Scale - GDS), and functional status (Activity of Daily Living - ADL, Instrumental ADL - IADL) were assessed before and after the intervention. We found a within-group improvement of MMSE, ADL, and GDS in the active group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the active group. The combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

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 (P<0.05) for the ITT and completer groups based on ASEX item #1, but not by dosing groups. Maca 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.

A flight investigation of simulated data link communications during single-pilot IFR flight

NASA Technical Reports Server (NTRS)

Parker, J. F.; Duffy, J. W.; Christensen, D. G.

1983-01-01

A Flight Data Console (FDC) was developed to allow simulation of a digital communications link to replace the current voice communication system used in air traffic control (ATC). The voice system requires manipulation of radio equipment, read-back of clearances, and mental storage of critical information items, all contributing to high workload, particularly during single-pilot operations. This was an inflight study to determine how a digital communications system might reduce cockpit workload, improve flight proficiency, and be accepted by general aviation pilots. Results show that instrument flight, including approach and landing, can be accomplished quite effectively using a digital data link system for ATC communications. All pilots expressed a need for a back-up voice channel. When included, this channel was used sparingly and principally to confirm any item of information about which there might be uncertainty.

Cognitive effects of exogenous melatonin administration in elderly persons: a pilot study.

PubMed

Peck, Joel S; LeGoff, Daniel B; Ahmed, Iqbal; Goebert, Deborah

2004-01-01

Given that circadian rhythm disruption is associated with impairments in cognitive performance similar to those found in age-related cognitive decline, the authors investigated whether exogenous melatonin administration would improve cognitive functioning in healthy elderly subjects. This double-blind, placebo-controlled pilot study assigned 26 healthy elderly subjects to receive either melatonin 1 mg or placebo nightly for 4 weeks. Participants completed a sleep questionnaire and a battery of cognitive tests at baseline and at 4 weeks. Melatonin administration improved reported morning "restedness" and sleep latency after nocturnal awakening, and also improved scores on the California Verbal Learning Test-interference subtest. Melatonin administration at a dose of 1 mg nightly may be effective in improving certain aspects of cognitive functioning and subjective reports of sleep quality in elderly subjects. It may prove to be a useful therapeutic agent in the treatment of age-related cognitive decline.

Does touch inhibit visual imagery? A case study on acquired blindness.

PubMed

von Trott Zu Solz, Jana; Paolini, Marco; Silveira, Sarita

2017-06-01

In a single-case study of acquired blindness, differential brain activation patterns for visual imagery of familiar objects with and without tactile exploration as well as of tactilely explored unfamiliar objects were observed. Results provide new insight into retrieval of visual images from episodic memory and point toward a potential tactile inhibition of visual imagery. © 2017 The Institute of Psychology, Chinese Academy of Sciences and John Wiley & Sons Australia, Ltd.

Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

PubMed Central

Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

2016-01-01

Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

PubMed

Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

2017-05-03

The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

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

PubMed Central

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

2015-01-01

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

Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions

PubMed Central

Dobkin, Bruce H.

2014-01-01

Based on the suboptimal research pathways that finally led to multicenter randomized clinical trials (MRCTs) of treadmill training with partial body weight support and of robotic assistive devices, strategically planned successive stages are proposed for pilot studies of novel rehabilitation interventions Stage 1, consideration-of-concept studies, drawn from animal experiments, theories, and observations, delineate the experimental intervention in a small convenience sample of participants, so the results must be interpreted with caution. Stage 2, development-of-concept pilots, should optimize the components of the intervention, settle on most appropriate outcome measures, and examine dose-response effects. A well-designed study that reveals no efficacy should be published to counterweight the confirmation bias of positive trials. Stage 3, demonstration-of-concept pilots, can build out from what has been learned to test at least 15 participants in each arm, using random assignment and blinded outcome measures. A control group should receive an active practice intervention aimed at the same primary outcome. A third arm could receive a substantially larger dose of the experimental therapy or a combinational intervention. If only 1 site performed this trial, a different investigative group should aim to reproduce positive outcomes based on the optimal dose of motor training. Stage 3 studies ought to suggest an effect size of 0.4 or higher, so that approximately 50 participants in each arm will be the number required to test for efficacy in a stage 4, proof-of-concept MRCT. By developing a consensus around acceptable and necessary practices for each stage, similar to CONSORT recommendations for the publication of phase III clinical trials, better quality pilot studies may move quickly into better designed and more successful MRCTs of experimental interventions. PMID:19240197

77 FR 42187 - Relay Services for Deaf-Blind Individuals

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-18

... currently approved collection. Respondents: Individuals or households; businesses or other for- profit... the start of the pilot program. (c) Each program certified under the NDBEDP must retain all records... reimbursement claims as frequently as monthly. Each certified program that wishes to take advantage of this...

Design of an infrared camera based aircraft detection system for laser guide star installations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Friedman, H.; Macintosh, B.

1996-03-05

There have been incidents in which the irradiance resulting from laser guide stars have temporarily blinded pilots or passengers of aircraft. An aircraft detection system based on passive near infrared cameras (instead of active radar) is described in this report.

"Let's Talk about Drugs": Pilot Study of a Community-Level Drug Prevention Intervention Based on Motivational Interviewing Principles

ERIC Educational Resources Information Center

Newbery, Natasha; McCambridge, Jim; Strang, John

2007-01-01

Purpose: The feasibility of a community-level drug prevention intervention based upon the principles of motivational interviewing within a further education college was investigated in a pilot study. Design/methodology/approach: The implementation over the course of a single term of "Let's Talk about Drugs" was studied with both action…

Tonsillitis: MedlinePlus Health Topic

MedlinePlus

... Library of Medicine) Article: The debate continues: a prospective, randomised, single-blind study comparing Coblation... Article: Overnight in-hospital observation following tonsillectomy: retrospective study of post-operative intervention. Article: Immune thrombocytopenia ...

Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression.

PubMed

George, Duncan; Gálvez, Verònica; Martin, Donel; Kumar, Divya; Leyden, John; Hadzi-Pavlovic, Dusan; Harper, Simon; Brodaty, Henry; Glue, Paul; Taylor, Rohan; Mitchell, Philip B; Loo, Colleen K

2017-11-01

To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment. In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months. Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse. Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505). Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

A Validated Task Analysis of the Single Pilot Operations Concept

NASA Technical Reports Server (NTRS)

Wolter, Cynthia A.; Gore, Brian F.

2015-01-01

The current day flight deck operational environment consists of a two-person Captain/First Officer crew. A concept of operations (ConOps) to reduce the commercial cockpit to a single pilot from the current two pilot crew is termed Single Pilot Operations (SPO). This concept has been under study by researchers in the Flight Deck Display Research Laboratory (FDDRL) at the National Aeronautics and Space Administration's (NASA) Ames (Johnson, Comerford, Lachter, Battiste, Feary, and Mogford, 2012) and researchers from Langley Research Centers (Schutte et al., 2007). Transitioning from a two pilot crew to a single pilot crew will undoubtedly require changes in operational procedures, crew coordination, use of automation, and in how the roles and responsibilities of the flight deck and ATC are conceptualized in order to maintain the high levels of safety expected of the US National Airspace System. These modifications will affect the roles and the subsequent tasks that are required of the various operators in the NextGen environment. The current report outlines the process taken to identify and document the tasks required by the crew according to a number of operational scenarios studied by the FDDRL between the years 2012-2014. A baseline task decomposition has been refined to represent the tasks consistent with a new set of entities, tasks, roles, and responsibilities being explored by the FDDRL as the move is made towards SPO. Information from Subject Matter Expert interviews, participation in FDDRL experimental design meetings, and study observation was used to populate and refine task sets that were developed as part of the SPO task analyses. The task analysis is based upon the proposed ConOps for the third FDDRL SPO study. This experiment possessed nine different entities operating in six scenarios using a variety of SPO-related automation and procedural activities required to guide safe and efficient aircraft operations. The task analysis presents the roles and responsibilities in a manner that can facilitate testing future scenarios. Measures of task count and workload were defined and analyzed to assess the impact of transitioning to a SPO environment.

Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol.

PubMed

Wall, Peter Dh; Ahmed, Imran; Metcalfe, Andrew; Price, Andrew J; Seers, Kate; Hutchinson, Charles E; Parsons, Helen; Warwick, Jane; Rahman, Bushra; Brown, Jaclyn; Underwood, Martin

2018-04-10

This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible. Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State Examination will be evaluated as outcome tools for measuring cognitive impairment at days 1, 2 and 7 postoperatively. Thigh pain, blood transfusion requirements, venous thromboembolism, revision surgery, surgical complications, mortality and Oxford knee and five-level EuroQol-5D scores will be collected over 12 months. Integrated qualitative research study : 30 trial patients and 20 knee surgeons will take part in semistructured interviews. Interviews will capture views regarding the pilot trial and explore barriers and potential solutions to a full trial. Multicentre cohort study : UK National Joint Registry data will be linked to Hospital Episode Statistics to estimate the relationship between tourniquet use and venous thromboembolic event, length of hospital stay, risk of revision surgery and death. The study will conclude with a multidisciplinary workshop to reach a consensus on whether a full trial is warranted and feasible. National Research Ethics Committee (West Midlands-Edgbaston) approved this study on 27 January 2016 (15/WM/0455). The study is sponsored by University of Warwick and University Hospitals Coventry and Warwickshire. The results will be disseminated via high-impact peer-reviewed publication. ISRCTN20873088; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Treatment of Maladaptive Shame in Borderline Personality Disorder: A Pilot Study of "Opposite Action"

ERIC Educational Resources Information Center

Rizvi, Shireen L.; Linehan, Marsha M.

2005-01-01

This study sought to pilot test a short-term intervention for maladaptive shame in borderline personality disorder (BPD) based on the skill of "opposite action" from dialectical behavior therapy. Five women with BPD were treated with the intervention using a single-subject, multiple-baseline design. Results indicate that, although state ratings of…

Tai Chi for People with Visual Impairments: A Pilot Study

ERIC Educational Resources Information Center

Miszko, Tanya A.; Ramsey, Vincent K.; Blasch, Bruce B.

2004-01-01

This pilot study assessed the physical and psychological outcomes of a tai chi exercise program for eight adults with visual impairments. It found that after eight weeks of orientation and mobility training and tai chi practice, the participants' single leg-stance time and total knee flexion work and power improved, as did their frequency of,…

The Effectiveness of a Multidisciplinary Group Rehabilitation Program on the Psychosocial Functioning of Elderly People Who Are Visually Impaired

ERIC Educational Resources Information Center

Alma, Manna A.; Groothoff, Johan W.; Melis-Dankers, Bart J. M.; Suurmeijer, Theo P. B. M.; van der Mei, Sijrike F.

2013-01-01

Introduction: The pilot study reported here determined the effectiveness of a multidisciplinary group rehabilitation program, Visually Impaired Elderly Persons Participating (VIPP), on psychosocial functioning. Methods: The single-group pretest-posttest pilot study included 29 persons with visual impairments (aged 55 and older) who were referred…

The acute effect of pleasurable music on craving for alcohol: A pilot crossover study.

PubMed

Mathis, Walter S; Han, Xiaotong

2017-07-01

Chronic administration of drugs of abuse leads to a dopamine deficient state in the mesolimbic system, causing dysphoria in abstinence and contributing to craving and return to use. Recent functional imaging studies have shown that listening to personally pleasing music activates the mesolimbic reward system in a fashion similar to drugs of abuse. It has been proposed that such activation could ameliorate the dysphoria and craving of the hypodopaminergic state. The present study sought to evaluate the efficacy of listening to personally pleasing or moving music on reducing craving in abstinent alcoholics using a single-blind, within-subject randomized block design, with three randomly determined presentations of each condition. Twelve participants with Alcohol Use Disorder on a residential substance rehabilitation unit reported their level of craving with a Visual Analog Scale before and after listening to either the participant-selected song or white noise. Using a mixed model to analyze the crossover design, the music intervention was found to have a statistically significant advantage in craving reduction compared to the noise control. Our results indicate that personally pleasing music might have a role in augmenting substance use disorder treatment via craving reduction. Further study is warranted to elucidate factors which predict the most robust response from this intervention. Copyright © 2017 Elsevier Ltd. All rights reserved.

Single Pilot Workload Management During Cruise in Entry Level Jets

NASA Technical Reports Server (NTRS)

Burian, Barbara K.; Pruchnicki, Shawn; Christopher, Bonny; Silverman, Evan; Hackworth, Carla; Rogers, Jason; Williams, Kevin; Drechsler, Gena; Runnels, Barry; Mead, Andy

2013-01-01

Advanced technologies and automation are important facilitators of single pilot operations, but they also contribute to the workload management challenges faced by the pilot. We examined task completion, workload management, and automation use in an entry level jet (ELJ) flown by single pilots. Thirteen certificated Cessna Citation Mustang (C510-S) pilots flew an instrument flight rules (IFR) experimental flight in a Cessna Citation Mustang simulator. At one point participants had to descend to meet a crossing restriction prior to a waypoint and prepare for an instrument approach into an un-towered field while facilitating communication from a lost pilot who was flying too low for ATC to hear. Four participants experienced some sort of difficulty with regard to meeting the crossing restriction and almost half (n=6) had problems associated with the instrument approach. Additional errors were also observed including eight participants landing at the airport with an incorrect altimeter setting.

Different groups, different threats: a multi-threat approach to the experience of stereotype threats.

PubMed

Shapiro, Jenessa R

2011-04-01

Two studies demonstrated that different negatively stereotyped groups are at risk for distinct forms of stereotype threats. The Multi-Threat Framework articulates six distinct stereotype threats and the unique constellations of variables (e.g., group identification, stereotype endorsement) that elicit each stereotype threat. Previous research suggests that different negatively stereotyped groups systematically vary across these stereotype threat elicitors; a pilot study confirms these differences. Across two studies, groups that tend to elicit low stereotype endorsement (religion, race/ethnicity, congenital blindness) were less likely to report experiencing self-as-source stereotype threats (stereotype threats requiring stereotype endorsement) and groups that tend to elicit low group identification (mental illness, obesity, blindness later in life) were less likely to report experiencing group-as-target stereotype threats (stereotype threats requiring group identification). This research suggests that traditional models may overlook the experiences of stereotype threats within some groups and that interventions tailored to address differences between stereotype threats will be most effective.

Effects of a Group-Mediated Exercise and Dietary Intervention in the Treatment of Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: Results From the IDEA-P Trial.

PubMed

Focht, Brian C; Lucas, Alexander R; Grainger, Elizabeth; Simpson, Christina; Fairman, Ciaran M; Thomas-Ahner, Jennifer M; Buell, Jackie; Monk, J Paul; Mortazavi, Amir; Clinton, Steven K

2018-04-19

Although androgen-deprivation therapy (ADT) is the foundation of treatment for prostate cancer, the physiological impacts of ADT result in functional decline and enhanced risk of chronic disease and metabolic syndrome. The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is a single-blind, randomized, pilot trial comparing the effects of a group-mediated, cognitive-behavioral (GMCB) exercise and dietary intervention (EX+D) with those of a standard-of-care (SC) control during the treatment of prostate cancer patients undergoing ADT. A total of 32 prostate cancer patients (M age = 66.28, SD = 7.79) undergoing ADT were randomly assigned to the 12-week EX+D intervention (n = 16) or control (n = 16). The primary outcome in IDEA-P was change in mobility performance with secondary outcomes including body composition and muscular strength. Blinded assessment of outcomes were obtained at baseline and at 2- and 3-month follow-ups. Favorable adherence and retention rates were observed, and no serious intervention-related adverse events were documented. Intent-to-treat ANCOVA controlling for baseline value and ADT duration demonstrated that EX+D resulted in significantly greater improvements in mobility performance (p < .02), muscular strength (p < .01), body fat percentage (p < .05), and fat mass (p < .03) at 3-month follow-up, relative to control. Findings from the IDEA-P trial suggest that a GMCB-based EX+D intervention resulted in significant, clinically meaningful improvements in mobility performance, muscular strength, and body composition, relative to controls. Collectively, these results suggest that the EX+D was a safe and well-tolerated intervention for prostate cancer patients on ADT. The utility of implementing this approach in the treatment of prostate cancer patients on ADT should be evaluated in future large-scale efficacy trials. NCT02050906.

Horatio Audio-Describes Shakespeare's "Hamlet": Blind and Low-Vision Theatre-Goers Evaluate an Unconventional Audio Description Strategy

ERIC Educational Resources Information Center

Udo, J. P.; Acevedo, B.; Fels, D. I.

2010-01-01

Audio description (AD) has been introduced as one solution for providing people who are blind or have low vision with access to live theatre, film and television content. However, there is little research to inform the process, user preferences and presentation style. We present a study of a single live audio-described performance of Hart House…

Safety, tolerability, clinical, and joint structural outcomes of a single intra-articular injection of allogeneic mesenchymal precursor cells in patients following anterior cruciate ligament reconstruction: a controlled double-blind randomised trial.

PubMed

Wang, Yuanyuan; Shimmin, Andrew; Ghosh, Peter; Marks, Paul; Linklater, James; Connell, David; Hall, Stephen; Skerrett, Donna; Itescu, Silviu; Cicuttini, Flavia M

2017-08-02

Few clinical trials have investigated the safety and efficacy of mesenchymal stem cells for the management of post-traumatic osteoarthritis. The objectives of this pilot study were to determine the safety and tolerability and to explore the efficacy of a single intra-articular injection of allogeneic human mesenchymal precursor cells (MPCs) to improve clinical symptoms and retard joint structural deterioration over 24 months in patients following anterior cruciate ligament (ACL) reconstruction. In this phase Ib/IIa, double-blind, active comparator clinical study, 17 patients aged 18-40 years with unilateral ACL reconstruction were randomized (2:1) to receive either a single intra-articular injection of 75 million allogeneic MPCs suspended in hyaluronan (HA) (MPC + HA group) (n = 11) or HA alone (n = 6). Patients were monitored for adverse events. Immunogenicity was evaluated by anti-HLA panel reactive antibodies (PRA) against class I and II HLAs determined by flow cytometry. Pain, function, and quality of life were assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and SF-36v2 scores. Joint space width was measured from radiographs, and tibial cartilage volume and bone area assessed from magnetic resonance imaging (MRI). Moderate arthralgia and swelling within 24 h following injection that subsided were observed in 4 out of 11 in the MPC + HA group and 0 out of 6 HA controls. No cell-related serious adverse effects were observed. Increases in class I PRA >10% were observed at week 4 in the MPC + HA group that decreased to baseline levels by week 104. Compared with the HA group, MPC + HA-treated patients showed greater improvements in KOOS pain, symptom, activities of daily living, and SF-36 bodily pain scores (p < 0.05). The MPC + HA group had reduced medial and lateral tibiofemoral joint space narrowing (p < 0.05), less tibial bone expansion (0.5% vs 4.0% over 26 weeks, p = 0.02), and a trend towards reduced tibial cartilage volume loss (0.7% vs -4.0% over 26 weeks, p = 0.10) than the HA controls. Intra-articular administration of a single allogeneic MPC injection following ACL reconstruction was safe, well tolerated, and may improve symptoms and structural outcomes. These findings suggest that MPCs warrant further investigations as they may modulate some of the pathological processes responsible for the development of post-traumatic osteoarthritis following ACL reconstruction. ClinicalTrials.gov ( NCT01088191 ) registration date: March 11, 2010.

The effect of surface electrical stimulation on swallowing in dysphagic Parkinson patients.

PubMed

Baijens, Laura W J; Speyer, Renée; Passos, Valeria Lima; Pilz, Walmari; Roodenburg, Nel; Clavé, Père

2012-12-01

Surface electrical stimulation has been applied on a large scale to treat oropharyngeal dysphagia. Patients suffering from oropharyngeal dysphagia in the presence of Parkinson's disease have been treated with surface electrical stimulation. Because of controversial reports on this treatment, a pilot study was set up. This study describes the effects of a single session of surface electrical stimulation using different electrode positions in ten patients with idiopathic Parkinson's disease (median Hoehn and Yahr score: II) and oropharyngeal dysphagia compared to ten age- and gender-matched healthy control subjects during videofluoroscopy of swallowing. Three different electrode positions were applied in random order per subject. For each electrode position, the electrical current was respectively turned "on" and "off" in random order. Temporal, spatial, and visuoperceptual variables were scored by experienced raters who were blinded to the group, electrode position, and status (on/off) of the electrical current. Interrater and interrater reliabilities were calculated. Only a few significant effects of a single session of surface electrical stimulation using different electrode positions in dysphagic Parkinson patients could be observed in this study. Furthermore, significant results for temporal and spatial variables were found regardless of the status of the electrical current in both groups suggesting placebo effects. Following adjustment for electrical current status as well as electrode positions (both not significant, P > 0.05) in the statistical model, significant group differences between Parkinson patients and healthy control subjects emerged. Further studies are necessary to evaluate the potential therapeutic effect and mechanism of electrical stimulation in dysphagic patients with Parkinson's disease.

Single-cell genomic profiling of acute myeloid leukemia for clinical use: A pilot study

PubMed Central

Yan, Benedict; Hu, Yongli; Ban, Kenneth H.K.; Tiang, Zenia; Ng, Christopher; Lee, Joanne; Tan, Wilson; Chiu, Lily; Tan, Tin Wee; Seah, Elaine; Ng, Chin Hin; Chng, Wee-Joo; Foo, Roger

2017-01-01

Although bulk high-throughput genomic profiling studies have led to a significant increase in the understanding of cancer biology, there is increasing awareness that bulk profiling approaches do not completely elucidate tumor heterogeneity. Single-cell genomic profiling enables the distinction of tumor heterogeneity, and may improve clinical diagnosis through the identification and characterization of putative subclonal populations. In the present study, the challenges associated with a single-cell genomics profiling workflow for clinical diagnostics were investigated. Single-cell RNA-sequencing (RNA-seq) was performed on 20 cells from an acute myeloid leukemia bone marrow sample. Putative blasts were identified based on their gene expression profiles and principal component analysis was performed to identify outlier cells. Variant calling was performed on the single-cell RNA-seq data. The present pilot study demonstrates a proof of concept for clinical single-cell genomic profiling. The recognized limitations include significant stochastic RNA loss and the relatively low throughput of the current proposed platform. Although the results of the present study are promising, further technological advances and protocol optimization are necessary for single-cell genomic profiling to be clinically viable. PMID:28454300

How to treat two adjacent missing teeth with dental implants. A systematic review on single implant-supported two-unit cantilever FDP's and results of a 5-year prospective comparative study in the aesthetic zone.

PubMed

Van Nimwegen, W G; Raghoebar, G M; Tymstra, N; Vissink, A; Meijer, H J A

2017-06-01

To conduct a systematic review on the clinical outcome of single implant-supported two-unit cantilever FDP's and to conduct a 5-year prospective comparative pilot study of patients with a missing central and lateral upper incisor treated with either a single implant-supported two-unit cantilever FDP or two implants with solitary implant crowns in the aesthetic zone. Medline, Embase and the Cochrane Central Register of Controlled Trials were searched (last search 1 August 2016) for eligible studies. In the comparative pilot study, an implant-cantilever group of five patients with a single implant-supported two-unit cantilever FDP (NobelReplace Groovy Regular Platform) was compared with an implant-implant group of five patients with two adjacent single implant-supported crowns (NobelReplace Groovy Regular Platform) in the aesthetic zone. Implant survival, marginal bone level (MBL) changes, pocket probing depth, papilla index and patient satisfaction were assessed during a 5-year follow-up period. Five of 276 articles were considered eligible for data extraction. Implant survival ranged from 96·6% to 100%. Marginal bone level changes were higher in the anterior region than in the posterior region. Technical complications occurred more often in the posterior than anterior region. In the 5-year comparative pilot study, no clinically significant differences in hard and soft peri-implant tissue levels occurred between both groups. Single implant-supported two-unit cantilever FDP's can be a viable alternative to the placement of two adjacent single implant crowns in the aesthetic zone. Due to technical complications, placement of two-unit cantilever crowns in the posterior region can be considered unwise. © 2017 John Wiley & Sons Ltd.

Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department.

PubMed

Reynolds, Stacy L; Studnek, Jonathan R; Bryant, Kathleen; VanderHave, Kelly; Grossman, Eric; Moore, Charity G; Young, James; Hogg, Melanie; Runyon, Michael S

2016-09-08

Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4-17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. NCT02521415. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Mission control of multiple unmanned aerial vehicles: a workload analysis.

PubMed

Dixon, Stephen R; Wickens, Christopher D; Chang, Dervon

2005-01-01

With unmanned aerial vehicles (UAVs), 36 licensed pilots flew both single-UAV and dual-UAV simulated military missions. Pilots were required to navigate each UAV through a series of mission legs in one of the following three conditions: a baseline condition, an auditory autoalert condition, and an autopilot condition. Pilots were responsible for (a) mission completion, (b) target search, and (c) systems monitoring. Results revealed that both the autoalert and the autopilot automation improved overall performance by reducing task interference and alleviating workload. The autoalert system benefited performance both in the automated task and mission completion task, whereas the autopilot system benefited performance in the automated task, the mission completion task, and the target search task. Practical implications for the study include the suggestion that reliable automation can help alleviate task interference and reduce workload, thereby allowing pilots to better handle concurrent tasks during single- and multiple-UAV flight control.

Effect of an oral supplementation with a proprietary melon juice concentrate (Extramel®) on stress and fatigue in healthy people: a pilot, double-blind, placebo-controlled clinical trial

PubMed Central

Milesi, Marie-Anne; Lacan, Dominique; Brosse, Hervé; Desor, Didier; Notin, Claire

2009-01-01

Background Recent studies have demonstrated a correlation between perceived stress and oxidative stress. As SOD is the main enzyme of the enzymatic antioxidant defence system of the body, we evaluated the effect of an oral daily intake of a proprietary melon juice concentrate rich in SOD (EXTRAMEL®) on the signs and symptoms of stress and fatigue in healthy volunteers. Methods This randomized, double blind, placebo controlled clinical study was conducted with seventy healthy volunteers aged between 30 and 55 years, who feel daily stress and fatigue. They took the dietary supplement based on the melon juice concentrate (10 mg Extramel® corresponding to 140 IU SOD per capsule) or a placebo one time daily during 4 weeks. Stress and fatigue were measured using four observational psychometric scales: FARD, PSS-14, SF-12 and Epworth scale. The study was conducted by Isoclin, a clinical research organization, located in Poitiers, France. Results No adverse effect was noted. The supplementation with the proprietary melon juice concentrate bringing 140 IU SOD/day significantly improved signs and symptoms of stress and fatigue linked to performance, physical (pain, sleep troubles), cognitive (concentration, weariness, sleep troubles) or behavioural (attitude, irritability, difficulty of contact) compared to the placebo. In the same way, quality of life and perceived stress were significantly improved with SOD supplementation. Conclusion This pilot study showed that an oral supplementation with a proprietary melon juice concentrate rich in SOD may have a positive effect on several signs and symptoms of perceived stress and fatigue. PMID:19754931

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

PubMed Central

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

Guided training relative to direct skill training for individuals with cognitive impairments after stroke: a pilot randomized trial

PubMed Central

Skidmore, Elizabeth R.; Butters, Meryl; Whyte, Ellen; Grattan, Emily; Shen, Jennifer; Terhorst, Lauren

2016-01-01

Objective To examine the effects of direct skill training and guided training for promoting independence after stroke. Design Single-blind randomized pilot study. Setting Inpatient rehabilitation facility. Participants Forty-three participants in inpatient rehabilitation with acute stroke and cognitive impairments. Interventions Participants were randomized to receive direct skill training (n=22, 10 sessions as adjunct to usual inpatient rehabilitation) or guided training (n=21, same dose). Main Outcome Measure The Functional Independence Measure assessed independence at baseline, rehabilitation discharge, and months 3, 6, and 12. Results Linear mixed models (random intercept, other effects fixed) revealed a significant intervention by time interaction (F4,150=5.11, p<0.001), a significant main effect of time (F4,150=49.25, p<0.001), and a significant effect of stroke severity (F1,150=34.46, p<.001). There was no main effect of intervention (F1,150=0.07, p=0.79). Change in Functional Independence Measures scores was greater for the DIRECT group at rehabilitation discharge (effect size of between group differences, d=0.28) and greater for the GUIDE group at months 3 (d=0.16), 6 (d=0.39), and 12 (d=0.53). The difference between groups in mean 12 month change scores was 10.57 points. Conclusions Guided training, provided in addition to usual care, offered a small advantage in the recovery of independence, relative to direct skill training. Future studies examining guided training in combination with other potentially potent intervention elements may further advise best practices in rehabilitation for individuals with cognitive impairments after acute stroke. PMID:27794487

Comparison of once-daily versus twice-weekly terbinafine administration for the treatment of canine Malassezia dermatitis - a pilot study.

PubMed

Berger, Darren J; Lewis, Thomas P; Schick, Anthea E; Stone, Richard T

2012-10-01

Terbinafine, an allylamine antifungal, is used in pulsatile dose regimens for superficial mycoses in human medicine. To compare the clinical efficacy of twice-weekly versus once-daily terbinafine administration to determine whether preliminary proof-of-concept evidence exists for pulsatile administration of terbinafine in the treatment of canine Malassezia dermatitis and to determine whether twice-weekly treatment results in fewer clinical and owner-perceived adverse events. Twenty client-owned dogs with Malassezia dermatitis. In this randomized, single-blinded clinical trial, dogs were randomly assigned to receive terbinafine (30 mg/kg) either once daily for 21 days (n = 10) or once daily on two consecutive days per week for six doses (n = 10). On day 0 and day 21, a mean yeast count was calculated from eight anatomical locations via adhesive tape-strip cytology, clinical lesion scores were assigned to the same locations, and owners assessed pruritus using a visual analog scale. There was no significant difference between treatment groups with respect to the reduction in mean yeast count (P = 0.343) and clinical lesion scores (P = 0.887). Pruritus measured by visual analog scale was significantly decreased in the twice-weekly treatment group compared with the daily treatment group (P = 0.047). Seven of 20 dogs had a clinically measurable or owner-reported adverse event during treatment that included gastrointestinal disturbances, excessive panting and elevated hepatic enzymes, with no significant difference noted between treatment groups. This pilot study indicates that twice-weekly terbinafine administration may be an effective alternative treatment for canine Malassezia dermatitis and merits further investigation. © 2012 The Authors. Veterinary Dermatology © 2012 ESVD and ACVD.

Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial

PubMed Central

Mathew, Sanjay J.; Murrough, James W.; Rot, Marije aan het; Collins, Katherine A.; Reich, David L.; Charney, Dennis S.

2013-01-01

The N-methyl-d-aspartate (NMDA) glutamate receptor antagonist ketamine may have rapid, albeit transient, antidepressant properties. This study in patients with treatment-resistant major depression (TRD) aimed to (1) replicate the acute efficacy of single-dose intravenous (i.v.) ketamine; (2) test the efficacy of the glutamate-modulating agent riluzole in preventing post-ketamine relapse ; and (3) examine whether pretreatment with lamotrigine would attenuate ketamine’s psychotomimetic effects and enhance its antidepressant activity. Twenty-six medication-free patients received open-label i.v. ketamine (0.5 mg/kg over 40 min). Two hours prior to infusion, patients were randomized to lamotrigine (300 mg) or placebo. Seventeen patients (65%) met response criterion (≥50% reduction from baseline on the Montgomery–Asberg Depression Rating Scale) 24 h following ketamine. Lamotrigine failed to attenuate the mild, transient side-effects associated with ketamine and did not enhance its antidepressant effects. Fourteen patients (54%) met response criterion 72 h following ketamine and proceeded to participate in a 32-d, randomized, double-blind, placebo-controlled, flexible-dose continuation trial of riluzole (100–200 mg/d). The main outcome measure was time-to-relapse. An interim analysis found no significant differences in time-to-relapse between riluzole and placebo groups [log-rank χ2 = 0.17, d.f. = 1, p = 0.68], with 80% of patients relapsing on riluzole vs. 50% on placebo. The trial was thus stopped for futility. This pilot study showed that a sub-anaesthetic dose of i.v. ketamine is well-tolerated in TRD, and may have rapid and sustained antidepressant properties. Riluzole did not prevent relapse in the first month following ketamine. Further investigation of relapse prevention strategies post-ketamine is necessary. PMID:19288975

Combining levodopa and virtual reality-based therapy for rehabilitation of the upper limb after acute stroke: pilot study Part II

PubMed Central

Samuel, Geoffrey Sithamparapillai; Oey, Nicodemus Edrick; Choo, Min; Ju, Han; Chan, Wai Yin; Kok, Stanley; Ge, Yu; Dongen, Antonius M Van; Ng, Yee Sien

2017-01-01

INTRODUCTION This study aimed to evaluate the safety and efficacy of a combination of levodopa and virtual reality (VR)-based therapy for the enhancement of upper limb recovery following acute stroke. METHODS This was a pilot single-blinded case series of acute stroke patients with upper extremity hemiparesis. Patients were randomised to standard care with concomitant administration of either levodopa alone (control group) or combination therapy consisting of VR-based motivational visuomotor feedback training with levodopa neuromodulation (VR group). Main clinical outcome measures were the Fugl-Meyer Upper Extremity (FM-UE) assessment and Action Research Arm Test (ARAT). Kinematic measurements of affected upper limb movement were evaluated as a secondary measure of improvement. RESULTS Of 42 patients screened, four patients were enrolled in each of the two groups. Two patients dropped out from the control group during the trial. Patients receiving combination therapy had clinically significant improvements in FM-UE assessment scores of 16.5 points compared to a 3.0-point improvement among control patients. Similarly, ARAT scores of VR group patients improved by 15.3 points compared to a 10.0-point improvement in the control group. Corresponding improvements were noted in kinematic measures, including hand-path ratio, demonstrating that the quality of upper limb movement improved in the VR group. CONCLUSION Our results suggest that VR-based therapy and pharmacotherapy may be combined for acute stroke rehabilitation. Bedside acquisition of kinematic measurements allows accurate assessment of the quality of limb movement, offering a sensitive clinical tool for quantifying motor recovery during the rehabilitation process after acute stroke. PMID:27311739

An individualized exercise programme with and without behavioural change enhancement strategies for managing fatigue among frail older people: a quasi-experimental pilot study.

PubMed

Liu, Justina Y-W; Lai, Claudia Ky; Siu, Parco M; Kwong, Enid; Tse, Mimi My

2017-04-01

To evaluate the feasibility and preliminary effects of an individualized exercise programme with and without behavioural change enhancement strategies for frail older people with fatigue. A three-arm, single-blinded, quasi-experimental pilot study. Community health centres. A total of 79 frail older people with fatigue, mean age 79.32 years (±7.72). The combined group received a 16-week combined intervention consisting of exercise training and a behavioural change enhancement programme. The exercise group received exercise training and health talks, whereas the control group received only health talks. Feasibility was assessed through the participants' recruitment, retention, attendance and adherence, feedback, and reports of adverse events. The preliminary effects were assessed by the participants' level of fatigue, physical endurance, self-efficacy, and self-perceived compliance with exercise. Feasibility was achievable with high recruitment (87.2%) and low overall attrition (7.1%) rates. A similar reduction in fatigue was identified in all groups, but a trend of greater improvement in physical endurance was observed in the combined group than in the other two groups. The combined group also had a significantly better attendance rate [F(2,76) = 5.64, p < 0.01)] and higher self-perceived exercise compliance than the exercise group. The combined intervention has the potential to enhance the participants' adherence to exercise regimens by improving their attendance in training sessions and their self-perceived exercise compliance. They are important to maintaining an appropriate level of engagement in daily exercises, especially at the beginning stages of behavioural change, when the participants are establishing the habit of exercising daily.

Guided self-help cognitive-behaviour Intervention for VoicEs (GiVE): Results from a pilot randomised controlled trial in a transdiagnostic sample.

PubMed

Hazell, Cassie M; Hayward, Mark; Cavanagh, Kate; Jones, Anna-Marie; Strauss, Clara

2018-05-01

Few patients have access to cognitive behaviour therapy for psychosis (CBTp) even though at least 16 sessions of CBTp is recommended in treatment guidelines. Briefer CBTp could improve access as the same number of therapists could see more patients. In addition, focusing on single psychotic symptoms, such as auditory hallucinations ('voices'), rather than on psychosis more broadly, may yield greater benefits. This pilot RCT recruited 28 participants (with a range of diagnoses) from NHS mental health services who were distressed by hearing voices. The study compared an 8-session guided self-help CBT intervention for distressing voices with a wait-list control. Data were collected at baseline and at 12weeks with post-therapy assessments conducted blind to allocation. Voice-impact was the pre-determined primary outcome. Secondary outcomes were depression, anxiety, wellbeing and recovery. Mechanism measures were self-esteem, beliefs about self, beliefs about voices and voice-relating. Recruitment and retention was feasible with low study (3.6%) and therapy (14.3%) dropout. There were large, statistically significant between-group effects on the primary outcome of voice-impact (d=1.78; 95% CIs: 0.86-2.70), which exceeded the minimum clinically important difference. Large, statistically significant effects were found on a number of secondary and mechanism measures. Large effects on the pre-determined primary outcome of voice-impact are encouraging, and criteria for progressing to a definitive trial are met. Significant between-group effects on measures of self-esteem, negative beliefs about self and beliefs about voice omnipotence are consistent with these being mechanisms of change and this requires testing in a future trial. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Water-based vs. non-water-based physiotherapy for rehabilitation of postural deformities in Parkinson's disease: a randomized controlled pilot study.

PubMed

Volpe, Daniele; Giantin, Maria Giulia; Manuela, Pilleri; Filippetto, Consuelo; Pelosin, Elisa; Abbruzzese, Giovanni; Antonini, Angelo

2017-08-01

To compare the efficacy of two physiotherapy protocols (water-based vs. non-water-based) on postural deformities of patients with Parkinson's disease. A single blind, randomized controlled pilot study. Inpatient (Rehabilitative Department). A total of 30 patients with idiopathic Parkinson's disease. Participants were randomly assigned to one of two eight-week treatment groups: Water-based ( n = 15) or non-water-based physiotherapy exercises ( n = 15). Changes in the degree of cervical and dorsal flexion and in the angle of lateral inclination of the trunk (evaluated by means of a posturographic system) were used as primary outcomes. Unified Parkinson Disease Rating Scale section III, Time Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale and the Parkinson's disease quality of life questionnaire (39 items) were the secondary outcomes. All outcomes were assessed at baseline, at the end of training and eight weeks after treatment. Patients were always tested at the time of their optimal antiparkinsonian medication ('on' phase). After the treatment, only Parkinson's disease subjects randomized to water-based treatment showed a significant improvement of trunk posture with a significant reduction of cervical flexion (water-based group: -65.2°; non-water-based group: +1.7°) and dorsal flexion (water-based group: -22.5°; non-water-based group: -6.5°) and lateral inclination of the trunk (water-based group: -2.3°; non-water-based group: +0.3°). Both groups presented significant improvements in the secondary clinical outcomes without between-group differences. Our results show that water-based physiotherapy was effective for improving postural deformities in patients with Parkinson's disease.

Goal-orientated cognitive rehabilitation for dementias associated with Parkinson's disease-A pilot randomised controlled trial.

PubMed

Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Brand, Andrew; Hoare, Zoe; Martyr, Anthony; Clare, Linda

2018-05-01

To examine the appropriateness and feasibility of cognitive rehabilitation for people with dementias associated with Parkinson's in a pilot randomised controlled study. This was a single-blind pilot randomised controlled trial of goal-oriented cognitive rehabilitation for dementias associated with Parkinson's. After goal setting, participants were randomised to cognitive rehabilitation (n = 10), relaxation therapy (n = 10), or treatment-as-usual (n = 9). Primary outcomes were ratings of goal attainment and satisfaction with goal attainment. Secondary outcomes included quality of life, mood, cognition, health status, everyday functioning, and carers' ratings of goal attainment and their own quality of life and stress levels. Assessments were at 2 and 6 months following randomisation. At 2 months, cognitive rehabilitation was superior to treatment-as-usual and relaxation therapy for the primary outcomes of self-rated goal attainment (d = 1.63 and d = 1.82, respectively) and self-rated satisfaction with goal attainment (d = 2.04 and d = 1.84). At 6 months, cognitive rehabilitation remained superior to treatment-as-usual (d = 1.36) and relaxation therapy (d = 1.77) for self-rated goal attainment. Cognitive rehabilitation was superior to treatment as usual and/or relaxation therapy in a number of secondary outcomes at 2 months (mood, self-efficacy, social domain of quality of life, carers' ratings of participants' goal attainment) and at 6 months (delayed recall, health status, quality of life, carer ratings of participants' goal attainment). Carers receiving cognitive rehabilitation reported better quality of life, health status, and lower stress than those allocated to treatment-as-usual. Cognitive rehabilitation is feasible and potentially effective for dementias associated with Parkinson's disease. Copyright © 2018 John Wiley & Sons, Ltd.

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

PubMed

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.

Oral challenge test with sodium metabisulfite in steroid-dependent asthmatic patients.

PubMed

Prieto, L; Juyol, M; Paricio, A; Martínez, M A; Palop, J; Castro, J

1988-01-01

Oral challenge tests were carried out with sodium metabisulfite solution doses of 0.5, 1, 10, 25, 50 mg and encapsulated doses of 100 and 200 mg, as well as with lactose-placebo, on 44 non-atopic patients with steroid-dependent bronchial asthma, without clinical evidence of intolerance to these agents. Only those patients with an acceptable and not very labile pulmonary function were tested. A single-blind challenge protocol was performed in 22 patients (sodium metabisulfite solutions at pH 2.2 to 2.6) and the positive responses were confirmed by double-blind challenge. The other 22 were tested directly in a double-blind manner (pH4). Initially, 6/44 presented a positive reaction. However, a careful analysis and the confirmation by double-blind challenge of the positive responses obtained with the single-blind test, allowed us to identify 4 false positive responses. Thus, the true prevalence of sulfite sensitivity in our population is 4.5%. A patient with intolerance to sulfite agents also suffered aspirin-induced asthma. The labile tendency of the pulmonary function of the asthmatic patients may have contributed to some false positive reactions and probably explain the very high prevalence found in some studies. It does not appear that the variations of pH decisively influence the result of the challenge test.

High dose hydrocortisone immediately after trauma may alter the trajectory of PTSD: interplay between clinical and animal studies.

PubMed

Zohar, Joseph; Yahalom, Hila; Kozlovsky, Nitsan; Cwikel-Hamzany, Shlomit; Matar, Michael A; Kaplan, Zeev; Yehuda, Rachel; Cohen, Hagit

2011-11-01

High-dose corticosteroids have been reported to reduce symptoms of acute stress and post-traumatic stress in polytrauma patients and in animal studies. The underlying mechanism of action remains largely unclear. These issues were addressed in parallel in the clinical and preclinical studies below. In this preliminary study, 25 patients with acute stress symptoms were administered a single intravenous bolus of high-dose hydrocortisone (100-140 mg) or placebo within 6 h of a traumatic event in a prospective, randomized, double-blind, placebo-controlled pilot study. Early single high-dose hydrocortisone intervention attenuated the core symptoms of both the acute stress and of subsequent PTSD in patients. High-dose hydrocortisone treatment given in the first few hours after a traumatic experience was associated with significant favorable changes in the trajectory of exposure to trauma, as expressed by the reduced risk of the development of PTSD post-trauma. In parallel, a comparative study of morphological arborization in dentate gyrus and its modulating molecules was performed in stress-exposed animals treated with high-dose hydrocortisone. Steroid-treated stressed animals displayed significantly increased dendritic growth and spine density, with increased levels of brain-derived neurotrophic factor (BDNF) and obtunded postsynaptic density-95 (PSD-95) levels. The animal study provided insights into the potential mechanism of this intervention, as it identified relevant morphological and biochemical associations to the clinical observations. Thus, evidence from clinical and animal studies suggests that there is a "window of opportunity" in the early aftermath of trauma to help those who are vulnerable to the development of chronic PTSD. Copyright © 2011 Elsevier B.V. and ECNP. All rights reserved.

Analytical performance study of solar blind non-line-of-sight ultraviolet short-range communication links.

PubMed

Xu, Zhengyuan; Ding, Haipeng; Sadler, Brian M; Chen, Gang

2008-08-15

Motivated by recent advances in solid-state incoherent ultraviolet sources and solar blind detectors, we study communication link performance over a range of less than 1 km with a bit error rate (BER) below 10(-3) in solar blind non-line-of-sight situation. The widely adopted yet complex single scattering channel model is significantly simplified by means of a closed-form expression for tractable analysis. Path loss is given as a function of transceiver geometry as well as atmospheric scattering and attenuation and is compared with experimental data for model validation. The BER performance of a shot-noise-limited receiver under this channel model is demonstrated.

Effects of 5-aminolevulinic acid supplementation on home-based walking training achievement in middle-aged depressive women: randomized, double-blind, crossover pilot study.

PubMed

Suzuki, Hiroshi; Masuki, Shizue; Morikawa, Akiyo; Ogawa, Yu; Kamijo, Yoshi-Ichiro; Takahashi, Kiwamu; Nakajima, Motowo; Nose, Hiroshi

2018-05-08

Depressive patients often experience difficulty in performing exercise due to physical and psychological barriers. We examined the effects of 5-aminolevulinic acid (ALA) with sodium ferrous citrate (SFC) supplementation during home-based walking training in middle-aged depressive women. Nine outpatients [53 ± 8 (SD) yr] with major depressive disorder participated in the pilot study with randomized, placebo-controlled, double-blind crossover design. They underwent two trials for 7 days, each performing interval walking training (IWT) with ALA + SFC (ALA + SFC) or placebo supplement intake (PLC) intermittently with >a 10-day washout period. For the first 6 days of each trial, exercise intensity for IWT was measured by accelerometry. Before and after each trial, subjects underwent a graded cycling test, and lactate concentration in plasma ([Lac - ] p ), oxygen consumption rate ([Formula: see text]), and carbon dioxide production rate ([Formula: see text]) were measured with depression severity by the Montgomery-Åsberg Depression Rating Scale (MADRS). We found that the increases in [Lac - ] p , [Formula: see text] and [Formula: see text] during the test were attenuated only in ALA + SFC ([before vs. after] × workload; all, P < 0.01), accompanied by increased training days, impulse, and time at fast walking during IWT (all, P < 0.05) with decreased MADRS-score (P = 0.001). Thus, ALA + SFC supplementation increased IWT achievement to improve depressive symptoms in middle-aged women.

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

PubMed

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.

Qigong Sensory Training Pilot Study: A Tactile Home Program for Children with or At-Risk for Autism

ERIC Educational Resources Information Center

Tal-Atzili, Orit; Salls, Joyce

2017-01-01

This pilot study investigated the efficacy of Qigong Sensory Training, a parent-implemented tactile intervention, in improving sensory processing and self-regulation in children with or at-risk for autism who were enrolled in early intervention. A pretest-posttest, single-subject design was implemented with three families. After 5 months, atypical…

Use of 99mTc-Tilmanocept as a Single Agent for Sentinel Lymph Node Identification in Breast Cancer: A Retrospective Pilot Study.

PubMed

Unkart, Jonathan T; Wallace, Anne M

2017-09-01

99m Tc-tilmanocept received recent Food and Drug Administration approval for lymphatic mapping in 2013. However, to our knowledge, no prior studies have evaluated the use of 99m Tc-tilmanocept as a single agent in sentinel lymph node (SLN) biopsy in breast cancer. Methods: We executed this retrospective pilot study to assess the ability of 99m Tc-tilmanocept to identify sentinel nodes as a single agent in clinically node-negative breast cancer patients. Patients received a single intradermal injection overlying the tumor of either 18.5 MBq (0.5 mCi) of 99m Tc-tilmanocept on the day of surgery or 74.0 MBq (2.0 mCi) on the day before surgery by a radiologist. Immediate 3-view lymphoscintigraphy was performed. Intraoperatively, SLNs were identified with a portable γ-probe. A node was classified as hot if the count (per second) of the node was more than 3 times the background count. Descriptive statistics are reported. Results: Nineteen patients underwent SLN biopsy with single-agent 99m Tc-tilmanocept. Immediate lymphoscintigraphy identified at least 1 sentinel node in 13 of 17 patients (76.5%). Intraoperatively, at least 1 (mean, 1.7 ± 0.8; range, 1-3) hot node was identified in all patients. Three patients (15.8%) had 1 disease-positive SLN. Conclusion: In this small, retrospective pilot study, 99m Tc-tilmanocept performed well as a single agent for intraoperative sentinel node identification in breast cancer. A larger, randomized clinical trial is warranted to compare 99m Tc-tilmanocept as a single agent with other radiopharmaceuticals for sentinel node identification in breast cancer. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

Efficacy and safety of fractional carbon dioxide laser for treatment of unwanted facial freckles in phototypes II-IV: a pilot study.

PubMed

El Zawahry, Bakr; Zaki, Naglaa; Hafez, Vanessa; Abdel Hay, Rania; Hay, Rania Abdel; Fahim, Aya

2014-11-01

Facial freckles are a cosmetic concern to Egyptians, particularly young females. Several therapeutic lines exist with variable response rates and limitations. Fractional carbon dioxide (FCO2) laser provides minimal ablation and therefore less down time and less side effects. The efficacy and safety of this laser technology have still not been studied in freckles. The aim of this study is to assess the efficacy and safety of FCO2 laser in the treatment of unwanted facial freckles in Egyptians. Twenty patients undergone a single session of FCO2 laser and then were followed up clinically a month later. Photographs were taken before treatment and at follow-up visit and were assessed by three blinded investigators. Percent of global improvement was measured on a 4-point grading scale. Patient's satisfaction and adverse events were recorded. Two patients (10 %) showed grade 1 improvement, while eight patients (40 %) showed grade 2 improvement. Nine patients (45 %) showed grade 3 improvement, and only one patient (5 %) showed grade 4 improvement. FCO2 laser resurfacing is effective and safe in treatment of facial freckles in skin phototypes II-IV. It can offer a more practical alternative to topical treatments, and a cheaper alternative to Q-switched lasers.

Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study

PubMed Central

Jiménez-Rejano, J. J.; Chillón-Martínez, R.; Gómez-Benítez, M. A.; De-La-Casa-Almeida, M.

2018-01-01

Background There are a great number of interventions in physiotherapy, but with little evidence of their effectiveness in chronic low back pain. Therefore, this study assesses effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics and the combination of both to decrease pain and lumbar disability while increasing joint mobility and quality of life in patients with chronic nonspecific low back pain. Methods A randomized, single-blinded, controlled, clinical trial with sample (n = 27) was comprised of patients between 20 and 65 years, diagnosed with pain of mechanical origin characterized by having a duration of at least 12 weeks and no serious complications. Each group received 8 interventions of 30 minutes. Results Friedman ANOVA test obtained statistically significant differences of Oswestry, NRS, and Schober variables (p < 0.05) in the three measurements (pretest, posttest 1, and posttest 2), in each individual group. ANOVA Kruskal-Wallis test was used for comparison between groups, and Oswestry Disability values were significantly higher (p = 0.024) in the group receiving both treatments. Conclusion Both individual groups reduce pain levels, improve disability, and increase the flexibility of the lumbar spine. The combination therapy provides greater benefits in terms of lumbar disability. This study is registered on March 8, 2016, with NCT02721914. PMID:29681973

Does Bedside Sonography Effectively Identify Nasogastric Tube Placements in Pediatric Critical Care Patients?

PubMed

Atalay, Yunus Oktay; Aydin, Ramazan; Ertugrul, Omer; Gul, Selim Baris; Polat, Ahmet Veysel; Paksu, Muhammet Sukru

2016-12-01

A nasogastric tube (NGT) insertion is a common procedure in intensive care units, with some serious complications that result from the malposition of the NGT tip. This pilot study was designed to investigate the efficiency of ultrasound in verifying correct NGT placement and to compare these results with radiographic findings. This was a single-center, double-blind prospective study of patients who had received an NGT in the pediatric critical care unit. Twenty-one patients aged 1 month to 18 years were included in this study. All NGTs were inserted by the same critical care physician. After insertion, the physician first confirmed NGT placement by the auscultation of the epigastrium following the insufflation of air. Confirmation was supplemented with an abdominal radiograph. A radiologist who was unaware of the radiographic findings performed bedside sonography on all patients and verified the location of the NGTs. The findings from these 2 physicians were then compared. NGTs were inserted without any complications, and none of the NGTs were positioned in the respiratory tract in any of the patients. All NGT tips were visualized by radiography and sonography with a sensitivity of 100%. Bedside sonography performed by a radiologist is an effective and sensitive diagnostic procedure for confirming the correct NGT position in patients in the pediatric critical care unit.

Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study.

PubMed

Bellido-Fernández, L; Jiménez-Rejano, J J; Chillón-Martínez, R; Gómez-Benítez, M A; De-La-Casa-Almeida, M; Rebollo-Salas, M

2018-01-01

There are a great number of interventions in physiotherapy, but with little evidence of their effectiveness in chronic low back pain. Therefore, this study assesses effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics and the combination of both to decrease pain and lumbar disability while increasing joint mobility and quality of life in patients with chronic nonspecific low back pain. A randomized, single-blinded, controlled, clinical trial with sample ( n = 27) was comprised of patients between 20 and 65 years, diagnosed with pain of mechanical origin characterized by having a duration of at least 12 weeks and no serious complications. Each group received 8 interventions of 30 minutes. Friedman ANOVA test obtained statistically significant differences of Oswestry, NRS, and Schober variables ( p < 0.05) in the three measurements (pretest, posttest 1, and posttest 2), in each individual group. ANOVA Kruskal-Wallis test was used for comparison between groups, and Oswestry Disability values were significantly higher ( p = 0.024) in the group receiving both treatments. Both individual groups reduce pain levels, improve disability, and increase the flexibility of the lumbar spine. The combination therapy provides greater benefits in terms of lumbar disability. This study is registered on March 8, 2016, with NCT02721914.

[Prevalence of blindness and moderate and severe visual impairment among adults aged 50 years or above in Yangxi County of Guangdong Province: the China Nine-Province Survey].

PubMed

Ge, Jian; He, Mingguang; Zhao, Jialiang; Fang, Min; Ellwein, Leon B; He, Ning; Yang, Mei; Wang, Yu; Gao, Xuecheng

2014-03-01

To investigate the prevalence of blindness and moderate and severe visual impairment among adults aged 50 years or above in Yangxi County of Guangdong Province, China. It was a population-based cross-section study.Geographically defined cluster sampling was used in randomly selecting 5 531 individuals aged 50 years or above in Yangxi County from September 2006 to January 2007. The survey was preceded by a pilot study where operational methods were refined and quality assurance evaluation was carried out. All participants were enumerated using village registers followed by door-to-door visits.Eligible individuals were invited to receive visual acuity measurement and eye examination.Statistical analyses were performed using Stata/SE Statistical Software, release 9.0. Chi-square test was used to investigate the association of age, gender and education with presenting and best corrected visual acuity. Five thousands five hundreds and thirty-one individuals were enumerated and 4 589 persons were examined, the response rate was 82.97%. Based on the criteria of World Health Organization visual impairment classification in 1973, the prevalence of blindness and moderate and severe visual impairment defined as best corrected visual acuity was 2.38% (109/4 589) and 9.44% (433/4 589) respectively. The prevalence of blindness and moderate and severe visual impairment defined as presenting visual acuity was 2.68% (123/4 589) and 18.15% (833/4 589) respectively. The prevalence of blindness and moderate and severe visual impairment was higher in aged (trend χ(2) = 1 239.34, P < 0.01) , female (χ(2) = 37.88, P < 0.01) and illiterate (trend χ(2) = 235.11, P < 0.01) persons. Cataract was the first leading cause of blindness and visual impairment. The prevalence of blindness and moderate and severe visual impairment is higher among older adults aged 50 years or above in Yangxi County. Cataract remains as the first leading cause of blindness and visual impairment.

Measurement-only verifiable blind quantum computing with quantum input verification

NASA Astrophysics Data System (ADS)

Morimae, Tomoyuki

2016-10-01

Verifiable blind quantum computing is a secure delegated quantum computing where a client with a limited quantum technology delegates her quantum computing to a server who has a universal quantum computer. The client's privacy is protected (blindness), and the correctness of the computation is verifiable by the client despite her limited quantum technology (verifiability). There are mainly two types of protocols for verifiable blind quantum computing: the protocol where the client has only to generate single-qubit states and the protocol where the client needs only the ability of single-qubit measurements. The latter is called the measurement-only verifiable blind quantum computing. If the input of the client's quantum computing is a quantum state, whose classical efficient description is not known to the client, there was no way for the measurement-only client to verify the correctness of the input. Here we introduce a protocol of measurement-only verifiable blind quantum computing where the correctness of the quantum input is also verifiable.

Double-blind, controlled, clinical trial planned in germany to investigate the efficacy of psychotherapy combined with triptorelin in adult male patients with severe pedophilic disorders: presentation of the study protocol.

PubMed

Briken, Peer; Berner, Wolfgang

2012-01-01

The treatment of paraphilias, especially of pedophilia, centers upon cognitive-behavioral psychotherapy and pharmacologic interventions. Two open, uncontrolled clinical studies using the synthetic LHRH-agonist triptorelin suggested that, combined with psychotherapy, antiandrogen treatment reduced deviant sexual fantasies, urges, and behaviors in paraphilic patients. There is a need for further research using controlled, randomized trials to examine the effectiveness of sexual offender treatment including psychotherapeutic and pharmacologic interventions. The aim of this pilot study is to evaluate the efficacy and tolerability of cognitive-behavioral psychotherapy together with intramuscular (IM) 3-monthly injections of triptorelin in adult men with severe pedophilia. In this multicenter, forensic psychiatric hospital-based, double-blind, controlled, parallel group phase IV trial conducted in Germany, convicted male sexual offenders aged ≥ 18 years with pedophilia, as defined by DSM-IV-TR criteria, will be randomized to receive study-specific psychotherapy together either with triptorelin or placebo for 12 months (total of 4 injections). This is a pilot study, therefore exploratory data analyses will be carried out of three different target parameters: 1. Changes in psychosexual characteristics using the Multiphasic Sex Inventory (scale: sexual abuse of children) 2. Changes in the risk of violent sexual behavior using the Sexual Violence Risk-20 total score 3. Changes in serum testosterone concentration Treatment effects will be assessed by comparing baseline values with those at the final examination (month 12). The absence of real-life stimulants to test for actual recidivism limits possible findings. The study will be conducted in agreement with the European GCP-guideline, all relevant legal requirements, and the legal framework for voluntary treatment of convicted sexual offenders in Germany.

Study of Synthetic Vision Systems (SVS) and Velocity-vector Based Command Augmentation System (V-CAS) on Pilot Performance

NASA Technical Reports Server (NTRS)

Liu, Dahai; Goodrich, Ken; Peak, Bob

2006-01-01

This study investigated the effects of synthetic vision system (SVS) concepts and advanced flight controls on single pilot performance (SPP). Specifically, we evaluated the benefits and interactions of two levels of terrain portrayal, guidance symbology, and control-system response type on SPP in the context of lower-landing minima (LLM) approaches. Performance measures consisted of flight technical error (FTE) and pilot perceived workload. In this study, pilot rating, control type, and guidance symbology were not found to significantly affect FTE or workload. It is likely that transfer from prior experience, limited scope of the evaluation task, specific implementation limitations, and limited sample size were major factors in obtaining these results.

Compensation for time delay in flight simulator visual-display systems

NASA Technical Reports Server (NTRS)

Crane, D. F.

1983-01-01

A piloted aircraft can be viewed as a closed-loop, man-machine control system. When a simulator pilot is performing a precision maneuver, a delay in the visual display of aircraft response to pilot-control input decreases the stability of the pilot-aircraft system. The less stable system is more difficult to control precisely. Pilot dynamic response and performance change as the pilot attempts to compensate for the decrease in system stability, and these changes bias the simulation results by influencing the pilot's rating of the handling qualities of the simulated aircraft. Delay compensation, designed to restore pilot-aircraft system stability, was evaluated in several studies which are reported here. The studies range from single-axis, tracking-task experiments (with sufficient subjects and trials to establish statistical significance of the results) to a brief evaluation of compensation of a computer-generated-imagery (CGI) visual display system in a full six-degree-of-freedom simulation. The compensation was effective - improvements in pilot performance and workload or aircraft handling-qualities rating (HQR) were observed. Results from recent aircraft handling-qualities research literature which support the compensation design approach are also reviewed.

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache.

PubMed

Rolle, Guido; Tremolizzo, Lucio; Somalvico, Francesco; Ferrarese, Carlo; Bressan, Livio C

2014-09-01

Osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) may be used for managing headache pain and related disability, but there is a need for high-quality randomized controlled trials to assess the effectiveness of this intervention. To explore the efficacy of OMTh for pain management in frequent episodic tension-type headache (TTH). Single-blind randomized placebo-controlled pilot study. Patients were recruited from 5 primary care settings. Forty-four patients who were affected by frequent episodic TTH and not taking any drugs for prophylactic management of episodic TTH were recruited. Patients were randomly allocated to an experimental or control group. The experimental group received corrective OMTh techniques, tailored for each patient; the control group received assessment of the cranial rhythmic impulse (sham therapy). The study included a 1-month baseline period, a 1-month treatment period, and a 3-month follow-up period. The primary outcome was the change in patient-reported headache frequency, and secondary outcomes included changes in headache pain intensity (discrete score, 1 [lowest perceived pain] to 5 [worst perceived pain]), over-the-counter medication use, and Headache Disability Inventory score. Forty patients completed the study (OMTh, n=21; control, n=19). The OMTh group had a significant reduction in headache frequency over time that persisted 1 month (approximate reduction, 40%; P<.001) and 3 months (approximate reduction, 50%; P<.001) after the end of treatment. Moreover, there was an absolute difference between the 2 treatment groups at the end of the study, with a 33% lower frequency of headache in the OMTh group (P<.001). This feasibility study demonstrated the efficacy of OMTh in the management of frequent episodic TTH, compared with sham therapy in a control group. Osteopathic manipulative therapy may be preferred over other treatment modalities and may benefit patients who have adverse effects to medications or who have difficulty complying with pharmacologic regimens. This protocol may serve as a model for future studies. © 2014 The American Osteopathic Association.

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.

PubMed

Sundseth, Jarle; Fredriksli, Oddrun Anita; Kolstad, Frode; Johnsen, Lars Gunnar; Pripp, Are Hugo; Andresen, Hege; Myrseth, Erling; Müller, Kay; Nygaard, Øystein P; Zwart, John-Anker

2017-04-01

Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. http://www.clinicaltrials.gov NCT 00735176.19.

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

PubMed Central

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 diet supplemented with a probiotic cheese helps to reduce BMI and arterial BP values, recognized symptoms of metabolic syndrome. Trial registration Current Controlled Trials ISRCTN76271778 PMID:24120179

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.

PubMed

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 helps to reduce BMI and arterial BP values, recognized symptoms of metabolic syndrome.

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.

PubMed

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.

Communication strategies and timeliness of response to life critical telemetry alarms.

PubMed

Bonzheim, Kimberly A; Gebara, Rani I; O'Hare, Bridget M; Ellis, R Darin; Brand, Monique A; Balar, Salil D; Stockman, Rita; Sciberras, Annette M; Haines, David E

2011-05-01

A centralized electrocardiogram telemetry monitoring system (TMS) facilitates early identification of critical arrhythmias and acute medical decompensation. Timely intervention can only be performed if abnormalities are communicated rapidly to the direct caregiver. The study objectives were to measure effectiveness of bi-directional voice communication badges versus one-way alphanumeric pagers for telemetry alarm response and communication loop closure. A sequential observational pilot study of nursing response to TMS alarms compared communication technologies on four nursing units in a 1,061 bed tertiary care hospital with 264 TMS channels of telemetry over a 2-year period. Subsequently, the communication technologies were compared in a randomized fashion on a 68-bed progressive cardiac care unit. Caregivers were blinded to the protocol. All alarm responses were recorded during two periods using either pagers or voice communication devices. Alarm response time and closure of the communication loop were analyzed in a blinded fashion. The direct communication functionality of the badge significantly shortened the time to first contact, time to completion, and rate of closure of the communication loop in both the pilot and study phases. Median time to first contact with the communication badge was 0.5  min, compared to 1.6  min with pager communication (p < 0.0003). Communication loop closure was achieved in 100% of clinical alarms using the badge versus 19% with the pager (p < 0.0001). Communication badge technology reduced alarm time to first contact and completion as well as facilitated communication loop closures. Immediate two-way communication significantly impacted practice, alarm management, and resulted in faster bedside care.

Robustness of methods for blinded sample size re-estimation with overdispersed count data.

PubMed

Schneider, Simon; Schmidli, Heinz; Friede, Tim

2013-09-20

Counts of events are increasingly common as primary endpoints in randomized clinical trials. With between-patient heterogeneity leading to variances in excess of the mean (referred to as overdispersion), statistical models reflecting this heterogeneity by mixtures of Poisson distributions are frequently employed. Sample size calculation in the planning of such trials requires knowledge on the nuisance parameters, that is, the control (or overall) event rate and the overdispersion parameter. Usually, there is only little prior knowledge regarding these parameters in the design phase resulting in considerable uncertainty regarding the sample size. In this situation internal pilot studies have been found very useful and very recently several blinded procedures for sample size re-estimation have been proposed for overdispersed count data, one of which is based on an EM-algorithm. In this paper we investigate the EM-algorithm based procedure with respect to aspects of their implementation by studying the algorithm's dependence on the choice of convergence criterion and find that the procedure is sensitive to the choice of the stopping criterion in scenarios relevant to clinical practice. We also compare the EM-based procedure to other competing procedures regarding their operating characteristics such as sample size distribution and power. Furthermore, the robustness of these procedures to deviations from the model assumptions is explored. We find that some of the procedures are robust to at least moderate deviations. The results are illustrated using data from the US National Heart, Lung and Blood Institute sponsored Asymptomatic Cardiac Ischemia Pilot study. Copyright © 2013 John Wiley & Sons, Ltd.

The Bipolar Depression Electrical Treatment Trial (BETTER): Design, Rationale, and Objectives of a Randomized, Sham-Controlled Trial and Data from the Pilot Study Phase

PubMed Central

Pereira Junior, Bernardo de Sampaio; Nunes, Paula; Benseñor, Isabela Martins; Lotufo, Paulo Andrade; Machado-Vieira, Rodrigo; Brunoni, André R.

2015-01-01

Background. Bipolar depression (BD) is a prevalent condition, with poor therapeutic options and a high degree of refractoriness. This justifies the development of novel treatment strategies, such as transcranial direct current stimulation (tDCS) that showed promising results in unipolar depression. Methods. We describe a randomized, sham-controlled, double-blinded trial using tDCS for refractory, acutely symptomatic BD (the bipolar depression electrical treatment trial, BETTER). Sixty patients will be enrolled and assessed with clinical and neuropsychological tests. The primary outcome is change (over time and across groups) in the scores of the Hamilton Depression Rating Scale (17 items). Biological markers such as blood neurotrophins and interleukins, genetic polymorphisms, heart rate variability, and motor cortical excitability will be assessed. Twelve anodal-left/cathodal-right 2 mA tDCS sessions over the dorsolateral prefrontal cortex will be performed in 6 weeks. Results. In the pilot phase, five patients received active tDCS and were double-blindly assessed, two presenting clinical response. TDCS was well-tolerated, with no changes in cognitive scores. Conclusion. This upcoming clinical trial will address the efficacy of tDCS for BD on different degrees of refractoriness. The evaluation of biological markers will also help in understanding the pathophysiology of BD and the mechanisms of action of tDCS. PMID:25878904

An Investigation of the Ability to Recover from Transients Following Failures for Single-Pilot Rotorcraft

NASA Technical Reports Server (NTRS)

Mansur, M. Hossein; Schroeder, Jeffery A.

1988-01-01

A moving-base simulation was conducted to investigate a pilot's ability to recover from transients following single-axis hard-over failures of the flight-control system. The investigation was performed in conjunction with a host simulation that examined the influence of control modes on a single pilot's ability to perform various mission elements under high-workload conditions. The NASA Ames large-amplitude-motion Vertical Motion Simulator (VMS) was utilized, and the experimental variables were the failure axis, the severity of the failure, and the airspeed at which the failure occurred. Other factors, such as pilot workload and terrain and obstacle proximity at the time of failure, were kept as constant as possible within the framework of the host simulation task scenarios. No explicit failure warnings were presented to the pilot. Data from the experiment are shown, and pilot ratings are compared with the proposed handling-qualities requirements for military rotorcraft. Results indicate that the current proposed failure transient requirements may need revision.

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

PubMed

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); however, group differences were not significant (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.

A 12-week randomized double-blind parallel pilot trial of Sinetrol XPur on body weight, abdominal fat, waist circumference, and muscle metabolism in overweight men.

PubMed

Cases, Julien; Romain, Cindy; Dallas, Constantin; Gerbi, Alain; Rouanet, Jean Max

2015-01-01

Overweight and obesity are associated to increased risk of developing non-communicable diseases that might dramatically affect life expectancy according World Health Organization. Overweight, obesity, and decline in physical activity are correlated to a significant propensity to lose skeletal muscle mass as a result of prolonged inflammation and oxidative stress whereas cohort surveys and clinical investigations have demonstrated health benefits of Citrus-based polyphenols to reverse such regression. Overweight men were included in a double-blind, randomized, parallel pilot trial where they received daily for a 12-week period 900 mg of a Citrus-based polyphenol extract, Sinetrol® XPur. Body composition, anthropometric, and blood parameters were assessed before and at the end of the intervention period. After 12 weeks, while the silhouette slimmed down, metabolic parameters were significantly improved and skeletal muscle catabolism held back. These data suggest that over a 12-week period, the efficacy of the supplement improve both overweight process and correlated skeletal muscle mass metabolism.

Choosing blindly but wisely: differentially private solicitation of DNA datasets for disease marker discovery.

PubMed

Zhao, Yongan; Wang, Xiaofeng; Jiang, Xiaoqian; Ohno-Machado, Lucila; Tang, Haixu

2015-01-01

To propose a new approach to privacy preserving data selection, which helps the data users access human genomic datasets efficiently without undermining patients' privacy. Our idea is to let each data owner publish a set of differentially-private pilot data, on which a data user can test-run arbitrary association-test algorithms, including those not known to the data owner a priori. We developed a suite of new techniques, including a pilot-data generation approach that leverages the linkage disequilibrium in the human genome to preserve both the utility of the data and the privacy of the patients, and a utility evaluation method that helps the user assess the value of the real data from its pilot version with high confidence. We evaluated our approach on real human genomic data using four popular association tests. Our study shows that the proposed approach can help data users make the right choices in most cases. Even though the pilot data cannot be directly used for scientific discovery, it provides a useful indication of which datasets are more likely to be useful to data users, who can therefore approach the appropriate data owners to gain access to the data. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study.

PubMed

Dias, Rodrigo S; Kerr-Corrêa, Florence; Moreno, Ricardo A; Trinca, Luzia A; Pontes, Anagloria; Halbe, Hans W; Gianfaldoni, Arlete; Dalben, Ivete S

2006-01-01

This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg). Seventy-two menopausal women (mean age: 53.6 +/- 4.27 years) diagnosed with depression (Montgomery-Asberg Depression Rating Scale [MADRS] scores > or = 20) were treated with venlafaxine and one of the following hormone therapy combinations, in a double-blind regimen: estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20); estrogen + medroxyprogesterone acetate (group 2, n = 20); methyltestosterone only (group 3, n = 16); and no hormone therapy (group 4, n = 16). Study duration was 24 weeks. Primary efficacy outcome was remission according to the MADRS, whereas secondary efficacy measures included the Clinical Global Impression (CGI), Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ). Forty-eight patients completed the study. All groups showed significant improvement from baseline. Group 3 demonstrated significant improvement on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048) and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but also had the highest dropout rate. Groups 1 and 3 had significant CGI improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45% (P = 0.08), respectively. There were no differences in the WHQ or BKI scores among the groups. Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study.

Identifying Issues and Concerns with the Use of Interval-Based Systems in Single Case Research Using a Pilot Simulation Study

ERIC Educational Resources Information Center

Ledford, Jennifer R.; Ayres, Kevin M.; Lane, Justin D.; Lam, Man Fung

2015-01-01

Momentary time sampling (MTS), whole interval recording (WIR), and partial interval recording (PIR) are commonly used in applied research. We discuss potential difficulties with analyzing data when these systems are used and present results from a pilot simulation study designed to determine the extent to which these issues are likely to be…

Video Modeling for Teaching Daily Living Skills to Children with Autism Spectrum Disorder: A Pilot Study

ERIC Educational Resources Information Center

Meister, Christine; Salls, Joyce

2015-01-01

This pilot study investigated the efficacy of point-of-view video modeling as an intervention strategy to improve self-help skills in children with autism spectrum disorder (ASD). A single-subject A-B design was implemented with eight school-aged children ages 7.5 years to 13.5 years. Six of the students participated in general education classes…

Degenerative Changes of Spine in Helicopter Pilots

PubMed Central

Byeon, Joo Hyeon; Kim, Jung Won; Jeong, Ho Joong; Sim, Young Joo; Kim, Dong Kyu; Choi, Jong Kyoung; Im, Hyoung June

2013-01-01

Objective To determine the relationship between whole body vibration (WBV) induced helicopter flights and degenerative changes of the cervical and lumbar spine. Methods We examined 186 helicopter pilots who were exposed to WBV and 94 military clerical workers at a military hospital. Questionnaires and interviews were completed for 164 of the 186 pilots (response rate, 88.2%) and 88 of the 94 clerical workers (response rate, 93.6%). Radiographic examinations of the cervical and the lumbar spines were performed after obtaining informed consent in both groups. Degenerative changes of the cervical and lumbar spines were determined using four radiographs per subject, and diagnosed by two independent, blinded radiologists. Results There was no significant difference in general and work-related characteristics except for flight hours and frequency between helicopter pilots and clerical workers. Degenerative changes in the cervical spine were significantly more prevalent in the helicopter pilots compared with control group. In the cervical spine multivariate model, accumulated flight hours (per 100 hours) was associated with degenerative changes. And in the lumbar spine multivariate model, accumulated flight hours (per 100 hours) and age were associated with degenerative changes. Conclusion Accumulated flight hours were associated with degenerative changes of the cervical and lumbar spines in helicopter pilots. PMID:24236259

Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol.

PubMed

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.

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

NASA Astrophysics Data System (ADS)

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

2017-12-01

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 < 0.05). Statistically significant differences were observed in HGS scores in the group 2 at week 2 and in AUSCAN scores at week 6 ( p < 0.05). Intergroup comparisons of the scores revealed significant differences between the peloid therapy group and control group in VAS, HAQ, AUSCAN, HGS, and PS scores at week 2 and week 6 ( p < 0.05). This study demonstrates that peloid therapy might be an effective and confident treatment modality in the management of symptomatic osteoarthritis of the hand and may provide effective pain control and improvements in the hand functions, quality of life, and grip strength.

Blind quantum computing with weak coherent pulses.

PubMed

Dunjko, Vedran; Kashefi, Elham; Leverrier, Anthony

2012-05-18

The universal blind quantum computation (UBQC) protocol [A. Broadbent, J. Fitzsimons, and E. Kashefi, in Proceedings of the 50th Annual IEEE Symposiumon Foundations of Computer Science (IEEE Computer Society, Los Alamitos, CA, USA, 2009), pp. 517-526.] allows a client to perform quantum computation on a remote server. In an ideal setting, perfect privacy is guaranteed if the client is capable of producing specific, randomly chosen single qubit states. While from a theoretical point of view, this may constitute the lowest possible quantum requirement, from a pragmatic point of view, generation of such states to be sent along long distances can never be achieved perfectly. We introduce the concept of ϵ blindness for UBQC, in analogy to the concept of ϵ security developed for other cryptographic protocols, allowing us to characterize the robustness and security properties of the protocol under possible imperfections. We also present a remote blind single qubit preparation protocol with weak coherent pulses for the client to prepare, in a delegated fashion, quantum states arbitrarily close to perfect random single qubit states. This allows us to efficiently achieve ϵ-blind UBQC for any ϵ>0, even if the channel between the client and the server is arbitrarily lossy.

Blind Quantum Computing with Weak Coherent Pulses

NASA Astrophysics Data System (ADS)

Dunjko, Vedran; Kashefi, Elham; Leverrier, Anthony

2012-05-01

The universal blind quantum computation (UBQC) protocol [A. Broadbent, J. Fitzsimons, and E. Kashefi, in Proceedings of the 50th Annual IEEE Symposiumon Foundations of Computer Science (IEEE Computer Society, Los Alamitos, CA, USA, 2009), pp. 517-526.] allows a client to perform quantum computation on a remote server. In an ideal setting, perfect privacy is guaranteed if the client is capable of producing specific, randomly chosen single qubit states. While from a theoretical point of view, this may constitute the lowest possible quantum requirement, from a pragmatic point of view, generation of such states to be sent along long distances can never be achieved perfectly. We introduce the concept of ɛ blindness for UBQC, in analogy to the concept of ɛ security developed for other cryptographic protocols, allowing us to characterize the robustness and security properties of the protocol under possible imperfections. We also present a remote blind single qubit preparation protocol with weak coherent pulses for the client to prepare, in a delegated fashion, quantum states arbitrarily close to perfect random single qubit states. This allows us to efficiently achieve ɛ-blind UBQC for any ɛ>0, even if the channel between the client and the server is arbitrarily lossy.

The effects of display and autopilot functions on pilot workload for Single Pilot Instrument Flight Rule (SPIFR) operations

NASA Technical Reports Server (NTRS)

Hoh, Roger H.; Smith, James C.; Hinton, David A.

1987-01-01

An analytical and experimental research program was conducted to develop criteria for pilot interaction with advanced controls and displays in single pilot instrument flight rules (SPIFR) operations. The analytic phase reviewed fundamental considerations for pilot workload taking into account existing data, and using that data to develop a divided attention SPIFR pilot workload model. The pilot model was utilized to interpret the two experimental phases. The first experimental phase was a flight test program that evaluated pilot workload in the presence of current and near-term displays and autopilot functions. The second experiment was conducted on a King Air simulator, investigating the effects of co-pilot functions in the presence of very high SPIFR workload. The results indicate that the simplest displays tested were marginal for SPIFR operations. A moving map display aided the most in mental orientation, but had inherent deficiencies as a stand alone replacement for an HSI. Autopilot functions were highly effective for reducing pilot workload. The simulator tests showed that extremely high workload situations can be adequately handled when co-pilot functions are provided.

A randomized, double-blind, pilot study of rifaximin 550 mg versus placebo in the prevention of travelers' diarrhea in Mexico during the dry season.

PubMed

Flores, Jose; Dupont, Herbert L; Jiang, Zhi-Dong; Okhuysen, Pablo C; Melendez-Romero, Juan H; Gonzalez-Estrada, Alexei; Carrillo, Ismael; Paredes, Mercedes

2011-01-01

Rifaximin has been shown to be effective in treating and preventing travelers' diarrhea (TD) during the summer season. The goal of this double-blinded multicenter trial was to assess the efficacy and safety of rifaximin 550 mg administered once daily for 14 days compared with placebo in the prevention of TD during the dry season in Mexico. There were 101 participants randomized. Overall, 25 participants developed TD during the 3 weeks of the study: 22% from the rifaximin group and 29% from the placebo group (p = 0.4). Mild diarrhea (defined as only one or two unformed stools during a 24-h period plus at least one abdominal symptoms) developed in only 3 (6%) participants taking rifaximin compared with 10 (21%) taking placebo during the first week of study (p = 0.03). No clinically significant or serious adverse events were reported. Antibiotic prophylaxis of TD in Mexico during the dry season needs to be further studied and its benefits weighed against the benefits of self-treatment. © 2011 International Society of Travel Medicine.

Theatre Is a Valid Add-On Therapeutic Intervention for Emotional Rehabilitation of Parkinson's Disease Patients

PubMed Central

De Vita, Paolo; Fragola, Michele; Rampelli, Silvia; Lena, Francesco; Dilettuso, Fulvia; Iacopini, Marta; d'Avella, Raffaella; Borgese, Maria Concetta; Mazzotta, Silvia; Lanni, Deborah; Grano, Marco; Lubrani, Sara; Modugno, Nicola

2017-01-01

Conventional medical treatments of Parkinson's disease (PD) are effective on motor disturbances but may have little impact on nonmotor symptoms, especially psychiatric ones. Thus, even when motor symptomatology improves, patients might experience deterioration in their quality of life. We have shown that 3 years of active theatre is a valid complementary intervention for PD as it significantly improves the well-being of patients in comparison to patients undergoing conventional physiotherapy. Our aim was to replicate these findings while improving the efficacy of the treatment. We ran a single-blinded pilot study lasting 15 months on 24 subjects with moderate idiopathic PD. 12 were assigned to a theatre program in which patients underwent “emotional” training. The other 12 underwent group physiotherapy. Patients were evaluated at the beginning and at the end of their treatments, using a battery of eight clinical and five neuropsychological scales. We found that the emotional theatre training improved the emotional well-being of patients, whereas physiotherapy did not. Interestingly, neither of the groups showed improvements in either motor symptoms or cognitive abilities tested by the neuropsychological battery. We confirmed that theatre therapy might be helpful in improving emotional well-being in PD. PMID:29359066

Feasibility and safety of exercise stress testing using an anti-gravity treadmill with Tc-99m tetrofosmin single-photon emission computed tomography (SPECT) myocardial perfusion imaging: A pilot non-randomized controlled study.

PubMed

Daly, Patrick; Kayse, Regina; Rudick, Steven; Robbins, Nathan; Scheler, Jennifer; Harris, David; O'Donnell, Robert; Dwivedi, Alok K; Gerson, Myron C

2017-08-31

Exercise is the AHA/ACC guideline-recommended stress modality for myocardial perfusion imaging, but many patients are unable to exercise to target heart rate on a conventional treadmill. We examined the feasibility and safety of stress imaging using an anti-gravity treadmill in patients with perceived poor exercise capacity. 49 patients were recruited for stress testing by anti-gravity treadmill (n = 29) or to a regadenoson control group (n = 20). Seventeen anti-gravity test patients (59%) reached target heart rate obviating the need for a pharmacologic stress agent. Adverse effects of the anti-gravity treadmill were limited to minor muscle aches in 5 subjects. Stress myocardial perfusion image quality judged by 3 blinded readers on a 5-point scale was comparable for the anti-gravity treadmill (4.30 ± SD 0.87) vs pharmacologic stress (4.28 ± SD 0.66). Stress testing using an anti-gravity treadmill is feasible and may help some patients safely achieve target heart rate.

Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children: a randomized, double-blind, lot-to-lot consistency trial.

PubMed

Umeh, Rich; Oguche, Stephen; Oguonu, Tagbo; Pitmang, Simon; Shu, Elvis; Onyia, Jude-Tony; Daniyam, Comfort A; Shwe, David; Ahmad, Abdullahi; Jongert, Erik; Catteau, Grégory; Lievens, Marc; Ofori-Anyinam, Opokua; Leach, Amanda

2014-11-12

For regulatory approval, consistency in manufacturing of vaccine lots is expected to be demonstrated in confirmatory immunogenicity studies using two-sided equivalence trials. This randomized, double-blind study (NCT01323972) assessed consistency of three RTS,S/AS01 malaria vaccine batches formulated from commercial-scale purified antigen bulk lots in terms of anti-CS-responses induced. Healthy children aged 5-17 months were randomized (1:1:1:1) to receive RTS,S/AS01 at 0-1-2 months from one of three commercial-scale purified antigen bulk lots (1600 litres-fermentation scale; commercial-scale lots), or a comparator vaccine batch made from pilot-scale purified antigen bulk lot (20 litres-fermentation scale; pilot-scale lot). The co-primary objectives were to first demonstrate consistency of antibody responses against circumsporozoite (CS) protein at one month post-dose 3 for the three commercial-scale lots and second demonstrate non-inferiority of anti-CS antibody responses at one month post-dose 3 for the commercial-scale lots compared to the pilot-scale lot. Safety and reactogenicity were evaluated as secondary endpoints. One month post-dose-3, anti-CS antibody geometric mean titres (GMT) for the 3 commercial scale lots were 319.6 EU/ml (95% confidence interval (CI): 268.9-379.8), 241.4 EU/ml (207.6-280.7), and 302.3 EU/ml (259.4-352.3). Consistency for the RTS,S/AS01 commercial-scale lots was demonstrated as the two-sided 95% CI of the anti-CS antibody GMT ratio between each pair of lots was within the range of 0.5-2.0. GMT of the pooled commercial-scale lots (285.8 EU/ml (260.7-313.3)) was non-inferior to the pilot-scale lot (271.7 EU/ml (228.5-323.1)). Each RTS,S/AS01 lot had an acceptable tolerability profile, with infrequent reports of grade 3 solicited symptoms. No safety signals were identified and no serious adverse events were considered related to vaccination. RTS,S/AS01 lots formulated from commercial-scale purified antigen bulk batches induced a consistent anti-CS antibody response, and the anti-CS GMT of pooled commercial-scale lots was non-inferior to that of a lot formulated from a pilot-scale antigen bulk batch. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

PubMed

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®. This pilot study confirms the usefulness of quantitative and qualitative MRI as a sensitive tool to assess a structure modifying drugs in knee osteoarthritis.

[Prevalence of blindness and moderate and severe visual impairment among adults aged 50 years or above in Shuangcheng City of Heilongjiang Province: the China Nine-Province Survey].

PubMed

Zhang, Liqiong; Cui, Hao; Zhao, Jialiang; Ellwein, Leon B; Li, Zhijian; Li, Mingsheng; Yu, Nannan; Wang, Yu; Gao, Xuecheng

2014-03-01

To investigate the prevalence of blindness and moderate and severe visual impairment among adults aged 50 years or above in Shuangcheng City of Heilongjiang Province, China. It was a population-based cross-section study. Geographically defined cluster sampling was used in randomly selecting 5 841 individuals aged 50 years or above in 28 basic sample units in Shuangcheng City from September to December 2006. The survey was preceded by a pilot study where operational methods were refined and quality assurance evaluation was carried out. All participants were enumerated through village registers followed door-to-door visits.Eligible individuals were invited to receive visual acuity measurement and eye examination. Statistical analyses were performed using Stata/SE Statistical Software, release 9.0. Chi-square test was used to investigate the association of age, gender and education with presenting and best corrected visual acuity. Five thousands four hundreds and eighty-one individuals were enumerated and 5 047 persons were examined, the response rate was 92.08%. Based on the criteria of World Health Organization visual impairment classification in 1973, the prevalence of blindness and moderate and severe visual impairment defined as best corrected visual acuity was 1.72% (87/5 047) and 4.69% (237/5 047) respectively. The prevalence of blindness and moderate and severe visual impairment defined as presenting visual acuity was 1.90% (96/5 047) and 7.23% (365/5 047) respectively. The prevalence of blindness and moderate and severe visual impairment was higher in aged (trend χ(2)=674.44, P < 0.01), female (χ(2)=39.61, P < 0.01) and illiterate (trend χ(2)=142.82, P < 0.01) persons. Cataract (52.70%) was still the first leading cause of blindness and visual impairment. The percentage of the retinal diseases, including age-related macular degeneration, high myopic retinopathy and diabetic retinopathy was 11.31% among the eyes with blindness and moderate and severe visual impairment. Un-corrected refractive error(13.38%) also was the main cause of visual impairment. The prevalence of blindness and moderate and severe visual impairment in Shuangcheng City is relatively higher in China Nine Province Survey. Cataract, retinal diseases and un-corrected refractive error are the main causes of the blindness and moderate and severe visual impairment.

Effect of caffeine on simulator flight performance in sleep-deprived military pilot students.

PubMed

Lohi, Jouni J; Huttunen, Kerttu H; Lahtinen, Taija M M; Kilpeläinen, Airi A; Muhli, Arto A; Leino, Tuomo K

2007-09-01

Caffeine has been suggested to act as a countermeasure against fatigue in military operations. In this randomized, double-blind, placebo-controlled study, the effect of caffeine on simulator flight performance was examined in 13 military pilots during 37 hours of sleep deprivation. Each subject performed a flight mission in simulator four times. The subjects received either a placebo (six subjects) or 200 mg of caffeine (seven subjects) 1 hour before the simulated flights. A moderate 200 mg intake of caffeine was associated with higher axillary temperatures, but it did not affect subjectively assessed sleepiness. Flight performance was similar in both groups during the four rounds flown under sleep deprivation. However, subjective evaluation of overall flight performance in the caffeine group tended to be too optimistic, indicating a potential flight safety problem. Based on our results, we do not recommend using caffeine pills in military flight operations.

Predicting the language proficiency of Chinese student pilots within American airspace: Single-task versus dual-task English-language assessment

NASA Astrophysics Data System (ADS)

Noble, Clifford Elliott, II

2002-09-01

The problem. The purpose of this study was to investigate the ability of three single-task instruments---(a) the Test of English as a Foreign Language, (b) the Aviation Test of Spoken English, and (c) the Single Manual-Tracking Test---and three dual-task instruments---(a) the Concurrent Manual-Tracking and Communication Test, (b) the Certified Flight Instructor's Test, and (c) the Simulation-Based English Test---to predict the language performance of 10 Chinese student pilots speaking English as a second language when operating single-engine and multiengine aircraft within American airspace. Method. This research implemented a correlational design to investigate the ability of the six described instruments to predict the mean score of the criterion evaluation, which was the Examiner's Test. This test assessed the oral communication skill of student pilots on the flight portion of the terminal checkride in the Piper Cadet, Piper Seminole, and Beechcraft King Air airplanes. Results. Data from the Single Manual-Tracking Test, as well as the Concurrent Manual-Tracking and Communication Test, were discarded due to performance ceiling effects. Hypothesis 1, which stated that the average correlation between the mean scores of the dual-task evaluations and that of the Examiner's Test would predict the mean score of the criterion evaluation with a greater degree of accuracy than that of single-task evaluations, was not supported. Hypothesis 2, which stated that the correlation between the mean scores of the participants on the Simulation-Based English Test and the Examiner's Test would predict the mean score of the criterion evaluation with a greater degree of accuracy than that of all single- and dual-task evaluations, was also not supported. The findings suggest that single- and dual-task assessments administered after initial flight training are equivalent predictors of language performance when piloting single-engine and multiengine aircraft.

High-Performance Visible-Blind UV Phototransistors Based on n-Type Naphthalene Diimide Nanomaterials.

PubMed

Song, Inho; Lee, Seung-Chul; Shang, Xiaobo; Ahn, Jaeyong; Jung, Hoon-Joo; Jeong, Chan-Uk; Kim, Sang-Wook; Yoon, Woojin; Yun, Hoseop; Kwon, O-Pil; Oh, Joon Hak

2018-04-11

This study investigates the performance of single-crystalline nanomaterials of wide-band gap naphthalene diimide (NDI) derivatives with methylene-bridged aromatic side chains. Such materials are found to be easily used as high-performance, visible-blind near-UV light detectors. NDI single-crystalline nanoribbons are assembled using a simple solution-based process (without solvent-inclusion problems), which is then applied to organic phototransistors (OPTs). Such OPTs exhibit excellent n-channel transistor characteristics, including an average electron mobility of 1.7 cm 2 V -1 s -1 , sensitive UV detection properties with a detection limit of ∼1 μW cm -2 , millisecond-level responses, and detectivity as high as 10 15 Jones, demonstrating the highly sensitive organic visible-blind UV detectors. The high performance of our OPTs originates from the large face-to-face π-π stacking area between the NDI semiconducting cores, which is facilitated by methylene-bridged aromatic side chains. Interestingly, NDI-based nanoribbon OPTs exhibit a distinct visible-blind near-UV detection with an identical detection limit, even under intense visible light illumination (for example, 10 4 times higher intensity than UV light intensity). Our findings demonstrate that wide-band gap NDI-based nanomaterials are highly promising for developing high-performance visible-blind UV photodetectors. Such photodetectors could potentially be used for various applications including environmental and health-monitoring systems.

Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

PubMed

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 attainment, carers' perception of patients' goal attainment and patients' and carers' health status and psychosocial well-being, measured at the same time points. Cost-effectiveness will be examined to explore the design of a larger cost-effectiveness analysis alongside a full trial. This pilot study will evaluate the application of cognitive rehabilitation for the management of cognitive difficulties associated with Parkinson's disease dementia and dementia with Lewy bodies. The results of the study will inform the design of a fully powered randomised controlled trial. ISRCTN16584442 DOI 10.1186/ISRCTN16584442 13 April 2015.

Effect of transdermal magnesium cream on serum and urinary magnesium levels in humans: A pilot study

PubMed Central

Tanner, Amy; Sullivan, Keith; McAuley, William; Plesset, Michael

2017-01-01

Background Oral magnesium supplementation is commonly used to support a low magnesium diet. This investigation set out to determine whether magnesium in a cream could be absorbed transdermally in humans to improve magnesium status. Methods and findings In this single blind, parallel designed pilot study, n = 25 participants (aged 34.3+/-14.8y, height 171.5+/-11cm, weight 75.9 +/-14 Kg) were randomly assigned to either a 56mg/day magnesium cream or placebo cream group for two weeks. Magnesium serum and 24hour urinary excretion were measured at baseline and at 14 days intervention. Food diaries were recorded for 8 days during this period. Mg test and placebo groups’ serum and urinary Mg did not differ at baseline. After the Mg2+ cream intervention there was a clinically relevant increase in serum magnesium (0.82 to 0.89 mmol/l,p = 0.29) that was not seen in the placebo group (0.77 to 0.79 mmol/L), but was only statistically significant (p = 0.02)) in a subgroup of non-athletes. Magnesium urinary excretion increased from baseline slightly in the Mg2+ group but with no statistical significance (p = 0.48). The Mg2+ group showed an 8.54% increase in serum Mg2+ and a 9.1% increase in urinary Mg2+ while these figures for the placebo group were smaller, i.e. +2.6% for serum Mg2+ and -32% for urinary Mg2+. In the placebo group, both serum and urine concentrations showed no statistically significant change after the application of the placebo cream. Conclusion No previous studies have looked at transdermal absorbency of Mg2+ in human subjects. In this pilot study, transdermal delivery of 56 mg Mg/day (a low dose compared with commercial transdermal Mg2+ products available) showed a larger percentage rise in both serum and urinary markers from pre to post intervention compared with subjects using the placebo cream, but statistical significance was achieved only for serum Mg2+ in a subgroup of non-athletes. Future studies should look at higher dosage of magnesium cream for longer durations. Trial registration ISRCTN registry ID No. ISRTN15136969 PMID:28403154

QUETIAPINE IMPROVES RESPONSE INHIBITION IN ALCOHOL DEPENDENT PATIENTS: A PLACEBO-CONTROLLED PILOT STUDY

PubMed Central

Moallem, Nathasha; Ray, Lara A.

2013-01-01

Rationale Quetiapine has been shown to be a promising medication for the treatment of alcoholism. As an atypical antipsychotic medication with antagonist activity at D1 and D2, 5-HT1A and 5-HT2A, H1 and α1 and α2 receptors, quetiapine has been found to decrease impulsivity in other psychiatric disorders but its effects on impulsivity have not been studied in alcohol dependent patients. Objective This study seeks to test the effects of quetiapine on a specific dimension of impulsivity, namely response inhibition. This pilot study seeks to further elucidate the mechanisms of action of quetiapine for alcohol use disorders. Method A total of 20 non-treatment seeking alcohol dependent individuals were randomized to one of the following conditions in a double-blind, placebo-controlled design: (1) quetiapine (400 mg/day); or (2) matched placebo. Participants completed two counterbalanced intravenous placebo-alcohol administration sessions as well as behavioral measure of response inhibition (i.e. stop signal task) pre and post placebo-alcohol administration sessions. Results Analyses revealed a significant effect of quetiapine in improving response inhibition as measured by the stop signal task. These results provide preliminary evidence suggesting that quetiapine improves response inhibition in alcohol dependent patients, as compared to placebo. Conclusion This pilot study contributes a novel putative mechanism of action of quetiapine in alcoholism, namely an improvement in response inhibition. PMID:22037407

Manned Systems Utilization Analysis. Study 2.1: Space Servicing Pilot Program Study. [for automated payloads

NASA Technical Reports Server (NTRS)

Wolfe, R. R.

1975-01-01

Space servicing automated payloads was studied for potential cost benefits for future payload operations. Background information is provided on space servicing in general, and on a pilot flight test program in particular. An fight test is recommended to demonstrate space servicing. An overall program plan is provided which builds upon the pilot program through an interim servicing capability. A multipayload servicing concept for the time when the full capability tug becomes operational is presented. The space test program is specifically designed to provide low-cost booster vehicles and a flight test platform for several experiments on a single flight.

Efficacy of aquatic therapy for multiple sclerosis: a systematic review.

PubMed

Corvillo, Iluminada; Varela, Enrique; Armijo, Francisco; Alvarez-Badillo, Antonio; Armijo, Onica; Maraver, Francisco

2017-12-01

Multiple sclerosis (MS) is a chronic, inflammatory, progressive, disabling autoimmune disease affecting the central nervous system. Symptoms and signs of MS vary widely and patients may lose their ability to walk. To date the benefits of aquatic therapy often used for rehabilitation in MS patients have not been reviewed. The aim of this study was to systematically review the current state of aquatic treatment for persons with MS (hydrotherapy, aquatic therapy, aquatic exercises, spa therapy) and to evaluate the scientific evidence supporting the benefits of this therapeutic option. The databases PubMed, Scopus, WoS and PEDro were searched to identify relevant reports published from January 1, 2011 to April 30, 2016. Of 306 articles identified, only 10 fulfilled the inclusion criteria: 5 randomized controlled, 2 simple randomized quasi-experimental, 1 semi-experimental, 1 blind controlled pilot and 1 pilot. Evidence that aquatic treatment improves quality of life in affected patients was very good in two studies, good in four, fair in two and weak in two.

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.

PubMed

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.

Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses

PubMed Central

Akbar, Umer; Raike, Robert S.; Hack, Nawaz; Hess, Christopher W.; Skinner, Jared; Martinez‐Ramirez, Daniel; DeJesus, Sol

2016-01-01

Objectives Evidence suggests that nonconventional programming may improve deep brain stimulation (DBS) therapy for movement disorders. The primary objective was to assess feasibility of testing the tolerability of several nonconventional settings in Parkinson's disease (PD) and essential tremor (ET) subjects in a single office visit. Secondary objectives were to explore for potential efficacy signals and to assess the energy demand on the implantable pulse‐generators (IPGs). Materials and Methods A custom firmware (FW) application was developed and acutely uploaded to the IPGs of eight PD and three ET subjects, allowing delivery of several nonconventional DBS settings, including narrow pulse widths, square biphasic pulses, and irregular pulse patterns. Standard clinical rating scales and several objective measures were used to compare motor outcomes with sham, clinically‐optimal and nonconventional settings. Blinded and randomized testing was conducted in a traditional office setting. Results Overall, the nonconventional settings were well tolerated. Under these conditions it was also possible to detect clinically‐relevant differences in DBS responses using clinical rating scales but not objective measures. Compared to the clinically‐optimal settings, some nonconventional settings appeared to offer similar benefit (e.g., narrow pulse widths) and others lesser benefit. Moreover, the results suggest that square biphasic pulses may deliver greater benefit. No unexpected IPG efficiency disadvantages were associated with delivering nonconventional settings. Conclusions It is feasible to acutely screen nonconventional DBS settings using controlled study designs in traditional office settings. Simple IPG FW upgrades may provide more DBS programming options for optimizing therapy. Potential advantages of narrow and biphasic pulses deserve follow up. PMID:27000764

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

PubMed

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

2017-08-01

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

Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses.

PubMed

Akbar, Umer; Raike, Robert S; Hack, Nawaz; Hess, Christopher W; Skinner, Jared; Martinez-Ramirez, Daniel; DeJesus, Sol; Okun, Michael S

2016-06-01

Evidence suggests that nonconventional programming may improve deep brain stimulation (DBS) therapy for movement disorders. The primary objective was to assess feasibility of testing the tolerability of several nonconventional settings in Parkinson's disease (PD) and essential tremor (ET) subjects in a single office visit. Secondary objectives were to explore for potential efficacy signals and to assess the energy demand on the implantable pulse-generators (IPGs). A custom firmware (FW) application was developed and acutely uploaded to the IPGs of eight PD and three ET subjects, allowing delivery of several nonconventional DBS settings, including narrow pulse widths, square biphasic pulses, and irregular pulse patterns. Standard clinical rating scales and several objective measures were used to compare motor outcomes with sham, clinically-optimal and nonconventional settings. Blinded and randomized testing was conducted in a traditional office setting. Overall, the nonconventional settings were well tolerated. Under these conditions it was also possible to detect clinically-relevant differences in DBS responses using clinical rating scales but not objective measures. Compared to the clinically-optimal settings, some nonconventional settings appeared to offer similar benefit (e.g., narrow pulse widths) and others lesser benefit. Moreover, the results suggest that square biphasic pulses may deliver greater benefit. No unexpected IPG efficiency disadvantages were associated with delivering nonconventional settings. It is feasible to acutely screen nonconventional DBS settings using controlled study designs in traditional office settings. Simple IPG FW upgrades may provide more DBS programming options for optimizing therapy. Potential advantages of narrow and biphasic pulses deserve follow up. © 2016 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Single-pilot workload management in entry-level jets.

DOT National Transportation Integrated Search

2013-09-01

Researchers from the NASA Ames Flight Cognition Lab and the FAAs Flight Deck Human Factors Research Laboratory at the Civil Aerospace Medical Institute (CAMI) examined task and workload management by single pilots in Very Light Jets (VLJs), also c...

Is Single Gender Schooling Viable in the Public Sector? Lessons from Californias Pilot Program. Final Report.

ERIC Educational Resources Information Center

Datnow, Amanda; Hubbard, Lea; Woody, Elisabeth

In 1997, California became the first state to conduct large-scale experimentation with single gender public education. This longitudinal study examined the impact of single gender academies in six California districts, focusing on equity implications. Data from observations and interviews with educators, policymakers, and students indicated that…

Continuous glucose monitoring and hypoglycemia unawareness in type 1 diabetes: a pilot study.

PubMed

Zalzali, Mohamed; Houdelet-Guerinot, Valérie; Socquard, Eric; Thierry, Aurore; Delemer, Brigitte; Lukas-Croisier, Céline

2017-09-01

Looking for strict normoglycemia in type 1 diabetes increases the risk of hypoglycemia, exposing to hypoglycemia unawareness. It has been shown that the early correction of hypoglycemia can help recovering the perception of hypoglycemia. The purpose of this prospective study was to assess the value of sensor-augmented insulin-pump therapy to treat hypoglycemia unawareness. Eleven patients with type 1 diabetes and partial or total hypoglycemia unawareness received sensor-augmented insulin-pump therapy combined to the low blood glucose-suspend feature (Paradigm® Veo™ pump and Enlite® sensors) for three months. Eighty per cent of the patients improved their hypoglycemia unawareness with an increase in the hypoglycemia perception threshold of 31 mg/dL as evaluated by blinded continuous glucose monitoring. These results were correlated to a self-assessment quiz evaluation. Results were sustained at six months (three months after patients stopped using the system). Sensitive neuropathy, untreated hypoglycemia and the area under the curve for hypoglycemia events were associated with less chance of recovery. These devices were globally considered by the patients as simple to use, with no major disadvantages and only a single withdrawal occurred. Sensor-augmented insulin-pump therapy should be considered as a possible treatment of hypoglycemia unawareness.

Pilot study of pyridostigmine in constipated patients with autonomic neuropathy

PubMed Central

Bharucha, Adil E.; Camilleri, Michael; Burton, Duane; Low, Phillip A.; Gehrking, Tonette L.; Zinsmeister, Alan R.

2008-01-01

Background The effects of cholinesterase inhibitors, which increase colonic motility in health, on chronic constipation are unknown. Our aims were to evaluate the efficacy of cholinesterase inhibitors for dysautonomia and chronic constipation and to assess whether acute effects could predict the long term response. Methods In this single-blind study, 10 patients with autonomic neuropathy and constipation were treated with placebo (2 weeks), followed by an escalating dose of pyridostigmine to the maximum tolerated dose (i.e., 180–540 mg daily) for 6 weeks. Symptoms and gastrointestinal transit were assessed at 2 and 8 weeks. The acute effects of neostigmine on colonic transit and motility were also assessed. Results At baseline, 4, 6, and 3 patients had delayed gastric, small intestinal, and colonic transit respectively. Pyridostigmine was well tolerated in most patients, improved symptoms in 4 patients, and accelerated the geometric center for colonic transit at 24 h by ≥0.7 unit in 3 patients. The effects of i.v. neostigmine on colonic transit and compliance predicted (P < 0.05) the effects of pyridostigmine on colonic transit. Conclusions Pyridostigmine improves colonic transit and symptoms in some patients with autonomic neuropathy and constipation. The motor response to neostigmine predicted the response to oral pyridostigmine. PMID:18622640

Interventions for older persons reporting memory difficulties: a randomized controlled pilot study.

PubMed

Cohen-Mansfield, Jiska; Cohen, Rinat; Buettner, Linda; Eyal, Nitza; Jakobovits, Hanna; Rebok, George; Rotenberg-Shpigelman, Shlomit; Sternberg, Shelley

2015-05-01

The objective of this study is to compare three different interventions for persons who report memory difficulties: health promotion, cognitive training, and a participation-centered course, using a single-blind, randomized controlled design. Participants were 44 Israeli adults with memory complaints, aged 65 years or older. The main outcome variable was the Global Cognitive Score assessed using the MindStreams(®) mild cognitive impairment assessment, a computerized cognitive assessment. The Mini-Mental State Examination and the self-report of memory difficulties were also utilized. To assess well-being, the UCLA Loneliness Scale-8 was used. Health was evaluated by self-report instruments. All three interventions resulted in significant improvement in cognitive function as measured by the computerized cognitive assessment. All approaches seemed to decrease loneliness. The only variable which showed a significant difference among the groups is the self-report of memory difficulties, in which the cognitive training group participants reported greater improvement than the other groups. Multiple approaches should be offered to older persons with memory complaints. The availability of diverse options would help fit the needs of a heterogeneous population. An educational media effort to promote the public's understanding of the efficacy of these multiple approaches is needed. Copyright © 2014 John Wiley & Sons, Ltd.

Head and facial anthropometry of mixed-race US Army male soldiers for military design and sizing: a pilot study.

PubMed

Yokota, Miyo

2005-05-01

In the United States, the biologically admixed population is increasing. Such demographic changes may affect the distribution of anthropometric characteristics, which are incorporated into the design of equipment and clothing for the US Army and other large organizations. The purpose of this study was to examine multivariate craniofacial anthropometric distributions between biologically admixed male populations and single racial groups of Black and White males. Multivariate statistical results suggested that nose breadth and lip length were different between Blacks and Whites. Such differences may be considered for adjustments to respirators and chemical-biological protective masks. However, based on this pilot study, multivariate anthropometric distributions of admixed individuals were within the distributions of single racial groups. Based on the sample reported, sizing and designing for the admixed groups are not necessary if anthropometric distributions of single racial groups comprising admixed groups are known.

76 FR 17936 - Federal Housing Administration (FHA): Notice of FHA PowerSaver Home Energy Retrofit Loan Pilot...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-31

... Housing Administration (FHA): Notice of FHA PowerSaver Home Energy Retrofit Loan Pilot Program AGENCY...: Notice. SUMMARY: This notice announces HUD's FHA Home Energy Retrofit Loan Pilot Program (Retrofit Pilot... to conduct an Energy Efficient Mortgage Innovation pilot program targeted to the single family...

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

PubMed

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.

Is adding a new class of cones to the retina sufficient to cure color-blindness?

PubMed

Cornelissen, Frans W; Brenner, Eli

2015-01-01

New genetic methods have made it possible to substitute cone pigments in the retinas of adult nonhuman primates. Doing so influences the animals' visual abilities, demonstrating that the gene therapy was effective. However, we argue that no studies conducted so far have unambiguously demonstrated that the experimental animals have also acquired the ability to make new color distinctions. Simply put, it has been shown that animals that underwent the gene treatment can now-in addition to finding a red ball on a grayish background-find a green ball on a grayish background. However, it has not been shown that the animals can distinguish a red ball from a green one. For most people, that essential ability would be the primary reason for wanting to undergo a treatment for color-blindness in the first place, for instance, because their color-blindness currently prevents them from pursuing a career as a pilot or firefighter. It is important to point out such possible limitations of gene therapy for color-blindness to avoid unwarranted expectations in both clinicians and patients. To explain the origin of our concerns, we simulate how replacing the pigment of some cones is expected to influence the outcomes on the behavioral test used so far. The simulations show that this test does not provide conclusive evidence that the animals acquired the ability to make new chromatic distinctions. In our view, it is therefore premature to claim that human color-blindness can be cured through gene therapy. We propose a test that would provide more conclusive evidence of fundamentally altered color vision after gene therapy.

Classification of response-types for single-pilot NOE helicopter combat tasks

NASA Technical Reports Server (NTRS)

Mitchell, David G.; Hoh, Roger H.; Atencio, Adolph, Jr.

1987-01-01

Two piloted simulations have recently been conducted to evaluate both workload and handling qualities requirements for operation of a helicopter by a single pilot in a nap-of-the-earth combat environment. An advanced cockpit, including a moving-map display and an interactive touchpad screen, provided aircraft mission, status, and position information to the pilot. The results of the simulations are reviewed, and the impact of these results on the development of a revised helicopter handling qualities specification is discussed. Rate command is preferred over attitude command in pitch and roll, and attitude hold over groundspeed hold, for low-speed precision pointing tasks. Position hold is necessary for Level 1 handling qualities in hover when the pilot is required to perform secondary tasks. Addition of a second crew member improves pilot ratings.

Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study.

PubMed

Suter, Melissa J; Gora, Michalina J; Lauwers, Gregory Y; Arnason, Thomas; Sauk, Jenny; Gallagher, Kevin A; Kava, Lauren; Tan, Khay M; Soomro, Amna R; Gallagher, Timothy P; Gardecki, Joseph A; Bouma, Brett E; Rosenberg, Mireille; Nishioka, Norman S; Tearney, Guillermo J

2014-06-01

Biopsy surveillance protocols for the assessment of Barrett's esophagus can be subject to sampling errors, resulting in diagnostic uncertainty. Optical coherence tomography is a cross-sectional imaging technique that can be used to conduct volumetric laser endomicroscopy (VLE) of the entire distal esophagus. We have developed a biopsy guidance platform that places endoscopically visible marks at VLE-determined biopsy sites. The objective of this study was to demonstrate in human participants the safety and feasibility of VLE-guided biopsy in vivo. A pilot feasibility study. Massachusetts General Hospital. A total of 22 participants were enrolled from January 2011 to June 2012 with a prior diagnosis of Barrett's esophagus. Twelve participants were used to optimize the laser marking parameters and the system platform. A total of 30 target sites were selected and marked in real-time by using the VLE-guided biopsy platform in the remaining 10 participants. Volumetric laser endomicroscopy. Endoscopic and VLE visibility, and accuracy of VLE diagnosis of the tissue between the laser cautery marks. There were no adverse events of VLE and laser marking. The optimal laser marking parameters were determined to be 2 seconds at 410 mW, with a mark separation of 6 mm. All marks made with these parameters were visible on endoscopy and VLE. The accuracies for diagnosing tissue in between the laser cautery marks by independent blinded readers for endoscopy were 67% (95% confidence interval [CI], 47%-83%), for VLE intent-to-biopsy images 93% (95% CI, 78%-99%), and for corrected VLE post-marking images 100% when compared with histopathology interpretations. This is a single-center feasibility study with a limited number of patients. Our results demonstrate that VLE-guided biopsy of the esophagus is safe and can be used to guide biopsy site selection based on the acquired volumetric optical coherence tomography imaging data. ( NCT01439633.). Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study

PubMed Central

Suter, Melissa J.; Gora, Michalina J.; Lauwers, Gregory Y.; Arnason, Thomas; Sauk, Jenny; Gallagher, Kevin A.; Kava, Lauren; Tan, Khay M.; Soomro, Amna R.; Gallagher, Timothy P.; Gardecki, Joseph A.; Bouma, Brett E.; Rosenberg, Mireille; Nishioka, Norman S.; Tearney, Guillermo J.

2018-01-01

Background Biopsy surveillance protocols for the assessment of Barrett’s esophagus can be subject to sampling errors, resulting in diagnostic uncertainty. Optical coherence tomography is a cross-sectional imaging technique that can be used to conduct volumetric laser endomicroscopy (VLE) of the entire distal esophagus. We have developed a biopsy guidance platform that places endoscopically visible marks at VLE-determined biopsy sites. Objective The objective of this study was to demonstrate in human participants the safety and feasibility of VLE-guided biopsy in vivo. Design A pilot feasibility study. Setting Massachusetts General Hospital. Patients A total of 22 participants were enrolled from January 2011 to June 2012 with a prior diagnosis of Barrett’s esophagus. Twelve participants were used to optimize the laser marking parameters and the system platform. A total of 30 target sites were selected and marked in real-time by using the VLE-guided biopsy platform in the remaining 10 participants. Intervention Volumetric laser endomicroscopy. Main Outcome Measurements Endoscopic and VLE visibility, and accuracy of VLE diagnosis of the tissue between the laser cautery marks. Results There were no adverse events of VLE and laser marking. The optimal laser marking parameters were determined to be 2 seconds at 410 mW, with a mark separation of 6 mm. All marks made with these parameters were visible on endoscopy and VLE. The accuracies for diagnosing tissue in between the laser cautery marks by independent blinded readers for endoscopy were 67% (95% confidence interval [CI], 47%–83%), for VLE intent-to-biopsy images 93% (95% CI, 78%–99%), and for corrected VLE post-marking images 100% when compared with histopathology interpretations. Limitations This is a single-center feasibility study with a limited number of patients. Conclusion Our results demonstrate that VLE-guided biopsy of the esophagus is safe and can be used to guide biopsy site selection based on the acquired volumetric optical coherence tomography imaging data. (Clinical trial registration number: NCT01439633.) PMID:24462171

Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

PubMed

Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

2013-03-09

Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task-oriented training compared with conventional hand exercises in people with rheumatoid arthritis or osteoarthritis of the hand. ClinicalTrials.gov: NCT01635582.

Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study.

PubMed

Stoppe, C; Fahlenkamp, A V; Rex, S; Veeck, N C; Gozdowsky, S C; Schälte, G; Autschbach, R; Rossaint, R; Coburn, M

2013-09-01

To date, only limited data exist about the use of xenon as an anaesthetic agent in patients undergoing cardiac surgery. The favourable cardio- and neuroprotective properties of xenon might attenuate postoperative complications, improve outcome, and reduce the incidence of delirium. Thus, the aims of this study were to investigate the feasibility and safety of balanced xenon anaesthesia in patients undergoing cardiac surgery and to gather pilot data for a future randomized multicentre study. Thirty patients undergoing elective coronary artery bypass grafting were enrolled in this randomized, single-blind controlled trial. They were randomized to receive balanced general anaesthesia with either xenon (45-50 vol%) or sevoflurane (1-1.4 vol%). The primary outcome was the occurrence of adverse events (AEs). Secondary outcome parameters were feasibility criteria (bispectral index, perioperative haemodynamic, and respiratory profile) and safety parameters (dosage of study treatments, renal function, intraoperative blood loss, need for inotropic support, regional cerebral tissue oxygenation). Furthermore, at predefined time points, systemic and pulmonary haemodynamics were assessed by the use of a pulmonary artery catheter. There were no patient characteristic differences between the groups. Patients undergoing xenon anaesthesia did not differ with respect to the incidence of AE (6 vs 8, P=0.464) compared with the sevoflurane group. No differences were detected regarding secondary feasibility and safety criteria. The haemodynamic and respiratory profile was comparable between the treatment groups. Balanced xenon anaesthesia is feasible and safe compared with sevoflurane anaesthesia in patients undergoing coronary artery bypass surgery. Acronym CARDIAX: A pre- and post-coronary artery bypass graft implantation disposed application of xenon. Clinical trial registration ClinicalTrials.gov: NCT01285271; EudraCT-number: 2010-023942-63. Approved by the ethics committee 'Ethik-Kommission an der Medizinischen Fakultät der Rheinisch-Westfälischen Technischen Hochschule Aachen (RWTH Aachen)': EK-218/10.

The effect of methylphenidate on postural stability under single and dual task conditions in children with attention deficit hyperactivity disorder - a double blind randomized control trial.

PubMed

Jacobi-Polishook, Talia; Shorer, Zamir; Melzer, Itshak

2009-05-15

To investigate the effects of Methylphenidate (MPH) on postural stability in attention deficit hyperactivity disorder (ADHD) children in single and dual task conditions. A randomized controlled double-blind study analyzing postural stability in 24 ADHD children before and after MPH vs. placebo treatments, in three task conditions: (1) Single task, standing still; (2) dual task, standing still performing a memory-attention demanding task; (3) standing still listening to music. MPH resulted in a significant improvement in postural stability during the dual task condition and while listening to music, with no equivalent improvement in placebo controls. MPH improves postural stability in ADHD, especially when an additional task is performed. This is probably due to enhanced attention abilities, thus contributing to improved balance control during performance of tasks that require attention. MPH remains to be studied as a potential drug treatment to improve balance control and physical functioning in other clinical populations.

Concordance and acceptability of electric stimulation therapy: a randomised controlled trial.

PubMed

Miller, C; McGuiness, W; Wilson, S; Cooper, K; Swanson, T; Rooney, D; Piller, N; Woodward, M

2017-08-02

A pilot single-blinded randomised controlled trial (RCT) was conducted to examine concordance with and acceptability of electric stimulation therapy (EST) in patients with venous leg ulcers (VLUs) who had not tolerated moderate to high compression. Participants were randomised to the intervention group (n=15) or a placebo control group (n=8) in which EST was used four times daily for 20 minutes per session. Participants were monitored for eight weeks during which time concordance with the treatment and perceptions of the treatment were assessed. Concordance with the total recommended treatment time was 71.4% for the intervention group and 82.9% for the control group; a difference that was not statistically significant. Participants rated EST as acceptable (84.6% intervention; 83.3% control), only two participants, both from the placebo control group, would not be willing to use EST again. The majority considered EST easier to use than compression (68.4%). EST was a practical and acceptable treatment among people who have been unable to tolerate moderate to high compression therapy.

The rehabilitation of attention in patients with mild cognitive impairment and brain subcortical vascular changes using the Attention Process Training-II. The RehAtt Study: rationale, design and methodology.

PubMed

Salvadori, Emilia; Poggesi, Anna; Valenti, Raffaella; Della Rocca, Eleonora; Diciotti, Stefano; Mascalchi, Mario; Inzitari, Domenico; Pantoni, Leonardo

2016-10-01

Cerebral small vessel disease (SVD) may cause attentional and executive cognitive deficits. No drug is currently available to improve cognitive performance or to prevent dementia in SVD patients, and cognitive rehabilitation could be a promising approach. We aimed to investigate: (1) the effectiveness of the Attention Process Training-II program in the rehabilitation of patients with mild cognitive impairment (MCI) and SVD; (2) the impact of the induced cognitive improvement on functionality and quality of life; (3) the effect of training on brain activity at rest and the possibility of a training-induced plasticity effect. The RehAtt study is designed as a 3-year prospective, single-blinded, randomized clinical trial. Inclusion criteria were: (1) MCI defined according to Winblad et al. criteria; (2) evidence of impairment across attention neuropsychological tests; (3) evidence on MRI of moderate/severe white matter hyperintensities. All enrolled patients are evaluated at baseline, and after 6 and 12 months, according to an extensive clinical, functional, MRI and neuropsychological protocol. The baseline RehAtt cohort includes 44 patients (66 % males, mean ± SD age and years of education 75.3 ± 6.8 and 8.3 ± 4.3, respectively). After baseline assessment, patients have been randomly assigned to 'attention training' or 'standard care'. Treatments and follow-up visits at 6 months are completed, while follow-up visits at 12 months are ongoing. This study is the first attempt to reduce attention deficits in patients affected by MCI with SVD. The results of this pilot experience will represent an essential background for designing larger multicenter, prospective, double-blinded, randomized and controlled clinical trials. NCT02033850 (ClinicalTrials.gov Identifier).

Final Report to Social Rehabilitation Administration, Department of Health, Education, and Welfare, Washington, D.C.

ERIC Educational Resources Information Center

Massachusetts Inst. of Tech., Cambridge. Sensory Aids Evaluation and Development Center.

Projects and activities reviewed include the DOTSYS production of the first braille book from teletypsetter input, the use of DOTSYS, mechanical and electronic features of the high speed braille embosser developed at the Massachusetts Institute of Technology, and the pilot demonstration program for Perkins School for the Blind. Also surveyed are…

Visually Impaired Musicians' Insights: Narratives of Childhood, Lifelong Learning and Musical Participation

ERIC Educational Resources Information Center

Baker, David

2014-01-01

With the support of the Royal National Institute of Blind People (RNIB), the life histories of five visually impaired (VI) musicians were collected and analysed between November 2011 and August 2012. This research was conducted as a pilot for a two-year, national investigation of VI musical participation, "Visually-impaired musicians'…

Single-pilot workload management in entry-level jets : appendices.

DOT National Transportation Integrated Search

2013-09-01

Researchers from the NASA Ames Flight Cognition Lab and the FAAs Flight Deck Human Factors Research Laboratory at the Civil Aerospace Medical Institute (CAMI) examined task and workload management by single pilots in Very Light Jets (VLJs), also c...

Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

PubMed

Vernon, Howard; Triano, John T; Soave, David; Dinulos, Maricelle; Ross, Kim; Tran, Steven

2013-10-01

Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials. © 2013. Published by National University of Health Sciences All rights reserved.

Effects of acute beta-adrenergic antagonism on verbal problem solving in autism spectrum disorder and exploration of treatment response markers.

PubMed

Zamzow, Rachel M; Ferguson, Bradley J; Ragsdale, Alexandra S; Lewis, Morgan L; Beversdorf, David Q

2017-08-01

Autism spectrum disorder (ASD) is characterized by impairments in social communication as well as restricted, repetitive behaviors. Evidence suggests that some individuals with ASD have cognitive impairments related to weak central coherence and hyperrestricted processing. Reducing noradrenergic activity may improve aspects of network processing and thus improve cognitive abilities, such as verbal problem solving, in individuals with ASD. The present pilot study explores the effects of acute administration of the beta-adrenergic antagonist propranolol on verbal problem solving in adults and adolescents with ASD. In a within-subject crossover-design, 20 participants with ASD received a single dose of propranolol or placebo on one of two sessions in a double-blinded, counterbalanced manner. Verbal problem solving was assessed via an anagram task. Baseline measurements of autonomic nervous system functioning were obtained, and anxiety was assessed at baseline and following drug administration. Participants solved the anagrams more quickly in the propranolol condition, as compared to the placebo condition, suggesting a potential cognitive benefit of this agent. Additionally, we observed a negative linear relationship between response to propranolol on the anagram task and two measures of baseline autonomic activity, as well as a positive linear relationship between drug response and baseline anxiety. These relationships propose potential markers for treatment response, as propranolol influences both autonomic functioning and anxiety. Further investigation is needed to expand on the present single-dose psychopharmacological challenge and explore the observed effects of propranolol in a serial-dose setting.

Modeling human pilot cue utilization with applications to simulator fidelity assessment.

PubMed

Zeyada, Y; Hess, R A

2000-01-01

An analytical investigation to model the manner in which pilots perceive and utilize visual, proprioceptive, and vestibular cues in a ground-based flight simulator was undertaken. Data from a NASA Ames Research Center vertical motion simulator study of a simple, single-degree-of-freedom rotorcraft bob-up/down maneuver were employed in the investigation. The study was part of a larger research effort that has the creation of a methodology for determining flight simulator fidelity requirements as its ultimate goal. The study utilized a closed-loop feedback structure of the pilot/simulator system that included the pilot, the cockpit inceptor, the dynamics of the simulated vehicle, and the motion system. With the exception of time delays that accrued in visual scene production in the simulator, visual scene effects were not included in this study. Pilot/vehicle analysis and fuzzy-inference identification were employed to study the changes in fidelity that occurred as the characteristics of the motion system were varied over five configurations. The data from three of the five pilots who participated in the experimental study were analyzed in the fuzzy-inference identification. Results indicate that both the analytical pilot/vehicle analysis and the fuzzy-inference identification can be used to identify changes in simulator fidelity for the task examined.

Double-blind optimization of subcallosal cingulate deep brain stimulation for treatment-resistant depression: a pilot study.

PubMed

Ramasubbu, Rajamannar; Anderson, Susan; Haffenden, Angela; Chavda, Swati; Kiss, Zelma H T

2013-09-01

Deep brain stimulation (DBS) of the subcallosal cingulate (SCC) is reported to be a safe and effective new treatment for treatment-resistant depression (TRD). However, the optimal electrical stimulation parameters are unknown and generally selected by trial and error. This pilot study investigated the relationship between stimulus parameters and clinical effects in SCC-DBS treatment for TRD. Four patients with TRD underwent SCC-DBS surgery. In a double-blind stimulus optimization phase, frequency and pulse widths were randomly altered weekly, and corresponding changes in mood and depression were evaluated using a visual analogue scale (VAS) and the 17-item Hamilton Rating Scale for Depression (HAM-D-17). In the open-label postoptimization phase, depressive symptoms were evaluated biweekly for 6 months to determine long-term clinical outcomes. Longer pulse widths (270-450 μs) were associated with reductions in HAM-D-17 scores in 3 patients and maximal happy mood VAS responses in all 4 patients. Only 1 patient showed acute clinical or mood effects from changing the stimulation frequency. After 6 months of open-label therapy, 2 patients responded and 1 patient partially responded. Limitations include small sample size, weekly changes in stimulus parameters, and fixed-order and carry-forward effects. Longer pulse width stimulation may have a role in stimulus optimization for SCC-DBS in TRD. Longer pulse durations produce larger apparent current spread, suggesting that we do not yet know the optimal target or stimulus parameters for this therapy. Investigations using different stimulus parameters are required before embarking on large-scale randomized sham-controlled trials.

Pilot study of the impact sacroiliac joint manipulation has on walking kinematics using motion analysis technology

PubMed Central

Ward, John S.; Coats, Jesse; Sorrels, Kenneth; Walters, Mathew; Williams, Trevor

2013-01-01

Objective The purpose of this study was to evaluate the feasibility of engaging in a series of larger studies measuring the effect of sacroiliac joint manipulation on walking kinematics using motion analysis technology. Methods Twelve college students engaged in a baseline 90-second gait analysis at 1.5 mph using infrared VICON cameras. Following this, they underwent a prone heel comparison test for functional leg length inequality. Upon examination, participants were then classified as follows: left short leg, right short leg, or no short leg. Participants in each of the 2 short leg branches of this study were then randomized to receive either chiropractic manipulative therapy to the posterior superior iliac spine on the short limb side or no manipulation. Recruitment was ongoing for this pilot study until 1 participant was recruited in each of the following 5 comparative study groups: left short leg—manipulation, left short leg—no manipulation (control 1), right short leg—manipulation, right short leg—no manipulation (control 2), and no short leg (control 3). All participants then underwent another 90-second gait analysis. Data were then grouped and submitted to a blinded biomechanist to determine if there were any unique biomechanical differences between the groups. Results No statistically significant differences were measured because of this being a pilot study with a small sample size. Conclusions The data from this study indicate that a series of larger studies with this design is feasible. PMID:24396314

A pilot single centre, double blind, placebo controlled, randomized, parallel study of Calmagen® dermaceutical cream and lotion for the topical treatment of tinea and onychomycosis.

PubMed

Parekh, Manoj; Ramaiah, Girisha; Pashilkar, Prachi; Ramanujam, Ranjani; Johnston, Peter; Ilag, Leodevico L

2017-09-18

Most of the current anti-fungal treatments are chemical-based, fungistatic, have low efficacy in the treatment of tinea and toxicity concerns, while onychomycosis remains recalcitrant to most antifungal therapies. The study aimed to establish the fungicidal, efficacy and safety profile of Calmagen® dermaceutical cream and lotion containing AMYCOT® as a topical treatment in patients with severe to very severe presentations of fungal skin (tinea) and nail infections (onychomycosis). A randomized, placebo-controlled, double blind, parallel, single centre study was conducted on 28 subjects with severe to very severe tinea or onychomycosis. All patients were randomized in a ratio of 1:1 for treatment or placebo group. Subjects in the treatment arm received Calmagen® cream or lotion, while subjects in the placebo arm received a similar inert topical preparation. Tinea subjects were treated with cream for four weeks, while onychomycosis subjects were treated with lotion for 12 weeks. Mycological cure, the primary endpoint, was assessed by three parameters: KOH (potassium hydroxide) smear, fungal culture and live spore count. Clinical cure was defined as Investigator Global Assessment (IGA) response of 'cleared' or 'excellent'. All three parameters constituting mycological cure were confirmed in 92.8% (13/14) of subjects in the treatment arm, while all 14 subjects in the placebo arm remained positive for KOH smear. Calmagen® cream and lotion treatment showed a significant improvement in all three parameters: KOH smear, (95% CI (Calmagen): 79.4, 100.0; 95% CI (placebo): 0.0, 0.0; p < 0.0001); fungal culture (95% CI (Calmagen); 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019); and live spore count (95% CI (Calmagen): 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019). Clinical cure was achieved in all subjects in the treatment arm while none in the placebo arm were clinically cured. No treatment-related adverse effects were observed in either group. The Calmagen® cream and lotion containing AMYCOT® represent a potentially safe and efficacious natural alternative in the treatment of Tinea and onychomycosis. This trial has been registered with the clinical trial registry-India (CTRI; registration number: CTRI/2012/03/002522 ).

Single pilot IFR operating problems determined from accidental data analysis

NASA Technical Reports Server (NTRS)

Forsyth, D. L.; Shaughnessy, J. D.

1978-01-01

The accident reports examined were restricted to instrument rated pilots flying in IFR weather. A brief examination was made of accidents which occurred during all phases of flight and which were due to all causes. A detailed examination was made of those accidents which involved a single pilot which occurred during the landing phases of flight, and were due to pilot error. Problem areas found include: (1) landing phase operations especially final approach, (2) pilot weather briefings, (3) night approaches in low IFR weather, (4) below minimum approaches, (5) aircraft icing, (6) imprecise navigation, (7) descending below minimum IFR altitudes, (8) fuel mismanagement, (9) pilot overconfidence, and (10) high pilot workload especially in twins. Some suggested areas of research included: (1) low cost deicing systems, (2) standardized navigation displays, (3) low cost low-altitude warning systems, (4) improved fuel management systems, (5) improved ATC communications, (6) more effective pilot training and experience acquisition methods, and (7) better weather data dissemination techniques.

A single session, group study of exposure and Eye Movement Desensitization and Reprocessing in treating Posttraumatic Stress Disorder among Vietnam War veterans: preliminary data.

PubMed

Rogers, S; Silver, S M; Goss, J; Obenchain, J; Willis, A; Whitney, R L

1999-01-01

This report summarizes data gathered thus far from an ongoing study. Two groups (total N = 12) of Vietnam War veterans diagnosed with Posttraumatic Stress Disorder (PTSD) received a single session of exposure or Eye Movement Desensitization and Reprocessing (EMDR) focusing on the veterans' most distressing war experience. Group assignment was random, treatment providers were blind to assessment data, and the pre- and posttreatment assessor was blind to treatment assignment. Both groups showed improvement on the Impact of Event Scale. EMDR treatment resulted in greater positive changes in within-session Subjective Units of Discomfort levels and on self-monitored severity of intrusive recollection. A trend toward decreased heart rate reactivity was observed in both groups. Results must be considered carefully due to the small number of subjects used in the study.

High Zn Content Single-phase RS-MgZnO Suitable for Solar-blind Frequency Applications

NASA Astrophysics Data System (ADS)

Liang, H. L.; Mei, Z. X.; Liu, Z. L.; Guo, Y.; Azarov, A. Yu.; Kuznetsov, A. Yu.; Hallen, A.; Du, X. L.

2010-11-01

Single-phase rock-salt MgZnO films with high Zn content were successfully fabricated on the templates of MgO (111)/α-sapphire (0001) by radio-frequency plasma assisted molecular beam epitaxy. The influence of growth temperature on epitaxy of MgZnO alloy films was investigated by the combined studies of crystal structures, compositions, and optical properties. It is found that the incorporation of Zn atoms into the rock-salt MgZnO films is greatly enhanced at low temperature, confirmed by in-situ reflection high-energy electron diffraction observations and ex-situ X-ray diffraction characterization. Zn fraction in the single-phase rock-salt Mg0.53Zn0.47O film was determined by Rutherford backscattering spectrometry. Optical properties of the films were investigated by transmittance spectroscopy and reflectance spectroscopy, both of which demonstrate the solar-blind band gap and its dependence on Zn content.

Combining destination diversion decisions and critical in-flight event diagnosis in computer aided testing of pilots

NASA Technical Reports Server (NTRS)

Rockwell, T. H.; Giffin, W. C.; Romer, D. J.

1984-01-01

Rockwell and Giffin (1982) and Giffin and Rockwell (1983) have discussed the use of computer aided testing (CAT) in the study of pilot response to critical in-flight events. The present investigation represents an extension of these earlier studies. In testing pilot responses to critical in-flight events, use is made of a Plato-touch CRT system operating on a menu based format. In connection with the typical diagnostic problem, the pilot was presented with symptoms within a flight scenario. In one problem, the pilot has four minutes for obtaining the information which is needed to make a diagnosis of the problem. In the reported research, the attempt has been made to combine both diagnosis and diversion scenario into a single computer aided test. Tests with nine subjects were conducted. The obtained results and their significance are discussed.

Auditory cues for orientation and postural control in sighted and congenitally blind people

NASA Technical Reports Server (NTRS)

Easton, R. D.; Greene, A. J.; DiZio, P.; Lackner, J. R.

1998-01-01

This study assessed whether stationary auditory information could affect body and head sway (as does visual and haptic information) in sighted and congenitally blind people. Two speakers, one placed adjacent to each ear, significantly stabilized center-of-foot-pressure sway in a tandem Romberg stance, while neither a single speaker in front of subjects nor a head-mounted sonar device reduced center-of-pressure sway. Center-of-pressure sway was reduced to the same level in the two-speaker condition for sighted and blind subjects. Both groups also evidenced reduced head sway in the two-speaker condition, although blind subjects' head sway was significantly larger than that of sighted subjects. The advantage of the two-speaker condition was probably attributable to the nature of distance compared with directional auditory information. The results rule out a deficit model of spatial hearing in blind people and are consistent with one version of a compensation model. Analysis of maximum cross-correlations between center-of-pressure and head sway, and associated time lags suggest that blind and sighted people may use different sensorimotor strategies to achieve stability.

Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial.

PubMed

Combs-Miller, Stephanie A; Kalpathi Parameswaran, Anu; Colburn, Dawn; Ertel, Tara; Harmeyer, Amanda; Tucker, Lindsay; Schmid, Arlene A

2014-09-01

To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose (duration/frequency/intensity) on improving walking function, activity, and participation after stroke. Single-blind, pilot randomized controlled trial with three-month follow-up. University and community settings. A convenience sample of participants (N = 20) at least six months post-stroke and able to walk independently were recruited. Thirty-minute walking interventions (body weight-supported treadmill training or overground walking training) were administered five times a week for two weeks. Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity. Walking speed (comfortable/fast 10-meter walk), walking endurance (6-minute walk), spatiotemporal symmetry, and the ICF Measure of Participation and ACTivity were assessed before, immediately after, and three months following the intervention. The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately (change of 0.11 m/s vs. 0.06 m/s, respectively; p = 0.047) and three months (change of 0.14 m/s vs. 0.08 m/s, respectively; p = 0.029) after training. Only the overground walking training group significantly improved comfortable walking speed (p = 0.001), aspects of gait symmetry (p = 0.032), and activity (p = 0.003) immediately after training. Gains were maintained at the three-month follow-up (p < 0.05) for all measures except activity. Improvements in participation were not demonstrated. Overgound walking training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study. © The Author(s) 2014.

Nutrition therapy in cachectic cancer patients. The Tight Caloric Control (TiCaCo) pilot trial.

PubMed

De Waele, Elisabeth; Mattens, Sabrina; Honoré, Patrick Maurice; Spapen, Herbert; De Grève, Jacques; Pen, Joeri J

2015-08-01

Cancer is a common disease and many patients are diagnosed with advanced stages. Due to cancer generalization, patients may become ill-nourished and even cachectic. Malignancy-related cachexia is associated with worsening physical function, reduced tolerance to anticancer therapy and increased mortality. We assessed the effect of a patient-tailored nutritional approach in newly discovered, treatment-naive cancer patients with cachexia. In a randomized, single-blinded, controlled pilot study, patients were treated with either intensive, biometric parameter-oriented dietary counseling (nutrition therapy) compared to regular dietary counseling (control), before and during conventional cancer treatment. Twenty patients were enrolled over a one-year period, 10 receiving nutrition therapy and 10 controls. The primary endpoint was recovery of body composition after nutrition therapy. Secondary endpoints declined in morbidity and mortality with nutrition therapy. Average weight evolution in the control group after 3, 6 and 12 months was 0.19 ± 7.87 kg, -9.78 ± 7.00 kg and -5.8 kg, and in the nutrition therapy group 0.69 ± 2.4 kg, 0.77 ± 2.58 kg and 1.29 ± 3.76 kg. Control patients had a significantly longer average hospital stay than subjects from the nutrition therapy group (37.6 vs. 3.4 days). Eight nutrition therapy patients and 1 control patient were still alive after 2 years. Nutrition therapy based on patient-specific biophysical parameters helps to maintain body weight and induces a more optimal nutritional balance in cachectic cancer patients. Moreover, survival in cancer patients improved when their nutritional status, even partially, ameliorated. Copyright © 2015 Elsevier Ltd. All rights reserved.

Cognitive and Neural Effects of Vision-Based Speed-of-Processing Training in Older Adults with Amnestic Mild Cognitive Impairment: A Pilot Study.

PubMed

Lin, Feng; Heffner, Kathi L; Ren, Ping; Tivarus, Madalina E; Brasch, Judith; Chen, Ding-Geng; Mapstone, Mark; Porsteinsson, Anton P; Tadin, Duje

2016-06-01

To examine the cognitive and neural effects of vision-based speed-of-processing (VSOP) training in older adults with amnestic mild cognitive impairment (aMCI) and contrast those effects with an active control (mental leisure activities (MLA)). Randomized single-blind controlled pilot trial. Academic medical center. Individuals with aMCI (N = 21). Six-week computerized VSOP training. Multiple cognitive processing measures, instrumental activities of daily living (IADLs), and two resting state neural networks regulating cognitive processing: central executive network (CEN) and default mode network (DMN). VSOP training led to significantly greater improvements in trained (processing speed and attention: F1,19  = 6.61, partial η(2)  = 0.26, P = .02) and untrained (working memory: F1,19  = 7.33, partial η(2)  = 0.28, P = .01; IADLs: F1,19  = 5.16, partial η(2)  = 0.21, P = .03) cognitive domains than MLA and protective maintenance in DMN (F1, 9  = 14.63, partial η(2)  = 0.62, P = .004). VSOP training, but not MLA, resulted in a significant improvement in CEN connectivity (Z = -2.37, P = .02). Target and transfer effects of VSOP training were identified, and links between VSOP training and two neural networks associated with aMCI were found. These findings highlight the potential of VSOP training to slow cognitive decline in individuals with aMCI. Further delineation of mechanisms underlying VSOP-induced plasticity is necessary to understand in which populations and under what conditions such training may be most effective. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Caffeine's Influence on Nicotine's Effects in Nonsmokers

PubMed Central

Blank, Melissa D.; Kleykamp, Bethea A.; Jennings, Janine M.; Eissenberg, Thomas

2011-01-01

Objective To determine if nicotine's effects are influenced by caffeine in nonsmoking, moderate-caffeine consuming individuals (N=20). Methods The first 3 sessions included one of 3 randomly ordered, double-blind caffeine doses (0, 75, or 150 mg, oral [po]) and 2 single-blind nicotine gum doses (2 and 4 mg) in ascending order. The fourth session (single blind) repeated the 0 mg caffeine condition. Results Nicotine increased heart rate and subjective ratings indicative of aversive effects, and decreased reaction times. These effects were independent of caffeine dose and reliable across sessions. Conclusions In nonsmokers, nicotine effects are not influenced by moderate caffeine doses. PMID:17555378

Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study).

PubMed

Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui

2017-07-12

Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised controlled trial of the intervention. Although not powered to determine effectiveness, these preliminary data provide justification for a larger trial, incorporating a full process evaluation, to determine whether this intervention can significantly reduce falls in this high-risk population. ClinicalTrials.gov identifier: NCT02178527 ; Date of registration: 17 June 2014.

Development and validation of a questionnaire assessing the quality of life impact of Colour Blindness (CBQoL).

PubMed

Barry, John A; Mollan, Susan; Burdon, Michael A; Jenkins, Michelle; Denniston, Alastair K

2017-10-02

Congenital colour vision deficiency (CVD), commonly called 'colour blindness', affects around 8% of men and 0.4% of women. Although many aspects of health (e.g. change in colour of urine) and healthcare (e.g. coloured medication, colour-coded diagnostic tests), and modern life depend upon colour coding (e.g. graphs, maps, signals), the impact of colour blindness on everyday life is not generally considered a topic of importance. This study is the first to create and validate a questionnaire measuring the quality of life (QoL) impact of being colour blind. This study consisted of two phases. Firstly, the questionnaire design and development phase was led by an expert panel and piloted on a focus group. Secondly, an online sample of 128 men and 291 women filled in the questionnaire, and the psychometric properties of the questionnaire were analysed using principal components analysis (PCA). The scores of colour blind (CB) participants and normal-sighted controls, controlling for age and sex, were compared using matched t-tests. The PCA resulted in a questionnaire with three domains (or subscales): QoL for Health & Lifestyle, QoL for Work, and QoL for Emotions. Controlling for age, there was a significantly greater negative impact on QoL for CB people than normal-sighted controls in regards to confusion over colour in various aspects of their health (p = 5 × 10 -7 ), work (p = 1.3 × 10 -7 ), and emotional life (p = 6 × 10 -5 ). Colour blindness can significantly impact quality of life for health, emotions, and especially careers. The tool developed here could be useful in future clinical studies to measure changes in CBQoL in response to therapy in conditions where colour vision is affected. We also discuss ways in which everyday problems related to colour vision might be reduced, for example, workplaces could avoid colour coding where a non-colour alternative is possible.

Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized, double-blind pilot study.

PubMed

Levy, Robert M; Saikovsky, Roman; Shmidt, Evgeniya; Khokhlov, Alexander; Burnett, Bruce P

2009-05-01

Flavocoxid (Limbrel), a proprietary mixture of flavonoid molecules (baicalin and catechin), was tested against a traditional nonsteroidal anti-inflammatory drug, naproxen, for the management of the signs and symptoms of moderate osteoarthritis (OA) in humans. Discomfort and global disease activity were used as the primary end points, and safety assessments were also taken for both treatments as a secondary endpoint. In this double-blind study, 103 subjects were randomly assigned to receive either flavocoxid [500 mg twice daily (BID)] or naproxen (500 mg BID) in a 1-month onset of action trial. Outcome measures included the short Western Ontario and McMaster University Osteoarthritis Index, subject Visual Analogue Scale for discomfort and global response, and investigator Visual Analogue Scale for global response and fecal occult blood. Both flavocoxid and naproxen showed significant reduction in the signs and symptoms of knee OA (P < or = .001). There were no statistically detectable differences between the flavocoxid and naproxen groups with respect to any of the outcome variables. Similarly, there were no statistically detectable differences between the groups with respect to any adverse event, although there was a trend toward a higher incidence of edema and nonspecific musculoskeletal discomfort in the naproxen group. In this short-term pilot study, flavocoxid was as effective as naproxen in controlling the signs and symptoms of OA of the knee and would present a safe and effective option for those individuals on traditional nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors. A low incidence of adverse events was reported for both groups.

Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial.

PubMed

Mandel, David R; Eichas, Katy; Holmes, Judith

2010-01-12

Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. ACTRN12609000435280.

Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial

PubMed Central

2010-01-01

Background Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Methods Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Results Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. Trial registration ACTRN12609000435280 PMID:20067641

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

PubMed

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.

Long-term effect of acupuncture for treatment of tinnitus: a randomized, patient- and assessor-blind, sham-acupuncture-controlled, pilot trial.

PubMed

Jeon, Sun Woo; Kim, Kyu Seok; Nam, Hae Jeong

2012-07-01

The aim of this study was to investigate the long-term effect of acupuncture for treatment of tinnitus. This study is a randomized, patient- and assessor-blind, sham-acupuncture-controlled, pilot trial. Participants were adults (18-60 years old) with chronic (≥6 months), unilateral tinnitus, and without moderate or severe hearing loss. Thirty-three (33) participants were randomized to one of two treatment groups: real acupuncture and sham-acupuncture (nonmeridian; no specific response, de qi). Participants received 10 sessions of acupuncture treatment (twice a week for 5 weeks), and usual patient care education. The subjective outcome was the score of Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) from baseline to 3 months after. Pure Tone Average (PTA) and Speech Discrimination (SD) from baseline to 3 months after were assessed as objective outcomes. A significant interaction between time and group in VAS (p=0.017) was evident, but not in THI, PTA, and SD scores. THI showed significant improvement at the end of treatment and 3 months after, compared to baseline, in real acupuncture (p=0.004). In SD, a significant long-term effect of real acupuncture was observed until 3 months after (p=0.011). However, the effect of real acupuncture in PTA was not maintained until 3 months after the end of treatment. No significant difference in the sham-acupuncture treatment group was evident. No statistical difference in any outcome was observed between real and sham acupuncture. Only in the mean percent change of VAS, real acupuncture showed statistical significance, compared with sham-acupuncture from baseline to 3 months after (p=0.019). Through evaluation of subjective (THI and VAS) and objective outcomes (PTA and SD), this study demonstrates the long-term effect of real acupuncture.

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.

PubMed

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.

Accuracy of straight leg raise and slump tests in detecting lumbar disc herniation: a pilot study.

PubMed

M'kumbuzi, V R P; Ntawukuriryayo, J T; Haminana, J D; Munyandamutsa, J; Nzakizwanimana, E

2012-01-01

To determine the accuracy of the Straight Leg Raise (SLR) and slump tests in detecting Lumbar Disc Herniation (LDH). Cross-sectional diagnostic accuracy study. Two referral hospitals in Kigali, Rwanda: King Faisal Hospital and Centre Hospitalier Universitaire de Kigali. All patients aged 18 to 70 who had an MRI and who were experiencing pain in the low back, leg or low back and leg. Closed Magnetic Resonance Imaging (MRI) investigations for each patient as witnessed by a radiologist who read the image were recorded by the first researcher and blinded to other researchers. The SLR and slump tests were performed three times on each patient by independent testers who were blinded to the result of the first test. The test order was randomized for each subject and the two tests were separated by one day wash-out period. Data were analyzed using a 2x2 table to ascertain diagnostic statistics including sensitivity and specificity with 95% confidence intervals. Thirty three from a possible 37 patients mean age 41.58 ± 10 years completed all of the tests. The sensitivity of SLR was greater (0.875; CI: 0.690-0.957) than that of the slump tests (0.800; CI: 0.6087-0.911) (p = 0.01) in detecting LDH. The specificity for SLR was 0.429 (CI: 0.158-0.750) and for slump was 0.714 (CI: 0.359-0.918). Substantial agreement (K = 0.774) was obtained between the SLR and MRI. The SLR was more accurate in detecting LDH. Further validation of this pilot finding is required by studying a larger sample.

Single pilot IFR accident data analysis

NASA Technical Reports Server (NTRS)

Harris, D. F.; Morrisete, J. A.

1982-01-01

The aircraft accident data recorded and maintained by the National Transportation Safety Board for 1964 to 1979 were analyzed to determine what problems exist in the general aviation single pilot instrument flight rules environment. A previous study conducted in 1978 for the years 1964 to 1975 provided a basis for comparison. The purpose was to determine what changes, if any, have occurred in trends and cause-effect relationships reported in the earlier study. The increasing numbers have been tied to measures of activity to produce accident rates which in turn were analyzed in terms of change. Where anomalies or unusually high accident rates were encountered, further analysis was conducted to isolate pertinent patterns of cause factors and/or experience levels of involved pilots. The bulk of the effort addresses accidents in the landing phase of operations. A detailed analysis was performed on controlled/uncontrolled collisions and their unique attributes delineated. Estimates of day vs. night general aviation activity and accident rates were obtained.

A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis.

PubMed

Al-Smadi, J; Warke, K; Wilson, I; Cramp, A F L; Noble, G; Walsh, D M; Lowe-Strong, A S

2003-11-01

To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) upon low back pain (LBP) in people with multiple sclerosis (MS). A randomized double-blind placebo controlled clinical pilot study. Fifteen people with MS were recruited and randomly allocated to one of the following groups under double blind conditions (n = 5 per group): TENS 1 (4 Hz, 200 micros), TENS 2 (110 Hz, 200 micros), placebo TENS. Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up. The following outcome measures were taken at weeks 1, 6, and 10: visual analogue scale (VAS) (for current LBP, right leg pain, left leg pain); Leeds Multiple Sclerosis Quality of Life Questionnaire; Roland Morris Disability Questionnaire; Short Form-36 (SF-36) Version 1; and the McGill Pain Questionnaire (MPQ). VAS for current LBP, right and left leg pain were also taken before and after treatment, and once a week during the follow-up period. Analysis showed no statistically significant effects for any of the data. However, both active treatment groups showed a trend of improvement in the majority of the outcome measures. Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant. Further work in this area is warranted and should include a larger number of participants in the form of a randomized controlled clinical trial to determine the efficacy of this modality.

Multicenter Randomized Controlled Trial on Duration of Therapy for Thrombosis in Children and Young Adults (Kids-DOTT): Pilot/Feasibility Phase Findings

PubMed Central

Goldenberg, N.A.; Abshire, T.; Blatchford, P.J.; Fenton, L.Z.; Halperin, J.L.; Hiatt, W.R.; Kessler, C.M.; Kittelson, J.M.; Manco-Johnson, M.J.; Spyropoulos, A.C.; Steg, P.G.; Stence, N.V.; Turpie, A.G.G.; Schulman, S.

2015-01-01

BACKGROUND Randomized controlled trials (RCTs) in pediatric venous thromboembolism (VTE) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. METHODS Kids-DOTT is a multicenter RCT investigating non-inferiority of a 6-week (shortened) vs. 3-month (conventional) duration of anticoagulation in patients <21 years old with provoked venous thrombosis. Primary efficacy and safety endpoints are symptomatic recurrent VTE at 1 year and anticoagulant-related, clinically-relevant bleeding. In the P/F phase, 100 participants were enrolled in an open, blinded endpoint, parallel-cohort RCT design. RESULTS No eligibility violations or randomization errors occurred. Of enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in pre-specified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. Retention at 1 year was 82%. Inter-observer agreement between local vs. blinded central determination of venous occlusion by imaging at 6 weeks post-diagnosis was strong (κ-statistic=0.75; 95% confidence interval [CI] 0.48–1.0). Primary efficacy and safety event rates were 3.3% (95% CI 0.3–11.5%) and 1.4% (0.03–7.4%). CONCLUSIONS The P/F phase of Kids-DOTT has demonstrated validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention, and endpoint rates to inform the fully-powered RCT. PMID:26118944

A pilot randomised controlled trial to assess the utility of an e-learning package that trains users in adverse drug reaction causality.

PubMed

Conroy, Elizabeth J; Kirkham, Jamie J; Bellis, Jennifer R; Peak, Matthew; Smyth, Rosalind L; Williamson, Paula R; Pirmohamed, Munir

2015-12-01

Causality assessment of adverse drug reactions (ADRs) by healthcare professionals is often informal which can lead to inconsistencies in practice. The Liverpool Causality Assessment Tool (LCAT) offers a systematic approach. An interactive, web-based, e-learning package, the Liverpool ADR Causality Assessment e-learning Package (LACAeP), was designed to improve causality assessment using the LCAT. This study aimed to (1) get feedback on usability and usefulness on the LACAeP, identify areas for improvement and development, and generate data on effect size to inform a larger scale study; and (2) test the usability and usefulness of the LCAT. A pilot, single-blind, parallel-group, randomised controlled trial hosted by the University of Liverpool was undertaken. Participants were paediatric medical trainees at specialty training level 1+ within the Mersey and North-West England Deaneries. Participants were randomised (1 : 1) access to the LACAeP or no training. The primary efficacy outcome was score by correct classification, predefined by a multidisciplinary panel of experts. Following participation, feedback on both the LCAT and the LACAeP was obtained, via a built in survey, from participants. Of 57 randomised, 35 completed the study. Feedback was mainly positive although areas for improvement were identified. Seventy-four per cent of participants found the LCAT easy to use and 78% found the LACAeP training useful. Sixty-one per cent would be unlikely to recommend the training. Scores ranged from 4 to 13 out of 20. The LACAeP increased scores by 1.3, but this was not significant. Improving the LACAeP before testing it in an appropriately powered trial, informed by the differences observed, is required. Rigorous evaluation will enable a quality resource that will be of value in healthcare professional training. © 2015 The Authors. International Journal of Pharmacy Practice published by John Wiley & Sons Ltd on behalf of Royal Pharmaceutical Society.

High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study.

PubMed

Luo, Fang; Wang, Tao; Shen, Ying; Meng, Lan; Lu, Jingjing; Ji, Nan

2017-05-01

A recent study showed that 50% of patients who suffered from refractory neuralgia of the infraorbital nerve obtained satisfactory efficacy after pulsed radiofrequency (PRF) treatment. A pilot study showed that increasing the output voltage of PRF significantly improved the efficacy for trigeminal neuralgia; however, whether increasing the output voltage of PRF can improve the treatment outcomes for neuralgia of the infraorbital nerve is unknown. To evaluate the efficacy and safety of high voltage PRF treatment in comparison with standard voltage PRF for neuralgia of the infraorbital nerve. Prospective, single-center, double-blinded, randomized, controlled trial. Beijing Tiantan Hospital, Capital Medical University. A total of 60 patients with refractory neuralgia of the infraorbital nerve were randomly divided into the high voltage PRF group and the standard voltage PRF group to treat their infraorbital nerves. Neither the patients, pain physicians, nor the follow-up evaluators knew the patient group assignments. The primary outcome measure was the one-year response rate. The secondary outcome measures included the time to take effect after PRF, the one-month, 3-month, and 6-month response rates, the relapse rate, and adverse reactions. The intent-to-treat analysis showed that the one-month, 3-month, 6-month, and one-year response rates were all 90% in the high voltage group, which were significantly higher than the rates in the standard voltage group (67% [P < 0.05], 67% [P < 0.05], 63% [P < 0.05], and 60% [P <0.01], respectively). Furthermore, 27% of the patients in the high-voltage group and 13% of the patients in the standard voltage group experienced minor transient (10 - 30 days) numbness in the innervation area after PRF; no other serious adverse reactions were observed in the 2 groups (P > 0.05). We did not investigate the dose-effect relationship between the output voltage and efficacy or the effect of a higher pulse dose on efficacy. This study was a single-center study, and multi-center, randomized, controlled studies are needed to obtain the highest level of empirical evidence. Additionally, the follow-up period lasted only one year in this study; thus, long-term efficacy needs to be further confirmed. The results showed that high voltage PRF was effective and safe for patients with refractory neuralgia of the infraorbital nerve and could become a treatment option in patients who do not respond to conservative treatment.

Multi-Center Trial of Baclofen for Abstinence Initiation in Severe Cocaine Dependent Individuals

PubMed Central

Kahn, Roberta; Biswas, Kousick; Childress, Anna-Rose; Shoptaw, Steve; Fudala, Paul J.; Gorgon, Liza; Montoya, Ivan; Collins, Joseph; McSherry, Frances; Li, Shou-Hua; Chiang, Nora; Alathari, Husam; Watson, Donnie; Liberto, Joseph; Beresford, Thomas; Stock, Christopher; Wallace, Christopher; Gruber, Valerie; Elkashef, Ahmed

2009-01-01

Background Cocaine dependence is a major public health problem for which there is no FDA-approved pharmacological treatment. Baclofen is a GABAB receptor agonist that in preclinical and early pilot clinical trials has shown promise for the treatment of cocaine dependence. The purpose of this multi-site, double-blind study, was to compare the safety and efficacy of baclofen (60 mg/day) versus placebo in an 8-week treatment of individuals with severe cocaine dependence. The primary outcome measure was subjects' self-reported cocaine use substantiated by urine benzoylecgonine (BE). Analysis of the data did not show a significant difference between the groups treated with baclofen and placebo. The current results do not support a role for 60mg baclofen in treating cocaine dependence in the population studied. The contrast of this result to earlier, preclinical and human pilot data with baclofen may reflect the trial's focus on severe cocaine-dependent users, and/or the need for a higher baclofen dose. Baclofen's potential as a relapse prevention agent was not tested by the current design, but may be a useful target for future studies. PMID:19414226

A Pilot Study of Neurofeedback for Chronic PTSD.

PubMed

Gapen, Mark; van der Kolk, Bessel A; Hamlin, Ed; Hirshberg, Laurence; Suvak, Michael; Spinazzola, Joseph

2016-09-01

EEG Biofeedback (also known as neurofeedback) has been in use as a clinical intervention for well over 30 years; however, it has made very little impact on clinical care. One reason for this has been the difficulty in designing research to measure clinical change in the real world. While substantial evidence exists for its efficacy in treating attention deficit/hyperactivity disorder, relatively little evidence exists for its utility in other disorders including posttraumatic stress disorder (PTSD). The current study represents a "proof-of-concept" pilot for the use of neurofeedback with multiply-traumatized individuals with treatment-resistant PTSD. Participants completed 40 sessions of neurofeedback training two times per week with sensors randomly assigned (by the study coordinator, who was not blind to condition) to sensor placements of either T4-P4 or T3-T4. We found that neurofeedback significantly reduced PTSD symptoms (Davidson Trauma Scale scores averaged 69.14 at baseline to 49.26 at termination), and preceded gains in affect regulation (Inventory of Altered Self-Capacities-Affect Dysregulation scores averaged 23.63 at baseline to 17.20 at termination). We discuss a roadmap for future research.

Stimulation targeting higher motor areas in stroke rehabilitation: A proof-of-concept, randomized, double-blinded placebo-controlled study of effectiveness and underlying mechanisms

PubMed Central

Cunningham, David A.; Varnerin, Nicole; Machado, Andre; Bonnett, Corin; Janini, Daniel; Roelle, Sarah; Potter-Baker, Kelsey; Sankarasubramanian, Vishwanath; Wang, Xiaofeng; Yue, Guang; Plow, Ela B.

2016-01-01

Purpose To demonstrate, in a proof-of-concept study, whether potentiating ipsilesional higher motor areas (premotor cortex and supplementary motor area) augments and accelerates recovery associated with constraint induced movement. Methods In a randomized, double-blinded pilot clinical study, 12 patients with chronic stroke were assigned to receive anodal transcranial direct current stimulation (tDCS) (n = 6) or sham (n = 6) to the ipsilesional higher motor areas during constraint-induced movement therapy. We assessed functional and neurophysiologic outcomes before and after 5 weeks of therapy. Results Only patients receiving tDCS demonstrated gains in function and dexterity. Gains were accompanied by an increase in excitability of the contralesional rather than the ipsilesional hemisphere. Conclusions Our proof-of-concept study provides early evidence that stimulating higher motor areas can help recruit the contralesional hemisphere in an adaptive role in cases of greater ipsilesional injury. Whether this early evidence of promise translates to remarkable gains in functional recovery compared to existing approaches of stimulation remains to be confirmed in large-scale clinical studies that can reasonably dissociate stimulation of higher motor areas from that of the traditional primary motor cortices. PMID:26484700

Effects of lithium carbonate on performance and biomedical functions.

DOT National Transportation Integrated Search

1977-07-01

The effects of a single 600-mg dose of lithium carbonate were evaluated in a study of 15 healthy, normal male subjects. Subjects were studied, on two occasions, by utilizing a double-blind design--once receiving the lithium carbonate and once receivi...

Placebo-controlled pilot trial testing dose titration and intravenous, intramuscular and subcutaneous routes for ketamine in depression.

PubMed

Loo, C K; Gálvez, V; O'Keefe, E; Mitchell, P B; Hadzi-Pavlovic, D; Leyden, J; Harper, S; Somogyi, A A; Lai, R; Weickert, C S; Glue, P

2016-07-01

This pilot study assessed the feasibility, efficacy and safety of an individual dose-titration approach, and of the intravenous (IV), intramuscular (IM) and subcutaneous (SC) routes for treating depression with ketamine. Fifteen treatment-refractory depressed participants received ketamine or midazolam (control treatment) in a multiple crossover, double-blind study. Ketamine was administered by IV (n = 4), IM (n = 5) or SC (n = 6) injection. Dose titration commenced at 0.1 mg/kg, increasing by 0.1 mg/kg up to 0.5 mg/kg, given in separate treatment sessions separated by ≥1 week, with one placebo control treatment randomly inserted. Mood, psychotomimetic and hemodynamic effects were assessed and plasma ketamine concentrations assayed. Twelve participants achieved response and remission criteria, achieved at doses as low as 0.1 mg/kg. All three routes of administration resulted in comparable antidepressant effects. Fewest adverse effects were noted with the SC route. Antidepressant response, adverse effects and ketamine concentrations were dose-related. Antidepressant response occurred at a range of doses and at <0.5 mg/kg. The dose-titration approach is a practical method for optimizing the efficacy - side-effects trade-off on an individual patient basis. This pilot study provides preliminary evidence for SC injection as a practical, feasible and efficacious treatment approach. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effects of rivastigmine on actigraphically monitored motor activity in severe agitation related to Alzheimer's disease: a placebo-controlled pilot study.

PubMed

Mahlberg, Richard; Walther, Sebastian; Eichmann, Uta; Tracik, Ferenc; Kunz, Dieter

2007-01-01

Acetylcholinesterase inhibitors (AChEIs) are effective in the treatment of cognitive symptoms in Alzheimer's disease (AD). Because the behavioral and psychological symptoms of dementia (BPSD) have also been attributed to central cholinergic deficits, we examined whether the AChEI rivastigmine can reduce motor activity as measured in a rater-independent manner by wrist actigraphy in agitated AD patients. A total of 20 consecutive AD inpatients (13 females, 7 males, 80.4+/-9.1 years, S.D.) were included from our geriatric psychiatry unit, all of whom were exhibiting agitated behavior not attributable to delirium. Patients were assigned randomly and in a single-blinded fashion to rivastigmine 3mg or placebo for 14 days. Motor activity levels were monitored using an actigraph worn continuously on the wrist of the non-dominant hand. At the beginning and end of the study, patients were assessed using the Neuropsychiatric Inventory (NPI) and Nurses' Observation Scale for Geriatric Patients (NOSGER). Patients in the rivastigmine group exhibited less agitation than placebo recipients on the NPI-agitation subscale, but not on NOSGER. Actigraphic measurements showed a tendency towards reduced motor activity in the rivastigmine group. Because rivastigmine usually exerts its main effects after a longer period of time, the short-term effects seen in our study justify further controlled clinical trials examining the use of rivastigmine in BPSD by means of actigraphy.

Anti-stress Effect of Green Tea with Lowered Caffeine on Humans: A Pilot Study.

PubMed

Unno, Keiko; Yamada, Hiroshi; Iguchi, Kazuaki; Ishida, Hitoshi; Iwao, Yasunori; Morita, Akio; Nakamura, Yoriyuki

2017-01-01

Theanine, an amino acid in tea, has significant anti-stress effects on animals and humans. However, the effect of theanine was blocked by caffeine and gallate-type catechins, which are the main components in tea. We examined the anti-stress effect of green tea with lowered caffeine, low-caffeine green tea, on humans. The study design was a single-blind group comparison and participants (n=20) were randomly assigned to low-caffeine or placebo tea groups. These teas (≥500 mL/d), which were eluted with room temperature water, were taken from 1 week prior to pharmacy practice and continued for 10 d in the practice period. The participants ingested theanine (ca. 15 mg/d) in low-caffeine green tea. To assess the anxiety of participants, the state-trait anxiety inventory test was used before pharmacy practice. The subjective stress of students was significantly lower in the low-caffeine-group than in the placebo-group during pharmacy practice. The level of salivary α-amylase activity, a stress marker, increased significantly after daily pharmacy practice in the placebo-group but not in the low-caffeine-group. These results suggested that the ingestion of low-caffeine green tea suppressed the excessive stress response of students. This study was registered at the University Hospital Medical Information Network (ID No. UMIN14942).

Aircraft Detection System Ensures Free-Space Laser Safety

NASA Technical Reports Server (NTRS)

Smithgall, Brian; Wilson, Keith E.

2004-01-01

As scientists continue to explore our solar system, there are increasing demands to return greater volumes of data from smaller deep-space probes. Accordingly, NASA is studying advanced strategies based on free-space laser transmissions, which offer secure, high-bandwidth communications using smaller subsystems of much lower power and mass than existing ones. These approaches, however, can pose a danger to pilots in the beam path because the lasers may illuminate aircraft and blind them. Researchers thus are investigating systems that will monitor the surrounding airspace for aircraft that could be affected. This paper presents current methods for safe free space laser propagation.

Six-year clinical outcome of single implant-retained mandibular overdentures--a pilot study.

PubMed

Passia, Nicole; Wolfart, Stefan; Kern, Matthias

2015-10-01

The aim of this prospective pilot study was to evaluate the prosthodontic maintenance as well as the implant outcome of single implant-retained mandibular overdentures over an observation period of 6 years. Eleven edentulous patients received one single implant in the midline of the mandible. Denture bases were temporarily relined and 2 months later provided with a ball attachment for implant retention. Implant related parameters and prosthodontic maintenance interventions were assessed 4 weeks after implant loading and then once a year. Over a mean observation period of 75.9 months, no implant was lost. The most frequent prosthetic maintenance intervention was activation of the matrix due to loss of retention, followed by exchange of the female part. Eight denture bases had to be repaired after a fracture in the midline area. Within the limitations of this preliminary clinical study, the concept of a single midline implant to retain a mandibular complete denture was a successful treatment option for elderly edentulous patients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Nonmydriatic Fundus Camera in Diabetic Retinopathy Screening: A Cost-Effective Study with Evaluation for Future Large-Scale Application

PubMed Central

Scarpa, Giuseppe; Urban, Francesca; Tessarin, Michele; Gallo, Giovanni; Midena, Edoardo

2016-01-01

Aims. The study aimed to present the experience of a screening programme for early detection of diabetic retinopathy (DR) using a nonmydriatic fundus camera, evaluating the feasibility in terms of validity, resources absorption, and future advantages of a potential application, in an Italian local health authority. Methods. Diabetic patients living in the town of Ponzano, Veneto Region (Northern Italy), were invited to be enrolled in the screening programme. The “no prevention strategy” with the inclusion of the estimation of blindness related costs was compared with screening costs in order to evaluate a future extensive and feasible implementation of the procedure, through a budget impact approach. Results. Out of 498 diabetic patients eligible, 80% was enrolled in the screening programme. 115 patients (34%) were referred to an ophthalmologist and 9 cases required prompt treatment for either proliferative DR or macular edema. Based on the pilot data, it emerged that an extensive use of the investigated screening programme, within the Greater Treviso area, could prevent 6 cases of blindness every year, resulting in a saving of €271,543.32 (−13.71%). Conclusions. Fundus images obtained with a nonmydriatic fundus camera could be considered an effective, cost-sparing, and feasible screening tool for the early detection of DR, preventing blindness as a result of diabetes. PMID:27885337

Development of cockroach immunotherapy by the Inner-City Asthma Consortium

PubMed Central

Wood, Robert A.; Togias, Alkis; Wildfire, Jeremy; Visness, Cynthia M.; Matsui, Elizabeth C.; Gruchalla, Rebecca; Hershey, Gurjit; Liu, Andrew H.; O’Connor, George T.; Pongracic, Jacqueline A.; Zoratti, Edward; Little, Frederic; Granada, Mark; Kennedy, Suzanne; Durham, Stephen R.; Shamji, Mohamed H.; Busse, William W.

2014-01-01

Background Cockroach allergy is a key contributor to asthma morbidity in children living in urban environments. Objective We sought to document immune responses to cockroach allergen and provide direction for the development of immunotherapy for cockroach allergy. Methods Four pilot studies were conducted: (1) an open-label study to assess the safety of cockroach sublingual immunotherapy (SLIT) in adults and children; (2) a randomized, double-blind biomarker study of cockroach SLIT versus placebo in adults; (3) a randomized, double-blind biomarker study of 2 doses of cockroach SLIT versus placebo in children; and (4) an open-label safety and biomarker study of cockroach subcutaneous immunotherapy (SCIT) in adults. Results The adult SLIT trial (n = 54; age, 18–54 years) found a significantly greater increase in cockroach-specific IgE levels between the active and placebo groups (geometric mean ratio, 1.92; P < .0001) and a trend toward increased cockroach-specific IgG4 levels in actively treated subjects (P = .09) but no evidence of functional blocking antibody response. The pediatric SLIT trial (n = 99; age, 5–17 years) found significant differences in IgE, IgG, and IgG4 responses between both active groups and the placebo group but no consistent differences between the high- and low-dose groups. In the SCIT study the treatment resulted in significant changes from baseline in cockroach IgE, IgG4, and blocking antibody levels. The safety profile of cockroach immunotherapy was reassuring in all studies. Conclusions The administration of cockroach allergen by means of SCIT is immunologically more active than SLIT, especially with regard to IgG4 levels and blocking antibody responses. No safety concerns were raised in any age group. These pilot studies suggest that immunotherapy with cockroach allergen is more likely to be effective with SCIT. PMID:24184147

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

PubMed

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.

Aerobic or Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial).

PubMed

Greenwood, Sharlene A; Koufaki, Pelagia; Mercer, Thomas H; Rush, Robert; O'Connor, Ellen; Tuffnell, Rachel; Lindup, Herolin; Haggis, Lynda; Dew, Tracy; Abdulnassir, Lyndsey; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C

2015-10-01

Cardiovascular disease remains the leading cause of death in kidney transplant recipients. This pilot study examined the potential effect of aerobic training or resistance training on vascular health and indexes of cardiovascular risk in kidney transplant recipients. Single-blind, randomized, controlled, parallel trial. 60 participants (mean age, 54 years; 34 men) were randomly assigned to aerobic training (n=20), resistance training (n=20), or usual care (n=20). Participants were included if they had a kidney transplant within 12 months prior to baseline assessment. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Aerobic training and resistance training were delivered 3 days per week for a 12-week period. The usual-care group received standard care. Pulse wave velocity, peak oxygen uptake (Vo2peak), sit-to-stand 60, isometric quadriceps force, and inflammatory biomarkers were assessed at 0 and 12 weeks. The anticipated 60 participants were recruited within 12 months. 46 participants completed the study (aerobic training, n=13; resistance training, n=13; and usual care, n=20), resulting in a 23% attrition rate. Analyses of covariance, adjusted for baseline values, age, and dialysis vintage pretransplantation, revealed significant mean differences between aerobic training and usual care in pulse wave velocity of -2.2±0.4 (95% CI, -3.1 to -1.3) m/s (P<0.001) and between resistance training and usual care of -2.6±0.4 (95% CI, -3.4 to -1.7) m/s (P<0.001) at 12 weeks. Secondary analyses indicated significant improvements in Vo2peak in the aerobic training group and in Vo2peak, sit-to-stand 60, and isometric muscle force in the resistance training group compared with usual care at 12 weeks. There were no reported adverse events, cardiovascular events, or hospitalizations as a result of the intervention. Pilot study, small sample size, no measure of endothelial function. Both aerobic training and resistance training interventions appear to be feasible and clinically beneficial in this patient population. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial.

PubMed

Sun, Zhong-ren; Yue, Jin-huan; Tian, Hong-zhao; Zhang, Qin-hong

2014-12-23

The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ). The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research. ChiCTR-TRC-13003911. 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.

Dynamic training devices in CRM training

NASA Technical Reports Server (NTRS)

Lawver, J.

1984-01-01

Pilot training effectiveness and flying safety of a seasonal tour flight company are described. The change from single pilot to two pilot operated twin otters is examined. The use of the ATC 810 training device, its possibilities and training capacity is outlined. Problem areas which may arise, emergency system and pilot/passenger interaction are analyzed.

Coil geometry effects on scanning single-coil magnetic induction tomography

NASA Astrophysics Data System (ADS)

Feldkamp, Joe R.; Quirk, Stephen

2017-09-01

Alternative coil designs for single coil magnetic induction tomography are considered in this work, with the intention of improving upon the standard design used previously. In particular, we note that the blind spot associated with this coil type, a portion of space along its axis where eddy current generation can be very weak, has an important effect on performance. The seven designs tested here vary considerably in the size of their blind spot. To provide the most discerning test possible, we use laboratory phantoms containing feature dimensions similar to blind spot size. Furthermore, conductivity contrasts are set higher than what would occur naturally in biological systems, which has the effect of weakening eddy current generation at coil locations that straddle the border between high and low conductivity features. Image reconstruction results for the various coils show that coils with smaller blind spots give markedly better performance, though improvements in signal-to-noise ratio could alter that conclusion.

A virtual experimenter to increase standardization for the investigation of placebo effects.

PubMed

Horing, Bjoern; Newsome, Nathan D; Enck, Paul; Babu, Sabarish V; Muth, Eric R

2016-07-18

Placebo effects are mediated by expectancy, which is highly influenced by psychosocial factors of a treatment context. These factors are difficult to standardize. Furthermore, dedicated placebo research often necessitates single-blind deceptive designs where biases are easily introduced. We propose a study protocol employing a virtual experimenter - a computer program designed to deliver treatment and instructions - for the purpose of standardization and reduction of biases when investigating placebo effects. To evaluate the virtual experimenter's efficacy in inducing placebo effects via expectancy manipulation, we suggest a partially blinded, deceptive design with a baseline/retest pain protocol (hand immersions in hot water bath). Between immersions, participants will receive an (actually inert) medication. Instructions pertaining to the medication will be delivered by one of three metaphors: The virtual experimenter, a human experimenter, and an audio/text presentation (predictor "Metaphor"). The second predictor includes falsely informing participants that the medication is an effective pain killer, or correctly informing them that it is, in fact, inert (predictor "Instruction"). Analysis will be performed with hierarchical linear modelling, with a sample size of N = 50. Results from two pilot studies are presented that indicate the viability of the pain protocol (N = 33), and of the virtual experimenter software and placebo manipulation (N = 48). It will be challenging to establish full comparability between all metaphors used for instruction delivery, and to account for participant differences in acceptance of their virtual interaction partner. Once established, the presence of placebo effects would suggest that the virtual experimenter exhibits sufficient cues to be perceived as a social agent. He could consequently provide a convenient platform to investigate effects of experimenter behavior, or other experimenter characteristics, e.g., sex, age, race/ethnicity or professional status. More general applications are possible, for example in psychological research such as bias research, or virtual reality research. Potential applications also exist for standardizing clinical research by documenting and communicating instructions used in clinical trials.

NASA's Single-Pilot Operations Technical Interchange Meeting: Proceedings and Findings

NASA Technical Reports Server (NTRS)

Comerford, Doreen; Brandt, Summer L.; Lachter, Joel B.; Wu, Shu-Chieh; Mogford, Richard H.; Battiste, Vernol; Johnson, Walter W.

2013-01-01

Researchers at the National Aeronautics and Space Administration (NASA) Ames Research Center and Langley Research Center are jointly investigating issues associated with potential concepts, or configurations, in which a single pilot might operate under conditions that are currently reserved for a minimum of two pilots. As part of early efforts, NASA Ames Research Center hosted a technical interchange meeting in order to gain insight from members of the aviation community regarding single-pilot operations (SPO). The meeting was held on April 10-12, 2012 at NASA Ames Research Center. Professionals in the aviation domain were invited because their areas of expertise were deemed to be directly related to an exploration of SPO. NASA, in selecting prospective participants, attempted to represent various relevant sectors within the aviation domain. Approximately 70 people representing government, academia, and industry attended. A primary focus of this gathering was to consider how tasks and responsibilities might be re-allocated to allow for SPO.

Private Pilot Practical Test Standards for Airplane (SEL, MEL, SES, MES)

DOT National Transportation Integrated Search

1995-05-01

The Private Pilot - Airplane Practical Test Standards book has been : published by the Federal Aviation Administration (FAA) to establish the : standards for the private pilot certification practical tests for the airplane : category and the single-e...

EFFECT OF A NOVEL ESSENTIAL OIL MOUTHRINSE WITHOUT ALCOHOL ON GINGIVITIS: A DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL

PubMed Central

Botelho, Marco Antonio; Bezerra, José Gomes; Correa, Luciano Lima; Fonseca, Said Gonçalves da Cruz; Montenegro, Danusa; Gapski, Ricardo; Brito, Gerly Anne Castro; Heukelbach, Jörg

2007-01-01

Several different plant extracts have been evaluated with respect to their antimicrobial effects against oral pathogens and for reduction of gingivitis. Given that a large number of these substances have been associated with significant side effects that contraindicate their long-term use, new compounds need to be tested. The aim of this study was to assess the short-term safety and efficacy of a Lippia sidoides ("alecrim pimenta")-based essential oil mouthrinse on gingival inflammation and bacterial plaque. Fifty-five patients were enrolled into a pilot, double-blinded, randomized, parallel-armed study. Patients were randomly assigned to undergo a 7-day treatment regimen with either the L. sidoides-based mouthrinse or 0.12% chlorhexidine mouthrinse. The results demonstrated decreased plaque index, gingival index and gingival bleeding index scores at 7 days, as compared to baseline. There was no statistically significance difference (p>0.05) between test and control groups for any of the clinical parameters assessed throughout the study. Adverse events were mild and transient. The findings of this study demonstrated that the L. sidoides-based mouthrinse was safe and efficacious in reducing bacterial plaque and gingival inflammation. PMID:19089126

Split face study on the cutaneous tensile effect of 2-dimethylaminoethanol (deanol) gel.

PubMed

Uhoda, Isabelle; Faska, Najat; Robert, Caroline; Cauwenbergh, Geert; Piérard, Gérald E

2002-08-01

Beyond subjective assessments, the effect of skin tensors is difficult to assess. The present 2-phase randomized double-blind split face study was designed to compare the effect of a gel containing 3% 2-dimethylaminoethanol (deanol, DMAE) with the same formulation without DMAE. In a first pilot study, sensorial assessments and measures of the skin distension under suction were performed in eight volunteers. In a second study conducted in 30 volunteers, shear wave propagation was measured. Large interindividual variations precluded any significant finding in the first study. The DMAE formulation showed, however, a significant effect characterized by increased shear wave velocity in the direction where the mechanical anisotropy of skin showed looseness. The DMAE formulation under investigation increased skin firmness.

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Training self-feeding skills in children who are deaf and blind.

PubMed

Luiselli, J K

1993-10-01

There are very few studies that describe programs to train self-feeding skills in young children who are deaf and blind. This research reports two single-case studies on the acquisition of self-feeding in children with developmental disabilities and combined visual and auditory impairments. Study 1 included the use of prompting, prompt-fading, and contingent sensory reinforcement procedures to train independent self-feeding in a 7-year-old girl. Study 2 incorporated social reinforcement and response interruption to refine the self-feeding skills of a 6-year-old boy. Both studies were conducted by direct-care providers within an educational setting and reported maintenance of skill acquisition at 4 and 8 months posttraining.

Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

PubMed

Yang, Chiu-Ling; Chen, Chung-Hey

2018-01-01

Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Perceptual Repetition Blindness Effect

NASA Technical Reports Server (NTRS)

Hochhaus, Larry; Johnston, James C.; Null, Cynthia H. (Technical Monitor)

1994-01-01

Before concluding Repetition Blindness is a perceptual phenomenon, alternative explanations based on memory retrieval problems and report bias must be rejected. Memory problems were minimized by requiring a judgment about only a single briefly displayed field. Bias and sensitivity effects were empirically measured with an ROC-curve analysis method based on confidence ratings. Results from five experiments support the hypothesis that Repetition Blindness can be a perceptual phenomenon.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

PubMed

Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials.gov NCT01782755 . Registered on 29 January 2013.

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

PubMed Central

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

2015-01-01

The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV. PMID:25533447

Analysis of general aviation single-pilot IFR incident data obtained from the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

Bergeron, H. P.

1983-01-01

An analysis of incident data obtained from the NASA Aviation Safety Reporting System (ASRS) has been made to determine the problem areas in general aviation single-pilot IFR (SPIFR) operations. The Aviation Safety Reporting System data base is a compilation of voluntary reports of incidents from any person who has observed or been involved in an occurrence which was believed to have posed a threat to flight safety. This paper examines only those reported incidents specifically related to general aviation single-pilot IFR operations. The frequency of occurrence of factors related to the incidents was the criterion used to define significant problem areas and, hence, to suggest where research is needed. The data was cataloged into one of five major problem areas: (1) controller judgment and response problems, (2) pilot judgment and response problems, (3) air traffic control (ATC) intrafacility and interfacility conflicts, (4) ATC and pilot communication problems, and (5) IFR-VFR conflicts. In addition, several points common to all or most of the problems were observed and reported. These included human error, communications, procedures and rules, and work load.

STEMS pilot trial: a pilot cluster randomised controlled trial to investigate the addition of patient direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain

PubMed Central

Ogollah, Reuben O; Jowett, Sue; Kigozi, Jesse; Tooth, Stephanie; Protheroe, Joanne; Hay, Elaine M; Salisbury, Chris; Foster, Nadine E

2017-01-01

Introduction Around 17% of general practitioner (GP) consultations are for musculoskeletal conditions, which will rise as the population ages. Patient direct access to physiotherapy provides one solution, yet adoption in the National Health Service (NHS) has been slow. Setting A pilot, pragmatic, non-inferiority, cluster randomised controlled trial (RCT) in general practice and physiotherapy services in the UK. Objectives Investigate feasibility of a main RCT. Participants Adult patients registered in participating practices and consulting with a musculoskeletal problem. Interventions 4 general practices (clusters) randomised to provide GP-led care as usual or the addition of a patient direct access to physiotherapy pathway. Outcomes Process outcomes and exploratory analyses of clinical and cost outcomes. Data collection Participant-level data were collected via questionnaires at identification, 2, 6 and 12 months and through medical records. Blinding The study statistician and research nurses were blinded to practice allocation. Results Of 2696 patients invited to complete study questionnaires, 978 participated (intervention group n=425, control arm n=553) and were analysed. Participant recruitment was completed in 6 months. Follow-up rates were 78% (6 months) and 71% (12 months). No evidence of selection bias was observed. The direct access pathway was used by 90% of patients in intervention practices needing physiotherapy. Some increase in referrals to physiotherapy occurred from one practice, although waiting times for physiotherapy did not increase (28 days before, 26 days after introduction of direct access). No safety issues were identified. Clinical and cost outcomes were similar in both groups. Exploratory estimates of between group effect (using 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS)) at 6 months was −0.28 (95% CI −1.35 to 0.79) and at 12 months 0.12 (95% CI −1.27 to 1.51). Conclusions A full RCT is feasible and will provide trial evidence about the clinical and cost-effectiveness of patient direct access to physiotherapy. Trial registration number ISRCTN23378642. PMID:28286331

Implicit Binding of Facial Features During Change Blindness

PubMed Central

Lyyra, Pessi; Mäkelä, Hanna; Hietanen, Jari K.; Astikainen, Piia

2014-01-01

Change blindness refers to the inability to detect visual changes if introduced together with an eye-movement, blink, flash of light, or with distracting stimuli. Evidence of implicit detection of changed visual features during change blindness has been reported in a number of studies using both behavioral and neurophysiological measurements. However, it is not known whether implicit detection occurs only at the level of single features or whether complex organizations of features can be implicitly detected as well. We tested this in adult humans using intact and scrambled versions of schematic faces as stimuli in a change blindness paradigm while recording event-related potentials (ERPs). An enlargement of the face-sensitive N170 ERP component was observed at the right temporal electrode site to changes from scrambled to intact faces, even if the participants were not consciously able to report such changes (change blindness). Similarly, the disintegration of an intact face to scrambled features resulted in attenuated N170 responses during change blindness. Other ERP deflections were modulated by changes, but unlike the N170 component, they were indifferent to the direction of the change. The bidirectional modulation of the N170 component during change blindness suggests that implicit change detection can also occur at the level of complex features in the case of facial stimuli. PMID:24498165

Implicit binding of facial features during change blindness.

PubMed

Lyyra, Pessi; Mäkelä, Hanna; Hietanen, Jari K; Astikainen, Piia

2014-01-01

Change blindness refers to the inability to detect visual changes if introduced together with an eye-movement, blink, flash of light, or with distracting stimuli. Evidence of implicit detection of changed visual features during change blindness has been reported in a number of studies using both behavioral and neurophysiological measurements. However, it is not known whether implicit detection occurs only at the level of single features or whether complex organizations of features can be implicitly detected as well. We tested this in adult humans using intact and scrambled versions of schematic faces as stimuli in a change blindness paradigm while recording event-related potentials (ERPs). An enlargement of the face-sensitive N170 ERP component was observed at the right temporal electrode site to changes from scrambled to intact faces, even if the participants were not consciously able to report such changes (change blindness). Similarly, the disintegration of an intact face to scrambled features resulted in attenuated N170 responses during change blindness. Other ERP deflections were modulated by changes, but unlike the N170 component, they were indifferent to the direction of the change. The bidirectional modulation of the N170 component during change blindness suggests that implicit change detection can also occur at the level of complex features in the case of facial stimuli.

Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms.

PubMed

Albrecht, Helmut; Vernon, Margaret; Solomon, Gail

2012-12-27

Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient's End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. The study was registered with clinicaltrials.gov (NCT01046136).

Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms

PubMed Central

2012-01-01

Background Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. Methods The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient’s End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Results Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Conclusions Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. Trial registration The study was registered with clinicaltrials.gov (NCT01046136). PMID:23270519

Rolling into spatial disorientation: simulator demonstration of the post-roll (Gillingham) illusion.

PubMed

Nooij, Suzanne A E; Groen, Eric L

2011-05-01

Spatial disorientation (SD) is still a contributing factor in many aviation accidents, stressing the need for adequate SD training scenarios. In this article we focused on the post-roll effect (the sensation of rolling back after a roll maneuver, such as an entry of a coordinated turn) and investigated the effect of roll stimuli on the pilot's ability to stabilize their roll attitude. This resulted in a ground-based demonstration scenario for pilots. The experiments took place in the advanced 6-DOF Desdemona motion simulator, with the subject in a supine position. Roll motions were either fully automated with the subjects blindfolded (BLIND), automated with the subject viewing the cockpit interior (COCKPIT), or self-controlled (LEAD). After the roll stimulus subjects had to cancel all perceived simulator motion without any visual feedback. Both the roll velocity and duration were varied. In 68% of all trials subjects corrected for the perceived motion of rolling back by initiating a roll motion in the same direction as the preceeding roll. The effect was dependent on both rate and duration, in a manner consistent with semicircular canal dynamics. The effect was smallest in the BLIND scenario, but differences between simulation scenarios were non-significant. The results show that the effects of the post-roll illusion on aircraft control can be demonstrated adequately in a flight simulator using an attitude control task. The effect is present even after short roll movements, occurring frequently in flight. Therefore this demonstration is relevant for spatial disorientation training programs for pilots.

14 CFR 61.58 - Pilot-in-command proficiency check: Operation of an aircraft that requires more than one pilot...

Code of Federal Regulations, 2013 CFR

2013-01-01

...-powered; (5) For a pilot authorized by the Administrator to operate an experimental turbojet-powered aircraft that possesses, by original design or through modification, more than a single seat, the required proficiency check for all of the experimental turbojet-powered aircraft for which the pilot holds an...

14 CFR 61.58 - Pilot-in-command proficiency check: Operation of an aircraft that requires more than one pilot...

Code of Federal Regulations, 2014 CFR

2014-01-01

...-powered; (5) For a pilot authorized by the Administrator to operate an experimental turbojet-powered aircraft that possesses, by original design or through modification, more than a single seat, the required proficiency check for all of the experimental turbojet-powered aircraft for which the pilot holds an...

Multi-reactor power system configurations for multimegawatt nuclear electric propulsion

NASA Technical Reports Server (NTRS)

George, Jeffrey A.

1991-01-01

A modular, multi-reactor power system and vehicle configuration for piloted nuclear electric propulsion (NEP) missions to Mars is presented. Such a design could provide enhanced system and mission reliability, allowing a comfortable safety margin for early manned flights, and would allow a range of piloted and cargo missions to be performed with a single power system design. Early use of common power modules for cargo missions would also provide progressive flight experience and validation of standardized systems for use in later piloted applications. System and mission analysis are presented to compare single and multi-reactor configurations for piloted Mars missions. A conceptual design for the Hydra modular multi-reactor NEP vehicle is presented.

Efficacy of proactive long-term maintenance therapy of canine atopic dermatitis with 0.0584% hydrocortisone aceponate spray: a double-blind placebo controlled pilot study.

PubMed

Lourenço, Ana M; Schmidt, Vanessa; São Braz, Berta; Nóbrega, Diana; Nunes, Telmo; Duarte-Correia, José H; Matias, Daniela; Maruhashi, Emi; Rème, Christophe A; Nuttall, Tim

2016-04-01

Long-term remission between flares of canine atopic dermatitis (CAD) can be difficult to achieve. Therefore, additional strategic forms of treatment are needed in order to target flare prevention. The concept of proactive therapy is recommended in the European guidelines for the treatment of human atopic eczema. To evaluate the efficacy of a proactive treatment regimen with a 0.0584% hydrocortisone aceponate (HCA) spray for CAD. Client-owned dogs with spontaneous atopic dermatitis (AD) (n = 41). This pilot study was conducted as a randomised, placebo-controlled, double-blinded clinical trial with an end-point of treatment failure. Dogs were treated once daily to remission, then randomly assigned to receive either the HCA spray (n = 21) or a placebo (n = 20) spray on two consecutive days each week. All dogs were on appropriate flea control. No topical or systemic anti-inflammatory or antimicrobial agents were permitted. Intention-to-treat analysis was used. At Day 0, all the dogs were in remission or had mild AD based on their Canine Atopic Dermatitis Extent and Severity Index, version 3 (CADESI-03) scores. The time to relapse was significantly higher in the HCA group (median 115 d; range 31-260 d) compared to the placebo group (median 33 d; range 15-61 d) (P < 0.0001). No adverse events were attributable to the HCA spray. Four dogs were lost to follow-up and four were withdrawn after receiving prohibited medication. These results indicate that proactive long-term therapy of CAD with an HCA spray administered on two consecutive days each week is effective and well-tolerated. © 2016 ESVD and ACVD.

A double-blind, randomized pilot trial of chromium picolinate for binge eating disorder: results of the Binge Eating and Chromium (BEACh) study.

PubMed

Brownley, Kimberly A; Von Holle, Ann; Hamer, Robert M; La Via, Maria; Bulik, Cynthia M

2013-07-01

Chromium treatment has been shown to improve mood, appetite, and glucose regulation in various psychiatric and medical patient populations. The authors propose that chromium may be useful in the treatment of binge eating disorder (BED). Twenty-four overweight adults with BED were enrolled in a 6-month double-blind placebo-controlled trial and randomly assigned to receive either 1000mcg chromium/day ("high dose"; n=8) or 600mcg chromium/day ("moderate dose"; n=9) as chromium picolinate or placebo (n=7). Mixed linear regression models were used to estimate mean change in binge frequency and related psychopathology, weight, symptoms of depression, and fasting glucose. Fasting glucose was significantly reduced in both chromium groups compared to the placebo group; similarly, numerically, but not significantly, greater reductions in binge frequency, weight, and symptoms of depression were observed in those treated with chromium versus placebo, although statistical power was limited in this pilot trial. For fasting glucose, the findings suggest a dose response with larger effects in the high dose compared to moderate dose group. These initial findings support further larger trials to determine chromium's efficacy in maintaining normal glucose regulation, reducing binge eating and related psychopathology, promoting modest weight loss, and reducing symptoms of depression in individuals with BED. Studies designed to link the clinical effects of chromium with changes in underlying insulin, serotonin, and dopamine pathways may be especially informative. If efficacious, chromium supplementation may provide a useful, low-cost alternative to or augmentation strategy for selective serotonin reuptake inhibitors, which have partial efficacy in BED. ClinicalTrials.gov NCT00904306. Copyright © 2013 Elsevier Inc. All rights reserved.

A Double-blind, Randomized Pilot Trial of Chromium Picolinate for Binge Eating Disorder: Results of the Binge Eating and Chromium (BEACh) Study

PubMed Central

Brownley, Kimberly A.; Holle, Ann Von; Hamer, Robert M.; Via, Maria La; Bulik, Cynthia M.

2015-01-01

Objective Chromium treatment has been shown to improve mood, appetite, and glucose regulation in various psychiatric and medical patient populations. The authors propose that chromium may be useful in the treatment of binge eating disorder (BED). Method Twenty-four overweight adults with BED were enrolled in a 6-month double-blind placebo-controlled trial and randomly assigned to receive either 1000mcg chromium/day (“high dose”; n=8) or 600mcg chromium/day (“moderate dose”; n=9) as chromium picolinate or placebo (n=7). Mixed linear regression models were used to estimate mean change in binge frequency and related psychopathology, weight, symptoms of depression, and fasting glucose. Results Fasting glucose was significantly reduced in both chromium groups compared to the placebo group; similarly, numerically, but not significantly, greater reductions in binge frequency, weight, and symptoms of depression were observed in those treated with chromium versus placebo, although statistical power was limited in this pilot trial. For fasting glucose, the findings suggest a dose response with larger effects in the high dose compared to moderate dose group. Conclusion These initial findings support further larger trials to determine chromium’s efficacy in maintaining normal glucose regulation, reducing binge eating and related psychopathology, promoting modest weight loss, and reducing symptoms of depression in individuals with BED. Studies designed to link the clinical effects of chromium with changes in underlying insulin, serotonin, and dopamine pathways may be especially informative. If efficacious, chromium supplementation may provide a useful, low-cost alternative to or augmentation strategy for selective serotonin reuptake inhibitors, which have partial efficacy in BED. ClinicalTrials.gov NCT00904306. PMID:23751236

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.

PubMed

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 < 0.001), whereas a reduction was not observed in the treatment as usual group (p = 0.651). Moreover, there were significant decreases in depression, anxiety, and stress, as well as a greater increase in emotion regulation functioning, mindfulness, and quality of life observed in the intervention group 6 months after the treatment compared with the treatment as usual condition. The results of this pilot trial demonstrate that 16 weeks of ISTDP delivered by 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.

'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.

PubMed

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.

A Methodology for Evaluating the Fidelity of Ground-Based Flight Simulators

NASA Technical Reports Server (NTRS)

Zeyada, Y.; Hess, R. A.

1999-01-01

An analytical and experimental investigation was undertaken to model the manner in which pilots perceive and utilize visual, proprioceptive, and vestibular cues in a ground-based flight simulator. The study was part of a larger research effort which has the creation of a methodology for determining flight simulator fidelity requirements as its ultimate goal. The study utilized a closed-loop feedback structure of the pilot/simulator system which included the pilot, the cockpit inceptor, the dynamics of the simulated vehicle and the motion system. With the exception of time delays which accrued in visual scene production in the simulator, visual scene effects were not included in this study. The NASA Ames Vertical Motion Simulator was used in a simple, single-degree of freedom rotorcraft bob-up/down maneuver. Pilot/vehicle analysis and fuzzy-inference identification were employed to study the changes in fidelity which occurred as the characteristics of the motion system were varied over five configurations i The data from three of the five pilots that participated in the experimental study were analyzed in the fuzzy inference identification. Results indicate that both the analytical pilot/vehicle analysis and the fuzzyinference identification can be used to reflect changes in simulator fidelity for the task examined.

A Methodology for Evaluating the Fidelity of Ground-Based Flight Simulators

NASA Technical Reports Server (NTRS)

Zeyada, Y.; Hess, R. A.

1999-01-01

An analytical and experimental investigation was undertaken to model the manner in which pilots perceive and utilize visual, proprioceptive, and vestibular cues in a ground-based flight simulator. The study was part of a larger research effort which has the creation of a methodology for determining flight simulator fidelity requirements as its ultimate goal. The study utilized a closed-loop feedback structure of the pilot/simulator system which included the pilot, the cockpit inceptor, the dynamics of the simulated vehicle and the motion system. With the exception of time delays which accrued in visual scene production in the simulator, visual scene effects were not included in this study. The NASA Ames Vertical Motion Simulator was used in a simple, single-degree of freedom rotorcraft bob-up/down maneuver. Pilot/vehicle analysis and fuzzy-inference identification were employed to study the changes in fidelity which occurred as the characteristics of the motion system were varied over five configurations. The data from three of the five pilots that participated in the experimental study were analyzed in the fuzzy-inference identification. Results indicate that both the analytical pilot/vehicle analysis and the fuzzy-inference identification can be used to reflect changes in simulator fidelity for the task examined.

Expanding Audio Access to Mathematics Expressions by Students with Visual Impairments via MathML. Research Report. ETS RR-17-13

ERIC Educational Resources Information Center

Frankel, Lois; Brownstein, Beth; Soiffer, Neil

2017-01-01

This report describes the pilot conducted in the final phase of a project, Expanding Audio Access to Mathematics Expressions by Students With Visual Impairments via MathML, to provide easy-to-use tools for authoring and rendering secondary-school algebra-level math expressions in synthesized speech that is useful for students with blindness or low…

Changing trends in the prevalence of blindness and visual impairment in a rural district of India: Systematic observations over a decade

PubMed Central

Khanna, Rohit C; Marmamula, Srinivas; Krishnaiah, Sannapaneni; Giridhar, Pyda; Chakrabarti, Subhabrata; Rao, Gullapalli N

2012-01-01

Context: Globally, limited data are available on changing trends of blindness from a single region. Aims: To report the changing trends in the prevalence of blindness, visual impairment (VI), and visual outcomes of cataract surgery in a rural district of Andhra Pradesh, India, over period of one decade. Settings and Design: Rural setting; cross-sectional study. Materials and Methods: Using a validated Rapid Assessment of Cataract Surgical Services (RACSS) method, population-based, cross-sectional survey was done in a rural district in the state of Andhra Pradesh, India. Two-stage sampling procedure was used to select participants ≥50 years of age. Further, a comparative analysis was done with participants ≥50 years from the previously concluded Andhra Pradesh Eye Disease Study (APEDS) study, who belonged to the same district. Statistical Analysis: Done using 11th version of Stata. Results: Using RACSS, 2160/2300 (93.9%) participants were examined as compared with the APEDS dataset (n=521). Age and sex adjusted prevalence of blindness in RACSS and APEDS was 8% (95% CI, 6.9–9.1%) and 11% (95% CI, 8.3–13.7%), while that of VI was 13.6% (95% CI, 12.2–15.1%) and 40.3% (95% CI, 36.1–44.5%), respectively. Cataract was the major cause of blindness in both the studies. There was a significant reduction in blindness following cataract surgery as observed through RACSS (17.3%; 95% CI, 13.5–21.8%) compared with APEDS (34%; 95% CI, 20.9–49.3%). Conclusion: There was a significant reduction in prevalence of blindness and VI in this rural district of India over a decade. PMID:22944766

Changing trends in the prevalence of blindness and visual impairment in a rural district of India: systematic observations over a decade.

PubMed

Khanna, Rohit C; Marmamula, Srinivas; Krishnaiah, Sannapaneni; Giridhar, Pyda; Chakrabarti, Subhabrata; Rao, Gullapalli N

2012-01-01

Context : Globally, limited data are available on changing trends of blindness from a single region. Aims : To report the changing trends in the prevalence of blindness, visual impairment (VI), and visual outcomes of cataract surgery in a rural district of Andhra Pradesh, India, over period of one decade. Settings and Design : Rural setting; cross-sectional study. Materials and Methods : Using a validated Rapid Assessment of Cataract Surgical Services (RACSS) method, population-based, cross-sectional survey was done in a rural district in the state of Andhra Pradesh, India. Two-stage sampling procedure was used to select participants ≥50 years of age. Further, a comparative analysis was done with participants ≥50 years from the previously concluded Andhra Pradesh Eye Disease Study (APEDS) study, who belonged to the same district. Statistical Analysis : Done using 11 th version of Stata. Results : Using RACSS, 2160/2300 (93.9%) participants were examined as compared with the APEDS dataset (n=521). Age and sex adjusted prevalence of blindness in RACSS and APEDS was 8% (95% CI, 6.9-9.1%) and 11% (95% CI, 8.3-13.7%), while that of VI was 13.6% (95% CI, 12.2-15.1%) and 40.3% (95% CI, 36.1-44.5%), respectively. Cataract was the major cause of blindness in both the studies. There was a significant reduction in blindness following cataract surgery as observed through RACSS (17.3%; 95% CI, 13.5-21.8%) compared with APEDS (34%; 95% CI, 20.9-49.3%). Conclusion : There was a significant reduction in prevalence of blindness and VI in this rural district of India over a decade.

Description of various test scenarios for temporary blinding of pilots by means of bright optical radiation during darkness

NASA Astrophysics Data System (ADS)

Reidenbach, Hans-Dieter

2011-06-01

Up to now the knowledge is limited as far as adverse effects are concerned which are the result of temporary blinding from high brightness optical products, like laser pointers, but it is mandatory to be aware of the degree and influence on various visual functions of persons performing challenging activities, especially under mesopic or even scotopic conditions. Therefore various test scenarios have been designed in the laboratory and bright optical radiation from highbrightness LEDs and laser products applied as light sources in order to simulate the temporary blinding of pilots during a night-flight, especially during landing. As an important realistic test object the primary flight display (PFD) of a commercial aircraft has been integrated in the respective test set-up and various alignments on the PFD could be adjusted in order to measure the time duration which is needed to regain the ability to read the respective data on the PFD after an exposure. The pilot's flight deck lighting situation from a full flight simulator A 320 has been incorporated in the test scenarios. The level of exposure of the subjects has been limited well below the maximum permissible exposure (MPE) and the exposure duration was chosen up to a maximum of 10 s. A total of 28 subjects have been included in various tests. As a critical value especially the visual search time (VST) was determined. A significant increase of VST between 2.5 s and 8 s after foveal irradiation has been determined in a specially designed test with a primary flight display (PFD) whereas an increase of 9.1 s for peripheral and 9.9 s for frontal irradiation resulted in an exercise (flight maneuver) with a Microsoft flight-simulator. Various pupil diameters and aversion responses of the subjects during the irradiation might be responsible for the relatively large spread of data, but on the other hand a simple mean value would not comply with the spectrum of functional relationships and possible individual inherent physiological and voluntary active reactions of the irradiated persons, respectively.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

PubMed

Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and hospital length of stay, and mortality. The morbidity, mortality, and cost of VAP underscore the need for cost-effective prophylactic interventions. The PROSPECT Pilot Trial is the initial step toward rigorously evaluating whether probiotics decrease nosocomial infections, have no effect, or actually cause infections in critically ill patients. ClinicalTrials.gov. NCT01782755.